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AIDS TREATMENT NEWS Issue #206, September 2, 1994
   phone 800/TREAT-1-2, or 415/255-0588

CONTENTS:

AIDS Pathogenesis -- New Understanding

Why AIDS Drug Development Has Failed

Accelerated Approval: Statement to FDA

Announcements

   HIV Infection in Women Conference, February 22-24, 1995

   Paris Global Summit on AIDS -- Action Alert, More U.S. 
   Effort Needed

   Yokohama Overview: List of Topics Available

   San Francisco: Personal Survival Strategies, September 28

   Cryptosporidiosis: Los Angeles Trial of Garlic Extract

   SEARCH Alliance Seeks Medical Director

   AIDS Medicine & Miracles -- Boulder, Colorado, September 
   29 - October 2

California AIDS Legislation -- Action Alerts


***** AIDS Pathogenesis -- New Understanding

by John S. James

While there was new information at the Tenth International 
Conference on AIDS, August 7-12 in Yokohama, that meeting 
mainly served to summarize the current state of scientific 
knowledge about many aspects of HIV disease -- areas of 
evolving consensus, and also continuing disagreement among 
experts. In pathogenesis -- the study of the mechanisms by 
which disease develops -- there are still vast unknowns, gaps 
in knowledge filled only by guesses. For example, it is known 
that relatively few T-helper cells are killed directly by HIV 
-- and no one knows what is causing the disappearance of most 
of the cells, although there are several theories.

Despite the unknowns, there is more clarity today about HIV 
pathogenesis than is commonly realized. The developing 
knowledge will be useful for understanding the limitations of 
current treatments, and the requirements for better ones. 
This article looks at part of the evolving picture of HIV 
disease, focusing on aspects highlighted at the conference.

** Latent Infection Surprisingly Large

In a major plenary address, Dr. Ashley T. Haase of the 
University of Minnesota reported finding an "extraordinarily 
large" number of cells in lymph nodes and some other tissues 
infected by HIV early in the disease process. For example, 25 
percent or more of CD4 cells in the lymph nodes were found to 
be infected; but only about one percent of those were 
actively producing virus at any one time. The others were 
latently infected; HIV had entered the cell and become part 
of its genetic inheritance, but because the cell was not 
activated, the HIV was not reproducing or creating abnormal 
proteins. These latently infected cells are undetectable by 
the immune system, since the HIV genetic information remains 
quietly inside the nucleus of the cell and does not affect 
the cell surface; for the same reason, this latent infection 
is undetectable by most laboratory methods. Dr. Haase's team 
used a special technique called in situ PCR; this causes PCR 
(polymerase chain reaction, which detects a particular DNA 
sequence by causing it to successively duplicate itself) to 
occur within each cell, allowing latently infected cells to 
be distinguished from uninfected ones in the laboratory.

This latent infection, a "Trojan horse," may not cause damage 
while it remains latent; but at any time some of the cells 
will become activated. Then more virus is produced, spreading 
the infection and/or killing the cell. The latently infected 
cells form a reservoir of virus which is not affected by the 
immune system, or by AZT or similar drugs; this reservoir 
enables the virus to persist, and may also be involved in 
transmission of HIV from person to person.

This view of HIV infection was not new at Yokohama, but grew 
out of several years of work at the Department of 
Microbiology of the University of Minnesota Medical School in 
Minneapolis; a major paper was published in 1993. (1)

[Comment: This information does suggest approaches to 
treatment, even though there are no known drugs which can 
selectively attack the latently infected cells, or the HIV 
genetic material within them. AZT, etc., and also the 
protease inhibitors, or other drugs which target various 
enzymes in the HIV life cycle, can help to prevent the 
infection from spreading into new cells; protease inhibitors 
might be better than AZT-type drugs for doing this, because 
they cause the newly-produced virus to be defective and non-
infectious, while AZT, etc., only help block infection of new 
cells after it is already underway.

These antivirals can be combined with other treatment 
approaches which may reduce the amount of activation. 
Aggressive diagnosis and treatment of opportunistic or other 
infections can help, since infections increase the activation 
of immune cells.

