AIDS Treatment News Issue #377, January 25, 2002
    phone 800-TREAT-1-2, or 215-546-3776

CONTENTS

2002 Overview: The Role of Activism

This special issue looks at 2002 -- and how you can help.

** Heart Disease Prevention
Heart attacks are killing more people with AIDS. There are
many ways to help prevent them.

** Drug Interactions Need More Attention
New interactions of drugs with other drugs (or with
supplements) keep being discovered.

** More Uses for Tenofovir?
It may have fewer problems with side effects and resistance
than most other antiretrovirals.

** New Kinds of Treatment
Here we look at some of the less-known possibilities.

** Legal/Medical Issues
Especially funding (ADAP, Social Security, Medicare,
Medicaid), and discrimination.

** Drug Pricing
Price increases threaten treatment for many U.S. patients.

** Improving Activism
How can activists get more people involved -- and make the
social atmosphere less stressful?

** Improving Fundraising
Should organizations have to put so much money and effort
into donor experiences or entertainment that are unrelated
to their mission?

** Funding Medical Research and Drug Development
The big gap is that no one will do the first human study.

** Diet and Inflammation? (Personal Note)
Our experience and other information suggest that something
in modern "junk food" diets may interfere with the body's
handling of inflammation -- with far-reaching health
consequences.


***** 2002 Overview: The Role of Activism

by John S. James

As we enter 2002 many lives are being lost in the U.S. and
around the world because opportunities to save them are
being neglected or squandered, often due to lack of
followup. The system does not work by itself.  Problems
fester indefinitely unless advocates push for attention and
solutions. New activism is now emerging. But we need to
understand what creates opportunities for activists, and
how the process can work better. This article will outline
some AIDS treatment issues, to show people who want to help
how to find more information, and to help them find people
and organizations they can work with.

To get a better sense of what is happening, we watched the
emails and papers crossing our desk this month. The issues
are endless; this article cannot touch 10% of what is going
on. We had to omit many areas -- including the biggest of
all, Africa and the world, where the epidemic kills 8,000
people every day. The global pandemic and global response
need separate articles, and cannot be summarized
meaningfully. It is hard to report because of uncertainty
on the most central issue: how much are countries and
people, rich and poor alike, finding the will to deal
seriously with the epidemic after two decades of neglect?


***** Heart Disease Prevention

Though it can take years for official statistics to become
available, clearly we are hearing of more heart attacks and
deaths among young people who would not previously have
been considered at high risk. While some antiretroviral
drugs contribute to risk factors, long-term prospective
studies have shown increased risk and death from
cardiovascular disease before the protease inhibitors and
modern combination treatment became available.(1) We
strongly suspect that antiretroviral treatment is
increasing cardiovascular disease in two very different
ways -- by side effects of the drugs themselves, but also
by keeping people alive longer so that have more chance to
develop long-term effects of AIDS.

Much can be done:

* Cardiologists have found conditions that predict much
greater risk of death in persons with HIV.(1) Often these
can be treated.

* Cardiovascular risks are cumulative. Even when some are
unavoidable due to HIV or the treatments currently
available, others can be reduced by following standard
guidelines published for the general population.

  * Risk can be reduced by lifestyle changes such as better
diets, exercise, quitting smoking, and probably by drinking
a glass of red wine a day (for some patients).

* On diet, more evidence is showing that trans fatty acids
(found in partially hydrogenated oils used in commercially
baked goods and fast foods -- but also found in products
from ruminant animals) seem to be associated with seriously
increased risk of heart attacks.(2,3). A recent New York
Times editorial noted that the U.S. FDA "has estimated that
honest disclosure of trans fats on package labels could
prevent 2,100 to 5,000 deaths from heart disease each year"
("Foot-Dragging on Fat," New York Times, January 26, 2002).
Apparently industry pressure has so far stopped the FDA
from requiring this disclosure. The AIDS community can
educate itself and others about this heart risk and how to avoid it.

* Nutritional approaches still considered experimental
include measuring homocysteine in the blood and using
certain supplements to help reduce it if necessary.

* When nutritional and lifestyle changes are not enough,
prescription drugs are already used in HIV treatment to
help control abnormal lipid levels or other metabolic
changes that increase cardiovascular risk. These drugs are
widely used in the general population. They can have side
effects and should be closely monitored, especially for
persons with HIV.

Almost certainly, cardiovascular illness and death of
people with HIV could be significantly reduced if everybody
could see an HIV specialist, and when needed an HIV-
knowledgeable cardiologist, with the different doctors able
to work together, and with enough time to work with their
patients. In practice almost nobody gets ideal medical
care.

What activists can do is to help make sure that both
standard, and credible experimental, medical information on
reducing the risk become more widely available in the AIDS
community. We need to pay more attention to this issue, and
to the many lifestyle and medical options for dealing with
it. We can educate ourselves, distribute information, and
work to assure that HIV patients can see HIV specialists --
and cardiologists when necessary.

References

1. Barbaro G, Fisher SD, Pellicelli AM, and Lipshultz SE.
The expanding role of the cardiologist in the care of HIV
infected patients. HEART. 2001; volume 86, page 365-367.

2. Oomen CM, and others. Association between trans fatty
acid intake and 10-year risk of coronary heart disease is
the Zutphen Elderly Study: a prospective population-based
study. THE LANCET. March 10, 2001; volume 357, issue 9258,
pages 746-751.

3. Aro A. Complexity of issue of dietary trans fatty acids.
THE LANCET. March 10, 2001; volume 357, issue 9258, page
732.


***** Drug Interactions Need More Attention

New interactions involving antiretrovirals and other drugs
often used by persons with HIV -- or interactions with
nutritional supplements, like garlic or St. John's wort --
keep being discovered; clearly many others are unknown.
Usually one drug (or supplement) either raises or lowers
the blood level of another drug -- sometimes by several
fold. Raised levels can result in serious side effects;
lowered levels may cause the drug not to work as intended,
or allow HIV to develop resistance. Sometimes it is
possible to compensate for these interactions by changing
the dose of one or more drugs.

Since the list of known interactions keeps changing
(several were reported at the recent ICAAC conference, for
example), the best way to present the information is
probably Web sites that allow anyone to type in a list of
drugs they are taking or planning to take, and receive a
report of any known interactions. There have been such
sites for several years. As a community, we need to keep
informed about what's best and most current, and encourage
physicians and patients to check for known interactions
when they change medications -- or if they use certain
nutritional supplements.


***** More Uses for Tenofovir?

The recently approved antiretroviral tenofovir may be
particularly important, because it appears to have fewer
side effects than other antiretrovirals, and also less
problem with resistance. It might be ideal for prevention
of maternal transmission of HIV -- and possibly could be
reformulated as an effective microbicide, allowing women to
protect themselves from HIV infection without relying on
men. But because tenofovir was first tested in treatment of
advanced HIV disease, it seems to have been largely kept on
the shelf for other uses, pending more data. Trials in
first-line therapy are ongoing now.

We suspect this drug deserves more attention now, even
before completion of the current trials (they will not
answer all the questions anyway). It could be especially
important as a starting point for developing low-side-
effect treatments for patients who otherwise have poor
options because of severe toxicities with other drugs. In
the real world, we cannot answer every question with formal
trials, so we should collect experience systematically to
get the best information possible. We need to investigate:
if reasonably effective antiretroviral regimens with less
serious side effects are possible using the drugs now
approved; if major resistance to tenofovir does develop,
does the virus pay a price in ways that reduces its ability
to cause disease; and even whether it might make sense to
use this drug alone for certain patients -- not as a good
option, but possibly a better option than any other
available to them.

We should also look into why this treatment was so much
more effective as an antiviral in some animal trials with
viruses related to HIV, than in human studies. Some of the
animal tests found huge viral load reductions when the drug
was used alone, compared to only about a 0.6 log reduction
in patients. Could this difference have been due to the
fact that the animal studies injected the active substance
(PMPA), while humans use an oral prodrug (tenofovir)
designed to be converted to PMPA by the body?
Pharmaceutical companies have usually stayed away from any
HIV drug that would have to be injected frequently. But if
an injected drug had anywhere near the antiretroviral
potency of PMPA in the animal trials, many people would
very much want to use it. (A larger dose of the oral
tenofovir is apparently not more effective, so the
difference would not be just from the dose.)


***** New Kinds of Treatment

Everyone knows that patients urgently need new kinds of
treatments (as well as better drugs in existing classes,
mainly antiretrovirals). But it has always been hard to get
new ideas developed. Almost by definition a new idea has
not made money before, so the money people are not
interested. Developing new drugs and new classes of drugs
is expensive, due to the need to protect public health --
and because the system also reflects the need of large
companies to monopolize the market and keep out small
competitors.

Some of the lesser-known possibilities we intend to look at
in 2002 include:

** Topoisomerase inhibitors. In 1994 AIDS TREATMENT NEWS
reported on a class of drugs being developed for cancer,
but not for HIV, though some experts believed they should
be tested as antiretrovirals (see Topotecan, CPT-11
(Irinotecan), Camptothecin, and Other Topoisomerase I
Inhibitors, AIDS TREATMENT NEWS #197, April 15, 1994).
Recently treatment activist Eric Goldman followed up and
found that patent and policy snafus have apparently
prevented these drugs from being tested and developed for
HIV.

  There seems to be a pervasive gap in drug development,
where no one gets the first human data from a handful of
patients (or even from one person). Government saves money
by giving exclusive licenses to promising compounds tested
in the laboratory -- but usually industry will not invest
in human testing unless human proof of principle already
exists. This appears to be a general problem that may have
prevented many valuable treatments for AIDS and other
conditions from ever coming into use.

  In the specific case of topoisomerase inhibitors, some of
these drugs have already been approved for cancer.
Therefore it should be possible to watch viral load in
persons treated for cancer who also have HIV. If there is
substantial antiretroviral activity, it should be possible
to restart the research that has been neglected for years.

Eric Goldman is preparing a comprehensive article on his
investigation into why topoisomerase inhibitors were not
researched for HIV; at this time (January 2002) only two
short articles are available. The following are similar but
not identical:
http://www.thebody.com/sfac/topotecan.html
http://www.searchforacure.org/hope/article.asp?sty=16

** Murabutide. This immune-based treatment, being developed
in France, may strengthen the innate immune response --
which may also create conditions helpful for HIV-specific
immunity.

** Prostratin. This drug, from a tree in Samoa, may drive
latent HIV out of hiding so that it can be targeted by
other drugs or by the immune system.

** Low-dose naltrexone. This potential treatment has been
available for many years (AIDS TREATMENT NEWS reported on
it almost 15 years ago) but has not attracted much
attention. We are looking at it now because of favorable
anecdotal reports -- and also because there is little
downside to using it. For the case in favor, see:
http://www.lowdosenaltrexone.org


***** Legal/Medical Issues

We asked Ronda Goldfein and Yolanda Lollis of the AIDS Law
Project of Pennsylvania where activism could be most useful
for their clients, both at the Federal and at state and
local levels. They suggested the following. We added some
comments in parentheses:

* Social Security disability determination for HIV. Today
the side effects of antiretrovirals and other medications
are not recognized as disabling conditions, however
disabling they may actually be. Also, diabetes and
hypertension need to be in the HIV listing as conditions
that can cause disability.

* ADAP (AIDS Drug Assistance Program) formularies. Some do
not include diabetes and hypertension medications.

* Prescription coverage for Medicare. This is a major
national issue where the AIDS community needs to be heard.
A great many clients of the AIDS Law Project are seriously
affected (the drugs they need can cost $10,000 per year or
more). They say, "I worked my whole life, and now I'm on
disability and cannot get my drugs covered?"

* Syringe exchange. [We will look at this in a separate
article.]

* Medicaid reimbursement. Payments to doctors are often
completely inadequate, making it hard to find physicians
who will take Medicaid patients, because they lose money
treating them.

* Names reporting. Many people are uneasy about appearing
on a government list of people with HIV, and as a result
they avoid getting tested if their names must be reported.
Unique-identifier systems avoid this problem, but are
slightly more expensive to implement.

* Dental discrimination. In many places it is very hard to
find a dentist who will treat anyone with HIV.

* Nursing homes. Many do not want to take people with HIV.
When a nursing home is needed it is for a medical
emergency, so patients, their families, and supporters are
not in a good position to fight. And as people with AIDS
live longer, they will need nursing home care for the usual
problems of aging. (Providing good HIV-related care will be
a medical challenge as well as a discrimination issue. But
limiting people to HIV-specialty nursing homes would
require most to be far from their friends and families.
Perhaps communication technology such as computer
conferencing, along with traveling HIV-specialist
physicians, could enable more nursing homes to deliver
routine HIV care at least.)

* Other HIV discrimination. Cases handled by the AIDS Law
Project are "as varied as life itself."

  Note: If you need assistance with an AIDS-related legal
issue you may be able to get help from an AIDS legal
services organization near you. To find out if there is one
in your area, check The Directory of Legal Resources for
People with AIDS and HIV, by the American Bar Association
AIDS Coordination Project, phone 202-662-1025, or go to:
http://www.abanet.org/irr/aidsproject/publications/aids-dir.html


***** Drug Pricing

Recently some pharmaceutical companies have imposed
substantial, unexpected price increases for HIV drugs.
These increases mean that more people will not get
necessary treatment, since ADAP and other public program
budgets have already been set, and these programs are
already denying drugs through waiting lists because of lack
of money.

Apparently the reason for the price increases is to keep
corporate profits up despite the weaker economy and other
pressures on pharmaceutical company revenue, especially the
resistance to high prices by HMOs and other third-party
payers. These increases come at a time of great financial
pressures on ADAP, Medicaid, and other government programs,
due especially to the financial problems of state
governments -- as well as continuing increases in the cost
of private health insurance. And these price increases come
after the budgets of ADAP and other programs have already
been set. With drugs costing more when less money is
available, thousands of people will not get the care they
need. (Patient Assistance Programs, run by pharmaceutical
companies, provide free drug to some patients with no other
way to pay. But these programs are designed to work poorly,
as the paperwork stops many if not most who could qualify
from applying. Basically those with enough social support
to cause a public issue if they die for lack of the drugs
can probably get them. Most others probably cannot.)

In U.S. medicine the financing system does not work, and
big institutions are best able to take care of themselves -
- dumping the costs of a failed system onto persons with
major illnesses, who are least able to pay. We need to work
for comprehensive reform -- and meanwhile be sure that
communities are organized so that patients' interests will
at least be represented, along with those of big pharma,
big insurance, and big government.

We will keep our readers informed as we learn more about
new price increases and their consequences.


***** Improving Activism

AIDS activists continue to be highly effective. But there
are not enough people to do the work that needs to be done.
Perhaps the most important challenge to AIDS treatment
activists today is making it easier for new people to
become involved.

Historically, most ACT UP chapters and other treatment
activist organizations had no training program to help with
the steep learning curve (on treatment information, on
learning how to deal with pharmaceutical, government, and
other officials, on working with press and the media, and
on working with allies and within the organization itself).
This is changing; for example, the new national
organization ATAC (AIDS Treatment Activist Coalition) is
intensely interested in training and mentoring new
activists. For more information, see:
http://www.atac-usa.org

Often treatment activists are so involved in the issues
that there is little thought to maintenance of the
organization -- for example, little outreach to explain to
the community what they are doing and why, and to let
people know what assistance they need. Several years ago
ACT UP Golden Gate (now Survive AIDS) solved several of
these problems by getting a weekly column on AIDS treatment
in the BAY AREA REPORTER, a San Francisco gay newspaper.
The columns were written by a "writers pool" of five or six
members, and most had an action-alert box in addition. It
took considerable work from a coordinator to make sure that
a volunteer finished an article every week.

ACT UP Philadelphia successfully reaches across race and
class barriers, and as a result is probably the largest ACT
UP chapter in the world. It can get hundreds of people to
demonstrations even outside the city, in Washington or New
York. Project TEACH, an excellent education program of
Philadelphia FIGHT, has trained hundreds of peer educators
in treatment and activism.

A widespread problem retaining people is that AIDS
activists have traditionally been too harsh with each
other, apparently more so than in most social movements.
Most of the disputes have been due to personality
differences, accidents, misunderstandings, or escalating
"flame wars" where each tries to outdo the other with
insults -- rather than substantive disagreements. People
needed to give each other more slack, and that is happening
now. Everyone knows there is more than enough work to go
around, and that nobody can be sure they are right.

If we may mention our own work in conflict prevention, we
have developed a kind of education designed to take place
in the interaction rituals of everyday life -- not in
special classes or settings. The idea is to design
"practices" (self-training exercises completely integrated
with whatever we are doing anyway) for using routine
errands and other throwaway moments to build skills for
better communication, personal interaction, and
relationship development. For more information, see:
http://www.communicationpractices.org


***** Improving Fundraising

The fundraising process needs more attention now, due to a
weaker economy, less government revenue, and a global war
that may last for decades. The AIDS community will need to
be more efficient in delivering services and advocacy, and
in finding money for them.

In the U.S., individual donors give far more money to
philanthropy than foundations and corporations put
together. Most of the individual donations are to religious
organizations. Church members usually have personal
experience with the church they are giving to. But in AIDS,
donations often go by default to a few big organizations
with high-profile names, from donors who know little about
their services. And much effort and expense goes into
events like walks, rides, and other emotional experiences
for donors -- an activity requiring very different skills
from effective service delivery. Only large organizations
can afford professional development departments -- and only
a few can be largely successful year after year at two
entirely different missions simultaneously (with the
fundraising mission directly determining organizational
survival, while the official mission does not). It is said
that one can't dance at two weddings with one tush. But
that is what we expect almost every service organization to
do.

No wonder so many groups need technical help with
fundraising.

Besides more technical help, we would like to see more
focus on educating and involving donors in what is actually
going on (in addition to seeking money through name
recognition, or by producing donor events and experiences
having little to do with the service or advocacy mission).
We reluctantly believe that all these approaches are
inevitable. Modern society has thousands of different
worlds, and most people live in only a few of them. Those
who do not need services are unlikely to understand them.
Those who do are unlikely to have much money to donate.
This disconnect makes it hard to raise money, and to
deliver services well. But until there is a deeper
commitment to making the world work, it may be the best we
can do.


***** Funding Medical Research and Drug Development

For improving medical research, the place to start is to
ask researchers what problems they face when they are
trying to get important work done. Remember that often they
cannot be activists or try to improve the system, because
they must protect relationships with those who control
their resources. Someone else must do the reform.

One of the greatest problems holding up medical research
and development is the difficulty of getting the first
human experience with promising new ideas. What usually
happens is that academic researchers develop potential
treatment approaches, often with Federal funding. They
publish one or more papers in scientific journals. Then
progress stops, because no one does the first test in a
human being. Government usually avoids practical drug
development, leaving that to industry -- but industry
seldom picks up development unless it already has human
proof of principle. Potentially lifesaving treatments can
sit on the shelf indefinitely, and no one pays attention.

Possibly medical research needs a role like that of a
producer -- one who handles the business of getting a
project done, but in this case for cures for diseases,
instead of for movies or plays. AIDS activists have
sometimes stepped into that role when necessary. A notable
example was the late Bill Thorne of ACT UP Golden Gate, who
was largely responsible for the completion of a pivotal
clinical trial that had stalled, and for FDA approval of
human growth hormone for AIDS-related wasting. Everybody
involved knew that he was the key person in making it
happen. (His work was entirely volunteer; others made the
money from the grossly overpriced drug.)

In vaccines, IAVI (the International AIDS Vaccine
Initiative) has taken on the role of making projects
happen. In cancer, the U.S. National Cancer Institute has
long studied early clinical use of new agents. But much of
medical research today is like an entertainment industry
without producers, where the artists themselves must do all
that work, or no one will.


***** Diet and Inflammation? (Personal Note)

by John S. James

In November 2000, AIDS TREATMENT NEWS published an
interview with Lynde Francis, who runs The Centre, an AIDS
treatment organization in Harare, Zimbabwe. Because her
clients had no access to antiretrovirals, she had to do
what could be done with nutrition and lifestyle changes.
Part of the recommendation was to eat a traditional diet,
avoiding modern "junk foods."

I couldn't see how this could make a difference in HIV
disease. But later I tried such a diet for a different
problem, a severe wrist pain -- after a "junk food" dinner
repeatedly seemed to make the problem worse the next day.
For me the diet appeared close to 100% effective. My wrist
had become steadily worse for several months; it was better
after a few days on the diet. The problem was essentially
gone in a few weeks, and has not returned in over a year
since.

I coined the name "The Century Diet" as a personal
reminder. The only rule is, "Don't eat anything that wasn't
available 100 years ago."

My experience and other information suggests that something
in the modern diet (possibly trans fatty acids?) can
interfere with the body's ability to handle inflammation
properly. If so, this process could be contributing to
widespread health problems, including repetitive stress
injury, cardiovascular disease, and perhaps some
complications of HIV. (On repetitive stress injury, note
that computers are widely blamed, even though for decades
manual typists were at the keyboard as much, and had to
press the keys harder. Apparently some other change of
modern life allowed the stress to cause more injury.)
Research could find the culprit(s) fairly easily, by
clinical testing with a few volunteers who are close to
the borderline between having symptoms or not. Diets and
meals could be "fractionated" -- successively divided and
tested to see which ingredient causes the symptom --
somewhat like medicinal plant products are fractionated
chemically to find an active ingredient.

Since this issue is mostly outside the focus of AIDS
TREATMENT NEWS, we set up an email list where anyone
interested can continue the discussion. For more
information, see: http://groups.yahoo.com/group/centurydiet


***** AIDS TREATMENT NEWS

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Editor and Publisher: John S. James
Associate Editor: Tadd T. Tobias, R.N.

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therapies, but seeks to increase the options available.

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AIDS Treatment News Issue #378, March 8, 2002
  phone 800-TREAT-1-2, or 215-546-3776

CONTENTS

** Retroviruses Conference Reassuring on New Treatments,
Viral Targets, Research
Researchers are reporting more potentially important
information today than at conferences in the last few years.
But some of the new reports are confusing or contradictory.

** Lipoatrophy and Antiretroviral Drug Changes
Certain treatment changes may prevent lipoatrophy (abnormal
fat loss) from getting worse in many patients -- and lead to
a slow return of some of the lost fat.

** Retroviruses Conference: Web Coverage
Here are some Web sites with talks, abstracts, posters, and
summaries from the recent Retroviruses conference.

** d4T and Lactic Acidosis with Neuromuscular Weakness: FDA
Warning
Patients with certain symptoms associated with high lactate
should get medical attention immediately, and may need to
suspend antiretroviral treatment.

** FDA Approves New Dosing for Amprenavir and Ritonavir
Combination
The FDA approved dosing for the amprenavir (Agenerase(R)) or
ritonavir (Norvir(R)) combination, allowing either once-daily
or twice-daily dosing.

** FDA Approves Once-Daily Efavirenz Formulation, Revised
Labeling
The FDA approved a new 600-mg efavirenz (Sustiva(R)) tablet,
to be taken once daily. The smaller sizes remain available.

** AIDS Treatment and Related Conferences, March through
December 2002
Here is our list of upcoming conferences that may be of
interest to our readers.


***** Retroviruses Conference Reassuring on New Treatments,
Viral Targets, Research

The recent Retroviruses conference in Seattle reported more
progress in AIDS research than perhaps any conference in the
last few years. But the potential new drugs and research
findings are still in early stages, and include some
contradictory or confusing results. Experimental treatments
may look good in early human tests but may or may not prove
safe and effective for long-term use.

Here is an overview on lipoatrophy -- fat wasting -- a
problem our readers have asked about. In future issues we
expect to cover new drugs, treatment interruption, other
lipodystrophy and drug side effects, and many other topics.

Note: the '-M', '-T', or '-W' in the abstract numbers in this
conference just means that the presentation was a poster on
Monday, Tuesday, or Wednesday. 'LB' in the abstract name
means Late Breaker -- new research results that could not be
submitted by the regular deadline but were considered
important enough to be accepted anyway.

Other Retroviruses Conference Information

A one-hour telephone recording of an expert summary,
organized by HIVandHepatitis.com, is available toll-free at
800-428-6051; when asked for an ID number, enter 227184 for
this recording. You will be asked for your name, affiliation,
and telephone number. This is a formality; you can say
anything, even that you don't want to give the information,
and the process will still go forward.

In some cities local AIDS service organizations are
presenting programs with expert speakers who review
conference highlights. In New York, for example, the National
AIDS  Treatment Advocacy Project will have a one-day update
Saturday April 6, on the Retroviruses conference and on
HIV/Hepatitis C co-infection. Advance registration is
required due to building security; to register, call NATAP
during business hours at either 888-26-NATAP, or 212-219-
0106. For other programs, check with service organizations in
your area.

For in-depth information, see "Retroviruses Conference Web
Coverage" in this issue.


***** Lipoatrophy and Antiretroviral Drug Changes

by John S. James

Lipoatrophy is abnormal fat loss, often seen especially in
the face, arms, and legs. Sometimes fat inside the abdomen (a
different kind of fat) will increase at the same time the fat
underneath the skin is disappearing. It is believed that
lipoatrophy is caused primarily by antiretrovirals --
although there are different views on whether some protease
inhibitors, some nucleoside analogs, or the combination of
both is most responsible. Doctors have noted that usually the
lost fat is not quickly regained even if the antiretrovirals
are stopped. Many patients are distressed especially by the
loss of facial fat.

The Retroviruses conference included some reports on partial
success in managing lipoatrophy with certain drug changes.
(See note below on additional information available online.)

* [Abstract 32] Patients with moderate or severe lipoatrophy
who were taking either d4T (Zerit(R)) or AZT (Retrovir(R))
were randomly assigned to either continue their treatment, or
substitute abacavir (Ziagen(R)) for the d4T or AZT. This
research team, including leading lipodystrophy researchers
Carr and Cooper in Sydney, Australia, randomized 111 adult
patients. Careful high-tech measurements of limb fat (using
either DEXA or CT) found an improvement in lipoatrophy in the
group that switched to abacavir, but not the group that
continued on their d4T or AZT, in the six months of this
trial. The lost fat returned slowly, however -- patients did
not change their average rating of their own lipoatrophy in
the six months of this trial. And researchers estimated that
at the rate of change which was measured, it would take
several years for the lipoatrophy to disappear.(1)

The patients in this study started with a high CD4 count
(average 577), and a viral load that was stable at under 400
copies with the regimen they were on. Eighty four percent of
them had been taking d4T, 16% had been taking AZT.

The switch to abacavir also resulted in a decline in lactate
(a good sign), and a modest decline in viral load of 0.25
logs.

Other Lipoatrophy Studies at the Retroviruses Conference

Two Glaxo-supported studies also reported some measurable
improvement in lipoatrophy -- with switches that were
entirely to Glaxo drugs:

* [Abstract 701-T] A team at several U.S. universities found
improvements in lipoatrophy when d4T was replaced by either
AZT or abacavir. Of 118 volunteers enrolled, 86 switched to
abacavir, the others to AZT (as Combivir). Lipoatrophy
improvement was found at 24 weeks. The study will run for a
total of 48 weeks.(2)

Note that this study and the one above are similar in one
respect, that both switched most of the volunteers from d4T
to abacavir (except of course for the control group in the
Australian study, which did not switch at all).

* [Abstract 700-T] A team in Perth, Australia reported
considerable success with lipoatrophy at 48 weeks, in a
controlled trial in which volunteers were randomly assigned
to either switch from d4T and/or a protease inhibitor to AZT
+ 3TC + abacavir, or not to switch their therapy. Those who
switched did better than those who did not.(3)

* [Abstract 684a-T] Another study found a seemingly very
different result. A group of 337 patients who did NOT have
any signs of lipoatrophy were studied 21 months later; 13.1%
of them (44/337) had developed moderate or severe
lipoatrophy. The risk factors were white race, and severity
of disease. When the statistics were adjusted for HIV disease
severity, "there appeared to be little, if any, effect of any
antiretroviral agent or class of agents on the development of
lipoatrophy."(4)

We do not know why this study did not find an association
between development of lipoatrophy and particular
antiretrovirals, while the three studies above had found that
switching antiretrovirals could to some degree reverse
lipoatrophy which had developed on the original treatment
regimen (which would imply that some regimens are more
responsible than others for the development of this
condition).

* [Abstract LB13] Rosiglitazone, a diabetes drug which
increases subcutaneous fat in patients with type 2 diabetes,
did not significantly increase subcutaneous fat in a 24-week
trial with 15 HIV patients with lipoatrophy who were on the
drug, compared to 15 controls.(5)

* [Abstract 704-T] A cosmetic treatment for facial
lipoatrophy -- injections with polylactic acid (NewFill) --
was reported for 16 patients, 14 men and 2 women, by
physicians in Paris. The doctors reported that the treatment
was "safe, convenient, and effective" in those patients.(6)

Comment: Caution on Switching Drugs

There are many factors to consider in switching
antiretroviral regimens. This decision should be made with
the help of an experienced HIV physician -- who might want to
change other drugs in the regimen to improve antiviral
activity or mitigate other side effects, or to make the
regimen easier to use. Abacavir may not be the best drug for
the particular patient (it just happened to be studied more
and reported at this conference). And if abacavir is used,
the patient and physician must be alert to the
hypersensitivity reaction which occurs in about 5% of
patients; if this happens, the abacavir must be stopped and
NEVER started again.

But lipoatrophy is not just a cosmetic problem; it is a sign
that the drug regimen may be causing serious side effects. If
the regimen is not changed, the problem is likely to get
worse. One possible strategy is to act once it is clear that
lipoatrophy is starting, and look for an antiretroviral
regimen that has been shown to stop or slowly reverse this
condition after it has started, in many patients.

For background and cautions on changing therapy, see the
following articles on the lipoatrophy information presented
at this Retroviruses conference:

"Switching Antiretroviral Therapy for Lipoatrophy," by David
Alain Wohl, M.D., at:
http://www.natap.org
(look for the 9th Conference on Retroviruses and
Opportunistic Infections report).

Also see "Switching Therapy to Manage Lipoatrophy: More
Evidence of Limited Benefits," by Graeme Moyle, M.D.,
M.B.B.S., at:
http://www.medscape.com/viewarticle/429162
(If this is your first time using the Medscape site, you will
need to sign up for a free registration in order to read this
article.)

References

1. Carr A, Smith D, Workman C, Hoy J, Doong N, Amin J, Law M,
Cooper DA, and the MITOX Study Group. Switching stavudine or
zidovudine to abacavir for HIV lipoatrophy: A randomized,
controlled, open-label, multicentre, 24-week study. 9th
Conference on Retroviruses and Opportunistic Infections,
Seattle, February 22-28, 2002 [abstract #32].

2. McComsey G, Lonergan T, Fisher R and others. Improvements
in lipoatrophy (LA) are observed after 24 weeks when
stavudine (d4T) is replaced by either abacavir (ABC) or
zidovudine (ZDV). 9th Conference on Retroviruses and
Opportunistic Infections, Seattle, February 22-28, 2002
[abstract #701-T].

3. John M, James I, McKinnon E, and others. A randomized,
controlled open-label study of revision of antiretroviral
regimens containing stavudine (d4T) and/or a protease
inhibitor (PI) to zidovudine (ZVD)/lamivudine(3TC)/Abacavir
(ABC) to prevent or reverse lipoatrophy: 48-week data. 9th
Conference on Retroviruses and Opportunistic Infections,
Seattle, February 22-28, 2002 [abstract #700-T].

4. Lichtenstein K, Delaney K, Ward D, Moorman A, Wood K, and
Holmberg S. Incidence and risk factors for lipoatrophy
(abnormal fat loss) in ambulatory HIV-1-infected patients.
9th Conference on Retroviruses and Opportunistic Infections,
Seattle, February 22-28, 2002 [abstract #684a-T].

5. Sutinen J, Hakkinen AM, Westerbacka J and others.
Rosiglitazone in the treatment of HAART-associated
lipodystrophy (HAL): A randomized, double-blind, placebo-
controlled trial. 9th Conference on Retroviruses and
Opportunistic Infections, Seattle, February 22-28, 2002
[abstract #LB13].

6. Lafaurie M, Dolivo J, Boulu D, Madelaine I, and Molina JM.
Treatment of HIV-associated lipoatrophy of the face with
intradermal injections of polylactic acid. 9th Conference on
Retroviruses and Opportunistic Infections, Seattle, February
22-28, 2002 [abstract #704-T].


***** Retroviruses Conference: Web Coverage

The following sites have important information from the 9th
Conference on Retroviruses and Opportunistic Infections,
Seattle, February 24-28, 2002. And you may want to check
back, as most of them will post additional reports in the
future.

Note: if one of the links given below does not work, it may
be because the site has been reorganized since this article
was published. In that case you may still be able to find the
information by starting at the home page of the site and
looking from there. For example, in case
http://www.thebody.com/confs/retro2002/retro2002.html
does not work, try starting at
http://www.thebody.com, look for a section on reports from
conferences, then look for the 9th Retroviruses conference.
Usually these reports remain online for about a year.

http://www.retroconference.org
The official conference Web site.)

The most useful information on this site is:

(1) Audio, video, and slides from the major plenary and
symposium overview talks and panels (but not from the many
technical sessions where new data were presented). There were
still some computer glitches as we went to press.

(2) Searchable abstracts of both oral and poster talks. You
can search for all abstracts that contain any given word --
including an author's last name, a drug name or medical term,
or the abstract number if you know it. To search the
abstracts, first make sure you are at the 9th Conference on
Retroviruses and Opportunistic Infections (the site will
change for next year's meeting), and select "Search Program
and Abstracts."

(3) Many of the presentations will also have posters online.
The posters have much more information than the abstracts,
but there is no software available to do a computer search on
them. These posters are usually formatted for display in a
poster hall, but it is possible to read them online.

http://www.thebody.com/confs/retro2002/retro2002.html
The Body has many expert summaries of different research
areas presented at the Retroviruses conference.

http://www.hivandhepatitis.com
This site has many conference articles, along with other news
reports.

http://www.medscape.com/conference/retrovirus2002
Medscape has dozens of expert reviews. (The first time you
use the Medscape site you need to register, but registration
is free.)

http://www.natap.org/2002/9retro/ndx9retro.htm
Reports from the National AIDS Treatment Advocacy Project.

http://hivinsite.ucsf.edu/
A major HIV site run by the University of California San
Francisco Medical Center. The Retroviruses coverage is
currently at:
http://hivinsite.ucsf.edu/InSite.jsp?page=cf9croi-00-00

http://www.medadvocates.org/news/main10818.html#Conf
Medical Advocates, a nonprofit organization, has grouped some
of the abstracts and posters by drug or other topic.


***** d4T and Lactic Acidosis with Neuromuscular Weakness:
FDA Warning

The U.S. Food and Drug Administration emailed the following
warning on March 1, 2002. The FDA also reported this
information at the 9th Conference on Retroviruses and
Opportunistic Infections on February 28 [abstract LB14].

[Comment: Patients should remember that this warning
describes a rare condition associated with drugs that have
been used by thousands of people for many years. It may have
little impact on treatment decisions. But patients and
doctors need to be aware of the possibility, so that patients
can get medical attention early if the problem is suspected,
and suspend or change their treatment if necessary. JSJ]

"Changes have been made in the WARNINGS, PRECAUTIONS, ADVERSE
REACTIONS, and PATIENT INFORMATION sections of the ZERIT
(stavudine, d4T) label to describe the occurrence of lactic
acidosis and neuromuscular toxicity in patients using
stavudine.

A total of 25 patients with neuromuscular weakness resembling
Guillain-Barré syndrome in association with lactic acidosis
were reported to the FDA's Adverse Event Reporting System. In
most cases, antiretroviral therapy was continued in the
presence of symptoms that might have been due to lactic
acidosis, such as abdominal pain, nausea, and fatigue,
leading to death in six of the patients. Most of these
patients (22 out of 25) were receiving antiretroviral
combinations containing stavudine. Although causality has not
been established, these findings were consistent with recent
reports in peer-reviewed journals that the use of stavudine
in antiretroviral combination therapy may increase the risk
of lactic acidosis. Therefore, the stavudine label now
includes a warning that its use may increase the risk of
lactic acidosis, which represents a rare, but serious adverse
event. The label now includes the symptoms of the newly
described symptomatic hyperlactemia syndrome, and the
recommendation for prompt suspension of all antiretroviral
therapy in suspected cases of lactic acidosis with or without
neuromuscular weakness. Permanent discontinuation of
stavudine should be considered in confirmed cases of lactic
acidosis.

Please refer to the Zerit label for full prescribing
information. A copy of the revised labeling is available at:
http://www.fda.gov/cder/foi/label/2002/20412S017.pdf

Bristol-Myers Squibb Company, which makes and markets Zerit,
is distributing a letter to health care providers giving more
detailed information. The letter reads:

February 2002
Dear Healthcare Provider,

Bristol-Myers Squibb Company would like to remind healthcare
providers caring for persons with HIV of the potential for
lactic acidosis as a complication of therapy with nucleoside
analogues, including ZERIT (stavudine), d4T. The early signs
and symptoms of clinical events associated with
hyperlactatemia should receive careful attention because of
the life-threatening potential of the most extreme
manifestation, lactic acidosis syndrome (LAS).

Bristol-Myers Squibb has received reports of rare occurrences
of rapidly ascending neuromuscular weakness, mimicking the
clinical presentation of Guillain-Barré syndrome (including
respiratory failure), in HIV-infected patients receiving
stavudine in combination with other antiretrovirals. Some
cases were fatal. Most of the cases were reported in the
setting of lactic acidosis or symptomatic hyperlactatemia
and, in most, antiretroviral therapy had been continued in
the presence of non-specific signs compatible with early
symptomatic hyperlactatemia that preceded the development of
neuromuscular signs and symptoms. If motor weakness develops
in a patient receiving stavudine, the drug should be
discontinued.

Confirmed elevations of serum lactate may be associated with
a broad spectrum of clinical manifestations, ranging from
asymptomatic hyperlactatemia, through symptomatic non-
acidotic hyperlactatemia (SHL), to acute severe LAS. Early
signs and symptoms associated with a high lactate may be
subtle and include generalized fatigue, digestive symptoms
(nausea, vomiting, abdominal pain, and sudden unexplained
weight loss), respiratory symptoms (tachypnea and dyspnea),
or neurologic symptoms (including motor weakness). Patients
with these symptoms should promptly interrupt antiretroviral
therapy, and a full medical work-up should be performed
rapidly.(i) Permanent discontinuation of stavudine should be
considered for patients with confirmed LAS. It is important
to note that symptoms associated with hyperlactatemia may
continue or worsen following discontinuation of
antiretroviral therapy.

At this time, prospective monitoring of lactate levels does
not appear to be helpful in predicting the subsequent
occurrence of SHL or LAS.(i)

Although relative rates of lactic acidosis have not been
assessed in prospective well-controlled trials, longitudinal
cohort and retrospective studies suggest that this infrequent
event may be more often associated with antiretroviral
combinations containing stavudine.(ii, iii, iv)

See the enclosed full prescribing information for ZERIT((r))
for additional information regarding the recommended use of
stavudine. If you have any further questions, please contact
the Medical Information Department at Bristol-Myers Squibb
Company at 1-800-426-7644.

Sincerely, Michael R. Stevens, PharmD, Vice President,
Medical Affairs, Virology

i. Brinkman K. Management of hyperlactatemia: no need for
routine lactate measurements. AIDS 2001; 15: 795-797.

ii. John M, Moore CB, James IR, et al. Chronic
hyperlactatemia in HIV-infected patients taking
antiretroviral therapy. AIDS 2001; 15: 717-723.

iii. Lonergan JT, Havlir D, Barber E, Mathews WC. Incidence
and Outcome of Hyperlactatemia Associated with Clinical
Manifestations in HIV-Infected Adults Receiving NRTI-
Containing Regimens. 8th Conference on Retroviruses and
Opportunistic Infections. Chicago, February 2001 [abstract
624].

iv. Gerard Y, Maulin L, et al. Symptomatic hyperlactatemia:
an emerging complication of antiretroviral therapy. AIDS
2000; 14: 2723-2730.


***** FDA Approves New Dosing for Amprenavir and Ritonavir
Combination

The FDA sent the following email on February 6, 2002:

On February 5, 2002, FDA approved a new dosing regimen for
Agenerase (amprenavir) and Norvir (ritonavir) used in
combination. The Dosage and Administration section of the
amprenavir package insert was revised to include the
following statement:

Concomitant Therapy: If Agenerase and ritonavir are used in
combination, the recommended dosage regimens are: Agenerase
1200 mg with ritonavir 200 mg once daily or Agenerase 600 mg
with ritonavir 100 mg twice daily.

The following revisions were also made to the Agenerase
package insert regarding the use of the Agenerase plus
ritonavir.

* The Clinical Pharmacology section was revised to add
information about the pharmacokinetics of amprenavir when it
is co-administered with ritonavir.

* Table 8 (Established and Other Potentially Significant Drug
Interactions) was revised to state that when amprenavir and
ritonavir are co-administered, the dose of amprenavir should
be reduced.

* The Precautions section was revised to provide additional
information about possible cholesterol, triglyceride and
liver transaminase elevations when amprenavir is co-
administered with ritonavir.

* The Precautions section was also revised to provide
information about the potential for lipid elevations;
guidance on monitoring and managing these clinical chemistry
abnormalities was included.

* The Adverse Reactions section was revised to include a
table describing common adverse events observed in patients
who received amprenavir 600mg + ritonavir 100mg BID (twice
daily) and amprenavir 1200mg + ritonavir 200mg QD (once
daily).

The label hyperlinked below in PDF format:
http://www.fda.gov/cder/foi/label/2002/21007s010lbl.pdf


***** FDA Approves Once-Daily Efavirenz Formulation, Revised
Labeling

The FDA sent the following email on February 4:

The FDA approved on February 1, 2002, a new formulation of
Sustiva (efavirenz), a non nucleoside reverse transcriptase
inhibitor for the treatment of HIV infection. Sustiva will
now be available as a 600 mg tablet to be taken once daily,
in combination with a protease inhibitor and/or nucleoside
analogue reverse transcriptase inhibitors (NRTIs). Sustiva,
will continue to be available in the 50mg, 100, and 200 mg
capsules in addition to the new 600 mg tablet.

In addition, the Sustiva label was revised to include new
statements in the DOSAGE AND ADMINISTRATION section. The
revised statements are shown within >< symbols, below.

'Adults: The recommended dosage of SUSTIVA is 600 mg orally,
once daily, in combination with a protease inhibitor and/or
nucleoside analogue reverse transcriptase inhibitors (NRTIs).
>It is recommended that SUSTIVA be taken on an empty stomach,
preferably at bedtime. The increased efavirenz concentrations
observed following administration of SUSTIVA with food may
lead to an increase in frequency of adverse events. Dosing at
bedtime may improve the tolerability of nervous system
symptoms.<'

In addition the CLINICAL PHARMAOLOGY and PRECAUTIONS sections
have been updated to include drug interaction information on
Sustiva with the following medications: St. John's wort,
lorazepam, methadone, cetirizine and rifabutin. The ADVERSE
REACTION section was also revised to update the incidences of
adverse events and laboratory abnormalities seen in clinical
trials.

The revised label hyperlinked below in PDF format:
http://www.fda.gov/cder/foi/label/2002/21360lbl.pdf


***** AIDS Treatment and Related Conferences, March through
December 2002

AIDS TREATMENT NEWS compiled this list and checked the Web
sites as we went to press in early March. Please let us know
of other meetings that should be on this list. We can run
updates if necessary.

* 2002 National STD Prevention Conference, March 4-7, San
Diego
http://www.stdconference.org/

* The Presidential Advisory Council on HIV/AIDS (PACHA),
March 14 - 15, Washington DC
http://www.pacha.gov

* The Crisis of Neglected Diseases: Developing Treatments and
Ensuring Access, March 14, New York City,
http://www.neglecteddiseases.org/ Organized by MSF (Doctors
Without Borders) and others -- not focused on AIDS but
relevant to global medical care.

* 15th International Conference on Antiviral Research,
Prague, Czech Republic, March 17-21
http://isar-icar.com/icarmain.html

* National AIDS Update Conference (NAUC), March 19-22, San
Francisco (sponsored by the American Foundation for AIDS
Research)
http://www.nauc.org

* 2002 HIV Advocacy Network Conference, "Making Room at the
Table: Keeping HIV/AIDS on the Priority List," Saturday March
23, 8:30 a.m. to 5:00 p.m. For more information contact Elisa
Quarles, 415-487-3085, or George Greenwell, 415-487-3080, at
the San Francisco AIDS Foundation.

* Conference on the International Patent System, March 25-27,
Geneva,
http://patentagenda.wipo.int/meetings/2002/index.html

* HIV-1 Protection and Control by Vaccination, April 5-11,
Keystone, Colorado
http://www.keystonesymposia.org/Meetings/ViewMeetings.cfm?MeetingID=613

* HIV Pathogenesis: Recent Advances in the Biology and
Pathogenesis of Primate Lentiviruses, April 5-11, Keystone,
Colorado
http://www.keystonesymposia.org/Meetings/viewmeetings.cfm?Meetingid=612

* CANCELLED: 4th European Symposium on the Clinical
Implications of HIV Drug Resistance, had been scheduled for
April 5-7, in Frankfurt, Germany
http://www.intmedpress.com/frankfurt/

* Rally to support The Global Fund to Fight AIDS,
Tuberculosis, and Malaria, April 10, Washington DC
email: actup@...

* Third International Workshop on Clinical Pharmacology of
HIV Infection, April 11-13, Washington DC (co-sponsored by
the U.S. Food and Drug Administration)
http://www.virology-education.com/index2.html
(click on the conference)

* Fifth International Conference on Healthcare Resource
Allocation for HIV/AIDS, April 15-17, Rio de Janeiro, Brazil
http://www.iapac.org/conference/01news.html

* Antiviral Chemotherapy: New Directions for clinical
Applications and Research, April 18-20, San Francisco,
California
http://medicine.ucsf.edu/cme/2002cal/K131.html

* 3rd European Workshop On Lipodystrophy & Metabolic
Disorders, April 25-27, Marbella, Spain
http://www.kobe-lipodystrophy.com/

* 12th Annual Clinical Care Options for HIV Symposium, April
25-28, Miami, Florida "This meeting is designed for and
limited to experienced frontline primary HIV care physicians,
clinical researchers, other advanced frontline clinicians
actively treating HIV infected individuals... For faculty and
agenda details, please visit the Symposium website at
www.imedoptions.com <http://www.imedoptions.com>  or forward
e-mail inquiries to registration@...."

* The Second Collaborative Research Seminar on HIV and Other
Viral Entry Inhibitors, May 3-5, 2002, The Waldorf Astoria,
New York, NY The Macrae Group, 230 East 79th St, Suite 8E, NY
10021, 212-988-7732 212-717-1222 macraegrp@...
Abstract deadline 3/15; registration for this conference cost
$795 ($300 student).

* CPCRA (Spring 2002 Group Meeting of the Terry Beirn
Community Programs for Clinical Research on AIDS), May 4-6,
Reston, Virginia
http://www.cpcra.org

* Fifth Annual Conference on Vaccine Research, May 6-8,
Baltimore MD
http://www.nfid.org/conferences/vaccine02/

* Microbicides 2002, May 12-15, Antwerp, Belgium
http://www.itg.be/micro2002/

* International AIDS Candlelight Memorial, May 19, in 500
cities in 75 countries
http://www.candlelightmemorial.org/

* Digestive Disease Week 2002, May 19-22, San Francisco,
California
http://www.ddw.org

* Technical Assistance -- How to Get It Right, MSF (Doctors
Without Borders), OXFAM, and others will hold a conference on
implementation of the Doha Declaration on international trade
rules and public health, May 28, Geneva
http://www.accessmed-msf.org/

* First International Young Peoples Conference on Aids in
Africa, May 28 - June 1, 2002, Mombasa Kenya. Contact William
O'Dour, The Secretariat, Afyoac's First International Africa
Young Peoples Conference on Aids, Kisumu, Kenya, Tel : 254 35
51512, Fax: 254 35 21834, Mobile: 072 -741222,
afyoac@...

* First African AIDS Vaccine Program (AAVP), June 3-4, Cape
Town, South Africa. For information contact Marie-Louise
Chang, changml@...

* AIDSWATCH (largest AIDS lobbying/education event), June 9-11,
Washington DC
http://www.napwa.org/

* 12th International Symposium on HIV & Emerging Infectious
Diseases, June 13-15, Toulon, France
http://www.avps.org

* Neuroscience of HIV Infection, June 19-22, Düsseldorf,
Germany
http://www.uky.edu/SMRT/neurosci.html

* XI International HIV Drug Resistance Workshop: Basic
Principles & Clinical Implications, July 2-5, Seville, Spain
http://www.informedhorizons.com/resistance2002/

* Communities in Action: Knowledge, Commitment and Challenge,
July 7 (community forum at Barcelona, with space for 1500
delegates -- registration deadline May 10),
http://www.aids2002.com

* XIV International AIDS Conference, July 7-12, Barcelona,
Spain
http://www.aids2002.com
(Note: There will be many satellite meetings as well, usually
in the days before the main conference.)

* AACTG (Adult AIDS Clinical Trials Group) 2000 Summer
Meeting (Adult AIDS Clinical Trials Group), July 27-31,
Arlington, Virginia
http://aactg.s-3.com/

* 2002 International Meeting of the Institute of Human
Virology, September 9-13, Baltimore, MD
http://www.ihv.org/

* United States Conference on AIDS, September 19-22, Anaheim,
California
http://www.nmac.org/usca/default.htm

* 4th International Workshop on Adverse Drug Reactions and
Lipodystrophy in HIV, September 22-25, San Diego, California
http://conferences.intmedpress.com/lipodystrophy

* 42nd Interscience Conference on Antimicrobial Agents and
Chemotherapy (ICAAC), September 27-30, San Diego, California
http://www.icaac.org/ICAAC.asp

* 5th International Workshop on HIV, Cells of
Macrophage/Dendritic Lineage and Other Reservoirs, October
13-15, Rome, Italy,
http://www.eac.it

* DNA Vaccines 2002: The Gene Vaccine Conference, October 23-
25, Edinburgh, UK
http://www.dnavaccine.com/

* Infectious Diseases Society of America (IDSA), October 24-
27, Chicago, Illinois
http://www.idsociety.org/ME/AM2002/ToC.htm

* American Public Health Association (APHA), November 9-13,
Philadelphia
http://www.apha.org/meetings/

* CPCRA (Winter 2002 Group Meeting of the Terry Beirn
Community Programs for Clinical Research on AIDS), November
16-18, Washington DC,
http://www.cpcra.org

* 6th International Congress on Drug Therapy in HIV
Infection, Glasgow, Scotland, November 17-21,
http://www.hiv6.com

* AACTG (Adult AIDS Clinical Trials Group) 2000 Winter
Meeting, December 3-7, Arlington, Virginia
http://aactg.s-3.com/

* Third HIV DRP Symposium, Antiviral Drug Resistance,
December 8-11, 2002, Chantilly, Virginia
http://web.ncifcrf.gov/campus/symposium/

* HIV DART 2002, Frontiers in Drug Development for
Antiretroviral Therapies, December 15-19, Naples, FL,
http://www.informedhorizons.com/hivdart2002

For other AIDS conference lists, see:
http://www.thebody.com/treat/conf.html#upcoming


***** AIDS TREATMENT NEWS

Published twice monthly

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Editor and Publisher: John S. James
Associate Editors: Jennifer Cohn, Tadd T. Tobias, R.N.
Reader Services: Allison Dinsmore

Statement of Purpose:
AIDS TREATMENT NEWS reports on experimental and standard
treatments, especially those available now. We interview
physicians, scientists, other health professionals, and
persons with AIDS or HIV; we also collect information from
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ISSN # 1052-4207

Copyright 2002 by John S. James. Permission granted for
noncommercial reproduction, provided that our address and
phone number are included if more than short quotations are
used.


--
John S. James
AIDS Treatment News
jjames@...
http://www.aidsnews.org

We have had continuing email compatibility problems with the PDF file
attachment, so we will send plain text unless we can get the problems fixed.

Maybe someone could refer us to instructions for getting the attachment to
work with all the different software systems out there. The problem is that
while some people get both the text and the attachment fine, others get the
attachment only and no text. Others receive the attachment as unreadable
codes which replace the text. At least one received the attachment as all
black.

Also, we just switched computers (from Windows to Mac OS X), and the PDF
files for our newsletter are coming out several times larger than before
(although PDFs of text-only files are not larger). The file size will cause
delays for those with slow Internet connections -- another reason for not
sending the PDF copies.

If you can help us with these problems, please reply to this message and let
us know. Meanwhile, here is issue #377, sent as plain text only, for those
who could not get receive it the first time.

******************************************************

AIDS Treatment News Issue #377, January 25, 2002
    phone 800-TREAT-1-2, or 215-546-3776

CONTENTS

2002 Overview: The Role of Activism

This special issue looks at 2002 -- and how you can help.

** Heart Disease Prevention
Heart attacks are killing more people with AIDS. There are
many ways to help prevent them.

** Drug Interactions Need More Attention
New interactions of drugs with other drugs (or with
supplements) keep being discovered.

** More Uses for Tenofovir?
It may have fewer problems with side effects and resistance
than most other antiretrovirals.

** New Kinds of Treatment
Here we look at some of the less-known possibilities.

** Legal/Medical Issues
Especially funding (ADAP, Social Security, Medicare,
Medicaid), and discrimination.

** Drug Pricing
Price increases threaten treatment for many U.S. patients.

** Improving Activism
How can activists get more people involved -- and make the
social atmosphere less stressful?

** Improving Fundraising
Should organizations have to put so much money and effort
into donor experiences or entertainment that are unrelated
to their mission?

** Funding Medical Research and Drug Development
The big gap is that no one will do the first human study.

** Diet and Inflammation? (Personal Note)
Our experience and other information suggest that something
in modern "junk food" diets may interfere with the body's
handling of inflammation -- with far-reaching health
consequences.


***** 2002 Overview: The Role of Activism

by John S. James

As we enter 2002 many lives are being lost in the U.S. and
around the world because opportunities to save them are
being neglected or squandered, often due to lack of
followup. The system does not work by itself.  Problems
fester indefinitely unless advocates push for attention and
solutions. New activism is now emerging. But we need to
understand what creates opportunities for activists, and
how the process can work better. This article will outline
some AIDS treatment issues, to show people who want to help
how to find more information, and to help them find people
and organizations they can work with.

To get a better sense of what is happening, we watched the
emails and papers crossing our desk this month. The issues
are endless; this article cannot touch 10% of what is going
on. We had to omit many areas -- including the biggest of
all, Africa and the world, where the epidemic kills 8,000
people every day. The global pandemic and global response
need separate articles, and cannot be summarized
meaningfully. It is hard to report because of uncertainty
on the most central issue: how much are countries and
people, rich and poor alike, finding the will to deal
seriously with the epidemic after two decades of neglect?


***** Heart Disease Prevention

Though it can take years for official statistics to become
available, clearly we are hearing of more heart attacks and
deaths among young people who would not previously have
been considered at high risk. While some antiretroviral
drugs contribute to risk factors, long-term prospective
studies have shown increased risk and death from
cardiovascular disease before the protease inhibitors and
modern combination treatment became available.(1) We
strongly suspect that antiretroviral treatment is
increasing cardiovascular disease in two very different
ways -- by side effects of the drugs themselves, but also
by keeping people alive longer so that have more chance to
develop long-term effects of AIDS.

Much can be done:

* Cardiologists have found conditions that predict much
greater risk of death in persons with HIV.(1) Often these
can be treated.

* Cardiovascular risks are cumulative. Even when some are
unavoidable due to HIV or the treatments currently
available, others can be reduced by following standard
guidelines published for the general population.

  * Risk can be reduced by lifestyle changes such as better
diets, exercise, quitting smoking, and probably by drinking
a glass of red wine a day (for some patients).

* On diet, more evidence is showing that trans fatty acids
(found in partially hydrogenated oils used in commercially
baked goods and fast foods -- but also found in products
from ruminant animals) seem to be associated with seriously
increased risk of heart attacks.(2,3). A recent New York
Times editorial noted that the U.S. FDA "has estimated that
honest disclosure of trans fats on package labels could
prevent 2,100 to 5,000 deaths from heart disease each year"
("Foot-Dragging on Fat," New York Times, January 26, 2002).
Apparently industry pressure has so far stopped the FDA
from requiring this disclosure. The AIDS community can
educate itself and others about this heart risk and how to avoid it.

* Nutritional approaches still considered experimental
include measuring homocysteine in the blood and using
certain supplements to help reduce it if necessary.

* When nutritional and lifestyle changes are not enough,
prescription drugs are already used in HIV treatment to
help control abnormal lipid levels or other metabolic
changes that increase cardiovascular risk. These drugs are
widely used in the general population. They can have side
effects and should be closely monitored, especially for
persons with HIV.

Almost certainly, cardiovascular illness and death of
people with HIV could be significantly reduced if everybody
could see an HIV specialist, and when needed an HIV-
knowledgeable cardiologist, with the different doctors able
to work together, and with enough time to work with their
patients. In practice almost nobody gets ideal medical
care.

What activists can do is to help make sure that both
standard, and credible experimental, medical information on
reducing the risk become more widely available in the AIDS
community. We need to pay more attention to this issue, and
to the many lifestyle and medical options for dealing with
it. We can educate ourselves, distribute information, and
work to assure that HIV patients can see HIV specialists --
and cardiologists when necessary.

References

1. Barbaro G, Fisher SD, Pellicelli AM, and Lipshultz SE.
The expanding role of the cardiologist in the care of HIV
infected patients. HEART. 2001; volume 86, page 365-367.

2. Oomen CM, and others. Association between trans fatty
acid intake and 10-year risk of coronary heart disease is
the Zutphen Elderly Study: a prospective population-based
study. THE LANCET. March 10, 2001; volume 357, issue 9258,
pages 746-751.

3. Aro A. Complexity of issue of dietary trans fatty acids.
THE LANCET. March 10, 2001; volume 357, issue 9258, page
732.


***** Drug Interactions Need More Attention

New interactions involving antiretrovirals and other drugs
often used by persons with HIV -- or interactions with
nutritional supplements, like garlic or St. John's wort --
keep being discovered; clearly many others are unknown.
Usually one drug (or supplement) either raises or lowers
the blood level of another drug -- sometimes by several
fold. Raised levels can result in serious side effects;
lowered levels may cause the drug not to work as intended,
or allow HIV to develop resistance. Sometimes it is
possible to compensate for these interactions by changing
the dose of one or more drugs.

Since the list of known interactions keeps changing
(several were reported at the recent ICAAC conference, for
example), the best way to present the information is
probably Web sites that allow anyone to type in a list of
drugs they are taking or planning to take, and receive a
report of any known interactions. There have been such
sites for several years. As a community, we need to keep
informed about what's best and most current, and encourage
physicians and patients to check for known interactions
when they change medications -- or if they use certain
nutritional supplements.


***** More Uses for Tenofovir?

The recently approved antiretroviral tenofovir may be
particularly important, because it appears to have fewer
side effects than other antiretrovirals, and also less
problem with resistance. It might be ideal for prevention
of maternal transmission of HIV -- and possibly could be
reformulated as an effective microbicide, allowing women to
protect themselves from HIV infection without relying on
men. But because tenofovir was first tested in treatment of
advanced HIV disease, it seems to have been largely kept on
the shelf for other uses, pending more data. Trials in
first-line therapy are ongoing now.

We suspect this drug deserves more attention now, even
before completion of the current trials (they will not
answer all the questions anyway). It could be especially
important as a starting point for developing low-side-
effect treatments for patients who otherwise have poor
options because of severe toxicities with other drugs. In
the real world, we cannot answer every question with formal
trials, so we should collect experience systematically to
get the best information possible. We need to investigate:
if reasonably effective antiretroviral regimens with less
serious side effects are possible using the drugs now
approved; if major resistance to tenofovir does develop,
does the virus pay a price in ways that reduces its ability
to cause disease; and even whether it might make sense to
use this drug alone for certain patients -- not as a good
option, but possibly a better option than any other
available to them.

We should also look into why this treatment was so much
more effective as an antiviral in some animal trials with
viruses related to HIV, than in human studies. Some of the
animal tests found huge viral load reductions when the drug
was used alone, compared to only about a 0.6 log reduction
in patients. Could this difference have been due to the
fact that the animal studies injected the active substance
(PMPA), while humans use an oral prodrug (tenofovir)
designed to be converted to PMPA by the body?
Pharmaceutical companies have usually stayed away from any
HIV drug that would have to be injected frequently. But if
an injected drug had anywhere near the antiretroviral
potency of PMPA in the animal trials, many people would
very much want to use it. (A larger dose of the oral
tenofovir is apparently not more effective, so the
difference would not be just from the dose.)


***** New Kinds of Treatment

Everyone knows that patients urgently need new kinds of
treatments (as well as better drugs in existing classes,
mainly antiretrovirals). But it has always been hard to get
new ideas developed. Almost by definition a new idea has
not made money before, so the money people are not
interested. Developing new drugs and new classes of drugs
is expensive, due to the need to protect public health --
and because the system also reflects the need of large
companies to monopolize the market and keep out small
competitors.

Some of the lesser-known possibilities we intend to look at
in 2002 include:

** Topoisomerase inhibitors. In 1994 AIDS TREATMENT NEWS
reported on a class of drugs being developed for cancer,
but not for HIV, though some experts believed they should
be tested as antiretrovirals (see Topotecan, CPT-11
(Irinotecan), Camptothecin, and Other Topoisomerase I
Inhibitors, AIDS TREATMENT NEWS #197, April 15, 1994).
Recently treatment activist Eric Goldman followed up and
found that patent and policy snafus have apparently
prevented these drugs from being tested and developed for
HIV.

  There seems to be a pervasive gap in drug development,
where no one gets the first human data from a handful of
patients (or even from one person). Government saves money
by giving exclusive licenses to promising compounds tested
in the laboratory -- but usually industry will not invest
in human testing unless human proof of principle already
exists. This appears to be a general problem that may have
prevented many valuable treatments for AIDS and other
conditions from ever coming into use.

  In the specific case of topoisomerase inhibitors, some of
these drugs have already been approved for cancer.
Therefore it should be possible to watch viral load in
persons treated for cancer who also have HIV. If there is
substantial antiretroviral activity, it should be possible
to restart the research that has been neglected for years.

Eric Goldman is preparing a comprehensive article on his
investigation into why topoisomerase inhibitors were not
researched for HIV; at this time (January 2002) only two
short articles are available. The following are similar but
not identical:
http://www.thebody.com/sfac/topotecan.html
http://www.searchforacure.org/hope/article.asp?sty=16

** Murabutide. This immune-based treatment, being developed
in France, may strengthen the innate immune response --
which may also create conditions helpful for HIV-specific
immunity.

** Prostratin. This drug, from a tree in Samoa, may drive
latent HIV out of hiding so that it can be targeted by
other drugs or by the immune system.

** Low-dose naltrexone. This potential treatment has been
available for many years (AIDS TREATMENT NEWS reported on
it almost 15 years ago) but has not attracted much
attention. We are looking at it now because of favorable
anecdotal reports -- and also because there is little
downside to using it. For the case in favor, see:
http://www.lowdosenaltrexone.org


***** Legal/Medical Issues

We asked Ronda Goldfein and Yolanda Lollis of the AIDS Law
Project of Pennsylvania where activism could be most useful
for their clients, both at the Federal and at state and
local levels. They suggested the following. We added some
comments in parentheses:

* Social Security disability determination for HIV. Today
the side effects of antiretrovirals and other medications
are not recognized as disabling conditions, however
disabling they may actually be. Also, diabetes and
hypertension need to be in the HIV listing as conditions
that can cause disability.

* ADAP (AIDS Drug Assistance Program) formularies. Some do
not include diabetes and hypertension medications.

* Prescription coverage for Medicare. This is a major
national issue where the AIDS community needs to be heard.
A great many clients of the AIDS Law Project are seriously
affected (the drugs they need can cost $10,000 per year or
more). They say, "I worked my whole life, and now I'm on
disability and cannot get my drugs covered?"

* Syringe exchange. [We will look at this in a separate
article.]

* Medicaid reimbursement. Payments to doctors are often
completely inadequate, making it hard to find physicians
who will take Medicaid patients, because they lose money
treating them.

* Names reporting. Many people are uneasy about appearing
on a government list of people with HIV, and as a result
they avoid getting tested if their names must be reported.
Unique-identifier systems avoid this problem, but are
slightly more expensive to implement.

* Dental discrimination. In many places it is very hard to
find a dentist who will treat anyone with HIV.

* Nursing homes. Many do not want to take people with HIV.
When a nursing home is needed it is for a medical
emergency, so patients, their families, and supporters are
not in a good position to fight. And as people with AIDS
live longer, they will need nursing home care for the usual
problems of aging. (Providing good HIV-related care will be
a medical challenge as well as a discrimination issue. But
limiting people to HIV-specialty nursing homes would
require most to be far from their friends and families.
Perhaps communication technology such as computer
conferencing, along with traveling HIV-specialist
physicians, could enable more nursing homes to deliver
routine HIV care at least.)

* Other HIV discrimination. Cases handled by the AIDS Law
Project are "as varied as life itself."

  Note: If you need assistance with an AIDS-related legal
issue you may be able to get help from an AIDS legal
services organization near you. To find out if there is one
in your area, check The Directory of Legal Resources for
People with AIDS and HIV, by the American Bar Association
AIDS Coordination Project, phone 202-662-1025, or go to:
http://www.abanet.org/irr/aidsproject/publications/aids-dir.html


***** Drug Pricing

Recently some pharmaceutical companies have imposed
substantial, unexpected price increases for HIV drugs.
These increases mean that more people will not get
necessary treatment, since ADAP and other public program
budgets have already been set, and these programs are
already denying drugs through waiting lists because of lack
of money.

Apparently the reason for the price increases is to keep
corporate profits up despite the weaker economy and other
pressures on pharmaceutical company revenue, especially the
resistance to high prices by HMOs and other third-party
payers. These increases come at a time of great financial
pressures on ADAP, Medicaid, and other government programs,
due especially to the financial problems of state
governments -- as well as continuing increases in the cost
of private health insurance. And these price increases come
after the budgets of ADAP and other programs have already
been set. With drugs costing more when less money is
available, thousands of people will not get the care they
need. (Patient Assistance Programs, run by pharmaceutical
companies, provide free drug to some patients with no other
way to pay. But these programs are designed to work poorly,
as the paperwork stops many if not most who could qualify
from applying. Basically those with enough social support
to cause a public issue if they die for lack of the drugs
can probably get them. Most others probably cannot.)

In U.S. medicine the financing system does not work, and
big institutions are best able to take care of themselves -
- dumping the costs of a failed system onto persons with
major illnesses, who are least able to pay. We need to work
for comprehensive reform -- and meanwhile be sure that
communities are organized so that patients' interests will
at least be represented, along with those of big pharma,
big insurance, and big government.

We will keep our readers informed as we learn more about
new price increases and their consequences.


***** Improving Activism

AIDS activists continue to be highly effective. But there
are not enough people to do the work that needs to be done.
Perhaps the most important challenge to AIDS treatment
activists today is making it easier for new people to
become involved.

Historically, most ACT UP chapters and other treatment
activist organizations had no training program to help with
the steep learning curve (on treatment information, on
learning how to deal with pharmaceutical, government, and
other officials, on working with press and the media, and
on working with allies and within the organization itself).
This is changing; for example, the new national
organization ATAC (AIDS Treatment Activist Coalition) is
intensely interested in training and mentoring new
activists. For more information, see:
http://www.atac-usa.org

Often treatment activists are so involved in the issues
that there is little thought to maintenance of the
organization -- for example, little outreach to explain to
the community what they are doing and why, and to let
people know what assistance they need. Several years ago
ACT UP Golden Gate (now Survive AIDS) solved several of
these problems by getting a weekly column on AIDS treatment
in the BAY AREA REPORTER, a San Francisco gay newspaper.
The columns were written by a "writers pool" of five or six
members, and most had an action-alert box in addition. It
took considerable work from a coordinator to make sure that
a volunteer finished an article every week.

ACT UP Philadelphia successfully reaches across race and
class barriers, and as a result is probably the largest ACT
UP chapter in the world. It can get hundreds of people to
demonstrations even outside the city, in Washington or New
York. Project TEACH, an excellent education program of
Philadelphia FIGHT, has trained hundreds of peer educators
in treatment and activism.

A widespread problem retaining people is that AIDS
activists have traditionally been too harsh with each
other, apparently more so than in most social movements.
Most of the disputes have been due to personality
differences, accidents, misunderstandings, or escalating
"flame wars" where each tries to outdo the other with
insults -- rather than substantive disagreements. People
needed to give each other more slack, and that is happening
now. Everyone knows there is more than enough work to go
around, and that nobody can be sure they are right.

If we may mention our own work in conflict prevention, we
have developed a kind of education designed to take place
in the interaction rituals of everyday life -- not in
special classes or settings. The idea is to design
"practices" (self-training exercises completely integrated
with whatever we are doing anyway) for using routine
errands and other throwaway moments to build skills for
better communication, personal interaction, and
relationship development. For more information, see:
http://www.communicationpractices.org


***** Improving Fundraising

The fundraising process needs more attention now, due to a
weaker economy, less government revenue, and a global war
that may last for decades. The AIDS community will need to
be more efficient in delivering services and advocacy, and
in finding money for them.

In the U.S., individual donors give far more money to
philanthropy than foundations and corporations put
together. Most of the individual donations are to religious
organizations. Church members usually have personal
experience with the church they are giving to. But in AIDS,
donations often go by default to a few big organizations
with high-profile names, from donors who know little about
their services. And much effort and expense goes into
events like walks, rides, and other emotional experiences
for donors -- an activity requiring very different skills
from effective service delivery. Only large organizations
can afford professional development departments -- and only
a few can be largely successful year after year at two
entirely different missions simultaneously (with the
fundraising mission directly determining organizational
survival, while the official mission does not). It is said
that one can't dance at two weddings with one tush. But
that is what we expect almost every service organization to
do.

No wonder so many groups need technical help with
fundraising.

Besides more technical help, we would like to see more
focus on educating and involving donors in what is actually
going on (in addition to seeking money through name
recognition, or by producing donor events and experiences
having little to do with the service or advocacy mission).
We reluctantly believe that all these approaches are
inevitable. Modern society has thousands of different
worlds, and most people live in only a few of them. Those
who do not need services are unlikely to understand them.
Those who do are unlikely to have much money to donate.
This disconnect makes it hard to raise money, and to
deliver services well. But until there is a deeper
commitment to making the world work, it may be the best we
can do.


***** Funding Medical Research and Drug Development

For improving medical research, the place to start is to
ask researchers what problems they face when they are
trying to get important work done. Remember that often they
cannot be activists or try to improve the system, because
they must protect relationships with those who control
their resources. Someone else must do the reform.

One of the greatest problems holding up medical research
and development is the difficulty of getting the first
human experience with promising new ideas. What usually
happens is that academic researchers develop potential
treatment approaches, often with Federal funding. They
publish one or more papers in scientific journals. Then
progress stops, because no one does the first test in a
human being. Government usually avoids practical drug
development, leaving that to industry -- but industry
seldom picks up development unless it already has human
proof of principle. Potentially lifesaving treatments can
sit on the shelf indefinitely, and no one pays attention.

Possibly medical research needs a role like that of a
producer -- one who handles the business of getting a
project done, but in this case for cures for diseases,
instead of for movies or plays. AIDS activists have
sometimes stepped into that role when necessary. A notable
example was the late Bill Thorne of ACT UP Golden Gate, who
was largely responsible for the completion of a pivotal
clinical trial that had stalled, and for FDA approval of
human growth hormone for AIDS-related wasting. Everybody
involved knew that he was the key person in making it
happen. (His work was entirely volunteer; others made the
money from the grossly overpriced drug.)

In vaccines, IAVI (the International AIDS Vaccine
Initiative) has taken on the role of making projects
happen. In cancer, the U.S. National Cancer Institute has
long studied early clinical use of new agents. But much of
medical research today is like an entertainment industry
without producers, where the artists themselves must do all
that work, or no one will.


***** Diet and Inflammation? (Personal Note)

by John S. James

In November 2000, AIDS TREATMENT NEWS published an
interview with Lynde Francis, who runs The Centre, an AIDS
treatment organization in Harare, Zimbabwe. Because her
clients had no access to antiretrovirals, she had to do
what could be done with nutrition and lifestyle changes.
Part of the recommendation was to eat a traditional diet,
avoiding modern "junk foods."

I couldn't see how this could make a difference in HIV
disease. But later I tried such a diet for a different
problem, a severe wrist pain -- after a "junk food" dinner
repeatedly seemed to make the problem worse the next day.
For me the diet appeared close to 100% effective. My wrist
had become steadily worse for several months; it was better
after a few days on the diet. The problem was essentially
gone in a few weeks, and has not returned in over a year
since.

I coined the name "The Century Diet" as a personal
reminder. The only rule is, "Don't eat anything that wasn't
available 100 years ago."

My experience and other information suggests that something
in the modern diet (possibly trans fatty acids?) can
interfere with the body's ability to handle inflammation
properly. If so, this process could be contributing to
widespread health problems, including repetitive stress
injury, cardiovascular disease, and perhaps some
complications of HIV. (On repetitive stress injury, note
that computers are widely blamed, even though for decades
manual typists were at the keyboard as much, and had to
press the keys harder. Apparently some other change of
modern life allowed the stress to cause more injury.)
Research could find the culprit(s) fairly easily, by
clinical testing with a few volunteers who are close to
the borderline between having symptoms or not. Diets and
meals could be "fractionated" -- successively divided and
tested to see which ingredient causes the symptom --
somewhat like medicinal plant products are fractionated
chemically to find an active ingredient.

Since this issue is mostly outside the focus of AIDS
TREATMENT NEWS, we set up an email list where anyone
interested can continue the discussion. For more
information, see: http://groups.yahoo.com/group/centurydiet


***** AIDS TREATMENT NEWS

Published twice monthly

Subscription and Editorial Office:
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  email: aidsnews@...
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Editor and Publisher: John S. James
Associate Editor: Tadd T. Tobias, R.N.

Statement of Purpose:
AIDS TREATMENT NEWS reports on experimental and standard
treatments, especially those available now. We interview
physicians, scientists, other health professionals, and
persons with AIDS or HIV; we also collect information from
meetings and conferences, medical journals, and computer
databases. Long-term survivors have usually tried many
different treatments, and found combinations that work for
them. AIDS TREATMENT NEWS does not recommend particular
therapies, but seeks to increase the options available.

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ISSN # 1052-4207

Copyright 2002 by John S. James. Permission granted for
noncommercial reproduction, provided that our address and
phone number are included if more than short quotations are
used.

AIDS Treatment News Issue #377, January 25, 2002
    phone 800-TREAT-1-2, or 215-546-3776

CONTENTS

2002 Overview: The Role of Activism

This special issue looks at 2002 -- and how you can help.

** Heart Disease Prevention
Heart attacks are killing more people with AIDS. There are
many ways to help prevent them.

** Drug Interactions Need More Attention
New interactions of drugs with other drugs (or with
supplements) keep being discovered.

** More Uses for Tenofovir?
It may have fewer problems with side effects and resistance
than most other antiretrovirals.

** New Kinds of Treatment
Here we look at some of the less-known possibilities.

** Legal/Medical Issues
Especially funding (ADAP, Social Security, Medicare,
Medicaid), and discrimination.

** Drug Pricing
Price increases threaten treatment for many U.S. patients.

** Improving Activism
How can activists get more people involved -- and make the
social atmosphere less stressful?

** Improving Fundraising
Should organizations have to put so much money and effort
into donor experiences or entertainment that are unrelated
to their mission?

** Funding Medical Research and Drug Development
The big gap is that no one will do the first human study.

** Diet and Inflammation? (Personal Note)
Our experience and other information suggest that something
in modern "junk food" diets may interfere with the body's
handling of inflammation -- with far-reaching health
consequences.


***** 2002 Overview: The Role of Activism

by John S. James

As we enter 2002 many lives are being lost in the U.S. and
around the world because opportunities to save them are
being neglected or squandered, often due to lack of
followup. The system does not work by itself.  Problems
fester indefinitely unless advocates push for attention and
solutions. New activism is now emerging. But we need to
understand what creates opportunities for activists, and
how the process can work better. This article will outline
some AIDS treatment issues, to show people who want to help
how to find more information, and to help them find people
and organizations they can work with.

To get a better sense of what is happening, we watched the
emails and papers crossing our desk this month. The issues
are endless; this article cannot touch 10% of what is going
on. We had to omit many areas -- including the biggest of
all, Africa and the world, where the epidemic kills 8,000
people every day. The global pandemic and global response
need separate articles, and cannot be summarized
meaningfully. It is hard to report because of uncertainty
on the most central issue: how much are countries and
people, rich and poor alike, finding the will to deal
seriously with the epidemic after two decades of neglect?


***** Heart Disease Prevention

Though it can take years for official statistics to become
available, clearly we are hearing of more heart attacks and
deaths among young people who would not previously have
been considered at high risk. While some antiretroviral
drugs contribute to risk factors, long-term prospective
studies have shown increased risk and death from
cardiovascular disease before the protease inhibitors and
modern combination treatment became available.(1) We
strongly suspect that antiretroviral treatment is
increasing cardiovascular disease in two very different
ways -- by side effects of the drugs themselves, but also
by keeping people alive longer so that have more chance to
develop long-term effects of AIDS.

Much can be done:

* Cardiologists have found conditions that predict much
greater risk of death in persons with HIV.(1) Often these
can be treated.

* Cardiovascular risks are cumulative. Even when some are
unavoidable due to HIV or the treatments currently
available, others can be reduced by following standard
guidelines published for the general population.

  * Risk can be reduced by lifestyle changes such as better
diets, exercise, quitting smoking, and probably by drinking
a glass of red wine a day (for some patients).

* On diet, more evidence is showing that trans fatty acids
(found in partially hydrogenated oils used in commercially
baked goods and fast foods -- but also found in products
from ruminant animals) seem to be associated with seriously
increased risk of heart attacks.(2,3). A recent New York
Times editorial noted that the U.S. FDA "has estimated that
honest disclosure of trans fats on package labels could
prevent 2,100 to 5,000 deaths from heart disease each year"
("Foot-Dragging on Fat," New York Times, January 26, 2002).
Apparently industry pressure has so far stopped the FDA
from requiring this disclosure. The AIDS community can
educate itself and others about this heart risk and how to avoid it.

* Nutritional approaches still considered experimental
include measuring homocysteine in the blood and using
certain supplements to help reduce it if necessary.

* When nutritional and lifestyle changes are not enough,
prescription drugs are already used in HIV treatment to
help control abnormal lipid levels or other metabolic
changes that increase cardiovascular risk. These drugs are
widely used in the general population. They can have side
effects and should be closely monitored, especially for
persons with HIV.

Almost certainly, cardiovascular illness and death of
people with HIV could be significantly reduced if everybody
could see an HIV specialist, and when needed an HIV-
knowledgeable cardiologist, with the different doctors able
to work together, and with enough time to work with their
patients. In practice almost nobody gets ideal medical
care.

What activists can do is to help make sure that both
standard, and credible experimental, medical information on
reducing the risk become more widely available in the AIDS
community. We need to pay more attention to this issue, and
to the many lifestyle and medical options for dealing with
it. We can educate ourselves, distribute information, and
work to assure that HIV patients can see HIV specialists --
and cardiologists when necessary.

References

1. Barbaro G, Fisher SD, Pellicelli AM, and Lipshultz SE.
The expanding role of the cardiologist in the care of HIV
infected patients. HEART. 2001; volume 86, page 365-367.

2. Oomen CM, and others. Association between trans fatty
acid intake and 10-year risk of coronary heart disease is
the Zutphen Elderly Study: a prospective population-based
study. THE LANCET. March 10, 2001; volume 357, issue 9258,
pages 746-751.

3. Aro A. Complexity of issue of dietary trans fatty acids.
THE LANCET. March 10, 2001; volume 357, issue 9258, page
732.


***** Drug Interactions Need More Attention

New interactions involving antiretrovirals and other drugs
often used by persons with HIV -- or interactions with
nutritional supplements, like garlic or St. John's wort --
keep being discovered; clearly many others are unknown.
Usually one drug (or supplement) either raises or lowers
the blood level of another drug -- sometimes by several
fold. Raised levels can result in serious side effects;
lowered levels may cause the drug not to work as intended,
or allow HIV to develop resistance. Sometimes it is
possible to compensate for these interactions by changing
the dose of one or more drugs.

Since the list of known interactions keeps changing
(several were reported at the recent ICAAC conference, for
example), the best way to present the information is
probably Web sites that allow anyone to type in a list of
drugs they are taking or planning to take, and receive a
report of any known interactions. There have been such
sites for several years. As a community, we need to keep
informed about what's best and most current, and encourage
physicians and patients to check for known interactions
when they change medications -- or if they use certain
nutritional supplements.


***** More Uses for Tenofovir?

The recently approved antiretroviral tenofovir may be
particularly important, because it appears to have fewer
side effects than other antiretrovirals, and also less
problem with resistance. It might be ideal for prevention
of maternal transmission of HIV -- and possibly could be
reformulated as an effective microbicide, allowing women to
protect themselves from HIV infection without relying on
men. But because tenofovir was first tested in treatment of
advanced HIV disease, it seems to have been largely kept on
the shelf for other uses, pending more data. Trials in
first-line therapy are ongoing now.

We suspect this drug deserves more attention now, even
before completion of the current trials (they will not
answer all the questions anyway). It could be especially
important as a starting point for developing low-side-
effect treatments for patients who otherwise have poor
options because of severe toxicities with other drugs. In
the real world, we cannot answer every question with formal
trials, so we should collect experience systematically to
get the best information possible. We need to investigate:
if reasonably effective antiretroviral regimens with less
serious side effects are possible using the drugs now
approved; if major resistance to tenofovir does develop,
does the virus pay a price in ways that reduces its ability
to cause disease; and even whether it might make sense to
use this drug alone for certain patients -- not as a good
option, but possibly a better option than any other
available to them.

We should also look into why this treatment was so much
more effective as an antiviral in some animal trials with
viruses related to HIV, than in human studies. Some of the
animal tests found huge viral load reductions when the drug
was used alone, compared to only about a 0.6 log reduction
in patients. Could this difference have been due to the
fact that the animal studies injected the active substance
(PMPA), while humans use an oral prodrug (tenofovir)
designed to be converted to PMPA by the body?
Pharmaceutical companies have usually stayed away from any
HIV drug that would have to be injected frequently. But if
an injected drug had anywhere near the antiretroviral
potency of PMPA in the animal trials, many people would
very much want to use it. (A larger dose of the oral
tenofovir is apparently not more effective, so the
difference would not be just from the dose.)


***** New Kinds of Treatment

Everyone knows that patients urgently need new kinds of
treatments (as well as better drugs in existing classes,
mainly antiretrovirals). But it has always been hard to get
new ideas developed. Almost by definition a new idea has
not made money before, so the money people are not
interested. Developing new drugs and new classes of drugs
is expensive, due to the need to protect public health --
and because the system also reflects the need of large
companies to monopolize the market and keep out small
competitors.

Some of the lesser-known possibilities we intend to look at
in 2002 include:

** Topoisomerase inhibitors. In 1994 AIDS TREATMENT NEWS
reported on a class of drugs being developed for cancer,
but not for HIV, though some experts believed they should
be tested as antiretrovirals (see Topotecan, CPT-11
(Irinotecan), Camptothecin, and Other Topoisomerase I
Inhibitors, AIDS TREATMENT NEWS #197, April 15, 1994).
Recently treatment activist Eric Goldman followed up and
found that patent and policy snafus have apparently
prevented these drugs from being tested and developed for
HIV.

  There seems to be a pervasive gap in drug development,
where no one gets the first human data from a handful of
patients (or even from one person). Government saves money
by giving exclusive licenses to promising compounds tested
in the laboratory -- but usually industry will not invest
in human testing unless human proof of principle already
exists. This appears to be a general problem that may have
prevented many valuable treatments for AIDS and other
conditions from ever coming into use.

  In the specific case of topoisomerase inhibitors, some of
these drugs have already been approved for cancer.
Therefore it should be possible to watch viral load in
persons treated for cancer who also have HIV. If there is
substantial antiretroviral activity, it should be possible
to restart the research that has been neglected for years.

Eric Goldman is preparing a comprehensive article on his
investigation into why topoisomerase inhibitors were not
researched for HIV; at this time (January 2002) only two
short articles are available. The following are similar but
not identical:
http://www.thebody.com/sfac/topotecan.html
http://www.searchforacure.org/hope/article.asp?sty=16

** Murabutide. This immune-based treatment, being developed
in France, may strengthen the innate immune response --
which may also create conditions helpful for HIV-specific
immunity.

** Prostratin. This drug, from a tree in Samoa, may drive
latent HIV out of hiding so that it can be targeted by
other drugs or by the immune system.

** Low-dose naltrexone. This potential treatment has been
available for many years (AIDS TREATMENT NEWS reported on
it almost 15 years ago) but has not attracted much
attention. We are looking at it now because of favorable
anecdotal reports -- and also because there is little
downside to using it. For the case in favor, see:
http://www.lowdosenaltrexone.org


***** Legal/Medical Issues

We asked Ronda Goldfein and Yolanda Lollis of the AIDS Law
Project of Pennsylvania where activism could be most useful
for their clients, both at the Federal and at state and
local levels. They suggested the following. We added some
comments in parentheses:

* Social Security disability determination for HIV. Today
the side effects of antiretrovirals and other medications
are not recognized as disabling conditions, however
disabling they may actually be. Also, diabetes and
hypertension need to be in the HIV listing as conditions
that can cause disability.

* ADAP (AIDS Drug Assistance Program) formularies. Some do
not include diabetes and hypertension medications.

* Prescription coverage for Medicare. This is a major
national issue where the AIDS community needs to be heard.
A great many clients of the AIDS Law Project are seriously
affected (the drugs they need can cost $10,000 per year or
more). They say, "I worked my whole life, and now I'm on
disability and cannot get my drugs covered?"

* Syringe exchange. [We will look at this in a separate
article.]

* Medicaid reimbursement. Payments to doctors are often
completely inadequate, making it hard to find physicians
who will take Medicaid patients, because they lose money
treating them.

* Names reporting. Many people are uneasy about appearing
on a government list of people with HIV, and as a result
they avoid getting tested if their names must be reported.
Unique-identifier systems avoid this problem, but are
slightly more expensive to implement.

* Dental discrimination. In many places it is very hard to
find a dentist who will treat anyone with HIV.

* Nursing homes. Many do not want to take people with HIV.
When a nursing home is needed it is for a medical
emergency, so patients, their families, and supporters are
not in a good position to fight. And as people with AIDS
live longer, they will need nursing home care for the usual
problems of aging. (Providing good HIV-related care will be
a medical challenge as well as a discrimination issue. But
limiting people to HIV-specialty nursing homes would
require most to be far from their friends and families.
Perhaps communication technology such as computer
conferencing, along with traveling HIV-specialist
physicians, could enable more nursing homes to deliver
routine HIV care at least.)

* Other HIV discrimination. Cases handled by the AIDS Law
Project are "as varied as life itself."

  Note: If you need assistance with an AIDS-related legal
issue you may be able to get help from an AIDS legal
services organization near you. To find out if there is one
in your area, check The Directory of Legal Resources for
People with AIDS and HIV, by the American Bar Association
AIDS Coordination Project, phone 202-662-1025, or go to:
http://www.abanet.org/irr/aidsproject/publications/aids-dir.html


***** Drug Pricing

Recently some pharmaceutical companies have imposed
substantial, unexpected price increases for HIV drugs.
These increases mean that more people will not get
necessary treatment, since ADAP and other public program
budgets have already been set, and these programs are
already denying drugs through waiting lists because of lack
of money.

Apparently the reason for the price increases is to keep
corporate profits up despite the weaker economy and other
pressures on pharmaceutical company revenue, especially the
resistance to high prices by HMOs and other third-party
payers. These increases come at a time of great financial
pressures on ADAP, Medicaid, and other government programs,
due especially to the financial problems of state
governments -- as well as continuing increases in the cost
of private health insurance. And these price increases come
after the budgets of ADAP and other programs have already
been set. With drugs costing more when less money is
available, thousands of people will not get the care they
need. (Patient Assistance Programs, run by pharmaceutical
companies, provide free drug to some patients with no other
way to pay. But these programs are designed to work poorly,
as the paperwork stops many if not most who could qualify
from applying. Basically those with enough social support
to cause a public issue if they die for lack of the drugs
can probably get them. Most others probably cannot.)

In U.S. medicine the financing system does not work, and
big institutions are best able to take care of themselves -
- dumping the costs of a failed system onto persons with
major illnesses, who are least able to pay. We need to work
for comprehensive reform -- and meanwhile be sure that
communities are organized so that patients' interests will
at least be represented, along with those of big pharma,
big insurance, and big government.

We will keep our readers informed as we learn more about
new price increases and their consequences.


***** Improving Activism

AIDS activists continue to be highly effective. But there
are not enough people to do the work that needs to be done.
Perhaps the most important challenge to AIDS treatment
activists today is making it easier for new people to
become involved.

