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.


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AIDS Treatment News
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