Now online:

*** TMC125: Important One-Year Trial Now Recruiting in U.S.
    An new NNRTI that greatly reduces HIV resistance to this major class
of drugs is now recruiting at about 50 U.S. medical centers. It is
active against virus resistant to efavirenz and nevirapine. [2004-05-18]
    Full article: http://www.aidsnews.org/2004/05/tmc125.html

*** Gonorrhea: New Treatment Recommendations for Gay Men, MSM
    On April 30, 2004 the U.S.  CDC changed the gonorrhea treatment
recommendation for men who have sex with men, due to development of
resistance to the oral antibiotics otherwise preferred. [2004-05-18]
    Full article: http://www.aidsnews.org/2004/05/gonorrhea.html

*** May 20 "Time's Up!" AIDS Protest in Washington D.C.
    Rallies at the Democratic and Republican headquarters will call for
more serious attention to the disease that is now the leading cause of
death worldwide for all people age 15 through 59. [2004-05-18]
    Full article: http://www.aidsnews.org/2004/05/protest.html

*** How to Network Action Alerts, So That Others Can Help
    Future political action alerts will travel gracefully through
existing networks of familiarity and trust, being re-focused as needed
for each audience -- so that supporters you may never know can help
your effort be successful. Most alerts today do not work this way. We
explain why not, and show how to make action alerts work better.
[2004-05-18]
    Full article: http://www.aidsnews.org/2004/05/action-alerts.html

*** Online Glossaries of HIV/AIDS Terms
    Here are four English glossaries, and three Spanish glossaries, that
explain AIDS-related medical terms. [2004-05-18]
    Full article: http://www.aidsnews.org/2004/05/glossaries.html

*** Checking Your Drug Interactions
    Here are three HIV-related Web sites and one printed document that
you can use to check for some of the interactions between HIV drugs and
other drugs you are using at the same time. Some of them also have
information on known interactions between AIDS-related drugs and some
herbal treatments or foods. [2004-05-18]
    Full article: http://www.aidsnews.org/2004/05/drug-interactions.html


*** AIDS TREATMENT NEWS
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the announcements above (without sending them all).
    For more information see www.aidsnews.org

--
John S James
AIDS Treatment News
www.aidsnews.org

Starting May 2004, AIDS Treatment News will email summaries and links
to the full text of new articles, instead of emailing the whole
article. All articles will still be free on our site --
www.aidsnews.org -- with no registration required. We are making this
change so that we can report news immediately, improve our newsletter
by getting statistics on what our readers want, and change online
articles when necessary to reflect new information.

To avoid excessive email we will collect the summaries and send about 5
email announcements per month -- not on a fixed schedule, but when
important news happens.

If you received this message on April 27, 2004 then you are already
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We welcome comments and  suggestions. Send  them to
aidsnews@... -- and please begin your Subject line with the
word Suggestion,  to make sure your message comes to our attention.

To provide a complete record  through 2004, we are sending summaries
and links, below, for articles already published in AIDS Treatment News
this year.




*** Clinton Foundation Negotiates $140/Year HIV Treatment, But U.S.
Won't Buy
    The Clinton Foundation, World Bank, UNICEF, and the Global Fund to
Fight AIDS, Tuberculosis, and Malaria announced that they could
negotiate prices as low as $140 per year for triple-combination
antiretroviral therapy. But the Bush Administration is refusing to buy
generic medicines for its major HIV treatment program.
   Full article: http://www.aidsnews.org/2004/03/clinton140.html


*** Atherosclerosis Risk Increased with HIV; Treatment Effects Unclear
    A major report on heart disease and HIV found that HIV infection
itself is associated with increased risk, independently of other
factors like age, cholesterol, and smoking. Another major report did
find differences among antiretrovirals, but the information is hard to
summarize.
   http://www.aidsnews.org/2004/03/atherosclerosis.html


*** Atazanavir (Reyataz): New Recommendations If Combined with
Tenofovir (Viread) -- and Warning on Viagra, Cialis, and Levitra
    The FDA published new information on drug interactions that patients
taking Reyataz should know.
    http://www.aidsnews.org/2004/03/reyataz.html


***Abacavir Hypersensitivity Reaction Predicted by Genetic Test
    Researchers in Australia found an accurate test to predict who cannot
tolerate Ziagen (abacavir). This is still a research test, not in
general use.
    http://www.aidsnews.org/2004/03/abacavir.html


*** Update on Sculptra (New-Fill) Hearing
    An FDA advisory committee unanimously recommended approval of this
facial treatment for people with HIV -- with restrictions to prevent
general cosmetic use, pending data to justify such approval.
   http://www.aidsnews.org/2004/03/sculptra.html


*** Lessons from Two "Triple Nuke" Failures (New Training Module)
    A CME (continuing medical education) module for physicians explains
the problem with two antiretroviral regimens that failed last year.
Several possible causes for the failure had been proposed. Now it
appears that the problem was too low a genetic barrier to HIV
developing certain resistance mutations.
    http://www.aidsnews.org/2004/03/triplefailures.html


*** Retroviruses Conference: Summaries for Physicians
    This collection of CME trainings for physicians gives an in-depth
review of major reports from the Retroviruses conference (February 8-11
in San Francisco), focusing on what HIV physicians need to know.
    http://www.aidsnews.org/2004/03/retrosummaries.html


*** Medicines for the World: A Way Forward
    For poor and middle-income countries we should negotiate large sales
involving many countries, with all the interests at the table. Large
deals and public consensus could make it viable for companies to
develop treatments for diseases affecting poor regions.
    http://www.aidsnews.org/2004/03/medicinesforworld.html


*** Atazanavir (Reyataz) New Recommendation with Tenofovir (Viread);
Warning with Viagra, Cialis, and Levitra
    On March 19 the FDA notified the public of new prescribing
information and precautions for atazanavir (brand name Reyataz), if
taken in combination with tenofovir (Viread) -- and warned of risks
with Viagra or similar drugs.
    http://www.aidsnews.org/2004/02/atazanavir.html


*** Action Alerts: Please Improve Them for Networking
    Political action alerts could be much more effective if they were
designed to be shared -- to be easily picked up by other interested
organizations and sent to their members, or to other people and
organizations that listen to them. From our experience we suggest five
ways to make existing action alert work this way.
   http://www.aidsnews.org/2004/02/alerts.html


*** FDA Advisory Hearing on New-Fill (Sculptra), March 25, 2004 in
Gaithersburg, Maryland
    The FDA will discuss U.S. approval for New-Fill, a facial treatment
that Americans have had to go abroad for, although it is approved in
Europe and has been used by about 100,000 people worldwide. Those who
want to speak at the hearing should notify the FDA by March 15.
    http://www.aidsnews.org/2004/02/sculptra.html


*** Antiretroviral Pipeline: New-Drug Reports from Retroviruses
Conference
    The three experimental drugs most discussed at the important 11th
Conference on Retroviruses and Opportunistic Infections (\ 8-11, San
Francisco) were: BMS-488043, a new kind of entry inhibitor; Reverset, a
nucleoside analog active against most resistant viruses; and Schering
D, which blocks viral attachment to the CCR5 co-receptor on the cell.
    Other compounds discussed included PA-457, SPD-754,  GW873140,
GW678248, SN1212/1461, TMC114, TNX-355, PRO140, UK-427,857, AK602,
KRH-2731, mifepristone (RU-486), and chloroquine.
    http://www.aidsnews.org/2004/02/newdrugs.html


*** Nevirapine Precautions Published
    New instructions tell physicians who is most at risk for rare but
serious side effects when starting this important drug -- for example,
women with a CD4 count above 250.
    http://www.aidsnews.org/2004/02/nevirapine.html


*** Micronutrient Supplementation Shows Promise in Placebo-Controlled
Trial
    A supplement containing 33 vitamins, minerals, and antioxidants
seemed to help persons with HIV. This trial was organized by Jon
Kaiser, M.D., who has specialized in combining mainstream and
complementary HIV treatments, and is based in part on the work of
Marianna Baum, Ph.D., who has studied nutritional deficiencies in
persons with HIV.
    http://www.aidsnews.org/2004/02/micronutrient.html


*** Lipodystrophy: Conference on Imaging Technologies in Clinical
Management, Montreal, April 2-3, 2004
    This new conference with leading HIV physicians will look at DEXA and
other imaging technologies to measure the effects of lipodystrophy on
the abnormal wasting or accumulation of body fat.
    http://www.aidsnews.org/2004/02/lipo.html


*** "Poppers," Some Other Drugs, May Increase HIV Infection Risk
    Users of amphetamines ("crystal"), hallucinogens, or inhaled nitrites
("poppers") had higher rates of HIV infection than non-users,(1) in an
analysis of the Vaxgen trial data presented at the 11th Conference on
Retroviruses and Opportunistic Infections, February 8-11, 2004.
    http://www.aidsnews.org/2004/02/poppers.html


*** New Testing for Very Early HIV Diagnosis
    Because persons newly infected with HIV may be especially infectious
before the body has created antibodies to partially control the
infection, there is a new public-health push to also look for the virus
itself in routine HIV testing. North Carolina has used this approach
statewide for over a year, and discovered the first indications of a
new HIV epidemic among college students, especially African-American
men. Results were reported at the recent Retroviruses conference.
    http://www.aidsnews.org/2004/02/earlytest.html


*** Prison HIV and Hepatitis C Sites
    Of the hundreds of good Web sites on HIV, hepatitis C, and prison
issues, AIDS Treatment News has chosen about 40 to help you get started
in finding the information or resources you need. Annotated links are
at:
    http://www.aidsnews.org/prison/


*** Improving AIDS Conferences with Online Information
    Today, scientists and others arrive at major conferences without
knowing whom they should meet and talk to outside of their own field.
The whole medical-research enterprise is damaged when researchers miss
these connections. The key to improvement is to have the main data
presentations online, allowing conferences to focus on exploration and
discussion, instead of lectures that must rush through the new data. We
outline many other advantages, such as allowing researchers to update
their online presentations before or after the conference if they wish.
    http://www.aidsnews.org/2004/02/online.html


*** Institute of Medicine Calls for Universal Health Insurance by 2010
    On January 14, 2004 the prestigious Institute of Medicine (IOM)
called for the U.S. to implement universal health care by 2010.
Currently 43,000,000 Americans are uninsured, and lack of health
insurance causes 18,000 unnecessary deaths each year in the U.S. Eighty
percent of the uninsured are members of working families -- but a
quarter of U.S. workers are not offered health insurance at all, and
few Americans can afford to buy the expensive individual policies.
These and dozens of other facts in the new report will help anyone who
is making a case for change.
    http://www.aidsnews.org/2004/01/IOM.html


*** Remembering Greg Smith
    In 1990 Greg Smith was sentenced to 25 years in prison for allegedly
threatening and biting a prison guard while having HIV. For 13 years he
advocated for better prison health care, and was often visited and
helped by members of ACT UP Philadelphia and other prison activists. He
died in prison in November 2003. On January 29 about 75 members of ACT
UP Philadelphia held a memorial demonstration at the home of the
sentencing judge in Haddonfield, New Jersey.
    http://www.aidsnews.org/2004/01/GregSmith.html

*** "Shy" Study Suggests New Treatment Mechanism [December 2003]
    A study found that socially inhibited persons with HIV did much
worse than others virologically. The researchers suspect that the
biochemistry of chronically high anxiety could increase the growth of
HIV; if so, these effects might be controlled with drugs already
approved for other purposes. This  theory should be easy to test in
small clinical trials. If confirmed, it might lead to a new kind of
treatment to reduce viral load and disease progression for some
patients.
    http://www.aidsnews.org/2003/12/Shy.html


--
John S James
AIDS Treatment News
www.aidsnews.org

AIDS TREATMENT NEWS Issue #397, December 26, 2003
     phone 800-TREAT-1-2, or 215-546-3776

CONTENTS:

** "Shy" Study Suggests New Treatment Mechanism
A study found that socially inhibited persons with HIV did much
worse than others virologically -- due to biological differences
that might be reversible with readily available drugs. This
theory would be easy to test in small clinical trials. If it
works, it might lead to a new kind of treatment that could
greatly reduce viral load for some patients.

** Abbott Laboratories Increases Norvir Price Fivefold
On December 4, Abbott Laboratories increased the price of its
drug Norvir fivefold -- possibly the largest out-of-the-blue
overnight price increase for a life-critical medicine in
history.

** ADAP Washington Visit Feb. 23-25; Scholarship Deadline
January 16
On February 23-25 you can join people from around the U.S. in
Washington D.C. to tell your representatives about the
importance of emergency funding for the AIDS Drug Assistance
Program, which makes treatment possible for tens of thousands of
people. If you want to apply for hotel, travel, and per-diem
expenses, the deadline is next week.

** African-Americans and AIDS Conference, Philadelphia, Feb. 23-
24
This annual conference, primarily for medical professionals who
treat African Americans with HIV, will take place this year in
Philadelphia. We list highlights of the program.

** AIDS TREATMENT NEWS Will Publish Online, Print 12 Issues a
Year
We will continue the print edition, but also publish preprints
of articles online as news happens.

** Buyers' Club List, December 2003
Here is our annual update of AIDS-related buyers clubs and
similar organizations

** AIDS TREATMENT NEWS Index, 2003


***** "Shy" Study Suggests New Treatment Mechanism

by John S. James

A careful study of 54 asymptomatic, HIV-positive gay men,
published December 15, 2003, in the journal BIOLOGICAL
PSYCHIATRY found that "socially inhibited" individuals had a
viral load setpoint eight times higher than others -- and a much
worse response to antiretroviral treatment as well, with only
about one eighth of the viral load reduction of the other
volunteers (all treated volunteers were starting HAART for the
first time).(1) The study also showed that elevated activity of
the autonomic nervous system explained most of this difference -
- showing "the first clinical evidence that differential
neuronal activity mediates relationships between psychological
risk factors and infectious disease pathogenesis" (quotation
from the abstract). Apparently socially inhibited persons have a
higher baseline stress level, and control excess stress by
limiting social interaction.

The authors note other studies showing that norepinephrine,
which is released in response to stress, changes the function of
cells in several ways that result in faster HIV replication.
They note that naturally occurring differences in autonomic
nervous system activity can be associated with up to a 100-fold
difference in HIV viral load -- and suggest testing drugs that
might become powerful adjunctive therapies, slowing HIV
progression and greatly improving antiretroviral treatment in
many patients.

A recent article in THE WASHINGTON POST discussed this work, and
related work of other scientists.(2) For example, a link between
depression and HIV progression may be mediated by different
biochemical pathways -- opening doors to different treatments
for depressed patients than for those with a high stress level.

Comment: Designing Clinical Trials

There are already approved drugs, widely used for other
purposes, that can reduce some of the mechanisms that may be
responsible for poor control of HIV and poor response to
antiretrovirals in certain patients. But until recently, nobody
had any reason to imagine using them as part of a strategy for
reducing HIV viral load. (For example, beta-blockers are used to
lower effects of norepinephrine. But the link with depression
might lead to entirely different drug candidates, for to
different patients.)

Once plausible drugs are identified, they could be tested
relatively easily, because viral load is a continuous
measurement that reaches a new setpoint fairly rapidly. For
example, one might select patients who are poorly controlling
HIV (so that they have a large scope for improvement), who meet
other criteria such as social inhibition suggesting that the
drug being tested might work particularly well (so that success
is easy to see), and who also have a fairly stable viral load,
either on treatment or off (so that changes can more easily be
attributed to the drug being tested). These patients would be
randomized to either take the drug immediately or wait a few
weeks; in either case their viral load would be carefully
monitored for several weeks or months. If the drug worked as
hoped, there would be a large decrease in viral load without any
other change in antiretroviral treatment. If this happened, the
volunteers would be followed indefinitely to see if the
treatment could be continued successfully. These trials would
only require a few patients each. They could be designed,
recruited, and conducted in months, not years.

It is likely that drug candidates can be found that are already
widely available and well known in human use. Some of them may
be inexpensive. Often manufacturers of non-HIV drugs do not want
an HIV use discovered (because they fear that patients, or their
family members or friends, will wrongly suspect that someone is
secretly being treated for AIDS -- threatening a large market
for a much smaller one). But if a drug is already in widespread
use, the manufacturer's cooperation in researching it, while
helpful, would not be necessary. The community will need to pay
attention, however, and take initiative to make things happen.
The system cannot be trusted to work by itself.

At a time when progress in conventional antiretroviral treatment
has slowed, here is a wide-open area that, if it works, could
rapidly lead to major treatment advances.

References

(1) Cole SW, Kemeny ME, Fahey JL, Zack JA, and Naliboff BD.
Psychological risk factors for HIV pathogenesis: Mediation by
the autonomic nervous system. BIOLOGICAL PSYCHIATRY December 15,
2003; volume 54, pages 1444-1456.

(2) "Stress Found to Weaken Resistance to Illness" by Shankar
Vedantam, WASHINGTON POST, December 22, 2003, page A12.


***** Abbott Laboratories Increases Norvir Price Fivefold

by John S. James

In an entirely unexpected move on December 4, 2003, Abbott
Laboratories increased the U.S. wholesale price of its 100-mg
capsules of ritonavir (Norvir(R)), to five times what it had
been the day before -- and increased the price of the liquid
formulation comparably. Norvir, originally approved in 1996 and
with estimated sales of over $1.3 billion to date, is widely
used in small doses to "boost" the effect of other protease
inhibitors, and the new price will greatly increase the cost of
several widely used treatments. The new price may be the largest
overnight, unexpected price jump in history for a life-critical
drug.

Abbott did not announce the increase except in a letter to
wholesalers stating the new price (we learned about the change
through emails from patients). After opposition from doctors'
and other organizations, and stories in THE WALL STREET JOURNAL,
CHICAGO TRIBUNE (Abbott is located outside Chicago), and other
news media, Abbott sent a Dear Doctor letter to HIV physicians,
saying that it had carefully planned the increases so that they
would not block patients' access. It said it would provide the
drug free to those who pay out of pocket (about 5% of patients
using the drug, according to Abbott) regardless of their
financial status -- and would not raise the price for ADAP or
Medicaid until June 2005. [Note: It could not raise these
government prices much until 2005 anyway, due to existing
regulations and agreements]. For those paying through private
insurance (about 40%), Abbott said it had contacted "many"
health-insurance providers and found that they do not restrict
HIV medications through a formulary, nor plan to increase co-
pays or premiums. (Prices outside the U.S. are unchanged because
of price controls in the major markets.)

In fact, patients are already changing their treatment
(especially from full-dose Norvir), despite the risk of
switching from a regimen they know is working for them to one
they do not know (see "Price of AIDS Drug Soars Fivefold" in the
SEATTLE TIMES, January 5, 2004). And another problem not visible
right away is that some insurance companies keep raising
premiums for those who need expensive care, eventually making
the insurance prohibitive and abandoning these patients.

Abbott did not raise the price of the small ritonavir dose in
Abbott's Kaletra product -- immediately putting competitors'
protease inhibitors at a major disadvantage if they use the
boosted dosing most doctors now recommend. Abbott just added
another $2500, $5000, or $10,000 per year (wholesale cost) to
the price of its competitors' products (depending on how much
Norvir needs to be taken to slow the body's destruction of the
other drug).

The five-fold price increase could also inhibit the development
of new boosted protease inhibitors, now becoming increasingly
successful treatment options. "Why bother to invest in these
areas if Abbott has effectively priced you out of the market in
the U.S.?" one scientist asked.(1)

Community Response

On December 18, 2003, the HIV Medicine Association asked Abbott
to "reconsider the recent 500 percent price increase of
ritonavir (Norvir(R)), a drug which as you know is necessary to
the success of virtually all protease inhibitor combinations for
the treatment of HIV infection. The HIV Medicine Association
(HIVMA) represents 2,600 physicians and other health care
providers who practice HIV medicine. While we recognize the
value of ritonavir, we are alarmed by your decision to raise the
cost of protease inhibitor (PI) regimens to the point where many
people who need these life-saving drug combinations will
struggle to pay for them or will not have access to them at
all."(2)

Efforts have started to organize a boycott across all Abbott
products. A five-fold drug price increase speaks to everybody,
and opens a Pandora's box for a whole new level of corporate
abuses. A boycott could be effective if buying from Abbott
becomes something to avoid in the medical community, and major
hospitals and other institutions redirect large orders when they
have the opportunity, when equally good products are available
from competitors. Antitrust avenues are being explored as well
(not even Microsoft could raise its competitors' prices); we
have heard that state attorney general offices are interested.
Also, several ritonavir patents were developed with government
support, and under a Federal law known as the Bayh-Dole Act, the
government could license a third party to produce the drug if
the patent holder fails to make it available on reasonable
terms.

And AIDS treatment activists are talking with other groups
affected by pharmaceutical-industry abuses.

Comment: Drug Development

In addition to specific remedies, we also need a new look at the
big picture of how medicines are developed.

People died in the clinical trials and clinical experience that
led to the modern use of boosted protease inhibitors. Patients
need options, but now one company wants to take away much of the
benefit of what has been learned, in order to increase its
market share and profit. Congress has given big pharmaceutical
corporations a monopoly on life and death, but this system
cannot work unless the power is used with some restraint and
respect for public interest.

Americans are told they must suffer exorbitant prices for
critical drugs to provide incentive to develop new medicines.
But in fact, the industry's record in creating medical
breakthroughs is remarkably poor in light of the great advances
in biological sciences, and the great resources pharmaceutical
companies have at their disposal. The biggest reason, we
believe, is one that gets far too little attention -- that the
pharmaceutical industry does nothing to develop non-patentable
treatments, and very little to develop even proprietary
treatments if the rights are unclear or scattered among
competitors, who seldom cooperate well. Many if not most of the
best medical and scientific leads are off the table entirely
under the current system, simply because of ownership and rights
issues. Nothing can be done without a clearly visible hook of
something to sell -- a way to build a business, perhaps, but not
a way to discover new knowledge or create new medicines.

Pharmaceutical companies are marketing organizations, not
research organizations. They conduct or fund only a little basic
research (much of it for public-relations purposes), and usually
farm out clinical research to specialized companies.

And increasingly pharmaceutical companies are lobbying
organizations, with more Federal lobbyists, 623, than members of
Congress, 535. These lobbyists include 23 former members of
Congress, who have special access to their colleagues. The
industry spends over $78 million a year on Federal lobbying(3) -
- an average of over $145,000 every year to influence each
member of Congress, with all this money often targeted to
changing just a small number of key votes. Campaign
contributions, real and fake "issue" ads, and monies to change
public discussion by influencing academics, medical journals,
think tanks, physicians, reporters, activists, and other
"thought leaders" are not counted in this total.

This is why an unworkable system that threatens everyone's life
is so hard to change.

Meanwhile, government, university, non-profit, and
public/private groups sometimes develop new drugs (a recent
example is the emergency contraceptive, Plan B). But they have
been discouraged from doing so by the ideology that this is
industry's job -- even while "open source" development in other
fields is showing new ways to organize the work of thousands of
individuals and teams around the world to create and run large
projects successfully.

Pharmaceutical pricing has become a serious issue everywhere in
the world (even where there are price controls -- which have
worked less well for new drugs because there is no baseline
price, and in any event are under attack by the U.S.
government). A five-fold, out-of-the-blue price increase sets a
precedent that can hurt anyone. And it moves us further toward a
world where the big advances of 21st-century medicine for
cancer, Alzheimer's, autoimmune, infectious, and other diseases
will routinely be reserved for rich or well-insured minority,
while others live or die without them.

The first step toward a better way is to open drug development
to a variety of teams, structures, and institutions, not just
one. What big pharma can do, and do well, is to bring together
the loose ends left by others to accomplish the critically
important and intensely political task of getting proprietary
drugs into rich or well-insured bodies. Today's pharmaceutical
industry can make a better Viagra. But will not develop
medicines for diseases of poor countries -- or non-proprietary
treatments for anyone, even when they are the best at any price.

For More Information, and How to Help

A place to start is the AIDS Treatment Activist Coalition
(ATAC). It has posted materials on the Norvir price increase on
its site: http://www.atac-usa.org/

Treatment activists who join ATAC can participate in ongoing
discussions on the Norvir price increase, ADAP funding, drug
development options, prison health care, and other issues.

References

(1) Unnamed pharmaceutical-company scientist quoted by Keith
Alcorn of AIDSMAP, in "Ritonavir price increased: What are the
consequences in 2004?" at:
http://www.aidsmap.com/news/newsdisplay2.asp?newsId=2466
(follow the link to Part 2).

(2) A press release and the letter to Abbott from the HIV
Medical Association are at: http://www.hivma.org

(3) AMERICA'S OTHER DRUG PROBLEM: A BRIEFING BOOK ON THE RX DRUG
DEBATE, prepared by Public Citizen's Congress Watch, at:
http://www.citizen.org/rxfacts


***** ADAP Washington Visit Feb. 23-25; Scholarship Deadline
January 16

As AIDS TREATMENT NEWS went to press we received the following
notice from Save ADAP, of the AIDS Treatment Activist Coalition,
about an effort to prevent thousands of Americans from being
denied HIV treatment solely due to lack of funding. Because a
scholarship deadline is next week, we included the information
here.

"Save ADAP members from around the country will be visiting our
nation's policy makers on February 23-25, 2004 in Washington
D.C. to ask Congress for an Emergency Supplemental funding for
the crumbling AIDS Drug Assistance Program (ADAP). We are
inviting other people living with HIV/AIDS and service providers
to join us. Save ADAP is providing 50 full scholarships for
people who cannot afford to pay for the trip themselves.
Priority will be given to ADAP clients, people on ADAP waiting
lists, women, people of color, PWA/HIVs, and frontline service
providers living in one of the following ADAP crisis states
(Alabama, Alaska, Arkansas, Colorado, Idaho, Indiana, Kentucky,
Montana, Nebraska, New Hampshire, New Mexico, North Carolina,
Oklahoma, Oregon, South Dakota, Texas, Washington, West
Virginia, Wyoming.)

"The scholarship will cover round-trip travel, hotel, and a per-
diem for the entire trip. There will be a half-day orientation
on Feb. 23rd, followed by visits to both of your U.S. Senators
and your House Representative on the two remaining days.

Deadline for applications is Friday, January 16, 2004. Please
send the following information to TheAccessProject@... or
fax it to 212-260-8869. For questions, please contact Lei Chou
at the AIDS Treatment Data Network 212-260-8868 x.21

Name:
Address:
Phone:
e-mail:
Race/Gender:
ADAP client? Y/N
On an ADAP Waiting list? Y/N
HIV Service Provider? Y/N
If yes, what is your job?
Do you need a Scholarship? Y/N

Background:

"In 2003, ADAP served over 90,000 Americans living with HIV
disease. This important program has been under funded for the
last four years. Congress appropriated a $35 million increase
for fiscal year 2004, but this amount falls far short of the
$215 million needed to keep pace with the growing demand. This
is a critical turning point for the program, starting a new
fiscal year with a $180 million budget shortfall, the largest
ever, representing roughly 1/5 of the entire budget. As we are
nearing the end of the current ADAP fiscal year (3/31/2004),
there are already over 700 people on waiting lists across ten
states, with another six implementing program cut backs and
access restrictions. To ensure current ADAP clients coverage,
close to half of the ADAPs around the country will be starting
their new fiscal year with their doors closed to new clients.

"In order to prevent the further collapse of ADAP, we are asking
Congress and the Administration to provide an Emergency
Supplemental funding of $180 million dollars for ADAP for the up
coming fiscal year. To this end, Save ADAP is conducting a
national grassroots campaign to take the message to our
representatives in Washington D.C. Save ADAP members from around
the country will be visiting Congressional offices on February
24th and 25th to educate the law makers on the importance of
ADAP, and to warn against the dire consequences of underfunding
this program. Please join us in this effort to Save ADAP. Please
contact Lei Chou at TheAccessProject@... or 212-20-8868 x21
if you want to participate in this event."

For more information about Save ADAP, see:
http://www.atac-usa.org/adap.html


***** African-Americans and AIDS Conference, Philadelphia, Feb.
23-24

The 2004 National Conference on African-Americans and AIDS -- "a
national forum on HIV/AIDS for health professionals who provide
care for African-Americans" -- will take place in Philadelphia,
February 23 and 24, at the Wyndham Franklin Plaza Hotel.

This year for the first time the conference will have a separate
track on advanced HIV management, separated from the basic
track.

Conference admission is $100 (which includes both days,
continental breakfast, box lunches on both days, and the
reception), through February 10. After February 10, or at the
door, this price goes up to $135. If you want to stay at the
hotel, special conference rates are available.

Program Highlights -- Day 1
* Elaine M. Daniels, M.D., Ph.D.: Epidemiology of HIV in the
United States
* Beny J. Primm, M.D.: Introduction of guest speakers
* Danny Glover: Special guest speaker
* Victoria A. Cargill, M.D., M.S.C.E.: Minority Population
Research Initiatives
* Mary Lawrence-Hicks, N.P.: HIV Complementary Therapy and
Support Care
* Cleo Manago: Protective Factors and Policies
* Working lunch on African-American women, and new activism
* Valerie E. Stone, M.D., M.P.H.: Clinical Management Strategies
* Glenn Treisman, M.D., Ph.D.: Psychiatric Co-Morbidities in the
HIV-Infected Patient
* Marc Ghany, M.D.: Hepatitis and HIV Co-Infection, Clinical
Management, New Strategies
* Wilbert Jordan, M.D.: Working Specialized Clinic Models
* Henry Francis, M.D.: Legal and Illegal Drug Use
* Evening reception

Program Highlights, Day 2
* Phill Wilson: New Directions in HIV/AIDS Policy
* Jonathan Zenilman, M.D., and Celia Maxwell, M.D.: Men, Women,
and STDs
* Jocelyn Elders, M.D., Special guest speaker
* Robert Fullilove III, Ed.D.: The Modern Diaspora from Africa
and the Caribbean and Cultural Fluency
* Jean R. Anderson, M.D.: Clinical Management of HIV in Women
* Working lunch panel including Wilbert Jordan, M.D., Keith
Cylar, and Darrell P. Wheeler, Ph.D.
* Wilbert Jordan, M.D.: Focused Intervention: Novel Approaches
to Outreach
* George W. Roberts, Ph.D.: HIV prevention for African-Americans
* Darrell P. Wheeler, Ph.D.: Special Research Involving Black,
HIV-Infected Gay, Bisexual, SGL, Transgender, and Heterosexual
MSM
* Keith Cylar, Special Needs of the HIV-Infected Homeless

For more information, see:
http://www.minority-healthcare.com


***** AIDS TREATMENT NEWS Will Publish Online, Print 12 Issues a
Year

Starting in January 2004, AIDS TREATMENT NEWS is moving to a
system of publishing drafts or preprints of articles online as
news happens, then publishing these stories monthly in the print
edition. Since the online preprints may change as necessary, the
printed article will be the official version.

The print edition will continue to be published as usual.
Subscribers will see no difference, and do not need to take any
action as a result of this change.

When the new Web site is ready, it will be available at
http://www.aidsnews.org


***** Buyers' Club List, December 2002

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.

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. Call ahead for
current information.

Arizona

Body Positive's Vitamin and Herb Shop
1144 E. McDowell Rd, Suite 200
Phoenix AZ 85004
602-307-5330x2239
http://www.phoenixbodypositive.org/vitamin/index.htm

Travis Wright Memorial Buyers' Club
Southern Arizona AIDS Foundation
http://www.saaf.org/
wellness@...
375 S. Euclid Ave
Tucson AZ 85719
800-771-9054 or 520-628-7223
fax: 520-628-6222;  TTY: 800-367-8937

California

Rainbow Grocery Cooperative (20% PWA discount on vitamins, 10%
on groceries, with the Helping Hand card)
http://www.rainbowgrocery.coop/ or
http://www.rainbowgrocery.org/
vitamins@...
1745 Folsom St.
San Francisco CA 94103
415-863-0620

Colorado

Denver Buyers' Club
pwacolo@...
1290 Williams St.
Mailing address: P.O. Box 300339, Denver CO 80203-0339
303-329-9379x108, fax: 303-329-9381
Bilingual Spanish/English  TTY: through operator

District of Columbia

Carl Vogel Center
cvchiv@...
1012 14th St. NW, Suite 700, Washington DC 20005
202-638-0750, fax: 202-638-0749
Membership: annual cost $25 (includes a BIA test, reduced prices
for massage and acupuncture, an educational symposium, a
newsletter, and reduced prices for supplements).
The Carl Vogel Center now offers mental health services and
treatment education.

Georgia

AIDS Treatment Initiatives
info@...
139 Ralph McGill Blvd. NE Suite 305
Atlanta GA 30308-3311
888-874-4845 or 404-659-2437
fax: 404-450-9412

Massachusetts

Treatment Information Network's Boston Buyers' Club
http://www.bostonbuyersclub.com/
info@...
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/ (see note below)
118 Park Avenue
Newark, NJ 07104
888-951-5433, or 973-497-2333
fax: 973-497-0498
Note: DAAIR has temporarily stopped selling nutritional
supplements; it may resume in April 2004. Until then it is
selling prescription medicines only.

Texas

Houston Buyers' Club
http://www.houstonbuyersclub.com/
info@...
3224 Yoakum Blvd.
Houston TX 77006
800-350-2392, or 713-520-5288
fax: 713-521-7419
Local and mail order (U.S., and many other countries).
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, 2003

Abacavir+tenofovir+3TC failure 393
Abbott raises Norvir price five fold 397
Access for all, Thailand conference theme 395
ADAP organizing 388
ADAP Washington trip 397
Aegis 388
Africa Action 390
Africa trials -- no drugs 391
African-Americans and AIDS Conference 388
African-Americans and AIDS Conference 397
AIDS TREATMENT NEWS online publication 397
AIDS TREATMENT NEWS 396
Antibiotic-resistant staph 388
Atazanavir (Reyataz) approved 392
Bahamas antiretroviral prices, Clinton 389
Biomedical research cuts 392
Bush AIDS initiative 388
Bush AIDS initiative 391
Buyers' club lists 397
Cholesterol management 394
Ciasullo, Eric, on returning to work 395
Clinical Care Options for Hepatitis 391
Clinical Care Options 388
Clinton Foundation lowers Caribbean price 389
Clinton Foundation, HAART 40 cents/day 395
Cohen, Dr. Cal, on Retroviruses conf., pt 1 389
Cohen, Dr. Cal, on Retroviruses conf., pt 2 390
Co-trimoxazole for staph 388
Counterfeit Procrit 389
Deep salvage 390
Drug development 397
Efavirenz vs. nevirapine 389
Emtriva (FTC) approved 393
Export problem, WTO 394
Federal policy problems 392
Fosamprenavir approved 395
FTC (Emtriva) approved 393
Fundraising, online 392
FUZEON (T-20) 389
Glaxo research grants 391
Global Fund to Fight AIDS, TB, and Malaria 388
Grassroots organizing 388
Heart disease guidelines 394
Highly experienced patients 390
HIV Insite 388
HIV nutrition info for doctors 391
HIV treatment guidelines, July 393
HIV treatment guidelines, November 2003 396
HIVandHepatitis.com 388
Hoffmann-La Roche, T-20 389
Huge price variations in generics 391
IAS conference reports on Web 393
International AIDS Society conf., Paris 392
Lexiva (908, Fosamprenavir) 389
Lexiva approved 395
Medicaid cuts planned 390
Medicaid organizing 388
Medscape 388
Microbicides 391
MRSA 388
NATAP 388
Nelson Mandela on HIV treatment access 393
Neuropathy treatment, new guidelines 396
Nevirapine reduced maternal transmission 394
Nevirapine toxicity 389
Nevirapine vs. efavirenz 389
Norvir price fivefold rise 397
Paris conference reports on Web 393
Pediatric HIV guidelines, November2003 396
Pharmaceutical company lobbying facts 397
Pharmacy benefits managers, profit 391
Philadelphia FIGHT 391
Planetwork conference 392
Pneumocystis still cause of death in U.S. 391
Prevention policy problems 392
Prices of drugs 391
Prison Health News 390
Prison skin infections 388
Retroviruses conference, Web coverage 388
Returning to work after disability 395
Reyataz approved 392
Safety net failure 391
SARS Web information 390
Save ADAP committee 397
Search for a Cure, clinical trials forum 395
Social network software, for fundraising 392
Social Security disability definition 392
Staph infection treatments 388
Starting antiretroviral therapy 389
Subscriptions to share 396
T-20 cost 389
TAC (Treatment Action Campaign) 390
Tenofovir+ddI+3TC failure 395
Thailand conference 2004, deadlines 395
The Body web site 388
Treatment Action Campaign 390
Treatment interruption 390
Treatment interruption 394
Triglycerides management 394
Trizivir arm stopped in trial 390
UNAIDS report for 2003 396
VaxGen's AIDSVAX trial 389
World AIDS $4.7 billion, WorldCom $35B 396
World Trade Organization rules 394
WORLD, women and HIV 391\
WTO rules limit access to poor countries 394


***** AIDS TREATMENT NEWS

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
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 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 12 times per year, and print
copies are sent by first class mail. Articles are available at
http://www.aidsnews.org

To subscribe, you can call 800-TREAT-1-2 or 215-546-3776:
* 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.
* 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.

ISSN # 1052-4207

Copyright 2004 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
www.aidsnews.org

AIDS TREATMENT NEWS Issue #396, November 30, 2003
     phone 800-TREAT-1-2, or 215-546-3776

CONTENTS:

** World AIDS $4.7 Billion -- WorldCom $35 Billion
The entire worldwide campaign to save tens of millions of people
is a distant second to the campaign to save one corporation.

** UNAIDS Report for 2003: Most Deaths and New Infections Ever;
Some Good News
The global AIDS epidemic is still getting worse. There have been
successes, however, and many countries are at a critical stage
where they could prevent a major epidemic if they act now; while
some are beginning to do so, others are not. Overall there has
been a big growth in commitment by governments of rich countries
and developing countries alike, though financially the current
effort is only about half of what is needed. Stigma remains a
major obstacle to stopping the spread of HIV and getting those
infected diagnosed and treated.

** New Neuropathy Treatment Guidelines
These expert guidelines for treating neuropathic pain are
particularly important, since most of the treatments are off
label -- meaning that they have been approved by the FDA but not
for this particular purpose. These guidelines will help educate
doctors about what treatments are best, and should also help in
getting insurance reimbursement for care that clearly represents
expert consensus but is not in the official labeling at this
time.

** Revised U.S. Adult and Adolescent Antiretroviral Treatment
Guidelines; Also Revised Pediatric Guidelines
Both the U.S. adult and pediatric guidelines were revised in
November 2003.

** AIDS TREATMENT NEWS: Changes Next Year
During the next year we must change our traditional business
model. Also, we plan to do more reporting online, and continue
the printed newsletter as well.

** Subscriptions to Share: New Way to Sell Content or Help
Fundraising Online
While exploring business models for the newsletter we found a
radically different way to sell information or help raise funds
online. A system designed to encourage sharing allows
subscribers or donors to use parts of their subscription to
create new subscriptions for others, without the publisher's
involvement -- eliminating registration, reducing transaction
costs, encouraging larger subscriptions or donations, and
creating opportunities for bringing people together around an
idea, purpose, or cause.


***** World AIDS $4.7 Billion -- WorldCom $35 Billion

by John S. James

A month ago newspapers reported a huge bankruptcy settlement
that wiped out about $35 billion in debt for one corporation,
the notorious WorldCom.

"A federal bankruptcy judge yesterday gave his approval to a
plan by telecommunications giant WorldCom and its creditors to
exit bankruptcy by the end of the year. The decision wipes out
in one stroke nearly $35 billion in debt, and positions the
scandal-plagued company to again become a viable business and a
formidable player in the intensely competitive industry."
PHILADELPHIA INQUIRER, November 1, 2003.

The total worldwide spending for AIDS prevention, treatment, and
care was $4.7 billion in 2002, the latest year for which figures
are available (UNAIDS, REPORT ON THE STATE OF HIV/AIDS
FINANCING, June 2003).

The comparison speaks for itself -- $4.7 billion to control an
epidemic killing 3,000,000 people this year, vs. $35 billion in
debt restructuring to rehabilitate a single company heavily
involved in one of the biggest scams in history.

The failure to respond to AIDS is a human problem, not a fact of
nature. All of us can do our part to demand political will. The
basic commitment is to insist on workable arrangements instead
of settling for something less. WorldCom apparently has
effective political consensus and cooperation on a viable path
forward. But AIDS still does not.


***** UNAIDS Report for 2003: Most Deaths and New Infections
Ever; Some Good News

Three million people died of AIDS this year compared with 2.7
million last year, and five million were newly infected -- both
more than ever before, according AIDS EPIDEMIC UPDATE: DECEMBER
2003, compiled and published by UNAIDS, the United Nations Joint
Programme on HIV/AIDS. Forty million people are now living with
HIV, up slightly from last year.

There is good news from a number of individual countries, as
well as increased commitment from many governments, and
increased total resources worldwide devoted to the epidemic.
Some prevention programs have worked well. But many countries
are at a critical stage where they could abort a major epidemic
if they act now. Unfortunately some of their governments are
still not serious about AIDS.

AIDS Epidemic Update: December 2003 is available at:
http://www.unaids.org

A few situations, among hundreds of others:

* Swaziland, in Southern Africa, shows how fast HIV can spread.
In 2002 almost 39% of the entire adult population age 15-49 had
HIV. Ten years before it was 4%. (Imagine what this means for
Eastern Europe, many parts of Asia, and other places where
governments are not dealing with an early epidemic that could
still be stopped, if only people mobilize in time.)

* In Africa, fewer than 2% of those who need treatment now can
get it. In heavily affected countries, only about 1% of women
have access to services for prevention of mother-to-child
transmission.

* In many African countries, HIV prevalence seems to be
stabilizing at a high level -- but this is not really good news.
The reason the percentage infected is not higher is that more
people are dying.

* In the U.S., about half of the 40,000 new infections this year
are of African-Americans (who make up 12% of the population) --
often women who avoid high-risk behavior themselves but get HIV
from men who are secretly having risky sex or sharing needles --
just one of many illustrations of how stigma and discrimination
make AIDS control more difficult.

* Successes include Kampala, Uganda (about 8% of pregnant women
now have HIV, an indicator of prevalence in the general adult
population -- a "remarkable feat" according to the report). No
other country has done as well, although big drops have also
occurred in Ethiopia and Rwanda.

* "Globally, the AIDS response is moving into a new phase.
Political commitment has grown stronger, grass-roots
mobilization is becoming more dynamic, funding is increasing,
treatment programmes are shifting into gear, and prevention
efforts are being expanded." (AIDS EPIDEMIC UPDATE: DECEMBER
2003).

Total public and private global spending on AIDS prevention,
treatment, and care is now about $4.7 billion dollars
($4,700,000,000) a year, compared to a need of $10 billion --
better than before, but scandalously low for an epidemic killing
3,000,000 people per year and likely to kill tens of millions
more.

* As programs scale up, another critical shortage is trained
personnel. HIV treatment is needed now to keep medical and other
trained people alive. Also, despite critical shortages,
thousands of nurses in Africa are now unemployed due to caps on
spending for public services.

Facts like these hint at what individuals and organizations can
do. Many of the problems are local, and can only be handled by
those directly involved. But many others (especially the lack of
resources) are global. And many problems in the developing world
originate in the U.S. and other rich countries.


***** New Neuropathy Treatment Guidelines

by John S. James

An expert panel has recommended five different kinds of drugs
that are suitable for treating neuropathy pain in some patients.
The review and recommendations were published in the November
issue of ARCHIVES OF NEUROLOGY(1). These guidelines mention HIV
but are not HIV-specific. They are available free on the Web (at
least when we checked on December 1, 2003) at:
http://archneur.ama-assn.org/cgi/content/full/60/11/1524

  From the article:

   "First-line Medications. The efficacy of gabapentin, the 5%
lidocaine patch, opioid analgesics, tramadol hydrochloride, and
tricyclic antidepressants (TCAs) has been consistently
demonstrated in multiple randomized controlled trials. Each one
can be used as an initial treatment for neuropathic pain in
certain clinical circumstances. Opioid analgesics and TCAs
generally require greater caution than the other options. For
each of these 5 medications, brief reviews of the relevant
randomized clinical trials and specific treatment
recommendations follow. Treatment recommendations are summarized
in Table 2."

Not recommended but sometimes used are NSAIDS; many experts
believe they are not effective for this kind of pain.

(However, AIDS TREATMENT NEWS has heard anecdotal reports of
relief with Voltaren Emulgel, an NSAID in a topical formulation.
The topical form is not sold in the U.S., but may be available
from Internet pharmacies for under $20. See our 1999 article at:
http://www.aids.org/atn/a-321-01.html)

The same issue of ARCHIVES OF NEUROLOGY also has an article on
surgical treatment for neuropathy pain(2), and an editorial(3).

References

1. Dworkin RH, Backonja M, Rowbotham MC, and others. Advances in
Neuropathic Pain: Diagnosis, Mechanisms, and Treatment
Recommendations. ARCHIVES OF NEUROLOGY November 2003; volume 60,
number 11, pages 1524-1534

2. Giller CA. The Neurosurgical Treatment of Pain. ARCHIVES OF
NEUROLOGY November 2003; volume 60, number 11, pages 1537-1540.

3. Rosenberg RN. Pain 2003. ARCHIVES OF NEUROLOGY November 2003;
volume 60, number 11, page 1520.


***** Revised U.S. Adult and Adolescent Antiretroviral Treatment
Guidelines; Also Revised Pediatric Guidelines

by John S. James

Small but important revisions to the U.S. Guidelines for the Use
of Antiretroviral Agents in HIV-1-Infected Adults and
Adolescents were published in a revised document on November 10,
2003. The latest HIV treatment guidelines are always available
at:
http://www.aidsinfo.nih.gov/guidelines/

The revised guidelines include warnings against two three-drug
NRTI combinations that should never be used as a triple regimen
(abacavir + tenofovir + lamivudine, and tenofovir + didanosine +
lamivudine), because these regimens failed to control viral load
in treatment-naive volunteers in recent clinical trials, leading
to development of viral resistance in some patients. The problem
with these regimens is well known -- but unless the warning is
in the guidelines, some physicians with little HIV experience
may make a mistake.

The warning against combining d4T + ddI (stavudine plus
didanosine) due to risk of toxicities now clearly applies not
only in pregnancy but to anyone (unless the benefits outweigh
the risks for a particular patient). The previous edition of the
guidelines had been criticized for being ambiguous on this.

The revised guidelines warn against combining atazanavir +
indinavir (possible worse hyperbilirubinemia), and FTC + 3TC
(similar resistance profile, without additional benefit).

And they also include additional information on T-20
(enfuvirtide).

Atazanavir and FTC have been added to the guidelines as
potential alternative drugs in certain regimens. (The new
guidelines also make it clear that "alternative" recommendations
can be the preferred treatment for some patients.)

This edition includes a helpful "What's New in This Document?"
section just after the cover page.

Patients who want to check to see how their treatment compares
should note that much of the information is in the tables at the
end of the document. Remember that HIV-expert physicians may
have good reason for not following the guidelines in some cases.

Pediatric HIV Guidelines Revised

A revised GUIDELINES FOR THE USE OF ANTIRETROVIRAL AGENTS IN
PEDIATRIC HIV INFECTION was published November 26, 2003, by the
U.S. Department of Health and Human Services. It is also
available at the U.S. government Web site for official HIV
treatment and related guidelines:
http://www.aidsinfo.nih.gov/guidelines/


***** AIDS TREATMENT NEWS: Changes Next Year

by John S. James

At AIDS TREATMENT NEWS we are considering two long-term changes,
and want to share our thinking with our readers. You can send
comments to us at: aidsnews@....

First, we must change because our traditional business model has
gone away. For almost 15 years AIDS TREATMENT NEWS was supported
mainly by individual subscriptions. But today many of our
subscribers are on disability or otherwise unable to pay, so we
provide the newsletter without cost to old and new subscribers
(including over 200 prisoners). AIDS TREATMENT NEWS is not
currently set up as a non-profit, so we pay for the free
subscriptions out of pocket without funding. We do not accept
grants or contributions from pharmaceutical companies or others
whose products we might cover, although they can subscribe.

Business subscriptions now account for most of our income, which
concerns us. Today the pharmaceutical industry funds almost all
AIDS treatment publications. So far this system has worked
better than we would have expected, but that could change any
time. If the community loses its independent publications it
will be in trouble. AIDS TREATMENT NEWS must change its business
model, or slide into increasing dependence on industry.

Second, during the next year we will begin reporting primarily
online -- while still making print copies available, because
many people want or need them. Online reporting will allow us to
cover breaking news and other stories we now miss because they
are history by the time our print newsletter reaches
subscribers. Online publication will also allows us to update
articles when necessary (we plan to publish a record of the
changes).

We are considering three business models to replace the one that
no longer exists. Starting with the best, they are:

1. AIDS TREATMENT NEWS would be housed within a nonprofit, and
all online distribution would be free. The print edition would
then be self-supporting, especially if funding could be found to
pay for prisoners and others who need free copies. We might
outsource the printing and distribution to a separate
organization, so that we could focus on the reporting. We are
seeking funding for the online edition, and for those who need
free print subscriptions.

2. The second choice is to continue the current business model,
but find support for the free print subscriptions.

3. The third choice is to charge a small fee for subscriptions
online.

Selling information online has been notoriously difficult for
many who have tried it. While exploring the possibility, we
devised a radically new method (called Subscriptions to Share)
that we think could work for selling subscriptions, and also for
online fundraising. But we want to focus on AIDS, not on
developing business or fundraising methods -- and our online
newsletter should be free instead of low cost. Subscriptions to
Share remains a possibility, however. We summarized it below in
the hope that it will be useful to others.


***** Subscriptions to Share: New Way to Sell Content or Help
Fundraising Online

by John S. James

While exploring future options for AIDS TREATMENT NEWS I found a
flexible way to sell information or help raise funds online.
While AIDS TREATMENT NEWS may not use it because we want to make
our information free, I'm publishing this summary to help small
publications and other projects that might benefit. For the full
article see the Web link below.

The Need

One of the biggest obstacles to small publications today is the
difficulty of charging low prices for online content. Thousands
of people now make a living selling knick-knacks on eBay because
they can reach a global market through the Internet. But few
writers and editors can make an independent living that way
(unless they serve a high-priced, usually corporate market) --
largely because the transaction cost and inconvenience of
charging any money at all will greatly reduce readership,
probably by 90% or more. Even requiring free registration at a
Web site can seriously reduce its use.

The world would be a better place if thousands of individuals
and small organizations could make a living writing, editing, or
publishing online, charging maybe 25 or 50 cents per newsletter
issue, or per article downloaded. I believe the publishing
industry has missed opportunities to do this, because of its
obsession with preventing subscribers from sharing proprietary
information. Designing systems to encourage sharing gives a very
different perspective.

Subscriptions that Propagate

We will show how to sell subscriptions online with no
registration at all. The publisher does not need a user name,
email address, or any other contact information for subscribers.
The reason is that all subscribers can break off pieces of their
subscription and sell or donate them as totally new
subscriptions of whatever size, without the publisher's
involvement. These new subscriptions can also reproduce -- and
so on to any depth. While the publisher does not need to do
anything in this reselling or giving away of his or her
information, the publisher does get paid for it -- and can
control it, since the publisher's server keeps track of all
subscriptions and handles fulfillment.

For example, the publisher can sell one large subscription to a
public library, which can then give away hundreds of tiny
subscriptions (access to one download, or a handful of them) for
clients to use anywhere. Or an individual can buy a subscription
and offer dozens of small subscription grants, worth a few
dollars each, to anyone anywhere in the world who explains in
two or three sentences how they will use it to support a
particular cause -- bringing people together around that cause,
and putting it on the table for public discussion.

Publishers do not need to contact subscribers when articles come
out, since anyone can get notices and summaries through open
list serves.

Less obvious consequences of Subscriptions to Share include:

* A single subscription can give access to hundreds of different
publishers -- and hundreds of different charities as well,
automatically keeping tax records and printing documentation on
request.

* A subscription can sell digital tickets to fundraising or
commercial events (if the event sponsor offers the service and
the subscription owner allows it). These digital tickets (like
the subscriptions themselves) are small codes, as short as four
characters long, that can easily be written down or given over
the phone, but are almost impossible to guess. At the event they
are scanned or typed in. A single digital ticket can admit one
person or any number, whether they arrive together or
separately. If payment is through an existing subscription no
financial transfer is necessary. This means that in one minute
online you could make reservations and buy a single ticket for a
dozen people arriving in several groups, phone the code to each
group, and meet inside the theater. If someone cannot make it
you can call somebody else and give them the code -- no need to
resell any ticket, nor arrange to meet outside.

* Corporations or others that want to distribute bulk copies of
an article (either online or in print) can buy a license
automatically through the publisher's Web site, charging their
existing subscription. The server prints a permission notice to
be included with the copies -- with a coded transaction number
as proof of purchase of the license.

* Subscriptions can also be pure donations for fundraising --
not giving access to articles or tickets. This means that a
donor who could commit to raise, say, $100, could give the whole
amount to the organization immediately, and then "sell" portions
of that donation to other contributors later -- even much later.
The "owner" of any portion of the donation can confirm its
authenticity and amount at any time through the Web site that
manages the subscription.

* This donation system also means that people can contribute
more, since they have a good chance of being able to get their
money back if they ever need it in the future, by "selling"
parts or all of their donation to other donors friendly both to
them and to the cause. This kind of donation generates a gift
economy where people give money when they have it and can get it
back if they need it, keeping resources in use. Of course the
organizations get the donations free and clear.

* Using prepaid subscriptions, even small donations can easily
be given throughout the world. For example, a Web page could
show several faces, or dozens or hundreds of faces; you can move
the pointer over a face to hear that person's appeal in their
voice (and see a written translation in any of a dozen
languages), click to give 50 cents or a dollar to the cause,
click as often as you like or use a separate link for a large
donation, and hear their thank-you. Certainly these pages will
generate marketing statistics to allow successive improvement.
Legal complications should be minimal, since all money changes
hands through conventional means such as credit cards. This
system only removes paperwork from the decision process, at the
point of purchase or donation.

* A single subscription to a subscription agency can allow
payment to any number of businesses and/or charities, through
prior agreements they have with the agency. Therefore owning one
or a few subscriptions could enable someone to buy from many
publishers, or donate to many organizations, even if they never
knew of them before. (Of course the subscription owner can limit
access if he or she chooses. Needless to say, the offspring of
any subscription will share all its limits.)

* This system gives readers and donors more control of
publishers' or charities' agendas, by telling the organizations
exactly what is purchased or donated, and when.


***** How It Works

The key to this system is a code we call a "chit," typically
eight characters long. With eight characters (each a number or
letter, not case sensitive), a publisher, charity, or
subscription agency has enough combinations to issue over a
million different chits (a million subscriptions) -- and yet if
an intruder tries to guess, their chance of getting any correct
code to use is less than a million to one. (And if they do get
hold of an unauthorized code, all they can do with it is use up
the value of that subscription -- which the publisher will
probably replace free for the customer, since fulfillment cost
is usually zero.)

Each chit gives full access to its subscription; there is no
separate user name or password. A subscription may allow a
certain number of article downloads from the publisher's Web
site. For example, a $20 subscription might give 100 downloads
(20 cents each). Subscriptions could also be denominated in
currency (such as dollars or euros) instead of downloads.

The chit also gives access to the subscription's account-
management page on the publisher's site. Many subscribers will
never need to use this page. Others will use it to create and
customize new subscriptions, license bulk copies, cancel a
subscription if necessary, or for other purposes.

While the chits created by the publisher's server are typically
eight random characters, subscribers can create new
subscriptions with any new chit name they want, provided it is
not already in use by that publisher. These chits can be any
length, from just one character to thousands (both these
extremes have real uses). The subscriber can add or subtract
various powers from each newly created chit, creating customized
new subscriptions for distribution to others.

The consequences of theft of a chit are small, so people can
carry the code around and use or share it freely. The worst
possible loss is the value of the subscription -- and if that is
a concern, its owner can create a smaller subscription to carry
around or share, while keeping the master in a safe place.

This is just the beginning. Our full article shows how to reduce
harm or even gain benefit from unauthorized copies of sold
information. It introduces other concepts such as sharing chits
among teams; revocable and irrevocable subscriptions; prepaid,
renewed, and per-use subscriptions; anonymous subscriptions and
why they should cost more; expiration warnings to unknown
subscribers; marked donation-only subscriptions; syndication for
free use on Web sites; discounts and stop-loss provisions;
propagation of restrictions; free or low-cost repeat downloads
as a marketing tool; the importance of free information and open
list serves for selling content; fully digital collectables that
print limited-edition plaques for memorable or historic projects
(options include the subscription's own history, art work chosen
by its owner, and a secure autograph through public-key
cryptography); subscribing to publications, databases, causes,
or campaigns; dealing with theft; why chits have little or no
street value; creative chit names including single letters,
quotes, creeds, or entire documents; customized subscription
expiration; and subscriptions as contests, puzzles or games.

For More Information

The latest full article is at:
http://www.communicationpractices.org/subshare.html

Please send comments to me at:
subshare@...