Historically, most ACT UP chapters and other treatment
activist organizations had no training program to help with
the steep learning curve (on treatment information, on
learning how to deal with pharmaceutical, government, and
other officials, on working with press and the media, and
on working with allies and within the organization itself).
This is changing; for example, the new national
organization ATAC (AIDS Treatment Activist Coalition) is
intensely interested in training and mentoring new
activists. For more information, see:
http://www.atac-usa.org

Often treatment activists are so involved in the issues
that there is little thought to maintenance of the
organization -- for example, little outreach to explain to
the community what they are doing and why, and to let
people know what assistance they need. Several years ago
ACT UP Golden Gate (now Survive AIDS) solved several of
these problems by getting a weekly column on AIDS treatment
in the BAY AREA REPORTER, a San Francisco gay newspaper.
The columns were written by a "writers pool" of five or six
members, and most had an action-alert box in addition. It
took considerable work from a coordinator to make sure that
a volunteer finished an article every week.

ACT UP Philadelphia successfully reaches across race and
class barriers, and as a result is probably the largest ACT
UP chapter in the world. It can get hundreds of people to
demonstrations even outside the city, in Washington or New
York. Project TEACH, an excellent education program of
Philadelphia FIGHT, has trained hundreds of peer educators
in treatment and activism.

A widespread problem retaining people is that AIDS
activists have traditionally been too harsh with each
other, apparently more so than in most social movements.
Most of the disputes have been due to personality
differences, accidents, misunderstandings, or escalating
"flame wars" where each tries to outdo the other with
insults -- rather than substantive disagreements. People
needed to give each other more slack, and that is happening
now. Everyone knows there is more than enough work to go
around, and that nobody can be sure they are right.

If we may mention our own work in conflict prevention, we
have developed a kind of education designed to take place
in the interaction rituals of everyday life -- not in
special classes or settings. The idea is to design
"practices" (self-training exercises completely integrated
with whatever we are doing anyway) for using routine
errands and other throwaway moments to build skills for
better communication, personal interaction, and
relationship development. For more information, see:
http://www.communicationpractices.org


***** Improving Fundraising

The fundraising process needs more attention now, due to a
weaker economy, less government revenue, and a global war
that may last for decades. The AIDS community will need to
be more efficient in delivering services and advocacy, and
in finding money for them.

In the U.S., individual donors give far more money to
philanthropy than foundations and corporations put
together. Most of the individual donations are to religious
organizations. Church members usually have personal
experience with the church they are giving to. But in AIDS,
donations often go by default to a few big organizations
with high-profile names, from donors who know little about
their services. And much effort and expense goes into
events like walks, rides, and other emotional experiences
for donors -- an activity requiring very different skills
from effective service delivery. Only large organizations
can afford professional development departments -- and only
a few can be largely successful year after year at two
entirely different missions simultaneously (with the
fundraising mission directly determining organizational
survival, while the official mission does not). It is said
that one can't dance at two weddings with one tush. But
that is what we expect almost every service organization to
do.

No wonder so many groups need technical help with
fundraising.

Besides more technical help, we would like to see more
focus on educating and involving donors in what is actually
going on (in addition to seeking money through name
recognition, or by producing donor events and experiences
having little to do with the service or advocacy mission).
We reluctantly believe that all these approaches are
inevitable. Modern society has thousands of different
worlds, and most people live in only a few of them. Those
who do not need services are unlikely to understand them.
Those who do are unlikely to have much money to donate.
This disconnect makes it hard to raise money, and to
deliver services well. But until there is a deeper
commitment to making the world work, it may be the best we
can do.


***** Funding Medical Research and Drug Development

For improving medical research, the place to start is to
ask researchers what problems they face when they are
trying to get important work done. Remember that often they
cannot be activists or try to improve the system, because
they must protect relationships with those who control
their resources. Someone else must do the reform.

One of the greatest problems holding up medical research
and development is the difficulty of getting the first
human experience with promising new ideas. What usually
happens is that academic researchers develop potential
treatment approaches, often with Federal funding. They
publish one or more papers in scientific journals. Then
progress stops, because no one does the first test in a
human being. Government usually avoids practical drug
development, leaving that to industry -- but industry
seldom picks up development unless it already has human
proof of principle. Potentially lifesaving treatments can
sit on the shelf indefinitely, and no one pays attention.

Possibly medical research needs a role like that of a
producer -- one who handles the business of getting a
project done, but in this case for cures for diseases,
instead of for movies or plays. AIDS activists have
sometimes stepped into that role when necessary. A notable
example was the late Bill Thorne of ACT UP Golden Gate, who
was largely responsible for the completion of a pivotal
clinical trial that had stalled, and for FDA approval of
human growth hormone for AIDS-related wasting. Everybody
involved knew that he was the key person in making it
happen. (His work was entirely volunteer; others made the
money from the grossly overpriced drug.)

In vaccines, IAVI (the International AIDS Vaccine
Initiative) has taken on the role of making projects
happen. In cancer, the U.S. National Cancer Institute has
long studied early clinical use of new agents. But much of
medical research today is like an entertainment industry
without producers, where the artists themselves must do all
that work, or no one will.


***** Diet and Inflammation? (Personal Note)

by John S. James

In November 2000, AIDS TREATMENT NEWS published an
interview with Lynde Francis, who runs The Centre, an AIDS
treatment organization in Harare, Zimbabwe. Because her
clients had no access to antiretrovirals, she had to do
what could be done with nutrition and lifestyle changes.
Part of the recommendation was to eat a traditional diet,
avoiding modern "junk foods."

I couldn't see how this could make a difference in HIV
disease. But later I tried such a diet for a different
problem, a severe wrist pain -- after a "junk food" dinner
repeatedly seemed to make the problem worse the next day.
For me the diet appeared close to 100% effective. My wrist
had become steadily worse for several months; it was better
after a few days on the diet. The problem was essentially
gone in a few weeks, and has not returned in over a year
since.

I coined the name "The Century Diet" as a personal
reminder. The only rule is, "Don't eat anything that wasn't
available 100 years ago."

My experience and other information suggests that something
in the modern diet (possibly trans fatty acids?) can
interfere with the body's ability to handle inflammation
properly. If so, this process could be contributing to
widespread health problems, including repetitive stress
injury, cardiovascular disease, and perhaps some
complications of HIV. (On repetitive stress injury, note
that computers are widely blamed, even though for decades
manual typists were at the keyboard as much, and had to
press the keys harder. Apparently some other change of
modern life allowed the stress to cause more injury.)
Research could find the culprit(s) fairly easily, by
clinical testing with a few volunteers who are close to
the borderline between having symptoms or not. Diets and
meals could be "fractionated" -- successively divided and
tested to see which ingredient causes the symptom --
somewhat like medicinal plant products are fractionated
chemically to find an active ingredient.

Since this issue is mostly outside the focus of AIDS
TREATMENT NEWS, we set up an email list where anyone
interested can continue the discussion. For more
information, see: http://groups.yahoo.com/group/centurydiet


***** AIDS TREATMENT NEWS

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Editor and Publisher: John S. James
Associate Editor: Tadd T. Tobias, R.N.

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therapies, but seeks to increase the options available.

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AIDS TREATMENT NEWS #376, December 28, 2001
     phone 800-TREAT-1-2, or 215-546-3776

CONTENTS

** HIV Resistance: Data and Spin
National press stories largely misinterpreted the new study
which found high levels of HIV drug resistance in U.S.
patients.

** Barcelona Conference Abstract, Scholarship Deadlines
Early 2002
Online abstract submissions for the XIV International AIDS
conference in Barcelona (July 7-12, 2002) need to be
received by January 21 (note time zones); deadline is
January 14 for paper or disk abstract submissions to be
received. Scholarship applications are due February 1.

** African-Americans and AIDS Conference, February 25-26,
Washington
Nationally prominent speakers will address this year's
conference.

** AIDS TREATMENT NEWS Denialist Series
During the last year and a half AIDS TREATMENT NEWS has
published a series of articles answering fringe theories
(that HIV is harmless, HIV doesn't exist, people should not
be tested for HIV or take antiretrovirals if positive,
etc.) Here are the references and links to all the articles
in our series.

** Medical Marijuana Grants: Application Deadlines January
15, May 1, and September 1
The Marijuana Policy Project announced grants up to $50,000
for projects on law reform, especially medical marijuana.

** Buyers' Club List, December 2001
Our annual list of AIDS-related buyers' clubs and contact
information.

** AIDS TREATMENT NEWS Index, 2001
Annual index of this year's articles


***** HIV Resistance: Data and Spin

John S. James

On December 18 the first report was presented from a new
study of the prevalence of drug-resistant HIV in U.S.
patients in early 1999.(1) This study found that somewhere
between 50 and 78 percent of these patients (depending on
how you count patients whose viral resistance could not be
measured) had some degree of reduced susceptibility to at
least one antiretroviral. White, gay, middle class, insured
patients had the most resistance, on the average, while
those with less access to care had less. The national press
eagerly picked up that story; and when we got home from the
ICAAC conference in Chicago where the preliminary report
was presented, we found that people all over the country
had heard it -- and little else from the conference.

A closer look shows that while the study results are valid
(though not as surprising as they might appear), the
central messages that carried the press story appear to be
misinterpretations -- ones that could have future
consequences for society's political will to deal with the
HIV epidemic, both in the U.S. and abroad:

1. The main message that went out through the press is that
drugs are not working because of resistance. In fact, as
one of the researchers noted to AIDS TREATMENT NEWS, the
good news is that treatments are still saving lives despite
viral drug resistance. And most of the press ignored the
fact, brought out at a press conference at ICAAC, that many
of the patients found to have resistant virus started
antiretrovirals years ago with inadequate regimens, and
added new drugs one at a time as they became available in
the 1990s -- conditions that facilitate resistance
development. Patients starting treatment today do not use
drugs that way.

2. The publicly available abstract of the study, as well as
statements to the press, correctly reported that resistance
was associated with markers of access to care. (Those with
good access to medical care usually started treatment
earlier, and therefore had more time to develop resistance
-- and also they often started with the suboptimal two-drug
or one-drug regimens.) But the emotional subtext that sold
the newspapers was the implication that gay white men,
despite all their advantages, were not doing their part to
control the epidemic.

How the Study Was Done

This resistance study used samples collected in a major
national survey of HIV care in the U.S., the HCSUS study
(HIV Cost and Services Utilization Study).(2) The
importance of HCSUS is that while most studies describe the
particular patients who are available for the researchers
(through a particular medical institution or clinical
trial, for example), HCSUS carefully selected a sample to
be as representative as possible of all HIV-positive
persons receiving medical care in the U.S. (except in the
military, in prison, or in a hospital emergency
department), in the first two months of 1996. HCSUS
randomly selected 4042 patients and interviewed 76% of
them. It found that in January and February of 1996, about
230,000 HIV-infected adults received medical care.(2) HCSUS
also found that "the patient population was
disproportionately male, black, and poor," that many
Americans with HIV were receiving care less than twice a
year, and that the total cost of medical care for Americans
with HIV was less than 1% of all direct personal health
expenditures.(2)

In the new resistance study, over 1900 plasma samples
obtained from HCSUS volunteers about three years later (in
late 1998 to early 1999) were analyzed using the ViroLogic
PhenoSense resistance test. Sixty-three percent of these
samples had a viral load of over 500 copies of HIV, and 89%
of those had resistance test results (those with a viral
load lower than 500 cannot be tested for resistance with
standard tests). Of those who could be tested, 78% had
reduced susceptibility to at least one antiretroviral.

There was confusion in news reports over whether resistance
was found in 78% of the patients, or in about half of them.
This is because the most conservative calculation assumed
no resistance in any of the patients who could not be
tested for resistance. Therefore, 78% (of those
successfully tested who were found to be resistant to at
least one antiretroviral) times 63% (of those eligible for
resistance testing since they had a viral load of over 500
copies), gives 49% of the total study population in which
reduced susceptibility to at least one antiretroviral was
documented. (This calculation is approximate, because in
the actual study weighting factors were used to make the
sample of patients studied be more representative of the
U.S. HIV patient population.) Those who could not be tested
probably tended to have less resistance than the others
(since most had a low viral load, indicating the drugs were
probably working well), but certainly persons with viral
load under 500 can have drug-resistant virus.

This study did not collect adherence information except for
self-reports, and does not have enough data to look at
adherence.

AIDS TREATMENT NEWS talked with Dr. Nick Hellmann of
Virologic, one of the authors of the resistance report. He
noted that despite this viral resistance, the death rate in
the U.S. has still been kept relatively low since modern
combination treatment was introduced. He suspects that part
of the reason is that unlike bacteria, HIV usually pays a
significant price for drug resistance, and is likely to
become less able to replicate and cause rapid worsening of
disease. He noted that while it might be possible for HIV
to evolve to be both highly resistant and highly
pathogenic, this appears to be uncommon.

Comment

This study did indeed find more resistance (HIV with
reduced susceptibility to antiretrovirals) than expected.
But much of this result is not really surprising given the
study design. The patients selected were all in care in the
U.S. in early 1996, but had their blood drawn and virus
tested three years later in late 1998 to early 1999. With
this sampling, many of the patients would have been on
antiretrovirals for a long time, giving more time for
resistance to occur. Since all were in care in early 1996
and known at that time to have HIV, it is likely that many
of them started on suboptimal therapies. This selection
(plus the fact that resistance was tested for many drugs,
and just one positive test led to the volunteer being
counted as having resistant virus) may partly explain why
this study found much more resistance than other studies.

The groups that started treatment earlier -- including gay
men, and those with insurance -- had more resistance,
probably because they had more time for it to develop (as
well as more chance of having been exposed to the two-drug
or one-drug antiretroviral regimens no longer in use).

Could the new publicity on high prevalence of resistance
contribute to the arguments against providing
antiretroviral treatment in Africa? This study only looked
at the U.S. But it is reasonable to assume that if
treatment is introduced correctly in African countries, the
results of this U.S. study would not apply. There will be
less resistance than in the U.S., if patients are started
on modern regimens and managed correctly.

Also, the kinds of HIV that are not native to the U.S. (but
have been common for years in Africa and other parts of the
world) have not spread here to any large extent. Quite
likely the major reason is those at risk of HIV in the U.S.
are far more likely to get infected by a native virus,
which probably blocks infection by other HIV strains. So
the media image of resistant "superviruses" spreading from
Africa throughout the world is contrary to the facts
observed for years.

The right message to take from this study is that viral
resistance is a serious problem, and people should be more
careful to use antiretrovirals correctly. It is also
important to prevent transmission of resistant virus to
persons who are HIV-negative. For those already infected,
generally it is best to have HIV fully suppressed whenever
antiretrovirals are used, so that there is little or no
viral replication, and resistant virus cannot evolve. But
for many patients this goal is not feasible. For these
patients and for everyone else with HIV, we need new drugs
that are more effective, less toxic, and less susceptible
to viral resistance. We especially need new classes of
treatments, including new targets for antiretrovirals, and
immune-based therapies to help the body itself control HIV.

References

1. Richman DD, Bozzette S, Morton S, Chien S, Wrin T,
Dawson K, and Hellmann N. The prevalence of antiretroviral
drug resistance in the U.S.  41st International Conference
on Antimicrobial Agents and Chemotherapy, Chicago, December
18 [abstract LB-17].

2. Bozzettee SA, Berry SH, Duan N, Richman D and others.
The care of HIV-infected adults in the United States. THE
NEW ENGLAND JOURNAL OF MEDICINE. December 24, 1998; volume
339, number 26, pages 1897-1904.


*****Barcelona Conference Abstract, Scholarship Deadlines
Early 2002

The following deadlines are rapidly approaching for the XIV
International AIDS Conference, Barcelona, Spain, July 7-12,
2002:

* January 14: Abstract submissions if by paper or disk;

* January 21: Abstract submissions online
(http://www.aids2002.com);

* February 1: Scholarship applications.

See http://www.aids2002.com for application forms and more
information.


***** African-Americans and AIDS Conference, February 25-
26, Washington

The 2002 National Conference on African-Americans and AIDS
will be held at the DC Renaissance Hotel in Washington,
D.C.

Speakers include:

* Kweisi Mfume, president/CEO of The National Association
for the Advancement of Colored People;
* Beny J. Primm, M.D., The Addiction Research and Treatment
Corporation;
* Celia J. Maxwell, M.D., FACP, Howard University;
* Anthony S. Fauci, M.D., National Institutes of Health;
* Valerie Stone, M.D., Brown University;
* Phill Wilson, African-American HIV/AIDS Policy Training
Institute;
* Robert Fullilove, Ph.D., Columbia University
* Glenn Treisman, M.D., Ph.D., Johns Hopkins University.

"This Conference is designed for clinicians who care for
African-American patients infected with HIV/AIDS, nurses,
pharmacists, HIV/AIDS service organization professionals,
social workers, healthcare media, legislators, and other
allied health professionals concerned about HIV/AIDS in
African-Americans."

This year the conference must charge a $50 admission fee,
which includes breakfast and lunch. There are some
scholarships for people with HIV. Up to 15 hours of
Category 1 CME credit will be available.

For more information, including a full list of speakers,
see http://www.ncaaa.net


***** AIDS TREATMENT NEWS Denialist Series

In our last issue we completed our series of articles,
mostly by Bruce Mirken, answering the "AIDS denialist"
assertions that HIV is harmless (or does not exist), HIV
treatment should be avoided, HIV-related medical tests are
inaccurate and useless, etc. Here we have collected the
references and links to our articles so that the whole
series can be found more easily.

The first article in this series appeared in April 2000,
and the last article in December 2001. The first two
articles below are deliberately out of sequence, so that
our summary of what the series is about can be listed
first. The series actually began in the issue before the
summary.

As we stated in the summary, "Our concern is not the ideas-
-we agree that all sorts of ideas should be explored and
debated--but rather the direct translation of casual
speculation and debating points into the medical care of
patients with life-threatening illness."

The series:

"AIDS Denialists: How to Respond," by John S. James,
AIDS TREATMENT NEWS #342, May 5, 2000
http://www.aids.org/immunet/atn.nsf/page/a-342-10

"Answering the AIDS Denialists: CD4 (T-Cell) Counts, and
Viral Load," by Bruce Mirken, AIDS TREATMENT NEWS #341
http://www.aids.org/immunet/atn.nsf/page/a-341-02

"AIDS Treatment Improves Survival: Answering the 'AIDS
Denialists,' by Bruce Mirken, AIDS TREATMENT NEWS #350
http://www.aids.org/immunet/atn.nsf/page/i-350

"HIV Treatment and Survival: Easy Language Version," by
Bruce Mirken, AIDS TREATMENT NEWS #354
http://www.aids.org/immunet/atn.nsf/page/a-354-08
(This flyer shortens and simplifies the survival article in
issue #350. Agencies can reproduce it as an easy-to-read
backgrounder for clients.)

"Answering the AIDS Denialists: Is AIDS Real?," by Bruce
Mirken, AIDS TREATMENT NEWS #356
http://www.aids.org/immunet/atn.nsf/page/a-356-06

"Viral Load and T-Cell (CD4) Counts: Why They Matter," by
Bruce Mirken, AIDS TREATMENT NEWS #364
http://www.aids.org/immunet/atn.nsf/page/a-364-09
(Easy language version of the CD4 and viral load article in
issue #341, above.)

"HIV Testing 101 (Part 1 of 2)," by Bruce Mirken,
AIDS TREATMENT NEWS #374
http://www.aids.org/immunet/atn.nsf/page/a-374-05

"HIV Testing 101 (Part 2 of 2)," by Bruce Mirken,
AIDS TREATMENT NEWS #375
http://www.aids.org/immunet/atn.nsf/page/a-375-04

The following articles are not part of the same series, but
are related:

"Treatment Interruption: Experts Sound Cautious Note at San
Francisco Forum; Meeting Proceeds Despite Disruption," by
Bruce Mirken, AIDS TREATMENT NEWS #341
http://www.aids.org/immunet/atn.nsf/page/a-341-01
(This meeting on treatment interruption was invaded by
about a dozen AIDS denialists, resulting in minor injury to
a member of the staff of Project Inform, the meeting
organizer.)

"Durban Declaration on HIV and AIDS,"
AIDS TREATMENT NEWS #346
http://www.aids.org/immunet/atn.nsf/page/a-346-03

"Africa: Interview with South African High Court Justice
Edwin Cameron," by Bruce Mirken, AIDS TREATMENT NEWS #368
http://www.aids.org/immunet/atn.nsf/page/a-368-03


***** Medical Marijuana Grants: Application Deadlines
January 15, May 1, and September 1

On January 3 the Marijuana Policy Project in Washington
D.C. announced that grants up to $50,000 will be awarded to
"organizations and projects that articulate effective
tactics and strategies to regulate marijuana similarly to
alcohol and to make marijuana available for medical use.
Grants will not be awarded to hemp-related projects, state
ballot initiatives, or political campaigns." (But a major
focus will be changing marijuana laws in specific
jurisdictions -- especially passing medical marijuana bills
in Maryland, New Mexico, and Vermont.)

The deadline for the first round of grant submissions is
January 15, 2002, and the first round checks will be issued
by March 31, 2002. For those who miss the January 15
deadline, the deadlines for the next rounds are scheduled
for May 1 and September 1.

For more information and instructions for applying, see
http://www.mpp.org/grants/index.html Or contact the grants
department of the Marijuana Policy Project, 202-462-5747
ext. 270.


***** Buyers' Club List, December 2001

AIDS TREATMENT NEWS publishes a buyers' club list each
December. For a short overview and introduction to the
meaning, history, and services of these organizations, see
AIDS TREATMENT NEWS #309, December 18, 1998.

We focus on buyers' clubs specializing in HIV (we also
included Rainbow Grocery in San Francisco, because of its
extensive selection of supplements and excellent
information about them). All the organizations listed below
are nonprofit. Most can provide products by mail order.
Most have fact sheets or other information, and some have a
nutritionist or other expert available at certain times to
answer questions. Some offer financial assistance with
purchases if necessary. Most are open to the public, but
some require membership (which may require an annual fee,
or be restricted geographically or in other ways). Call
ahead for current information.

We have not listed medical marijuana buyers' clubs here.
The best way to find out about any in your area is by
referral from a local AIDS service organization, support
group, or healthcare professional.

Arizona

Being Alive Buyers' Club
http://www.apaz.org/ (click "Buyer's Club")
edgarr@...
1427 North Third St., Phoenix AZ 85004
602-253-2437, fax: 602-253-5577



Travis Wright Memorial Buyers' Club
Southern Arizona AIDS Foundation Buyers' Club
http://www.saaf.org/BChome.htm
info@...
375 S. Euclid Ave, Tucson AZ 85719
800-771-9054 or 520-628-7223
fax: 520-628-7222;     TTY: 800/367-8937

California

Rainbow Grocery Cooperative (20% PWA discount, with the
Helping Hand card)
http://www.rainbowgrocery.org/ (no products online 12/01)
vitamins@...
1745 Folsom St., San Francisco CA 94103
415-863-0620

Colorado

Denver Buyers' Club (PWA Coalition Colorado)
1290 Williams St., Suite 102
Mailing address: P.O. Box 300339, Denver CO 80203-0339
303-329-9379, fax: 303-329-9381,  pwacolo@...
www.pwacoalitionofcolorado.com (starting Feb. 2002)
Bilingual Spanish/English     TTY: thru operator

District of Columbia

Carl Vogel Center
http://www.carlvogelcenter.org
cvc@...
1012 14th St. NW, Suite 707, Washington DC 20005
202-638-0750, fax: 202-638-0749
Membership: annual cost $25 (includes a BIA test,  reduced
prices for massage acupuncture, educational symposium,
newsletter, reduced prices for supplements).

Georgia

AIDS Treatment Initiatives
http://www.aidstreatment.org
info@...
159 Ralph McGill Blvd. NE Suite 510, Atlanta GA 30308-3311
888-874-4845 or 404-659-2437
fax: 404-659-2438

Massachusetts

Treatment Information Network's/Boston Buyers' Club
http://www.vitatime.com/
bosbuyrclb@...
Boston Living Center, 29 Stanhope St., 3rd Floor
Boston MA 02116
800-435-5586, or 617-266-2223
fax: 617-450-9412

New York

DAAIR (Direct Access Alternative Information Resources)
http://www.daair.org
email: info@...
31 East 30th St. #2A, New York NY 10016
888-951-5433 or 212-725-6994
fax: 212-689-6471
Note: The largest buyers' club. Membership by sliding
scale, $5, $10, or $25 per year; new members receive
treatment information pack. Also, "Preventing and Managing
Side Effects and HIV Symptoms" is available at
http://www.daair.org (no membership required -- click the
Countering Toxicities button on the home page), or by mail
by request if necessary.

Texas

Houston Buyers' Club
http://www.houstonbuyersclub.com/
hbc@...
3400 Montrose Blvd. #605, Houston TX 77006
800-350-2392
713-520-5288, fax: 713-521-7419
Note: HOW TO MANAGE SIDE EFFECTS, a 48-page booklet by Lark
Lands, Michael Mooney, Nelson Vergel, and others is
available without charge. You can request a copy by phone,
mail, or email.


***** AIDS TREATMENT NEWS Index, 2001

20th year of AIDS    364
911    371
Abacavir    373
Access, international (see Global epidemic)
ACT UP Philadelphia    367
ADAP program    366
ADAP program    371
Africa (see also South Africa)
Africa -- home care    361
Africa    359
Africa    360
Africa    363
Africa    371
Africa    372
Africa    373
African American conference    376
African Americans    359
Agenerase    373
AIDS research -- 20 views    368
AIDS Treatment Activist Coalition    370
AIDSWatch    362
AmFAR HIV/AIDS TREATMENT DIRECTORY    363
AmFAR TREATMENT INSIDER    362
Amprenavir    373
Antibodies and HIV    365
Antibody testing    374
Antibody testing    375
Antiretrovirals list    372
ATAC    370
Barcelona (see International AIDS Conference)
Bioterrorism--immune research    373
Bone disease    366
Brazil    359
Bristol-Myers Squibb    361
Buenos Aires conference    368
Buenos Aires conference    369
Burkina Faso    363
Busch, Barry    367
Buyers' club list    376
Cameron, Justice Edwin    368
CD4 count    364
Civil society    365
Cohen, Jon    367
Coinfection (HIV and HCV)    371
Conference reports on Web    373
Counterfeit drugs    365
d4T+ddI    358
Denialists    364
Denialists    374
Denialists    375
Denialists, AIDS TREATMENT NEWS series    376
Developing countries (see Access, international)
Direct action    364
Doctors Without Borders (see MSF)
Doha    371
Drug donations    361
Efavirenz    362
Efavirenz    373
European parliament    363
Fact sheets    358
FDA    362
FDA    369
Fibrosis    370
Funding -- international (see Global epidemic)
Garlic    375
GB virus C    372
Gilead Sciences (see Tenofovir)
GlaxoSmithKline    360
GlaxoSmithKline    371
GlaxoSmithKline    372
Global epidemic    362
Global epidemic    363
Global epidemic    367
Global epidemic    369
Global epidemic    370
Global epidemic    372
Global epidemic    373
Guidelines    361
Heart disease    370
Hepatitis C    359
Hepatitis C    371
Hepatitis    375
HIV drugs    372
HIV incidence    359
HIV prevention    364
HIV resistance    368
HIV testing, part I of II    374
HIV testing, part II of II    375
Homocysteine    370
IAPAC    369
IAS Conference    368
IAS Conference    369
ICAAC conference    375
ICAAC conference    376
Immune-based treatment    360
Innate immune system    373
Intellectual property -- patent proposal    366
Intellectual property (see also Global epidemic)
Intellectual property    359
Intellectual property    360
Intellectual property    363
Intellectual property    371
Interaction, garlic & saquinavir    375
Intermittent treatment    375
International (see Global epidemic)
International AIDS Candlelight Memorial    364
International AIDS Conference    372
International AIDS Conference    376
Johns Hopkins Report    361
Kaletra    362
Kaletra    373
Liver (see Hepatitis)
Liver fibrosis    370
Malawi    371
Marijuana Policy Project    376
Maternal infant transmission    364
Maternal transmission lawsuit    374
Medical marijuana    376
Medscape    369
Merck    361
Merck    367
Mirken, Bruce    376
Mitochondrial toxicity    366
MSF    361
Names reporting    367
NATAF    370
Nevirapine    358
Nevirapine    374
New Mexico AIDS InfoNet    358
North American AIDS Treatment Action Forum    370
Pediatric AIDS    374
Pharmacokinetics    375
Pipeline (HIV drugs)    372
Post-exposure prophylaxis    358
Pregnancy    358
Protease inhibitors    370
Protease inhibitors    375
Research -- 20 views    368
Resistance conference    368
Resistance prevalence    376
Resistance tests    374
Retroviruses conference 2001    359
Retroviruses conference 2001    361
Retroviruses conference 2002    372
Richman, Douglas    376
Salvage therapy    362
San Francisco    359
Saquinavir    373
Saquinavir    375
Scondras, David    371
Social organization    367
South Africa    359
South Africa    360
South Africa    361
South Africa    364
South Africa    368
South Africa    374
STI (structured treatment interruption)    369
Structured intermittent therapy    375
Sustiva    362
Sustiva    373
Syringe prescription    364
T-20    373
TAC (Treatment Action Campaign)    374
TAG (Treatment Action Group)    364
TAG (Treatment Action Group)    369
T-cell (CD4) count    364
Tenofovir    360
Tenofovir    364
Tenofovir    370
Tenofovir    372
Tenofovir approved    373
Therapeutic drug monitoring    363
Trade rules    371
Treatment access    359
Treatment guidelines (see Guidelines)    361
Treatment interruption    369
Treatment vs. prevention controversy    362
Treatment vs. prevention controversy    365
Tuberculosis guidelines    371
Twinning organizations    363
UNGASS    359
UNGASS    365
UNGASS    366
UNGASS    367
United Nations (see UNGASS)
Vaccines    359
Vaccines    367
Viral load 6-day changes    374
Viral load    364
Viramune    374
ViroLogic    376
Women, treatment    368
Women, treatment    372
World AIDS Day    373
Ziagen    373

***** AIDS TREATMENT NEWS

Published twice monthly

Subscription and Editorial Office:
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   phone 800/TREAT-1-2 toll-free, or 215-546-3776
   fax 215-985-4952 (email is preferred)
   email: aidsnews@...
   useful AIDS links: http://www.aidsnews.org

Editor and Publisher: John S. James
Associate Editor: Tadd T. Tobias, R.N.

Statement of Purpose:
AIDS TREATMENT NEWS reports on experimental and standard
treatments, especially those available now. We interview
physicians, scientists, other health professionals, and
persons with AIDS or HIV; we also collect information from
meetings and conferences, medical journals, and computer
databases. Long-term survivors have usually tried many
different treatments, and found combinations that work for
them. AIDS TREATMENT NEWS does not recommend particular
therapies, but seeks to increase the options available.

AIDS TREATMENT NEWS is published 18 times per year, and
print copies are sent by first class mail. Email is
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To subscribe, you can call 800-TREAT-1-2 or 415-255-0588:
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ISSN # 1052-4207

Copyright 2001 by John S. James. Permission granted for
noncommercial reproduction, provided that our address and
phone number are included if more than short quotations are
used.

When we sent this email issue yesterday, the message text was deleted for
at least some recipients; only the attachment in PDF format was received.
Here we are re-sending the text, without the attachment.

John S. James, AIDS Treatment News



AIDS TREATMENT NEWS Issue #375, December 21, 2001
     phone 800-TREAT-1-2, or 215-546-3776

Contents

** Garlic Reduces Saquinavir Blood Levels 50%; May Affect
Other Drugs
Ordinary doses of a garlic supplement cut blood levels of
the protease inhibitor saquinavir in half, for reasons that
are largely unknown. Other protease inhibitors and other
antiretrovirals have not been tested. Patients and
physicians should be cautious about using garlic while on
any antiretroviral treatment, at least until more is known.

** NIH 7-Day On-Off Trial May Reduce Drug Side Effects,
Cost; Why It's Not Ready for Use
A 7-day on/off treatment regimen has kept HIV suppressed
for up to a year so far in carefully selected patients. But
the findings do not apply at all to most patients, and for
them the regimen is likely to be harmful. Researchers and
doctors agree that this approach is not ready for use
outside of carefully controlled studies.

**AIDS and Hepatitis News from ICAAC Conference: Phone
Overview, Web Reports
The most important news on both AIDS and hepatitis
treatment, from the ICAAC conference (December 16-19 in
Chicago), is available through a one-hour telephone
playback of a discussion by experts. Also, we show where to
find in-depth reports on the Web.

** HIV Testing 101 (Part 2 of 2)
This article looks at the reliability of HIV testing, and
answers arguments of AIDS denialists who say that HIV has
not been proven to exist, or does not cause AIDS, and that
HIV tests are unreliable. It also looks at detecting acute
HIV infection, the "detuned" antibody test for detecting
recent infection, and some of the issues around consent,
confidentiality, and anonymous HIV testing.

** AIDS TREATMENT NEWS New Publication Schedule
Starting in January we will publish 18 issues per year,
instead of twice monthly.


***** Garlic Reduces Saquinavir Blood Levels 50%; May
Affect Other Drugs

by John S. James

A study at the U.S. National Institute of Allergy and
Infectious Diseases found that garlic supplements reduced
blood levels of the protease inhibitor saquinavir by 51%.
The garlic preparation, an amount equivalent to about two
4-gram cloves per day, was taken for 21 days by healthy
HIV-negative volunteers. Then saquinavir was given for four
days, and compared to a baseline four-day saquinavir dosing
before the garlic was started.(1)

Later, after a 10-day washout with no saquinavir and no
garlic, the volunteers were given a third 4-day dose of
saquinavir. Even after 10 days off garlic, the saquinavir
blood levels after a third four-day dosing only reached 60-
70% of the original baseline blood levels -- indicating a
persistent effect of the garlic.

Other findings of this study are complex, and the mechanism
of this interaction is not clear. It probably involves the
body's CYP450 enzyme system, yet the garlic appears to be
affecting the oral bioavailability of saquinavir, not its
elimination from the body. And there were two distinct
groups of volunteers in how the garlic affected them. Most
had a big decline in saquinavir levels after the 21 days of
garlic use, with good recovery after the 10-day washout
period. But three volunteers did not have a significant
decline in saquinavir blood levels during the 21 days of
garlic use -- but did have a big drop after the washout.

It is not clear how other drugs besides saquinavir will be
affected. One study failed to find a statistically
significant interaction with ritonavir, which affects the
CYP450 enzyme system differently; however, that study used
only four days of garlic treatment.

Saquinavir study co-author Judith Falloon, M.D., said, "We
saw a definite, prolonged interaction. The clear
implication is that doctors and patients should be cautious
about using garlic supplements during HIV therapy."

Comment: Do Companies Care
If Their Drugs Work?

Clearly we need more drug interaction studies to guide
physicians and patients in how to use medications --
especially when there is reason to suspect an interaction,
or when a supplement is in wide use by those taking a
certain medication. Drug interaction studies are usually
small, inexpensive, and easy to do; this one, for example,
had only 10 volunteers (six women and four men -- one woman
was excluded from analysis due to lack of adherence), and
each volunteer took the drug for a total of 12 days,
reducing both side effects and expense.

We are fortunate that the U.S. National Institutes of
Health tested garlic, a supplement widely used by people
with HIV -- and found that it cut blood levels of
saquinavir in half. This interaction could lead to drug
failure and development of viral resistance, just as if
patients cut their doses in half before taking them.
Effects of garlic (and most other supplements) on other
protease inhibitors are currently unknown.

While NIH should be commended, we need to ask why
manufacturers don't do more interaction testing as a matter
of course. Antiretrovirals are premium products with huge
profit margins, costing thousands of dollars a year --
prices supposedly financing research and development. And
more importantly, these are critical medicines that can
determine whether patients live or die.

Yes, there are many supplements and even more approved
drugs, but not very many are widely used by persons with
HIV. And serious interactions are often fairly predictable
from what is already known about the pharmacology of the
drugs and supplements. Interaction testing is usually fast
and cheap -- and none need be done on antiretrovirals that
don't make it, only on those soon to be approved and
marketed. What is needed is ongoing strategic initiative to
identify potentially serious problems and spend a little
money to head them off before they happen -- not years
later.

Aside from the impact on human health, testing the most
obvious potential interactions would contribute to the
bottom line. Companies don't benefit when their drugs fail
and patients stop using them, and their doctors and other
doctors become less likely to choose those drugs for other
patients. After paying all the costs of developing
antiretrovirals and marketing them, when companies finally
get a chance to make a profit, they are throwing much of it
away.

The problem is that corporations do not act in their long-
term interests unless they are organized to do so. Groups
within companies are afraid of generating bad news. They
may not realize that this bad news is really good news,
because it allows them to make their drug more successful
in the real world by targeting those patients most likely
to benefit.

References

1. Piscatelli SC, Burstein AH, Welden N, Gallicano KD and
Falloon J. The Effects of Garlic Supplements on the
Pharmacokinetics of Saquinavir. CLINICAL INFECTIOUS
DISEASES. January 15, 2001; volume 34.


***** NIH 7-Day On-Off Trial

May Reduce Drug Side Effects, Cost; Why It's Not Ready for
Use

by John S. James

On December 4 researchers at the U.S. National Institute of
Allergy and Infectious Diseases published an early report
of their 7-day-on/7-day-off trial of antiretrovirals.(1)
This study found that a handful of selected patients, with
a selected antiretroviral regimen, were able to use the
drugs intermittently, with a schedule of 7 days on and 7
days off. They were able to maintain viral suppression for
32-68 weeks so far, with only half the drug use and clearly
reduced side effects. The researchers emphasize that this
regimen is not ready for use outside of controlled clinical
trials. The reasons are explained in the article, but not
in most news reports.

The Purpose of the Trial

The goal of this trial is to see if it is possible to
maintain HIV suppression with a reduced amount of
antiretroviral drugs, in order to reduce toxicity and cost.
There is no effort in this study to improve the treatment
by allowing some return of the virus in order to stimulate
the body's immune system against it.

Instead, this trial started with the observation that when
HIV is very well suppressed by antiretrovirals, and the
treatment is interrupted, it usually takes 2-3 weeks for
detectable virus to return. Since there is so little HIV
replication in that first week (assuming, of course, that
the virus had been very well controlled when treatment was
stopped), there should be little chance for the virus to
develop resistance in that first week off the drugs. Then
the treatment would be started again, keeping the virus
suppressed. So far it seems to be working in this 10-
patient proof-of-concept trial.

Cholesterol decreased 22% in this study, and triglycerides
decreased 51%, after 24 weeks of intermittent treatment --
probably because patients had less exposure to the drugs.
The researchers do not expect much change in lipodystrophy,
however.

Comment: Why It's Not Ready to Use

We are concerned that people may start trying treatment
interruptions without medical advice, in cases when it is
entirely inappropriate for them. Here are some facts to
consider:

* First and most important, all the volunteers in this
trial had very well suppressed virus before they began.
Viral load had to be below 500 copies for more than six
months, and below 50 copies when they started the trial;
also, they had to have a CD4 count of greater than 300. If
someone tried this intermittent schedule when their virus
was not suppressed, the whole idea of this trial would not
apply. Instead, the frequent interruptions would cause
periods of inadequate drug levels while the virus was
replicating -- excellent conditions for the development of
viral resistance.

* Also, all the volunteers in this trial received a four-
drug regimen "selected to provide potent antiretroviral
therapy with a high genetic barrier to the development of
drug resistance" -- d4T, 3TC, indinavir, and a small dose
of ritonavir (mainly to keep the indinavir in the blood
longer). As an extra precaution, the last dose of ritonavir
before each treatment interruption was not given, in order
to clear the indinavir from the body faster.

* In addition, a research study can test viral load and
other blood levels frequently, to detect treatment failure.
Once a patient waited only three extra days to resume
treatment (10 days instead of 7), and as a result had a
viral load of over 3,000 copies. He was able to continue
the study and regain viral suppression, but this case
illustrates that control of HIV with this treatment
schedule may leave little room for error.

* We still need to know whether this schedule works in
longer-term use, whether it works in more advanced
patients, and whether it can be used with other
antiretroviral regimens. But the proof-of-concept trial
suggests that when more is known, intermittent treatment
might significantly reduce both cost and toxicity of
antiretroviral therapy, and help to make it available in
developing countries where cost is a major obstacle.

References

1. Dybul M, Chun T, Yoder C, and others. Short-cycle
structured intermittent treatment of chronic HIV infection
with highly active antiretroviral therapy: Effects on
virologic, immunologic, and toxicity parameters.
PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES USA, Early
Edition online (December 4, 2001).


***** AIDS and Hepatitis News from ICAAC Conference: Phone
Overview, Web Reports

A one-hour review of the most important AIDS and hepatitis
news at the 41st Conference on Antimicrobial Agents and
Chemotherapy (ICAAC, Chicago, December 16-19) is available
without charge through a toll-free phone number. You can
hear a recording of a one-hour teleconference with leading
experts, which took place in the evening of December 18.

To hear the recording, call 800-428-6051; when asked to
enter a code, it is 212440. No registration is required.

This teleconference was organized by HIVandHepatitis.com,
with unrestricted educational grants from Roche
Laboratories, Inc., and Bristol-Myers Squibb Corporation.

Web Reports

Original written reports are being posted on several Web
sites, including:
http://www.thebody.com
http://hiv.medscape.com/ (one-time registration required,
but it's quick and free)
http://www.hivandhepatitis.com
http://www.natap.org

Also, you can find the official site through
http://www.icaac.org -- select "Annual ICAAC", then select
"Program and Abstracts online" for the 41st ICAAC (the 2001
conference). You will need to give your email address and
choose a password to use this site. There is plenty of
AIDS-related information; for example, a search for 'HIV'
in the abstract text returns almost 200 abstracts. You
might need to create an "itinerary" to view the abstracts;
if so, the software can be confusing.


***** HIV Testing 101 (Part 2 of 2)

by Bruce Mirken

[Note: Part 1 of this article appeared in AIDS TREATMENT
NEWS #374, November 23, 2001.]

Detecting Acute HIV Infection

Shortly after getting infected with HIV, many patients have
an acute (or "primary") HIV infection, a period of flu-like
illness with symptoms like fever and malaise that could be
caused by influenza or many other diseases. Many scientists
and physicians believe it is important to treat during
acute this HIV infection (provided, of course, that it gets
diagnosed then). But there are still questions remaining
about treating acute infection.(1,2)

To confirm an acute HIV infection in symptomatic
individuals with potential HIV risk factors, current
guidelines(2) recommend use of HIV RNA (viral load) tests.
[The regular HIV antibody test will not detect acute HIV
infection because the patient is still in the "window
period" before antibodies have been produced.] False
positives can occur with viral load tests, but a review of
the data in the August, 1999 AMERICAN FAMILY PHYSICIAN(1)
suggests it is usually possible to differentiate these from
the real thing: "During the symptomatic phase of acute HIV
infection, the viral RNA shows in excess of 50,000 copies
per mL. Three instances of false-positive HIV-1 RNA tests
have been reported; in each instance, however, the person
was not having symptoms and the viral load [reported] was
less than 2,000 copies per ml. The presence of high-titer
HIV-1 RNA (more than 50,000 copies per mL) in the absence
of HIV antibodies establishes diagnosis of acute HIV
infection."

At present there is no viral load test approved by the FDA
for the purpose of diagnosing HIV infection in individual
patients. In September the FDA did approve a viral load
test developed by National Genetics Institute for screening
large pools of donated blood plasma.

If viral load testing is not available, current treatment
guidelines(2) recommend testing for p24 antigen, a viral
protein. In either case, the diagnosis should be confirmed
by antibody testing once the window period has elapsed.

"Detuned" ELISA

A variation of standard antibody testing, presently
approved in the U.S. only for research, is the
sensitive/less sensitive or "detuned" ELISA. The detuned
test takes advantage of the fact that antibody levels rise
in a predictable pattern during roughly the first four to
six months after infection, eventually reaching a plateau
that often stays roughly constant for many years.

Current ELISAs can detect relatively low levels of
antibodies. The detuned testing approach involves taking
samples that are confirmed HIV-positive by these tests, but
then retesting them with a less sensitive, diluted ELISA.
This less sensitive test can only detect antibodies at the
higher levels achieved during the period six months or more
after infection. Thus, the detuned approach distinguishes
between recent and established infections, so it is a
potentially valuable tool for epidemiologists trying to
chart the pattern of new infections. It is not used in
patient care at this time.

Accuracy of Antibody Testing --
and Denialist Arguments

Constantine(3) sums up the general consensus among experts
and institutions such as the CDC when he says "The antibody
tests are nearly 100 percent sensitive (unless a person is
in the window period) and about 99 percent specific." Such
levels of accuracy have been documented in a number of
studies, including periodic evaluations of commercially
available test kits conducted by the World Health
Organization.

Still, AIDS denialists (the self-styled "AIDS dissidents"
who claim that HIV is either harmless or doesn't exist)
continue to claim that HIV antibody tests are unreliable.
Many of their arguments seem to derive from a series of
articles written by Christine Johnson in the mid-1990s,
several of which are available on denialist web
sites.(4,5,6)

Johnson's argument boils down to two key points: 1) HIV has
never been properly isolated, so the HIV proteins used in
the tests haven't been proven to actually come from HIV, 2)
Even if HIV is real, the proteins are not unique and cross-
react with many other antigens, rendering a positive result
meaningless. Johnson's list of some 60 factors she
describes as "known to cause false-positive HIV-antibody
test results" turns up regularly in denialist literature.

The claim that HIV has never been properly isolated, based
on the writing of a group in Perth, Australia, is too
technical and complex to examine thoroughly here. However,
it is elegantly demolished in Michael Coon's article, "HIV,
AIDS and the Distortion of Science," available on the AEGIS
web site.(7) In short, Coon argues that the Perth Group set
up artificial, phony criteria for "proof" of HIV's
isolation that bear no relation to how virology works in
the real world.

The second argument, though, contains a grain of truth.
Cross-reactions are possible, and a number of factors can,
on occasion, produce false-positive HIV antibody test
results. What Johnson fails to address in any detail is
that such effects are typically transient and rare,
affecting few individuals.

For example, one well-known cause of false-positives
Johnson lists is influenza vaccination.(8,9) But she
neglects to mention that a key reference she cites
described the phenomenon as "infrequent" and "of short
duration," while in another only 10 false-positives were
found among 133,000 individuals who had flu shots prior to
testing, with half of those reverting to negative within
six months.(9)

Constantine adds, "I doubt very much that it has been
firmly documented that 60 factors can interfere with
antibody tests. In fact, it has been long sought to try and
identify the causes of false positive results, and only a
few have really been documented to consistently interfere
(e.g. pregnancy, certain autoimmune diseases, some
infectious diseases). However, even these do not
consistently cause problems with the tests... There are
very few false positives that can't be resolved with
further testing."

Consent, Anonymity, and Counseling

(1) Anonymous Testing

Prior to HIV, blood testing was considered a routine
procedure, with such minimal dangers that formal informed
consent was rarely required. But because HIV presented
massive psychosocial risks, from employment discrimination
to rejection by family and reduced access to health care,
special procedures were widely adopted.(10) These included
specific informed consent and pre- and post-test
counseling. Many states set up test sites where people
could get tested anonymously, without ever giving their
name.

Anonymous testing (other than the home test, below) was
never universally available, Morin notes, but was and is
offered in many places, despite the recent move by numerous
states to adopt a system of names-based HIV reporting (a
few, including California, are implementing HIV reporting
via codes that don't reveal the person's name). The CDC and
others urged that the option for anonymous testing should
be kept available, believing fear of disclosure would keep
some from being tested, and most states have followed this
recommendation.

Because local laws and procedures vary, Morin recommends
that anyone concerned about anonymity or disclosure contact
their local health department to check. A number of AIDS
service organizations operate hotlines, which should also
be able to provide this information.

Those living in areas with no anonymous test sites can
still be tested anonymously via home collection test kits,
which are sold in many drug stores. Introduced in the mid-
'90s, the kits were controversial because counseling is
provided by telephone rather than in person. Morin says
fears that telephone counseling would prove inadequate
haven't been borne out, but sales of the kits have been
less than expected. Still, "the FDA ruled that you cannot
bar their sale in any state, so even in states that don't
have anonymous testing people can use home test kits to
anonymously be tested," he says.

But, he adds, things change when the individual seeks
treatment: "If you go to your doctor and the doctor does a
viral load test, you get reported through the viral load
test to the health department. So there's no way to keep
treatment for HIV anonymous."

(2) Consent and Counseling

As with anonymity, requirements for consent and counseling
vary from state to state. Most, but not all, states require
specific informed consent -- sometimes in writing -- for
HIV testing. Approximately one-fifth of states require pre-
test counseling, with many listing specifically what that
counseling must include. The U.S. Department of Health and
Human Services recommends that all HIV testing include
counseling that covers the test itself, basic information
about HIV and AIDS, how to avoid spreading the virus, the
confidentiality of the results, the possible impact of the
results on the person being tested, and discussion of to
whom results should be disclosed, such as sex or needle-
sharing partners.(11) Counselors should also be able to
give referrals to medical and psychosocial support
services.

Counseling and consent procedures vary greatly, remain
controversial and may continue to change. Even states that
require informed consent may allow HIV testing without
consent in special circumstances. For example, many permit
involuntary testing of a patient when health workers have
been exposed to the person's blood. Some test prisoners or
people accused of sex crimes, and at least two, New York
and Connecticut, require mandatory testing of newborns,
which indirectly reveals the mother's HIV status, but does
not tell if the infant has been infected.

In October 2000 the Institute of Medicine recommended that
HIV testing be included as a routine part of prenatal care.
Women would be informed of the test and could opt out, but
specific consent would not be required. Thus far the U.S.
Public Health Service has stopped short of urging an end to
informed consent in such cases, simply suggesting that
providers recommend HIV testing to all pregnant patients.

References

1. Perlmutter, Barbara Lee et al, "How to Recognize and
Treat Acute HIV Syndrome," AMERICAN FAMILY PHYSICIAN,
August, 1999, http://www.aafp.org/afp/990800ap/535.html.

2. U.S. Public Health Service, "Guidelines for the Use of
Antiretroviral Agents in HIV-Infected Adults and
Adolescents" (August 13, 2001),
http://www.hivatis.org/trtgdlns.html.

3. Constantine, Niel, "HIV Antibody Assays," HIV KNOWLEDGE
BASE, HIV InSite Sept. 2001,
http://hivinsite.ucsf.edu/InSite.jsp?page=kb-02-02-01.

4. Johnson, Christine, "Whose Antibodies Are They Anyway?"
CONTINUUM, Sept./Oct., 1996,
http://www.virusmyth.net/aids/data/cjtestfp.htm.

5. Johnson, Christine, "Is Anybody Really Positive?" HEAL
MAGAZINE, 1995,
http://www.virusmyth.net/aids/data/chjtests2.htm

6. Johnson, Christine, "Playing Russian Roulette in the
Laboratory," Virusmyth,
http://www.virusmyth.net/aids/data/chjroulette.htm.

7. Coon, Michael, "HIV, AIDS and the Distortion of
Science," Misc Health AIDS, August, 2000,
http://www.aegis.org/topics/hiv_exist.html.

8. MacKenzie, William, et al, "Multiple False-positive
Serologic Tests for HIV, HTLV-1 and Hepatitis C Following
Influenza Vaccination, 1991," JOURNAL OF THE AMERICAN
MEDICAL ASSOCIATION, Vol. 268, No. 8, Aug. 26, 1992, p.
1015-1017.

9. Arnold, NL, and others. "Donor Follow-up of Influenza
Vaccine-Related Multiple Viral Enzyme Immunoassay
Reactivity," VOX SANG, Vol. 67, No. 2, 1994, p. 191-194.

10. Wolf, Leslie, and Lo, Bernard, "Ethical Dimensions of
HIV/AIDS," AIDS KNOWLEDGE BASE, HIV InSite,
http://hivinsite.ucsf.edu/InSite.jsp?page=kb-08-01-05.

11. U.S. Department of Health and Human Services,
"Voluntary HIV Counseling and Testing: Facts, Issues and
Answers,"
http://hivinsite.ucsf.edu/InSite.jsp?doc=2098.2099&page=pr-04-03.

12. Food and Drug Administration, "HIV and AIDS,"
http://www.fda.gov/oashi/aids/test.html (this regularly-
updated page contains information about FDA actions
relating to HIV-related tests).


***** AIDS TREATMENT NEWS New Publication Schedule

by John S. James

AIDS TREATMENT NEWS has traditionally published 24 issues
per year. But in 2001 we ran behind and will only publish
19 issues.

Starting in 2002 we are changing our publication frequency
-- from twice monthly to 18 issues per year. We may publish
more than 18 issues.

Enough news is happening today to fill several newsletters,
and we could easily write 24 issues per year. The problem
is information overload. Because so much work is being done
now, there is more background and context that reflects on
the importance and credibility of research findings and
other news. The most important reporting today will need
time for investigating and understanding this background.


***** AIDS TREATMENT NEWS

Published twice monthly

Subscription and Editorial Office:
   1233 Locust St., 5th floor
   Philadelphia, PA 19107
   phone 800/TREAT-1-2 toll-free, or 215-546-3776
   fax 215-985-4952 (email is preferred)
   email: aidsnews@...
   useful AIDS links: http://www.aidsnews.org

Editor and Publisher: John S. James
Associate Editor: Tadd T. Tobias, R.N.

Statement of Purpose:
AIDS TREATMENT NEWS reports on experimental and standard
treatments, especially those available now. We interview
physicians, scientists, other health professionals, and
persons with AIDS or HIV; we also collect information from
meetings and conferences, medical journals, and computer
databases. Long-term survivors have usually tried many
different treatments, and found combinations that work for
them. AIDS TREATMENT NEWS does not recommend particular
therapies, but seeks to increase the options available.

AIDS TREATMENT NEWS is published 18 times per year, and
print copies are sent by first class mail. Email is
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To subscribe, you can call 800-TREAT-1-2 or 415-255-0588:
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Copyright 2001 by John S. James. Permission granted for
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--
John S. James
AIDS Treatment News
http://www.aidsnews.org

AIDS TREATMENT NEWS Issue #375, December 21, 2001
     phone 800-TREAT-1-2, or 215-546-3776

Contents

** Garlic Reduces Saquinavir Blood Levels 50%; May Affect
Other Drugs
Ordinary doses of a garlic supplement cut blood levels of
the protease inhibitor saquinavir in half, for reasons that
are largely unknown. Other protease inhibitors and other
antiretrovirals have not been tested. Patients and
physicians should be cautious about using garlic while on
any antiretroviral treatment, at least until more is known.

** NIH 7-Day On-Off Trial May Reduce Drug Side Effects,
Cost; Why It's Not Ready for Use
A 7-day on/off treatment regimen has kept HIV suppressed
for up to a year so far in carefully selected patients. But
the findings do not apply at all to most patients, and for
them the regimen is likely to be harmful. Researchers and
doctors agree that this approach is not ready for use
outside of carefully controlled studies.

**AIDS and Hepatitis News from ICAAC Conference: Phone
Overview, Web Reports
The most important news on both AIDS and hepatitis
treatment, from the ICAAC conference (December 16-19 in
Chicago), is available through a one-hour telephone
playback of a discussion by experts. Also, we show where to
find in-depth reports on the Web.

** HIV Testing 101 (Part 2 of 2)
This article looks at the reliability of HIV testing, and
answers arguments of AIDS denialists who say that HIV has
not been proven to exist, or does not cause AIDS, and that
HIV tests are unreliable. It also looks at detecting acute
HIV infection, the "detuned" antibody test for detecting
recent infection, and some of the issues around consent,
confidentiality, and anonymous HIV testing.

** AIDS TREATMENT NEWS New Publication Schedule
Starting in January we will publish 18 issues per year,
instead of twice monthly.


***** Garlic Reduces Saquinavir Blood Levels 50%; May
Affect Other Drugs

by John S. James

A study at the U.S. National Institute of Allergy and
Infectious Diseases found that garlic supplements reduced
blood levels of the protease inhibitor saquinavir by 51%.
The garlic preparation, an amount equivalent to about two
4-gram cloves per day, was taken for 21 days by healthy
HIV-negative volunteers. Then saquinavir was given for four
days, and compared to a baseline four-day saquinavir dosing
before the garlic was started.(1)

Later, after a 10-day washout with no saquinavir and no
garlic, the volunteers were given a third 4-day dose of
saquinavir. Even after 10 days off garlic, the saquinavir
blood levels after a third four-day dosing only reached 60-
70% of the original baseline blood levels -- indicating a
persistent effect of the garlic.

Other findings of this study are complex, and the mechanism
of this interaction is not clear. It probably involves the
body's CYP450 enzyme system, yet the garlic appears to be
affecting the oral bioavailability of saquinavir, not its
elimination from the body. And there were two distinct
groups of volunteers in how the garlic affected them. Most
had a big decline in saquinavir levels after the 21 days of
garlic use, with good recovery after the 10-day washout
period. But three volunteers did not have a significant
decline in saquinavir blood levels during the 21 days of
garlic use -- but did have a big drop after the washout.

It is not clear how other drugs besides saquinavir will be
affected. One study failed to find a statistically
significant interaction with ritonavir, which affects the
CYP450 enzyme system differently; however, that study used
only four days of garlic treatment.

Saquinavir study co-author Judith Falloon, M.D., said, "We
saw a definite, prolonged interaction. The clear
implication is that doctors and patients should be cautious
about using garlic supplements during HIV therapy."

Comment: Do Companies Care
If Their Drugs Work?

Clearly we need more drug interaction studies to guide
physicians and patients in how to use medications --
especially when there is reason to suspect an interaction,
or when a supplement is in wide use by those taking a
certain medication. Drug interaction studies are usually
small, inexpensive, and easy to do; this one, for example,
had only 10 volunteers (six women and four men -- one woman
was excluded from analysis due to lack of adherence), and
each volunteer took the drug for a total of 12 days,
reducing both side effects and expense.

We are fortunate that the U.S. National Institutes of
Health tested garlic, a supplement widely used by people
with HIV -- and found that it cut blood levels of
saquinavir in half. This interaction could lead to drug
failure and development of viral resistance, just as if
patients cut their doses in half before taking them.
Effects of garlic (and most other supplements) on other
protease inhibitors are currently unknown.

While NIH should be commended, we need to ask why
manufacturers don't do more interaction testing as a matter
of course. Antiretrovirals are premium products with huge
profit margins, costing thousands of dollars a year --
prices supposedly financing research and development. And
more importantly, these are critical medicines that can
determine whether patients live or die.

Yes, there are many supplements and even more approved
drugs, but not very many are widely used by persons with
HIV. And serious interactions are often fairly predictable
from what is already known about the pharmacology of the
drugs and supplements. Interaction testing is usually fast
and cheap -- and none need be done on antiretrovirals that
don't make it, only on those soon to be approved and
marketed. What is needed is ongoing strategic initiative to
identify potentially serious problems and spend a little
money to head them off before they happen -- not years
later.

Aside from the impact on human health, testing the most
obvious potential interactions would contribute to the
bottom line. Companies don't benefit when their drugs fail
and patients stop using them, and their doctors and other
doctors become less likely to choose those drugs for other
patients. After paying all the costs of developing
antiretrovirals and marketing them, when companies finally
get a chance to make a profit, they are throwing much of it
away.

The problem is that corporations do not act in their long-
term interests unless they are organized to do so. Groups
within companies are afraid of generating bad news. They
may not realize that this bad news is really good news,
because it allows them to make their drug more successful
in the real world by targeting those patients most likely
to benefit.

References

1. Piscatelli SC, Burstein AH, Welden N, Gallicano KD and
Falloon J. The Effects of Garlic Supplements on the
Pharmacokinetics of Saquinavir. CLINICAL INFECTIOUS
DISEASES. January 15, 2001; volume 34.


***** NIH 7-Day On-Off Trial

May Reduce Drug Side Effects, Cost; Why It's Not Ready for
Use

by John S. James

On December 4 researchers at the U.S. National Institute of
Allergy and Infectious Diseases published an early report
of their 7-day-on/7-day-off trial of antiretrovirals.(1)
This study found that a handful of selected patients, with
a selected antiretroviral regimen, were able to use the
drugs intermittently, with a schedule of 7 days on and 7
days off. They were able to maintain viral suppression for
32-68 weeks so far, with only half the drug use and clearly
reduced side effects. The researchers emphasize that this
regimen is not ready for use outside of controlled clinical
trials. The reasons are explained in the article, but not
in most news reports.

The Purpose of the Trial

The goal of this trial is to see if it is possible to
maintain HIV suppression with a reduced amount of
antiretroviral drugs, in order to reduce toxicity and cost.
There is no effort in this study to improve the treatment
by allowing some return of the virus in order to stimulate
the body's immune system against it.

Instead, this trial started with the observation that when
HIV is very well suppressed by antiretrovirals, and the
treatment is interrupted, it usually takes 2-3 weeks for
detectable virus to return. Since there is so little HIV
replication in that first week (assuming, of course, that
the virus had been very well controlled when treatment was
stopped), there should be little chance for the virus to
develop resistance in that first week off the drugs. Then
the treatment would be started again, keeping the virus
suppressed. So far it seems to be working in this 10-
patient proof-of-concept trial.

Cholesterol decreased 22% in this study, and triglycerides
decreased 51%, after 24 weeks of intermittent treatment --
probably because patients had less exposure to the drugs.
The researchers do not expect much change in lipodystrophy,
however.

Comment: Why It's Not Ready to Use

We are concerned that people may start trying treatment
interruptions without medical advice, in cases when it is
entirely inappropriate for them. Here are some facts to
consider:

* First and most important, all the volunteers in this
trial had very well suppressed virus before they began.
Viral load had to be below 500 copies for more than six
months, and below 50 copies when they started the trial;
also, they had to have a CD4 count of greater than 300. If
someone tried this intermittent schedule when their virus
was not suppressed, the whole idea of this trial would not
apply. Instead, the frequent interruptions would cause
periods of inadequate drug levels while the virus was
replicating -- excellent conditions for the development of
viral resistance.

* Also, all the volunteers in this trial received a four-
drug regimen "selected to provide potent antiretroviral
therapy with a high genetic barrier to the development of
drug resistance" -- d4T, 3TC, indinavir, and a small dose
of ritonavir (mainly to keep the indinavir in the blood
longer). As an extra precaution, the last dose of ritonavir
before each treatment interruption was not given, in order
to clear the indinavir from the body faster.

* In addition, a research study can test viral load and
other blood levels frequently, to detect treatment failure.
Once a patient waited only three extra days to resume
treatment (10 days instead of 7), and as a result had a
viral load of over 3,000 copies. He was able to continue
the study and regain viral suppression, but this case
illustrates that control of HIV with this treatment
schedule may leave little room for error.

* We still need to know whether this schedule works in
longer-term use, whether it works in more advanced
patients, and whether it can be used with other
antiretroviral regimens. But the proof-of-concept trial
suggests that when more is known, intermittent treatment
might significantly reduce both cost and toxicity of
antiretroviral therapy, and help to make it available in
developing countries where cost is a major obstacle.

References

1. Dybul M, Chun T, Yoder C, and others. Short-cycle
structured intermittent treatment of chronic HIV infection
with highly active antiretroviral therapy: Effects on
virologic, immunologic, and toxicity parameters.
PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES USA, Early
Edition online (December 4, 2001).


***** AIDS and Hepatitis News from ICAAC Conference: Phone
Overview, Web Reports

A one-hour review of the most important AIDS and hepatitis
news at the 41st Conference on Antimicrobial Agents and
Chemotherapy (ICAAC, Chicago, December 16-19) is available
without charge through a toll-free phone number. You can
hear a recording of a one-hour teleconference with leading
experts, which took place in the evening of December 18.

To hear the recording, call 800-428-6051; when asked to
enter a code, it is 212440. No registration is required.

This teleconference was organized by HIVandHepatitis.com,
with unrestricted educational grants from Roche
Laboratories, Inc., and Bristol-Myers Squibb Corporation.

Web Reports

Original written reports are being posted on several Web
sites, including:
http://www.thebody.com
http://hiv.medscape.com/ (one-time registration required,
but it's quick and free)
http://www.hivandhepatitis.com
http://www.natap.org

Also, you can find the official site through
http://www.icaac.org -- select "Annual ICAAC", then select
"Program and Abstracts online" for the 41st ICAAC (the 2001
conference). You will need to give your email address and
choose a password to use this site. There is plenty of
AIDS-related information; for example, a search for 'HIV'
in the abstract text returns almost 200 abstracts. You
might need to create an "itinerary" to view the abstracts;
if so, the software can be confusing.


***** HIV Testing 101 (Part 2 of 2)

by Bruce Mirken

[Note: Part 1 of this article appeared in AIDS TREATMENT
NEWS #374, November 23, 2001.]

Detecting Acute HIV Infection

Shortly after getting infected with HIV, many patients have
an acute (or "primary") HIV infection, a period of flu-like
illness with symptoms like fever and malaise that could be
caused by influenza or many other diseases. Many scientists
and physicians believe it is important to treat during
acute this HIV infection (provided, of course, that it gets
diagnosed then). But there are still questions remaining
about treating acute infection.(1,2)

To confirm an acute HIV infection in symptomatic
individuals with potential HIV risk factors, current
guidelines(2) recommend use of HIV RNA (viral load) tests.
[The regular HIV antibody test will not detect acute HIV
infection because the patient is still in the "window
period" before antibodies have been produced.] False
positives can occur with viral load tests, but a review of
the data in the August, 1999 AMERICAN FAMILY PHYSICIAN(1)
suggests it is usually possible to differentiate these from
the real thing: "During the symptomatic phase of acute HIV
infection, the viral RNA shows in excess of 50,000 copies
per mL. Three instances of false-positive HIV-1 RNA tests
have been reported; in each instance, however, the person
was not having symptoms and the viral load [reported] was
less than 2,000 copies per ml. The presence of high-titer
HIV-1 RNA (more than 50,000 copies per mL) in the absence
of HIV antibodies establishes diagnosis of acute HIV
infection."

At present there is no viral load test approved by the FDA
for the purpose of diagnosing HIV infection in individual
patients. In September the FDA did approve a viral load
test developed by National Genetics Institute for screening
large pools of donated blood plasma.

If viral load testing is not available, current treatment
guidelines(2) recommend testing for p24 antigen, a viral
protein. In either case, the diagnosis should be confirmed
by antibody testing once the window period has elapsed.

"Detuned" ELISA

A variation of standard antibody testing, presently
approved in the U.S. only for research, is the
sensitive/less sensitive or "detuned" ELISA. The detuned
test takes advantage of the fact that antibody levels rise
in a predictable pattern during roughly the first four to
six months after infection, eventually reaching a plateau
that often stays roughly constant for many years.

Current ELISAs can detect relatively low levels of
antibodies. The detuned testing approach involves taking
samples that are confirmed HIV-positive by these tests, but
then retesting them with a less sensitive, diluted ELISA.
This less sensitive test can only detect antibodies at the
higher levels achieved during the period six months or more
after infection. Thus, the detuned approach distinguishes
between recent and established infections, so it is a
potentially valuable tool for epidemiologists trying to
chart the pattern of new infections. It is not used in
patient care at this time.

Accuracy of Antibody Testing --
and Denialist Arguments

Constantine(3) sums up the general consensus among experts
and institutions such as the CDC when he says "The antibody
tests are nearly 100 percent sensitive (unless a person is
in the window period) and about 99 percent specific." Such
levels of accuracy have been documented in a number of
studies, including periodic evaluations of commercially
available test kits conducted by the World Health
Organization.

Still, AIDS denialists (the self-styled "AIDS dissidents"
who claim that HIV is either harmless or doesn't exist)
continue to claim that HIV antibody tests are unreliable.
Many of their arguments seem to derive from a series of
articles written by Christine Johnson in the mid-1990s,
several of which are available on denialist web
sites.(4,5,6)

Johnson's argument boils down to two key points: 1) HIV has
never been properly isolated, so the HIV proteins used in
the tests haven't been proven to actually come from HIV, 2)
Even if HIV is real, the proteins are not unique and cross-
react with many other antigens, rendering a positive result
meaningless. Johnson's list of some 60 factors she
describes as "known to cause false-positive HIV-antibody
test results" turns up regularly in denialist literature.

The claim that HIV has never been properly isolated, based
on the writing of a group in Perth, Australia, is too
technical and complex to examine thoroughly here. However,
it is elegantly demolished in Michael Coon's article, "HIV,
AIDS and the Distortion of Science," available on the AEGIS
web site.(7) In short, Coon argues that the Perth Group set
up artificial, phony criteria for "proof" of HIV's
isolation that bear no relation to how virology works in
the real world.

The second argument, though, contains a grain of truth.
Cross-reactions are possible, and a number of factors can,
on occasion, produce false-positive HIV antibody test
results. What Johnson fails to address in any detail is
that such effects are typically transient and rare,
affecting few individuals.

For example, one well-known cause of false-positives
Johnson lists is influenza vaccination.(8,9) But she
neglects to mention that a key reference she cites
described the phenomenon as "infrequent" and "of short
duration," while in another only 10 false-positives were
found among 133,000 individuals who had flu shots prior to
testing, with half of those reverting to negative within
six months.(9)

Constantine adds, "I doubt very much that it has been
firmly documented that 60 factors can interfere with
antibody tests. In fact, it has been long sought to try and
identify the causes of false positive results, and only a
few have really been documented to consistently interfere
(e.g. pregnancy, certain autoimmune diseases, some
infectious diseases). However, even these do not
consistently cause problems with the tests... There are
very few false positives that can't be resolved with
further testing."

Consent, Anonymity, and Counseling

(1) Anonymous Testing

Prior to HIV, blood testing was considered a routine
procedure, with such minimal dangers that formal informed
consent was rarely required. But because HIV presented
massive psychosocial risks, from employment discrimination
to rejection by family and reduced access to health care,
special procedures were widely adopted.(10) These included
specific informed consent and pre- and post-test
counseling. Many states set up test sites where people
could get tested anonymously, without ever giving their
name.

Anonymous testing (other than the home test, below) was
never universally available, Morin notes, but was and is
offered in many places, despite the recent move by numerous
states to adopt a system of names-based HIV reporting (a
few, including California, are implementing HIV reporting
via codes that don't reveal the person's name). The CDC and
others urged that the option for anonymous testing should
be kept available, believing fear of disclosure would keep
some from being tested, and most states have followed this
recommendation.

Because local laws and procedures vary, Morin recommends
that anyone concerned about anonymity or disclosure contact
their local health department to check. A number of AIDS
service organizations operate hotlines, which should also
be able to provide this information.

Those living in areas with no anonymous test sites can
still be tested anonymously via home collection test kits,
which are sold in many drug stores. Introduced in the mid-
'90s, the kits were controversial because counseling is
provided by telephone rather than in person. Morin says
fears that telephone counseling would prove inadequate
haven't been borne out, but sales of the kits have been
less than expected. Still, "the FDA ruled that you cannot
bar their sale in any state, so even in states that don't
have anonymous testing people can use home test kits to
anonymously be tested," he says.

But, he adds, things change when the individual seeks
treatment: "If you go to your doctor and the doctor does a
viral load test, you get reported through the viral load
test to the health department. So there's no way to keep
treatment for HIV anonymous."

(2) Consent and Counseling

As with anonymity, requirements for consent and counseling
vary from state to state. Most, but not all, states require
specific informed consent -- sometimes in writing -- for
HIV testing. Approximately one-fifth of states require pre-
test counseling, with many listing specifically what that
counseling must include. The U.S. Department of Health and
Human Services recommends that all HIV testing include
counseling that covers the test itself, basic information
about HIV and AIDS, how to avoid spreading the virus, the
confidentiality of the results, the possible impact of the
results on the person being tested, and discussion of to
whom results should be disclosed, such as sex or needle-
sharing partners.(11) Counselors should also be able to
give referrals to medical and psychosocial support
services.

Counseling and consent procedures vary greatly, remain
controversial and may continue to change. Even states that
require informed consent may allow HIV testing without
consent in special circumstances. For example, many permit
involuntary testing of a patient when health workers have
been exposed to the person's blood. Some test prisoners or
people accused of sex crimes, and at least two, New York
and Connecticut, require mandatory testing of newborns,
which indirectly reveals the mother's HIV status, but does
not tell if the infant has been infected.

In October 2000 the Institute of Medicine recommended that
HIV testing be included as a routine part of prenatal care.
Women would be informed of the test and could opt out, but
specific consent would not be required. Thus far the U.S.
Public Health Service has stopped short of urging an end to
informed consent in such cases, simply suggesting that
providers recommend HIV testing to all pregnant patients.

References

1. Perlmutter, Barbara Lee et al, "How to Recognize and
Treat Acute HIV Syndrome," AMERICAN FAMILY PHYSICIAN,
August, 1999, http://www.aafp.org/afp/990800ap/535.html.

2. U.S. Public Health Service, "Guidelines for the Use of
Antiretroviral Agents in HIV-Infected Adults and
Adolescents" (August 13, 2001),
http://www.hivatis.org/trtgdlns.html.

3. Constantine, Niel, "HIV Antibody Assays," HIV KNOWLEDGE
BASE, HIV InSite Sept. 2001,
http://hivinsite.ucsf.edu/InSite.jsp?page=kb-02-02-01.

4. Johnson, Christine, "Whose Antibodies Are They Anyway?"
CONTINUUM, Sept./Oct., 1996,
http://www.virusmyth.net/aids/data/cjtestfp.htm.

5. Johnson, Christine, "Is Anybody Really Positive?" HEAL
MAGAZINE, 1995,
http://www.virusmyth.net/aids/data/chjtests2.htm

6. Johnson, Christine, "Playing Russian Roulette in the
Laboratory," Virusmyth,
http://www.virusmyth.net/aids/data/chjroulette.htm.

7. Coon, Michael, "HIV, AIDS and the Distortion of
Science," Misc Health AIDS, August, 2000,
http://www.aegis.org/topics/hiv_exist.html.

8. MacKenzie, William, et al, "Multiple False-positive
Serologic Tests for HIV, HTLV-1 and Hepatitis C Following
Influenza Vaccination, 1991," JOURNAL OF THE AMERICAN
MEDICAL ASSOCIATION, Vol. 268, No. 8, Aug. 26, 1992, p.
1015-1017.

9. Arnold, NL, and others. "Donor Follow-up of Influenza
Vaccine-Related Multiple Viral Enzyme Immunoassay
Reactivity," VOX SANG, Vol. 67, No. 2, 1994, p. 191-194.

10. Wolf, Leslie, and Lo, Bernard, "Ethical Dimensions of
HIV/AIDS," AIDS KNOWLEDGE BASE, HIV InSite,
http://hivinsite.ucsf.edu/InSite.jsp?page=kb-08-01-05.

11. U.S. Department of Health and Human Services,
"Voluntary HIV Counseling and Testing: Facts, Issues and
Answers,"
http://hivinsite.ucsf.edu/InSite.jsp?doc=2098.2099&page=pr-04-03.

12. Food and Drug Administration, "HIV and AIDS,"
http://www.fda.gov/oashi/aids/test.html (this regularly-
updated page contains information about FDA actions
relating to HIV-related tests).


***** AIDS TREATMENT NEWS New Publication Schedule

by John S. James

AIDS TREATMENT NEWS has traditionally published 24 issues
per year. But in 2001 we ran behind and will only publish
19 issues.

Starting in 2002 we are changing our publication frequency
-- from twice monthly to 18 issues per year. We may publish
more than 18 issues.

Enough news is happening today to fill several newsletters,
and we could easily write 24 issues per year. The problem
is information overload. Because so much work is being done
now, there is more background and context that reflects on
the importance and credibility of research findings and
other news. The most important reporting today will need
time for investigating and understanding this background.


***** AIDS TREATMENT NEWS

Published twice monthly

Subscription and Editorial Office:
   1233 Locust St., 5th floor
   Philadelphia, PA 19107
   phone 800/TREAT-1-2 toll-free, or 215-546-3776
   fax 215-985-4952 (email is preferred)
   email: aidsnews@...
   useful AIDS links: http://www.aidsnews.org

Editor and Publisher: John S. James
Associate Editor: Tadd T. Tobias, R.N.

Statement of Purpose:
AIDS TREATMENT NEWS reports on experimental and standard
treatments, especially those available now. We interview
physicians, scientists, other health professionals, and
persons with AIDS or HIV; we also collect information from
meetings and conferences, medical journals, and computer
databases. Long-term survivors have usually tried many
different treatments, and found combinations that work for
them. AIDS TREATMENT NEWS does not recommend particular
therapies, but seeks to increase the options available.

AIDS TREATMENT NEWS is published 18 times per year, and
print copies are sent by first class mail. Email is
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To subscribe, you can call 800-TREAT-1-2 or 415-255-0588:
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ISSN # 1052-4207

Copyright 2001 by John S. James. Permission granted for
noncommercial reproduction, provided that our address and
phone number are included if more than short quotations are
used.

--
John S. James
AIDS Treatment News
http://www.aidsnews.org

AIDS TREATMENT NEWS Issue #374, November 23, 2001
     phone 800-TREAT-1-2, or 215-546-3776

Contents

** Viral Load: Small Change by Sixth Day of Treatment Can
Often Predict Poor Response
It may be possible to detect a failing antiretroviral
regimen, in many cases, after the first six days of
treatment.

** New Resistance Test Combines Phenotype and Genotype
The first resistance testing which combines both phenotypic
and genotypic testing, from the same company on the same
report, is intended especially for difficult treatment
decisions.

** Protease Inhibitors in Children: Combination Therapy
Reduced Death by Two Thirds
A study of over a thousand HIV-infected children from 1996
through 1999 provides more definitive information on the
benefits of improved treatment. The article and an
accompanying editorial also discuss the risks of treatment
in children, prevention of maternal transmission of HIV,
and the status of efforts to prevent and treat pediatric
AIDS in developing countries.

** South Africa: Activists, Physicians Sue Government to
Prevent Maternal Transmission, Ask International Support
After five years of civil society lobbying for widespread
programs to prevent maternal transmission in South Africa,
activists have sued the government, which has been notably
reluctant to move toward widespread access to
antiretroviral treatment.

** HIV Testing 101 (Part 1 of 2)
A look at antibody testing for HIV -- including ELISA and
confirmatory testing with Western blot, the "window period"
between infection and when the body produces antibodies
that can be detected, oral HIV testing, urine testing, and
the rapid test.


***** Viral Load: Small Change by Sixth Day of Treatment
Can Often Predict

Poor Response

by John S. James

A U.S. National Institutes of Health study of 124 pediatric
and adult patients taking protease inhibitors for the first
time found that the change in viral load in the first six
days of the treatment was able to predict many cases of
poor response of the regimen by week 12. Therefore
treatment could be changed quickly in these cases (instead
of at 4 or 8 weeks, as recommended by current U.S.
guidelines), reducing the development of drug resistance by
minimizing the time on an ineffective therapy.

In this study, "reduction in plasma HIV-1 of less than 0.72
log by day 6 after initiation of therapy predicted poor
long-term responses in more than 99% of the patients." For
those with less than a 0.96 log reduction, the chance of
poor response at 12 weeks was 95%. But while very good at
predicting some cases of drug failure, 6-day viral load was
not as good at assuring long-term success. This is because
unpredictable events can occur after day six, such as new
mutations that cause viral resistance.

In clinical practice, some patients will not get their
blood drawn on exactly the sixth day. Presumably the cut-
off value for counting drug failure should be adjusted if
the second blood draw is at, for example, 7 days, although
the paper did not discuss this. However, this study found
that samples taken at day 13 or day 28 were not as
predictive as those taken at day 6 -- probably because of
the more complex factors affecting viral load after the
initial period of rapid decline.

Prediction may be better if there is also a viral load test
on day 3, 4, or 5 -- due to natural fluctuations of viral
levels, and also due to the variability of test results.
The researchers did not seem to think that this extra test
would be necessary in clinical practice.

This research team previously reported that the trough
(lowest) drug concentration in blood plasma at the end of
the first week, but not the dose, correlated with viral
decline, and predicted long-term response. But it would be
hard to measure blood levels of three or more drugs, or to
know how sensitive the virus was to them. The authors
suggest that the much simpler measurement of early viral
load change is good enough.

Comment

Physicians might want to look at viral load decline by day
six of certain new treatments -- in order to quickly change
a clearly ineffective regimen. But the patients and
treatments in this study were often not representative of
what physicians see today. We hope the guidelines
committees will study all the available information, and
decide if a day-six viral load test should now be
recommended for patients starting or changing
antiretroviral therapy -- or if additional studies should
be done first.


***** New Resistance Test Combines Phenotype and Genotype

by John S. James

On November 15 ViroLogic, Inc. announced a new testing
service that combines phenotypic and genotypic resistance
testing on a single report. The new test, named PhenoSense
GT, is expected to be used especially for patients whose
treatment is complicated by difficult or complex HIV
resistance. The company expects to get test results back to
physicians within 14 days.

Phenotypic resistance testing uses part of the patient's
virus to construct a new virus that is then grown in the
lab and tested with varying concentrations of the approved
anti-HIV drugs, using automated equipment (it would be
difficult to grow the unchanged patient's virus in a
laboratory). Genotypic testing looks for mutations known to
be associated with resistance to the various drugs; it is
usually less expensive than phenotypic testing, but more
difficult to interpret. While the results are often
similar, the two kinds of tests can give different
information in some cases.

The PhenoSense GT assay includes resistance testing for the
newly approved drug tenofovir.

The number to call for ordering this test is 1-800-777-
0177. Unfortunately the price is $1210.

New information on HIV resistance will be presented at the
ICAAC conference in Chicago in mid December.

Comment

We believe that offering the two tests on one integrated
report, by a single company that applies compatible
standards and quality assurance throughout, opens
opportunities to provide better information to physicians.
How well it is accepted in practice remains to be seen.

As with other resistance testing, a major challenge will be
giving physicians the help that they need to get the most
out of the test. HIV physicians must keep up with many
things, and cannot all be expected to be drug-resistance
experts. At this time we do not know what information the
company plans to provide to help physicians interpret the
report.

What we would like to see eventually is a semi-automated
system that would compare patterns in the reported data
with a database of past experience, and add to the report
any one or more of perhaps thousands of pre-written notes,
calling the physician's attention to significant
information that might otherwise be overlooked. Ideally,
artificial-intelligence software would make the first
selection of these interpretive notes. Then an HIV-
resistance expert or panel of experts would look at every
report that was not clearly routine, changing the selection
or text of the notes when there is a good reason to do so
(these experts could work online from anywhere). Any
improvements by the human expert(s) would go to the
physician, and also be used to improve the software for the
future.


***** Protease Inhibitors in Children: Combination Therapy
Reduced Death by Two Thirds

by John S. James

A November 22 article in the NEW ENGLAND JOURNAL OF
MEDICINE reported on a cohort of 1028 HIV-infected children
studied from 1996 through 1999(1). After statistical
analysis to adjust for the fact that those starting
treatment tended to be sicker, the study found that
introduction of an antiretroviral regimen including a
protease inhibitor was associated with a two-thirds
reduction in risk of death (hazard ratio 0.33). The total
reduction in death -- reflecting many treatment advances,
not just antiretroviral therapy -- was more impressive:
5.3% mortality in 1996, 2.1% in 1997, 0.9% in 1998, and
0.7% in 1999. Both findings were highly statistically
significant, p<0.001.

This study could not compare combinations including a
protease inhibitor with combinations including an NNRTI
(efavirenz, nevirapine, or delavirdine) because too few of
the children were on NNRTI combinations -- only 3% in the
last year of the study, 1999 -- compared to 73% on
protease-inhibitor combinations, and 24% receiving only
nucleoside analogs. But an accompanying editorial(2) noted
that combination therapy with NNRTI drugs can achieve the
same result. All the children were on antiretroviral
therapy of some kind by 1999.

African American and Hispanic children were found to start
therapy later. After statistical adjustment for severity of
illness, this effect became less, and was no longer
statistically significant. However, the authors suggested
continued vigilance to ensure equitable access to
treatment.

The authors also urged continued vigilance about the long-
term risks of today's antiretroviral drugs when started in
childhood; serious metabolic and other side effects have
been seen in children as well as adults. This cohort study
(PACTG 219) is continuing, and will be able to provide more
information about long-term outcome and risk vs. benefit.

The accompanying editorial looked at treatment in
developing countries. In the United States, the rate of HIV
transmission from infected pregnant women to their children
went from 25% to 1.4% with standard antiretroviral therapy;
in those children who do get infected, beginning treatment
in the first three months of life can stop viral
replication completely and preserve normal immune function,
provided proper treatment is continued. However,
infrastructure in the developing world is just beginning to
be created -- the United Nations AIDS Summit this year set
a goal of only a 20% reduction in mother-to-child
transmission by 2005. "Our efforts must focus on devising
simple, relatively inexpensive, triple-combination regimens
for the treatment of all HIV-1-infected pregnant women and
all HIV-1-infected children. Such a regimen could be
provided for $5 per day and would have a substantial effect
on the prevention and treatment of HIV-1 disease in the
developing world. These efforts would represent an
important step toward changing the face of pediatric HIV-1
infection for the many millions who are affected by it
around the world."(2)

References

1. Gortmaker SL, Hughes M, Cervia J, and others. Effect of
combination therapy including protease inhibitors on
mortality among children and adolescents infected with HIV-
1. THE NEW ENGLAND JOURNAL OF MEDICINE November 22, 2001;
volume 345, number 21, pages 1522-1528.

2. Sullivan JL and Luzuriaga K. The Changing Face of
Pediatric HIV-1 Infection. THE NEW ENGLAND JOURNAL OF
MEDICINE November 22, 2001; volume 345, number 21, pages
1568-1569.

Note: The abstract is available online to anyone at:
http://content.nejm.org/cgi/content/short/345/21/1522
The abstract has links to the full text and the editorial -
- but these are only available to subscribers to the
Journal.


***** South Africa: Activists, Physicians Sue Government to
Prevent Maternal Transmission, Ask International Support

by John S. James

On November 26 South Africa's Treatment Action Campaign
(TAC),  supported by  about 200 doctors, sued the South
African government, asking for wider use of nevirapine to
prevent mother-to-infant transmission of HIV. About 70,000
infants every year are born with HIV in South Africa, and
about half of these infections at birth could be prevented
by a single tablet of nevirapine given to the mother, and a
single dose to the infant. This lawsuit follows five years
of lobbying by civil-society organizations.

The government is currently running a pilot program that
offers testing, counseling, and nevirapine if needed to
about 10% of pregnant women. It argues that it needs time
to evaluate this program before expanding it; TAC says that
the current program will not allow any expansion beyond the
18 current sites until at least April 2003. The government
also says that it cannot afford antiretrovirals, because it
has only $207 million a year to spend on public-sector
medicines for the country of over 40 million people.

How you can support TAC in this case? At this time TAC is
asking for letters to be sent to South Africa, and also for
individuals and organizations to sign the Bredell Consensus
Statement -- a statement on HIV treatment in South Africa,
endorsed by participants of the Bredell Conference, which
took place October 18 and 19. Since the situation will
change over time, check their Web site,
http://www.tac.org.za. This site also includes court papers
and other background on the case.

Comment

It is widely believed that the real issue for the
government is not the cost of the nevirapine for preventing
maternal-infant transmission (which the drug's manufacturer
Boehringer Ingelheim has offered free, although the cost of
so little nevirapine would not be a barrier in any case),
but that once the government provides the drug routinely to
HIV-positive pregnant women, there will certainly be more
pressure to also treat the mothers, fathers, and others.
Antiretrovirals are heavily patented and expensive in South
Africa. While generic nevirapine is available from India,
which has different patent laws, the South African
government is afraid to use compulsory licensing or other
means to override patents and obtain drugs it can afford,
due to fear of economic retaliation. While South Africa is
considered a middle-income country, so much of its
population is infected that it could not pay for widespread
access at the high prices set by the manufacturers.

A related problem is that South Africa's President Mbeki
personally has a hard time backing down from a position
once he has taken it. In this case, he picked up conspiracy
theories over a year ago from AIDS denialists who argued
that antiretrovirals are inappropriate because HIV does not
cause AIDS -- or because AIDS in Africa does not exist, and
the deaths are due to other illnesses and to poverty
instead. So officials under him are constrained in what
they can do.

The result is that South Africa is not successfully making
the plans, building the infrastructure, and getting the
experience to deal with one of the highest rates of HIV
infection in the world.


***** HIV Testing 101 (Part 1 of 2)

by Bruce Mirken

[Note: On November 9, 2001, the U.S. Centers for Disease
Control and Prevention issued two revised guidelines
encouraging health care providers to routinely offer HIV
testing more often. The goal is to increase the number of
people who know their HIV status. These guidelines are
available at:
http://www.cdc.gov/hiv/ctr, or by calling 1-800-458-5231.

[We had asked previously asked Bruce Mirken to write an
introduction to HIV testing, including reliability of the
tests today, oral HIV tests, rapid HIV tests, anonymous
testing, the home test kit (which makes anonymous testing
available in all states), and viral load testing to detect
HIV in the "window period" before the immune system has
produced antibodies, which standard HIV tests detect. JSJ]

* * * * *

HIV antibody testing has been with us since 1985. Testing
technology has evolved considerably over the years, with a
variety of new and improved tests coming into use, both in
research and daily practice. Since determining one's HIV
status is the first step in treatment decisions, it is
important to understand the tests being used today,
including their limitations.

The Basic Testing Procedure

"The primary purpose of the test in 1985 was to screen the
blood supply," recalls Steve Morin, director of the
University of California San Francisco's AIDS Policy
Research Center. At the time there were no treatments
available for HIV infection, and no one knew how likely it
was that an HIV-infected person would get AIDS or how
quickly it might happen. The only medical interventions
available dealt with the opportunistic diseases that
appeared once the immune system was weakened, so there was
no pressing need for people to find out their HIV status.

Still, it was clear that some who believed themselves at
risk would want to know.

