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AIDS TREATMENT NEWS Issue #210, November 4, 1994
   phone 800/TREAT-1-2, or 415/255-0588

CONTENTS:

Searle Abandons Its Protease Inhibitor

Protease Inhibitors -- Task Force Proposed

HIV RNA -- Time to Wake Up and Save Lives

New AIDS Treatment Information Service, 800/HIV-0440

Human Growth Hormone -- Canadian Number Disconnected for U.S.
Callers

AIDS Patents Now Available Free through Internet

Drugs for Infants and Children: Call for Reform

California: AIDS Drug Assistance Program, New Drugs Proposed;
Title II Public Input Sought

Title II National Organization Formed

Global AIDS Summit, Paris, December 1


***** Searle Abandons Its Protease Inhibitor

In a November 4 conference call, Searle announced that it was
stopping development of its protease inhibitor SC-52151,
saying that despite promising results in laboratory tests,
two clinical trials have shown no indication of antiviral
activity in people. The company issued the following
statement:

"Based on the results from two studies, Searle has decided to
halt development of its candidate HIV protease inhibitor SC-
52151. The highly promising results seen in earlier IN VITRO
studies were not confirmed in either Searle #005, a clinical
study of the use of the compound as monotherapy in people
with advanced HIV infection, or ACTG #282, a formulation and
dosage study. While well-absorbed into the bloodstream and
achieving the desired blood levels, SC-52151 produced no
measurable effect on any standard surrogate marker of anti-
HIV activity -- CD4, p24 antigen, and PCR RNA -- in
patients."

The problem with SC-52151 appears to be unique to the Searle
drug, and not to affect other protease inhibitors such as the
Merck compound. Searle researchers believe that the drug
binds to a protein (AAG) in the blood, and is then removed by
the liver. Laboratory tests have shown that adding this
protein causes the drug to lose antiviral activity. A similar
experiment with the Merck compound did not show loss of
activity.

More importantly, other protease inhibitors have shown a
striking though temporary drop of viral load in people; the
Searle drug produced no such effect. This means that we
already know the other drugs will not fail in the same way as
SC-52151 did.


***** Protease Inhibitors -- Task Force Proposed

 A proposal for a high-level task force on protease
inhibitors received strong support from FDA Commissioner
David A. Kessler, M.D., and from Philip R. Lee, M.D.,
Assistant Secretary for Health, U.S. Department of Health and
Human Services, at the October 27-28 meeting of the National
Task Force on AIDS Drug Development. After the proposal was
presented, Dr. Kessler suggested a special meeting of the
National Task Force in early 1995 devoted solely to protease
inhibitors.

 The protease task force was suggested by Jules Levin, an
AIDS activist from Brooklyn, New York. We were not at the
meeting; the following summary is from documentation he
provided to us:

 "We are at a crucial juncture for all of us. We are in the
early stages of the development of the protease inhibitors.
We need a proper plan for their orderly and effective
development.

 "I propose we form the Protease Task Force to plan for and
guide the development of this new class of drugs. It would be
a collaborative and coordinated effort to address all of the
attendant issues. Some of these are:

 * How best to design the overall approach for all trials,
both pre-marketing and post-marketing;

 * What combinations ought to be examined in which trials;

 * Which controls to use;

 * What markers for efficacy and safety will be utilized;

 * Potential drug interactions between the protease
inhibitors and other medications used by people with AIDS;

 * The need for expanded access for those with more advanced
HIV disease; and

 * Other questions we want answered, and how best to address
them.

 "The participants on the Protease Task Force would represent
the following groups:

 * Physicians who treat large numbers of HIV patients;

 * Representatives from the HIV-affected and activist
community;

 * Government representation from the Food and Drug
Administration, and the National Institutes of Health; and

 * All of the pharmaceutical companies developing protease
inhibitors.

 "We urgently need discussion of access for those with more
advanced HIV disease. This group includes persons with T-
helper counts under 50, as well as others with higher counts
who have exhausted approved treatment alternatives. [Note:
persons with T-helper counts under 50 have been excluded from
most if not all current trials of protease inhibitors.] These
people have been subjected most harshly to the mistakes of
the past; and they have volunteered for the trials of
nucleoside analogs and other drugs. We cannot abandon them
now."

 Mr. Levin told the National Task Force that "the issue
burning up the wires between people with HIV is, 'When are we
getting access to protease inhibitors?'"