OK to distribute this summary unchanged, through December 2003.
After December check the Web site above for the latest version.


--
John S James
AIDS Treatment News
www.aidsnews.org

AIDS TREATMENT NEWS Issue #395, October 31, 2003
     phone 800-TREAT-1-2, or 215-546-3776

CONTENTS:

** Lexiva (Fosamprenavir) Approved
The FDA approved a prodrug that becomes amprenavir in the body,
but has practical advantages over amprenavir.

** Warning Against Once-Daily Tenofovir+ddI+3TC, and "Triple
Nuke" Combinations
Another regimen consisting only of nucleoside-analog drugs has
shown unsatisfactory suppression of HIV.

** Clinton Foundation Gets Big Price Reduction -- to 40 Cents a
Day for Three-Drug Combination
The price of triple-combination antiretroviral treatment in poor
countries can now be less than 40 cents a day.

** Retroviruses Conference Reminder: Community, Press Deadlines
November 14
Anyone attending the Retroviruses conference in February as
either community scholarship or community press must apply by
the November 14 deadlines.

** Thailand International Conference Submission Deadlines
(Theme: Access for All)
Deadlines and other information on the big International AIDS
Conference in summer 2004.

** Clinical Trials Forum: World AIDS Day (December 1), Boston
Researchers and volunteers in clinical trials currently open to
persons with HIV will explain their trials, and what one should
consider when deciding whether to volunteer.

** Returning to Work After Disability: What You Should Know
A leader in the movement to help people consider returning to
work after disability looks at some of the medical,
financial/legal, vocational, and psychosocial issues involved --
and how to get help with them (interview, part 1 of 2).


***** Lexiva (Fosamprenavir)  Approved

On October 20 the U.S. Food and Drug Administration approved the
protease inhibitor Lexiva(TM) (generic name fosamprenavir, also
called 908). Lexiva is converted into amprenavir (Agenerase), a
previously approved protease inhibitor, in the body. Lexiva is
easier to take than amprenavir because of the smaller pill
burden (usually 4 pills a day including the ritonavir, vs. 16
pills a day for Agenerase), and lack of food restrictions. It
was developed by GlaxoSmithKline and Vertex Pharmaceuticals
Incorporated.

Persons taking Lexiva should review the safety and other patient
information, including dangerous interactions with certain other
drugs. Information for patients (and prescribing information for
physicians) is at http://www.lexiva.com

For More Information

For a brief review by the FDA of the pivotal clinical trials,
see:
http://www.thebody.com/fda/lexiva.html?m18
(or search for Lexiva on http://www.thebody.com)

For Glaxo's review, see:
http://www.gsk.com/press_archive/press2003/press_10212003a.htm

For an extensive review by the AIDS treatment activist
organization TAG (Treatment Action Group), supporting approval -
- but only when Lexiva is "boosted" with a low dose of ritonavir
to increase blood levels of Lexiva -- see:
http://www.aidsinfonyc.org/tag/tx/fosamprenavir.html


***** Warning Against Tenofovir+ddI+3TC, and "Triple Nuke"
Combinations

On October 14, 2003 Gilead Sciences warned health care
professionals against a using ddI plus 3TC plus tenofovir
combination, after many patients on that regimen failed to
control the virus and developed mutations to the drugs. The
"dear doctor" letter, "High Rate of Virologic Failure in
Patients with HIV Infection Treated with a Once-Daily Triple
NRTI Regimen containing Didanosine, Lamivudine, and Tenofovir"
is on the FDA Website,
http://www.fda.gov/medwatch/SAFETY/2003/viread_deardoc.pdf

The letter also cautioned against all-NRTI regimens in general,
as three other such regimens showed disappointing antiviral
results in clinical trials.


***** Clinton Foundation Gets Big Price Reduction -- to 40 Cents
a Day for Three-Drug Combination

On October 23 the Clinton Foundation HIV/AIDS Initiative
announced that four generic pharmaceutical manufacturers had
agreed to reduce prices for some African and Caribbean countries
to about $140 per year for triple-drug antiretroviral therapy --
less than 40 cents a day. The reductions were possible because
business executives volunteering with the Foundation helped
reduce raw-materials cost, in part by developing a much larger
market for the drugs in poor countries; the Foundation is also
developing funding for infrastructure. The drugs are nevirapine,
3TC, and either AZT or d4T; the combinations will be
manufactured in a single pill taken twice a day.

UNAIDS (the Joint United Nations Programme on HIV/AIDS)
applauded the announcement in an October 23 press statement, and
noted that it would help the "3x5" initiative of the World
Health Organization and UNAIDS (the effort to get treatment
access to 3,000,000 people by 2005), and the work of the Global
Fund to Fight AIDS, Tuberculosis, and Malaria.

For more information see "Clinton Program Would Help Poor
Nations Get AIDS Drugs," by Mark Schoofs, THE WALL STREET
JOURNAL, October 23, 2003, and "Clinton Group Gets Discount for
AIDS Drugs" by Lawrence Altman, THE NEW YORK TIMES, October 23.


***** Retroviruses Conference Reminder: Community, Press
Deadlines November 14

NOVEMBER 14 is the deadline for both community scholarship
applications and community newsletter press applications, for
the important 11th Conference on Retroviruses and Opportunistic
Infections (February 8-11, 2004, in San Francisco). The
scholarship information was not on the site as we went to press
on November 1.

All other press (newspapers, TV, etc.) must register by January
7; registration may close earlier if the slots fill up. No press
registration will be allowed onsite.

The "community scholarship" route is the only way for many
people with HIV to get into the conference -- even if they do
not need the money. This conference is only open to researchers
and a few others; one cannot get in just by paying admission.

Remember that after your scholarship or press application is
accepted, you will still need to complete the registration and
housing process by a later deadline.

More information can be found at:
http://www.retroconference.org


***** Thailand Conference Submission Deadlines (Theme: Access
for All)

by John S. James

The XV International AIDS Conference -- organized by the
International AIDS Society, the Thai Ministry of Public Health,
UNAIDS, and four AIDS organizations, will take place July 7-16,
2004 in Bangkok, Thailand. A recent email alert noted several
deadlines; we added some others from the conference Website to
this list. All the dates below are 2004. (One deadline, for
commercial exhibits, is December 31, 2003.)

* January 14: Abstract submission by paper forms and disk or CD
must be received (note online deadline a week later).
* January 21: Online abstract submission deadline (Online is
preferred; in case of last-minute submission, note time zones.)
* February 2: Skills-building workshop submissions due.
* February 2: Registration fee goes up.
* February 2: Scholarship applications must be received.
* February 2: NGO exhibition request deadline.
* April 1: Deadline for guaranteed hotel reservation.
* May 26: Late-breaker abstract submission (online only).

Note that there might be no onsite registration.

For complete information see the conference Web site:
http://www.ias.se/bangkok/start.aspx

Comment: Protests on Thailand

There have been protests against holding the conference in
Thailand, due to what most observers believe is the government-
sponsored killings of more than 2,000 suspected drug dealers or
users, especially in February, March, and April 2003. For more
information see "A Wave of Drug Killings is Linked to Thai
Police," NEW YORK TIMES, April 8, 2003. Other major references,
including Amnesty International and TIME MAGAZINE, can be found
by a search (for example, for "Thailand drugs killing" [without
the quotes] at http://www.google.com). Also, search Google for
"Thai Drug Users Network" (include the quotes in this search).

The major international AIDS conferences take four years to
organize, and this one would have been almost impossible to move
in the time available.

Comment: Access for All

AIDS TREATMENT NEWS proposed the theme "access for all" for
activists at the Vancouver international conference in 1996
(article is at http://www.aids.org/atn/a-248-10.html). We are
glad to see this theme today at a world AIDS conference.

The good news on HIV treatment access is that pilot programs are
now starting in many poor countries around the world,
potentially offering treatment to many people for the first
time. The challenge is finding the funding to go beyond pilot
programs. At this time most rich countries are neglecting the
global epidemic, in their focus on Iraq and on their
relationship with the only superpower.


***** Clinical Trials Forum: World AIDS Day (December 1), Boston

On World AIDS Day (December 1, 2003) Search for a Cure will hold
a free community forum on clinical trials for persons with HIV -
- including information on hepatitis and other co-infections,
nutrition, microbicides, and other related topics. People can
speak with researchers running the trials and with volunteers
currently in studies, at information tables for many trials now
open in New England. Experts will discuss what to consider when
thinking about volunteering for a trial. Search for a Cure will
distribute a manual on major HIV clinical trials in New England,
and how to find out about trials elsewhere. A free dinner is
included in this program.

Many AIDS trials are being seriously delayed because not enough
patients enroll. Search for a Cure hopes to help increase
enrollment when possible. Other organizations may want to try
similar programs in their cities.

This free consumer forum will start with dinner from 5:30 to
6:30, followed by the program from 6:30 to 8:30, December 1,
2003, at The Ballroom at Longwood Towers, 20 Chapel St. in
Brookline (across from Longwood D Line T stop). Call Search For
A Cure at 617-536-2474 for reservations, and for directions or
other information.


***** Returning to Work After Disability; What You Should Know

Interview with Eric Ciasullo, manager of the San Francisco
Department of Public Health's HIV/AIDS Return to Work
Initiative. Ciasullo is currently Chair of the Board of
Directors of the National Association of People with AIDS
(NAPWA), and was recently appointed to the California State
Rehabilitation Council.

by John S. James

Tens of thousands of people with HIV want to return to work at
least part time but are afraid of losing medical benefits, or
losing disability income and then being unable to work in the
future. Recent Federal legislation has reduced this problem, but
information, planning, and expert advice are still essential.
Many people need retraining or new skills in order to re-enter
the workforce successfully; often excellent opportunities are
available through state government rehabilitation departments,
but the HIV world has not been familiar with these services.
Others ran up huge tax, student loan, credit card, or other
debts while trying to stay alive; they may be able to
renegotiate some of these debts while they are disabled, and
should do what they can to clean up these problems before
leaving disability and returning to work.

Recently, Governor Gray Davis of California appointed AIDS
advocate Eric Ciasullo to the California State Rehabilitation
Advisory Council, which oversees the California Department of
Rehabilitation. Mr. Ciasullo has long been active in HIV
prevention, housing, and other services -- most recently in
helping people with HIV consider returning to work, and getting
any help they need to return to work successfully. He himself
has been on AIDS disability and is now working full time for the
San Francisco Department of Public Health. AIDS TREATMENT NEWS
interviewed him on October 10, 2003, in San Francisco.

In the interview Mr. Ciasullo suggested a number of resources,
most of them available on the Web. They are listed in a separate
section below. In some areas it may be difficult to find good
advice on benefits and other issues in planning for returning to
work. You might start by asking your doctor for a referral, or
asking a case manager or social worker if they could help, or
could refer you to an expert. You might check with your local
health department, especially if you do not have a case manager
already. Some questions could be answered by the National
STD/AIDS Hotline, 800-342-2437, 24 hours a day seven days a
week. This hotline also has a number for Spanish speakers, and
TTY access for the hearing impaired; TTY is 800-243-7889 Monday
through Friday 10 a.m. to 10 p.m. Eastern time.

In addition, the Social Security Administration funds
organizations in every state to assist beneficiaries in making
choices about work (see the Social Security service providers
list at the end of this article). The best benefits advisers in
an area may work out of other offices as well. Before talking
with an expert you might want to read background information --
for example, see the Web sites in the Resources section at the
end of this article.

* * *

ATN: Could you give some examples showing the kinds of issues
people face when leaving disability and returning to work?

Eric Ciasullo: Everybody's situation is so different. It is hard
to show a few representative examples, so much as dynamics that
occur across the board but to different degrees. For instance,
in San Francisco we've found that more than half of those
interested in work want to do something very different from what
they did before disability. Many people want to do work that
feels meaningful. Many of us have been recipients of social
services and want to give something back. We tend to be less
tolerant of activity that is not directed to a human bottom
line.

Because HIV disproportionately affects people based on race,
education and class, many of us were untrained or under-trained
workers. We may never have really been in the workplace, or if
we have, only as casual labor. We may have worked in what some
folks refer to as the "underground" or unregulated economy. We
may need to be trained in work that is not physical labor, or
where we will not be on our feet most of the time, because there
are still a lot of physical considerations with HIV. We may need
reasonable accommodations -- like being able to sit down, take
frequent breaks, nap in the afternoon if necessary, or take more
bathroom breaks than some of our co-workers. The more skilled we
become as workers, the more likely we are to work for employers
that are able to make these kinds of accommodations.

ATN: What about returning to work at least part time, earning
income and being able to keep medical benefits, or to go back on
disability if necessary?

Ciasullo: Recent changes in Federal law have made this easier
[see discussion in the "Financial and Legal..." section below].
But still it is very important for people considering work to
meet with some kind of benefits counselor or advisor, so that
they understand the particularities of their situation, and the
impact of work on benefits.

Disabled workers with HIV are usually on SSI or SSDI. These two
Federal programs work in completely different ways. The
incentives are totally different. The attachment to health care
is totally different. State by state access through Medicaid is
totally different. Of course, most people with HIV don't have
private disability policies, but even those policies are all
written differently. Even the earning limits that allow people
to access the AIDS Drug Assistance Program (ADAP) are different
county by county. That's why it's so important for people to get
good information and advice before they make decisions about
work.

For many of us who are concerned with helping PLWHA work through
their barriers to employment, the Kohlenberg/Goldblum
Considering Work Model is helpful in describing four overlapping
arenas that need to be addressed: Medical, Financial/Legal,
Vocational, and Psychosocial. [See the Considering Work model,
in the Resources section below.]

Medical Considerations

In the medical arena it's typical for folks to be asking, "am I
really well enough to work? What if I have to change meds, or
the meds stop working? How will the stress of working affect my
health? Will my adherence be compromised -- will I be able to
take the medications correctly and consistently? Can I manage my
meals around my meds while still working? Will I be able to
manage my other daily activities while still working? Is my
health stable enough to go back to work, and what will happen if
it changes?"

For many of us, health maintenance is a pretty careful and
delicate balancing act, and integrating self-care activities
with the demands of employment can be a formidable challenge.
That's one of the reasons why many of us encourage people to
gradually increase their activities: maybe first try creating a
sort of "shadow work" schedule of training or volunteer work,
then if they can, start working first on a part-time basis.

Financial and Legal -- New Ability to Work and Keep Federal
Benefits

In the financial and the legal arena, people are frequently very
anxious about what will happen to their financial and health
benefits if they start working, particularly if they're not able
to maintain their work efforts. Often we had to fight really
hard to get benefits, and it's natural that we'd be concerned
that even talking about work could jeopardize the essential
stability that those benefits provide. In fact, until just
recently, work activity could trigger a continuing disability
review (CDR) of your Social Security benefits. Fortunately,
that's no longer the case; the Ticket to Work and Work
Incentives Improvement Act of 1999, or TWWIIA, brought important
improvements. Some of the most prominent features of the
legislation are that a CDR cannot be triggered by work activity,
and if a CDR is actually scheduled, the fact that someone is
working cannot be used to demonstrate that they are not
disabled.

Also, there has been a significant increase in what people can
earn on the books, legally, while maintaining all of their SSDI
benefits, and/or a portion of their SSI benefits. This is why I
always emphasize that part-time employment is something that a
lot of us should really consider to improve our financial
situations, and to look for some of the social benefits that
come from working.

For people whose SSI or SSDI benefits are discontinued due to
earnings, there's a five-year period in which the process for
getting back on benefits is greatly expedited. The actual rules
are quite different for SSI and SSDI, though, so it's very
important to find out exactly how the different programs work.

But the anxiety remains -- what happens if I give up my benefits
so that I can work, then have to stop working? Some of these
concerns are inevitable given the uncertainties in our lives,
but some of them are rooted in old rules that are no longer in
place. A lot of folks still have a very limited understanding of
what the new work incentives are.

I encourage people considering work entry or re-entry,
especially if they have the freedom of some time, to take
advantage of training opportunities, to try to be patient enough
to look for a job that's going to be rewarding, one that has
private group health insurance, and if possible, to find an
employer with a private disability insurance policy. With those
things in place, the gamble you are making on your health is
that if you are able to sustain your efforts for a couple years,
should you become disabled and unable to work again, your
financial standing will be better than it was before you went
back to work. That should be part of the incentive that we're
creating for ourselves.

ATN: What about continuing Medicaid and/or Medicare, if someone
finally leaves disability and can go back to work but is unable
to get insurance through the job?

Ciasullo: Well, the rules are different. Medicaid is attached to
SSI, and Medicare is attached to SSDI. Medicare continues for
almost 8 years after SSDI benefits have ended. Medicaid is
trickier, because it involves both federal and state laws. Under
the new Federal work incentives, however, states have the option
of providing Medicaid to working people with disabilities whose
earnings are too high for them to qualify for Medicaid under
other existing rules. The intention -- and we will have to lobby
state by state -- is that if I am on SSI and went back to work,
I should be able to purchase Medicaid for an affordable price.
So if we organize around this effectively, and in this AIDS
activists really need to take the lead from our colleagues in
the cross-disability community, many of us will have a capacity
to buy into a state-sponsored plan even if we're not covered by
group health insurance policies.

Vocational Training

If we're honest with ourselves, many of us who are on disability
have energy that we could put to productive use. Most of us who
aren't desperately fighting for life right now might have some
ability to work with some of our time. Many experts believe that
work plays a vital role in maintaining our physical and mental
health, that it alleviates depression, contributes to a sense
that life has meaning, and keeps us engaged as active
participants in our communities. Maybe that work won't be paid
employment; it may start with sustained activity that benefits
other people as volunteer work or an internship, or it may be
school and training.

Even those of us who left the workforce with job-related skills
might find that the skills we had are out of date or no longer
relevant. Some of us aren't able to do the kind of work we
previously did, even if we don't need retraining for that job.
Or health and stamina, the vagaries of living with the virus,
might demand that we limit our activities to part-time
employment, or intermittent employment, or a job that is
basically sedentary.

The reality is that most of could find real benefit in taking
time for ourselves to deal with unresolved issues around basic
education, or to get trained or retrained for jobs that make
sense for our lives now.

State Departments of Rehabilitation

ATN: I was amazed at the employment help and services a friend
of mine was able to get in California. He does not have HIV but
was disabled in an automobile accident. With help from the
state, he has been able to return to work full time.

Ciasullo: He probably received services from the California
Department of Rehabilitation (DOR). Unfortunately most folks in
"AIDS World" are unfamiliar with these state agencies (called
vocational rehabilitation in some states). Before the recall,
Governor Davis named me to the State Rehabilitation Council, the
body that provides oversight to issues of policy planning and
consumer advocacy, to the state Department of Rehabilitation in
California. Federal law mandates that every state VR agency
seats such a Council, and it's an arena I'm hoping other AIDS
activists will start to explore.

In San Francisco, fully 15% of the clients that DOR serves right
now are people living with HIV who are looking to enter or re-
enter the workforce. The San Francisco District of the
Department of Rehabilitation has shown amazing leadership in
setting up services for people with HIV and doing outreach to
the AIDS community. Unfortunately, this isn't the case
nationwide -- or even statewide -- and a lot of work needs to be
done to educate folks in "AIDS World" about the kinds of
services that the state departments of rehabilitation can
provide -- and to educate these departments about the particular
needs of people with HIV.

My friend Betty Kohlenberg is a private rehab counselor who
teaches that HIV is really very distinct from other
disabilities. It affects every body system, has social
implications beyond any other disability, maintains incredible
stigma and issues of social judgment; these issues have direct
bearing on PLWHA who are interested in re-entering the
workforce.

The fact is, many rehabilitation agencies are not familiar with
our issues. There are still a lot of stereotypes and
misconceptions, and basic ignorance about the nature of HIV
disease, that need to be overcome within many public agencies.
It is still common to hear of disability counselors erroneously
assuming that workers with HIV pose certain health risks -- like
telling their clients that they cannot go back to work in the
restaurant industry because they're "contagious" -- still
operating on misconceptions from 20 years ago and not realizing
that most HIV-positive workers pose no threat to customers or
co-workers. There is still a lot of work to be done.

The benefit of state rehabilitation organizations is that
frequently, and certainly in San Francisco, people with HIV are
getting support that just cannot be found anywhere else to help
them with training, sometimes even with college or graduate
school, along with career counseling, job placement services,
and a host of vocational assessment services. Different states
are funded to different degrees and have different rules for
operating. But even in states that are fairly well funded for
vocational rehabilitation, there is still a need to bridge the
communities, and to find funding that will help give people with
HIV the tools they need to gain access to those systems, and to
provide some of the training and outreach we need for those
systems to help them understand the needs of people with HIV.

Psychosocial Issues

Even when people are medically stable, supported with legal and
benefits information, and armed with training that can make them
competitive in the workforce, there can be a host of
psychosocial barriers to employment. Often people who have been
out of the workforce for a long time are dealing with
internalized stigma around that fact alone, let alone their HIV
diagnosis. There may be significant unaddressed issues around
depression or anxiety. Because of the social isolation many of
us experience in disability, some of us might need some help re-
entering a more mainstream environment. We may need to do it in
stages.

Getting ready to enter the workforce can also de-stabilize our
social networks. Sometimes friends and family can discourage us
from taking risks associated with returning to work, or pressure
us to leave well enough alone. Sometimes friends who are also
disabled can feel threatened by our efforts to "mainstream."
These are serious issues which need to be addressed as such --
our social networks are really important to us, and sometimes
have been the "x factor" keeping us alive this long.

For some people who have been disabled with HIV, addiction or
drug abuse was an issue before the diagnosis, or became one
after the diagnosis. So changing our relationship to drugs and
alcohol can be part of the process of work re-entry. In
California, for instance, there is a widespread acceptance of
the benefits of medical marijuana, which can be particularly
helpful in dealing with some of the nausea associated with a lot
of HIV meds -- but using it habitually can create problems in
many work settings.

And for PLWHA in the gay community, the incredible epidemic of
crystal (amphetamines) can be an obstacle to employment in a
league of its own. I don't want to talk about this in simplistic
terms, and I haven't seen any research to support this, but it
strikes me that for some of us, disability can be a gateway to
addiction - and when this is the case, it needs to be addressed
head-on if folks are going to have any lasting success in their
efforts around entering or re-entering the workforce.

[Part II of this interview will include the Ticket to Work
program, handling debts before leaving disability, current
developments around returning to work, and an expanded Resources
list.]

Resources Quick List

Part II of this interview will have the full resources list.
Meanwhile, here is a list of some sites with information:
http://www.ssa.gov/work
http://www.ssa.gov/work/ServiceProviders/bpaofactsheet.html
http://www.bkohlenberg.com
http://www.phoenixrisingreentry.org/
http://www.workingpositive.net/

The following two sites focus on California as well as the U.S.:
http://www.apla.org/apla/worksvcs/workindex.html
http://www.positiveresource.org/

***** AIDS TREATMENT NEWS

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AIDS TREATMENT NEWS Issue #394, September 12, 2003
     phone 800-TREAT-1-2, or 215-546-3776

CONTENTS:

** WTO Accepts Rules Limiting Medicine Exports to Poor Countries
In a controversial decision on August 30, 2003, the World Trade
Organization agreed to complex rules limiting the export of
medications to developing countries. Reaction to the decision so
far has shown a complete disconnect between trade delegates and
the WTO, both of which praise the new rules as a humanitarian
advance, and those working in treatment access in poor
countries, who believe that they will effectively block
treatment from reaching many who need it. We have prepared a
background paper that analyzes this decision and its
implications and offers the opinions of key figures on both
sides of the debate.

It is clear that the rules were largely written for and probably
by the proprietary pharmaceutical industry, and imposed on the
countries in the WTO mainly by the United States. The basic
conflict is that this industry does not want the development of
international trade in low-cost generic copies of its patented
medicines -- not even for poor countries where little or no
market exists. Yet millions of people die each year without
medication for treatable conditions such as AIDS, and drug
pricing remains one of several major obstacles to controlling
global epidemics.

** Nevirapine Reduced Mother-to-Child Transmission Better Than
AZT -- At 70 Times Less Cost
A follow-up of a Uganda study shows that a single dose of
nevirapine to the mother in labor and a single dose to the
infant shortly after birth continues to show excellent results
when the infants reach 18 months -- despite breast feeding for
99% of the infants, and some HIV transmission that occurred as a
result.

** Treatment Interruption: Study Found Poor Result for Highly
Treated, Highly Resistant Patients
A four-month treatment interruption did not help patients who
were not controlling their virus because it had extensive
resistance to HIV drugs.

** New Guidelines for Avoiding Heart Disease by Managing High
Cholesterol, Triglycerides, or Related Problems in HIV
These guidelines, based on new heart guidelines for the general
public and including HIV-specific issues, have many useful
suggestions.


***** WTO Accepts Rules Limiting Medicine Exports to Poor
Countries

by John S. James

On August 30, 2003, a World Trade Organization (WTO) meeting in
Geneva, Switzerland adopted new rules on exporting generic
copies of patented drugs to poor countries. The WTO and some of
its trade delegates presented these rules as a grand
humanitarian solution that will now make AIDS and other
medicines more available to the poor. In fact, almost everything
in the texts was written on behalf of multinational
pharmaceutical corporations, and demanded for their benefit by
the United States and to a lesser extent by European and other
rich countries. The pharmaceutical industry, with the U.S.
government in tow, won the decision by splitting the richer from
the poorer developing countries and bringing great pressure to
bear, while most of the international-trade establishment just
wanted this issue off the table one way or another.

Organizations actually providing treatment in developing
countries fear that the new system will obstruct access, and
that poor countries that cannot manufacture their own
pharmaceuticals will be worse off in the future. Médecins sans
Frontières (Doctors Without Borders, the worldwide relief
organization that won a 1999 Nobel prize for its work) and Oxfam
(a major British famine-relief organization) said in a joint
press issued August 30, 2003, "Today's WTO agreement that is
ostensibly intended to get drugs to the poorest countries does
not provide a workable solution. [It] was designed to offer
comfort to the U.S. and the Western pharmaceutical industry....
Unfortunately, it offers little comfort for poor patients.
Global patent rules will continue to drive up the price of
medicines.... Yesterday, over twenty developing countries were
voicing concerns about the text. Today, they have come under
tremendous pressure to adopt it. However, this disappointing
outcome must not prevent countries from immediately taking
measures that are allowed under WTO patent rules in order to
access affordable medicines and save lives."

The one victory of the developing countries was the elimination
of a disease list -- which would have banned all pharmaceutical
exports of generic copies of patented drugs for any disease
except AIDS, tuberculosis, malaria, and a short list of others,
mostly tropical infections that are not commercially important
in rich countries. If the U.S. had had its way, exporting
generics of patented drugs for cancer, diabetes, asthma, and
almost all other diseases, even to the world's poorest
countries, would have been flatly prohibited. In December 2002
the U.S. alone blocked world agreement at another World Trade
Organization meeting by demanding the disease list. But
developing countries would not accept it, so the proprietary
pharmaceutical industry decided to change its strategy and rely
on other restrictions instead.

The most important fact about all pharmaceutical trade rules is
that in case of a catastrophic emergency in the U.S. or other
powerful countries, such as a major chemical or biological
attack or deadly epidemic, these countries will do whatever they
need to do, and none of the rules will be worth the paper they
are written on. But this basic assurance is not available to
developing countries, for whom over 20 million dead of AIDS does
not rise to that level of emergency. If rich and powerful
governments did not have a pass when it counts, but were truly
bound by the rules they make others obey even at the sacrifice
of lives, then the entire design and content of the rules would
be different -- a central reality known to all but usually
absent from analysis and discussion.

See our References below for links to the full text of the
August 30 agreement [1, 2], the WTO August 30 press release [3],
and to the Doha Declaration [4], a WTO agreement two years ago
that trade rules should not prevent countries from protecting
public health.

Historical Context

Most new medicines are patented for up to 20 years, and patent
holders can charge any price they want -- commonly $10,000 or
more per patient per year for HIV treatment in the United States
(up to 20 times what a generic manufacturer could charge and
still make a profit). Because they are new, all antiretrovirals
are patented in rich countries, and in most other countries
where a viable market could exist. Usually patent holders have
no incentive to market their drugs in poor countries -- but do
not want generic manufacturers or anyone else doing so, because
the example of low-cost drugs might upset their markets in rich
countries, especially the U.S. Millions died without treatment
in poor countries while the issue of treating them with patent-
protected drugs (the only ones available) was mostly kept off
the table until about four years ago.

Patent laws are national, not international, but the trade
agreement that formed the WTO demands that all countries conform
their patent laws to the European system, and include patents on
pharmaceuticals, which had not been required before 1995.
Developing countries were given until 2006 to change their
patent laws to comply fully with the new rules (recently
extended to 2016 for least-developed countries); this is why
India, for example, can manufacture and export AIDS drugs today.
(India allows patenting of a drug manufacturing process but not
of the final molecule -- a successful system to encourage
domestic industry to compete in low-cost drug production. But
India will have to change its patent laws by 2006, and then
generic exports of new medicines will no longer be allowed
except under the new rules just adopted.)

Existing WTO rules allow a country to use "compulsory licensing"
(granting the right to manufacture a patented product without
the patent-holders consent) under certain conditions -- and to
_import_ a drug under a compulsory license. But these rules also
say the drug must be manufactured primarily for domestic use --
so starting in 2006 or some time before then, there might be no
one legally able to _export_ the drug even to a country allowed
to import it. Since poor countries usually cannot pay the
patent-holder's price, and cannot make the drugs domestically,
how could their people obtain new pharmaceutical treatments?
This "export problem" has been a major trade controversy for
over two years, and was the reason for the WTO meeting of 146
countries that just adopted the new rules.

In November 2001 all countries in the WTO accepted the landmark
"Doha Declaration," which said, "We agree that the TRIPS
agreement [the WTO's intellectual property rules] does not and
should not prevent members from taking measures to protect
public health." The August 30 rules were supposed to implement
the Doha Declaration, but instead they restricted it. For
example, the 10 nations that hope to join the European Union
(mostly poor countries in Eastern Europe) "agreed that they
would only use the system as importers in situations of national
emergency or other circumstances of extreme urgency" [2] until
they join the EU -- and then that they will not import generic
versions of patented pharmaceuticals even in such an emergency.
(The countries are Czech Republic, Cyprus, Estonia, Hungary,
Latvia, Lithuania, Malta, Poland, Slovak Republic, and
Slovenia.) Pressuring these countries not to respond even to a
national emergency in order to protect profits of pharmaceutical
companies is hardly an "implementation" of the Doha Declaration
that trade rules should not prevent countries from protecting
public health.

Reactions For and Against the New WTO Export Rules

Here are some quotes that show the great differences of opinion
about the new trade rules on pharmaceuticals. Basically,
everyone says that they want to help poor countries get
treatment -- but that is where the semblance of agreement ends.

The following background will help those not familiar with this
complex issue to understand the quotes below:

* The WTO ratifies decisions by unanimous consensus of all 146-
member countries. But the actual decisions are made in small,
secret meetings set up by the U.S. and other powerful countries,
to craft agreements that they want, and may be able to get
through the whole body. Then great pressures are used to bring
everyone into line -- especially by the world's only superpower,
whose decisions affect every country in countless ways.

* In this case five countries negotiated the text that the
others had to accept or reject without change; these countries
were the U.S., Brazil, India, Kenya, and South Africa. Clearly
the U.S. had the most instruments of pressure at its disposal.
The other four countries will be able to produce many
pharmaceuticals domestically, so the lives of their citizens
were not at stake in the decision, as they are for many poor
countries. India will lose some business if the rules prove
mostly unworkable -- but its potential revenue from sales to the
poorest countries is not great, and far less than its potential
sales to the U.S. [5] (provided India stays on good terms with
the superpower). And once these four countries accepted the U.S.
demands, they were removed as potential leaders of any movement
by developing countries to get an agreement more in their
interest.

* Once a government has accepted a WTO agreement (for any
reason), it is not going to criticize it in public, no matter
what it thinks internally. Therefore official statements from
rich and poor countries alike can be expected to be supportive.
Those who work in health care in developing countries may or may
not be free to speak publicly about what they know.

* The U.S. and some international press, unfamiliar with the
background of this issue, mainly reported the WTO position,
presenting the new rules as a great humanitarian advance. But
activists working in the area see the whole point of this
agreement as stopping the development of low-cost trade among
poor countries in generic versions of medicines protected by
patents in rich countries -- sacrificing lives to protect a
dysfunctional business model that denies new medical advances to
most of the people who need them.

* Poor countries even more than rich ones had strong incentives
to get this issue out of the way before the crucial WTO meeting
beginning September 10 in Cancún, Mexico. They desperately want
reforms in other areas, especially agricultural trade rules.
Rich countries spend over $300,000,000,000 (300 billion dollars)
every year supporting their farmers [6], mostly big corporations
-- undercutting lower-cost producers in developing countries that
cannot pay such support, and keeping whole nations and
regions in poverty.

* "TRIPS" is the "Trade-Related Aspects of Intellectual Property
Rights," the part of the WTO agreement that deals with patent,
copyright, and related laws; it took effect on January 1, 1995.
Though TRIPS was designed with no thought whatever to its effect
on access to AIDS or other treatment in poor countries, it does
contain general safeguards that activists have used to argue for
access, or against worse restrictions (sometimes called "TRIPS-
plus") that the U.S. is imposing through other treaties. For
technical background on TRIPS, see:
http://www.wto.org/english/tratop_e/trips_e/trips_e.htm

* Almost all patents are held in rich countries (for reference
and discussion see BMJ (BRITISH MEDICAL JOURNAL) September 13,
2003,
http://bmj.com/cgi/content/full/327/7415/571?etoc

Therefore pharmaceutical patents bring no commercial benefit to
most poor countries but only raise the prices of drugs -- or
more likely exclude all but the elite from new medicines
entirely. Patents can help motivate research and development of
new drugs -- but only for those who can buy them at high prices.

* The August 30 agreement is temporary, to be replaced by mid
2004 with a permanent amendment to TRIPS that "will be based,
where appropriate, on this Decision" [2]. So the issue must be
revisited next year. There may be no real test of the rules by
then, however -- since legally these rules act by providing a
waiver of an existing WTO rule, and the countries that have been
exporting AIDS drugs will not need the waiver by that time. On
the other hand, a generic manufacturer in a rich country that is
already required to comply fully with TRIPS (such as Canada,
where at least one company has been interested in producing AIDS
medicines for poor countries but has been blocked by Canadian
law) might be able to use the new WTO rules now. (In this
instance, Canada would need new legislation before any of its
generic companies could try to use compulsory licenses -- and
the much richer proprietary pharmaceutical industry that largely
wrote these rules would probably oppose such amended
legislation.)

* An urgent task now and for the next year is to find
possibilities that might work under the new rules (or work
around them) to deliver treatment to poor countries, and make
sure that critical doors are not closed when the permanent TRIPS
wording is devised. The final wording might not be public until
just before the vote, but still health activists can educate the
international-trade community about what provisions are most
important for access to medical care, and why they matter.

Range of Views on the Issue

* "The two decisions that the General Council reached today --
the Motta text [1] [named for a WTO official] and the Chairman's
statement [2] -- will ensure that the system will not be abused.
The additional clarifications contained in the Chairman's
statement [The General Council Chairperson's Statement] add
strong provisions to prevent diversion, and increase the
likelihood that the solution will benefit patients in the
world's poorest countries as envisioned in the Doha Declaration.
Taken as a whole, this solution reaffirms the critical role of
patents in the development of new medicines." -- Pharmaceutical
Research and Manufacturers of America (PhRMA), August 30, 2003
press release. [IFPMA, the International Federation of
Pharmaceutical Manufacturers Associations, also released a press
statement supporting the decision.]

* Law professor and Health GAP member Brook Baker explained the
procedures that will be required under the new rules: "In order
to import medicines in a country where a drug has been patented,
the following steps must be followed: (1) the importing country
must seek a voluntary license on commercially reasonable terms
for a commercially reasonable period of time; (2) failing that
someone must apply for a compulsory license; (3) if the
compulsory license is for import, the importing country must
assess its generic industry's capacity to produce the medicine
locally; (4) if capacity is insufficient, it must notify the WTO
of its decision and explain and justify its decision re capacity
in detail; (5) the importing country must notify a potential
exporter; (6) that exporter must in turn seek a voluntary
license on commercially reasonable terms for a commercially
reasonable period of time; (7) that exporter must seek a
compulsory license from its own government on a single-country
basis; (8) compensation by royalty must be set based on
standards of reasonableness in the importing country; (9) if a
license is granted, the exporter must investigate pill size,
shape, coloring, labeling, and packaging of the patent-holder's
product in the importing country and differentiate its new
product in all respects, regardless of cost; (10) obviously, the
generic producer will need to seek product registration and
prove bio-equivalence based on a pill of different size and
shape. This process must be fulfilled over and over again for
each and every drug and for each and every country to which the
drug will be exported. This procedural nightmare may create a
cottage industry for lawyers, but it will not expedite the
delivery of affordable medicines to people dying of treatable
diseases." -- "Vows of Poverty, Shrunken Markets, Burdensome
Manufacturing and Other Nonsense at the WTO," August 28, 2003,
http://lists.essential.org/pipermail/ip-health/2003-August/005176.html

* "All people of good will and good conscience will be very
happy today with the decision that the WTO members have made.
It's especially good news for the people of Africa who
desperately need access to affordable medicine." -- Kenyan
Ambassador Amina Chawahir Mohamed, quoted in THE WASHINGTON
POST, August 31, 2003.

* "America is arm-twisting. It's a triumph for corporate greed."
-- Gitura Mwaura, chair of the Kenya Coalition for Access to Essential
Medicines, quoted by Reuters, August 28, 2003 and
published in THE NEW YORK TIMES. Another Kenyon quoted in the
same article, Gichinga Ndirangu, trade communication manager for
the Heinrich Boll Foundation in Nairobi, said "they just
outflanked the developing countries."

* "This will absolutely save millions of lives that would be
lost without it." -- Faizel Ismail, South Africa's
representative to the WTO, THE NEW YORK TIMES, August 31, 2003.

* "The sense is really that it is way too much red tape, and
that it is not a feasible solution to the problem." -- Jonathan
Berger, AIDS law project at Witwatersrand University,
Johannesburg, South Africa, quoted by Reuters, August 28, 2003.

* "We are under tremendous pressure. It's a question of whether
other countries will assent to the fact that this is as far as
the U.S. government is willing to go. The deal is on the table
and the U.S. attitude is, 'Take it or leave it.'" -- Trade
ambassador from "a large Asian country whose government had
raised concerns about the plan," THE WASHINGTON POST August 30,
2003.

* "You cannot expect every poor country in the world to produce
lifesaving drugs. There is no question that to get access, we
are going to have to allow countries to import generic drugs
from richer countries." -- Michael H. Merson, dean of the public
health school at Yale University, quoted in THE WASHINGTON POST,
August 30, 2003.

* "The solution could have been very simple and straightforward,
using a model such as the World Health Organization and other
experts have suggested. The complexities imposed by rich
countries are designed to uphold drug company monopolies and to
discourage widespread generic competition in poor countries." --
Gaelle Krikorian, Act Up-Paris, joint press release by ACT Up
Paris and Health GAP, September 11, 2003.

* "No matter how desperate the health need, a developing country
without the capacity to produce a needed drug (which is
virtually all of them) will have to ask another government to
suspend the relevant patent and license a local company to
produce and export it. Few countries, if any, will be prepared
to help other countries in this way, as it would provoke
retaliation by the US which fiercely defends the commercial
interests of the pharmaceutical corporations.

"Furthermore, the agreement is wrapped in so much red tape that
it becomes largely unworkable - it amends a clause of only 20
words, yet runs to more than seven whole pages. In practice,
most poor countries will end up paying the high price for
patented medicines or, most probably, doing without." -- Oxfam,
"WTO Patent Rules Will Still Deny Medicines to the Poor," press
statement August 27, 2003.

* "The current decision is only a temporary waiver, and a
permanent amendment to the TRIPS is scheduled for 2004. We call
upon the WTO member countries to draft an amendment to the TRIPS
that simplifies and clarifies the procedures and removes
unnecessary obstacles to the export of medicines to address
public health problems." Joint statement on TRIPS and public
health, September 10, by 14 non-government organizations in
Cancún: ACT Up Paris; Consumer Project on Technology; Consumers
International; Essential Action; European AIDS Treatment Group;
Health Action International; Health GAP; International People's
Health Council; Médecins sans Frontières; OXFAM International;
People's Health Movement; SEATINI; Third World Network; Women in
Development

* "They're playing with fire. The sensitivities of this are
obvious and we're right on the edge here." -- Jon Huenemann,
former U.S. assistant trade representative, quoted in THE WALL
STREET JOURNAL, September 5, 2003 on Brazil's plan to use
compulsory licensing to authorize government importing of three
generic drugs for HIV (efavirenz, lopinavir, and nelfinavir)
until it can make sufficient quantities domestically, unless the
patent holders will give Brazil a larger discount. Brazil now
pays 63% of its AIDS drug budget for these three alone. [For
technical reasons Brazil's plans are not directly related to the
new WTO rules; we included this quote to show the emotion around
the issue.]

In 2001 the U.S. itself threatened to use compulsory licensing
of pharmaceuticals (which it normally opposes) to import a
generic version of an antibiotic for anthrax at a lower price,
when the drug was under patent in the U.S. but not in other
countries. AIDS has killed over a million times more people than
the anthrax attacks in the U.S.

Comment

Today epidemics are more dangerous than before, due to higher
population densities and greatly increased long-distance travel.
At the same time scientific and medical advances offer more
opportunities than ever to control disease and enable people to
live longer and healthier lives. The key stumbling block is the
lack of political will to deal with illnesses that mostly affect
the poor. It is appalling that instead of responding to these
problems and opportunities, the WTO has adopted language clearly
written by industry to prevent "South-South" (poor country)
generic trade in new medicines, eliminating or greatly
restricting some of the most useful options for public health
before they even come into view.

The problem of diversion of the drugs for the poor into rich
countries (a main argument for the new rules) is mostly a
smokescreen. Diversion has been minor and easily controlled,
since the pills of all legitimate manufacturers must already
look different. But even if this issue were significant,
governments and the WTO should prioritize public health over
corporate revenue.

The biggest single obstacle to global health today is lack of
resources -- including funding, infrastructure, training, and
rational procurement and distribution systems for medicines.
Pharmaceutical patents -- and the worldwide dark cloud of
restrictions that flow from them, blocking medical research as
well as access to treatment -- may be number two or three. Both
have a common root in the lack of political will.

The central problem in AIDS is political, as it has always been.
No law of nature prevents the most powerful business and
government leaders from applying their influence and creativity
on behalf of the common good as well as private interests. A
completely different perspective is possible. If people could
organize the political and institutional will to save lives and
make systems that work for everyone, then it would not be hard
to assemble the needed resources, build medical infrastructure,
deal with stigma, trade restrictions, and other problems, and
get the global epidemics under control.

Note: Kate Krauss of AIDS Policy Project
[ http://www.aidspolicyproject.org ] contributed to this article.

References

(1) Text of "Implementation of Paragraph 6 of the Doha
Declaration on the TRIPS Agreement and Public Health" -- rules
limiting medicine exports, adopted August 30, 2003:
http://www.wto.org/english/tratop_e/trips_e/implem_para6_e.htm
(Also see reference 2, below.)

(2) Additional rules favoring pharmaceutical companies were
issued in "The General Council Chairperson's Statement," August
30, 2003:
http://www.wto.org/english/news_e/news03_e/trips_stat_28aug03_e.htm

(3) World Trade Organization press release, August 30, 2003:
http://www.wto.org/english/news_e/pres03_e/pr350_e.htm

(4) Full text of the November 2001 Doha Declaration on the TRIPS
Agreement and Public Health, November 20, 2001:
http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm

(5) THE ECONOMIST, September 6, 2003, "Indian Pharmaceuticals:
Patently Ambitious," page 56.

(6) The $300 billion figure is from THE ECONOMIST, September 6,
2003, "The Cancun Challenge," pages 59-61.


***** Nevirapine Reduced Mother-to-Child Transmission Better
Than AZT -- At 70 Times Less Cost

A single dose of nevirapine given to an HIV-positive woman
during labor, and a single dose given to her infant soon after
birth, reduced HIV transmission 41% better than AZT when the
infants were age 18 months, in a study conducted by researchers
at Makerere University in Kampala, Uganda, and at the U.S.
National Institute of Allergy and Infectious Diseases (NIAID)
[1]. About 26% of the children in the AZT group were infected by
18 months, vs. about 16% of children in the nevirapine group.
The AZT regimen consisted of one or more doses to the women
during labor, and twice-daily doses to the infants during their
first week. The simpler nevirapine treatment cost about 70 times
less than the AZT treatment.

Nevirapine did not seem to have any long-term antiviral effect.
Rather, it gave better early protection when the infants were
most vulnerable to infection. After the treatment, infants in
both groups continued to get infected at about the same rate due
to breastfeeding, which most of the women had stopped by 18
months (the average time breastfeeding was nine months).

An accompanying editorial suggested that two to three days of
AZT plus 3TC could be added to the mother's treatment to prevent
development of viral resistance to nevirapine, which can happen
when even a single dose of nevirapine is used alone. Or, much
better, the mothers could be started on combination
antiretroviral treatment [2].

About 800,000 children are infected with HIV each year through
mother-to-child transmission, and hundreds of thousands of these
cases could be prevented. Cost of the nevirapine is not the
problem. The main obstacle has been funding and implementing the
programs to use it (which usually require testing, counseling,
dealing with stigma such as violence against women who test
positive, staff training, prenatal care, and associated
infrastructure). Only about 1% of Africans now have access to
services for prevention of mother-to-child transmission of HIV,
according to a World Health Organization report issued September
1, 2003.

References

1. Jackson JB, Musoke P, Fleming T, and others. Intrapartum and
neonatal single-dose nevirapine compared with zidovudine for
prevention of mother-to-child transmission of HIV-1 in Kampala,
Uganda: 18-month follow-up of the HIVNET 012 randomized trial.
THE LANCET. September 13, 2003; issue 362, number 9387, pages
859-67. [Note: This article and the accompanying editorial below
are available free to non-subscribers at
http://www.thelancet.com -- free registration is required.]

2. Beckerman KP. Long-term findings of HIVNET 012: The next
steps. THE LANCET. September 13, 2003; pages 842-843.


***** Treatment Interruption: Study Found Poor Result for Highly
Treated, Highly Resistant Patients

by John S. James

Patients whose antiretroviral treatment was no longer working
well due to extensive drug resistance were randomly assigned to
two different groups. In one, the control group, they changed
their treatment immediately to a new antiretroviral regimen
devised by their doctor with the help of viral resistance
testing. In the other, the treatment-interruption group,
patients also changed their treatment based on resistance
testing, but first they went off all antiretrovirals for four
months. The idea was to see if the virus would partly revert to
more drug-sensitive strains during the treatment interruption,
in the hope that the drugs would work better later when they
were restarted.

The virus did tend to revert to more drug-susceptible strains in
two thirds of the treatment-interruption patients. However those
patients still did worse over all. While the two groups had the
same number of deaths (8 in each), the treatment-interruption
group had more cases of disease progression -- defined as the
first occurrence of a new AIDS-defining condition in that
patient. At just under one year, the total number of cases of
death or disease progression (the primary endpoint this study
was set up to look for) was 22 of the 138 patients in the
treatment-interruption group, vs. 12 of 132 patients in the
control group that did not interrupt treatment. Only 2% of the
patients were lost to follow-up during this time.

In this trial the treatment interruption group had a CD4 count
about 85 cells lower than the control group while treatment was
discontinued, and a viral load 1.2 logs higher (about 16 times
higher).

This study was conducted by the CPCRA -- the Terry Beirn
Community Programs for Clinical Research on AIDS. This group has
very good patient follow-up, in part because patients are
studied scientifically during the course of their regular
medical care, instead of entering into a separate clinical
trial. For example, in this study patients in both groups were
given a regimen prescribed for them by their doctor, which could
be changed if needed at any time -- instead of having a standard
regimen specified in a research protocol, which usually allows
limited changes or none unless the patient leaves the study.

Comment

Even when a patient's virus does become more drug sensitive on
the whole, plenty of resistant virus is still there. Today's
resistance tests cannot detect low levels of any particular
strain. And even if there were no viral copies, the DNA in some
of the body's infected cells still contains the information,
like a library of all viral strains the patient ever had. So
when the drugs are started up again the susceptible virus may be
suppressed better at first, but usually it does not take long
for the resistant virus to come back.

Treating patients who are already resistant to most or all
available HIV drugs remains difficult and controversial, with
trade-offs between HIV progression, new resistance development,
and drug toxicity. New drugs are being developed with different
resistance patterns, and often the question is what to do now
while waiting for enough good drugs to put together a viable
suppressive regimen.

In any case this negative result should not prejudice people
against clinical trials of other kinds of intermittent
antiretroviral treatment, with very different patients,
procedures, and goals.

References

1. Lawrence J, Mayers DL, Hullsiek KH and others. Structured
treatment interruption in patients with multidrug-resistant
human immunodeficiency virus. NEW ENGLAND JOURNAL OF MEDICINE
August 28, 2003; volume 349, number 9, pages 837-846.


***** New Guidelines for Avoiding Heart Disease by Managing High
Cholesterol, Triglycerides, or Related Problems in HIV

by John S. James

On September 1, 2003, the Infectious Disease Society of America
(IDSA) released new guidelines for treating dyslipidemia (blood
fat and some related disorders) in persons with HIV. These
guidelines were prepared by a team of clinical scientists on the
Cardiovascular Subcommittee of the AIDS Clinical Trials Group
(ACTG), who updated preliminary recommendations published in
2000. These guidelines also reflect the updated cholesterol
guidelines for the general public, which were published in 2001.
The result is an authoritative (for 2003) and practical document
filled with useful suggestions and advice. The new guidelines,
11 pages of text plus 147 references, were written mainly for
physicians.

  From the executive summary:

"We recommend that HIV-infected adults undergo evaluation and
treatment on the basis of NCEP ATP III guidelines [National
Cholesterol Education Project -- Adult Treatment Panel III] for
dyslipidemia, with particular attention to potential drug
interactions with antiretroviral agents and maintenance of
virologic control of HIV infection. When drugs become necessary,
we recommend as initial therapy pravastatin or atorvastatin for
elevated low-density lipoprotein cholesterol levels and
gemfibrozil or fenofibrate when triglyceride concentrations
exceed 500 mg/dL."

Basically these guidelines apply the NCEP standards for reducing
cardiovascular [heart and blood-vessel] disease risk for the
general public, to people with HIV. There are a number of HIV-
specific considerations, for example avoiding interactions of
lipid-lowering drugs with antiretrovirals. Perhaps even more
than in the general population, lifestyle changes such as diet
and exercise (and of course quitting smoking) are recommended
before lipid-lowering drugs, except in urgent cases.

The new guidelines review the following topics:
* Evidence that certain antiretrovirals cause more lipid
problems than others;
* Possibilities of switching antiretrovirals;
* Studies of the risk of cardiovascular disease in persons with
HIV, using the NCEP to help decide about lifestyle changes and
lipid-lowering drugs;
* Therapeutic use of niacin to help correct cholesterol levels,
or fish oils to reduce triglycerides, which may be tried in some
cases;
* When to refer a patient to an expert in treating dyslipidemia
in persons with HIV;
* Drug interactions, including certain lipid-lowering drugs to
avoid because they can interact dangerously with
antiretrovirals.

The guidelines were published in CLINICAL INFECTIOUS DISEASES,
September 1, pages 613-627. They are also available at the Web
site of NATAP, the National AIDS Treatment Advocacy Project,
http://www.natap.org/2003/sept/Guidelines.htm


***** AIDS TREATMENT NEWS

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AIDS Treatment News
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AIDS TREATMENT NEWS Issue #393, July 25, 2003
     phone 800-TREAT-1-2, or 215-546-3776

CONTENTS:

** Failure of Combination Abacavir + Tenofovir + Lamivudine
(3TC)
An antiretroviral combination worked much less well than
expected in controlling HIV. Patients using all three of these
drugs together should talk with their doctor and consider
changing treatment.

** FTC (Emtriva) Approved
A new antiretroviral was approved July 2 -- the 19th now
approved in the U.S. It is chemically related to 3TC.

** New HIV Treatment Guidelines Give More Advice
New U.S. treatment guidelines give doctors and patients more
guidance -- especially on what antiretrovirals to start with.
Advice on when to start has not changed. While the new
guidelines are more useful than previous editions, it remains
critically important to have a physician with extensive
experience in treating HIV.

** HIV Drugs Approved as of August 2003
Here is a list of the 19 antiretrovirals currently approved in
the U.S., listed alphabetically by generic name within each of
the four drug classes. Brand names and other common names are
also included.

** Major HIV Treatment Conference in Paris -- Finding Reports
Online
Several Web sites have excellent coverage of the 2nd IAS
(International AIDS Society) Conference on HIV Pathogenesis and
Treatment, July 13-16 in Paris. Usually readers can look through
a list of titles and click to read the reports important to
them. We also comment on how software advances could greatly
improve medical conferences over the next several years.

** Nelson Mandela on Treatment Access
"If we discard the people who are dying from AIDS, then we can
no longer call ourselves decent people."



***** Failure of Combination Abacavir + Tenofovir + Lamivudine
(3TC)

In late July 2003 GlaxoSmithKline warned physicians that a
three-drug combination of lamivudine (Epivir(R)), abacavir
(Ziagen(R)) and tenofovir (Viread(TM)) had failed to control HIV
effectively in about half the treatment-naive patients in a
clinical trial. The cause of the reduced response to this
particular regimen is not known, but it may involve mutations
causing cross-resistance to the drugs; Glaxo is also checking
for chemical interactions inside the cell. The problem is not
due to any one of the drugs; rather, for some reason this
particular combination turned out not to work well.

The company advised:

"Abacavir and lamivudine in combination with tenofovir should
not be used as a triple antiretroviral therapy when considering
a new treatment regimen for naive or pre-treated patients;

"Any patient currently controlled on therapy with this
combination should be closely monitored and considered for
modification of therapy; and

"Any usage of this triple combination with other antiretroviral
agents should be closely monitored for signs of treatment
failure."


***** FTC (Emtriva) Approved

by John S. James

The U.S. FDA announced the approval of FTC (brand name
Emtriva(TM), generic name emtricitabine, former brand name
Coviracil(TM)) on July 2, 2003.

FTC is chemically related to 3TC. It was approved primarily on
the basis of two clinical trials: one comparing FTC with d4T,
and the other comparing it with 3TC. FTC is taken once per day
with or without food. Special dosing is needed for patients with
kidney problems.

Shortly before approval, a clinical trial comparing FTC and d4T
was stopped early by its Data Safety Monitoring Board (a
somewhat unusual occurrence) because the patients in that trial
who were randomly assigned to FTC were clearly doing better than
those randomly assigned to d4T. (Note that all patients in this
trial were also taking ddI [Videx(R)] and efavirenz
[Sustiva(R)]; combining d4T and ddI is no longer recommended
because of side effects, a problem that probably contributed to
the superiority of FTC in this study.)

European approval is likely by late 2003.

FTC was approved mainly on the basis of two trials: the
comparison with d4T above, and a trial in which patients who
were on treatment including 3TC were randomly assigned to either
stay on their current regimen or switch the 3TC to FTC. The
patients in both groups did comparably well. Four percent of
those on FTC discontinued it due to adverse events, vs. none who
stayed on 3TC -- but this difference is hard to interpret since
those who could not tolerate 3TC would have stopped that
treatment earlier and could never have entered this particular
trial.

FTC has had a long development history involving several
companies, but now will be marketed worldwide by Gilead
Sciences, Inc. (The drug has been shown to be active against HIV
clades A, C, D, E, F, and G, --as well as against clade B, which
causes almost all AIDS cases in the U.S.) In the U.S., Gilead
announced that the "wholesaler acquisition cost" is $252.83 for
a bottle of 30 capsules, a one-month supply.

The FDA's announcement noted that FTC has only been approved for
adults age 18 and over, as pediatric safety and effectiveness
have not been established. It suggested using resistance testing
with pre-treated patients to check that their virus is likely to
be susceptible to FTC (the mutations M184V or M184I are the most
common cause of viral resistance to FTC). It noted that about 1%
of patients in clinical studies overall have discontinued FTC
due to adverse events. It also recommended that all patients be
tested for the presence of chronic hepatitis B virus before
starting antiretroviral treatment for HIV, and that patients co-
infected with hepatitis B be closely monitored for at least
several months after FTC is discontinued, as there have been
hepatitis B flare-ups when treatment is stopped. As with all
members of this drug class (nucleoside reverse transcriptase
inhibitors), the prescribing information carries a black-box
warning about risk of lactic acidosis and liver toxicity.

The new HIV treatment guidelines (see article in this issue) did
not consider FTC, because it was approved after the guidelines
had been developed. FTC will be discussed in the next version.

Comment

As with any new drug, FTC's place in clinical practice will
develop over time. This antiretroviral may have important
advantages, but other treatments are much better known. Our
guess is that many physicians will be conservative at first, but
will use FTC as more is learned about long-term safety and
effectiveness, and about which patients are most likely to
benefit.