Activation could also be reduced by various kinds of drugs. 
One example is immune suppressive therapies, which can be 
dangerous, but might be used in some cases, for example in 
early treatment, before serious immune deficiency has 
developed; or treatments might be used to reduce particular 
immune responses which are overactive. Various drugs are 
being tried to reduce abnormally high levels of TNF (tumor 
necrosis factor), which increase activation of HIV. Still 
another approach is to screen for drugs which inhibit the LTR 
(long terminal repeat) of HIV; it is now believed that 
certain CD8 cells inhibit HIV quite effectively by producing 
a substance (so far unidentified) which inhibits the LTR. 
Drugs to reduce activation are not likely to provide the 
whole answer, since some activation of immune-system cells is 
necessary for normal functioning; but reducing activation can 
be one of a number of approaches toward helping the immune 
system maintain or re-establish control of the HIV 
infection.]

** Major Lymph-Node Study Examines AZT, ddI Effects

DATRI-003 (run by the Division of AIDS Treatment Research 
Initiative, of the U.S. National Institute of Allergy and 
Infectious Diseases), is the largest study to date using 
lymph-node biopsies; 32 patients had two biopsies, eight 
weeks apart, and some of them started or changed treatment 
after the first biopsy. This study is important because HIV 
infection is especially active in lymph nodes. But some of 
the preliminary results are confusing or hard to interpret; 
we will know more when a full report is available.

All 32 patients had T-helper counts above 250, often much 
higher. They were divided into four groups. In group 1, 
patients had not had any antiretroviral therapy, and AZT was 
started. In group 2, there was no prior therapy, and none was 
started. In group 3, patients were already on AZT, and it was 
continued. In group 4, they were already on AZT, and ddI was 
added.

There was essentially no change in the percentage of infected 
cells in the lymph nodes of the different groups. (This 
result would be expected, as there is no reason to think that 
AZT or ddI could eradicate infection in cells where it was 
already established.)

Viral replication did decrease in the six patients who added 
ddI to their treatment (group 4); this was seen by measuring 
HIV RNA in both the lymph nodes and in the blood, although 
the decrease in the lymph nodes, which was seen in four of 
the six, was not statistically significant. Surprisingly, 
however, no effect was seen on viral replication in the lymph 
nodes in the group which started AZT -- although their T-
helper count did rise.

One possible explanation of this difference is that those who 
started AZT began with a high T-helper count (mean 654), 
while those who added ddI begin with a mean of 394; the 
authors suggested that the antiviral effect of these drugs 
may be less in early disease. However, we would like to see 
the full report (which is currently being prepared for 
publication), since viral levels can be hard to measure in 
early HIV infection, even with the new tests. Is it clear 
that AZT did not reduce viral replication, or could a 
reduction have been missed because there is less to measure 
at that early disease stage, and there were only a few 
patients in this study arm? It would be a surprise if AZT 
does not affect viral replication in the lymph nodes in early 
HIV disease; therefore, we want to see more information 
before reaching that conclusion.

There has also been some confusion about this study due to 
the current lack of standardization of terminology. In the 
Yokohama conference abstract, the authors used the term "HIV 
burden" to mean the proportion of infected cells. The authors 
plan to avoid this terminology in the future, because "viral 
burden" is sometimes used to mean the number of copies of 
viral RNA in blood plasma; "viral load", "viral activity," 
"viral reproduction" have also been used, more or less 
interchangeably, for the latter meaning. No one knows how 
this usage will standardize in the future; our guess is that 
"proportion of infected cells" will refer to the former 
meaning, while either "viral activity" (or perhaps "viral 
load" or "viral burden") will be used for the latter. The two 
meanings are quite different, since the proportion of 
infected cells apparently becomes established early in HIV 
disease and then tends changes only slowly, while the number 
of copies of viral RNA in blood plasma can change greatly 
within days, due to changes in drug treatment or for other 
reasons. Because of this rapid response, and because the 
proportion of infected cells is difficult to determine, while 
tests to measure plasma HIV RNA have now become routinely 
available (see AIDS Treatment News #204, August 5, 1994), and 
because HIV RNA level indicates the number of viral particles 
and correlates with the ability to grow the virus in culture, 
the plasma RNA level is becoming the measurement of interest 
for testing new drugs, and for individualizing therapy with 
existing drugs.