 After the presentation, Dr. Kessler said the development of
protease inhibitors is the most important work the National
Task Force can do now, that the time is right.

 Jules Levin urged the AIDS community to rally and offer
support, so that the FDA and Secretary Lee do not lose focus
on this issue. If you can help, call Jules at 718/624-8541.


***** HIV RNA -- Time to Wake Up and Save Lives

by John S. James

Accurate tests for the level of HIV RNA in blood plasma --
which shows the number of HIV virions present in the blood --
are now commercially available to physicians, and have been
available for research use for some time. The greatest need
now is to use these tests in many small, rapid trials, to
learn how to better use the drugs we already have, and others
which could readily be made available. We need to try many
strategies to reduce the viral load as much as possible, and
keep it down. We need to individualize these strategies for
individual patients, because it is clear that existing,
available drugs and combinations of drugs can work very well
for some people but not at all for others. We need to quickly
learn who is benefiting, and test other options for those who
are not.

Many researchers agree with this kind of strategy. But the
mainstream is not yet ready to move. Instead, it wants to
first do other trials to prove beyond a doubt that HIV RNA
testing is useful for testing drugs. These trials will take
years -- if they can be conducted at all.

Yet it is already clear that HIV RNA is a much better measure
of the virus in the bloodstream than any other test we have.
It is also becoming clear that this viral load in the blood
reflects viral reproduction in the lymph nodes and elsewhere.
Reducing the level of virus in the blood does NOT mean that
it has been removed from the lymph nodes or other tissues;
but usually it does mean that the virus throughout the body
has become, at least temporarily, less active.

We need to learn how to use combinations of drugs and other
treatments to keep HIV inactive indefinitely. It will
probably be hard to do this. But we now have tests that open
doors to creativity by researchers, physicians, and patients,
because they can tell rapidly and reliably whether a
treatment is working for a patient to reduce the virus -- and
how long it is working. When it stops working, new approaches
can be tried. As experience develops and knowledge is
exchanged -- in research settings, and also in physicians'
offices -- we will learn what strategies are most likely to
work, and how to deliver better care to patients in all
stages of HIV disease.

Examples: Approved Antiretrovirals

What drugs should be tested in this way? One good place to
start is with the drugs already approved by the FDA as
antiretrovirals -- AZT, d4T, ddI, ddC -- and combinations of
those drugs. First, establish a baseline value of HIV RNA for
an individual patient, while the patient is on a stable
treatment regimen. If that value is low, and the patient is
otherwise doing well, the decision might be to leave well
enough alone -- but to watch the test in the future. If the
value is high, then switch to (or add) other regimens which
make sense for that patient; within about two weeks the test
will show whether the new regimen is working to reduce the
virus. If it is not, other options can be tried.

What is "low" and what is "high"? This is still being
learned, but a rule of thumb is that anything under 10,000
copies of RNA per milliliter of plasma is fairly low, and
anything over 100,000 copies is fairly high. [Note that some
testing companies report the number of copies for other than
one milliliter of plasma; in this case the number on the lab
report needs to be multiplied by 20, or by some other factor,
to get the number per milliliter.] Some researchers believe
that it may be good enough to keep the HIV RNA under some
threshold amount, probably somewhere between 10,000 and
100,000; others suspect that it may be important to keep the
value as low as possible. At this time no one knows for sure.

Example: Acyclovir

Besides the four approved antiretrovirals, many other
treatments can be tested this way. For example, two major
trials and one epidemiological study have unexpectedly
suggested that acyclovir may substantially improve survival
of persons with advanced HIV disease. But none of these
studies was planned in advance to test that possibility, and
none has given definitive answers, so this issue remains
controversial. There are at least four unpublished studies
with additional information; but it is clear that at least
three of the four, and perhaps all of them, will not give
definitive answers either.

Acyclovir does NOT inhibit HIV directly; but it might help
indirectly by inhibiting certain herpes viruses, which are
believed to make HIV more active. If so, this indirect
benefit might be indicated by a decrease in HIV RNA. If such
a decrease is seen -- and a small, rapid trial would be
enough to find out -- then physicians might be more confident
about using acyclovir for improving survival of people with
AIDS, and targeting the treatment to those most likely to
benefit.