***** New HIV Treatment Guidelines Give More Advice

by John S. James

New HIV treatment guidelines for adults and adolescents,
developed by a panel of experts convened by the U.S. Department
of Human Services, were published July 14, 2003. This standard
differs from previous editions in giving more direction to
physicians, especially in choosing specific drugs. You can
download this and other guidelines documents at
http://AIDSinfo.nih.gov -- click Guidelines, then Adult  and
Adolescent Guidelines.

Advice on *when* to start antiretrovirals has not changed. But
instead of the previous system (pick one drug from column A and
two from column B), the new guidelines recommend choosing one of
basically two preferred regimens, with alternates available if
needed. There is also more guidance for doctors on how to deal
with drug failure and choosing a new regimen.

Much of the useful information is contained in the 29 tables at
the end of the 96-page document.

Comment

Guidelines are never the final word in a complicated, fast-
changing, and controversial area of medicine. It is still
critically important to have the advice of a physician with
extensive experience in treating HIV.


***** HIV Drugs Approved as of August 2003

Here are all the antiretroviral drugs approved in the U.S. at
the end of July 2003. We list them by drug class:

* NRTIs (nucleoside reverse transcriptase inhibitor) target
reverse transcriptase (an enzyme of HIV), by providing false
building blocks that the enzyme puts into new copies of the
virus it is building. Occasionally the false building blocks can
be incorporated into human DNA, causing toxicity.

* NNRTIs (non-nucleoside reverse transcriptase inhibitor) target
the same reverse transcriptase enzyme, but do not provide false
building blocks.

* Protease inhibitors target HIV protease, an enzyme necessary
for late steps in the formation of new copies of HIV. Some
protease inhibitors may inhibit certain human proteases as well,
causing toxicity.

* Fusion inhibitors block infection early by preventing HIV from
fusing with and entering a human cell. Only one fusion inhibitor
has been approved so far, and this particular drug is expensive
to manufacture and difficult to use.

None of these drugs can be taken alone to treat an established
HIV infection. They must be used in well-designed combination
regimens.

NRTIs:
Abacavir (Ziagen)
Didanosine - ddI (Videx)
Emtricitabine - FTC (Emtriva -- previous brand name Coviracil)
Lamivudine - 3TC (Epivir)
Stavudine - d4T (Zerit)
Tenofovir DF (Viread)
Zalcitabine - ddC (Hivid,)
Zidovudine - AZT (Retrovir)

NNRTIs
Delavirdine (Rescriptor)
Efavirenz (Sustiva, brand name Stocrin in many countries)
Nevirapine (Viramune)

PROTEASE INHIBITORS:
Amprenavir (Agenerase)
Atazanavir (Reyataz, formerly named Zrivada)
Indinavir (Crixivan)
Lopinavir+ritonavir (Kaletra)
Nelfinavir (Viracept)
Ritonavir (Norvir)
Saquinavir (Fortovase, earlier formulation Invirase)

FUSION INHIBITORS
Enfuvirtide (Fuzeon)

Combination Medications

These brand names are combinations of two or three of the
medicines above in one pill. Combinations reduce the number of
pills patients must take each day. They can also help meet
requirements of health plans that limit the number of
"prescriptions" per month regardless of medical need.
Combivir (AZT + 3TC)
Trizivir (abacavir + AZT + 3TC)


***** Major HIV Treatment Conference in Paris -- Finding Reports
Online

by John S. James

Here are some of the best Web sites for information about the
2nd IAS (International AIDS Society) Conference on HIV
Pathogenesis and Treatment, July 13-16 in Paris. On these sites
you can scan headlines and titles, then click on the articles
you want to read. Keep in mind that new information from the
Paris conference is being added all the time on these sites and
elsewhere -- and that over the next several months much of the
information from this conference will become less current, as
newer findings are reported.

Notes:

(1) If a Web link in this article does not work, the site may
have been reorganized. In that case go to the home page (usually
the first part of the Web address, through the .com or .org) and
look for the IAS (International AIDS Society) conference reports
from there.

(2) It is best to read or skim through all the titles on the Web
pages shown below. If there are many titles, a shortcut is to
use the search (find) command in your browser. But this browser
search will miss relevant articles if the titles do not happen
to use the same words you specify.

** Best Organized Site: Clinical Care Options,
http://clinicaloptions.com/go/ias2003

This site, written primarily for medical professionals, may
become the best Web presentation, and perhaps the most useful
coverage of this conference overall.

Its IAS conference coverage is organized as seven tracks:
* Daily news
* First-line antiretroviral therapy
* Antiretroviral resistance & salvage therapy
* Clinical implications of studies of HIV pathogenesis
* Pharmacology & adverse effects of therapy
* Metabolic complications and lipodystrophy
* Opportunistic infections and coinfections

The daily news stories include protease inhibitors and
cardiovascular disease, sex differences in fat redistribution
(including noting that lipoatrophy is much more common in people
with HIV than had been expected), new T-20 information, high
drug resistance in newly diagnosed people with HIV in Europe,
and a number of reports on particular protease inhibitors and
other antiretrovirals.

The other six sections include over 50 "capsule summaries" that
present major clinical trials or other important conference
presentations in a standardized table format. (For example, in
the "Metabolic Complications and Lipodystrophy" track, the
capsule summary on cardiovascular disease in a large cohort
receiving antiretroviral therapy has outline-type presentations
divided into these categories: Summary and key conclusions;
Background; Summary of study design; Baseline characteristics of
study population; and Main findings. Other capsule summaries can
have different section titles, and narrative is allowed when
needed.) This kind of presentation may seem strange at first,
but we found it effective for presenting key information
quickly. In August, Clinical Care Options expects to add
analysis of the same information by three experts in each of the
six areas covered in these tracks -- hopefully building on the
capsule summaries, and providing more scrutiny and debate on the
clinical implications than a single author's comments.

You need to register on the site to read the articles -- a free,
one-time process that takes five to ten minutes. Most Web
browsers can keep track of your user name and password, avoiding
the need to log on every time you use the site.

** Quick Summaries for Patients: The Body,
http://www.thebody.com/confs/ias2003/complete.html

This page has titles and links to more than 50 short reports,
divided into 25 topic areas (as of July 25, 2003). Readers can
scan the titles, or search for a particular word in any of the
titles, using the search function provided by most browsers. For
example, we searched for "lipoatrophy" (which means fat wasting
-- lipoatrophy can cause a sunken-face appearance, and often means that
one's antiretroviral regimen needs to be changed). We
found a topic area with five reports on lipoatrophy, and an
additional report outside that topic area.

Some of the other topic areas involve:
* Drug resistance
* Antiretroviral therapy
* Complications of antiretroviral therapy
* Clinical trial results

While The Body is designed for patients, the IAS conference was
held for medical professionals; some medical terms are
unavoidable. If you want to search for a drug, the generic name
is usually the best -- although you might want to try other
names as well. For example, Fuzeon (the brand name of the drug
also known as T-20) appears in a title as the generic name,
enfuvirtide. More importantly, be aware that different research
can be confusing and contradictory, and some will be found to be
wrong. Science is normally that way near the leading edge; only
in schoolbooks are there usually clear lines between right and
wrong ideas.

** Reports for physicians: Medscape,
http://www.medscape.com/viewprogram/2536

The Medscape HIV site reviews important late-breaker
presentations (results too late to be submitted for regular
consideration for the conference, but allowed in by a special
procedure because of their value and timeliness). Late breaker
session #1 includes the high rate of resistance found in Europe
that was widely reported in the general press, the failure of
week-on-week-off antiretroviral treatment, and the very
important study showing that HIV transmission by breastfeeding
could be prevented by treating the infant with either 3TC or
nevirapine. Late breaker session #2 included a Canadian study on
factors associated with resistance development (chiefly high
viral load -- and intermediate adherence between 60% and 90%),
good results from atazanavir in avoiding metabolic toxicities,
and promising results from two new drugs active against many
resistant viruses --SPD754, a nucleoside analog, and TMC114, a
protease inhibitor.

Outside the late breakers, some of the reports currently on the
site include:
* Treatment access initiatives in developing countries;
* 48-week data for enfuvirtide (Fuzeon, T-20);
* Update on treatment interruption (15 abstracts were presented
at the conference);
* Viral dynamics and fitness;
* Drug resistance update;
* New approaches to antiretroviral therapy;
* Complications of antiretroviral therapy;

Note: this site requires free registration. Also, early news
reports now on the site may be replaced later by CME (continuing
medical information) modules.

** NATAP,
http://www.natap.org/2003/IAS/ndxIAS.htm

The National AIDS Treatment Advocacy Project now has more than
15 articles, on subjects including antiretroviral regimens, drug
resistance, hepatitis C treatment, human growth hormone, and
methadone interactions.

** HIVandHepatitis.com,
http://www.hivandhepatitis.com/2003icr/2ndias/main.html

This site has over 40 articles on clinical trials, new
experimental antiretrovirals, viral resistance, dosing,
complications of antiretroviral therapy (over 15 articles),
salvage therapy, pharmacology, drug supply, treatment
interruption, preventing transmission, immune reconstitution,
and vaccines.

** IAPAC AIDScan,
http://www.iapac.org

The International Association of Physicians in AIDS Care
published the daily newsletter AIDScan on the four days of the
conference, with short articles on over a dozen major topics.

** Kaiser -- Video Webcasts, and Transcripts,
http://www.kiasernetwork.org/paris2003

This site has video "webcasts" and also transcripts of selected
sessions. But there are serious limitations:
* The slides, central to most of the presentations, are not
available.
* Only a small fraction of the talks have webcasts or
transcripts -- mostly the large, general lectures and debates
with important background information, but little new data (as
that might be proprietary).
* The video images are often poor quality -- and the transcripts
include many errors, so they must be read cautiously. (The
alternative would have been major delays, if all the speakers in
each session had to edit and return the transcripts of their
remarks before the session could go online.)

** Official IAS Conference Site,
http://www.ias2003.org/

The conference abstracts -- given to participants as a book, and
also as a CDROM -- are not online as of the end of July, but are
expected to be on this site in a few weeks. The Final Programme
-- a 3-megabyte PDF file of the 350-page program book given to
participants -- is currently available (except that the Late
Breakers section has been omitted).

** Official IAS Site,
http://www.ias.se/

This is the official site of the International AIDS Society
organization (as opposed to the official site for the Paris
conference of this organization). It has a 26-page article by
AIDS writer Mark Mascolini on clinical studies at the 2nd IAS
Conference on HIV Pathogenesis and Treatment.

[Also note Mark's review of a different conference, the XII
International HIV Drug Resistance Workshop, June 10-14, 2003 in
Los Cabos, Mexico. The links to both articles are currently on
the IAS home page, http://www.ias.se/ ]


Comment on Webcast and Future Conference Technology

The Present: For now we have found that the best way to present
conference information for those who were not in the meeting is
through expert reviews, like those on most of the sites
mentioned above. When webcasts are used, they should show good-
quality reproduction of the speaker's slides, not poor-quality
video of the speaker. Often  the talks are useless without the
slides.

Many conferences provide abstracts online before the meeting,
but this one did not. When people travel from around the world
to spend a few days together, they need to study and plan in
advance so they can best use their time for meeting and working
with others. Not having the abstracts ahead of time hurts
participants, as well as those who need the information but were
not at the conference.

Some of the Web sites and articles above could be better
organized and written, to avoid unnecessary difficulties for
readers.

The Future: We believe the next big improvement will be speakers
creating presentations designed primarily for viewing online.
These will allow flexible arrangements of charts, animated
charts, sound, text, and video -- and allow interactive pathways
through the material if desired, including intelligent searches
based on authors' marks or annotations. Templates will allow
easy learning and setup for simple presentations, such as a
series of slides with a recorded voice lecture for each.

Then anyone could view the presentation in its original quality
at any time, either before, during, or after the meeting, and
from anywhere in the world. At the conference, speakers could
take a few minutes to explain an abbreviated view of their
presentation, then open the session to discussion; listeners
could take few notes because they would know they could review
the full information any time, and search for exactly what they
needed. Audience comments and/or group decisions could be added
to the permanent online record if the author desired. These
presentation modules would replace the abstract, slides,
pointer, lecture, webcast, transcript, and more, all in perfect
technical quality.

Then conferences could shift focus from hundreds of people
sitting in auditoriums for lectures, to working groups that come
together to build relationships and get things done. And the
other six billion people who could not get to the meeting could
still participate in that work.


***** Nelson Mandela on Treatment Access

"The world must do more, much more on every front in the fight
against AIDS. Of course, it means dramatically expanding our
prevention efforts, but the most striking inequity is our
failure to provide the lifesaving treatment to the millions of
people who need it most. The single most important step we must
now take is to provide access to treatment throughout the
developing world. There is no excuse for delay. We must start
now. If we discard the people who are dying from AIDS, then we
can no longer call ourselves decent people."

Nelson Mandela, July 15, 2003, at the International AIDS Society
conference in Paris -- quoted by Stephen Lewis, United Nations
Special Envoy on HIV/AIDS in Africa, speaking in Durban, South
Africa, August 3.


***** AIDS TREATMENT NEWS

Published twice monthly

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   1233 Locust St., 5th floor
   Philadelphia, PA 19107
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AIDS Treatment News
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AIDS TREATMENT NEWS Issue #392, June 27, 2003
     phone 800-TREAT-1-2, or 215-546-3776

CONTENTS

** Major Scientific AIDS Conference, Paris July 13-16; Reports
Online
Scientists will present results of basic medical research and of
HIV drug clinical trials at the International AIDS Society
conference in Paris in mid July.

** New Protease Inhibitor Atazanavir (Reyataz(TM)) Approved
A new protease inhibitor has much less effect than others in
raising blood levels of cholesterol and triglycerides, probably
reducing some health risks -- but early data suggests that this
benefit may not translate into reduced lipodystrophy. There are
other side effects, and doctors and patients will need to be
especially careful about drug interactions.

** Federal AIDS Policy Emergencies
Federal policy problems and changes urgently need attention.
Here we note some of what is happening in Social Security
disability, ADAP, Medicaid, Medicare, prevention, and basic
biomedical research.

** AIDS, Computers, and Organizing: Part I, Toward a Revolution
in Fundraising?
(A Report from the Planetwork Conference)
This month I attended Planetwork, a three-day meeting in San
Francisco on new online tools for social organizing, to improve
civil society and allow people around the world to work together
for common projects and goals. Over 100 presenters told of many
important experiments and a few spectacular successes -- mostly
unknown in the AIDS world today. These advances will change how
we live and work, and AIDS activists and organizations will
benefit by knowing about them and taking a lead in exploring how
to use this work to help solve problems we face. This article is
the first of three reports on these developments that AIDS
TREATMENT NEWS will publish over the next few months.


***** Major Scientific AIDS Conference, Paris July 13-16;
Reports Online

The 2nd IAS Conference on HIV Pathogenesis and Treatment will
take place July 13-16, 2003, in Paris. This conference is
organized by the International AIDS Society (IAS), which also
puts on the International AIDS Conference, which happens in
even-numbered years (the next one will be near Bangkok,
Thailand, in July 2004).

The Paris conference has been called "THE international forum
that brings together scientists and clinical researchers working
on HIV/AIDS from both the developed and developing world,
forging alliances to jointly address the most pressing issues in
the combat against this global emergency" (quote from Professor
Joep Lange, chairman of the International AIDS Society). [Note:
the International AIDS Society should not be confused with the
International AIDS Society-USA, an unrelated organization.]

The final program of the Paris conference was posted June 30 at
http://www.ias2003.org/ . The 360-page document (a 3 megabyte
file) can be searched on your computer for a keyword or phrase,
such as a medical term, drug name, or presenter's name.

Two official Internet providers for the conference are noted on
page 15 of the program:

* Kaisernetwork.org will provide Webcasts of the plenary talks
and some of the other major sessions. You can find them at:
http://www.kaisernetwork.org/paris2003
or through the IAS Web site above.

* Medscape will provide conference coverage and continuing
medical education programs based on this conference. See:
http://www.medscape.com/hiv . Note: free registration is
required.

On June 30 Medscape said its coverage will include "daily news
and expert commentary; an executive summary of the conference
that will be published within one week of the conference's
close; and a series of approximately 15 topical reviews, which
will be available to physicians for continuing medical education
credit, that will be published within 3 weeks following the
meeting. Slide kits and slide-based presentations of selected
conference sessions will also be published on Medscape at that
time."


***** New Protease Inhibitor Atazanavir (Reyataz(TM)) Approved

On June 20 the FDA approved the new once-a-day protease
inhibitor atazanavir (brand name Reyataz), manufactured by
Bristol-Myers Squibb. Atazanavir has little effect on the blood
lipids cholesterol and triglycerides, and on May 13 the FDA's
advisory committee of outside experts had unanimously
recommended approval (see AIDS TREATMENT NEWS #391, May 30,
2003). Atazanavir can be taken as two pills once daily with
food. In patients who have already had extensive HIV treatment,
atazanavir may need to be "boosted" with a low dose of ritonavir
(Norvir(R)) to maintain atazanavir blood levels (a reduced dose
of atazanavir is recommended in this case; see Web site below to
check current information). As with all other current
antiretrovirals, atazanavir must be used as part of a
combination regimen.

The advisory committee had some concern that the FDA was not be
able to review all the data on treatment-experienced patients
before the legal deadline for drug approval.

On June 20 Bristol-Myers Squibb, the manufacturer of atazanavir,
issued a press release including the following cautions:

"Do not take REYATAZ if you are taking the following medicines:
ergot derivatives, Versed(R), Halcion(R), Orap(R), Propulsid(R),
Camptosar(R), Vascor(R), Crixivan(R), Mevacor(R), Zocor(R),
Rifampin, St. John's wort, AcipHex(R), Nexium(R), Prevacid(R),
Prilosec(R) or Protonix(R). [Not a complete list -- JSJ] Do not
use Viagra(R) while you are taking REYATAZ without first
speaking with your healthcare provider. Discuss all
prescription, non-prescription and herbal products you are
taking or plan to take with your healthcare provider.

"Increases in indirect bilirubin (bilirubin is made by the
liver) have been reported in patients taking REYATAZ. This may
result in yellowing of the skin and/or eyes. These symptoms
usually go away after you stop taking REYATAZ.

"Changes in the way your heart beats may occur when taking
REYATAZ. If you get dizzy or lightheaded these could be symptoms
of a heart problem. An increase of lactic acid in the blood
(lactic acidosis), which can cause death, has been reported in
patients taking REYATAZ with other anti-HIV medicines called
nucleoside analogues. In some patients taking protease
inhibitors, increased bleeding (in patients with hemophilia),
diabetes and high blood sugar have occurred. If you have liver
disease, including hepatitis B or C, your liver disease may get
worse when you take anti-HIV medicines like REYATAZ."

For a current copy of the atazanavir "labeling" (information for
doctors), see the full prescribing information at
http://www.reyataz.com/ . Always use a current copy of the
prescribing information, especially for a newly approved drug,
since it will change as new information becomes available.


***** Federal AIDS Policy Emergencies

by Kate Krauss and John S. James

Members of ACT UP Philadelphia have begun to track the numerous
federal cutbacks and policy changes affecting U.S. AIDS services
and are assembling a list in a single document. Crucial programs
such as Social Security disability, ADAP, Medicare, HIV
prevention, and biomedical research are all currently under
fire.

We are preparing lists of organizations that publish quality
action alerts on these issues, and would appreciate
recommendations.

ADAP (AIDS Drug Assistance Program)

Fifteen states including New York have instituted waiting lists
or other access restrictions; six others are expected to
implement restrictions soon. Activists estimate that at least
12,000 people with HIV who need this program cannot access it
this year -- in many instances this means that people who need
HIV treatment will not be getting it at all. Unless Congress
passes an emergency-spending bill for the ADAP, the situation
will only grow worse until March 31, 2005. See AIDS Treatment
Data Network for more information http://ATDN.org/

New Social Security Disability Definition: Public Comments
Deadline July 8

The definition of who is "disabled" due to HIV infection was
last revised in 1993, and is being updated to reflect modern
treatment. You can see the proposed definition (and submit
public comments) by visiting:
http://www.ssa.gov/disability/newrules_immunesystemdisorders.htm
You can also read comments already submitted by others.

[Note: If this link does not work, try visiting
http://ssas.com , then click on Connect Board, then click on
Listings, then scroll down to Immune System listings.]

Lambda Legal has asked doctors and lawyers experienced with
HIV to sign on to its 18-page letter to the Social Security
Administration; others can refer to this letter in their public
comments (refer to the "HIV-Legal Joint Comments"). The letter
suggests changes to the proposed new rules, for example to
give examiners guidance on the side effects of medications,
to not require certain laboratory tests no longer commonly used,
to accurately reflect the consequences of co-infection with
hepatitis C, to tell examiners that lifestyle and adherence are
not necessarily to blame if an antiretroviral regimen fails, to
include CNS lymphoma in the lymphoma listings, to include herpes
zoster, CD4 count under 100, and several other conditions, and
to acknowledge that treatment now exists for several
opportunistic conditions that were untreatable in 1993, so they
should be considered disabling only if treatment fails. For more
information contact attorney Hayley Gorenberg at Lambda Legal,
212-809-8585 or hgorenberg (at) lambdalegal.org

We have heard from others that the disability revision is a
legitimate effort to update the rules for modern conditions --
but raises broader concerns. One problem is that government works
through lists of diagnoses, and tries to save money. But what we
most hear from individuals is that they can work either part
time or full time, but do not know how long that will continue.
They need to be able to go back to work without losing their
benefits, and then being destitute and without medical care if
they lose their job.

Another problem is that the new rules may give officials many
more occasions to call people in for hearings that can revoke
their benefits. Such procedures have been abused in the past to
remove people who are clearly disabled, just to save money.
Also, a large increase in hearings and revocations would
complicate financial and medical planning, which can be very
difficult already.

Medicaid

Medicaid provides healthcare, including prescription drugs, for
low-income, elderly, and disabled people including about 260,000
people with AIDS. The largest federally funded healthcare
program for people with AIDS, it is also typically the second
largest state budget item after education. But the depressed
U.S. economy has reduced tax revenues and many states are
running huge deficits.

In response, dozens of states are attempting to save money by
lowering the maximum personal income allowed for eligibility,
dropping hundreds of thousands of "optionals" (people who meet
slightly relaxed eligibility requirements) from Medicaid rolls,
reducing access to prescription drugs, and eliminating access to
nursing home care and other services. In Texas, for example,
disabled patients cannot earn more than $552 per month to
qualify for the program. In South Carolina, the governor is
planning to reduce the maximum number of prescriptions per month
from 4 to 3. In California, the governor attempted to de-fund
hospice care this year until aggressive public policy advocacy
by the hospice community restored the money. Many states have
instituted highly restrictive Medicaid drug formularies,
effectively putting expensive drugs out of reach for many people
with AIDS.

Advocates succeeded in pushing Congress to disburse $10 million
directly to Medicaid through a temporary increase in the Federal
Medical Assistance Percentage, but that is a small part of the
shortfall.

In addition, President Bush is aggressively advocating for a
plan that would limit federal contributions to the program
regardless of a state's costs. Such a plan would encourage
states to further reduce benefits and establish obstacles to
patient care in the interests of cost containment. A state-by-
state list of Medicaid cuts is available from TIICANN at 202-
588-1775, or by emailing Tom McCormack: tomxix@....
Families USA has information on both Medicaid and Medicare,
http://www.familiesusa.org/

Medicare

Medicare provides health care (but not prescription medications)
for many people with AIDS. Prescription coverage plans that have
been approved by Congress will not be fully implemented until
2006 and will require recipients to spend $3,500 (in the House
version) to $3700 (in the Senate version) out of pocket before
catastrophic coverage kicks in (either 90% in the Senate version
or 100% in the House version). (People with incomes of $60,000
or higher would have to pay more out of pocket before
catastrophic coverage takes effect.) U.S. drug regimen costs for
people with AIDS start at about $10,000 and can total $30,000 or
more per year. In states where the AIDS Drug Assistance Program
is weak and patients do not also qualify for Medicaid, these
costs will mean that people with AIDS cannot afford their
medications. A compromise between the House and Senate versions
of the bill is expected to be reached in conference committee
later this summer.

Families USA offers important updates on Medicare:
http://www.familiesusa.org/ . The Kaiser Family Foundation also
has an important information source on Medicare:
http://www.kff.org

Prevention

The U.S. Centers for Disease Control (CDC) instituted far-
reaching changes to its prevention policy and funding priorities
in April 2003 in an effort to remove barriers to testing and
care. Programs to test more people, get those who are HIV-
positive into treatment and care, and help them prevent
transmission to others are widely supported.

Unfortunately the CDC will greatly reduce or discontinue funding
support groups, safe sex workshops, and other programs to help
those who are high risk and HIV-negative protect themselves.
Organizations that provide primary prevention, including many
groups that target people of color, will get much less funding
under this plan.

The CDC now promotes widespread, routine testing in doctors'
offices, prisons, and among pregnant women -- but will no longer
promote specialized counseling for those who are tested. And
while this testing will find more people who test positive, the
agency has not allocated more money for counseling and care.

The CDC has also changed its practices under pressure from
conservative critics who do not like gay-friendly AIDS
organizations. Last fall, the CDC audited several groups that
participated in a protest against HHS Secretary Tommy Thompson
at the 2002 Barcelona International AIDS Conference. The CDC
cited federal funding of the groups to justify the audits, but
many activists saw them as retribution for the protest. New
York's Gay Men's Health Crisis and the African Services
Committee were among those audited.

The CDC is also cracking down on AIDS organizations that use
sexually explicit materials, and on June 13, 2003 sent a letter
to San Francisco's 19-year-old Stop AIDS Project accusing the
group of breaking a federal law that prevents federally-funded
organizations from encouraging or promoting sexual activity.
Ironically, the organization had recently passed audits (also a
result of pressure from right-wing conservatives) by the Office
of the Inspector General and the CDC. The audits determined that
Stop AIDS programs were adequately supervised by the San
Francisco Health Department and were in keeping with community
standards.

Conservatives are also influencing scientific research at the
CDC: research grant applicants are now discouraged from using
standard terms to describe the populations and behaviors they
plan to study (men who have sex with men, anal sex, etc.).

Serious Cut in Basic Biomedical Research

In a last-moment bureaucratic move, the Bush Administration's
Office of Management and the Budget (OMB) ordered the National
Institute of Allergy and Infectious Diseases (NIAID) to spend
$233 million on a bulk purchase of anthrax vaccine. The result
is that over $200 million must be taken away from basic research
in HIV, other infectious diseases, and immunology. Congress had
not appropriated funds for the vaccine purchase, apparently
because it thought that this money should not come from the
NIAID research budget but from other government channels, and
the Administration had not requested the money in those budgets.

Even without the diversion, only about 25% of NIAID grants
judged scientifically worthy would have been funded. With $233
million taken out, only 18% will be funded. No one knows ahead
of time which of the projects may turn out to be critically
important.

The pharmaceutical industry does very little basic medical
research because of lack of commercial incentive. Instead, it
relies on the Federal government to fund researchers at
universities and other institutions. As a result, the studies
rejected due to the diversion of funds will be delayed or not
done.

NATURE, considered by many to be the world's most prestigious
scientific journal, called this case "a prime example of how
centralized control could undercut the NIH's mission of
protecting the health of the United States and the world"
("Biodefence Takes Its Toll," NATURE, June 5, 2003, issue #423).


***** AIDS, Computers, and Organizing: Part I, Toward a
Revolution in Fundraising?
(A Report from the Planetwork Conference)

by John S. James

Recently I attended Planetwork, a three-day conference in San
Francisco on new ways of using computers and online technology
to help people work together for a better future(1). Some new
communication and organizing tools, many available now, could
make a big difference in AIDS and health. I have a background in
computers and was the only AIDS writer there, and will report to
the community on some of this new work, and why it is important
for us.

Over 300 people, some from as far as London, heard 100
presenters, many of them well-known leaders in the computer
industry, in three parallel meeting tracks. The conference was
supported by registration fees and by industry partnerships,
mostly with small technology companies.

This article will look at software for extending existing social
networks, as a way to help people around the world work together
on common goals and projects -- even when some of them have no
computer, email, or Web access.

Online Social Networks -- and Fundraising

A key theme of the conference was establishing trusted
communication online, to assist existing networks of friends and
colleagues who already work together and trust each other. A
semi-official "white paper" for the conference ("The Augmented
Social Network: Building Identity and Trust into the Next
Generation Internet") explored some of these ideas(2). "Trust" in
this case refers to personal judgment, especially knowing
someone and having confidence that you can recommend him or
her to associates for a working relationship -- not to computer
security against technical attacks. [And it does not at all refer
to the so-called "trusted computing" concept, a major project
of Microsoft and others to encrypt every email and document in
your computer so that government and corporations can control
what you do with it. For more information on that effort see John
Markoff, "A Safer System for Home PC's Feels Like Jail to Some
Critics," NEW YORK TIMES June 30, 2003; or see Richard Stallman,
"Can You Trust Your Computer,"
http://www.gnu.org/philosophy/can-you-trust.html ]

To show what augmented social networks could mean for AIDS, here
is a fundraising scenario we expect to be happening within a few
years. The software required either exists today or could easily
be written. What will take time is for people to learn about
this possibility and start using it together.

For this example we will take a hard problem -- raising money
for local AIDS and health clinics and other grassroots projects
in developing countries. But the same tools could work for many
purposes.

It is well known that small amounts of money can save lives or
otherwise make a big difference in poor countries (see the new
documentary film, A CLOSER WALK, http://www.acloserwalk.org/).
Today almost all money donated goes through governments, big
nonprofits or churches, or other large organizations. For some
projects this is the best or only way to proceed. But many
people would be more willing to give directly through a personal
connection. (We suspect that these two kinds of giving will be
more synergistic than competitive -- that if donors had good
ways to give directly they would become more personally
involved, leading to more political will to support government,
nonprofit, and church programs, rather than less.)

The problem today is that the people and personal networks who
can donate are far away, both geographically and socially, from
the people and personal networks where their money could do the
most good. Most potential donors living in the U.S., for
example, do not know anyone in any developing country --
especially in remote villages where many of the people live, and
where a little money could often go farthest. And most donors
today do not personally know who is really doing the most
important work, but must rely on public relations and carefully
crafted images, which they know very well are unreliable --
discouraging commitment and contributions. On the other side,
those who have the first-hand knowledge usually have no good way
to reach many donors and establish credibility.

How could computers help? Imagine that a few years in the
future, you hear that $25 could save a life in poor areas
through health care or famine relief (as is the case today).
Perhaps you want to make a small contribution directly to an
organization or person on the scene -- for example, a local
group somewhere in Africa that is doing superb work but may not
be part of any big charity or international organization. You
want to contribute based on the personal recommendation of
someone you trust. Usually there are people you trust -- but
none of them are at the scene, so they cannot help you directly.

So instead of making dozens of phone calls to try to find a
chain of recommendations that reaches from your personal network
into villages in Africa, you go to a social-network Web site
where basically anyone in the field (global AIDS or health in
this case) could publish a profile for themselves -- including a
list of people or groups they recommend.

For example, since you are reading this newsletter, perhaps you
trust me. I do not know who in poor countries could best use
your contribution -- but I do know well-regarded doctors,
activists, and others who work or volunteer there, whose
judgment and recommendations I trust. Perhaps none of them know
what is really happening on the ground in a particular area, but
they are closer than you or I, and will know people closer
still.

Health activists and professionals who work regularly in
developing countries could create a profile of themselves on a
social-network Web site for international AIDS, or international
health. Their profile would include a list individuals and
organizations that they recommend as doing good work -- and who
could also put their own profiles on the site, where they list
others they recommend. Those listed need not have access to
computers, nor speak English or whatever language is used on the
site, because their colleagues who want to recommend them and
help raise funds could work with them to prepare and submit
their profiles. These profiles might include specific projects
that need doing, with a budget for each.

At the simplest level, the way social-networking programs work
is that you can click a link on anyone's profile to see their
network of friends or trusted colleagues. Then you can click on
any of those profiles to see that person's network, etc. Just
with this much, you could start with one person or several
people you trust, then check through the networks partly by
trial and error to get closer to the kind of project you are
looking for -- either geographically (Africa, for example), or
by other categories. But software tools (discussed below) could
greatly help.

Networks of personal recommendation have always been important
in almost every human activity. But usually it is difficult in
personal networks to go through a chain of more than two or
three referrals -- especially across international borders, time
zones, and language barriers, or into regions that have no
telephones, computers, or other modern communication. Even when
communication is possible it is not feasible to make dozens of
phone calls in different languages to explore social networks
and establish a trusted chain of referrals, all for the sake of
perhaps a $25 contribution.

But with a social-network Web site, potential donors or anyone
else can explore these personal and professional networks
whenever they want -- without necessarily setting up their own
profile or making any other arrangements in advance. They can
start by finding one or more people they trust who have profiles
on the site, and then look for chains of trusted referrals to
projects they want to support.

I would guess that in a specialized area like global AIDS, the
average length of the shortest personal-referral chain from, for
example, an interested U.S. citizen to a clinic or other project
in a village in Africa, would be less than the proverbial "six
degrees of separation," but more than the two or so degrees that
can comfortably be managed informally. The first time a
potential donor uses this system, he or she might spend an
evening exploring the links through these social and
professional circles, looking at perhaps several dozen of the
thousands of profiles on the site, to find one or more chains of
perhaps three, four, or five connections that work for them --
ending with an organization or individual they want to help.
Since part of the work of setting up the Web site would be to
provide a way that funds could be transferred legally,
inexpensively, and conveniently, with a few keystrokes the
donation could be done. Each recipient organization, individual,
or agency would have a way to be notified that the contribution
had arrived and credit was available; that would be part of
their profile. They would also be able to contact and thank the
donor and tell how their contribution was used, unless the donor
asked not to be identified publicly.

Advantages to Consider

* In AIDS we already have networks built on personal trust and
long-time working relationships, and these function well. But we
need better ways to connect the separated networks, so that they
can coordinate better when appropriate. Social-network software
-- especially databases of personal and professional recommendations,
within a given field or for a particular
purpose -- could support larger projects and activities, without
the problems of a centralized, top-down command structure (which
has not worked well in AIDS).

* Speakers at the Planetwork conference were quite familiar with
academic studies of social networks, at Stanford University and
elsewhere. One of the findings has been that important benefits
like learning about a new job are more likely to come from loose
social connections (for example, an acquaintance of a friend)
than from tight connections (being part of the same corporation,
school, or other social structure). Social-network software
extends these loose connections.

* Software tools can help in searching the network for a
credible chain of recommendations. For example, a potential
donor could list any number of profiles of people or
organizations they trust, as a starting point -- and also list
any number of potential recipients, as a goal -- and ask the
system to find any connections automatically. They could also
specify potential recipients either geographically (all
organizations in Africa, for example), or by kind of mission
(such as caring for orphans), or both -- and then find the
chains of trusted links and list them by strength of the
connection. Searches could also specify keywords, names, or
subject areas in the profiles. The software could also show who
throughout the whole database recommends a particular project or
organization. Other tools could allow users to click to see a
visual picture of the whole social-network database, showing how
much it is a unified network vs. a collection of separate groups
-- and if the latter, then who are the crucial links between the
groups. Potential donors could use their choice of such software
tools, or just follow links one by one to find groups they want
to support.

* Potential recipients (and others in the database) can speak
any language, and do not need to have access to computers --
since those who are recommending them will be motivated to help
them enter their project description and other profile
information.

* The profiles could belong to individuals or to organizations
interchangeably (in that the system handles them the same in
either case, although potential donors can specify one or the
other in their data searches or views). Profiles could also
belong to other entities, including software robots (computer
programs that do things you might expect a person to be doing) -
- perhaps created by the database administrators to make the
system work better. For example, a robot's profile could look
like a person's profile, but change every day to reflect
reputations or other information in the entire database --
perhaps in order to direct users to hot topics, special
opportunities, and other time-sensitive information. Robots
might also help donors combine to fund larger projects than any
one of them could handle individually.

* A number of social-networking Web sites already exist,
providing proof of concept. One often mentioned at the
Planetwork conference was Friendster
(http://www.friendster.com), which connects people for dating or
making new friends through their existing social networks,
unlike the usual matching services that connect strangers. Any
such system needs a critical mass, and Friendster is now taking
off on the East Coast of the U.S.

* Participants in social-networking software are not interrupted
when their referral network is traversed; they do not have to
answer a phone call or email. This makes possible much more
exploration of existing referral network. Donors deciding how to
use their money can look through hundreds of person-to-person
links, instead of only a few.

* All the information on these sites is public and voluntarily
given. Anyone who creates a profile can choose what they want to
reveal about themselves. At the same time, social-network sites
have strong pressures for honesty and accuracy, since peoples'
friends and colleagues are on the same site, and can see how one
presents oneself.

* Some churches raise money through public donations, in which
members of the congregation parade near the collection basket in
front of the group, and everybody can see what is dropped in.
Other churches provide envelopes so that members can donate
privately. The online referral database offers both
possibilities, and can allow each donor to choose whether or not
to make their donations public -- which I think will be the
prevailing system.

* A fundraising site could be useful for connecting people even
if they do not want to donate. Such visitors should be welcomed,
as they increase traffic and general usefulness of the site --
and might change their mind and donate after all. In addition,
it would be costly to police the site to keep out those who do
not intend contribute, since the whole idea is to allow donors
to explore possibilities, without any guarantee of finding a
match that speaks to them.

* Donation guided by online exploration of networks of personal
trust, relationship, and recommendation could become widely
popular. There are many successful models and precedents for
online activities that involve other people -- either in one's
own social network, for games or discussion among strangers, and
for activism in issues important to society in general. Here is
a way to combine these kinds of interpersonal activity online --
and participate meaningfully in donation decisions, with the
help of the best personalized expert guidance anywhere.

* This kind of social-network software could help in many areas
outside of fundraising -- for example, in improving elections of
political candidates. Already, probably most voters decide whom
to vote for mainly through personal recommendations. But today
the chain of personal referrals, if traced back, is likely to be
found to originate in television ads or other crafted
manipulation (you may have noticed that news reports are most
informative about what is really going on just after the
election, when they can tell the truth because it no longer
matters). Online referral networks could improve the political
process by providing more people with trusted connections to a
variety of experts -- who, unlike political advertisements, do
not always have pre-established positions they are paid to
support regardless of the facts. Another political use would be
to help people judge the credibility of action alerts, even from
organizations they do not know -- providing a much larger
potential base for public mobilization and response to the most
important alerts.

* A down side of referral networks is that recommendations can
be traded -- you scratch my back and I scratch yours -- or even
sold. This kind of activity, which can span the range from
normal social process to corruption, can occur wherever personal
referrals are used. For example, several decades ago scientific
papers started being rated by how many future papers referenced
them; collusion quickly developed and was quickly recognized,
but is still with us today.

In the referral database, one way to reduce this problem would
be to have rating agencies, companies in the business of
investigating claims and publishing relevant findings, good or
bad, on the database. They would not need to audit everyone, but
might check those who are most important on the database, for
example those who can change large flows of money. Rating
agencies could also help with the "transitivity" problem: if A
recommends B and B recommends C and C recommends D -- with all
the recommendations within the same professional context and
purpose -- then to what extent can those who trust A's
recommendations also trust D's? (If enough money depends on
answer -- for example, if A is a celebrity and D is a widely
respected expert at a critical scene -- then an independent
agency might investigate and provide its findings on how well
fans of A know what they are getting with D.) Donors could
follow or ignore these agencies' reports as they wish. [Note: I
added the idea of rating agencies, which I not hear at the
conference. Many presenters mentioned online reputation,
however.]

Interestingly, the four kinds of entities on the database that
have been discussed so far -- individuals, organizations,
robots, and rating agencies -- all use the same format, a
profile of the individual, with an unlimited number of referrals
to others. The software need not even distinguish between these
different entities. (There is at least one other kind of entity -
- imaginary characters that could represent factions, themes
like reconciliation, or abstract themes that may be nameless --
or could serve to bring separated social networks together.
These fictitious people are also handled by the database exactly
like real people. Such characters have developed, totally
unplanned, in existing social-network software, and can become
among the most popular "persons" in the system -- showing the
need for this kind of device.)

Note: How to Be Useful

One of the most useful presentations at the Planetwork
conference was "The Multiple Dimensions of Emergent Media," by
Mark Graham, a computer conferencing pioneer who founded
Peacenet and was president of Whole Earth Media, in addition to
many other credentials. His talk referred listeners to over 30
Web sites of new-media tools and experiments(3). He also
suggested some guidelines for successful projects in this field
-- guidelines not just for technology, but for effectiveness and
building constituency in whatever one does:

* Think big but keep it simple;

* Solve problems, don't invent solutions;

* Do your homework -- know what has been done before;

* Connect with and learn from others;

* Be true to your vision;

* Focus on deliverables and keep it real.

Ultimately the purpose of technology is people. The point of the
fundraising scenario outlined above is to make possible a
personal connection between people who have very different
lives, and who otherwise would not have a trusted channel
between them. With such channels available, donors can make
better decisions, and are more likely to become personally
involved.

Next: Blogs (Web logs) and their software tools, Moveon.org,
online communities, RSS and news aggregation, instant uploading
and publication of photos from camera-equipped cell phones,
online video editing, advanced Google techniques, and more.

References

(1) PLANETWORK: Networking a Sustainable Future, conference June
6-8, 2003, at the Presidio in San Francisco,
http://www.planetwork.net

(2) THE AUGMENTED SOCIAL NETWORK: BUILDING IDENTITY AND TRUST
INTO THE NEXT GENERATION INTERNET. For a 2-page abstract and a
link to the full 77-page paper, click "WHITE PAPER" on
http://www.planetwork.net

(3) Links mentioned in Mark Graham's talk are at:

http://mark.path.net/planetwork


***** AIDS TREATMENT NEWS

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Editor and Publisher: John S. James
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 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
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--
John S. James
AIDS Treatment News
www.aidsnews.org

AIDS TREATMENT NEWS Issue #391, May 30, 2003
     phone 800-TREAT-1-2, or 215-546-3776

Contents

** Bush Signs Global AIDS Bill
The new bill for global AIDS relief authorizes up to $15 billion
for treatment and prevention over the next five years. We show
where to find the full text of the bill -- and publish a brief
comment by Congresswoman Nancy Pelosi.

** HIV Nutrition Papers Published
Dozens of experts and five government agencies prepared this
collection of articles for physicians on how to incorporate
nutrition into HIV medical practice.

** Atazanavir Background Documents Available
If you want lots of background information about atazanavir
(Reyataz(TM)), a protease inhibitor likely to be approved soon,
you can find it on the FDA Web site.

** First Clinical Care Options for Hepatitis, June 19-22
For years the Clinical Care Options for HIV conference has
brought together about 300 front-line HIV doctors to hear from
leading experts and discuss treatment of patients. This year for
the first time a similar meeting will be held on viral
hepatitis.

** Surprising Causes of Death in Texas Hospital Study: Safety
Net Questions
Pneumocystis is still one of the leading causes of death of
people with HIV in at least some parts of the U.S. Such
statistics can show where medical care access is working and
where it is not.

** Glaxo Drug Discovery and Development Research Grants
(Including Microbicides); Deadline July 31
Grants up to $150,000 will be awarded for innovative research
ideas.

** Africa: Problems Getting Antiretrovirals for Trials
Many trials on how to best provide treatment in developing
countries are on hold because nobody will donate or pay for the
drugs.

** Funding Alert: Wake Up and Support WORLD
As governments cut back, the AIDS community must fund
information and advocacy or lose control of its future. We need
activists who can be credible with both service providers and
donors, and serve as diplomats between them.

** Huge Price Variations in Generic Drugs
Huge, secret price variations create huge profits for the well
connected, raising prices for patients and the public. One drug
with an "average wholesale price" of $2.66 per pill was actually
sold to pharmacies for 5 cents per pill.

** Philadelphia: June is AIDS Education Month
We include a short program and a Web link for full information.


***** Bush Signs Global AIDS Bill

On May 27 President Bush signed legislation passed by both
houses of Congress authorizing up to $15 billion in funding over
the next five years for global AIDS, tuberculosis, and malaria
treatment and prevention for 12 African and two Caribbean
countries. The money must still be appropriated -- usually the
more difficult step in Congress. But authorization is an
important start, and the U.S. is expected to use it to lobby for
more commitment from other major governments at the G-8 summit
(Group of Eight nations), June 1-3 in Evian, France.

You can read the full text of this legislation at the Web site
of the Library of Congress, http://thomas.loc.gov. There you can
search for the bill number, H.R.1298. The latest version is the
current one.

Congresswoman Nancy Pelosi of San Francisco, the House
Democratic Leader and the most informed member of Congress on
AIDS, commented briefly on both the strengths and weaknesses of
this bill in a speech on May 21 (Extensions of Remarks, May 23):

* Ms. PELOSI. Mr. Speaker, I rise in strong support of H.R.
1298, The United States Leadership Against HIV/AIDS,
Tuberculosis and Malaria Act of 2003. The statistics on AIDS are
staggering. According to the United Nations, AIDS has killed
over 20 million people since the epidemic began. Every day
nearly 14,000 people become infected with HIV, primarily in the
developing world and another 8,500 people die.

* It's almost too much to comprehend, but we can respond. And we
must. Experts say that a strong global response could prevent
nearly two-thirds of the 45 million new infections that are
projected by 2020, saving tens of millions of lives.

* This legislation will strengthen our response to the global
AIDS pandemic by improving coordination among relevant U.S.
agencies, establishing additional accountability mechanisms, and
fostering international cooperation through increased
contributions to the multilateral Global Fund to Combat
HIV/AIDS, Tuberculosis, and Malaria. The increased contribution
of up to $1 billion for the Global Fund in FY2004 is accompanied
by a 33 percent cap on the U.S. contribution to challenge other
donor countries to match our increased commitment.

* The promises made in H.R. 1298, however, must be matched by
real resources. Planning and coordination alone will not solve
this monumental crisis. Prevention and treatment require money.
This is a good first step, now we must appropriate the funds
necessary to enact this plan and demonstrate the depth of our
commitment to the world.

* H.R. 1298 authorizes $15 billion for our multilateral and
bilateral efforts, including $3 billion in FY2004.
Unfortunately, the Bush budget provides only $1.6 billion in
FY2004, with only $200 million going to the Global Fund. We must
do better.

* I also have deep reservations about the provision that gives
abstinence programs a third of USAID's prevention funding. This
crisis is too severe and our response is too critical to let our
efforts be undermined by catering to ideological pressure.

* The fight against AIDS is far from over, and this legislation
provides an important opportunity to strengthen our commitment
to a future where AIDS is no longer a threat. I urge my
colleagues to support the motion to concur.


***** HIV Nutrition Papers Published

More than 50 medical experts and five U.S. government agencies
worked together to produce a series of papers on integrating
nutrition with HIV medicine.1 These papers, addressed mainly to
medical professionals, review "general nutritional management,
evaluation and intervention for wasting, insulin resistance, fat
redistribution, dyslipidemia, lactic acidosis, food safety, and
bone abnormalities" (from the introduction). They summarize
nutrition doctors should know about when treating HIV disease.

The titles of the articles are:
* Introduction: Integrating Nutrition Therapy into Medical
Management of Human Immunodeficiency Virus (introduction by John
G. Bartlett)
* General Nutrition Management in Patients Infected with Human
Immunodeficiency Virus
* Assessment of Nutritional Status, Body Composition, and Human
Immunodeficiency Virus-Associated Morphologic Changes
* Weight Loss and Wasting in Patients Infected with Human
Immunodeficiency Virus
* Lipid Abnormalities
* Body Habitus Changes Related to Lipodystrophy
* Insulin and Carbohydrate Dysregulation
* Lactic Acidemia in Infection with Human Immunodeficiency Virus
* Emerging Bone Problems in Patients Infected with Human
Immunodeficiency Virus
* Food and Water Safety for Persons Infected with Human
Immunodeficiency Virus

References

Integrating nutrition therapy into medical management of human
immunodeficiency virus (series of articles). CLINICAL INFECTIOUS
DISEASES. April 1, 2003; vol. 36, supplement 2. The articles are
available to the public at:
http://www.journals.uchicago.edu/CID/journal/contents/v36nS2.html


***** Atazanavir Background Documents Available

Atazanavir (brand name Reyataz(TM)) is a new protease inhibitor
developed by Bristol-Myers Squibb that is likely to be approved
soon. A May 13, 2003 hearing of the FDA's Antiviral Drugs
Advisory Committee decided that the drug has been proven safe
and effective, and recommended approval.

Atazanavir, taken once per day, caused much less cholesterol and
triglyceride problems than the other protease inhibitors with
which it has been compared; however, this improvement did not
seem to translate to less lipodystrophy, in the limited data now
available. Atazanavir may need to be "boosted" with a small dose
of ritonavir in order to be most effective with experienced
patients. And some drug interactions will need to be watched
carefully to prevent excessive blood levels of atazanavir, which
could cause potentially serious changes in heart rhythm.

For much more extensive information on atazanavir see the two
documents prepared for the May 13 hearing -- one by the FDA
staff, the other by Bristol-Myers Squibb. They are at:
http://www.fda.gov/ohrms/dockets/ac/03/briefing/3950b1.htm

Remember that this information was current as of May 2003, and
will become obsolete as new data become available.


***** First Clinical Care Options for Hepatitis, June 19-22

For 13 years the Clinical Care Options for HIV Symposium has
brought together about 300 front-line HIV doctors for an annual
meeting on treating HIV. This year the sponsor, iMedOptions, is
beginning a similar meeting on viral hepatitis. The First Annual
Clinical Care Options for Hepatitis Symposium, for "experienced,
front-line, primary care physicians, gastroenterologists and
infectious disease specialists involved in the care of patients
with viral hepatitis" will be held June 19-22, 2003, in Laguna
Niguel, California.

For more information visit
http://imedoptions.com/hep2003
or phone 800-878-6260.


***** Surprising Causes of Death in Texas Hospital Study: Safety
Net Questions

by John S. James

A study of the changing causes of death of people with HIV at
Parkland Memorial Hospital, a major hospital in Dallas, Texas,
found that pneumocystis (also called PCP) is still a major cause
of death. And more than half of those with HIV who died of all
causes in the study period of 1999-2000 were *not* receiving
modern antiretroviral treatment. During this period pneumocystis
caused 17% of the deaths, end-stage liver disease 13%, and non-
Hodgkin lymphoma 7%. Bacterial pneumonia not considered HIV
associated, sepsis, and other non-AIDS-defining infections
caused 18% of the deaths, and a group of conditions considered
probably immunodeficiency related caused 9%. In a comparison
period in 1995, before modern antiretroviral treatment (HAART)
was available, more of the deaths were from AIDS-related
conditions. But end-stage liver disease caused 10% of the deaths
in the earlier period, showing that it is not a new problem.

There was a large decrease in deaths of HIV-infected persons
overall -- from 119 deaths in 1995 to 44 in 1999 and 47 in 2000.

Comment

It is often hard to draw conclusions from statistical
comparisons of deaths, because the numbers can depend on many
factors (like hospital admissions policies) not related to
medical care. But the fact that pneumocystis remains the leading
cause of death of people with HIV, at one major hospital at
least, raises questions about how well the safety net has been
working.

There has long been a widespread assumption that almost anyone
in the U.S. can get HIV treatment one way or another. We do not
know how much this is true. Perhaps the belief persists because
those who cannot get treatment also cannot get to public
attention.

Pneumocystis prophylaxis costs very little, and failure to use
it is not due to the expense of the drugs. In this study many
patients were not on prophylaxis because their HIV was not
diagnosed -- suggesting lack of medical care, due either to lack
of access or to the patients' decisions.

Adherence to HAART was a problem, with 39% (18 patients) of
those who died in 1999-2000 without HAART listed as not
receiving HAART because they were not adherent -- and 26% not
receiving HAART because they were diagnosed shortly before
death. We know from general experience that many adherence
problems result from difficulty in obtaining a continuing supply
of medicine -- including inflexible reimbursement rules that may
make it difficult to replace lost medicines, or that leave too
short a window to refill a prescription when patients have many
other balls in the air. Physicians may not know whether non-
adherence is due to economic obstacles.

Parkland Memorial Hospital is well regarded and accepts patients
on an ability-to-pay basis. But Texas has long been seen as one
of the worst states for access to HIV care (though improving
now, due to grassroots organizing).

Cause-of-death studies can give us unique information about how
well the medical safety net is working or not working. This one
suggests that access to care may be less than generally
believed, even before the funding crisis that is developing now.

References

Jain MK, Skiest DJ, Cloud JW, Jain CL, Burns D, and Berggren RE.
Changes in mortality related to human immunodeficiency virus
infection: Comparative analysis of inpatient deaths in 1995 and
in 1999-2000. CLINICAL INFECTIOUS DISEASES. April 15, 2003;
number 36, pages 1030-1038.


***** Glaxo Drug Discovery and Development Research Grants
(Including Microbicides); Deadline July 31

GlaxoSmithKline will award research grants from $25,000 to
$150,000 ($500,000 total) "for innovative HIV/AIDS drug research
in recognition of the need to produce new alternatives and hope
in the fight against the HIV/AIDS pandemic." These grants "are
intended to further the development of inventive treatments for
HIV/AIDS, including: therapies aimed at treating infection;
prophylactic vaccines; or microbicides designed to prevent
transmission of the virus." Applications will be judged by a
panel of outside experts; recipients will be announced at the
ICAAC conference in September 2003; and the grants will be paid
by November 1. There is no obligation to license resulting
technologies to Glaxo.

For more information and application forms, visit
http://www.dddresearchgrant.com or call 888-527-6935.


***** Africa: Problems Getting Antiretrovirals for Trials

Researchers are having continuing difficulties getting the drugs
for trials of antiretrovirals in developing countries. Writer
Jon Cohen outlined the problem in an article in the current
SCIENCE magazine (May 26, 2003).

The U.S. National Institutes of Health conducts some drug trials
in developing countries -- but will not pay for the drugs, which
are normally donated by the manufacturer for U.S. trials leading
to drug approval. But generally the drugs used in these
developing-country trials have already been approved in the
U.S., and companies have little incentive to donate them for
these trials, which usually focus on operations research on how
to best deliver treatment in developing countries. And for
ethical reasons the U.S. insists that patients be offered
continued treatment after the trial -- a disincentive for the
manufacturers or anyone else to provide drugs. For various
reasons the researchers often cannot or do not want to use
lower-cost generic versions of the drugs.

Cohen quotes well-known AIDS researcher Bruce Walker, whose
study in South Africa has been delayed for a year:

"Right now, there are plenty of groups like ours that are ready
to treat people, and we can't get drugs... The absurdity of the
situation is that 95% of HIV infections exist in countries where
you have minimal experience giving the drugs...

"We're letting a lot of people die because we're saying [you
must treat] forever. We have plenty of people who were dying who
are now alive because they're on therapy. People would rather be
alive and faced with having to figure out what they're going to
do in three years than be dead."

Comment

These problems would never be tolerated if it were killing
people in the U.S. and Europe instead of mostly in Africa.

In recent years a few activists have successfully demanded that
the ethical standards that evolved in developed countries be
applied without flexibility to research everywhere -- a policy
some Africans called ethical imperialism. Now the consequences -
- sometimes no research at all -- are here.

The consensus that researchers must offer continued treatment
after a trial evolved in the context of testing experimental
drugs -- on volunteers who took the risk of unknown side effects
or of a drug that did not work, and had no control over whether
they received the experimental drug or were randomly assigned to
something else. The company hoping to benefit commercially from
the research was expected to offer continued treatment to these
volunteers either until the drug was approved (so patients could
buy it if it helped them), or dropped from development (usually
because the drug did not work or was unsafe). To morph this
ethical standard onto operations research in developing
countries -- with drugs already known to work and approved for
routine use, with no pharmaceutical company standing to benefit,
with no time limit on how long the researchers must plan to
finance the drugs after the trial, and with much lower cost
generics becoming available for continued treatment but not to
the researchers -- is an absurdity never imagined when the
consensus for continuing access to treatment developed.

The world must not stand by and let critically important
research be halted because companies and governments evade
responsibility, or because of the unthinking misuse of well-
intentioned ideas.


***** Funding Alert: Wake Up and Support WORLD

by John S. James

People with HIV in the U.S. face a growing emergency as Federal
policy starves human services during an economic downturn, and
essential medical care becomes less available to most people who
need it. Since almost no one can afford antiretroviral treatment
entirely out of pocket, and private insurance has found ways of
avoiding or dumping patients who become seriously ill, public
programs have become a last resort. Now these programs are under
the worst financial threat ever. People are already being denied
treatment for AIDS and other diseases who until recently could
have obtained it, and the crisis will get worse. Communities
must think carefully about what they can do to protect
themselves. Some facts are clear:

* Private charity can never pay for most peoples' medications at
$10,000 or more per person per year, in addition to other
medical care and expenses of patients unable to work full time.