And that, Morin notes, led to "a fear that people who
wanted to know whether they were infected or not would go
to donate blood in order to find out." To head off this
possible threat to the blood supply, federal and state
governments set up alternative test sites, where people
could be tested without giving blood. Back then, the main
public health value of HIV testing was "as a prevention
tool," Morin says, "to counsel people... about not
transmitting the virus to anyone else."

That changed with the advent of antiretroviral therapy and
prophylaxis (preventive treatment) aimed at preventing
opportunistic infections. Over time, HIV testing became a
gateway to treatment, as well as a prevention tool.

Although there have been technological changes, HIV testing
in the U.S. still follows the same basic testing procedure
as in 1985: HIV infection is only considered confirmed
after two tests have been done, a screening test and a
confirmatory test. In a recent article for the University
of California San Francisco's HIV InSite
(http://hivinsite.ucsf.edu), University of Maryland
researcher Niel Constantine explains that "screening tests
possess a high degree of sensitivity, whereas confirmatory
assays have a high specificity. Tests with high sensitivity
produce few false-negative results, whereas tests with high
specificity produce few false-positive results." Because
the screening tests can produce false positives, a second
screening test is typically run on the same sample - in
duplicate - with the confirmatory tests only run on samples
that are repeatedly positive ("reactive" in lab parlance).

The combination of the two types of tests produces results
that are "highly accurate," Constantine notes, but
technical errors are possible, and biological factors can
occasionally produce problems.

The most common screening test is the enzyme-linked
immunosorbent assay (ELISA), sometimes called enzyme
immunoassay (EIA). The most often used confirmatory test is
the Western blot. Identical technology is used in tests for
numerous illnesses, including Lyme disease, Constantine
explains. Indeed, the immunological methods underlying
these tests are so fundamental that Sally Liska, head of
the city of San Francisco's Public Health Laboratory, calls
it "serology 101."

The ELISA is used for initial screening because of both its
high sensitivity and its practical advantages, Liska adds:
"It's a lot easier to do many specimens on an ELISA. It's
smaller volume, it's less handling, it's more automated."

Over 40 different ELISA HIV test kits are available from
various manufacturers, though only a fraction of these are
licensed by the FDA - a requirement if they are to be used
in the U.S. (a few tests are approved for research only).
These tests use artificial HIV proteins that are able to
capture antibodies to the virus. Once those antibodies are
caught, Constantine explains, they "can be detected using
other reagents that are usually coupled to an indicator
such as a dye or enzyme that can produce color." The change
in color is read by a machine.

The Western blot is somewhat similar, but uses an
electrical field that separates out the various components
by their molecular weight. This allows identification of
antibodies to specific viral antigens, which show up as
identifiable "bands" on a strip of test paper.

The Western blot, Liska says, "is a little more complicated
to do... It's more hands-on." Because it is less sensitive,
she adds, it "should never be run by itself."

Although the Western blot is the most common confirmatory
test, others are sometime used, including the indirect
fluorescent antibody assay (IFA) and the
radioimmunoprecipitation assay (RIPA). "If performed and
interpreted correctly, these extremely specific tests
should not produce biologic false-positive results,"
Constantine writes.

The "Window" Period Just After Infection

One major drawback of antibody tests is the "window"
period: the time it takes the body to produce antibodies
after infection has begun. The standard tests for HIV do
not detect the virus itself, but the antibodies that the
body produces in response. During the period before the
antibodies are produced, a person can be infected with HIV
and can infect others, but still test negative on the HIV
antibody test.

For the first tests licensed, this window period ranged
from six to 12 weeks, but improved technology has allowed
the detection of lower levels of antibodies, making it
possible to identify them earlier. "Currently used tests
can detect HIV infection between three and five weeks in
most individuals," Constantine says. "This is true of just
about all of the ELISAs and the rapid tests [discussed
further below]. Some tests are a little more consistent in
detecting at the three week period, but in general they are
all equivalent." To some degree, he explains, "it also
depends on the individual (who may not produce antibodies
as fast as another)."

Oral HIV Testing

All of the early tests were done on blood. More recently
developed tests look for antibodies in oral fluid or urine.

The oral test, which follows the same
screening/confirmatory protocol as blood tests, has the
advantage of being a noninvasive procedure that can be done
in settings where blood draws would be impractical or
unsafe. Presently just one brand of oral test, called
OraSure, is FDA-approved. It is not a saliva test, but
instead uses a small pad to draw fluid from within the
gums. These fluids are in fact derived from blood,
Constantine explains. "Therefore they include the same
fluid (plasma) that is used for testing with serum-based
tests."

"We're not taking fluid that's already available" in the
mouth, Liska notes. "It's not saliva or spit."

The pad used to draw the fluid is attached to a small
handle resembling a toothbrush. It is placed against the
gum, where it must remain for at least two full minutes to
collect a proper sample.

Because the saliva present in the mouth dilutes the
antibodies obtained, oral tests must be able to detect
weaker concentrations of antibodies than blood tests. In
general oral tests have been found to be just as accurate,
but Liska believes "the oral fluid test may not be as
sensitive for early seroconverters as the blood test."

Urine HIV Testing

Urine tests exist as well, but have not been as popular as
the oral fluid test. This may be because the FDA has not
yet approved a confirmatory urine test, so anyone with a
positive urine test must return for a confirmatory test .

Rapid HIV Testing

Another innovation has been the development of rapid tests.
In conventional tests the sample is collected and sent to a
central laboratory for processing, a procedure that usually
requires the patient to return a week or more later for the
results. Rapid tests (which come in both blood and oral
versions) are done on-site and give a reading within half
an hour. As with the ELISA, a positive reading on a rapid
test requires a second, confirmatory assay such as a
Western blot.

An advantage of rapid tests is that they eliminate the
problem of testers who don't return for their results. Non-
return rates are fairly low in doctors' offices and
anonymous test sites, but can be quite high in other
settings, including STD clinics, whereas many as one third
of patients never come back to get their results.

According to Constantine, rapid tests have "proved to be as
accurate as the ELISA when performed carefully by
experienced personnel. Technical errors are common with
these assays, however, because users become careless with
these simple procedures." To deal with this problem, many
rapid tests now include a built-in control that indicates
whether or not the test was done properly. At present, the
FDA has licensed one rapid test, made by Murex Diagnostics.

*  *  *

[Part II will include viral load testing for acute
(primary) HIV infection, the "detuned ELISA," accuracy of
HIV tests today and answers to "denialist" claims they are
unreliable, anonymous testing, home testing anonymously,
informed consent for testing, and counseling.]


***** AIDS TREATMENT NEWS

Published twice monthly

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Editor and Publisher: John S. James
Associate Editor: Tadd T. Tobias, R.N.

Statement of Purpose:
AIDS TREATMENT NEWS reports on experimental and standard
treatments, especially those available now. We interview
physicians, scientists, other health professionals, and
persons with AIDS or HIV; we also collect information from
meetings and conferences, medical journals, and computer
databases. Long-term survivors have usually tried many
different treatments, and found combinations that work for
them. AIDS TREATMENT NEWS does not recommend particular
therapies, but seeks to increase the options available.

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--
John S. James
AIDS Treatment News
http://www.aidsnews.org

AIDS TREATMENT NEWS Issue #373, October 26, 2001
     phone 800-TREAT-1-2, or 215-545-3776

CONTENTS

** Tenofovir Approved: Broad Indication
The FDA approved this important new anti-HIV drug on
October 26, without restricting it to heavily pretreated
patients.

** T-20 Small Program, CD4 < 50, Will Enroll November 27 at
3:00 P.M.
A small safety study for patients with a CD4 count under 50
and who cannot construct a viable antiviral regimen with
approved drugs will open for registration on November 27.
Only the first 56 physicians who call in, and have exactly
three eligible patients each, will be accepted.

** Treatment News from Recent Conferences: Finding Web
Reports
Several important AIDS treatment conferences are reported
extensively on different Web sites. Here is a way to
quickly find what is new in particular areas of treatment
and research.

** Anthrax, Bioterrorism Fears Stimulate Immune, Other
Research
The need for defense against biological warfare is pushing
the development of new drugs that could fight many
diseases. Many of these work by changing the body's immune
response; others use different mechanisms. Some of the
approaches now being studied are related to certain
traditional or alternative treatments.

** Africa: Funding Sought for Epidemic Control
Over 75 members of Congress have called for new funding to
fight epidemics worldwide, especially in developing
countries.

** World AIDS Day Web Page
Where to find information about World AIDS Day, December 1.


***** Tenofovir Approved: Broad Indication

by John S. James

On October 26 the FDA approved Viread (tm) -- generic name
tenofovir disoproxil fumarate, or tenofovir DF. The
approval was expected; less expected was the broad
indication, which both the company and treatment activists
wanted, but which some of the advisory committee had
questioned (see "Tenofovir: FDA Hearing on Important New
Antiretroviral," AIDS TREATMENT NEWS #372, October 19,
2001). From the package insert:

"INDICATIONS AND USAGE

"VIREAD is indicated in combination with other
antiretroviral agents for the treatment of HIV-1 infection.
This indication is based on analyses of plasma HIV-1 RNA
levels and CD4 cell counts in a controlled study of VIREAD
of 24 weeks duration and in a controlled, dose ranging
study of VIREAD of 48 weeks duration. Both studies were
conducted in treatment-experienced adults with evidence of
HIV-1 viral replication despite ongoing antiretroviral
therapy. Studies in antiretroviral naive patients are
ongoing; consequently, the risk-benefit ratio for this
population has yet to be determined.

"Additional important information regarding the use of
VIREAD for the treatment of HIV infection:

"* There are no study results demonstrating the effect of
VIREAD on clinical progression of HIV.

"* The use of VIREAD should be considered for treating
adult patients with HIV strains that are expected to be
susceptible to tenofovir as assessed by laboratory testing
or treatment history."

A patient-oriented description of the drug appears at:
http://www.aidsmeds.com/drugs/tenofovir.htm

The Medscape drug-interaction calculator, recently updated
to include tenofovir, is at:
http://hiv.medscape.com/Medscape/HIV/DrugInteractions/index.cfm

An FDA Talk Paper is at:
http://www.fda.gov/bbs/topics/ANSWERS/2001/ANS01111.html

And the complete package insert can be found on the Gilead
site at:
http://www.gilead.com/prod_pdf/viread_pi.pdf


***** T-20 Small Program, CD4 < 50, Will Enroll

November 27 at 3:00 P.M.

by John S. James

A small and difficult T-20 expanded-access program will
begin receiving phone calls from U.S. physicians on
November 27 at 3:00 p.m. Eastern time. The first 56
eligible physicians will be accepted. Each physician must
have exactly 3 patients who qualify for this program when
they call. The 168 patients accepted will be eligible to
receive T-20 when the program starts -- in the first
quarter of 2002, depending on drug supply.

T-20 is the first member of a new class of anti-HIV drugs
called fusion inhibitors, which block the entry of HIV into
cells. Because it works by a different mechanism than any
approved drug, virus resistant to the approved drugs is not
expected to be resistant to T-20. However, T-20 resistance
can develop when the drug is used, as with the other
antiretrovirals.

Patients must have a CD4 count under 50, a viral load over
10,000, and be at least 16 years old. Physicians are asked
to give preference to patients "who have had an AIDS
defining opportunistic infection, neoplasm or condition AND
CD4 lymphocyte count <50 cells/mm(3), both while on HAART
within the last 90 days."

T-20 is being developed jointly by Roche Pharmaceuticals
and Trimeris, Inc., and is currently in phase III clinical
trials. This new program is called Protocol T20-305, "Open
Label Safety Study of T-20 in Patients with Advanced HIV
Disease who are Unable to Construct a Viable Antiviral
Regimen."

Physicians interested in this program should make sure that
they have a November 2 Dear Doctor letter from Trimeris and
Roche, which was sent to 2,000 AIDS-treating physicians on
November 2; currently it is on the Web at
http://www.hivandhepatitis.com/recent/resistance/110701a2.html
Also, a physician or patient with questions about T-20 can
call Professional Product Information at Roche, 1-800-526-
6367, 8:00 a.m. to 6:30 p.m. Eastern time Monday through
Friday, either before or after November 27. (Note: This is NOT
the number to call starting November 27 at 3:00 P.M.; see the
physician letter for complete information.)


***** Treatment News from Recent Conferences: Finding Web
Reports

by John S. James

Much treatment information came out at several conferences
in October and early November. It did not get major press
attention because there was no big headline story or single
coherent message. Unless you know someone who was there,
the best way to learn about these conferences shortly after
they happen is through Web reports by researchers,
physicians, or other experts. While few will read all this
material, patients and medical professionals can scan to
find information about problems they are having, treatments
they are using, or relevant leads.

You can scan the lists of major topics, below, to decide
what you want to see, then go to the Web sites to read the
selected summaries. Note that these reports are written
mainly for medical professionals, and some are more
difficult than others.

These conference Web reports provide quick, accessible
treatment education updates in areas you choose. This
article lists major topics reported (as of mid November
2001, when we went to press).

Recent Conferences

* IDSA 2001 (annual conference of the Infectious Diseases
Society of America), October 25-28 in San Francisco;

* The 3rd International Workshop on Adverse Drug Reactions
and Lipodystrophy in HIV, October 23-26 in Athens, Greece;

* The 8th European Conference on Clinical Aspects and
Treatment of HIV Infection (ECCATH), October 28-31 in
Athens, Greece (by the European AIDS Clinical Society);

And for reports on liver diseases,

* 66th Annual Scientific Meeting of the American College of
Gastroenterology, October 19-24, Las Vegas;

* AASLD (American Association for the Study of Liver
Diseases),  will be held November 9-13, Dallas.

Web Sites with Conference Coverage

The following four sites have extensive reporting on these
conferences (though only The Body covered all five of
them).

Note the more specific Web addresses for some of the
conference coverage, further below. But if one of these
addresses does not work (perhaps because the site has been
reorganized), use the address here to get to the home page,
and then look for the conference coverage on the site. Some
sites take down their conference reports after one year.

* The Body, http://www.thebody.com, has the most extensive
conference coverage.

* HIV and Hepatitis.com,

http://www.hivandhepatitis.com has perhaps the most
extensive coverage of AIDS and hepatitis treatment news on
the Web.

* Medscape, http://www.medscape.com has many excellent
medical resources. (You need to register and choose a
password to use this site, but the registration is free.)

* NATAP (National AIDS Treatment Advocacy Project),
http://www.natap.org has valuable information, though some
of it has been technical and hard to read.

While these Web sites are credible, nothing is perfect.
These rapid Web reports, often online within days of a
meeting, sometimes within a day, do not always leave time
for thorough fact checking. And the pervasive "spin"
throughout the entire U.S. medical field, especially
pharmaceuticals, makes all treatment reporting difficult.
The trials conducted and results published reflect complex,
often secret negotiations between corporate, professional,
regulatory, organizational, personal and other interests.
There is no way to cover a field as complex as AIDS and
even be aware of all of the important spin.

Approved HIV Drug Names

We use generic drug names in this article -- or the more
familiar abbreviations AZT (generic name zidovudine), ddI
(didanosine), d4T (stavudine), and 3TC (lamivudine).
Generic names are usually but not always used on the sites.
For those more familiar with the brand name, here is a
table of the brand names and generic names of the anti-HIV
drugs currently approved in the U.S. Since all
antiretrovirals are patented in this country, there is only
one brand name here for each generic (except for
saquinavir, which has an earlier, weaker formulation named
Invirase).

Agenerase   amprenavir
Combivir   [AZT+3TC]
Crixivan   indinavir
Epivir   lamivudine (3TC)
Fortovase   saquinavir
Hivid   zalcitabine (ddC)
Kaletra   lopinavir/ritonavir
Norvir   ritonavir
Rescriptor   delavirdine
Retrovir   zidovudine (AZT)
Sustiva   efavirenz
Trizivir   [abacavir+AZT+3TC]
Videx   didanosine (ddI)
Viracept   nelfinavir
Viramune   nevirapine
Viread   tenofovir DF
Zerit   stavudine (d4T)
Ziagen   abacavir

Major Topics Covered

Here are some of the most important topics on each site, as
of November 14. New reports may still be added. If we have
missed other sites that should be included, please let us
know.

Also note that the same research is often presented at more
than one conference. So the same Web site can have
different writeups on the same research.

We wrote the title lines below to give a less technical
view of the contents of each summary. You can usually spot
the corresponding writeup by following the link provided to
reach a table of contents for that conference Web report.
Many of the summaries are short, a page or less; a few are
considerably longer.


** IDSA (39th Annual Meeting of the Infectious Diseases
Society of America), October 25-28, San Francisco

The Body
http://www.thebody.com/confs/idsa2001/idsa2001.html
(click "Conference Summaries")

* Can short-term changes in viral load predict long-term
response?

* Transmission of drug-resistant HIV;

* Lopinavir/ritonavir in heavily pretreated patients;

* Starting therapy at a T-cell count of 350;

* Simplifying protease-inhibitor treatment by switching to
abacavir;

* Nevirapine and liver toxicity in HIV patients with
hepatitis C;

* Nevirapine vs. protease inhibitors -- long-term cohort
study;

* Using amprenavir after nelfinavir use;

* Amprenavir+abacavir+3TC, 48-week data;

* Abacavir+efavirenz+AZT+3TC,  preliminary 48-week results;

* Four-drug study, efavirenz+abacavir+AZT+3TC;

* Hepatitis G co-infection and HIV treatment;

* EPO (erythropoietin, Epoetin Alfa) in anemic HIV
patients;

* Prior antiretroviral therapy and genotype testing;

* How well can patients predict their T-cell and viral load
test results?

* Cutting-Edge Issues in HIV Medicine (symposium)

- Challenges of Antiretroviral Therapy in the Developing
World;

- Future Horizons in Antiretroviral Drugs;

- Structured Treatment Interruption: Panacea or Pandora?

- HIV and HCV Co-Infection -- Current Status and Future
Directions.

HIVandHepatitis.com
http://www.hivandhepatitis.com/2001conf/39idsa/main.html

"Report on Salvage Therapy from the 39th Annual Meeting of
the IDSA," by Daniel R. Kuritzkes, M.D. This essay looks at
real-world experience in very heavily pretreated patients
with: lopinavir/ritonavir (Kaletra); indinavir+ritonavir;
delavirdine strategy to boost protease inhibitor levels;
and amprenavir use after nelfinavir.

Medscape
(Note: The following URL is on to lines.)
http://hiv.medscape.com/Home/Topics/AIDS/directories/
dir-AIDS.ConfSummaries.html
(then select 39th Annual Meeting of the Infectious Diseases
Society of America)

These are the HIV-related titles now on the site:

* Antiretroviral Agents and Response to Therapy

* Optimizing Long-term HIV Treatment Strategies Through a
Greater Understanding of Disease Pathogenesis

* Metabolic Complications and Adverse Drug Reactions in HIV

* Update: Incidence, Diagnosis, and Clinical Manifestations
of HIV-Related Opportunistic Infections

* PI vs. Boosted PI vs. Efavirenz: And the Winner (Again)
Is?

* Switching from a Protease Inhibitor: The Answers Are
Known, It's Time to Move On

* Four-Drug HAART Regimen in Patients with Advanced HIV
Disease

* HIV Evolution Limited by Successful HAART

* A New and Simple Way to Diagnose Pneumocystis carinii
Pneumonia

* Evidence for Increased Risk of Heart Disease in Treated
HIV Infection

* Myocardial Infarction: A Consequence of HIV Disease,
Treatment, or Both?

* Has HAART Really Improved Mortality in Patients with
Advanced HIV Disease?

* Rates of Most HIV-Related Diseases No Longer Falling

Note: Bioterrorism, and other infectious diseases, have
separate sections in this Web report from the IDSA
conference.


** 8th European Conference on Clinical Aspects and
Treatment of HIV-Infection

The Body
http://thebody.com/confs/eccat2001/eccat2001.html   (click
"Conference Summaries")

* TMC-125, experimental NNRTI, produced 2-log HIV reduction
in volunteers; [Note: "NNRTI" is an abbreviation for "non-
nucleoside reverse transcriptase inhibitor," a class of
anti-HIV drug. Two drugs in this class are currently
approved, nevirapine and efavirenz.]

* Indinavir/ritonavir vs. saquinavir/ritonavir;

* NNRTI use and lipodystrophy study;

* Nevirapine and HDL cholesterol ("good cholesterol");

* Tipranavir, a new kind of protease inhibitor;

* Tenofovir intensification study;

* Cardiovascular risk factors, association with
antiretroviral therapy;

* First-line treatment choice and lipid metabolism;

* Switching from protease inhibitors to NNRTIs;

* Tenofovir, antiretroviral activity regardless of baseline
demographics, CD4, viral load;

* Long-term followup of switching from protease inhibitors
to NNRTIs with undetectable viral load;

* Lack of drug interaction between tenofovir and several
other anti-HIV drugs;

* Once-daily treatment with experimental drug emtricitabine
(FTC, brand name Coviracil), ddI, and efavirenz, 2-year
followup;

* Atazanavir (experimental protease inhibitor) 48-week data
on lack of lipid elevation;

* Nevirapine, ddI, and d4T long-term followup;

* Minor interaction between efavirenz and
saquinavir/ritonavir.

HIV and Hepatitis.com
http://www.hivandhepatitis.com/2001conf/8thclinical/main.html

* Atazanavir at 48 weeks;

* Saquinavir/ritonavir new dosage regimen;

* Lopinavir (Kaletra) 3-year data in treatment naive
patients;

* Switching from protease inhibitor(s) to NNRTI;

* Once daily d4t;

* T-20 (experimental fusion inhibitor, a new class of
antiretroviral);

* Saquinavir and efavirenz interaction corrected with
ritonavir;

* Efavirenz, ddI, and FTC (Coviracil) combination, 96-week
study;

* Nevirapine and lipid profile improvement;

* Once daily vs. twice daily nevirapine;

* No important drug interaction between tenofovir and
indinavir, lopinavir, 3TC, or efavirenz;

* TMC 125, experimental NNRTI;

* Efavirenz vs. nevirapine in treatment-naive patients;

* Switching from a protease inhibitor to efavirenz.

NATAP
http://www.natap.org/ -- select 'Conference Reports' (on
left), then '2001' (if necessary), then select the
conference by name

* Atazanavir vs. nelfinavir;

* T-20 late phase II results;

* Extended-release d4T;

* Tibotec/Virco presentations, including TMC 125 (an
NNRTI), and a method for predicting response to protease
inhibitors;

* T-20 data in adults and children, and T-1249 data in
adults. (T-1249 is a "second generation" T-20.)

* Indinavir/ritonavir vs. saquinavir/ritonavir, both twice
daily;

* Hepatitic C and B.


** 3rd International Workshop on Adverse Drug Reactions and
Lipodystrophy in HIV

The Body
http://www.thebody.com/confs/adrl2001/adrl2001.html
(click "Conference Summaries")

* Mitochondrial function may not be causing lactate
elevation;

* Increased lipolysis (fat destruction) in HIV, with or
without fat redistribution;

* Inhibiting lipolysis improves insulin sensitivity;

* Lactate risk factors in antiretroviral therapy;

* More tumor necrosis factor released from skin fat in HIV
patients with lipodystrophy;

* Lab studies comparing indinavir, nelfinavir, and
amprenavir effects on fat cells -- and protection by
rosiglitazone;

* Lipodystrophy and metabolic disorders 48 weeks after
switching from protease inhibitors to Trizivir, vs. not
switching;

* Prospective study of lipid elevation with two
antiretroviral regimens.

HIV and Hepatitis.com
http://www.hivandhepatitis.com/2001conf/3rdlipo/main.html

In an excellent but quite technical summary of the
lipodystrophy workshop, ten papers by leading experts
describe what happened in various areas:

By Andrew Carr, M.D.: Mitochondrial Toxicity and Lactic
Acidemia; Liver Disease; Hypersensitivity; and Thyroid
Disease.

By Graeme Moyle M.D., M.B.B.S.: Insulin Resistance;
Adipocytes (fat cells); Clinical Data; Switch Studies;
Cardiovascular Disease; and Clinical Risk.

NATAP
http://www.natap.org/, select 'Conference Reports' (on
left), and then '2001'

* Overview;

* Lipodystrophy;

* Amprenavir;

* List of conference highlights;

* Abacavir;

* Mitochondrial toxicity and lipodystrophy;

* Nevirapine;

* Thyroid abnormalities;

* Lactic acidosis and mitochondrial toxicity;

* Potential therapy for lipodystrophy;

* Heart disease risk;

* Abnormalities of glucose metabolism.

Liver Disease Conferences Coverage


** The following conferences are most relevant for coverage
of hepatitis or other liver-related illness.


** 66th Annual Scientific Meeting of the American College
of Gastroenterology, October 19-24, Las Vegas

The Body
http://thebody.com/confs/gastroenterology/gastroenterology.html
(click "Conference Summaries")

* Hepatitis C;

* Liver disease in AIDS;

* New treatments for hepatitis C;

* PEG-interferons: When to use them;

* PEG-interferons: How to use them;

* Lamivudine (3TC) for hepatitis C: When to start, when to
stop.


** AASLD (American Association for the Study of Liver
Diseases), November 9-13, Dallas

The Body
http://www.thebody.com/confs/aasld2001/aasld2001.html

Check the site; coverage incomplete as we went to press.

HIV and Hepatitis.com
http://www.hivandhepatitis.com/2001conf/52aasld/main.html

Check the site; coverage just began as we went to press.

NATAP, http://www.natap.org/, select 'Conference Reports'
(on left), then '2001'

Check the site; coverage just began as we went to press.


***** Anthrax, Bioterrorism Fears Stimulate Immune, Other
Research

Comment by John S. James

A November 7 press report ("All-Purpose Drugs Are Being
Tested," by Jeff Donn, The Associated Press) surveyed some
of the work being done on finding drugs to treat many
diseases -- the opposite of the traditional "magic bullet"
approach of targeting only one particular bacterium or
virus. Many of these "all purpose" potential drugs work by
strengthening the immune system -- especially innate
immunity, which is less well understood that the more
familiar "adaptive" immunity involving T-cells (with which
the body quickly produces a customized response to a
particular invader, hopefully in time to cure the illness).
Invertebrate animals survive and fight infection with only
innate immunity.

Some of the approaches now being studied have long been
used in traditional or "alternative" medical treatments.
Others are far from ready for human test.

The AP story mentions:

* Certain cytokines and peptidoglycans that may stimulate
natural immunity. These approaches are being examined as
possible defenses against bioterrorism, including anthrax
or smallpox. If they work, they might have great impact on
more routine medical practice as well.

* "Androstene steroids" to block the action of cortisone
(according to the reporter's writeup, which we have not yet
checked further).

* Ways to correct the immune-system damage caused by
exposure to nuclear radiation. Success here might lead to
ways of strengthening the immune system in HIV, malaria,
and other diseases.

* A drug that acts like the popular supplement NAC (N-
acetylcysteine) may help treat certain bacterial toxins, by
reducing free-radical damage.

* Old remedies based on silver are now getting scientific
study, after one consistently worked as well as
tetracycline in laboratory tests against certain bacteria.

The new focus on bioterrorism will greatly stimulate
research on immune-based treatments, neglected traditional
medical approaches, and on completely new approaches as
well. It will bring in new people and resources, and move
with urgency and serious support -- no longer at the
leisurely pace of academic medical journals, or under the
commercial short-term focus on already-proven profit areas.
Here is the urgency we have long sought but seldom found.
The AIDS community should pay close attention.


***** Africa: Funding Sought for Epidemic Control

by John S. James

In the U.S. Congress, 8 Senators and more than 70
Representatives have signed a Dear Colleague letter seeking
1.2 billion dollars in emergency supplemental funding for
the global AIDS crisis. The letter will soon be sent to
President Bush.

Despite the great costs resulting from the September 11
attacks, the money is available, as the U.S. is now about
halfway through a $100 billion economic stimulus package.
This $100 billion needs to be spent anyway, on something,
in order to stimulate the U.S. economy. Less than 2% of
this money would cover the U.S. share of a good start on
global control of HIV/AIDS, tuberculosis, and malaria --
and encourage serious contributions from others.

For more information, including ways you can help, see the
Global AIDS Alliance,
http://www.globalaidsalliance.org


***** World AIDS Day Web Page

"To help journalists and others interested in HIV/AIDS
issues, the Kaiser Family Foundation has created a World
AIDS Day web page, http://www.kff.org/worldaidsday/ "

World AIDS Day is December 1. There is little central
organizing; instead, local agencies and communities do
their own events. As a result, there is no overall
calendar. Persons interested in events in their area should
check with local AIDS organizations.

The Kaiser Family Foundation page includes links to about
10 other Web pages on World AIDS Day.

***** AIDS TREATMENT NEWS

Published twice monthly

Subscription and Editorial Office:
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   phone 800/TREAT-1-2 toll-free, or 215-546-3776
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   email: aidsnews@...
   useful AIDS links: http://www.aidsnews.org

Editor and Publisher: John S. James
Associate Editor: Tadd T. Tobias, R.N.

Statement of Purpose:
AIDS TREATMENT NEWS reports on experimental and standard
treatments, especially those available now. We interview
physicians, scientists, other health professionals, and
persons with AIDS or HIV; we also collect information from
meetings and conferences, medical journals, and computer
databases. Long-term survivors have usually tried many
different treatments, and found combinations that work for
them. AIDS TREATMENT NEWS does not recommend particular
therapies, but seeks to increase the options available.

AIDS TREATMENT NEWS is published 24 times per year, on the
first and third Friday of every month, and print copies are
sent by first class mail. Email is available (see below).
Back issues are available at http://www.aidsnews.org

To subscribe, you can call 800-TREAT-1-2 or 415-255-0588:
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ISSN # 1052-4207

Copyright 2001 by John S. James. Permission granted for
noncommercial reproduction, provided that our address and
phone number are included if more than short quotations are
used.

--
John S. James
AIDS Treatment News
http://www.aidsnews.org

AIDS TREATMENT NEWS Issue #372, October 19, 2001
     phone 800-TREAT-1-2, or 215-546-3776

CONTENTS

** Tenofovir: FDA Hearing on Important New Antiretroviral
Report on the FDA advisory committee hearing on tenofovir
(Viread(TM)), a new antiretroviral about to be approved.

** Apparently Harmless Virus Associated with Reduced HIV
Death
Infection with a virus that does not cause any known
disease has been associated with a much better survival
rate in persons with HIV. The mechanism of action is
unknown. With further research, this finding might lead to
a new class of drugs to help control HIV.

** Retroviruses Conference: Major Deadlines Nov. 16
Anyone going to the Retroviruses conference next February
either as community press or through the community
scholarship program must apply by November 16. Applications
from developing-country researchers and clinicians applying
for international scholarships are also due on that date.

** Barcelona International Conference, July 7-12, 2002:
Time to Start Planning
Early applicants can get more convenient housing and a
reduced admission price, and many international tickets go
on sale early in the year.

** "A Day for Women" Medical Information Meeting, November
3 in New York
A one-day meeting on women's HIV treatment issues will
allow participants to ask questions of the experts. The
meeting is free, but registration is required due to
limited space.

** New HIV Drugs: Extensive Lists, Additional Information
Here are links to lists of HIV drugs in development, and to
an article about some of the most important ones.

** Africa Access News
Much is happening in the fight for access to treatment in
developing countries, especially countries in sub-Saharan
Africa.


***** Tenofovir: FDA Hearing on Important New
Antiretroviral

by John S. James

The FDA's one-day public hearing on tenofovir (brand name
Viread(TM)), a new antiretroviral being developed by Gilead
Sciences, took place October 3 near Washington D.C. (see
AIDS TREATMENT NEWS # 370, August 24, 2001). This meeting
of the Antiviral Drugs Advisory Committee (a group of
outside experts convened by the FDA) also included
consultants selected for this particular meeting because of
their special expertise.

Everyone who spoke agreed that tenofovir should be
approved; the FDA had no issue with approval, which is
expected shortly. In clinical trials the drug has shown a
0.6 log decrease sustained for the length of the trial (up
to a year so far), when added to an antiretroviral regimen
which was failing to suppress the virus -- a difficult test
for a drug, and probably not the way tenofovir will
generally be used. (Usually at least some of the other
drugs in the regimen would be changed, often after
resistance testing -- although it is too early to know for
sure how tenofovir will be used in practice.) Resistance to
tenofovir seems slow to develop, although resistant viruses
do occur. The drug is easy to use (it is taken only once a
day, with food), and so far has shown excellent safety in
human tests, with side effects comparable to those reported
by volunteers who received the placebo.

One major issue at the hearing was whether the FDA should
recommend tenofovir for combination use in HIV treatment
for any patient -- including those starting antiretrovirals
for the first time -- or only recommend it for advanced
patients, where there is currently more data. All activists
who spoke wanted the general indication, but for a variety
of reasons the committee tended toward the more restrictive
one (there was no formal vote). Activists want to free
doctors and patients from possible reimbursement hassles if
they decide to use the drug in front-line therapy; they
also wanted to make sure the company was not punished for
testing tenofovir first in advanced patients, which
activists and the FDA have urged companies to do, since
these patients most need new options.

But committee members were concerned that less is known
about first-line use and more will be known next year, when
the indication could be changed. Some felt that the lack of
complete information about first-regimen use changed the
risk/benefit ratio of using a new combination vs. a
standard one. Others noted that ADAPs (the AIDS Drug
Assistance Programs, run separately by each state) are
unlikely to micromanage patients, so they will not deny
reimbursement if a physician uses the drug outside of the
indications formally approved by the FDA. Some saw the
drug's indication as mainly a marketing issue. (Doctors are
free to prescribe an approved drug for any patient, without
being bound by the indications.)

Some observers think the FDA may approve the general
indication but with a note saying that studies in
treatment-naive patients are not yet complete.

Long-Term Safety Issues

Human safety data were very good -- in particular, there
was none of the kidney toxicity that had been seen in
adefovir when studied for HIV at doses of 60 and 120 mg
daily. (Adefovir, a much less effective antiretroviral in
the same drug class as tenofovir, is no longer being
developed for HIV, but is a promising potential treatment
for hepatitis B, in much smaller doses.)

But animal studies using tenofovir doses much higher than
those given to people had found a bone problem,
osteomalacia -- a lack of normal mineralization of the bone
(this disease is called rickets in children, osteomalacia
in adults). While the danger appears to be low -- the
condition can be treated, and reversed completely in
animals when the drug was stopped -- two bone experts
brought by the FDA as consultants to the committee thought
that certain steps should be taken now in order to head off
possible problems in the future:

(1) Gilead should do some simple research to find out which
potential mechanism caused the problem in the animals. Was
bone failing to mineralize properly because of a deficiency
of the minerals in the body? Or was the drug interfering
with enzymes involved in the mineralization process? The
company might be able to learn much by analyzing samples
already in its freezers.

(2) The bone specialists recommended that certain baseline
tests be done before tenofovir is started -- at least to
look for vitamin D deficiency and certain other simple
nutritional problems that could easily be corrected with
nutritional supplements or other treatments. One of the
consultants listed baseline studies he would ideally like
to do today -- probably too many to be feasible for
widespread clinical practice -- but noted that once the
mechanism studies had been done, much of that baseline
testing could become unnecessary. Pregnant women and
children could be at particular risk for any bone
mineralization problem.

We left the hearing with the impression that this issue
should not delay approval of tenofovir -- the drug is
needed now, and the bone risks are not immediate if they
exist at all. But the discussion pointed out the need for
biochemical research on the mechanism of the bone changes
in animals, and strongly suggested at least some baseline
testing when the drug is started, for correction of
relevant nutritional deficiencies if necessary.

(According to Gilead, much of this work had already been
done but was not presented at the hearing because the FDA
was already comfortable with the data. And bone markers are
now being measured in study 903, a clinical trial of
tenofovir in treatment-naive patients.)

Other Possibilities

Tenofovir may have other important uses than the HIV
treatment for which it will be approved:

* Hepatitis B. Tenofovir may prove to be an effective
hepatitis B treatment. One activist urged that this use be
planned for in co-infected people, instead of left to
chance, so that the hepatitis B as well as HIV treatment
could be optimized, to reduce the risk of patients
developing tenofovir-resistant hepatitis B.

* Mother-to-infant transmission. One committee member noted
theoretical reasons why this drug might be effective. If so
it would have an advantage over nevirapine, in that
resistance to tenofovir is much slower to develop. [We
would also like to know if adding a single dose or very
short course of tenofovir to the single dose of nevirapine
could make the regimen more effective in preventing
maternal transmission -- a possibility which would seem to
be quite feasible to test, because of the safety of
tenofovir, the fact that nevirapine is far from 100%
effective (allowing a better regimen to be detected), and
the fact that everyone in the trial would get at least the
accepted nevirapine regimen.]

* Microbicide use? PMPA, the active form of tenofovir,
proved very effective in preventing HIV infection in early
animal studies (tenofovir is a chemical modification of
PMPA, designed so that the drug could be given orally, as
PMPA cannot). We do not recall microbicide possibilities
coming up at this hearing, which had a different focus; but
PMPA is now being studied by the U.S. National Institute of
Allergy and Infectious Diseases as a possible vaginal
microbicide. An effective microbicide would have a great
impact on the global HIV epidemic because it would provide
a prevention method controlled by women.

For More Information

A summary and a transcript will be on the FDA Web site, at:
http://www.fda.gov/ohrms/dockets/ac/acmenu.htm (click on
'2001', then 'Anti-Viral Drugs Advisory Committee').

Usually the transcript is available 30 days after the
meeting, the summary approximately 90 days after. Some
other information about the October 3 meeting is already on
this site.


***** Apparently Harmless Virus Associated with Reduced HIV
Death

by John S. James

Two independent studies published September 6, 2001, in the
NEW ENGLAND JOURNAL OF MEDICINE(1,2) found that persons
with HIV who were also infected with a virus not known to
cause disease had a much lower death rate than those who
were not infected -- with the risk of death being reduced
about two to four times, depending on how the comparisons
were done. The mechanism of this effect is not known,
although there are some hints from laboratory studies. An
accompanying editorial includes a warning against attempts
to infect people deliberately, at least until more is
known(3).

The finding is not new; five early studies had reported a
similar result, and one had failed to find it (that study
was done differently); for references, see the Discussion
section of the September 6 Tillmann paper(2).

The virus, called GB virus C, is fairly common; it is found
in about 1.8% of healthy blood donors, 15% of persons
positive for hepatitis C, and up to 35% of persons with
HIV(3). This virus was first found in 1995, and is
sometimes called hepatitis G virus, but that name is used
infrequently since the virus does not appear to cause
hepatitis or any other disease. Most people infected with
GB virus C clear the infection normally; then they have
antibodies, but no live virus can be found. Persons who
have cleared the infection seem to have a somewhat reduced
death rate from HIV, but not as much protection as those
whose GB virus C infection is still active.

Comment

The importance of this finding is that it offers a window
to a possible new understanding of HIV and a new way of
controlling it.

HIV not only develops resistance to most drugs fairly
rapidly; it also seems to evolve similarly to get around
the patient's immune system. But GB virus C infection is
associated with lower viral loads and improved survival
even years later (although it is probably not associated
with higher T-cell counts). If this virus is causing these
effects, it is doing so in some way that HIV cannot easily
evolve around.

Perhaps there is no causal relationship, and GB virus C
infection gives no benefit but is only a marker for
something already in the patient that is responsible for
the better outcome. Even in this case there would still be
an unknown mechanism in the patient that is not easy for
HIV to evolve around, and that might be exploited to
develop a new kind of drug treatment -- one probably closer
to immune-based therapy than to traditional
antiretrovirals.

The hardest kind of clinical trial to conduct is one that
shows a survival benefit. Here we already have a clear
survival benefit -- and thousands of patients who could be
studied with nothing more intrusive than a blood draw.

References

1.Xiang J, Wunschmann W, Diekema DJ, and others. Effect of
coinfection with GB virus C on survival among patients with
HIV infection. NEW ENGLAND JOURNAL OF MEDICINE. September
6, 2001; volume 345, number 10, pages 707-714.

2. Tillmann HL, Heiken H, Knapik-Botor A, and others.
Infection with GB virus C and reduced mortality among HIV-
infected patients. NEW ENGLAND JOURNAL OF MEDICINE.
September 6, 2001; volume 345, number 10, pages 715-724.

3. Stosor V. and Wolinsky S. GB virus C and mortality from
HIV infection. NEW ENGLAND JOURNAL OF MEDICINE. September
6, 2001; volume 345, number 10, pages 761-762.


***** Retroviruses Conference: Major Deadlines Nov. 16

The important 9th Conference on Retroviruses and
Opportunistic Infections will take place February 24-28,
2002, at the Washington State Convention and Trade Center
in Seattle, Washington. This conference has always been
full, and this year will be limited to 3,800. Registration
is also limited to certain categories of people. Important
deadlines for "community" participation, as well as
international scholarships, are November 16. Researchers
and clinicians have other deadlines.

These applications must be received by November 16:

* Community scholarships -- Applicants must meet certain
conditions, and provide an appropriate letter of support.
See complete information on the conference Web site, below

* Community press -- AIDS newsletters, etc. must register
by November 16. See information on the conference Web site
as to how to do so. It may be difficult to be accepted if
one's publication is not already known to the conference.

* International scholarships -- "Researchers and clinicians
from developing countries working in the area of AIDS
research who, without financial support, would be unable to
participate in the conference" must apply for these
scholarships by November 16.

After being accepted applicants must meet other deadlines
to register for the conference and for housing.

If you want to go to the conference, be sure to check the
Web to confirm this information and to learn how to apply.
The conference Web site is:
http://www.retroconference.org/2002/

The Retrovirus Conference Secretariat is: Westover
Management Group, Inc., 115 South Saint Asaph St.,
Alexandria, VA 22314, 703-535-6862, fax 703-535-6899, email
info@....


***** Barcelona International Conference, July 7-12, 2002:
Time to Start Planning

The XIV International AIDS Conference will take place in
Barcelona, Spain, July 7-12, 2002; this conference meets in
different countries every even-numbered year. While not
difficult to get into, the International Conference is
expensive except for media (due to frills which developed
early and have resisted protests since -- protests
especially strong last time, in Durban, South Africa). It
helps to register early in order to get housing closer to
the meeting and minimize the daily travel time to get to
one's hotel room and back. And early registration costs
less: $850 before February 1, $950 February 1 and before
May 1, and $1050 starting May 1, with a much lower rate for
students. Note that international airfares typically go on
sale early in the year.

For information about this conference see
http://www.aids2002.com

Comment

While we certainly agree that the cost of the international
AIDS conferences needs to be lowered, we think that what is
most important is to improve the use of online
communication throughout the year -- allowing education and
collaboration around the world at far less expense than
attending any international conference. Then the
conferences could focus more on facilitating working
groups, and less on lectures in auditoriums.


***** "A Day for Women" Medical Information Meeting,
November 3 in New York

The 2nd annual women's conference by NATAP (National AIDS
Treatment Advocacy Project) will take place Saturday
November 3, 9:30 a.m. to 4:00 p.m. at the New York
University Medical Center, Auditorium E & F, 401 East 30th
St (between 1st Avenue and FDR Drive). There is no charge,
but preregistration is required and seating is limited. To
register, call NATAP at 212-219-0106, or 888-26-NATAP. You
are requested to enter at 550 1st Avenue and bring valid
photo ID.

Speakers include Judith Currier, M.D., on women's
complications, lipodystrophy, and vaccines; Janet Mitchell,
M.D., on GYN and women's infections and care; Kathleen
Squires, M.D., on women's HIV treatment, epidemiology, and
natural history, and Valerie Stone, M.D., on HIV treatment
and adherence. There will be morning and afternoon breakout
sessions for questions and answers.

For more information, call NATAP at 212-219-0109 between
10am - 6pm, Monday thru Friday.


***** New HIV Drugs: Extensive List, Additional Information

The most complete recent list we have seen of anti-HIV
drugs in development -- over 60 total, including the
approved drugs -- was posted recently by Ben Cheng of
Project Inform, on the Web site of the new AIDS Treatment
Activist Coalition.

The list, at
http://www.atac-usa.org/RDACommittee.html (scroll down, or
click on "Chart on drugs in development", has the generic
or chemical name of each compound, the class of drug
(nucleoside analog, protease inhibitor, etc.), the phase of
development (preclinical, phase I, phase II, phase III, or
approved), and the pharmaceutical company doing the work.

For another extensive list of drugs in (or formerly in)
development, see the Treatment Action Group (TAG) Web site:
http://www.aidsinfonyc.org/tag/science/pipeline.html

For more information about some of the more prominent new
drugs currently being researched, see "New Agents for Anti-
HIV Therapy," by Joseph J. Eron Jr., M.D., and Robert L.
Murphy, M.D. It is available on the Medscape site,
http://hiv.medscape.com (click on 'New Agents for Anti-HIV
Therapy' if this link is still there, or search the site
for the author's last name, and look for the title in the
results returned). Note: The Medscape site requires
registration, but registration is free, and it need be done
only once (provided you remember the user ID and password
you choose). Most articles on continuing-education medical
sites remain online for one year.


***** Africa Access News
by John S. James

** Online Petition Through November 2

See note at the end of this article.

** Huge Mining Company Says It Cannot Treat Low-Income
Workers

According to an October 9 article in the FINANCIAL TIMES,
the London-based company Anglo American decided it could
not provide antiretroviral treatment to most of its
employees in South Africa. Only about 14,000 senior staff
will be eligible for the AIDS medicines. The company
employs about 160,000 people in Africa, most of them in
South Africa -- where about 21% of the employees have HIV.

"The saving you achieve can be substantial, but we really
don't know how it will stack up," said one official. "We
feel that the cost will be greater than the saving." The
company said it would need funding from international donor
agencies to distribute AIDS treatment further.

The National Union of Mineworkers (South Africa) called the
policy "inherently racist and discriminatory, with
beneficiaries of the scheme being, in the main, white
workers and the black elite. The foot soldiers who generate
wealth in the bowels of the earth are excluded."

**South Africa: Glaxo Offers Voluntary License on AZT/3TC

On October 7 GlaxoSmithKline said it would grant a
voluntary license to Aspen Pharmacare, South Africa's
largest generic drug company, to manufacture and sell AZT
and 3TC -- a move sought by activists as well as by Aspen.
Apparently this license will only allow the drug to be sold
to government and NGO (nonprofit) organizations in South
Africa -- not in other African countries. Glaxo will charge
a royalty of 30% of net sales, which will be donated to
nonprofits fighting AIDS in the country.

The final price of the Aspen drugs is not known but is
widely expected to be much higher than prices available
from generic manufacturers in India; however, the agreement
will avoid legal obstacles that have kept the Indian drugs
out of the South Africa. (India has patent laws designed to
encourage pharmaceutical manufacturers to compete in low-
cost production methods -- a system which has worked very
well in providing low-cost medicines for that country, but
now may have to be ended because of the World Trade
Organization treaty, which requires all countries to adopt
a U.S./European patent system even for domestic drug
production.)

Note: In a separate announcement on October 3, not related
to AIDS, GlaxoSmithKline offered discounts averaging 30%
for U.S. elderly persons with limited income and without
prescription coverage. Those who qualify must be 65 or
older, and with income no greater than 300% of the federal
poverty level (which today means less than $26,000 for
individuals and $35,000 for couples). Qualifying persons
will receive a card which they will present at pharmacies.
Other companies may be under pressure to match these
discounts, since otherwise their products will now become
more expensive than competing Glaxo products for the
eligible patients.

** Generic Company Charges Patent Abuse in South Africa

On or around October 7, a South African affiliate of Cipla,
the Indian generic pharmaceutical company, filed legal
action in South Africa, accusing GlaxoSmithKline and
Boehringer Ingelheim, the maker of nevirapine, of abusing
their patents to keep prices high.

The action, described by observers as "legally
groundbreaking" and "a major move," could potentially open
the door to South African sales of HIV medications at
prices much lower than those which will result from the
voluntary licensing agreement announced the same day.

Note: For a legal analysis arguing that South Africa is
permitted under international trade rules to take "certain
legal steps to ensure meaningful reductions in drug
prices," see TRIPPING OVER PATENTS: AIDS, ACCESS TO
TREATMENT AND THE MANUFACTURING OF SCARCITY, by Jonathan
Michael Berger, University of Toronto. It can be downloaded
from:
www.tac.org.za/archive.htm (go to Research Papers).

Also on international patents (although perhaps not
relevant to this South African case) note PATENT POLITICS,
by Michael H. Davis, Cleveland State University College of
Law. Davis argues that the "ordinary practitioner" test of
nonobviousness, which determines that some patents are
granted and some are not, is inherently subjective,
allowing patent laws to implement national industrial
policy without democratic oversight -- and also making
patent law not rationally transferable across national
borders. The abstract and link to the full article are
available through the Social Science Research Network, at:

http://papers.ssrn.com/sol3/cf_dev/AbsByAuth.cfm?per_id=230701


** UN Secretary General, Pharmaceutical Companies Issue
Joint Statement

On October 5 United Nations Secretary General and
executives of seven major pharmaceutical companies met and
issued an 8-point joint statement on access to treatment.
It is at:
http://www.un.org/News/Press/docs/2001/sgsm7982.doc.htm

Comment: we find it good as far as it goes -- though it
does not go very far.

** South Africa: Major Conflict Over Death Report

A report by the Medical Research Council (South Africa's
government medical-research institution, like the U.S.
National Institutes of Health) found that AIDS had become
the largest single cause of death in the country, and that
40% of the deaths last year of South Africans age 15-49
were AIDS related. The South African government under
President Thabo Mbeki -- which has refused to provide
antiretroviral treatment through the public health system,
even for prevention of mother-to-infant transmission --
refused to release the report, which was leaked to the
press.

The report also predicted that in 10 years AIDS in South
Africa would cause more than double the deaths of all other
causes combined, and that life expectancy in the country
would drop from 54 years to 41.

On October 16, after extensive protests over its
suppression, the report was released at:
http://www.mrc.ac.za

On October 17 the Guardian (UK) covered the controversy:
http://www.guardian.co.uk/Archive/Article/0,4273,4278717,00.html

** UK Poll Shows Strong Support for Dual Pricing

On October 8 the British charity Voluntary Service Overseas
released a survey showing that 87% of people who responded
thought it was right for people with HIV in poor countries
to pay less for the medicines than people in the UK,
according to THE GUARDIAN, UK, October 8.

We do not know of a similar U.S. poll, but almost certainly
a large majority here would agree.

** For More Information

For more information on treatment access in Africa, see the
Web site of the Treatment Action Campaign (TAC), the
leading AIDS treatment activist group in South Africa, at
http://www.tac.org.za/

** Action Alert: Online Petition on Drug Patent Rules Open
Until November 2

A petition by Oxfam America, "The World Demands Fairer
Rules on Patents," is open for signatures at the Oxfam
America site:
http://www.oxfamamerica.org/petition/petition.html

Or you can sign at the Global Treatment Access site:
http://www.globaltreatmentaccess.org

The complete text of the petition is:
"14 million people in the developing world die every year
from treatable diseases, including HIV/AIDS, malaria, and
tuberculosis. The high cost of medicines is a key factor.
World Trade Organization patent rules are pushing up the
price of these medicines. I urge WTO members, in particular
the United States, to demonstrate their commitment to put
health before wealth by changing and clarifying the global
patent rules at the forthcoming WTO summit conference."

Note: The reference to the WTO summit is to the Ministerial
Conference of the World Trade Organization (WTO), which
occurs every two years; the last meeting was in Seattle in
1999. The next meeting is scheduled for November 9-13 in
Doha, Qatar, but might be moved to Singapore for security
reasons.

***** AIDS TREATMENT NEWS

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Editor and Publisher: John S. James
Associate Editor: Tadd T. Tobias, R.N.

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therapies, but seeks to increase the options available.

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--
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AIDS Treatment News
http://www.aidsnews.org

AIDS Treatment News Issue #371, September 21, 2001
     phone 800-TREAT-1-2, or 215-546-3776

Contents

** September 11: What Happens Now?
The terrorist attack will likely set back control of an epidemic
that kills 8,000 people every day.

** Tuberculosis: Guidelines Changed for Latent TB Treatment
Experts urge caution with a two-drug regimen after cases of severe
liver injury, including some fatalities.

** HIV/HCV Coinfection: One-Day Conference October 11 in
Washington
The Forum for Collaborative HIV Research will hold a one-day forum
on research needs in HIV/hepatitis C coinfection

** AmfAR Announces Research Grants: Letters of Intent Due October
23
The American Foundation for AIDS Research will fund research on
new viral targets, including use of combinatorial libraries.

** ICAAC Postponed to December 16-19; "Salvage" Workshop Also
Postponed
Two medical conferences were postponed because of concerns about
air travel.

** ADAP Funding Crisis: Talking Points
Patients in a growing number of states are not getting needed
medicines due to underfunding of the AIDS Drug Assistance Program
by Congress and some states.

** U.S., Switzerland Oppose Developing-Country Proposal on Access
to Medicines
A proposal by 52 developing countries to make sure that trade
rules do not prevent access to medications has been opposed by
five rich countries, led by the U.S. and Switzerland.

** AIDS TREATMENT NEWS Publication Schedule
We published only one issue instead of two in August, and again in
September.

** Malawi Plan to Control AIDS Epidemic: Interview with David
Scondras, Search for a Cure
Malawi has developed a model plan to control the epidemic --
including treatment of persons already infected.


***** September 11: What Happens Now?

by John S. James

Several major AIDS organizations in Manhattan were in the disaster
area near the World Trade Center. It appears that everyone in
those offices got out alive, although some lost friends or
relatives. The long-term consequences for the global fight against
AIDS, tuberculosis, malaria, and other major infectious diseases
remain unknown but ominous.

Every day HIV infection alone kills more people than died at the
World Trade Center and other terrorist attacks on September 11
(AIDS EPIDEMIC UPDATE: DECEMBER 2000 by UNAIDS estimated 3 million
deaths in 2000 -- over 8200 per day -- and the numbers have risen
since then). But even on September 10 the prospects for worldwide
response did not look good. The epidemic did get media attention
during the previous year. But it was becoming clear that the U.S.
and other rich countries did not have the political will to pay
more than a fraction of the cost of a serious program for
controlling the disease. (The total cost would be about $10
billion per year from the entire world -- about $2 billion from
the U.S. if the cost were shared in proportion to the size of each
country's economy). The problem wasn't lack of money; in just one
week after the September 11 attack, the U.S. had found and signed
into law $40 billion -- money no one had thought about, let alone
proposed, just seven days before.

We still believe as we did on September 10 that ultimately there
is enough interest and good will in the U.S. to support a
proportional contribution to the money and leadership of an
effective worldwide AIDS and infectious epidemic program. The
central problem is that nobody has found an effective strategy for
dealing with the three fundamental political divisions that have
always blocked an effective response to the epidemic.

1. The international pharmaceutical industry is more interested in
protecting its patent rights than in controlling the epidemic.
Some companies cut prices to some poor countries by 80 to 90
percent when they had to, but then largely washed their hands of
the global problem, leaving prices that will largely remain unused
(except for prevention of mother-to-infant transmission) because
they are still so far beyond reach. There is no plan that
pharmaceutical companies, medical professionals, and activists can
get behind enthusiastically and bring to Congress, international
agencies, foundations, and other decision makers (as they can with
the AIDS Drug Assistance Program for funding treatment for U.S.
patients).

Industry so far has tried to lead an unworkable campaign to
preserve drug patents everywhere, with piecemeal charity for some
poor countries -- negotiated between each country and company,
revocable any time, and with secret political quid pro quo. What
could work instead is to preserve drug patents in rich countries
while relaxing them in poor ones where there is no significant
market anyway, then pushing for global funding for systematic bulk
purchases, which can and should be profitable to the patent
holders (we want them with us when going to funders). Countries
neither rich nor poor will need a mixed system. This approach
could greatly relieve the global access problem -- and end
industry's horrible public relations from people dying because
they cannot pay impossibly high prices for needed medications.
Events are already moving in this direction, but with industry
impeding this solution instead of helping to lead it (for example,
see "U.S., Switzerland Oppose Developing-Country Proposal on
Access to Medicines," in this issue).

2. Also critically important is the conflict around sexuality
throughout the world, and the resulting stigma around AIDS. A
great many individuals and institutions have so much invested in
saying "No!" that they find it difficult to pivot emotionally and
be helpful to someone infected through sex or drugs, or to support
measures to make behavior they oppose less dangerous. As a result,
it is hard to mobilize consistent support for rational, can-do
responses to this worldwide health emergency.

3. In addition, the HIV epidemic increasingly affects mostly the
poor, whose life and death interests are usually not taken
seriously. This problem increases with the growing inequality in
the modern world.

All this was in place on September 10, and still is. No one can
predict what will happen now. Some concerns:

* A major war now will further divert money, attention, and other
resources away from other issues, including health, education, and
development. With no clear enemy, there could be a permanent war
against terrorism, not seeking victory but rather building a
constituency for continuing conflict, like the drug war. It could
become a race to the bottom among governments and terrorists, each
trying to outdo the others in death and destruction.

* The harm to the U.S. economy from the attacks will result in
fewer resources for health programs of all sorts.

* Wars always result in curtailment of civil liberties. Over the
years AIDS activists have relied heavily on direct action
(demonstrations, often including civil disobedience) to get AIDS
onto the table of decision makers, when otherwise it would not
have been. Our impression since September 11 is that while most
demonstrations have been called off, more people are coming to
activist meetings than ever before because they need to talk with
others about what has happened and what it means. But there is
much concern about what kinds of activism will or will not be
allowed in the future -- especially in view of the major efforts
to make big changes in laws in days, with little or no chance for
public discussion or input (for fact sheets and other information,
see: //www.aclu.org; for recent Web links, see
http://www.indymedia.org -- especially the 'IMC News Blast' or
other edited summaries on that site).

Yet there has also been more solidarity among Americans in the
week and a half since the disaster -- from willingness to help
those affected, to expressions of patriotism, to activism for
peace, to people being less isolated from each other in everyday
life.

No one can predict what will happen. There is no U.S. precedent
for the attack of September 11 -- and few attacks in any country
with so many killed and so little warning. We can only do our best
work each day.


***** Tuberculosis: Guidelines Changed for Latent TB Treatment

The U.S. Centers for Disease Control and the American Thoracic
Society have issued new guidelines calling for more caution in
using the two-month regimen of rifampin and pyrazinamide. The
change resulted from reports of 21 cases of severe liver injury
with the two-drug regimen. Five of these patients died, and 16
recovered.

The new guidelines were published in the August 31, 2001 MMWR
(MORBIDITY AND MORTALITY WEEKLY REPORT), volume 50, number 34,
pages 733-735. We cannot summarize them because there are many
special cases. For most patients, especially those who are HIV-
negative, the older nine-month regimen of isoniazid (INH) should
be used. The persons with HIV, the guidelines include the
following:

"Available data do not suggest excessive risk for severe hepatitis
associated with RIF-PZA treatment among HIV-infected persons. In a
large multinational trial, HIV-infected patients treated with RIF-
PZA had lower rates of serum aminotransferarase (AT) elevations
than those given INH alone. The RIF-PZA regimen also was well
tolerated when given twice weekly to HIV-infected persons in
Zambia and Haiti. However, experience from trials may not
translate to all clinical practice settings, and it may be prudent
to use 9 months of daily INH for treatment of HIV-infected persons
with LBTI [latent TB infection] when completion of treatment can
be assured."

The August 31 MMWR is available at
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5034a1.htm


***** HIV/HCV Coinfection: One-Day Conference October 11 in
Washington

The Forum for Collaborative HIV Research is sponsoring a one-day
meeting on HIV and hepatitis C coinfection on October 11 in
Washington D.C. "Speakers will focus on the pathogenesis,
prevalence, and treatment of coinfection with the goal of
highlighting what we do and do not know to identify the need for
additional research efforts and facilitate progress in research on
HCV/HIV coinfection."

For more information, see http://www.hivforum.org


***** AmfAR Announces Research Grants: Letters of Intent Due
October 23

The American Foundation for AIDS Research has announced targeted
research grants up to $75,000, fellowships, and travel grants, for
studies of new viral and cellular targets for anti-HIV agents,
including use of combinatorial libraries. The letter of intent is
due 5 p.m. October 23, 2001.

More information and application forms are available at
http://www.amfar.org


***** ICAAC Postponed to December 16-19; "Salvage" Workshop Also
Postponed

Due to the recent terrorist attack and concerns about air travel,
the 41st Interscience Conference on Antimicrobial Agents and
Chemotherapy (ICAAC), originally scheduled for September 22-25 in
Chicago, has been postponed until December 16-19; it will be held
at the McCormick Place in Chicago. This conference focuses
primarily on new antibiotics, and also has a strong HIV/AIDS
track. For more information, see the conference Web site at
http://www.icaac.org

Also, the International HIV Workshop on Management of Treatment-
Experienced Patients, which had been scheduled for September 19-21
in Chicago, has been postponed. For more information, see
http://conferences.intmedpress.com/mtep/


***** ADAP Funding Crisis: Talking Points

The AIDS Drug Assistance Program (ADAP) is running out of money in
increasing numbers of states; already hundreds of people who
cannot pay for drugs through insurance or out of pocket are not
getting the medicines they need. The ADAP Working Group is an
industry-activist coalition to seek funding for this program,
which is administered separately by each state. On September 20
the Glaxo Wellcome representative to the ADAP Working Group
circulated the following talking points -- facts about ADAP as of
September 2001 -- to use for supporting this program, in Congress
or elsewhere:

* The AIDS Drug Assistance Programs (ADAPs), funded primarily
under Title II of the Ryan White Care Act, are in trouble across
the nation.

* ADAP programs around the country provide needed medications to
treat HIV disease to low-income and underinsured individuals
living with HIV/AIDS.

* Last year, a $130 million increase was requested to fund ADAP
programs in fiscal year 2001.  Congress appropriated only $61
million for a total funding level of $589 million in federal
funding for fiscal year 2001, approximately $87 million less than
needed.

* We are now seeing the impact of this shortage on states,
particularly in the South.  Nine state ADAPs have already closed
[to new patients] including: Alabama, Arkansas, Georgia, Indiana,
Kentucky, Maine, Montana, and South Dakota.

* Prior to the end of this fiscal year, 7 more states may cap
enrollment or institute other program restrictions including:
Idaho, Florida, Missouri, Nevada, Oregon, Rhode Island, and West
Virginia.

* Currently, there are over 600 people on waiting lists.  As the
funding crisis grows, this number will increase.

* The number of clients served nationwide by state ADAPs has more
than doubled between 1996 and 2000, with ADAPs serving
approximately 70,000 clients a month.

* Recent reports of declining death rates and decreasing HIV-
related morbidity point directly to the importance and cost
savings of access to antiretroviral treatment and treatment
advances using combination therapies.

* In all parts of the United States, new HIV infections are
disproportionately affecting communities of color, rural
populations, inner city communities and women of color.

* The ADAP program is effective and accessible, providing the gift
of life to people across the country.  The very success of HIV
disease treatments continues to increase the need for ADAP.

* There have been several congressional delegation letters
expressing the need for fiscal year 2002 increased appropriations
of $120 million for ADAP.  We urge your careful consideration of
those requests.

* We join with our colleagues in speaking for patients across the
country that this increase would ensure that those enrolled in
ADAP treatment programs will not be cut off from these essential
treatments and necessary therapies will be available for those
identified by nationwide HIV outreach programs this year.

For additional information, see the ADAP Working Group site,
http://www.aidsinfonyc.org/awg/


***** U.S., Switzerland Oppose Developing-Country Proposal on
Access to Medicines

by John S. James

At a September 19 meeting in Geneva, Switzerland on access to
medicines, 52 developing countries asked the members of the WTO
(World Trade Organization) to agree that rules on international
patent protection (known as TRIPS) be interpreted in ways that
allow governments to ensure access to affordable medicines; they
were not asking for changes in the wording of TRIPS itself. The
United States and Switzerland, supported by Japan, Australia, and
Canada, opposed their proposal. The European Union did not support
either side and sought a negotiated solution; Norway was the only
rich country that sided with the developing countries. The
U.S./Swiss position "echoed the well-rehearsed views of the
international pharmaceutical companies," according to a press
release issued jointly by Doctors Without Borders, Oxfam, and
Third World Network.

The September 19 meeting was to prepare for the World Trade
Organization's fourth Ministerial Conference, scheduled for Doha,
Qatar, November 9-13, 2001.

For more information, see:

MSF (Doctors Without Borders -- Campaign for Access to Essential
Medicines):
http://www.accessmed-msf.org/index.asp

IFPMA (International Federation of Pharmaceutical Manufacturers
Associations):
http://www.ifpma.org/


***** AIDS TREATMENT NEWS Publication Schedule

AIDS TREATMENT NEWS usually is published twice a month, on the
first and third Friday. Because we have been behind schedule
recently, we are publishing only one issue in August and one in
September.


***** Malawi Plan to Control AIDS Epidemic: Interview with David
Scondras, Search for a Cure

by John S. James

In May 2001, when David Scondras was in Malawi, the headlines on
the May 19-20 WEEKEND NATION newspaper read, "Few on the AIDS
drugs; Babies May Be Saved; No Hope for the Poor." Almost the
whole front page was devoted to the epidemic.

Scondras was there working with health experts from Malawi and the
U.S. trying to change that picture -- by developing a plan to
control the epidemic in Malawi, a plan that could become a model
for other countries if it succeeds. While the number one goal is
to reduce HIV transmission, this plan will also include medical
treatment for those who need it -- and extensive operations
research to make sure that the program is working effectively.
This September, officials from Malawi are coming to Boston for
meetings to finalize the plan and begin steps toward
implementation. [The meeting was postponed after the September 11
terrorist attacks, but is still scheduled for September, with a
smaller delegation from Malawi.]

AIDS TREATMENT NEWS asked David Scondras to explain this project
to our readers. The interview took place on August 27, 2001.

ATN: Tell us what is happening now.

SCONDRAS: This will be the second trip that people from Malawi are
making to the United States to get help. Experts and officials,
including those responsible for Malawi's five-year plan to control
AIDS, are coming to Boston to, among other things, meet with
Jeffrey Sachs and others at Harvard's Center for International
Development. They will continue a process begun several months ago
in a previous trip, of having their countrywide plan reviewed by a
group of scientists that Search for a Cure pulled together, and
brought to Malawi as well as to Boston. Then, with the blessing of
the scientific community that is reviewing the plan, they will
seek funding from at least three different sources to implement
that countrywide plan as soon as humanly possible.

On this trip, Search for a Cure and Harvard are hosting them in
Boston for about a week.

ATN: How did this project develop?

SCONDRAS: Two years ago when I first went to Malawi, the president
of the country was on television and radio, explaining that there
were some medicines that could help this disease, but
unfortunately no one could afford them in Malawi, so they were
going to have to do without them. This entire picture changed when
we met with the Vice President and explained how these drugs work.
When it became clear that lowering viral load with these drugs
might help reduce transmission, it became obvious that these drugs
were a necessary part of the prevention program, not just help for
people who are sick. In that context people became much more
determined to see that there was access to them.

Finally, when CIPLA (a drug manufacturer in India) and other
generic producers offered generic drugs that were much, much less
expensive, there was an increase in morale in Malawi. And when the
Global AIDS Fund was announced, that morale reached the point that
the vice president of Malawi accepted an invitation from Search
for a Cure to come to the United States, and went to Harvard with
me and met with Jeffrey Sachs and put this whole program in
motion.

Malawi is determined to do a countrywide treatment program that
will stop the epidemic -- that's the objective. This will be one
of the tools.

ATN: Tell us about the country.

SCONDRAS: Malawi is a small country in sub-Saharan Africa, one
third of which is a giant lake. About 70% of the population of ten
million is small farmers. It has two big cities, Lilongwe and
Blantyre. It is one of the poorest countries in Africa, with a per
capita income in U.S. dollars around $250 per year. It has three
main Bantu languages; a major one is called Chichewa. English is a
second language for most people who are educated, because Malawi
was an English colony.

It is a very new democracy; it emerged from a struggle to end a
dictatorship only six years ago. The dictator had refused to allow
the word "AIDS" to be used. The first thing the new government did
was launch a prevention program across the country, with the
President singing anti-AIDS and behavior change songs on
television with schoolchildren -- to try to get people to
understand that AIDS is a crisis and people had to change their
behavior.

Development experts and economists came in to try to get the
country going after the dictatorship ended. But they quickly
realized that this country has about five years left to live.
Malawi has ten million people, over one million HIV-infected. It
has about 400,000 orphans who do not have HIV but whose parents
are dead as a result of the epidemic. Up to a point, extended
families and relatives can absorb orphans. But the ability to
sustain life is being stretched to its limits, as members of the
extended families are now dying, as workers are dying and
productivity is collapsing. The vice president compares the
situation to an earthquake or other natural catastrophe, and asks
why is the world so willing to help a country when there is a
sudden disaster like an earthquake, but so slow when there is a
crisis of equal magnitude that takes time to develop.

There has been a change. Malawi went from hopeless resignation to
a sense of aggressive optimism. They decided they are going to
live, and going to fight to live. This year Vice President Justin
Malewezi said:

"Malawi has not been spared this worldwide epidemic. Sixteen
percent of the population aged between 15 and 49 are HIV positive.
These people are commonly called People Living with HIV/AIDS.
However, these are not the only people living with the disease.
Every day we are burying our children, our sisters and brothers,
our workmates, our neighbors, our leaders, our teachers, doctors
and other professionals. In the suffering and death of our
brothers and sisters we face grief beyond words, sorrow beyond
tears. We will not stand by and watch while our people are dying."

A study by Hamoidi and Sachs looked at how the epidemic affects
individuals and families:

"To take an individual case, a husband and father of young
children, who earns a market income and who becomes HIV infected.
He is likely to face years of declining market income due to
absenteeism from work and reduced productivity before suffering a
premature death. Household income will be diverted to pay for
medical care, he is likely to sell assets and borrow at very high
interest rates to get minimal access to palliative care. Upon his
death, funeral costs will absorb savings from the extended family
while his children may be sent away to live with relatives and
their future education will be severely compromised. Tragically
this scenario is repeated in Malawi every day."

SCONDRAS: Malawi's plan [from which the above quotes are taken] is
a direct call for help, in human terms that are unmistakable and
explicit. If we don't respond to it, then there's something wrong
with us. We cannot say we didn't know about it.

ATN: Once the plan is ready, where does it go for funding?

SCONDRAS: Malawi already had a large and well-funded tuberculosis
program, using directly observed therapy (DOT), with community
workers who give medicine to individuals. Tuberculosis had been
almost wiped out -- but AIDS brought it back. So the DOT people
are willing to finance part of the program, as it affects their
ability to control tuberculosis. (A recent South African study of
people with HIV who use antiretrovirals vs. those who do not shows
a dramatic difference of five times more tuberculosis among those
who do not use the HIV drugs. So one can argue correctly that the
antiretroviral program is an effective tuberculosis program, as
70% of tuberculosis patients in Malawi are co-infected with HIV.)
The tuberculosis program is funded by the English contribution to
the European Community.

Malawi will have a DOT program for its HIV drugs, along the line
of what Dr. Paul Farmer has done on a smaller scale in Haiti. But
here it will be expanded to the whole country.

A second source of potential funding will be a request from the
Global AIDS Fund. The World Bank will be asked to change the
payments that Malawi is presently making on its debt, which are
considerable, and returning them to Malawi as grants targeted
specifically for this AIDS program.

In addition, Malawi is asking for a start-up grant from the World
Bank -- which has been directed to make 50% of its future
investments in developing countries in the form of grants instead
of loans. Incidentally the Bush Administration is supportive of
this shift from loans to grants.

There is also an effort to organize an international concert to
ask for support from the world community.

And in the U.S. Congress, Congresswoman Barbara Lee (D.,
California) is leading an effort to contribute an additional $150
million immediately to treatment.

ATN: How would Malawi purchase the drugs?

Malawi could use the International Dispensary Association (the
IDA) as a vehicle for drug purchases. The IDA (http://www.ida.nl/)
is a nonprofit organization based in Holland that has had a
terrific reputation over the years for being the purchaser of the
most inexpensive essential drugs for poor countries. They have
decided to add HIV drugs to their list. They don't just buy the
drug on behalf of the country; they also test the drugs on an
ongoing basis to maintain their quality. Clearly for small
developing countries, it is essential to have a dependable buyer
who will get you the best price and guarantee the quality of the
product. Malawi may choose to use the IDA for their HIV drugs,
especially since they already use it for their tuberculosis drugs.

Besides funding, other support is from volunteers who are helping
this effort and not getting paid, among them being quite a few
U.S. scientists, including Peter Salk, M.D., from the Jonas Salk
Foundation, and Robert Redfield, M.D., from the Institute of Human
Virology, and people from the U.S. Public Health Service.

Several of pharmaceutical companies are also going to try to help.

ATN: How is the AIDS program in Malawi organized?

SCONDRAS: Over a year and a half ago we helped put together a
meeting in Malawi, under the leadership of UNAIDS, which helped
create the Technical Working Group, a kind of committee with the
sanction of the cabinet of Malawi. This committee was given the
responsibility of developing a plan to use antiretrovirals in
Malawi, and overseeing its implementation. It is the only
committee I know of its kind that includes foreigners on it.

The Technical Working Group includes all the major stakeholders in
Malawi working with HIV, including the private hospitals and so
forth. That organization is headed by the director of the AIDS
program in Malawi. This is the organization that, if you are going
to do anything with HIV in Malawi, you have to get approval from.
Last week the Cabinet of Malawi gave the approval for moving
forward.

ATN: Is there any opposition?

SCONDRAS: The government of Malawi is fighting hard for this plan,
but not everyone is supportive. There is a lot of skepticism. Part
of the donor community has been trying to get Malawi to not do
this plan, still saying it's unrealistic, you should do prevention
only. Malawi is going forward anyway, because it does not see any
choice. Malawi knows that even a perfect vaccine tomorrow would be
too late to save the country. And besides that it would be immoral
not to try to save those already infected. This struggle has not
been made public, but people have a right to know about it.

ATN: What about foundation funding?

SCONDRAS: We will be seeking a planning grant to help finish
putting the program together.

Malawi wants to prove that you can stop an epidemic, and that
antiretrovirals can be part of that program, that it can be done.
But the first target for this program is reduction in transmission
of HIV.

ATN: Tell our readers about the research plans.

SCONDRAS: The plan itself makes a compromise between the demands
of science and the demands of the economy, ethics, and politics.
The scientific community wants to make sure through research on
the ground that the choice of medicines is correct, that the
delivery system is actually working, and so forth -- and that the
type of therapy used is the right one, and wants to see which
types of therapy might be better. Should we use interrupted
therapy? Does nutrition have a role? What about use of immune-
based therapies? You can imagine how many questions scientists
have. But it would take years to answer them all. Meanwhile the
country would collapse.

So Malawi is starting the program by basically enrolling everyone
into a best-guess approach -- using community-based directly
observed therapy that can be taken once a day. But many people, in
fact the majority, will be involved in a set of interlocking
clinical trials, which the scientists refer to as operations
research. These trials will test the different regimens and
different styles of delivering them, to find out which work
better. And as they learn what is best, they will phase out
certain treatments and switch people to others.

Malawi will maintain the research component, so that Malawi will
not only be a country that tries to stop the AIDS epidemic, but
also will become the world's largest clinical-trial system, to
find out the best way to reduce HIV transmission and improve on
existing therapies across the world. For example, studies could
test microbicides and see if they can reduce the rate of spread,
or test vaccines. The research component, the ability to track
data, analyze it, and feed it back to the working group and have
the government make decisions about what to do, has to be much
more advanced and larger than you would expect for a treatment
program. The advantage is that this research will help everyone in
the world, including people in the United States.

ATN: Could you summarize what's happening now?

SCONDRAS: In a few months Malawi will make history -- as its
leaders present this ambitious, countrywide program for stopping
AIDS in an African country to funders at the World Bank and the
Global AIDS Fund.

Malawi will not survive unless this program succeeds. Today a
million people are infected, there are 400,000 orphans, and the
whole country has only ten million people. If this plan works in
one of the poorest countries, then it can work elsewhere and will
become a beacon of hope for Africa and the rest of the world.

This effort has been put together by a team of volunteers
including some of the best medical minds in the world, students
from Harvard Business School, politicians, ministers, people with
HIV, people of good will from all walks of life, working together
with leaders from Malawi. It is possible because activists from
around the world have pushed for a worldwide AIDS fund, and for
reduced prices of antiretrovirals. Malawi will come to the United
States to work with some of this country's finest experts and
activists, all committed to finishing the design of the program
and finding the funds to put it into operation now.

Anyone interested in helping is welcome to call or write us and
join this effort. Many of us feel that one measure of our
civilization will be how the rich nations and people of the Earth
behaved during the most devastating epidemic in the history of the
world.

[For more information about the Malawi program, contact David
Scondras or Dede Ketover at Search for a Cure, 617-536-2474, or
email them at hope@...]

***** AIDS TREATMENT NEWS

Published twice monthly

Subscription and Editorial Office:
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Editor and Publisher: John S. James
Associate Editor: Tadd T. Tobias, R.N.

Statement of Purpose:
AIDS TREATMENT NEWS reports on experimental and standard
treatments, especially those available now. We interview
physicians, scientists, other health professionals, and persons
with AIDS or HIV; we also collect information from meetings and
conferences, medical journals, and computer databases. Long-term
survivors have usually tried many different treatments, and found
combinations that work for them. AIDS TREATMENT NEWS does not
recommend particular therapies, but seeks to increase the options
available.

AIDS TREATMENT NEWS is published 24 times per year, on the first
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--
John S. James
AIDS Treatment News
http://www.aidsnews.org

AIDS Treatment News #370, August 24, 2001
   phone 800-TREAT-1-2, or 215-546-3776

CONTENTS

** Liver Fibrosis in HIV/Hepatitis C Coinfection: HIV
Protease Inhibitors May Be Protective
A study to see if HIV protease inhibitors increased risk of
liver toxicity in persons coinfected with hepatitis C
unexpectedly found that they may reduce liver damage from
the disease.

** Tenofovir: FDA Hearing October 3, Public Comment
Deadlines September 26
An FDA advisory committee will hold a one-day public
hearing on this important new antiretroviral.

** Homocysteine, HIV, and Heart Disease
Too much homocysteine in the blood is associated with an
increased risk of heart and circulatory diseases. Blood
tests can detect the problem, and it can often be treated
with nutrition and supplements. Here is some background on
this potential approach to reducing cardiovascular risk.

** AIDS Treatment Activists Form New Coalition
A new treatment activist coalition, formed in mid August,
will develop national strategies, plan mentoring of new
activists, and help persons with HIV and activists find
consensus and work together on issues involving treatment
research and access to care.

** Action Alert: Global AIDS Funding
Senators especially need to hear that their constituents
care about international AIDS.

** NATAF Scholarship Deadline August 31; You Can Apply
Online
The North American AIDS Treatment Action Forum will be held
December 2-5 in Vancouver. But for those needing
scholarships, the deadline to apply for a scholarship is
now.


***** Liver Fibrosis in HIV/Hepatitis C Coinfection: HIV
Protease Inhibitors May Be Protective

by John S. James

A study of 182 patients at a major hospital in France
suggests that HIV protease inhibitors may help to reduce
liver fibrosis and cirrhosis in patients with both HIV and
hepatitis C.(1)

This study, conducted in patients with both hepatitis C and
HIV, was done to determine if protease inhibitors were
really harmful to such patients, as had been reported in
some cases. In fact, the opposite was found; use of
protease inhibitors was associated with significantly less
liver damage in this study. No one knows why, although the
authors suggested several possible mechanisms. This new
study is the first large, long-term followup of coinfected
patients which included liver biopsy data -- which may help
explain why it found different results.

The new study, published in the August 2000 HEPATOLOGY,
analyzed a cohort of patients who had been treated at the
hospital between 1995 and 2000, and on whom careful medical
records had been kept. A statistical analysis found four
independent predictors of progression to cirrhosis (severe
scarring of the liver): absence of protease inhibitor
therapy (relative risk 4.74), heavy alcohol use (greater
than or equal to 50 grams per day -- about 5 drinks a day -
- relative risk 4.71), CD4 count under 200 (relative risk
2.74), and age greater than 20 years at the time of
hepatitis C infection (relative risk 2.74).

The protective effect of antiretroviral treatment was found
only for protease inhibitors, not for nucleoside analog
drugs. (There were not enough patients treated with NNRTIs,
such as nevirapine or efavirenz, to make a comparison.)

The authors suggested that using protease inhibitors in HIV
therapy, reducing alcohol consumption, and keeping CD4
counts high might be beneficial in coinfected patients.

This study was limited because it was not a randomized
trial where patients were randomly assigned to use protease
inhibitors or not, with long-term followup with liver
biopsy. The authors noted that such as trial would be
impossible for both ethical and practical reasons.

References

1. Benhamou Y, Di Martino V, Bochet M, and others. Factors
affecting liver fibrosis in human immunodeficiency virus-
and hepatitis C virus-coinfected patients: Impact of
protease inhibitor therapy. HEPATOLOGY. August 2001; volume
34, pages 283-287.

Note

For more information on hepatitis C and coinfection with
HIV, see THE HEPATITIS REPORT by Michael Marco and Jeff
Schouten, available at http://www.treatmentactiongroup.org
(click on "HIV/HCV Coinfection").


***** Tenofovir: FDA Hearing October 3, Public Comment
Deadlines September 26

by John S. James

On October 3 the FDA's Antiviral Drugs Advisory Committee
will hold a public hearing on tenofovir (full chemical name
tenofovir disoproxil fumarate, or tenofovir DF; new brand
name Viread(TM)), an antiretroviral developed by Gilead
Sciences and currently in pre-approval expanded access.
Public comments are scheduled for the October 3 hearing,
and written statements can also be submitted. Both written
comments, and sign-up to make an oral presentation, are due
at the FDA by September 26. Details are included in the
official announcement below.

[Name and drug class: The full chemical name of tenofovir
is tenofovir disoproxil fumarate, or tenofovir DF; the new
brand name is Viread. Tenofovir is a *nucleotide* analog --
differing from the nucleoside analogs (AZT, d4T, etc.) in
that it requires less processing within cells, and
therefore is active in certain cells where the nucleoside
analogs generally are not. Both nucleotide analogs and
nucleoside analogs are reverse transcriptase inhibitors.]

On the following day, October 4, the same Advisory
Committee will discuss another drug, voriconazole, for
severe fungal infections.

Comment

Tenofovir is an important new HIV treatment because of its
resistance profile, potency, apparently low side effects,
and ease of use. The Committee is expected to recommend it
for approval. (The FDA does not have to follow the
recommendation of an Advisory Committee, but it almost
always does.)

A likely issue before the Committee will be whether to
recommend a broad indication (such as "indicated in
combination with other antiretroviral agents for the
treatment of HIV infection"), or a narrow one that would
limit the drug to advanced patients, where more data is
available. In either case physicians would legally be
permitted to prescribe the drug for any patient, but
insurance reimbursement will often be a problem if the drug
is labeled only for treatment-failure cases and physicians
want to use it earlier. We believe that approval with a
broad indication is important for several reasons:

* Tenofovir has already been shown to work well for
advanced HIV patients, the most difficult to treat. While
less information is available today for its use early in
treatment, everything we know about antiretrovirals
suggests that they work at least as well when used early in
treatment, and with at least as good a safety profile.

* Many patients cannot tolerate existing regimens because
of metabolic or other side effects. Their physicians may
want to try changing their regimen early, for example when
lipoatrophy (fat wasting) first begins to develop, to
prevent long-term harm. Even though much remains unknown
about metabolic side effects and how to manage them,
doctors and patients should have more options to try if
necessary, without having to fight HMO red tape or pay for
necessary drugs out of pocket.

* Some doctors are moving toward using stronger drug
combinations first, instead of keeping them in reserve for
when the other treatments fails -- and the patients have
become more difficult to treat. Medical opinion is still
largely unformed on this issue; no one knows for sure which
strategy is better, and in practice we will probably learn
from clinical experience before we learn from clinical
trials. Reimbursement obstacles should not block clinical
practice and experience.

* Adherence remains crucial, and is improved by regimens
that are easy to take. Tenofovir is taken as one tablet
once a day, so it can be a part of once-daily regimens,
important for patients with adherence difficulties and also
for tests of directly observed therapy.

* It has been hard to get companies to research new drugs
for advanced patients. Most prefer to test their drugs
earlier when it is usually easier to show viral-load
changes and lack of side effects. Gilead did test tenofovir
first in late-stage patients, and if it is punished with a
restrictive label, other companies will become even more
reluctant to test early for advanced patients, who need new
options the most. (Gilead is now running a large trial,
called Study 903, for treatment-naive patients, but data
will not be available until 2002.)

One can never be sure what will come out of an advisory
committee -- especially when the FDA has been under
increasing pressure in recent years to be more conservative
in its drug approvals. We hope HIV physicians will write or
speak to the Committee about their need for new treatment
options -- and tell the Committee and the FDA what labeling
for tenofovir would be best.

FDA Meeting Announcement, Distributed August 21:

The Food and Drug Administration (FDA) will hold a public
meeting of the Antiviral Drugs Advisory Committee on
October 3 and 4, 2001, 8:30 a.m. to 5 p.m. at the Town
Center Hotel, Maryland Ballroom, 8727 Colesville Road,
Silver Spring, MD. For directions, or information about
lodging, please call the hotel directly at (301) 589-5200.

On October 3, 2001, the committee will discuss new drug
application (NDA) 21-356, for Viread(TM), (tenofovir
disoproxil fumarate) Tablets, proposed for the treatment of
Human Immunodeficiency Virus (HIV) infection. The sponsor
is Gilead Sciences, Inc.

Additionally, on October 4, 2001, the committee will
discuss new drug application (NDA) 21-266, for Vfend(TM)
(voriconazole) Tablets, and (NDA) 21-267, Vfend(TM) I.V.
(voriconazole) for Infusion, Pfizer Global Research and
Development, proposed for the treatment of invasive
aspergillosis, serious Candida infections, infections
caused by Scedosporium spp. and Fusarium spp., rare and
refractory infections and empirical treatment.

This meeting is free and open to the public. No prior
registration is required to attend.

Interested persons are encouraged to present data,
information, or views, orally or in writing, on issues
pending before the committee.

If you would like to make an oral presentation, please send
the following information to: Tara Turner, Pharm.D., Center
for Drug Evaluation and Research (HFD-21), 5600 Fishers
Lane, Lane (for express delivery: 5630 Fishers Lane, rm.
1093) Rockville, MD 20857, by FAX at 301-827-6776, or by e-
mail to TurnerT@... by September 26, 2001.
* Name of speaker (and organization/affiliation if
appropriate)
* Address, phone and FAX numbers
* A brief summary statement of your comments
* Approximate amount of time you would like to speak

Oral presentations from the public are scheduled on both
days between approximately 1 p.m. and 2 p.m. Time allotted
for each presentation may be limited, depending on the
number of speakers.

Written submissions may also be sent to Dr. Turner by
September 26, 2001.

Please call the FDA Advisory Committee Information Line, 1-
800-741-8138 (301-443-0572 in the Washington, DC area),
code 12531, for up-to-date information on this meeting.


***** Homocysteine, HIV, and Heart Disease

by Jennifer E. Cohn

[Note: Abnormally high levels of homocysteine in the blood
are associated with increased risk of heart disease, and a
number of other diseases as well. These high levels can be
detected by a blood test, and are often caused by dietary
deficiencies that can be corrected.

[Reducing disease risk by controlling homocysteine level is
today considered experimental; for example, it is not part
of the new NCEP (National Cholesterol Education Program)
guidelines published May 16, 2001, probably because much of
the data is just emerging and is sometimes contradictory.
But because excessive homocysteine is strongly suspected to
be unhealthy in many ways, because it can be easily
controlled in many cases, and because vitamin B12
deficiency (which can cause excess homocysteine) is already
an important risk for persons with HIV, we believe there
should be more attention to this potential medical
strategy.

[Therefore we asked Jennifer Cohn, a medical student in
Philadelphia, to look into the literature on homocysteine
and cardiovascular risk and prepare a brief report, to help
raise awareness in the HIV community. JSJ]

* * *

Homocysteine is a non-essential amino acid; high levels
have been associated with cardiovascular disease. Excessive
homocysteine levels can be caused by a deficiency of folate
and/or vitamin B12. Deficiencies of folate can arise
because a person is not eating enough fruits and leafy
green vegetables. Vitamin B12 deficiency can occur in
vegetarians (since this vitamin is not found in plant
sources), but deficiencies are more commonly caused by poor
absorption, which can result from HIV disease, aging, and
other causes.

Excess homocysteine may have varying effects on an
individual's health. For example, increased levels of
homocysteine have been associated with both increased risk
of Alzheimer's and cardiovascular disease.(1,2)
Furthermore, some preliminary studies have demonstrated
that a certain form of homocysteine, called "reduced
homocysteine," may increase HIV viral replication.(3)
However, the literature on homocysteine levels and viral
replication is inconsistent(3, 4) -- so this article will
focus on one of the better documented effects of
homocysteine: its effect on the cardiovascular system.