[Note: There was much more information on pathogenesis at the 
Yokohama conference. We will continue our coverage in future 
articles.]

References

1. Embretson J, Zupancic M, Ribas JL, Burke A, Racz P, 
Tenner-Racz K, and Haase AT. Massive covert infection of 
helper T lymphocytes and macrophages by HIV during the 
incubation period of AIDS. Nature. March 25, 1993; volume 
362, number 6418, pages 359-362; comment on pages 292-293.

2. Cohen OJ, Pantaleo G, Graziosi C, Niu M, and Fauci AS. 
Effect of antiretroviral therapy on HIV burden and 
replication in lymphoid tissue. Tenth International 
Conference on AIDS, Yokohama, August 7-12, 1994 [abstract 
#001B).


***** Why AIDS Drug Development Has Failed

by John S. James

[Note: The following is from our statement to the San 
Francisco AIDS Foundation public policy forum on research 
issues, 8/23/94.]

The Problem

The recent Yokohama conference was badly reported in the 
press. Behind the gloom and doom on AIDS treatments, much 
valuable science was overlooked. AIDS Research is improving, 
and good work is finally being done; but drug development, a 
very different process by different people, is still a 
disaster. Why?

If you ask scientists, most will say that the lack of 
treatment progress results from the biological difficulty of 
the problem, of controlling the HIV virus. This is true -- 
but not the whole story. The lack of progress also results 
from systematic human mistakes. Yes, if the biology of 
stopping HIV were easy, even the crippled effort we have 
today would have already been successful. A hard problem 
means that we have to do better to succeed.

But there are political reasons why it has been difficult or 
impossible to successfully raise the alarm. And the same 
political obstacles are stopping progress today.

Medical Research Progress -- Where It Comes From

Almost all medical advance in the past, and still today, 
comes not from rational calculation or design, but from the 
unexpected, the unpredictable, the unknown. And the unknown 
first comes into view without a major corporate, 
professional, or political constituency behind it. But today, 
the process of mainstream drug development creates such high 
barriers and obstacles -- regulatory, financial, legal, and 
other -- that only the largest companies, with a major 
corporate commitment, can progress over them.

This means that the new ideas and information that come to 
doctors, scientists, and others through accident and chance 
observation -- the very ideas and information that feed 
medical progress -- usually cannot go anywhere. No matter 
what their intrinsic merit, they cannot move at all to build 
the credibility required to crank up the very expensive 
processes required today before the first human test. There 
is no path which leads over the barriers. So they are stuck 
forever.

Hundreds of entirely reputable ideas wait like this, frozen 
on display in peer-reviewed journals, or out of public sight 
in a scientist's or doctor's mind or in unpublished work. 
Eventually, a tiny handful may be picked up by a well-
financed corporate development project. But because of the 
great role of the unexpected in medical research, there is no 
reason to think that these lucky few are the cream of the 
crop. Instead, they are essentially selected at random, based 
more on patents, contracts, deals, and personalities than on 
perceived merit (however unreliable even the latter is).

As a result, the world has appallingly few shots at a 
significant treatment improvement. What is needed is a 
rational development path for the hundreds of other good 
ideas and proposals, so that they can begin the process of 
establishing their credibility, if they merit it. Many 
different possibilities would then have a chance at 
development. Eventually, the best of them could move into 
formal clinical trials.

AIDS Politics: The Unholy Alliance

It's no accident that this reform was not accomplished long 
ago.

Start with a big picture, beyond AIDS, beyond medicine. In 
any public-policy arena where regulation is involved, there 
is usually an ongoing battle between two superpowers, big 
business and consumer protection. And public policy is 
determined by where the battle line between them ends up. 
This battle is the normal and usual process by which we as a 
society balance different risks and different benefits 
against each other.