Small trials measuring viral load could help to answer
questions which are unlikely to be answered in any other way.
(1) Is AZT necessary to get this possible benefit from the
acyclovir? No one knows, since the previous trials which
suggested this benefit all used AZT in addition. (2) If
acyclovir is found to (indirectly) lower HIV in late-stage
disease, would it also help in earlier stage HIV infection?
None of the previous studies have shown such a benefit. But
they would probably not have found it even if it was there,
because people with early infection either were not included
in the studies, or would not have had time to get sick during
the period that the studies were run. (3) Which patients
benefit? Only those who have been infected with herpes (which
includes much of the general U.S. population, including a
large majority of gay men)? Only (or mainly) those who have
active herpes outbreaks? Or could those who have never been
infected also benefit, perhaps because the acyclovir
suppressed unknown viruses which might activate HIV?

Definitive answers to these questions would require trials
with hundreds of people, lasting for years. Obviously such
trials will never be run. But it would be easy to find out if
the amount of virus in the blood goes down after the
treatment is started. And this information -- which would
strongly suggest that the treatment is beneficial, although
it would not prove that -- would be useful for physicians and
patients making treatment decisions.

Example: "Alternative" Treatments

Dozens of herbs, nutritional supplements, and other
treatments without commercial or government sponsors have
come into substantial use by persons with HIV. Some -- for
example, certain herbs used in traditional medicine as anti-
infectives -- have shown anti-HIV activity in laboratory
tests. But conventional drug development, which costs an
average of over $100,000,000 per new drug approved, will
never be done for them.

It is quite possible that some "alternative" treatments do in
fact reduce viral load in people. They could then be tested
in combination trials with approved antivirals, protease
inhibitors, or other treatments, to help design better
antiviral regimens. But others, which are being taken in the
hope of an antiviral effect, will be found to have none.
Persons who are using those treatments clearly need to know
this information.

Recently a small underground trial tested the combination of
Ro 24-7429 (the abandoned Hoffmann-La Roche tat inhibitor)
plus pentoxifylline, a prescription drug, using blood tests
to detect changes in viral load. Laboratory experiments had
suggested that the two drugs might work very well together.
But in people, the combination was found to be completely
ineffective as an antiviral. Viral load went up, sometimes
greatly, in four of the five patients; in the fifth, the
viral load was down at four weeks, but the decrease was so
small that it was well within the error of the test. This
result has not previously been published; AIDS TREATMENT NEWS
is seeking more information and preparing a more complete
report.

There is no evidence of any benefit from Ro 24-7429; this
small trial answered the one remaining question, of whether
the combination with pentoxifylline would have antiviral
activity. If modern viral testing had been available when Ro
24-7429 was first tried in people, several years of wasted
effort could have been avoided.

The Obstacles Today

Testing for HIV RNA is now being incorporated in most new
trials of antiretrovirals -- not to prove that the drugs
work, but to help in understanding their action. We agree
this is appropriate. What, then, is the issue?

The central issue is not about technology, but about
professional, commercial, and political will. The small,
exploratory trials of available drugs are not being done
today for the same reasons they have not been done in the
past. These reasons include lack of commercial incentive,
excessive influence of industry over professional and
governmental agendas, and pervasive neglect of treatment and
research by the leadership of AIDS organizations. This is why
the trials we need are not being done -- despite the new
technology which would make them faster, cheaper, and more
reliable then ever before.

Perhaps the basic problem in AIDS research is that the
interest we share in saving lives does not translate into the
institutional arrangements necessary for doing so.


***** New AIDS Treatment Information Service, 800/HIV-0440

by John S. James

The AIDS Treatment Information Service (ATIS), sponsored by a
group of several U.S. Public Health Service agencies, is
providing information about AIDS treatments, based on
guidelines published by the Federal government. This service,
which is free and confidential, is open Monday through Friday
from 9 a.m. to 7 p.m. Eastern time, and can be reached at
800/HIV-0440 (800/448-0440); you can also send questions by
fax [phone]) or by mail (ATIS, P.O. Box 6303,
Rockville, MD 20849-6303). ATIS can answer questions in
English or Spanish.

ATIS began operation on October 31. It joins a number of
other AIDS information sources provided by Federal agencies,
of which some of the most important are:

* The National AIDS Hotline -- 800/342-AIDS, 24 hours;
800/344-SIDA (Spanish speakers), 8 a.m. to 2 a.m. Eastern
time; 800/AIDS-TTY (TTY access for the deaf), 10 a.m. to 10
p.m. This hotline answers general questions about AIDS, and
can refer callers to service organizations in their area.

