AIDS TREATMENT NEWS Issue #366, June 22, 2001
phone 800-TREAT-1-2, or 215-546-3776

CONTENTS

** United Nations: Special AIDS Session Next Week
The entire United Nations General Assembly will focus on
the AIDS epidemic next week. About 5,000 people are
expected to register for this meeting, most of which is
closed to the public; however, many satellite events are
open to public participation. The entire session will be
broadcast worldwide via the Web, and archives and
transcripts will also be available. This article provides
some Web sites to start with, and outlines some of the
major controversies around this session.

** Drug Patents and Developing Countries: New Proposal
An economist has proposed a way to help prevent World Trade
Organization rules from blocking access to medications in
poor countries.

** Bone Disease: Report on the Web
This Web site reviews a meeting last year on bone problems,
including avascular necrosis and osteopenia, which might or
might not be caused by HIV, and/or by the drugs used to
treat it.

** Mitochondrial Toxicity: Report on the Web
Mitochondrial toxicity may be the root cause of many
serious side effects of antiretroviral medications. This
report summarizes a meeting last year to review what was
known at that time.

**ADAP (AIDS Drug Assistance Program) Funding: Action
Needed
Federal and State underfunding of the AIDS Drug Assistance
Program has already caused half of all states to plan
restrictions of their program, which will result in
patients not receiving the drugs they have been prescribed.


***** United Nations: Special AIDS Session Next Week

by John S. James

On June 25-27 the entire United Nations General Assembly
will focus on AIDS. The goal is worldwide commitment and
consensus on dealing with the epidemic. The negotiations
leading up to this Special Session have been contentious,
even more so than most diplomatic meetings.

No matter what the outcome, this meeting will be historic
and will be a major focus of world attention. Here is some
background, and resources that you can use as a starting
point for finding information.

Official Web Page

The Web page for the United Nations General Assembly
Special Session on HIV/AIDS (often called UNGASS) is
http://www.un.org/ga/aids/

Here are some of the important documents available there
before the meeting:

* Under the heading "A call to action" are several recent
statements by United Nations Secretary General Kofi Annan,
who has provided exceptional leadership on this issue in
advance of the United Nations special session;

* The "Documents" section includes the "Revised Draft
Declaration of Commitment on HIV/AIDS" -- a single-text
statement that is being negotiated in order to reach as
much agreement as possible. (At this time, June 16, the
current draft is the 2nd published version, dated May 11.)

* The "Bulletin" is an electronic news bulletin to keep
participants informed. At this date (June 21) only one
issue has been published, with general background such as
AIDS statistics, overview of the meeting, and media
accreditation. Two more issues are planned by June 25.

* A "calendar" of dozens of official UN and unofficial
events around the time of the session.

* Other sections on background information, NGOs and civil
society, and media.

From the official media advisory:

Governments Will Convene to Plan Intensified Action to
Combat the Global Epidemic

The United Nations will hold a Special Session on HIV/AIDS
to galvanize leadership at the highest levels, intensify
international action and mobilize the resources needed to
combat the epidemic. The Special Session, to take place
from 25 to 27 June 2001 at UN Headquarters in New York,
will be the first ever to address a public health issue.

UN Secretary-General Kofi Annan and high-level government
delegations will address:

* The importance of political leadership in developing
effective responses and decreasing the stigma associated
with HIV/AIDS

* Encouraging all sectors of society to play a major role

* Increasing resources for treatment, prevention, and care

* Preventing new infections and alleviating the social and
economic impact of the epidemic

* Access to care and the development of new technologies
and treatments that are both effective and affordable

Governments are expected to adopt a Declaration of
Commitment setting targets and timetables. In addition to
statements in the Plenary, four interactive round tables
will discuss human rights, international funding and
cooperation, prevention and care, and the socio-economic
impact of HIV/AIDS. These will involve participants from
NGOs, the private sector and other civil society groups. A
full programme of press conferences and special events will
provide additional media opportunities.

Live Webcast, Plus Archive and Transcript

Kaisernetwork.org, a service of the Henry J. Kaiser Family
Foundation, is webcasting the entire UN Special Session on
HIV/AIDS, June 25-27. Anyone around the world can watch it
for free.

An archive and transcript will also be available, a few
days after the session.