In drug development, for AIDS or for other diseases, this 
battle proceeds, as elsewhere. But unfortunately, there is 
one key place in drug development where the battle does not 
work as it should, and instead produces pathological results. 
And this key place is the unexpected, the creative, the 
chance observations, the new ideas -- which proceed from the 
unknown, and form the river which feeds most of the potential 
for advances in treatment development, as discussed above.

In this one key area (which is unimportant for the present, 
but centrally important for the future) big business and 
consumer protection are not in conflict, but instead work 
together -- an unholy alliance against new ideas. For very 
different reasons, both of these superpowers want the 
barriers and obstacles, which any forward movement must 
cross, to be set as high as possible. Consumer protectionists 
want high barriers to protect the public against dangerous 
products and unscrupulous companies; big business wants high 
barriers to protect itself against competition by small 
business. Big business can pay almost any price; and later, 
with a monopoly of an essential drug, raise prices as high as 
necessary to get the money back and more.

Whether a potential advance is a major corporate development 
project with tens of millions of dollars behind it, or an 
accidental observation with no constituency yet, doesn't 
matter -- both are treated equally. But the multimillion 
dollar corporate effort can (with sufficient merit) overcome 
the barriers and prevail, while the new idea which has had no 
chance yet to build a constituency or financial support is 
stopped cold, usually forever.

This problem has not been solved because both consumer 
protection and big business have such a pervasive influence 
throughout the AIDS research and service communities. Almost 
everybody who is professionally involved worships at one or 
both of these altars. Big business funds thousands of 
projects by scientists, doctors, and service organizations -- 
as it should (and small business, incidentally, funds almost 
nothing in comparison). Meanwhile, consumer protectionists 
dominate policy almost everywhere in AIDS, from our friends 
in Congress, to the FDA of course, to AIDS Action Council and 
the large service organizations -- which, despite ongoing 
pressure from their major donors, have usually refused to 
become seriously involved with treatment development. To do 
so could jeopardize important relationships that they must 
maintain in order to accomplish their service missions.

The end result is that treatment progress is seldom allowed 
to happen outside of big-business control. And big business 
had no interest in AIDS until AZT made money, and is losing 
interest now as ddI, ddC, and d4T are unlikely to ever repay 
their development costs. The result? Near-guaranteed 
stagnation, which is what we have today, and have had since 
the beginning of the epidemic. This is why there has been so 
little progress in finding better treatments for HIV, and why 
so little relief is in sight.

HIV RNA: New Viral Tests and Their Importance

New viral blood tests, much more accurate than the ones used 
before, have recently become available to physicians. These 
may provide a partial escape from the bleak drug-development 
and political landscapes above. [For background on these 
tests, see "HIV RNA: New Blood Test for Individualized 
Therapy and Faster Trials," AIDS Treatment News #204, August 
5, 1994.]

These tests are important because they can indicate quickly 
(within a month, and possibly within days) whether a 
particular antiviral treatment is working for a particular 
patient. It doesn't matter if the treatment is mainstream, 
such as ddI, or "alternative," such as Chinese herbs; if the 
virus in the blood is reduced, the tests will show that.

This means that certain new treatments -- those in actual use 
by people with HIV, or which can be prescribed by physicians 
or otherwise obtained -- now will have a path to begin to 
build credibility. Probably the great majority of 
"alternative" treatments will be found not to work, and be 
largely discarded. But if one patient benefits dramatically 
from a treatment (as seen by reduction of virus in the 
blood), and then a second, third, and fourth also show a 
dramatic reduction, then there will probably be enough 
interest to get that treatment into a formal trial, either 
through a community-based research organization, or by 
finding a corporate sponsor. The potential new treatment will 
then be on a development path, instead of left waiting 
forever.

This almost never happened before the new tests were 
available, since it has been necessary to crank up an 
expensive and cumbersome trial before there was any credible 
data suggesting measurable benefit in people. Now, the 
credible data can start with one person's decision to use an 
unproven treatment, not for research but for their own 
medical care. If the early data is negative -- the usual case 
-- the patient can drop the treatment quickly, and perhaps 
try another. And if the data is promising enough, formal 
research can follow.