* But private funding is crucial for medical information to help
people take care of themselves, and for advocacy toward workable
policies so that people can receive the medical care they need.
The goal is not necessarily to get government to pay, but to
bring public and private institutions together for responsible
solutions to the growing lack of healthcare access in this
country. Government funds usually cannot be used for advocacy,
so without private support it will not be done.

* Pharmaceutical company funding of community organizations has
made possible important work. But it would be a serious mistake
to become entirely dependent on an industry that shares some
community goals (such as getting public programs to pay for
medicines), but must focus first and last on sales and profits.

* In the U.S., individuals give much more money to charitable
organizations (mostly to religious groups) than foundations and
corporations put together.

A major problem in fundraising is that most potential donors are
too busy to be personally involved in the work being funded, and
therefore are not very familiar with what is really going on. So
organizations reach donors emotionally, or by providing
networking opportunities for them. This is necessary and useful.
But it can reward organizations more for good fundraising than
for good service work.

We need activism that can bridge the communication gap between
those doing important advocacy or service and those who can fund
it. These activists need to know both groups and be credible in
both, to be a kind of ambassador between them. They may need
special talent, background, or training.

So far only a handful have been doing this work, as the AIDS
community has not made it a priority. The community must
recognize the importance of this role and provide encouragement,
models, training, and other support. Then organizations doing
important work can survive hard times.

If we do not have significant funding independent of government
and corporations, we will lose control of our future to forces
that have always been hostile to people with AIDS.

Example: WORLD

WORLD (Women Organized to Respond to Life-Threatening Diseases),
based in Oakland, California but working nationally and beyond,
is one of many advocacy and service organizations that do good
work and need community support for it.

WORLD, active for 12 years, has published 143 issues of its
monthly newsletter "by, for, and about HIV+ women and their
loved ones," currently reaching 12,000 people in 87 countries.
It conducts two retreats each year for HIV-positive women, and
also HIV University, a treatment school for women.

This year donations are down, and the newsletter had to be
suspended until money can be found for printing and postage. The
AIDS Walk usually funds the two retreats, but this year there
was only enough money for one, and the other had to be
cancelled. And funding has not yet been found for this year's
HIV University.

Your donation to WORLD, or to another advocacy or service
organization of your choice, would certainly help for the
current emergency. In addition, the major long-range issue is
that we need to get it together as a community to see that
advocacy, information, and other services are funded. Despite
the economy, many individuals still have enough money to be
major donors -- though they may not have time to personally
investigate what to give to and why. Perhaps some of our readers
can help make these connections.

If you may be able to help WORLD, contact executive director
Maura Riordan, mriordan@... or 510-986-0340. Or write
to her at WORLD, 414 13th Street, 2nd floor, Oakland, CA 94612.

***

  From "How Can You Help," in WORLD issue #143 (emphasis in
original):

"Be an ambassador for WORLD. Contact potential funders and tell
them what WORLD means to you. Or send their contact info to our
fabulous new executive director Maura Riordan
(mriordan@...), and we'll mail them an information
packet, with a note telling them you sent us.

"Write a letter telling potential funders how WORLD has helped
you or someone you love. Mail it to us, with permission to
publish or share your letter. We're very cautious about
confidentiality, so please provide a pseudonym if you don't want
your real name used."


***** Huge Price Variations in Generic Drugs

by John S. James

A WALL STREET JOURNAL investigation showed great price
variations in the marketing of some generic drugs in the U.S.
For example, the so-called "average wholesale price" (AWP) for
generic Prozac (fluoxetine), the most commonly prescribed
generic in the U.S., was $2.66 a pill -- while in fact,
pharmacies could actually buy the same pill for only 5 cents.

While most price differences are not this extreme, it has become
standard practice for a handful of "pharmacy-benefit managers"
to make big profits by exploiting secret price differences,
which are usually not known even by large employers who are
contracting for coverage of their employees. Although the
article does not emphasize this point, the figures make it clear
that the so-called "co-pay" (the $5, $10, $25, or other standard
amount paid by the patient when picking up their medication) can
actually be more than the full cost of the prescription --
suggesting that patients and their employers can unknowingly be
paying for health insurance that actually charges more for
certain medicines than if they had paid full price.

The article, "Hired to Cut Costs, Firms Find Profits in Generic
Drugs," by Barbara Martinez, is on the front page of the March
31, 2003 WALL STREET JOURNAL.

Comment

At this time all antiretrovirals are patented in the U.S.; for
them there are no generics, so the price issues are different.
But HIV patients often need many prescriptions in addition to
antiretrovirals.

A branch of treatment activism that develops expertise in the
complex, irrational world of drug prices could educate the
public about how to keep treatment available when it would
otherwise be denied, in a country where drug prices are rising
at a rate of about 15% per year. For example, it could help
people in finding insurance, choosing among employer or other
insurance plans, choosing among local, mail-order, and Internet
pharmacies, knowing about discount-card programs, dealing with
Medicaid and other public benefits, using patient-assistance
programs, and knowing when it is better to fill a prescription
out of pocket even if one has coverage. Such a movement could
also advocate for needed changes in health plans, policies, and
legislation.

Abusive drug pricing exists in part because when people need
their medicine they may not have time and energy for price
comparison. Today, when patients do have health care access
decisions to make, they seldom have good advice available. That
could change.


***** Philadelphia: June is AIDS Education Month

Each year in June Philadelphia FIGHT, a large AIDS clinic and
service organization, produces a series of AIDS education
programs. Most are free or low cost. Complete 2003 information
is online; confirm dates because some have changed.

* June 3, Opening Reception to honor religious and labor
leaders, no fee;

* June 5, Project Inform Town Meeting with Brenda Lein, on AIDS
treatment and research today, no fee;

* June 10, Prison Summit to "strategize on how to meet the needs
of people who are incarcerated and recently released, and
develop a plan for increased advocacy and activism on HIV-in-
prison issues," no fee;

* June 11, breakfast forum, Youth and HIV, with two physicians
from Children's Hospital of Philadelphia, $15.

* June 18, breakfast forum, "AIDSVAX and Vaccines...Now What?"
with David Weiner, M.D., from University of Pennsylvania Medical
School, $15.

* June 19, "Help for Third World Communities," with David
Bangsberg, M.D., M.P.H., from San Francisco General Hospital.
"This program will describe hands on experience from physicians
and others working in sub-Saharan Africa and elsewhere to try to
bring HIV care and medicine to people with limited access to
both. We will hear about several different efforts to help
people in the poorest communities gain access to care from
people actually working there, and we will address what we as a
community in Philadelphia might be able to do to help." No fee.

* June 20, outdoor film, "A Closer Walk" -- "a 2003 documentary
about the staggering impact of AIDS on the world" -- and other
films, 7 p.m. to 7 a.m. Suggested donation $3.

* June 26, outdoor film, "A Closer Walk" -- "a 2003 documentary
about the staggering impact of AIDS on the world" 7 p.m. to 11
p.m. Suggested donation $3.

For complete program information visit
http://www.fight.org/aem/calendar.asp or call the AIDS Library
at Philadelphia FIGHT, 215-985-4851.


***** AIDS TREATMENT NEWS

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Editor and Publisher: John S. James
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 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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Copyright 2003 by John S. James. Permission granted for
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--
John S. James
AIDS Treatment News
www.aidsnews.org

Our recent article on SARS information had a typo in one of the links
(the 'm' was left out of 'syndrome')
The sentence with the corrected link is:

One place to start is a Web page by the U.S. National Library of
Medicine:
http://www.nlm.nih.gov/medlineplus/severeacuterespiratorysyndrome.html

John

--
John S. James
AIDS Treatment News
www.aidsnews.org

AIDS TREATMENT NEWS Issue #390, April 4, 2003
     phone 800-TREAT-1-2, or 215-546-3776

CONTENTS

** Treatment Interruption; Advanced HIV; New Ideas:  Dr. Cal
Cohen Interview on Retroviruses Conference (part 2 of 2)
The conclusion of Dr. Cohen's interview includes an in-depth
look at current thinking on treatment interruption, strategies
for highly treatment-experienced patients, and other topics from
the recent Retroviruses conference.

** SARS Web Information
Where to find current information about Severe Acute Respiratory
Syndrome (SARS), a new disease that can cause severe or fatal
pneumonia.

** Abacavir Arm Stopped in Clinical Trial
A government clinical trial stopped treatment with abacavir plus
AZT plus 3TC, due to more viral rebound than other treatments in
the study. Many unknowns remain.

** Huge Medicaid Cuts Weighed in Washington
A $92 billion Medicaid cut passed by the U.S. House of
Representatives, and a plan by the Bush Administration to reduce
entitlement funding of medical care for the poor and elderly and
give states more power to choose whose benefits are ended, could
seriously reduce HIV care in the coming decade.

** Africa Activism: Money for AIDS Not for War; South Africa
Antiretrovirals
Africa Action seeks organizational endorsements for prioritizing
an epidemic that has already killed 25 million people.
Separately, South Africa's Treatment Action Campaign seeks
international support for government cooperation in making
antiretroviral treatment available there.

** PRISON HEALTH NEWS First Issue Available
AIDS TREATMENT NEWS helped start this new publication on HIV,
hepatitis C, and other major illnesses in U.S. prisons.
Subscriptions are free.


***** Treatment Interruption; Advanced HIV; New Ideas: Dr. Cal
Cohen Interview on Retroviruses Conference (part 2 of 2)

by John S. James

In our last issue Cal Cohen, M.D., discussed starting
antiretroviral treatment, new information on protease
inhibitors, and antiretroviral toxicity. Here he looks at
treatment interruption, and treatment of patients with advanced
illness who have already received many antiretrovirals. We also
asked about an early experiment with a human monoclonal
antibody, which might lead to a different kind of treatment
given by injection every two or three weeks.

The interview took place on February 21.

Treatment Interruptions

Dr. Cohen: There were a couple of very important presentations
on treatment interruptions [see abstracts #64 through #68lb on
this topic]. I would summarize them as follows:

We continue to learn from studies that in some cases people can
safely stop their medications. If somebody has had a good CD4
rise and then stops medication, CD4 counts do not plummet
rapidly, on average. The viral load, even as it goes up, may
leave most people able to tolerate some time off antiretrovirals
if that is their choice. The risks include a few percent who can
have symptoms associated with HIV rebound -- similar to what
some have when first exposed to HIV. We have also learned at
past meetings that the other risk of stopping -- rapidly falling
CD4 counts -- is greatest in those who have a history of very
low counts -- suggesting that immune reconstitution is not
always complete for those who have ever had very low CD4 counts.
But even this is a generalization -- there are some with low
counts in the past who have stopped and had some time off with
stable counts -- they just need more frequent monitoring if they
do stop.

New data at this meeting highlighted a caution -- that a few
percent of people will develop viral resistance when stopping
antiretrovirals. Understanding of why and when that happens is
still evolving. But it appears that if your viral load is higher
than 50 and you stop your antiretrovirals, that is when you are
more likely to develop resistance. And this resistance is most
likely to drugs with a "low genetic barrier" to the development
of resistance - especially 3TC and the non-nukes [efavirenz and
nevirapine].

We are seeing results of studies showing that people can take
weeks or even months off antiretrovirals (long-cycle approaches
to treatment interruption). For example, a Thai trial compared
short treatment cycles (7 days on and 7 days off), vs.
continuous treatment, vs. a strategy of stopping when the CD4
counts are above 350 and starting only after a 30% drop in the
counts.(1) The researchers noted that their volunteers needed to
be on medications only 33% of the time with this CD4-guided
strategy. This approach is promising to reduce drug exposure.
And it is similar to the strategy being tested in the
international "SMART" trial -- the largest trial ever attempted
in our field. (SMART compares long-cycle interruptions to
continuous therapy. It is tackling a key issue in structured
treatment interruption, which is whether it makes a difference
in the long term. Readers can learn more about the SMART study
at http://www.smart-trial.org )

But an important caution about treatment interruption also came
from this trial,(1) which showed that the 7-day-on-7-day-off
antiretroviral regimen for people with well-suppressed virus did
not always work. This trial had 73 volunteers, of whom about a
third did 7 days on and 7 days off, and there were virologic
escapes. There may be reasons that explain it, including
underlying resistance, or these volunteers not always having
less than 50 when they stopped. These are just conjectures, as
the research team did not fully explain why their results
differed so much from other studies that showed successful
suppression even after 7 days off. The bottom line is that the
7-7 regimen is still a research approach with rules yet to be
understood, which is why we remind people that this is still
research and not a recommendation. If everybody looked at the 7-
7 data from Dr. Dybul at the National Institutes of Health and
started doing it, the Thai data suggests that as many as half of
the people trying it could have virologic escape. Researchers
and doctors are cautious because sometimes we learn later on
that problems occur. We need time and experience to understand
the newer strategies in order to know how to apply our findings.

So these days if someone is considering a treatment
interruption, and they want to be as conservative as possible --
meaning to conserve the drugs they are on now for use next time
-- some of the studies suggested treatment interruption may be safe,
but it is also important to do so in a way that minimizes
creating resistance. Resistance occurs while the drugs are
leaving the bloodstream and are present in concentrations too
low to stop the virus from growing. So we can take advantage of
the higher genetic barrier to resistance of boosted protease
inhibitors. One approach I use is a week of boosted dual
protease inhibitors to avoid resistance. If someone is on, say,
AZT plus 3TC plus efavirenz, I may substitute a dual boosted
protease inhibitor combination, Kaletra plus saquinavir, for
example, for a week. This allows the AZT, 3TC, and efavirenz to
leave the bloodstream while continuing viral suppression. Then
you can stop the protease inhibitors, and these drugs have a
high enough genetic barrier that you are quite unlikely to lose
them to resistance. Otherwise, you might lose 3TC or efavirenz -
- and it seems to me a good use of that week on an alternative
regimen to not risk losing those very precious drugs. Get them
out of your system while the virus is suppressed.

James: As a practical matter, do you have trouble with
reimbursement if you prescribe these drugs for just one week?

Dr. Cohen: In my experience, no, because it appears the same as
if I am just switching to this combination; no insurance refuses
to pay for medication switches. And certainly our pharmacies
here in Massachusetts are enlightened enough that if I want to
give somebody a week's supply instead of a month's supply they
are OK with that. It may be different elsewhere.

Choosing Drugs for Highly Treatment Experienced Patients ("Deep
Salvage")

James: What was new at this meeting for people who have had
extensive antiretroviral treatment, and have already developed
resistance to a number of the drugs?

Dr. Cohen: At this meeting we saw two very important pieces of
the puzzle. One area is new drugs. Another is an idea on how to
wait instead of switching antiretrovirals too soon.

Given that there are important new drugs coming, the question is
what to do if somebody is on a combination now that is holding
them at some acceptable viral load. If they do not have enough
new drugs that can work for them to create an effective, potent
regimen that makes it likely they will re-establish suppression,
we have seen that if you switch too early they will lose those
drugs and be back where they started, only worse since they now
have even fewer options. So there has always been an interest in
postponing the switch until you have a good switch. The
difficult question for a couple of years has been, what do you
do while you wait? Because keeping someone on a regimen allowing
partial suppression, but unfortunately also allowing the virus
to create more and more mutations, creates more and more cross
resistance, potentially losing options you've been trying to
save somebody for.

No one has a great answer, but Steve Deeks presented some very
preliminary but creative work, that for many was one of the
highlights of the meeting for innovativeness.(2) Since after
resistance non-nukes are generally useless, he has people on a
combination of nucleoside analogs and protease inhibitors, as
most of us do. He then focused on a group who were still
receiving benefit from the antivirals -- those whose current
viral load on meds was lower than their set point -- suggesting
that at least some of the meds were working. Then he thought,
maybe we could "save" a class -- and keep people on just
nucleoside analogs, or just protease inhibitors, minimizing
creating more resistance to either one class or the other -- and
minimizing toxicity from one class as well.

He showed that when he stopped the protease inhibitors,
maintaining the nucleosides only, at least for weeks if not
months, the viral load stayed suppressed; he could maintain this
viral load even without the protease inhibitors for months. Five
patients did the reverse, and stayed on the protease inhibitors,
and he did see a viral load increase of a little over half a log --
suggesting that, at least for now, stopping the protease
inhibitors and maintaining nucleosides may be a better way to
postpone switching and preserve the protease inhibitors for the
future. If you are off the protease inhibitors you will not
develop new PI mutations, so drugs like tipranavir may stay more
active for you. That's the logic.

Dr. Deeks also pointed out that this approach does not last
forever. It may be a stalling maneuver. It does provide food for
thought, and maybe another option for a while. But he noted that
in time the nucleoside-inhibitor-only approach will lead to
rebound -- so it might be necessary to restart the protease
inhibitors for some period of time, to take advantage of the
fact that the protease inhibitors can reduce the blood level of
even resistant virus. The key is to emphasize that these
observations are the beginning of a story -- and we have much to
learn about when these observations hold true, as well as when
we will see different outcomes. But it has some relevance for
some people now.

There are new drugs coming. We saw data on tipranavir that shows
that the company now has a dose worth using, and that it works
well against many protease-inhibitor-resistant mutations. T-20
is already well established and approved for sale at least in
the U.S. as of March 2003; in this meeting we saw data to show
that T-1249 works if you have T-20 resistance, and it works
quite well. We also saw data about other new classes of drugs,
including many other entry inhibitors, CCR-5 inhibitors, and one
drug from a completely new class that may be a viral assembly
inhibitor. Many of these new drugs are still only in the test
tube; there is a little clinical data. But it was promising that
people are finding new drugs and new drug classes that work
against resistant viruses.

Human Monoclonal Antibody

James: What do you think about the early test of the anti-HIV
antibody TNX-355 -- a new kind of possible treatment that was
injected once, and still inhibited HIV two weeks later?(3)

Dr. Cohen: It's not clear ultimately where this drug will go --
but there might be an injectable treatment given every two weeks
or so. In the trial so far they gave only one dose, and two
weeks later the virus reached its lowest point. We have never
before seen a drug that a single dose took two weeks to reach
its maximum response; it is not entirely clear why that
happened. This finding was curious but suggests that this drug
binds to the cells for a prolonged period and maintains the
effects for far longer than our usual oral medication. It raises
a host of questions because we have not used drugs with these
characteristics before.

James: Activists were disappointed that there was no human data
on TMC125, a new and very powerful non-nucleoside.(4)

Dr. Cohen: Yes, there may be issues with the formulation. This
drug has been burdened by a formulation that requires many pills
per day, and the company is working hard to improve on that
before moving ahead. As I understand it, they are closer to
proceeding to the next phase of research.

There are many drugs we will hear about over time -- some will
be developed more slowly than others. We are hearing less data
about some potential drugs since many trials are just under way.
Because we do not hear about something does not necessarily mean
there is no new information about it. Sometimes the trials are
being planned or have started, but are not mature enough to be
presented at scientific meetings.

Summary

James: Could you summarize some of your main take-home points
from the meeting?

Dr. Cohen:

(1) We continue to learn that we are far from preventing HIV
infection with a vaccine. Therefore prevention through behavior
changes that are maintained is critical to protecting oneself
reducing the size of the epidemic. We also don't know much more
about the risk from re-exposure to HIV, so for now we suggest
caution as more is learned.

(2) We know that treatment works, and we are learning more about
the tradeoffs with different approaches. There is no perfect
regimen for everyone, but clearly some choices have well-
established advantages over others.

(3) We must continue to be vigilant about side effects. While
searching for ways to both prevent and reverse them, we must
also be alert for newer side effects that we do not yet know
much about. We are only six years into the "HAART" era -- and
without a cure in place, we have decades to go.

(4) Starting treatment is no longer a single decision to be made
once -- people can stop and restart multiple times in different
patterns. The benefits and risks of these approaches are finally
beginning to be defined. And through longer-term studies finally
underway, we hope to be able to move from the era of knowing
that we can stop medications in some cases, to knowing whether
we should stop medications. It will take many people in long-
term studies to answer this question.

(5) The only way forward is more research. We all need to be
vigilant about supporting HIV research, as well as advocating
for our own field.

References

Note: These references are to the 10th Conference on
Retroviruses and Opportunistic Infections, Boston February 10-
14, 2003. They are available at http://www.retroconference.org
and will remain there for about a year. The abstracts should be
readable on all computers, but the browser's Internet security
setting should not be too high, or the software to search the
abstracts will not work.

1. J Ananworanich, P Cardiello, P Srasuebkul, and others. HIV-
NAT 001.4: A Prospective Randomized Trial of Structured
Treatment Interruption in Patients with Chronic HIV Infection.
[Abstract #64]

2. SG Deeks, JN Martin, R Hoh, T Wrin, C Petropoulos, and RM
Grant. Continued reverse transcriptase inhibitor therapy is
sufficient to maintain short-term partial suppression of multi-
drug resistant viremia. [Abstract #640]

3. DR Kuritzkes, JM Jacobson, W Powderly and others. Safety and
preliminary anti-HIV activity of an anti-CD4 mAb (TNX-355;
formerly HU5A8) in HIV-infected patients. [Abstract #13]

4. K Das, AD Clark, and PL Boyer. Could multiple modes of
binding of a potent NNRTI TMC125-R165335 explain its potency
against common drug-resistant mutants? [Abstract #613 - Poster
available]


***** SARS Web Information

by John S. James

Almost everyone has now heard of SARS (severe acute respiratory
syndrome), a new disease that can cause a serious and sometimes
fatal pneumonia. As we go to press (April 2, 2003) the news is
changing very rapidly. Just a week ago it looked like SARS might
be dying out -- but then Hong Kong reported over 50 new cases in
one day. Conferences and other public events are being postponed
or cancelled in that city and some other parts of Asia. This
disease could end on its own, or it could become a worldwide
pandemic and kill many people. Currently there are over 80
suspected cases in the U.S., most acquired from travel abroad.

SARS is believed to be caused by a previously unknown virus.
Some but not all patients have severe breathing difficulties and
need a respirator. So far the fatality rate has been about 4%.
Recently Hong Kong physicians reported success in treating
seriously ill patients with antibodies from those who had
recovered -- a well-known technique that has been used
successfully with other infectious diseases.

At this time experts believe that SARS is spread mostly by close
personal contact, as in hospitals or homes, especially by
coughing or sneezing. Some patients appear to be much more
contagious than others. No one knows how well the infection can
travel through the air in public places. It might also be spread
by objects recently handled by an infected person.

For Current Information

One place to start is a Web page by the U.S. National Library of
Medicine:
http://www.nlm.nih.gov/medlineplus/severeacuterespiratorysyndroe.html

For more detailed information, see the U.S. Centers for Disease
Control and Prevention (CDC) page:
http://www.cdc.gov/ncidod/sars/

We have not yet seen any HIV-specific information about SARS.

Comment

We suggest that more be done to support people in complying with
public-health directives -- especially travelers far from home
who are asked not to fly if they have possible symptoms. If they
fear being stranded in a foreign country thousands of miles from
home with no place to stay, uncertain medical care, and problems
getting a flight home when they recover, they will have strong
incentive to lie and conceal their illness. It would cost little
for public-health systems to help make arrangements for the few
travelers affected at this time.

New diseases will become increasingly serious due to crowded
populations, massive air travel, and possibly bioterrorism.
Proper support for public health, long neglected by governments
that care only for the rich (who can afford private medicine),
will become a life-or-death issue for everyone.


***** Abacavir Arm Stopped in Clinical Trial

by John S. James

A major government clinical trial comparing three HIV treatments
stopped the arm using abacavir plus AZT plus 3TC (Trizivir(R))
alone, after patients in that arm "experienced virologic failure
earlier and more frequently than patients who were randomized to
receive either of the other two treatment regimens being
evaluated in the study." However, all three of the study arms
seemed to do well virologically, given the relatively advanced
HIV infection the volunteers started with. And "there were no
concerns about the toxicity of the study drugs."

This trial (known as AACTG protocol A5095) compared abacavir
plus AZT plus 3TC vs. efavirenz (Sustiva(R)) plus AZT plus 3TC,
vs. all four drugs (abacavir plus efavirenz plus AZT plus 3TC).
In this study the volunteers were antiretroviral naive, but
started with a high viral load (median over 78,000 copies, with
43% of the volunteers having over 100,000) and low CD4 count
(median 238). A data review at 32 weeks found that 21% of those
randomly assigned to the Trizivir alone still had a viral load
over 200 copies after at least 16 weeks of treatment (which was
defined as "virologic failure" in this study), compared to 10%
of the volunteers in the other two groups combined. The
difference was seen both in the group with viral load over
100,000 copies when they started the trial, and the group with
lower viral load. Because the difference was statistically
significant and met the pre-determined standard for stopping a
treatment arm, the Data Safety Monitoring Board (DSMB) had no
choice but to stop abacavir plus AZT plus 3TC and offer the
participants other treatment. A March 10, 2003, letter from the
U.S. Division of AIDS to the researchers, containing all the
information initially available, is at:
http://www.niaid.nih.gov/daids/default.htm

Because the other two arms of this trial are continuing, the
DSMB released the least amount of information necessary, to
avoid any risk of biasing study results. For example, we do not
know if the virologic "failure" usually meant a viral load
barely above 200, or considerably higher. Also, we have no
information about adherence and missing doses. The study was
double-blinded and placebo controlled, so all volunteers took
five pills at night and two in the morning, and if some were
more careless about missing the morning than the evening dose,
that could have biased the result in the direction seen, since
all the efavirenz was in the evening dose, but every drug in the
Trizivir-only arm would have been affected by missing the
medicine in the morning.

Some additional information will be submitted to the
International AIDS Society conference, July 13-17 in Paris;
however, the other two study arms will still be ongoing, so full
information may not be available even then. Continuing the two
remaining arms will help address the question of whether adding
a fourth drug to certain 3-drug HAART combination regimens
provides enough additional virologic benefit to be worth the
added cost in side effects and expense.

Comment

There is no perfect HIV treatment, and we have not seen any rush
to change drug regimens because this Trizivir arm was stopped.
The new information does have doctors' attention, and will be
reflected in medical consensus as more is learned.


***** Huge Medicaid Cuts Weighed in Washington

by John S. James

In March 2003 the U.S. House of Representatives voted to cut $92
*billion* dollars from Medicaid over the next 10 years, mainly
to finance tax cuts for the richest Americans (the war on Iraq
and its followup had not yet been accounted for, and could
result in further massive cuts). The Senate voted for no
Medicaid cuts, and possibly an increase in some funding. Now a
House/Senate conference committee will decide between the two
budget plans, probably but not necessarily coming to some
compromise between them. Medicaid pays for much of the HIV
treatment in this country, in addition to other programs
including long-term care for the elderly.

Meanwhile, the Bush Administration has proposed what has been
estimated at a $600 billion tax cut -- when many states already
face their worst financial crisis in decades. The Bush proposal
for Medicaid is not known in detail, but it appears that states
that agree to give up entitlement to Federal matching funds for
Medicaid will be able to split two large block grants, one for
long-term care and one for all other care. But the grants would
have to be budget neutral -- and to meet this requirement,
states could cut prescription drug coverage, home health
services, primary care case management, physical therapy, dental
care, and other services. (For more information, including a
list of who is most likely to lose benefits, see the
Pennsylvania Health Law Project:
http://www.phlp.org/Bushproposal.htm )

For More Information on Medicaid and HIV

For background on Medicaid policy, see the Kaiser Family
Foundation, http://www.kff.org -- especially the section "Kaiser
Commission on Medicaid and the Uninsured."

For state profiles on HIV and Medicaid, see http://www.hivma.org
(published by the Infectious Diseases Society of America),
especially http://www.hivma.org/HIV/CEN/ToC.htm   Most but not
all states have a profile available on this site.

How You Can Help

- Join the Medicaid Defense Group, "an ad-hoc coalition of
HIV/AIDS advocates fighting to preserve, improve, and expand
Medicaid." To join, email Lei Chou at theaccessproject@....

- Join Project Inform's Treatment Action Network. For more
information contact Ryan Clary, tan@....


***** Africa Activism: Money for AIDS Not for War; South Africa
Antiretrovirals

(1) Africa Action: Money for AIDS, Not for War

Africa Action, based in Washington D.C., is seeking
organizational endorsements for its call to give priority to the
global AIDS epidemic, which will kill 3,000,000 people in the
coming year. From the statement:

"AIDS is an urgent wake-up call to a deeper crisis in the state
of the world. The huge global inequalities that fuel this
pandemic are de-stabilizing and they are deadly. Only racism has
allowed the loss of so many lives to AIDS. Fighting a war
against AIDS is the most important positive step toward building
a stable future for everyone."

The full statement and endorsement information are at:
http://php.africaaction.org/action/moneyaids.php

(2) South Africa: Activists Call for Global Support in Campaign
for Antiretrovirals

The Treatment Action Campaign (TAC) and hundreds of AIDS
activists in South Africa have called for international support
for a new civil disobedience campaign to get their government to
provide antiretroviral treatment for HIV, which is killing 600
people a day in that country. The government does not want to
offer treatment because of the cost. Antiretrovirals on the
private market are completely out of reach of the great majority
of citizens. As a result, the average life expectancy of black
South Africans in Cape Town is expected to be reduced to 40
years.

TAC has prepared documents charging the Minister of Health and
Minister of Finance with homicide, and asked the police to
arrest the ministers. In Durban, police used water cannons and
other violence to disperse a protest, sending several TAC
members to the hospital. In other cities protests occurred
without incident.

"We cannot wait any longer for a visible and dynamic response
from the government, business and international community. We do
not need any more reports to tell us what we already know --
HIV/AIDS is killing 600 people a day in this country and ruining
lives and hopes. But with will and commitment this does not have
to happen. With leadership from business and government,
together with labour and communities, it is still possible to
save lives and restore hope."

International supporters can fax or phone the South African
embassy or consulate. Also, international demonstrations in
support may take place April 24 and/or April 27. For background,
see the TAC site, http://www.tac.org.za/  For U.S. specifics,
see the Health Gap site, http://www.healthgap.org/


***** PRISON HEALTH NEWS First Issue Available

A newsletter for prisoners, family members, and medical staff,
focusing on HIV, hepatitis, and other major illnesses in prison,
is available without charge. The first issue looks at taking
care of one's health, getting necessary medical services both in
prison and after release, the different stages of HIV infection,
and hepatitis C. It also has organizations to write for help.

Future plans include articles on nutrition, exercise, specific
drug treatments, how to advocate for yourself, HIV and hepatitis
C co-infection, depression, and getting assistance with housing,
medical care, drug treatment, finding work, and other needs when
you get out.

This newsletter was first intended as a prison edition of AIDS
TREATMENT NEWS. But it became a separate publication not limited
to AIDS. It is published by Philadelphia FIGHT, a nonprofit
service organization that provides healthcare, education, and
other services to people with HIV in Philadelphia. It has been
funded by an unrestricted educational grant from Ortho Biotech,
and is seeking additional funding.

To subscribe to PRISON HEALTH NEWS, send a request to: Laura
McTighe, Philadelphia FIGHT, 1233 Locust St., 5th floor,
Philadelphia PA 19107.

***** AIDS TREATMENT NEWS

Published twice monthly

Subscription and Editorial Office:
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   useful AIDS links: http://www.aidsnews.org

Editor and Publisher: John S. James
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 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 2003 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
www.aidsnews.org

AIDS TREATMENT NEWS Issue #389, March 14, 2003
     phone 800-TREAT-1-2, or 215-546-3776

CONTENTS

** Retroviruses Conference Clinical News: Interview with Cal
Cohen, M.D.
We asked a leading AIDS physician to summarize some of the
important treatment messages for physicians and patients, from
the 10th Conference on Retroviruses and Opportunistic
Infections, a major scientific meeting. Part 1 of the 2-part
interview looks at starting antiretroviral therapy (including
tenofovir vs. d4T, and efavirenz vs. nevirapine), new protease-
inhibitor information, and antiretroviral drug toxicity.

** First AIDS Vaccine Tested Did Not Protect, But Gives
Scientific Leads
AIDSVAX, the first HIV preventive vaccine to finish a human
efficacy trial, did not protect against infection, but is likely
to provide much information on designing better vaccines

** T-20: Most Expensive AIDS Drug Ever at $25,000 Per Year?
A new kind of HIV treatment will probably cost several times as
much as other AIDS drugs and be unavailable to many who need it.

** Clinton Team Lowers Drug Price 7-Fold in Caribbean
At the recent Retroviruses conference, President Clinton told
how his organization lowered the price the government of the
Bahamas paid for HIV treatment, from $3600 to $500 per year.

** Help Wanted: Treatment Information and Advocacy at Project
Inform, Spanish Bilingual Preferred
Resume requested by March 21, 2003.

** Warning, Counterfeit Procrit(R) (Epoetin Alfa)
The FDA and Ortho Biotech have warned health professionals and
patients to check for counterfeit Procrit, which may contain
dangerous bacteria and have no active ingredient.


***** Retroviruses Conference Clinical News: Interview with Cal
Cohen, M.D.

by John S. James

Cal Cohen, M.D., has been an AIDS physician since the mid 1980s.
Currently he is research director of the Community Research
Initiative of New England, and teaches at Harvard Medical School
in Boston, Massachusetts. He has a clinical practice in Boston
at Harvard Vanguard Associates.

We asked Dr. Cohen to discuss some of the most important
information from the 10th Conference on Retroviruses and
Opportunistic Infections, February 10-14 in Boston -- focusing
mostly on the news that physicians and patients can use now.

This is part 1 of the 2-part interview.

***

Dr. Cohen: Some of the clinical highlights of this conference
were:

* More proven options for beginning antiretroviral therapy;

* More information on switching antiretrovirals if necessary --
including possible options on delaying the switch until a better
new regimen is available, and also information on structured
treatment interruption;

* Reports on lipodystrophy, heart-disease risk, and other side
effects of some antiretrovirals;

* Viral resistance to drugs, and ways to minimize it; and

* New drugs in the pipeline -- a "bumper crop," as one prominent
researcher said.

Starting Antiretroviral Therapy

Dr. Cohen: At this meeting we saw more data about the
differences in the second year of taking d4T (Zerit(R)) vs.
tenofovir (Viread(R)).(1) About 600 volunteers were randomly
assigned to take one or the other of these drugs; in either case
they also took 3TC (Epivir(R)) and efavirenz (Sustiva(R)). The
trade-off presented was good news for tenofovir on safety; only
1% of the patients had lipodystrophy (as defined by the
researchers) vs. 12% for d4T. Tenofovir patients had less
neuropathy as well (not a surprise) -- and also a better lipid
profile. The safety certainly favors tenofovir. Yet many
patients can tolerate d4T; in this trial more than 80% of those
on d4T did not have visually apparent lipodystrophy even after
two years.

Is there some way to predict who is most vulnerable to
lipodystrophy? Researchers are working on that. And if
lipodystrophy does develop, how reversible is it? We have
learned at this and other meetings that it can be reversible,
especially if we catch it early enough.

The tradeoff on tenofovir plus 3TC (vs. d4T with 3TC) is what
may happen with resistance. If someone does develop virologic
escape from this tenofovir starting regimen, about 25% of the
time they will have the K65R mutation (but that was only about
1% of the patients in this trial -- see below). This mutation,
along with the 3TC resistance mutation M184V, can create
resistance to many of the other nucleosides, and leave only AZT
and d4T predicted to be active nucleoside drugs for people with
these mutations.

But with d4T plus 3TC, if you get resistance and viral rebound,
usually you only get resistance to the 3TC and less likely to
d4T, which has a different genetic barrier to viral resistance.
In the tenofovir vs. d4T trial above, of the 28 people who had
virologic escape, there were 2 cases of K65R on d4T and 7 with
tenofovir. So the difference is all of 5 people, in a study of
600 -- a difference of about 1% so far, having the additional
risk of getting the more serious viral resistance with the
tenofovir. Still this is the trade-off people need to consider -
- increased risk of lipodystrophy, vs. the extra 1% risk of
worse cross-resistance to nucleoside analogs.

One possible way to minimize both lipodystrophy and cross
resistance is for somebody to start on d4T for perhaps six
months, then switch over to tenofovir once their viral load is
clearly less than 50 copies, for example. Most important with
either regimen, however, is to make sure that the treatment is
working and suppressing the virus.

James: Even though d4T may work well for some patients, is it
still agreed that nobody should use d4T plus ddI, because of the
toxicity of the combination?

Dr. Cohen: Yes. While both drugs have uses separately in some
patients, they should not be used in combination.

Efavirenz vs. Nevirapine in Starting Regimens

Dr. Cohen: The so-called 2NN study (for 2 non-nucleosides) had
four arms. It compared efavirenz (Sustiva(R) in the U.S., also
known as Stocrin(R) in some countries), vs. nevirapine
(Viramune(R)) once a day, vs. nevirapine twice a day, vs. the
combination of efavirenz and nevirapine. All volunteers also
received d4T plus 3TC. This study enrolled over 1200 volunteers
in 17 countries in Europe, North and South American, Australia,
and South Africa.(2,3)

The first, easy conclusion is that there is no good reason to
combine nevirapine and efavirenz; that arm did not do better in
any important way, so we can forget that combination. In
comparing nevirapine once vs. twice a day, there was a
demonstration of more liver toxicity in the once a day arm vs.
twice a day. So it may be safer to consider nevirapine a twice a
day drug, even though in overall success they seemed about
equal.

What about comparing efavirenz vs. nevirapine, one main purpose
of this study? They were more similar than different but
technically not equivalent. Some prior studies have not done
well for nevirapine. This one, the first head-to-head comparison
with efavirenz, increased the data supporting nevirapine as a
decent drug.

The problem is the toxicity profile of nevirapine, including a
higher percent of liver toxicity with either once or twice a day
nevirapine than with efavirenz. Two deaths among the 800 or so
volunteers taking nevirapine in this study were attributed to
nevirapine [one from liver failure, the other from an
antibiotic-resistant staph infection acquired in a hospital
while recovering from Stevens-Johnson syndrome]. We have known
from other studies that there is a rare but potentially fatal
liver complication that occurs in the first weeks or months of
use of nevirapine. This was reported for example in the study of
FTC vs. 3TC done a few years ago in South Africa -- where
reports of very rare but fatal liver toxicity were noted. This
is another factor to consider as we construct the first regimen
for a patient.

James: Do we know from that study if the person who died of
liver failure was monitored correctly for liver toxicity?

Dr. Cohen: We do not know yet from the report at this
conference, and it would be helpful to learn from the company if
this occurred despite monitoring, or if this volunteer was not
monitored according to the protocol. It is important to know if
the recommended blood tests could usually find this liver
problem in time.

So on nevirapine this trial provides more data to inform the
choice. It does not tell us which drug is better.

It is still fair to say that Sustiva (efavirenz) is at least as
good as Viramune (nevirapine), and may be better in some ways.
There was nothing presented that made nevirapine a better choice
-- except for those who cannot tolerate the well-known efavirenz side
effects of vivid dreams and mood changes. Overall,
nevirapine is probably just as good or slightly worse on
average. The statistics for this trial allow us to state with
confidence that nevirapine is similar and no more than 12% less
successful than efavirenz.

Protease Inhibitor Information

Dr. Cohen: Within the protease inhibitors, we saw new data from
the drug 908, which is the reformulation of amprenavir. It did
much better than nelfinavir, and impressively it did well even
at much higher viral loads. It may be the best data we have seen
in an un-boosted protease inhibitor doing well at high viral
loads.(4,5,6)

It is not clear if clinicians will choose to use 908 earlier in
treatment (when this drug is approved), because there are some
lipid disturbances. But 908 certainly is interesting in the same
way that Kaletra is interesting, because not only is it very
potent, but also if you do get viral escape and rebound, boosted
protease inhibitors including 908 plus low-dose ritonavir did
help protect from resistance not only to the protease
inhibitors, but also to the other drugs in the regimen.

[Note: a "boosted" protease inhibitor means that the drug is
used in combination with another protease inhibitor -- often but
not necessarily a small dose of ritonavir, which slows the
body's metabolism of many drugs, thereby keeping the blood level
of the other protease inhibitor high. Kaletra (lopinavir plus
ritonavir) is automatically boosted, because it includes a small
ritonavir dose in the pill.]

One of the most attractive things about a boosted protease
inhibitor as a starting regimen is not only its potency, which
is clear and established, but also this high genetic barrier to
resistance. For some patients -- particularly those whose
adherence may be spotty or erratic -- the danger of using a non-
nuke (efavirenz or nevirapine) is that the patient might lose it
early in their treatment to viral resistance, due to poor
adherence. If someone might not be ready to start antiretroviral
therapy but wants to give it a try, there is something to be
said for the boosted protease inhibitor and taking advantage of
that high genetic barrier to resistance. (Of course, if someone
has side effects from ritonavir, for example gastrointestinal
upset, then the regimen becomes less desirable as a way to find
out if one wants to be on treatment. Therefore many physicians
prefer to start with two nucleoside analogs and a non-nuke for
beginning treatment -- another tradeoff to consider.)

Data on 908 had been presented earlier at the Glasgow meeting.
At the Retroviruses meeting, a poster provided data about the
lack of viral resistance on boosted 908.(6) The researchers did
not find protease inhibitor resistance in that arm -- and
indeed, found less resistance to the nucleosides as well. It
probably takes more non-adherence to get viral rebound on a
boosted protease inhibitor than on the other available
antiretroviral regimens. If you do rebound it is probably
because you stopped the drugs, not because you missed a few
doses.

A new experimental protease inhibitor -- atazanavir -- looks
attractive because of its lack of lipid disturbances. This drug
does not have a lot of the toxicities including insulin
resistance that have tainted protease inhibitors so far.(7)

The other piece of the puzzle on atazanavir can be seen as an
evolution of three stages of controversy around resistance and
cross-resistance.

The first-generation discussion was the nelfinavir vs. indinavir
battle, in which nelfinavir had a more salvageable pathway
(meaning better treatment options if resistance does develop to
the drug).

The second battle was the boosted PI, where no resistance
developed when those drugs were used.

And now we have a third version of the story, which is if you
use atazanavir first and get rebound, you actually get
hypersusceptibility of the virus to other protease inhibitors --
meaning that the virus is more susceptible to the drugs (at
least predicted, based on the mutations seen). The clinical
meaning of that is not yet known. But we do have information
about hypersusceptibility with other drugs, suggesting that it
does seem sometimes to make a difference. So it may or may not
sway clinicians to want to use it for that reason. And there are
controversies around whether atazanavir is as potent a drug as
we might need for some patients. There may be some patients with
a high viral load and low CD4 where you may not want to trust
atazanavir, at least with two nukes. It does add another layer
of controversy or complexity in what makes these regimens
attractive.

Overall, it was a very good meeting in making us feel that we
have more options than before, more attractive options, and
different ways to balance the tradeoffs. So we feel less stuck,
with more flexibility.

Antiviral Drug Toxicity

Dr. Cohen: This meeting also focused on blood cholesterol and
lipids, with analysis of data from a very large cohort of study
volunteers in Western Europe and the U.S., to see if there is
any evidence of increased risk of heart disease in those on
treatment. As you know, this analysis, called the D.A.D. study,
did find an increase of about 25% in the rate of heart attacks
[per year of exposure] in people on any antiretroviral
treatment.(8)

The limitation of this study, or at least the analysis done so
far, is that it did not sort out which drugs may be more likely
or less likely to cause heart disease. Given that HIV treatment
is needed, this study said there is a risk but did not say what
to do about it. It did not entirely answer whether the lipid
effect of treatment completely explains the problems -- meaning
that if you avoid the lipid problem then can you avoid the risk
(the alternative is that there is some other mechanism at work).
One of the surprising and confusing points of the analysis
presented is that they found that those who had lipodystrophy
had a *lower* risk of heart attacks. In general, drugs that
cause lipodystrophy tend to have more blood cholesterol and
triglyceride problems. So you have the paradox, in that one
effect of these drugs is to increase lipids, and the other
effect is to increase lipodystrophy, but these seem to go in
opposite directions on heart risk. So while there is cause for
concern, this trial does not yet tell us what to do -- other
than avoid smoking, since nothing has changed about that.

Choosing different drugs is still a question of trade-offs;
there is still no perfect regimen, although we get closer. At
this meeting, the news on the nucleosides was the differences
between them -- and particularly, since almost everybody
continues to agree that 3TC is such a good drug that it deserves
to be used up front, the question of which nucleoside you pair
with it.

Note: Part 2 of this 2-part interview will include treatment
interruption, "deep salvage" in very treatment-experienced
patients, an experimental human monoclonal antibody, and a brief
summary of some of the major take-home messages for doctors and
patients.

References

Unless otherwise stated the references are to the 10th
Conference on Retroviruses and Opportunistic Infections, Boston
February 10-14, 2003.

Note: You can find all of the following abstracts at the
official conference site, http://www.retroconference.org; they
will remain there for about a year. To find a particular
abstract, you can either search for the poster number, for an
author, or for a word in the title. You can also search by
subject -- by looking for all abstracts that contain a
particular key word, such as the generic name of a drug. In the
listing below we indicated if a poster is also available online
with the abstract (as of March 1, 2003, when we checked -- other
posters may be added later). Researchers were encouraged but not
required to submit online posters (for oral as well as poster
presentations), which have more information than the abstracts.
Usually these posters were submitted digitally, not as
photographs, so they can be seen and read clearly online.

The abstracts and posters should be readable on all computers,
but you need (1) to have the free Acrobat reader for the posters
(if you do not already have it, you can download it from
http://www.adobe.com/products/acrobat/readstep2.html), and (2)
to *not* have your browser's Internet security setting too high,
or the software to search the abstracts may not work.
(Unfortunately the Webcast sessions, also on the official site,
use a Microsoft format and can only be heard on Windows.)

1. S Staszewski, JE Gallant, AL Pozniak, and others. Efficacy
and safety of tenofovir DF (TDF) versus stavudine (d4T) when
used in combination with lamivudine and efavirenz in
antiretroviral naïve patients: 96-week preliminary interim
results. [Abstract #564b]

2. F van Leth, E Hassink, P Phanuphak, and others. Results of
the 2NN study: a randomized comparative trial of first-line
antiretroviral therapy with regimens containing either
nevirapine alone, efavirenz alone or both drugs combined,
together with stavudine and lamivudine. [Abstract #176]

3. F van Leth, P Phanuphak, B Gazzard, and others. Lipid changes
in a randomized comparative trial of first-line antiretroviral
therapy with regimens containing either nevirapine alone,
efavirenz alone or both drugs combined, together with stavudine
and lamivudine (2NN Study). [Abstract #752 - Poster available]

4. J Nadler, A Rodriguez-French, J Millard, and P Wannamaker.
The NEAT Study: GW433908 efficacy and safety in ART-naïve
subjects, final 48-week analysis. [Abstract #177]

5. E DeJesus, A LaMarca, M Sension, C Beltran, and P Yeni. The
Context study: efficacy and safety of GW433908/RTV in PI-
experienced subjects with virological failure (24 week results)
[Abstract #178]

6. S Macmanus, P Yates, S White, N Richards, and W Snowden.
GW433908 in ART-naive subjects: absence of resistance at 48
weeks with boosted regimen and APV-like resistance profile with
unboosted regimen. [Abstract #598 - Poster available]

7. R Murphy, V Pokrovsky, W Rozenbaum, and others. Long-term
efficacy and safety of atazanavir with stavudine and lamivudine
in patients previously treated with nelfinavir or ATV: 108-week
results of BMS study 008/044. [Abstract #555 - Poster available]

8. N Friis-Moler, R Weber, A D'Arminio Monforte and others.
Exposure to HAART is associated with an increased risk of
myocardial infarction: The D:A:D Study. [Abstract #130]


***** First AIDS Vaccine Tested Did Not Protect, But Gives
Scientific Leads

by John S. James

The first "phase III" trial -- one large enough to determine
whether a treatment works -- of an AIDS vaccine in humans found
that the vaccine (called AIDSVAX, produced by VaxGen in
Brisbane, California) failed to protect people from HIV
infection. But thousands of blood tests now being analyzed will
likely provide important information for making better vaccines.
Some of this work will be reported at the "HIV Vaccine
Development: Immunological and Biological Challenges" meeting
beginning March 29 in Banff, Canada.

Many scientists did not expect AIDSVAX to work, because this
vaccine only produces antibodies against HIV and does not
stimulate another branch of the immune system called cellular
immunity. Recently, however, there has been renewed interest in
antibodies -- partly because of growing knowledge about how to
select the right antibodies, and also because cellular immunity
alone may not prevent infection but only slow disease
development. HIV vaccines might need to use both.

The VaxGen report led to controversy because of suggestions that
AIDSVAX might work partially in Blacks, or Asians. In Black
volunteers, only 4 of 203 who received the vaccine later became
infected with HIV, compared to 9 of 111 who received the
placebo; in Asians the numbers were 2 of 20 vs. 2 of 53. There
is a widespread consensus that no conclusions about human
effectiveness can be drawn from such small numbers -- although
more research is needed to look for possible racial differences,
and this work has started. (This vaccine is not relevant to
Africa because it was made specifically for the clade B virus,
which causes the AIDS epidemic in the U.S., Europe, and some
other areas, but is not common in Africa, where AIDS is caused
by clade C and other clades of HIV.)

For more information on the science and controversy around the
February 24 VaxGen report, see:

* "Understanding the Results of the AIDSVAX Trial, by AVAC, the
AIDS Vaccine Advocacy Coalition, http://www.avac.org/, or
directly at:
http://www.avac.org/pdf/UnderstandingAIDSVAX.pdf (capitalization
*does* matter).

* Articles by Jon Cohen in SCIENCE magazine, February 28, 2003
and March 7, 2003 (and any following issues).


***** T-20: Most Expensive AIDS Drug Ever at $25,000 Per Year?

by John S. James

On February 24 Hoffmann-La Roche Ltd. announced a European price
for T-20, an experimental drug expected to be approved soon by
the U.S. FDA, probably in March 2003 [it was approved March 13].
The price, 52 Euros per day or almost $21,000 per year, is
expected to be close to the U.S. price, which will not be
announced until the drug is approved. If so, U.S. retail prices
are likely to be around $25,000 per year, several times the cost
of other AIDS drugs.

Roche said that the price "reflects the structural complexity of
Fuzeon and its highly sophisticated manufacturing process"
requiring more than 100 production steps. Trimeris, Inc. and
Hoffmann-La Roche Inc. (the U.S. branch of the Swiss company)
said that "U.S. patients currently enrolled in the FUZEON Early
Access Program will continue receiving FUZEON for free until it
is commercially available and participants' reimbursement can be
achieved." (Trimeris, Inc. is the small company that initially
developed T-20. It was then was acquired by Roche, which
financed the improved manufacturing, large clinical trials, and
other work needed for commercialization.)

The AIDS Treatment Activist Coalition (http://www.atac-usa.org)
said, "It is a tragic state of affairs in drug development when
an encouraging breakthrough drug cannot be accessed by the
people who need it most."

Comment

T-20 (also called FUZEON(TM), or enfuvirtide) is not a miracle
drug. It is about equally effective as other AIDS drugs, and
considerably more difficult to use, because it must be carefully
mixed by the patient, and injected twice per day. The advantage
is that T-20 is in a different class of drugs and works entirely
differently than other approved HIV treatments, so virus that
has become resistant to the other drugs is still susceptible to
T-20. Patients whose virus has become resistant need two or more
highly active antiretrovirals as a basis for a combination that
may get the virus under control again, and T-20 could be one of
those. But only a minority of patients would use T-20 even if
price were not an issue.

It is true that T-20 is difficult to manufacture and has been
expensive to develop. But how can the company get its investment
back if the price is so high that few of those who need the drug
(already a small market) can obtain it? Private insurance has
years of experience in getting rid of persons with HIV and other
expensive patients, who then end up in public programs. These
programs, like Medicaid and ADAP, are facing unprecedented
financial pressures and already cutting back. When they must
choose between providing T-20 or providing antiretrovirals to
four or five other patients who need them just as much, they are
unlikely to pay for T-20.

Much of the research and development cost of T-20 is really the
expense of developing expertise in a new field of
pharmaceuticals that is likely to be important in many areas of
medicine, not just HIV. Roche should accept that it is not going
to make all the money back on this one drug at any price.

In the future T-20 will likely be replaced by one or more small-
molecule drugs (from Roche, Trimeris, or others) that do the
same job with much less difficulty and expense. T-20 itself has
already provided the proof of principle, by showing that
patients can benefit from its action. Activists may need to make
sure that patent technicalities do not impede the development of
these different drugs by any companies.

Meanwhile, we fear that the cost of T-20 will force an issue
people wanted to avoid -- class differences in medical care.
Will we be moving toward separate treatment guidelines for those
who can and cannot pay?


***** Clinton Team Lowers Drug Price 7-Fold in Caribbean

by John S. James

On February 10, 2003, President William Jefferson Clinton gave
the keynote speech at the 10th Conference on Retroviruses and
Opportunistic Infections in Boston. As an example of the lack of
systems in place dealing with AIDS, he noted that his team
working in the Caribbean had in one week drastically lowered the
price the Bahamas paid for drugs:

"The week after we started working in the Bahamas we found out
that the government was buying, not from a big drug company, but
from a generic source, but through an agent or two, AIDS drugs
at $3,600 a year. Generically produced AIDS drugs at $3,600 a
year. Our people on the ground there, said, "This is nuts." They
went back and cut the deal directly with the manufacturer, and
in one week they went from paying $3,600 a year to $500 a year
per person, which means they're now serving more than seven
times as many people for the same amount of money, and another
1,000 people will live because of it. That's the good news. It's
a nice story, isn't it?

"It's horrible! Why does somebody have to drop in from another
country to figure out how to save 1,000 lives with the money
you're already spending? Why isn't somebody worldwide in charge
of this? When the South African drug case was settled, it turned
out to be largely a bust, because no one was put in charge of
figuring out how many people needed the medicine in which
countries, how much they could get it for, how much could they
pay, and who would close the gap. There has never been a system
to drive this.... We know that, without systems, madness like
this will happen. And since there are lots of countries that
cannot afford the $3,600 a year, there are a lot of people that
don't have medicine they would otherwise have. Nobody is in
charge of this deal. No one is in charge.

"So we're going to do what we can to make sure, in the countries
we touch, we give them a maximum chance to save more lives more
quickly. I hope that we can make a difference. I believe we can
tone up these systems very quickly, and move quickly from
treating scores of people to treating thousands of people."

Comments

Other activists could not expect such quick results. Besides
being a former president, Clinton's team had been invited to
help with AIDS in the Caribbean, and had signed a memorandum of
understanding with 15 governments there.

Today many people in poor countries still must pay several times
as much for generic antiretrovirals on the private market as
what the manufacturer sells them for. There is no rational
economic reason for such a large price increase -- thousands of
dollars per person per year to distribute a product that costs
so little to transport and store. Clearly the problems differ in
various countries and regions. Activists must look for ways to
overcome particular barriers, while also working toward workable
worldwide systems for distributing live-saving medicine.

Note: The full text of President Clinton's speech is at:
http://www.clintonpresidentialcenter.com/retroviral_2003.html


***** Help Wanted: Treatment Information and Advocacy at Project
Inform, Spanish Bilingual Preferred

Project Inform in San Francisco is seeking an Information and
Advocacy Associate "to research and write treatment information
for Project Inform publications and educational materials on
anti-HIV treatments, HIV-associated complications, and related
issues," and to work with other staff "to develop overall
information and advocacy priorities for the organization and to
participate in treatment advocacy efforts." Ability to speak and
write in Spanish is strongly preferred. A resume is requested by
March 21, 2003, but the job will remain open until filled.

The full announcement is available at:
http://www.projectinform.org/org/Jobs/index.html


***** Warning, Counterfeit Procrit(R) (Epoetin Alfa)

On March 12 the U.S. FDA and Ortho Biotech warned of counterfeit
Procrit, which is dangerous because the batches found are not
sterile, and have no active ingredient. The lot numbers are:
P007645 - 40,000 units/mL, Expiration 10-2004
P004677 - 40,000 units/mL, Expiration 02-2004
P004839 - 40,000 units/mL, Expiration 02-2004

These lot numbers were also used on authentic Procrit. Sometimes
the packages can be distinguished with the help of photos on the
Ortho Biotech Web site:
http://www.procrit.com/counterfeit/letter.html

Anyone finding suspicious product should contact the FDA's
Center for Biologics Evaluation and Research, 1-800-835-4709,
prompt #1, then prompt #5. Also call Ortho Biotech at 1-800-325-
7504.


***** AIDS TREATMENT NEWS

Published twice monthly

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Editor and Publisher: John S. James
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 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
www.aidsnews.org

AIDS TREATMENT NEWS Issue #388, February 7, 2003
     phone 800-TREAT-1-2, or 215-546-3776

CONTENTS

** Antibiotic-Resistant Skin Infections Spreading among Gay Men,
Also in Prisons
An outbreak of staphylococcus skin infection, causing large
boils that are difficult to treat because these bacteria are
resistant to many antibiotics, has spread recently among gay men
in some cities, and also in certain prisons. In the past this
infection occurred mainly in hospitals.

** Retroviruses Conference, Feb. 10-14; Sites to Watch for News
AIDS TREATMENT NEWS will cover the important 10th Conference on
Retroviruses and Opportunistic Infections starting in our next
issue. Here are some Web sites to check for other reports,
especially during the next few weeks.

