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.


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