***** Accelerated Approval: Statement to FDA

by John S. James

[The U.S. Food and Drug Administration has requested public 
comment for the September 12-13 meeting of its Antiviral 
Advisory Committee, which will examine accelerated approval 
-- the regulations now in effect which allow critically 
needed drugs to be approved based on blood tests which show 
virological or immunological improvement, with further 
research to be done later. (The alternative to accelerated 
approval is to require statistical proof that the new drug 
improves survival or reduces serious illness before it is 
approved, and such studies commonly involve thousands of 
people and take several years to complete.) Drug-approval 
policy requires a weighing of risks and benefits, and the FDA 
has heard proposals that it retreat from its accelerated-
approval system to make sure that companies get better data 
before drugs are approved.

[The meeting will be at the Holiday Inn Plaza Ballroom, 8777 
Georgia Ave., Silver Spring, Maryland, starting at 8:30 a.m. 
on September 12 and September 13; all parts of this meeting 
are open to the public, and there might be times to make a 
brief statement to the Committee even without prior 
arrangement. Also, written statements can be submitted after 
the meeting. Address them to Antiviral Advisory Committee, 
c/o Lee Zwanziger, Ph.D., Advisors and Consultants Staff 
(HFD-9), Parklawn Building, Room 8B45, 5600 Fishers Lane, 
Rockville, MD 20857; or fax them to 301/443-0699. For more 
information, call Dr. Zwanziger at 301/443-5455.]

The following is an outline of our talk to the Committee:

* While everybody agrees that better data is needed, what 
AIDS Treatment News is hearing from people with HIV disease 
is the strong, widespread feeling that access remains most 
important to them, and must not be sacrificed. This is true 
whether or not people are highly educated about treatments. 
When conventional treatments are failing, no special 
education is needed to know that other possibilities have 
shown promise, and to want to try them.

* Parallel track and other pre-approval access programs 
cannot replace accelerated approval, as companies are 
increasingly refusing or unable to pay for them.

* The concerns around accelerated approval of ddC and other 
AIDS drugs reflect the inadequacy of the drugs, not 
fundamental flaws in the approval process.

* Within the research and medical communities, there is a 
rapidly growing consensus that plasma RNA is a much better 
indicator of antiviral effect than the measurements we have 
had in the past. This new marker will almost certainly 
improve future decisions about antivirals. Accelerated-
approval decisions will not be based on any one marker, 
however, but will reflect a judgment involving all 
information available. We should avoid premature decisions or 
doctrines which would limit flexibility and prevent timely 
and effective use of new technologies as professional 
consensus develops.

For example, it may be tempting to impose the doctrine that 
whenever accelerated approval is given, it must be in the 
context of a development plan that will eventually use 
clinical endpoints to prove or disprove the drug's 
superiority to standard treatment. In some cases, this 
approach may make sense; in other cases, different ways of 
organizing post-marketing studies may be more effective in 
obtaining the information physicians need to optimize use of 
the drug. And the human costs of clinical-endpoint trials 
(which tend to keep people on protocols that don't work for 
them so that body counts can be obtained) are often 
underestimated. These costs are highest for marginal drugs, 
where the resulting information is of least value.

* A major problem in drug development is that most credible 
treatment possibilities do not even begin clinical research, 
because the cost barriers to eventual approval are too high. 
This is especially tragic in view of the historical 
experience that important medical advances are seldom 
predictable -- meaning that the few drugs which do get big-
corporate backing are not the cream of the crop, but closer 
to a random selection. Critical treatment advances may be 
quietly lost, if they do not look good ahead of time and 
therefore never get the chance to begin developing 
credibility. Accelerated approval can reduce cost barriers by 
deferring major expenses until after there is an income 
stream, encouraging early testing by making the ultimate 
development path more feasible.