** Building Grassroots Support for AIDS
Citizen-action campaigns (like getting people to call Congress
or their state representatives to support Medicaid, ADAP, or
other program for access to medical care) could get much more
response if they were made accessible to the millions of people
who are already supportive but not already involved. We suggest
several ways to make action alerts and other citizen organizing
work better.

** Bush Proposes Near Tripling of U.S. Commitment on Global HIV
Epidemic
The presidential initiative to increase funding for global AIDS
prevention and treatment is widely seen as a groundbreaking
advance. But critical time will be lost if the U.S. focuses so
heavily on building its own new system, instead of using
multinational organizations like the Global Fund that are ready
now.

** African-Americans and AIDS, Conference Feb. 24 and 25, New
York
This national meeting brings leading experts and professionals
together for lectures and networking. It offers continuing
education credit for doctors and nurses, but is open to all.


***** Antibiotic-Resistant Skin Infections Spreading among Gay
Men, Also in Prisons

by John S. James

In the last few months doctors have seen a large increase in
aggressive, antibiotic-resistant "staph" (Staphylococcus aureus)
skin infections in gay men in some areas -- and a separate
epidemic in certain prisons. Symptoms include boils or blisters;
treatment can be difficult, and sometimes requires
hospitalization. One HIV doctor in Los Angeles who used to see
about one case a year is now seeing two a week. In the past this
infection occurred mainly in hospitals.

Physicians should note a February 1, 2003 review in the BRITISH
MEDICAL JOURNAL ("Old Drugs for New Bugs," BMJ 2003; volume 326,
pages 235-236) on evidence for the value of older antimicrobials
for resistant bacteria, including staph. It suggests using co-
trimoxazole (Bactrim(R) or other brand names) as an alternative
to vancomycin for resistant S aureus (also called MRSA). In one
case co-trimoxazole was used successfully after a patient had
failed the new and very expensive antibiotic linezolid
(Zyvox(R)). The article is at:
http://bmj.com:80/cgi/content/full/326/7383/235?maxtoshow=?eaf

Below is a fact sheet published by the Los Angeles County
Department of Human Services on how to avoid the infection (or
avoid spreading it if you have it). Also, a fact sheet by the
U.S. CDC, revised February 7, 2003, is at:
http://www.cdc.gov/ncidod/hip/aresist/mrsafaq.htm

For a recent overview, see "Skin Infection Spreads Among Gay Men
in L.A.," LOS ANGELES TIMES, January 27, 2003.

Fact Sheet Published by Los Angeles County Department of Human
Services"
Antibiotic-resistant "Staph" Skin Infections

"Recently, doctors in Los Angeles have been seeing an increasing
number of patients with skin infections caused by Staphylococcus
aureus ("Staph") bacteria that are resistant to many antibiotics
(drugs that kill bacteria). The Los Angeles County Department of
Health Services is working with doctors and other healthcare
providers to better understand why this is happening and how to
prevent antibiotic (drug) resistant Staph infections from
spreading.

"What is a Staph infection? Staph is a bacteria commonly found
on human skin. Sometimes it does not cause any problems;
sometimes it causes minor infections, such as pimples or boils.
Staph skin infections often begin with an injury to the skin.
Staph enters the skin weakened by the injury and develops into
an infection. Symptoms of a Staph infection include redness,
warmth, swelling, tenderness of the skin, and boils or blisters.

"How do Staph skin infections spread? The cleanest person can
get a Staph infection. Staph can rub off the skin of an infected
person onto the skin of another person during prolonged (skin to
skin) contact between them. Or, the Staph can come off of the
infected skin of a person onto commonly shared objects and
surfaces, and get onto the skin of the person who uses it next.
Examples of commonly shared objects include personal hygiene
objects (i.e. towels, soap, clothes), benches in saunas or hot
tubs, and athletic equipment -- in other words, anything that
could have touched the skin of a Staph infected person can carry
the bacteria to the skin of another person.

"How can I prevent myself from getting infected? Avoid prolonged
skin to skin contact with anyone you suspect could have a Staph
skin infection. Do not share personal items with other persons.
Clean objects and surfaces that you share with other persons,
such as athletic equipment, before you use it. Always wash your
skin, clothes, and towels that might be carrying Staph.

"What should I do if I think I have a Staph skin infection? If
you suspect that you might have a Staph skin infection, consult
your doctor or healthcare provider as soon as possible. Early
treatment can help prevent the infection from getting worse. Be
sure to follow each direction from your doctor or healthcare
provider closely, even when you start to feel better. Weak or
incomplete treatments of Staph infections lead to stronger,
antibiotic-resistant bacteria.

"If my health care provider has told me that I have an
antibiotic-resistant Staph infection, what can I do to keep
others from getting infected? You can prevent spreading an
antibiotic-resistant Staph skin infection to those you live with
or others by following these steps:

"1. Keep the infected area covered with clean, dry bandages. Pus
from infected wounds is very infectious.

"2. Wash your hands frequently with soap and warm water,
especially after changing your bandages or touching the infected
skin.

"3. Regularly clean your bathroom and personal items. Wash
linens and clothes that become soiled with hot water and bleach,
when possible. Drying clothes in a hot dryer, rather than air-
drying, also helps kill bacteria in clothes.

"4. Tell any healthcare providers who treat you that you have an
antibiotic-resistant Staph skin infection.


***** Retroviruses Conference, Feb. 10-14; Sites to Watch for
News

The important 10th Conference on Retroviruses and Opportunistic
Infections is February 10-14, 2003, in Boston. We will report
some of the developments beginning in our next issue, #389.

Meanwhile, here are some Web sites that are likely to publish
reports during or shortly after the meeting:

* Official Retroviruses site,
http://www.retroconference.org/2003/

* The Body,
http://www.thebody.com/confs/retro2003/retro2003.html

* Clinical Care Options, http://www.clinicaloptions.com (new
site from experienced team, plans extensive reviews, CME)

* HIVandHepatitis.com, http://www.hivandhepatitis.com

* Medscape, http://www.medscape.com/viewprogram/2221

* HIV Insite, http://hivinsite.ucsf.edu/InSite.jsp?page=md-02-04

* Aegis, http://www.aegis.org

* National AIDS Treatment Activist Project, http://www.natap.org


***** Building Grassroots Support for AIDS

by John S. James

Today in the U.S. we are facing one of the worst climates ever
for access to medical care and social services for AIDS and
other needs. Government budget problems, combined with the
dysfunctional financing of medical care, are threatening
Medicaid, ADAP, and the long-standing agreement that most people
with HIV in the U.S. can get treatment.

For years the AIDS community has done well in the media and in
building public consensus on what needs to be done. But we have
been much less effective in grassroots organizing -- in giving
those who agree with us effective, satisfying actions for making
their values and priorities known. Perhaps 1% of U.S. citizens
who care about AIDS have *ever* let any of their political
representatives know it. So Congress, the White House, and state
and local governments seldom hear from their constituents back
home. And that hurts everything that happens in AIDS.

After watching this happen for years, I have become convinced
that we could do *much* better in mobilizing popular support, by
slightly refocusing some of what we are already doing. AIDS
organizations and activists already have the skills and
resources required.

Improving Action Alerts

As an example of what is needed, consider what must be changed
to improve Internet action alerts so that they are truly
accessible to everyone who cares, not only to experts or
insiders.

A year ago, it was clear that we were being hurt in Washington
because members of Congress were hearing about AIDS (especially
international issues) mainly from media and a few activists and
professionals, but not from the voters in their districts. Since
then important progress has been made. Now there are usually
several action alerts and sign-on letters circulating at any one
time. As a result, more people are contacting their
representatives, and AIDS is treated more seriously in political
circles.

These action alerts vary in quality and credibility. Some
include errors that could easily be fixed, such as misspellings
or obsolete information. More important are judgment issues that
are harder to detect -- such as whether the alert is based on a
thought-out, workable strategy, or only on somebody being upset
one day and wanting to do something. And many alerts try to get
people to act by hammering on how bad the problem is -- while
those most likely to respond already know this, but need help
with other obstacles.

The main problem is that unless people recognize a sponsoring
organization or already know the issue very well, they have no
way of knowing which action alerts they truly want to support.
Therefore many alerts that may look accessible (because they
correctly avoid jargon, abbreviations, or insider code meanings)
are still effectively available only to those already involved.
The general public, even those who completely agree on the
issues, cannot use them intelligently.

Even very experienced activists have sometimes had to retract
their endorsement of a campaign that turned out not to be what
it seemed. How can we expect people to speak out on our issue if
we do not negotiate the necessary credibility up front?

The Right Target Audience: Those Who Care But Are Not Already
Connected

Action alerts should be credible, feasible, and rewarding to all
who agree on the issue -- not just AIDS specialists. Here are
some pointers:

* Any action request or other grassroots campaign should be
designed for a target audience -- not for no one in particular.

For most alerts, we suggest addressing someone who already
agrees on that issue, but may live miles away from the nearest
AIDS organization or activist, and not personally know anyone
involved. Imagine also that this person wants to bring the alert
to his or her church group, civic or political club, or other
social circle -- also non-experts. An action alert package must
provide exactly what is needed to do so. Probably it will
include a one-page explanation, plus a background document (or
Web link, preferably to a page designed for that campaign) for
anyone who wants more information.

People usually join causes not as individuals, but as members of
social circles. Therefore, campaigns should facilitate group
involvement, as well as helping individuals who want to act on
their own.

* The action alert should be based on human values and not
assume special knowledge of facts, or of their special
significance. If it does include facts, these should be
separated from the action item, so that people are not asked to
sign someone else's research. Otherwise the alert will lose
supporters unnecessarily, because many will feel that they do
not have enough background to publicly endorse the factual
statement. For example, everyone would agree that children
should not die, but not everyone would sign a statement saying
that 610,000 children under 15 died of AIDS in 2002.

* The way to make an action alert credible to the general public
is to negotiate it in advance among different organizations
and/or public figures, including some that are widely known and
respected by the general public (such as Doctors Without
Borders, which recently won a Nobel prize), or major churches,
or popular celebrities. This may seem like a lot of work, but in
fact it is already being done. For years AIDS organizations have
developed sign-on letters, often endorsed by over a hundred
well-known organizations, including both AIDS and non-AIDS
health, political, religious, and other groups.

These sign-on letters do help. But unfortunately they waste most
of their potential, because once they are released they are
finished. They do not involve the public because they give
people no chance to act. Usually the letter and signatures are
delivered to some office, and perhaps a press release goes out.
Then it is all forgotten, because there is no follow-through.

On the other hand, most action alerts do have the follow-through
in public involvement -- but did not bother with consensus
development. Generally they are sent out by one organization
that is all but unknown outside the AIDS field. No wonder they
cannot generate many letters, phone calls, or other actions
requested, since only AIDS specialist can be confident that the
action request is credible.

Imagine what could be done by combining consensus development
with actions that any supporter could take. These action alerts
could break out of AIDS circles and reach many more people.

* One way to make it much easier for someone to bring an action
alert to his or her church group (for example) is to get a
national office of that church to endorse it. Then all the
members of the national group have an occasion to bring the
matter up if they want to.

The way to get organizations to work together on a citizen-
action campaign is to reach a meeting of the minds first. This
requires ongoing dialog to discover areas for working together.
Instead of bringing a finished product or preconceived plan, see
what can be developed mutually. The AIDS catastrophe affects so
many people and organizations that the opportunities for working
together are endless.

* Once this groundwork is done, one still must tell people about
their opportunity to help. Reaching the public is a separate
challenge. But there are self-starters who can pick up an issue
from a friend's email or a newspaper, without needing an
organization to provide someone to hold their hand. And we can
publicize campaigns by coordinating them with major news
stories.

* We should pay attention to developing actions that fit
gracefully into peoples' lives. We need to understand and
address their real reluctances to act. Contacting state or
federal political representatives, civic or political
organizations, corporate offices, etc. should not be a high-
anxiety chore.

Perhaps citizen action could become a practice worth doing for
its own sake -- designed to guide us through effective styles of
everyday living. Imagine a discipline like Tai Chi, only built
on interpersonal moves instead of physical ones. (This writer
started a Web site to explore the possibility,
http://www.communicationpractices.org.)

The bottom line is that by properly targeting our action
campaigns, and negotiating the right consensus and sign-on in
advance, we can involve many more people than before -- without
necessarily building a major national grassroots organization,
something the AIDS community has not yet been able to do. Better
use of the skills we already have could increase public response
many times over. We are addressing people who already agree with
us on the issues. The critical need now is to provide specific
actions that truly work for them.


***** Bush Proposes Near Tripling of U.S. Commitment on Global
HIV Epidemic

by John S. James

In what is widely seen as a groundbreaking advance, President
Bush proposed additional U.S. funding of almost $10,000,000,000
over the next five years for fighting the global HIV epidemic.
The president made this unexpectedly major announcement in the
State of the Union speech on January 29, 2003. If appropriated
by Congress, the money would bring the total spending over five
years to about to about $15,000,000,000. The measure will have
strong bipartisan support, but passage is not assured.

The proposed U.S. initiative is for 14 countries, 12 of them in
Africa, that together have about half of the HIV-infected people
in the world. Over five years, it aims to prevent 7,000,000 new
HIV infections (60% of the number projected for those
countries), treat 2,000,000 people with HIV, and care for
10,000,000 HIV-infected individuals and AIDS orphans. (The
countries are Botswana, Cote d'Ivoire, Ethiopia, Guyana, Haiti,
Kenya, Mozambique, Namibia, Nigeria, Rwanda, South Africa,
Tanzania, Uganda, and Zambia; for initial ideas on how the
program may work within these countries, see the January 29,
"Fact Sheet; the President's Emergency Plan for AIDS Relief" at
http://www.whitehouse.gov/news/releases/2003/01/20030129-1.html
-- check later information if available). The program will start in
fiscal year 2004 (the U.S. government fiscal year 2004 begins
October 1, 2003), with funding expected to begin slowly and ramp
up in later years. This proposal is not finished, and much is
being worked out now in discussions among the White House,
Congress, and global AIDS and health organizations.

The announcement came as a surprise even to members of Congress,
and European and other governments -- apparently because
President Bush and his administration were weighing many factors
and were not sure what HIV program (if any) would be announced
until shortly before the speech. It was known that
administration officials and AIDS experts had been working
quietly for months to develop an initiative to address the
global epidemic. We have heard that President Bush was given
several proposals, and chose one (the one, incidentally, with
the largest total funding). This plan includes a comprehensive
prevention program (including abstinence and condoms), and an
equal emphasis on prevention and treatment, including
antiretrovirals.

This high-profile announcement is already changing the tone of
the discussion, with talk in Washington shifting from whether
there should be a larger U.S. program to how to make it work. A
key issue is getting European and other donor nations to also
increase their commitment to fighting an epidemic that could
kill a third of the entire population of many countries, and is
spreading rapidly today in huge populations in Asia and Eastern
Europe.

Some Widespread Criticisms

While the announcement was universally welcomed and the plan is
considered credible, there have also been some widespread
concerns:

* Even if Congress acts favorably, this plan will not formally
start until October, and then will build slowly as the U.S.
negotiates and develops new management and oversight structures
in the 14 countries instead of using what is already available.
Meanwhile, the Global Fund to Fight AIDS, Tuberculosis, and
Malaria, started by United Nations Secretary-General Kofi Annan
(and now to be headed by U.S. Secretary of Health and Human
Services Tommy Thompson), is running today and has excellent
proposals ready to go, delayed only by lack of money. But the
president's initiative de-emphasizes the Global Fund, and we
have heard that administration officials are lobbying Congress
not to provide more money. Either they want to see a track
record first, with statistical proof of results like number of
infections prevented, or they want to control the geopolitical
impact of the funding. In either case the result is more delay.
Yet in an epidemic, the best time to act is now.

Activists have, however, noted one advantage of the president's
initiative over the Global Fund. The new U.S. program is likely
to provide antiretroviral treatment to more people than the
Global Fund, which developed earlier when treatment was more
controversial. Today it is more widely recognized that treatment
must be included to make prevention work, since otherwise people
have no incentive to come forward for testing, or to help
organize prevention and care programs in their communities.

* Health and development experts are concerned that the
president's proposal is heavily weighted toward bilateral
agreements between the U.S. and each of the 14 countries,
instead of multilateral institutions like the Global Fund.
Multilateral approaches can better leverage contributions from
other donor countries, and coordinate the worldwide fight.
Separate donor programs could increase bureaucracy (including
multiple application and reporting requirements for the
recipient countries) and reduce effectiveness.

Instead of using the Global Fund or other international
agencies, the president's initiative calls for oversight by a
Special Coordinator for International HIV/AIDS Assistance, to be
confirmed by the Senate with a rank of ambassador, and report
directly to the Secretary of State. It includes some support for
the Global Fund, but only about ten percent of the total.
Development experts hope that this small support for
multilateral programs can be increased.

* The president's initiative proposed $10,000,000,000 in new
money and $5,000,000,000 being spent already, both over five
years. Where will the billion dollars a year in "old" money come
from? "Mr. Bush in his State of the Union speech proposed new
spending to fight AIDS and HIV in Africa and the Caribbean. But
his budget for 2004 would reduce by about the same amount the
funding that aides had said would be sought for a separate
development-aid initiative for poor nations," ("Budget for Hard
Times Offers New Plans but Many Cutbacks, by John D. McKinnon
and Greg Hitt, THE WALL STREET JOURNAL, February 4.)

The president's budget request, released February 3, includes
major cuts in child health and survival programs, which include
routine vaccination, according to the BOSTON GLOBE ("U.S. Seeks
Cuts in Health Programs Abroad," by John Donnelly, Feb. 5). "The
bottom line is with 10.5 million children dying around the world
each year from easily preventable causes -- things that could be
stopped at very low costs -- this is an area where the world
community has really dropped the ball over the last decade. When
you recognize that you have dropped the ball, you don't drop it
even further." (Nils Daulaire, Global Health Council, quoted in
the BOSTON GLOBE, February 5.)

Civil society and the public will have to watch these and other
issues closely. Certainly funding for AIDS must not come at the
cost of programs like child survival.

Community Support Needed

The president's proposal will need public support to make sure
that it is implemented and works as well as possible:

* Congress must decide whether or not to spend the money.
Members of Congress must hear from their constituents back home
that they care about the global epidemic. AIDS and health
organizations have generally been effective in working with
experts and the media, educating the public on the seriousness
of the epidemic and building consensus that this country must
help in the solution. They can and must do better in giving non-
experts practical ways to express their values and concerns --
to their political representatives, in their social circles, and
otherwise. (See "Building Grassroots Support for AIDS" in this
issue.)

* How can people get involved in helping? So far, much of the
non-government work in pushing government to make sure that
President Bush would have well-developed options if he decided
to have an AIDS initiative was done by the Advocacy Network for
Africa (ADNA), a group of 231 member organizations (as of
January 19, 2003; the list is at
http://www.africaaction.org/adna/adnalist.htm). Readers can look
over this list to find organizations they might like to work
with, and see if there is a program where they could help.

Also important is that evangelical Christians are becoming more
interested in AIDS in Africa, especially in the last year, and
more inclined to see the epidemic there as a health problem
instead of a moral one (see "Unlikely Allies Influenced Bush to
Shift Course on AIDS Relief," by Mike Allen and Paul Blustein,
WASHINGTON POST, Jan. 30). It is likely this change is happening
now because conservative Christianity is spreading rapidly in
Africa, and religious organizations see their members die --
often for reasons beyond their control, as when a faithful wife
is infected by her husband. Also, in February 2002, arch-
conservative Senator Jesse Helms told conservative Christians
that "I have been too lax too long in doing something really
significant about AIDS," and was going to keep AIDS in Africa on
his agenda for his remaining months in office. This new
involvement of evangelical Christians may have been key to a
national consensus that made the Bush proposal possible.

Comment: Is the Cup Half Full or Half Empty?

After the State of the Union speech, most AIDS experts and
activists saw the president's initiative as a major
breakthrough. Two weeks later they still see it that way,
although concerns like those above are widely stated. We see
this proposal as a big step forward, but one that needs public
involvement to help make it work.

One of the problems facing national leaders who want to work on
AIDS is their fear that they will be attacked no matter what
they do. This fear is realistic, because in fact most
governments and their leaders around the world have done
appallingly badly on AIDS. But if this is going to change, we
must have workable paths forward.

For these reasons we have chosen to emphasize the positive --
without denying that, as with any major new proposal, problems
exist and changes will be needed as the work goes forward.


***** African-Americans and AIDS, Conference,  Feb. 24 and 25,
New York

The 2003 National Conference on African-Americans and AIDS will
take place Feb. 24-25 at the New York Marriott Marquis in New
York City. This conference will focus mainly on treatment and
care, but include other topics as well. It offers continuing
education credit for physicians and nurses. Admission is $90 in
advance, $120 on site; some scholarships are available. This
conference is sponsored by The Foundation for Better Health
Care.

Speakers and panelists include:
Jean Anderson, M.D.
Guthrie Birkhead, M.D.
Victoria Cargill, M.D., M.S.C.E.
Charles E. Clifton
Keith Cylar
Elaine M. Daniels, M.D.,, Ph.D.
Thomas E. Douglas
Henry "Skip" Francis, M.D.
Debra Fraser-Howze
Robert Fullilove, Ed. D.
Donna Futterman, M.D.
Danny Glover
Barney S. Graham, M.D., Ph.D.
Wilbert Jordan, M.D.
Jake Liang, M.D.
Cleo Manago
Marsha A. Martin D.S.W.
Celia Maxwell, M.D.
Sandra McDonald
Bill Peters
Beny J. Primm, M.D.
Rep. Charles Rangel
George W. Roberts, Ph.D.
Pernessa Seale
Cheryl Smith, M.D.
Valerie Stone
Glenn Treisman, M.D., Ph.D.
Darrell Wheeler, Ph.D.
Phill Wilson
Jonathan Zenilman, M.D.

For more information visit http://www.ncaaa.net, or contact:
The National Conference on African Americans and AIDS
c/o ExpoTrac
PO Box 1280
Woonsocket, RI 02895
phone 410-766-4142, fax 401-765-6677.


***** 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
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 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
available (see below). Back issues are available at
http://www.aidsnews.org

To subscribe, you can call 800-TREAT-1-2 or 215-546-
3776:
* 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 2003 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
www.aidsnews.org

AIDS TREATMENT NEWS Issue #387, December 27, 2002
     phone 800-TREAT-1-2, or 215-546-3776

CONTENTS

** ADAP and Medicaid Financial Emergencies Growing
Advocates are trying to limit the shortfalls that are
keeping more and more people from getting medically
necessary treatment.

** Smallpox Vaccination Followup: IOM Suggests Changes,
Widespread Civilian Vaccinations to Begin
A new report from the prestigious Institute of Medicine,
asked by the government to study smallpox vaccination
program, urged several changes.

** Boston: Community Forum on Retroviruses Conference, Feb. 14
Search for a Cure organized this report to the community on
new treatment information from the 10th Conference on
Retroviruses and Opportunistic Infections -- which takes
place in Boston this year and ends February 14.

** AIDS TREATMENT NEWS Backdated for This Issue
Our traditional year-end issue was late this year; we
backdated it to December, but are reporting the news as of
late January, when we went to the printer.

** Buyers' Club List, December 2002
Our annual list of AIDS-related buyers' clubs and contact
information.

** Index 2002, AIDS TREATMENT NEWS
Our annual index for 2002.


***** ADAP and Medicaid Financial Emergencies Growing

by John S. James

January 21, 2003: Advocates are working urgently in
Congress and state legislatures to prevent decisions that
could ultimately deny access to medical care to millions of
low or middle income Americans with HIV or other illnesses.
As this issue goes to press:

* 140 AIDS organizations have sent a consensus letter to
each U.S. Senator, asking for $162 million in additional
funding for ADAP and other Ryan White programs. The letter
notes that many states already have waiting lists for
people needing medication under this program -- and Texas
may drop many patients already on antiretrovirals. The
letter notes that the reason for the crisis is that more
people are living longer due to HIV treatment, and also
that new drugs are becoming available.

* On January 17, four U.S. Senators, including, one
Republican, co-sponsored a dear-colleague letter on ADAP
and Ryan White funding -- addressed to the Chairman and
Ranking Member of the Senate Subcommittee on Labor, Health
and Human Services, Education. It will be open for
additional signatures by Senators for at least several more
days.

* These letters list states that now have waiting lists for
people who need treatment for HIV or AIDS -- and note that
Texas is considering cutting off as many as 2,500 people
currently receiving treatment through ADAP by June 1 (by
retroactively changing eligibility rules so that some of
the people already in the program will no longer qualify
for ADAP in Texas).

* In Oregon, 12,000 people will lose Medicaid coverage,
including almost 400 with HIV or AIDS. Advocates there are
developing a weekly update to provide facts and reduce
rumors and speculation.

* We are starting to hear of herbal and other "alternative"
treatments being considered for those who can no longer
afford standard medical care.

* States across the U.S. are facing their worst budget
crisis in over half a century -- while the Federal
government has also gone from large surpluses to large
deficits, even before another war against Iraq.

What Zackie Achmat recently said about South Africa will
increasingly apply to the United States: "The country is
realizing that people can actually buy life, and that this
is unacceptable" (quoted in THE NEW YORK TIMES, January 13,
2002).

What You Can Do

Millions of Americans already agree about the importance of
the AIDS epidemic, and of access to healthcare, but
probably 99% of them have *never* been heard by their
political representatives, or in any public way. While
specialists and organizations are already doing excellent
work, we urgently need new advocacy campaigns designed to
allow anyone to help, whenever and however they can. These
campaigns need more accessible Web sites and action alerts.
But even more importantly, they need political discussion
and negotiation among AIDS and other organizations, to
develop common actions signed onto by many of the most
trusted organizations and individuals working in health.

Fortunately AIDS advocacy already has a long tradition of
consensus letters, often signed by dozens of major
organizations. But then the letter is delivered to some
official, and perhaps a press release goes out, but that's
it. Usually these campaigns have had no role for
individuals or groups who want to help but cannot be
heavily involved. We need similar consensus development for
campaigns that the public can run with.

Such campaigns will enable hundreds of thousands of
citizens to communicate at least occasionally with their
federal, state, and local representatives. Congress and
other officials will know that these people care about AIDS
and health, greatly improving government commitment and
political will. Millions of people already agree on the
issues. They need better opportunities to act.

Meanwhile, here are some places to start:

* Check in with AIDS organizations in your area to see what
they are doing, or how they suggest you get involved. This
year many statewide advocacy programs will come together in
response to the funding emergencies. Statewide campaigns
can work with others on Federal issues as well.

* Get to know your political representatives' main
interests, and the staff person(s) handling health.
Sometimes it is better to work with the local office staff,
as they are usually more accessible and less rushed than
those in Washington. Let them know that you are interested
in health, and AIDS. Maybe they can help you understand
what is happening in Congress in these areas. You do not
need to wait for an action alert, since you may want to
start building a working relationship before you need to
ask for a vote.

To find the names and contact information of your
representative and your state's two senators, see
http://www.congressmerge.com/. This site also has
background information -- including short, practical
guidelines for communicating effectively with Congress. And
you may want to be informed about your representatives'
committee memberships and other major interests, even
outside of the health area.

* To receive national alerts on AIDS treatment access
issues (about one per month), join the Treatment Action
Network of Project Inform, http://www.projectinform.org/.

* For much more detail on current campaigns, join ATAC, the
AIDS Treatment Activists Coalition,
http://www.atac-usa.org/ -- especially the Save ADAP email
list (currently about 10 emails per day).

We will closely follow advocacy and activism in 2003, and
let you know as consensus-based, user-friendly campaigns
are developed.


***** Smallpox Vaccination Followup: IOM Suggests Changes,
Widespread Civilian Vaccinations to Begin

by John S. James

January 21, 2003: The first phase of voluntary civilian
smallpox vaccinations -- for about 500,000 persons who will
serve in first-response teams in case of a smallpox attack
-- is expected to start in a few days; later, "phase II" will recommend
voluntary vaccination for up to 10,000,000
healthcare workers and others. On January 17 the
prestigious Institute of Medicine released a number of
recommendations for changes in the program. The IOM report,
which had been requested by the U.S. Centers for Disease
Control and Prevention (CDC), is available at
http://nationalacademies.org/, along with a press release
summarizing important concerns and recommendations.

People with HIV must not be vaccinated against smallpox
(unless there is a smallpox attack, in which case the risks
and benefits would have to be reconsidered -- or unless a
safer vaccine is developed, which will take years). Many
others should not be vaccinated as well. In fact, about 30%
of the U.S. population is believed to have one or more
contraindications, and should not be vaccinated. And since
this vaccine contains a live virus, persons with HIV or
other contraindications need to avoid close contact
(especially household contact) with those who have been
vaccinated recently, probably for two to three weeks.

Here are some of the concerns reflected in the IOM report
that our readers should know about:

* Compensation: Who will cover medical and other expenses
in case of adverse reactions to the vaccine, or to catching
the vaccinia virus from someone recently vaccinated? The
Homeland Security Act of 2002 provides a Federal system of
compensation for vaccine injuries, but only in cases of
negligence in its manufacture or administration (thus
shielding the manufacturer from liability). But in cases of
adverse reactions where there is no negligence, currently
each state is being left to decide about compensation, if
any. The IOM report recommends that the CDC try to "clarify
each state's workers compensation program's position on
coverage for smallpox vaccine-related injuries and
illnesses for workers covered under their programs" -- and
in other ways to quickly resolve the compensation problem.

[In our view, the compensation issue shows a serious
corruption in modern U.S. society -- that governments and
corporations use their power to wash their hands of a
public expense and leave it to those least able to pay, in
this case the individuals who become ill from adverse
reactions. The cost of adverse reactions in this Federal
program is clearly a Federal responsibility. We do not need
50 different state systems of rules and litigations,
designed under the pressure of the worst state budget
crisis in 50 years. Private insurance also may find ways to
evade responsibility, under "acts of war" or other clauses.
Congress and the president can fix this problem, perhaps by
amending the Homeland Security Act to deal with non-
negligent vaccine injuries as well as negligent ones.]

* The IOM report recommends that the CDC use an existing
system to actively look for adverse events, instead of
waiting passively for such reports to come in. It supports
the use of a data safety monitoring board, which is
currently planned, but wants it to be more independent of
government agencies.

* Consent forms must clearly explain the risks of
vaccination, and the status of compensation in case of
adverse events. (Current government planning is to leave
consent forms as well as compensation up to the states.)

* There should be a pause between phase I (500,000
vaccinated) and phase II (10,000,000 vaccinated), to allow
for evaluation and corrections if necessary.

* The CDC should prepare educational material for household
contacts of persons to be vaccinated -- realizing that some
of them will be unwilling to disclose contraindications
such as HIV or pregnancy, and will need information on how
to protect themselves. And those being vaccinated should
have confidential opt-out provisions, like blood donors do,
so that people will not be socially pressured to receive
the vaccine, despite contraindications they are unwilling
to disclose. (Blood donors who suspect they might have HIV
or other undisclosed illness, but have been pressured to
donate and are unwilling to opt out in front of others, can
quietly check a box on a form and continue through with the
donation process, knowing that their blood will never be
transfused into anybody.)

Note: Healthcare Workers Vaccination, HIV Testing and
Disclosure

On January 15 Lambda Legal, AmFAR, and the Gay and Lesbian
Medical Association issued a joint statement on HIV testing
and disclosure during the vaccination program. It is
available at:
http://www.thebody.com/lambda/smallpox_vaccine.html


***** Boston: Community Forum on Retroviruses Conference,
Feb. 14

Search for a Cure will sponsor a free community forum on
treatment news from the important 10th Conference on
Retroviruses and Opportunistic Infections, on the last day
of the conference, February 14, 1-3 p.m. at the Sheraton
Boston hotel. Lunch will be provided. Advance registration
is required; to register, call Search for a Cure, 617-536-
2474 (OK to leave a message if necessary), or register by
email, hope@.... In either case include your name and
a way to contact you, and note that you are registering for
the community meeting on February 14th.

The summary on new treatment information will be presented
by Cal Cohen, M.D., with a panel including Sigal Yawetz,
M.D., and treatment information specialists Jules Levin of
NATAP, George Carter of FIAR, and John S. James of AIDS
TREATMENT NEWS. This meeting is funded by Search for a
Cure; the Retroviruses conference donated the room.

For more information on Search for a Cure, see
http://www.searchforacure.org/.


***** AIDS TREATMENT NEWS Backdated for This Issue

Our 2002 year-end issue was delayed, so this issue was
backdated December 27, 2002 (the last Friday of the year),
although it actually went to the printer on January 23,
2003. We used the December date so the year-end 2002 index
will be filed correctly with the other 2002-dated copies in
libraries, consistent with previous years. However, the
news reported in this issue is current as of late January.

The backdating will not affect the total number of issues
received by subscribers.


***** Buyers' Club List, December 2002

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 involve an annual fee,
or be restricted geographically or in other ways). Call
ahead for current information.

Arizona

Being Alive Buyers' Club
http://www.apaz.org/ (click "Buyer's Club")
chadO@... or robertS@...
1427 North Third St., Phoenix AZ 85004
602-253-2437x136 or x138, fax: 602-253-5577

Travis Wright Memorial Buyers' Club
Southern Arizona AIDS Foundation
http://www.saaf.org/
wellness@...
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.coop/ (or
http://www.rainbowgrocery.org/)
vitamins@...
1745 Folsom St., San Francisco CA 94103
415-863-0620

Colorado

Denver Buyers' Club
pwacolo@...
1290 Williams St., Suite 102
Mailing address: P.O. Box 300339, Denver CO 80203-0339
303-329-9379, fax: 303-329-9381
Bilingual Spanish/English     TTY: through operator

District of Columbia

Carl Vogel Center
cvchiv@...
1012 14th St. NW, Suite 700, Washington DC 20005
202-638-0750, fax: 202-638-0749
Membership: annual cost $25 (includes a BIA test,  reduced
prices for massage and acupuncture, an educational
symposium,  a newsletter, and reduced prices for
supplements).
The Carl Vogel Center now offers mental health services and
treatment education.

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: 404-450-9412

Massachusetts

Treatment Information Network's/Boston Buyers' Club
http://www.bostonbuyersclub.com/
info@...
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@...
119 W 23rd St., Suite 404, New York, NY 10011
212-255-9280
fax: 212-255-9280
Note: The largest buyers' club in the United States.
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/
info@...
3400 Montrose Blvd. #604, 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.


***** Index 2002, AIDS TREATMENT NEWS

Aaron Diamond Research Center 384
Abbreviated Guide ... HIV 380
Access to care 387
Achmat, Zackie 387
ACT UP 385
ACTG 384 trial changes 382
Activism 377
Activism 379
Activism 385
Activism 387
ADAP crisis 381
ADAP crisis 382
ADAP crisis 386
ADAP crisis 387
ADAP waiting list advice 381
ADAP 380
Advocacy 387
African Services Committee 385
AIDS Drug Assistance Program (see ADAP)
AIDSWatch lobbying 380
Amprenavir approved 378
Anti-HIV factor 384
Atazanavir 379
Avascular necrosis 379
Barcelona conference take-home messages 382
Barcelona conference visa problems 381
Barcelona conference Web sites 381
Barcelona online reports 382
Benefits issues 377
Bone problems 379
Buyers' club list 387
Chinese activist, Dr. Wan Yanhai 383
Coca-Cola protest 384
Conferences and meetings list 378
Congress 387
Cost of international conferences 381
Counterfeit drugs 380
C-Reactive Protein 385
d4T -- side effects 378
d4T and lipoatrophy 378
Deca Durabolin availability problems 381
Defensins 384
Doctors Without Borders 385
Doha, Qatar 386
Drug interactions 377
Drug pricing 377
Efavirenz once daily 378
Epogen 380
Facial injections 378
Fundraising 377
FUZEON (see T-20)
Global Fund 379
Government AIDS Web site 386
Grossman, Dr. Howard, interview 383
Guidelines on metabolic complications 385
Health GAP 385
Heart disease prevention 377
Heart disease 385
Hepatitis C 384
HIV harm reduction 384
ICAAC conference, clinical trials 384
Integrase inhibitor 379
Intellectual property 385
Intellectual property 386
Interactions of drugs 377
Johns Hopkins short guide 380
Junk foods 377
Kaiser, Jon, M.D.  383
Lactic acidosis 378
Legal issues 377
Lipoatrophy -- drug changes 378
Lipodystrophy strategies 383
Marijuana lung report 385
Marijuana 379
Measles may suppress HIV 379
Medicaid crisis 387
Medicaid funding 380
Medical privacy rules 379
Medical research funding 377
Metabolic complications -- guidelines 385
MSF (Doctors Without Borders)  385
Nandrolone availability problems 381
Nandrolone generic 382
NATAF conference 382
NDRI (National Disease Research Interchange) 385
Network of People ... Nigeria 385
Neuromuscular weakness 378
Nevirapine patient assistance program 385
New drugs at Retroviruses conference 379
Nigeria -- patent meeting 385
Nonoxynol-9 dangers 381
Nonoxynol-9 dangers 384
Once-a-day dosing 383
Oxfam 385
Patents on pharmaceuticals 385
Patents on pharmaceuticals 386
Patient assistance programs 385
Peginterferon (hepatitis C) 384
PHATAM (Pan African HIV/AIDS Treatment Access Movement)
	 383
Philadelphia, AIDS Education Month 380
Political organizing 387
Prevention -- tenofovir 385
Pricing of drugs 377
Protease inhibitors 383
Remune controversy 380
Resistance testing 383
Retroviruses conference 378
Retroviruses conference 387
Retroviruses conference, Web coverage 378
Ribavirin (hepatitis C) 384
S-1360 integrase inhibitor 379
Search for a Cure 387
Serostim 380
Smallpox vaccination begins 386
Smallpox vaccination questions 387
Superinfection risk 383
T-20 383
T-20 384
Tenofovir access in poor countries 386
Tenofovir for prevention 385
Tenofovir 377
Tenofovir 383
Tipranavir 379
Tissue donation 385
TMC125 379
Topoisomerase inhibitors 379
Treatment Action Movement of Nigeria 385
Treatments, misc. experimental 377
U.S. government AIDS Web site 386
Vaccine Research Center, NIAID 385
Vaccine trial 385
Viread 377
Visa problems 381
Wan Yanhai released 384
Wan Yanhai 383
WTO trade rules 386

***** 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 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
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
available (see below). Back issues are available at
http://www.aidsnews.org

To subscribe, you can call 800-TREAT-1-2 or 215-546-3776:
* 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 2003 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
www.aidsnews.org

AIDS TREATMENT NEWS #386, December 20, 2002
    phone 800-TREAT-1-2, or 215-546-3776

CONTENTS:

** Smallpox Vaccination Begins in U.S. -- Precautions Needed
People with HIV and certain other medical conditions must avoid
smallpox vaccination, and also vaccinia infection from others
who have been vaccinated recently.

** U.S. Blocks Trade Agreement on Generic Drug Access in Poor
Countries
Governments can override patents for legitimate purposes,
including public health. But many small or poor countries have
no pharmaceutical industry to manufacture medicines themselves,
and global trade rules being phased in will prevent others from
exporting to them without the patent holder's permission.
Negotiations to solve this problem broke down when the U.S.
insisted that any agreement apply only to AIDS, tuberculosis,
malaria, and similar major epidemics -- excluding cancer, heart
disease, and hundreds of other diseases.

** Tenofovir (Viread(R)) Access for Poor Countries
Gilead Sciences announced that it will make its drug tenofovir
available at cost in all of Africa, and in some of the poorest
countries elsewhere.

** ADAP Crisis: Sign-On Letter for Organizations, Before January
6 If Possible
The AIDS Drug Assistance Program is facing its worst crisis
ever. Advocates are asking for organizations to sign a consensus
letter to be faxed to Congress.

** Retroviruses Conference: Caution, January 10 Housing
Deadline; Registration Still Open
Even if you have been accepted to the Retroviruses conference
and do not need housing there, you must complete the housing
process by January 10 to prevent your registration from being
cancelled.

** New Government AIDS Web Site, Phone Number
A new site, www.aidsinfo.nih.gov, has government-approved
treatment information, as well as searchable listings of
government and private clinical trials.


***** Smallpox Vaccination Begins in U.S. -- Precautions Needed

by John S. James

On December 13 President Bush announced that the U.S. will begin
a smallpox vaccination program. It will be mandatory for about
500,000 military personnel, with voluntary but recommended
vaccination for over 400,000 civilian health-care workers most
likely to encounter smallpox in case it is spread deliberately.
A few in the military started receiving the vaccine immediately;
the program for civilian health workers may start in January.
Eventually, vaccination might be recommended for as many as 10
million health and emergency workers in the U.S.

People with HIV or certain other medical conditions -- probably
millions of Americans -- cannot be vaccinated safely because the
vaccine uses a live virus, called vaccinia. Vaccinia can cause a
dangerous infection, especially in persons with immune
deficiencies. Persons at risk from vaccination need to be aware
of other precautions as well, since one can get this infection
not only by being vaccinated, but also by close contact
(especially household contact) with someone who has been
vaccinated within about three weeks. Vaccinia can be spread by
contact with someone's vaccination site, or contact with
materials that have touched the site. If vaccinia infection does
occur, there are recommended treatments -- VIG (vaccinia immune
globulin), and cidofovir, an approved drug that can have serious
side effects -- but the infection can be fatal despite
treatment. Hospitals are concerned that their healthcare workers
who get vaccinated could infect patients, many of whom have
immune deficiencies. Some hospitals may send vaccinated staff
home during the two to three weeks they could be contagious,
some may decide just to keep them out of certain wards, and a
few have refused to participate in the national vaccination
program.

In case of actual exposure to smallpox, or cases found anywhere
in the world, vaccination might be worth the risk even for many
who would otherwise be screened out. Fortunately, vaccination
does protect against smallpox even if it is given shortly after
exposure (in the first three days if possible). Therefore most
people can wait, and decide about vaccination only if a smallpox
outbreak occurs.

New kinds of smallpox vaccines are being tested. Some of them
may be safe enough for many people with HIV or others who should
not get the current one.

A much smaller program is starting in England, vaccinating about
300 healthcare workers against smallpox. Israel recently
vaccinated about 17,000 medical and rescue workers in
preparation for a U.S. war on Iraq -- apparently with little
problem from side effects. We have not heard of smallpox
vaccination plans in other countries.

For More Information

The U.S. government is planning a massive public education
campaign about smallpox vaccination. This information is being
prepared by leading experts and will probably be the best
available. Until it is ready, those wanting recent information
can check the following. (Note: We published these links on
December 23, 2002. Be sure to look for more recent information.)

* On December 13 the White House issued a question-and-answer
document about the vaccination program; it is at:
http://www.whitehouse.gov/news/releases/2002/12/20021213-3.html

* The American Public Health Association published an interim
policy statement at:
http://www.apha.org/legislative/policy/smallpox.htm
and a press release on the new White House plan at:
http://www.apha.org/news/press/2002/smallpoxresponse.htm

* The NEW ENGLAND JOURNAL OF MEDICINE is publishing several
articles about smallpox in the January 30, 2003 issue, but has
released them early at:
http://nejm.org/earlyrelease/early.asp

* Three articles in the December 20 SCIENCE (these require a
subscription or payment to read online):
"Rough-and-Tumble Behind Bush's Smallpox Policy,"
http://www.sciencemag.org/cgi/content/summary/298/5602/2312?etoc
"Treating Vaccine Reactions: Two Lifelines, But No Guarantees,"
http://www.sciencemag.org/cgi/content/summary/298/5602/2313?etoc
"Looking for Vaccines That Pack a Wallop Without the Side
Effects,"
http://www.sciencemag.org/cgi/content/summary/298/5602/2314?etoc

* JAMA (JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION) recently
published an article on the risk of getting an infection from
someone who has recently been vaccinated; see "Contact Vaccinia
-- Transmission of Vaccinia from Smallpox Vaccination," October
16, 2002. Note that this article is based on experience from
before the HIV epidemic.

* For detailed practical information see The Military Vaccines
Web Site:
http://www.vaccines.army.mil/smallpox.asp

Comment

So far the vaccination program is mostly getting good medical
reviews. Public health experts are especially relieved that it
is not trying to vaccinate the whole population, as some had
proposed.

No one knows the risk of an attack. The case for the program is
that if smallpox does occur, there will be teams already
vaccinated and ready to respond -- and equally important, some
current experience in large-scale vaccination and a program that
is ready to go, allowing many more people to be protected
quickly if necessary. The U.S. already has enough doses to
vaccinate everyone in the country, even before new vaccine is
manufactured.

The world is not as lucky. "Last year epidemiologists were very
concerned to learn that the WHO's vaccine safety net of 200
million doses had been destroyed in the late 1980s when the
United States withheld funds and the agency was unable to pay
$50,000 to refrigerate the supply." (Lawrence Brilliant, M.D.,
"Are We Safe? Halting the Next Plague," THE OPRAH MAGAZINE, June
2002.)

It is strange to plan for smallpox in a vacuum, disconnected
from how we got into this situation or how to avoid it in the
future. But the vaccination program is a fact, and everyone with
HIV or certain other medical conditions will need to consider
precautions.

Be sure to get the latest information. This article, published
in late December 2002, will soon be obsolete.


***** U.S. Blocks Trade Agreement on Generic Drug Access in Poor
Countries

by John S. James

On December 20, international trade talks in Geneva, Switzerland
failed to resolve the major remaining issue on access to generic
versions of patented medicines in developing countries to meet
public-health needs. All 143 other countries were ready to
accept a compromise text negotiated on December 16. But the U.S.
insisted on an additional restriction -- to limit the agreement
to AIDS, tuberculosis, malaria, and similar major epidemics.
Cancer, heart disease, asthma, and hundreds of other illnesses
would have been excluded. Developing countries would not accept
this restriction, and European countries did not want to re-open
the difficult negotiations.

All treatment activists we have heard from think that the
compromise, which was reluctantly agreed to by poor countries,
would have been harmful. They feared that it would create a
cumbersome process, easily open to obstruction, that would
rarely or never be used to help anyone obtain medicine, while
damaging some of the understandings in place. Some feared it
could threaten or even end the historic consensus reached last
year by the world's governments that trade rules should not be
an obstacle to public health. Negotiations will start again in
early 2003, attempting to reach agreement by February 11.

Background

Traditionally patent laws were decided separately by each
nation, not by international organizations. And until about
1995, while patents on pharmaceuticals were widely recognized
among rich countries, they were not uniformly binding on
developing countries. But starting with the World Trade
Organization (WTO) treaty in 1995, almost every country on Earth
was pressured to sign on to a set of trade rules that included
pharmaceutical patents. These rules established deadlines for
developing countries, and required full compliance by 2006
(later extended to 2016 for least-developed countries). Patent
holders can set whatever price they want, and apparently no
thought was given to the fact that major corporations would
regularly price life-critical new drugs totally out of reach of
most of the world's people.

Current WTO rules allow a country to override a patent to meet a
legitimate public need, under certain conditions, through a
mechanism called compulsory licensing. But within a few years
the existing rules may block export for compulsory licensing,
stopping its use in any country not big enough and rich enough
to have its own domestic pharmaceutical industry. The Geneva
negotiations that just failed were called to deal specifically
with this production-for-export problem.

In November 2001 in Doha, Qatar, all the countries in the trade
negotiations agreed that WTO rules would not prevent countries
from taking measures to protect public health (the United States
reluctantly signed on in order to keep the negotiations moving).
Developing countries were promised that the export problem would
be corrected in 2002, presumably in accordance with the Doha
agreement. But several rich countries -- the U.S., Canada,
Japan, the European Union, and Switzerland -- pushed for
restrictions on behalf of their pharmaceutical companies.
Developing countries this month were pressured to accept these
harmful restrictions. But they drew the line at caving in to the
disease limitation finally demanded by the United States.

Shortly after rejecting the agreement, the U.S. said it would
not bring action against certain drug exports while the talks
continued. This statement was widely seen as a public-relations
move unlikely to have any practical effect. For generic
manufacturers must get drug approvals in each country, and deal
with other time-consuming and expensive obstacles as well,
before export can happen. They need stability and are unlikely
to base business decisions on a unilateral statement designed to
look good, but that can be taken back any time.

For more information see news reports in the WASHINGTON POST
("Talks on Low-Cost Drug for Poor Nations Stall," by Paul
Bluestein, December 21), THE NEW YORK TIMES ("Trade Talks Fail
to Agree on Drugs for Poor Nations," by Elizabeth Becker,
December 21), THE GUARDIAN (UK) ("U.S. Wrecks Cheap Drugs Deal,"
by Larry Elliott and Charlotte Denny, December 21 -- which
reported that Vice President Cheney apparently made the decision
not to accept the compromise), THE WALL STREET JOURNAL ("U.S.
Retreats from Earlier Move to Keep Drugs from Poor Nations," by
Michael M. Phillips, December 23), or other newspapers and wire
services. For a more detailed description of the negotiations
see INSIDE U.S. TRADE ("TRIPS Draft Strikes Balance on Many
Issues, but Isolates U.S. on Scope," December 20).

Quotes

"We're basically talking about a system that could help save
millions. If a good system isn't created, you can imagine a
world a few years from now where multinational companies control
the patents for everyone." (Ellen 't Hoen of Doctors Without
Borders, quoted in THE NEW YORK TIMES, December 21.)

"President Bush wants to argue that the diseases American
children receive treatment for are off limits to poor children
in poor countries, but they cannot win that argument." (James
Love, director of the Consumer Project on Technology, quoted in
THE NEW YORK TIMES, December 21).

"You have to ask yourself, are you going to have a patent system
or not? If you're going to permit people to import drugs to
treat cancer, diabetes and heart disease, what are you going to
do when someone says, I want Viagra on the list?" (Unnamed U.S.
trade official, quoted in the WASHINGTON POST, December 21.)

Comment: Issues Needing Attention

* Pharmaceutical patents are unique in ways that need more
recognition. For example, they rely on human trials where
patients may risk their health or even their lives to test an
experimental drug. And if the trial is successful, it cannot be
repeated for another drug for the same illness, as that would
involve giving people a treatment then known to be less than the
standard of care. Vaccines in particular may be tested in
thousands of people; once they are known to work, how could a
similar vaccine ethically be tested on other thousands? In
addition, patents today often claim natural substances that are
part of the human body, for which there may be no biological
workaround. And needless to say, medical patents are more likely
than others to be life-critical.

We do not argue that pharmaceutical patents should be abolished,
but that they involve unique social responsibilities -- which
the multinational corporations have so far largely dismissed. If
industry continues to obstruct instead of helping to build
systems that work for people, it is our duty as citizens (of the
United States especially) to prevent our government from being
used as a tool by irresponsible corporations to bully others.

* The Geneva negotiations that failed in 2002 will continue in
2003, writing rules that may become law all over the world for
years to come. In developing these rules, everyone needs to be
aware that we are near the beginning of an era of unprecedented
progress in medicine. So far the great advances in biological
understanding have been poorly translated into practical
treatments, but that will change. Imagine the consequences if
penicillin and all other antibiotics had been denied to most of
the world for ten to 20 years for intellectual-property reasons;
then imagine this happening again and again in cancer,
Alzheimer's, diabetes, and other major diseases.

* Patent or no patent, companies are not interested in regions
too poor to support a lucrative market. And in the poorest
countries, most people cannot pay even generic prices out of
pocket. What patents do in these areas is to deprive both
governments and non-governmental organizations of tools they
need to reduce the burden of disease -- with little or no
compensating benefit to anyone. Trade negotiators, in seeking
"balance" between pharmaceutical companies and poor people
needing treatment, may have overlooked the extent to which the
world's richest companies can litigate a molehill into a
mountain.

* Patents might conceivably be made to work in poor countries,
with successful drugs being licensed to international agencies
for regional or worldwide use. But this possibility remains
unproven so far.

* Drug patents are said to support public interest by creating
incentive for innovation. This is true in rich countries, but
the full truth is more interesting. Pharmaceutical corporations
do pay for expensive clinical trials, but otherwise do much less
science than generally believed. They are primarily marketing
organizations.

* For a report on how patent misuse seriously blocks research,
see "Drug Abuse: Where Have All the New Meds Gone?" in THE NEW
REPUBLIC, October 7, 2002. For example, it noted that Bristol
Myers Squibb was not working on over 50 proteins that might be
involved in cancer, "because the patent holders either would not
allow it or were demanding unreasonable royalties." The article
is currently online at:
http://www.biohope.org/media/article.cfm?articleid=3054&state=na

* Another major cause of the disappointing progress in
translating huge scientific advances into practical treatment
progress is that medical research is mostly divided between
academics interested in pure science and corporations interested
in pure profit. Research also needs a middle ground. It needs
top scientific teams committed to practical results, but allowed
to develop anything they choose in order to advance human
health, and to communicate freely about their work. Then they
can look for the best opportunities anywhere in their field of
competence, instead of being caged into some corporate purpose
that might not have a good path forward just then -- or being
stuck in an academic environment where they can do basic science
and publish their findings, but not develop them for human
health.

We can begin reform by asking researchers what real obstacles
they face, what support they need to be effective, and how the
systems must be changed.

* It should be unthinkable that thousands of people die every
day because they cannot afford the medicines they need -- in
part because of government rules made to "balance" their
interests against those of a handful of huge corporations that
contribute lavishly to politicians, think tanks, and other
"thought leaders." We had thought there was consensus for
change. But this is the Age of Abuse, and the consensus did not
include Washington. Clearly millions in the U.S. alone would
object if they understood, yet not one in a thousand of them has
ever made their voice heard on this matter. Activists must do
much better in preparing this issue so that not only specialists
but also people anywhere can pick it up and run with it.


***** Tenofovir (Viread(R)) Access for Poor Countries by John S.
James

On December 17 Gilead Sciences announced that it would make its
antiretroviral (tenofovir disoproxil fumarate, brand name
Viread) available at cost to qualified organizations providing
HIV treatment in all 53 nations in Africa, and 15 additional
countries classified as "least developed" by the United Nations.
The company said the program would be running by the second
quarter of 2003. Information and technical assistance in
applying for and using the drug will also be provided.

Also, Gilead will participate in the 3,000-patient Development
of Antiretroviral Therapies (DART) study, sponsored by the UK's
Medical Research Council, which will begin in 2003 in Uganda and
Zimbabwe, to evaluate antiretroviral treatment strategies where
resources are limited. In addition it is studying tenofovir to
prevent transmission of HIV.

The text of the press announcement is at:
http://www.gilead.com/wt/sec/pr_1040081128
For more information about the drug, see http://www.viread.com

Comment

Tenofovir is an important drug because it is easy to use (one
pill per day), has less problem with side effects than most
antiretrovirals, and leads to relatively slow development of HIV
drug resistance. However, side effects and drug resistance do
occur -- and resistant virus is likely to be cross-resistant to
AZT and to some other HIV drugs as well. So when used to treat
existing HIV infection, tenofovir must be combined with other
antiretrovirals to reduce this resistance.

This is not the only program to provide an antiretroviral at
cost in some poor countries. It may be better designed than some
of the others, in reducing cumbersome country-by-country
negotiation and administration.

There are some concerns. "At cost" can translate to several
times the price at which a generic manufacturer could sell the
same drug at a profit. This is because proprietary
pharmaceutical companies have so high a profit margin on each
pill sold that they have little incentive to automate production
efficiently. Also, accounting practices can differ greatly,
including which expenses to count in the "cost" of a particular
operation. The real issue is not to get rid of profit, but to
develop workable systems for getting treatment to people who
cannot afford rich-country market prices, using both efficient
production and public funding. If companies could profit by
doing this right, everyone would be better off.

It is impossible to solve all problems at once. Gilead did not
have to do anything, and we welcome its program as a step in the
right direction.


***** ADAP Crisis: Sign-On Letter for Organizations, Before
January 6 If Possible

The AIDS Drug Assistance Program is facing its worst budget
shortfall ever. Many states are starting waiting lists, reducing
eligibility, or reducing the list of drugs covered. Patients
could even be taken off their medications if their state changes
eligibility requirements to save money.

Gay Men's Health Crisis, Care Resource, Project Inform,
Treatment Action Group, and other are circulating a letter from
organizations serving people with HIV, asking Congress to
support a $162 million increase for the AIDS Drug Assistance
Program in the final Fiscal Year 2003 appropriations bill. This
letter will be faxed to all members of Congress.

Organizations wishing to sign this letter should e-mail Amanda
Diers, AmandaFLAAC@..., by 5 pm Eastern time, Monday,
January 6, 2003. Additional signatures will be collected later.

* * * * *

Dear Senator/Representative

The undersigned organizations serving the needs of people living
with HIV write to ask that Congress provide a minimum of $162
million in additional federal funding for AIDS Drug Assistance
Programs for FY 2003.