* The AIDS Clinical Trials Information Service (ACTIS) --
800/TRIALS-A (800/874-2572), Monday through Friday 9 a.m. to
7 p.m. Eastern time, which can provide information about
clinical trials in your area -- what drugs are being tested,
entry criteria, etc., and whom to call locally for further
information.

ATIS staff are working with these and other information
services to build a treatment information referral network,
which will be used to link callers to appropriate resources.

Surgeon General Joycelyn Elders, M.D., urged "community-based
organizations and AIDS service organizations all over
American (to) help get the word out about ATIS."

The sponsoring agencies are: Agency for Health Care Policy
and Research, Centers for Disease Control and Prevention,
Health Resources and Services Administration, Indian Health
Service, National Institutes of Health, and the Substance
Abuse and Mental Health Services Administration.

Comment

The organizers of ATIS asked this writer and others for input
and advice while designing this system. We believe that ATIS
can be important, but users need to understand its
limitations.

First, like any treatment information service, it can provide
information, but not treatment advice. The people answering
the phone are information specialists, not physicians; and
even physicians could not provide advice by phone without
examining the patient or getting a medical history.

A more serious limitation is that ATIS can only provide
Federally-published information; otherwise there would be
endless uncertainty about what could and what could not be
included. But Federal AIDS information is extensive --
including, for example, the treatment guidelines of the
Agency for Health Care Policy and Research (AHCPR), articles
in the MMWR SERIES (MORBIDITY AND MORTALITY WEEKLY REPORT,
published by the U.S. Centers for Disease Control and
Prevention), and U.S. National Institutes of Health consensus
statements. ATIS will also refer callers to non-Federal
agencies when appropriate, as the National AIDS Hotline
commonly does.


***** Human Growth Hormone -- Canadian Number Disconnected
      for U.S. Calls

In our last issue, AIDS TREATMENT NEWS published a phone
number in Canada for obtaining human growth hormone for HIV-
related wasting syndrome, a major cause of death for persons
with AIDS. As this issue went to press, we learned that this
number for physicians (800/935-8853, for the Serono Canada
Information Line for Human Growth Hormone in HIV-Associated
Wasting) has been disconnected for U.S. callers; it still
works for callers from Canada.

According to a leading treatment activist working on this
issue, U.S. access to the program was cut off after Serono's
lawyers received a letter from the FDA saying that the FDA
did not approve Serono to import human growth hormone for
compassionate use at this time.

Comment

These intended shipments of human growth hormone, to persons
in the U.S. for treatment of AIDS-related wasting, would
appear to be within the FDA policy allowing personal use of
drugs approved abroad. The potential for abuse by athletes is
a complication, but must not be allowed to prevent access for
essential medical use.

Two other companies (Genentech Inc., and Eli Lilly and
Company) already sell human growth hormone in the U.S., where
it has been approved and available for years to treat growth
hormone deficiency in children. While an approved drug can
normally be prescribed "off label" for other medical uses,
the distribution of growth hormone is tightly controlled by a
unique system set up by the companies and the FDA to prevent
abuse. So far, we do not know of anyone who has been able to
obtain growth hormone from U.S. sources for AIDS-related use.

Another way to provide the drug would be through a "treatment
IND" program, which Serono has applied to the FDA for
permission to start.

For several years there has been interest in human growth
hormone as a possible treatment for AIDS wasting syndrome.
But the first results from a large-scale trial, sponsored by
Serono Laboratories, were released only recently, in August
1994, at the International Conference on AIDS in Yokohama.
Clearly government and/or corporate attention is needed so
that U.S. citizens with this life-threatening condition can
receive the drug.


***** AIDS Patents Now Available Free through Internet

by John S. James

On October 26, the U.S. Department of Commerce announced that
the text of more than 1500 AIDS-related patents is now online
on the Internet. The patents can be searched by any word in
the text, or in other ways; and the full patent (or only
parts of it) can be printed out immediately.

AIDS TREATMENT NEWS tried out this database shortly after it
was available; we believe it will be valuable to researchers
seeking in-depth information about certain treatments. The
system is very easy to use, once one is set up to use the
Internet. First, we had no trouble finding the patent
database, without being told where it was located; we looked
under U.S. government, then under Department of Commerce,
then under the PTO (Patent and Trademark Office), then under
AIDS. Once we got there, using the database was self-
explanatory; instructions are available, but we did not need
them for simple searches.