* In addition, the movement toward individualized therapy 
will make accelerated approval more important than it has 
been in the past, as physicians and patients rely less on 
averages and more on viral and other measurements for rapid 
indications of which treatments are working for which people.


***** Announcements:


** HIV Infection in Women Conference, February 22-24, 1995

The first national scientific meeting on HIV infection in 
adult and adolescent women will take place February 22-24, at 
the Sheraton Washington Hotel in Washington, D.C. This 
conference is sponsored by the National Institutes of Health, 
the Centers for Disease Control, the Food and Drug 
Administration, the Public Health Service Office on Women's 
Health, and other Federal agencies. Due to delays in getting 
final approval, the conference was not announced publicly 
until recently.

To receive the Announcement and Call for Abstracts, or for 
exhibitor information, contact: HIV Infection in Women 
Conference, Conference Secretariat, Suite 300, 655 15th St. 
NW, Washington, DC 20005, phone 202/639-4111, fax 202/347-
6109.


** Paris Global Summit on AIDS, December 1 -- Action Alert, 
   More U.S. Effort Needed

The French government has invited heads of state of 42 
countries to attend a Global Summit on AIDS, in Paris on 
December 1. Five working groups (on safety of the blood 
supply, vaccine and treatment research, care and social 
support, prevention of transmission, and protecting 
vulnerable populations) will hold preliminary meetings in 
September and October.

Mervyn Silverman, M.D., president of the American Foundation 
for AIDS Research (AmFAR), has said that "several results are 
clearly attainable, especially in guaranteeing the safety of 
the world's blood supply and significantly improving the 
effectiveness of prevention and care efforts in the 
developing world."

The U.S. has said that it will send Health and Human Services 
Secretary Donna E. Shalala (instead of President Clinton); 
meanwhile, U.S. officials have shown little interest in the 
preparatory meetings. It is urgent that President Clinton and 
other officials hear from citizens that the Paris AIDS Summit 
demands their attention.

A background article by AIDS activist Eric Sawyer will be 
published in Spanish in SIDAhora, a newsletter of the PWA 
Coalition in New York; we could not confirm English 
publication by press time. For more information about the 
Summit, contact the Global AIDS Action Network (GAAN), 
415/488-1453, or by fax at 415/488-1942.


** Yokohama Overview: List of Topics Available

A short overview listing important topics covered at the 
Tenth International Conference on AIDS is available from 
Project Inform. Call the hotline, 800/822-7422 (or 415/558-
9051 from San Francisco), and ask for a copy of the overheads 
from the August 31 Project Inform Town Meeting on the 
Yokohama conference. There are 27 overheads, reduced to fit 
onto three sheets of paper. (Hotline hours are Monday through 
Saturday 10 a.m. to 4 p.m. Pacific time.)

Note: These overheads were used as the basis for a two and a 
half hour Yokohama update, by the four Project Inform 
speakers who attended the conference. The overheads are not 
always self explanatory, but do provide a list of the major 
topics addressed in Yokohama.


** San Francisco: Personal Survival Strategies, September 28

"Living with HIV: Personal Strategies for Long-Term Survival" 
will be addressed by a panel of speakers on Wednesday, 
September 28, 7:30 p.m. at the Metropolitan Community Church, 
150 Eureka St. (between 18th and 19th streets) in San 
Francisco. Admission is free, donation requested.

The speakers are Will Carter, Sandy Davis, Jeff Getty, Darcy 
Ike, Joel Thomas, and Hank Wilson.

For more information, call the Project Inform hotline, 
415/558-9051.


** Cryptosporidiosis: Los Angeles Trial of Garlic Extract

SEARCH Alliance, a community-based research organization in 
Los Angeles, is conducting a small, uncontrolled trial of 
allicin, an oil derived from garlic, as a treatment for 
cryptosporidiosis. The trial will enroll 25 patients and last 
for three weeks, with five outpatient visits. Five patients 
have already been enrolled.

According to the concept sheet from SEARCH Alliance, "the 
primary objectives are to determine the safety of oral and 
rectal administration of allicin, while monitoring the change 
in symptomatology and character of stool specimens in 
individuals with cryptosporidiosis." Allicin has shown 
activity against many disease-causing organisms; this 
exploratory trial was organized after anecdotal reports of 
good results in two patients.