This year, 13 state AIDS Drug Assistance Programs (ADAPs) have
been forced to take steps to limit access to life-saving HIV
medications for uninsured and underinsured Americans due to
inadequate funding. Texas, for example, has recently announced
that in order to close its deficit, it will retroactively lower
its income limits from 200% of the federal poverty level (300%
with spend downs) to 140%. That action will require the removal
of 2500 presently enrolled ADAP clients from the program by June
1, 2003. New York must also address a $10 million structural
deficit in 2003 and a projected $50 million deficit in 2004 if
either state and/or federal funding is not increased by that
amount. According to the most recent National Alliance of State
and Territorial AIDS Directors (NASTAD) Report, the following
states have also initiated waiting lists as of 12/5/2002:
Alabama (175), Indiana (34), Kentucky (62), Montana (2), North
Carolina (60), Oregon (18) and South Dakota (43).

Idaho, Nebraska and Wyoming have closed to new enrollees. In
addition to New York and Texas, Colorado, Florida, Georgia,
Nevada and South Carolina have projected the need to impose
access restrictions in early 2003.

One major factor driving increased ADAP need is enrollment
growth, which is due to the success of the new drugs in
decreasing deaths and slowing progression to AIDS. Since the
introduction of effective combination HIV therapies in 1996,
America's death rate from AIDS has fallen by over 50%. Because
people are staying alive longer, they need ADAP longer and so
enrollment continues to climb. While this should be taken as a
sign of the program's success, resources flowing to ADAPs are
not being increased to take care of the swelling numbers of
people that are being kept alive.

Ironically, attempting to save money in the short term may cost
taxpayers more money in the long term. Recent data presented by
the University of Alabama at Birmingham at the International
AIDS Conference in Barcelona demonstrates that the average cost
of care for a person with early HIV disease is approximately
$14,000 a year while waiting to treat that person until they are
disabled costs about $34,000 a year.

Fears of particularly serious problems for FY 2003 are
exacerbated by the expected arrival of new drugs that few
programs in crisis are likely to be able to afford. Fuzeon (T-
20), the first fusion inhibitor to reach the market, could
provide urgently needed support for patients whose anti-
retroviral options have run out when it is approved in early
2003 but the drug is expected to be expensive, which could force
ADAPs to ignore the need for the drug. The second class of drugs
that most ADAPs are unlikely to be able to afford are those to
treat HCV. While HCV has become the number one cause of death
among people with HIV, most states are resistant to adding new
classes of treatment when resources are scarce.

Finally, in order to make best use of ADAP funding, we ask that
you fund all services provided under the Ryan White CARE Act at
the highest possible levels. Without the support services
provided by the CARE act, many ADAP clients would have no
realistic access to the medical care and auxiliary services they
require to maximize the usefulness of anti-HIV medical regimens.

We believe that it is imperative to provide life-extending HIV
drugs to all Americans in need. We hope that you will agree.

Sincerely,


***** Retroviruses Conference: Caution, January 10 Housing
Deadline; Registration Still Open

If you are going to the Retroviruses conference (10th Conference
on Retroviruses and Opportunistic Infections, Feb. 10-14 in
Boston), you must deal with housing through the conference, to
prevent your registration from being cancelled. We are finding
that not everyone knows this.

Only two groups are allowed to not rent a room at one of the six
official hotels -- those staying with a friend or family member
within 50 miles, and those sharing a room with someone else
attending the conference. But still you must inform the
conference that this is the case.

The easiest way to deal with the housing process is to click the
customized link included with your emailed acceptance notice.

According to the Web site, registration is still open online, at
http://www.retroconference.org (as of December 29). Registration
and housing will close on January 10; registration will close
earlier if the limit of 3,800 is reached.

Registration for this conference costs $650, plus $135 deposit
for the first night's housing.


***** New Government AIDS Web Site, Phone Number

A new government Web site --
http://www.aidsinfo.nih.gov -- merges two previous services
(AIDS Clinical Trials Information Service, and AIDS Treatment
Information Service), plus other government-approved AIDS
information. For those who prefer to call, the telephone help
line hours are noon to 5 p.m. Monday through Friday Eastern
time; the phone number is 800-448-0440 or 301-519-0459, and
Spanish speakers are available.

The site includes official guidelines for treatment and
prevention of HIV, opportunistic infections, and tuberculosis,
and also guidelines for HIV testing and counseling. It also
includes a database of both government and industry clinical
trials, which can be searched by location, medical condition,
and/or drug being tested. In addition, "the site's Education and
Resource Center is a virtual one-stop shop offering links and
other downloadable resources specially designed for patients,
researchers, health care providers, and the public" (quote from
NIAID press release). On the site you can also subscribe to an
electronic newsletter.

Comment

This site is well-organized and getting good reviews for
usability.


***** 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
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  email: aidsnews@...
  useful AIDS links: http://www.aidsnews.org

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 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 available (see
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To subscribe, you can call 800-TREAT-1-2 or 215-546-3776:
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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 #385, November 22, 2002
    phone 800-TREAT-1-2, or 215-546-3776

Contents

** New Guidelines on Metabolic Complications of HIV and
Antiretroviral Treatment
Experts have published consensus recommendations on lipid
abnormalities, fat redistribution, glucose intolerance and
diabetes, lactic acidemia, and bone disease

** Nevirapine Patient Assistance Program: Model for Better
Administration?
Unlike the many notoriously burdensome patient-assistance
programs, this one requires a one-page application and
proof of income once a year, and sends medicines to the
doctor's office.

** Heart-Disease Risk and C-Reactive Protein
A study of almost 28,000 healthy women has found that this
marker of inflammation is a better predictor of heart
disease than cholesterol level.

** Vaccine Against Three Kinds of HIV Begins Human Tests
A vaccine from the new Vaccine Research Center of the U.S.
National Institutes of Health is ready to begin human
testing.

** Prevention: New Approach Will Test Tenofovir for Persons
at High Risk
An antiretroviral already in use in HIV treatment will be
tested for prevention.

** U.S. AIDS Research Needs Tissue Donations
National Institutes of Health research projects need
donation of tissues, either removed as a byproduct of
surgery or collected after death.

** Call for U.S. Action on AIDS, Washington DC November 26
ACT UP and others want the White House to pay attention to
the global AIDS epidemic and to problems in the U.S.

** Drug Patents and Developing Countries: Problems Remain
Reports from Australia and Nigeria show that this issue has
not gone away.

** Marijuana Lung Health Report: Less Than Meets the Eye?
An international news story on the dangers of marijuana had
no new information -- only an unsigned nine-page paper and
a press release.


***** New Guidelines on Metabolic Complications of HIV and
Antiretroviral Treatment

On November 1 a panel of 12 leading experts on metabolic
complications of HIV and antiretroviral treatment published
guidelines for managing these complications, and a review
of what is already known(1). The panel looked at glucose
intolerance and diabetes, lipid abnormalities such as high
triglycerides, body fat distribution changes, lactic
acidemia, and bone problems (both osteonecrosis and
osteopenia). Guidelines were accepted by consensus of the
full panel -- which was funded by the International AIDS
Society--USA (not to be confused with the International
AIDS Society, a different organization).

In the absence of urgently needed studies to get better
treatment information, "the panel recommends routine
assessment and monitoring of glucose and lipid levels and
assessment and monitoring of lactic acidemia and bone
abnormalities if clinical signs or symptoms are detected.
With the exception of body fat distribution abnormalities,
specific treatments for these complications are also
recommended." Changes in antiretroviral therapy are also
suggested, to avoid drugs believed to contribute to the
patient's problems.

A copy of the guidelines is available online at:
http://www.iasusa.org/pub/metcomp.html

References

1. Schambelan M, Benson C, Carr A, and others. Management
of metabolic complications associated with antiretroviral
therapy for HIV-1 infection: Recommendations of an
International AIDS Society-USA panel. JAIDS (JOURNAL OF
ACQUIRED IMMUNE DEFICIENCY SYNDROMES). November 2002;
volume 31, pages 257-275,
http://www.iasusa.org/pub/metcomp.html


***** Nevirapine Patient Assistance Program: Model for
Better Administration?

Comment by John S. James

The new Boehringer Ingelheim patient assistance program for
nevirapine for U.S. residents may be an improvement over
other programs, in that it streamlines the paperwork and
administration. A patient applies once for a year -- by
sending a one-page application plus proof of income. A new
foundation set up by Boehringer Ingelheim promises a
response in two days. Then the patient picks up the drug
four times per year at the doctor's office. At the end of
the year the patient can apply again for the next year --
and will be sent a reminder to do so.

It seems that the doctor doesn't have to do burdensome
paperwork for this program -- only write the prescription,
and hold the medicine package for the patient four times
per year. This should prevent a major problem for medical
staffs, and open the program to more people in public
clinics.

However, the income eligibility level for nevirapine is
calculated differently than for the company's non-HIV
drugs, for reasons that are not clear. What should be done
instead is to have uniform income levels but allow patients
to deduct out-of-pocket medical expenses in meeting the
income requirement.

A bigger problem may be in the interpretation of, "Be
ineligible for prescription assistance through Medicaid."
If a patient is eligible for Medicaid prescription coverage
but that coverage does not include nevirapine, does he or
she just have to do without AIDS treatment? No one eligible
for Medicaid could pay for this drug out of pocket, and
public programs are increasingly running out of money.

We believe the important advance here is that this program
could work efficiently. Many other patient-assistance
programs seem designed to get the drug only to those who
have enough of a support network around them to possibly
make an issue in the media if they don't get treated, while
limiting expenses by denying treatment to others. The very
paperwork used to restrict those programs makes them
expensive to run. But this new program could control costs
by delivering drug efficiently to patients who have no
other way to get it, at little cost to the company.

For more information or to apply, visit:
http://us.boehringer-ingelheim.com/about/
philanthropy/Patient_Assistance_Program.html
(note: there is no carriage return or space between the two
lines above).


***** Heart-Disease Risk and C-Reactive Protein

by John S. James

In an important study reported this month, in which almost
28,000 healthy U.S. women were followed for eight years,
the level of C-reactive protein, a marker of inflammation,
was a better predictor than LDL cholesterol of first heart
attack or related disease(1). And there was almost no
correlation between the two markers (both blood tests) --
meaning that these tests are finding different at-risk
populations, and using both together would be a better
predictor than using either alone. Smaller studies have
already reported that high C-reactive protein was
associated with heart attacks, strokes, and artery disease;
the new study confirmed those findings with better data.

C-reactive protein is easy to measure, but this test is not
yet generally used in clinical practice. Also, it has not
been proven that interventions to reduce the inflammation
will lower the risk of disease, although this appears
likely. The authors conducted an earlier study(2) and
recommend a larger trial of statins for this purpose.

These studies did not involve HIV. However, standard
guidelines for lowering heart risk are often used in HIV
treatment. And inflammation might be a greater problem in
persons with HIV disease than in the general population.

The HIV community should follow this developing research
(as well as other experimental tests for measuring heart
risk, such as homocysteine levels). Some HIV-specific
research would be easy to do -- for example, testing
whether certain populations have a higher level of C-
reactive protein would require only one blood sample and
laboratory test from each member of a cohort. Perhaps AIDS
medicine could be a leader in bringing the new information
into clinical practice.

References

1. Ridker PM, Rifai N, Rose L, Buring JE, and Cook NR.
Comparison of C-reactive protein and low-density
lipoprotein cholesterol levels in the prediction of first
cardiovascular events. NEW ENGLAND JOURNAL OF MEDICINE.
November 14, 2002; volume 347, number 20, pages 1557-1565.

2. Ridker PM, Rifai N, Clearfield M, and others.
Measurement of C-reactive protein for the targeting of
statin therapy in the primary prevention of acute coronary
events. NEW ENGLAND JOURNAL OF MEDICINE. June 28, 2001;
volume 344, pages 1959-1965.


***** Vaccine Against Three Kinds of HIV Begins Human Tests

The new Vaccine Research Center at the U.S. National
Institute of Allergy and Infectious Diseases is starting
the first human trial of its vaccine candidate, developed
to target HIV clades (subtypes) A, B, and C. Together these
subtypes are responsible for about 90% of the world's AIDS
epidemic (clade B causes almost all of the infections in
the U.S.). Also, it might be more difficult for HIV to
develop mutations to escape control by a multiclade
vaccine, since it targets the virus in different ways.

Fifty healthy HIV-negative volunteers between 18 and 40 are
needed for the first trial, which will be conducted at the
National Institutes of Health in Bethesda, Maryland. This
placebo-controlled trial will check for safety and also for
immune responses to HIV. Later trials will run in several
U.S. sites, as well as in Haiti and South Africa.

For more information about the trial, including ways to
volunteer, call 1-866-833-LIFE (5433), email
vrcforlife@..., or visit:
http://www.niaid.nih.gov/vrc  or
http://www.clinicaltrials.gov


***** Prevention: New Approach Will Test Tenofovir for
Persons at High Risk

by John S. James

In a new approach to HIV prevention, the Bill & Melinda
Gates Foundation will fund a multi-national trial of the
antiretroviral drug tenofovir, taken orally once daily by
HIV negative persons at high risk, to see if it can prevent
HIV infection. The study, by Family Health International,
will take three years, and will focus on sexually active
adults in countries with high HIV incidence. If it works,
this method could be particularly important for women who
cannot negotiate condom use or other ways of protecting
themselves.

Dr. Helene Gayle of the Bill & Melinda Gates Foundation
noted that experience in using antiretrovirals to protect
healthcare workers exposed to HIV, and infants exposed
during childbirth, offered hope that it might be possible
to prevent sexual transmission as well.

Comment

This study is important because it could open a new front
in HIV prevention -- and provide a woman-controlled
protection method before microbicides or vaccines are
available. Animal studies have suggested that the drug may
prevent infection. And tenofovir, approved for over a year
in the U.S. for use in HIV treatment, has fewer side
effects than other antiretrovirals, so it may be acceptable
to persons at high risk but not already infected.


***** U.S. AIDS Research Needs Tissue Donations

Patients and physicians should know that researchers
working on at least a dozen projects funded by the U.S.
National Institutes of Health need tissue from persons with
HIV for medical research. This includes important studies
of viral reservoirs, as well as research into genes that
influence how HIV causes AIDS in some but not all
individuals, and other questions about how the virus acts
in the body. Sometimes tissue removed in biopsies or
surgeries is enough. But sometimes the organs and tissues
needed can only be collected after death.

In both cases the patient must give consent in advance. For
example, when a patient consents to surgery that may result
in tissue that would be discarded, the doctor can ask about
interest in donating it for medical research.

NIAID (the U. S. National Institute of Allergy and
Infectious Diseases, which does most of the AIDS research
at the National Institutes of Health) asked the National
Disease Research Interchange (NDRI) to collect the tissue
needed. NDRI, a nonprofit organization headquartered in
Philadelphia, has contracts with physicians and hospitals
throughout the country to obtain and properly preserve the
tissue and make sure that it reaches qualified researchers.
NDRI has been providing tissue for cancer and other disease
research for over 20 years and has now started an HIV
program. NDRI is not a tissue bank (although it has
freezers and can prepare and store tissue in special
circumstances); instead, it facilitates arrangements for
the tissue to reach the researcher in a timely fashion and
in proper condition for the study.

Not everyone's tissue can be used; each research project
has its own requirements. Inclusion of a person's tissue
often depends on his or her medical condition. For example,
at this time (November 2002) researchers most need tissue
from persons who were on HAART and asymptomatic, but died
in an accident or other cause unrelated to HIV. Research
requirements change with the different projects and cannot
be predicted in advance. But NDRI would like to hear from
anyone who is HIV positive and willing to donate -- either
after surgery, or in case of death -- and can answer
questions about current needs and research projects.

Persons volunteering to donate in case of death are
strongly urged to explain their wishes to their families.
Even if a potential donor has consented, his or her family
can refuse and overrule their decision.

U.S. residents with HIV who might consider tissue donation,
or HIV physicians, can contact NDRI at 800-222-6374
extension 237 for more information. Or check
http://www.ndri.com for information about NDRI.


***** Call for U.S. Action on AIDS, Washington DC November 26

ACT UP and several co-sponsors have called for a peaceful
protest at the White House on November 26, less than a week
before World AIDS Day, to demand Federal action against
AIDS in the U.S. and worldwide. Demonstrators will meet at
noon at McPherson Square, 15th & Eye Streets NW, and march
to the White House a few blocks away. Organizers want the
Administration to act on the "Saving Families and
Communities" initiative recently endorsed by nearly 300
organizations around the world.

The sponsoring organizations are ACT UP New York, ACT UP
Philadelphia, Health Gap, African Services Committee,
Housing Works, and NYC AIDS Housing Network. Free buses
will be available from several New York locations and from
downtown Philadelphia.

For more information visit
http://www.healthgap.org/WAD.html
or email Paul Davis in Philadelphia,
pdavis@...,
or Sharonann Lynch in New York,
salynch@....


***** Drug Patents and Developing Countries: Problems
Remain

by John S. James

Despite a widespread and growing consensus that drug
patents should not continue to block access to treatment in
poor countries, this issue remains. Two recent examples:

* In Sydney, Australia, 25 countries met to work out a
compromise on drug exports to take to the 140 member
countries of the World Trade Organization (WTO). The
problem that prompted the meeting is that while a country
can issue a compulsory license if necessary for its
domestic use (manufacturing the drug and paying a small
royalty to the patent holder), current rules did not make
clear that any other country could export the drug to them.
So countries like India or Brazil could issue a compulsory
license to manufacture patented drugs for their own use --
but countries that could not manufacture the drugs
internally could not obtain them this way. This problem
will become critical in 2006, when India and other generic
drug-manufacturing countries are required to change their
patent laws to the U.S./European system to comply with WTO
rules.

When the meeting ended on November 15, Oxfam and MSF
(Doctors Without Borders) jointly issued a press release
calling the Sydney summit a step back for access to
medicines. A key problem with the rules adopted is that the
exporting country (as well as the importing country) would
have to issue a compulsory license. "This makes the needy
importing country unacceptably dependent on the political
will of another government, and increases the
administrative burden. Potential suppliers would also be
under enormous pressure from industrialized countries such
as the US and EU not to help out." Compulsory licenses for
a pharmaceutical have seldom if ever been issued.

The day the Sydney meeting began, a WASHINGTON POST
editorial noted, "From a policy point of view, there is no
good argument for allowing patents to restrict access to
medicine in poor countries and those just climbing out of
poverty; patents generally make sense only in richer
countries, where consumers can afford the new therapies
produced in response to the incentive of patent-protected
profits." ("Drugs for the Poor," WASHINGTON POST editorial,
November 14).

Note Nov. 22: A week after Sydney we are hearing that there
was no meeting of the minds, that reports of an informal
consensus were exaggerated. The U.S. and European Union
want more restriction against overriding pharmaceutical
patents in developing countries for public health, while
poor countries in Africa and elsewhere want less. And more
than a hundred countries that must agree to a final WTO
treaty were not in Sydney at all.

* In Nigeria, activists protested a meeting to be held
November 20-22 in Abuja, Nigeria, to "decide on the final
draft for Nigeria's Intellectual Property (IP) law, which
will, among other things, regulate importation of medicines
for many of the most common epidemics in Africa, including
HIV/AIDS."

According to activists, (from the Treatment Action Movement
of Nigeria, AIDS Alliance Nigeria, Journalists Against AIDS
Nigeria, and other organizations), the meeting to determine
Nigeria's intellectual-property law is sponsored by the
U.S. Department of Commerce -- and civil society in Nigeria
has been kept out. Activists fear the new law could stop
access to antiretrovirals in Nigeria, including the
government's new program to make HIV treatment widely
available.

"'It is outrageous that such an important meeting as one to
draft an IP bill that will have implications on the fate of
3.5 million Nigerians living with HIV/AIDS, is being done
without our input,' said Pat Matemilola, president of the
Network of People living with HIV/AIDS in Nigeria
(NEPWHAN). 'Considering the great import of decisions that
would emanate from this meeting as regards continued access
to life-saving treatment, we feel that our lives are being
jeopardized by this omission. We demand that the conveners
of this meeting call us to the table. Our lives must not be
toyed with.'"

(The quotations above are from a November 18 press alert
from the Treatment Action Movement.)


***** Marijuana Lung Health Report: Less Than Meets the
Eye?

by John S. James

On or around November 12 the British Lung Foundation made
news in England, the U.S., and probably around the world by
releasing a report implying that marijuana smoke is more
harmful than tobacco smoke in causing lung and other
cancers and infections. The report, nine pages of text plus
90 references, is available at
http://www.lunguk.org/news/a_smoking_gun.pdf

We found the "shocking new report" (quote from the British
Lung Foundation Web site) more interesting for what did not
make the news than for what did:

* This report was based on no new information -- only a re-
telling of what was already published. It could have been
produced and released at any time. (We could not find any
date on the paper, incidentally, except for a 2002
copyright notice on the picture of a marijuana leaf. The
press release accompanying the report on the Web was also
undated, as of November 18.)

* No one signed this report -- which seems to have been put
together in a hurry, judging by an obvious misspelling
("wieght," page 2, on the Web as of November 18, a week
after the story went out to the world) and examples of poor
editing which sometimes leave the meaning unclear. Without
authors, it is hard to follow up on how the sometimes-
incomplete science became headline-making assertions.

* One question involves the interpretation of the fact that
today's marijuana has more of the psychoactive ingredient
THC than marijuana in the 1960s and 1970s. The BLF's report
carefully says that as a result, "studies investigating the
long-term effects of smoking cannabis have to be
interpreted cautiously."

No one could object to careful interpretation of studies.
But the public will assume that a higher concentration of
THC makes the product more dangerous. We suspect the
opposite -- that more THC in marijuana reduces the danger,
since many people smoke until they get the effect they
want, then stop. If they are going to get the same amount
of THC anyway, a higher THC concentration would result in
less of the smoke and tar brought into the lungs with it.

In that case, it is hard to see how the higher
concentration today would invalidate earlier studies that
did not show long-term harm.

Also, while everyone agrees that today's marijuana is more
potent than that of the 1960s, some dispute the estimate
quoted in this report that it has 15 times the THC content.
They say this figure was based on a small number of poorly
stored samples, which may have deteriorated during storage.

* We do not know if the report's statement that three or
four marijuana cigarettes are as harmful as 20 or more
tobacco cigarettes takes account of the fact that marijuana
cigarettes are often much thinner -- and that marijuana
smokers are likely to smoke much less by weight than
tobacco smokers. And many medical marijuana users find
relief from just a small puff or two, and have no desire to
use more.

* Other inferences presented in the BLF report also need a
closer look. For example, is it reasonable to suggest "an
association between cannabis use and opportunistic
bacterial and fungal pneumonias" in HIV patients, based on
a single reference to a 1985 publication on risk factors in
patients referred for possible AIDS care? Is it accurate to
highlight cancer risk in one of the two major
recommendations of the report, when there is no conclusive
evidence that marijuana causes cancer in humans, only
laboratory data suggesting that marijuana smoke may do so
(U.S. Institute of Medicine report, 1999, p. 119 -- see
References below).

* These concerns just scratch the surface. Others will need
to go through the 90 references to see if they are cited in
an unbiased fashion, or used to support preconceived
conclusions.

Comment

Until proven otherwise we will assume that all smoke is
unhealthy (even from incense or campfires); it is a matter
of degree. With marijuana, vaporizers that heat the
substance to a controlled temperature but do not burn it
have proven acceptable to users. They may largely eliminate
the hazard of inhaling smoke.

On a different issue, the drug war is harmful. In the U.S.,
marijuana laws have contributed to a huge increase in the
prison population, with vast racial disparities. Recently
the U.S. attorney general has singled out legitimate
medical use of marijuana for special law-enforcement
attention and abuse.

A recent TIME MAGAZINE cover story on marijuana (November
4, 2002) reported that most Americans do not want marijuana
legalized, but do not want users to go to jail either.
Public fear of legalization is understandable, if it could
bring high-powered corporate promotions, as with tobacco --
including campaigns to target young people and get
customers wherever the companies can. U.S. society needs
but does not have a middle ground -- for activities that
individual adults can do personally without breaking the
law, yet which are officially discouraged and cannot be
commercially promoted. Such a middle ground will become
increasingly necessary as technology progresses, so we
should be thinking about it now.

The BLF paper on marijuana is not a scientific or medical
review but a political document -- a fact the press largely
overlooked. It appears to have been rushed into print now
in order to counter recent efforts in the UK and elsewhere
to ease the drug war.

For More Information

UNDERSTANDING MARIJUANA: A NEW LOOK AT THE SCIENTIFIC
EVIDENCE, by Mitchell Earleywine and G. Alan Marlatt,
Oxford University Press, published August, 2002.

MARIJUANA AS MEDICINE: THE SCIENCE BEYOND THE CONTROVERSY,
by Alison Mack and Janet E. Joy, National Academy Press,
published January 2001. This book explains the findings of
the 1999 study of medical marijuana by the U.S. Institute
of Medicine (MARIJUANA AS MEDICINE: ASSESSING THE SCIENCE
BASE).

You can read and search this book (or the IOM study) online
without charge, at
http://books.nap.edu/ (search titles for "marijuana"). The
study is also online in a different format at:
http://www.nap.edu/readingroom/books/marimed/

For Web sites on medical marijuana, we found that searching
http://www.google.com for "medical marijuana" worked well.
Be aware that Google sells ads that may appear with search
results -- but they are marked as sponsored links, and do
not appear beyond the first three positions.

[Note: OK to distribute this article if it is reproduced
unchanged -- including this notice with the publication
date (November 22, 2002) and our contact information
(http://www.aidsnews.org).]


***** AIDS TREATMENT NEWS

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AIDS TREATMENT NEWS Issue #384, October 18, 2002
    phone 800-TREAT-1-2, or 215-546-3776

CONTENTS

** Animal Retroviral Infections Suggest Third Kind of
Potential Treatment: HIV Harm Reduction
Besides antivirals and immune-based treatments, a third
approach is to reduce the harm caused indirectly by HIV,
which is probably more important than the direct killing of
infected cells. Some animals do not get sick when infected
with HIV-like viruses despite very high viral loads --
suggesting that they have successfully evolved to tolerate
the virus instead of eradicating or suppressing it.
Understanding how they do so might lead to a new kind of HIV
treatment.

**T-20 (FUZEON) Gets Priority Review
The FDA plans to decide on T-20 approval within six months.

** ICAAC Clinical Trials Review Available
You can read a quick summary of the HIV clinical trial
results presented at a scientific conference on anti-
infection drugs.

** Hepatitis C: FDA Public Meeting on Peginterferon Plus
Ribavirin, Nov. 14
An FDA advisory committee will hold a public meeting on a new
treatment for hepatitis C.

** Anti-HIV Factor Discovered
Scientists at the Aaron Diamond AIDS Research Center believe
they have discovered a major component of a long-sought
soluble anti-HIV factor produced by certain CD8 cells.

** Retroviruses Scholarship, Community Press, Other Deadlines
Soon
Scientific abstracts are due October 23, and important
community deadlines begin November 1 for international
travelers, November 8 for U.S. community press and
scholarship applicants.

** Treat-Your-Workers.org; International Coca-Cola Protest
October 17
ACT UP and others demand better medical coverage for African
workers with HIV.

** Chinese AIDS Activist Released
Dr. Wan Yan Hai was released September 20.

** Nonoxynol-9 Dangers: Health Experts Warn Against Rectal
Use
Dozens of experts and organizations call for stopping all
rectal use of N-9.


***** Animal Retroviral Infections Suggest Third Kind of
Potential Treatment: HIV Harm Reduction

Comment by John S. James

All the approved HIV treatments so far are antiretrovirals --
drugs that directly target some step in viral replication. In
the future we may have another kind of treatment, immune-
based therapy, which strengthen the immune system's ability
to control HIV, instead of attacking the virus directly.

A third approach, less talked about so far, might be called
HIV harm-reduction treatment -- preventing the virus from
causing harm despite a continuing high viral load. This could
work because HIV seems to cause most of its damage indirectly
-- by the toxic tat protein, for example, or by dysregulation
of immune responses leading them to kill normal cells --
rather than by killing infected cells, which the body could
normally replace. If so, then ways to block the indirect
damage might become a new kind of treatment. (We distinguish
HIV harm reduction from immune-based therapies because the
former would not necessarily target the immune system at all
-- and also because it would have to be tested differently,
since it might not decrease viral load, which immune-base
therapies might be expected to do.)

One observation supporting this way of thinking is described
in an abstract at the recent conference of the Institute of
Human Virology, September 9-13, 2002, in Baltimore.(1) Mark
Feinberg of Emory University noted that in monkeys and other
primates, all known retroviral infections in their natural
hosts did not cause AIDS-like disease. But the same viruses,
in primates that are not natural hosts, do cause persistent
infection, loss of CD4+ T-cells, and susceptibility to
opportunistic infections. And in these animals that do get
sick, low viral loads and strong cellular immune responses
predict slower disease progression -- as they do in humans
with AIDS.

But at least some animals naturally infected with SIV (simian
immunodeficiency virus) successfully control the infection in
a very different way. In the sooty mangabey monkey, for
example, the immune system does not suppress viral load,
which stays high, yet the animal does not become ill. From
the abstract:

"... Surprisingly we have found that SIV-infected sooty
mangabey monkeys do not develop AIDS despite high level virus
replication, short longevity of infected cells and limited
anti-SIV specific cellular immune responses....
Interestingly, an attenuated host immune response to the
infection is manifest from early times during primary
infection, suggesting that sooty mangabey evolution has
selected for a limited, rather than an aggressive, host
response. In all, these data suggest that the direct
consequences of high level virus replication alone cannot
account for the progressive CD4+ T cell depletion leading to
AIDS, and that active antiviral cellular immune responses may
not always be beneficial. Indeed, SIV-infected sooty
mangabeys may be spared, by their failure to mount
significant antiviral immune responses, much of the indirect
bystander damage seen in pathogenic primate lentivirus
infections that both contributes to accelerated CD4 depletion
and compromises host immune regenerative capacity. In
contrast, following zoonotic transmission of SIV to non-
natural hosts, the generation of active but incompletely
effective immune responses may indirectly both increase the
magnitude of overall T cell destruction and reduce the host
immune regenerative capacity, thereby leading to the
development of progressive immune deficiency as T cells lost
to cumulative direct and indirect consequences of virus
infection are not replaced."(1)

How to Proceed

A treatment that prevents AIDS by reducing damage from HIV
might be hard to recognize. It might not decrease viral load
at all, or even increase it. The ultimate proof would be that
people would not get sick over a long period of time. But it
would probably be impossible to conduct clinical trials in
the straightforward way -- randomly assigning patients to
antiretrovirals with or without the new treatment -- because
the effectiveness of antiretrovirals has made it almost
impossible to run clinical-endpoint trials. Instead, new
drugs today are approved by their effect on viral load, an
endpoint that would not work in this case. (In fact, if an
existing drug for some other medical purpose happened to work
this way and prevent the development of AIDS without lowering
viral load, we would probably not know it, even if many
patients with HIV had used the drug coincidentally.)

How then might it be possible to get a handle on the
development of this kind of drug? Here are some possible
approaches:

* Many patients have "discordant" viral load and CD4 counts.
Instead of fitting the usual pattern of having higher CD4
counts if they have low viral load or vice versa, they either
have a high CD4 count despite a high viral load, or a low CD4
count even though their viral load is low.

These two kinds of discordant patients could be compared to
each other, to look for differences in how they respond to
HIV infection. What could be learned from patients who can
tolerate a high viral load and still maintain a high CD4
count -- especially those who remained healthy despite having
the high viral load for a long time? If the mechanisms could
be identified, perhaps some kind of pharmaceutical
intervention could help other patients do likewise.

If there are some patients who, like the sooty mangabeys, are
long-term non-progressors despite having a high viral load,
we probably would not have recognized them. Instead we would
have treated their viral load, and attributed non-progression
to the treatment. But these patients might be identified by
careful examination of their medical records.

* Basic research could look for the mechanisms involved,
either in sooty mangabeys, other animals, or in any humans
known to tolerate a high HIV viral loads and remain healthy.

Of course differences in the virus as well as the host could
be responsible for reduced disease progression despite high
viral load. But still the host somehow avoids disease even
though the virus reproduces well and does cause disease in
non-native hosts.

* For many years some physicians and researchers were
interested in immune suppressive drugs to treat HIV. Their
experience should be reviewed -- especially since sooty
mangabeys seem to have evolved an effective defense against
AIDS that includes a notably unaggressive immune response.
Existing drugs may be too non-selective or have too many side
effects for widespread use. More selective immune-suppressive
drugs could be developed.

* Once a candidate harm-reduction drug is identified, it
could be tested to see if it improves the health of patients
who cannot control the virus with any existing treatment.
Since their viral load cannot be controlled in any case, an
experimental treatment to reduce viral damage could ethically
be tested while the viral load stays high (necessary to see
if the new treatment worked). A placebo control would be used
since there is no approved HIV harm-reduction treatment. The
volunteers could either take antiretrovirals or not as they
chose. The study could look for T-cell count increases,
reduction of symptoms believed to be caused by the high viral
load, and/or other evidence of clinical improvement. Such
endpoints could show significant change quickly in a small
number of patients (unlike the "clinical endpoint" of disease
progression, which requires hundreds if not thousands of
volunteers because it counts low-probability, all-or-nothing
events instead of measuring continuous data on everybody).

A treatment that prevented viral damage without reducing
viral load would not have the public-health advantage of
antiretroviral treatment in making patients less likely to
transmit the virus to others. But in practice, this kind of
treatment would probably be combined with antiretrovirals for
maximum benefit, so the risk of transmission would still be
reduced.

A possible advantage of HIV harm reduction is that HIV
develops resistance to all known antiretrovirals -- and to
the body's immune responses as well. But a harm-reduction
treatment would create different evolutionary incentives, as
HIV variants would not need to evade either the therapy or
the body's defenses in order to survive. They could do best
by not provoking the immune system. And in the sooty mangabey
example the viral load does not increase without limit until
it kills the animal; there is still a setpoint, still a
limit, and the animal remains healthy. So a harm-reduction
treatment may also allow relatively harmless viruses (which
would have an advantage here) to help crowd out more
dangerous ones.

Perhaps such reasons explain why animals apparently evolved a
strategy of maintaining health by preventing harm, even from
continuous high levels of viruses still able to cause disease
in other species. Human long-term non-progressors (at least
those who have been identified) use a different strategy, of
aggressive immune defense that keeps viral replication low
enough to greatly delay escape from immune control. It seems
likely that the former approach is the better one for
controlling a virus that can mutate so rapidly. Possibly some
patients are already benefiting from it, but under current
medical and research practices we do not see them. For where
viral load testing is available, treatment is available too,
and almost no one gets viral load tests repeatedly unless
they plan to treat a high viral load. Usually antiretroviral
treatment would reduce the viral load and be credited for
non-progression. And experimental HIV therapies that fail to
lower viral load are not studied today.

As a result, a new kind of potential treatment for AIDS may
have been overlooked.

References

1. Feinberg M. Ignorance is bliss: how the natural hosts for
SIV infection remain healthy despite long-term, high-level
virus replication. JOURNAL OF VIROLOGY. 2002; volume 5,
number 1, abstract #8.


***** T-20 (FUZEON) Gets Priority Review

On October 11 Roche and Trimeris, Inc. announced that the FDA
had granted priority review to FUZEON (TM) (generic name
enfuvirtide, formerly known as T-20). This means that the FDA
plans to review the application for approval in six months,
and announce the results by March 16, 2003 (six months after
the application for approval was submitted).

Enfuvirtide works differently from any currently approved HIV
drugs: it blocks a step in the process by which HIV fuses
with a cell membrane and enters the cell. Since it has an
entirely different mechanism of action, virus that has become
resistant to approved drugs will not automatically be
resistant to this one. However, resistance to enfuvirtide
does develop, as with other antiretrovirals. This drug also
must only be used in combination treatments, never alone.

Enfuvirtide must be injected twice a day, can be difficult to
use, and is difficult to manufacture so it will probably be
expensive. For these reasons it will likely be used mainly by
patients who do not have other good options.


***** ICAAC Clinical Trials Review Available

ICAAC, the Inter-Science Conference on Antimicrobial Agents
and Chemotherapy, was held this year in San Diego, September
27 - 30. This annual conference focuses mainly on the
development of new antibiotics and antivirals. On October 11
HIVandHepatitis.com published a review of the HIV clinical
trial presentations at ICAAC, by Charles Hicks, M.D.; it is
available at:
http://www.hivandhepatitis.com/2002conf/iccac2002/pages/35.html

Some of the topics:

* Atazanavir, an experimental protease inhibitor being
developed by Bristol-Myers Squibb, was compared in a large
international trial with efavirenz (brand name Sustiva -- or
Stocrin in some countries);

* 3TC (Epivir) was successfully dosed for once-daily use;

* Coviracil, an experimental nucleoside reverse-transcriptase
inhibitor, was compared with d4T; and

* For certain advanced patients, a combination of amprenavir
(Agenerase) and lopinavir plus ritonavir (Kaletra), with some
extra ritonavir (Norvir) added to overcome an interaction
that would reduce the levels the other two drugs, appeared to
work well.

All of  these trials showed promising results that may
improve HIV treatment in the future.


***** Hepatitis C: FDA Public Meeting on Peginterferon Plus
Ribavirin, Nov. 14

On November 14 the Antiviral Drugs Advisory Committee will
review the application by Hoffmann-La Roche for approval of
peginterferon alfa-2a combined with ribavirin. The meeting
will include time for public comment, and comments can also
be submitted in writing. If you want to address the committee
you need to notify the staff before November 6 and submit a
brief written statement about your presentation. Written
statements to the Committee should be submitted by November
6.

The meeting will be held November 14, 2002, from 8:30 a.m. to
4 p.m. at the Holiday Inn, Versailles Ballroom, 8120
Wisconsin Avenue, Bethesda, MD. This location is near
Washington D.C. and easily reachable by the Red Line subway.

More information is available from the FDA Advisory Committee
Information Line, 1-800-741-8138 or 301-443-0572. You will be
asked to enter a code; the code for the Antiviral Advisory
Committee is 12531.

Comment

We have heard that peginterferon will be approved as a single
drug soon, maybe this week. The Advisory Committee will
consider the combination with ribavirin. Our understanding is
that Roche plans to sell its peginterferon alone as well.

FDA advisory committee meetings are often the best place to
learn in-depth information about a new drug before it is
approved. They are not called for every new drug application,
only for those that present new, difficult, or particularly
important issues. Usually a transcript and a summary appear
later on the FDA Web site.

The FDA is not required to follow the recommendations of its
advisory committees, but it almost always does.


***** Anti-HIV Factor Discovered

by John S. James

On September 26 scientists at the Aaron Diamond AIDS Research
Center (ADARC) announced that they had identified a
significant contributor to a long-sought antiviral factor,
secreted by certain CD8 T-cells, that inhibits HIV
replication.(1) This work does not change treatment now, but
could lead to the development of a new class of HIV drugs. It
was widely reported in the press.

The research team at ADARC, headed by Linqi Zhang, believes
that this factor includes three previously known chemicals
called alpha defensins. Through various tests, they found
that these chemicals were produced by stimulated CD8 cells of
three of the long-term non-progressors they are studying
(they picked their three best non-progressors among their
patients, in order to have the best chance of identifying how
their cells are able to keep HIV in check). After the
chemicals were identified -- with the help of a protein-chip
technology that allows rapid, sensitive testing -- it was
found in laboratory tests that antibodies to those chemicals
could largely eliminate the anti-HIV activity of those cells
-- helping to confirm that an anti-HIV factor is really these
three defensins.

Only one to two percent of HIV patients are long-term non-
progressors. Since 1986 it has been known that their cells
can produce some substance or substances that inhibit HIV.(2)
In 1995 it was shown that some of the activity was due to
three other chemicals called beta chemokines. But the beta
chemokines only block some HIV viruses, those that use the
CCR5 receptor on the CD4 cell to enter the cell -- not
viruses that use the CXCR4 receptor, which often evolve later
in HIV infection.

The defensins are believed to block all HIV, and to act
through a completely different mechanism -- possible
involving viral transcription, instead of viral entry into
the cell. These chemicals have been found not only in long-
term non-progressors but in at least some healthy uninfected
persons as well, and in several primate species. However they
are seldom found in HIV patients who are not non-progressors.

The defensins would be very difficult to use as drugs, if
they could be used at all. But when their action is better
understood, it may be possible to devise other treatments
that have the same effect. Another approach would be to
maintain and enhance the body's ability to produce defensins.
Either kind of treatment might convert patients into long-
term non-progressors who would not become ill despite HIV
infection.

References

(1) Zhang L, Yu W, He T and others. Contribution of human
alpha-defensin-1, -2, and -3 to the anti-HIV activity of CD8
antiviral factor. SCIENCE EXPRESSs. September 26, 2002.

(2) Walker CM, Moody DJ, Stites DP, and Levy JA. CD8+
lymphocytes can control HIV infection in vitro by suppressing
virus replication. SCIENCE. December 19, 1986; volume 234,
number 4783, pages 1563-1566.


***** Retroviruses Scholarship, Community Press, Other
Deadlines Soon

by John S. James

The annual Retroviruses conference, one of the world's most
important scientific meetings on HIV, will not take place
until February 2003, but scholarship and other deadlines are
approaching. For community members without an accepted
scientific abstract, the scholarship or community press
applications are the only way to get into this meeting.
Therefore some will need to apply for the scholarship whether
or not they need the money.

This year the 10th Conference on Retroviruses and
Opportunistic Infections will be held in Boston for the first
time, at the Hynes Convention Center, February 10-14, 2003.

Deadlines by Date

* For scientists, abstracts are due October 23 at 5:30
Eastern time (except late breakers).

* Also for scientists, the Fellow Travel Grant applications
are due October 23.

* For international scholarships, the application deadline is
November 1.

* For U.S. community scholarships, the deadline is November
8.

* For community press, the deadline is also November 8.

* Preferred registration and housing for invited speakers and
authors of accepted abstracts (two per abstract) is open
November 18 - 29.

* Registration for other researchers and clinicians (without
an accepted abstract) is open December 2 - January 10.
Caution -- sometimes this conference fills almost
immediately; in case that happens these applications must be
sent as soon as this period begins. This year the conference
will accept 3,800 registrations.

* The late breaker abstract deadline is January 6 at 5:30
Eastern time.

Be sure to check the conference Web site,
http://www.retroconference.org, to confirm these dates and to
get the forms and other information needed to apply.


***** Treat-Your-Workers.org; International Coca-Cola Protest
October 17

by John S. James

"AIDS is the crisis of our generation, and we will be defined
by our response to it. Years from now, we will have to answer
to our own children: did we stand by as millions died, or did
we take action? We have a chance to make a real difference in
shaping the outcome of this pandemic. We hope you will join
us in this endeavor." From Student Global AIDS Campaign,
cover letter transmitting THE COCA-COLA CAMPAIGN: A MANUAL
FOR STUDENT ORGANIZERS.

Since a July 2002 announcement in Barcelona during the
international AIDS conference there, activists in Africa, the
U.S., and Europe have called for a global day of protest
against Coca-Cola on October 17, asking for better health
coverage for African workers and their families. Behind this
protest are several developments.

Coca-Cola already provided health coverage including
antiretrovirals to its corporate employees in Africa -- about
1200 workers, mostly white collar. But that is only about 2%
of the 60,000 workers producing and distributing Coca-Cola
products in Africa. Most of the work is outsourced to
bottlers and other independent contractors, who typically
compete against each other with low prices and margins --
creating a race to the bottom in worker health care, unless
the larger corporation sets standards for contractors or
otherwise intervenes. African and other activists saw that if
multinational corporations could wash their hands of
responsibility simply by outsourcing their work, access to
treatment in developing countries would be gravely set back.
While treatment can reduce employee turnover and associated
costs, sometimes it is cheaper to abandon and replace low-
wage, low-skill workers who get sick, than to provide medical
care.

On September 26 the Coca-Cola Africa Foundation announced a
major treatment initiative in which the Foundation and three
partners (GlaxoSmithKline, PharmAccess International, and
Population Services International) will work with Coca-Cola's
40 bottlers in Africa to help them expand their health
coverage to include HIV infection and antiretroviral drug
treatment. This program is estimated to cost the Coca-Cola
Africa Foundation $4 million to $5 million per year.
According to Coca-Cola Africa, a total of 44% of bottler
employees "had agreed to this program or were on exiting
programs that covered prevention and awareness and
treatment," as of October 14.

While acknowledging that this program is potentially an
important step forward, activists said there were several
deficiencies, including that:

* This program covers workers and their spouses -- but not
their children or other dependents;

* The cost sharing required of the bottlers, and co-payments
required from the workers, are likely to prevent many from
participating; and

* There is no proof of commitment to rapid rollout of the
treatment program, and no plan to expand it beyond Africa.

For More Information

The best Web site on this campaign is
http://www.treat-your-workers.org, by Health GAP. It includes
background, contacts, and activist toolkits including a 30-
page manual on how to organize, from the Student Global AIDS
Campaign -- a handbook we hope is adapted to other campaigns
to change the appalling lack of political will on the global
HIV catastrophe.

The Web site of the Coca-Cola Africa Foundation is:
http://www.aidsprogramsinafrica.coca-cola.com.


***** Chinese AIDS Activist Released

Dr. Wan Yan Hai, the AIDS activist detained by Chinese
security on August 24, (see AIDS TREATMENT NEWS #383,
September 6, 2002) was unexpectedly released in Beijing on
September 20. His release came after United Nations and the
U.S. State Department officials negotiated behind the scenes,
and ACT UP led an international activist mobilization to free
him. The groups Human Rights in China, The Committee to
Protect Journalists, Human Rights Watch, the Canadian
HIV/AIDS Legal Network, and Amnesty International also worked
for Dr. Wan's release.

On September 13, Human Rights Watch and the Canadian HIV/AIDS
Legal Network gave Dr. Wan its first Award for HIV and Action
on Human Rights, which was accepted by his wife, Su
Zhaosheng. Other factors may also have played a role: major
news outlets such as THE NEW YORK TIMES covered the case
early and extensively, and scholars and diplomats worldwide
sent letters to Chinese government officials.

Wan was detained for posting information about China's AIDS
epidemic on his organization's web site
(http://www.aizhi.org), one of the best independent sources
of AIDS information available in China. The United Nations
estimates that China may have 10 million HIV-positive
citizens by 2010 if aggressive measures are not taken.


***** Nonoxynol-9 Dangers: Health Experts Warn Against Rectal
Use

by John S. James

On September 27 over 80 health experts and organizations
released a letter warning against all rectal use of
nonoxynol-9 (N-9) -- a spermicide mistakenly used to kill
HIV, when actually it makes transmission worse. The letter
came after a quiet campaign that persuaded most but not all
manufacturers to remove the substance from their products.
Experts agree that rectal use is dangerous and never
appropriate -- and that N-9 should not be included in any
condoms or lubricant.

On October 10 the Bay Area Reporter, a San Francisco gay
newspaper, reported that all lubricant manufacturers had now
promised to stop making lubricant with N-9. This followed an
earlier series of articles in the B.A.R. that prompted some
local retailers to remove N-9 products from their shelves.

From the September 27 consensus letter:

"Call to Discontinue Nonoxynol-9 for Rectal Use

"We, the undersigned, in light of recent statements by the
World Health Organization and the Centers for Disease
Control, urge all people to cease the rectal use of products
containing Nonoxynol-9 (N-9). We are concerned that many
people mistakenly believe that N-9 provides extra protection
against HIV and STDs when used rectally when in fact there is
reason to think that rectal use of N-9 may increase risk of
infection.

"The Centers for Disease Control states: 'N-9 can damage the
cells lining the rectum, thus providing a portal of entry for
HIV and other sexually transmissible agents. Therefore, N-9
should not be used as a microbicide or lubricant during anal
sex.'

"The World Health Organization states: 'N-9 should not be
used rectally.' (Further) 'There is no published scientific
evidence that N-9-lubricated condoms provide any additional
protection against pregnancy or STIs compared with condoms
lubricated with other products.

"'Since adverse effects due to the addition of N-9 to condoms
cannot be excluded, such condoms should no longer be
promoted.'"

For More Information

* On September 25 The Wall Street Journal published "Some
Makers, Venders Drop N-9 Spermicide on HIV Risk.

* The World Health Organization consensus report is at:
http://www.who.int/reproductive-health/rtis/nonoxynol9.html

* And on September 28, 2002, The Lancet formally published
results of a major study in Africa that showed that N-9 could
increase HIV transmission -- available at
http://www.thelancet.com (free registration required).


***** 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 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 available (see below). Back issues are available at
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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 #383, September 6, 2002
    phone 800-TREAT-1-2, or 215-546-3776

Contents

** HIV Medicine After Barcelona Conference: Interview with Howard Grossman,
M.D.
We asked a leading HIV physician to summarize some of the treatment issues
that clinicians are now looking at after the Barcelona conference. Topics in
this interview include:
* Tenofovir, including for first-line therapy;
* The shift from protease inhibitors to non-nucleoside RT inhibitors, for
many but not all patients;
* Benefits of once-a-day regimens;
* Lipodystrophy, and strategies for avoiding or reducing it;
* Viral resistance testing;
* T-20
* Prevention -- including danger of superinfection with a new HIV strain

** Pan-African AIDS Treatment Movement Launched
Activists from 21 African countries have launched a movement to organize the
different sectors of societies, along with international institutions, to
address the epidemic more successfully.

** Chinese Activist Detained by Police, Immediate Action Needed
Dr. Wan Yanhai, widely considered one of China's leading AIDS activists, was
detained by police in Beijing August 24. Amnesty International and AIDS
organizations have called for immediate letters and email on his behalf.

** Philadelphia, New York: Dr. Jon Kaiser's Treatment Update, September 17,
18
A San Francisco physician who has long used both standard and natural
treatments in HIV will speak at a free public meeting in Philadelphia Sept.
17, and New York Sept. 18.


***** HIV Medicine After Barcelona Conference: Interview with Howard
Grossman, M.D.

by John S. James

Howard A. Grossman, M.D., is a leading HIV physician who has practiced HIV
medicine in New York City since 1987. He is also Assistant Clinical
Professor of Medicine at Columbia University and Associate Attending
Physician at St. Luke's Roosevelt Hospital. With his associate and a
physician assistant, his clinic works with approximately 850 people living
with HIV. AIDS TREATMENT NEWS interviewed Dr. Grossman on August 16, 2002.

ATN: Let's start with new regimens. How do you approach treatment options
today? For example, what do you think of tenofovir [VIREAD(R)], both for
treatment-experienced patients, and for those starting antiretrovirals?

GROSSMAN: It has been poorly communicated to patients that our great desire
would be to put everybody on therapy when we first find out they were
infected, if we had therapies that were not toxic, easy to take, and
long-lasting. But given the fact that we don't, we settled on the 350 T-cell
count as a general guideline for starting antiretrovirals. It keeps bearing
up in study after study that it is a pretty good place to set that line.

But when you start looking at much less toxic drugs like tenofovir, or at
somebody who could take a triple nucleoside regimen that does not have
really bad toxicity, and might be able to take that treatment for years, it
reopens the question of when to start. Nothing is set in stone in HIV
medicine. No question is forever closed.

ATN: What are doctors combining tenofovir with?

GROSSMAN: Tenofovir with abacavir [ZIAGEN(R)] and 3TC [EPIVIR(R)] is a good
regimen, all once-a-day. Or tenofovir with ddI [VIDEX(R)] and 3TC, although
some people worry that you might be more likely to develop a K65R mutation,
which could affect other nucleoside analogs. Or use a non-nucleoside that
does not have major side effects. Less toxic regimens re-open the question
about when is the best time to start antiretrovirals.

ATN: For the non-nucleoside, would you choose efavirenz [SUSTIVA(R)], for
someone who does not have a big problem with the mood changes or other
mental effects?

GROSSMAN: I like efavirenz, but we are using more nevirapine [VIRAMUNE(R)].
I think with once-a-day therapy, morning dosing works better than nighttime
dosing. Most patients are more likely to forget to take a dose at night.

ATN: You haven't had viral breakthroughs with nevirapine?

GROSSMAN: No, we have seen good efficacy. And a number of studies at the
Barcelona international conference showed pretty comparable efficacy between
nevirapine and efavirenz. The problem is that Boehringer-Ingelheim has not
done the studies. Those at the international conference were done by private
investigators, and not supported by Boehringer Ingelheim. The company
dropped the ball on getting answers to the questions.

ATN: I had the impression that people were choosing efavirenz as their first
choice.

GROSSMAN: I don't think that is necessary. Efavirenz is certainly a fine
choice for people who can tolerate it, and I do have lots of patients on it.
But again, with once-a-day, I think that morning dosing works better.

ATN: What do you typically combine with nevirapine in a starting regimen?

GROSSMAN: Often I put people on nevirapine, 3TC, and tenofovir. With this
regimen few patients will have major side effects. There can be problems,
but not as much as with other drugs.

ATN: And with nevirapine, it's the rash, and you have to watch the liver
enzymes?

GROSSMAN: Right. And nobody can tell who is going to have the acute hepatic
syndrome. Today that is totally unpredictable. But it is rare. There have
only been a handful of cases reported of acute hepatic necrosis. This seems
to be an unpredictable, rare, and very acute syndrome that has happened in
some people with very high CD4 counts.

The liver toxicity that is more common is an asymptomatic rise in liver
enzymes that occurs in the first 6 weeks of treatment. If people develop
elevated liver enzymes and symptoms, they can stop the drug and the symptoms
disappear. And if they make it past the six weeks they probably won't get
this problem. That is why Boehringer-Ingelheim has recommended that people
starting Nevirapine get their liver function tests done every 2 weeks for
the first 6 weeks.

ATN: Any other thoughts about regimens for starting antiretroviral therapy?

GROSSMAN: I strongly believe in once-a-day therapy. I consider it the big
breakthrough of the last year and next year.

It is being accepted in a reverse of the usual way. Usually in HIV, the
first people to develop new strategies are investigators and academics. In
this case, however, the investigators have been holding back on once-a-day
therapy. But it has caught on in a huge way in the community. For the
doctors in the trenches who have patients who are difficult to treat, it has
been a no-brainer that once-a-day is the way to go.

In Barcelona there were two posters about patients preferring once-a-day
therapy. Both were studies sponsored by Bristol-Myers Squibb, which has a
big stake in promoting once-a-day. But many of the research physicians have
been holding back.

For my patients it has made a tremendous difference. We offer once-a-day to
everybody who has a possibility of taking it -- even if that means changing
their regimen, because I think it makes such a difference in terms of
increased adherence, increased efficacy and patient satisfaction.

At Barcelona I presented a poster on once-a-day, looking at the first 50
patients we treated, and it was successful. But there was not much
information at the conference about qd [once-a-day] therapy.

There was interesting information about ritonavir/saquinavir. One poster
compared it vs. indinavir/ritonavir, both twice a day in this trial [P. Cahn
and others, abstract #WeOrB1265], and the number of adverse events, change
in LDL cholesterol, and change in triglycerides, was lower in the
ritonavir/saquinavir group. Yet they did just as well virologically.

Another poster looked at switching patients from another protease inhibitor
regimen that failed to a ritonavir/saquinavir protease inhibitor regimen
[J.G. Baril and others, #WePeB5902]. This retrospective chart review of 12
patients found generally good results.

But so far I have not had good success with once-a-day protease inhibitors.
I had a couple patients on amprenavir/ritonavir once-a-day, and a couple
patients on saquinavir/ritonavir once-a-day, but that takes lots of pills.
When we get newer protease inhibitors, like atazanavir and GSK908,
once-a-day PIs will become practical.

There was also a followup to the Kaletra (lopinavir/ritonavir) once-a-day
vs. twice a day trial in treatment-naive patients [J. Feinberg and others,
#TuPeB4445]. Now they are reporting at 72 weeks, and there was no
significant difference between the arms in virologic suppression.

But in this study, trough levels on the twice-daily Kaletra regimen cluster
very close to 100 times the IC-50 [meaning that the lowest drug level in the
blood, usually just before the patient takes the next dose, is about 100
times the amount needed to inhibit 50% of the virus] -- a good place. Trough
levels on once-a-day have much more variation. Some patients are much closer
to the IC-50.

I tried this Kaletra regimen in 5 patients who were not treatment-naive, and
we measured their lopinavir trough levels after 2 weeks, and all 5 were
below the IC-50. So I took everybody off once-a-day Kaletra. While the trial
seems to be achieving good results, I am not sure that it is expandable
beyond naive patients. I don't think people should try this outside of a
study.

ATN: What do you think about continuing antiretroviral therapy in heavily
treated patients who cannot control the virus with any currently available
drugs?

GROSSMAN: I have advanced patients who have a viral load over 750,000 copies
-- they are definitely not controlling the virus. I think they still get
some benefit from the drugs. But their T-cells are too low to show if there
is a response. Usually if they do not have overwhelming side effects, I
recommend that they stay on the drugs.

I think from Steve Deeks' data a couple years ago and some other studies,
that patients get some benefit from antiretrovirals even if the virus is
resistant and cannot be well controlled with the drugs.


Lipodystrophy

ATN: On lipodystrophy, what are you seeing? What drugs or combinations seem
to be associated more with the problem?

GROSSMAN: I see both fat accumulation and fat wasting. Fat accumulation is
sometimes hard to diagnose. I use what I call the pinch test. If the patient
says they are getting a big stomach, I ask if they can pinch it. If you can
pinch it, it's probably not lipodystrophy, but just fat. Lipodystrophy is
visceral fat -- it is deep, and hard, and different from the subcutaneous
fat you get because you are eating too much, or not getting enough exercise,
or getting older. This is one way to help people feel more comfortable.

