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
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