For more information, or to watch the webcast, visit
http://www.kaisernetwork.org/healthcast/un/aids/jun01

Areas of Agreement

On June 16 the Background section of the official Web site
includes a one-paragraph summary under "What Will the
Outcome Be?" It summarizes some of the major areas of at
least nominal agreement:

"Given the urgency of the epidemic, at the special session
governments are expected to agree on a Declaration of
Commitment that will outline priority areas where stronger
action must be taken. These are likely to include
prevention, improved access to care and treatment, care of
children orphaned by AIDS, expanded public/private sector
partnerships, the need for an accelerated multisectoral
response to the epidemic and for resources commensurate
with the crisis."

Controversies

Some of the major areas of disagreement are:

* Whether to name vulnerable groups, such as men who have
sex with men, in the Declaration of Commitment. The current
draft includes the following section, which some countries
object to:

"By 2003, develop national strategies, policies and
programmes, through a participatory approach, to promote
and protect the health of those most vulnerable to, and at
greatest risk of HIV infection, such as: children in
especially difficult circumstances, men who have sex with
men, sex workers and their clients, injecting drug users
and their sexual partners, persons confined in institutions
and prison populations, refugees and internally displaced
persons and people separated from their families due to
work or conflict."

According to a June 15 Associated Press story, an Egyptian
diplomat commented, "Does it have to be so explicit? This
is shocking for my society." He proposed "irresponsible
sexual behavior" instead. And the Iranian Ambassador said
negotiations should "not be considered as an opportunity by
certain quarters in the Western world to push the envelope
on areas where there is cultural sensitivity, ideological
sensitivity, ethical sensitivity" (from same Associated
Press story).

Apparently the U.S. wants to use general language such as
"vulnerable individuals" instead of naming the groups.

Many AIDS professionals and activists consider the issue
important because they want to use the document that
emerges to pressure their governments to focus prevention
resources where the epidemic is spreading fastest. Many
countries, including the U.S., have targeted prevention
resources irrationally because of a population's
disadvantaged or unpopular political position, or minority
status.

* Human rights. Here is the current text, which some
countries want changed, although as of today (June 21)
there seems to have been progress toward narrowing the
areas of controversy:

"HIV/AIDS AND HUMAN RIGHTS

"Respect for human rights reduces vulnerability to HIV/AIDS

"Respect for the rights of people living with HIV/AIDS
drives an effective response

"By 2003, complete policy reviews of existing non-
discrimination legislation and protective laws, drawing as
appropriate on the United Nations Guidelines on HIV/AIDS
and Human Rights, in order to adopt new or strengthen
existing legislation to protect the human rights of people
living with HIV/AIDS, eliminate discrimination and ensure
their equal rights in education, employment and services;

"By 2005, ensure that national legislation is in place to
promote, protect and respect the rights of people living
with HIV/AIDS to information, quality care, support,
confidentiality and privacy;

"By 2005, develop and implement national strategies that:
assist women to exercise control over and make their own
decisions relating to their sexuality in order to protect
themselves from HIV infection; and promote shared
responsibility of men and women to ensure safe sex and
prevent HIV infection;

"By 2005, implement measures to increase capacities of
women and young girls to protect themselves from risk of
infection, principally through gender-sensitive prevention
education and the provision of reproductive health
services;

"By 2005, develop and begin to implement national
strategies to promote women's full enjoyment of all human
rights and reduce their vulnerability to HIV/AIDS through
the elimination of all forms of violence against women and
girls, including harmful traditional and customary
practices, abuse and rape, battering, and trafficking in
women and girls."

Apparently the U.S. does not want any movement toward
health care as a human right. And some countries do not
like the idea of human rights and are reluctant to see it
extended.

* Treatment Access vs. Prevention and/or Intellectual
Property

The current draft focuses on prevention and only two
paragraphs on treatment and care. But pharmaceutical
companies -- and therefore the U.S. and some other
delegates -- have problems with the following paragraph,
apparently because they do not want any language suggesting
collective action toward differential pricing or other ways
of making medications affordable:

"By 2003, ensure that national strategies are developed in
close collaboration with the international community, civil
society and the business sector to increase substantially
the availability of antiretroviral drugs and of essential
drugs, for the treatment of HIV infection and opportunistic
infections, by addressing factors affecting the provision
of these drugs, including technical and system capacity,
pricing, including differential pricing and by examining
alternatives for increasing access and affordability of
HIV/AIDS related drugs."