Many studies of non-HIV infected individuals have shown
elevated serum homocysteine levels to be a risk factor for
vascular disease. In particular, a review article by
Boushey et al. (1995) highlighted homocysteine as a causal
factor for arteriosclerotic vascular disease.(1)
Individuals with a high level of serum homocysteine had 2.5
times the risk of developing vascular disease as those with
a normal level; this makes serum homocysteine levels a
stronger risk factor for vascular disease than serum
cholesterol. In another study, Stubbs et al. (2000)
demonstrated that for patients being admitted for acute
cardiac events, serum homocysteine levels were an excellent
predictor of later cardiac events such as another heart
attack or death from a heart attack.(5)

The mechanism by which homocysteine acts is still unclear.
However, research suggests that it affects the lining of
blood vessels.(6) Increased serum homocysteine levels may
damage this lining or make it hard for blood vessels to
relax, making it easier for arteriosclerotic plaques to
develop. Homocysteine may also change factors in blood
itself so that the blood becomes more prone to clot.(1,6)

How does homocysteine affect people with HIV?
Unfortunately, at the present time few studies are
investigating this question. However, it is probably a
reasonable assumption that homocysteine increases the risk
of vascular disease in people with HIV in the same way as
it does in people without HIV -- but if persons have
already developed other risk factors for cardiovascular
disease, high homocysteine levels may be even riskier for
them. And persons with HIV may have a more difficult time
absorbing Vitamin B12, leading to an increase in serum
homocysteine.(7)

Some drugs may also increase homocysteine levels. Examples
of such drugs include nicotinic acid (niacin), theophylline
(used for asthma, emphysema and bronchitis), methotrexate
and L-Dopa.(8)

The most important and easiest treatment is taking dietary
supplements of Vitamin B12, Vitamin B6, folic acid and TMG
(betadine), in addition to eating a balanced diet including
fruits and green leafy vegetables.(1,7) While there are
suggested daily amounts of supplements, the only reliable
way to know if a patient is taking the right amounts to
control a high serum homocysteine level is by having a
blood test for homocysteine.

References

1. Boushey CJ, Beresford SA, Omenn GS, and others. A
quantitative assessment of plasma homocysteine as a risk
factor for vascular disease: Probable benefits of
increasing folic acid intakes. JAMA. October 4, 1995;
volume 274, number 13, pages 1049-57.

2. Muller F, Svardal AM, Aukrust P, and others. Elevated
plasma concentration of reduced homocysteine in patients
with human immunodeficiency virus infection. AMERICAN
JOURNAL OF CLINICAL NUTRITION. February 1996; volume 63,
number 2, pages 242-8.

3. Simon G, Moog C and Obert G. Effects of glutathione
precursors on human immunodeficiency virus replication.
CHEMICAL BIOLOGICAL INTERACTIONS. June 1994; volume 91,
numbers 2-3, pages 217-24.

4. Balzarini J, De Clercq E, Serafinowski P, and others.
Synthesis and antiviral activity of some new S-adenosyl-L-
homocysteine derivatives. JOURNAL OF MEDICAL CHEMISTRY.
November 27, 1992; volume 35, number 24, pages 4576-83.

5. Stubbs PJ, Al-Obaidi MK, Conroy RM and others. Effect of
plasma homocysteine concentration on early and late events
in patients with acute coronary syndromes. CIRCULATION.
August 8, 2000; volume 102, number 6, pages 605-10.

6. Al-Obaidi MK, Philippou H, Stubbs PJ, and others.
Relationships between homocysteine, factor VIIa, and
thrombin generation in acute coronary syndromes.
CIRCULATION. February 1, 2000; volume 101, number 4, pages
372-7.

7. Remacha AF, Riera A, Cadafalch J and others. Vitamin B-
12 abnormalities in HIV-infected patients. EUROPEAN JOURNAL
OF HAEMATOLOGY. July 1991; volume 47, number 1, pages 60-4.

8. Cardiovascular Consultants Medical Group: Homocysteine
and the Heart, July 30, 2001,
http://www.cardiacconsultants.com/homocysteine.htm


***** AIDS Treatment Activists Form New Coalition

by John S. James

Twenty-one U.S. AIDS treatment activists met for three days
in August and began to outline a new coalition to improve
AIDS research, treatment access, and empowerment of new
activists in communities most affected by the epidemic. The
August 17-19 meeting, hosted by The Center for AIDS: Hope
and Remembrance Project in Houston, Texas, resulted from
earlier community meetings held at the annual Retroviruses
conference in 2000 and 2001.

The new organization, tentatively named AIDS Treatment
Activist Coalition, will address several concerns:

* There is no national organization or meeting of AIDS
treatment activists to discuss and develop overall
strategy. (NATAF, the North American AIDS Treatment Action
Forum, serves another purpose, educating new activists and
advocates.)

* Each year there are at least a dozen pharmaceutical
company meetings with AIDS treatment activists. These
meetings are called by different companies, each of which
sets the agenda and decides who will be invited to
represent patients and the public. U.S. activists want to
move toward the European system of ongoing, structured
meetings with the companies, where the community selects
its own representatives and invites the company whose
products will be discussed, instead of letting industry
determine who will represent the community at major
company/community meetings. ATAC also hopes to improve
communication about the discussions that take place at
these meetings, so that activists who do not attend can be
informed.

* Treatment activists must be more representative of the
demographics of the epidemic (including more people of
color, women, and young people). The new organization will
emphasize mentoring, educating, and empowering new
activists -- and may require members to recruit others from
underrepresented groups.

* Today a small number of highly experienced activists are
overcommitted. We need to help provide more opportunities
for treatment education, and otherwise make it feasible for
more people to become treatment activists.

ATAC will focus on biomedical research, including
diagnostics, vaccines and microbicides as well as drugs,
and will include AIDS-related illnesses such as hepatitis C
and tuberculosis, as well as HIV infection and its
complications.

Membership policies, bylaws, and other specifics are still
being determined. For example, it is likely that membership
will be open to all persons with HIV and their advocates,
with members joining as individuals (not as representatives
of organizations) and paying nominal dues; but there might
or might not also be a separate category of organizational
member for nonprofit organizations. The organizers are
seeking input from the public and can be reached through
the email addresses below.

Standing committees so far are Bylaws; Communication;
Fundraising; Membership; Mentoring; and Research,
Development, and Access.

For More Information; Contacting ATAC

ATAC has started a Web site at http://www.atac-usa.org; you
can also send email to info@...

ATAC has a temporary steering committee, and you can also
contact the members individually:
Parrish Crosby Parrishfc@...
Yvette Delph YvetteDelph@...
Larry Diaz sadatatx@...
Mike Donnelly MrDonnelly@...
Gregg Gonsalves greggg@...
Michael Marco Mikemarco@...
Bob Munk bobmunk@...
Claire Rappoport clairer@...

Notes:

(1) This writer participated in the organizing meeting in
Houston, and drafted the statement above with the
assistance and approval of the group.

(2) We are especially impressed that this coalition has
started useful work immediately, within a week of its
organizing meeting; see http://www.atac-usa.org


***** Action Alert: Global AIDS Funding

by John S. James

It is especially important now for U.S. citizens to let
their two Senators know they are concerned about funding to
control AIDS and other infectious diseases around the
world. The Democrats have been worse on this issue than the
Republicans -- not because they are opposed, but because
they do not think people care. Calls before Labor Day are
most important. But it never hurts to let Congress know
that their constituents care about AIDS in Africa and
elsewhere, and infectious diseases everywhere.

Background

An August 20 alert from the Treatment Action Network of
Project Inform summarizes the situation:

"On April 26th, 2001, United Nations Secretary General Kofi
Annan launched the 'Global AIDS and Health Fund'. This
international fund is intended to treat and prevent
HIV/AIDS, tuberculosis, and malaria for those without
access to medicine, health care, and prevention programs.

"This spring, President Bush pledged a $200 million
contribution to this fund. While a small step forward, this
amount falls well short of the $2 billion asked of the
United States and lowered the bar for other contributors.
Major donors have scaled back their contributions and the
momentum has slowed. Advocates have turned to Congress to
increase this pledge.

"While the process hasn't finished in the House of
Representatives or the Senate, it appears that the House
will approve about the same amount as the President has
pledged. It is critical that the Senate propose a much
larger amount. The House and Senate will have to meet to
negotiate a final amount to send to the President for
approval. To prepare for these negotiations, it is crucial
that the Senate come to the table with a large number,
rather than the smallest!

"Constituent pressure is essential to ensure that elected
officials make the global AIDS crisis a priority. If
everyone who cares about the international AIDS epidemic
meets with, calls, or writes a letter to their Senators
this month, we could have a major impact in focusing their
attention on this issue. Please take a few minutes to
respond to this Alert!

... "You can find contact information for your two U.S.
Senators by accessing their individual websites through the
main U.S. Senate website. Go to http://www.senate.gov, then
click "List Senators By State". You'll find links to both
of your Senators underneath your state. Each website will
have Washington and district phone, fax, and mailing
addresses."

Notes:

(1) It is best to avoid email to political offices unless
you know that they are prepared to include email in their
counts of public opinion on issues. If you do email your
Senators, include your street address so they will know it
is coming from a constituent. You might call their office
and ask if email is a good way to communicate with them --
or if you should write or call instead.

(2) This alert is intended for the month of August (before
Labor Day). But it is never too late to let your
representatives know that you care about AIDS in Africa and
elsewhere, and infectious diseases throughout the world.

Doing our part to control epidemics is entirely feasible
and is the right thing to do, and it makes us all safer in
an increasingly populated, mobile, and interconnected
world.


***** NATAF Scholarship Deadline August 31; You Can Apply
Online

"The 2001 North American AIDS Treatment Action Forum
(NATAF) will be held December 2-5 at the Sheraton Vancouver
Wall Centre Hotel, Vancouver, Canada. The forum is designed
to educate individuals interested in becoming HIV/AIDS
advocates and educators; to enhance their skills and
knowledge; and to develop inclusive, national strategies to
ensure the continuity and success of the treatment advocacy
movement.

"NATAF 2001 is open to anyone interested in broadening
their knowledge of HIV/AIDS research and treatment issues,
and learning to use this knowledge to advocate on behalf of
everyone living with HIV/AIDS. Participants include the
volunteers, staff, and board members of community-based
organizations, case managers, social workers, AIDS
educators and outreach workers, pharmaceutical and
government representatives, healthcare professionals and
people living with HIV/AIDS.

"Scholarships Deadline August 31st: Deadline for
scholarships application is 6:00 PM (Eastern) on August 31,
2001. For information about scholarships or to apply
online, please go to
http://www.nmac.org/nataf/2001/scholarship/scholarship.htm

Note:

Project Inform included the following to it's Treatment
Action Network (tan@...) "While many of the
questions on the scholarship form ask about your agency,
applications are especially encouraged from individuals not
association with an agency or organization. Put "N/A" on
the agency questions and focus on the personal statement
section."


***** AIDS TREATMENT NEWS

Published twice monthly

Subscription and Editorial Office:
   1233 Locust St., 5th floor
   Philadelphia, PA 19107
   phone 800/TREAT-1-2 toll-free, or 215-546-3776
   fax 215-985-4952 (email is preferred)
   email: aidsnews@...
   useful AIDS links: http://www.aidsnews.org

Editor and Publisher: John S. James
Associate Editor: Tadd T. Tobias, R.N.

Statement of Purpose:
AIDS TREATMENT NEWS reports on experimental and standard
treatments, especially those available now. We interview
physicians, scientists, other health professionals, and
persons with AIDS or HIV; we also collect information from
meetings and conferences, medical journals, and computer
databases. Long-term survivors have usually tried many
different treatments, and found combinations that work for
them. AIDS TREATMENT NEWS does not recommend particular
therapies, but seeks to increase the options available.

AIDS TREATMENT NEWS is published 24 times per year, on the
first and third Friday of every month, and print copies are
sent by first class mail. Email is available (see below).
Back issues are available at http://www.aidsnews.org

To subscribe, you can call 800-TREAT-1-2 or 415-255-0588:
* Businesses, Institutions, Professionals: $325/year. Early
email available (see below).
* Nonprofit organizations: $150/year.
* Individuals: $140/year, or $80 for six months. If you
cannot afford a subscription, please write or call about
our sliding scale.
* Outside North, Central, or South America, add airmail
postage: $20/year, $10 for six months.
* Bulk rates and multiple discount subscriptions are
available; contact our office for details.
* Payment can be by check, VISA, Mastercard, American
Express, bank draft, purchase order, international postal
money order, or travelers checks.

Early email: Business, nonprofit and full-rate individual
subscribers can receive an early copy by email, before the
issue is printed--in addition to their regular copy, at no
extra charge. It's OK to direct the email copy to someone
else. Call our office to add email to your subscription.

Free email: Free delivery for individuals (delayed one week).
To subscribe, send a blank email to:
aidsnews-subscribe@yahoogroups.com

ISSN # 1052-4207

Copyright 2001 by John S. James. Permission granted for
noncommercial reproduction, provided that our address and
phone number are included if more than short quotations are
used.

--
John S. James
AIDS Treatment News
http://www.aidsnews.org

AIDS TREATMENT NEWS Issue #369, July 27, 2001
     phone 800-TREAT-1-2, or 215-546-3776

CONTENTS:

** Global Epidemic, U.S. Response: A Winning Strategy, What
You Can Do
The global effort against the AIDS epidemic is stalling on
the issue of resources. The main reason is that the U.S.
Congress is not hearing from constituents that they care
about the epidemic in poor countries (where about 90% of
the cases are located); many other countries follow the
U.S. lead in how seriously they take the global epidemic.
About 10,000 letters to Congress per month would make all
the difference -- one letter from every 25,000 Americans.
We analyze why it has not happened so far -- and how to
change the course of the worldwide response to AIDS.

** Treatment Interruption: Erroneous Press Report
A July 20 press report on structured treatment interruption
erroneously said it does not work.

** Vaccines: Major Conference Sept. 5-8 in Philadelphia
AIDS Vaccine 2001, one of the most important AIDS
conferences of the year, takes place next month in
Philadelphia.

** IAS Buenos Aires Conference: Medscape CME Summaries
Three excellent summaries from the recent Buenos Aires
conference report on current patient management, new
treatments, and complications of HIV disease.

** FDA: New Email List on HIV/AIDS
Now there is a single source for all AIDS-related
announcements from the FDA.

** Science Project Director Wanted -- Treatment Action
Group (TAG)
TAG, a leading activist organization, is seeking a
scientific policy director.


***** Global Epidemic, U.S. Response: A Winning Strategy,
What You Can Do

by John S. James

*** How to change the lack of political will now blocking
worldwide AIDS control. ***

World consciousness on the HIV epidemic in developing
countries -- about 90% of the global epidemic -- has
changed greatly in the last three years. In 1998 the World
AIDS Conference in Geneva took the theme "Bridging the Gap"
-- meaning the gap between access to treatment in rich and
poor countries. But outside the conference there was no
institutional support for saving lives in poor countries;
once the speeches were done, that was it. And we all knew
it.

Now it is no longer OK to let tens of millions of people
die without treatment when treatment is available. And
especially since the XIII International AIDS Conference
last summer in Durban, South Africa, real changes have
begun. Prices of antiretrovirals have been reduced up to
90% in some poor countries -- either by generic
manufacturers, or by major pharmaceutical companies trying
to head them off. Treatment is now widely recognized as an
important part of HIV prevention and control, especially
since it gives people incentive to get tested and work with
the public-health system. (With no chance of treatment,
they have the opposite incentives.)

The big problem now is funding. Even with the price
reductions many countries cannot pay for the necessary
prevention and treatment programs without help. United
Nations Secretary General Kofi Annan proposed a global fund
of $7 to $10 billion per year to control HIV, tuberculosis,
and malaria; economists agree that the money is available,
and health experts agree that if well spent, it could do
the job. Yet the Global AIDS and Health Fund is going to
start with only a fraction of the amount required -- and
even that includes one-time contributions, multi-year
contributions all counted in a single year, and money
already being spent on AIDS that has been redirected or
renamed to make the Fund look bigger. (For current pledge
totals to the Global AIDS and Health Fund, see
http://www.un.org/News/ossg/aids.htm)

The problem is not lack of money -- many institutions and
some individuals could write a check for the entire amount
required from all countries in the world -- but lack of
political will. In the U.S., we are hearing from political
experts that the biggest problem is not policy
disagreements about what to do about global AIDS, but
rather that global AIDS is not a priority for either
political party -- simply because Congress is not hearing
from constituents that this is a problem for them. These
experts tell us that if Congress received 10,000 calls or
letters per month expressing concern about the global AIDS
epidemic and other infections diseases, the entire
situation would be transformed.

That's about one call or letter per month for every 25,000
people in the United States -- to entirely change our
country's response to the greatest epidemic of modern
times. And it would change much of the world's response as
well. If the world's only superpower takes global AIDS
seriously, many other countries will also.

So why hasn't it happened already?

A big part of the problem has been the lack of good
legislative vehicles (such as bills or amendments) for
expressing concern -- or rather, the lack of knowledge
about how to use the vehicles that do exist. With the way
Congress works, letters and phone calls should target
actual legislation or other decisions in front of Congress
at the time; otherwise they may never be counted, because
the office staff will probably not categorize, total, and
report them, among the many thousands of communications
that come in to each Congressional office.

To overcome this problem, advocates and the public alike
must understand that what is most important is that
Congress knows the public it represents does care about
AIDS and other epidemics in developing countries. So even
if specific legislation fails, or is flawed, or was not
introduced in a politically astute way, your call or letter
is still important because it adds up to the 10,000
communications per month that Congress needs to get from
throughout the U.S. -- to know that people in their
district care about the global epidemic (and therefore they
need to care about it as well, and act accordingly).

When you write or call it helps to know that you are not
trying to change anyone's position (the Senator or
Representative and their advisers and office staff probably
agree with you already), but to let them know you care
about the issue, and want them to give it the priority it
deserves. You don't need to debate or make technical
arguments.

Political organizers can miss this reality because they are
used to controversial issues where the most important part
of a call or letter is where it makes clear which side the
writer takes. Here it's not an question of sides, but of
priority. Political organizations can also miss the point
because usually their main goal is to pass or block
specific legislation or other policies -- while the main
goal here is cumulative impact on prioritizing the issue.

Also, lobbyists may find it hard to work on both domestic
and international AIDS; but for the public, calls or
letters to Congress or the White House on each of these add
to the total momentum on AIDS, infectious diseases, and
health, increasing the priority (the political will) on
both U.S. and international AIDS.

Next Steps

In August, September, and October of this year
international AIDS will come before Congress many times, as
the new Global AIDS and Health Fund begins. Many AIDS
organizations will put out action alerts when calls or
letters are needed. Remember that what often counts most is
letting Congress know you care about international AIDS,
rather than the particulars of the legislation or amendment
at issue.

We believe that a winning strategy is to use each
appropriate piece of legislation to build cumulative
momentum on this issue. Can we organize friendly contests
on who can get the most communications from constituents to
Congress (and/or to the White House)?

Every U.S. citizen can contribute substantially to better
worldwide control of AIDS and other infectious diseases --
saving millions of lives, contributing to the safety of our
country, and improving the quality of life for everyone. A
few hundred committed, determined activists -- with the
widespread community support they already have -- would be
more than enough to do it.

Better political mobilization would help. We see action
alerts with no date, with misspellings, or with no
indication of whether they are still current. Or the action
alerts are hard to find on a Web site. Some of them direct
users only to an automated email response, without
justifying whether emails to Congress are effective
(despite widespread doubt that Congress listens to email).

Some give little guidance -- for example, urging readers to
write the Treasury Department with no further details. None
seems to have benefited from simple focus groups that ask
supporters not familiar with writing Congress, etc. to
relate what questions and obstacles come up as they try to
respond to the alert. And many apparently lack a winning
legislative strategy -- or if they do have one, they
conceal it well from readers.

Years ago we noted the bad state of AIDS action alerts and
grassroots organizing. Much of the problem stemmed from the
ambivalence of inside-the-Beltway organizations toward
grassroots action: they needed it to be effective, but were
threatened by it as well. The community still urgently need
organizers who define grassroots as their mission, and
learn do it well.

The epidemic will not wait for perfect organization, and
neither can we. Determined individuals throughout the
country can use the information available (and insist on
better information when necessary) to make sure the U.S.
and other governments respond seriously to the worldwide
epidemic -- not only in rhetoric, but in resources as well.


***** Treatment Interruption: Erroneous Press Report

by John S. James

On July 20 an erroneous Reuters report on structured
treatment interruption (STI -- also called structured
intermittent therapy, or SIT), titled "Experts Caution
Against an AIDS Therapy," appeared in several newspapers,
including the Web site of THE NEW YORK TIMES. The report
said that STI does not work, and quoted Dr. Bruce D. Walker
of Harvard as saying it had shown poor results. We were at
the meeting reported -- a two-day clinical discussion
organized by the International Association of Physicians in
AIDS Care -- and in fact the information on STI was mostly
positive, although the physicians agreed that it should be
done in careful research studies and is not ready for
widespread use until more is known.

Dr. Walker issued the following correction, which was
widely distributed on email lists:

"I am quite upset to have been grossly misquoted in a
recent report from Reuters regarding my views on STI.
Augmentation of immune responses from STI has been clearly
shown in treated acute HIV infection, and our own studies
continue to show success in the majority of persons who
have participated in a complicated STI trial. Although the
durability of control and the exact clinical benefit in
terms of overall outcome of infection has not been shown,
the results show that at least transient immune control can
be achieved. In contrast to the promising results in acute
infection, similar immune boosting and control of viremia
in chronically-infected individuals appear to be difficult
to achieve. However, there may be benefit from reduced drug
exposure in persons with chronic infection, and there are
also other adjunctive measures that may confer benefit,
such as therapeutic vaccines. At Massachusetts General
Hospital we have a trial that is ongoing looking at
therapeutic vaccination and STI in chronic infection, and
others are soon to open. For now I recommend that persons
not try STI on their own but that these approaches be
supervised in a research setting to enhance safety and to
ensure that we learn the most we can in the most
expeditious fashion. We and others have clearly shown that
the immune response to HIV can be boosted after a person
becomes infected, and we have to believe that we can be
smart enough to induce even better responses that will lead
to persistent clinical benefit."

Another physician's name was misspelled in the article
(making the erroneous report easy to find through computer
searches -- look for "Steerer").

Comment

The reason for concern is that patients may change
treatment decisions or drop out of clinical trials, based
on wrong information.

What happened here is that this story was not written by
Reuters Health, the unit which usually writes medical
stories for the wire service, but by a reporter from
another Reuters unit who had never covered an AIDS meeting
before. And this event was hard to report because it was
not intended for media (although not closed to the press
either). IAPAC brought together some of the leading HIV
physicians and clinical researchers in the country to
discuss difficult issues in antiretroviral treatment, so
that guidelines for physicians can be prepared. The two-day
meeting itself was excellent, and we look forward to the
guidelines, which should be published in a few weeks.

This incident illustrates that news reports on medical
subjects too often include serious errors. Media stories --
in treatment newsletters as well as the general press --
can be used as leads for further investigation, but should
never be the main reason for changing treatment decisions.


***** Vaccines: Major Conference Sept. 5-8 in Philadelphia

AIDS Vaccine 2001, a major scientific conference on AIDS
vaccine development, will take place September 5-8 at the
Philadelphia Marriott. Sponsors include the U.S. National
Institutes of Health, U.S. Centers for Disease Control and
Prevention, UNAIDS, the World Health Organization, and the
Agence Nationale de Recherches sur le SIDA, in France. The
organizing committee is David L. Baltimore, Ph.D., Beatrice
H. Hahn, M.D., Norman L. Letvin, M.D., Douglas D. Richman,
M.D., and Melissa Sordyl. The program committee includes
scientists from China, France, India, Kenya, South Africa,
Uganda, and UK, as well as the U.S.

The advance registration deadline has recently been
extended to August 17. After that, persons should register
onsite at the Philadelphia Marriott.

International press note: "Representatives from non-U.S.
media are required to pre-register by Friday, August 24,
2001 in order to receive press credentials to attend the
AIDS Vaccine 2001 conference. On-site media registration is
not available for non-U.S. media due to the need to verify
media credentials in advance" (quoted from the conference
Web site, August 5). This has been a problem in at least
one previous AIDS conference, as reporters are not used to
registering in advance to cover news, and will often not
learn of the requirement in time. We are concerned that
international journalists may be turned away.

Program

The conference has more than 60 sessions. Talks include:
* The Global Need for an AIDS Vaccine (keynote talk in
opening session)
* Lessons from Acute Infection and Relevance to Vaccine
Development
* Innate Immunity
* Candidate Vaccines
* Access and Implementation
* Novel Envelope Immunogens
* Experience with AIDS Clinical Trials in Humans: What
We've Learned
* Design, Oversight, and Review of Phase III Efficacy
Trials
* Therapeutic Vaccines and Immune Response
* The Genesis of HIV Diversity
* Late Breaker and Innovative Strategies Session

In addition there are many poster sessions, mostly on
technical topics.

For more information, see the conference Web site,
http://www.aidsvaccine2001.org


***** IAS Buenos Aires Conference: Medscape CME Summaries

On July 31 the Medscape Web site, named the official
provider of online coverage for the new International AIDS
Society conference which took place July 8-11, 2001 in
Buenos Aires, Argentina, released three Continuing Medical
Education programs for medical professionals. Anyone can
use them for a review of current knowledge in some of the
major areas of HIV treatment. These programs will remain
online for one year.

The Medscape site requires a one-time registration, but it
is cost-free.

Here we list the titles of the programs and the articles
required for CME credit in each one. Each program also has
several other articles available which are not listed here.

I. Current Patient Management:

* New Light Through Old Windows: Fine-tuning the Use of
Approved Antiretrovirals, by Graeme Moyle, M.D., M.B.B.S.

* Pharmacokinetics, Pharmacodynamics, and Pharmacogenomics:
The Continuing Evolution of Pharmacologic Issues in HIV
Disease, by Stephen Becker, M.D.

* Update on Antiretroviral Drug Resistance, by Daniel R.
Kuritzkes, M.D.

* Management of HIV-Infected Women and Mother-to-Child HIV
Transmission, by Alexandra M. Levine, M.D.

II. Novel Therapeutic Strategies

* HIV Entry -- From Molecular Insights to Specific
Inhibitors, by William A. O'Brien, M.D., M.S.

* Investigational Antiretrovirals in Existing Classes, Mike
Youle, M.B.B.S.

* Strategies for Immune Reconstitution in HIV Disease, by
Ronald T. Mitsuyasu, M.D.

* Insights From Basic Science: Implications for HIV
Treatment and Prevention, Mark A. Wainberg, Ph.D.

III. Complications of HIV Disease

* Opportunistic Infections: Still a World-Wide Problem,
Even in the HAART Era, by Henry Masur, M.D.

* New Developments in AIDS-Related Hematology and Oncology,
by Alexandra M. Levine, M.D.

* Adverse Effects of Antiretroviral Therapy: More Noise,
Less Clarity?, by William G. Powderly, M.D.


***** FDA: New Email List on HIV/AIDS

The U.S. Food and Drug Administration has started an email
list anyone can join, to provide AIDS-related information
from the Agency. The official announcement, below, gives
details.

Note: The sign-up process shows users confusing options --
but they can be ignored. Just stay with the defaults
provided, unless you know you want something else.

"An e-mail list has been established by the Division of
Antiviral Drug Products (Center for Drug Evaluation and
Research) and the Office of Special Health Issues (Office
of the Commissioner) of the Food and Drug Administration
(FDA) to provide updates on safety and regulatory issues
related to HIV/AIDS products.

"The purpose of this e-mail list is to give patients,
industry, academia, other government agencies and other
interested parties one source for FDA HIV/AIDS related
information. Information such as product approvals,
significant labeling changes, safety warnings, notices of
upcoming public meetings and alerts to proposed regulatory
guidances for comment will be distributed through this e-
mail list.

"To join the e-mail list, please go to
<http://list.nih.gov/archives/fda-hiv-aids.html>. Your name
and e-mail address is considered confidential and will not
be released.

"If you are interested in regulatory guidance and
requirements for blood safety, you should also register for
the FDA's Center for Biologics Evaluation and Research e-
mail list at http://www.fda.gov/cber/pubinfo/elists.htm

"The HIV/AIDS e-mail list is not intended or designed to
accept comments or input, but merely to disseminate
important HIV/AIDS-related information and alert interested
parties about HIV/AIDS related issues for public comment.

"Information will be distributed through this e-mail list
as it becomes available, rather than on a regularly
scheduled basis.

"For additional information about the FDA HIV/AIDS e-mail
list please contact the Office of Special Health Issues at
oshi@...."


***** Science Project Director Wanted -- Treatment Action
Group (TAG)

On August 5 the Treatment Action Group circulated a 3-page
job announcement and description for Basic Science Project
Director. The full announcement may be available through
http://treatmentactiongroup.org

  From the announcement:

Job Description. The Basic Science Project Director will be
responsible for developing and implementing TAG policy,
programs and advocacy projects focusing on basic and
applied research on HIV infection, including:
* Etiology and pathogenesis of HIV infection;
* Epidemiology and natural history of HIV infection;
* Fundamental primate and human immunology;
* HIV virology, viral dynamics, and virus-host
interactions;
* Discovery and pre-clinical development of potential drugs
against new anti-HIV targets;
* Discovery and development of anti-HIV vaccines;
* Discovery and development of anti-HIV (and anti-STD)
microbicides;
* Discovery and development of immune-based therapies
(IBTs) useful for treating HIV infection; and
* Other relevant basic, pre-clinical and early clinical
research relevant to TAG's mission of expediting research
leading to more effective treatments, a vaccine, and a cure
for HIV infection.

The Basic Science Project Director will report directly to
TAG's Senior Policy Director and will work closely with
other TAG policy and program staff and consultants,
developing and implementing advocacy strategies to ensure
the most expeditious, ethical and efficacious development
of useful new drugs, biologics, treatment regimens and
strategies to treat HIV in the USA and internationally.

The Basic Science Project Director will develop, implement,
and advocate for TAG's basic science and immunology
research advocacy efforts with other HIV community
advocates and organizations as well as with the
pharmaceutical, biotechnology and diagnostics industries,
academic and community based researchers, clinicians, U.S.
government agencies such as the Food and Drug
Administration (FDA) and National Institutes of Health
(NIH), and other local, state, and national AIDS research,
treatment and policy-making bodies as well as organizations
such as UNAIDS, the World Health Organization (WHO), and
other multilateral agencies and foundations.

... [background on TAG]

To Apply. Interested candidates should send a letter
expressing their qualifications and interest in the
position with a resume/C.V. and three references with
contact information to:

Basic Science Project Director Search
c/o Regina Gillis
Treatment Action Group (TAG)
350 Seventh Ave. Ste. 1603
New York, NY 10001


***** AIDS TREATMENT NEWS

Published twice monthly

Subscription and Editorial Office:
   1233 Locust St., 5th floor
   Philadelphia, PA 19107
   phone 800/TREAT-1-2 toll-free, or 215-546-3776
   fax 215-985-4952 (email is preferred)
   email: aidsnews@...
   useful AIDS links: http://www.aidsnews.org

Editor and Publisher: John S. James
Associate Editor: Tadd T. Tobias

Statement of Purpose:
AIDS TREATMENT NEWS reports on experimental and standard
treatments, especially those available now. We interview
physicians, scientists, other health professionals, and
persons with AIDS or HIV; we also collect information from
meetings and conferences, medical journals, and computer
databases. Long-term survivors have usually tried many
different treatments, and found combinations that work for
them. AIDS TREATMENT NEWS does not recommend particular
therapies, but seeks to increase the options available.

AIDS TREATMENT NEWS is published 24 times per year, on the
first and third Friday of every month, and print copies are
sent by first class mail. Email is available (see below).
Back issues are available at http://www.aidsnews.org

To subscribe, you can call 800-TREAT-1-2 or 415-255-0588:
* Businesses, Institutions, Professionals: $325/year. Early
email available (see below).
* Nonprofit organizations: $150/year.
* Individuals: $140/year, or $80 for six months. If you
cannot afford a subscription, please write or call about
our sliding scale.
* Outside North, Central, or South America, add airmail
postage: $20/year, $10 for six months.
* Bulk rates and multiple discount subscriptions are
available; contact our office for details.
* Payment can be by check, VISA, Mastercard, American
Express, bank draft, purchase order, international postal
money order, or travelers checks.

Early email: Business, nonprofit and full-rate individual
subscribers can receive an early copy by email, before the
issue is printed--in addition to their regular copy, at no
extra charge. It's OK to direct the email copy to someone
else. Call our office to add email to your subscription.

Free email: Free delivery for individuals (delayed one week).
To subscribe, send a blank email to:
aidsnews-subscribe@yahoogroups.com

ISSN # 1052-4207

Copyright 2001 by John S. James. Permission granted for
noncommercial reproduction, provided that our address and
phone number are included if more than short quotations are
used.

AIDS TREATMENT NEWS Issue #368, July 13, 2001
     phone 800-TREAT-1-2, or 215-546-3776

CONTENTS

** Buenos Aires Conference on Treatment and Research: Web
Reports Available
A new AIDS conference attracted 3,000 scientists to Buenos
Aires, Argentina, and featured over 700 presentations --
unusually large participation for a meeting's first year.
This basic and clinical scientific research conference will
happen every odd-numbered year, when the international AIDS
conference is not held. We list some of the major topic
areas, and provide Web addresses for conference reports and
abstracts of the presentations.

** AIDS Research Today: 20 Views
One of the first organizations to conduct community-based
AIDS research asked researchers, physicians, and community
members to look at the current status and direction of AIDS
research and write a short article for publication. Twenty
responses appear in the current CRIA Update, which is
available either online or by mail.

** Africa: Interview with South African High Court Justice
Edwin Cameron
Justice Edwin Cameron of the South African High Court has
become a leading advocate for AIDS treatment and other
medical care in Africa. AIDS TREATMENT NEWS interviewed
Justice Cameron during his recent visit to San Francisco.

** Women's HIV Treatment Issues: Course for Medical
Professionals, July 26-27
A two-day course at Johns Hopkins will help physicians and
other medical professional treat HIV infection in women.

** HIV Resistance Meeting Web Reports
Where to find information from last month's meeting on HIV
resistance, which took place June 4-8 in Scottsdale,
Arizona.


***** Buenos Aires Conference on Treatment and Research:
Web Reports Available

   by John S. James

   A new scientific conference created by the International
AIDS Society (IAS) took place July 8-11 in Buenos Aires.
Even before the first meeting, the 1st IAS Conference on
Pathogenesis and Treatment had emerged as an important
conference, with about 3,000 scientists attending and 748
scientific presentations (out of about 1,000 submitted);
you can read abstracts of the presentations through the Web
links below. This conference will occur every two years,
during the odd numbered years when there is no
international AIDS conference.

The IAS created the new meeting to focus mainly on basic
and clinical science and the interaction between them --
including new treatments, vaccines, studies of
pathogenesis, and how research can contribute to making
good prevention, treatment and care available to the
approximately 90% of persons with HIV who currently do not
have access because they live in poor countries. The
scheduled keynote and plenary speakers were:

David Ho: Learning Basic Science from Clinical Trials

Julio Montaner: Current Controversies in Antiretroviral
Treatment

Stefano Vella: Fostering Access to HIV Treatment

Anthony Fauci: Immunopathogenesis of HIV Disease: Host
Factors in Pathogenesis of HIV Disease: Implications for
Therapeutic Strategies

Francoise Barre-Sinoussi: HIV: Twenty Years After the
Discovery of the AIDS Epidemic

Margaret Johnston: Virologic and Immunologic Concepts in
Vaccine Design

Brigitte Autran: Immune Reconstitution: Translating
Immunologic Knowledge into Therapy

Eric Hunter: The Next Target in Therapy: Viral Entry

Ashley Haase: Virologic and Immunologic Concepts on HIV
Transmission

David Cooper: Antiretroviral Therapy Toxicity: The Second
Round, Beyond Lipodystrophy

John Mellors: Resistance: From Molecular Basis to Clinical
Research

In addition, the U.S. National Institutes of Health
organized a one-day meeting the day before the conference
on "Formulating a Comprehensive HIV/AIDS Research Agenda in
Resource-Poor Setting."

AIDS TREATMENT NEWS did not attend this meeting. In future
issues we may summarize some of the presentations.
Meanwhile, extensive reports are available on the Web.

Web Access

The IAS has named Medscape as the official provider of
online conference coverage for this meeting. The Medscape
site for this conference can be reached through a link on
the Medscape home page, http://www.medscape.com

The official Conference site, which has background
information on the conference, is:
http://www.aids2001ias.org

You can search and read the abstracts of the conference by
reaching a search page through the IAS home page:
http://www.ias.se

(At this time the search function is confusing. You do
*not* need to log in with a user name and password in order
to search or read these conference abstracts. We have not
yet been able to do an 'and' search (it does an 'or'
instead) -- but with fewer than a thousand abstracts, one
can live with that. So far we have not found a link from
the Buenos Aires conference page, only from the IAS home
page -- nor have we found a link to instructions for more
advanced searches. We hope these glitches will be
corrected.)

Other Web sites with extensive coverage of this meeting
include:
http://www.thebody.com/confs/ias2001/ias2001.html
http://www.hivandhepatitis.com/2001conf/ias/main.html


***** AIDS Research Today: 20 Views

by John S. James

Twenty commentaries on the current status of AIDS research,
by "researchers, clinicians, and community members from
varying disciplines, experience and backgrounds" appear in
the Summer 2001 issue of CRIA Update, published by the
Community Research Initiative on AIDS. These brief
summaries offer diverse and informed views of what is
happening today in AIDS research -- and what may happen
over the next several years.

You can find these summaries at http://www.criany.org, or
mail a request to: CRIA, 230 West 38th St., 7th floor, New
York, NY 10018 (ask for the AIDS research issue).

Comment on Research

One idea largely missing from these commentaries (including
our own) is the possibility of a treatment breakthrough --
and the question of how to organize research to facilitate
a major, unexpected advance.

For example, one possible area for such a breakthrough
could be a treatment to disrupt the process by which, in
most patients, HIV eventually turns off the immune system's
original ability to control it well (a possibility
discussed in the CRIA Update by Sean R. Hosein of CATIE,
the Canadian AIDS Treatment Information Exchange, on
excessive levels of IL-10 in HIV disease, and the
possibility of treatments to lower them). Such an immune-
based treatment could work in both developed and developing
countries (where it might not need to wait for
antiretroviral combinations to become available).

Looking for a breakthrough -- a treatment good enough to
be, in effect, approved by acclamation -- means we would
not have to wait to solve the problem of immune-based
surrogate markers, which will probably take years (and may
be essentially unsolvable, if an effective immune-based
treatment must first be proven by clinical endpoints before
a surrogate marker can be established). In the IL-10
example, a monoclonal antibody to reduce IL-10 might
provide a proof of principle. If it clearly worked (for
example, by greatly lowering viral load or reducing the
need for antiretrovirals), then it would not be hard to
organize a major effort to find simpler or even natural
treatments to do so.

The big problem here would be the legal obstacles created
by a clinical-trial system designed for big-company drug
development. For example, the right kind of trial might be
in one patient, looking for an efficacy result even from
the first human volunteer, with no attempt to prove
efficacy first in animals.

The existing rules serve two purposes -- to protect the
public from unethical corporate experimentation, and to
protect the same corporations from competition by making it
almost impossible for anyone else to finance the whole
drug-development process. Of course, if anyone could show
truly convincing data, ways could be found to move fast.
The problem is getting permission to do the earliest proof-
of-principle human studies -- without entanglement in the
gold-plated clinical trial system which already has its own
mindset, investments, pipeline, and calendar in place, and
naturally resists encroachment on its well-manicured turf.

So we continue to fight an epidemic with rules and
procedures designed for routine, non-emergency research and
development.


***** Africa: Interview with South African High Court
Justice Edwin Cameron

by Bruce Mirken

Few moments in the history of the AIDS epidemic have been
as pivotal as the speech South African High Court Justice
Edwin Cameron gave one year ago at the International AIDS
Conference in Durban, South Africa. In a talk that SCIENCE
magazine writer Jon Cohen recently called "one of the most
remarkable acts of activism I've seen in 12 years of
covering AIDS," Cameron told of how he grew ill with AIDS
in 1997, a dozen years after becoming HIV positive, and his
near-miraculous return to health on combination therapy.
"Amidst the poverty of Africa, I stand before you because I
am able to purchase health and vigor," he told the hushed
audience. "I am here because I can afford to pay for life
itself."

He compared those who sit back and allow the world's poor
to die for lack of access to HIV/AIDS treatment to those
who passively allowed the evils of Nazi Germany and South
African apartheid to unfold. The speech crystallized
sentiment in favor of providing treatment in impoverished
nations, leading to a variety of proposals, from drug
company price cuts to U.N. Secretary General Kofi Annan's
proposed international AIDS fund.

A year later Cameron is still acting as a conscience of a
world that is too willing to let poor people die. AIDS
TREATMENT NEWS spoke to him during a visit to San Francisco
June 19.

*  *  *

ATN: A year has passed since your Durban speech. How has
the response been--in action, not just rhetoric?

CAMERON: There are two major changes. One is the change at
the level of rhetoric, and one must never underestimate the
importance of rhetoric. The Durban conference changed the
discourse about drug access. Up to Durban it had been
accepted that we lived in a globalized world in which drug
pricing was a given. Durban changed that irrevocably.
Durban cast a moral judgment on drug companies' prices.

The rhetoric of drug company pricing was vital, and that
rhetoric has changed. Supplanting it has been an
international consensus that drug treatment ought to be
made available in Africa--a consensus shared by almost
everyone except the South African government, I might say.
Our minister of health on the fifth of June reiterated that
she's not providing drugs in the public sector.

The second change, of course, has been at the level of drug
pricing, which has been dramatic. Some combination
therapies have come down in price by 80 percent. Two nukes
and one NNRTI are now available for $100 a month--which is
still out of reach of 90 percent of Africans but is no
longer out of reach of 99 percent.

ATN: In recent months there has been some pulling back from
that consensus, more voices saying, "Well, maybe we really
can't do this, maybe prevention is more important," etc.

CAMERON: First of all, the treatment/prevention dichotomy
is entirely false, because treatment offers the most
persuasive way of making prevention work--at a
physiological level, a psychological level, a social level.
It's a false proposition to suggest that treatment is an
area of concentration neglecting prevention.

With regard to your question about pulling back, I don't
think one should underestimate the issues. There are real
behavioral and institutional issues [in providing
treatment]. Realistic approaches don't neglect those. The
Harvard Declaration--despite very considerable conceptual
flaws, and there are huge conceptual flaws in it--is a
visionary breakthrough because it actually addresses in a
hard-headed way the practicalities of treatment access.

You may be right that there's been a pulling back, but no
one ever said that this was going to be easy. Every single
argument that the do-nothing camp advances doesn't
withstand scrutiny. In fact, the infrastructural
initiatives that drug access will require will assist
health care delivery in regard to other diseases like
malaria and tuberculosis. Certainly it's going to take some
infrastructural initiatives in Africa, but once they're up
and running they're going to alleviate other pressures.

ATN: What about the widely-quoted comments by USAID head
Andrew Natsios arguing that drug treatment is impractical
because most Africans "don't know what Western time is...
and if you say one o'clock in the afternoon, they don't
know what you are talking about"?

CAMERON: As a legitimization of inaction, it's appalling.
It's almost as though it's a cheap target because he makes
Africa sound like a Bongo-Bongoland, and that's an insult
to Africans. The same rhetoric was used 40 years ago to
justify not giving Africans the vote--the same rhetoric of
incompetence and lack of sophistication. The same rhetoric
was used not only by white colonialists but by black
African dictators to justify denying African people
fundamental rights.

The real point is that there are issues--behavioral issues
of compliance, issues of infrastructure and delivery. What
I want to focus on when someone says foolish things like
that is how do we address the real issues, not how do we
counter misdirected rhetoric.

ATN: What's your impression of the U.S. government's role?

CAMERON: I think the [Secretary of State Colin] Powell trip
to Africa in May had a very productive resonance. It
actively gave a sense of a Secretary of State who was
concerned and was engaged. I know that he's been criticized
as not following through on rhetoric, but the substantive
message of the trip was the Secretary of State at least--a
very highly, highly placed official in the administration--
wants to be engaged. He appeared to be personally moved by
the extent of AIDS. And what he said--and again, never
underestimate the importance of rhetoric--he said that
there is no bigger war, with thirty million lives at stake
this is the biggest war on the globe at the moment

My sense is that the administration might be able to
deliver more than people expect it to.

ATN: What about the U.N.?

CAMERON: Kofi Annan is the right person to head this. His
global fund is a breakthrough. Again, like the Harvard
statement, it creates a vision which requires
implementation. But a year ago we even lacked the vision.
Precedent steps to action are changing the rhetoric,
creating the vision and making plans. And setting in place
the preconditions, one of the preconditions being
substantial reductions in pricing. We need more reductions,
but at least there have been those changes since a year
ago.

ATN: Is it worrisome to you that there hasn't exactly been
a rush to donate billions of dollars to Kofi Annan's AIDS
fund?

CAMERON: Yes, of course it worries me. I would like that
pledge to be made unreservedly and immediately by the G-7
or G-8 now, today. Once the money is there, the real issues
of implementation loom enormous--like democracy in Africa,
like the coming of independence presented real challenges
to us in how we crafted our constitutions, how we permitted
freedom of association and freedom of expression.

We're going to have to start realistically. Botswana, a
nation of 1.6 million, with the highest percentage
prevalence of any nation in the world, over 30 percent, has
undertaken to provide antiretroviral treatment in the
public sector. It will offer a good model, because it's an
ethnically homogeneous society with a high per capita
national wealth and strong governmental commitment.

What I'm saying is the funding is essential and yes, it
must be provided immediately--and then the work can begin.

ATN: How significant, in terms of day-to-day efforts to
deal with AIDS in South Africa, has President Mbeki's
interest in the denialists been?

CAMERON: [After a long pause and a half-suppressed
chuckle]: It's a question I always welcome, especially when
a tape recorder's running. Let me be diplomatic. The year
during which President Mbeki openly gave sustenance to
denialist beliefs was a year of horror--for AIDS
prevention, for AIDS implementation, for everything. It was
a year of nightmare.

In October of last year the President accepted advice that
he back off on the issue publicly. In April this year he
gave an interview in which he said that he wouldn't have an
HIV test because it would merely be giving substance to
what he called "one particular paradigm." I believe that
it's a grievous tragedy that we are still approaching the
matter as though these are debatable paradigms.

The underlying anxiety that everyone has is whether the
President's own ambivalence on the paradigm that HIV causes
AIDS is leading the government's continued dithering on
drug provision. The minister of health, on the fifth of
June in Parliament, on the very anniversary of the first
MMWR report on AIDS, reasserted her government's refusal to
provide antiretroviral treatment. She then said--very
significant--I wish to assure members of parliament that
our position is "not ideological."

It remains to be seen whether the President's ideological
position on whether HIV causes AIDS is in fact not at the
root of the government's position. If it is, the words of
Professor William Makgoba, who is the President of our
Medical Research Council--he gave the James Hill Memorial
Lecture to the National Institutes of Health in April this
year--he said that if dissident views have impeded our
treatment of AIDS, "history may say we have collaborated in
the greatest genocide of our time." I cannot do more than
quote those words.

ATN: Is that what's behind the South African government's
reluctance on treatment, even on things like mother-to-
child transmission? Or is something else involved?

CAMERON: Like the free provision of nevirapine by
Boehringer-Ingelheim--an offer made a year ago to South
Africa, still not accepted. No, I can't think of any other
issues related to that. The minister of health says,
"toxicity." The birth of 200 babies with HIV every day is a
toxic issue that outclasses on any scale the doubts about
the toxicity of nevirapine, which could reduce those 200
births every day in South Africa to 100.

ATN: American AIDS denialists say that there is no AIDS
epidemic in Africa. They admit some people are ill and even
dying, but say they're dying from endemic, poverty-related
diseases that have plagued Africans for generations.

CAMERON: It's demonstrable, pernicious, willful, distorted
untruthfulness. What is significant about our death rate in
South Africa is not just that it's increased--the
dissidents, particularly [Charles] Geshekter, explain this
on the basis that the figures for South Africa before 1994
excluded the bantustans. But that's not the only way that
our death rate figures have changed. The shape of the
figures has changed. Women in mid-life are now dying more
than men are dying. Women in their 20s and 30s are dying in
a way that women nowhere else in the world are dying--
before men.

This is an epidemic. It is an infectious agent. It is
called HIV. It leads to a syndrome of immune dysfunction
that leads to a terrible and lingering death. And most
importantly it is avoidable by virologically specific
treatments. And to deny that there is an epidemic in South
Africa is *precisely* the same as denying that five and a
half million Jews died in the Holocaust in the second world
war. It is a denial of the same epic and the same
pernicious, ideologically loaded proportions.

ATN: How important a role have activists from the U.S. and
other developed countries played in efforts to bring
HIV/AIDS treatment to Africa?

CAMERON: Central. Pivotal. Critical. The change in rhetoric
and the reduction in drug prices were the direct
consequence of principled, strategic intervention by angry
activists. The AIDS epidemic has reshaped the way we think
about ourselves as humans. I don't think it's too dramatic
or pretentious to say that. 20 years ago we thought that
we'd conquered disease, there was a medical model of human
well-being that was certainly entrenched. AIDS has shaken
that.

AIDS activists in America in the 1980s changed the nature
of the doctor-patient relationship, the nature of the
research community's relationship to the patient community.
It changed the way that the gay and lesbian community
related to the larger society. And activists are still
leading the debate. They are changing the way in which
people permit themselves to see other people.

ATN: What can people in the U.S. or other places outside of
Africa do now?

CAMERON: Three things, which all sound quite grandiose, but
we've got to start somewhere: Pressure on the drug
companies to permit generic production of patented
medicines. Secondly, pressure on governments to make the
funds available. The question with the funds is not whether
it's affordable, the question is one of will. It really is.
$7-$9 billion a year--which is for all Kofi Annan's
associated costs, not just for AIDS--is not a great amount
on any metric.

And thirdly, individual initiatives are also very
important. This is something that is underestimated. There
is an organization called AIDS Empowerment and Treatment
International. AIDSETI has got 800 to 1,000 people on
treatment this year who wouldn't otherwise have had
treatment. It collects drugs, gets donations, makes
treatment available with monitoring, with medical
supervision, even in Africa.

What I'm saying is that there is something that everyone
can do. Every organization ought to think of partnering
with an organization in Africa. $5,000 dollars equals the
salary of one nurse for one year in South Africa. There are
organizations currently that can use recyclable drugs.

We don't only have to be grandiose in what we think we can
do. The problem also requires minute, person-to-person,
organization-to-organization responses. If we look only at
the grandiose we risk paralysis, but there's a great deal
we can do at organizational and personal levels now.

ATN: Is there anything else you'd like to add?

CAMERON: I think what AIDS asks us to do is to give people
on both sides of the First World/Third World divide a sense
of empowerment about themselves. The people in the First
World should realize that there is something they can do,
not feel a sense of paralysis or helpless guilt. And the
same in Africa, that this is a problem that we can
confront.


***** Women's HIV Treatment Issues: Course for Medical
Professionals, July 26-27

Johns Hopkins University will offer a 2-day update for
primary care providers on HIV care for women, July 26 and
27. "This course is designed to offer support to the
primary care provider in caring for HIV-positive women.
Specific clinical problems, their evaluation and
management, epidemiology and scope of HIV infection will be
discussed. Participants can expect to become more familiar
with health care issues of HIV-positive women and the
management of clinical complications."

For more information, see:
http://www.hopkins-aids.edu/educational/
events/womissues_2001/womissues_2001.html
(Note: Do not include the carriage return; you may need to
create a word-processing document, paste in the URL, edit
out the carriage return, then paste the address into your
browser.)


***** HIV Resistance Meeting Web Reports

Each summer there is a small, invitation-only International
Workshop on HIV Drug Resistance and Treatment Strategies;
this year the 5th workshop in this series was held June 4-
8, 2001 in Scottsdale, Arizona. Recently, a 9000-word
detailed technical report of this meeting, written by
leading HIV researcher Daniel R. Kuritzkes, M.D., was
published on Medscape:
http://hiv.medscape.com

This report should be read by HIV-specialist physicians and
other medical professionals; most patients will find it
difficult, but may want to scan it to look for any
information that might be relevant to their treatment.

Dr. Kuritzkes summarized the highlights "perhaps of most
immediate relevance to day-to-day clinical practice":

* Y318F is a newly recognized mutation associated with
NNRTI resistance.

* Treatment-naive patients with novel mutations at 215 are
at risk for rapid selection of resistance to zidovudine.

* Data continue to confirm that stavudine and zidovudine
are cross-resistant.

* Presence of mutations at codons 82, 54, and 10 together
with 4 additional PI resistance mutations is significantly
associated with failure of lopinavir/ritonavir.

* Ritonavir boosting of indinavir may partially overcome
indinavir resistance.

* Resistance mutations confer a loss of viral fitness
relative to wild-type, but the clinical significance of
this remains unclear.

* The CCTG 575 study failed to show a benefit from
phenotyping in guiding the selection of a salvage regimen,
except in the subgroup of patients with virus resistant to
more than 3 protease inhibitors at baseline.

* The benefits and risks of treatment interruptions are
still under investigation, but risks may include emergence
of lamivudine resistance.

* The majority of zidovudine- and abacavir-resistant
viruses remain susceptible to tenofovir, although cross-
resistance is observed in virus with multi-NRTI resistance.

* New technologies to assess resistance to entry inhibitors
such as T-20 and T-1249 are in development.

The abstracts and other reports from the meeting may be
available through
http://www.intmedpress.com (after a complicated
registration procedure).

Other reports are can be found at:
http://www.hivandhepatitis.com/2001conf/hivresis/main.html
http://www.natap.org/2001/5thresist/ndx5thresist.htm


***** AIDS TREATMENT NEWS

Published twice monthly

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Editor and Publisher: John S. James
Associate Editor: Tadd T. Tobias

Statement of Purpose:
AIDS TREATMENT NEWS reports on experimental and standard
treatments, especially those available now. We interview
physicians, scientists, other health professionals, and
persons with AIDS or HIV; we also collect information from
meetings and conferences, medical journals, and computer
databases. Long-term survivors have usually tried many
different treatments, and found combinations that work for
them. AIDS TREATMENT NEWS does not recommend particular
therapies, but seeks to increase the options available.

AIDS TREATMENT NEWS is published 24 times per year, on the
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--
John S. James
AIDS Treatment News
http://www.aidsnews.org

AIDS TREATMENT NEWS Issue #367, June 29, 2001
     phone 800-TREAT-1-2, or 215-546-3776

CONTENTS

** AIDS Vaccines and Activism: Interview with Jon Cohen
Like most people, we had assumed that with all the talk
about AIDS vaccines, any obvious holes in the research and
development effort to produce a vaccine were being
addressed. In fact, serious problems persist, often with no
one handling them. Freelance writer Bruce Mirken asked Jon
Cohen, who for years reported on AIDS research for SCIENCE
magazine and has recently published a book about the
problems in AIDS vaccine development, to discuss what is
happening today, what has changed since his book went to
press, and what people can do now to help get effective
AIDS vaccines developed and tested faster.

** United Nations AIDS Meeting: Observations
The recent 3-day United Nations General Assembly Special
Session on HIV/AIDS produced unanimous approval of a
surprisingly strong document -- weakened only slightly to
keep conservatives on board when they objected to wording
on sex or human rights. We note some of the major areas of
agreement -- and also controversies including listing
vulnerable groups, and the three-hour fight over whether to
seat a representative of a gay organization. We also note
the denial of U.S. visas to some civil-society delegates
who should have been at the session -- and what can be done
about this for future meetings.

** Global AIDS Epidemic: Getting Things Done
The world has plenty of resources, and plenty of good will,
to effectively control AIDS, tuberculosis, malaria, and
other major health problems. What, then, is lacking? We
believe the key is to organize social roles allowing those
who want to help to do so.

** Names Reporting: Pennsylvania, California Activists
Change the Momentum
Many AIDS activists and others are uncomfortable with the
government having their names on a list of people who are
HIV-positive; others are concerned that such lists will
cause persons to avoid being tested. Public health experts
do need case reporting to get accurate information on the
incidence of HIV in order to devise properly targeted
control strategies. Cases can be reported by unique
identifiers instead of names to reduce confidentiality
concerns; however, several years ago the Federal government
decided to favor names reporting, and most states have gone
along. In Pennsylvania, activists recently began what first
seemed a hopeless effort for a system of HIV reporting by
unique identifiers instead of names. While the outcome is
not yet determined, activists have changed the political
momentum in favor of unique identifiers.


***** AIDS Vaccines and Activism: Interview with

Jon Cohen

by Bruce Mirken

Longtime SCIENCE reporter Jon Cohen has earned a reputation
as one of the most perceptive observers of HIV/AIDS
research. In his recent book, SHOTS IN THE DARK: THE
WAYWARD SEARCH FOR AN AIDS, (Norton and Co., 2001) he
analyzed the disorganization and lack of coordination in
the AIDS vaccine research effort. He argued for creation of
a "March of Dollars," an entity that would play a role
similar to that of the March of Dimes in developing a polio
vaccine: keeping an eye on the whole field and making sure
that gaps are filled.

AIDS Treatment News spoke with Cohen on June 20, after he
spoke at a University of California San Francisco-sponsored
event marking the 20th year of the AIDS epidemic:

AIDS TREATMENT NEWS: In light of your suggestion for a
March of Dollars, how do you look at developments since you
wrote the book?

COHEN: There have been some big changes. Merck has revealed
the details of their AIDS vaccine program, and it's a
substantial program. I think it is the first time a big
pharmaceutical has really revealed a serious, large program
to find an AIDS vaccine, and that's all for the good. But
it would be great to see some competition, still, and I
don't see any really hot competition similar to the
competition to develop antiretrovirals.

IAVI (the International AIDS Vaccine Initiative) has more
money than ever, with Bill and Melinda Gates pledging an
extra $100 million a year ago. And I think the world's
attention towards the problem in Africa is a major shift
that I hinted at at the end of my book, but that has
continued. I think as people concentrate on the real
magnitude and scope of the epidemic and do see that more
people have now died than died from the Black Plague, it
increases the sense of urgency to find a vaccine.

Scientifically there haven't been any really dramatic
insights into how to make a vaccine, but there have been
several publications in the past year that show more and
more solid protection in monkeys. That's good.

ATN: Obviously nobody has stepped forward to create a March
of Dollars, but do you see any progress toward fulfilling
the functions you envisioned for such an organization?

COHEN: I hear hallway whispers. My idea for a March of
Dollars really was meant to be provocative. It's not that I
believe there has to be a March of Dollars. I believe more
is needed, and outlined a fantasy organization that I would
like to see.

I see no organization attempting to fill gaps, to analyze
what could be enriched, if you will, in the basic research
arena. That could help. I still think it would be good for
a smart group of people to meet four times a year and to
freely distribute money to laboratories that they think
could stimulate progress. That's not happening anywhere.

As far as a master monkey study [Cohen described at length
in his book how studies of candidate vaccines using monkeys
and SIV are not standardized, making it virtually
impossible to compare results from tests of different
products done in different labs], I don't see real momentum
for it. I have heard hallway whispers of some people trying
to organize such things, but have not seen it happening --
certainly not with the agenda I laid out, which is: After
[candidate vaccines] work in monkeys better than others,
move them into humans with the intent of taking them to
efficacy trials, unless safety problems emerge.

And THAT would be a shift in the way that everything moves
forward now. Everything moves forward based on immune
responses in humans. Fine, let people do things that way.
In addition, let's cover the other base; let's also move
forward more empirically. It worked in monkeys, that's the
rationale. It's not the levels of cytotoxic T-lymphocytes
in human volunteers, nor levels of neutralizing antibodies;
it's not all these fancy immunologic measurements. It's
simply, this vaccine worked in monkeys.

ATN: You talked about the need for activism. What issues
should activists be looking out for right now?

COHEN: I think it's very analogous to the drug activism
arena. Activists existed when there were no drugs on the
market. And what did they do? Well, they hounded the
companies: 'Where are you now? What's your progress now?
What'd you do last week? What'd you do last month? What'd
you do last year?' They wrote report cards on researchers.
They kept track of where the money was moving between
different people. They scrutinized the field and they
followed the money. And they issued reports and were
relentless. They shut down Wall Street, they shut down the
NIH (U.S. National Institutes of Health). They did dramatic
moves in San Francisco on the streets during the [6th]
International [AIDS] Conference.

All that brought attention to the drug search and put the
companies on notice that every move they make would be
scrutinized, and they would be yelled at to move faster at
every turn. And I think it helped.

None of that is happening. None of it. Yes, the AIDS
Vaccine Advocacy Coalition is writing reports and they are
good, but that is a small group of activists. And they are
not employing street theater tactics. They're not receiving
the type of attention that ACT UP once enjoyed, or that TAG
[Treatment Action Group] enjoyed.

ATN: For people who are interested in vaccine development
and where pressure might be applied, what should they be
looking at?

COHEN: There are AIDS conferences that happen all the time.
There are probably 3 or 4 big AIDS vaccine conferences a
year. At one of them I was the only journalist--that was at
Keystone. At one of them I don't think there were any
journalists there because I didn't go, the AIDS vaccine
conference in Puerto Rico that was sponsored by IAVI. It
was an important conference, and I don't think there was a
single journalist there. I mean, hello? If this were drugs
there would have been a hundred or a thousand journalists
there.

And there's a big AIDS vaccine conference coming up in
September in Philadelphia, and then there's another one in
France. All of these conferences have a tremendous amount
of information, and they should be monitored. There should
be activists there. And there often are; Bill Snow [of
AVAC] goes, but there are one or two activists. It is
nowhere near the level warranted. [For lists of upcoming
AIDS conferences, see links at:
http://www.aidsnews.org/#conferences ]

So that's one place to start. Another is to read the
literature, follow the journals, follow the papers that
come out, and follow the companies that have programs and
check in with them regularly the same way activists have
done with drugs: Write reports, create documents for
journalists to build on. I don't mean to be self-serving,
but read my book. I say that because it's the only book out
there on this topic.

ATN: What other sources of information would you recommend?

COHEN: You can look on the Web, too, at the NIH's Web site
(http://www.niaid.nih.gov/daids/vaccine/default.htm), and
at IAVI's Web site (http://www.iavi.org). The IAVI
newsletter is tremendous. It's an excellent source to keep
up with what's going on.

ATN: There has been a shift away from looking for
"sterilizing immunity" (complete prevention of infection)
and toward looking at preventing disease. What does that
mean for vaccine efficacy trials--how big they'll need to
be, how long they'll need to run?

COHEN: There are two schools of thought. I think it has
profound implications. One school of thought is that it's
not a big deal for efficacy trials, that enough people will
become infected and will not opt to take [antiretroviral]
drugs that you'll be able to get a clean answer.

Certainly, though, there's a numbers game going on. The
problem is this: If people start taking drugs shortly after
becoming infected, you're going to have a very hard time
seeing a vaccine's impact on delaying or preventing disease
because the drugs are going to confuse that. But if many
people opt not to take drugs, statistically speaking you
might have enough people to make an evaluation of whether
the vaccine works.

Logically I would think the trials would have to become
larger or they would have to go on for longer periods of
time, one or the other. Any way about it, it becomes more
expensive and more difficult.

And then you also have ethical issues that arise because of
this that are really thorny. In poor countries that have no
access to drugs right now you can get a cleaner answer. Is
it ethical to stage a trial there--even if people
volunteer--without offering the people who become infected
treatment? Some people say you have to offer them
treatment, it's the only ethical thing to do. Others
counter, "Well, there's the principle of undue influence."
Would it be unduly influencing someone's decision to join a
trial if they knew that they would get treatment?

I think those are real issues. I don't have any pat answers
for them. I think it's certainly a more complex picture
today than it was before the advent of drugs.

ATN: Is there anything else that we should particularly
watch out for in the next few months or years?

COHEN: I think one thing that's interesting now is how the
line is blurring in the very definition of a vaccine. The
simple way to describe a vaccine is "something that you
take and then you never have the bug in you." Well that's
clearly not the way that AIDS vaccine researchers are
thinking about things now. A vaccine might do one of three
things: It might prevent infection, it might prevent or
delay disease and allow you to be infected, or it might be
used after you become infected to bolster your immune
system.

In the third category, that's an idea that's been around
for years--since the very first AIDS vaccine in 1986 was
tested as a therapeutic, the Zagury trial. And it's still
unclear that it's ever benefited anyone. But as these
acutely infected studies begin to show auto-vaccination in
essence--people who go on and off drugs have their virus
return [and] their immune system seems to actually benefit
from a short exposure to the virus again, because when they
go off drugs the next time they're more likely to contain
the infection for a longer period of time. It argues very
strongly for a therapeutic vaccine used in an acute
infection setting with strategic treatment interruption.
That's yet another version of what an AIDS vaccine might
do.

It's also possible that AIDS vaccines used in conjunction
with drugs will reduce the emergence of resistance. That
could be another parameter that you could look at. So I
think there's some much more fluid definitions of what a
vaccine is or might be today than there ever has been--by
mainstream thinkers, not fringe thinkers. It's no longer
fringie to think about therapeutic vaccination. It's now
mainstream. It was very fringie for years.


***** United Nations AIDS Meeting

Observations by John S. James

The 189 member states of the United Nations General
Assembly met June 25-27, 2001, and unanimously approved a
document that can be an important tool around the world for
urging governments and others to take responsibility for
helping to control the global epidemic. Almost everyone
agrees that the meeting was largely a success, though only
time will show its results. Here are some of the key
issues:

* The central question is whether governments around the
world will find the political will to be serious about
AIDS, and take measures to end the epidemic and meanwhile
reduce its destruction and suffering. For many reasons
governments have avoided acknowledging or dealing with the
disease. Yet everyone knows that the epidemic will not go
away by itself but will become incomparably worse, with
many parts of the world affected as severely as southern
Africa, where as much as a third of the entire adult
population is HIV-infected, and half of teenage boys and
girls are likely to die of AIDS.

About a dozen heads of state came to the meeting, all from
developing countries, almost all from Africa. No heads of
state came from any rich country -- nor from any of the
Eastern European or Asian countries where the epidemic is
rapidly spreading. Most countries sent their health
minister instead. (The U.S. sent both its health minister,
Secretary of Health and Human Services Tommy Thompson, and
Secretary of State Colin Powell, a leader on global AIDS.)

One African head of state who did not attend was Thabo
Mbeki of South Africa -- even though he was in Washington
at the time, and traveled to West Point, Pennsylvania to
visit a Merck AIDS research lab on the last day of the
meeting. His absence illustrates one factor keeping
governments away from AIDS -- embarrassment. Almost
everyone sees Mbeki's handling of the epidemic in South
Africa as disastrous.

But the meeting produced good news as well on government
political will. All the countries accepted a strongly
worded Declaration of Commitment (see below). The United
Nations session brought AIDS to the attention of government
officials who otherwise have not dealt with it. It clearly
changed the tone of some of the discussions in the U.S.
Congress (and probably as many other governments as well),
at least for now.

* Many new donations, commitments, and programs were
announced at this special session on HIV/AIDS. Many of
these were donations to the Global AIDS and Health Trust
Fund now being developed (which will also fund programs for
tuberculosis and malaria, where relatively little money can
have great importance in saving lives and improving human
health). Also important were other donations, such as
offers to help train thousands of doctors and set up
medical clinics. Many people believe that what is important
is the total level of funding (including appropriate in-
kind contributions), not only cash for the Fund.

* The General Assembly unanimously adopted a strong
Declaration of Commitment, including detailed timetables
and goals for achieving results, such as reducing mother-
to-child and other new infections. The Declaration
emphasizes women's rights (women are often infected because
they do not have the power to refuse sex or negotiate safe
practices). It notes that "stigma, silence, discrimination,
and denial, as well as lack of confidentiality" undermine
prevention, treatment, and care, and must be addressed. It
names prevention as the mainstay of response, and also
notes that "prevention, care, support and treatment for
those infected and affected by HIV/AIDS are mutually
reinforcing elements of an effective response and must be
integrated...." It recognizes the importance of access to
medication, notes the need to reduce the cost of drugs and
related technologies, and outlines ways of doing so.

In discussing resources, it sets a goal of $7 to $10
billion per year by 2005, and urges developed countries to
try to meet the target of 0.7% of their GNP for development
assistance, as they have previously committed to do (only a
handful have so far). (In April of this year, African
countries agreed to a target of 15% of their national
budgets on health-sector improvements to help address the
epidemic.) The Declaration of Commitment includes a fairly
weak section on debt relief.

It has a major section on research and development,
"including biomedical, operations, social, cultural, and
behavioral research and in traditional medicine...."
Research infrastructure, research cooperation, ethics of
human research, drug side effects, the female condom, and
of course vaccines and microbicides, are all explicitly
addressed.

What is most remarkable about this document is that all
countries in the United Nations accepted it -- after fairly
minor compromises which weakened it only slightly.

The Declaration of Commitment is available at
http://www.un.org/ga/aids/

Controversies at United Nations AIDS Session

* Removal of naming vulnerable groups

Some mostly-Islamic countries, and also the U.S., did not
want to name vulnerable groups, especially men who have sex
with men, or sex workers and their clients. So the
following language (from the May 11 draft Declaration of
Commitment was replaced:

"By 2003, develop national strategies, policies and
programmes, through a participatory approach, to promote
and protect the health of those most vulnerable to, and at
greatest risk of HIV infection, such as: children in
especially difficult circumstances, men who have sex with
men, sex workers and their clients, injecting drug users
and their sexual partners, persons confined in institutions
and prison populations, refugees and internally displaced
persons and people separated from their families due to
work or conflict;"

The entire section on vulnerable groups was rewritten, and
in many respects strengthened; the following paragraph
(number 62 in the final document) includes the replacement
for the language listing groups some countries did not want
named:

"By 2003, in order to complement prevention programmes that
address activities which place individuals at risk of HIV
infection, such as risky and unsafe sexual behaviour and
injecting drug use, have in place in all countries
strategies, policies and programmes that identify and begin
to address those actors that make individuals particularly
vulnerable to HIV infection, including underdevelopment,
economic insecurity, poverty, lack of empowerment of women,
lack of education, social exclusion, illiteracy,
discrimination, lack of information and/or commodities for
self-protection, all types of sexual exploitation of women,
girls and boys, including for commercial reasons; such
strategies, policies and programmes should address the
gender dimension of the epidemic, specify the action that
will be taken to address vulnerability and set targets for
achievement;"

* Removal of reference to the United Nations HIV/AIDS and
Human Rights International Guidelines

Many of the same countries wanted no mention of this
document, the result of the Second International
Consultation of HIV/AIDS and Human Rights, a meeting
organized jointly by the Office of the United Nations High
Commissioner for Human Rights and UNAIDS. The guidelines
were described as follows by ICASO, the International
Council of AIDS Service Organizations, in email on World
AIDS Day (December 1, 2000), before the current controversy
had emerged:

"There are 12 guidelines in all, each containing action-
oriented measures. For example, they call upon states to:
provide political and financial support to ensure that
community organizations are able to carry out their
activities effectively; review and reform public health
laws to ensure that they are consistent with international
human rights obligations; enact or strengthen anti-
discrimination and other protective laws to protect
vulnerable groups, people living with HIV/AIDS, and to
provide for speedy and effective remedies when the laws are
broken; enact laws and regulations to ensure safe,
effective and affordable medications, and adequate
prevention and care information."

The 58-page document is available at:
http://www.unaids.org/publications/documents/human/

Apparently these conservative governments wanted to remove
any reference to this document because it could support the
human rights of gays and lesbians (although gays and
lesbians are not mentioned in the 12 guidelines). Although
far from a majority, these countries had leverage because
of the great desire of most countries to have unanimous
agreement of all UN member countries on the Declaration of
Commitment. After long negotiating sessions lasting until
2:30 or 3:00 a.m. each night, agreement was reached to drop
this reference, as well as the listing of vulnerable
groups, from the document. In return the conservatives
agreed to approve the document, even though they did not
get other changes they wanted.

* Allowing International Gay and Lesbian Human Rights
Commission at Human Rights Roundtable

The entire General Assembly spent almost three hours on the
morning of the first day on whether a representative of the
International Gay and Lesbian Human Rights Commission
(IGLHRC, based in San Francisco and New York) could sit on
a round table on human rights -- after about nine
governments, apparently led by Egypt, objected because she
represented a gay organization. Some of these governments
did not want to be identified, and were not publicly known
when we last checked. Perhaps coincidentally or perhaps
not, Karyn Kaplan, the speaker they tried to ban, is also a
leader in the movement to make medications more affordable
in poor countries.

As we understand the procedure, any country could veto a
non-government representative from the round table; even
one country would have been enough, and their veto could
not be appealed. But a representative could be added to the
round table by a two-thirds vote. So Ms. Kaplan was added
back by a vote of 62 in favor, none opposed, and 30
abstaining -- with the countries most opposed not voting at
all, in a failed attempt to deny a quorum and prevent the
vote from counting.

The U.S. delegation voted in favor of her speaking, and
also was helpful in the negotiations.

While it may seem unreasonable that the General Assembly
spent almost three hours to allow a short speech on human
rights, there was a bigger issue involved. A decision the
other way could have been a message and precedent that gay
organizations (and perhaps gay individuals) were not
accepted as equal partners in the United Nations fight
against global AIDS.

Not all of the governments that tried to block the quorum,
or were less than supportive by abstaining, were
necessarily against a gay representative, as there were
also procedural issues involved. In addition, the General
Assembly is divided into blocks of nations that usually
vote together, so it is likely that some votes were cast in
block solidarity, or traded for votes on other issues, or
represented reluctance to offend Egypt or other countries
that were upset that Ms. Kaplan was being voted back on the
roundtable after they thought they had her removed.

So far no one has been able to fully explain to us what
really happened here, or why. It is not clear what Egypt or
the other countries that objected expected to gain, even if
they had won. It seems that the attack on equal gay
participation was largely used to pursue other ongoing
issues at the UN -- issues sometimes difficult for an
outsider at that institution to understand.

* Visa denials

Many AIDS organizers who should have been at the United
Nations AIDS session were not allowed to participate. Most,
apparently, were vetoed by their own governments, some of
which do not like AIDS organizations. No reasons were given
for these denials, so it is not known how many were barred
this way.

Some were stopped by U.S. officials at U.S. embassies in
several countries, who would not give them the waiver
required for an HIV-positive non-citizen to enter the
United States. Apparently some were also stopped by U.S.
officials because they did not have enough money -- as if
they were tourists instead of AIDS experts attending a
major United Nations meeting. It is our understanding that
U.S. policy was to give the HIV waivers, but that by law
the final decision to give visas is up to each embassy.
There are many countries and therefore many U.S. embassies,
and it seems that not all of them took the AIDS meeting
seriously.

While it is too late for a remedy for this meeting,
something can be done about the larger issue of irrational
travel restrictions and gross discourtesy or worse to
international visitors. These problems happen because the
travelers are not citizens of the countries they are
entering, so they have no political power there, and the
usual checks and balances which would otherwise offer some
protection do not exist. So irrational restrictions and
harassment of even routine visitors can grow with little
restraint.

What is needed is an international movement on behalf of
travelers, and probably immigrants as well, which could
function like the ACLU does in protecting political liberty
in the U.S., by fighting test cases within each country. It
could and should improve on the ACLU model by picking cases
for their public-relations appeal as well as their legal or
procedural value. It would attract citizens of any country
by helping to protect them in their own travels -- and also
appeal to national pride, organizing those who want to make
their own society more hospitable to business travelers,
workers, tourists, customers, relatives, refugees, and any
other visitors who are not excluded for legitimate reasons.


***** Global AIDS Epidemic: Getting Things Done

Comment by John S. James

We cannot wait for governments to find the political will
to deal with AIDS just through their own bureaucratic
processes. The initiative must come from people in all
areas of life -- including government, industry, the
professions, and the general public. The world has more
than enough resources to deal with HIV/AIDS (and also
tuberculosis, malaria, and other infectious diseases); and
there are millions of people who care and can help. The big
shortage is of attractive, workable opportunities for
channeling this concern into effective action.

For example, we heard from one U.S. HIV physician that he
wanted to donate his vacations for several years to go to
Africa or wherever he was needed, to train doctors in
diagnosing and treating HIV disease. But he could find no
program that had set up arrangements for doing so. (Some
U.S. HIV doctors and researchers already work in Africa,
but usually full time; we also need opportunities for
doctors who want to maintain their current practice but
could donate vacations, or work during other special
occasions.)

For a different example, consider the great change in the
worldwide discussion of treatment access and prices of
medicines. Three years ago, almost everyone took
antiretroviral prices of about $10,000 per patient per
year, even in the poorest countries, for granted -- along
with the death without treatment of almost everyone with
HIV in Africa and other poor regions. The change could not
have happened without the work of a fairly small number of
activists around the world -- in ACT UP in the U.S. and
France, Treatment Action Committee in South Africa, the
Health GAP Coalition in the U.S., and other organizations.
How did workable opportunities for involvement in this
activism come into being? We do not know.

As key issues now move toward infrastructure, there will be
more need than ever for both volunteer and professional
involvement. Not everyone need work abroad. For example, if
HIV doctors cannot find suitable programs through which to
volunteer vacation time, then activists could find out why.
Perhaps some organization already has such a program but is
not well known. Or maybe someone needs to bring together
funders with organizations like Doctors Without Borders,
which already do this kind of work. Perhaps some medical
organization already sends physicians abroad but has never
worked in HIV before, and might be willing to start now.
Volunteers need to research such possibilities and start
bringing people together.

And of course almost all countries need lots of work in
generating public pressure so that governments will have
the political will for serious commitment in AIDS and other
infectious diseases, and will develop the large-scale
programs that require governments involvement.

We greatly need the work of determined activists, volunteer
or professional, with "people" skills or organizing skills,
as well as those with medical or other technical training
and experience. But this need does not automatically
translate into workable roles that people can choose for
themselves. Clearly we already have the need, the
resources, and the people willing to help with AIDS and
other infectious diseases. The big challenge is how to
develop the human structures so that the resources get used
and the work gets done.

[Note: This writer has a personal Web site,
http://www.communicationpractices.org, to explore the
development of self-education practices for improving human
relationships. We believe this work can contribute to the
conscious development of social roles, helping to improve
institutions as well.]


***** Names Reporting: Pennsylvania, California Activists
Change the Momentum

by Jim Straub

This past April the Pennsylvania State Legislature proposed
using a names-based reporting system to track HIV infection
in Pennsylvania. Many in the HIV/AIDS community oppose such
an approach, since the collection of HIV-positive
individuals' names and personal information may cause fewer
people to seek testing and threaten the safety and privacy
of those who do. Activists in Pennsylvania, who maintain
that a coded system called unique identifiers could track
HIV adequately without the risks of names reporting, had
spent a great deal of time in the past several years trying
to persuade the state legislature to adopt a non-names
based HIV reporting system. However, the Pennsylvania
Department of Health finally dismissed the unique
identifier system as being too expensive and unwieldy, and
the state moved ahead with a public comment period that
would precede the adoption of names reporting.

At the point that the public comment period began, many
veteran activists and advocates felt that the battle had
been lost. "A lot of us felt like we had lost and were
stuck with names reporting now," said Julie Davids of the
Critical Path AIDS project in Philadelphia. "We had
advocated for unique identifiers for a long time, but when
the Department of Health said they wanted names, me and a
lot of other people felt like throwing the towel in then."

Feeling defeated, many of Pennsylvania's important AIDS
advocates began moving on to other battles. However, a
handful of HIV-positive people who felt deeply opposed to
names reporting's potential impacts on their lives picked
up the issue. Barry Busch, a member of ACT UP Philadelphia,
describes his initial efforts: "A lot of bigwigs had given
up, but I just kept pestering them to take a stand and make
a big stink about this. I and some other people started
calling ASOs (AIDS service organizations) around the state,
and also informed some journalists about this."

Busch's efforts struck a chord, and before long the lost
momentum around names reporting was more than regained.
Several newspaper articles described the potential problems
with the names reporting system the state was considering,
and activists from ASOs began calling each other across the
state to plan a lobby day in the capitol. Before long the
trickle became a flood, with first Philadelphia's City
Council, and then Mayor, coming out against names reporting
and even suggesting that Philadelphia might refuse to
comply with a names-based reporting system.

"That really got them talking in the capitol," said Busch
of City Council's threat to refuse to comply with names
reporting. "A similar thing happened in California, when
that state was considering names reporting. Basically, San
Francisco's department of health said it wasn't giving up
any names to the state, no matter what. Thanks to their
stubbornness, California now has a safe, efficient system
of HIV reporting that doesn't report names. And I think
Pennsylvania might be joining them soon." Indeed, many of
the state legislators who initially favored names reporting
have changed their stances since the recent furor over the
issue.

While AIDS activists who oppose names reporting concede the
battle is hardly over, it is certain that the momentum
around the issue has changed dramatically. On the brink of
defeat, some of the most powerful voices of AIDS advocacy
in Pennsylvania had fallen silent. It took, instead, a
handful of people who felt deeply about the issue's impact
on their lives calling to ASOs statewide to spark a sudden
grassroots resurgence of debate about names reporting. With
several other states also now considering enacting names-
based HIV reporting systems, perhaps Pennsylvania's lesson
can be useful elsewhere.

[Jim Straub is a member of ACT UP Philadelphia.]


***** AIDS TREATMENT NEWS

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AIDS Treatment News
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AIDS TREATMENT NEWS Issue #366, June 22, 2001
     phone 800-TREAT-1-2, or 215-546-3776

CONTENTS

** United Nations: Special AIDS Session Next Week
The entire United Nations General Assembly will focus on
the AIDS epidemic next week. About 5,000 people are
expected to register for this meeting, most of which is
closed to the public; however, many satellite events are
open to public participation. The entire session will be
broadcast worldwide via the Web, and archives and
transcripts will also be available. This article provides
some Web sites to start with, and outlines some of the
major controversies around this session.

** Drug Patents and Developing Countries: New Proposal
An economist has proposed a way to help prevent World Trade
Organization rules from blocking access to medications in
poor countries.

** Bone Disease: Report on the Web
This Web site reviews a meeting last year on bone problems,
including avascular necrosis and osteopenia, which might or
might not be caused by HIV, and/or by the drugs used to
treat it.

** Mitochondrial Toxicity: Report on the Web
Mitochondrial toxicity may be the root cause of many
serious side effects of antiretroviral medications. This
report summarizes a meeting last year to review what was
known at that time.

**ADAP (AIDS Drug Assistance Program) Funding: Action
Needed
Federal and State underfunding of the AIDS Drug Assistance
Program has already caused half of all states to plan
restrictions of their program, which will result in
patients not receiving the drugs they have been prescribed.


***** United Nations: Special AIDS Session Next Week

by John S. James

On June 25-27 the entire United Nations General Assembly
will focus on AIDS. The goal is worldwide commitment and
consensus on dealing with the epidemic. The negotiations
leading up to this Special Session have been contentious,
even more so than most diplomatic meetings.

No matter what the outcome, this meeting will be historic
and will be a major focus of world attention. Here is some
background, and resources that you can use as a starting
point for finding information.

Official Web Page

The Web page for the United Nations General Assembly
Special Session on HIV/AIDS (often called UNGASS) is
http://www.un.org/ga/aids/

Here are some of the important documents available there
before the meeting:

* Under the heading "A call to action" are several recent
statements by United Nations Secretary General Kofi Annan,
who has provided exceptional leadership on this issue in
advance of the United Nations special session;

* The "Documents" section includes the "Revised Draft
Declaration of Commitment on HIV/AIDS" -- a single-text
statement that is being negotiated in order to reach as
much agreement as possible. (At this time, June 16, the
current draft is the 2nd published version, dated May 11.)

* The "Bulletin" is an electronic news bulletin to keep
participants informed. At this date (June 21) only one
issue has been published, with general background such as
AIDS statistics, overview of the meeting, and media
accreditation. Two more issues are planned by June 25.

* A "calendar" of dozens of official UN and unofficial
events around the time of the session.

* Other sections on background information, NGOs and civil
society, and media.

  From the official media advisory:

Governments Will Convene to Plan Intensified Action to
Combat the Global Epidemic

The United Nations will hold a Special Session on HIV/AIDS
to galvanize leadership at the highest levels, intensify
international action and mobilize the resources needed to
combat the epidemic. The Special Session, to take place
from 25 to 27 June 2001 at UN Headquarters in New York,
will be the first ever to address a public health issue.

UN Secretary-General Kofi Annan and high-level government
delegations will address:

* The importance of political leadership in developing
effective responses and decreasing the stigma associated
with HIV/AIDS

* Encouraging all sectors of society to play a major role

* Increasing resources for treatment, prevention, and care

* Preventing new infections and alleviating the social and
economic impact of the epidemic

* Access to care and the development of new technologies
and treatments that are both effective and affordable

Governments are expected to adopt a Declaration of
Commitment setting targets and timetables. In addition to
statements in the Plenary, four interactive round tables
will discuss human rights, international funding and
cooperation, prevention and care, and the socio-economic
impact of HIV/AIDS. These will involve participants from
NGOs, the private sector and other civil society groups. A
full programme of press conferences and special events will
provide additional media opportunities.

Live Webcast, Plus Archive and Transcript

Kaisernetwork.org, a service of the Henry J. Kaiser Family
Foundation, is webcasting the entire UN Special Session on
HIV/AIDS, June 25-27. Anyone around the world can watch it
for free.

An archive and transcript will also be available, a few
days after the session.

For more information, or to watch the webcast, visit
http://www.kaisernetwork.org/healthcast/un/aids/jun01

Areas of Agreement

On June 16 the Background section of the official Web site
includes a one-paragraph summary under "What Will the
Outcome Be?" It summarizes some of the major areas of at
least nominal agreement:

"Given the urgency of the epidemic, at the special session
governments are expected to agree on a Declaration of
Commitment that will outline priority areas where stronger
action must be taken. These are likely to include
prevention, improved access to care and treatment, care of
children orphaned by AIDS, expanded public/private sector
partnerships, the need for an accelerated multisectoral
response to the epidemic and for resources commensurate
with the crisis."

Controversies

Some of the major areas of disagreement are:

* Whether to name vulnerable groups, such as men who have
sex with men, in the Declaration of Commitment. The current
draft includes the following section, which some countries
object to:

"By 2003, develop national strategies, policies and
programmes, through a participatory approach, to promote
and protect the health of those most vulnerable to, and at
greatest risk of HIV infection, such as: children in
especially difficult circumstances, men who have sex with
men, sex workers and their clients, injecting drug users
and their sexual partners, persons confined in institutions
and prison populations, refugees and internally displaced
persons and people separated from their families due to
work or conflict."

According to a June 15 Associated Press story, an Egyptian
diplomat commented, "Does it have to be so explicit? This
is shocking for my society." He proposed "irresponsible
sexual behavior" instead. And the Iranian Ambassador said
negotiations should "not be considered as an opportunity by
certain quarters in the Western world to push the envelope
on areas where there is cultural sensitivity, ideological
sensitivity, ethical sensitivity" (from same Associated
Press story).

Apparently the U.S. wants to use general language such as
"vulnerable individuals" instead of naming the groups.

Many AIDS professionals and activists consider the issue
important because they want to use the document that
emerges to pressure their governments to focus prevention
resources where the epidemic is spreading fastest. Many
countries, including the U.S., have targeted prevention
resources irrationally because of a population's
disadvantaged or unpopular political position, or minority
status.

* Human rights. Here is the current text, which some
countries want changed, although as of today (June 21)
there seems to have been progress toward narrowing the
areas of controversy:

"HIV/AIDS AND HUMAN RIGHTS

"Respect for human rights reduces vulnerability to HIV/AIDS

"Respect for the rights of people living with HIV/AIDS
drives an effective response

"By 2003, complete policy reviews of existing non-
discrimination legislation and protective laws, drawing as
appropriate on the United Nations Guidelines on HIV/AIDS
and Human Rights, in order to adopt new or strengthen
existing legislation to protect the human rights of people
living with HIV/AIDS, eliminate discrimination and ensure
their equal rights in education, employment and services;

"By 2005, ensure that national legislation is in place to
promote, protect and respect the rights of people living
with HIV/AIDS to information, quality care, support,
confidentiality and privacy;

"By 2005, develop and implement national strategies that:
assist women to exercise control over and make their own
decisions relating to their sexuality in order to protect
themselves from HIV infection; and promote shared
responsibility of men and women to ensure safe sex and
prevent HIV infection;

"By 2005, implement measures to increase capacities of
women and young girls to protect themselves from risk of
infection, principally through gender-sensitive prevention
education and the provision of reproductive health
services;

"By 2005, develop and begin to implement national
strategies to promote women's full enjoyment of all human
rights and reduce their vulnerability to HIV/AIDS through
the elimination of all forms of violence against women and
girls, including harmful traditional and customary
practices, abuse and rape, battering, and trafficking in
women and girls."

Apparently the U.S. does not want any movement toward
health care as a human right. And some countries do not
like the idea of human rights and are reluctant to see it
extended.

* Treatment Access vs. Prevention and/or Intellectual
Property

The current draft focuses on prevention and only two
paragraphs on treatment and care. But pharmaceutical
companies -- and therefore the U.S. and some other
delegates -- have problems with the following paragraph,
apparently because they do not want any language suggesting
collective action toward differential pricing or other ways
of making medications affordable:

"By 2003, ensure that national strategies are developed in
close collaboration with the international community, civil
society and the business sector to increase substantially
the availability of antiretroviral drugs and of essential
drugs, for the treatment of HIV infection and opportunistic
infections, by addressing factors affecting the provision
of these drugs, including technical and system capacity,
pricing, including differential pricing and by examining
alternatives for increasing access and affordability of
HIV/AIDS related drugs."

There is also controversy over whether to provide
antiretroviral treatment in Africa and other poor regions,
vs. focusing on prevention and limiting treatment to low-
cost, unpatented antibiotics, and only using
antiretrovirals for prevention of mother-to-infant
transmission.