But I also see many patients with fat accumulation that is lipodystophy.
Often the prominent belly, if it is muscular, is not as big a problem for
them as facial wasting is for many people.

In the gay community some people have eroticized the lipodystrophy look --
facial wasting, prominent cheekbone, veins showing everywhere. But a
collapsed-in face is usually much harder for people to deal with than a big
abdomen.

And doctors who do not ask patients to take their clothes off in the office
may not see it. I know many doctors who don't.

While there probably is some HIV-related lipodystrophy, and some related to
the nucleoside analogs in general, clearly we are seeing something different
now than in the past. You sit in a room with 400 patients, and look around,
and think, "This is unbelievable."

If you live in New York, or San Francisco, or West Hollywood, or probably
Philadelphia, where many people walk on the street, you see it. If you live
in places where people travel in cars, you don't see how pervasive it is.

ATN: What are you using for it? What regimen changes, or treatments?

GROSSMAN: Clearly d4T and the protease inhibitors seem to be the bad drugs.
Which one causes more, whether it happens mainly with one or the other or is
worst with both, we are not sure. My response has been to avoid both, until
researchers figure out what is going on. We start almost nobody on protease
inhibitors -- unless they come in with a virus with the K-103 mutation, due
to transmitted resistance to non-nucleoside drugs. Otherwise I don't touch
the protease inhibitors, and I stay away from d4T. Why take that risk for
patients when we have other choices?

ATN: On resistance testing, what is new that people should be thinking
about?

GROSSMAN: Sax at Harvard showed that in places where resistant virus is
common, as in most of the major cities in the U.S., resistance testing
before beginning treatment becomes cost effective [P.E. Sax, #MoPeB3129]. In
cost for good outcome, it is comparable to other medical treatments that are
well accepted.

We started doing resistance testing before treating people who were
chronically infected -- which goes against conventional wisdom. But I think
there are enough mutations in the community from AZT, and some of the
non-nucleoside and protease inhibitor mutations, that will hang around years
after somebody is infected with a resistant virus. This makes it worthwhile
to test for resistance, if they were infected in an area with a fairly high
prevalence of resistant virus (around 7%). I test them before starting
therapy to see if we come up with any antiretrovirals we should avoid.

After patients are on therapy, we test everybody who fails. I do both
genotyping and phenotyping, because in many patients the picture is complex.
You get enough discordance between the genotype and phenotype that having
both kinds of resistance testing can be very useful.

ATN: Do you use the new ViroLogic service that combines both?

GROSSMAN: Yes, the Phenosense GT. Virco has a good test too, but I like the
amount of data ViroLogic has on their report. And now they are doing their
experimental replicative capacity test as well, looking at the "fitness" of
the virus.

ATN: What do you think of the fitness test?

GROSSMAN: I am going to try it and see. At this point [August 2002] we are
just looking to see if it is useful or not. There need to be prospective
studies.

ATN: What else should patients know about using antiretrovirals?

GROSSMAN: It is very important to come back to the doctor for testing when
starting certain drugs. With the nevirapine regimens, for example, the
company recommends clearly that people get their liver functions tested
every two weeks in the first 6 weeks on therapy. We must be careful and
catch serious toxicities early.

Many patients who start antiretrovirals are used to seeing the doctor every
three months. When you start these meds, you need to follow up with the
doctor much more frequently at first. Unless the practitioner specifically
makes the appointments, patients may not show up again for three months. And
in addition to safety, we really want to see viral responses at 4 weeks and
8 weeks and 12 weeks [after starting antiretrovirals].

Especially when someone starts taking antiretroviral medication, I think
they should be seen two weeks after they start, to make sure they are doing
it right, if nothing else. If they are taking the drugs improperly for
months, the chance of developing resistance is high.

ATN: Is there anything else you would like to add on antiretroviral therapy?

GROSSMAN: The tenofovir data is excellent. The 48 week data from Gilead's
trial where it was added to failing therapy had remarkable results [A.L.
Pozniak and others, #WeOrB1266]. People maintained their decrease in viral
load after 48 weeks, even though their initial baseline therapy had failed
to maintain undetectable virus. And Gilead finally released their data in
treatment-naive patients, which also shows good efficacy. I am very willing
to use tenofovir for first-line therapy. I think it makes so much sense.


T-20

On T-20, people need to understand that it takes 30 minutes to mix this
drug, which is injected twice a day. You have to put a little bit of fluid
in and shake it very carefully, a little bit more and shake very carefully
again; you cannot get any bubbles, you cannot bruise the drug because
otherwise you denature the protein. It is very complicated to mix, and
almost everybody gets injection-site reactions. In studies they found only a
3% drop-out rate due to injection-site reactions; but these were desperate
patients who were highly treatment experienced and failing pretty much their
last regimen, and T-20 was their last chance.

I am not sure what will happen when T-20 comes into wide use. People need to
know that while it is a good drug it is certainly not a wonder drug, and it
will be very difficult for those people who take it. The company is well
aware of that. But the press has not covered how long it takes to mix it; I
have not read that anywhere. People need to know that taking T-20 will have
an impact on their lives, and they need to think about how they will handle
this. You cannot use a mixer or anything that speeds up the process.

New data show that both of the day's doses can be mixed in the morning, with
the afternoon dose left in the refrigerator. This, at least, will make it a
bit easier for those who take it.


Prevention

ATN: On superinfection -- people with HIV getting infected again with
another strain of HIV -- are changes needed in counseling people?

GROSSMAN: There were two cases at Barcelona -- the one from Bruce Walker
that got all the publicity, and another one from Geneva that was even more
impressive because of the testing they did. Clearly both of these people
became superinfected with another virus, even though they were doing well
with their STI (strategic treatment interruption) regimens, being patients
who had been picked up during seroconversion. They suddenly had a burst of
virus, and it turned out to be a different virus than they had before. When
scientists looked back at their stored samples, the second virus was not
there. In the Geneva case the man had been to Brazil and had unprotected
sex, and three or four weeks later he had the burst of virus -- and that
virus was one typically found in Brazil, not one typical for Geneva. [S.
Jost and others, #ThOrA1381]

I think it is very worrisome. We were trying to come up with some more
personalized sex guidelines for people in the early 90s -- rules that would
help people have more protected sex, but that were also more reasonable and
individual. So we said, if both of you were positive, maybe it did not
matter as much that you use a condom. But I think people got carried away.
In New York, San Francisco, Paris, and Los Angeles, many people are not
using condoms anymore at all! Many bathhouses are not giving them out; they
are not around. We are seeing a rise in new HIV infections across the board
in men, especially young men, and we are seeing a rise in other STDs. It is
amazing to me how little younger men know about STDs these days. We have
been so focused on HIV that we have forgotten to teach about good old
syphilis, gonorrhea, warts, etc.

And clearly there is a risk of HIV superinfection even if you are both
HIV-positive. It may not be a huge, high risk, but the risk is that you
could get a second HIV virus and do worse medically.

The implications for vaccines are tremendous, because it means that even a
well-controlled person who has good CTL immune responses and good responses
to the initial virus can be infected with another HIV.

ATN: What about oral sex?

The HOT (HIV Oral Transmission) study, out of San Francisco, is following
over 200 men who have sex with men and are believed to have no risk except
receptive oral sex [K. Page-Shafer and others, #TuPeC4872]. So far they have
found no recent HIV cases.

Clearly there have been reported cases. But this is a large study and seems
to show that though it does happen, the rate is low. Over the years,
Europeans and Australians have focused their prevention messages totally on
unprotected anal intercourse, and their HIV incidence rates have dropped
tremendously. We gave the mixed messages that we don't know about oral sex,
we are not sure, and we've totally confused everyone. As a result, our
incidence is high. I think people get frustrated and say, "Nothing is going
to protect me, I might as well just do what I'm going to do." Focusing on
unprotected anal intercourse is where I think we should be.

An epidemiology study in San Francisco found continuing increases in
unprotected anal intercourse, including with multiple partners [S. Gibson
and others, #MoPeC3430]. There was a big increase in rectal gonorrhea, and a
huge increase in early syphilis -- 17 cases in 1997, 10 in 1998, 29 in 1999,
47 in 2000, and 140 in 2001 [figures from the abstract]. HIV incidence also
increased greatly, although it may have peaked in 1999.

ATN: Overall, what do you think will be most important from the Barcelona
conference for treatment of patients with HIV?

The main messages from Barcelona were:

* The global epidemic is still a total disaster, but some individual people
have been making great progress.

* What I call the 'PI Paradigm" -- that protease inhibitors are stronger;
that people with high viral loads need them (or boosted PIs); that they are
the only drugs that control lymph node viral proliferation, etc. -- took a
big hit at this conference. The best performing regimen we have seen to date
has been efavirenz/Combivir(R) given every 12 hours. These are the drugs
that have been studied. It is my belief, however, that what we are seeing
here is not really drug specific; rather it is an indicator that NNRTI/2NRTI
regimens work as well, or better, than PI-containing regimens. And they are
much better tolerated.

* We still don't know what causes lipodystrophy and elevated lipids.

* We still don't know for sure whether there is an increased incidence of
cardiac disease in people on long-term therapy.

*STDs and new HIV infections are on the rise in young gay men of all races
and ethnicities in the U.S. and Europe. Here in the US they are
disproportionately affecting young gay men of color.


***** Pan-African AIDS Treatment Movement Launched

On August 26, 2002, AIDS activists from 21 African countries announced the
Pan-African HIV/AIDS Treatment Access Movement (PHATAM). They had met for
three days in South Africa, during the World Summit on Sustainable
Development. Twelve AIDS, health, and religious organizations convened the
PHATAM organizing meeting. The new group will focus primarily on treatment,
including antiretrovirals, but will also work on prevention and other ways
to control the epidemic.

From the PHATAM Declaration of Action, published August 25:

"Without treatment, the 28 million people living with HIV/AIDS (PLWAs) on
our continent today will die predictable and avoidable deaths over the next
decade.  More than 2 million have died of HIV/AIDS in Africa just this year.
This constitutes a crime against humanity.  Governments, multilateral
institutions, the private sector, and civil society must intervene without
delay to prevent a holocaust against the poor.  We must ensure access to
antiretroviral (ARV) treatment as part of a comprehensive continuum of care
for all people with HIV who need it.  In this regard, at a minimum, we call
for the immediate implementation of the World Health Organization goal to
ensure antiretroviral (ARV) treatment for at least three million people in
the developing world by 2005.  Together with our international allies, we
will hold governments, international agencies, donors and the private sector
accountable to meet this target."

Three international action dates were announced:

"* A Global Day of Action on the Global Fund to Fight AIDS, Tuberculosis and
Malaria on 9 October 2002 to demand more money from donor countries,
prioritization of treatment in national proposals and funding decisions,
increased transparency and monitoring of fund disbursements, and active
involvement of PLWAs in Country Coordinating Mechanisms

"* A Global Day of Action Against Coca-Cola, the largest private employer in
Africa, and other multinationals on 17 October 2002 to demand ARV treatment
for all HIV-positive workers and their families

"* A Global Day for Access to HIV/AIDS Treatment on 1 December, World AIDS
Day, 2002"

For more information see the Declaration of Action, which is available at
http://www.tac.org.za. (Documents on this site are organized by date, and
the Declaration of Action was added on September 3.


***** Chinese Activist Detained by Police, Immediate Action Needed

Dr. Wan Yanhai, China's foremost AIDS activist, disappeared in Beijing on
August 24. According to Liang Yen Yen, one of the coordinators of Dr. Wan's
Aizhi (AIDS) Action Project, he has been detained and is being "examined" by
the Chinese Ministry of State Security. He is accused of exposing state
secrets; namely the AIDS epidemic in China's Henan province brought on by
blood selling.

Dr. Wan's wife Su Zhaosheng has called on AIDS activists and other allies to
help in the effort to expedite his release.

Dr. Wan, 38, is a noted free speech advocate who founded the first AIDS
telephone hotline in China and operates an important AIDS information web
site. A current Fulbright scholar, Dr. Wan is studying the effectiveness of
abstinence-only programs in the U.S. and China.

For the past decade, Dr.Wan has been working on HIV prevention education,
gay & lesbian rights, mental health issues, the rights of people with HIV,
and religious issues. He is the 2002 winner of the Human Rights Watch Award
for Action on HIV and Human Rights.

According to the Committee to Protect Journalists:

"Wan has also been an outspoken opponent of new Internet regulations,
enacted August 1, which require publishers of all China-based Web sites to
register with the government and censor their content or risk being shut
down. In late July, Wan and 17 others initiated a "Declaration of Internet
Citizens' Rights," which called for freedom of expression, association, and
information on the Internet.

"Reporting on AIDS is strictly censored in China's press, and Chinese and
foreign journalists who investigate the topic have faced harassment or
detention. Because of this, Wan Yanhai's Web site has become one of the only
independent sources of information on the disease in China."

In July, Aizhi Action Project was shut down and stripped of its legal
registration by the Chinese government.

Dr. Wan's disappearance, which has been covered extensively by THE NEW YORK
TIMES, National Public Radio and other news outlets, has prompted an
international reaction. On September 2, activists held a protest in Hong
Kong.

Amnesty International issued an international appeal for immediate letters
on his behalf, and U.S. AIDS activists have issued their own appeals.

On September 2, 2002, Amnesty International asked that letters and emails
for Dr. Wan's release be sent immediately to Chinese officials in Beijing
and to Chinese embassies throughout the world. To a send such a message,
check:

http://www.amnestyusa.org/outfront, or
http://www.iglhrc.org/world/ne_asia/China2002Sep.html, or
http://www.whereiswan.org.


***** Philadelphia, New York: Dr. Jon Kaiser's Treatment Update, September
17, 18

Jon Kaiser, M.D., who combines standard HIV antiretroviral treatment with
nutrition, exercise, and other natural treatment approaches will be speaking
in Philadelphia on Tuesday, Sept. 17, at Graduate Hospital Auditorium, 18th
and Lombard St., 6-9 p.m. A light dinner will be served. For more
information, see http://www.jonkaiser.com.

There is no charge for this program, which is sponsored by Action AIDS,
MANNA, Philadelphia Health Alternatives, and Philadelphia FIGHT.

As we went to press the New York talk was set for Sept. 18, St. Vincent's
Hospital, Cronin Auditorium, 10th floor, Cronin Bldg., 170 W. 12th St., 6-9
p.m. Light dinner will be served, and no admission charged. Sponsors are St.
Vincent's AIDS Education and Training, and FIAR (Foundation for Integrative
AIDS Research).


***** AIDS TREATMENT NEWS

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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 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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more than short quotations are used.

AIDS TREATMENT NEWS Issue #382, August 9, 2002
    phone 800-TREAT-1-2, or 215-546-3776

CONTENTS

** Barcelona Conference: New Online Report
An excellent collection of articles, written mainly for HIV
medical professionals, summarizes some of the important medical
information from the Barcelona conference.

** Barcelona Conference Daily News Links
These sites have short reports, usually published within a day or
two and focusing on a single medical presentation. You can quickly
scan what's available, then read what you need.

** ACTG 384 at Barcelona: The Bottom Line
Unexpected early results from a major clinical trial will change
some treatment decisions.

** Nandrolone: Generic Now in Stock
On June 28 we reported that the anabolic steroid nandrolone
suddenly became unavailable in the U.S. (except perhaps for a
compounded version). Since then a new generic product has reached
some pharmacy shelves.

** "Save ADAP" Campaign Starts August 12 -- What You Can Do Now
An excellent instruction kit for advocacy is available.

** National AIDS Treatment Advocates Forum (New Orleans, December
2002): Scholarship Deadline Aug. 16
Financial assistance deadline for NATAF is Friday of this week.

** Barcelona Comments
What do we see as most important from the conference -- or missing
from it? Besides new drugs, we look at how vaccines could be
developed much faster -- and at leadership (and lack of it) in
controlling a global epidemic that is becoming much worse than was
expected even recently.


***** Barcelona Conference: New Online Report

by John S. James

On August 9 an excellent in-depth summary of what HIV medical
professionals and well-informed patients most need to know from
the XIV International AIDS Conference (July 7-12 in Barcelona,
Spain) was published on the Medscape Web site,
http://hiv.medscape.com  It consists of four articles, and a test
that physicians, pharmacists, and RNs can take for continuing
medical education (CME) credit (but anyone can read the articles
or take the test for their own information). [Note: The first time you
use this site you will probably need to register, but registration is
free.]

The articles are:

* Initial Antiretroviral Therapy: Further Insights on When to
Start and What to Use, by Joseph J. Eron Jr., M.D.,

* Antiretroviral Therapy in Treatment-Experienced Patients, by
William A. O'Brien, M.D., M.S.,

* Update on Lipodystrophy...Or Is It Just Lipoatrophy?, by Donald
P. Kotler, M.D., and

* Opportunistic Infections and Coinfections: Focus on Fungi and
Hepatitis, by William G. Powderly, M.D.

Many patients will find one of the first two articles most
important, because they discuss some of the newer options in
antiretroviral treatment. The lipodystrophy article is the most
complex, because our basic understanding of HIV-related
lipodystrophy may be changing. In addition to these four articles,
there is some optional material that is not required for CME
credit.

This CME course is available at:
http://hiv.medscape.com, and will remain online for one year.

Comment

The first reports from Barcelona were next-day coverage of
individual sessions, which were published by several different
organizations. Now, a month after the conference, we are getting
reports that summarize information from many conference sessions
and from other sources as well, outlining how our understanding
has changed due to the findings presented at the meeting.

We missed the Barcelona conference unexpectedly (see AIDS
TREATMENT NEWS #381) -- and especially missed the many informal
conversations in hallways and other informal meetings that help to
put the whole conference in perspective. Fortunately these
conversations continue by email -- although this medium would be
more useful if people would learn to communicate better when
sending email to large groups (for example, by making each message
coherent to others who may not be as involved as the sender in the
background and context of that message).

The official conference site,

http://www.aids2002.org, leaves much to be desired -- although
fortunately it does allow searching for any word in the abstracts,
important for locating specialized information.

So far, the Medscape CME is the best summary we have seen of the
clinical importance of this conference. It is likely that several
comparable reports will be published over the coming months.


***** Barcelona Conference Daily News Links

The next-day reporting from the conference had to focus on
individual meetings instead of broader perspectives. Still, some
of these reports may be the best source available for particular
information you need. You can use these links to read quickly
through the dozens of titles, to find what is important for you.

Note: Web sites often get reorganized, so some of these links may
not work when you try them. In that case, go to the home page of
the site (usually the part of the address through the .com or
.org), and look for the reports from there.

The annotations in brackets below are our own.

* Medscape [information for medical professionals and patients]
http://www.medscape.com/viewprogram/1980 also see
http://www.medscape.com/pages/editorial/newsbeats/aids

* Kaiser Family Foundation [general conference news widely
syndicated on other sites]
http://www.kaisernetwork.org/aids2002/

* Health & Development Networks [important international coverage]
http://www.hdnet.org/home2.htm

* The Body [focus on new drugs and other medical news]
http://www.thebody.com/confs/aids2002/aids2002.html

* International Association of Physicians in AIDS Care (IAPAC),
http://www.iapac.org/ [Choose IAPAC AIDScan for their daily
newsletter on the conference.]

* HIV and Hepatitis.com [many news reports]
http://www.hivandhepatitis.com

* National AIDS Treatment Advocacy Project [occasional medical
articles, also strong on hepatitis]
http://www.natap.org/

* For a short (6 pages single spaced) overview of the conference,
focusing on medical information that will affect patient care over
the next several years, see "A Roundup of Barcelona" by Pablo
Tebas, available at:
http://www.thebody.com/confs/aids2002/tebas10.html
From the Roundup: "The science -- at least the clinical part --
was very good this time, much better than in Durban or in
Retrovirus this year. Major trials like ACTG 384, INITIO, Gilead
903, and the TORO trials were presented during the Barcelona
conference. These trials will mark the next months if not years of
HIV treatment."


***** ACTG 384 at Barcelona: The Bottom Line

by John S. James

ACTG 384 is a large clinical trial by the U.S. Institute of
Allergy and Infectious Diseases, which enrolled over 900
treatment-naive volunteers. Shortly before the Barcelona
conference, one of the six different treatment regimens tested was
found to be clearly better than the others. So volunteers will be
told which regimen they were on, and advised on options for
changing therapy when appropriate.

Letters were written to study volunteers before the conference;
however, local IRB (institutional review board, intended to
protect volunteers in clinical trials) for most of the study sites
required that they review the letters before they could be
distributed. Since the reviews had to wait for the IRB process,
few volunteers received the news before the Barcelona meeting.

Two abstracts on this study were presented at late breakers at
Barcelona (numbers LbOr20A and LbOr20B). These hard-to-read
abstracts can be found by a search on the official conference
site, probably reachable at:
http://www.aids2002.org/Search/AbstractSearch.asp (be careful to
use the Abstract Search, not the Quicklinks search confusingly
placed above it); you can search for the abstract numbers.

But what matters most is:

1. Efavirenz plus AZT plus 3TC was a better starting regimen than
the other five tested in this trial;

2. Regimens including d4T plus ddI had more toxicity than others;
and

3. There are questions about how to apply these results to
treatment today (see article by Peter Ruane, M.D., at:
http://www.medscape.com/viewarticle/438430).

Comment

1. This is an important trial -- despite issues of whether the
questions it was designed around will ever be answered, or were
the best questions to ask. The comparisons between regimens do not
generalize to drug classes (whether it is better to start with a
protease inhibitor or an NNRTI, for example), but apply mainly to
regimens chosen from those available several years ago. Still, the
trial is important because it collected good-quality data after
randomized treatment assignments -- data likely help in many ways
to improve HIV care. We will be hearing much more from this trial
over the next few years.

2. The local IRB review of the researchers' recent letter to the
volunteers, which delayed its delivery to most participants, made
no sense. The local IRBs will not change this letter, nor stop it
from going out. So the whole exercise was empty process. We
hope the current dysfunctional relationship between local and
national IRBs will be part of the badly needed review of
protection of volunteers in medical research. Perhaps national
studies should be reviewed by national IRBs that can be trusted --
with local IRBs able to block the study initially, but not
routinely involved when it is too late to make any contribution.


***** Nandrolone: Generic Now in Stock

In June we reported that nandrolone was no longer regularly
available in the U.S.; generic versions had disappeared three
years ago, and the more expensive brand name Deca Durabolin had
just been withdrawn from the market by the manufacturer. In late
July we learned that a generic version is now available through at
least some pharmacies. The Schein brand was found in a New York
pharmacy at a retain price of $13 per vial (1 ml, 200 mg/ml). This
is close to the old generic price.

There may be more information on the nandrolone situation at
http://www.medibolics.com or at http://www.houstonbuyersclub.com
(On the Medibolics site, you might search the home page for 'Deca'
or 'nandrolone', using the search in your own Web browser).


***** "Save ADAP" Campaign Starts August 12 -- What You Can Do Now

About 10,000 Americans eligible for AIDS treatment are now on
waiting lists for the AIDS Drug Assistance Program (ADAP), because
of lack of funds. As we go to press, the AIDS Treatment Activist
Coalition is about to release an action alert on what you can do
now, especially in August and September. It includes clear,
accurate instructions for writing to your Representative and two
Senators, for writing to local newspapers on this issue, and for
attending any local meetings your representatives in Congress have
with their constituents.

If you do not get the alert through an AIDS email list, look for
it at http://www.atac-usa.org  You can also email Ryan Clary at
Project Inform rclary@..., and ask for a copy of the
Save ADAP alert.


***** National AIDS Treatment Advocates Forum (New Orleans,
December 2002): Scholarship Deadline Aug. 16

The National AIDS Treatment Advocates Forum, sponsored by the
National Minority AIDS Council (NMAC), brings together about 400
treatment advocates from the U.S. and other countries for skills
building to help assure the continued success of the treatment
advocacy movement. This year's NATAF meeting will be held in New
Orleans, LA, on December 8-11, 2002.

Scholarships (which can include the $150 registration fee, the
hotel, and a $100 travel credit) are available. The deadline for
scholarship applications is Friday, August 16. You can apply
online at:

http://www.nmac.org/nataf/2002/scholarship.htm  You will need
information about yourself and your agency, so it's best to check
the application form ahead of time, and submit it online later.

The mission of NATAF includes:

"Updating participants on the latest treatment and research
information;
Providing opportunities to build advocacy skills;
Providing opportunities to develop inclusive strategies to
advocate for people living with HIV/AIDS;
Promoting collaboration, networking and mentoring among all
participants."


***** Barcelona Comments

by John S. James

The XIV International AIDS Conference, July 7-12 in Barcelona,
Spain, was the biggest AIDS conference ever, with more than 15,000
people and more than 10,000 research, program, and other reports
presented. Some have wrongly concluded that little important
medical or scientific information was included. But it can be hard
to find what you need, so we will continue to point to the best
and most accessible reviews as new ones become available.

But first, here are some (not all) of the important take-home
messages, as we see them:

* Clinical care. Lots of information will affect treatment of
patients over the next several years -- including new drugs,
better ways to use existing drugs, and better understanding of why
HIV treatment is difficult. For example, the approved drugs
efavirenz and tenofovir, and T-20, which should be approved within
a year, continue to look good. For a link to in-depth clinical
information, see "Barcelona Conference: New Online Report" in this
issue.

Incidentally, T-20 is expensive to manufacture -- and there are
likely to be serious equity issues in who gets access within the
U.S. But we doubt that there will be major access issues in
developing countries. This is because T-20 is injected twice a
day, and therefore is likely to be used only by those who need it
because they have developed extensive viral resistance to other
HIV drugs. So few people in developing countries have received any
antiretroviral treatment that there is not likely to be much need
for T-20 for several years. By that time there should be other new
antiretrovirals that can be provided more easily.

* Vaccines -- What's Missing on Faster Testing? The discussion we
have seen from the Barcelona conference has missed what may be the
most important practical fact about vaccine development -- that by
far the fastest way today to develop a preventive vaccine is to
test candidates as therapeutic vaccines first. This is because
therapeutic vaccines can be tested in weeks in a handful of HIV-
positive volunteers during structured treatment interruptions, to
see if they show any anti-HIV effect by delaying the return of the
virus humans. But getting any idea of whether a preventive vaccine
works takes thousands of people in trials that run for years.
(There were a handful of presentations on therapeutic vaccines in
Barcelona -- including DermaVir, a vaccine designed to be applied
to the skin, that could begin human trials this fall.)

Eventually the development paths for preventive and therapeutic
vaccines may diverge. But this has not happened yet, because so
much is still unknown about immune protection from HIV.

Scientists now can measure a seemingly endless number of potential
immune responses -- and often can stimulate these responses in
human volunteers with vaccine-like treatments. The problem is that
we don't know which immune responses actually help to protect
against HIV (and we may know less after the Barcelona conference
than we thought we knew before). If we had a vaccine that would
greatly reduce the return of viral load after antiretroviral
therapy was stopped, that would not prove it would protect against
initial infection; additional tests would still be required. But
such a vaccine would be a much better candidate for a preventive
trial than any we now have. Therapeutic vaccine testing can
quickly screen many ideas, allowing for successive improvements in
basic science and in products alike, greatly advancing the search
for a preventive vaccine.

And although it is clearly a setback for vaccine development, we
are not too worried by the news that a person's immune response to
HIV infection may not protect against another HIV infection.
Clearly the immune system does largely contain the virus in
early infection, so immune control of HIV is possible. And
vaccines can be engineered to produce many immune responses that
natural infection usually does not produce.

* Global epidemic. The biggest need now is to prevent India,
China, Indonesia, Eastern Europe, and other large population
centers from developing major epidemics like the one in Africa,
which could ultimately kill a quarter of the population or more --
especially parents, and workers in their most productive years.
These epidemics are already in their early stages. They could be
mostly stopped if the proper steps are taken now -- but while
proven prevention programs exist, they are not being scaled up in
most countries, due to lack of leadership and the resulting lack
of resources. If current trends continue, the number of people
killed or otherwise affected will be far larger than in Africa,
because the population is greater.

For an in-depth look at a world epidemic much worse than many
people thought even recently see the UNAIDS publication, REPORT ON
THE GLOBAL HIV/AIDS EPIDEMIC, JULY 2002. Epidemics that were
thought to be leveling off because they were running out of new
people to infect have instead increased to levels that were not
thought possible. (Links to this report and other UNAIDS
information are at:
http://www.unaids.org/whatsnew/newadds/index.html  The links are
in chronological order; this report is one of several published
July 2, 2002.)

Also from the United Nations, an expert panel recently convened by
UNAIDS and WHO estimated that just expanding the prevention
successes already achieved in some countries could prevent two
thirds of new infections save 29 million lives by 2010. But a
three-year delay in acting would reduce the effectiveness by 50%.
(The report, "Can We Reverse the HIV/AIDS Pandemic with an
Expanded Response," was published in THE LANCET, July 6, 2002. A
July 3 press release and link to a downloadable copy are at:
http://www.unaids.org/whatsnew/press/eng/pressarc02/Lancet_040702.
html  These can also be reached through the "whatsnew" link
above.)

* Treatment access. Only 30,000 people in Africa are now receiving
antiretroviral treatment (less than 1% of those who clearly need
it). On the positive side, many new programs are expected to start
in the coming year, so this number should be considerably higher
next year. Also good news is the strong consensus that treatment
needs to be part of prevention, which gives people a reason to be
tested and to fight against the stigma that stops so much of what
needs to be done. Most experts now agree that condemning almost
everyone with HIV in developing countries to death on the grounds
that prevention is more cost-effective than treatment will not
work as prevention in the real world. (A less obvious factor is
that the great majority of those who need treatment will not get
it anyway, no matter what we do; for example, most of those who
are infected do not know it, and do not want to be tested.
Policies can give or deny hope without suddenly requiring enormous
resources for treatment.)

* Leadership and Resources. By different groups' estimates, the
public money needed to control AIDS, tuberculosis, and malaria
around the world would be about ten billion dollars
($10,000,000,000) per year. This is less than Africa alone pays on
debt service every year (which is over $14,000,000,000). The share
of this money needed from the U.S. and other rich countries to
control these three epidemics worldwide would be about the cost of
a movie and a bag of popcorn for each person once a year. People
are willing to pay this but world leaders are not ready to move.
So opportunities to control HIV epidemics in their early stages
are being lost forever.

Also, despite much progress, intellectual-property rules and trade
restrictions do remain a problem on the ground, and are still
keeping treatment away from many people in Africa and elsewhere
who would otherwise have a possibility of getting it -- a human
sacrifice which in this case does not add one dollar to the
funding of research for new treatments in the future, the reason
cited for justifying the pharmaceutical patents in the first
place. Other major access problems include unworkable distribution
systems, uncoordinated regulatory requirements throughout much of
the world, and of course lack of medical infrastructure.

The greatest disappointment from Barcelona is that most of the
governments of the world, led by the U.S. government, are still
not serious about dealing with the epidemic. President Bush set
the tone for the U.S. (and therefore other rich countries) shortly
before the Barcelona meeting, by killing a serious effort in
Congress to move forward on global health -- replacing it with a
speech about saving babies by preventing mother-to-child
transmission, which everyone already supports. It is generally
believed that most European and other countries use the U.S.
government's seriousness (or lack of it) as a benchmark for their
own commitment on the worldwide epidemics of HIV and other
diseases. There is widespread concern that once again, top leaders
will downplay the problem until the bodies pile up, and as much as
a third of the population in some of the worlds' largest
population centers already has an incurable infection.

Could we do better at asking for resources? At organizing
grassroots support everywhere for AIDS control around the world?
Of course.

Former presidents Nelson Mandela and William Clinton addressed
political issues in their talks during the closing ceremony. Both
focused most (and in different ways) on the problem of AIDS
stigma. But here we selected short quotes focusing mainly on
leadership.

Mandela

"There is no doubt that strong leadership is the key to an
effective response in the war against AIDS. Leadership starts at
the top. When the top person is committed, the response is much
more effective.

"This means not only political leaders, but also business leaders,
union leaders, religious leaders, traditional leaders, and the
leaders of NGOs. One has to make special mention of the role
played by NGOs and the leadership in those organizations. These
are often small organizations with meager resources that have made
an impact far beyond what would have been expected from their
size. One is often moved to reflect that, if only the big
institutions of government and business had made a similar effort
proportionately, we might very well already have turned the tide
of the AIDS pandemic." (Former president Nelson Mandela,
Barcelona, July 12, 2002.)

Clinton

"The first responsibility of leaders in the AIDS epidemic, in my
view, before they seek new funding, or launch new initiatives, or
expand treatment and prevention -- their first obligation is to
make the case loudly and repeatedly that AIDS is not a threat
against people of a particular group or country or continent; AIDS
is a threat against all of us. The AIDS epidemic has been so
devastating so quickly because it has exploited our worst human
instinct -- the instinct that demonizes, or at best is indifferent
to, people we see as different. We were slow to act on AIDS
because the wealthier, more powerful people in the world saw
people with AIDS as different. They're sex workers; they're drug
addicts; they're poor; they're gay; they're from another country,
another continent, another race. We're not from another race;
we're from the same race -- the human race. We need to get this
right today. Tomorrow may be too late." (Former president William
J. Clinton, Barcelona, July 12, 2002.)

Recordings and transcripts of both talks are at:
http://kaisernetwork.org/aids2002/webcast_12_a.cfm


***** AIDS TREATMENT NEWS

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Editor and Publisher: John S. James
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AIDS TREATMENT NEWS #381, June 28, 2002
    phone 800-TREAT-1-2, or 215-546-3776

CONTENTS:

** Nonoxynol-9 Harmful, Should Not Be Used in Condoms, Lube
This chemical is still used in condoms and lubricants to kill HIV
-- although it has been shown to actually increase HIV infection.
Rectal use may be particularly harmful. A new report from the
World Health Organization summarizes the evidence and makes
recommendations.

** Barcelona International Conference, July 7-12 -- Web Sites to
Watch
These Web sites will have news from the big AIDS conference in
Barcelona, Spain -- both during the meeting, and in the weeks and
months after it.

** Nandrolone (Deca Durabolin) Disappears in U.S., Generic May
Return in July
The last regularly available version of nandrolone, a drug widely
used to treat AIDS wasting, was suddenly withdrawn in the U.S. in
May, and has largely disappeared from pharmacies. A new generic
version may be available now. We suggest some Web sites to
check for information if your doctor or pharmacy has trouble
getting this drug.

** Barcelona: Visa Barriers May Disrupt Conference
Almost everyone from Africa or Asia needs a visa to enter Spain -
- although citizens of the U.S. and over 50 other countries do
not. Many delegates from developing countries have had great
difficulties getting a Spanish visa to attend the big
international conference in Barcelona; we do not know how many
were kept away as a result. In addition, we look at another
access and solidarity issues, the price of the international AIDS
conferences -- and show that other large meetings can make a
profit on a tenth the price.

*Thousands Face Loss of Treatment in ADAP Money Crisis
An in-depth look at why the AIDS Drug Assistance Program is
running out of money in many states -- and what might be done to
improve the situation.

** On an ADAP Waiting List? Advice from Treatment Activists
Here are some practical steps to consider if you have problems
getting treatment because of the ADAP funding crisis.


***** Nonoxynol-9 Harmful, Should Not Be Used in Condoms, Lube

by John S. James

On June 25, 2002 the World Health Organization published a 27-
page report summarizing what is known about nonoxynol-9 (N-9) --
the failed microbicide that actually increases risk of HIV
transmission. They concluded that N-9 should never be used for
preventing HIV transmission, has no value in preventing other
sexually transmitted diseases, and should never be used rectally,
where the problem may be much worse than with vaginal use. (The
report acknowledges that women at *low* risk of HIV infection may
use N-9 occasionally as a moderately effective, female-controlled
form of birth control, when better means are not available to
them.)

Condoms should not include N-9 for any use. However, if the only
condom available has N-9, it is better than no condom.

On May 10, 2002 the U.S. Centers for Disease Control and
Prevention updated its GUIDELINES FOR THE TREATMENT OF SEXUALLY
TRANSMITTTED DISEASES, also warning against using N-9 for STD
prevention.

Background and Comment

N-9 kills HIV in the laboratory. But it also causes irritation in
the vagina or rectum that can allow HIV to infect. A major
clinical trial in women, reported two years ago at the
International AIDS Conference in Durban, South Africa, studied
over 800 sex workers randomly given either an N-9 or placebo gel,
and found 48% more new HIV infections among those using N-9.

No one has done such a study with rectal use. But in both humans
and animals the irritation is worse, with "sloughing of sheets of
epithelium." The damage is later repaired, but by then HIV could
have been transmitted.

A recent survey found that about 40% of condoms sold in the U.S.
are lubricated with N-9, and about 40% of gay men look for it.
Manufacturers of condoms and lube have no incentive to include N-
9, except for this mistaken public demand; and all of these
manufacturers also market parallel versions of their products
without N-9. Now that there is a clear, official consensus that
N-9 is harmful, especially for rectal use, it is likely to start
disappearing from condoms and lubes.

The community will need to help get the word out, since no one
has a commercial incentive to do so, and government agencies are
reluctant to speak about anal sex.

References

1. WHO/CONRAD TECHNICAL CONSULTATION ON NONOXYNOL-9, WORLD HEALTH
ORGANIZATION, GENEVA, 9 - 10 OCTOBER 2001, SUMMARY REPORT. (This
is the report published June 25, 2002; the October 2001 meeting
brought together experts to examine the evidence and prepare
recommendations.)

As we go to press the report is available through
http://www.who.int/reproductive-health/rtis/index.htm
and also through: http://www.conrad.org

2. "World Health Organization/Conrad Report Warns Against Use of
Nonoxynol-9 As Microbicide," press statement issued June 25,
available at the Web sites above.


***** Barcelona International Conference, July 7-12 -- Web Sites
to Watch

by John S. James

The XIV International AIDS Conference will take place July 7-12
in Barcelona, Spain -- with important satellite meetings starting
several days before. These meetings happen only once every two
years; no breakthroughs are expected, but important research and
medical developments will be presented. And AIDS workers from
around the world will meet and organize on dealing with the
global epidemic.

Personal note: Due to a mild pneumonia, we had to cancel our
plans to go to Barcelona, and also delay this issue. So we will
refer our readers to the best conference coverage by others. As
this issue goes to press, the meeting has just begun, and little
coverage exists so far. Here are some sites you may want to
watch.

Official conference site: http://www.aids2002.org

The official Web site works better than it used to, and now has
the conference abstracts online, as well as other program
information.

Kaiser Family Foundation: http://kaisernetwork.org (also
http://www.kff.org/aids2002)

The Kaiser Family Foundation is producing daily news reports from
the conference, which are syndicated and appear on several other
AIDS Web sites as well. We will follow them on this site, since
the other ones may not run all of the stories.

Medscape, http://hiv.medscape.com

Medscape usually has excellent conference coverage. Later, the
material may be organized into CME (Continuing Medical Education)
modules, which are designed for physicians or other medical
professionals, but are available to anyone who wants to use them.
Note: The first time you use the Medscape site you need to
register, but registration is free.

HIV and Hepatitis.com, http://www.hivandhepatitis.com

This site has AIDS and hepatitis news stories -- including
reports from the XI International HIV Drug Resistance Workshop,
July 2-5, 2002, in Seville, Spain

Health & Development Networks, http://www.hdnet.org/home2.htm

Health & Development Networks, based in Dublin, Pretoria, and
Chiang Mai, has for years maintained major email lists on
international AIDS. It is publishing original reports from the
Barcelona conference.

International Association of Physicians in AIDS Care,
http://www.iapac.org

IAPAC is publishing a daily newsletter from the Barcelona
conference. It is available on their site.

The Body, http://www.thebody.com

The Body will publish original next-day coverage of the Barcelona
conference.

National AIDS Treatment Advocacy Project (NATAP),
http://www.natap.org

Besides coverage of the Barcelona conference, NATAP also has
reports from the XI International HIV Drug Resistance Workshop,
July 2-5, 2002, in Seville, Spain.

Women At Barcelona, http://www.womenatbarcelona.net

This project brings information about women and AIDS to the
public in Barcelona -- and makes conference information more
accessible to the great majority of those affected, who are not
AIDS specialists.

UNAIDS, http://www.unaids.org

UNAIDS, the accepted authority on the global epidemic, has
conference information as it relates to the United Nations.


***** Nandrolone (Deca Durabolin) Disappears in U.S., Generic May
Return in July

by John S. James

In late May or early June treatment activists learned that the
only version of nandrolone currently available in the U.S. (brand
name Deca Durabolin) was being discontinued. Soon we started
hearing from patients whose pharmacies told them they could not
find the drug. Nandrolone is approved for anemia due to renal
insufficiency, but many doctors use it off label for AIDS
wasting.(1,2,3) Usually the patients, doctors, and pharmacists
had heard nothing about the drug going away. It just disappeared
from the supply chain.

Nandrolone remains available in other countries. But because it
is a controlled substance due to abuse by body builders, patients
cannot import those products for personal use. Until three years
ago there were lower-cost generic nandrolone products available
in the U.S. Then they also disappeared with little notice.

Other anabolics that had also been used off label in AIDS have
been discontinued -- and then later come back with an HIV label
(FDA approval for the HIV use), but with a huge price increase,
typically more than 10 times their former cost. We do not know if
that will happen with nandrolone.

Activists have investigated and been told that a new generic
nandrolone will be available after the July 4 weekend. But what
we have heard so far is confusing and contradictory.

Recently we heard that a compounded version of nandrolone is
available now.

Because the situation is unclear and rapidly changing, check Web
sites of organizations that have been following this issue,
including http://www.houstonbuyersclub.com, http://www.atac-
usa.org, and http://www.medibolics.com for the latest
information.

References

1. Sattler FR, Jaque SV, Schroeder ET, and others. Effects of
pharmacological doses of nandrolone decanoate and progressive
resistance training in immunodeficient patients infected with
human immunodeficiency virus. JOURNAL OF ENDOCRINOLOGY AND
METABOLISM. April 1999; volume 84, number 4, pages 1268-1276.

2. Strawford A, Barbieri T, Neese R, and others. Effects of
nandrolone decanoate therapy in borderline hypogonadal men with
HIV-associated weight loss. JOURNAL OF ACQUIRED IMMUNE DEFICIENCY
SYNDROMES AND HUMAN RETROVIROLOGY. Feb. 1999; volume 20, number
2, pages 137-46.

3. Gold J, High HA, Li Y, and others. Safety and efficacy of
nandrolone decanoate for treatment of wasting in patients with
HIV infection. AIDS. June 1996; volume 10, number 7, pages 745-
52.


***** Barcelona: Visa Barriers May Disrupt Conference

by John S. James

About 90% of the AIDS epidemic today is in poor or developing
countries, and these regions are expected to be a major focus of
the XVI International AIDS Conference 2002 (July 7-12 in
Barcelona, Spain). But Spanish embassies in India, the Congo, and
many other developing countries are denying scientists,
journalists, and conference scholarship recipients the visas they
need to enter Spain to attend. One week before the meeting, it
appears that many will be unable to go -- including recipients of
scholarships partly financed by the Spanish government itself.
(Citizens of the U.S., the countries in the European Union, and
about 45 other countries do not need visas to visit Spain, so
this problem does not affect them directly. The visa-free
countries, listed at http://www.aids2002.org, include almost none
in Africa or Asia.)

AIDS TREATMENT NEWS learned:

* As of June 28, no one from the DRC (the Congo) had been allowed
to travel to Spain -- including at least one leading scientist.
Visa applications were either denied, or not responded to at all.

* We have also heard of serious problems in India, Pakistan,
Bangladesh, Sri Lanka, Nigeria, Kenya, the Ivory Coast, and
Colombia -- and this is not an exhaustive list. Often people have
been put through application procedures that may be impossible to
meet in time no matter what they do. For example, according to
Indian applicants, Spanish embassy staffs were instructed to give
out very few application forms. One woman with young children was
told to travel 2,000 km to Delhi to possibly get the form -- and
then pay to stay there a week while it was processed. Sometimes
the applicant cannot get a form at all, or the filled-out form is
not accepted, or the applicant never gets an answer. Some have
been told to call within a short time window on only one day a
week -- then told the computer is down and they need to call the
following week. Applicants in Colombia have been told they need
to wait up to six months for a visa.

* A pre-conference meeting for professional, mainstream
journalists from developing countries may have half of the
journalists excluded because they could not get Spanish visas.

* The Barcelona conference organizers have arranged scholarships
for leading AIDS workers and activists from developing countries.
An issue for them is that applicants for a Spanish visa must
prove they have enough money to travel to Spain -- but those
eligible for scholarships may not have it. The Spanish Ministry
of Foreign Affairs, replying on the visa controversy, which came
to public attention only on June 18, said "sometimes the visa
applicants do not fulfill the requirements that Spanish law
requests, such as the minimum economic means that an individual
must have when entering the country, and that the process will
ultimately depend on whether delegates are able to fulfill these
legal conditions." Apparently the fact that their expenses are
being paid by a scholarship from the conference did not count.
Also, they may have to show their original tickets -- not a fax
or electronic ticket -- but unlike those who buy their own, they
have little or no control over when they receive them.

Additionally, African, Asian, and other poor-country delegates
reaching Spain through other countries in Europe may need travel
visas for those countries as well -- another chance for a glitch
that could keep them out of the conference.

* According to the Conference organizers, the Spanish government
has informed its embassies around the world about the conference,
and told them who is invited to attend, so they can get visas.
The Conference Web site has published a list of exactly what
documents applicants should need. At some Spanish consulates in
some countries this system is working. In others it is not.

* These problems are not new. At the Vancouver international AIDS
conference in 1996, according to one conference organizer, the
staff had to work for months on Canadian visa problems -- in the
end, about a dozen delegates were unable to get visas and could
not come. Also, according to this organizer, one of the problems
proved to be corruption at some of the local embassies, with
local staff seeking payment to get documents processed.
(Incidentally, after the Vancouver conference, only two of the
more than a thousand scholarship recipients at that conference
sought refugee status in Canada -- though fear of refugee
applicants reaching Canada was a major reason for the visa
problems. One has since returned to his country; the other is
still in Canada and doing AIDS outreach work.)

We have not seen any indication that the current difficulties
resulted from September 11 or the fear of terrorism. In India,
for example, the discrimination appears to be against the whole
nation, through efforts to limit the total number of Indians
entering Spain -- a de facto quota with no effort whatever to
determine who might be dangerous.

[Note, July 9: As the conference begins, some of the problems
were resolved in time for persons to attend; 20 from Nigeria were
granted visas, for example. We do not yet know how many delegates
from developing countries were ultimately admitted to Spain, and
how many were not.]

Comment: Race and Travel

What we are hearing from developing countries is that beyond the
immediate issue, the important problem is that people from poor
countries are not welcome in Europe or the U.S. -- not even for
the most legitimate travel by those who are leaders in their
countries and very unlikely to try to stay. This discrimination
is mostly against Africans and Asians, and in the developing
world is generally seen as racist. Meanwhile, many Europeans are
understandably upset that the sheer number of immigrants is
changing the whole character of their societies. (In the U.S.,
obstacles to AIDS conference delegates are even worse, as the
U.S. will not admit anyone with HIV, except through waivers that
could target them for discrimination in their own or other
countries.)

One avenue for action is suggested by the fact that in the United
States at least, few people have any idea how serious the visa
discrimination is (even for HIV-negative visitors). It is assumed
that most Africans and Asians cannot travel here or to Europe
simply because they cannot afford to -- but not that governments
are arbitrarily limiting the number of those allowed to come,
even for medical or scientific meetings. Since this issue has not
been on the table, it would help to raise consciousness and make
sure U.S. and European citizens know what obstacles their
governments impose, mostly on Africans and Asians but also on
people from poor countries elsewhere, who want to visit for any
reason. African or Asian citizenship has been made an obstacle to
participation in the modern world.

We are also hearing from developing countries that international
AIDS conferences should not be held in countries where visa
problems are predictable. One Asian activist suggested India,
Malaysia, or Nepal as having the necessary infrastructure without
the discriminatory policies. There must be others as well.

Why Can't International Conferences Cost Less?

If the AIDS world does discuss holding future international AIDS
conferences only in locations where people of all nations are
allowed to attend, then we should also address the other big
solidarity issue around these conferences -- their admission
price, around $1,000 for the five-day meeting. We have seen a
large, multi-track conference run in a first-class hotel in San
Francisco, one of the world's most expensive cities, for about a
tenth the per-day admission price of the international AIDS
conferences. We checked and found that not only is there no
subsidy, but this meeting makes a small profit every year.

How could a conference in San Francisco pay expenses at a tenth
the admission charge of the AIDS meetings? The key was to design
low cost from the ground up. For example, this conference is held
off season (so sometimes it's raining instead of sunny outside),
using hotel space that would otherwise be empty (in contrast to
the AIDS conferences, which are held in the middle of the tourist
season, adding to logistical difficulties as well as expense). A
good businessperson who is committed to low cost handles the
negotiations with the hotel and with other suppliers. The meeting
was never a cash cow for anyone.

To help rethink the price of international meetings, activists
could talk to meeting planners with developing-world experience,
and develop and publish scenarios for how to hold conferences
that are open to everybody, easy to get to, and self-supporting
at a tenth the price of the current setup (which then might be
reduced to zero through donations, grants, or other funding). It
does seem possible.


***** Thousands Face Loss of Treatment in ADAP Money Crisis

by Kate Krauss

Some time next spring the first fusion inhibitor, T-20, is
expected to be approved by the Food and Drug Administration. For
some people with AIDS, this drug will be part of a "salvage"
therapy that could keep them alive. T-20 is a complicated drug to
manufacture and will have a very high price tag. Without
financial help, most patients will not be able to afford it.

But state AIDS Drug Assistance Programs (ADAPs) may be unable to
pay for T-20 when it becomes available next year. At least 12
states have already depleted their ADAP funding for this year,
and many more are expected to run out of funds by the end of the
year. Says Lei Chou, of the AIDS Treatment and Data Network and
co-author of the ADAP MONITORING PROJECT: ANNUAL REPORT,  "The
ADAP funding shortage has the potential to create a two-tiered
system: people who get access to new salvage therapies and people
who don't."

The twelve states currently in trouble have established waiting
lists, expenditure caps, or restrictions on drug access; two
more, New York and Florida, are also contemplating cuts. A recent
attempt by activists to include $82 million dollars for ADAP in
the Federal Emergency Budget Supplemental failed when no
politician was willing to take the lead on the measure.

In North Carolina, the waiting list is 574 people long(1); Oregon
is actually planning to remove people from its ADAP rolls(2).
"It's a dire situation -- a lot of people are waiting to get
life-sustaining medications," said Arthur Okrant, the head of
North Carolina's AIDS programs.

What Went Wrong

Several factors have lead to the program's current predicament.
People with AIDS are living longer and are enrolled in the
program longer; ADAP served 140,000 nationwide last year(3). They
are using more complex and expensive regimens. And drug prices
are skyrocketing -- retail HIV drug prices increased 10.4%
between 2000 and 2001 even though the inflation rate in 2001 was
only 1.6%(4). Overall, monthly per capita costs for state ADAPs
rose 81% between FY 1996 and FY 2000. Between June 1999 and June
2000 alone, costs increased 9%(5) -- triple the inflation
rate(6).

Another important reason for the funding crunch is the Bush
administration's decision to increase the ADAP budget by only $50
million this year -- far below the $130 million estimated
need(7). Says Chou, "ADAP is reaching a breaking point regarding
our ability to ask for what is needed and what Congress and the
Administration are willing to give out. It needs to become an
entitlement program."

Many states contribute nothing to the program. More than a dozen
states, ranging from New Jersey to North Dakota, rely solely on
Federal funding for their ADAPs(8). States that do help pay for
the program are facing their own funding crises because of the
economic recession. Most are struggling to pay for basic
entitlement programs like education and Medicaid; they are
scarcely in a position to increase their spending for ADAP.

What To Do About the ADAP Funding Shortage

On a policy level, the ADAP may not be sustainable if drug prices
continue to increase at 9% or more per year. One possibility,
which has been endorsed in a report by the Office of Inspector
General(9), is to extend Veterans Administration deep drug
discounts to state ADAPs(10). However, legislation would be
needed to give states access to VA pricing -- and it would likely
be opposed by the pharmaceutical industry and by the VA itself,
which fears that it would be unable to get the same low prices if
the ADAPs were included(11). In addition, VA pricing is used for
programs where drugs are bought in bulk -- and many state ADAPs
use a reimbursement system instead.

A more obvious solution is for drug manufacturers to simply cut
their prices for ADAPs. Activists with the Fair Pricing Coalition
and the Consumer Caucus of the ADAP Working Group, along with
several others, recently induced GlaxoSmithKline, Pfizer, and
Abbott to freeze HIV drug prices for two years. Why? According to
Fair Pricing Coalition co-founder Martin Delaney (also co-founder
of Project Inform), "They're very worried about the Congress, and
that they won't be in a position to ask for ADAP money that goes
into their coffers if they aren't seen as collaborating with the
community. One of them said it was because they felt we all
needed a two-year "period of stability" in which we weren't
fighting about prices on a micro level and could use the time to
work together on building long-term solutions. One of them
has...made it explicit that they want to work on the long-term
solutions."

Companies may be also be aware that drug pricing is a hot-button
issue for the general public. Chris Aldridge, of the National
Alliance of State and Territorial AIDS Directors, commented:
"Drug companies need to see that state ADAPS make up a very small
part of their market. And that more money available will just
sell more drugs." Purchases by entities such as the ADAPs
comprise less than 1% of the total U.S. pharmaceutical
market(12).

Another idea might be to begin an effort to reauthorize the ADAP
as an entitlement program. The AIDS Drug Assistance Program was
originally envisioned to address an emergency -- the urgent need
to provide expensive medications to people with AIDS until the
crisis passed. Unfortunately, 40,000 Americans still become
infected with HIV every year, and the AIDS epidemic continues
unabated. Making ADAP a permanent entitlement would provide
stability for people who rely on the program, presumably for the
rest of their lives.

Still another approach is to expand Medicaid (which provides care
and medication) to include people living with HIV who have not
yet been diagnosed with AIDS. The Early Treatment for HIV Act
would allow states to extend Medicaid coverage to a significant
proportion of people now covered by ADAP (however, it would leave
many others out). A coalition of activists including NAPWA,
Project Inform and AIDS Action is advocating for this bill, which
has been introduced in both the House (H.R. 2063) and Senate (SB
987) and is gathering co-sponsors at this writing.

Another way to conserve ADAP dollars is to check applicants for
Medicaid eligibility. The federal agencies that administer
Medicaid and ADAP are pushing states to establish online
databases that allow them to quickly verify a patient's
eligibility for Medicaid, so that they are not mistakenly put on
ADAP instead (although some patients may need both). This can
relieve some pressure on the ADAP as well as on other programs of
the Ryan White Care Act.

Finally, renewed grassroots lobbying and other advocacy efforts
are needed. In the past, activists criticized AIDSWatch, the
national AIDS lobby day, for rebuffing participants who wanted to
discuss state AIDS issues with their legislators (instead of
focusing on Federal funding alone). Concerned about this, some
activists gradually dropped out of the program. But AIDSWatch
represents a crucial opportunity for the AIDS community to speak
as a powerful, single voice on funding issues. It also offers
training and a model that people living with HIV/AIDS can use in
lobbying legislators back at home. If it can incorporate
community concerns, AIDSWatch could become a focal point of a new
campaign for domestic AIDS funding.

On a smaller scale, a brand-new grassroots group, the ADAP
working group of the AIDS Treatment Activist Coalition (ATAC)
will be lobbying for ADAP funding later this summer. Organizers
plan to schedule local district visits in August (see Advocacy
Groups, below).

And AIDS service providers must step up to the plate and lobby
with their clients. While many believe this is not their job,
others AIDS service organizations have become expert lobbyists.
"It's the easiest thing in the world," says Jeff Graham, the
Executive Director of Atlanta's AIDS Survival Project. He
especially underscores the role that AIDS services organizations
can have in lobbying their state legislatures. "Going to state
lawmakers is crucial," says Graham. "The mentality is that AIDS
funding is a federal issue, but more and more it's local.
Georgia, which used to pay nothing into the AIDS Drug Assistance
Program, now spends $11 million on the program. Nonprofits can
lobby -- there are provisions built into the tax laws. There is
an urgent need for service providers to lobby, and in these times
they have a moral imperative to do it." Project Inform's Ryan
Clary, an ADAP advocate and community organizer, echoed Graham's
remarks: "It's so important for AIDS service organizations to
lobby, and to bring their clients to lobby, not just the
president of the board."

Others point to the need for outside pressure from activist
groups. Says Chou, "There is a severe need for people to work
outside the system right now to combat drug company price
increases. People are in jobs that deal with access to treatment
but are funded by the drug companies. There is a limit to what we
can do and what we can say." He advises activists to "Look at the
situation with a clear eye and go where they see they are needed
most."

See Advocacy Groups, below after the References, for a selected
list of organizations engaged in advocating for AIDS programs.