As a test, we used the system to look for patents relevant to
"compound Q," long a controversial potential treatment for
HIV. The technical name for compound Q is trichosanthin, so
we searched for that. We found 10 patents, and looked at the
"front page" for each. This page has the patent number, the
date the application was filed and the date the patent was
issued, the inventors, the assignee (the company assigned the
rights), an abstract of the patent, and other brief
information. We also searched under "RIP" (ribosome-
inactivating protein, which is the class of agents to which
Compound Q belongs), and found 18 patents, including many of
the trichosanthin ones. We printed out one complete patent,
and saved another in our computer, so we could use a word
processor to locate all instances of certain words within the
text.

Computer and Internet Information

The patent database is available through World Wide Web, a
"hypertext" system for navigating the Internet. With World
Wide Web, you see a document, with certain words or phrases
underlined (or otherwise highlighted or noted). You simply
"click" on any highlighted word or phrase to get more
information on that topic. That information may be in a
different computer, even on a different continent; you as the
user do not need to know where it physically resides. This
makes World Wide Web so easy to use that even computer
novices can be effective in minutes -- provided that an
expert sets up the software for them.

The only drawback is that, for beginners, getting set up to
use the Internet can be difficult. We have heard there are
new products, such as "Internet in a Box," which make it much
easier to get started, but we have not seen these products
ourselves.

Some Internet services also allow use of World Wide Web with
an ordinary terminal program, without the graphical interface
provided by Web browsers like Mosaic or MacWeb. And those
without access to World Wide Web can use the patent database
through an electronic mail gateway; for more information,
send a message containing the single word HELP to
[e-mail].

In case the system you are using needs a URL (Universal
Resource Locator) to find the U.S. Patent and Trademark
database, you can use http://www.uspto.gov; From there it
should be straightforward to find the AIDS patent database.
(We did not publish the URL for the AIDS patent database
itself, since this may change soon when the database is moved
to a larger computer.)

Additional Information

Patents are useful for researchers seeking in-depth
information, but seldom for guiding treatment decisions. It
usually takes years before patents are granted; until then
the applications are confidential. This means that medical
practice will usually be far ahead of the patent. But the
patent will often have the most detailed technical
information available -- more detailed than articles in
technical journals -- because the patent system is set up to
force inventors to fully disclose their technology in order
to assert their claim of exclusive right to it. This makes
the Patent and Trademark Office a huge database of useful
information, open to the public; even while the patent is in
force and the technology is proprietary, others can use this
information (with or without the patent owner's permission)
to make other inventions, or for other purposes.

The information placed in the AIDS patent database this month
is not new; anyone could buy printed copies of the same
patents, and various systems for computer searching are
available, although usually they are expensive. The advantage
of the new system is that it makes AIDS-related patents
easily and immediately available, 24 hours a day, in a
computer-searchable form, to researchers throughout the
world. There is no charge for the service, nor any need to
get permission or make advance arrangements to use it.

This patent database software was designed for the U.S.
Patent and Trademark Office by CNIDR (Clearinghouse for
Networked Information Discovery and Retrieval), an
organization created by MCNC, of Research Triangle Park,
North Carolina. MCNC [formerly called Microelectronics Center
of North Carolina, but now known by its initials] is a
private, nonprofit corporation, established in 1992 with the
support of the National Science Foundation. AT&T is also
contributing to this project by providing computer services,
as the demand is expected to overload the computers at MCNC.


***** Drugs for Infants and Children: Call for Reform

Infants and children with life-threatening diseases face a
shocking lack of drugs tested for safety in children -- and
tested for the stability of the improvised formulations
doctors are often forced to use. At the same time,
unnecessary efficacy testing in children -- for example,
testing in children of biologically inappropriate ages --
delays treatment availability, and creates obstacles to the
testing which is necessary. Arthur J. Ammann, M.D., Research
Director of the Pediatric AIDS Foundation, and a member of
the National Task Force on AIDS Drug Development, analyzed
these problems in a presentation to the Task Force on October
28. He made 14 recommendations for improvement, directed
toward the approval of drugs for life-threatening conditions
simultaneously for both children and adults.

We cannot summarize the 10-page testimony of Dr. Ammann -- an
expert in drug development who was formerly a leading
researcher at Genentech, Inc. The bottom line is that this
problem is far more serious than generally realized -- and
far more correctable. The kinds of re-thinking proposed would
improve drug development generally, for adults as well as for
children.