Recently two U.S. officials created a firestorm of
controversy by suggesting that Africans could not take
their medicines on time -- first an unnamed senior Treasury
Dept. official in late April, then over a month later,
Andrew Natsios, the new director of the U.S. Agency for
International Development -- leading to calls for the
latter's resignation, including an op ed in The Washington
Post, June 15, and a student campaign to send him watches.
Some observers are less concerned about the unfortunate
remarks themselves than by what they may reveal about moves
toward a U.S. policy of writing off tens of millions of
people already infected in poor countries -- whether to
defend prevention program funding, to save money, or to
avoid intellectual-property challenges resulting from
raised expectations and efforts to obtain access to
patented antiretrovirals.

One code word to watch is "care." Often it means hospice
care or other inexpensive treatment -- not including
antiretrovirals to address the central cause of the
illness.

For More Information

To follow these and other issues during and after the
United Nations General Assembly Special Session on
HIV/AIDS, see:

* The official session Web site (described above),
http://www.un.org/ga/aids/

* The official email discussion forum, Break the Silence.
To join, send an e-mail message to: join-break-the-
silence@... To see the archive of messages already
sent, go to http://www.hdnet.org (at this time there is a
full archive for those who have joined the list, and a
selected, categorized archive open to anyone).

* The news bulletin of the meeting. The easiest way to find
is it to check the official Web site for copies as they are
published.

* For information about the campaign for treatment access
in developing countries, see:
http://www.accessmed-msf.org/ (You may need to click on the
logo to enter the site), and
http://www.globaltreatmentaccess.org



***** Drug Patents and Developing Countries: New Proposal

by John S. James

A creative new idea on using existing patent laws and
procedures to deal with the conflict between intellectual
property and access to medication in developing countries
was posted on the World Bank's Annual Bank Conference on
Development Economics ("A Patent Proposal for Global
Diseases," by Jean O. Lanjouw, Yale University, the
Brookings Institution and NBER, April 2001,
http://econ.worldbank.org/files/1733_lanjouw.pdf).

We cannot judge the technical merits, but certainly new
ideas on this issue need attention -- especially at this
time when access to treatment will be considered at the
United Nations General Assembly Special Session on
HIV/AIDS, June 25-27, 2001.

The current problem is that the existing TRIPS
(intellectual property) provisions of the World Trade
Organization treaty require every country to have
U.S./European style patent laws in force by 2006. This
provision, adopted with no thought for its effect on access
to health care, could be a disaster for poor countries,
because pharmaceutical companies price their drugs for
rich-country markets, and have incentives to write off the
poor who do not count financially, instead of having
greatly varying prices which might lead to public-relations
problems in rich countries. But at the same time, some
intellectual-property advocates hope that the new
patentability of drugs for developing-country diseases
might lead to medical research and drug development on
diseases which are largely limited to poor countries,
diseases largely neglected until now. [Medicines could be
sold profitably in poor countries, but they would have to
be developed and marketed differently than in rich
countries.]

The proposal is to use a procedural change in the patent
offices of rich countries, to make pharmaceutical companies
choose whether to protect their new drug patents in rich
countries or in poor countries -- but not in both. Then for
diseases like cancer, which affect both rich and poor
countries, companies would choose to protect their patents
in rich countries -- allowing low-cost generic copies to be
sold in poor countries, which are a negligible market in
comparison. But for diseases like malaria, which affect
poor countries almost entirely, companies would choose
patent protection in poor countries. In theory prices would
not be prohibitive, as the medications would have to be
priced for poor countries in order to sell at all.

This policy could be implemented entirely by one or a few
developed countries, without requiring any change in
international treaties.

Abstract of "A Patent Proposal for Global Diseases":

"There are two identifiable types of diseases in developing
countries. Some, such as malaria, are specific to poor
countries, but many others, such as cancer, have a high
incidence in all countries. These differences give rise to
quite distinct drug markets. In particular, for global
diseases, pharmaceutical industry profits derived from
having a monopoly over sales in poor countries make only a
marginal contribution to total world-wide profit and
therefore the incentives to invest in research. At the same
time, even a small price increase due to such a monopoly in
a poor country can greatly reduce the number of people able
to purchase patented drugs and the welfare of those who do.
This paper describes a policy that could improve on the
current patent regime by acknowledging these differences in
markets and what they imply for optimal patent protection.
It allows protection to strengthen for diseases specific to
developing countries where a clear argument can be made
that some form of new incentives are warranted. At the same
time, it effectively keeps protection at its current level
in situations where increased profits are less likely to
generate new innovation."

The paper is available at:
http://econ.worldbank.org/files/1733_lanjouw.pdf

Comment

Clearly the preferred solution would be to change the WTO
TRIPS so that it does not block most of the world's
population from access to new medicines. But we do not know
if such a change is possible. In case it is not, devices
like the one proposed by Lanjouw need to be considered.


***** Bone Disease: Report on the Web

A 54-page background report on bone disease in persons with
HIV (including avascular necrosis, and also osteopenia) can
be found in Bone Metabolism and HIV Disease Meeting Report,
published by the Forum for Collaborative HIV Research.

Contents include:
* Bone disease and HIV
* Overview of the local regulation of bone
* Crosstalk: Bone and the Immune System
* Cytokine aspects of bone biology
* Increased prevalence of avascular necrosis in HIV-
infected adults, and
* Bone metabolism in HIV Disease: New and old paradigms

This paper reports on a meeting that occurred August 29,
2000, so readers should also check more recent information.

The report is available at http://www.hivforum.org;
currently it's under "Publications and Reports," then under
"Metabolic Abnormalities." Note that Forum reports are more
focused on research policy than on practical treatment or
management information.


***** Mitochondrial Toxicity: Report on the Web

A 67-page background report on mitochondrial toxicity --
widely suspected though not proven to be a basic cause of
many serious side effects of certain antiretrovirals -- has
been published on the Web by the Forum for Collaborative
HIV Research. Since this paper reports on a meeting that
took place June 5-6, 2000, readers should also check more
current information.

Topics include background on mitochondrial dysfunction,
clinical aspects in adults and children, and diagnosis and
therapeutics.

The report is available at http://www.hivforum.org;
currently it's under "Publications and Reports," then under
"Metabolic Abnormalities."


***** ADAP (AIDS Drug Assistance Program) Funding: Action
Needed

Almost half of all states have already indicated that they
may have to restrict their AIDS Drug Assistance Program by
the end of 2001. Restrictions can include waiting lists,
caps on services, cutting drugs off the formulary, or even
closing the program to new enrollment because money is low.
Additional states may be affected as well.

Recently we learned that California is looking at its
program to decide what drugs to remove from its program if
necessary.

The basic problem is that federal and state funding has not
kept up with the greater number of patients who need
treatment, since people today are living longer. The new
guidelines that call for starting treatment somewhat later
will help to balance expenses, but is not enough to make up
the difference.

On June 14 Project Inform's Treatment Action Network sent
out an alert listing some of the states soon to be
affected:

In the last appropriations bill, ADAP received $60 million
less than projected as needed to provide standard of care
for its clients. In addition, the number of new clients and
the costs of drugs continue to rise, putting an additional
strain on many state ADAPs. Many programs are expected to
face serious problems in the next few months without an
emergency supplemental. According to a recent report by the
National Alliance of State and Territorial AIDS Directors
(NASTAD), nearly half of all states have indicated that
they might have to place emergency restrictions on their
programs this year, such as implementing or expanding
waiting lists, capping services, and/or making cuts to the
list of available drugs. Currently, there are ADAP waiting
lists in Alabama, Arkansas, Georgia, Indiana, Kentucky,
Maine, Montana, Oklahoma, South Carolina, and South Dakota.
Even states with the most comprehensive ADAPs such as
California, New York, and Pennsylvania are expected to feel
the effects of the budget shortfall.

That action alert asked recipients to call or email
President Bush, and their two U.S. Senators (you can find
contact information for Senators from their Web sites,
which can be reached through http://www.senate.gov).

What You Can Do

The ADAP situation is changing daily. To be informed how
you can help on this and other treatment and access issues,
you can join Project Inform's Treatment Action Network.
Send an email to tan@..., and ask to receive
their action alerts.


***** AIDS TREATMENT NEWS

Published twice monthly

Subscription and Editorial Office:
   1233 Locust St., 5th floor
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   phone 800/TREAT-1-2 toll-free, or 215-546-3776
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   useful AIDS links: http://www.aidsnews.org

Editor and Publisher: John S. James
Associate Editor: Tadd T. Tobias

Statement of Purpose:
AIDS TREATMENT NEWS reports on experimental and standard
treatments, especially those available now. We interview
physicians, scientists, other health professionals, and
persons with AIDS or HIV; we also collect information from
meetings and conferences, medical journals, and computer
databases. Long-term survivors have usually tried many
different treatments, and found combinations that work for
them. AIDS TREATMENT NEWS does not recommend particular
therapies, but seeks to increase the options available.

AIDS TREATMENT NEWS is published 24 times per year, on the
first and third Friday of every month, and print copies are
sent by first class mail. Email is available (see below).
Back issues are available at http://www.aidsnews.org

To subscribe, you can call 800-TREAT-1-2 or 415-255-0588:
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ISSN # 1052-4207

Copyright 2001 by John S. James. Permission granted for
noncommercial reproduction, provided that our address and
phone number are included if more than short quotations are
used.

--
John S. James
AIDS Treatment News
http://www.aidsnews.org

AIDS TREATMENT NEWS Issue #365, May 25, 2001
     phone 800-TREAT-1-2, or 215-546-3776

Contents

** Antibodies and HIV: New Evidence.  Interview with Ruth
Ruprecht, M.D., Ph.D.
While most antibodies are not effective against HIV, an
immunologist has found some that are. This research might
be very important for vaccine development, for protecting
infants from infection (including from breast milk), and
possibly for developing better treatments for persons
already infected.

** Danger: Counterfeit Neupogen(R) (Filgrastim)
A counterfeit drug with no active ingredient is circulating
in the United States; it could be a serious health risk to
patients. The fake product is easy to recognize, by using
instructions and photos on the company's Web site.

** Danger: Counterfeit Serostim(R) (Human Growth Hormone)
A warning from the company and the FDA about a new
counterfeit human growth hormone -- the second such case
this year.

** June 23: New York March and Rally Before United Nations
AIDS Session
A major rally will take place in New York, just before the
opening of the United Nations General Assembly Special
Session on AIDS (UNGASS). It is seeking funding, debt
cancellation, and political will to make treatments
available to save the lives of persons in developing
countries with HIV.

** United Nations: Civil Society Snubbed at Final
Preparatory Meeting on AIDS
Many of the AIDS organizers, some of whom traveled long
distances at their own expense, found they had little input
into preparations for the United Nations AIDS session in
June.

** Global AIDS: Back to the Past?
We believe the potential availability of affordable
treatment in Africa transformed AIDS from an unsolvable
tragedy to an opportunity to save lives, making
mobilization possible. But in the last few weeks, a push to
avoid funding treatment in order to focus on prevention
weakened the momentum against AIDS as a whole.


***** Antibodies and HIV: New Evidence. Interview with Ruth
Ruprecht, M.D., Ph.D.

By David Scondras, Search For A Cure, and John S. James,
AIDS Treatment News

Background

HIV infection causes the body to produce large amounts of
antibodies -- specialized proteins produced by the immune
system to fight infecting bacteria or other organisms. But
most of the antibodies produced in response to HIV
infection are not effective in stopping the virus -- and
some of them may even increase HIV infection. So in recent
years, many scientists have given up on antibody approaches
to HIV vaccines or treatments. (Instead they are working
with the other major branch of the immune system, cellular
immunity, which now looks very promising for control of
HIV. However, cellular immunity by itself cannot clear most
HIV infections.)

At a recent conference on immune research in HIV, held
April 27-29 at the Institute of Human Virology at the
University of Maryland in Baltimore, Ruth M. Ruprecht,
M.D., Ph.D., an immunologist at the Dana-Farber Cancer
Institute and Professor of Medicine at Harvard Medical
School, presented an update on her team's ongoing work with
HIV antibodies. She agrees with her colleagues that most
antibodies against HIV are not effective. But some are (as
other investigators and Dr. Ruprecht had shown) -- and she
has selected three of them for further research. These
three, injected together, have successfully prevented
infection in monkeys, even when they are given large doses
of HIV-like viruses.

If this approach continues to be successful, it could have
huge implications:

(1) Vaccines could be engineered to cause the body to
produce antibodies already known to work. Such antibody-
inducing vaccines might be effective by themselves -- or
might be combined with approaches that generate cellular
immunity to produce vaccines more effective than either
kind alone. Vaccine development could be greatly
accelerated, because it would be possible to test quickly,
in volunteers, whether or not a candidate vaccine induced
production of the desired antibodies. Problems could be
found and fixed quickly, before the vaccine went into a
large, multi-year trial.

(2) Antibodies might also be able to prevent mother-to-
infant transmission -- without the side effects or
potential toxicities of antiretrovirals, without the risk
of producing drug-resistant virus, and possibly without
requiring the mothers to avoid breast feeding.

(3) It is possible that selected antibodies might help in
the treatment of persons already infected. So far there are
no data, as this has not been tried even in animals.

But many years ago there were experiments with "passive
immunotherapy" for HIV -- collecting serum donated from
persons who were doing well for a long time despite HIV
infection, and transfusing this serum into persons who were
sick. Despite some promising results, this work did not
continue. From the modern perspective, these early attempts
do make some sense -- Dr. Ruprecht explained that a few
patients do produce antibodies that are effective in
stopping HIV. But today we also know that some people are
slow progressors for different reasons, some of which have
nothing to do with antibodies, so there is no reason to
think that transfusing their plasma would be beneficial to
others. Using rationally selected, engineered antibodies
would appear more promising.

Incidentally, passive immunotherapy has long been used to
treat certain other infectious diseases. And recently it
was found effective in animal tests in both preventing and
treating ebola virus infection.(1)

Dr. Ruprecht uses monoclonal antibodies (pure antibodies
produced by genetically modified cells) rather than serum
or immunoglobulins prepared from serum, that deliver a
variable mixture of many different antibodies. So far,
monoclonal antibodies have been much too expensive to use
as treatments. But now it is becoming possible to produce
antibodies in plants, such as tobacco. So price need not be
an obstacle -- if it is found that antibodies could work as
treatment for someone already infected with HIV, which
today is not known.

Note: David Scondras interviewed Dr. Ruprecht on April 28,
and prepared a transcript. Since he then had to leave for
AIDS work in Malawi, John S. James, who was present at the
interview, edited the transcript and wrote the background
section above. Dr. Ruprecht made corrections before the
interview was published.

* * *

Interview with Dr. Ruprecht

SCONDRAS: What is the goal of your work?

RUPRECHT: We want to develop an immunological approach to
prevent mother-to-child transmission of HIV.
Simultaneously, we are also looking for a way to rationally
design an HIV vaccine.

The idea came from how we manage hepatitis B. To prevent
mother-to-child transmission, pregnant women are screened
for the virus. If they are positive, their infants get two
inoculations: the first consists of hepatitis B
immunoglobulins [which contain antibodies against the
hepatitis B virus, providing passive immunity], and the
second is the hepatitis B vaccine.

Used together, the vaccine plus immunoglobulins confer 98%
effective protection to the baby. If you use the
immunoglobulins alone, they are only 70% effective.

Turning to HIV, people who have HIV infection make very
little neutralizing [effective] antibody compared to people
with other viral infections. Instead, with HIV, the body
makes lots of antibodies to parts of the virus that are not
important. This kind of antibody does not stop the virus
from infecting cells and damaging the immune system.
Indeed, it is now known that HIV makes the body produce
antibodies that may even help the virus infect cells.

That was part of the reason I decided to stay away from
polyclonal sera [such as antibody preparations made from
the blood of persons whose HIV was progressing slowly]. You
cannot do a rational analysis of the specific antibodies.

SCONDRAS: Hasn't this approach of looking at antibodies
been tried before?

RUPRECHT: Every once in a while, a patient develops
relatively high titers of neutralizing antibodies [meaning
that they produce antibodies that effectively block HIV].
It is also known that monoclonal antibodies can be made
from these people. But in scientific research, the pendulum
had swung away from antibodies.

SCONDRAS: How did you think that antibodies could play an
important role anyway?

RUPRECHT: I knew that antibodies help prevent hepatitis B
virus infection. I also knew that the hepatitis B virus has
some similarities to HIV. So I decided to focus on finding
potent antibodies from HIV-infected people. Other
investigators have succeeded in engineering cultured cells
to produce just a single antibody, called monoclonal
antibody. My colleagues kept isolating B cells [the cells
in the blood that produce antibodies], and kept screening
until they found cells that produced antibodies that
successfully neutralized HIV. Then we could learn to mass
produce the monoclonal antibodies. Today this is possible;
in fact, tobacco plants can be engineered to produce these
antibodies.

The Animal Tests

RUPRECHT: We decided to combine antibodies that worked
against HIV, in the hope that a cocktail of antibodies
would be more effective than one antibody alone. We looked
for overall potency of triple combinations, picked a
combination that stopped HIV in the test tube, and then
tested if that combination would stop a virus similar to
HIV that can grow in animals.

The three antibodies that we picked are human monoclonal
antibodies, targeting conserved epitopes of the envelope of
HIV. [The "envelope" is the outside part of the virus, that
antibodies can get to. "Epitopes" are particular shapes of
parts of HIV; antibodies target foreign substances by being
shaped just right to fit them. "Conserved" epitopes means
ones that do not change much from one strain of HIV to
another (probably because when they do change as a result
of mutations, the virus is not able to survive).]

This kind of therapy that uses antibodies is called
"passive immunotherapy." It is important for babies, in
particular, because it may be able to protect babies from
getting HIV from their mothers, and also protect them from
getting HIV from breast milk from the infected mother.
Antibodies stay in the blood for a fairly long time [so it
might be possible to protect babies with only a few
injections, instead of shots or pills every day].

SCONDRAS: Is there any connection between this and
developing a vaccine to protect people from HIV?

RUPRECHT: Yes. We have antibodies now that are completely
characterized [meaning that we know to what part of HIV
they bind]. If these antibodies can provide complete
protection from HIV transmission, then a vaccine that
elicits these antibodies should be protective.

SCONDRAS: Is it possible that these antibodies could be a
therapy for people who have HIV?

RUPRECHT: We just do not know yet -- no experiments have
been conducted to test this approach.

SCONDRAS: Why do you think you may have found the right
antibodies?

RUPRECHT: We have data showing that these three antibodies
can completely protect against SHIV challenge in adult
rhesus monkeys. [SHIV is a virus which combines parts of
SIV, which infects monkeys, and parts of human HIV.] We
have also shown that newborn monkeys could be protected
completely with the triple combination of antibodies
against mucosal SHIV infection. Then we tried a much more
aggressive SHIV strain, and it was stopped in some newborn
animals. We purposely infected these monkeys with much,
much more virus than is usually transmitted from mothers to
babies, and the antibodies worked well.

One other point: The antibodies we have identified are of
the IgG subtype, not IgA, the typical mucosal antibodies.
This implies that you do not need mucosal immunity to HIV
to protect people from HIV.

SCONDRAS: Dr. RUPRECHT: How did you get started in AIDS
research ?

RUPRECHT: I was about to start a thesis in physical
chemistry in Switzerland, my native country, but my real
love was molecular biology. When I was in the U.S. as a
summer intern in chemistry, I discovered that the U.S.
graduate-school system would allow me to make this change
of fields, unlike my school in Europe. So I decided on the
spur of the moment to stay in the US, and went to Columbia
University. I worked on cancer-causing retroviruses and
studied the mechanism of reverse transcriptase.

After getting my Ph.D., I attended a two-year medical
school at the University of Miami, and then completed my
residency in internal medicine at UCLA. I was there when
the first HIV patients came to the hospital. I started a
fellowship, moved back to New York City, then got an
academic position in 1984 at the Dana-Farber Cancer
Institute, and have worked in AIDS research ever since.

References

(1) M. Gupta, S. Mahanty, M. Bray, R. Ahmed and P.E.
Rollin. Passive transfer of antibodies protects
immunocompetent and immunodeficient mice against lethal
Ebola virus infection without complete inhibition of viral
replication. Journal of Virology. May 2001; volume 75,
pages 4649-4654.


*****Danger: Counterfeit Neupogen(R) (Filgrastim)

On May 10 Amgen Inc. warned medical professionals that
counterfeit vials labeled as Neupogen (filgrastim) have
been found in the United States (but not in other countries
at that time). These vials contain a clear liquid, but no
active ingredient -- a fraud that could be life-threatening
to patients.

The Amgen Web site has detailed instructions for
distinguishing the counterfeit product, which is easy to
do, because there are differences in the lot number,
packaging, and labeling. For example, lot number P000948 is
counterfeit; while lot number P000890 with one expiration
date is counterfeit, but the same lot number with another
expiration date is probably authentic. Since other fake
labels may be printed, check the Amgen Web site,
http://www.amgen.com

(Try clicking Corporate Center, then Amgen News -- check
the May 10 or 11 press release, which has photos showing
the differences, and see if there are any later press
releases.)


***** Danger: Counterfeit Serostim(R) (Human Growth
Hormone)

On May 17 Serono, Inc. and the U.S. FDA warned that new
counterfeit drug labeled Serostim had been found. There had
been a warning of a previous case of counterfeit Serostim
in January of this year. From the press release:

"Serono, Inc. and the U.S. Food and Drug Administration
(FDA) are informing distributors, pharmacies, physicians
and patients of the existence of a new counterfeit lot of
Serono's Serostim(R) 6 mg [somatropin (rDNA origin) for
injection]. The counterfeit material, which is made to
resemble Serostim(R), bears lot number MNH605A. Any product
labeled as Serostim(R) and carrying this lot number should
be considered to be counterfeit.

"Patients in possession of the counterfeit lot should
return it immediately to their pharmacy for a replacement.
Patients seeking additional information may also call
Serono's product information line at 1-888-275-7376.

"Serono is sending a 'Notification of Counterfeit Product'
letter to wholesale distributors, pharmacies, physicians
and AIDS service organizations to alert them. The
counterfeit material was neither manufactured nor
distributed by Serono and is definitely not Serostim(R).
Therefore, it cannot be assumed that the counterfeit
product is either safe or effective.

"Serono is cooperating fully with the FDA in its effort to
stop the distribution of the counterfeit product and to
prosecute those responsible for it.

"Serostim(R) (SEHR'-uh-stihm) is approved in the U.S. for
the treatment of AIDS wasting."


***** June 23: New York March and Rally Before United
Nations AIDS Session

Dozens of organizations have called for a march and rally
in New York on June 23, just before the United Nations
General Assembly Special Session on AIDS (UNGASS). Some
international delegates and organizers who have traveled to
New York for the United Nations session are planning to
join the march.

Sponsors include the African Services Committee, Bailey
House, Global AIDS Alliance (GAA), Health GAP Coalition,
and ACT UP New York -- in cooperation with NAPWA South
Africa, and the Treatment Action Campaign (TAC) in South
Africa. Endorsers include many other AIDS, international,
and social-justice organizations. [Note: This is not to be
confused with the June 3 march on the 20th year since the
discovery of AIDS, which takes place in Washington.]

This event is the same day as the NYC Dyke March, and one
day before New York's Lesbian/Gay Pride parade.

For more information, see
http://www.stopglobalaidsnow.org

***** United Nations: Civil Society Snubbed at Final
Preparatory Meetings on AIDS

by John S. James

On June 25 - June 27 the United Nations will hold an
historic special session on AIDS, often called UNGASS
(United Nations General Assembly Special Session). Two
preparatory sessions were scheduled to allow official
delegates and civil society to interact; the last one was
May 21-25. The United Nations also set up an email
discussion list, Break the Silence, for organizations and
individuals throughout the world to have their voices heard
during the preparation for the Special Session. (At the
June 25-27 official meeting it will be too late for
significant changes and initiatives, as most of the outcome
will have been set up in advance.)

The preparation process uses the well-known "single text"
method of negotiation. A document is drafted, put out for
comment, and then changed periodically in the attempt to
reach agreement. The second version of this document (May
28, 2001) is now being circulated; it is on the UNAIDS Web
site, at http://unaids.org

The email discussion list is working well. Readers may want
to subscribe by sending email to:
join-break-the-silence@...

The first session set up for meetings between official
United Nations delegates and civil society also went very
well, although perhaps by accident. Due to glitches in the
agenda, there were entirely unexpected opportunities for
official delegates and civil society members to meet and
discuss AIDS.

The May 21-25 preparatory session was different. According
to a May 24 press release by 12 organizations from the
U.S., Canada, Venezuela, Ukraine, Brazil, UK, India, and
Norway:

"Many NGOs [non-governmental organizations, usually called
nonprofits in the U.S.] traveled to New York from around
the world, responding to the invitation of the President of
the General Assembly, but found themselves unable to
participate meaningfully or share their expertise with
delegates, contrary to the General Assembly's own
resolution which called for involvement of civil society in
the development of a Declaration of Commitment to be signed
by all 189 UN member states in June. While a handful of
countries strongly supported civil society's contributions,
two brief "dialogue" sessions - scheduled during the lunch
and evening hours - went unattended by the majority of
countries. Anand Grover from the Lawyers Collective
HIV/AIDS Unit, Mumbai, India, said 'I am very disappointed
at the absence of the delegates from countries who are most
affected, their short attention span, and the lack of
meaningful government participation.'

"Yesterday the United States went so far as to ask all NGO
representatives to leave the room, including those with
ECOSOC accreditation who are normally entitled to observe
country delegation negotiations. Since the US made a formal
complaint, the Chair was forced to take the action,
although he was perfectly willing to have the NGOs stay in
room. 'This is a very bad precedent for the future and
makes NGOs worry as to what will happen at the General
Assembly itself,' said Carol Lubin, one of those who was
ejected."

The NGOs called on the United Nations to encourage member
nations to include civil society and especially people with
HIV or AIDS in their delegations, encourage member states
to attend sessions they set up for dialog with civil
society, and otherwise ensure that civil society can
participate meaningfully in the process of developing
worldwide programs for controlling AIDS.

There is particular concern that some countries want to
roll back human rights in general, and some do not want to
acknowledge or even name vulnerable groups (such as men who
have sex with men, injecting drug users, transgenered
individuals, and sex workers) because of prevailing
attitudes.

Comment

The fundamental problem, we suspect, is that any successful
global AIDS program is likely to threaten powerful
interests: big pharmaceutical companies (fearful about
patent rights), some conservative religions (threatened by
sex), and even part of "AIDS Inc." (concerned that momentum
for other AIDS programs might damage theirs). We suspect
that political problems like these are what has kept the
world from dealing successfully with AIDS so far. It will
be hard to negotiate among all the special interests that
hold some degree of veto power over global progress against
disease.


***** Global AIDS: Back to the Past? Comment by John S.
James

Summary: The new affordability of treatment in poor
countries made possible the unprecedented high-level
mobilization against global AIDS earlier this year, by
transforming AIDS in poor regions from an unsolvable
tragedy to a moral issue and chance to save lives. But then
a backlash turned funders against treatment -- transforming
AIDS again, from a chance to save lives to a chance to sit
by and watch tens of millions die. As a result, AIDS lost
some political support and momentum -- not only for
treatment, but for prevention as well. If treatment is a
key to mobilization, we need to recognize that.

* * *

Just weeks ago, governments of rich and poor countries
alike seemed more likely than ever before to mobilize
serious commitment to controlling the global AIDS epidemic.
There was growing consensus that 7 to 10 billion dollars
per year -- the amount proposed by United Nations Secretary
General Kofi Annan, about 1% of world military spending --
would be enough to greatly reduce the spread of AIDS, treat
many of those who are ill, do operational research to make
sure the programs are effective, speed the development of
vaccines and new treatments, and greatly reduce the burden
of tuberculosis, malaria, and other infectious diseases.

But suddenly rich-country governments in the U.S. and
Europe pulled back. The U.S. contributed $200,000,000 to
the United Nations fund -- about 2% of the need, about a
tenth of what would have been regarded as serious. European
governments so far have not contributed anything. And in
the recently concluded World Health Assembly, the U.S. and
European governments actively blocked proposals to help
poor countries buy low-cost medicines -- on behalf of the
proprietary pharmaceutical industry, which seems to fear
that any plan to make patented medicines permanently
affordable in poor areas would threaten its patents or
ability to charge high prices in the U.S. and other rich
countries.

What happened?

We suspect that one key cause of the loss of momentum on
global AIDS is something that has not been discussed or
recognized even by the participants.

For years it was an article of faith that public money for
AIDS control in poor countries should go to prevention,
never to treatment. Few said otherwise, because at $10,000
per year for drugs alone (or even $2000), HIV treatment was
not going to become widely available in poor areas no
matter what anyone said or did.

Some prevention advocates have long feared that treatment
would out-compete prevention politically (probably because
it saves the lives of identifiable people, unlike
prevention), resulting in resources being misdirected to
treatment of the terminally ill instead of to stopping the
epidemic. But in fact, treatment gives people reason to be
tested, reason to mobilize to save their own lives or their
family members or friends, reason to become involved in
comprehensive AIDS-control programs. It also motivates the
fight against AIDS stigma, by transforming it from
something unpleasant but only rarely life-threatening, to a
direct threat to the lives of specific people. Some
professionals have missed the fact that treatment access is
a strategic cause to improve prevention and reduce the
spread of HIV, as well as a humanitarian cause to save
lives because it is the right thing to do.

These arguments had no consequences until recently, when
generic pharmaceutical manufacturers started offering some
modern combination antiretrovirals at under $500 per year.
At this price widespread treatment in Africa became
thinkable for the first time.

We believe this new possibility of treatment in poor
regions fundamentally transformed world thinking about
AIDS. Before, most of the public in the U.S., and probably
other rich countries as well, basically saw the global
epidemic as an unsolvable tragedy (or as a bottomless
resource pit) in Africa. Tens of millions of people already
infected were doomed, and nothing could be done to change
that, nothing anyone did could make any meaningful
difference.

But with drugs less than $500 per year, the perception of
global AIDS changed from a hopeless cause to a moral issue
and chance to save lives. Now people could get involved.
The result was the first-ever move toward serious
government commitment to control the epidemic, and other
major infectious diseases -- not just through treatment,
but through prevention, research, treatment, whatever was
needed.

The "Harvard plan" -- a widely discussed analysis of how to
provide treatment in developing countries, released in
early April -- also helped to show it was doable, and at a
cost amounting to "small change" in the global economy.

But then a backlash occurred. Some prevention experts
became alarmed and upset by the new momentum behind
treatment. As one "international health official who asked
not to be identified" told The Washington Post:

"It's so politically incorrect to say, but we may have to
sit by and just see these millions of [already infected]
people die," he said, acknowledging that this was an option
that would be considered unacceptable in the developed
world. "Very few public health professionals are willing to
take on the wrath of AIDS activists by saying that. But a
whole lot of them talk about this in private." (Global AIDS
Strategy May Prove Elusive: More Funds Available, but
Consensus Lacking, Washington Post, April 23, 2001, page
A01).

We do not know to what extent anyone went to the major
funders -- the handful of key staff people involved in AIDS
funding in the U.S. and European governments, and major
foundations -- and soured them on treatment. AIDS activists
were surprised to find unexpected lack of support in
Congressional offices, and to hear international-
development experts new to AIDS saying the fight was to
save future generations. One Congressional bill earmarked
10% or less for treatment, vs. 70% for prevention. Overall,
there was a sudden surge in official sentiment for
abandoning those in poor countries who are already infected
-- and the millions more who will become infected there.

One might think that pharmaceutical companies would lobby
for global treatment, providing balance. If anything, the
opposite was true. Widespread treatment in poor countries
might threaten their patents and high prices in rich
countries -- the cash cow that supports the entire
industry.

Potential donor governments seem to have responded mainly
not by shifting future money from treatment to prevention,
but by losing interest in AIDS. Why?

We believe that what happened is that with treatment
marginalized, AIDS was transformed again -- from a moral
issue and chance to save lives, to a chance to sit by and
let tens of millions of people die. Government officials
and their staffs are people, too; and when this happened,
they lost enthusiasm for the whole project of controlling
global AIDS. Other world issues are always available.

Many have said (correctly, we believe) that without hope of
treatment, prevention will not work well. What has been
overlooked is that without hope of treatment in poor
countries, it becomes very difficult to mobilize against
global AIDS in rich countries. The triple track of
advocating funding for research, prevention, and treatment
-- long successful for U.S. domestic AIDS programs --
should be considered for international funding advocacy as
well.

As one activist put it, treatment is easier to sell than
condoms. Of course the point is not to substitute treatment
for prevention, but to facilitate widespread mobilization
to do whatever is necessary to stop the epidemic.

We suspect that hope of treatment was the key that
transformed the meaning of the global epidemic, and made
possible the beginnings of the unprecedented mobilization
earlier this year. When this hope was removed, the movement
stalled. Rich-country governments, which had never made a
commitment to a properly funded campaign against global
AIDS and other infectious diseases, reverted to business as
usual.

This is only a theory -- that the possibility of treatment
in developing countries was central to the rise and then a
sudden fall in high-level interest in global AIDS. Many
theories are wrong. We urge those involved to consider this
one, and see if it holds true.

If hope of treatment is key to effective political
mobilization against the global epidemic -- critical to
involving people in rich countries even though they are not
directly affected (as they already have access), as well as
people in poor ones who are directly affected -- we need to
recognize that fact and design comprehensive research,
prevention, and treatment programs that do not abandon
those already infected.


***** AIDS TREATMENT NEWS

Published twice monthly

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Editor and Publisher: John S. James
Associate Editor: Tadd T. Tobias

Statement of Purpose:
AIDS TREATMENT NEWS reports on experimental and standard
treatments, especially those available now. We interview
physicians, scientists, other health professionals, and
persons with AIDS or HIV; we also collect information from
meetings and conferences, medical journals, and computer
databases. Long-term survivors have usually tried many
different treatments, and found combinations that work for
them. AIDS TREATMENT NEWS does not recommend particular
therapies, but seeks to increase the options available.

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--
John S. James
AIDS Treatment News
http://www.aidsnews.org

AIDS TREATMENT NEWS Issue #364, May 11, 2001
     phone 800-TREAT-1-2, or 215-546-3776

CONTENTS

** Tenofovir: Gilead Applies for Approval; Expanded Access
Liberalized
Patients who cannot construct a viable antiretroviral
regimen with approved drugs will now have easier access to
tenofovir, a drug that is currently experimental but may be
approved in about six months. Tenofovir is significant
because it appears to maintain its antiretroviral activity,
with resistant HIV developing relatively slowly.

** June 3 Demonstration in Washington to Mark 20th Year of
AIDS
Over 100 major AIDS organizations have called for a rally
in Washington D.C. to mark the 20th year since the
discovery of AIDS.

** International AIDS Candlelight Memorial, May 20
This year's Candlelight Memorial will occur in over 500
communities around the world.

** Updated Guidelines for Prevention of Mother-to-Infant
Transmission
Changes in the U.S. standard were announced May 4.

** Syringe Prescription Study Unexpected Bonus: Helping
Long-Time Users Quit Drugs
A study to see if syringe prescription by physicians could
reduce needle sharing also found an additional bonus --
helping some clients get off drugs, by getting them into
medical care and making possible conversations which
otherwise would not happen.

** TAG Seeks Policy Director
The New York-based Treatment Action Group is hiring a
policy director.

** South Africa Court Case -- Documents on the Web
Where to find background on the widely publicized case,
which ended April 19.

** AIDS TREATMENT NEWS Publication Schedule: No Issues
Dated April 2001

** Viral Load and T-Cell (CD4) Counts: Why They Matter
Simple-language flyer by writer Bruce Mirken answering
denialist arguments against standard blood tests. We
formatted this article for distribution to clients.


***** Tenofovir: Gilead Applies for Approval; Expanded
Access Liberalized

by Dave Gilden

Tenofovir, Gilead Sciences' candidate reverse transcriptase
inhibitor, could be approved in about six months. In an
unexpected move, the company announced May 1 that it had
filed a New Drug Application with the FDA. After approval,
tenofovir could be prescribed for any adult with HIV,
according to the company's proposed labeling. Gilead will
soon proceed with similar marketing applications in Europe.

Tenofovir, or PMPA, stops the infection of new cells by
halting the gene-building activity of HIV's reverse
transcriptase enzyme. The drug is similar to nucleoside
analogs such as ddI but requires less intracellular
processing to reach its active state. Tenofovir is
distinguished by its long intracellular half-life, which
allows once-a-day dosing. It also has a somewhat different
resistance profile than the standard nucleoside analogs, so
it may be active against many HIV isolates that have
mutated to resist the approved nucleoside analogs. In
trials so far, resistance to tenofovir has been slow to
develop -- although it has been found.

Tenofovir's safety profile is considerably improved over
adefovir, a closely related compound developed by Gilead.
Adefovir was rejected by the FDA because of severe kidney
toxicities coupled with modest efficacy.

Gilead's new drug may be helpful in a salvage regimen, but
it does not represent any dramatic breakthrough. In a 189-
person phase II treatment-intensification trial,(1)
tenofovir was added to volunteers' previous regimens at
doses of 0 mg (placebo), 75 mg, 150 mg or 300 mg per day.
The trial participants had a mean 4.6 years prior anti-HIV
therapy and a mean baseline viral load of 5,000. At study
entry, 94% of the enrollees also had HIV with mutations
conferring resistance to various nucleoside analogs,
principally AZT and 3TC. HIV in more than half of the
participants also had resistance to protease inhibitors.
The trial participants on 300 mg/day - the preferred dose -
recorded viral load reductions averaging about 0.6 log
(75%) through both weeks 24 and 48. The presence or absence
of AZT or 3TC resistance was not associated with a major
difference in the response. The modest, stable viral load
reduction was not accompanied by any appreciable change in
CD4 count, either.

Gilead scientists are reporting almost identical
preliminary results from a similar 552-person phase III
treatment-intensification trial. Both these trials make it
clear that tenofovir requires concomitant active
antiretrovirals from other drug classes to form a regimen
that can successfully suppress HIV. This is true in
treatment-naďve individuals, who appear to have a better
response to tenofovir, as it is in those with a history of
treatment failure. In its 600-person phase III trial for
those without prior treatment, Gilead is comparing
tenofovir directly to the nucleoside analog d4T, each
combined with the nucleoside analog 3TC and the NNRTI
efavirenz.

Expanded Access: Gilead Drops CD4, Viral Load Exclusions

Since last February, an expanded-access program has been
open to people whose advanced disease state and treatment
history mandate immediate use of new drugs to suppress
their HIV (see AIDS TREATMENT NEWS #360, February 23,
2001). Gilead always intended that this program would be
very small. It at first restricted entry to persons with
viral loads over 10,000 and CD4 counts under 100 - plus
documented treatment failure with at least two protease
inhibitors or one PI and one non-nucleoside reverse
transcriptase inhibitor (NNRTI). (Those with a CD4 count
between 100 and 200 could also apply if they had had an
AIDS-defining opportunistic infection within the last 90
days.)

Expanded-access enrollment has been even slower than
anticipated. Public dissatisfaction over the paltry
enrollment figures led Gilead to abandon its viral load and
CD4 count entry criteria. As to speeding up the enrollment
process, Debbie Fletcher of Gilead said in an interview,
"About 20% of the doctors have submitted incomplete
registration materials and had their applications returned.
The paper work can go back and forth and back and forth.
Our field representatives will follow up with the
physicians who don't finish filling out the forms."

One HIV specialist summed up his frustrating experience
with Gilead: "Paperwork did go back and forth. It took them
weeks to turn it around and tell you they needed something
more. Then you would send that, and they would come up with
something else."

The Coalition for Salvage Therapy has asked the company for
a full and regular accounting of the program's enrollment.
In a strongly worded letter, this national activist network
said that applicants to the program "are not only patients
with few or no remaining options for treatment, but also
patients whose disease has been allowed to progress to the
point where 'waiting for things to get sorted out' with the
program is simply not an option." The Coalition had long
pressured Gilead for a much broader expanded-access
distribution before finally settling for the present
restricted effort.

For the expanded-access program, Gilead advises doctors to
prescribe at least one new anti-HIV agent in addition to
tenofovir. Tenofovir naturally substitutes for other
nucleoside analogs, not for protease inhibitors or NNRTIs.
Some treatment activists have argued that Gilead should
abandon the requirement that enrollees have past failure
with PIs or NNRTIs. The program should be open to anyone
lacking new nucleoside analogs to create a viable treatment
combination.

This is the way tenofovir expanded access works in France,
where the drug is recommended for patients with nucleoside
analog intolerance or with nucleoside analog-resistant HIV,
as demonstrated by resistance assays. In the United
Kingdom, tenofovir is available to any patient who, in the
judgment of his or her doctor, could not otherwise
construct an effective anti-HIV regimen. Regulations in
both countries preclude strict entry criteria, including
CD4 count or viral load limits.

When tenofovir is approved, the issues around expanded
access will be largely academic. At least the program is
growing. Enrollment has picked up dramatically in the U.S.,
where about 150 people are now signed up. Also, Gilead has
asked Germany, Italy and Spain for permission to extend the
program beyond the U.S., UK and France. Further information
can be obtained from Gilead at 1-800-Gilead-5 in the US and
33-1-44-90-34-46 in Europe.

References

1. Miller MD et al. Baseline and Final Phenotypic Analysis
of HIV-1 from Patients Adding Tenofovir Disoproxil Fumarate
(TDF) Therapy to Background ART. 8th Conference on
Retroviruses and Opportunistic Infections. February 4-8,
2001. Poster 441.


***** June 3 Demonstration in Washington to Mark 20th Year
of AIDS

On June 3 over 100 organizations, including the NAMES
Project AIDS Memorial Quilt, National Minority AIDS
Council, National Association of People with AIDS, Project
Inform, Gay Men's Health Crisis, and many ACT UP chapters
will mark the 20th year of the AIDS crisis with a march on
the Pharmaceutical Research and Manufacturers Association,
Congress, and the White House. There will be a reading of
all 80,000 names within the AIDS Memorial Quilt, although
the Quilt itself will not be displayed.

The organizers are calling for youth and children to lead
the march. Worldwide, over 4,000,000 children under 15 have
been killed by AIDS, and over 13,000,000 children have been
orphaned.

For more information, see
http://www.AIDSaction20.org Marchers are urged to make
hotel arrangements soon. The march will begin at noon on
June 3 in Washington D.C.


***** International AIDS Candlelight Memorial, May 20

On May 20 the annual International AIDS Candlelight
Memorial is taking place at more than 500 communities
around the world. More information, including local
contacts, is at
http://www.candlelightmemorial.org


***** Updated Guidelines for Prevention of Mother-to-Infant
Transmission

On May 4 the U.S. Public Health Service released an updated
version of the official guidelines for use of
antiretrovirals to reduce perinatal HIV transmission. The
following sections have been changed:

* "Antiretroviral Clinical Scenarios" (beginning on page
17);

* "Recommendations for Monitoring of Women and Their
Infants" (beginning on page 39); and

* "Clinical Research Needs" (beginning on page 41).

You can obtain a copy of the guidelines without charge in
any of three ways:

(1) http://hivatis.org/trtgdlns.html , the Web site of the
HIV/AIDS Treatment Information Service;

(2) by calling 1-800-448-0440 or 301-519-0459, Monday
through Friday 9-5 Eastern Time (TTY 888-480-3739); or

(3) by mailing a request to HIV/AIDS Treatment Information
Service, P.O. Box 6303, Rockville, MD 20849-6903. It may
take 7-10 days plus shipping time to receive the document.

Ask for the Perinatal Guidelines. (The full official title
is "Public Health Service Task Force Recommendations for
the Use of Antiretroviral Drugs in Pregnant HIV-1 Infected
Women for Maternal Health and Interventions to Reduce
Perinatal HIV-1 Transmission in the United States."

Note: For information in English, Spanish, or Portuguese
about federally approved treatment for HIV and AIDS, you
can contact health information specialists at the HIV/AIDS
Treatment Information Service, Monday through Friday 9-5 at
the phone numbers, email, or mailing address above.


***** Syringe Prescription Study Unexpected Bonus: Helping
Long-Time Users Quit Drugs

by John S. James

A pilot study in Rhode Island, allowing physicians to
prescribe syringes in order to reduce that state's
exceptionally high rate of HIV infection among injection
drug users, not only reduced needle sharing as hoped, but
also helped some patients get into drug treatment programs
and quit their drug abuse entirely. These people had been
injecting drugs for a median of 10 years. A description of
the project appeared in May issue of the American Journal
of Public Health(1).

On May 4 we spoke to principal investigator Josiah D. Rich,
M.D., M.P.H., an infectious-disease specialist. He
explained that until recently Rhode Island had one of the
harshest syringe laws in the nation. Possession of each
syringe was a felony punishable by up to five years in
prison, and the average sentence for possession of syringes
alone was 11 months. As a result drug users often did not
carry syringes but re-used those available where they
bought their drugs, and Rhode Island is one of only four
states where more than 50% of AIDS cases are due to
injecting drugs. And the state spent was spending over a
million of dollars a year arresting, trying, and
imprisoning people for syringes.

A coalition of medical organizations and others worked to
change the law, and they won a partial victory in 1998;
possession of syringes was reduced to a misdemeanor, but
they remained illegal (until 2000) and drug users had
difficulty getting sterile syringes. Lobbyists said it
would take at least two years to change the law again.
Evaluation of the law revealed that doctors could prescribe
syringes if approved by the state Department of Health; a
drug user could have a prescription and buy and possess
syringes legally, like a diabetic. So a study, the Rhode
Island Blood Borne Pathogen Harm Reduction Program, was
designed to see if prescribing syringes would help to
reduce sharing and HIV transmission.

The program began when the director of the Rhode Island
Department of Health, with the support of many medical
organizations, wrote to all licensed physicians in the
state, inviting them to join the program under certain
conditions. At this time the program employs four
physicians at two locations in Providence, Rhode Island and
has enrolled 350 drug users and prescribed 50,000 syringes.
The published report is preliminary, as data are still
coming in, but it appears that needle re-use has dropped
dramatically and that the syringes are being disposed of
properly.

The surprise for researchers was the great interest among
these hard-core users not only in obtaining the syringes,
but also in getting into drug treatment. There was an
overwhelming response, despite the fact that those who
approached the program were very high risk, with most of
them having injected illegal drugs for at least 10 years.
Half were homeless. A large majority had hepatitis C, and
many had hepatitis B as well.

"What is most remarkable is that these long-time users were
very interested in drug treatment -- half said did want
treatment to help them stop using drugs. We do not ask
immediately. We take a medical history, do a physical, and
discuss the findings. We tell them that their behavior is
very dangerous because of the risk of infectious diseases,
overdose, and other lifestyle problems. I recommend, as
their doctor, that we work together to try to get them to
stop.

"But if they are not able or willing to stop at this time,
I teach them sterile technique that doctors use for
injection -- including the use of a sterile syringe.

"They come to us to ask for syringes. So they have to admit
that they inject drugs, and here there are no negative
consequences to admitting that they are injecting drugs.
Who else can have this discussion with them? Usually the
people they talk to about their drug use -- their dealer,
pimp, or peers -- have a vested interest in them continuing
to use drugs.

"This program has a unique window into peoples' lives. We
can ask them, if you decide to stop, what would you do?
Would you go to detox? What was your experience in detox
last time? What if there are no beds now -- would you just
give up?

"It is most rewarding when patients come in and say they do
not need syringes -- that they have looked at their lives
and stopped their drug use because they are tired of what
it is doing to them. We see that as doctors, we can really
help these people."

This is the first time that a physician syringe
prescription program has ever been tried (although a few
physicians have prescribed syringes to individual
patients). The May 2001 article(1) includes recommendations
for those who want to try such a program elsewhere --
starting with knowing the local legal situation.(2)

  From the article:(1)

"Because of the illicit nature of drug use, a tremendous
amount of mistrust and fear often leads to poor interaction
with the medical establishment. Prescription of syringes by
a physician can serve as a tool for reaching out to a high-
risk and often out-of-treatment population of drug users.
It is a way for the health care community to tap into drug-
using networks and bring those populations into a medical
care system..."

"That the physician-patient interaction is based on the
acknowledgement of injecting behaviors engenders trust and
seems to open the door for discussion of a whole host of
injecting-related activities, including commercial sex,
participation in the underground economy, violence, and
abuse. The participants seem to be open and honest about
their drug use.

They understand that physicians are trying to help them in
a non-judgmental way and are quite appreciative of the
efforts. Participants are extremely willing to participate
in health care including hepatitis B vaccination; testing
for hepatitis, HIV, and other sexually transmitted
diseases; and followup."

This study was funded in part by the American Foundation
for AIDS Research (AmFAR).

References

1. Rich JD, Macalino GE, McKenzie M, Taylor LE, and Burris
S. Syringe prescription to prevent HIV infection in Rhode
Island: A case study. AMERICAN JOURNAL OF PUBLIC HEALTH.
May 2001; volume 91, number 5, pages 1-2.

2. Burris S, Lurie P, Abrahamson D, and Rich JD. Physician
prescribing of sterile injection equipment to prevent HIV
infection: Time for action. ANNALS OF INTERNAL MEDICINE.
August 1, 2000; volume 133, number 3, pages 218-226.


***** TAG Seeks Policy Director

The Treatment Action Group (TAG), a New York-based
nonprofit organization focusing on AIDS research and
treatment policy, is hiring a policy director. From the
announcement:

"The Policy Director will have a broad-based background
incorporating an understanding of science, government, and
policy, and ideally would have experience managing highly-
qualified people working in policy roles. The Policy
Director will be the key staff person responsible for
setting and implementing and coordinating the overall
policy agenda for TAG -- in conjunction with the executive
director -- and thus for oversight, facilitation, and
supervision of the policy and program work of the
agency..."

For years TAG has been one of the most important AIDS
treatment advocacy organization. It has been called a
"think tank without walls," as it provides computer and
communication equipment to staff who work from home
offices. It also has a small central office. Staff travel
frequently to research and treatment meetings and
conferences. Its Web site is
http://www.treatmentactiongroup.org

"Interested candidates should send a letter expressing
their qualifications and interest in the position with a
resume/CV and three references with contact information by
31 May 2001 to: Policy Director Search, c/o Regina Gillis,
Treatment Action Group, 350 Seventh Ave., Suite 1603, New
York, NY 10001, phone 212-971-9022, fax 212-971-9019, email
tagnyc@...


***** South Africa Court Case -- Documents on the Web

Documents in the lawsuit by 39 pharmaceutical companies
against Nelson Mandela and the government of South Africa,
dropped April 19 after becoming a public-relations disaster
for the companies, are available on the TAC (Treatment
Action Campaign) Web site, http://www.tac.org.za

  From the other side, the International Association of
Pharmaceutical Manufacturers Associations has the one-page
"Joint Statement of Understanding between the Republic of
South Africa and the Applicants, and a press release, at
its Web site, http://www.ifpma.org/ (select News).

In our view the real significance of this case was not so
much the legal issues, but rather in showing that world
public opinion will no longer allow lifesaving medicines to
be priced out of reach of millions of people in poor
countries in order to avoid the risk of disturbing
lucrative markets in rich countries. Three years ago when
the case was filed, very few people were aware of this
issue. Now millions are aware, and millions are demanding
access to treatment. Industry is welcome to help in
developing systems that work, rules everyone can live with.
When industry fails to provide viable leadership, the work
will be done without them.


***** AIDS TREATMENT NEWS Publication Schedule: No Issues
Dated April 2001

Because we have been more than a month behind our twice-
monthly publication schedule, we will not publish any
issues dated April 2001. All subscriptions will be extended
a month to compensate, so subscribers will receive the same
number of issues.

Our previous issue, #363, was dated March 30. This issue,
#364, is dated May 11.


***** Viral Load and T-Cell (CD4) Counts: Why They Really
Matter

[Note: This article is part of our series answering the
AIDS denialists, who say that HIV does not cause AIDS and
who often urge patients to reject medical advice. Writer
Bruce Mirken prepared this simple-language version to help
agencies prepare materials for their clients.]

If you are being treated for HIV or AIDS, your doctor uses
a number of blood tests to check how you're doing.  One of
the most important tests measures VIRAL LOAD, the amount of
HIV in your blood.  Another very important test counts your
CD4 CELLS, sometimes called T-CELLS.  CD4 cells are a key
part of your body's disease-fighting defenses, called the
immune system.

But some people claim that HIV doesn't really cause AIDS.
These people, known as "AIDS deniers," "denialists" or
"AIDS dissidents," also say that viral load and CD4 tests
are meaningless.  They claim these tests don't really tell
anything about your health, and that they might even hurt
you by frightening you for no reason.

What Do Viral Load and CD4 Tests Really Tell Us?

What are CD4 Cells?

CD4 cells help to organize your body's defenses against
disease.  Doctors can take a sample of your blood and count
the number of CD4 cells.  Healthy adults and teenagers
usually have a CD4 count of at least 800 cells per CUBIC
MILLIMETER of blood (a cubic millimeter is a very small
amount, roughly one small drop).

What does HIV do to CD4 counts?

HIV attacks CD4 cells, and as time goes by people with HIV
often see their CD4 counts drop.  The lower your CD4 count,
the greater your chances of getting a number of very
serious diseases.  When your CD4 count is below 200, the
risk of illness becomes severe.

I've heard that you can have a low CD4 count and still be
healthy.  Is that true?

While there have been a few medical reports of people who
seemed healthy even though they had very low CD4 counts,
these cases are rare.  Research overwhelmingly shows that
people with low CD4 counts are much more likely to get sick
than people who have a normal amount of CD4 cells.

The AIDS denialists who claim that CD4 counts are
meaningless often point to a study of AIDS patients called
the Concorde study, in which people who had a small
increase in CD4 counts did not live longer than those whose
CD4 counts stayed the same. But that study was done nearly
10 years ago, before modern combination therapy, and the
CD4 increases were very small. Newer studies with more
potent treatments show that a big boost in CD4 cells almost
always lowers the risk of getting seriously ill.

For example, the deadly pneumonia called PCP occurs much
more often in people with very low CD4 counts.  In one
study with over 1,000 patients, almost everyone who got PCP
had a CD4 count below 200.  Study after study has shown the
same thing:  The lower your CD4 count, the greater your
chance of getting PCP or other serious infections.

The AIDS denialists leave out these important facts.

Why are viral load tests used?

CD4 counts give you and your doctor a good idea of how much
damage HIV has done to your immune system.  But you also
need to know how fast that damage is happening.  Viral load
tests, which tell the doctor how much HIV is in your blood,
are a very important clue to how quickly HIV is doing harm.

These tests go by several different names, like PCR
(polymerase chain reaction) or bDNA (branched DNA), but
they all work roughly the same way.  They count HIV's
genetic material--the building blocks of the virus

What does viral load tell us?

People with a high viral load are much more likely to get
sick or die of AIDS than people with a low viral load.

The AIDS denialists sometimes suggest reasons why these
tests might give a wrong answer.  They point to a few old
reports, from when viral load tests were new and still
experimental, as evidence that they don't work. But there
is a huge pile of newer evidence showing that viral load
tests work extremely well.  Many studies have shown that
people with high viral loads are more likely to get sick or
die from AIDS-related illnesses than people whose viral
load is lower.

For example, one very important study has followed
thousands of gay men since 1984.  A few years ago
researchers did viral load tests on the very earliest blood
samples from that study and then looked at how many of
those patients were still alive.  The men with the highest
viral loads were 77 times more likely to have died of AIDS
than those with the lowest viral loads.  Other studies in
the U.S. and Europe have shown the same thing:  A higher
viral load almost always means a higher risk of sickness
and death.

What happens when treatment reduces my viral load?

Studies have shown that when treatment reduces your viral
load, it also reduces your chance of getting an AIDS-
related infection or dying.  Recently, a group of expert
scientists reviewed 18 studies of anti-HIV drugs, which
involved over 5,000 patients.  Over and over again they
found the same thing:  The more viral load was reduced, the
healthier the patients stayed.

The Bottom Line

No medical test is perfect, and mistakes or
misunderstandings sometimes happen.  You should always go
over your test results carefully with your doctor to make
sure you understand them.

But the people who claim that viral load and CD4 tests are
useless are not telling the truth.  These tests give you
and your doctor important information that can help you
make the best treatment choices.


***** AIDS TREATMENT NEWS

Published twice monthly

Subscription and Editorial Office:
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Editor and Publisher: John S. James
Associate Editor: Tadd T. Tobias

Statement of Purpose:
AIDS TREATMENT NEWS reports on experimental and standard
treatments, especially those available now. We interview
physicians, scientists, other health professionals, and
persons with AIDS or HIV; we also collect information from
meetings and conferences, medical journals, and computer
databases. Long-term survivors have usually tried many
different treatments, and found combinations that work for
them. AIDS TREATMENT NEWS does not recommend particular
therapies, but seeks to increase the options available.

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phone number are included if more than short quotations are
used.

--
John S. James
AIDS Treatment News
http://www.aidsnews.org

AIDS TREATMENT NEWS Issue #363, March 30, 2001
     phone 800-TREAT-1-2, or 215-546-3776

Contents

** Africa Access: AIDS Activists Organizing Burkina Faso
Summit on Generics
AIDS activists internationally have organized a meeting in
Africa for health ministers from developing countries,
funders, and others; interview with Paul Davis and Asia
Russell, ACT UP Philadelphia.

** European Parliament Supports Treatment Access in
Developing Countries
On March 15 the European Parliament "called for the
development of a system that allows developing countries
equitable access to affordable medicines and vaccines." It
urged the pharmaceutical companies suing South Africa to
drop their lawsuit (which they did on April 19).

** Therapeutic Drug Monitoring: Medscape Web Resource Page
Medscape, a major medical Internet site, recently started a
page of links to information about the possibility of
measuring blood levels of antiretrovirals, in order to
adjust doses for individual patients if necessary, to
maintain effective levels and avoid side effects. This page
will be updated to include new information.

** AmFAR Treatment Directory: How to Obtain a Free Copy
Free copies of the AmFAR HIV/AIDS TREATMENT DIRECTORY are
available from the National Prevention Information Network
of the U.S. Centers for Disease Control -- along with other
information on HIV, sexually transmitted diseases, and
tuberculosis.

** Twinning U.S. and African AIDS Organizations: NMAC
Training in U.S. Cities
The National Minority AIDS Council has started an organized
program of pairing U.S. and African AIDS organizations. A
series of six four-day trainings will be held in U.S.
cities, starting in May.

** Barcelona 2002: International AIDS Conference Seeks
Scientific Program Coordinator
The next international AIDS conference, July 2002 in Spain,
is seeking a coordinator to help organize the scientific
program.


***** Africa Access: AIDS Activists Organizing Burkina Faso
Summit on Generics

Interview with Paul Davis and Asia Russell, by John S.
James

Earlier this year Paul Davis and Asia Russell traveled to
Paris to help plan the Summit on Generics, a meeting for
health ministers from developing countries and others,
originally scheduled for May 3-7 in Burkina Faso, West
Africa -- shortly before the important World Health
Assembly in Geneva. Activists from Paris and from Burkina
Faso had organized the generics meeting. We asked Paul
Davis and Asia Russell, both members of ACT UP Philadelphia
and of the Health GAP Coalition, to tell our readers what
was happening.

This interview took place in early March. Paul and Asia
made changes on April 5.

AIDS TREATMENT NEWS: What was the meeting in Paris, and why
was it important?

RUSSELL: Every year in May the top government health
officials from around the world meet in Geneva, at a
conference called the World Health Assembly. This year the
U.S. delegation will be headed by Tommy Thompson, the new
Secretary of Health and Human Services appointed by
President Bush. All countries that are members of the World
Health Organization can send a delegation.

Last year a few AIDS activists from the U.S. and elsewhere
went to the World Health Assembly meeting, and found that
delegates from poor countries were at a big disadvantage.
The U.S. delegation had almost 30 members, but many small
countries could only afford to send one, two, or three. So
the agendas of the rich countries -- mostly set by big
pharmaceutical companies -- were the ones the meeting
served.

DAVIS: For example, one of the important issues for poor
countries is to get the World Health Organization to give
them practical help by compiling a database of worldwide
prices for high-quality drugs. But pharmaceutical companies
are strongly opposed; they want to sell their drugs at
their prices to countries that do not have the resources to
compile this information themselves.

So last year at the World Health Assembly, people were
lured away to parties and receptions and meeting rooms, and
the United States in one unseemly maneuver convened a
meeting of mostly wealthy countries to make decisions that
included this database of drug prices around the world.
They killed this database at a closed-door meeting when
most of the delegates were absent. So we ran around to
inform the delegates from the global South [the world's
poorer countries] to attend this meeting, that it was
happening right then, and they were excluded from decision
making. They were very angry when they found out what had
happened.

AIDS TREATMENT NEWS: What is being done differently this
year?

DAVIS: This year ACT UP Paris and African and other AIDS
NGOs [non-government organizations, usually called
nonprofits in the U.S.] have organized a pre-meeting for
health ministers, people with AIDS, activists, health care
providers and others in Burkina Faso, in early May, shortly
before the World Health Assembly meeting in Geneva. The
Burkina Faso meeting builds on the experience last summer
at the World AIDS Conference in Durban, South Africa, where
ACT UP Paris called a very successful meeting of health
ministers and generic drug manufacturers to talk about drug
availability and procurement. At Burkina Faso the
participants will have a chance to talk and strategize
among themselves, and then bring their own agendas,
including access to high-quality affordable medicines, to
the World Health Assembly in Geneva. The World Health
Assembly meeting, in turn, will set the mandate for the
World Health Organization for the next year.

The meeting in Paris that Asia Russell and I just attended
was a planning session for the Burkina Faso meeting, which
will be called the Summit on Generics.

AIDS TREATMENT NEWS: Who else is helping organize the
Summit on Generics?

DAVIS: ReMeD (Réseau Médicaments et Développement / Drugs
and Development Network) a rational drugs use agency which
is doing a lot on the ground in Africa, has been partners
with ACT UP Paris in organizing this meeting. RAP+ (African
Network of People with AIDS), Health Action International,
which has many local groups in Africa, Women Fighting AIDS
in Kenya (WOFAK) and many other groups were also helping in
Paris. MSF (Doctors Without Borders), and Oxfam GB, are
also sponsors of the Summit on Generics.

DAVIS: This meeting has several purposes:

* This will be a very crowded calendar year for treatment
access campaign issues. The Summit on Generics in Burkina
Faso will be a place to share information among those
seeking wider access to AIDS medicine.

* It will also help share information and build solidarity
among national campaigns. Already at the Paris meeting
there were people from Burkina Faso, South Africa,
Zimbabwe, Kenya, Cote d'Ivoire, Burundi, Cameroon, and
several other countries.

If we are successful in creating a bulk procurement and
distribution program at the U.N. level, it still will
require local support within nations. So there are many
threads coming together in this Summit. The planning
meeting was put together very well.

* The Summit on Generics will serve as a pre-meeting or
orientation to other meetings coming up during the year in
addition to the World Health Assembly. This includes the
United Nations Special Session on HIV and AIDS (UNGASS) and
the G-8 meeting in July in Genoa, Italy.

* And after the health ministers and treatment access
campaigners have talked among themselves, they will meet
with funders -- corporate sponsors, foundations, rich-
country donors and others, and with decision makers, to
talk about practical solutions. Now that we have made
progress in getting the United States to be somewhat less
of an obstruction to access to medicine, it is time for
rich countries, especially the U.S., and foundations to be
involved in solutions. This is the agenda we will bring to
the World Health Assembly, where we will be focusing on the
essential drugs list; this is among the proposals we are
bringing to UNGASS, where we will focus on bulk drug
procurement; and we will also be focusing on debt
cancellation later in the year. So we will be trying to tie
up many strings in the Burkina Faso Summit on Generics.

We hope this summit can serve as a pre-meeting to
strategize, and prepare an agenda, because in the past the
people who came with an agenda were mainly pharmaceutical-
company representatives.

RUSSELL: In the fight for treatment access, generic drugs
for HIV treatment need to be talked about as a key tool
that poor countries can use to translate the desire for
sustained access to affordable medication into reality.

Especially in Africa, some key medications are patent
protected, while others are not currently patented--so
there is a lot of information about intellectual property
law and the recourses countries have, such as compulsory
licensing, that will be shared and discussed at this
important Summit on Generics. Even countries where there is
little patent protection currently, and where generics
could provide low cost, quality access, are facing dramatic
new restrictions to their domestic patent laws, thanks to
the rules of the World Trade Organization. Now is a
critical time to be strategizing with an array of activist
and health care organizations about coordinated efforts to
fight for access to affordable medication.

To listen to the brand-name pharmaceutical companies,
generics amount to no more than "piracy." Much of this
summit will be cutting through some of the myths with
facts, and talking in a hands-on way about the resources
people need and next steps people can take in order to make
access to affordable medicine a reality.

Note: The Web site for the Summit on Generics is
http://www.genericsnow.org

Note: We have received word that the Summit on Generics may
be postponed due to scheduling difficulties. For more
information, check the Web site or contact ACT UP Paris:
Sylvain Coudret, Planet Africa, Commission Nord/Sud, Act
Up-Paris, BP287 - 75525 Paris Cedex 11; fax: (011) 33-1-48-
06-16-74, email: planetafrica@...


***** European Parliament Supports Treatment Access in
Developing Countries

Introduction by John S. James

On March 15 the European Parliament adopted the following
resolution on access to HIV and other treatment in poor
countries. It is not widely known in the U.S., so we are
reprinting it here.

Paragraph number 6 (see below), on the TRIPS agreement, was
particularly fought for by international AIDS activists.
TRIPS (the agreement on Trade-Related Aspects of
Intellectual Property Rights) is the part of the WTO (World
Trade Organization) treaty dealing with intellectual
property.

Note: The European Parliament, also not well known in the
U.S., is in fact a model for democratic governance in an
age of growing globalization. For over 20 years it has been
directly elected by citizens of different countries,
bypassing national governments (one person one vote, but
with some weighting to help small countries). Today it has
significant power, with veto authority over about 80% of
European Union legislation. For more information (in your
choice of 11 languages) see http://www.europarl.eu.int/

For a look at the development of international civil
society today, and a call for a popularly elected world
assembly, see "Toward a Global Parliament" by Richard Falk
and Andrew Strauss, FOREIGN AFFAIRS January/February 2001,
volume 80 number 1. Both authors are professors of
international law, but the article is written for
nonspecialists.

Note: As this issue went to press, the April 19 withdrawal
of the pharmaceutical industry lawsuit against South Africa
made headlines around the world -- marking a milestone in
the development of international civil society. We will
have more information in AIDS TREATMENT NEWS #364.

* * * * *

Statement approved by European Parliament, March 15, 2001:

Access to Medicines for AIDS Patients in the Third World

The European Parliament,

-- having regard to its previous resolutions on AIDS and
sexually transmitted diseases,

A. whereas 95% of people infected with HIV live in the
developing world, including more than 25 million in sub-
Saharan Africa, one of the world's most infected regions,

B. whereas over half of all new cases are amongst young
people under the age of 25, who make up the most
economically active part of the population, and each 15-
year-old in South Africa has a 50% risk of becoming
infected and dying from AIDS,

C. whereas it is predicted that in South Africa, where 1 in
10 South Africans are HIV positive, HIV/AIDS will reduce
life expectancy by 20 years by 2010, and whereas hundreds
of thousands of South Africans die every year from AIDS,
tuberculosis and malaria,

D. whereas anti-retroviral drugs have already reduced the
number of AIDS deaths in Europe and the USA by 75%, but the
price of these drugs keeps these medicines out of reach of
millions of infected people, notably in Africa,

E. whereas the Commission's February 2001 Communication on
a Programme of Actions to combat HIV/AIDS, malaria and
tuberculosis includes a commitment to tiered pricing where
developing countries pay the lowest possible price for
medicines, an acknowledgement of the possibility of
exploring the best use of compulsory licensing systems and
a commitment to launch a debate in the WTO on reconciling
the TRIPS agreements with the objectives of health
protection in developing countries,

F. whereas Article 31 of the WTO/TRIPS Agreement permits a
country to enact national laws permitting the use of a
patented product without the authorization of the patent-
holder (compulsory licensing) under certain specified
circumstances,

G. whereas many drugs are unaffordable because of patents
which allow the companies a monopoly for 20 years from the
date when the patent is filed,

H. whereas the court case between 39 pharmaceutical
companies and the South African Government over the terms
of its 1997 Medicines Act has now been adjourned in order
that the Pharmaceutical Manufacturers Association of South
Africa can provide the information requested by Judge
Ngoepe,

I. whereas the Kenyan Government has announced its
intention to implement a law that would allow it to obtain
cheap life-saving medicines, under the provisions of the
current TRIPS Agreement,

J. whereas the US has taken legal action in the framework
of the TRIPS Agreement at the WTO against Brazil, which has
shown that through improvements in its health care system,
combined with the provision of generic medicines, it is
possible to halve the mortality rate of people with AIDS,
for allowing the national production of generic medicines,

K. whereas the EU has asked the new US Administration to
work with it on an initiative to get anti-AIDS drugs to the
developing world at prices it can afford and this issue
will be dealt with at the EU-US June Summit in Stockholm,

L. whereas tropical diseases such as malaria, tuberculosis
and sleeping sickness kill millions of people each year,
particularly because of the increase in resistance or the
non-existence of treatments due to research having been
abandoned simply on grounds of commercial profitability,

1. Calls for the development of a system allowing
developing countries equitable access to medicines and
vaccines at affordable prices, while expressing its
solidarity and support for the Governments of South Africa
and Kenya in their struggle to use WTO-compliant
legislation to gain access to the cheapest possible life-
saving medicines;

2. In this context welcomes the statement by Commissioner
Lamy that the Commission supports the right of developing
countries to use the safeguards in the WTO/TRIPS Agreement,
including compulsory licensing, and the commitment by the
Commission to launch a debate in the WTO on reconciling the
TRIPS Agreement with objectives regarding health protection
in developing countries;

3. Calls on the pharmaceutical companies that issued a
legal challenge to the South African 1997 Medicines Act to
withdraw from the case;

4. While respecting the intellectual property rights of the
pharmaceutical industry, calls on the Commission to
strengthen the ability of developing countries to resist
the pressure to introduce more stringent patent laws than
those currently required under the WTO TRIPS Agreement;

5. Calls on the Commission to work with the Member States
to show international leadership in the struggle for life-
saving medicines by encouraging technology transfer and
support for the strengthening and/or development of local
production capacity;

6. Calls for the current review of the TRIPS Agreement to
ensure that the rights of developing countries to obtain
the cheapest possible life-saving medicines, whether
patented or generic, are guaranteed, and further calls on
all the interested parties to actively engage in this
process;

7. Instructs its President to forward this resolution to
the Commission, the Council, the WTO, the ACP-EU Joint
Parliamentary Assembly and the OAU.


***** Therapeutic Drug Monitoring: Medscape Web Resource
Page

by John S. James

Therapeutic drug monitoring (TDM) means measuring the level
of a drug actually found in the blood (or inside certain
blood cells), in order to adjust the drug dose up or down,
either to make sure there is enough to inhibit HIV or to
avoid side effects. The reason for measuring drug levels is
that people are different, both in how well they absorb
drugs from the stomach or intestines, and in how rapidly
the body destroys or eliminates the drugs. For various
reasons, there is most interest today in measuring blood
levels of protease inhibitors.

For years there has been reluctance to measure HIV drug
levels in routine patient care, because the current one-
size-fits-all dosing is more convenient. Companies are
racing to make their medicines easier to take (preferably a
single pill once a day), and adjustable dosing would
probably require more pills and/or increase the chances of
error. Companies have incentive to sell their existing
products -- not to bring attention to their variable blood
levels or other complications.

TDM is not yet part of standard HIV care, but increasingly
new information suggests that it may become important for
helping antiretrovirals work better. In the future, it is
likely that shortly after one has started taking a protease
inhibitor (and perhaps other antiretrovirals as well), the
blood level will be tested in order to adjust the dose if
necessary.

Recently the Medscape HIV/AIDS Web site
(http://hiv.medscape.com) added a page of links to recent
articles, conference summaries, news reports, and other
information about therapeutic drug monitoring in HIV
treatment. This page will be updated as new information
becomes available. Currently the link is under "Resource
Centers" on the home page.

Note: You need to register in order to read the articles on
the Medscape site, but registration is a one-time process
and is free. You will need to make up a user name and a
password, and write them down for when you use the site
again; you will also be asked to complete a short survey.
This site has much useful information and is worth the
trouble of registering.


***** AmFAR Treatment Directory: How to Obtain a Free Copy

In our last issue we reviewed the new AmFAR HIV/AIDS
TREATMENT DIRECTORY, and suggested contacting the AmFAR
(the American Foundation for AIDS Research) New York office
for a copy. That office cannot handle the volume of
requests, and asked us to let readers know that they can
obtain a free copy from the National Prevention Information
Network (NPIN), 1-800-458-5231, Monday through Friday 9
a.m. to 6 p.m. Eastern Time, or by email at
info@..., or by mail at NPIN, P.O. Box 6003,
Rockville, MD 20849. NPIN can send a copy to U.S. or
international addresses. Be sure to include your mailing
address including ZIP code, and the name of the book, the
AmFAR HIV/AIDS TREATMENT DIRECTORY.

For more information on educational materials about AIDS,
sexually transmitted diseases, or tuberculosis, see
http://www.cdcnpin.org

The AmFAR office does offer a paid subscription to the
directory, allowing you to receive the new issues
automatically when they come out. For more information on
subscribing, call 1- 800-38-AMFAR.

Anyone can read the online version of the directory at
http://www.amfar.org/td


***** Twinning U.S. and African AIDS Organizations: NMAC
Training in U.S. Cities

The National Minority AIDS Council (NMAC), working with the
U.S. Office of AIDS Research (OAR), will be holding a
series of 4-day workshops on partnerships between U.S. and
African AIDS organizations. Two African organizers --
selected by a coalition of African organizations -- will
attend each of these workshops.

The following dates and locations were announced April 20,
2001:

* May 15-18 in Seattle (with Martha Nthenge who works at
KANCO, Nairobi, Kenya and Amina Ridwani, who works with
MAWA, in Mombasa, Kenya); for more information about the
Seattle meeting, see:
http://www.nmac.org/conference/regionals/seattle/letter.htm

* June, to be announced;

* July 10-13, in New York City;

* July 31 - August 3, in San Juan, Puerto Rico;

* October, in San Antonio, Texas; and

* October 30 - November 2, New Orleans.

  From the Announcement:

What Is Twinning?

Twinning is a formal, substantive collaboration between two
organizations. The word formal implies that there is an
agreement or contract that is either written or verbal
which substantively indicates that the interaction is
significant and that it lasts for a period of time.
Twinning should be two-way in order for both organizations
to benefit from the collaboration and learn from each
other.

Twinning is a type of collaboration that is critical to the
success of the work that HIV/AIDS organizations do.
Collaboration implies that two organizations are working
with each other on a specific project to exchange
information or skills. If twinning is carried out
successfully, vital information is exchanged between the
organizations. This exchange of significant information
allows them to create opportunities to work together.

Benefits Of Twinning

Strengthening Capacity
Identification & Sharing Of Best Practices
Increased Program Effectiveness
Decreased Cultural Barriers
Relationship Building
Networking
Solidarity
Building Of A Global Movement

Follow Up

It is our hope that in February of 2002 [NMAC] will bring
the 12 NGOs from Africa who participated in this program
back to the US to once again meet with their twinned NMAC
constituents. This meeting will be a follow-up to evaluate
the process, make recommendations for future activities and
to continue the process and benefits of twinning.

It is also NMAC's hope that should the process work well
with these African NGOs, that we will broaden our reach
during our 2002 regionals to include NGOs from Central and
South America as well as South East Asia and India.

How To Get Involved

Attend one of the NMAC Regional Trainings 2001. Two African
NGOs will attend each of our regional trainings starting in
Seattle (see schedule below), different African NGOs will
attend the remaining 6 trainings. Please review the
twinning document and learn more about the regional
training by going to:
http://www.nmac.org/conference/regionals/seattle/letter.htm
(after the Seattle meeting, you may need to start at:
http://www.nmac.org).

If you want to be considered as a potential "twin", please
contact Jay Blackwell, Email: jblackwell@..., phone 1-
202-234-5120.


***** Barcelona 2002:

International AIDS Conference Seeks Scientific Program
Coordinator

The major international AIDS conference takes place every
two years, and the next one will be in Barcelona, Spain,
July 7-12, 2002. The organizer of this conference, Fundacio
Barcelona AIDS 2002, is seeking a scientific program
coordinator. From the April 12 announcement:

Scientific Programme Coordinator

Programme organizers seek highly qualified candidate to
coordinate and implement planning for scientific programme
of the Conference. Responsibilities include technical and
logistical issues, liaison between organizers,
international scientific community and international
agencies. The applicant should have: research knowledge and
international experience with public health issues, basic,
clinical and/or social sciences in the HIV/AIDS field,
including developing countries; excellent interpersonal and
organizational skills; ability to take initiative and work
independently. English speaking and writing proficiency
(working knowledge of Spanish useful but not required).
Policy development and advocacy experience are desirable.

Position will be based in Barcelona from time of hire
through September 2002. Salary based on candidate's skills
and experience.

To apply, send your CV and 3 references with a cover letter
by email to: aids2002@... or by mail to: Fundacio
Barcelona SIDA 2002. c/ Pomaret, 21. Barcelona 08017. Spain

Application Deadline: Open until position is filled.


***** AIDS TREATMENT NEWS

Published twice monthly

Subscription and Editorial Office:
   1233 Locust St., 5th floor
   Philadelphia, PA 19107
   phone 800/TREAT-1-2 toll-free, or 215-546-3776
   fax 215-985-4952 (email is preferred)
   email: aidsnews@...
   useful AIDS links: http://www.aidsnews.org

Editor and Publisher: John S. James
Associate Editor: Tadd T. Tobias

Statement of Purpose:
AIDS TREATMENT NEWS reports on experimental and standard
treatments, especially those available now. We interview
physicians, scientists, other health professionals, and
persons with AIDS or HIV; we also collect information from
meetings and conferences, medical journals, and computer
databases. Long-term survivors have usually tried many
different treatments, and found combinations that work for
them. AIDS TREATMENT NEWS does not recommend particular
therapies, but seeks to increase the options available.

AIDS TREATMENT NEWS is published 24 times per year, on the
first and third Friday of every month, and print copies are
sent by first class mail. Email is available (see below).
Back issues are available at http://www.aidsnews.org

To subscribe, you can call 800-TREAT-1-2 or 415-255-0588:
* Businesses, Institutions, Professionals: $325/year. Early
email available (see below).
* Nonprofit organizations: $150/year.
* Individuals: $140/year, or $80 for six months. If you
cannot afford a subscription, please write or call about
our sliding scale.
* Outside North, Central, or South America, add airmail
postage: $20/year, $10 for six months.
* Bulk rates and multiple discount subscriptions are
available; contact our office for details.
* Payment can be by check, VISA, Mastercard, American
Express, bank draft, purchase order, international postal
money order, or travelers checks.

Early email: Business, nonprofit and full-rate individual
subscribers can receive an early copy by email, before the
issue is printed--in addition to their regular copy, at no
extra charge. It's OK to direct the email copy to someone
else. Call our office to add email to your subscription.

Free email: Free delivery for individuals (delayed one week).
To subscribe, send a blank email to:
aidsnews-subscribe@yahoogroups.com

ISSN # 1052-4207

Copyright 2001 by John S. James. Permission granted for
noncommercial reproduction, provided that our address and
phone number are included if more than short quotations are
used.

--
John S. James
AIDS Treatment News
http://www.aidsnews.org

AIDS TREATMENT NEWS Issue #362, March 23, 2001
     phone 800-TREAT-1-2, or 215-546-3776

CONTENTS

** Building Alliances for World Health Funding
This key moment in history offers the chance for a
breakthrough in world health for AIDS and many other
conditions, as political consensus demands that over 20
million people with HIV not be left to die without
treatment. We believe that instead of seeking earmarked HIV
funding, the AIDS community should work through broad
health alliances focusing on poor countries, to find
several billion dollars a year of new funding for projects
in HIV, tuberculosis, malaria, other infections, vaccines,
microbicides, behavioral prevention, research, training,
nutrition, clean water, and other cost-effective programs.

** FDA Gives Salvage Therapy Testing a Push Forward
Pharmaceutical companies like to test their drugs in
patients who are less seriously ill, so that the drugs will
look good. A recent FDA meeting focused attention on the
need for more trials in advanced patients, the importance
of long-term safety followup for all patients, and how the
necessary trials and monitoring could be conducted.

** AIDSWatch May 5-8: Visit Your Representatives in
Washington
The annual AIDSWatch, where hundreds of people travel to
Washington to meet their political representatives, takes
on special importance this year.

** AmFAR HIV/AIDS Treatment Directory Available
This 300-page directory explains almost all available
HIV/AIDS treatments, both approved and experimental, and
the major ongoing clinical trials. It also has practical
reference lists and tables, and articles on current
subjects.

** AIDS TREATMENT NEWS Publication Schedule


***** Building Alliances for World Health Funding

by John S. James

The last year has brought historic change in world
consensus -- from writing off and abandoning almost
everyone with HIV in African and other poor countries, to
serious discussion of how treatment could be provided to
many or most who need it. The key to this change was the
widespread realization that HIV treatment could be made
available for well under $500 per patient per year if
generic competition is allowed, instead of far higher
prices which, in practice, meant that widespread treatment
in poor countries was not going to happen. This change
became possible through the work of activists around the
world, over the opposition of some of the world's richest
corporations.

Today political leaders internationally are talking about
how to raise the several billion dollars a year that
worldwide access to antiretrovirals may cost even at the
new low prices (since $500 per year is still far beyond the
means of most individuals and governments in poor
countries). The money, "spare change" in the world economy,
is certainly possible; the real issue is building sustained
political commitment that will last beyond the current
flurry of attention.

What is the next step? We believe that now the AIDS
community should help broaden the discussion beyond
antiretrovirals alone, or treatment of people with HIV
only, through alliances and coalitions to fund world health
-- finding several billion new dollars a year for HIV,
tuberculosis, malaria, other illnesses, clean water,
nutrition, education, infrastructure, transparency, and
whatever else is needed, funding cost-effective health
projects which can differ greatly from place to place
according to local needs.

Practical and Political Advantages

A campaign for world health funding has important practical
advantages over a specific campaign for antiretroviral
funding:

(1) Persons with HIV need antibiotics, nutrition, safe
water, and many other kinds of care, as well as
antiretrovirals. Many medical professionals in poor
countries are asking for these other treatments first, to
save lives now. It wouldn't make sense to say, "No, here
are antiretrovirals only." Other health interventions must
be available for rational care.

(2) It would be wrong and a political nightmare to limit
treatment to persons with HIV -- to say to patients who
need an antibiotic to save their life, for example, that
they must be HIV-positive to get it.

(3) Politically the AIDS community alone is unlikely to
sustain enough of the current momentum to raise several
billion dollars a year for antiretrovirals. Historically
the world epidemic has been scandalously underfunded, for
prevention and otherwise, and we have been unable to change
that. But a larger campaign for health, focusing mainly but
not entirely on poor countries, could bring in many more
organizations, activists, and other supporters, and would
have a very good chance of finding this money.

(4) The donors and the recipient countries will control how
the money is spent through decisions made later, so the
campaign now to find the money will not have much control
over how it is ultimately spent. Politically this is
fortunate, since it means we can work together for health
funding, without fighting each other over where the money
will go. We *can* build consensus now on transparency and
accountability, to help assure that the funds will be well
spent.

(5) The AIDS community today has a window of opportunity to
use the recent world consensus and political momentum to
broaden the discussion beyond AIDS, toward a larger health
movement that can sustain victories and momentum into the
future. It's the right thing to do, and it can build a
solid base for future success.

* We would like to hear your comments, suggestions, ideas.
Send them to jjames@..., or mail them to AIDS
TREATMENT NEWS, Philadelphia FIGHT, 1233 Locust St., 5th
floor, Philadelphia, PA 19107.


***** FDA Gives Salvage Therapy Testing a Push Forward

by Emily Bass

The FDA is taking its most active role to date in
encouraging drug companies to address the needs of persons
with HIV who have exhausted all their treatment options.
Due to a long history of drug failures, these people
require innovative salvage therapies that are unaffected by
the drug resistance their HIV has built up.

In January, the FDA Antiviral Drugs Advisory Committee held
a meeting on salvage therapy trial design. The meeting
addressed thorny issues, including who to include in these
trials; how to design them; and how to put together a
successful New Drug Application (NDA) for a salvage therapy
agent. Many of the new recommendations will appear in a
"guidance document" on the use of HIV RNA measurements to
support accelerated and traditional approval for phase III
trials. Released for comment over a year ago, the finalized
version should be available by the end of 2001, said Jeff
Murray, an FDA antiviral medical officer.

These events are a major step forward, treatment advocates
respond. Michael Marco, of the Treatment Action Group
(TAG), commented after the FDA advisory committee meeting,
"Today is the day when industry can stop saying the FDA is
not sending a clear message."

Major Uncertainties on How to Test and Approve

Five years ago, protease inhibitors uncapped a revolution
for people living with HIV. Today, many of the people who
swallowed the first of these pills are facing a new
dilemma. Although the FDA has "routinely" asked for anti-
HIV drug developers to look at the effects of their drugs
in treatment-experienced populations, little such
information has been gathered, said Heidi Jolson, outgoing
head of the Antiviral Division, at the January meeting.

Although doctors and patients have no choice other than to
tackle difficult decisions about stopping or switching
therapies, drug developers have been able to sidestep the
issue by testing new drugs in treatment-naive individuals,
where the drugs have the most striking activity. Trial
results affect the drug's approval and marketing, and can
also have an immediate influence on the company's stock
price.

Any trial has to include a "background regimen" of active
drugs that support the company's experimental candidate in
attacking trial participants' HIV. Then there has to be an
agreed-on method to isolate and evaluate the benefit of the
particular drug in development. These requirements become
difficult to fulfill in salvage therapy trials. Persons
with long treatment histories and rebounding HIV likely
have many strains of drug-resistant virus, and constructing
an acceptably active supporting regimen may not be
feasible. The experimental drug may have only a partial or
transient effect as a result.

Persons eligible for salvage therapy trials also tend to
have more advanced disease and experience HIV-associated
opportunistic conditions. The symptoms and treatment of
such infections or malignancies may complicate use of
potentially toxic antiretrovirals.

Researchers considering salvage trials as well as many
patients have changed their treatment goals. An
undetectable viral load may be an unrealistic goal for
salvage therapy, while a 0.5 log (two-thirds) drop in viral
load is enough to discernibly improve health and boost CD4
counts. But will the prospect of a minimal, perhaps
temporary drop in viral load be enough to enroll sufficient
participants in a trial?

Companies have to address all these complexities while
simultaneously finding a trial design that makes their new
drug look good: effective, nontoxic and easy to take. The
updated FDA guidance documents will provide the clearest
road map yet for traversing this wild and woolly zone of
trial design in treatment-experienced patients. Among other
things, the new guidelines will urge drug developers to co-
sponsor trials, and depart from tried-and-true drug
approval packages consisting of several trials in
treatment-naive patients. Specific statements will be made
about how to use baseline resistance testing and other
diagnostics to identify the types of patients that are most
suitable for participation in particular salvage therapy
trials. The document will also advise on "superiority"
designs that use the maximum number of drugs likely to have
activity, whether experimental or approved, in an
"optimized background therapy" regimen.

Guidance documents are the foundation for negotiations
between trial sponsors and the FDA. In order to gain FDA
approval for a drug, a company or researcher submits a
package of data from a series of clinical trials. The
guidance documents give recommendations on how best to
design these trials to gain approval. Whether these
documents will be enough to spur pharmaceutical companies
into relatively unfamiliar territory remains to be seen.
The recommendations are only suggestions, not requirements.
"There's no teeth beyond encouraging [new trial designs],"
acknowledged Murray.

Some parts of the FDA's advice may be more appealing than
others. In particular, drug companies may be more willing
to assemble nontraditional NDAs. At the January meeting,
Jolson bestowed the FDA's blessing on NDAs made up of one
traditional trial that shows how well a drug works in
treatment-naive populations, paired with rational, well-
designed "supportive" trials that offer evidence that the
drug also works in treatment-experienced individuals. This
statement reflects the 1997 FDA Modernization Act, which
revised FDA drug approval requirements by stating, "data
from one adequate and well-controlled clinical
investigation and confirmatory evidence" may be sufficient
and constitute "substantial evidence" of a drug's merits.
Previously, at least two large comparison trials, with a
placebo or accepted treatment as a control arm, were
required to support an NDA.

Abbott Pharmaceuticals was one of the first companies to
use the new simpler package. The approval of its protease
inhibitor, Kaletra (lopinavir) was based, in part, on a 57-
person uncontrolled trial in protease-inhibitor-experienced
individuals. The trial, which correlated response to a
Kaletra-containing regimen with baseline tests of protease-
inhibitor resistance, provided valuable information about
the drug in treatment-experienced patients. Still, it was
not without its limitations. (See "Doctors Hesitate on
Kaletra," TREATMENT INSIDER, January 2001,
http://199.105.91.6/treatment/hiv+/january.pdf ). In order
to enroll, patients had to be NNRTI-naive. What the results
showed, therefore, is that treatment-experienced patients
responded well to a regimen containing Kaletra and another
drug, the NNRTI Sustiva (efavirenz). Abbott maintains that
the improvement in viral control was due to Kaletra, but it
can support this claim only with the indirect evidence
linking the extent of resistance to Kaletra with lack of
response.

