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).]


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