For more information, contact Dr. Ammann at the Pediatric
AIDS Foundation, 81 Digital Drive, Novato, CA 94949, 415/883-
1796.


***** California: AIDS Drug Assistance Program, New Drugs
      Proposed; Title II Public Input Sought

by John S. James

California's AIDS Drug Assistance Program (ADAP) pays for
certain drugs required by AIDS/HIV patients, for those with
annual gross income under $50,000. For those with under 400
percent of the Federal poverty level, the drugs are provided
free; for those with incomes over that amount, but under
$50,000, a copayment may be required.

To qualify, you must also have a prescription signed by a
physician licensed in California, and not have the drugs
covered by your health insurance program. (If your health
insurance requires a copayment which creates a financial
hardship, the program may help with the copayment.)

For more information about qualifying for the program,
California residents can contact their county's health
department. Also, a brochure published by California lists
the following hotline numbers: Northern California, 800/367-
2432; Southern California, 800-922-2437; Spanish hotline
(Southern California only), 800/400-7432. However, the people
who answer the phone are sometimes not informed about the
program.

The drugs currently covered are: acyclovir, amphotericin B,
atovaquone, azithromycin, AZT, clarithromycin, clindamycin,
clofazimine, clotrimazole, dapsone, ddC, ddI, ethambutol,
fluconazole, flucytosine, foscarnet, ganciclovir,
ketoconazole, nystatin, paromomycin, pentamidine (aerosol),
pentamidine (intravenous), pyrimethamine, rifabutin,
sulfadiazine, and trimethoprim-sulfamethoxazole.

In addition, the physician advisors to the program have
recommended adding the following drugs: d4T, trimethoprim,
all chemotherapies, megace, itraconazole, G-CSF (Neupogen),
EPO Procrit), alpha interferon, marinol, trimetrexate. Their
highest priority recommendation is d4T. Whether these drugs
are added will depend on their estimated cost to the program,
and whether the money is available.

This year there has been an unexpected decrease in ADAP
expenditures, due to a fall-off in demand for AZT. Exact
figures are not available, apparently due to lack of
statistical staff at the California State Office of AIDS. If
the figures are not provided by December 6 and 7, $1,000,000
held in reserve for ADAP is likely to be transferred to home
and community-based care for persons with AIDS or HIV. [As of
today, the preliminary recommendations for the different
programs are: $15,158,881 for health care and support
services administered through local HIV CARE consortia -- the
50 percent, required by law; $7,449,105 for ADAP; $1,500,000
for CARE/Health Insurance Premium Payment Program; $2,178,000
for Home and Community-Based Care to expand statewide;
$1,515,888 for planning and evaluation, $1,515,888 for
administration, and $1,000,000 in reserve for ADAP.]

These programs are Federally funded by Title II of the Ryan
White Comprehensive AIDS Resources Emergency (CARE) Act of
1990. (Title II pays for state AIDS programs; Title I funds
heavily-impacted cities.) This act authorized funding for
five years, and will expire after 1995 unless it is
reauthorized by Congress. Reauthorization of Ryan White is
perhaps the highest Federal priority of AIDS service
organizations today. [Note: AUTHORIZATION does not by itself
make the money available. Congress must also APPROPRIATE the
funding each year, in competition with other priorities; in
fact, the Ryan White Care Act has never been fully funded (up
to its authorized level). Without reauthorization of Ryan
White, Congress could still authorize and appropriate money
annually for the same purpose, but there would be an
additional fight for AIDS funding every year, and probably
less money would be available.]

Title II Funding Distribution -- Public Comments Sought by
November 15, and on December 6 and 7

Recommendations for distributing Title II money will be
finalized by the HIV Comprehensive Care Working Group, at its
meeting at the Waterfront Hilton Beach Resort, 21100 Pacific
Coast Highway, Huntington Beach, California, on December 6
and 7. A public comment period is scheduled for 9 a.m. on
December 6.

In addition, public comment will be taken on November 15,
from 4 to 6:30 p.m., at hearings in six cities: Fresno, Long
Beach, Oakland, Redding, San Diego, and Ukiah -- or can be
mailed to the CARE Section of the Office of AIDS until
November ll. These comments, unfortunately, will not be
transcribed until after the decisions have been made; instead
they may be summarized for the working group. Public comment
may be more influential at the meeting of the Working Group
itself.