Arranged Marriages

Drug companies may be less enthusiastic about a planned FDA
recommendation for co-sponsorship of experimental agents.
Rather than having each company compete separately, the FDA
will support drug companies testing two or more new agents
at once. This would provide information about how drugs
worked as part of a combination, rather than individually.
It could, theoretically, lead to approval of both drugs
with the requirement that they be used together. Jim Rooney
of Gilead Sciences testified at the FDA meeting as a
representative of the Inter-Company Collaboration (ICC), a
trade group that seeks to promote joint trials that combine
drugs from several companies. In an interview, he argued
that this type of cooperation could work for companies, "as
long as the indication could be modified later based on
data from additional studies in different patient
populations with different combinations, etc."

It may take more than a polite request from the FDA to get
companies to break the mold of competitive research. "I
can't say what kind of incentive could be provided [to
companies who collaborate] beyond saving on patient
resources," said the FDA's Jeff Murray. To date, there have
been no significant jointly sponsored trials of new agents,
even to determine how the drugs affect each other's
metabolic elimination. Gilead and Trimeris have taken steps
to include each other's experimental drugs, tenofovir and
T-20, respectively, in ongoing efficacy trials. Trial
participants are allowed to include the experimental drugs
in their background regimens. This could be important for
individuals deciding whether to take a single new agent or
wait until a better combination becomes available. But
having the option to take one experimental drug while in
trial for another will not provide valuable data about how
the two work as a strategy.

Activists and treatment advocates are ready to flex their
muscles to see relevant salvage therapy trials become a
reality. "If the FDA is enthusiastic, the community is
enthusiastic, and the researchers' only concern is that we
may not be able to persuade the drug companies [to
collaborate], I think we may have a chance," says Yvette
Delph, Antiviral Project Director of TAG. "I think the FDA
has far more persuasive power than it has been willing to
wield."

Futuristic Designs

Traditional trial designs work like simple addition
problems: experimental drug W is added to an approved
combination X+Y+Z. At the end of the trial, there is data
on whether X+Y+Z plus W works better than X+Y+Z alone. The
next, hotly debated generation of trials will be more akin
to multiplication. One model, which received considerable
support at the FDA meeting, was the "modified factorial
design." This type of trial is conceived in manner similar
to a multiplication table, with particular drugs rather
than numbers heading individual rows and columns. Each
multiple -- in this case a combination of drugs -- occupies
a different "cell," whose composition is determined by the
intersecting rows and columns.

The advantage of this design is that it allows several new
drugs to be tested in a single trial. Such a trial might
place all participants on optimized background therapy and
then randomly assign them to different cells, each of which
contains at least one, and possibly more experimental
drugs. The results from each of the cells could then be
compared to identify the most effective combinations.

There are drawbacks to this design. FDA advisory committee
member John Mellors (University of Pittsburgh) pointed out
that such trials will have to be quite large, to ensure
that there are enough people in each cell for meaningful
statistical comparisons. In addition, not all cells are
created equal. While each participant gets at least one new
drug, he or she may be deprived of the most promising
combinations. Modified factorial design could also lead to
a tangle of data on side effects, in which it might be
difficult to clearly assign blame.

These and other criticisms notwithstanding, the FDA used
the meeting to re-emphasize its support of modified
factorial trials as part of approval packages. Dr. Jolson
reminded attendees of a 1999 letter to industry indicating
support for this approach.

Fast Approval, Plus Long-Term Followup

For some patients with no treatment options, time is of the
essence. Although the FDA guidance document will not
include a clear statement about the appropriate length of
salvage therapy trials, Murray said that the FDA could
accept as little as 16 weeks of data on evaluating salvage
therapy safety and efficacy. At present, 24 weeks of data
is the standard minimum. Researchers support this slimmed-
down timeframe. "I'd vote for it one hundred percent," said
Dr. Michael Saag (University of Alabama at Birmingham), who
spoke at the FDA meeting. "Yes, it's taking a risk to
release a potentially toxic medication for which we don't
have a safety profile beforehand, but how does that
toxicity look to a patient who is going to die [without the
drug]."

In this scenario, drug approval will not hinge on 16-week
data alone. However, 24- and 48-week safety and efficacy
information might be gathered in a separate trial, perhaps
in a less pretreated population. "We often let companies
submit under earlier data and then update during the review
[process] anyway," said Murray. A TAG discussion paper
agrees that 16-week data could be used for "possible
submission for accelerated approval" but underscores that
"safety issues mandate the continuation of such studies up
to 48 weeks and beyond (after approval)."

The move to accept shorter trials comes as the consequences
from the first round of rapid approvals are becoming
painfully clear. All of today's antiretrovirals earned
approval with unprecedented speed, via the FDA's
"accelerated" approval process. Today, long-term
toxicities, such as lipodystrophy and bone disease, are
emerging. These toxicities were not apparent in the trials
conducted for approval of the drugs. Even one- to two-year
studies did not begin to show how common, or severe, these
problems would become.

To Saag and others, this long-term data is the crux of the
issue, not the eight weeks lopped off of a 24-week trial.
Here again, the FDA's power to change the industry is
limited. Its actual tactics are limited to the extreme step
of removing a drug from the market and the rather mild
threat of changing the wording of a drug's official package
insert. Accelerated approval is conditional, and can be
revoked if a company does not fulfill its post-approval
commitments to long-term follow-up and monitoring. Still,
many companies have altogether failed to make good on
promises of Phase IV post-marketing studies.

In the face of this patchy record of long-term HAART use,
there is a growing call for new data collection systems to
fill in the blanks. One possibility is to establish well-
coordinated databases that track adverse events and side
effects in all patients on approved therapies. "What may be
useful is to have more prospective cohorts that are
monitoring everyone [for toxic events]," said Yvette Delph.
As the list of long-term toxicities grows, it may be
increasingly difficult for the drug industry to sidestep
its obligations to help create such collection systems.

The salvage therapy arena has become an important one for
all parties concerned. Patients on failing therapy are
looking for rapid rescue. And drug companies are looking
for rapid testing and marketing of their products.
Meanwhile, the case for accelerated review of first-line
therapies is waning, now that the FDA has approved 14 anti-
HIV agents. The agency now is looking at how to meet the
unmet needs in HIV with all deliberate speed.

Salvage therapy is chief among such needs, and community,
industry and government have some convergence of interest
in demonstrating new drugs' efficacy in this setting.
Still, problems with determining individual agents'
contribution to combination regimens as well as the agents'
long-term effects may yet undermine the efforts at
cooperation evinced at the January meeting.

[This article was first published on the AmFAR Web site,
http://199.105.91.6/treatment/insider/salvage1.html
but has not previously appeared in print.]


***** AIDSWatch May 5-8: Visit Your Representatives in
Washington

This year is the 10th annual AIDSWatch, which brings
hundreds of people to Washington to help educate their
Senators and Representative on AIDS issues. AIDSWatch this
year will address funding for HIV prevention, AIDS
research, care and treatment (including ADAP and other Ryan
White programs), housing, substance abuse and mental
health, and international efforts. AIDSWatch is coordinated
by the National Association of People with AIDS, and
supported by over 175 national and regional AIDS
organizations.

AIDSWatch is particularly important at this time because
there is a new Administration, and many new members of
Congress who may not be familiar with AIDS programs and
their importance to constituents.

There is no fee to participate in AIDSWatch, but you need
to register by April 20, and pay your own travel and
expenses. On Saturday May 5 and Sunday May 6 training
sessions will familiarize participants with the issues, and
with how Congress works. On May 7 and 8 there will be a
rally at the Capitol, scheduled meetings with members of
Congress and their staffs, and an evening reception for
participants and members of Congress.

There are eight official AIDSWatch hotels, all near Dupont
Circle. They require early registration to get the
negotiated meeting rates.

For more information see
http://www.napwa.org/aidswatc.htm , or contact NAPWA
(National Association of People with AIDS), 1413 K St. NW,
7th floor, Washington D.C. 20005, 202-898-0414 ext. 124,
fax 202-898-0435.


***** AmFAR HIV/AIDS Treatment Directory Available

The 300-page HIV/AIDS TREATMENT DIRECTORY (volume 11,
number 1, winter 2001), is available without charge from
AmFAR (the American Foundation for AIDS Research) in New
York.

Major sections include:

* treatments for HIV infection (listed alphabetically
within each of three categories, FDA-approved drugs,
experimental agents, and immune-based therapies);

* treatments and treatment results for opportunistic
infections;

* articles on current issues: "Muscle, Fat, and HIV,"
"Nucleoside Analog Toxicity," and two articles on treatment
in Uganda, and in a separate section, "The Shifting Pattern
of Opportunistic Illness";

* actively recruiting clinical trials;

* the U.S. treatment guidelines for adults and adolescents,
pediatric guidelines, and guidelines on prevention of
opportunistic infections. [The adult guidelines were
recently changed, after this edition of the directory had
gone to press. So the adult guidelines, pages 91-103 of
volume 11 number 1, are not current and should not be used;
the current guidelines are available at
http://www.hivatis.org or by mail from HIV/AIDS Treatment
Information Service, P.O. Box 6303, Rockville, MD 20849-
6303. A new edition of the treatment directory with the
current guidelines should be published around June 2001.]

* information on understanding your lab results;

* a directory of state ADAP (AIDS Drug Assistance Program)
phone numbers;

* a directory of pharmaceutical company patient assistance
programs;

* an index to manufacturers, arranged alphabetically by
drug name;

* newsletters and other treatment information resources;
and

* the "HIV Experimental Vaccine Directory."

You can obtain a printed copy of the HIV/AIDS TREATMENT
DIRECTORY from American Foundation for AIDS Research, 120
Wall St., 13th Floor, New York, NY 10005, phone 212-806-
1600, or email txdir@....  An online version of the
directory is available at http://www.amfar.org/td


***** AIDS TREATMENT NEWS Publication Schedule

AIDS TREATMENT NEWS is usually published on the first and
third Friday of each month. This month we are behind, and
this issue, the first in March, actually went to the
printer on March 29.

To avoid confusion in the future, we want to maintain our
schedule of two issues each month. This month, to make the
publication dates more realistic, we are dating the issues
on the last two Fridays (March 23 and March 30), instead of
the first and third Fridays.

We expect to catch up in April, and resume our regular
publication schedule.


***** AIDS TREATMENT NEWS

Published twice monthly

Subscription and Editorial Office:
   1233 Locust St., 5th floor
   Philadelphia, PA 19107
   phone 800/TREAT-1-2 toll-free, or 215-546-3776
   fax 215-985-4952 (email is preferred)
   email: aidsnews@...
   useful AIDS links: http://www.aidsnews.org

Editor and Publisher: John S. James
Associate Editor: Tadd T. Tobias

Statement of Purpose:
AIDS TREATMENT NEWS reports on experimental and standard
treatments, especially those available now. We interview
physicians, scientists, other health professionals, and
persons with AIDS or HIV; we also collect information from
meetings and conferences, medical journals, and computer
databases. Long-term survivors have usually tried many
different treatments, and found combinations that work for
them. AIDS TREATMENT NEWS does not recommend particular
therapies, but seeks to increase the options available.

AIDS TREATMENT NEWS is published 24 times per year, on the
first and third Friday of every month, and print copies are
sent by first class mail. Email is available (see below).
Back issues are available at http://www.aidsnews.org

To subscribe, you can call 800-TREAT-1-2 or 415-255-0588:
* Businesses, Institutions, Professionals: $325/year. Early
email available (see below).
* Nonprofit organizations: $150/year.
* Individuals: $140/year, or $80 for six months. If you
cannot afford a subscription, please write or call about
our sliding scale.
* Outside North, Central, or South America, add airmail
postage: $20/year, $10 for six months.
* Bulk rates and multiple discount subscriptions are
available; contact our office for details.
* Payment can be by check, VISA, Mastercard, American
Express, bank draft, purchase order, international postal
money order, or travelers checks.

Early email: Business, nonprofit and full-rate individual
subscribers can receive an early copy by email, before the
issue is printed--in addition to their regular copy, at no
extra charge. It's OK to direct the email copy to someone
else. Call our office to add email to your subscription.

Free email: Free delivery for individuals (delayed one week).
To subscribe, send a blank email to:
aidsnews-subscribe@yahoogroups.com

ISSN # 1052-4207

Copyright 2001 by John S. James. Permission granted for
noncommercial reproduction, provided that our address and
phone number are included if more than short quotations are
used.

AIDS TREATMENT NEWS Issue #361, February 28, 2001
     phone 800-TREAT-1-2, or 215-546-3776

CONTENTS

** Retroviruses Conference: Johns Hopkins Report
On March 1 the HIV newsletter from Johns Hopkins University
published several short, focused reports on the
Retroviruses conference, written primarily for physicians.
These are available on the Web or by mail. We list most of
the major topics covered.

** Obtaining the New HIV Treatment Guidelines
How to order the new HIV/AIDS official adult treatment
guidelines by mail if you do not have computer access; how
to get your questions about treatments answered at the same
office; and other guidelines available including prevention
of opportunistic infections, and what to do in case of
occupational exposure to HIV. In addition, the official Web
site for the guidelines has a marked copy which shows where
the current adult guidelines are changed from the previous
version.

** Merck, Bristol-Myers Squibb Announce Major Price
Reductions for Poorest Countries: Major Access Progress but
Questions Remain
Two major pharmaceutical companies have announced new and
much lower prices for antiretrovirals for African and some
other poor countries, along with a uniform pricing policy
which should simplify negotiations for access to the drugs.

** MSF (Doctors Without Borders) Petition Against South
Africa Lawsuit, Deadline April 15
Doctors Without Borders is collecting signatures from
around the world, asking major pharmaceutical companies to
drop the lawsuit which for three years has prevented South
Africa from implementing its post-Apartheid reform of its
medicines law.

** Southern Africa Home Care: Conference Report
These Web reports of a recent conference in Gabarone,
Botswana, provide an African view of the epidemic and the
home-care approaches now in use.

** AmFAR Seeks Medical Writer/Editor in New York


***** Retroviruses Conference: Johns Hopkins Report

by John S. James

The March 1, 2001 issue of THE HOPKINS HIV REPORT has
several short, focused summaries of some of the important
treatment information from the recent Retroviruses
conference (8th Conference on Retroviruses and
Opportunistic Infections, Chicago, February 4-8, 2001).
Written "for practitioners caring for patients with
HIV/AIDS," it can also inform patients who have educated
themselves about the disease. Because it targets busy
people, the articles are short and to the point. This issue
of THE HOPKINS HIV REPORT focuses heavily on
antiretrovirals, and also includes an important section on
hepatitis C.

Other major topics include the new treatment guidelines
(see "Obtaining the New HIV Treatment Guidelines" in this
issue), new antiretrovirals in development, when to start
antiretroviral therapy, treating experienced patients, drug
concentrations and interactions, adherence, and women's
issues.

A table of contents with links to each of the articles is
at:
http://hopkins-aids.edu/publications/report/mar01_toc.html

For those without Web access, here are instructions for
ordering by mail: "THE HOPKINS HIV REPORT is available for
free upon request. All requests to be added to our mailing
list should include complete mailing information and be
sent to: THE HOPKINS HIV REPORT P.O. Box 5252, Baltimore,
MD 21224, Attn: Distribution. Change of address should be
mailed to the address listed above as well. All other
correspondence should be sent to Mary Beth Hansen, Managing
Editor, THE HOPKINS HIV REPORT, JHU Division of Infectious
Diseases, 2700 Lighthouse Point East, Suite 220, Baltimore,
MD 21224."

Some Highlights of the Johns Hopkins Retroviruses
Conference Issue

* "New Antiretroviral Agents" by Joel E. Gallant, M.D.,
M.P.H., summarizes many of the potential new
antiretrovirals discussed at the conference -- including
some still in laboratory testing, some in clinical trials,
and a few in expanded access. You can get more information
about any particular drug by searching for it by name in
the abstracts of the Retroviruses conference
(http://www.retroconference.org -- choose Conference
Abstracts to get a search screen for the current year's
conference; also, you can usually find an abstract by
number through a search for the number) -- or in other
databases, such as the National Library of Medicine,
http://gateway.nlm.nih.gov, or AEGIS, (AIDS Education
Global Information System), http://www.aegis.org

The drugs are categorized as follows (the examples here are
not complete lists):

-NRTIs: Emtricitabine (FTC), DAPD, ACH-126,443

-NNRTIs: Capravirine, TMC-120, DPC 083

-Nucleotide Reverse Transcriptase Inhibitors: Tenofovir

-Protease Inhibitors: Tipranavir, BMS 232,632, Mozenavir
(DMP-450), GW433908

-Entry Inhibitors: These include attachment inhibitors (for
example, PRO-542), coreceptor (chemokine) antagonists (AMD-
3100, SC-351125 (SCH-C), SCH-D, and PRO-140), and fusion
inhibitors (T-20, T-1249)

-Integrase Inhibitors: S-1360

* "New Guidelines for the Use of Antiretroviral Agents in
HIV-Infected Adults and Adolescents," by John G. Bartlett,
M.D.

"For most clinicians caring for HIV-infected patients, the
most useful aspect of the guidelines will be the tabular
information on recommended regimens, food restrictions,
side effects, side effect monitoring, recommendations for
managing [drug] class adverse reactions, and dose
recommendations for combination therapy."

The article also includes this note, which emphasizes the
importance of seeing an HIV-experienced physician for one's
care:

"A preliminary study by the AETC National Resource Center
[AIDS Education Training Centers, http://www.aids-ed.org/]
indicates that about 98% of physicians with more than 20
HIV-infected patients are aware of these guidelines, and
96% have read at least part of them. However, among
physicians with less than 20 HIV-infected patients, only
71% had heard of the guidelines, and only 52% had read at
least part of them."

Also see "When Should Highly Active Antiretroviral Therapy
Be Initiated," by Timothy R. Sterling, M.D., in the March 1
Hopkins report. It discusses studies presented at the
Retroviruses conference that contributed to the decision to
recommend later treatment in the new guidelines --
including at least three separate studies which found an
increased risk of death among those who waited too long and
started treatment at a CD4 count under 200.

* "Antiretroviral Therapy: Naive Patients and Early
Therapy," by Joel E. Gallant, M.D., M.P.H., includes many
reports on individual drugs, developments in once-daily
therapy, and when viral "blips" during therapy may be
important.

* "Treatment of the Antiretroviral-Experienced Patient," by
Gregory M. Lucas, M.D., looks at:

- salvage options for patients with failure of highly
active antiretroviral therapy (HAART)

- switches from protease inhibitor (PI)-based regimens to
PI-sparing regimens as a strategy to simplify therapy or
minimize toxicity

- cross-resistance among nucleoside analogs

- "continuing HAART in the setting of persistent viremia."

* The section on drug interactions and pharmacokinetics
("Drug Transporter, Drug Concentrations, and Drug
Interactions," by Adriana Andrade, M.D., M.P.H. and Charles
Flexner, M.D., included:

- An overview of the complex but potentially important
research on P-glycoprotein (P-gp), a molecular "pump" that
can remove drugs from cells, preventing the drugs from
working. Inhibitors of P-gp are being developed for cancer
and other treatment. But P-gp appears to interfere with HIV
as well as with drugs, meaning that inhibiting it could
have both wanted and unwanted effects.

- A garlic supplement [taken twice a day for over two weeks
in this study] was found to greatly lower the blood level
of saquinavir (Fortovase(R)), to about half of what it had
been without the garlic. The mechanism is not known, and it
is not know what other drugs may be affected. For now,
patients are being cautioned about using garlic supplements
if they are taking protease inhibitors -- especially if
they are using a regimen with saquinavir as the sole
protease inhibitor.

- A study of indinavir (Crixivan) blood levels in patients
using marijuana [4% THC cigarettes three times a day for 14
days] in the marijuana clinical trial at the University of
California San Francisco found that indinavir levels may be
decreased. But only one of the values was statistically
significant, and no recommendations for changes in therapy
were made.

- A test of how well laboratories in the U.S. and Europe
measure blood levels of antiretroviral drugs found
generally poor quality, [with only one of 13 labs tested
being within 20% of the true value for all tests, and one
result being off by 10 times; see Retroviruses abstract
#734]. A quality-control program was recommended.

* "Women's Issues," by Jean R. Anderson, M.D., included new
findings on reducing perinatal transmission, indications
that HAART antiretroviral therapy may help improve outcome
in cervical dysplasia, and discussion of the serious
problem of increased incidence of some drug toxicities in
women.

THE HOPKINS HIV REPORT also includes sections on hepatitis
C co-infection (and hepatitis B), and on adherence. These
are difficult to summarize. Hepatitis C received much
attention at this conference. It is probably the most
important co-infection today in persons with HIV [at least
in the U.S.]. HIV accelerates progression of hepatitis C,
and liver disease due to hepatitis C is becoming an
increasingly important cause of illness and death in
persons with HIV.


***** Obtaining the New HIV Treatment Guidelines

The new GUIDELINES FOR THE USE OF ANTIRETROVIRAL AGENTS IN
HIV-INFECTED ADULTS AND ADOLESCENTS were released February
5; they are available at many Web sites, but the official
site for all the U.S. Department of Health and Human
Services HIV treatment guidelines is the HIV/AIDS Treatment
Information Service, http://www.hivatis.org

For a printed copy, you can call 800-448-0440, or mail a
request to HIV/AIDS Treatment Information Service, P.O. Box
6303, Rockville, MD 20849-6303. Note: it will probably take
the office 7-10 days to ship a printed copy of the
guidelines -- in addition to the time required for mail
delivery. Be sure to ask for the adult guidelines if that
is what you want, as there are currently five different HIV
guidelines available (see below).

The official Web site (http://www.hivatis.org) also has a
separate copy of the new adult guidelines with changes
highlighted in yellow, so you can see what is different
from the last version.

When we checked this site in March 2001, the guidelines
could either be viewed while online or printed; however, we
were unable to save a copy of the file for viewing on the
computer when not connected to the Internet. A dial-up (low
speed) connection did work OK for viewing. When we checked,
the HTML (Web) format version had a summary of the changes,
which was not included in the PDF format or printed
document.

What Has Changed?

The most prominent change is that the new guidelines are
more conservative about when to start treatment.

"In general, treatment should be offered to individuals
with fewer than 350 CD4+ T cells/mm3 or plasma HIV RNA
levels exceeding 30,000 copies/mL (bDNA assay) or 55,000
copies/mL (RT-PCR assay). The strength of the
recommendation to treat asymptomatic patients should be
based on the willingness and readiness of the individual to
begin therapy; the degree of existing immunodeficiency as
determined by the CD4+ T cell count; the risk of disease
progression as determined by the CD4+ T cell count and
level of plasma HIV RNA; the potential benefits and risks
of initiating therapy in asymptomatic individuals; and the
likelihood, after counseling and education, of adherence to
the prescribed treatment regimen." (From the Summary. This
discussion does not apply to all patients -- see the full
Summary.)

There is also a new section in this edition of the adult
treatment guidelines, "Considerations for Antiretroviral
Therapy in Women."

Since most HIV physicians were already treating in
accordance with the new guidelines even before their
publication, this recommendation is not expected to change
HIV practice very much. More important to day-by-day
medical care will be the extensive practical information
for physicians, which has been provided in 24 tables in the
document. The guidelines committee presented this
information as tables because members thought physicians
would be more likely to use it in that form than if
presented as text.

Other Guidelines Available

Besides the adult guidelines, the HIV/AIDS Treatment
Information Service can send current guidelines on:

* Prevention of opportunistic infections;

* Treatment of HIV in children;

* Prevention of mother-to-child transmission; and

* Recommendations for healthcare workers exposed to HIV.

The office also has other patient education material.

Getting Your Questions Answered

The HIV/AIDS Treatment Information Service can answer
individual questions, either by phone or by postal mail
address above, or by email to atis@.... It can
provide information from its database, but of course cannot
give medical advice.


***** Merck, Bristol-Myers Squibb Announce Major Price
Reductions for Poorest Countries: Major Access Progress but
Questions Remain

By John S. James

On March 7 Merck & Co. Inc. announced it would sell
Crixivan(R) (indinavir) in some poor countries for $600 per
patient per year, and Stochrin(R) (efavirenz, better known
in the U.S. as Sustiva(R)) for $500. The same price will be
available to governments, international agencies,
nonprofits, and private companies such as employers who
want to provide access to AIDS treatment to their
employees. The only condition placed on this program is
that the drugs must be used in the country and not
exported. Merck claims that it will not make a profit on
these sales to developing countries. It said it expects to
triple production of Crixivan to meet the new demand.

And on March 14 Bristol-Myers Squibb Company announced that
it was making its drugs ddI and d4T available "in every
country in Africa" at 15 cents per day for d4T and 85 cents
per day for ddI, which it said is below its cost, "under
its existing ACCESS partnership program with international
agencies, including UNAIDS, World Health Organization,
World Bank, UNICEF and U.N. Population Fund." (March 14
company press release).

Bristol-Myers Squibb also said that it would not let its
patents interfere with access to its AIDS drugs in Africa.
"The company will ensure that its patents do not prevent
inexpensive HIV/AIDS therapy in Africa. The patent for
Zerit, rights to which are owned by Yale University and
Bristol-Myers Squibb, will be made available at no cost to
treat AIDS in South Africa under an agreement the company
has recently concluded with Yale. The company has no other
patent rights in Africa which it will allow to prevent AIDS
therapy there," (March 14 press release). Outside of
Africa, "we will maintain our existing ACCESS pricing
program and address the subject on a country-by-country
basis." (About 70% of people with HIV or AIDS in the world
live in sub-Saharan Africa.)

Last May, Merck, Bristol-Myers Squibb, and three other
major pharmaceutical companies announced major price
reductions for developing countries, through the ACCESS
program with UNAIDS and other agencies. But that program
required country-by-country price negotiations between each
government and the companies. Only three countries
(Senegal, Rwanda, and Uganda) have completed these
negotiations, while about 30 others have expressed
interest; after 10 months, only about 2500 people are being
served. The new procedure should be much simpler in
practice, because of the transparent (public), uniform
price.

With prices currently announced for poor countries by other
pharmaceutical companies (which might be reduced in the
near future), prices to Africans for triple therapy
including either Crixivan or Stochrin (efavirenz) will
still be over $1000 per person per year. Two Indian generic
manufacturers (Cipla Ltd., and Hetero Drugs Ltd.) have now
offered a nevirapine-based triple combination for as low as
$350 per year or less. (Efavirenz and nevirapine are in the
same drug class, non-nucleoside reverse transcriptase
inhibitors; indinavir (Crixivan) is a protease inhibitor.
Indinavir is more difficult to manufacture than nevirapine;
we do not know about efavirenz.)

A March 7 WALL STREET JOURNAL report attributed Merck's and
other new pricing programs for poor countries to
"increasing concern by pharmaceuticals executives that
generic competitors are winning a public-relations battle
that could eventually undermine international patents --
their most precious asset."

In a March 19 op ed in THE NEW YORK TIMES, one of the
inventors of d4T, William Prusoff of the Yale University
School of Medicine, looked at the history that led to the
current developments. He supported the drug being either
cheap or free in sub-Saharan Africa, while also
acknowledging the contribution of Bristol-Myers Squibb,
which tested the d4T at its expense in more than 13,000
patients in the U.S. and Europe before it was able to get
any income from sales. He is amazed at how rapidly this
issue has moved recently.

Comment

These programs are clearly an important step forward, and
have generally been welcomed by agencies and advocates
trying to make treatment available. But clearly the $500 or
$600 price will require international assistance for
countries with income levels less than that and public
health expenditures sometimes less than $10 per person per
year -- in addition to money for training and other
infrastructure. Eventually millions of people will come in
for treatment, and it is not known how much funding will be
available to help provide it.

While we do not contest the companies' statements that it
will not profit on the sale of the drugs at these prices to
developing countries, we do note that any such calculation
is based on many accounting choices, which are not public.
Also note that with the huge profit margins on patented
pharmaceuticals in the industrialized world, patent holders
have little incentive to reduce production cost, since it
makes up so small a part of the price. So even accepting
the companies' statements fully, developing countries will
have to bear production costs set by rich-world economics
and not appropriate for them.

For the same reasons, there is not necessarily any conflict
between Bristol-Myers Squibb's statement that it will sell
ddI at a loss, and at least one generic company's quote for
ddI at a fraction of the price. Bristol has little
incentive to reduce production cost; generic companies have
great incentive. This is one of the reasons many activists
insist that generic competition must remain an available
option for providing these life-critical but expensive
drugs in poor countries.

We should think through the pros and cons of having an
individual-patient price (such as $600 per year for
Crixivan) for critical drugs for poor countries -- as
opposed to governments, international agencies, and others
contracting to pay pharmaceutical companies a flat price to
manufacture whatever amount of drug is needed for treatment
programs there. The problem with the individual-patient
price is that it could end up being charged as an out-of-
pocket expense to individual patients, who often have no
possibility of paying that much. On the other hand, the
problem with not having an individual price is loss of
flexibility; for example, the drugs might be restricted to
governments, some of which will not have distribution
programs ready even when some private employers want to
provide coverage. Perhaps using both would be best:
government and other public programs could receive the
drugs at a flat price regardless of quantity, yet
employers, insurance plans, and other private organizations
could buy the drugs for each patient they treat, if for
whatever reason the government did not provide them.

Both generics and reduced-price drugs from patent holders
will likely be used in the world's poorest countries.
Either way, the key to treatment access for most people
will be effective institution building to bring together
the necessary support -- including money, education and
other infrastructure, and rules that everyone can live
with.


***** MSF (Doctors Without Borders) Petition Against South
Africa Lawsuit, Deadline April 15

On March 19 we received the following announcement from
Médecins Sans Frontičres (Doctors Without Borders), asking
for signatures on their online petition by April 15:

Médecins Sans Frontičres (MSF) asks you to support South
Africa's efforts to make essential medicines more
accessible to its people by signing the global "Drop the
Case" petition at http://www.msf.org by April 15.

The petition calls on 39 pharmaceutical companies to drop
their lawsuit against the South African government.  The
lawsuit is blocking the implementation of legislation that
aims to improve access to essential medicines by making
drugs more affordable.

With over four million already infected with HIV, South
Africa has the highest number of people living with
HIV/AIDS in the world.  Very few can afford the treatment
that has extended and improved the lives of people in
richer countries.  High prices are effectively denying
medicines to poor patients, condemning them to a premature
death.

MSF asks you to visit our website at http://www.msf.org to
sign the petition and demonstrate your support.

Please also forward this message to other concerned people
that you know.  MSF is working with organizations around
the world to try to collect as many signatures as possible
by mid-April, when the case resumes in court.  We will then
present the signatures to the 39 drug companies and to
governments.

*Thank you for your concern, Médecins Sans Frontičres
Access to Essential Medicines Campaign*


***** Southern Africa Home Care: Conference Report

The first regional Southern African conference on home care
for persons with HIV took place March 5-8, 2001 in
Gabarone, Botswana. Internet reports, written by
correspondents from South Africa, Uganda, Botswana, and
Ghana are available at:

http://www.healthnet.org/programs/procaare-
hma/procaare.200103/threads.html#00006

Topics include nursing, psychosocial support, medical care,
living with HIV or AIDS, the role of the private sector,
and orphans.

The reporting was organized by Health & Development
Networks (http://www.hdnet.org), an organization "to
mobilize a more effective response to HIV/AIDS and other
health-and-development-related issues by improving
information, communication, and the quality of debate."
HDNET, which has offices in the Republic of Ireland and in
South Africa, has hosted AIDS email lists and other online
information for many years.


***** AmFAR Seeks Medical Writer/Editor in New York

The American Foundation for AIDS Research (AmFAR) is hiring
a medical editor for its treatment publications, including
the AmFAR HIV/AIDS Treatment Directory. This job is at the
organization's New York City location.

"The Editor will develop and edit style, accuracy and
comprehensiveness of treatment information for various
publications, and write reports and articles. Responsible
for collecting and verifying pre-clinical and clinical
treatment-related information from local, national and
international conferences, clinical research sites,
foundations, government, drug manufacturers and on-line
literature.

"Ideal candidate is science writer with at least a BS and 3
years experience in science/technical fields, and strong
general science background. Knowledge of statistical and
medical terminology, and history, pathogenesis and
epidemiology of HIV/AIDS required, with background in
reviewing and abstracting scientific literature desirable.

"Very competitive salary and benefit package. Send resume
and letter with salary requirements to: Susan Kennedy,
Director - Human Resources, 120 Wall Street, 13th Floor,
New York, NY 10005, (212) 806-1625, (212) 806-1606 fax,
susan.kennedy@....


***** AIDS TREATMENT NEWS

Published twice monthly

Subscription and Editorial Office:
   1233 Locust St., 5th floor
   Philadelphia, PA 19107
   phone 800/TREAT-1-2 toll-free, or 215-546-3776
   fax 215-985-4952 (email is preferred)
   email: aidsnews@...
   useful AIDS links: http://www.aidsnews.org

Editor and Publisher: John S. James
Associate Editor: Tadd T. Tobias

Statement of Purpose:
AIDS TREATMENT NEWS reports on experimental and standard
treatments, especially those available now. We interview
physicians, scientists, other health professionals, and
persons with AIDS or HIV; we also collect information from
meetings and conferences, medical journals, and computer
databases. Long-term survivors have usually tried many
different treatments, and found combinations that work for
them. AIDS TREATMENT NEWS does not recommend particular
therapies, but seeks to increase the options available.

AIDS TREATMENT NEWS is published 24 times per year, on the
first and third Friday of every month, and print copies are
sent by first class mail. Email is available (see below).
Back issues are available at http://www.aidsnews.org

To subscribe, you can call 800-TREAT-1-2 or 415-255-0588:
* Businesses, Institutions, Professionals: $325/year. Early
email available (see below).
* Nonprofit organizations: $150/year.
* Individuals: $140/year, or $80 for six months. If you
cannot afford a subscription, please write or call about
our sliding scale.
* Outside North, Central, or South America, add airmail
postage: $20/year, $10 for six months.
* Bulk rates and multiple discount subscriptions are
available; contact our office for details.
* Payment can be by check, VISA, Mastercard, American
Express, bank draft, purchase order, international postal
money order, or travelers checks.

Early email: Business, nonprofit and full-rate individual
subscribers can receive an early copy by email, before the
issue is printed--in addition to their regular copy, at no
extra charge. It's OK to direct the email copy to someone
else. Call our office to add email to your subscription.

Free email: Free delivery for individuals (delayed one week).
To subscribe, send a blank email to:
aidsnews-subscribe@yahoogroups.com

ISSN # 1052-4207

Copyright 2001 by John S. James. Permission granted for
noncommercial reproduction, provided that our address and
phone number are included if more than short quotations are
used.

AIDS TREATMENT NEWS Issue #360, February 23, 2001
     phone 800-TREAT-1-2, or 215-546-3776

CONTENTS:

** Tenofovir DF Expanded Access
An important new drug is now available through a special
program for patients with advanced AIDS who have failed
approved therapies.

** New Immune-Based Treatment Approach: Trial Recruiting in
San Francisco
A clinical trial of a new kind of immune-based treatment --
using a drug widely available in Japan for other purposes -
- is now recruiting in San Francisco.

** Africa Access: Moving Fast, Outcome Uncertain
In many developing countries fewer than one in a thousand
persons with HIV receive modern treatment, mainly because
they cannot pay for the drugs, which are often sold at
rich-country prices although they cost little to
manufacture. Affordable treatments are clearly possible,
but have been held back for years due to pharmaceutical
companies' fears over patent protection. Now there is
intense interest in finding solutions, and several possible
approaches are on the table.

** South Africa Lawsuit: March 5 Worldwide Protest
Information
For three years some the world's largest pharmaceutical
companies have been suing South Africa to stop
implementation of its post-apartheid medicine reform law;
the case is scheduled to go to trial March 5. Solidarity
protests are planned for that date in Australia, Brazil,
Canada, France, Germany, Italy, Philippines, South Africa,
Thailand, United Kingdom, the United States, and probably
elsewhere as well.

** AIDS TREATMENT NEWS Publication Schedule, February-March
2001


***** Tenofovir DF Expanded Access

On February 1 Gilead Sciences announced a much-enlarged
expanded access program for tenofovir DF (tenofovir
disoproxil fumarate), a potentially important new drug
which is now in a phase III clinical trial with over 500
treatment-experienced patients (averaging more than five
years of HIV treatment before beginning this trial). The
new pre-approval program is limited to "patients who have
failed commercially available antiretroviral treatment
regimens, have limited treatment options and are at risk
for disease progression." It is now open in the U.S. and
France, and will soon begin in Germany, Italy, Spain, and
the United Kingdom. Gilead hopes to apply for marketing
approval for tenofovir DF in mid 2001 in both the U.S. and
Europe, and the drug has been designated for fast-track
evaluation by the U.S. FDA.

Criteria for U.S. Program

"The U.S. program will make tenofovir DF available to
patients at least 18 years of age with HIV infection who
have had a CD4 count less than or equal to 100 cells/mm(3)
and an HIV RNA level of greater than or equal to 10,000
copies/mL by PCR within the past two months. Patients must
also have failed treatment with at least two protease
inhibitors (PIs) or one PI and one non-nucleoside analog
reverse transcriptase inhibitor. Additionally, patients
with a CD4 cell count between 100 cells/mm(3) and 200
cells/mm(3) and an AIDS-defining opportunistic infection
within the last 90 days may also be eligible."

"Physicians will be required to evaluate patients at
baseline and after one month on therapy, then every two
months until drug discontinuation or study termination
following the protocol guidelines. Data collection is
limited to the report of serious adverse events, and no
specific laboratory testing is required except as indicated
for standard medical care."

The drug is taken as one pill per day -- and patients
should also be taking at least one other new
antiretroviral.

Phase III Results

On February 20 Gilead released 24-week results from the
ongoing phase III trial in treatment-experienced patients.
Those randomly assigned to tenofovir had a 0.6 log decrease
in viral load, compared to a negligible change in those
taking placebo. Both the tenofovir and placebo arms had the
same dropout rate, 6% -- indicating a good safety profile
at the 24-week time point. (This trial will run for 48
weeks.)

The drug is also being tested in a separate phase III trial
in treatment-naive patients.

For More Information

For more information about the tenofovir DF expanded access
program in the U.S., and for physicians to request
registration materials, call 1-800-GILEAD-5 (1-800-445-
3235) between 8 a.m. and 6 p.m. Monday through Friday
Eastern time. For the European program, call 33-1-44-90-34-
46.


***** New Immune-Based Treatment Approach: Trial Recruiting
in San Francisco

by John S. James

A new kind of potential treatment is about to begin its
first human trial in San Francisco.

A drug called Z-100 (also called Ancer 20) has been
approved for years in Japan and used by thousands of
patients there to stimulate growth of blood cells after
cancer therapy; doctors use it when filgrastim
(Neupogen(R)) would be used in the U.S. The drug, prepared
from the cell walls of the bacterium that causes
tuberculosis and injected in very small amounts, stimulates
the production of many cytokines in the process of causing
blood cell growth -- and has been found to increase the
production of MIP-1-alpha, which can help block many HIV
variants from entering cells, in laboratory tests with
cells from patients with HIV.(1) It appears to change the
immune response from Th2 toward Th1, which may be useful in
controlling this virus.

Laboratory tests with HIV found that Z-100 alone did not
reduce the growth of the virus -- but did reduce viral
growth when combined with a concentration of AZT which was
too low to be effective in itself.(2) These studies are
only suggestive, because patients usually respond
differently than cells in a laboratory culture.

The first study of Z-100 as a possible HIV treatment will
soon start at the University of California San Francisco
Medical Center. It will test Z-100 alone (without
antiretrovirals) in volunteers who are either
antiretroviral naive, or off antiretrovirals for at least
16 weeks, and whose CD4 count is between 300 and 800. Their
viral load must be between 2,000 and 50,000 copies, and
they must pass usual safety tests (liver enzymes, etc.).
Volunteers will be randomly assigned to take either 20
micrograms or 40 micrograms of Z-100, or placebo, for 8
weeks, followed by four weeks followup. There are no plans
currently for providing Z-100 after this trial.

Side effects of this drug are usually minor, mostly at the
injection site.

Comment

Volunteers should not expect personal benefit from this
trial, except from the laboratory testing that will be
provided. No one can predict whether this treatment will
work at all for HIV, or whether it will have any
antiretroviral activity if not combined with AZT or other
drugs. What is important is that this study is testing a
new approach to HIV treatment -- one which could readily be
applied if it is found to be helpful, since the drug
already exists and has been extensively used in patients.

For More Information

To find out more about this trial, patients or doctors can
call either Anna Smith, R.N. at 415-476-9296 ext 313, or
Brad Hare, M.D., at 415-514-0550 ext 360.

References

1. Suzuki F, Kobayashi M, Curry J, and others. The
induction of macrophage inflammatory protein (MIP)-alpha by
Z-100, a M. tuberculosis-derived arabinomannan, in cultures
of peripheral blood mononuclear cells (PBMC) from patients
with HIV infection. ABSTRACTS OF THE GENERAL MEETING OF THE
AMERICAN SOCIETY FOR MICROBIOLOGY, May 30 - June 3, 1999
[abstract V-30].

2. Sasaka H, Nomoto K, Pollard RB, and Suzuki F. M.
tuberculosis-derived arabinomannan (Z-100) enhances the
anti-HIV activity of zidovudine (AZT) in cultures of human
peripheral blood mononuclear cells. ANTIMICROBIAL AGENTS
AND CHEMOTHERAPY. 1998; September 24-27; 38:368 [abstract
I-18].


***** Africa Access: Moving Fast, Outcome Uncertain

Commentary by John S. James

Two years ago almost nothing was being done about access to
medical treatment in Africa and other developing countries;
today so much is happening that nobody could make a
complete list. Powerful people and institutions are looking
for a path forward. Clearly, workable solutions are within
reach -- and providing this treatment could be much less
costly than generally believed. But even though it is
feasible to distribute AIDS drugs in developing nations,
there is no guarantee it will happen.

The biggest problem now is lack of leadership on this issue
by governments and other major institutions. So the
immediate need is to find enough consensus among the
different stakeholders to induce governments to exercise
responsible leadership. But with most of the pharmaceutical
industry long opposed to any workable plan for widespread
access to treatment in developing countries, finding
consensus may be difficult. [For a fascinating and
appalling history of the global decisions not to provide
HIV/AIDS treatment to the poor, see Barton Gellman, "An
Unequal Calculus of Life or Death," WASHINGTON POST,
December 26, 2000, available at:
http://www.washingtonpost.com/wp-
dyn/world/issues/aidsinafrica/A51719-2000Dec26.html ]

Solutions Are Possible

The bottom line for any program on treatment access is
whether it actually makes treatment available. It is not
enough to generate press releases and heartwarming media
stories alone, as if to satisfy public demand until the
world's attention turns to something else. By this standard
there has been only one success so far: generic drug
manufacture and distribution, as in Brazil, and generic
competition to bring prices down. Pharmaceutical-company
discounts which still leave the drugs unaffordable, or
company "charitable" type programs which treat a select few
if they treat anybody at all, have not worked so far
(although these approaches cannot be ruled out for the
future).

But generic manufacture and competition will not solve the
problem by itself. Brazil can afford to treat its AIDS
patients at generic drug prices. But many African
countries, with much less money per person and a far higher
proportion of their population infected, cannot.

Jeffrey D. Sachs, a leading economist at the Harvard
University Center for International Development, recently
told the annual Retroviruses conference in Chicago, and
other forums as well, that government leadership is key,
and that without it, pharmaceutical-company programs could
not be expected to succeed on their own. He showed that the
resources required for assisting African and other poor
countries in controlling the epidemic (including access to
treatment, which is now recognized as a key element of HIV
prevention campaigns) would be a minor expense for the
world. He has outlined a solution in which pharmaceutical
companies follow through on their promises to drop prices
sufficiently in developing counties, governments respect
the companies' property rights, and rich countries together
contribute several billion dollars a year to buy the drugs
at the discounted prices. (You can hear Dr. Sachs' talk to
the Retroviruses conference at
http://www.retroconference.org -- select 'Hear the
Lectures', then select his address, "From Talk to Action in
Fighting AIDS in Developing Countries," and click the
button to start playback.)

There is no quick or total solution to making HIV or other
medical treatment available to everyone in the world. But
the AIDS community and others must urge governments and
other major institutions onto a path that will bring steady
improvement, by supporting doctors and others who are doing
the work, giving them the tools they need to be more
successful.

Why Treatment Will Cost Less Than It Seems

Until recently it was popular to estimate the cost of
providing HIV treatment to the 90% of people with AIDS now
denied it, by multiplying the price of the drugs (usually
$10,000 or $15,000 per year) by the number of persons
estimated to have HIV in developing countries -- resulting
in a figure of hundreds of billions of dollars per year in
drug cost, which of course could not be raised, thereby
ending discussion. This multiplication was never realistic,
for several reasons.

First, most people with HIV do not know they are infected,
and are not seeking medical care (and for many with
asymptomatic HIV, antiretroviral drugs would not be
recommended immediately even if cost were no obstacle).
There is no way around the fact that during the foreseeable
future, any treatment-access program contemplated for the
poorest countries will mostly treat those who are
symptomatic and come in for care. So already the cost of
providing treatment is reduced to a fraction of what had
been computed.

Even more important for limiting cost, the prices of the
drugs in poor countries can be reduced about 30 times or
more from current U.S. retail prices. On February 6, the
Indian generic manufacturer CIPLA offered to sell a triple-
combination HIV treatment (d4T, 3TC, and nevirapine) for
less than a dollar a day to MSF (Doctors Without Borders);
it offered a price of $600 per year to governments. So on
top of the reduced number of patients comes an
approximately 30-fold reduction in drug costs. The offer
itself has changed public awareness and generated much
discussion.

And the $350 price is available today. By the time much of
Africa is being treated there will have been huge scale-ups
in the manufacturing, resulting in further drug price
reductions.

In addition, researchers are now testing intermittent
schedules, such as one week on and one week off for certain
antiretroviral regimens, in the hope of reducing side
effects as well as drug cost; a team at the U.S. National
Institutes of Health reported early results at the recent
Retroviruses conference (Dybul M, Fauci AS, and others,
Short-Cycle Intermittent HAART: A Pilot Study, 8th
Conference on Retroviruses and Opportunistic Infections,
Chicago February 4-8, 2001, Abstract #354). Unfortunately
nevirapine probably could not be used in this way, because
it has a long half life in the body and would remain
present at low levels after the other drugs were
eliminated, creating conditions for HIV to develop
nevirapine resistance; a protease inhibitor might be used
instead.

Another huge cost reduction is less obvious and has been
largely overlooked. On February 23 the WALL STREET JOURNAL
reported that there was no great rush by governments to
take up the CIPLA offer of treatment at $600 per patient
per year ("Economy: Offer to Sell AIDS Drugs at a Discount
in Africa Is Met with Caution, Uncertainty.") That is not
really news; there was no reason to expect a rush. At
previous prices (around $10,000 per year per patient), the
issue was never on the table for African governments. And
providing AIDS treatment to a population which has not had
it is more than a matter of deciding to buy drugs;
professional and public education, training, management of
side effects, and many other infrastructure problems need
to be addressed. Until now there was no reason to develop
this infrastructure, since access was hopeless anyway due
to the prices of the drugs. Now planning can begin; but
doctors, officials, organizers, activists, and others need
to hear about the new availability and development
treatment and distribution plans to put on the table for
their governments, which then need to act. All this does
not happen in 17 days (the time between the CIPLA
announcement and the WALL STREET JOURNAL article).

So in addition to the other factors which greatly reduce
the cost of providing AIDS treatment to poor countries,
there is the slow scale-up -- which not only delays
expenses, but also eliminates some of them, since mistakes
and inefficiencies can be found and corrected while
programs are relatively small.

And finally, though it is hard to calculate, the remaining
costs of treatment must be offset against the costs of not
providing it. Opportunistic infections, hospitalization or
other care, faster spread of HIV, faster spread of
tuberculosis and other diseases, sick time, funeral leaves
for workers (sometimes for services many miles away), loss
of teachers, the need to replace trained workers, care of
orphans, the list goes on.

Who Will Negotiate?

How will the different stakeholders work together toward
serious government leadership on the AIDS epidemic? This is
the most difficult issue.

We have followed developing-country treatment access for
years, but it has been hard to find anyone in industry to
talk to about it. Pharmaceutical-company officials have
been either uninformed about the issue or unwilling to
address it, or fanatically committed to defending their
intellectual-property rights to the exclusion of everything
else (including the tens of millions of people being left
to die). The obvious group to address this issue, PhRMA
(the Pharmaceutical Research and Manufacturers of America),
has been even more fanatical than the companies it
represents -- still denying that intellectual property is
an issue, even while thousands of patients die for no other
reason except that fluconazole and other drugs are patented
and priced completely out of reach of their doctors, who
cannot buy affordable generics in India or elsewhere
because of patent laws. (PhRMA cites other problems, such
as infrastructure and corruption, which are also real --
though less able than intellectual property to stop
discussion cold and take everything off the table).

Reading African press reports on these struggles shows a
different world from that painted by pharmaceutical-company
statements released for rich country public consumption.
Even when patent and trade laws technically allow
exceptions, pharmaceutical companies and their money have
been active behind the scenes, in the superpower
government, the local governments, international agencies,
the business community, and elsewhere, to block solutions
they see as any possible symbolic threat to patent rights
in rich countries. (They care little about lost sales in
poor countries, since their markets there are negligible;
they do care about precedents, ideas, or information that
might erode patent rights or prices elsewhere.)

Also, who will speak for the AIDS community? Industry might
do what it has done in other areas -- create a hand-picked,
kept community of organizations which have names or
numbers, but have not been involved in international
treatment access, or are financially dependent on industry,
or which otherwise can be controlled. Today the kept
community is becoming a standard public-relations strategy,
and AIDS treatment activists are alert to prevent it from
happening here.

A result of industry rigidity on intellectual property vs.
treatment access in developing countries is that activists
have had little opportunity for industry dialog, and no way
to act except through opposition. It has long been clear
that industry would not cooperate meaningfully on treatment
access in poor countries (this might or might not change in
the future). The only possibility of success was the
development of a public insistence too strong to be
stopped.

We are mostly optimistic as the current confusion sorts
itself out. A key organization will be MSF (Doctors Without
Borders). It has credibility on this issue, and credibility
in the larger world as well -- although it could do better
in explaining this issue to the public. It might become the
cornerstone of a forum where the different interests come
together to discover what common ground could be found.

An Impossible Dream?

Recently a reporter mentioned the possibility that the
pharmaceutical industry could "get religion." As strange as
it seems, we cannot see any economic or other reason why it
would be impossible.

Under the current system, now being imposed around the
world by the WTO treaty, governments must give
pharmaceutical companies monopolies over life and death
treatments, so that the companies can charge high prices
for patented drugs in order to pay for research, and reward
investment. Society demands nothing from the industry
beyond quality control, and general obedience to the law.
So companies are free to use their money to corrupt medical
research, medical publishing, medical practice, patient
advocacy, governments at all levels, and international
institutions. They are not even expected to maintain
adequate supplies of life-critical medications in rich
countries, let alone research diseases that affect mostly
poor regions, or give any thought or plan for access to
life-critical medicines outside of lucrative markets. There
is also no control over "incestuous drugs," even in rich
countries -- the mis-design of clinical trials to promote a
manufacturer's products instead of testing the treatments
which are best for patients. In the last year this system
has changed little, but the public has become much more
aware of it, through in-depth reports in leading national
newspapers and medical journals. These issues are not going
away; and if the pharmaceutical industry will not change
voluntarily, it is likely to have changes imposed.

Pharmaceutical patents are different from most patents not
only because the product can be essential to life. They are
also different because human beings have risked their
health or their life in clinical trials to get these
products tested. (This should be remembered when the United
States threatens other nations with economic retaliation if
they use publicly available clinical-trial data to approve
drugs competing with those of U.S. companies, on the
grounds that registration data is proprietary, and its use
to approve drugs within those countries is an unfair trade
practice.)

Would it be possible to change public opinion and business
and legal practice, so that holding a patent on a life-
critical medical treatment would be regarded as a calling,
as well as a business? There is a precedent in the
traditional role of the physician, who until recently was
also well rewarded, but with the understanding that the
practice of medicine was not only a business, but involved
more than just making of a buck.

Could we ask that proprietary pharmaceutical companies be
the leaders in the public interest around the use of their
patented medicines -- be out in front of everybody else in
advocating their best use, not just maximum sales?

Such a social contract would be expressed partly in law, as
it has been with physicians. But widely shared, less formal
expectations can also be effective. A pharmaceutical
company cannot be successful without the cooperation of
many people -- including investors, doctors, scientists,
corporate partners, politicians, and regulatory officials.
If any social contract is serious, then how well or how
badly a company fulfills its obligations will be weighed by
many people in deciding whether or not to do business with
the company.

Public-interest leadership need not cost money. Last week
in New York, about 60 ACT UP New York and other activists
visited a Glaxo SmithKline meeting for investors, to
protest the company's role in the March 5 pharmaceutical-
industry lawsuit against South Africa to block its
medicines reform law; about 20 of them entered the room.
Later, financial analysts were asked about the issue, and
were quoted as saying that Glaxo could sell its drugs in
Africa at cost without losing money.

But sometimes profit motive and public interest would
conflict -- as when a marketing department wants to use a
questionable or unethical promotional campaign. How could
incentives be designed to handle this situation?

One possibility is that companies large enough to own FDA-
approved patented pharmaceuticals would be expected to have
a public-interest department reporting directly to top
management -- not to marketing. This department would focus
on creative ways of advancing the public interest, more
than on saying No to company projects. But sometimes it
would say No, and then the issue would go to management to
make the decision -- and be responsible for it.


***** South Africa Lawsuit: March 5 Worldwide Protest
Information

On March 5 many of the world's biggest pharmaceutical
companies go to court in South Africa, against the South
African government's post-Apartheid reform of its medicines
law. For three years this lawsuit has kept South Africa
from implementing its reforms. The March 5 protest,
organized on short notice after the trial date was
scheduled, now includes actions in Australia, Brazil,
Canada (Toronto and Vancouver), France, Germany, Italy,
Philippines, South Africa (Cape Town, Durban, Pretoria),
Thailand, United Kingdom (Birmingham, Crawley, Kent,
London, Manchester, and other cities, see
http://www.resist.org.uk), and the United States (Berkeley,
Boston, New York, Philadelphia, Washington).

The Treatment Action Campaign in South Africa maintains the
latest list on its Web site:
http://www.tac.org.za

The TAC site also has a background paper on the South
African law and the industry lawsuit.

Also see:

* WASHINGTON POST February 24 editorial, "Patent Wrongs,"
available at:
http://washingtonpost.com/wp-dyn/opinion/A49618-2001Feb24.html

* THE NEW YORK TIMES February 25 editorial, "Fighting AIDS
in Africa."

* THE PEOPLE (Kenya) February 26 editorial, "AIDS Generic:
Patent Laws Killing Kenyans."



***** AIDS TREATMENT NEWS Publication Schedule, February-
March 2001

AIDS TREATMENT NEWS is usually published on the first and
third Friday of each month. This year our February issues
have been delayed, due to our move from San Francisco.

To reduce confusion later, we are publishing two February
issues; these will be dated February 23 (the last Friday in
February), and February 28 (the last day in February).


***** AIDS TREATMENT NEWS

Published twice monthly

Subscription and Editorial Office:
   1233 Locust St., 5th floor
   Philadelphia, PA 19107
   phone 800/TREAT-1-2 toll-free, or 215-546-3776
   fax 215-985-4952 (email is preferred)
   email: aidsnews@...
   useful AIDS links: http://www.aidsnews.org

Editor and Publisher: John S. James
Associate Editor: Tadd T. Tobias

Statement of Purpose:
AIDS TREATMENT NEWS reports on experimental and standard
treatments, especially those available now. We interview
physicians, scientists, other health professionals, and
persons with AIDS or HIV; we also collect information from
meetings and conferences, medical journals, and computer
databases. Long-term survivors have usually tried many
different treatments, and found combinations that work for
them. AIDS TREATMENT NEWS does not recommend particular
therapies, but seeks to increase the options available.

AIDS TREATMENT NEWS is published 24 times per year, on the
first and third Friday of every month, and print copies are
sent by first class mail. Email is available (see below).
Back issues are available at http://www.aidsnews.org

To subscribe, you can call 800-TREAT-1-2 or 415-255-0588:
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email available (see below).
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cannot afford a subscription, please write or call about
our sliding scale.
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ISSN # 1052-4207

Copyright 2001 by John S. James. Permission granted for
noncommercial reproduction, provided that our address and
phone number are included if more than short quotations are
used.

AIDS TREATMENT NEWS Issue #359, January 26, 2001
     phone 800-TREAT-1-2, or 215-985-4448

CONTENTS:

** Retroviruses Conference: Live Telephone Report Feb. 7
Hear a toll-free one-hour summary from the major scientific
AIDS conference of 2001, from experts who can answer your
questions -- or hear a recording of the call later.

** First HIV Vaccine for Africa Begins Trials
The first vaccine designed for an HIV strain prevalent in
Africa is about to begin human trials.

** African Americans and AIDS Conference, Feb. 19-20,
Washington, D.C.: Fauci, Gayle, Primm, Other Speakers
We list some of the major talks at this year's conference
on African Americans and AIDS, which was announced with
short notice.

** United Nations AIDS Session: Email Input Sought
Nonprofits and others have been invited to contribute to
preparation for the United Nations General Assembly Special
Session on AIDS, through an online forum available
throughout the world.

** March 5: "Global Day of Action against Drug Company
Profiteering," as Pharmaceutical Companies Sue South Africa
to Block Low-Cost Medicines
Worldwide protests are planned as international
pharmaceutical companies sue South Africa to block post-
apartheid medicine reforms.

** Africa Treatment Access: Contact President, Congress on
Africa Executive Order
The Bush Administration is considering whether to revoke
current U.S. policy not to retaliate against African
countries which seek affordable AIDS medicines through
World Trade Organization rules -- unless they also meet
additional intellectual-property restrictions which U.S.
pharmaceutical companies want.

** News Flash: Brazil; South Africa Lawsuit Letter

** Hepatitis C, Co-Infection Information Recommended
A leading activist particularly recommends two Web sites.

** AIDS TREATMENT NEWS Contacts, Schedule Update
New direct phone number, fax and email update.

** San Francisco Data Show HIV Rates Still Rising, Experts
Say
The best available information shows a continuing increase
in the proportion of HIV-negative gay and bisexual men who
become infected each year -- with those over age 25 at
greater risk than those under 25.


***** Retroviruses Conference: Live Telephone Report Feb. 7

A free one-hour telephone conference with a panel of
leading physicians, allowing you to ask questions, will
report highlights of the important Retroviruses conference
(8th Conference on Retroviruses and Opportunistic
Infections, February 4-8, 2001, in Chicago). The call will
take place February 7, 2001, 5 p.m. Pacific / 6 p.m.
Mountain / 7 p.m. Central / 8 p.m. Eastern time; to
participate, you need to register in advance.

The panelists will be:

* Calvin Cohen, M.D., Research Director, Community Research
Initiative of New England, and HIV Consultant, Harvard
Vanguard Medical Associates;

* David Cooper, M.D., Professor of Medicine and Director,
National Centre in HIV Epidemiology and Clinical Research,
University of New South Wales, Sydney, Australia;

* Steven Deeks, M.D., San Francisco General Hospital AIDS
Program;

* Roy Gulick, M.D., Director, Cornell University Clinical
Trials Unit, New York City;

* Michael Saag, M.D., Professor of Medicine, Division of
Infectious Diseases, University of Alabama at Birmingham
(UAB) and Director of the AIDS Outpatient Clinic at UAB;
and

* Ron Baker, Ph.D. (moderator), Editor-in-Chief, HIV and
Hepatitis.com

To register and get the phone number and instructions for
calling, call 1-800-880-5121 between 8:30 a.m. and 5:30
p.m. Eastern time, Monday through Friday.

Later, you can hear a recording of the call, by calling 1-
888-207-2647 and entering passcode 5253.

Note: For more in-depth information during and after the
conference, there will be many reports on the Web, and on
treatment email lists; we will also cover some of the
presentations in the next two issues of AIDS TREATMENT
NEWS. The telephone briefing provides a convenient
overview, and allows live questions of the panelists.


***** First HIV Vaccine for Africa Begins Trials

On January 27 IAVI (the International AIDS Vaccine
Initiative) announced that the first HIV vaccine designed
specifically for Africa will begin human trials, after
approval by the government of Kenya. From the IAVI
announcement:

"The preventive vaccine candidate is based upon subtype A
of HIV, the most common strain in East Africa. The vaccine
candidate is the product of an International AIDS Vaccine
Initiative-funded partnership between the research teams of
the Medical Research Council's Human Immunology Unit at
Oxford University in the United Kingdom and the University
of Nairobi.

   "It will be tested in a new, state of the art research
facility at the University of Nairobi, which was officially
opened by Kenya's Minister of Public Health, the Hon.
Professor Sam K. Ongeri, in December. Recruitment for the
trial began in December, and several of the 18 volunteers
needed for the Phase I trial have already been screened.

   "The partners also announced a new agreement under which
all existing and future patents covering the vaccine
candidate will be owned jointly by the Medical Research
Council, the University of Nairobi and the International
AIDS Vaccine Initiative (IAVI). The partners agreed to use
their patent ownership to help ensure access to a
successful AIDS vaccine in Kenya and in other developing
countries."

In other vaccine news, on January 29 Bill Gates gave a $100
million "challenge grant" (to be matched by other
contributions) to IAVI, to develop this or other AIDS
vaccines. Internet company Yahoo! then contributed $5
million.


***** African Americans and AIDS Conference, Feb. 19-20,
Washington, D.C.: Fauci, Gayle, Primm, Other Speakers

The 2001 National Conference on African Americans and AIDS
will take place February 19-20, 2001 at the Washington D.C.
Renaissance Hotel, 999 9th Street NW, Washington D.C. Due
to the late notice this year, registrations will be
accepted at the door, and conference organizers are
determined that no one will be turned away.

This conference comes shortly after news of disastrous
rates of HIV infection among gay African Americans and
other minorities. An epidemiological study in New York City
found HIV infection rate now more than 10 times as high
among African Americans than among whites (33% vs. 2%) in
gay men age 23-29. The researchers found no behavioral risk
factor which could explain the difference. The study, by L.
Torian and others, will be presented at the Retroviruses
conference in early February; a report appeared February 24
in New York Newsday.

Program of February 19-20 Conference

The current program includes:
* Sandra L. Thurman: Africa Update
* Special guest speaker: topic to be announced
* Eric P. Goosby, M.D.: A Bridge to Common Experiences
* Elaine M. Daniels, M.D., Ph.D.: The Epidemiology of HIV
in the United States
* John G. Bartlett, M.D., and Eric P. Goosby, M.D.: The
Kaiser Family Foundation/U.S. Department of Health and
Human Services Treatment Guidelines [new guidelines, to be
released in early February].
* Valerie Stone, M.D.: The Clinical Management of the
HIV/AIDS Patient
* Robert C. Gallo, M.D.: New Approaches to Therapy
* Working lunch: panel, with Phill Wilson moderator
* Anthony S. Fauci, M.D.: Drug Holidays, Structured
Treatment Interruptions, and Structured Intermittent
Therapy
* Jonathan Zenilman, M.D. and Celia J. Maxwell, M.D.
F.A.C.P.: Men, Women, and Sexually Transmitted Diseases
* David L. Thomas, M.D., J.D.: Hepatitis and HIV
* Henry "Skip" Francis, M.D.: Legal and Illegal Drug Use
* Cornelius Baker: topic to be announced
* Robert Fullilove III, Ph.D.: Does Culture Affect
Adherence?
* Helene Gayle, M.D., Ph.D.: The Life
Initiative/Epidemiology -- A Focus on Africa
* Beny J. Primm, M.D.: Special remarks
* Jean R. Anderson, M.D., and Lynne Mofenson, M.D.:
Pregnancy, Birth, and HIV Transmission
* Speaker to be announced: Women's Issues
* Deborah Parham, M.D.: Ryan White and the Challenge of
Africa
* Working lunch: panel, focus on women with female partners
* Glenn J. Triesman, M.D., Ph.D.: Psychiatric Issues
* William H Ruby, M.D.: Incarcerated Populations
* Phill Wilson: topic to be announced
* Stephen B. Thomas, Ph.D.: Closing Remarks

Registration

Registration: There is no fee to register, and the
registration desk will remain open through the conference.
It is best to register early, by contacting Stacey Everett
at Firehouse Event Planning, phone 609-936-1966, fax 609-
936-0479.

Continuing education credit: 16 hours Category One, no fee.

Funding

This program is funded through unrestricted educational
grants provided by:
* Bristol-Myers Squibb Company
* GlaxoSmithKline
* The Body.Com
* The U.S Health Resources Services Administration HIV/AIDS
Bureau
* Serono Laboratories, Inc.
* OraSure Technologies, Inc.
* Roche

Comment

At a time of growing problems around the pharmaceutical
industry and its relationship to individual and public
health goals, the program stands out as a clear success.
For the first two years it was funded entirely by Bristol-
Myers Squibb; this year funding is from multiple sources.

Yes, the conference serves a marketing purpose, since more
attention on this issue will probably result in more
African Americans with HIV receiving medical care -- and
some of them will use the sponsors' high-profit
antiretrovirals. But here the corporate purpose is
consistent with the public goal of getting people with HIV
into medical care, so that they and their doctors can make
informed decisions about what treatment, if any, to begin.
In this case, public and commercial goals coincide.


***** United Nations AIDS Session: Email Input Sought

Civil society throughout the world (including nonprofits
and businesses, especially in developing countries) has
been invited to participate in a United Nations General
Assembly Special Session on HIV and AIDS, June 25-27, 2001.
For most organizations it will be difficult to participate
in person, but they can join a special email discussion
forum set up to hear information and views in preparation
for the official meeting. The best time to join the email
discussion is now, because important preliminary meetings
will take place at the end of February.

* For more information about the United Nations special
session see http://www.unaids.org; also see
http://www.hdnet.org (Health and Development Networks,
which "has been commissioned by UNAIDS to help ensure that
NGO and community voices are channeled, in a transparent
way, into the UN General Assembly special session on
HIV/AIDS").

* One possible way to participate in person is through the
official delegation of your government. Also, some
nonprofit organizations already have official status at the
United Nations, and your group might be able to work
through them.

* To join the online discussion group at any time, send an
email to: break-the-silence@... The best time for
participation may be February, since a meeting to organize
the agenda will take place later this month.

Comment

We have heard unofficially that although the United Nations
session itself is in June, the content is likely to be
mostly set by then, so the most important times for
participation will be earlier, especially before February
26 - March 2, and April 23 - 27, which are informal
consultations for government delegates. These meetings will
take place in New York, and civil society organizations
might or might not be able to address the delegates.

For most organizations, the email discussion group will be
the most accessible way to participate.


***** March 5: "Global Day of Action against Drug Company
Profiteering," as Pharmaceutical Companies Sue South Africa
to Block Low-Cost Medicines

by John S. James

On March 5 a lawsuit by several dozen international
pharmaceutical companies against the government of South
Africa is scheduled to go to trial. For three years already
this lawsuit has prevented South Africa from implementing
post-Apartheid reform of its medicine laws. The case has
been little known in the U.S., except for a flurry of
publicity for the pharmaceutical companies when they said
they were suspending it. South Africans pointed out that
suspending the lawsuit (instead of dropping it) still left
them unable to implement their medicine-law reforms -- and
that the companies could resume the case at any time.

On January 19 the Treatment Action Campaign, the leading
AIDS activist organization in South Africa, called for
global day of mobilization and protests on March 5, to
bring attention to the lawsuit and the issues behind it.
For more information, and initial U.S. contacts for
activists, see below.

South African Law at Issue

The companies' major objection is a short part of the law,
Section 15C, which we quote in full:

The minister may prescribe conditions for the supply of
more affordable medicines in certain circumstances so as to
protect the health of the public, and in particular may-

(a) notwithstanding anything to the contrary contained in
the Patents Act, 1978 (Act No. 57 of 1978), determine that
the rights with regard to any medicine under a patent
granted in the Republic shall not extend to acts in respect
of such medicine which has been put onto the market by the
owner of the medicine, or with his or her consent;

(b) prescribe the conditions on which any medicine which is
identical in composition, meets the same quality standard
and is intended to have the same proprietary name as that
of another medicine already registered in the Republic, but
which is imported by a person other than the person who is
the holder of the registration certificate of the medicine
already registered and which originates from any site of
manufacture of the original manufacturer as approved by the
council in the prescribed manner, may be imported:

(c) prescribe the registration procedure for, as well as
the use of, the medicine referred to in paragraph (b).

[Apparently paragraph (b) refers primarily to parallel
importing of medicines made by the patent holder and sold
by the patent holder at discount elsewhere in the world. A
major problem in drug pricing is that large countries and
insurance plans can negotiate discounts, while smaller
countries and individuals often pay much more.]

Comment

The pharmaceutical companies object that Section 15C does
not protect their medicine patent rights. The whole
continent of Africa accounts for less than 1.5% of the
global market in pharmaceuticals, and the companies have
made little effort to market their expensive medications
there. Most observers believe that these companies are less
worried about loss of income from Africa than about the
creation of precedents which might hurt them elsewhere --
especially in the United States, where huge amounts of
drugs are sold at some of the worlds' highest prices, as
the government does not require or negotiate pharmaceutical
prices for its citizens, as governments of other
industrialized countries do.

Last year 2.4 million people died of HIV infection in
Africa; fewer than one in a thousand Africans infected with
HIV get modern treatment. The companies have responded with
much-criticized discount programs, to be negotiated
separately for each country, almost certainly in return for
the countries giving up rights to use generic equivalents
or other measures which could save the lives of their
citizens. These negotiations are some of the most unequal
in history, since delays can cost the countries the lives
of thousands of people, while the companies have nothing to
lose from delay except for the risk of looking bad in the
media. Recently the former deputy director of UNICEF called
these negotiations "a farce; they redefine the meaning of
bad faith" ("J'accuse!: The West is willfully turning its
back on the greatest human tragedy of our age," by Stephen
Lewis, THE GLOBE AND MAIL, Canada, January 26, 2001).

TAC Call for Global Day of Action against Drug Company
Profiteering

[Note: We omitted some sections specific to South Africa,
and marked the omissions with '...'.]

Mobilize Globally and Locally against Drug Company Power!
Produce Generic Antiretrovirals!
Increase Health and Welfare Spending!

2001 promises to be one of the most critical years for
access to HIV/AIDS treatments. In South Africa, the year
will witness attempts by multinational drug companies to
take the South African government to court for trying to
make medicines affordable for all people. TAC will continue
its Christopher Moraka Defiance Campaign against Unjust
Trade Laws and Patent Abuse. TAC will demand that the
government increase its health-care and welfare budgets
substantially to deal effectively with HIV/AIDS...

Mobilize Local and Global Action against Drug Companies

The drug companies - GlaxoSmithKline, Bristol-Myers Squibb,
Boehringer Ingelheim, Merck, Abbott and many others will
try to stop the South African government's attempt to make
medicines affordable to all its people. The law passed by
the country's first democratic Parliament under the
leadership of former President Mandela is now under attack.
TAC calls on all people to oppose the drug companies and to
support the legislation...

Global Action March 5 - March 12, 2001

a.. TAC calls on people in every country to mobilize
against drug company profiteering on Monday 5 March 2001.
On this day, the action by more than 40 multi national drug
companies against the South African government will be
heard in the Pretoria High Court. Millions of people will
die from HIV/AIDS and other illnesses, if the drug
companies succeed in their action. TAC specifically calls
on our allies Medecins Sans Frontičrs, Health Gap
Coalition, ACTSA and all the organizations who endorsed to
Global March for HIV/AIDS Treatment Access to mobilize. A
victory for the drug companies in this case will set back
the struggle for access to essential medicines in all
countries. TAC will mobilize actions against drug companies
throughout the week 5-12 March 2001...

Email: info@...
Website: http://www.tac.org.za

U.S. Contacts for March 5 Mobilization (as of January 28)

East Coast: ACT UP Philadelphia, 215-731-1844,
katie@...

West Coast: John Iversen, ACT UP East Bay, 510-568-1680,
johnnyi@...

For More Information

Check the following Web sites for information on this
lawsuit, and on the issues behind it:
http://www.tac.org.za
http://www.globaltreatmentaccess.org
http://www.healthgap.org

The pharmaceutical industry's case for opposing Section 15C
is stated in SUBMISSION OF THE PHARMACEUTICAL RESEARCH AND
MANUFACTURERS OF AMERICA (PhARMA) FOR THE NATIONAL TRADE
ESTIMATE REPORT ON FOREIGN TRADE BARRIERS, 2001 (November
27, 2000), section on South Africa (pages 150-152); it is
currently available at:
http://www.phrma.org/intnatl/news/2000-11-27.23.pdf


***** Africa Treatment Access: Contact President, Congress
on Africa Executive Order

by John S. James

According to recent news reports, the Bush Administration
is considering revoking the executive order Clinton signed
last May, that the U.S. would not require stricter patent
protection of AIDS medicines in Sub-Saharan Africa than is
required by the intellectual-property provisions of the
World Trade Organization. This executive order applies only
to Africa, and only to HIV/AIDS medications. It is opposed
by pharmaceutical companies.

We suspect that this news story was leaked in order to test
the political strength of supporters of treatment access
for Africa, vs. that of the pharmaceutical industry.
Although this industry has given millions of dollars of
campaign contributions, mostly to Republicans, no one knows
how President Bush will decide to handle this issue.

The Africa Policy Information Center
(http://www.africapolicy.org) provided some background in
an alert emailed on January 26:

"President Bush, after only three days in office, is
reportedly considering reversing President Clinton's
executive order preventing the U.S. from retaliating
against African nations that seek to draw upon entirely
legal provisions within the World Trade Organization to
secure affordable medicines for the treatment of HIV/AIDS.
The pharmaceutical industry, one of his largest corporate
contributors, has aggressively sought to prevent African
nations from using compulsory licensing and parallel
imports to obtain these medicines cheaply..." [This alert
is at
http://www.africapolicy.org/adna/hiv0101c.htm ]

Action

Write or call President George W. Bush at the White House,
Washington D.C. 20500, or 202-456-1111.

Write to your Senators at the U.S. Senate, Washington, D.C.
20501, and to your Congressional representative at the U.S.
House of Representatives, Washington, D.C. 20515, or call
their local or Washington offices. Make sure it is clear
that you are a constituent.

Talking points:

* The AIDS crisis is one of the great disasters in history,
and is worst in Africa;

* Brazil has achieved huge success in getting HIV treatment
to those who need it, greatly reducing both AIDS deaths and
new infections (see THE NEW YORK TIMES MAGAZINE, Sunday
January 28, 2001, cover story, "How to Solve the World's
AIDS Crisis," by Tina Rosenberg; also see THE WASHINGTON
POST, September 17, 2000, "Brazil Becomes Model in Fight
Against AIDS," by Stephen Buckley, page A22). The United
States should not use its economic power to stop Brazil, or
stop African countries from creating similar programs (see
"News Flash: Brazil..." in this issue).

* The pharmaceutical-company plans for discounts or free
drugs announced to date are unlikely to ever reach more
than a tiny minority of Africans who need treatment.

* The current executive order will not reduce profits for
future research and development, since all of Africa makes
up less than 1.5% of the global pharmaceutical market. Only
one in a thousand Africans with HIV are receiving modern
treatment today, and the vast majority who are priced out
of the market generate no profit or incentive for drug
research and development.


***** News Flash: Brazil; South Africa Lawsuit Letter

As this issue went to press:

(1) The World Trade Organization is convening a panel on a
United States complaint against Brazil's internationally
praised AIDS program, which manufactures low-cost generic
copies of antiretroviral drugs and makes them available
without charge to patients. "The U.S. complaint threatens
the Brazilian AIDS policy, which includes providing free
drugs to HIV infected people. The lives of hundreds of
thousands of patients depend on this system," says Bernard
Pecoul, director of MSF's (Doctors Without Borders') Access
to Essential Medicines campaign. "The US action will also
intimidate countries which would like to take up Brazil's
offer to help them produce AIDS medicine." More than 120
Brazilian AIDS organizations have called for support of the
Brazilian program.

More information will be available at:
http://www.globaltreatmentaccess.org

(2) AIDS activists and organizations are circulating a
community sign-on letter to all of the pharmaceutical
companies that are parties to the March 5 lawsuit against
South Africa. The letter and instructions for signing are
at:
http://www.globaltreatmentaccess.org


***** Hepatitis C, Co-Infection Information Recommended

Activist Brian Klein of the Hepatitis C Action and Advocacy
Coalition (HAAC), who is now taking a break from intensive
activism, particularly recommends two Web sites for
hepatitis C information: www.HCVadvocate.org, and
www.HIVandHepatitis.com

Also, "I strongly urge those of you who are advocates to
participate in the National Hepatitis C Advisory Council.
This organization is moving in a positive, ethical and
powerful direction to help to unify our community to work
on our common needs. And many of the state coalitions
initially set up by Schering-Plough are now being
administered by non-profit organizations. The involvement
of people living with hepatitis C in setting the agendas
for these coalitions is crucial."


***** AIDS TREATMENT NEWS Contacts, Schedule Update

AIDS TREATMENT NEWS moved to Philadelphia starting January
2. We apologize for delays and glitches which have occurred
during this move.

We now have our direct phone line, so we can be reached
either toll-free at 800-TREAT-1-2, or at 215-546-3776; both
numbers come in on the same line, so there is no need to
call twice. Our fax number is 215-985-4952 (be sure to
include "AIDS TREATMENT NEWS" prominently on the cover
page); email is preferred as it will reach us while we are
traveling.

Our best email address is aidsnews@...

Our mailing address is:
AIDS Treatment News
c/o Philadelphia FIGHT
1233 Locust St., 5th Floor
Philadelphia, PA 19107

Mail forwarding: Mail to the old P.O. box in San Francisco
was not forwarded correctly, and mail arriving there after
January 2 will not reach us until February. We apologize
for inconvenience to our correspondents.

Publication schedule: Our next issue will be delayed,
allowing coverage of the Retroviruses conference (February
4-8).


***** San Francisco Data Shows HIV Rates Still Rising,
Experts Say

by Bruce Mirken

The rate of new HIV infections among gay and bisexual men
in San Francisco is continuing to rise, a panel of experts
said January 24. The group of epidemiologists, city health
officials and AIDS prevention experts convened in a special
"consensus meeting" estimated that 2.2 percent of gay and
bisexual men who don't inject drugs and 4.6 percent of
gay/bisexual injection drug users will become newly
infected this year.

If correct that translates to 892 new seroconversions in
San Francisco, more than double the estimate reached at the
last consensus meeting in 1997 and a marked increase over
last year's interim estimate of 716 new infections per
year. And--contrary to popular stereotypes--the data the
scientists reviewed consistently showed that men over age
25 were more likely to seroconvert than those under 25.

The experts estimated annual seroconversions among male-to-
female transgendered individuals at 7.8 percent, or 152.
Time constraints prevented the group from evaluating data
on heterosexuals, including heterosexual injection drug
users; a second meeting covering those estimates will take
place in February.

The current report is in draft form only and will be
finalized after a two week public comment period. Still,
Mike Shriver, AIDS advisor to San Francisco Mayor Willie
Brown and a longtime AIDS activist, termed the data
discussed at the meeting "frightening."

The new estimates, extrapolated from several studies that
measured seroconversion rates in various samples of the
city's gay/bi male population, were hashed out over nearly
five hours January 19. Because last year's announcement
proved controversial--in part because it hit the press
before city officials expected, producing a jumble of
sometimes inconsistent statements--Shriver took the unusual
step of inviting four journalists to observe the meeting.
All discussions were on the record, but the journalists--
this reporter and staff reporters from the SAN FRANCISCO
CHRONICLE, BAR AREA REPORTER and SAN FRANCISCO FRONTIERS--
were asked not to publish the numbers until they were
released for public comment January 24.

All involved acknowledged that the process is imperfect and
that the figures are estimates, not hard numbers. HIV is
not a reportable condition in California and the ideal
research design--large "population-based" studies--is
expensive, cumbersome and thus fairly rare. So the
scientists had to try to review, interpret and synthesize a
variety of studies looking at specific groups of men who
don't necessarily constitute a representative cross-section
of the city's gay and bisexual population--a job rather
like trying to assemble a jigsaw puzzle with many of the
pieces missing.

Two University of California San Francisco researchers,
Susan Buchbinder and Cynthia Gomez, presented new,
unpublished data for the group to consider. Buchbinder
discussed results from two AIDS prevention studies, a
behavioral intervention study and vaccine study, and
compared them to the numbers from two roughly comparable
studies done in the early nineties. All involved HIV-
negative men who have anal sex and are thus at relatively
high risk for HIV infection.

The men in the new studies had a combined seroconversion
rate of 4.2 percent per year, compared to 2.2 percent and
2.7 percent in the earlier research. Nine percent reported
having unprotected receptive anal sex with partners they
knew to be HIV-positive--about triple the previous rate--
while an even larger percentage had unprotected receptive
anal sex with partners of unknown status.

Optimism about improvements in HIV treatment may be
contributing to the increase in risky behavior. 13 percent
of the men agreed that they are "less concerned about
having sex without a condom" due to the existence of
combination anti-HIV treatments, while 21 percent said that
treatment reduces a person's infectivity.

Gomez discussed data from the Seropositive Urban Men's
Study, which looked at HIV positive gay and bisexual men in
San Francisco and New York. Most of the men's sexual
partners were of unknown HIV status, Gomez said, noting
that researchers found "no difference" in results from the
two cities. And--in a number that mirrored Buchbinder's
findings--nine percent said that they had had unprotected
insertive anal sex in the last 90 days with partners they
knew to be HIV negative.

"That's the data that kept me up that night," Shriver said.

The most optimistic numbers came from the San Francisco
Young Men's Health Study, which since 1992 has tracked a
large group of gay/bi men who were under age 30 when it
began, which reported a seroconversion rate of 1.8 percent
per year.

Though most of the studies evaluated showed annual new
infection rates of four percent or higher, the group chose
to err on the side of being conservative. The comments from
most of the researchers indicated they thought the 2.2
percent per year figure is an underestimate.


***** AIDS TREATMENT NEWS

Published twice monthly

Subscription and Editorial Office:
   1233 Locust St., 5th floor
   Philadelphia, PA 19107
   800/TREAT-1-2 toll-free
   email: aidsnews@...
   useful links: http://www.aidsnews.org

Editor and Publisher: John S. James
Associate Editor: Tadd T. Tobias

Statement of Purpose:
AIDS TREATMENT NEWS reports on experimental and standard
treatments, especially those available now. We interview
physicians, scientists, other health professionals, and
persons with AIDS or HIV; we also collect information from
meetings and conferences, medical journals, and computer
databases. Long-term survivors have usually tried many
different treatments, and found combinations that work for
them. AIDS TREATMENT NEWS does not recommend particular
therapies, but seeks to increase the options available.

AIDS TREATMENT NEWS is published 24 times per year, on the
first and third Friday of every month, and print copies are
sent by first class mail. Email is available (see below).
Back issues are available at http://www.aidsnews.org

To subscribe, you can call 800-TREAT-1-2 or 415-255-0588:
* Businesses, Institutions, Professionals: $325/year. Early
email available (see below).
* Nonprofit organizations: $150/year.
* Individuals: $140/year, or $80 for six months. If you
cannot afford a subscription, please write or call about
our sliding scale.
* Outside North, Central, or South America, add airmail
postage: $20/year, $10 for six months.
* Bulk rates and multiple discount subscriptions are
available; contact our office for details.
* Payment can be by check, VISA, Mastercard, American
Express, bank draft, purchase order, international postal
money order, or travelers checks.

Early email: Business, nonprofit and full-rate individual
subscribers can receive an early copy by email, before the
issue is printed--in addition to their regular copy, at no
extra charge. It's OK to direct the email copy to someone
else. Call our office to add email to your subscription.

Free email: Free delivery for individuals (delayed one week).
To subscribe, send a blank email to:
aidsnews-subscribe@egroups.com

ISSN # 1052-4207

Copyright 2001 by John S. James. Permission granted for
noncommercial reproduction, provided that our address and
phone number are included if more than short quotations are
used.

AIDS TREATMENT NEWS Issue #358, January 12, 2001
     phone 800-TREAT-1-2

CONTENTS

** AIDS Treatment Fact Sheets: Interview with Bob Munk, New
Mexico AIDS InfoNet
Widely regarded as the best collection of single-page AIDS
fact sheets, these cover over 100 treatment-related topics;
each is available in both English and Spanish, and is
changed as necessary to remain current.

** Urgent, United Nations AIDS Session, Deadline
February 1, Email Input Any Time
Nonprofits and businesses must apply by February 1 to be
accredited to participate in person in consultations
leading up to this important U.N. session in June. You can
also participate through a special email discussion group,
regardless of the February 1 deadline -- but earlier is
better, as critical preliminary meetings start in
February.

** Nevirapine Warning on Post-Exposure Prophylaxis
Nevirapine should not be used to prevent infection after
HIV exposure, except in unusual circumstances, due to the
risk of side effects. This warning does not affect its use
in HIV treatment, or in prevention of mother to  child
transmission.

** d4T plus ddI: Warning for Pregnant Women
New data suggests that pregnant women may be at increased
risk of lactic acidosis from the combination of d4T and
ddI.


***** AIDS TREATMENT NEWS New Philadelphia Contacts

AIDS TREATMENT NEWS has moved to Philadelphia, and is now
being published with Philadelphia FIGHT. Editorial policies
will not change; John S. James is still editor and
publisher, and remains in complete control of the content.
This move frees us from the administrative work of
maintaining a separate office, and gives us daily contact
with an AIDS service provider running a nonprofit clinic,
Federally funded HIV/AIDS treatment research, and many
education and outreach programs.

Our new address is AIDS Treatment News, Philadelphia FIGHT,
1233 Locust St., 5th floor, Philadelphia, PA 19107. We will
keep our toll-free number, 800-TREAT-1-2; we can also be
reached at the same phone at 215-546-3776. Our new fax
number is 215-985-4952, but email is preferred as faxes may
not reach us while traveling.

We are keeping our email address, aidsnews@...

Because of the move, the first issues of 2001 will be
delayed. And our annual overview article, traditionally
published in the first issue of each year, has been
postponed.

John S. James, AIDS Treatment News


***** AIDS Treatment Fact Sheets: Interview with Bob Munk,
New Mexico AIDS InfoNet

by John S. James

In the three years since it started, the New Mexico AIDS
InfoNet has become widely recognized as perhaps the best
overall collection of single-page fact sheets on AIDS
treatment information. It now maintains over 100 of them,
each in English and Spanish. Topics include background on
HIV and AIDS, blood tests and what they mean, using
HIV/AIDS services, all approved antiretroviral treatments,
many opportunistic infections and their therapies,
alternative/complementary treatments, a separate section on
treatment side effects, and HIV prevention. All are in non-
technical language, and all are available on the Web
(http://www.aidsinfonet.org) plus two printable formats for
clients who may not have computer access. As with other
fact sheets, each one can be read separately as needed;
they do not need to be used in any sequence.

While this project was specifically designed to meet the
needs of clients of AIDS service organizations in New
Mexico, it has a national and international constituency as
well, with currently about half of the Web use coming from
outside the United States. It also provides a model for
presenting certain kinds of information effectively, either
online or off.

Bob Munk, a well-known AIDS activist, started this project
and has written most of the material. AIDS TREATMENT NEWS
interviewed him on December 23, 2000. [JSJ]

* * *

Interview with Bob Munk, New Mexico AIDS InfoNet

JSJ: Why did you first decide to write your own fact
sheets, instead of using existing ones?

Munk: We had to meet specific needs of clients in New
Mexico. It is a large and very rural state, so most clients
tend to be far away from AIDS service organizations. And it
was hard to get information in Spanish, which many prefer
because it is their native language.

We looked at existing fact sheets to see if they could meet
our needs. There were some good ones, but any particular
set had deficiencies. Most had a very limited range of
topics; most had no information at all about any
alternative or complementary therapies, which are of
serious interest to many clients in New Mexico.

Many were badly out of date--for example, a saquinavir fact
sheet in 1998 that said that saquinavir was the only
approved protease inhibitor, or a CMV fact sheet that did
not mention the existence of the intravitreal implants.
Others had a reading level that was too complex; on the
Flesch-Kincaid reading scale they came out at the 11th or
12th grade level. [For writers who want to test their own
documents, Flesch-Kincaid software is available within the
spelling checker of recent versions of Microsoft WORD.]

Another problem with some of the sites is that they might
issue multiple reports on a single topic--such as an
initial writeup, and then later an update when a new
treatment was approved. So the user had to be able to go to
their Web site and identify the different pieces and put
them together, first reading the obsolete report and then
the updates.

In consultation with front-line people--the case managers
of the AIDS service organizations in New Mexico--we agreed
to aim for an 8th grade reading level in a single-page (one
side) fact sheet. We don't consider 8th grade level "low
literacy." But we have heard from our case managers that
when they have a low-literacy client, if they have an
opportunity to sit down and discuss the information, the
fact sheet works as a memory aid to help the client
remember the discussion. The case managers believe that 8th
grade is a useful reading level. I'm not aware of other
fact sheets written at the same or lower level. The U.S.
Centers for Disease Control has some booklets that they
consider low literacy, but I find them almost insulting; I
don't know how well low-literacy clients receive them.

It's totally appropriate to have a wide range of reading
levels, including material that is much more complex or
technical. But service organizations need to be aware of
the range of resources available and try to match them to
the client. There is nothing wrong with a more technical
writeup, as long as the client can digest it. And there is
no reason that everyone with HIV should have a comfortable
familiarity with complex medical terminology.