There is also controversy over whether to provide
antiretroviral treatment in Africa and other poor regions,
vs. focusing on prevention and limiting treatment to low-
cost, unpatented antibiotics, and only using
antiretrovirals for prevention of mother-to-infant
transmission.

Recently two U.S. officials created a firestorm of
controversy by suggesting that Africans could not take
their medicines on time -- first an unnamed senior Treasury
Dept. official in late April, then over a month later,
Andrew Natsios, the new director of the U.S. Agency for
International Development -- leading to calls for the
latter's resignation, including an op ed in The Washington
Post, June 15, and a student campaign to send him watches.
Some observers are less concerned about the unfortunate
remarks themselves than by what they may reveal about moves
toward a U.S. policy of writing off tens of millions of
people already infected in poor countries -- whether to
defend prevention program funding, to save money, or to
avoid intellectual-property challenges resulting from
raised expectations and efforts to obtain access to
patented antiretrovirals.

One code word to watch is "care." Often it means hospice
care or other inexpensive treatment -- not including
antiretrovirals to address the central cause of the
illness.

For More Information

To follow these and other issues during and after the
United Nations General Assembly Special Session on
HIV/AIDS, see:

* The official session Web site (described above),
http://www.un.org/ga/aids/

* The official email discussion forum, Break the Silence.
To join, send an e-mail message to: join-break-the-
silence@... To see the archive of messages already
sent, go to http://www.hdnet.org (at this time there is a
full archive for those who have joined the list, and a
selected, categorized archive open to anyone).

* The news bulletin of the meeting. The easiest way to find
is it to check the official Web site for copies as they are
published.

* For information about the campaign for treatment access
in developing countries, see:
http://www.accessmed-msf.org/ (You may need to click on the
logo to enter the site), and
http://www.globaltreatmentaccess.org



***** Drug Patents and Developing Countries: New Proposal

by John S. James

A creative new idea on using existing patent laws and
procedures to deal with the conflict between intellectual
property and access to medication in developing countries
was posted on the World Bank's Annual Bank Conference on
Development Economics ("A Patent Proposal for Global
Diseases," by Jean O. Lanjouw, Yale University, the
Brookings Institution and NBER, April 2001,
http://econ.worldbank.org/files/1733_lanjouw.pdf).

We cannot judge the technical merits, but certainly new
ideas on this issue need attention -- especially at this
time when access to treatment will be considered at the
United Nations General Assembly Special Session on
HIV/AIDS, June 25-27, 2001.

The current problem is that the existing TRIPS
(intellectual property) provisions of the World Trade
Organization treaty require every country to have
U.S./European style patent laws in force by 2006. This
provision, adopted with no thought for its effect on access
to health care, could be a disaster for poor countries,
because pharmaceutical companies price their drugs for
rich-country markets, and have incentives to write off the
poor who do not count financially, instead of having
greatly varying prices which might lead to public-relations
problems in rich countries. But at the same time, some
intellectual-property advocates hope that the new
patentability of drugs for developing-country diseases
might lead to medical research and drug development on
diseases which are largely limited to poor countries,
diseases largely neglected until now. [Medicines could be
sold profitably in poor countries, but they would have to
be developed and marketed differently than in rich
countries.]

The proposal is to use a procedural change in the patent
offices of rich countries, to make pharmaceutical companies
choose whether to protect their new drug patents in rich
countries or in poor countries -- but not in both. Then for
diseases like cancer, which affect both rich and poor
countries, companies would choose to protect their patents
in rich countries -- allowing low-cost generic copies to be
sold in poor countries, which are a negligible market in
comparison. But for diseases like malaria, which affect
poor countries almost entirely, companies would choose
patent protection in poor countries. In theory prices would
not be prohibitive, as the medications would have to be
priced for poor countries in order to sell at all.

This policy could be implemented entirely by one or a few
developed countries, without requiring any change in
international treaties.

