Subject: AIDS TREATMENT NEWS #210
From: "John S. James" <[email-masked]>
Date: 05 Nov 94 23:02 PST

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 (301/738-6616) 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 
[email-masked].

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 914/331-7909, fax 914/331-3538. 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 

Copyright 1994 by John S. James.  Permission granted for 
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