Entry criteria include symptomatic diarrhea, a positive stool 
smear for cryptosporidia, and negative stool cultures for 
salmonella, shigella, campylobacter, giardia, and ameba.

For more information, contact Mark Lazarin or Charles 
Chesson, Ph.D., 213/930-8820.


** SEARCH Alliance Seeks Medical Director

SEARCH Alliance in Los Angeles, a non-profit community-based 
research organization which has the independence to pursue 
early testing of new treatment ideas, is seeking a Director 
of Clinical Research to replace its current Medical Director, 
Natalie Sanders, M.D. Candidates must have a current M.D. 
license, a strong background in HIV/AIDS, experience in 
clinical protocol development and trials research, and 
supervisory ability.

Fax or mail a cover letter with salary history to: SEARCH 
Alliance, 7461 Beverly Blvd., #304, Los Angeles, CA 90036, 
fax 213/934-3919.


** AIDS Medicine & Miracles -- Seventh Annual Conference, 
   Boulder, Colorado, September 29 - October 2

AIDS Medicine & Miracles, a conference which "focuses on 
creating a supportive, healing, retreat environment for PWAs, 
their loved ones and caregivers," will meet September 29 - 
October 2 at the Clarion Harvest House Hotel in Boulder, 
Colorado. Speakers include Joan Borysenko, Ph.D., Martin 
Delaney, Lark Lands, Ph.D., and Torkin Wakefield.

For more information, call 800/875-8770, or 303/447-8777. Or 
write to AIDS, Medicine and Miracles, P.O. Box 9130, Maxwell 
Building, Boulder, CO 80301-9130.


***** California AIDS Legislation -- Action Alerts


** Medical Marijuana Legislation to California Governor; 
   Federal Issues

Both houses of the California legislature have passed a bill 
to allow physicians to prescribe marijuana for medical 
purposes. Governor Wilson has until September 18 to decide 
whether or not to veto the legislation.

Letters to support this bill, S.B. 1364, Providing for the 
Medical Use of Marijuana, should be addressed to: Governor 
Pete Wilson, State Capitol, Sacramento, CA 95814. Also send a 
copy to the office of the sponsor, State Senator Milton 
Marks, 711 Van Ness St., Suite 310, San Francisco, CA 94102. 
Senator Marks is especially interested in hearing from 
persons who are suffering from effects of AIDS, cancer 
chemotherapy, glaucoma, or other serious conditions which 
marijuana might help.

This legislation, which would change marijuana from a 
"Schedule I" drug (no medical use) to "Schedule II" (drugs 
like morphine, considered to have serious abuse potential but 
with legitimate medical use) will not by itself allow 
physicians to prescribe marijuana, because it will still be 
Schedule I under Federal law. But it will send the strongest 
message to the Federal government to change its policy to 
allow medical use.

The bill has been endorsed by the California Medical 
Association, the California Nurses Association, the 
California Senior Legislature, and others.

Comment

Medical access to marijuana, which many patients with serious 
illness have said is the only effective relief for their 
condition, is supported by huge majorities throughout the 
country. But it is often hard to get politicians to respond. 
Both President Bush and President Clinton have been 
particularly intransigent; Bush ended a Federal 
compassionate-access program which had previously been in 
place, and Clinton decided to continue the ban, saying that 
more research is needed.

The "more research" argument is a smokescreen; anyone who 
knows patients knows that marijuana works best for some, 
while Marinol (a legal oral drug which contains the main 
active ingredient of marijuana), works better for others. 
Optimum medical care requires that both be available; proof 
that one or the other works better "on the average" would not 
be very useful. And when a desired drug effect is inherently 
subjective, such as pain relief or appetite stimulation, both 
scientific sense and simple humanity suggest trusting the 
patient's choice of what works for him or her.