Abstract of "A Patent Proposal for Global Diseases":

"There are two identifiable types of diseases in developing
countries. Some, such as malaria, are specific to poor
countries, but many others, such as cancer, have a high
incidence in all countries. These differences give rise to
quite distinct drug markets. In particular, for global
diseases, pharmaceutical industry profits derived from
having a monopoly over sales in poor countries make only a
marginal contribution to total world-wide profit and
therefore the incentives to invest in research. At the same
time, even a small price increase due to such a monopoly in
a poor country can greatly reduce the number of people able
to purchase patented drugs and the welfare of those who do.
This paper describes a policy that could improve on the
current patent regime by acknowledging these differences in
markets and what they imply for optimal patent protection.
It allows protection to strengthen for diseases specific to
developing countries where a clear argument can be made
that some form of new incentives are warranted. At the same
time, it effectively keeps protection at its current level
in situations where increased profits are less likely to
generate new innovation."

The paper is available at:
http://econ.worldbank.org/files/1733_lanjouw.pdf

Comment

Clearly the preferred solution would be to change the WTO
TRIPS so that it does not block most of the world's
population from access to new medicines. But we do not know
if such a change is possible. In case it is not, devices
like the one proposed by Lanjouw need to be considered.


***** Bone Disease: Report on the Web

A 54-page background report on bone disease in persons with
HIV (including avascular necrosis, and also osteopenia) can
be found in Bone Metabolism and HIV Disease Meeting Report,
published by the Forum for Collaborative HIV Research.

Contents include:
* Bone disease and HIV
* Overview of the local regulation of bone
* Crosstalk: Bone and the Immune System
* Cytokine aspects of bone biology
* Increased prevalence of avascular necrosis in HIV-
infected adults, and
* Bone metabolism in HIV Disease: New and old paradigms

This paper reports on a meeting that occurred August 29,
2000, so readers should also check more recent information.

The report is available at http://www.hivforum.org;
currently it's under "Publications and Reports," then under
"Metabolic Abnormalities." Note that Forum reports are more
focused on research policy than on practical treatment or
management information.


***** Mitochondrial Toxicity: Report on the Web

A 67-page background report on mitochondrial toxicity --
widely suspected though not proven to be a basic cause of
many serious side effects of certain antiretrovirals -- has
been published on the Web by the Forum for Collaborative
HIV Research. Since this paper reports on a meeting that
took place June 5-6, 2000, readers should also check more
current information.

Topics include background on mitochondrial dysfunction,
clinical aspects in adults and children, and diagnosis and
therapeutics.

The report is available at http://www.hivforum.org;
currently it's under "Publications and Reports," then under
"Metabolic Abnormalities."


***** ADAP (AIDS Drug Assistance Program) Funding: Action
Needed

Almost half of all states have already indicated that they
may have to restrict their AIDS Drug Assistance Program by
the end of 2001. Restrictions can include waiting lists,
caps on services, cutting drugs off the formulary, or even
closing the program to new enrollment because money is low.
Additional states may be affected as well.

Recently we learned that California is looking at its
program to decide what drugs to remove from its program if
necessary.

The basic problem is that federal and state funding has not
kept up with the greater number of patients who need
treatment, since people today are living longer. The new
guidelines that call for starting treatment somewhat later
will help to balance expenses, but is not enough to make up
the difference.

On June 14 Project Inform's Treatment Action Network sent
out an alert listing some of the states soon to be
affected:

In the last appropriations bill, ADAP received $60 million
less than projected as needed to provide standard of care
for its clients. In addition, the number of new clients and
the costs of drugs continue to rise, putting an additional
strain on many state ADAPs. Many programs are expected to
face serious problems in the next few months without an
emergency supplemental. According to a recent report by the
National Alliance of State and Territorial AIDS Directors
(NASTAD), nearly half of all states have indicated that
they might have to place emergency restrictions on their
programs this year, such as implementing or expanding
waiting lists, capping services, and/or making cuts to the
list of available drugs. Currently, there are ADAP waiting
lists in Alabama, Arkansas, Georgia, Indiana, Kentucky,
Maine, Montana, Oklahoma, South Carolina, and South Dakota.
Even states with the most comprehensive ADAPs such as
California, New York, and Pennsylvania are expected to feel
the effects of the budget shortfall.

That action alert asked recipients to call or email
President Bush, and their two U.S. Senators (you can find
contact information for Senators from their Web sites,
which can be reached through http://www.senate.gov).

What You Can Do

The ADAP situation is changing daily. To be informed how
you can help on this and other treatment and access issues,
you can join Project Inform's Treatment Action Network.
Send an email to tan@..., and ask to receive
their action alerts.


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