When we realized there was no set of fact sheets we could
just pick up and use, that we would have to develop our
own, we worked with the case managers to determine the
higher priority topics--which were basic diagnostic tests,
HIV medications, and opportunistic infections.

We also did a survey of New Mexico HIV service providers
and clients. We found that only about 40% of AIDS service
providers had access to the Internet; clearly the figure
for clients would be lower than that. So we knew from the
outset that we had to structure the project for hard-copy
printout. In working with our advisory board we came up
with the format we use: a single sheet with three columns
of text, which is the most readable and user friendly.

Fact Sheets Available Now

JSJ: Recently I counted 114 fact sheets on your site. Could
you summarize the main categories for our readers?

Munk: In the Background Information section we have 11 fact
sheets, including what is AIDS, HIV antibody testing,
several fact sheets on understanding your lab results, and
one on the drug approval process. The web site Background
section also has several links on AIDS epidemiology and
statistics.

We have five fact sheets on prevention topics, including
post-exposure prophylaxis [what to do if you have just been
exposed to HIV].

A section on HIV services includes how to begin, choosing a
doctor, telling others you are HIV positive, participating
in a clinical trial, and how to spot HIV/AIDS fraud.

There are 12 sheets on New Mexico programs--the only ones
which are specific to New Mexico--and the Web site has
links to four Federal programs.

Antiretroviral drugs are covered in several sections. A
general category includes several fact sheets on new drugs
being developed, a chart of drug names and manufacturers,
official treatment guidelines (it will need to be changed
when the new guidelines are released in January), T-cell
tests, viral load tests, resistance tests, the HIV life
cycle, adherence (compliance), and treatment interruptions.

There are also fact sheets on each of the 15 antiretroviral
drugs now approved in the U.S. These are categorized by
drug class: nucleoside analogs, non-nucleoside reverse
transcriptase inhibitors, and protease inhibitors. (There
are also fact sheets for Combivir and Trizivir, which
combine two or three approved antiretrovirals in one pill,
to reduce the number of pills that must be taken each day.)

The "Treatment: Opportunistic Infections" has 24 fact
sheets covering many of the most common opportunistic
infections, and some of the drugs used to treat them.

We have a new section on treatment side effects, including
fatigue, body shape changes, diarrhea, mitochondrial
toxicity, and bone problems.

A "Treatment: Special Topics" section currently has eight
fact sheets on nutrition, vitamins and minerals, drug
interactions, women and HIV, pregnancy and HIV, immune
restoration, hydroxyurea, and interleukin-2 (IL-2).

And the alternative and complementary section has an
overview, Chinese acupuncture, Chinese herbalism, Native
American traditional healing, cat's claw, DHEA, DNCB,
echinacea, essiac, hypericin (St. John's Wort), marijuana,
and silymarin (milk thistle). More will be added.

Our site also includes a huge collection of links to
HIV/AIDS Web sites, over 500 of them by categories. We do
not evaluate or describe these sites, but each month we
verify that each one still exists.

JSJ: Where do you get the information for the fact sheets?

Munk: I scan the email lists, such as AEGIS
(http://www.aegis.org), the daily CDC HIV/STD/TB Prevention
News Update (available through AEGIS, or at
http://www.cdcnpin.org/services/listserv.htm), and
treatment discussion groups, and attend AIDS treatment
conferences. When there is news important enough to go into
a one-page sheet, I revise ours if necessary.

What Should Be in a Fact Sheet or Web Page?

JSJ: What do you believe should be included in each fact
sheet or Web page?

Munk: There are different Internet guides to creating good
material. Some ideas of what should be on Web sites are
fairly consistent.

* There should be a way to find out who is writing the
material, and what are the sources. Our site has
information about me, and about the AIDS Education and
Training Center, where our project is based.

* A site should state whether the material is reviewed by
somebody. Is it just posted, or checked by experts first?

* Each page should have a date on it. Ideally it will be
clear whether that was the date the material was originally
written, the date it was posted, or the date it was last
reviewed and/or updated. Often there is no date; sometimes
you just get a date on a page, and do not know which it
represents.

* For HIV treatment information, the Web site ought to
disclose the sponsorship or source of funding for the
project. Readers should know whether a site is sponsored by
pharmaceutical companies or a single company. On my site I
do not list specific percentages, but we have governmental
funding and corporate funding, and the corporate funding is
from many different firms. If I were looking at a treatment
site, I would feel more comfortable if it had many sponsors
than if it had a single corporate sponsor.

* It helps to have an introductory page stating the purpose
of the Web site. If it's in conjunction with a commercial
venture, that's good to know. If it's educational, that's
also worth knowing.

* A site should be easy to navigate. People should be able
to get in, get what they want, and get out, quickly. And
particularly in a rural area, many people do not have high-
speed access; our site is deliberately not flashy; it has
low graphic content, so pages load quickly.

* None of our pages is terribly long. And we break each
page into sections, and group the section headers at the
top of each page. So as soon as the screen appears, the
reader knows what's below on that page.

* And to make use of the capabilities of the Internet, we
try to cross-link our fact sheets as much as possible. If a
fact sheet on antiretroviral therapy talks about T-cell
counts, T-cell count wording will be linked to the fact
sheet on T-cell tests. If it talks about viral load, it
will link to the viral load fact sheet. If it talks about
specific drugs we have fact sheets on, it will link to
those fact sheets.

* Mechanism for feedback: Is there a way to contact the
site to make comments or ask questions? We have that on
each page.

* Each Web site should have a privacy statement. Ours
states that the logging software records each visit
(including what country you are from, what browser you are
using, and which pages you visit) but does not link this
information to an individual person.

I also have an email update mechanism so that people who
want to be informed of changes get a monthly email from me,
saying what has been changed on the site, so they can go to
the Web and get the new version. If people send me their
email address for this list, I do not disclose it to
anybody at any time for any purpose.

When people use a search engine to look for a particular
topic, they may come into a site several levels down in its
hierarchy. So Web users need to educate themselves about
trying to find the main page for the site. For treatment
information, people need to figure out which sites they
trust. So if you use a search engine and come upon a fact
sheet you like, try to find the main entry page of the Web
site, and educate yourself about the stated purpose of the
site, who reviews the material, who sponsors it, and so on.

JSJ: It's a good idea to have a link to the main page, at
the bottom of every page of the site.

Munk: We have just put that in.

For more information on how to judge medical Web sites, see
Criteria for Assessing the Quality of Health Information on
the Internet, a work in progress, currently 55 pages, at:
http://hitiweb.mitretek.org/docs/criteria.html

The New Mexico AIDS InfoNet

JSJ: How did the New Mexico AIDS InfoNet begin?

Munk: Within New Mexico the HIV/AIDS services are organized
in a managed-care type of model. There are four primary
agencies that serve the entire state. So if we could make
sure that those four agencies (and particularly the case
managers of those agencies) had Internet access, and knew
how to reach treatment information in a form they could
readily print it out and distribute to clients, we would
have a useful resource.

What seemed ideal was to use the Internet not only as a way
of delivering information to the end user, but to leverage
the delivery of information, since the Internet is an ideal
way to update information quickly, and make it available to
people spread over a large area. From the beginning we
wanted have the material in a form that could be printed
*off* the Internet by agencies, and given to clients.
Currently our materials are used in this way by a number of
AIDS service organizations and clinics.

The New Mexico AIDS InfoNet started in 1997, when the state
director of HIV/AIDS services noticed an announcement for a
National Library of Medicine grant for electronic
information. A group of us then met about the needs in New
Mexico. Our first application was turned down. But I
decided to go ahead and start the project anyway, because
it seemed that it would have huge advantages for New
Mexico.

The project began in a statewide, state-funded services
planning agency. That agency lost its major contract at the
middle of 1998, so then the AIDS InfoNet project moved over
and affiliated with the AIDS Education and Training Center
at the University of New Mexico (a satellite of the
Mountain Plains AETC out of Denver). I attached the project
to them, so it's not a separate 501(c)3. We do not get
financial support from the university. We get a certain
amount of support from the National Library of Medicine; we
went back the following year and were successful, and have
been funded twice more by them. We also have a contract
with the New Mexico Department of Health; and in addition
we get a fair amount of support from pharmaceutical
companies.

Our first home on the Internet was University of California
San Francisco's HIV InSite (http://hivinsite.ucsf.edu/);
they hosted our materials until we could set up our own Web
site. We launched ours on January 1 1998, and have
maintained it since then.

  From the beginning of our Web site, each document was
created in three formats: a Web page (HTML); a Microsoft
Word document, and Adobe Acrobat format (.pdf). So persons
with either Microsoft Word or Adobe Acrobat could print the
fact sheets in their original format.

To make our own operation more efficient we do not provide
hard copy. There are a few special circumstances, for
example if someone is incarcerated and has no other access.
We may first try to identify a local AIDS service
organization, and make sure that they know about the New
Mexico AIDS InfoNet, and how to download and print our fact
sheets--and that a potential client needs them.

We have also made our materials available at no charge
through other HIV/AIDS Web sites, including AEGIS,
AIDS.org/Immunet, The Body, Medscape, the National Minority
AIDS Council, and University of California San Francisco's
HIV InSite.

JSJ: I'm impressed that you cover
mainstream/pharmaceutical, nutritional, and
alternative/complementary treatments in the same context.

Munk: Our advisory group felt strongly about that.
Everybody knows that many people with HIV and AIDS are
looking to alternative and complementary therapies as part
of their program. Yet almost all sites providing AIDS
treatment information--unless they were strictly focused on
alternative and complementary--made people go to different
sources to get information on Western approaches, and on
alternative/complementary approaches. We thought there was
no reason for that; if we could build trust and credibility
for a source of treatment information, why not also provide
information on alternative and complementary topics along
with the mainstream ones?

Clearly we are not cheerleaders for any of the herbal
substances, etc.; we take a research-based approach in what
we put in the fact sheets. And they are reviewed by the
Physician Administrator of the Infectious Disease Bureau of
the New Mexico Department of Health. So we do not praise
something like Cats Claw or Essiac, when there is no
research to support it. We try to put out a balanced fact
sheet, that says this is what has been researched, this is
what people are saying but it has not been supported by
research, and these are the downsides that people are
talking about as potential adverse effects, or that have
been documented in clinical research.

JSJ: When you look at anything on the Web, you realize it's
there for a reason. And then the question is, what reason?
And with many alternative sites, you have no way of knowing
if the reason is one you can trust. Is it only that
somebody wants to make money? Or that someone is a fanatic
for a particular remedy? This is true for mainstream sites
as well, but at least there are more checks and balances.

Munk: With many of the alternative/complementary
treatments, especially the supplements, often the only
place you can get information is somebody who is trying to
sell you the product. DAAIR (Direct Access Alternative
Information Resources, http://www.daair.org) does a very
good job providing information.

International Use

JSJ: What international interest are you finding?

Munk: About 50% of our Web site visits are from outside the
U.S. That's something we did not expect. It's a huge bonus
with the Internet--once you put information there, people
can use it from around the world. The primary access from
outside the U.S. has very consistently been from Mexico,
Peru, Argentina, Spain, and the UK.

People often ask is which version of Spanish we use. The
fact sheets are written in English and translated into
Spanish. They get a final edit by a native Spanish speaker
from Northern Mexico. People from other Spanish-speaking
countries have told us that while there may be some
differences in usage here and there, they basically have no
problems understanding the concepts.

JSJ: Perhaps the focus on simple language helps.

Munk: Actually that cuts the opposite way. If you are using
technical language, the words are identical all over the
world; with scientific terminology there is no regional
variation. And often with non-technical language I am using
colloquial wording, which is more susceptible to regional
differences. But it has not proved to be a problem. I have
not had any complaints; and people have requested the
updates from Spain, Peru, Argentina, and other countries.


***** Urgent, United Nations AIDS Session, Deadline
February 1, Email Input Any Time

Civil society throughout the world (including nonprofits
and businesses, especially in developing countries) has
been invited to participate in a United Nations General
Assembly Special Session on HIV and AIDS, June 25-27, 2001.
If your organization wants to send an accredited
representative, then unfortunately the deadline to apply to
be accredited is February 1 -- and the announcement and
instructions went out less than two weeks before this
deadline. But anybody can participate online, through an
email discussion group which you can join at any time.

* For more information about the special session, including
background, and how to apply to be accredited, see
http://www.unaids.org; also see http://www.hdnet.org
(Health and Development Networks, which "has been
commissioned by UNAIDS to help ensure that NGO and
community voices are channeled, in a transparent way, into
the UN General Assembly special session on HIV/AIDS").

* Another possible way to participate in person is through
the official delegation of your government (which might not
be subject to the February 1 deadline).

* Also, some nonprofit organizations already have official
status at the United Nations, and your group might be able
to work through them.

* To join the online discussion group at any time, send an
email to: break-the-silence@...

Comment

We have heard unofficially that although the United Nations
session itself is in June, the content is likely to be
mostly set by then, so the most important times for
participation will be earlier, especially February 26 -
March 2, and April 23 - 27, which are informal
consultations for government delegates; these meetings will
take place in New York. Accredited (and possibly other)
civil society organizations might or might not be able to
address the delegates at these consultations. Whether or
not your organization applies by the deadline and is
accredited, if you have information or issues you want
considered at this session, it makes sense to submit them
to the online discussion group as soon as possible, so that
they can be considered at the February 26 - March 2
consultation.

The online discussion group may be the most important way
for civil society to participate. It is certainly the most
accessible.


***** Nevirapine Warning on Post-Exposure Prophylaxis

HIV-negative persons taking antiretrovirals for
postexposure prophylaxis--prevention of infection
immediately after a needlestick or sexual exposure to HIV--
should avoid using nevirapine except in unusual situations,
according to recommendations published in the January 5
MMWR (Morbidity and Mortality Weekly Report) by the U.S.
Centers for Disease Control and Prevention (CDC).
Nevirapine has not been officially recommended for this
use, but physicians have used it because of its rapid
action and success in preventing mother to infant
transmission.

These recommendations do *not* affect use of nevirapine for
preventing mother-to-child transmission, where only a
single dose is used for the mother and the infant. They
also do not affect the use of this drug for treating HIV
infection.

The CDC published the following questions and answers about
the current knowledge of the safety of this drug:

"Occupational Postexposure Prophylaxis

"Q1: What is postexposure prophylaxis? Is it effective?

"A1: Postexposure prophylaxis (PEP) refers to using certain
drugs called antiretrovirals, or a combination of these
drugs, in an attempt to reduce the risk of HIV infection
for health care workers following an exposure to the blood
or body fluids of a patient with HIV. One study of health
care workers who took AZT for PEP after a needlestick
injury found an 81 percent reduction in HIV infection.

"Q2: Does CDC recommend nevirapine for PEP?

"A2: Nevirapine has not been recommended for PEP use and
has previously been associated with instances of serious
skin conditions, liver damage, and death when used for
treating HIV-infected individuals.

"Q3: Should the drug ever be used for PEP? Are there any
situations when the benefits of nevirapine for PEP outweigh
the risks?

"A3: The only possible exception would be if an individual
is exposed to HIV from a patient with known drug resistance
to all other available antiretrovirals. In this case,
consultation with an antiviral expert would be recommended,
and a thorough review of potential risks and benefits would
be necessary. After this review, if the exposed individual
decided to take nevirapine as part of his or her PEP,
she/he would need to be monitored closely for serious side
effects, including those reported in today s MMWR, and the
dose regimen should be followed as recommended by the
manufacturer.

"Q4: What are CDC recommendations regarding the use of PEP?

"A4: PEP is not recommended for all types of occupational
exposures to HIV. Because most occupational exposures do
not lead to HIV infection, the chance of possible serious
side effects (toxicity) from any of the drugs used to
prevent infection may be much greater than the chance of
HIV infection from such exposures. Both risk of infection
and possible side effects of drugs should be carefully
considered when deciding whether to prescribe PEP.
Exposures with a lower infection risk may not be worth the
risk of side effects associated with these drugs.

"For those deciding to take PEP, the US Public Health
Service (USPHS) recommends a four-week course of two drugs
(zidovudine and lamivudine) for most HIV exposures, or
zidovudine and lamivudine plus a protease inhibitor
(indinavir or nelfinavir) for exposures that may pose a
greater risk for transmitting HIV (such as those involving
a larger volume of blood or those involving a source
patient with advanced HIV disease). Differences in side
effects associated with the use of these drugs and the
possibility of drug resistance in the source patient may
influence which drug is selected in a specific situation.

"Determining which drugs and how many drugs to use or when
to change a treatment regimen should be guided by published
recommendations and the judgment of the treating physician.
Whenever possible, consulting an expert with experience in
the use of antiviral drugs is advised, especially if a
recommended drug is not available, if the source patient's
virus is likely to be resistant to one or more recommended
drugs, or if the drugs are poorly tolerated.

"Q5: Are there adverse side effects for the drugs
recommended for PEP?

"A5: All of the antiretroviral drugs for HIV have been
associated with side effects. The most common side effects
include upset stomach (nausea, vomiting, diarrhea),
tiredness, or headache. The few serious side effects that
have been reported in health-care workers using combination
postexposure treatment have included kidney stones,
hepatitis, and suppressed blood cell production. Protease
inhibitors (indinavir and nelfinavir) may interact with
other medicines and cause serious side effects and should
not be used in combination with certain drugs.

"Preventing Perinatal HIV Transmission

"Q1: Given these findings, does CDC still recommend
nevirapine for prevention of perinatal HIV transmission?
How do we know it is safe?

"A1: These findings relate to multiple doses of nevirapine
given as prophylaxis over several weeks and do not apply to
the use of a single dose of nevirapine given to mothers and
infants to prevent perinatal transmission of HIV. Current
USPHS perinatal antiretroviral recommendations include use
of nevirapine as one of the options for HIV-infected
pregnant women presenting in labor who are not tested for
HIV during their pregnancy. Recent UNAIDS/WHO
recommendations, based on both safety and efficacy, include
single-dose nevirapine to mothers and infants as one of the
options for prevention of mother-to-child HIV transmission
in developing countries.

"Treating Advanced HIV Disease

"Q1: Given these findings, does CDC still recommend
nevirapine as an option for treatment of HIV-infected
individuals?

"A1: With regard to treatment of HIV-infected individuals
with advanced disease, physicians should be aware that the
severe hepatotoxicity has been described in patients
receiving nevirapine as part of combination antiretroviral
drug regimens, although this complication appears to be
uncommon. The manufacturer's package insert contains a box
warning about this adverse effect, and current
antiretroviral guidelines list hepatotoxicity as a
potential adverse effect of nevirapine. Physicians should
weigh the potential benefits versus risks when prescribing
nevirapine, as well as all other medications, for HIV-
infected persons.

"Q2: Why does CDC recommend nevirapine for HIV-infected
individuals, but does not recommend the drug for PEP?

"A2: Individuals occupationally exposed to HIV have an
extremely small chance of becoming infected with HIV
without any PEP at all (about one in 300 for a needlestick
or cut exposure to HIV-infected blood). Thus, the risk of
serious side effects, including life-threatening liver
damage, to an otherwise healthy person must be weighed
carefully against the likelihood of the individual becoming
infected. Also, there are many effective alternative drugs
available for PEP.

" A patient with advanced HIV disease often develops
resistance to antiretrovirals and many of these drugs may
no longer be effective in fighting the virus. Thus, the
potential benefits of nevirapine for an infected
individual, for whom there may be no other options, may
outweigh the risk of adverse side effects.

"For Additional Information

"Guidelines for postexposure prophylaxis, the use of
antiretrovirals in HIV-infected adults and adolescents, and
interventions to reduce perinatal HIV transmission can be
found at: http://www.cdc.gov/hiv/treatment.htm "


***** d4T plus ddI: Warning for Pregnant Women

On January 5 the FDA and Bristol Myers Squibb warned
healthcare professionals about cases of lactic acidosis,
which can be fatal, in pregnant women using d4T (Zerit(R))
plus ddI (Videx(R)) as part of a combination regimen. The
FDA "talk paper" is reproduced here; Bristol Myers Squibb
sent a more technical letter to physicians, pharmacists,
and other medical professionals.

"FDA/Bristol Myers Squibb Issues Caution for HIV
Combination Therapy with Zerit and Videx in Pregnant Women

"FDA and Bristol Myers Squibb are warning health care
professionals that pregnant women may be at increased risk
of fatal lactic acidosis when prescribed the combination of
the HIV drugs stavudine (Zerit) and didanosine (Videx or
Videx EC) with other antiretroviral agents.

"Lactic acidosis occurs when cells of the body are unable
to convert food into usable energy. As a result, excess
acid accumulates in the body and vital organs such as the
liver or pancreas may be damaged. Severe lactic acidosis is
an infrequent, but well-described complication of the class
of HIV drugs known as nucleoside analogues. Pancreatitis is
also a well-described complication of Videx and Zerit.

"This new warning follows three reported cases of fatal
lactic acidosis, with or without pancreatitis, that
occurred in pregnant women taking Zerit and Videx in
combination with other drugs used to treat HIV. Two of the
cases were reported from ongoing clinical trials of an
investigational HIV drug, and one was identified through
worldwide post marketing surveillance. In addition FDA has
received several nonfatal reports of lactic acidosis, with
and without pancreatitis, occurring in pregnant women
receiving only Videx and Zerit. Although data have
suggested that women may be at increased risk for the
development of lactic acidosis and liver toxicity, it is
unclear whether pregnancy potentiates these known side
effects.

"On January 5, 2001, Bristol Myers Squibb issued a letter
to alert health care professionals to the potential
increased risk of lactic acidosis and liver damage in
pregnant women treated with the combination of Zerit and
Videx. Bristol Myers Squibb recommends that the combination
of the two drugs should be prescribed for pregnant women
only when the potential benefit clearly outweighs the
potential risk. One situation where the benefit may
outweigh the risk is the use of didanosine plus stavudine
in women who have exhausted other treatment options. The
letter points out that decisions about using the drugs for
pregnant women should be made by health care professionals
experienced in treating HIV infection.

"Because of these reports, the FDA will strengthen the
existing black box warnings to include this new prescribing
information. Women who are prescribed the combination drug
therapy should be closely monitored for clinical or
laboratory signs of lactic acidosis and liver damage. This
syndrome may develop abruptly, and in the absence of
abnormal laboratory values in the weeks preceding its
development. Therefore, it is imperative that healthcare
providers maintain a high index of suspicion when
monitoring these patients. Healthcare providers are
encouraged to report any adverse events related to
stavudine and didanosine to Bristol Myers Squibb Company
(800-426-7644). Reports may be submitted to FDA by
telephone (800-FDA-1088), fax (800-FDA-0178), online at
http://www.fda.gov/medwatch/ or by mail to: MedWatch (HF-2),
Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857."


***** AIDS TREATMENT NEWS

Published twice monthly

Subscription and Editorial Office:
   1233 Locust St., 5th floor
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   email: aidsnews@...
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Editor and Publisher: John S. James
Associate Editor: Tadd T. Tobias

Statement of Purpose:
AIDS TREATMENT NEWS reports on experimental and standard
treatments, especially those available now. We interview
physicians, scientists, other health professionals, and
persons with AIDS or HIV; we also collect information from
meetings and conferences, medical journals, and computer
databases. Long-term survivors have usually tried many
different treatments, and found combinations that work for
them. AIDS TREATMENT NEWS does not recommend particular
therapies, but seeks to increase the options available.

AIDS TREATMENT NEWS is published 24 times per year, on the
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ISSN # 1052-4207

Copyright 2001 by John S. James. Permission granted for
noncommercial reproduction, provided that our address and
phone number are included if more than short quotations are
used.

AIDS TREATMENT NEWS Issue #358, January 12, 2001
     phone 800-TREAT-1-2

CONTENTS

** AIDS Treatment Fact Sheets: Interview with Bob Munk, New
Mexico AIDS InfoNet
Widely regarded as the best collection of single-page AIDS
fact sheets, these cover over 100 treatment-related topics;
each is available in both English and Spanish, and is
changed as necessary to remain current.

** Urgent, United Nations AIDS Session, Deadline
February 1, Email Input Any Time
Nonprofits and businesses must apply by February 1 to be
accredited to participate in person in consultations
leading up to this important U.N. session in June. You can
also participate through a special email discussion group,
regardless of the February 1 deadline -- but earlier is
better, as critical preliminary meetings start in
February.

** Nevirapine Warning on Post-Exposure Prophylaxis
Nevirapine should not be used to prevent infection after
HIV exposure, except in unusual circumstances, due to the
risk of side effects. This warning does not affect its use
in HIV treatment, or in prevention of mother to  child
transmission.

** d4T plus ddI: Warning for Pregnant Women
New data suggests that pregnant women may be at increased
risk of lactic acidosis from the combination of d4T and
ddI.


***** AIDS TREATMENT NEWS New Philadelphia Contacts

AIDS TREATMENT NEWS has moved to Philadelphia, and is now
being published with Philadelphia FIGHT. Editorial policies
will not change; John S. James is still editor and
publisher, and remains in complete control of the content.
This move frees us from the administrative work of
maintaining a separate office, and gives us daily contact
with an AIDS service provider running a nonprofit clinic,
Federally funded HIV/AIDS treatment research, and many
education and outreach programs.

Our new address is AIDS Treatment News, Philadelphia FIGHT,
1233 Locust St., 5th floor, Philadelphia, PA 19107. We will
keep our toll-free number, 800-TREAT-1-2; we can also be
reached at the same phone at 215-546-3776. Our new fax
number is 215-985-4952, but email is preferred as faxes may
not reach us while traveling.

We are keeping our email address, aidsnews@...

Because of the move, the first issues of 2001 will be
delayed. And our annual overview article, traditionally
published in the first issue of each year, has been
postponed.

John S. James, AIDS Treatment News


***** AIDS Treatment Fact Sheets: Interview with Bob Munk,
New Mexico AIDS InfoNet

by John S. James

In the three years since it started, the New Mexico AIDS
InfoNet has become widely recognized as perhaps the best
overall collection of single-page fact sheets on AIDS
treatment information. It now maintains over 100 of them,
each in English and Spanish. Topics include background on
HIV and AIDS, blood tests and what they mean, using
HIV/AIDS services, all approved antiretroviral treatments,
many opportunistic infections and their therapies,
alternative/complementary treatments, a separate section on
treatment side effects, and HIV prevention. All are in non-
technical language, and all are available on the Web
(http://www.aidsinfonet.org) plus two printable formats for
clients who may not have computer access. As with other
fact sheets, each one can be read separately as needed;
they do not need to be used in any sequence.

While this project was specifically designed to meet the
needs of clients of AIDS service organizations in New
Mexico, it has a national and international constituency as
well, with currently about half of the Web use coming from
outside the United States. It also provides a model for
presenting certain kinds of information effectively, either
online or off.

Bob Munk, a well-known AIDS activist, started this project
and has written most of the material. AIDS TREATMENT NEWS
interviewed him on December 23, 2000. [JSJ]

* * *

Interview with Bob Munk, New Mexico AIDS InfoNet

JSJ: Why did you first decide to write your own fact
sheets, instead of using existing ones?

Munk: We had to meet specific needs of clients in New
Mexico. It is a large and very rural state, so most clients
tend to be far away from AIDS service organizations. And it
was hard to get information in Spanish, which many prefer
because it is their native language.

We looked at existing fact sheets to see if they could meet
our needs. There were some good ones, but any particular
set had deficiencies. Most had a very limited range of
topics; most had no information at all about any
alternative or complementary therapies, which are of
serious interest to many clients in New Mexico.

Many were badly out of date--for example, a saquinavir fact
sheet in 1998 that said that saquinavir was the only
approved protease inhibitor, or a CMV fact sheet that did
not mention the existence of the intravitreal implants.
Others had a reading level that was too complex; on the
Flesch-Kincaid reading scale they came out at the 11th or
12th grade level. [For writers who want to test their own
documents, Flesch-Kincaid software is available within the
spelling checker of recent versions of Microsoft WORD.]

Another problem with some of the sites is that they might
issue multiple reports on a single topic--such as an
initial writeup, and then later an update when a new
treatment was approved. So the user had to be able to go to
their Web site and identify the different pieces and put
them together, first reading the obsolete report and then
the updates.

In consultation with front-line people--the case managers
of the AIDS service organizations in New Mexico--we agreed
to aim for an 8th grade reading level in a single-page (one
side) fact sheet. We don't consider 8th grade level "low
literacy." But we have heard from our case managers that
when they have a low-literacy client, if they have an
opportunity to sit down and discuss the information, the
fact sheet works as a memory aid to help the client
remember the discussion. The case managers believe that 8th
grade is a useful reading level. I'm not aware of other
fact sheets written at the same or lower level. The U.S.
Centers for Disease Control has some booklets that they
consider low literacy, but I find them almost insulting; I
don't know how well low-literacy clients receive them.

It's totally appropriate to have a wide range of reading
levels, including material that is much more complex or
technical. But service organizations need to be aware of
the range of resources available and try to match them to
the client. There is nothing wrong with a more technical
writeup, as long as the client can digest it. And there is
no reason that everyone with HIV should have a comfortable
familiarity with complex medical terminology.

When we realized there was no set of fact sheets we could
just pick up and use, that we would have to develop our
own, we worked with the case managers to determine the
higher priority topics--which were basic diagnostic tests,
HIV medications, and opportunistic infections.

We also did a survey of New Mexico HIV service providers
and clients. We found that only about 40% of AIDS service
providers had access to the Internet; clearly the figure
for clients would be lower than that. So we knew from the
outset that we had to structure the project for hard-copy
printout. In working with our advisory board we came up
with the format we use: a single sheet with three columns
of text, which is the most readable and user friendly.

Fact Sheets Available Now

JSJ: Recently I counted 114 fact sheets on your site. Could
you summarize the main categories for our readers?

Munk: In the Background Information section we have 11 fact
sheets, including what is AIDS, HIV antibody testing,
several fact sheets on understanding your lab results, and
one on the drug approval process. The web site Background
section also has several links on AIDS epidemiology and
statistics.

We have five fact sheets on prevention topics, including
post-exposure prophylaxis [what to do if you have just been
exposed to HIV].

A section on HIV services includes how to begin, choosing a
doctor, telling others you are HIV positive, participating
in a clinical trial, and how to spot HIV/AIDS fraud.

There are 12 sheets on New Mexico programs--the only ones
which are specific to New Mexico--and the Web site has
links to four Federal programs.

Antiretroviral drugs are covered in several sections. A
general category includes several fact sheets on new drugs
being developed, a chart of drug names and manufacturers,
official treatment guidelines (it will need to be changed
when the new guidelines are released in January), T-cell
tests, viral load tests, resistance tests, the HIV life
cycle, adherence (compliance), and treatment interruptions.

There are also fact sheets on each of the 15 antiretroviral
drugs now approved in the U.S. These are categorized by
drug class: nucleoside analogs, non-nucleoside reverse
transcriptase inhibitors, and protease inhibitors. (There
are also fact sheets for Combivir and Trizivir, which
combine two or three approved antiretrovirals in one pill,
to reduce the number of pills that must be taken each day.)

The "Treatment: Opportunistic Infections" has 24 fact
sheets covering many of the most common opportunistic
infections, and some of the drugs used to treat them.

We have a new section on treatment side effects, including
fatigue, body shape changes, diarrhea, mitochondrial
toxicity, and bone problems.

A "Treatment: Special Topics" section currently has eight
fact sheets on nutrition, vitamins and minerals, drug
interactions, women and HIV, pregnancy and HIV, immune
restoration, hydroxyurea, and interleukin-2 (IL-2).

And the alternative and complementary section has an
overview, Chinese acupuncture, Chinese herbalism, Native
American traditional healing, cat's claw, DHEA, DNCB,
echinacea, essiac, hypericin (St. John's Wort), marijuana,
and silymarin (milk thistle). More will be added.

Our site also includes a huge collection of links to
HIV/AIDS Web sites, over 500 of them by categories. We do
not evaluate or describe these sites, but each month we
verify that each one still exists.

JSJ: Where do you get the information for the fact sheets?

Munk: I scan the email lists, such as AEGIS
(http://www.aegis.org), the daily CDC HIV/STD/TB Prevention
News Update (available through AEGIS, or at
http://www.cdcnpin.org/services/listserv.htm), and
treatment discussion groups, and attend AIDS treatment
conferences. When there is news important enough to go into
a one-page sheet, I revise ours if necessary.

What Should Be in a Fact Sheet or Web Page?

JSJ: What do you believe should be included in each fact
sheet or Web page?

Munk: There are different Internet guides to creating good
material. Some ideas of what should be on Web sites are
fairly consistent.

* There should be a way to find out who is writing the
material, and what are the sources. Our site has
information about me, and about the AIDS Education and
Training Center, where our project is based.

* A site should state whether the material is reviewed by
somebody. Is it just posted, or checked by experts first?

* Each page should have a date on it. Ideally it will be
clear whether that was the date the material was originally
written, the date it was posted, or the date it was last
reviewed and/or updated. Often there is no date; sometimes
you just get a date on a page, and do not know which it
represents.

* For HIV treatment information, the Web site ought to
disclose the sponsorship or source of funding for the
project. Readers should know whether a site is sponsored by
pharmaceutical companies or a single company. On my site I
do not list specific percentages, but we have governmental
funding and corporate funding, and the corporate funding is
from many different firms. If I were looking at a treatment
site, I would feel more comfortable if it had many sponsors
than if it had a single corporate sponsor.

* It helps to have an introductory page stating the purpose
of the Web site. If it's in conjunction with a commercial
venture, that's good to know. If it's educational, that's
also worth knowing.

* A site should be easy to navigate. People should be able
to get in, get what they want, and get out, quickly. And
particularly in a rural area, many people do not have high-
speed access; our site is deliberately not flashy; it has
low graphic content, so pages load quickly.

* None of our pages is terribly long. And we break each
page into sections, and group the section headers at the
top of each page. So as soon as the screen appears, the
reader knows what's below on that page.

* And to make use of the capabilities of the Internet, we
try to cross-link our fact sheets as much as possible. If a
fact sheet on antiretroviral therapy talks about T-cell
counts, T-cell count wording will be linked to the fact
sheet on T-cell tests. If it talks about viral load, it
will link to the viral load fact sheet. If it talks about
specific drugs we have fact sheets on, it will link to
those fact sheets.

* Mechanism for feedback: Is there a way to contact the
site to make comments or ask questions? We have that on
each page.

* Each Web site should have a privacy statement. Ours
states that the logging software records each visit
(including what country you are from, what browser you are
using, and which pages you visit) but does not link this
information to an individual person.

I also have an email update mechanism so that people who
want to be informed of changes get a monthly email from me,
saying what has been changed on the site, so they can go to
the Web and get the new version. If people send me their
email address for this list, I do not disclose it to
anybody at any time for any purpose.

When people use a search engine to look for a particular
topic, they may come into a site several levels down in its
hierarchy. So Web users need to educate themselves about
trying to find the main page for the site. For treatment
information, people need to figure out which sites they
trust. So if you use a search engine and come upon a fact
sheet you like, try to find the main entry page of the Web
site, and educate yourself about the stated purpose of the
site, who reviews the material, who sponsors it, and so on.

JSJ: It's a good idea to have a link to the main page, at
the bottom of every page of the site.

Munk: We have just put that in.

For more information on how to judge medical Web sites, see
Criteria for Assessing the Quality of Health Information on
the Internet, a work in progress, currently 55 pages, at:
http://hitiweb.mitretek.org/docs/criteria.html

The New Mexico AIDS InfoNet

JSJ: How did the New Mexico AIDS InfoNet begin?

Munk: Within New Mexico the HIV/AIDS services are organized
in a managed-care type of model. There are four primary
agencies that serve the entire state. So if we could make
sure that those four agencies (and particularly the case
managers of those agencies) had Internet access, and knew
how to reach treatment information in a form they could
readily print it out and distribute to clients, we would
have a useful resource.

What seemed ideal was to use the Internet not only as a way
of delivering information to the end user, but to leverage
the delivery of information, since the Internet is an ideal
way to update information quickly, and make it available to
people spread over a large area. From the beginning we
wanted have the material in a form that could be printed
*off* the Internet by agencies, and given to clients.
Currently our materials are used in this way by a number of
AIDS service organizations and clinics.

The New Mexico AIDS InfoNet started in 1997, when the state
director of HIV/AIDS services noticed an announcement for a
National Library of Medicine grant for electronic
information. A group of us then met about the needs in New
Mexico. Our first application was turned down. But I
decided to go ahead and start the project anyway, because
it seemed that it would have huge advantages for New
Mexico.

The project began in a statewide, state-funded services
planning agency. That agency lost its major contract at the
middle of 1998, so then the AIDS InfoNet project moved over
and affiliated with the AIDS Education and Training Center
at the University of New Mexico (a satellite of the
Mountain Plains AETC out of Denver). I attached the project
to them, so it's not a separate 501(c)3. We do not get
financial support from the university. We get a certain
amount of support from the National Library of Medicine; we
went back the following year and were successful, and have
been funded twice more by them. We also have a contract
with the New Mexico Department of Health; and in addition
we get a fair amount of support from pharmaceutical
companies.

Our first home on the Internet was University of California
San Francisco's HIV InSite (http://hivinsite.ucsf.edu/);
they hosted our materials until we could set up our own Web
site. We launched ours on January 1 1998, and have
maintained it since then.

  From the beginning of our Web site, each document was
created in three formats: a Web page (HTML); a Microsoft
Word document, and Adobe Acrobat format (.pdf). So persons
with either Microsoft Word or Adobe Acrobat could print the
fact sheets in their original format.

To make our own operation more efficient we do not provide
hard copy. There are a few special circumstances, for
example if someone is incarcerated and has no other access.
We may first try to identify a local AIDS service
organization, and make sure that they know about the New
Mexico AIDS InfoNet, and how to download and print our fact
sheets--and that a potential client needs them.

We have also made our materials available at no charge
through other HIV/AIDS Web sites, including AEGIS,
AIDS.org/Immunet, The Body, Medscape, the National Minority
AIDS Council, and University of California San Francisco's
HIV InSite.

JSJ: I'm impressed that you cover
mainstream/pharmaceutical, nutritional, and
alternative/complementary treatments in the same context.

Munk: Our advisory group felt strongly about that.
Everybody knows that many people with HIV and AIDS are
looking to alternative and complementary therapies as part
of their program. Yet almost all sites providing AIDS
treatment information--unless they were strictly focused on
alternative and complementary--made people go to different
sources to get information on Western approaches, and on
alternative/complementary approaches. We thought there was
no reason for that; if we could build trust and credibility
for a source of treatment information, why not also provide
information on alternative and complementary topics along
with the mainstream ones?

Clearly we are not cheerleaders for any of the herbal
substances, etc.; we take a research-based approach in what
we put in the fact sheets. And they are reviewed by the
Physician Administrator of the Infectious Disease Bureau of
the New Mexico Department of Health. So we do not praise
something like Cats Claw or Essiac, when there is no
research to support it. We try to put out a balanced fact
sheet, that says this is what has been researched, this is
what people are saying but it has not been supported by
research, and these are the downsides that people are
talking about as potential adverse effects, or that have
been documented in clinical research.

JSJ: When you look at anything on the Web, you realize it's
there for a reason. And then the question is, what reason?
And with many alternative sites, you have no way of knowing
if the reason is one you can trust. Is it only that
somebody wants to make money? Or that someone is a fanatic
for a particular remedy? This is true for mainstream sites
as well, but at least there are more checks and balances.

Munk: With many of the alternative/complementary
treatments, especially the supplements, often the only
place you can get information is somebody who is trying to
sell you the product. DAAIR (Direct Access Alternative
Information Resources, http://www.daair.org) does a very
good job providing information.

International Use

JSJ: What international interest are you finding?

Munk: About 50% of our Web site visits are from outside the
U.S. That's something we did not expect. It's a huge bonus
with the Internet--once you put information there, people
can use it from around the world. The primary access from
outside the U.S. has very consistently been from Mexico,
Peru, Argentina, Spain, and the UK.

People often ask is which version of Spanish we use. The
fact sheets are written in English and translated into
Spanish. They get a final edit by a native Spanish speaker
from Northern Mexico. People from other Spanish-speaking
countries have told us that while there may be some
differences in usage here and there, they basically have no
problems understanding the concepts.

JSJ: Perhaps the focus on simple language helps.

Munk: Actually that cuts the opposite way. If you are using
technical language, the words are identical all over the
world; with scientific terminology there is no regional
variation. And often with non-technical language I am using
colloquial wording, which is more susceptible to regional
differences. But it has not proved to be a problem. I have
not had any complaints; and people have requested the
updates from Spain, Peru, Argentina, and other countries.


***** Urgent, United Nations AIDS Session, Deadline
February 1, Email Input Any Time

Civil society throughout the world (including nonprofits
and businesses, especially in developing countries) has
been invited to participate in a United Nations General
Assembly Special Session on HIV and AIDS, June 25-27, 2001.
If your organization wants to send an accredited
representative, then unfortunately the deadline to apply to
be accredited is February 1 -- and the announcement and
instructions went out less than two weeks before this
deadline. But anybody can participate online, through an
email discussion group which you can join at any time.

* For more information about the special session, including
background, and how to apply to be accredited, see
http://www.unaids.org; also see http://www.hdnet.org
(Health and Development Networks, which "has been
commissioned by UNAIDS to help ensure that NGO and
community voices are channeled, in a transparent way, into
the UN General Assembly special session on HIV/AIDS").

* Another possible way to participate in person is through
the official delegation of your government (which might not
be subject to the February 1 deadline).

* Also, some nonprofit organizations already have official
status at the United Nations, and your group might be able
to work through them.

* To join the online discussion group at any time, send an
email to: break-the-silence@...

Comment

We have heard unofficially that although the United Nations
session itself is in June, the content is likely to be
mostly set by then, so the most important times for
participation will be earlier, especially February 26 -
March 2, and April 23 - 27, which are informal
consultations for government delegates; these meetings will
take place in New York. Accredited (and possibly other)
civil society organizations might or might not be able to
address the delegates at these consultations. Whether or
not your organization applies by the deadline and is
accredited, if you have information or issues you want
considered at this session, it makes sense to submit them
to the online discussion group as soon as possible, so that
they can be considered at the February 26 - March 2
consultation.

The online discussion group may be the most important way
for civil society to participate. It is certainly the most
accessible.


***** Nevirapine Warning on Post-Exposure Prophylaxis

HIV-negative persons taking antiretrovirals for
postexposure prophylaxis--prevention of infection
immediately after a needlestick or sexual exposure to HIV--
should avoid using nevirapine except in unusual situations,
according to recommendations published in the January 5
MMWR (Morbidity and Mortality Weekly Report) by the U.S.
Centers for Disease Control and Prevention (CDC).
Nevirapine has not been officially recommended for this
use, but physicians have used it because of its rapid
action and success in preventing mother to infant
transmission.

These recommendations do *not* affect use of nevirapine for
preventing mother-to-child transmission, where only a
single dose is used for the mother and the infant. They
also do not affect the use of this drug for treating HIV
infection.

The CDC published the following questions and answers about
the current knowledge of the safety of this drug:

"Occupational Postexposure Prophylaxis

"Q1: What is postexposure prophylaxis? Is it effective?

"A1: Postexposure prophylaxis (PEP) refers to using certain
drugs called antiretrovirals, or a combination of these
drugs, in an attempt to reduce the risk of HIV infection
for health care workers following an exposure to the blood
or body fluids of a patient with HIV. One study of health
care workers who took AZT for PEP after a needlestick
injury found an 81 percent reduction in HIV infection.

"Q2: Does CDC recommend nevirapine for PEP?

"A2: Nevirapine has not been recommended for PEP use and
has previously been associated with instances of serious
skin conditions, liver damage, and death when used for
treating HIV-infected individuals.

"Q3: Should the drug ever be used for PEP? Are there any
situations when the benefits of nevirapine for PEP outweigh
the risks?

"A3: The only possible exception would be if an individual
is exposed to HIV from a patient with known drug resistance
to all other available antiretrovirals. In this case,
consultation with an antiviral expert would be recommended,
and a thorough review of potential risks and benefits would
be necessary. After this review, if the exposed individual
decided to take nevirapine as part of his or her PEP,
she/he would need to be monitored closely for serious side
effects, including those reported in today s MMWR, and the
dose regimen should be followed as recommended by the
manufacturer.

"Q4: What are CDC recommendations regarding the use of PEP?

"A4: PEP is not recommended for all types of occupational
exposures to HIV. Because most occupational exposures do
not lead to HIV infection, the chance of possible serious
side effects (toxicity) from any of the drugs used to
prevent infection may be much greater than the chance of
HIV infection from such exposures. Both risk of infection
and possible side effects of drugs should be carefully
considered when deciding whether to prescribe PEP.
Exposures with a lower infection risk may not be worth the
risk of side effects associated with these drugs.

"For those deciding to take PEP, the US Public Health
Service (USPHS) recommends a four-week course of two drugs
(zidovudine and lamivudine) for most HIV exposures, or
zidovudine and lamivudine plus a protease inhibitor
(indinavir or nelfinavir) for exposures that may pose a
greater risk for transmitting HIV (such as those involving
a larger volume of blood or those involving a source
patient with advanced HIV disease). Differences in side
effects associated with the use of these drugs and the
possibility of drug resistance in the source patient may
influence which drug is selected in a specific situation.

"Determining which drugs and how many drugs to use or when
to change a treatment regimen should be guided by published
recommendations and the judgment of the treating physician.
Whenever possible, consulting an expert with experience in
the use of antiviral drugs is advised, especially if a
recommended drug is not available, if the source patient's
virus is likely to be resistant to one or more recommended
drugs, or if the drugs are poorly tolerated.

"Q5: Are there adverse side effects for the drugs
recommended for PEP?

"A5: All of the antiretroviral drugs for HIV have been
associated with side effects. The most common side effects
include upset stomach (nausea, vomiting, diarrhea),
tiredness, or headache. The few serious side effects that
have been reported in health-care workers using combination
postexposure treatment have included kidney stones,
hepatitis, and suppressed blood cell production. Protease
inhibitors (indinavir and nelfinavir) may interact with
other medicines and cause serious side effects and should
not be used in combination with certain drugs.

"Preventing Perinatal HIV Transmission

"Q1: Given these findings, does CDC still recommend
nevirapine for prevention of perinatal HIV transmission?
How do we know it is safe?

"A1: These findings relate to multiple doses of nevirapine
given as prophylaxis over several weeks and do not apply to
the use of a single dose of nevirapine given to mothers and
infants to prevent perinatal transmission of HIV. Current
USPHS perinatal antiretroviral recommendations include use
of nevirapine as one of the options for HIV-infected
pregnant women presenting in labor who are not tested for
HIV during their pregnancy. Recent UNAIDS/WHO
recommendations, based on both safety and efficacy, include
single-dose nevirapine to mothers and infants as one of the
options for prevention of mother-to-child HIV transmission
in developing countries.

"Treating Advanced HIV Disease

"Q1: Given these findings, does CDC still recommend
nevirapine as an option for treatment of HIV-infected
individuals?

"A1: With regard to treatment of HIV-infected individuals
with advanced disease, physicians should be aware that the
severe hepatotoxicity has been described in patients
receiving nevirapine as part of combination antiretroviral
drug regimens, although this complication appears to be
uncommon. The manufacturer's package insert contains a box
warning about this adverse effect, and current
antiretroviral guidelines list hepatotoxicity as a
potential adverse effect of nevirapine. Physicians should
weigh the potential benefits versus risks when prescribing
nevirapine, as well as all other medications, for HIV-
infected persons.

"Q2: Why does CDC recommend nevirapine for HIV-infected
individuals, but does not recommend the drug for PEP?

"A2: Individuals occupationally exposed to HIV have an
extremely small chance of becoming infected with HIV
without any PEP at all (about one in 300 for a needlestick
or cut exposure to HIV-infected blood). Thus, the risk of
serious side effects, including life-threatening liver
damage, to an otherwise healthy person must be weighed
carefully against the likelihood of the individual becoming
infected. Also, there are many effective alternative drugs
available for PEP.

" A patient with advanced HIV disease often develops
resistance to antiretrovirals and many of these drugs may
no longer be effective in fighting the virus. Thus, the
potential benefits of nevirapine for an infected
individual, for whom there may be no other options, may
outweigh the risk of adverse side effects.

"For Additional Information

"Guidelines for postexposure prophylaxis, the use of
antiretrovirals in HIV-infected adults and adolescents, and
interventions to reduce perinatal HIV transmission can be
found at: http://www.cdc.gov/hiv/treatment.htm "


***** d4T plus ddI: Warning for Pregnant Women

On January 5 the FDA and Bristol Myers Squibb warned
healthcare professionals about cases of lactic acidosis,
which can be fatal, in pregnant women using d4T (Zerit(R))
plus ddI (Videx(R)) as part of a combination regimen. The
FDA "talk paper" is reproduced here; Bristol Myers Squibb
sent a more technical letter to physicians, pharmacists,
and other medical professionals.

"FDA/Bristol Myers Squibb Issues Caution for HIV
Combination Therapy with Zerit and Videx in Pregnant Women

"FDA and Bristol Myers Squibb are warning health care
professionals that pregnant women may be at increased risk
of fatal lactic acidosis when prescribed the combination of
the HIV drugs stavudine (Zerit) and didanosine (Videx or
Videx EC) with other antiretroviral agents.

"Lactic acidosis occurs when cells of the body are unable
to convert food into usable energy. As a result, excess
acid accumulates in the body and vital organs such as the
liver or pancreas may be damaged. Severe lactic acidosis is
an infrequent, but well-described complication of the class
of HIV drugs known as nucleoside analogues. Pancreatitis is
also a well-described complication of Videx and Zerit.

"This new warning follows three reported cases of fatal
lactic acidosis, with or without pancreatitis, that
occurred in pregnant women taking Zerit and Videx in
combination with other drugs used to treat HIV. Two of the
cases were reported from ongoing clinical trials of an
investigational HIV drug, and one was identified through
worldwide post marketing surveillance. In addition FDA has
received several nonfatal reports of lactic acidosis, with
and without pancreatitis, occurring in pregnant women
receiving only Videx and Zerit. Although data have
suggested that women may be at increased risk for the
development of lactic acidosis and liver toxicity, it is
unclear whether pregnancy potentiates these known side
effects.

"On January 5, 2001, Bristol Myers Squibb issued a letter
to alert health care professionals to the potential
increased risk of lactic acidosis and liver damage in
pregnant women treated with the combination of Zerit and
Videx. Bristol Myers Squibb recommends that the combination
of the two drugs should be prescribed for pregnant women
only when the potential benefit clearly outweighs the
potential risk. One situation where the benefit may
outweigh the risk is the use of didanosine plus stavudine
in women who have exhausted other treatment options. The
letter points out that decisions about using the drugs for
pregnant women should be made by health care professionals
experienced in treating HIV infection.

"Because of these reports, the FDA will strengthen the
existing black box warnings to include this new prescribing
information. Women who are prescribed the combination drug
therapy should be closely monitored for clinical or
laboratory signs of lactic acidosis and liver damage. This
syndrome may develop abruptly, and in the absence of
abnormal laboratory values in the weeks preceding its
development. Therefore, it is imperative that healthcare
providers maintain a high index of suspicion when
monitoring these patients. Healthcare providers are
encouraged to report any adverse events related to
stavudine and didanosine to Bristol Myers Squibb Company
(800-426-7644). Reports may be submitted to FDA by
telephone (800-FDA-1088), fax (800-FDA-0178), online at
http://www.fda.gov/medwatch/ or by mail to: MedWatch (HF-2),
Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857."


***** AIDS TREATMENT NEWS

Published twice monthly

Subscription and Editorial Office:
   1233 Locust St., 5th floor
   Philadelphia, PA 19107
   800/TREAT-1-2 toll-free
   email: aidsnews@...
   useful links: http://www.aidsnews.org

Editor and Publisher: John S. James
Associate Editor: Tadd T. Tobias

Statement of Purpose:
AIDS TREATMENT NEWS reports on experimental and standard
treatments, especially those available now. We interview
physicians, scientists, other health professionals, and
persons with AIDS or HIV; we also collect information from
meetings and conferences, medical journals, and computer
databases. Long-term survivors have usually tried many
different treatments, and found combinations that work for
them. AIDS TREATMENT NEWS does not recommend particular
therapies, but seeks to increase the options available.

AIDS TREATMENT NEWS is published 24 times per year, on the
first and third Friday of every month, and print copies are
sent by first class mail. Email is available (see below).
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used.


--
John S. James
AIDS Treatment News
http://www.aidsnews.org

AIDS TREATMENT NEWS Issue #357, December 22, 2000
     phone 800-TREAT-1-2

CONTENTS

** European Jewish Ancestry: Activist Doctor Needs Stem
Cell Donation
Friends of Alan Berkman, M.D., who helped organize the
movement to make AIDS and other medications available in
developing countries, are seeking a genetically matched
stem-cell donor. Persons of Eastern European Jewish
ancestry can help Dr. Berkman and others by being tested
and joining the registry of potential donors.

** University of California AIDS Research: Conference
February 16, Los Angeles
This one-day conference presents AIDS research at the
University of California, from laboratory science to HIV
prevention studies.

** Help Wanted: Executive Director, Washington D.C.
The Forum for Collaborative HIV Research is seeking an
executive director; applications should be submitted by
January 15.

** Medicine Recycling: List of Donation Centers Published
December 2000
A list of organizations that can accept unused medications
for clinics in developing countries was published in the
December POZ magazine.

** Buyers' Club List, December 2000
Our annual list of AIDS-related buyers' clubs.

** AIDS TREATMENT NEWS Index, 2000
Annual index of this year's articles.


***** European Jewish Ancestry: Activist Doctor Needs Stem
Cell Donation

by John S. James

Alan Berkman, M.D. -- a key founder of the movement to make
AIDS treatment and other expensive drugs available in
Africa and other developing countries -- has Hodgkin's
lymphoma and needs a genetically matched stem cell
transplant within the next few weeks. So far no match has
been found. The most likely donor will be someone of
Eastern European Jewish ancestry.

"My folk came from Eastern Poland and Russia," says Dr.
Berkman. "Until World War II you probably could have found
dozens of people with my general genetic makeup. But a lot
of those genes died in the camps. Now we can only hope that
there are people out there, the children and grandchildren
of survivors, or from families that emigrated a long time
ago, who'll come forward."

Anyone at any risk of exposure to HIV -- even anyone who has
had gay male sex once since 1977 -- is banned from donating
blood under Federal rules. But you can help if you have
contacts with organizations or other groups who have many
members of Jewish or Eastern European ancestry.
Participating in this effort can help everyone in that
group, not only Dr. Berkman, by increasing the number of
persons with that genetic makeup who have been tested and
entered in the national registry, making it more likely to
find a match for future patients. Currently there are very
few persons of Jewish or Eastern European background in the
registry, making it unlikely that a match can be found when
needed.

You can be tested for your genetic type (called HLA type)
by a simple blood test, which your doctor can order. You
can be listed in the registry if you are medically eligible
to donate blood under Federal rules. Then in the unlikely
event that a patient needs your stem cells for a bone-
marrow transplant (which is likely to be lifesaving for him
or her), you could donate bone-marrow cells, a procedure
which is safe but more invasive than donating blood. "You
get the chance to possibly save the life of a relative you
never even knew you had" (quote from a spokesperson for the
HLA Registry Foundation -- see Web site below).

In many areas you can save money by getting the test
through medical organizations instead of a private
physician; for example, in New York City call 800-NY-BLOOD
for a test which costs $40 -- you can be in and out in half
an hour. In Pennsylvania the test is available through the
Pennsylvania Red Cross for $30. Certain racial and ethnic
groups can be tested free under U.S. government programs.
Anywhere in the U.S., to find a center near you, call the
National Marrow Donor Program, 800-526-7809.

For More Information

Background on HLA tissue typing and the bone-marrow
registry can be found at:
http://www.marrow.org (the National Marrow Donor Program),
or at
http://www.hlaregistry.org (The HLA Registry Foundation,
Inc.)

If you may be able to help in this effort to save the life
of Dr. Alan Berkman, contact John S. James at AIDS
Treatment News, jjames@...


***** University of California AIDS Research: Conference
February 16, Los Angeles

"California AIDS Research: Translating Research into Local
and Global Action," the Fourth Annual Conference on AIDS
Research in California, will be held February 16 at the
Sheraton Gateway Hotel, Los Angeles Airport. Registration
is free but space is limited; the online registration
deadline is January 15. For more information, see
http://www.ucop.edu/srphome/uarp or call the Universitywide
AIDS Research Program at 510-987-9855.

Abstracts of previous meetings are also online at the site.


***** Help Wanted: Executive Director, Washington D.C.

This week we received a job description and the following
summary from the Forum for Collaborative HIV Research:

"The Forum for Collaborative HIV Research, a project of the
Center for Health Services Research and Policy at the
George Washington University School of Public Health and
Health Services ("the Center"), is seeking an Executive
Director. The Director is an employee of the University,
hired at the level of Senior Staff Research Scientist and
can seek Faculty Appointment at the University. The
Director reports to the Forum's Executive Committee and the
Director of the Center.

"The mission of the Forum is to facilitate discussion on
emerging issues in HIV clinical research and the
translation of research results into care. The Forum is
governed by an Executive Committee that sets the Forum's
agenda and priorities. The Forum is a coalition of
constituencies engaged in and affected by HIV research and
drug development, including government agencies,
pharmaceutical companies, clinical researchers, health care
providers and patient advocates. The Forum helps to
identify gaps and impediments in optimizing the medical
management of HIV disease, develops recommendations to fill
those gaps, and then catalyzes constituents to implement
those recommendations. The Forum was founded in 1997.

"The Director will oversee all Forum projects and
administration, supervise Forum staff, be responsible for
fund-raising and financial oversight, facilitate the
Executive Committee, and oversee all Forum communications
and publications. The Director will, with the assistance of
Forum staff and the Executive Committee, develop plans for
project implementation, develop budgets, facilitate project
planning committees, represent the Forum at meetings and
conferences, speak about the Forum to its constituents, and
report on Forum activities to the Center and the Executive
Committee.

"Qualifications: The Forum Director should have extensive
experience in a scientific, health care, health services or
health care policy field related to HIV/AIDS. The Director
should have substantial knowledge about HIV/AIDS research
and drug development. The Director should also have
significant administrative and managerial experience in a
government, other non-profit or private entity setting that
would demonstrate ability to manage an office staff,
finances and organizational activities. The Director should
possess a post-graduate degree, or have other substantially
equivalent training that is relevant to HIV/AIDS.

"A cover letter stating interest and required salary along
with a resume should be submitted by January 15, 2001 to:
Bernadette Sharpsperson, 2021 K. St. NW STE 800,
Washington, D.C. 20006, 202-530-2334, 202-296-0025 FAX,
ihoseb@..."

For more information, contact Paul Oh at the phone, fax, or
email above.


***** Medicine Recycling: List of Donation Centers
Published December 2000

We are often asked where unused antiretrovirals and other
medications used in AIDS treatment can be donated for
shipment to clinics in developing countries, for patients
who otherwise would have no access to them. The December
issue of POZ magazine (page 60) published a list of 12
organizations in the U.S. which can receive these
medications for donation. The December 2000 issue will be
online at http://www.poz.com (you may need to click on the
current issue, and from there find the back issues).


***** Buyers' Club List, December 2000

by Tadd Tobias

AIDS TREATMENT NEWS publishes a buyers' club list each
December. For a short overview and introduction to the
meaning, history, and services of these organizations, see
our listing in AIDS TREATMENT NEWS #309, December 18, 1998.

This year we focused on buyers' clubs specializing in HIV
(we also included Rainbow Grocery in San Francisco, because
of its extensive selection of supplements and excellent
information about them). All the organizations listed below
are nonprofit. Most can provide products by mail order.
Most have fact sheets or other information, and some have a
nutritionist or other expert available at certain times to
answer questions. Some offer financial assistance with
purchases if necessary. Most are open to the public, but
some require membership (which may require an annual fee,
or be restricted geographically or in other ways). Call
ahead for open hours and other information.

We have not listed medical marijuana buyers' clubs here.
The best way to find out about any in your area is by
referral from a local AIDS service organization, support
group, or healthcare professional.

Arizona

Being Alive Buyers' Club
http://www.apaz.org/productcatalog.htm
bev@...
1427 North Third St., Phoenix AZ 85004
602-253-2437, fax: 602-253-5577

Travis Wright Memorial Buyers' Club
Southern Arizona AIDS Foundation Buyers' Club
http://www.saaf.org/BChome.htm
info@saaf
3755 Euclid Ave, Tucson AZ 85719
800-771-9054 or 520-628-7223
fax: 520-628-7222
TTY: 800/367-8937

California

Rainbow Grocery Cooperative (20% PWA discount)
http://www.rainbowgrocery.org/general/vitamins/vitamins.htm
vitamins@...
1745 Folsom St., San Francisco CA 94103
415-863-0620

Colorado

Denver Buyers' Club (PWA Coalition Colorado)
pwacolo@...
1290 Williams St.
Mailing address: P.O. Box 300339, Denver CO 80203
303-329-9379, fax: 303-329-9381
TTY: accepted through operator
Bilingual Spanish/English

District of Columbia

Carl Vogel Center
http://www.carlvogelcenter.org
cvc@...
1012-14th St. NW, Suite 707, Washington DC 20005
202-638-0750, fax: 202-638-0749
Membership: annual cost $25 (includes BIA testing, reduced
prices for massage acupuncture, educational symposium,
newsletter, reduced prices for supplements).

Georgia

AIDS Treatment Initiatives
http://www.aidstreatment.org
info@...
159 Ralph McGill Blvd. NE Suite 510, Atlanta GA 30308-3311
888-874-4845 or 404-659-2437
fax: 404-659-2438
TTY: 404-524-0464

Massachusetts

Treatment Information Network's/Boston Buyers' Club
http://www.vitatime.com/
bosbuyrclb@...
Boston Living Center, 29 Stanhope St., 3rd Floor
Boston MA 02116
800-435-5586, or 617-266-2223
fax: 617-450-9412

New York

DAAIR (Direct Access Alternative Information Resources)
http://www.daair.org
email: info@...
31 East 30th St. #2A, New York NY 10016
888-951-5433 or 212-725-6994
fax: 212-689-6471
New members receive a membership outreach pack of over 100
pages. PREVENTING AND MANAGING DRUG SIDE EFFECTS AND HIV
SYMPTOMS is available at http://www.daair.org (click the
Countering Toxicities button on the home page).

Texas

Houston Buyers' Club
http://houstonbuyersclub.com/
hbc@...
3400 Montrose Blvd. #605, Houston TX 77006
800-350-2392
713-520-5288, fax: 713-521-7419



***** AIDS Treatment News Index, 2000
Topic     Date   Issue     Title of article

2000     07-Jan-00  #334  2000 Outlook
3TC     17-Nov-00  #355  "Trizivir" Approved: Three Existing Drugs in One
abacavir     17-Nov-00  #355  "Trizivir" Approved: Three Existing Drugs in One
abacavir     04-Aug-00  #348  Ziagen (Abacavir): New Warning on Restarting
abacavir warning     18-Feb-00  #337  Abacavir Warning: Certain Respiratory
Symptoms Can Indicate...
Abbott Laboratories     23-Jun-00  #345  Kaletra (ABT-378/r) Application
for Accelerated Approval
Abbott Laboratories     21-Jan-00  #335  Liver Toxicity, Ritonavir, and
Hepatitis C: New Data Published
Abrams, Dr. Donald     04-Aug-00  #348  Marijuana Safety Study Completed:
Weight Gain, No Safety Problem
abstracts on Web     03-Nov-00  #354  Durban Conference Searchable
Abstracts Now Available on Web
ABT-378/r     17-Nov-00  #355  Community Update: New Drugs to Watch
ABT-378/r     22-Sep-00  #351  Kaletra (ABT-378/r) Approved
access to care     01-Dec-00  #356  California: MediCal Income Eligibility
Level Raised for Disabled
access to care     01-Dec-00  #356  Global Treatment Access: Call for 95%
Price Reduction; New GTAC
access to care     03-Nov-00  #354  Many People with HIV Not Getting Proper
Treatment
access to care     20-Oct-00  #353  HMOs, Health Insurance: More Problems
access to care     22-Sep-00  #351  Brazil AIDS Success: Washington Post Report
access to care     04-Aug-00  #348  Medicine Recycling to Latin America:
Interview with Jesus Aguais
access to care     28-Jul-00  #347  Access to Treatment Worldwide: From
Talk to Action at Durban
access to care     07-Jul-00  #346  HMO, Insurance Policies Threaten HIV
Care: Interview with Dr. X
access to care     07-Jul-00  #346  Tuberculosis: New Drug Class
Investigated through Public-Private...
access to care     23-Jun-00  #345  Durban: Global Call for Treatment Access
access to care     02-Jun-00  #344  World Issues Today: Interview with
Peter Piot, Executive Director...
ACT UP Golden Gate     21-Apr-00  #341  ACT UP Golden Gate Changes Name to
Survive AIDS
ACT UP New York     23-Jun-00  #345  Durban: Global Call for Treatment Access
ACT UP Philadelphia     18-Aug-00  #349  ACT UP Philadelphia Arrest Followup
ACT UP Philadelphia     04-Aug-00  #348  Philadelphia Protests: National
Support Needed
ACT UP Philadelphia     23-Jun-00  #345  Durban: Global Call for Treatment
Access
ACT UP San Francisco     19-May-00  #343  San Francisco: Misdemeanor
Charges in Treatment Meeting Disruption
ACT UP San Francisco     21-Apr-00  #341  ACT UP Golden Gate Changes Name
to Survive AIDS
ACT UP San Francisco     21-Apr-00  #341  Treatment Interruption: Experts
Sound Cautious Note at San Fran...
acupuncture     07-Jan-00  #334  Acupuncture Detoxification Meeting, San
Francisco, January 28 an
ADAP     03-Nov-00  #354  Many People with HIV Not Getting Proper Treatment
Africa     01-Dec-00  #356  New Report on World AIDS Epidemic
Africa     28-Jul-00  #347  Selenium: African Studies Reported at Durban
Africa     19-May-00  #343  Africa Treatment Access in the News
African American     17-Mar-00  #339  African Americans and AIDS:
Highlights of 2nd Annual Washington
African American     21-Jan-00  #335  African Americans and AIDS
Conference, February 24-25, Washington
AGENERASE     05-May-00  #342  Amprenavir (AGENERASE) Oral Solution:
Warning for Some Patients
AID for AIDS     04-Aug-00  #348  Medicine Recycling to Latin America:
Interview with Jesus Aguais
AIDS dissidents     07-Apr-00  #340  South Africa "AIDS Dissident" Dispute:
Time to Stop
AIDS Drug Assistance Program     03-Nov-00  #354  Many People with HIV Not
Getting Proper Treatment
AIDS Library     17-Nov-00  #355  AIDS Treatment News will Move to
Philadelphia on January 2
AIDS Research Institute     03-Nov-00  #354  Many People with HIV Not
Getting Proper Treatment
AIDS Treatment News     17-Nov-00  #355  AIDS Treatment News will Move to
Philadelphia on January 2
albendazole     17-Mar-00  #339  Treatment Models from India: Interview
with Shashank Joshi, M.D.
American Foundation for AIDS Research   03-Mar-00  #338  National AIDS
Update Conference, San Francisco, March 14-17
AmFAR     03-Mar-00  #338  National AIDS Update Conference, San Francisco,
March 14-17
amprenavir     05-May-00  #342  Amprenavir (AGENERASE) Oral Solution:
Warning for Some Patients
antibiotic drug resistance     18-Aug-00  #349  Global Resistance Day,
September 16, Toronto
antiretroviral treatment     01-Dec-00  #356  Structured Treatment
Interruption: Important Controlled Trial in
antiretroviral treatment     17-Nov-00  #355  Community Update: New Drugs
to Watch
antiretroviral treatment     03-Nov-00  #354  Has Anti-HIV Treatment Cut
AIDS Deaths?
antiretroviral treatment     22-Sep-00  #351  Brazil AIDS Success:
Washington Post Report
antiretroviral treatment     08-Sep-00  #350  AIDS Treatment Improves
Survival: Answering the "AIDS Deni
antiretroviral treatment     07-Apr-00  #340  AIDS Practice Issues Today:
Interview with Paul Bellman, M.D.
antiretroviral treatment     17-Mar-00  #339  Treatment Models from India:
Interview with Shashank Joshi, M.D.
antiretroviral treatment     03-Mar-00  #338  HAART and Medical Management:
The Realities of Clinic Care...
antiretroviral treatment     18-Feb-00  #337  A Call for More Cautious
Antiretroviral Treatment
antiretroviral treatment     18-Feb-00  #337  New Guidelines for HIV
Treatment; Resistance Testing Now Recommended
antiretroviral treatment     21-Jan-00  #335  Liver Toxicity, Ritonavir,
and Hepatitis C: New Data Published
Archbishop Ndungane     17-Mar-00  #339  Fluconazole: Pfizer Asked to Lower
Africa Price
AZT     17-Nov-00  #355  "Trizivir" Approved: Three Existing Drugs in One
Bartlett, Dr. John G.     17-Mar-00  #339  African Americans and AIDS:
Highlights of 2nd Annual Washington
Bay Area Reporter (newspaper)     21-Apr-00  #341  ACT UP Golden Gate
Changes Name to Survive AIDS
Bellman, Paul     07-Apr-00  #340  AIDS Practice Issues Today: Interview
with Paul Bellman, M.D.
benefits     07-Jan-00  #334  Disability Benefits: New Law Will Help
Disabled Return to Work
Berkman, Dr. Alan     22-Dec-00  #357  European Jewish Ancesry: Activist
Doctor Needs Stem Cell Donation
bibliography on NAC     06-Oct-00  #352  NAC and Glutathione: Recent
Publications
Boehringer Ingelheim Roxane Lab.     17-Nov-00  #355  Nevirapine (VIRAMUNE)
Strengthens Warning on Liver, Skin Toxicity
Boston     21-Jan-00  #335  Post-Exposure Prevention (PEP) for Sexual,
Needle Exposure Opens
Brazil     22-Sep-00  #351  Brazil AIDS Success: Washington Post Report
Bristol-Myers Squibb     03-Nov-00  #354  Enteric-Coated ddI Approved: FDA
Letter
Bristol-Myers Squibb     17-Mar-00  #339  African Americans and AIDS:
Highlights of 2nd Annual Washington
BUILD TO SURVIVE     17-Mar-00  #339  Anabolics, Exercise, Nutrition,
Supplements: New Book Available
Buyers' clubs     22-Dec-00  #357  Buyers' Club List, December 2000
California     01-Dec-00  #356  California: MediCal Income Eligibility
Level Raised for Disabled
California     03-Nov-00  #354  Many People with HIV Not Getting Proper
Treatment
CD4 counts     21-Apr-00  #341  Answering the AIDS Denialists: CD4 (T-Cell)
Counts, and Viral Lo
clinical trials     02-Jun-00  #344  Clinical Trials and Industry
Influence: Major Report
communication skills     07-Jul-00  #346  Communication Skills and HIV
Prevention
compounded testosterone cream     17-Mar-00  #339  Testosterone Cream
Available at CPS; Gel Approved by FDA
Conference on Retroviruses and Opportu  04-Feb-00  #336  Retroviruses
Conference: Overview, Information Available
Coovadia, Hoosen M. (Jerry)     19-May-00  #343  Durban Conference Status,
May 2000: Interview with Conference...
cramps     02-Jun-00  #344  Frequent Urination, Leg Cramps, Leg Weakness,
Erection Difficult
Critical Path AIDS Project     17-Nov-00  #355  AIDS Treatment News will
Move to Philadelphia on January 2
Critical Path AIDS Project     22-Sep-00  #351  Critical Path Newsletter:
Kiyoshi Kuromiya Memorial, Prison Reso...
Critical Path AIDS Project     19-May-00  #343  Kiyoshi Kuromiya, 1943-2000
cryptococcal meningitis     17-Mar-00  #339  Fluconazole: Pfizer Asked to
Lower Africa Price
Cunningham, Al     17-Mar-00  #339  African Americans and AIDS: Highlights
of 2nd Annual Washington
DAPD     17-Nov-00  #355  Community Update: New Drugs to Watch
ddI     03-Nov-00  #354  Enteric-Coated ddI Approved: FDA Letter
de-worming     17-Mar-00  #339  Treatment Models from India: Interview with
Shashank Joshi, M.D.
dementia     02-Jun-00  #344  "Mental" Issue Threatens Medical Care
denialists     01-Dec-00  #356  Answering the Denialists: Is AIDS Real?
denialists     03-Nov-00  #354  Has Anti-HIV Treatment Cut AIDS Deaths?
denialists     08-Sep-00  #350  AIDS Treatment Improves Survival: Answering
the "AIDS Denialists
denialists     28-Jul-00  #347  "HIV" Controversy: Nelson Mandela's Call to
End Disp
denialists     07-Jul-00  #346  Durban Declaration on HIV and AIDS
denialists     07-Jul-00  #346  San Francisco Statement on HIV and AIDS
denialists     19-May-00  #343  San Francisco: Misdemeanor Charges in
Treatment Meeting Disruption
denialists     05-May-00  #342  AIDS Denialists: How to Respond
denialists     21-Apr-00  #341  Answering the AIDS Denialists: CD4 (T-Cell)
Counts, and Viral Lo
denialists     21-Apr-00  #341  Treatment Interruption: Experts Sound
Cautious Note at San Franc
denialists     07-Apr-00  #340  South Africa "AIDS Dissident" Dispute: Time
to Stop
developing countries     01-Dec-00  #356  Global Treatment Access: Call for
95% Price Reduction; New GTAC
developing countries     04-Aug-00  #348  Medicine Recycling to Latin
America: Interview with Jesus Aguais
developing countries     28-Jul-00  #347  Access to Treatment Worldwide:
  From Talk to Action at Durban
developing countries     07-Jul-00  #346  Tuberculosis: New Drug Class
Investigated through Public-Private
developing countries     23-Jun-00  #345  Durban: Global Call for Treatment
Access
developing countries     02-Jun-00  #344  World Issues Today: Interview
with Peter Piot, Executive Directo
didanosine     03-Nov-00  #354  Enteric-Coated ddI Approved: FDA Letter
dietary supplements     17-Mar-00  #339  Dietary Supplement Regulation...
disability     01-Dec-00  #356  California: MediCal Income Eligibility
Level Raised for Disabled
disability     07-Jan-00  #334  Disability Benefits: New Law Will Help
Disabled Return to Work
disruption of meetings     19-May-00  #343  San Francisco: Misdemeanor
Charges in Treatment Meeting Disruption
disruption of meetings     21-Apr-00  #341  ACT UP Golden Gate Changes Name
to Survive AIDS
dissidents     see HIV denialists
DNA vaccine     02-Jun-00  #344  New Oral DNA Vaccine Funded for Trials
Doctors Without Borders     01-Dec-00  #356  Global Treatment Access: Call
for 95% Price Reduction; New GTAC
Doctors Without Borders     28-Jul-00  #347  Access to Treatment Worldwide:
  From Talk to Action at Durban
Doctors Without Borders     17-Mar-00  #339  Fluconazole: Pfizer Asked to
Lower Africa Price
Dr. X     07-Jul-00  #346  HMO, Insurance Policies Threaten HIV Care:
Interview with Dr. X
drug approval     20-Oct-00  #353  FDA Meeting on Approving Immune
Therapies: Background and Comment
drug donations     see also medicine recycling
drug donations     19-May-00  #343  Africa Treatment Access in the News
drug donations     07-Apr-00  #340  Pfizer Will Donate Fluconazole to South
Africa
drug interactions     18-Feb-00  #337  St. John's Wort Warning: Do Not
Combine with Protease Inhibitors
drug reform Web site     04-Aug-00  #348  Other Medical Marijuana News
drug safety     17-Nov-00  #355  Nevirapine (VIRAMUNE) Strengthens Warning
on Liver, Skin Toxicity
drug safety     04-Aug-00  #348  Marijuana Safety Study Completed: Weight
Gain, No Safety Problem
drug safety     04-Aug-00  #348  Ziagen (Abacavir): New Warning on Restarting
drug treatment     07-Jan-00  #334  Acupuncture Detoxification Meeting, San
Francisco, January 28 an
drug warnings     see side effects
Duesberg, Dr. Peter     01-Dec-00  #356  Answering the Denialists: Is AIDS
Real?
Durban conference     03-Nov-00  #354  Durban Conference Searchable
Abstracts Now Available on Web
Durban conference     28-Jul-00  #347  Weekly Intermittent Treatment: Caution
Durban conference     07-Jul-00  #346  Durban Declaration on HIV and AIDS
Durban conference     23-Jun-00  #345  Durban World Conference, July 9-14:
Online Coverage
Durban conference     23-Jun-00  #345  Durban: Global Call for Treatment Access
Durban conference     19-May-00  #343  Durban Conference Status, May 2000:
Interview with Conference...
easy-language version     03-Nov-00  #354  Has Anti-HIV Treatment Cut AIDS
Deaths?
efavirenz     05-May-00  #342  Efavirenz (Sustiva): Oral Liquid Expanded
Access Program for Chi
enteric coated     03-Nov-00  #354  Enteric-Coated ddI Approved: FDA Letter
ethics     02-Jun-00  #344  Clinical Trials and Industry Influence: Major
Report
Europe     01-Dec-00  #356  New Report on World AIDS Epidemic
executive order     19-May-00  #343  Africa Treatment Access in the News
expanded access programs     05-May-00  #342  Efavirenz (Sustiva): Oral
Liquid Expanded Access Program for...
Fauci, Dr. Anthony     28-Jul-00  #347  Weekly Intermittent Treatment: Caution
Fauci, Dr. Anthony     17-Mar-00  #339  African Americans and AIDS:
Highlights of 2nd Annual Washington
FDA     20-Oct-00  #353  FDA Meeting on Approving Immune Therapies:
Background and Commen
FDA     22-Sep-00  #351  Immune-Based Therapies: FDA Meeting October 16
FDA     17-Mar-00  #339  Dietary Supplement Regulation...
FDA     17-Mar-00  #339  FDA Drug-Approval Background: New Web Pages
FDA warning     18-Feb-00  #337  St. John's Wort Warning: Do Not Combine
with Protease Inhibitors
Feinstein, Senator Diane     19-May-00  #343  Africa Treatment Access in
the News
Florida     03-Nov-00  #354  Many People with HIV Not Getting Proper Treatment
flu medications     21-Jan-00  #335  Flu Epidemic: Shots, New Treatments
Available
flu shots     21-Jan-00  #335  Flu Epidemic: Shots, New Treatments Available
fluconazole     20-Oct-00  #353  South Africa: Historic "Defiance Campaign"
Imports G
fluconazole     07-Apr-00  #340  Pfizer Will Donate Fluconazole to South Africa
fluconazole     17-Mar-00  #339  Fluconazole: Pfizer Asked to Lower Africa
Price
Francis, Lynde     17-Nov-00  #355  Nutrition and HIV Infection: Experience
in Zimbabwe: Interview...
funding     03-Mar-00  #338  HAART and Medical Management: The Realities of
Clinic Care...
Gallo, Dr. Robert     02-Jun-00  #344  New Oral DNA Vaccine Funded for Trials
Gallo, Dr. Robert     17-Mar-00  #339  African Americans and AIDS:
Highlights of 2nd Annual Washington
gay men     23-Jun-00  #345  Excellent Book on Gay Men's Health
Gay Men's Health Crisis     23-Jun-00  #345  Excellent Book on Gay Men's Health
generic drugs     20-Oct-00  #353  South Africa: Historic "Defiance
Campaign" Imports G
generic drugs     28-Jul-00  #347  Access to Treatment Worldwide: From Talk
to Action at Durban
Getty, Jeff     21-Apr-00  #341  ACT UP Golden Gate Changes Name to Survive
AIDS
Glaxo Wellcome     18-Feb-00  #337  Abacavir Warning: Certain Respiratory
Symptoms Can Indicate Hype
Global Alliance for Vaccines and Immun  17-Mar-00  #339  Vaccine News,
March 2, 2000
global epidemic     01-Dec-00  #356  New Report on World AIDS Epidemic
global treatment access     01-Dec-00  #356  Global Treatment Access: Call
for 95% Price Reduction; New GTAC
glutathione     06-Oct-00  #352  NAC and Glutathione: Recent Publications
glutathione     06-Oct-00  #352  NAC: Stanford San Francisco Study Report
Shows Blood Glutathione
GMHC (Gay Men's Health Crisis)     23-Jun-00  #345  Excellent Book on Gay
Men's Health
guidelines     19-May-00  #343  Resistance Testing Recommended in New
IAS-USA Guidelines
guidelines     18-Feb-00  #337  New Guidelines for HIV Treatment;
Resistance Testing Now Recomme
Harare, Zimbabwe     17-Nov-00  #355  Nutrition and HIV Infection:
Experience in Zimbabwe: Interview w
Health GAP Coalition     23-Jun-00  #345  Durban: Global Call for Treatment
Access
Henry, Dr. Keith     03-Mar-00  #338  HAART and Medical Management: The
Realities of Clinic Care. Inte
Henry, Dr. Keith     18-Feb-00  #337  A Call for More Cautious
Antiretroviral Treatment
hepatitis C     21-Jan-00  #335  Liver Toxicity, Ritonavir, and Hepatitis
C: New Data Published
herbal treatment     17-Mar-00  #339  Treatment Models from India:
Interview with Shashank Joshi, M.D.
Herzenberg, Drs. L.A., Droge, Dr. Wulf  06-Oct-00  #352  NAC: Stanford San
Francisco Study Report Shows Blood Glutathione
HIV controversy     08-Sep-00  #350  AIDS Treatment Improves Survival:
Answering the "AIDS Denialists"
HIV controversy     28-Jul-00  #347  "HIV" Controversy: Nelson Mandela's
Call to End...
HIV controversy     07-Jul-00  #346  Durban Declaration on HIV and AIDS
HIV controversy     07-Jul-00  #346  San Francisco Statement on HIV and AIDS
HIV-specific immunity     07-Jan-00  #334  2000 Outlook
HIVandHepatitis site     22-Sep-00  #351  ICAAC; Lipodystrophy; IDSA:
Conference Summaries on Web
HMOs     20-Oct-00  #353  HMOs, Health Insurance: More Problems
HMOs     18-Aug-00  #349  Health Insurance Reimbursement Legislation
HMOs     07-Jul-00  #346  HMO, Insurance Policies Threaten HIV Care:
Interview with Dr. X
hypersensitivity reaction     18-Feb-00  #337  Abacavir Warning: Certain
Respiratory Symptoms Can Indicate...
IAVI     17-Mar-00  #339  Vaccine News, March 2, 2000
ICAAC conference     22-Sep-00  #351  ICAAC; Lipodystrophy; IDSA:
Conference Summaries on Web
IDSA conference     22-Sep-00  #351  ICAAC; Lipodystrophy; IDSA: Conference
Summaries on Web
IHV (Institute for Human Virology)     02-Jun-00  #344  New Oral DNA
Vaccine Funded for Trials
IL-2     07-Apr-00  #340  AIDS Practice Issues Today: Interview with Paul
Bellman, M.D.
immune response     20-Oct-00  #353  Vaccine Advance: Monkeys Still
Infected, but Protected from Illn
immune response     22-Sep-00  #351  New Findings on Immune Response to HIV
Tat May Contribute to...
Immune Response Corporation     03-Nov-00  #354  Bitter Publication Dispute
on Remune Study: More Than Meets the
immune-based treatment     03-Nov-00  #354  Bitter Publication Dispute on
Remune Study: More Than Meets the
immune-based treatment     20-Oct-00  #353  FDA Meeting on Approving Immune
Therapies: Background and Comment
immune-based treatment     22-Sep-00  #351  Immune-Based Therapies: FDA
Meeting October 16
India     17-Mar-00  #339  Treatment Models from India: Interview with
Shashank Joshi, M.D.
Infectious Diseases Society of America  22-Sep-00  #351  ICAAC;
Lipodystrophy; IDSA: Conference Summaries on Web
influenza     21-Jan-00  #335  Flu Epidemic: Shots, New Treatments Available
influenza medications     21-Jan-00  #335  Flu Epidemic: Shots, New
Treatments Available
Institute for Human Virology     02-Jun-00  #344  New Oral DNA Vaccine
Funded for Trials
insurance     18-Aug-00  #349  Health Insurance Reimbursement Legislation
insurance     07-Jul-00  #346  HMO, Insurance Policies Threaten HIV Care:
Interview with Dr. X
intellectual property     28-Jul-00  #347  Access to Treatment Worldwide:
  From Talk to Action at Durban
intellectual property     19-May-00  #343  Africa Treatment Access in the News
intermittent treatment     01-Dec-00  #356  Structured Treatment
Interruption: Important Controlled Trial in
International AIDS Society -- USA     19-May-00  #343  Resistance Testing
Recommended in New IAS-USA Guidelines
International AIDS Vaccine Initiative   17-Mar-00  #339  Vaccine News,
March 2, 2000
intestinal parasites     17-Mar-00  #339  Treatment Models from India:
Interview with Shashank Joshi, M.D.
Jordan Report 2000     17-Mar-00  #339  Vaccine News, March 2, 2000
Joshi, Shashank     17-Mar-00  #339  Treatment Models from India: Interview
with Shashank Joshi, M.D.
Kaletra     17-Nov-00  #355  Community Update: New Drugs to Watch
Kaletra     22-Sep-00  #351  Kaletra (ABT-378/r) Approved
Kaletra     23-Jun-00  #345  Kaletra (ABT-378/r) Application for
Accelerated Approval
Kuromiya, Kiyoshi     22-Sep-00  #351  Critical Path Newsletter: Kiyoshi
Kuromiya Memorial, Prison Reso
Kuromiya, Kiyoshi     19-May-00  #343  Kiyoshi Kuromiya, 1943-2000
leg weakness     02-Jun-00  #344  Frequent Urination, Leg Cramps, Leg
Weakness, Erection Difficult
lipodystrophy     07-Jan-00  #334  2000 Outlook
Lipodystrophy conference     22-Sep-00  #351  ICAAC; Lipodystrophy; IDSA:
Conference Summaries on Web
liver toxicity     17-Nov-00  #355  Nevirapine (VIRAMUNE) Strengthens
Warning on Liver, Skin Toxicit
liver toxicity     21-Jan-00  #335  Liver Toxicity, Ritonavir, and
Hepatitis C: New Data Published
long-term effectiveness research     07-Jan-00  #334  Three Activist
Meetings, San Francisco Late January
lopinavir     17-Nov-00  #355  Community Update: New Drugs to Watch
lopinavir     22-Sep-00  #351  Kaletra (ABT-378/r) Approved
lopinavir     23-Jun-00  #345  Kaletra (ABT-378/r) Application for
Accelerated Approval
managed care     18-Aug-00  #349  Health Insurance Reimbursement Legislation
managed care     03-Mar-00  #338  HAART and Medical Management: The
Realities of Clinic Care. Inte
Mandela, Nelson     28-Jul-00  #347  "HIV" Controversy: Nelson Mandela's
Call to End Disp
marijuana     04-Aug-00  #348  Marijuana Safety Study Completed: Weight
Gain, No Safety Problem
marijuana     04-Aug-00  #348  Other Medical Marijuana News
Mbeki, President Thabo     07-Apr-00  #340  South Africa "AIDS Dissident"
Dispute: Time to Stop
McCormack, Tom     07-Jan-00  #334  Disability Benefits: New Law Will Help
Disabled Return to Work
Medibolics     17-Mar-00  #339  Anabolics, Exercise, Nutrition,
Supplements: New Book Available
Medicaid     01-Dec-00  #356  California: MediCal Income Eligibility Level
Raised for Disabled
Medicaid     03-Nov-00  #354  Many People with HIV Not Getting Proper Treatment
MediCal     01-Dec-00  #356  California: MediCal Income Eligibility Level
Raised for Disabled
Medicare     07-Jan-00  #334  Disability Benefits: New Law Will Help
Disabled Return to Work
medicine recycling     04-Aug-00  #348  Medicine Recycling to Latin
America: Interview with Jesus Aguais
medicine recycling centers     22-Dec-00  #357  Medicine Recycling: List of
Donation Centers Published Dec. 2000
Medscape site     22-Sep-00  #351  ICAAC; Lipodystrophy; IDSA: Conference
Summaries on Web
Men Like Us     23-Jun-00  #345  Excellent Book on Gay Men's Health
methionine deficiency     02-Jun-00  #344  Frequent Urination, Leg Cramps,
Leg Weakness, Erection Difficult
microbicides     03-Mar-00  #338  First Microbicide Conference, March 13-16
near Washington D.C.
Mirken, Bruce     01-Dec-00  #356  Answering the Denialists: Is AIDS Real?
Mirken, Bruce     08-Sep-00  #350  AIDS Treatment Improves Survival:
Answering the "AIDS Deni
Mirken, Bruce     02-Jun-00  #344  "Mental" Issue Threatens Medical Care
Mirken, Bruce     21-Apr-00  #341  Answering the AIDS Denialists: CD4
(T-Cell) Counts, and Viral Lo
mitochondrial toxicity     04-Feb-00  #336  Retroviruses Conference:
Overview, Information Available
Mooney, Michael     17-Mar-00  #339  Anabolics, Exercise, Nutrition,
Supplements: New Book Available
MSF (Doctors Without Borders)     01-Dec-00  #356  Global Treatment Access:
Call for 95% Price Reduction; New GTAC
MSF (Doctors Without Borders)     28-Jul-00  #347  Access to Treatment
Worldwide: From Talk to Action at Durban
MSF (Doctors Without Borders)     17-Mar-00  #339  Fluconazole: Pfizer
Asked to Lower Africa Price
myelopathy     02-Jun-00  #344  Frequent Urination, Leg Cramps, Leg
Weakness, Erection Difficult
n-acetylcysteine     06-Oct-00  #352  NAC and Glutathione: Recent Publications
n-acetylcysteine     06-Oct-00  #352  NAC: Stanford San Francisco Study
Report Shows Blood Glutathione
NAC     06-Oct-00  #352  NAC and Glutathione: Recent Publications
NAC     06-Oct-00  #352  NAC: Stanford San Francisco Study Report Shows
Blood Glutathione
NATAP site     22-Sep-00  #351  ICAAC; Lipodystrophy; IDSA: Conference
Summaries on Web
National AIDS Update Conference     03-Mar-00  #338  National AIDS Update
Conference, San Francisco, March 14-17
national security     05-May-00  #342  AIDS Declared National Security Threat
Ndungane     17-Mar-00  #339  Fluconazole: Pfizer Asked to Lower Africa Price
needle exchange     18-Aug-00  #349  Prevention: Changing Focus in San
Francisco
neuropathy     07-Jan-00  #334  Neuropathy: Practical Book on Mainstream,
Alternative Options
nevirapine     05-May-00  #342  Nevirapine (Viramune): European Warning
nevirapine warning     17-Nov-00  #355  Nevirapine (VIRAMUNE) Strengthens
Warning on Liver, Skin Toxicit
New York     03-Nov-00  #354  Many People with HIV Not Getting Proper Treatment
New York     21-Jan-00  #335  Post-Exposure Prevention (PEP) for Sexual,
Needle Exposure Opens
NNRTI antiretrovirals     17-Nov-00  #355  Community Update: New Drugs to Watch
Numb Toes... (book)     07-Jan-00  #334  Neuropathy: Practical Book on
Mainstream, Alternative Options
nutrition     17-Nov-00  #355  Nutrition and HIV Infection: Experience in
Zimbabwe: Interview w
nutrition     17-Mar-00  #339  Treatment Models from India: Interview with
Shashank Joshi, M.D.
nutrition     07-Jan-00  #334  2000 Outlook
nutritional supplements     28-Jul-00  #347  Selenium: African Studies
Reported at Durban
nutritional supplements     28-Jul-00  #347  Selenium: Important New Review
of Health Findings
Oakland Buyers' Club     04-Aug-00  #348  Other Medical Marijuana News
oral vaccine     02-Jun-00  #344  New Oral DNA Vaccine Funded for Trials
pediatric     05-May-00  #342  Efavirenz (Sustiva): Oral Liquid Expanded
Access Program for Chi
PEP     21-Jan-00  #335  Post-Exposure Prevention (PEP) for Sexual, Needle
Exposure Opens
Pfizer, Inc.     07-Apr-00  #340  Pfizer Will Donate Fluconazole to South
Africa
Pfizer, Inc.     17-Mar-00  #339  Fluconazole: Pfizer Asked to Lower Africa
Price
pharmaceutical industry     02-Jun-00  #344  Clinical Trials and Industry
Influence: Major Report
Philadelphia FIGHT     17-Nov-00  #355  AIDS Treatment News will Move to
Philadelphia on January 2
Piot, Peter     02-Jun-00  #344  World Issues Today: Interview with Peter
Piot, Executive Directo
PMPA     17-Nov-00  #355  Community Update: New Drugs to Watch
post-exposure prevention     21-Jan-00  #335  Post-Exposure Prevention
(PEP) for Sexual, Needle Exposure Opens
prevention     18-Aug-00  #349  Prevention: Changing Focus in San Francisco
prevention     03-Mar-00  #338  First Microbicide Conference, March 13-16
near Washington D.C.
prison     22-Sep-00  #351  Critical Path Newsletter: Kiyoshi Kuromiya
Memorial, Prison Reso
psychiatric care     02-Jun-00  #344  "Mental" Issue Threatens Medical Care
public-private partnership     07-Jul-00  #346  Tuberculosis: New Drug
Class Investigated through Public-Private
Pulitzer Prize     21-Apr-00  #341  Africa Series Wins Pulitzer
Rasnick, David     01-Dec-00  #356  Answering the Denialists: Is AIDS Real?
reinfection     01-Dec-00  #356  Superinfection (Reinfection): New Study in
San Francisco Offers
Relenza     21-Jan-00  #335  Flu Epidemic: Shots, New Treatments Available
Remune     03-Nov-00  #354  Bitter Publication Dispute on Remune Study:
More Than Meets the
Remune     07-Apr-00  #340  AIDS Practice Issues Today: Interview with Paul
Bellman, M.D.
Republican convention     18-Aug-00  #349  ACT UP Philadelphia Arrest Followup
Republican convention     04-Aug-00  #348  Philadelphia Protests: National
Support Needed
research     03-Mar-00  #338  HAART and Medical Management: The Realities
of Clinic Care. Inte
resistance testing     19-May-00  #343  Resistance Testing Recommended in
New IAS-USA Guidelines
resistance testing     18-Feb-00  #337  HIV Resistance-Testing Information
on Web
resistance testing     18-Feb-00  #337  New Guidelines for HIV Treatment;
Resistance Testing Now Recomme
Retroviruses conference online reports  04-Feb-00  #336  Retroviruses
Conference: Overview, Information Available
Retroviruses conference, 2000     04-Feb-00  #336  Retroviruses Conference:
Overview, Information Available
Retroviruses conference, 2001     03-Nov-00  #354  Retroviruses Conference:
Registration Deadline for Community Att
Retroviruses conference, 2001     22-Sep-00  #351  2001 Retroviruses
Conference, Chicago: Deadlines Start in Octobe
returning to work     07-Jan-00  #334  Disability Benefits: New Law Will
Help Disabled Return to Work
RNC demonstration     18-Aug-00  #349  ACT UP Philadelphia Arrest Followup
RNC demonstration     04-Aug-00  #348  Philadelphia Protests: National
Support Needed
Roberts, Ian     05-May-00  #342  South Africa: Advisor Ian Roberts Resigns
safety     see side effects
safety, abacavir     04-Aug-00  #348  Ziagen (Abacavir): New Warning on
Restarting
safety, nevirapine     17-Nov-00  #355  Nevirapine (VIRAMUNE) Strengthens
Warning on Liver, Skin Toxicit
San Francisco     01-Dec-00  #356  Superinfection (Reinfection): New Study
in San Francisco Offers
San Francisco     21-Jan-00  #335  Post-Exposure Prevention (PEP) for
Sexual, Needle Exposure Opens
Schoofs, Mark     21-Apr-00  #341  Africa Series Wins Pulitzer
Scientific American May 2000     19-May-00  #343  Africa Treatment Access
in the News
scrub typhus     18-Aug-00  #349  Scrub Typhus: Infection Reduces Viral
Load in Some Patients
selenium     17-Nov-00  #355  Nutrition and HIV Infection: Experience in
Zimbabwe: Interview w
selenium     28-Jul-00  #347  Selenium: African Studies Reported at Durban
selenium     28-Jul-00  #347  Selenium: Important New Review of Health Findings
side effects     05-May-00  #342  Amprenavir (AGENERASE) Oral Solution:
Warning for Some Patients
side effects     05-May-00  #342  Nevirapine (Viramune): European Warning
side effects     18-Feb-00  #337  Abacavir Warning: Certain Respiratory
Symptoms Can Indicate Hype
Social Security     01-Dec-00  #356  California: MediCal Income Eligibility
Level Raised for Disabled
social venture capital     17-Mar-00  #339  Vaccine News, March 2, 2000
South Africa     20-Oct-00  #353  South Africa: Historic "Defiance
Campaign" Imports G
South Africa     05-May-00  #342  South Africa: Advisor Ian Roberts Resigns
South Africa     07-Apr-00  #340  Pfizer Will Donate Fluconazole to South
Africa
South Africa     07-Apr-00  #340  South Africa "AIDS Dissident" Dispute:
Time to Stop
South Africa     17-Mar-00  #339  Fluconazole: Pfizer Asked to Lower Africa
Price
SSDI     07-Jan-00  #334  Disability Benefits: New Law Will Help Disabled
Return to Work
SSI     01-Dec-00  #356  California: MediCal Income Eligibility Level
Raised for Disabled
St. John's Wort     18-Feb-00  #337  St. John's Wort Warning: Do Not
Combine with Protease Inhibitors
St. Paulo, Minnesota     18-Feb-00  #337  A Call for More Cautious
Antiretroviral Treatment
STI     21-Apr-00  #341  Treatment Interruption: Experts Sound Cautious
Note at San Franc
STI (strategic treatment interruption)  01-Dec-00  #356  Structured
Treatment Interruption: Important Controlled Trial in
STI (strategic treatment interruption)  28-Jul-00  #347  Weekly
Intermittent Treatment: Caution
strategic treatment interruption     01-Dec-00  #356  Structured Treatment
Interruption: Important Controlled Trial in
strategic treatment interruption     28-Jul-00  #347  Weekly Intermittent
Treatment: Caution
strategic treatment interruption     21-Apr-00  #341  Treatment
Interruption: Experts Sound Cautious Note at San Franc
superinfection     01-Dec-00  #356  Superinfection (Reinfection): New Study
in San Francisco Offers
supplements     17-Mar-00  #339  Dietary Supplement Regulation...
survival     03-Nov-00  #354  Has Anti-HIV Treatment Cut AIDS Deaths?
survival     08-Sep-00  #350  AIDS Treatment Improves Survival: Answering
the "AIDS Deni
Survive AIDS     21-Apr-00  #341  ACT UP Golden Gate Changes Name to
Survive AIDS
Sustiva     05-May-00  #342  Efavirenz (Sustiva): Oral Liquid Expanded
Access Program for Chi
T-20     17-Nov-00  #355  Community Update: New Drugs to Watch
T-cell counts     21-Apr-00  #341  Answering the AIDS Denialists: CD4
(T-Cell) Counts, and Viral Lo
TAC (South Africa)     23-Jun-00  #345  Urgent: South African Treatment
Activists Need Assistance
TAMIFLU     21-Jan-00  #335  Flu Epidemic: Shots, New Treatments Available
tat protein     22-Sep-00  #351  New Findings on Immune Response to HIV Tat
May Contribute to Vac
tax credit     21-Apr-00  #341  Vaccines: Call Congress to Support R&D Tax
Credit
tenofovir     17-Nov-00  #355  Community Update: New Drugs to Watch
testosterone cream     17-Mar-00  #339  Testosterone Cream Available at
CPS; Gel Approved by FDA
testosterone gel     17-Mar-00  #339  Testosterone Cream Available at CPS;
Gel Approved by FDA
Texas     03-Nov-00  #354  Many People with HIV Not Getting Proper Treatment
Thailand     17-Mar-00  #339  Fluconazole: Pfizer Asked to Lower Africa Price
The Body site     22-Sep-00  #351  ICAAC; Lipodystrophy; IDSA: Conference
Summaries on Web
Thorne, Bill     21-Apr-00  #341  ACT UP Golden Gate Changes Name to
Survive AIDS
tipranovir     17-Nov-00  #355  Community Update: New Drugs to Watch
treatment     08-Sep-00  #350  AIDS Treatment Improves Survival: Answering
the "AIDS Deni
Treatment Action Campaign (South Afric  23-Jun-00  #345  Urgent: South
African Treatment Activists Need Assistance
Treatment Action Campaign (South Afric  17-Mar-00  #339  Fluconazole:
Pfizer Asked to Lower Africa Price
TRIPS     19-May-00  #343  Africa Treatment Access in the News
trizivir     17-Nov-00  #355  "Trizivir" Approved: Three Existing Drugs in One
tuberculosis     07-Jul-00  #346  Tuberculosis: New Drug Class Investigated
through Public-Private
UNAIDS     01-Dec-00  #356  New Report on World AIDS Epidemic
UNAIDS     02-Jun-00  #344  World Issues Today: Interview with Peter Piot,
Executive Directo
Unimed Pharmaceuticals     17-Mar-00  #339  Testosterone Cream Available at
CPS; Gel Approved by FDA
United Nations     01-Dec-00  #356  New Report on World AIDS Epidemic
United Nations     02-Jun-00  #344  World Issues Today: Interview with
Peter Piot, Executive Directo
University of California     04-Aug-00  #348  Marijuana Safety Study
Completed: Weight Gain, No Safety Problem
urination     02-Jun-00  #344  Frequent Urination, Leg Cramps, Leg
Weakness, Erection Difficult
vaccination, therapeutic     22-Sep-00  #351  New Findings on Immune
Response to HIV Tat May Contribute to Vac
vaccine     20-Oct-00  #353  Vaccine Advance: Monkeys Still Infected, but
Protected from Illn
vaccine     02-Jun-00  #344  New Oral DNA Vaccine Funded for Trials
vaccine     21-Apr-00  #341  Vaccines: Call Congress to Support R&D Tax Credit
vaccine     17-Mar-00  #339  Vaccine News, March 2, 2000
vaginal microbicides     03-Mar-00  #338  First Microbicide Conference,
March 13-16 near Washington D.C.
Vergel, Nelson     17-Mar-00  #339  Anabolics, Exercise, Nutrition,
Supplements: New Book Available
VIDEX EC     03-Nov-00  #354  Enteric-Coated ddI Approved: FDA Letter
Village Voice     21-Apr-00  #341  Africa Series Wins Pulitzer
viral load     21-Apr-00  #341  Answering the AIDS Denialists: CD4 (T-Cell)
Counts, and Viral Lo
viral resistance     19-May-00  #343  Resistance Testing Recommended in New
IAS-USA Guidelines
VIRAMUNE     17-Nov-00  #355  Nevirapine (VIRAMUNE) Strengthens Warning on
Liver, Skin Toxicit
Viramune     05-May-00  #342  Nevirapine (Viramune): European Warning
vitamin A     17-Nov-00  #355  Nutrition and HIV Infection: Experience in
Zimbabwe: Interview w
vitamin C     17-Nov-00  #355  Nutrition and HIV Infection: Experience in
Zimbabwe: Interview w
vitamin E     17-Nov-00  #355  Nutrition and HIV Infection: Experience in
Zimbabwe: Interview w
Volberding, Dr. Paul     17-Nov-00  #355  Community Update: New Drugs to Watch
warnings     see side effects
warnings     04-Aug-00  #348  Ziagen (Abacavir): New Warning on Restarting
warnings, abacavir     04-Aug-00  #348  Ziagen (Abacavir): New Warning on
Restarting
warnings, nevirapine     17-Nov-00  #355  Nevirapine (VIRAMUNE) Strengthens
Warning on Liver, Skin Toxicity
weight gain     04-Aug-00  #348  Marijuana Safety Study Completed: Weight
Gain, No Safety Problem
Wilson, Phill     17-Mar-00  #339  African Americans and AIDS: Highlights
of 2nd Annual Washington
work     07-Jan-00  #334  Disability Benefits: New Law Will Help Disabled
Return to Work
World Bank     19-May-00  #343  Africa Treatment Access in the News
XIII International AIDS Conference     03-Nov-00  #354  Durban Conference
Searchable Abstracts Now Available on Web
XIII International AIDS Conference     23-Jun-00  #345  Durban World
Conference, July 9-14: Online Coverage
XIII International AIDS Conference     19-May-00  #343  Durban Conference
Status, May 2000: Interview with Conference...
Ziagen     04-Aug-00  #348  Ziagen (Abacavir): New Warning on Restarting
Ziagen     18-Feb-00  #337  Abacavir Warning: Certain Respiratory Symptoms
Can Indicate...
Zimbabwe     17-Nov-00  #355  Nutrition and HIV Infection: Experience in
Zimbabwe: Interview...
zinc     17-Nov-00  #355  Nutrition and HIV Infection: Experience in
Zimbabwe: Interview...