The major decision on the table is how to allocate the money
among three programs: ADAP, AIDS Case Management Program
(CMP), also referred to as Home and Community-Based Care
(HCBC), and CARE/Health Insurance Premium Payment Program
(CARE/HIPP). All of these programs serve people with AIDS or
HIV, and all three are important. The Working Group needs to
hear from those with personal experience with these programs.

For more information about how to have input into the Title
II process, including ADAP funding, contact David Lewis,
Project Inform, 415/558-8669, ext. 225; he is in the office
on Monday, Wednesday, and Friday. Or contact the California
Office of AIDS, 916/327-6804, and ask for time and place of
the Title II hearings on November 15, in one of the six
cities listed above.

Note: Project Inform, ACT UP, and other activists have spent
hundreds of hours improving the California AIDS Drug
Assistance Program. They secured funding increases, and
demanded the establishment of a medical advisory panel,
making possible the addition of 13 of the drugs listed above,
as of April 1994. They also decentralized the program, in San
Francisco at least, and insisted that its existence be
advertised to potential clients.


***** Title II National Organization Formed

by John S. James

A national organization of Title II recipient agencies and
others concerned is now being formed. Every state and
territory has Title II Federal funding, which supports
thousands of community-based agencies and AIDS programs. (The
process of distributing Title II funds is different in every
state; California is not typical.) Nationwide, grassroots,
organizing around Title II issues is now imperative.

For more information, contact the Title II National AIDS
Coalition (T. II N.A.C.), P.O. Box 1387, Kingston, NY 12401,
phone [phone], fax [phone]. The organizers want to
hear from anyone who (1) will consider joining later when
forms and letters are ready, or (2) can pitch in during the
next two to three months in the organizing process. A
national organizing conference has been set for Washington
D.C., February 10-13, with Congressional lobbying on the
13th.


***** Global AIDS Summit, Paris, December 1

Leaders of about 40 nations will gather in Paris on World
AIDS Day, December 1, for the first-ever international summit
meeting on AIDS. According to the organizers -- the French
government, and the World Health Organization -- this is the
first time in world history that heads of government will be
considering a health problem.

The meeting will seek:

* Funding for international research programs to develop
vaccines and better treatment;

* Agreements to reduce discrimination against people with
AIDS, including travel bans like those of the United States
and many Arab countries;

* Access to health care -- including prevention, education,
and treatment for vulnerable population groups;

* "A more effective global response to the AIDS pandemic
based upon the basic principles of respect for individual
rights and moral ethics."

The preparatory meetings have found that developing countries
are interested, but the developed countries, who would have
to supply much of the funding, are often reluctant.

U.S. Press Coverage -- No News

AIDS TREATMENT NEWS did computer searches of the full text of
all stories in several dozen leading U.S. newspapers, and
found only six that even mentioned the Paris summit once.
None mentioned it more than once. Only Reuters, the
international news service, cover the summit effectively.

Of the five U.S. newspapers that mentioned the summit, two
devoted two short paragraphs each. One had two sentences; the
other two, one sentence each. This may be the total U.S.
press coverage so far.

What is more alarming are reports of responsible U.S.
officials, and leading AIDS experts in private organizations,
not even knowing about preparatory meetings, after the
preparations were well under way.

The U.S. delegation to the Paris summit will be headed by
Health and Human Services Secretary Donna E. Shalala; it had
been hoped that at least Vice President Gore would attend
this summit, planned as a meeting of heads of state. Also, it
appears that Japan is willing to make a serious financial
commitment to stopping the global epidemic, but the U.S. is
offering little new money.

The commitment of many countries will be influenced by what
the U.S. does. A commitment comparable to that at the recent
Cairo meeting (the United Nations International Conference on
Population and Development, where the U.S. delegation was led
by Vice President Gore), would support the French effort to
build momentum for an effective international AIDS response.

Note that the Cairo conference attracted enormous U.S.
government and media attention, even though population is not
seen as a bread-and-butter issue that directly affects most
people in the U.S. AIDS affects individuals much more
severely, yet a comparable international meeting on AIDS has
received almost no attention. Perhaps we can study this
example to learn how to better mobilize interest, attention,
and support in the future.


***** AIDS TREATMENT NEWS
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AIDS TREATMENT NEWS reports on experimental and
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Treatment News does not recommend particular
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ISSN # 1052-4207

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