References

1. Steve Sherman, North Carolina Department of Public Health,
HIV/AIDS division.

2. Oregon Department of Community Health.

3. National Alliance of State and Territorial AIDS Directors, The
Henry J. Kaiser Family Foundation, and the AIDS Treatment and
Data Network, NATIONAL ADAP MONITORING PROJECT: ANNUAL REPORT,
APRIL 2002. http://www.atdn.org/access/adap

4. American Institutes for Research (AIR) analysis of Scott-Levin
data. This data is not available online. The AIR can be reached
at (202) 342-5000 or at http://www.air-dc.org/

5. National Alliance of State and Territorial AIDS Directors, The
Henry J. Kaiser Family Foundation, and the AIDS Treatment and
Data Network, NATIONAL ADAP MONITORING PROJECT: ANNUAL REPORT
MARCH 2001. http://www.atdn.org/access/adap/

6. United States Bureau of Labor Statistics:
http://www.bls.gov/bls/inflation.htm

7. GMHC TREATMENT ISSUES, Volume 16, Number 4, April 2002. "ADAP
Strapped," by Lei Chou and Anne Donnelly.
http://www.thebody.com/gmhc/issues/apr02/adap.html

8. National Alliance of State and Territorial AIDS Directors, The
Henry J. Kaiser Family Foundation, and the AIDS Treatment and
Data Network, NATIONAL ADAP MONITORING PROJECT: ANNUAL REPORT,
APRIL 2002. Appendix VIII: ADAP Budget FY201: Federal and State
Sources. http://www.atdn.org/access/adap

9. Office of the Inspector General, AIDS DRUG ASSISTANCE PROGRAM
COST CONTAINMENT STRATEGIES, OEI-05099-00610, September 2000.
http://oig.hhs.gov/oei/reports/oei-05-99-00610.pdf

10. National Alliance of State and Territorial AIDS Directors,
The Henry J. Kaiser Family Foundation, and the AIDS Treatment and
Data Network, ISSUE BRIEF: AIDS DRUG ASSISTANCE PROGRAMS --
GETTING THE BEST PRICE?, page 5, April, 2002.
http://www.atdn.org/access/adap/

11. Staff, Office of Rep. Henry Waxman (D-Ca.).

12. Office of the Inspector General, AIDS DRUG ASSISTANCE PROGRAM
COST CONTAINMENT STRATEGIES, OEI-05099-00610, September 2000.
http://oig.hhs.gov/oei/reports/oei-05-99-00610.pdf


Advocacy Groups

AIDS Treatment Activist Coalition (ATAC). This new group, formed
by leading treatment activists, works on many AIDS treatment
issues by email, so you can be involved even if there is no local
treatment activist organization. For more information, see
http://www.atac-usa.org

ATAC has a grassroots subgroup focused on advocating for $152
million for FY 2003 for the AIDS Drug Assistance Program. The
group plans to organize lobby visits across the country in August
2002 as well as letters to the editor and call-in days. New
people who are willing to work are welcome -- and the group will
be teaching newcomers how to organize lobby visits, write
effective letters to the editor, etc. For more information,
contact Ryan Clary at Project Inform: call 415-558-8669, ext. 224
or email him: tan@...

AIDSWatch 2003. The important national AIDS lobby day held each
spring in Washington, DC. For more information, see
http://www.napwa.org/aidswatch.htm, e-mail aidswatch@...,
or call 866-243-7282.

Community Advisory Board of Your State's ADAP. The Ryan White
Care Act mandates that each state ADAP have a community group to
advise it. For more information, contact your state public health
department's HIV/AIDS division (usually located in the state's
capitol city).

ACT UP Philadelphia. The largest and most active ACT UP chapter
regularly organizes state and federal lobby days that involve new
lobbyists. They are an important resource for first-time
lobbyists. Phone 215-731-1844 or email katie@...

Lobbying. Nonprofit organizations that are new to lobbying can
calculate the amount of money they are permitted to spend on it
under IRS rules based on their budget. A non-profit support
organization, tax attorney, or local IRS office can provide more
information about how to do this.

The National ADAP Monitoring Project. This group is composed of
staff members of the AIDS Treatment and Data Network
(http://www.atdn.org), the National Alliance of State and
Territorial AIDS Directors (http://www.nastad.org), and the
Kaiser Family Foundation (http://www.kff.org). It produces
important reports about issues such as ADAP drug pricing. The
group also writes an annual report on the state of ADAP. For more
information, see http://www.atdn.org/access/adap/

The ADAP Working Group. This longstanding alliance of AIDS
advocates and drug company representatives works to secure
funding for the ADAP. The consumer caucus of this organization
recently helped secure price freezes from three major drug
companies. See http://www.tiicann.org or call (202)-588-8868 for
more information.

Early Treatment for HIV Act. For more information about advocacy
efforts to support this bill, contact Ryan Clary at Project
Inform, 415-558-8669, ext. 224 or email him:
tan@....


***** On an ADAP Waiting List? Advice from Treatment Activists

by Kate Krauss

AIDS treatment activists submitted these suggestions during the
writing of the story on the current ADAP funding crisis
("Thousands Face Loss of Treatment in ADAP Money Crisis," AIDS
TREATMENT NEWS June 2002).

1. SIGN UP FOR THE ADAP WAITING LIST, don't just walk away. Make
sure that you keep in touch with your case manager so that he or
she can find you when it's your turn.

2. No matter how upset and frustrated you feel, DO NOT DROP OUT
OF CARE.

3. Remember that people who are newly diagnosed with HIV are
usually not supposed to start antiretroviral therapy until they
have fewer than 350 CD4 cells -- YOU MAY NOT NEED TO START YOUR
TREATMENT REGIMEN YET.

4. Push your physician or case manager to enroll you in PATIENT
ASSISTANCE PROGRAMS. These are drug company programs that provide
medications for low-income people who cannot obtain drugs through
another source. A savvy doctor's office manager or case manager
should fill out the paperwork. If you need advice on this, call
Project Inform's treatment hotline: 800-822-7422 (toll-free in
the United States) or 415-558-9051 (in the San Francisco Bay Area
or internationally). Hotline hours are Monday-Friday, 9am-5pm and
Saturday, 10am-4pm (Pacific Time). For a directory of patient
assistance programs, see http://phrma.org/searchcures/dpdpap/ or
call (800) 762-4636 for a copy. The directory is organized by
drug company name.

5. Some clinics keep STASHES OF AIDS MEDICATIONS for people like
you; some people with AIDS may operate a community "medicine
chest" of free, unused medications. Ask around in support groups.
Visit AIDS clinics and explain your situation -- discreetly. Get
out the word that you are stuck and you need help. Remember,
though, that interrupting antiviral therapy may be worse than
waiting to begin.

6. Find out if your community has an EMERGENCY MEDICATION FUND.

7. Check to SEE IF YOU QUALIFY FOR MEDICAID.

8. DOCUMENT YOUR SITUATION and distribute the information to AIDS
law organizations and other advocates. It will give them
ammunition to fight for funding. Offer to tell your story to
legislators or other officials.

9. JOIN AN ADVOCACY GROUP (see the list in the associated
article). Learn how to lobby and write letters to the editor.
Then do it. There is power in numbers.

10. PLAN CAREFULLY BEFORE YOU MOVE TO ANOTHER STATE -- ADAP
formularies vary widely from state to state, and some don't even
cover antiviral drugs. Some states require a six-month wait
before you can access benefits. Some ADAPS may have a waiting
list. Call local AIDS organizations and people with AIDS to get
current information -- before you move.


***** AIDS TREATMENT NEWS

Published twice monthly

Subscription and Editorial Office:
  1233 Locust St., 5th floor
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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 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
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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 #380, May 31, 2001
    phone 800-TREAT-1-2, or 215-546-3776

CONTENTS:

** Treatment Access Emergency: ADAP and Medicaid
Access to HIV and other medical care in the United States is
becoming an increasingly serious problem. Both the ADAP and
Medicaid programs urgently need activist attention.

** AIDSWatch Congressional Lobbying, June 9-11 in Washington
Each year hundreds of people meet in Washington D.C. for
workshops and visits with their Congressional
representatives. Information is available on the Web, from
the National Association of People with AIDS.

** Counterfeit Drugs: Check Combivir(R), Serostim(R),
Epogen(R)
In May alone there have been at least three reports of
mislabeled or counterfeit drugs that could have serious
consequences for patients.

** Medicaid Funding Cuts Affect People with AIDS Across the
U.S.
How state and federal budget problems are often making it
difficult or impossible for patients to get proper care from
Medicaid, which is by far the largest provider of AIDS care
in the U.S.

** Johns Hopkins HIV Treatment Short Guide
The 2002 Abbreviated Guide to Medical Management of HIV
Infection is a bedside reference to HIV treatment for medical
professionals. Well-informed patients can use it for
background and understanding of their own care.

** Remune Controversy Articles
Some leading HIV scientists want research to continue on the
HIV immunogen developed many years ago by Dr. Jonas Salk --
not because they believe it is an effective product, but
because important scientific issues could be addressed
quickly. Until recently this view was scarcely heard in the
public debate.

** Philadelphia: AIDS Education Month Talks and Programs
Philadelphia FIGHT's AIDS Education Month includes more than
10 programs on immune-based therapy, clinical trials,
recommended information sources, alternative therapies, the
need for an HIV specialty, what is happening in prevention,
responding to the global epidemic, and other topics.


***** Treatment Access Emergency: ADAP and Medicaid

by John S. James

A combination of unrelated events and changes in the last two
years is increasingly threatening the ability of thousands of
Americans with HIV to get medically necessary care. The
national economic slowdown, a crisis in state budgets, the
Federal focus on war, and the neglect of treatment-access
activism, have combined so that probably thousands of people
are being denied necessary treatment for economic reasons
alone, when they would have had access a year ago. The
problem is likely to get much worse before it gets better.
While most of the causes are beyond the control of readers of
AIDS TREATMENT NEWS, we can work on the activism.

Few patients are immune to these problems. Due to high prices
for drugs and tests, very few can pay the full cost of HIV
care entirely out of pocket. And private insurance has become
increasingly efficient at getting rid of people with
expensive illnesses -- especially HIV infection, since it is
not officially recognized as a medical specialty like cancer,
even though it is one in fact. Therefore HMOs can pay HIV
doctors the "healthy adult" rate, less than the cost of
providing care, in order to drive good doctors out of the
plan and keep patients away.

(1) As this issue goes to press, there may or may not be an
emergency mobilization on ADAP (the AIDS Drug Assistance
Program, funded by the Ryan White CARE Act), in the coming
days or weeks. The growing crisis in ADAP results from flat
Federal funding despite increasing needs, rising drug prices,
state budget shortfalls, and indirectly from increasing
Medicaid problems. Also, the traditional coalition of patient
advocates and industry to seek funding for ADAP has not been
very active in the last year.

(2) Medicaid is a huge program that has surprisingly little
advocacy for it, either in AIDS or otherwise. Many people
think of Medicaid as a program only for the poor -- not
realizing that it also pays for their own grandparent in a
nursing home. Medicaid provides for many more HIV patients
than ADAP, and pays for more of their medical care instead of
just drugs. After hearing from people who are having more and
more serious problems obtaining HIV care under Medicaid in
many states, activist Kate Krauss looked into the program and
wrote the background article below for AIDS TREATMENT NEWS.
She is also researching the ADAP crisis -- and how people can
help with both programs -- for a future article for this
newsletter.


***** AIDSWatch Congressional Lobbying, June 9-11 in
Washington

"AIDSWatch is the largest annual federal HIV/AIDS education
and advocacy initiative in the nation. Hundreds of people
living with HIV/AIDS, their friends and family, service
providers and advocates come to Washington, DC for intensive
training leading to direct discussion with Members of
Congress and their staff. The goal of AIDSWatch is to support
and obtain funding increases for all federal HIV/AIDS
programs." (Quoted from the site of the National Association
of People with AIDS.)

For more information see:
http://www.napwa.org/aidswatch.htm


***** Counterfeit Drugs: Check Combivir(R), Serostim(R),
Epogen(R)

by John S. James

Since May 10, pharmaceutical manufacturers and the FDA have
been warning medical professionals and patients about wrongly
labeled or counterfeit drugs.

* Combivir: On May 10, GlaxoSmithKline announced that it had
received four reports of bottles labeled as containing 60
tablets of Combivir (AZT plus 3TC) which actually contained
another antiretroviral, Ziagen(R) (abacavir); the FDA also
sent warnings. The main concern was that about 5% of patients
receiving abacavir develop a hypersensitivity reaction, which
could be life-threatening if not handled correctly. If
patients and their physician did not know they were taking
the drug, they would not be advised to be on guard for the
reaction.

In this case, the Ziagen itself was the legitimate product.

From the Glaxo press release of May 10:

"Pharmacists, physicians and patients should immediately
examine the contents of each Combivir(R) bottle to confirm
they do not contain Ziagen(R) tablets. The two kinds of
tablets are easily distinguishable. Combivir(R) is a white
capsule-shaped tablet engraved with "GX FC3" on one side; the
other side of the tablet is plain. Ziagen(R) is a yellow
capsule-shaped tablet engraved with "GX 623" on one face; the
other side is plain. The Combivir(R) label [meaning the
prescribing information for physicians, not the label on the
bottle - JSJ] shows a color photo of the tablet."

Pharmacist and patients who find the mislabeled medicine can
call Glaxo at 888-825-5249.

* Serostim: On May 17 Serono, Inc. and the FDA announced that
a counterfeit lot of Serostim, the company's human growth
hormone, had been distributed. The drug had a fictitious lot
number, MNH605A. "Any product labeled as Serostim(R) and
carrying this lot number should be considered to be
counterfeit." We have no information about what is in the
counterfeit drug, except that it is definitely not the
company's product. Patients or physicians who have questions
can call Serono at 1-888-275-7376.

* Epogen: On May 21 we received a notice from the FDA that
counterfeit Epogen (epoetin alpha) had been distributed. The
counterfeit contains active ingredient, but in a
concentration about 20 times too low. It is packed as EPOGEN
40,000 U/mL vials in ten-pack boxes, lot number P002970
expiration date: 7/03. More information is available at:
http://www.fda.gov/medwatch/SAFETY/2002/safety02.htm#epogen

Comment

From the information we have seen (summarized above), the
Ziagen falsely labeled as Combivir may be a result of
somebody's incompetence or negligence; it makes less sense as
a criminal design. Why use an expensive substitute that is
easily distinguishable? In the other cases, fake drugs and
labels were deliberately prepared and distributed.

It is not clear from the public information whether any of
the mislabeled or counterfeit drugs got into the legitimate
distribution chain (meaning that anyone's medicine could be
at risk) -- or whether they were ordered from unknown Web
sites that could have been set up by anybody. It should be
possible to protect the legitimate drugs, since distributors
and pharmacies are dealing with well-known suppliers, and the
source of each unit could be traced. There are indications
that at least some of the bad products may have been bought
on the Internet from unknown sites, although the public at
least does not know for sure. (See "Clusters of Counterfeit
Drugs" by Tim Kingston, SAN FRANCISCO FRONTIERS, May 30,
2002; you can request a copy by email from the author at
sfnews@....)

This is the latest of several incidents of counterfeiting of
drugs often used in AIDS treatment. Activists should follow
up on the investigations to find out what is learned about
where the problems are coming from. We need to know whether
or not there is any risk from the drugs on pharmacy shelves.


***** Medicaid Funding Cuts Affect People with AIDS Across
the U.S.

by Kate Krauss

[The first of two articles on the crisis in public benefits
for people with HIV/AIDS.]

It is not commonly known that the Medicaid program (MediCal
in California) is the single biggest source of publicly
funded AIDS treatment in the United States -- bigger than
Medicare and bigger than the Ryan White Care Act. Medicaid
spent $6.9 billion on people with AIDS in Fiscal Year
2001(1), more than three times as much as all titles of Ryan
White.(2) The program provided health care, including
prescription drug coverage, for roughly 260,000 low-income
and disabled people with HIV/AIDS during 2001(3); for
comparison, the AIDS Drug Assistance Program served about
140,000.(4)

In the mid-to-late 1990s, many states, buoyed by increased
revenues brought on by the economic boom, expanding Medicaid
eligibility criteria for children, the elderly, the disabled
and other groups.(5) But by early 2001, the economy had
drifted into recession and states were struggling to pay
their Medicaid bills with diminishing resources. Since then,
many have reduced patient eligibility, limited prescriptions,
and cut services at a time when programs like the AIDS Drug
Assistance Program are also stretched to the breaking point.

"I can't think of one state that isn't having problems,"
commented Neva Kaye of the National Academy for State Health
Policy. "There's a reason for the expansions in the past few
years - Medicaid programs saw a need. They don't want to step
back, but there is only so much money in the system."

In a recent survey by the National Conference of State
Legislatures, Medicaid was the number one program named as
being over budget: 27 states and the District of Columbia
reported Medicaid cost overruns, with four others indicating
concern about Medicaid spending.(6) It is usually the second
biggest state expenditure after education, and many states
are required by law to balance their budgets.

People with AIDS from Massachusetts to Oklahoma have been
affected by the cuts. Some of the hardest hit are sick PWAs
who require intensive medical care and numerous prescription
drugs but are least able to muster the resources they need to
get them. For instance, the Florida Medicaid program has
instituted a cap of four brand-name prescriptions per month,
with a time-consuming appeals process for patients who must
override the cap to receive important medications.(7)
Although HIV drugs are theoretically exempt from this limit,
newly approved antiretroviral drugs are often kicked out of
the computer -- and some pharmacists are not even aware of
the HIV rule. Other states are also exploring drastic
measures: in South Carolina, legislators are considering a
bill that would require Medicaid beneficiaries to reapply to
the program every six months.(8)

A Culprit: Skyrocketing Prescription Costs

According to independently funded public policy analysts, the
most important factor in the Medicaid budget shortfall is the
rapidly escalating price of prescription drugs. Medicaid drug
spending grew 18.1% per year between 1997 and 2000, more than
twice the overall growth of the program.(9) Meanwhile, a
recent FORTUNE 500 report named the US pharmaceutical
industry as the most profitable in the U.S: industrywide,
profits were also running $18.5% in 2001. In comparison,
Medicaid enrollment is nearly stagnant: the number of
enrollees increased less than 5% between 1999 to 2001, from
42 million to 44 million(10).

Unlike Ryan White money, which is distributed through a
system of formulas, Medicaid funding is keyed to the amount
of money a state elects to spend on the program. State funds
are matched at least 1:1 by federal dollars.(11) As a result,
some states have well-funded programs, while poorer states --
or states where Medicaid spending is not a high priority --
do not.

The Medicaid program also suffers from anonymity: citizens
are only dimly aware of what it is, exactly, and whom it
serves. Few people realize that nearly half of Medicaid
beneficiaries are children--and that at least 55% of all the
people with AIDS in the United States are on Medicaid. Among
other groups, the program serves many formerly middle class
men with AIDS (and some women) who have spent down their
assets in order to qualify for health coverage.

Without a visible constituency, Medicaid recipients are
especially vulnerable when it comes time to make state budget
decisions. There are no national groups for Medicaid AIDS
advocates, and few state advocates at all for people with
AIDS -- even though a key to better AIDS care nationwide lies
in pushing state legislatures to adequately fund the program
and pull down federal matching funds.

A Florida Example

In the current recession, the number of people who need
Medicaid is increasing just as revenues to support it are
drying up. The state of Florida typifies this phenomenon: the
state is facing enormous budget shortfalls while its
prescription drug costs have skyrocketed.

Michael Barry, a 42 year-old PWA living in Titusville,
Florida, had to fight for months to obtain his medications
because of the state's prescription cap. Barry, who tested
HIV-positive in 1985, has a CD4 count of only 7, suffers from
severe opportunistic infections, and requires more than two
dozen different medications. His physician prescribed Valcyte
for CMV, Kaletra for his HIV, and Neupogen to boost his white
blood cell count. The state rejected his prescriptions for
all three.

His physician, Gerald Pierone, M.D., also spent months
pushing the state to approve these medications. Finally
Barry, who lives on a $604 disability benefit, was forced to
hire a disability lawyer to press his case at a formal
appeal. As the appeal dragged on, he went without Neupogen
for three weeks. He eventually won the appeal and received
the drugs, but must reapply for them again in six months.
Barry says that some of his friends are getting sick without
medications because they don't have the energy to obtain them
under Florida's Medicaid system. "If you don't fight, you
die," he says.

Pierone concurs. "Some of my patients who need Neupogen have
gone through lapses that can potentially threaten their
health. I have had to keep patients in the hospital for two
or three days until the state approved their Valcyte
prescriptions. If I have a sick person with AIDS on ten
different drugs, many of them will be brand-name and we will
have to make dozens of phone calls to get them approved -- if
they are approved. Ultimately, the patients who have it
together will call us when they are denied a medication. The
ones who aren't as sophisticated just do without -- we may
not find out about it for two or three months."

With nearly every state affected, the health of some 260,000
low-income people with AIDS is at risk. Every day, thousands
of vulnerable people are trying to wade through paperwork and
overcome new obstacles to obtain basic medical care.

At the same time, thousands more do not qualify for Medicaid
at all: the program only covers people with an AIDS
diagnosis. One solution to this problem may be the Early
Treatment for HIV Act, which would make people who are HIV-
positive eligible for Medicaid if they meet their state's
income requirements. The bill would provide a stable source
of medical care to many thousands of people and would relieve
pressure on Ryan White programs.

Barry urges other people with AIDS to lobby on behalf of
increased AIDS funding. "If you have to, go to Washington and
fight for your rights. And vote for politicians who support
people with AIDS." Barry recently returned from a trip to
Washington, DC where he visited members of Congress to
advocate for more AIDS funding for Florida.

Information Resources

* The Kaiser Family Foundation publishes detailed, reliable
reports on HIV, Medicaid, the uninsured, and prescription
drug coverage (including the AIDS Drug Assistance Program).
Recent publications on Medicaid and prescription drugs can be
accessed at:
http://www.kff.org/content/2002/20020213/

* Fact Sheet on Medicaid and AIDS:
http://www.hcfa.gov/medicaid/obs11.htm

* Families USA
While not AIDS-specific, Families USA has issued a number of
useful Medicaid reports and created advocacy tools such as
this state advocate's kit for lowering prescription drug
prices:
http://www.familiesusa.org/html/drugkit/drugkit.htm

* Early Treatment for HIV Act. For more information, contact
Ryan Clary at Project Inform, 415-558-8669, ext. 224 or email
him: tan@.... (You can find an archive of past
action alerts at
http://www.projectinform.org/news/index.html, but it's more
important is to get on the list for current alerts, because
you often need to respond very quickly. Ask to receive
regular action alerts and other information on this bill.)

* Prescription Access Litigation. "This initiative targets
the illegal activities of pharmaceutical companies that
artificially inflate the price of prescription drugs. PAL is
a coalition of over 75 consumer and public interest
organizations from 30 states."
http://www.prescriptionaccesslitigation.org/


References

1. Report by Wayne Ferguson, Office of the Actuary, Health
Care Financing Administration (now the Centers for Medicare
and Medicaid Services), April 30, 2001.

2. Claude Franklin, Executive Officer HIV/AIDS Programs,
Health Resources Services Administration.

3.  Center for Medicaid and State Operations, Division of
Advocacy and Special Issues. Number includes people who are
HIV-positive but do not have an AIDS diagnosis who are
enrolled in Medicaid due to a disability apart from HIV.

4. ADAP Monitoring Project. The Henry J. Kaiser Family
Foundation (KFF) commissions the National ADAP Monitoring
Project and conducts it in partnership with the National
Alliance of State and Territorial AIDS Directors (NASTAD) and
the AIDS Treatment Data Network (ATDN):
http://www.atdn.org/access/adap/

5. Kaiser Commission on Medicaid and the Uninsured, March
2002. "Medicaid and State Budgets: An Overview of Five
States' Experiences in 2001":
http://www.kff.org/content/2002/4039/4039.pdf

6. State Fiscal Update, April 2002, by the Fiscal Affairs
Program of the National Conference of State Legislatures.
http://www.ncsl.org/

7. Jerry Wells, Pharmacy Program Manager, Florida Medicaid
Program.

8. Republican-sponsored bill being considered in the South
Carolina legislature,
H 4955: http://www.lpitr.state.sc.us/bills/4955.htm

9. "States Strive to Limit Medicaid Expenditures for
Prescribed Drugs," Kaiser Family Foundation Study, February,
2002:
http://www.kff.org/content/2002/20020213/4030.pdf

10. United States Congressional Budget Office.

11. "Federal Medical Assistance Percentages and Enhanced
Federal Medical Assistance Percentages," Effective October 1,
2002 - September 30, 2003 (Fiscal Year 2003):
http://aspe.os.dhhs.gov/health/fmap03.htm


***** Johns Hopkins HIV Treatment Short Guide

The 2002 ABBREVIATED GUIDE TO MEDICAL MANAGEMENT OF HIV
INFECTION, by John G. Bartlett, M.D. of the Johns Hopkins
University School of Medicine, is a quick reference for
medical professionals -- "intended for bedside clinical
management decisions. The parent text, Medical Management of
HIV Infection, provides the scientific foundation for
recommendations." It came out six months later and is more up
to date than the parent edition from which it was derived.
Well-informed patients may use either book to check on
details, understand background of their treatment and why
certain tests and other procedures are important, and find
recommended information sources. No guideline can consider
all individual cases, however, and experienced physicians
will often have good reasons for doing things differently; we
would certainly trust a specialist's decision over a
document. But for the increasing number of patients who are
getting inadequate care due to financial obstacles and a
dysfunctional medical system, references like these can help
in advocating for oneself.

The ABBREVIATED GUIDE is easy to get hold of. It is free on
the Web, or you can order copies for $5.

Some of the topics covered:

* Information sources -- about 20 Web sites and hotlines.

* About 60 pages of drug profiles, including not only
antiretrovirals but also many other drugs that are often used
in treating persons with HIV. Adverse effects are noted here,
and in a separate section as well.

* Chapters on hepatitis C, sexually transmitted diseases,
tuberculosis, other opportunistic infections, and other
complications.

* A section on pain management, based on the World Health
Organization model for chronic cancer pain;

* A list of abbreviations, and an index.

The book can be read online as a PDF file at the Johns
Hopkins AIDS Web site,
http://www.hopkins-aids.edu. A paper copy is available for $5
through the same site, but the online version may be easier
to read because you can change the viewing size of the type.
You can save or print a copy locally, for viewing when you
are not online. (Note: When looking up a page in the table of
contents if you are using the PDF version and reading the
computer screen, add 7 to the page number to find the page in
your PDF file viewer. That's because there are 7 introductory
pages in the file before page 1, so the page numbers as seen
by the viewer and as printed in the book differ by 7.)


***** Remune Controversy Articles

by John S. James

[Note: As we went to press the SAN DIEGO UNION published an
in-depth look at the Remune controversy. See "Time Running
Out for Salk-Backed AIDS Vaccine" by Penni Crabtree, June 2,
2002, http://www.uniontrib.com/ (you can search for Remune in
recent articles, and in archives).]

Activist David Scondras of Search for a Cure in Boston has
published a short article for general readers on why research
on Remune -- the AIDS immunogen designed about 15 years ago
by Dr. Jonas Salk -- should continue. Remune has become
controversial in scientific circles, with a majority view
that it does not work and we should move on. But some leading
HIV researchers strongly believe that further studies are
important, because of opportunities to answer questions about
immune-based therapy and vaccine science now. Because of the
financial situation of the developer, the Immune Response
Corporation, the future of the research is uncertain, and at
least one human trial has already been stopped.

We do not have our own views on the scientific questions. But
we are concerned that the intense emotions swirling around
this issue could lead to poor decisions. The public has not
known that top researchers have feared that important studies
may be dropped.

From Scondras' article:

"Remune, invented by the late Jonas Salk in 1987 in
collaboration with Dr. Dennis Carlo of the Immune Response
Corporation of San Diego, was tested in Spain for four years
on people with HIV. On July 27, 2001, a group of scientists
headed up by the internationally respected Dr. Joep Lange,
looked at the results of the four year study of 242 HIV
infected people. They found that those people who got Remune
were 37% less likely to fail their medicines than those who
did not. This is the first time a vaccine proved it can help
the body keep the amount of virus down.

"More recently, in March of this year, Peter M. Silvera, PhD,
of the Southern Research Institute in Frederick, Maryland,
showed that Remune when given with a fancy adjuvant called
CpG causes uninfected monkeys to develop two key immune
responses against HIV -- antibody and t-cell responses.

"Even more recently, data from the studies of Drs. Eric
Rosenberg and Bruce Walker of Massachusetts General Hospital,
shows that all of the people in their study who took Remune
developed strong anti HIV immune responses during a planned
treatment interruption, while none of the people who only
took antiviral medicine developed these responses. And Dr.
Fred Valentine of New York University has also tested Remune
and shown that it gives infected people new immune responses
against HIV.

"Taken together, these findings suggest that Remune is a good
candidate to test on a large scale as a preventive vaccine,
as well as a therapy for HIV.

"Unfortunately, without money it won't happen.

"Dr. Peter Salk, of the Jonas Salk foundation feels it would
be a "significant loss" to not test the vaccine further..."

The full article, "Our Best Shot," by David Scondras, is
available at http://www.searchforacure.org/, and also at
http://www.thebody.com/ (at the site you can search on
"Remune").


***** Philadelphia: AIDS Education Month Talks and Programs

by John S. James

Philadelphia FIGHT's annual AIDS Education Month program is
presenting more than 10 events in June. About half of them
charge no fee; and most of the rest are breakfast programs
for $15; one is a fundraiser and more expensive. Details are
at http://www.fight.org/aem -- or call 215-985-4448 ext. 110,
or email aem@.... Advance registration is suggested for
all programs.

Some highlights (*not* always in chronological order -- check
for full details):

* Immune Based Therapies Summit, June 5, 8:30 a.m. to 1:00
p.m., with Dr. Luis Montaner from Wistar Institute, Brenda
Lein, and Richard Jefferys, at The Church of St. Luke and the
Epiphany, 330 S. 13th Street (between Spruce and Pine
Streets). No fee.

* Alternative Therapies, June 13, 8:30 a.m. to 1:00 p.m. at
The Church of St. Luke and the Epiphany, with George Carter
(treatment writer), Chris Hudson (acupuncturist), and Jeanne
Reiche (nutritionist). Lunch included; no fee.

* Breaking into Clinical Trials (on what you should know
about enrolling), June 11, 6:00 - 8:00 p.m., with Diana
Williamson, M.D., M.P.H., and Jane Shull, executive director
of Philadelphia FIGHT. The Church of St. Luke and the
Epiphany. No fee.

* Transgendered People and the AIDS Epidemic, June 12,
breakfast forum at the White Dog restaurant, with Charlene
Moore. $15.

* Time for an HIV Specialty, June 19 with Barbara Turner,
M.D., M.P.H., and James Dean, M.D. Breakfast forum at the
White Dog, $15.

* Life = The Cost of a Movie and a Bag of Popcorn, June 26,
with Alan Berkman, M.D. (who founded Health GAP), on the
global epidemic. "For the cost of a movie and a bag of
popcorn for each person in the developed world the full cost
of treatment for the whole of sub-Saharan Africa could be
covered." [We did some quick calculations, and indeed one
movie a year could pay for antiretrovirals.] Breakfast forum
at the White Dog, $15.

* Librarian Update, June 6, designed for librarians and
information specialists who are answering questions from the
public, will focus on Web sites and other information
sources. No fee.

* Opening Reception, June 4, An Evening to Honor Project
Inform, 5:00 p.m. reception, 6:00 dinner and table talk, with
Brenda Lein, Director, Project Immune Restoration at Project
Inform. $65 for reception and dinner. Reservations must be
made in advance; call Laura Cramutola, 215-985-4448 ext. 108.

* Philadelphia FIGHT Open House and Reception, June 20, 5:30
- 8:30 p.m. at Philadelphia FIGHT, 1233 Locust Street; the
clinics and other programs will be open to the public. Fee
for the reception is $20. Reservations must be made in
advance; call Laura Cramutola, 215-985-4448 ext. 108.

Other programs in this series include a prevention workers'
summit, videos on living with HIV, and a candlelight vigil.
See http://www.fight.org/aem for full information.

***** 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 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 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 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
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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:
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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 #379, April 12, 2002
    phone 800-TREAT-1-2, or 215-546-3776

Contents

** Retroviruses Conference: Some New Drugs in the Pipeline
Some of the experimental drugs discussed at the Retroviruses
conference: TMC125, DPC-083, tipranavir, atazanavir, BMS-806,
SCH-C, T-20, and S-1360.

** Measles Found to Suppress HIV
Measles appeared to cause almost a 100-fold drop in HIV viral
load, in this study of children who were hospitalized with
measles and also had HIV. After they recovered from measles,
their HIV viral load went back up. Could this finding suggest
ideas for new drug or other treatments for HIV?

** New Cancer Drugs Might Help Treat HIV -- But Research Not
Done
A class of drugs now approved and used in cancer treatment
also showed anti-HIV activity in laboratory tests. But due to
complications in licensing the HIV rights, which were held by
the U.S. government, no one has done any human test to see if
these drugs might help reduce viral load.

** Bone Problems: Overview Article Available
An article in the current issue of POZ magazine looks at bone
complications -- especially osteonecrosis, which is causing
an increasing number of persons with HIV to need hip
replacements. No one knows if HIV drugs, the disease itself,
or both are responsible.

** Alert: International Epidemic, Disease Control
The key issue now in international AIDS is political
commitment -- especially funding for controlling AIDS and
other infectious epidemics. People anywhere can help by
letting their political representatives know that AIDS and
other global epidemics are important to them.

** Medical Privacy Rule Changes: Public Comments Due April 26
The Bush Administration has proposed changes to the Clinton
Administration rules on the privacy of medical records, rules
that have not yet gone into effect.

** Medical Marijuana Action Alert
Legislation is widely favored in Vermont, but the governor
may block it.


***** Retroviruses Conference: Some New Drugs in the Pipeline

by John S. James

Here are some of the experimental antiretroviral treatments
(not yet approved for general use) that were discussed at the
Retroviruses conference, February 24-28, 2002, in Seattle. We
organized them by drug class.

Non-Nucleoside Reverse Transcriptase Inhibitors

* TMC125

This is a very active antiretroviral of the NNRTI class (non-
nucleoside reverse transcriptase inhibitor -- the same class
as efavirenz, nevirapine, and delavirdine, the three NNRTI
drugs currently approved in the U.S.). But TMC125 was
rationally designed to overcome the main problem of this
class of drugs, the development of viral resistance. This was
accomplished, in part, by making the molecule flexible, so
that it can still fit in the "pocket" (the active site) of
the reverse-transcriptase enzyme, even when HIV mutates to
change the shape of that site.

In patients, TMC125 caused a faster drop in HIV viral load
than has been seen with any other single drug so far (in a
small, 12 patient study) -- an almost 2-log drop in only one
week from this drug alone, in treatment-naïve patients.(1) In
that week the median CD4 increase was 119. No one knows why
the drug worked so well. [Note: short, small clinical trials
like this are used to estimate the antiviral potency, by
measuring how fast the virus disappears from the blood in the
days after the drug is started. This kind of study gives an
idea of the antiviral activity of the new drug by itself,
without giving the virus much time to develop resistance to
it.]

TMC125 also works in patients who are highly resistant to
other NNRTIs. Another small study tested the drug for one
week in patients who were failing either efavirenz or
nevirapine, who had resistant virus with at least 10-fold
reduced sensitivity to the drug they were using (all of these
patients were at least 35-fold less sensitive to nevirapine).
After one week of using TMC125, the median viral load had
decreased 0.9 logs, and was still going down.(2)

These trials used an early phase I formulation of TMC125,
which required the volunteers to take many pills per day. The
formulation has been improved since then, though more work is
needed. Drugs of this class tend to be difficult to dissolve
because of their chemical nature (the molecule needs to bind
to a pocket in the viral enzyme with non-polar bonds), but
this problem can be overcome.

TMC125 was developed by Tibotec-Virco, a company
headquartered in Belgium that uses high-tech methods to
develop new drugs, especially antivirals (including treatment
for hepatitis C). It also offers HIV phenotypic resistance
testing (the Antivirogram) under the name Virco. Many of the
principals in the company have a background in tropical
medicine. On March 22 it was reported that Johnson & Johnson
had bought Tibotec-Virco -- probably good news, as it was
widely believed that Tibotec-Virco did not have enough money
to develop the drug quickly.

But because of the slow pace of drug development generally,
it is unlikely that the company will be able apply for
approval for TM125 before 2004, even if everything works as
well as possible.

* DPC-083

This NNRTI is related to efavirenz (Sustiva(R)), but is
active against many viruses that are resistant to efavirenz
and other approved NNRTIs.(3,4) It seems to cause less of a
problem with the mental changes that trouble some patients
when they start efavirenz.

Protease Inhibitors

* Tipranavir

Tipranavir, developed by Boehringer Ingelheim
Pharmaceuticals, is the first of a new class of "non-
peptidic" protease inhibitors (PIs) -- giving it a different
resistance profile from the approved PIs. It is active
against HIV that is heavily resistant to the approved drugs.
(As with the protease inhibitor Kaletra, a low dose of
ritonavir has to be used with tipranavir to keep the body
from rapidly destroying the drug.)

Forty one patients who were failing their second protease-
inhibitor regimen, were NNRTI naïve, and had a viral load
over 5,000 were given tipranavir along with other
antiretrovirals (including the NNRTI efavirenz). They had
average viral load reductions of more than 2 logs at 48 weeks
and beyond. Most of them (35 of 41) remained fully
susceptible to tipranavir at 48 weeks. One patient had been
resistant to tipranavir at baseline.(5)

The difference in the resistance profile of tipranavir can be
seen by comparing how resistant these patients were to
various protease inhibitors. For saquinavir, for example, the
average resistance was 17.4 fold (meaning it took about 17
times as much of the drug to suppress this resistant HIV,
compared to HIV that had not developed resistance. By this
measure, the average resistance to saquinavir was 17.4,
nelfinavir 27.8, indinavir 17.1, ritonavir 48.5, amprenavir
3.7, and tipranavir 1.5.

The development of this drug has been seriously delayed in
the past, and patient groups are starting to seek an
expanded-access program as soon as possible for those who
have no other viable option.

* Atazanavir

In 48-week data presented at the Retroviruses conference,
this protease inhibitor did not increase blood cholesterol,
LDL cholesterol, or triglycerides in treatment-naive
patients(6) -- suggesting that it may be useful in developing
HAART treatment regimens with fewer side effects.

And in a study of patients who were failing therapy, the
combination of atazanavir and saquinavir worked well at 48
weeks, both in blood lipid levels and in viral load
reduction.(7)

Atazanavir is now in phase III trials. It should soon be
available on expanded access for patients who cannot
construct viable treatment regimens otherwise. It will
probably be the next protease inhibitor approved.

Entry Inhibitors

Note that there are three different mechanisms of inhibiting
viral entry into cells -- mechanisms that are used by drugs
being developed today. BMS-806 blocks the first step -- the
binding of gp-120 of the virus with the CD4 receptor on the
cell. A later step is the binding with a co-receptor on the
cell (usually CCR5 or CXCR4); this step is the target of SCH-
C, described below. Then the final step is fusion of the
viral and cell membrane, which brings the viral genes into
the cell; this step is targeted by T-20, a drug well advanced
in clinical trials.

* BMS-806

This compound blocks entry by binding to gp-120 on HIV --
preventing the virus from binding to CD4 and then entering
cells.(8,9) It is new and has not yet been tested in
patients.

* SCH-C

This drug blocks viral interaction with the CCR5 co-receptor
on the cell. The low dose studied so far produced an average
of about a 0.7 log viral load decline by day 10.(10) Higher
doses will be studied next.

* T-20

We plan to cover this important drug in a later issue.

Integrase Inhibitors

* S-1360

This integrase inhibitor was synthesized by Shionogi & Co.
Ltd. in Japan, and is being developed in the U.S. in
partnership with GlaxoSmithKline. It is a small molecule that
is orally bioavailable(11) and is now being tested in
patients. Activists and others at the conference were
encouraged that an integrase inhibitor has finally progressed
this far.

Integrase inhibitors (like entry inhibitors) have a different
viral target than any currently approved drug. Therefore all
the viral resistance that has developed so far is unlikely to
affect these new drugs. HIV will be able to become resistant
to them, however, so the new drugs will have to be used
carefully in appropriate combinations. Their importance will
be in providing new kinds of treatment options -- as protease
inhibitors did when they were introduced.

References

  1. Sankatsing S, Weverling G, van 't Klooster G, Prins J,
and Lange J. TMC125 monotherapy for 1 week results in a
similar initial rate of decline of HIV-1 RNA as therapy with
a 5-drug regimen. 9th Conference on Retroviruses and
Opportunistic Infections, Seattle, February 24-28, 2002
[abstract # 5].

2. Gazzard B, Pozniak A, Arasteh K and others. TMC125, a
next-generation NNRTI, demonstrates high potency after 7 days
therapy in treatment-experienced HIV-1-infected individuals
with phenotypic NNRTI resistance. 9th Conference on
Retroviruses and Opportunistic Infections, Seattle, February
24-28, 2002 [abstract # 4].

3. Ruiz N, Nusrat N, Lauenroth-Mai E and others. Study DPC
083-203, a phase II comparison of 100 and 200 mg once-daily
DPC 083 and 2 NRTIs in patients failing a NNRTI containing
regimen. 9th Conference on Retroviruses and Opportunistic
Infections, Seattle, February 24-28, 2002 [abstract #6].

4. Ruiz N, Nusrat N, Lazzarin A and others. Study DPC 083-
201: A phase II double-blind (DB) comparison of 3 once daily
doses of the NNRTI DPC 083 vs 600 mg efavirenz (EFV) in
combination with 2 NRTIs in HIV antiretroviral (ARV)
treatment-naïve patients. 9th Conference on Retroviruses and
Opportunistic Infections, Seattle, February 24-28, 2002
[abstract # 7].

5. Schwartz R, Kazanjian P, Slater L and others. Resistance
to tipranavir is uncommon in a randomized trial of
tipranavir/ritonavir (TPV/RTV) in multiple PI-failure
patients (BI 1182.2). 9th Conference on Retroviruses and
Opportunistic Infections, Seattle, February 24-28, 2002
[abstract # 562-T].

6. Piliero PJ, Cahn P, Pantaleo G and others. Atazanavir: A
once-daily protease inhibitor with a superior lipid profile -
- results of clinical trials at week 48. 9th Conference on
Retroviruses and Opportunistic Infections, Seattle, February
24-28, 2002 [abstract # 706-T].

7. Haas D, Zala C, Schrader S, Thiry A, McGovern R and
Schnittman S. Atazanavir plus saquinavir once daily favorably
affects total cholesterol (TC), fasting triglyceride (TG),
and fasting LDL cholesterol (LDL) profiles in patients
failing prior therapy (trial AI424-009, week 48). 9th
Conference on Retroviruses and Opportunistic Infections,
Seattle, February 24-28, 2002 [abstract # 42].

8. Lin P-F, Robinson B, Gong Y-F and others. Identification
and characterization of a novel inhibitor of HIV-1 entry --
I: Virology and resistance. 9th Conference on Retroviruses
and Opportunistic Infections, Seattle, February 22-28, 2002
[abstract #9].

9. Lin P-F, Guo K, Fridell R, Ho H-T, Yamanaka G, and Colonno
R. Identification and characterization of a novel inhibitor
of HIV-1 entry -- II: Mechanism of action. 9th Conference on
Retroviruses and Opportunistic Infections, Seattle, February
24-28, 2002 [abstract # 10].

10. Reynes J, Rouzier R, Kanouni T and others. SCH C: Safety
and antiviral effects of a CCR5 receptor antagonist in HIV-1
infected subjects. 9th Conference on Retroviruses and
Opportunistic Infections, Seattle, February 24-28, 2002
[abstract # 1].

11. Yoshinaga T, Sato A,, Fujishita T, and Fugiwara T. S-
1360: in vitro activity of a new HIV-1 integrase inhibitor in
clinical development. 9th Conference on Retroviruses and
Opportunistic Infections, Seattle, February 24-28, 2002
[abstract #8].


***** Measles Found to Suppress HIV

A study in Africa found that viral load was apparently
reduced by almost two logs during acute measles infection in
children. After they recovered from measles, the HIV viral
load came back.(1)

Interpretation was complicated by the fact that no baseline
viral loads were available for the children before they came
down with measles. Instead, researchers measured viral load
in children who had been hospitalized with measles, and found
it surprisingly low -- a median of 5,339 copies. This
compared to 387,000 copies in the same children at a one-
month followup, after they had recovered from measles. A
comparison group of children with HIV but without measles or
other acute illness had a median viral load of 228,000.

This reduction was all the more remarkable since an illness
like measles would be expected to raise the viral load if it
did anything -- due to increased immune activation.

Comment

At least one other disease -- scrub typhus -- has also been
found to suppress HIV, but only in some patients.(2)

Clearly we need research to identify the exact mechanism of
viral suppression by measles or certain other diseases. It
might be possible to use this knowledge to design a new class
of treatment for HIV.

References

1. Moss WJ, Ryon JJ, Monze M, Cutts F, Quinn TC, and Griffin
DE. Suppression of human immunodeficiency virus replication
during acute measles. THE JOURNAL OF INFECTIOUS DISEASES.
2002; volume 185, pages 1035-1042.

2. Watt G, Kantipong P, de Souza M, and others. HIV-1
suppression during acute scrub-typhus infection. THE LANCET.
August 5, 2000; volume 356, pages 475-479.


***** New Cancer Drugs Might Help Treat HIV -- But Research
Not Done

by John S. James

A new class of cancer drugs -- topoisomerase inhibitors -- is
now in use in the United States for treating certain cancers.
But despite laboratory studies and other reason to believe
that these drugs might also work as antiretrovirals, they
have never been tested in people for treating HIV. An
activist who investigated the situation found that the U.S.
government owns the rights to use at least some of these
drugs for HIV, and licensed exclusive rights to a small
company that was unable to get funding to start human
research. And the big companies that are selling the drugs
for cancer are not interested in testing for HIV -- either
because of the exclusive license, or for other reasons.
Similar licensing problems could be blocking development of
other drugs that we have not heard about.

AIDS activist Eric Goldman investigated this situation and
published a short article in the current issue of Positively
Aware ("An HIV Treatment the World May Never See," by Eric
Goldman with David Scondras, Positively Aware March/April
2002, http://www.tpan.com -- click on POSITIVELY AWARE).

Comment

The current organization of AIDS medical research makes it
very difficult to get a new drug into the first human
testing, to establish a proof of principle that it might
work. Industry is reluctant to do this -- not so much because
it is expensive (industry does pay for the large clinical
trials needed for drug approval, which cost much more), but
because the reward is too distant. Once there is positive
human data, it is much easier to raise money and interest for
further research.

The case of topoisomerase inhibitors is unusual in that these
drugs have gone through the entire approval process for
cancer. Therefore, the first human trial for HIV would be
much less expensive, since formulation, tolerable dosing,
toxicity, and some long-term safety issues have already been
worked out. Still this work wasn't done, and no one is doing
it today.

Since these drugs are already in use, it would be quick and
easy to see if there is an effect on viral load in persons
treated for cancer who also happen to have HIV. If a major
reduction in viral load could be documented, it would much
easier to get further research started. Then the next step
could be a small trial in which the drugs were prescribed for
selected patients. (The first topoisomerase inhibitors are
given by injection, but a new one -- Orathecin, formerly
named Rubitecan -- now waiting for FDA approval for
pancreatic cancer, is taken orally. All can have serious side
effects. It is not known whether smaller doses could be used
in HIV treatment. Indeed, since the research has not been
done, no one knows whether these drugs, in any doses, could
have any value in treating HIV.)

We also need more investigation into the problems in
licensing policies and elsewhere that block early human
research that would be strongly in the public interest. As
Goldman points out in his article, there may not be any
single villain in this story -- each company and government
agency may have done what it was supposed to do. Lack of a
villain can make it harder to mobilize public interest for
reform. Still, the system is not working -- and is costing
many lives, if any of the drugs that should have been tested
would in fact be useful.

As a lawyer who works in intellectual property in the
entertainment industry, Goldman had the background to be
among the first to investigate the complicated tangle of
legal rights that has blocked these drugs and probably others
from being tested as they should. Now that he has shown the
way, other activists without this specialized background can
help develop the investigation.

A major problem in AIDS treatment today is that many patients
need new drugs, and the "pipeline" of potential new
antiretrovirals is disappointing. The biggest single block in
the pipeline -- the obstacles to the small human trials that
could establish proof of principle -- needs much more
attention.


***** Bone Problems: Overview Article Available

An overview of the growing problem of bone disease --
especially avascular necrosis (also called osteonecrosis, or
aseptic necrosis), which is requiring an increasing number of
hip replacements in persons who have had AIDS and been on
HAART for many years, was published in the April 2002 issue
of POZ ("Hip to the Future," by Anne-christine d'Adesky, page
28-31 and 39).

Avascular necrosis (which is different from osteopenia or
osteoporosis, caused be loss of bone minerals) occurs when
blood vessels that supply the bone constrict, cutting off
blood supply and causing bone death. No one knows the cause,
although there are many theories. The condition can be hard
to diagnose early, and it is not known how many people are
affected.

Finding the Article

Many AIDS service organizations and medical practices have
copies of POZ, often available free or available for
photocopying. Some newsstands may have copies.

Unfortunately the Web site, http://www.poz.com, does not have
the last six months of issues online (it does have back
issues older than six months). If you want to get the article
before it is online and cannot find a copy locally, you can
purchase the April 2002 POZ by calling 800-9-READPOZ (toll-
free from the U.S.), or 815-734-4151 (from anywhere).


***** Alert: International Epidemic, Disease Control

by John S. James

Every day 8,000 people die of AIDS, thousands more of
tuberculosis, and thousands more of malaria. Leading experts
agree that all three could be effectively controlled around
the world with a total investment of about $10 billion per
year, and the political will to match. This is not much money
compared to the global economy; in theory at least, a number
of individuals could write the check themselves.

But last year President Bush proposed $200 million for the
Global Fund for AIDS, Tuberculosis, and Malaria (later raised
to $300 million) -- about a tenth of the U.S. share of the
total cost to control these diseases, based on the size of
the U.S. economy. This year Bush proposed $200 million again.
Coming from the world's only superpower, this has set the bar
low, and donor countries and others around the world have
followed accordingly. If the U.S. does not take global
infectious disease seriously, other rich countries are
unlikely to do so. (Total U.S. foreign aid for all purposes
is about 0.1 percent of the U.S. gross domestic product -- a
fraction of what European countries contribute. Recently
President Bush called for increasing this by 50% over several
years -- an important positive development.

Also, conservative Senator Jesse Helms recently called for an
additional $500,000 from the U.S. for international AIDS
control, especially targeted for prevention of mother to
infant transmission. (We have not heard criticism of this
targeting, probably because mother-to-infant transmission is
indeed a major part of the epidemic, and there is no doubt
that the money could be well spent there. And some of these
programs treat the whole family.)

Later this month (April 2002), the Global Fund will have to
turn down many of the more than 300 projects from developing
countries that have requested funds in the current cycle. The
requests from the first round of proposals total about $1.15
billion now, or $5 billion if five-year commitments are made
-- and the Global Fund has only about 15% of that currently
available. And these initial requests were done under great
time pressure, and under pressure to scale back the amounts
asked for.

Comment

Political mobilization to get a reasonably adequate U.S.
response for the control of these major infectious diseases
is completely doable. There is lots of potential public
support. What then are the obstacles that have kept it from
happening so far? We see the following:

* Widespread public mobilization has been slow. For example,
church groups are natural sources of support, but AIDS
activists have been slow to get them involved. Some churches
even have staff or volunteers assigned to look for
opportunities to help in the world, but usually no one has
prepared them on this issue or explained that what is most
important is letting Congress, the media, and others know
that many Americans care about illness and death in
developing countries.

* After September 11, many government officials are serious
only about war.

* The pharmaceutical industry is not on the same page. Its
major concern is intellectual property, and any precedents
that might be set abroad that might someday limit its freedom
to charge high prices in the U.S. So it has leaned toward
charity programs negotiated separately and usually secretly
between each company and country (where the countries of
course give up freedom of action) -- and also toward
selective price reductions where companies make no profit
according to their own accounting, then wash their hands --
establishing a case that they are not profiteering, instead
of working together to solve the problem. There is nothing
like the U.S. domestic program where company and patient
representatives have gone to Congress together to support
funding for treatment access in the U.S. (Incidentally, we
believe that developing or manufacturing treatments for
developing countries *should* be profitable -- though clearly
the U.S. model of making the patient pay will not work. But
companies could work together with communities, officials,
and others to raise government and other monies to pay for
the needed drugs and medical infrastructure.)

* Donors and communities alike want assurance that money is
well spent on programs that work. But measuring results is
difficult -- not only here, but in nonprofit programs in all
fields.

Of all these obstacles, the biggest one so far has been lack
of public mobilization. Members of Congress need to hear that
their constituents care about global health and infectious
diseases. You can help by writing or calling your
representatives, especially when these issues are in the news
or have come to Congress for a vote.


***** Medical Privacy Rule Changes: Public Comments Due April
26

The Bush Administration has proposed significant changes in
the Clinton Administration's rules on medical privacy. The
proposed rule is open for public comment for a short period
of 30 days.

The WASHINGTON POST summarized the changes as follows: "The
proposal would alter the requirement, put in place by the
Clinton administration, that patients give their written
permission before their medical records may be disclosed to
doctors, hospitals, pharmacies and insurance companies. In
the new requirements, those who use their records must at
some point notify patients of their privacy rights."
("Medical Privacy Changes Proposed; Bush Plan Would Lessen
Patients' Say on Records," by Amy Goldstein, WASHINGTON POST,
March 22, 2002). The long version of the proposed changes --
40 pages of small print in the FEDERAL REGISTER -- is
available through the link below.

A government site, favoring the changes, is:
http://www.hhs.gov/ocr/hipaa/

Arguments pro and con can be found in the WASHINGTON POST
reference above, and in THE NEW YORK TIMES, "Bush Acts to
Drop Core Privacy Rule on Medical Data," also March 22, 2002.

Comment

We have not had time to fully analyze the changes and do not
intend to submit comments. But we want our readers to know
about the option.

We have mixed feelings about opposing the changes, because we
fear that in practice, the right to give consent before one's
medical records are used will be theoretical, not real. We
fear that in reality, patients will just have more paperwork
thrust at them to read and sign before they can get treatment
at all, from any facility. Since most people who have sought
medical care do not have a good option to just walk out and
abandon the quest, this is not a real choice.

The basic concern motivating opposition to the Bush
Administration proposal -- how can personal sovereignty be
maintained in a world of huge institutions that seldom
respect people -- is one of the central issues of our time.
But creating formal rights that are not practical to use
could discredit this quest and do more harm than good. We
need to find other ways to proceed.


***** Medical Marijuana Action Alert

We received the following press release from the Marijuana
Policy Project on March 29. On April 2, ACT UP New York wrote
an open letter to Vermont Governor Dean in support of the
bill to legalize marijuana for medical purposes, H. 645.

"A bill to legalize use of marijuana for medical purposes --
similar to laws already on the books in Alaska, California,
Colorado, Hawaii, Maine, Nevada, Oregon and Washington --
passed the Vermont House of Representatives March 15.
Vermont's Senate will consider the bill in April.

"The biggest obstacle to passage appears to be Vermont
Governor Howard Dean. Vermont newspapers have reported that
Dean, a physician, opposes the bill and is pressuring his
fellow Democrats, who control the Senate, to kill it before
it reaches his desk.

"Dean, who has been making strong political overtures to the
gay and lesbian community in preparation for a possible run
for president, is said to believe that more research is
needed. But research is not the issue. Everyone wants more
research, but because of government foot-dragging, progress
has been slow. There is no reason that those who benefit from
marijuana now -- for example, those who use it to ease the
nausea often caused by antiretroviral drugs -- should have to
risk arrest and jail while waiting for research to go
forward.

Letters are urgently needed -- by mail or fax -- to:
Gov. Howard Dean, M.D.
109 State Street, Pavilion
Montpelier, VT 05609-0101
Fax: 802-828-3339


***** 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
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  email: aidsnews@...
  useful AIDS links: http://www.aidsnews.org

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
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 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 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
was erroneously re-sent earlier today. There has not
been any change in the issue.

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

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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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
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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 #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

Subscription and Editorial Office:
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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
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
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Copyright 2002 by John S. James. Permission granted for
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--
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

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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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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

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
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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Free email: Free delivery for individuals (delayed one week).
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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 #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

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Editor and Publisher: John S. James
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AIDS TREATMENT NEWS reports on experimental and standard
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meetings and conferences, medical journals, and computer
databases. Long-term survivors have usually tried many
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them. AIDS TREATMENT NEWS does not recommend particular
therapies, but seeks to increase the options available.

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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
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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
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   phone 800/TREAT-1-2 toll-free, or 215-546-3776
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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 18 times per year, and
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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
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