***** AIDS TREATMENT NEWS
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Editor and Publisher: John S. James
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John S. James
AIDS Treatment News
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AIDS TREATMENT NEWS Issue #356, December 1, 2000
     phone 800-TREAT-1-2, or 415-255-0588

Contents

** Structured Treatment Interruption: Important Controlled
Trial in Monkeys
The first randomized controlled test of structured
treatment interruption found that certain immune responses
helped maintain an undetectable viral load during the
interruptions--at least in this study with monkeys. Later,
when treatment was permanently discontinued, the animals
with intermittent drug treatment did better than those that
had been on continuous antiretrovirals.

** Superinfection (Reinfection): New Study in San Francisco
Offers Free Resistance and Viral Load Testing
No one knows if a person who already has HIV can be
infected with a different strain. It is important to find
out, for many reasons, and a new research project is
looking for couples (of any sexual orientation) where both
partners are HIV-positive.

** New Report on World AIDS Epidemic
The United Nations released its annual AIDS report shortly
before World AIDS Day (December 1). It is the best
information anywhere on what is happening with the epidemic
around the world.

** Global Treatment Access: Call for 95% Price Reduction;
New GTAC Organization, Web Site
Doctors Without Borders and other health activists are
calling for large reductions in the prices for essential
drugs in poor countries.

** California: MediCal Income Eligibility Level Raised for
Disabled, Aged
New rules starting January 1 will allow more disabled
Californians to qualify for MediCal (Medicaid).

** Answering the AIDS Denialists: Is AIDS Real?
This article looks at theories that say AIDS does not
exist, or is not a new disease but only a collection of old
ones--and explains some of the history behind earlier
changes in the official definition of AIDS in the U.S.,
changes which caused some public confusion.


***** Structured Treatment Interruption: Important
Controlled Trial in Monkeys

by John S. James

The first randomized, controlled study of structured
treatment interruption (STI) found that monkeys on a three
week on, three week off treatment schedule controlled the
virus about as well as those which were on continuous
therapy (and therefore received twice as much of the
drugs). Also, those in the intermittent-treatment group
became able to control virus without treatment for a six-
month followup period when the drugs were stopped
permanently (after 21 weeks treatment in this study), while
those on continuous therapy usually could not.(1)

These results are not automatically applicable to patients,
for several reasons:

* This treatment was in macaque monkeys infected with
simian immunodeficiency virus (SIV), and treated with an
antiretroviral combination which includes an experimental
drug (PMPA) currently in human use only in clinical trials,
and

* This study began treatment early in infection (six weeks
after exposure), shortly after seroconversion had occurred.
Most patients are not diagnosed until much later, and it is
not known if this strategy would have worked in the animals
if treatment had been started late.

On the other hand, the animal test allowed genetically
similar individuals to all be infected with the same virus
at the same time--making it much easier to see differences
in treatment strategy that otherwise would have been hidden
by large, unknown variations in disease course caused by
these variables.

The researchers also used a new test for HIV-specific
immune function--counting the proportion of virus-specific
CD8 cells by using flow cytometry to measure which of the
cells produce gamma interferon in response to killed virus.
This test (called VIR, for virus-specific immune responses)
did distinguish the animals that could control the virus
from those that could not, while the more common test for
HIV-specific immunity (virus-specific CD4 stimulation
index) did not distinguish between the groups in this
study. (In addition, the new test would appear to be
relatively easy to develop for clinical practice, while the
stimulation-index test of immune function requires highly
trained laboratory staff and would be difficult to make
generally available.)

In this controlled trial three groups of animals were
compared: five which received no treatment, six which
received continuous antiretroviral treatment for 21 weeks,
and six which received four cycles of treatment for three
weeks, separated by three-week periods without the drugs.
The antiretroviral combination used was PMPA, ddI, and
hydroxyurea.

This study was done primarily by the RIGHT Institute
(Research Institute for Genetic and Human Therapy) in
Washington D.C. Franco Lori, M.D., and Julianna Lisziewicz,
Ph.D., are the principal authors.

Comment

Human studies of intermittent antiretroviral treatment are
happening now. If this approach proves successful in
certain identifiable patients, it could at least reduce the
cost and toxicity of antiretroviral therapy--and be a
significant step toward treatment strategies to assist the
immune system to control the virus instead of relying
entirely on antiretroviral drugs.

One hopeful sign was a late-breaker report at the Durban
AIDS conference by Shoshank R. Joshi, M.D., D.M, Retroviral
Physician at MGM hospital in Mumbai, India.(2) Twenty six
of his patients took antiretroviral combination therapy
(AZT or d4T, plus 3TC, plus saquinavir) on alternate
months, because they could not afford continuous treatment.
All of these patients had been recently diagnosed, were
asymptomatic, and had a CD4 count of over 300 but a viral
load over 20,000 when they started the intermittent
therapy. At the end of a year, all of them had undetectable
viral loads, and had remained asymptomatic and without side
effects from the treatment.

References

1. Lori F, Lewis MG, Xu J, and others. Control of SIV
rebound through structured treatment interruption during
early infection. SCIENCE. November 24, 2000; volume 290,
pages 1591-1593.

2. Joshi S, Joshi SS, Vergara PT, and others. Structured
interrupted therapy (SIT): Mumbai cohort. XIII
International AIDS Conference, Durban, South Africa, July
9-14, 2000 [abstract LbOr10].


***** Superinfection (Reinfection): New Study in San
Francisco Offers Free Resistance and Viral Load Testing

by John S. James

A new study in San Francisco will try to find out if
someone who already has HIV can be additionally infected
with a different strain of HIV. Some experts doubt that
such "superinfection" can occur--but no one knows because
cases would not be found by the tests used in standard
medical care.

The answer is very important, for at least three reasons:

(1) If two people who both have HIV have unprotected sex
with each other, are they at risk of additional infection
with a new strain (which might be more virulent, or might
already have resistance to certain antiretrovirals, or
could worsen the illness or complicate treatment in other
ways)?

(2) Whether or not superinfection occurs is very important
for vaccine research. If infection with one strain cannot
prevent infection with another, it would probably be
difficult (although not impossible) for a vaccine to do so.

(3) If superinfection does not occur it would be good news
for HIV-positive patients who need organ transplantation
for any reason, since it would suggest that organs from
HIV-positive donors could be used (instead of being thrown
away, as happens now).

This study, called Positive Partners, will initially enroll
20 sexually active HIV-positive couples. Here is a
description from the researchers, including an explanation
of who can participate, and contacts for more information.
Note that this study requires only two visits to the
research site in San Francisco, for interviews and blood
draws. It does not provide drugs nor require any changes in
one's treatment.

Can drug-resistant HIV be transmitted to someone already
HIV-positive? The Positive Partners Study will try to find
out!

Who is conducting this study and why?

The Positive Partners Study (P2) is a collaboration between
Dr. Robert Grant of the Gladstone Institute of Virology and
Immunology and Dr. Greg Greenwood at the Center for AIDS
Prevention Studies to study superinfection. P2 is a new and
unique study to demonstrate that it is feasible to recruit,
interview, and follow seroconcordant HIV-positive partners.
P2 is designed to examine whether new drug resistant
strains of HIV-1 can be sexually transmitted between
partners who are already both HIV-positive
(superinfection). This project is one key element in Dr.
Grant's broader virological research involving
reexamination of data from several other UCSF studies for
evidence of superinfection.

Who can participate?

Positive Partners will initially enroll 20 sexually active,
HIV-positive partners (M/M, M/F, & M/TG) who are both
taking HIV medications. Participants must be 18 years old
or older. Recruitment is on going so please share this
information with people who might be interested.

What will participants have to do?

Positive Partners will conduct two one-on-one confidential
interviews with each participant. We pay $25 in cash for
each interview completed. In addition, we offer FREE drug
resistance genotyping and phenotyping tests. These tests
determine the genetic structure of the present HIV strain
and how the strain stands up to medications being taken by
persons living with HIV. The tests are fairly new to the
market and are not covered by many insurance plans. They
can cost a patient upwards of $2000. We provide this
testing free of charge and will make the results available
to each participant and their physician, if the participant
chooses to release this information. We will also test for
the participant's T-cell count and viral load. In case
where participants experience a one-log increase in viral
load during the study year we ask them to come in for an
additional interview and specimen collection to see if the
increase is a result of a superinfection. In a case like
this where there has been a large increase in viral load
the drug resistance tests we provide can help participants
and their providers make medical decisions.

Laboratory assays will identify similarities and
differences in partners' viruses that will indicate if
superinfection has occurred (at baseline and 1-year follow-
up).

If I am interested and would like to screen or get more
information, where do I call?

If you or a patient, friend, or partner is interested in
participating or hearing about the study, Positive Partners
can be reached at 415-597-9292.

Where is Positive Partners located?

Positive Partners is located at 74 New Montgomery, Suite
600. This is downtown San Francisco between Market and
Mission Street, just off the BART/MUNI Montgomery Street
station.

For more information, call the Positive Partners
recruitment line, 415-597-9292. Or contact Jeff McConnell,
Project Director, Positive Partners Study, Center for AIDS
Prevention Studies, University of California San Francisco,
74 New Montgomery Street, Suite 700, San Francisco, CA
94105, phone 415-597-9394, fax: 415-597-9240,
jmcconnell@....

***** New Report on World AIDS Epidemic

by John S. James

On November 28 UNAIDS (the Joint United Nations Programme
on HIV/AIDS) and the World Health Organization issued their
annual report on the status of the global epidemic--an
authoritative though not infallible report that provides a
worldwide common basis for discussion. The 30-page AIDS
EPIDEMIC UPDATE: DECEMBER 2000 is difficult to summarize,
but here are some of the highlights:

* In 2000, the best estimates predict that 3 million people
will die of AIDS, and 5.3 million will become newly
infected with HIV. There have been over 21 million AIDS
deaths since the epidemic began.

* A major trouble spot is Eastern Europe. For example, the
Russian Federation will have more new HIV infections in
2000 than in all previous years combined.

* In Africa, new infections are down slightly (3.8 million
last year vs. 4 million the year before)--partly due to a
smaller pool of people at risk since so many have been
infected already, and partly due to prevention efforts in
some countries. Deaths are up slightly. An estimated 8.8%
of all adults (ages 15-49 years in these statistics) in
sub-Saharan Africa as a whole now have HIV, and over 25
million adults and children in this region are now living
with HIV. No one knows if the epidemic will explode in
Nigeria and other countries, as it has in southern Africa.

* In the U.S. and Western Europe, "prevention efforts are
stalled," with about 45,000 adults and children being
infected with HIV in North America.

* Australia and New Zealand hardly appear in the report,
with only 500 new HIV infections in 2000. (Australia has
long had effective prevention programs which the U.S. and
many other countries could have implemented but did not.)

* There are many success stories in certain areas; these
can be models for wider use. For example, in Belarus, a
harm-reduction program for drug users prevented 2,000 cases
of infection by its second year of operation, at a cost of
about $29 per infection prevented. And in Zimbabwe, church
groups have recruited community members to assist
households keeping orphans in homes where they live,
helping over 2700 households at a cost of about $10 per
family supported, vs. several hundred dollars a year to
keep a child in an orphanage in Africa. And in one study,
factory workers were trained to provide prevention
information to their colleagues--cutting new infections by
a third compared to factories that did not provide the
information, at a cost of about $6 per worker.

"At least U.S. $1.5 billion a year could make it possible
to achieve massively higher levels of implementation of all
the major components of successful prevention programmes
for the whole of sub-Saharan Africa. These would cover
sexual, mother-to-child and transfusion-related HIV
transmission, and would involve approaches ranging from
awareness campaigns through the media to voluntary HIV
counseling and testing, and the promotion and supply of
condoms." Another $1.5 billion would provide basic care for
many of the orphans and AIDS patients who need it, although
"making a start on coverage with combination antiretroviral
therapy would add several billion dollars annually to the
bill."


***** Global Treatment Access: Call for 95% Price
Reduction; New GTAC Organization, Web Site

Shortly before World AIDS Day (December 1), a coalition of
AIDS and health groups including MSF (Médecins Sans
Frontičrs, or Doctors Without Borders) called on
pharmaceutical companies to reduce prices of AIDS drugs 95%
in poor countries--reductions comparable to those already
in use for vaccines and contraceptives. MSF has carefully
compiled information from generic drug manufacturers and
other sources which indicates that the drugs could be sold
profitably at that price. Price reductions up to 85% have
already been offered by some companies, but even then drug
costs approach $1,000 to treat each patient for one year--
much too expensive for most individuals and governments in
poor countries.

The changing standard of care in rich countries (with
doctors now waiting longer to begin antiretroviral
treatment, reducing the number of patients who need to be
treated), and possibly structured treatment interruption
(see "Structured Treatment Interruption: Important
Controlled Trial in Monkeys" in this issue) may also help
to reduce costs, making top-quality treatment available for
many patients who would otherwise have none. (These factors
may not have been taken into account in the UNAIDS estimate
of several billion dollars annually for "making a start" on
antiretroviral therapy for sub-Saharan Africa.)

For recent information on international treatment-access
activism, see the new Web site of the Global Treatment
Access Campaign (GTAC),
http://www.globaltreatmentaccess.org

Note: While this issue is dated December 1, it went to
press too early to include announcements and other news
released on that day.


***** California: MediCal Income Eligibility Level Raised
for Disabled, Aged

Starting January 1 more disabled and elderly people will
become eligible for MediCal (Medicaid) in California.
Benefits expert Tom McCormack circulated the following
email explaining the change:

Effective January 1, 2001, California will raise its
MediCal (Medicaid) income eligibility level for single aged
and disabled persons to $926 monthly. That level had
previously been fixed at $692 (which remains the income
level for SSI and the state supplement to SSI).

The state will use the same income-counting methodology and
income disregards as are used in the SSI program:

* $20 of any income is disregarded;

*$65 and half the rest of earnings are disregarded;

*Impairment Related Work Expenses (IRWEs, cash out-of-
pocket medical costs, including transportation to medical
care) of the disabled are disregarded;

*One third of received child support is disregarded;

* Part of earnings of students under age 21 are
disregarded;

*Other miscellaneous disregards [see Section 1612 of the
Social Security Act.]; and

*Regular MediCal asset exemptions will continue to include
one lived-in home of any value, one vehicle of any value,
and limited amounts of liquid assets and funds designated
for burial.

Applications will be taken by county social services
offices--NOT by SSA.


***** Answering the AIDS Denialists: Is AIDS Real?

by Bruce Mirken

[Note: AIDS TREATMENT NEWS has published a series of
articles looking in depth at some of the bizarre ideas
about AIDS, theories which are being used to persuade
people to change or completely stop their medical
treatment, or to ignore precautions for preventing HIV
infection. One of the most bizarre is that the epidemic
does not exist but is just a new name for a collection of
old diseases. AIDS writer Bruce Mirken analyzes this claim
and similar theories that have also been widely promoted.
JSJ]

The AIDS denialists, who dispute not only the role of HIV
in AIDS but nearly all scientific knowledge about the
epidemic, regularly claim that the very notion of AIDS as a
distinct medical condition is a mistake. What medicine has
identified as a major epidemic, they insist, is nothing of
the sort.

A number of variations on this theme have been put forth.
Some have argued that AIDS is nothing but a "group fantasy"
or "epidemic hysteria."(1) Others claim that several
separate but real medical problems have been wrongly lumped
together. ACT UP San Francisco has repeatedly claimed that
"AIDS is over," suggesting that it did exist at one time
but has somehow come to an end.

While most in the denialist camp accept some physical cause
or causes for the illness we call AIDS, they claim science
has fundamentally misunderstood what is going on, leading
to faulty conclusions about causation.

"AIDS by definition is not new and is not a disease," the
web site of HEAL Toronto declares. "AIDS is a new name for
29 old illnesses and conditions, including yeast
infections, diarrhea, pneumonia, cancer and
tuberculosis."(2)Christine Maggiore of the Los Angeles
group Alive and Well adds that "every AIDS indicator
disease occurs among people who test HIV negative," existed
prior to AIDS, and has "medically proven causes that do not
involve HIV."(3)

AIDS, in this view, is just a new name given these old
diseases when they occur in people who test positive for
HIV antibodies. Furthermore, it is claimed that inclusion
of a positive HIV test in the criteria for an AIDS
diagnosis has created a phony connection between these
illnesses and HIV: "Pneumonia + positive HIV test = AIDS,"
Maggiore writes, but "Pneumonia + negative HIV test =
pneumonia," thus creating "the illusion of a perfect
correlation."(4)

Though factually wrong, such statements appear regularly in
denialist literature.

Another complaint is that the number of AIDS cases has been
artificially increased by repeated changes in the official
AIDS definition. Adding more conditions to the definition,
it is argued, pumps up the number of cases even though
those new cases may not even be ill.(2,4)

What Was New in 1981?

The notion that AIDS is simply "a new name for old
diseases" requires ignoring years of history and reams of
published medical data.

The official start of the AIDS epidemic dates from mid-
1981, when the U.S. Centers for Disease Control and
Prevention's MORBIDITY AND MORTALITY WEEKLY REPORT
described cases of Kaposi's sarcoma (KS) and Pneumocystis
carinii pneumonia (PCP) in young, previously healthy gay
men.(5,6) Detailed reports of these and other cases, a few
involving heterosexual drug injectors, were published in
several medical journals later that year.

Prior to 1980 KS and PCP were extraordinarily rare in the
U.S. Annual incidence of KS ranged from 2.1 to 6.1 cases
for every 10 million people,(7) usually occurring in older
men of European descent. The disease generally progressed
slowly, with an average survival time of 8-13 years.(7,8)

PCP was nearly as rare, and the drug used to treat it,
pentamidine isothionate, could only be obtained through the
CDC's Parasitic Disease Drug Service, which kept detailed
statistics. Strictly a disease of people with weakened
immunity due to disease, cancer chemotherapy or immune-
suppressive treatment for organ transplantation, PCP had
"never been convincingly demonstrated to occur in an
immunologically normal adult."(9)In one study 98 percent of
patients had known immune defects, and the others were all
seriously ill infants. Even though most were quite sick
even before their PCP, the disease often responded well to
treatment and relapses were rare.(10)

These new PCP and KS cases shattered the pattern. Most
patients were young men, often in their 20s and 30s, with
no identifiable reason for weakened immunity. Their KS was
"fulminant, malignant"(8) and rapidly progressing. Some had
both PCP and KS, and most had a cluster of other problems
including persistent fever, weight loss, swollen lymph
nodes, and other infections usually associated with
weakened immunity, including cytomegalovirus and
toxoplasmosis. This unremitting barrage set victims on a
downward spiral that commonly ended in death within a
year.(5,6,8,9,11,12,13,14)

This onslaught of infections in people with no known reason
for being sick was so unusual that the usually reserved
British journal THE LANCET called it "bizarre" twice in one
brief commentary.(15)Patients also showed unexplained
weakness in their immune responses, with a consistent
pattern of defects in their cellular
immunity.(5,6,8,9,11,12)

The physicians treating these patients had no doubt they
were seeing a new clinical syndrome ("syndrome" is the
medical term for a group of signs or symptoms that appear
together and indicate a particular condition). And these
doctors weren't babes in the woods. Several treated large
numbers of gay men living a "fast lane" existence including
multiple sex partners and recreational drugs, while others
worked at urban hospitals treating many drug addicts, yet
none of them had seen anything like this.(16)

The Evolving Definition of AIDS

As with any new syndrome, scientists' understanding of AIDS
evolved gradually, with the most obvious and severe
manifestations noticed first and rarer or subtler ones
recognized later. A careful review of how the CDC has
defined a case of AIDS contradicts the cartoon version
presented by the denialists and shows that the definition
has evolved cautiously--perhaps too cautiously at times.

(For simplicity this analysis will focus on the CDC's AIDS
case definition. While not followed universally, health
authorities in other industrialized countries often use the
CDC's work as a starting point. The enormous subject of
AIDS in Africa and other third world areas requires a
separate article.)

The CDC first published an AIDS case definition in
September, 1982. AIDS was simply defined as "a disease, at
least moderately predictive of a defect in cell-mediated
immunity, occurring in a person with no known cause for
diminished resistance to that disease." 13 specific
diseases were listed.(17)

HIV (then known as HTLV-III or LAV) was discovered in 1984,
but the CDC waited a full year, until after a discussion at
the Conference of State and Territorial Epidemiologists,
before revising the AIDS definition. This new definition
added a small number of conditions which would be
considered AIDS-defining if they occurred in a person with
a positive HIV test. But the original list of infections
still triggered an AIDS diagnosis without an HIV test if
they occurred in a person with depleted CD4 (T-helper)
cells and no known reason for immune dysfunction.(18)

It was soon clear that patients commonly experienced a much
broader array of illnesses than the indicator diseases
listed by the CDC. In 1987 the agency noted, "It became
apparent that some progressive, seriously disabling, even
fatal conditions (e.g. encephalopathy, wasting syndrome)
affecting a substantial number of HIV-infected patients
were not subject to epidemiological surveillance, as they
were not included in the AIDS case definition." So the
agency made another cautious revision, with encephalopathy
(dementia) and wasting syndrome being the most notable
additions to the list of indicator conditions.(19)

But the CDC's AIDS definition was still capturing only a
narrow piece of the picture, and not always the most severe
piece. "There are very many people who are very ill who
don't have AIDS by the CDC definition," said Los Angeles
AIDS specialist Scott Hitt, M.D. (who went on to head
President Clinton's AIDS Council) in 1990. "There are also
people with one KS lesion (qualifying them for an AIDS
diagnosis) who are doing very well."(20)

Part of the problem was that the only opportunistic
infections that made it into the CDC's database were
whatever conditions triggered a patient's initial
diagnosis. CDC spokespeople acknowledged they simply didn't
have the means to track the rest.(20)

Pressure mounted on the agency to adopt a definition that
was more reflective of the real-world clinical experience
of the most seriously ill patients, and after a lengthy
period of discussion and debate, the current definition
went into effect in January, 1993. For the first time it
allowed an AIDS diagnosis based purely on an immune system
measure: a CD4 cell count below 200 or a CD4 percentage
below 14. Based on strong epidemiological evidence, three
conditions were also added as AIDS indicator diseases in
people with HIV: invasive cervical cancer, pulmonary
tuberculosis and recurrent pneumonia (defined as two or
more episodes within one year).(21)

One thing did not change: The core list of 12 opportunistic
infections--PCP, toxoplasmosis, etc.--that dated from the
mid-1980s would still trigger an AIDS diagnosis even
without a positive HIV test.(21,22) In other words--and
contrary to the denialists' claims--a positive HIV test has
never been required to diagnose AIDS in people with these
otherwise rare illnesses.

At this point it is useful to refer again to Maggiore's
version of the AIDS definition, variations of which appear
throughout denialist literature: "Pneumonia + positive HIV
test = AIDS," but "pneumonia + negative HIV test =
pneumonia." In fact, pneumocystis pneumonia triggers an
AIDS diagnosis regardless of HIV status, and in HIV-
positive persons, more conventional bacterial and viral
pneumonias do not automatically trigger an AIDS diagnosis.
To qualify as AIDS they must happen at least twice within a
year, because only such multiple episodes are strongly
associated with immune suppression.(21) Simply put, the
"illusory correlation" so harped on by the denialists is an
illusion of their own invention.

Another favorite denialist complaint is that some of the
toxicities of certain AIDS drugs match items in the list of
AIDS-defining conditions. As with the assertions discussed
above, this claim is based on a skewed and often blatantly
inaccurate reading of the case definition. In any case, the
list of toxicities often cited as "AIDS by
prescription"(23) consists entirely of conditions whose
association with HIV was well established before AZT and
other antiretrovirals came into widespread use.

Duesberg's Epidemiology and Other Mysteries

A related but distinct thesis has been advanced by
University of California Berkeley Prof. Peter Duesberg:
AIDS is in fact several separate epidemics lumped together.
Proof, he and colleague David Rasnick suggest, lies in the
fact that members of different risk groups get different
diseases. KS, he notes, is seen mostly in gay men, while
"weight loss and tuberculosis predominate in intravenous
drug users, and pneumonia and candidiasis are almost the
only two of the 30 AIDS-defining diseases that are
diagnosed in hemophiliacs."(24)

These "distinct, subepidemic-specific diseases," Duesberg
and Rasnick argue, rule out a common cause, infectious or
otherwise. They further insist that AIDS indicator
conditions can be divided into those that are immune
deficiency-related, like PCP, and those that aren't, such
as KS. A significant proportion of AIDS cases, they note,
are diagnosed based on these "non immune deficiency
diseases."(24)

Duesberg's reading of the literature is, to put it gently,
selective. For one thing, despite his repeated assertions
to the contrary, an association between KS and weakened
immunity had been well established in the medical
literature prior to AIDS.(7)

As for his claims about differing opportunistic infections
in different risk groups, it is hardly a surprise that
populations with widely varying behaviors, lifestyles and
health risks would experience severe immune deficiency
somewhat differently, and such differences have indeed been
noted. But even a cursory glance at the medical literature
quickly dynamites Duesberg's claim that these differences
are so dramatic as to constitute separate epidemics. For
example, five years before Duesberg and Rasnick's assertion
that pneumonia and candidiasis are "almost the only two"
AIDS-defining conditions seen in hemophiliacs, a European
hemophiliac cohort found that of 37 diagnosed with AIDS, 6
had toxoplasmosis, 3 had wasting syndrome, 3 had dementia,
2 had MAC, 1 had CMV and 1 had lymphoma as their AIDS-
diagnosing illness.(25)

The same Duesberg/Rasnick article touts both the "drug-AIDS
hypothesis" and the "new name for old diseases" theory with
an impressive list of references purportedly showing that
AIDS-defining illnesses had been widely identified in drug
users prior to and without AIDS. Duesberg's chart has at
times been borrowed by other denialists.(24,26)

But again his "evidence" wilts under close examination. For
example, one reference he cites repeatedly--as evidence
that immune deficiency, candidiasis, lymphadenopathy and
weight loss had been documented in heroin addicts pre-AIDS-
-is 1973 article by Pillari and Narus from the AMERICAN
JOURNAL OF NURSING. But the article, it turns out, isn't a
study but simply an anecdotal description of patients seen
in one treatment program. It gives neither numbers of cases
nor occurrence rates for any of the conditions
described.(27)

In fact, Pillari and Narus specifically mention just one of
the four conditions Duesberg attributes to them,
lymphadenopathy. Candidiasis is perhaps implied by
nonspecific references to "fungal infections," while immune
deficiency and weight loss are implied even more vaguely
and indirectly. And although Duesberg's chart lists all
four conditions as "AIDS defining," nothing in the article
comes remotely close to describing an illness that would
meet the criteria for an AIDS diagnosis.(27)

Finally, a different spin has been put out by ACT UP San
Francisco. Some of their materials echo the general
denialist notion that the whole epidemic is a scam, but
their most-repeated phrase in recent years has been, "AIDS
is over." Such statements often refer to declining numbers
of AIDS cases and deaths.(28)

But extensive evidence links those declines to improved
anti-HIV treatment (for more on this see AIDS TREATMENT
NEWS' special issue, "Treatment and Survival," Sept. 8,
2000). And for the families of the 10,198 people who died
of AIDS during 1999 according to the most recent CDC
figures,(29) AIDS is certainly not over.

References

1. Schmidt, Casper G., "The group-fantasy origins of AIDS,"
in THE AIDS CULT, edited by John Lauritsen and Ian Young,
Asklepios USA, 1997.

2. MacDonald, Robert, "Healthy skepticism about HIV," HEAL
Toronto web site,
http://www.harmsen.net/heal/healthy_skeptic.html

3. Maggiore, Christine, WHAT IF EVERYTHING YOU KNEW ABOUT
AIDS WAS WRONG? American Foundation For AIDS Alternatives,
p. 51.

4. Maggiore, p. 1.

5. Gottlieb, MS, and others, "Pneumocystis pneumonia--Los
Angeles," MORBIDITY AND MORTALITY WEEKLY REPORT, 1981: 30:
250-52.

6. Friedman-Kien, A and others, "Kaposi's sarcoma and
pneumocystis pneumonia among homosexual Men--New York City
and California," MORBIDITY AND MORTALITY WEEKLY REPORT,
1981: 30: 305-08.

7. Safai, B. and Good, R., "Kaposi's sarcoma, a review and
recent developments," CLINICAL BULLETIN, 1980: 10: 62-69.

8. Friedman-Kien, A., "Disseminated Kaposi's sarcoma
syndrome in young homosexual men," JOURNAL OF THE AMERICAN
ACADEMY OF DERMATOLOGY. 1981: 5(4) 468-71.

9. Masur, H. and others, "An outbreak of community-acquired
pneumocystis carinii pneumonia," NEW ENGLAND JOURNAL OF
MEDICINE, 1981: 305: 1431-8.

10. Walzer, Peter D. and others, "Pneumocystis carinii
pneumonia in the United States," ANNALS OF INTERNAL
MEDICINE, 1974: 80: 83-93.

11. Gottlieb, Michael and others, "Pneumocystis carinii
pneumonia and mucosal candidiasis in previously healthy
homosexual men," NEW ENGLAND JOURNAL OF MEDICINE, 1981:
305: 1425-31.

12. Siegal, Frederick and others, "Severe acquired
immunodeficiencies in male homosexuals, manifested by
chronic perianal ulcerative herpes simplex lesions," NEW
ENGLAND JOURNAL OF MEDICINE, 1981: 305: 1439-44

13. Durack, David, "Opportunistic infections and Kaposi's
sarcoma in homosexual men," NEW ENGLAND JOURNAL OF
MEDICINE, 1981: 305: 1465-7.

14. Hymes, Kenneth and others, "Kaposi's sarcoma in
homosexual men--a report of eight cases," THE LANCET, 1981;
ii: 598-600.

15. "Immunocompromised homosexuals," THE LANCET, 1981, ii:
1325-6.

16. Shilts, Randy, AND THE BAND PLAYED ON, updated edition,
Penguin Books, 1988, chapters 2-8.

17. "Current trends update on acquired immune deficiency
syndrome (AIDS)--United States," MORBIDITY AND MORTALITY
WEEKLY REPORT, 1982: 31: 508-08.

18. "Current trends revision of the case definition of
Acquired Immunodeficiency Syndrome for National Reporting--
United States," MORBIDITY AND MORTALITY WEEKLY REPORT,
1985: 34: 373-5.

19. "Revision of the CDC Surveillance Case Definition for
Acquired Immunodeficiency Syndrome," MORBIDITY AND
MORTALITY WEEKLY REPORT, 1987: 36(supplement no. 1S).

20. Mirken, Bruce, "AIDS Name Game: Help or Misery Turns on
Obsolete Definition," LOS ANGELES READER, May 25, 1990, p.
3-4.

21. "1993 revised classification system for HIV infection
and expanded surveillance case definition for AIDS among
adolescents and adults," MORBIDITY AND MORTALITY WEEKLY
REPORT, 1992: 41: RR-17.

22. Kitty Bina and Dr. Richard Selick, CDC, personal
communication.

23. Maggiore, p. 30.

24. Duesberg, P. and Rasnick, D., "The AIDS dilemma: Drug
diseases blamed on a passenger virus," GENETICA, 104:85-
132, 1998.

25. Aronstan, A. and others, "HIV infection in haemophilia-
-a European cohort," ARCHIVES OF DISEASE IN CHILDHOOD,
1993: 68: 521-24.

26. Maggiore, p. 56.

27. Pillari, George, and Narus, June, "Physical effects of
heroin addiction," American Journal of Nursing, 1973, 73:
2105-8.

28. ACT UP San Francisco press release, "ACT UP San
Francisco launches survive AIDS campaign," March 27, 2000.

29. U.S. HIV and AIDS Cases Reported through December 1999,
year-end edition, Vol. 11, no. 2.


***** AIDS TREATMENT NEWS

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Editor and Publisher: John S. James
Associate Editor: Tadd T. Tobias
Reader Services: Tom Fontaine

Statement of Purpose:
AIDS TREATMENT NEWS reports on experimental and standard
treatments, especially those available now. We interview
physicians, scientists, other health professionals, and
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meetings and conferences, medical journals, and computer
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different treatments, and found combinations that work for
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--
John S. James
AIDS Treatment News
http://www.aidsnews.org

AIDS TREATMENT NEWS Issue #355, November 17, 2000
     phone 800-TREAT-1-2, or 415-255-0588

CONTENTS:

** Community Update: New Drugs to Watch
A report on two recent conferences summarized some of the
most important treatment changes today, new drugs in the
pipeline especially for patients who have already failed
many antiretrovirals, and current treatment philosophies
and challenges for AIDS medicine and research.

** Nevirapine (VIRAMUNE(R)) Strengthens Warning on Liver,
Skin Toxicities
A recent letter to doctors strengthened the U.S. warnings
and precautions on using this antiretroviral (which has
been approved and in widespread use for years), due to
serious complications in a small minority of patients; the
point of the changes is to catch such problems and stop the
drug in time. Patients obtaining refills or new
prescriptions should in the future receive a "patient
package insert," dated November 2000, based on the new
warnings.

** "Trizivir" Approved: Three Existing Drugs in One
New approval combines AZT, 3TC, and abacavir in one pill.

** Nutrition and HIV Infection: Experience in Zimbabwe--
Interview with Lynde Francis
For years Lynde Francis has run an AIDS service
organization in Harare, Zimbabwe, where few patients can
afford antiretrovirals, so nutritional improvement is often
the only treatment available. In this interview she
explains what she has found to be helpful. While specific
nutritional advice will vary, depending on many factors, we
believe that readers should be aware of this treatment
experience.

** AIDS TREATMENT NEWS Will Move to Philadelphia on January
2
At the end of this year AIDS TREATMENT NEWS will move to
Philadelphia to work with Philadelphia FIGHT, a well-known
AIDS treatment, research, and education organization. Our
policies and publication schedule will remain the same, and
readers will see little immediate change except for the
address.


***** Community Update: New Drugs to Watch

On November 6 a community forum, "HIV Therapy Update from
the Recent ICAAC and Glasgow Meetings," was sponsored by
three San Francisco AIDS organizations (the Conant
Foundation, the San Francisco AIDS Foundation, and the AIDS
Research Institute of the University of California San
Francisco); unlike most medical meetings, this one was
funded by the organizations themselves without seeking
pharmaceutical-company support. Here are a few bottom-line
treatment messages that we found most important:

* The medical community is favorably impressed with Kaletra
(lopinavir, formerly ABT-378, the newly-approved "second
generation" protease inhibitor. A major Abbott trial
presented 24-week data at ICAAC (40th Interscience
Conference on Antimicrobial Agents and Chemotherapy,
Toronto, September 17-20, 2000) and some 48-week data at
the Fifth International Congress on Drug Therapy in HIV
Infection (Glasgow, UK, October 22-26, 2000); complete 48-
week data will be available at the Retroviruses conference
(8th Conference on Retroviruses and Opportunistic
Infections, Chicago, February 4-8, 2001). Stephen Becker,
M.D., noted the impressive results with patients who were
highly treatment experienced (but naive to the NNRTI class
of antiretrovirals, in this trial). Also, very few patients
discontinued the trial because of toxicity or because of
virologic failure. Even patients with substantial
resistance to other protease inhibitors were likely to do
well.

Doctors do not agree on whether to reserve this drug for
"salvage" therapy when other treatment options have failed,
or to use it earlier in treatment, perhaps in initial
therapy. At least at this time Dr. Becker chooses to wait
and use it later.

Also, the development of Kaletra has been important as a
"proof of concept" for the strategy of using a low dose of
ritonavir (Norvir(R), another protease inhibitor from
Abbott Laboratories) in order to keep another protease
inhibitor in the body longer (by blocking a liver enzyme
which destroys these drugs). Kaletra has the ritonavir
included in the formulation, as it must be used with
ritonavir or it would be eliminated from the body too
quickly.

* Steven  Deeks, M.D., discussed some of the most promising
new HIV drugs in the pipeline. He named four: T-20,
tipranovir (a new kind of protease inhibitor), DAPD, and
tenofovir. All of these are active against many viruses
which are highly resistant to other drugs.

He also noted that there is now much excitement about HIV
integrase inhibitors, a major target for new drugs. But
these are farther away, probably about five years from
widespread use.

* Paul Volberding, M.D., discussed some of the major
challenges of HIV research today, including acute infection
(finding the cases is a challenge), finding people who are
not currently in care so that they can be offered
treatment, when to start antiretroviral therapy (the
medical community has backed off from the "hit early" part
of "hit hard, hit early"--but still treats hard, once one
does start antiretrovirals). A survey of very experienced
HIV physicians in San Francisco found that most started
treatment at a CD4 count averaging around 350 (and some as
late as a count of 200)--depending on other information
about the patient, of course. The survey also found that
combinations including the NNRTI drug class were the most
popular to start with [as opposed to either protease
inhibitors, or the triple nucleoside analog treatment with
abacavir].

[Note that this community forum took place in November
2000, and treatment strategies later will be different.
Sometimes our articles circulate on the Internet forever
and are read as fresh information after they are no longer
applicable.]

Other talks at the forum reviewed progress in preventive
vaccines, and in microbicides to prevent HIV transmission.


***** Nevirapine (VIRAMUNE(R)) Strengthens Warning on
Liver, Skin Toxicities

On November 9 Boehringer Ingelheim Roxane Laboratories
notified medical professionals that the FDA-required
labeling for its drug nevirapine had strengthened its
warnings about risks of liver and other toxicities, due to
reported cases of serious or fatal reactions to the drug.

All future U.S. prescriptions and refills of nevirapine
should come with a new patient package insert, which will
tell patients what they most need to know to use the drug
safely--including a description of symptoms which should
lead to an immediate call to one's physician, who may
decide to stop the drug permanently.

The first 12 weeks on nevirapine is especially critical, as
about two thirds of the reactions have happened in that
period. Also, the letter recommends that prednisone should
not to be used to prevent nevirapine-associated rash, as a
clinical trial found that this made the problem worse.

The full text of the letter to medical professionals is on
an FDA Web site at:
http://www.fda.gov/medwatch/safety/2000/virahp.pdf

Some of the warnings:

"*...Although clinical presentation varied among patients,
frequently occurring features included non-specific
prodromal signs and symptoms of fatigue, malaise, anorexia
and nausea, with or without abnormal serum transaminase
levels. In these reports, symptoms progressed to jaundice,
hepatomegaly, elevation of transaminase levels and
hepatitic failure over a period of several days. Patients
with signs or symptoms of hepatitis must immediately seek
medical evaluation, have liver tests performed, and be
advised to discontinue VIRAMUNE as soon as possible.

"* Based on these reports, the first 12 weeks of VIRAMUNE
therapy are a critical period during which intensive
clinical and laboratory monitoring, including liver
function tests, is essential to detect potentially life-
threatening hepatotoxicity and skin reactions. [emphasis in
original]

"* Although most serious hepatitic events occurred during
the first 12 weeks of VIRAMUNE therapy, approximately one-
third of cases have been reported to occur after this
critical period.

"* The optimal frequency of monitoring during the first 12
weeks of therapy with VIRAMUNE has not been established.
Some experts recommend clinical and laboratory monitoring
more often than once per month, and in particular, would
include monitoring of liver function tests at baseline,
prior to dose escalation and at two weeks post dose
escalation. After the initial 12-week period, frequent
clinical and laboratory monitoring should continue
throughout VIRAMUNE treatment.

"* Increased AST or ALT levels and/or a history of chronic
hepatitis (B or C) infection are associated with a greater
risk of hepatitic adverse events.

"*Serious hepatotoxicity, including liver failure requiring
transplantation in one instance, has been reported in HIV-
uninfected individuals receiving multiple doses of VIRAMUNE
in the setting of post-exposure prophylaxis, an unapproved
use.

"*If clinical hepatotoxicity occurs, VIRAMUNE should be
permanently discontinued and not restarted after recovery."

"In summary, the need for careful clinical and laboratory
monitoring of patients receiving VIRAMUNE must be
emphasized. The diagnosis of hepatotoxicity should be
considered for patients presenting with non-specific
symptoms of hepatitis even if liver function tests are
normal or alternative diagnoses are possible. These
considerations are especially critical during the first 12
weeks of therapy, when serious liver toxicity occurs most
frequently, but remain important throughout treatment with
VIRAMUNE."

Comment

Nothing in this letter addresses use of a single dose of
nevirapine to prevent mother-to-infant transmission of HIV;
these toxicities occurred in patients taking multiple
doses. Nor does the warning imply that the risk with this
drug is greater than with other antiretrovirals. If any
antiretroviral combination had a significantly better
safety and efficacy profile than the alternatives, then
those alternatives would not be used.

This warning underlines the need for care in using all
anti-HIV drugs, the need for the development of better
drugs, and the need for more creative research into why the
various toxicities occur, how to predict which patients are
most vulnerable to which drugs, and better ways to prevent
the problems from developing.


***** "Trizivir" Approved: Three Existing Drugs in One

On November 15 the FDA approved Trizivir(R), a product that
combines adult doses of three previously approved Glaxo-
Wellcome drugs -- AZT, 3TC, and abacavir -- into a single
tablet. The rationale is that taking only one tablet twice
a day without regard to food may improve adherence in some
patients. Some activists are concerned that this treatment
might be chosen for institutional convenience (for example
when treating prisoners) even when it is not the best
medical option for the individual.

The following writeup was released November 15 by the AIDS
Treatment Information Service, an agency which provides
AIDS treatment information for the U.S. government:

"November 15, 2000: The Food and Drug Administration (FDA)
today approved Trizivir for the treatment of HIV in adults
and adolescents. Each dose of Trizivir is a fixed-dose
combination of Ziagen (abacavir/ABC), Retrovir
(zidovudine/AZT), and Epivir (lamivudine/3TC), three
nucleoside reverse transcriptase inhibitors (NRTIs) already
approved by FDA. Trizivir is not recommended for treatment
in adults or adolescents who weigh less than 40 kilograms
because it is a fixed-dose tablet.

"Because Trizivir combines a single dose of three drugs
into one pill, it may be easier for some patients to comply
with their medication regimen. Each component of Trizivir
is also available separately. This combination product
should only be used by those whose treatment regimens would
otherwise include these doses of these three nucleoside
analogues. It may be used alone or in combination with
other antiretroviral agents for the treatment of HIV
infection, but should not be administered concomitantly
with abacavir, lamivudine, or zidovudine, which are already
contained in Trizivir. The recommended dose is one tablet
twice a day.

"For more information, contact our ATIS Health Information
Specialists at 1-800-448-0440 or at atis@....  You
can find the complete FDA press release at
http://www.hivatis.org/atisnew.html "


***** Nutrition and HIV Infection: Experience in Zimbabwe--
Interview with Lynde Francis

by John S. James

Lynde Francis is the founder and director The Centre, in
Harare, Zimbabwe, an organization run by and for people
living with HIV. She is also the regional contact for
Southern Africa for the ICW, the International Community of
Women Living with HIV and AIDS. We met Ms. Francis several
years ago in San Francisco, and interviewed her for this
article in Durban, South Africa on July 13, 2000.

These suggestions developed from her experience in
Zimbabwe; we do not suggest that they be applied literally
or mechanically in very different environments, such as the
U.S. But we do believe her results and experience are worth
knowing.

* * *

AIDS TREATMENT NEWS: What are some of the most important
lessons you have learned about nutrition and HIV treatment,
both for Africa and elsewhere?

Lynde Francis: In the developing world, nutrition is often
the only form of therapy available. We have learned that
with correct nutrition, which includes vitamin
supplementation and a holistic approach to HIV, you can
maintain health almost indefinitely if you start early
enough. And if you start when someone is already ill,
nutrition together with treatment of opportunistic
infections can put them back on their feet and back in
employment.

Also, when people are on pharmaceutical treatment,
nutrition supports them; you can use nutrition as a way of
avoiding side effects, and reconstituting the immune system
together with the drugs.

ATN: What approaches to nutrition do you recommend?

Francis: The rule of thumb is unrefined, unprocessed foods,
low fat, no sugar, and avoiding stimulants like caffeine.
By unrefined food I mean, if you eat bread, it should by
whole wheat bread; if you eat rice, it should be
unpolished, brown rice. If your staple is maise meal, as it
is in many parts of Africa, it should be stone ground maise
meal. It could include other grains like rye, like wheat
used as a rice which is delicious; it could include
sorghum, which is the traditional grain which was used
throughout Africa before maise came in.

The proteins you take in should be as much as possible
beans, lentils, peas, nuts, soya proteins, plus chicken and
fish. Pork should be avoided, and fatty beef products
should be avoided.

As far as possible avoid foods that have additives, like
coloring, flavoring, or preservatives. And eat foods which
are fresh and preferably indigenous, grown where you live.
It's a rule of thumb that if it grows locally, it's going
to be good for you and it's going to be appropriate because
it will grow at the right season.

Clean water of course is an absolute must; so if you don't
have access to clean water, it's vital that you properly
filter, purify, or boil.

We recommend a low-fat diet. One of the big exceptions to
that is yogurt. Yogurt is like a magic food, as is garlic.
Yogurt helps to control thrush. Sugar feeds thrush, so we
advise people to cut sugar out of their diet as much as
possible.

Garlic is a natural antibiotic and antiviral.. It is also
extremely good for thrush. And you can use it for vaginal
as well as for oral thrush.

We recommend that food be prepared freshly if possible, and
that much of the vegetable and fruit intake be raw--salads
and raw fruit and vegetables, which maintains all the
vitamin and mineral content. At least 30% of your intake of
food daily should be vegetables and fruits. Fifty percent
should be whole grains. Fifteen percent should be proteins.
And then 5% is the cherry on the cake--it's whatever else
you want, avocados, cheese and eggs--with a proviso that
when you have diarrhea, you should avoid dairy products,
and avoid all fat.

We mostly use locally available treatments in Africa,
because usually we don't have access to drugs. For example,
aloe vera is wonderful for herpes sores; slit the leaves
open, and the gel inside, when applied to sores and itching
of shingles, is miraculous. Another herb that's very good
for this condition is comfrey, making a poultice of comfrey
leaves.

We teach people in Africa recipes that are useful in
difficult times, like when you have diarrhea and wasting.

It is harder to teach good nutrition in the developed
world. In Africa we do not have three generations of junk
food to deal with. We all can remember our traditional
cuisine. In European countries and the U.S., this is more
difficult.

You need to think in terms of the five rules: unprocessed,
unrefined, low fat, no sugar, and one other rule, which is
little and often. It is more applicable to people who have
wasting, but it's applicable to anybody who wants to keep
up their appetite, which is to take small, attractive meals
more often. Rather than large heavy meals twice a day, take
small meals five times a day. Those are the basic rules.

ATN: Where can our readers get more information?

Francis: We have a booklet, Food for People Living with
HIV, which is applicable everywhere in the world. It has
recipes, it has a vitamin and mineral chart, it gives the
kinds of herbs and spices that can be used as therapies--
what's cooling, what's heating, remedies that can be used
to treat sores.

ATN: What vitamin and mineral supplements do you include?

Francis: We call it ZACES; that's an acronym that we
developed to help people remember the vitamins and
minerals. It's zinc, vitamin A, vitamin C, vitamin E, and
selenium. We call this the infection fighting, immune
boosting combination. We recommend that all our patients
take supplements of these. Even an adequate food intake is
not enough to deal with the level of immune suppression
that happens in HIV disease. We give them diet sheets, and
recommend that the supplements be taken in a balance.

ATN: For the vitamin A, could they use beta carotene
instead? I am reluctant to suggest vitamin A, because
people might take too much.

Francis: We have a problem getting beta carotene, because
it is very expensive for us. So we recommend that they take
vitamin A. It really works--especially when it is
supplemented with 20 mg of zinc daily, which is very cheap
for us to get.

ATN: What is the mission of your organization (The Centre,
in Harare, Zimbabwe)?

Francis: Our mission, basically, is to teach long-term
survival techniques to people living with the virus, based
on nutrition and a holistic approach.

I urge people to look more to nutrition as an adjunct to
therapy, or as an alternative to therapy. It's amazing the
resuscitation that we see--people who come in and they are
terminally ill, and you put them onto an adequate nutrition
regime and give them vitamin supplements, and it's like
Lazarus, it's like the way people describe what happened
with the antiretrovirals. We have seen people recover
completely just from getting their nutrition intake
adequate, and getting help on coming to terms with and
managing their disease.


***** AIDS TREATMENT NEWS Will Move to Philadelphia on
January 2

by John S. James

Starting January 2 AIDS TREATMENT NEWS will publish from
Philadelphia, Pennsylvania, where we will work closely with
Philadelphia FIGHT, a well-known AIDS treatment, research,
and information organization. I will remain in complete
control of the content of this newsletter, and readers will
notice little immediate change except for the new address
and phone numbers.

This move offers many advantages:

* Philadelphia FIGHT (http://www.fight.org) is an
excellently run organization which includes: the Jonathan
Lax Treatment Center, an HIV clinic for persons of all
income levels; community-based clinical trials funded by
the CPCRA program of the U.S. National Institutes of
Health; Critical Path AIDS Project, an AIDS treatment and
computer-access organization founded by Kiyoshi Kuromiya
and continuing after his death; the AIDS Library, open to
the public at Philadelphia FIGHT and by phone; and project
TEACH, which trains peer educators in AIDS treatment
information. Working with an organization with such diverse
hands-on AIDS treatment, research, information, and
outreach experience can help us develop articles, fact
sheets, and other resources which are widely useful.

* From Philadelphia it will be much easier to attend
meetings in the Washington, New York, and Baltimore areas--
a convenient two-hour train ride with comfortable seating
and power for a laptop.

* Working with FIGHT will greatly reduce the overhead of
running the AIDS TREATMENT NEWS office in pathologically
expensive San Francisco, enabling me to focus on research
and writing instead of paperwork and making ends meet. We
have learned that excessive overhead--the cost (in money,
time, or other resources) of just getting by--is more
destructive than generally realized.

AIDS TREATMENT NEWS has always had primarily a national
focus with some international coverage, and this will
continue. We have also included San Francisco area news,
because we had more readers there and knew that area better
than elsewhere; this too will continue, as we still have
many readers and contacts there, and will return several
times a year for conferences and other visits. We will also
increase our Philadelphia coverage, in coordination with
the Critical Path AIDS Project newsletter, which for years
has published in-depth Philadelphia information along with
national treatment articles. Both newsletters will continue
as separate publications.

Our current phone numbers will work through December, then
the local (area 415) numbers will have referral messages to
the new Philadelphia numbers. We already have a new U.S.
toll-free fax (and voicemail) number which will reach us
anywhere: 1-800-273-7168; we will keep it at least through
the transition. Faxes concerning AIDS TREATMENT NEWS
business should be sent to this number starting now; press
releases and other general faxes should be switched to
email and sent to jjames@.... Due to the move, we will
have shorter office hours during December,  but messages
can be left any time 24 hours a day.


***** AIDS TREATMENT NEWS

Published twice monthly

Subscription and Editorial Office:
   P.O. Box 411256
   San Francisco, CA 94141
   800/TREAT-1-2 toll-free
   415/255-0588 regular office number
   email: aidsnews@...
   useful links: http://www.aidsnews.org

Editor and Publisher: John S. James
Associate Editor: Tadd T. Tobias
Reader Services: Tom Fontaine

Statement of Purpose:
AIDS TREATMENT NEWS reports on experimental and standard
treatments, especially those available now. We interview
physicians, scientists, other health professionals, and
persons with AIDS or HIV; we also collect information from
meetings and conferences, medical journals, and computer
databases. Long-term survivors have usually tried many
different treatments, and found combinations that work for
them. AIDS TREATMENT NEWS does not recommend particular
therapies, but seeks to increase the options available.

AIDS TREATMENT NEWS is published 24 times per year, on the
first and third Friday of every month, and print copies are
sent by first class mail. Email is available (see below).
Back issues are available at http://www.aidsnews.org

To subscribe, you can call 800-TREAT-1-2 or 415-255-0588:
* Businesses, Institutions, Professionals: $270/year. Early
email available (see below).
* Nonprofit organizations: $135/year.
* Individuals: $120/year, or $70 for six months. If you
cannot afford a subscription, please write or call about
our sliding scale.
* Outside North, Central, or South America, add airmail
postage: $20/year, $10 for six months.
* Bulk rates and multiple discount subscriptions are
available; contact our office for details.
* Payment can be by check, VISA, Mastercard, American
Express, bank draft, purchase order, international postal
money order, or travelers checks.

Early email: Business, nonprofit and full-rate individual
subscribers can receive an early copy by email, before the
issue is printed--in addition to their regular copy, at no
extra charge. It's OK to direct the email copy to someone
else. Call our office to add email to your subscription.

Free email: Free delivery for individuals (delayed one
week). To subscribe, send email to aidsnews@...
with "subscribe" in the title or first line.

ISSN # 1052-4207

Copyright 2000 by John S. James. Permission granted for
noncommercial reproduction, provided that our address and
phone number are included if more than short quotations are
used.

AIDS TREATMENT NEWS Issue #354, November 3, 2000
     phone 800-TREAT-1-2, or 415-255-0588

[Note: This is our first issue sent through the Egroups
system. Coincidentally, issue #354 was delayed to all
subscribers.

Also this email may include advertisements sent by Egroups.
We have had the ads turned off for future issues.

We are sending two copies: a text version within this
message that any email software should be able to read,
and also an attached PDF file that can be used to print
the newsletter exactly as it is mailed. These issues will
be archived at http://www.egroups.com/group/aidsnews (in
addition to our complete, searchable back-issue archive
available through http://www.aidsnews.org).

If you have any problem with this transmission, please let
me know at aidsnews@... ]


CONTENTS

** Enteric-Coated ddI Approved: FDA Letter
A new form of ddI--named VIDEX EC--is easier to take.

** Retroviruses Conference: Registration Deadline for
Community Attendance is Nov. 17
AIDS advocates, activists, and "community press" must apply
by November 17 to attend the Retroviruses conference in
Chicago in February.

** Durban Conference Searchable Abstracts Now Available on
Web
Finally anyone can search and read the full text of the
abstracts of the XIII International Conference on AIDS.

** Bitter Publication Dispute on Remune Study: More Than
Meets the Eye?
Background on the high-profile dispute over the recent
publication of the large HIV immunogen study.

** Many People with HIV/AIDS Not Getting Proper Treatment
A study of four large states--Texas, Florida, California,
and New York--found that up to two thirds of persons who
need expensive HIV drugs are excluded by budgets, rules,
and other obstacles in the Medicaid and ADAP programs.

** Flu Shot Time: Vaccine Shortage in Many Areas
A nationwide shortage of influenza vaccine has limited
inoculations to person at high risk in many areas.

** Help Wanted: AIDS Writer for AmFAR in New York
The American Foundation for AIDS Research seeks a writer
for brochures, annual report, Web content, etc.

** AIDS TREATMENT NEWS Price Increase January 1; Act Now to
Renew at Current Rate
You can avoid the price increase by renewing before
December 31.

** HIV Treatment and Survival: Easy Language Version
"Low literacy" version of the longer article on AIDS
treatment and survival published last September in AIDS
TREATMENT NEWS #350.

** Has Anti-HIV Treatment Cut AIDS Deaths? (original for
copying)


***** Enteric Coated ddI Approved: FDA Letter

On October 31 the FDA approved a new once-daily formulation
of ddI which is easier and less complicated to take, avoids
certain drug interactions, and may reduce diarrhea or other
gastrointestinal side effects. But the overall safety and
efficacy of the drug remain about the same.

ddI (didanosine) is destroyed by acid in the stomach. So
the original drug had to be taken with a powerful antacid
to protect it--which had other disadvantages, including
causing diarrhea in some patients, and preventing
absorption of certain other drugs which require an acid
stomach to work properly. The new drug uses an enteric
coating--a substance which does not dissolve in the acid
environment of the stomach but does dissolve in the
alkaline environment of the small intestines, releasing the
drug there. We do not know why it took many years to
develop this improvement.

Here is a November 1 letter from the FDA describing the new
formulation:

Yesterday, October 31, 00, FDA approved a new formulation
of the nucleoside reverse transcriptase inhibitor, ddI,
called VIDEX EC.

VIDEX EC is an enteric coated, once daily formulation,
which, in combination with other antiretroviral agents, is
indicated for the treatment of HIV-1 infection in adults
whose management requires once-daily administration of
didanosine or an alternative didanosine formulation.

In VIDEX EC, the active ingredient, didanosine, is
protected against degradation by stomach acid by the use of
an enteric coating on the beadlets in the capsule. The
enteric coating dissolves when the beadlets empty into the
small intestine, the site of drug absorption.

In earlier, buffered formulations of didanosine,
administration with an antacid (buffer) provides protection
from degradation by stomach acid.

The peak plasma concentration (CMAX) of didanosine,
administered as VIDEX EC, is reduced approximately 40%
relative to didanosine buffered tablets.

The time to the peak concentration (TMAX) increases from
approximately 0.67 hours for didanosine buffered tablets to
2.0 hours for VIDEX EC.

The enteric coated capsule was approved because of
advantages related to not being buffered, since drug
interactions with ciprofloxacin, ketoconazole and
indinavir, that were caused by the buffer, are avoided.

Additionally, VIDEX EC can be swallowed without being
chewed or dispersed in water.

The previous formulation (which is buffered) was approved
last year for use in a once daily regimen.

The preferred didanosine regimen is twice daily with the
older buffered formulation because there is more efficacy
data with this regimen. There are limited data to date to
support the long-term durability of response with a once-
daily dosing regimen of didanosine.

The safety profile of the enteric coated and the buffered
products are the same.


***** Retroviruses Conference: Registration Deadline for
Community Attendance is November 17

Any "community" member who wants to attend the 8th
Conference on Retroviruses and Opportunistic Infections,
February 4-8, 2001, in Chicago, must act now. You cannot
get into this conference by paying at the door. If you
write for a well-known AIDS "community newsletter," you can
probably get in through the "community press" category, but
the registration deadline is Friday November 17. If you are
an AIDS advocate or activist not associated with a
publication, you may need to use the "scholarship" route
(even if you do not need the money); deadline for these
scholarship applications is also November 17. (AIDS
TREATMENT NEWS published Retroviruses conference deadlines
on September 22, but did not have the press and scholarship
deadlines at that time.)

Mainstream press have longer--until December 31 or until
the press slots are filled, whichever happens first.
Researchers and clinicians without papers accepted for
presentation the meeting can apply starting Friday,
December 1--and must apply as soon as possible at that
time. These doctors and scientists should remember to send
their faxes to reserve a place at this conference on World
AIDS Day (December 1).

Instructions for these and other application processes are
at http://www.retroconference.org


***** Durban Conference Searchable Abstracts Now Available
on Web

Finally the abstracts of the XIII International Conference
on AIDS (Durban, South Africa, July 9-14, 2000) are
available on the Web, through an easy-to-use  site set up
by the U.S. National Library of Medicine at
http://www.iac2000.org

You can search for any topic of interest. For example, type
"vitamin" into the "Abstract Text" field and click the
"Search" button and you will see the titles of 22 abstracts
related to nutrition (they contain the word "vitamin"
somewhere in the text). Click on any of the titles to get
the whole abstract.

You can also select any group of the titles and display the
abstracts together, which is convenient for printing.

But be careful; "vitamins" (plural) only gets eight of the
22 "vitamin" abstracts. If a word has different endings
("malignancy" vs. "malignancies"), you can type just the
first part (malignanc", for example--13 abstracts). You can
type a phrase ("viral load", which finds 517 abstracts); to
see a smaller list of the abstracts likely to be most
important for your search, put "viral load" into the
Abstract Title field instead of into Abstract Text (76
abstracts have "viral load" in the title). And if you are
looking for authors, see the "Help" section on how to enter
their names. [Note: Do not type quote marks when doing the
searches.]

We did not find instructions for more complex searches
("viral load" *and* "HIV" for example), and could not get
them to work. But you can search for abstracts which have
one word or phrase in the title, and another word or phrase
in the text.

Also, we do not know if an Abstract Text search will also
find abstracts which have the word or phrase you are
looking for only in the title, but not in the text. If not,
you could miss some of the most important abstracts you are
seeking. After doing an Abstract Text search, it might help
to scan through an Abstract Title search as well, to spot
anything important which is missing.

Searchable, full-text abstracts on the Web are especially
important since the abstracts on the CDROM disks given out
at the Durban conference have a serious error. All the less
than ('<') and greater than ('>') signs are reversed
(except when they are part of less-than-or-equal or
greater-than-or-equal, which are not reversed). Corrected
disks, which also include the late-breaker abstracts, have
been prepared but may not have been widely distributed.

The new Durban conference Web search page can also be
reached through the home page of the National Library of
Medicine's Specialized Information Services
(http://sis.nlm.nih.gov/hiv.cfm), which provides
information on HIV/AIDS, toxicology, and some other topics.


***** Bitter Publication Dispute on Remune Study: More Than
Meets the Eye?

by John S. James

On November 1 the NEW YORK TIMES  reported that the Immune
Response Corporation "tried to block the publication of a
scientific paper that showed its HIV vaccine was not
effective, and it has asked for damages of more than $7
million from the universities and researchers who published
the findings."(1) The disputed paper was published in the
same day's issue of JAMA (JOURNAL OF THE AMERICAN MEDICAL
ASSOCIATION,(2) along with several articles and editorials
on relationships with industry and conflict of interest in
medical research.(3,4,5,6) The NEW YORK TIMES story was
picked up or rewritten by many news outlets. Also see LOS
ANGELES TIMES, November 1.

Because we learned about this dispute shortly before press
time, we have not had time for our own investigation. But
in this case we see credible people on both sides--and
beyond the obvious issues, some difficult ones which did
not come out in the headlines. Of course it is wrong when
companies take legal action to pressure researchers and
universities to spin scientific results their way--that is
a no-brainer, and the community must support researchers'
right to report, especially when persons have volunteered
for participation medical research studies. This is part of
an enormous problem ["when an investigator has a financial
interest in or funding by a company with activities related
to his or her research, the research is lower in quality (2
references), more likely to favor the sponsor's product (5
references), less likely to be published (2 references),
and more likely to have delayed publication (1
reference)"(6)], and to that extent, the public was well
served by the press coverage.

But tougher questions about how best to serve the public
interest arise from the fact that today immune-based
therapy is an enormously important research area, and yet
there is no satisfactory way to test such treatments for
clinical efficacy in patients (see "FDA Meeting on
Approving Immune Therapies: Background and Comment," AIDS
TREATMENT NEWS #353, October 20, 2000). Immune Response
Corporation did what it had to do and ran a huge trial
originally designed to look for differences in survival
between those who did or did not receive Remune, the HIV
immunogen developed by the late Dr. Jonas Salk; both the
treatment and placebo arms had more than a thousand
patients each, who were allowed to use any antiretroviral
therapy they chose (including experimental treatments, or
including no antiretroviral therapy at all), in addition to
the immunogen or placebo, which was administered every
three months. But after the trial was designed, the
introduction of protease inhibitors reduced overall AIDS
deaths enough that the trial could not have detected that
the treatment improved survival even if it did--so the
trial was quickly changed to include AIDS-related illnesses
as well as deaths as end points.

But later, in May 1999, when the Data Safety Monitoring
Board (DSMB) secretly unblinded the data, it recommended
that the trial be stopped; "the basis for the
recommendation was the lack of evidence of a difference
between the HIV-1 Immunogen group and the control group
with respect to clinical progression and that continuation
of the study was unlikely to lead to a demonstrable
difference between the groups."(2) "Before the study began,
the predicted clinical endpoint event rate was 6%
progression per year, meaning that 6% of 2,500 patients
would progress to an AIDS defining condition or death each
year. However, when the study was stopped, only 0.73% per
year progressed using the original Centers for Disease
Control AIDS-defining conditions."(7) Due to the dispute
with the company, the study leadership was unable to obtain
the final data, and published from the data submitted to
the DSMB, with updates during the summer of 1999.

The treatment certainly did increase HIV-specific immunity
as shown by lymphocyte proliferation assay (p<.001),(2) but
this measure is not currently accepted as a surrogate
marker of drug efficacy, because there is no proof at this
time that increasing this response is clinically beneficial
to patients.

The company has long had a reputation of looking for
creative ways to interpret its data, which angers some
researchers and activists. A serious communication problem
with unconventional ways to look at data is that even if
they are valid, outside analysts have a hard time verifying
that--because they must ask, "If we were given unlimited
access to the raw data, and months to play with it (months
which we don't have), might we have found equally
convincing ways to come to very different conclusions?" Yet
when facing a serious situation where conventional ways of
analyzing studies of immune-based treatments do not work,
it might or might not serve the public interest to insist
on strict adherence to established data-interpretation
rules. Sometimes it is necessary to push ahead on faith in
what one is doing, break some rules and take some risks, or
nothing will happen.

The controversy over the publication of this study re-
emphasizes the importance of developing workable, well-
accepted standards for the relationship between researchers
and industry. But here again there are complications. For
example, telling sponsors to keep hands off of the
scientific publication clearly seems like a good idea. But
in this case the press, investors, and the public ended up
with a bottom line which is at least questionable, if not
wrong--that the "HIV vaccine was not effective" in general
and not just in this trial. Certainly this study did not
find a clinical benefit--but if no such finding were
possible because of unrelated improvements in HIV
treatment, the study did not find that the treatment was
not effective, either; rather, the result was inconclusive.
Can standards decree that a sponsor has no legitimate
interest in preventing such misunderstandings?

In this trial the treatment consisted of killed HIV plus an
adjuvant--a substance which makes vaccines work better. The
placebo consisted of the adjuvant alone. Has it been ruled
out that the adjuvant itself might have been beneficial,
without the killed virus--since the volunteers already had
their own HIV, including dead virus, on board? This seems
unlikely, given the lack of HIV-specific lymphocyte
proliferation in the "placebo" arm--but much is still
unknown, and if the adjuvant itself were effective, the
study result could have been negative even if the product
being tested were beneficial.

Other Important Findings

The paper included other information which should not be
overlooked because of the distraction due to the
controversy.

"This study provided the first information regarding
disease progression among a large group of well-treated
patients with CD4 cell counts between 300 and 549 x 10(6)/L
that was collected in the controlled setting of a
randomized trial. The progression rate of 1.8 per 100
person-years of observation was one third of what had been
reported in the literature prior to the widespread
introduction of protease inhibitors. This provides
additional evidence of the long-term benefits of highly
active antiretroviral therapies..."

The study also found a surprisingly high incidence of
lymphoma, "the second most common clinical progression
event" (the most common was oral candidiasis).

References

1. Hilts PJ. Company tried to bar report that H.I.V.
vaccine failed. THE NEW YORK TIMES. November 1, 2000, page
A20 (national edition).

2. Kahn JO, Cherng DW, Mayer K, Murray H, and Lagakos S.
Evaluation of HIV-1 immunogen, an immunologic modifier,
administered to patients infected with HIV having 300 to
549 x 10(6)/L CD4 cell counts: A randomized controlled
trial. JAMA. November 1, 2000; volume 284, number 17, pages
2193-2202.

3. Cho MK, Shohara R, Schissel A, and Rennie D. Policies on
faculty conflicts of interest at US universities. JAMA.
November 1, 2000; volume 284, number 17, pages 2203-2208.

4. Boyd EA and Bero LA. Assessing faculty financial
relationships with industry: A case study. JAMA. November
1, 2000; volume 284, number 17, pages 2209-2214.

5 Korn D. Conflicts of interest in biomedical research.
JAMA. November 1, 2000; volume 284, number 17.

6. DeAngelis CD. Conflict of interest and the public trust.
JAMA. November 1, 2000; volume 284, number 17.

7. Immune Response Corporation press release, October 31,
2000.


***** Many People with HIV/AIDS Not Getting Proper
Treatment

A report from the AIDS Research Institute of the University
of California San Francisco found that in the four large
states which were studied (Texas, Florida, California, and
New York), many patients are unable to obtain proper HIV
medications through both Medicaid and ADAP (the AIDS Drug
Assistance Program). In Texas, the worst of the four, about
half to two thirds of patients who rely on these public
programs are not getting proper treatment. The report was
scheduled for publication in March 2001, but was leaked to
the media in early November. An Associated Press story is
available at:
http://dailynews.yahoo.com/h/ap/20001103/hl/aids_treatment_1.html

Comment

This report puts numbers on a dirty little secret which has
been widely known but not much discussed--that even within
the U.S., whether you get lifesaving treatments for AIDS
depends greatly on where you live. Private insurance (not
studied in the research discussed here) also has great
geographic variations. Very few people can pay for
antiretrovirals entirely out of pocket, especially when
they earn less because of their illness.

Living in rural areas, and/or the South, have long appeared
to be significant risk factors for inadequate access to
expensive AIDS medication. But much of the variation seems
random.


***** Flu Shot Time: Vaccine Shortage in Many Areas

A nationwide shortage of this year's influenza vaccine has
temporarily closed the vaccination program of the San
Francisco Department of Public Health.

Because of the shortage, the Health Department's program
here is restricted to persons at highest risk of severe
complications from influenza: those "50 years of age or
older, chronically ill or immunocompromised, [or]
pregnant." Even this restricted program ran out of the
vaccine on the first day (Nov. 7) and had to close until
more can be obtained. Flu shots may still be available in
San Francisco through other public programs or through
private physicians. Or call the San Francisco Department of
Public Health Flu Telephone Referral Line, 415-554-2681,
for news on the Department's program.

Flu shots take about two weeks to become fully effective.

Persons with serious illness should check with their
physician or clinic to confirm that they should receive the
vaccine, and for information on where it is available.

Information about influenza in your area may be available
at http://www.fluwatch.com


***** Help Wanted: AIDS Writer, AmFAR in New York

On October 31 we received the following help-wanted
announcement from the New York office of the American
Foundation for AIDS Research:

"AmFAR seeks qualified individual to write/edit variety of
communications materials, including newsletter, brochures,
reports, web content, talking points, Annual Report, etc.
Emphasis on ability to translate science and policy issues
into clear language. Assist with in-house copy approval
process. Copy edit direct mail and event/conference
materials. Manage publications inventory. Excellent
writing, editing, and project management skills required.
Ability to work as part of team, multi-task, and meet
deadlines. B.A. plus 3-4 years related experience.
Fundraising background helpful. Knowledge of HIV/AIDS
preferred. Send cover letter, resume, and salary history to
Staff Writer, Dept HR-8, 120 Wall Street, 13th Floor, New
York, NY 10005. EOE"


***** AIDS TREATMENT NEWS Price Increase January 1; Act Now
to Renew at Current Rate

Effective January 1, 2000 we are raising all subscription
prices for AIDS TREATMENT NEWS except those for persons
with financial difficulties. The reason is the changing
demographics of the epidemic, which means we must provide
more free subscriptions, when we have less income because
fewer subscribers can afford to pay. Also, we want to avoid
becoming dependent on subscriptions from industry. (We have
never accepted grants, contracts, or contributions from
pharmaceutical companies or others whose products we
cover.)

Both renewals and new subscriptions are available at the
current rate if received by December 31; these rates are
listed on page 2 of this issue. You can pay by check, VISA,
Mastercard, American Express, purchase order, travelers
checks, or postal money order; see subscription
instructions on page 2. If you are renewing, please tell
us, so that we can make sure your payment is properly
credited.


***** HIV Treatment and Survival: Easy Language Version

A shorter, simplified version of Bruce Mirken's in-depth
article, "AIDS Treatment Improves Survival: Answering the
'AIDS Denialists'" (AIDS TREATMENT NEWS #350, September 8,
2000) appears on the last two pages of this newsletter. We
formatted it for easy copying so that service organizations
can make copies for their clients. (We prefer "easy
language" to the more common phrase "low literacy.")

OK to remove the footer line if you want to.

We also encourage service organizations to use this text in
their own brochures and other materials.


***** Has Anti-HIV Treatment Cut AIDS Deaths? (original for
copying)

See our Web site (http://www.aidsnews.org) for a PDF
version of AIDS TREATMENT NEWS #354. The fact sheet is on
pages 7 and 8 of this issue.

***** AIDS TREATMENT NEWS

Published twice monthly

Subscription and Editorial Office:
   P.O. Box 411256
   San Francisco, CA 94141
   800/TREAT-1-2 toll-free
   415/255-0588 regular office number
   email: aidsnews@...
   useful links: http://www.aidsnews.org

Editor and Publisher: John S. James
Associate Editor: Tadd T. Tobias
Reader Services: Tom Fontaine

Statement of Purpose:
AIDS TREATMENT NEWS reports on experimental and standard
treatments, especially those available now. We interview
physicians, scientists, other health professionals, and
persons with AIDS or HIV; we also collect information from
meetings and conferences, medical journals, and computer
databases. Long-term survivors have usually tried many
different treatments, and found combinations that work for
them. AIDS TREATMENT NEWS does not recommend particular
therapies, but seeks to increase the options available.

AIDS TREATMENT NEWS is published 24 times per year, on the
first and third Friday of every month, and print copies are
sent by first class mail. Email is available (see below).
Back issues are available at http://www.aidsnews.org

To subscribe, you can call 800-TREAT-1-2 or 415-255-0588:
* Businesses, Institutions, Professionals: $270/year. Early
email available (see below).
* Nonprofit organizations: $135/year.
* Individuals: $120/year, or $70 for six months. If you
cannot afford a subscription, please write or call about
our sliding scale.
* Outside North, Central, or South America, add airmail
postage: $20/year, $10 for six months.
* Bulk rates and multiple discount subscriptions are
available; contact our office for details.
* Payment can be by check, VISA, Mastercard, American
Express, bank draft, purchase order, international postal
money order, or travelers checks.

Early email: Business, nonprofit and full-rate individual
subscribers can receive an early copy by email, before the
issue is printed--in addition to their regular copy, at no
extra charge. It's OK to direct the email copy to someone
else. Call our office to add email to your subscription.

Free email: Free delivery for individuals (delayed one
week). To subscribe, send email to aidsnews@...
with "subscribe" in the title or first line.

ISSN # 1052-4207

Copyright 2000 by John S. James. Permission granted for
noncommercial reproduction, provided that our address and
phone number are included if more than short quotations are
used.

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