The real reason for Clinton's opposition is that the 
marijuana issue was used against him in the presidential 
campaign (when he admitted having smoked marijuana but said 
he didn't inhale), and he wants to focus attention elsewhere. 
Meanwhile, according to a recent article in the Atlantic 
Monthly, there may be more people in prison now for marijuana 
violations than ever before; and people who use the drug for 
medical purposes can go to prison, in part because seizure 
laws allow money, cars, and other assets to be taken and used 
by law-enforcement agencies. Thousands of letters asking 
Federal officials for medical access to marijuana sit in 
boxes, while government refuses to respond.

It may be necessary to develop tactics to continually 
embarrass the Clinton administration and other government 
bodies over the ban on medical marijuana. Politicians often 
refuse to do the right thing until other actions turn out to 
cost them more.


** Domestic Partner Legislation on Governor's Desk, Needs 
   Support

Limited domestic partner legislation has passed both houses 
of the California legislature, and is awaiting action by 
Governor Wilson. He has until late September to decide 
whether or not to veto the bill.

This bill, AB 2810, is the first domestic partnership 
legislation passed by any state legislature in the U.S. 
According to the LIFE AIDS Lobby (a gay and AIDS lobby in 
Sacramento), "The bill, by Assemblyman Richard Katz (D-Los 
Angeles), will enable all committed couples in California to 
register as 'domestic partners' and assume certain 
responsibilities and limited benefits. To qualify, couples 
must maintain a common residence, share basic living 
expenses, and meet other simple requirements. Under the bill, 
domestic partners will be recognized for family visitation 
rights at healthcare facilities, legal preference to 
administer each other's affairs should one partner become 
incapacitated, and the ability to use a standard legal form 
to will each other property." Note this bill does not help 
couples obtain health insurance.

This bill passed because it was supported by a coalition 
including gay and senior-citizen organizations. It is 
important for older people, many of whom cannot officially 
remarry without losing important pension and other benefits. 
Currently they are officially regarded as strangers when 
illness or emergency strikes. The bill is opposed by anti-gay 
legislators and organizations.

Letters in support of AB 2810 should be addressed to Governor 
Pete Wilson at the address below.


** Other AIDS Legislation

The LIFE AIDS Lobby has asked for support for two other 
bills, and opposition to one.

Support: AB 3102 (by Martinez) designates the State Office of 
AIDS as the lead state agency for HIV and AIDS policies, as 
recommended by a University of California evaluation of the 
Office of AIDS.

Support: AB 2610 (by Bronshvag), would allow local 
jurisdictions to create pilot programs for a one-to-one clean 
needle exchange.

Oppose: SB 1239 (by Russell), would allow non-consensual 
testing for HIV in certain cases when a doctor or healthcare 
worker has experienced a "significant exposure" to a 
patient's blood. The bill has weak confidentiality 
provisions, requiring only "good faith efforts" to keep the 
patient's HIV status private. This bill is sponsored by the 
California Medical Association, opposed by the California 
Nurses Association and others.

Address letters on any of these bills to: Governor Pete 
Wilson, State Capitol, Sacramento, CA 95814. Note: Do not 
address more than one bill in a single letter; always send a 
separate letter for each bill.

Or you can call Governor Wilson's office at 916/445-2864, or 
916/445-2841. (There may also be local office in your area; 
for example, in San Francisco the number is 415/703-2218, in 
Los Angeles it is 213/897-0322, in San Diego it is 619/525-
4641, and there are also offices in other cities.) When you 
call, it's best to know the bill number that you support or 
oppose.


** California Voter Registration Toll-Free Number

A convenient way to register to vote in California is to call 
a toll-free hotline run by the California Secretary of State. 
You leave your name and address, and receive a postage-paid 
form which takes about two minutes to fill out. The last day 
to register for the important November 8 election is October 
11.

You must re-register if you move, change your name, or wish 
to change political parties.

The voter hotline number is 800/345-VOTE. A Spanish-language 
hotline is also available, at 800/232-VOTA.

The Secretary of State's office encourages organizations to 
publish these numbers for their members.



***** AIDS TREATMENT NEWS
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AIDS Treatment News reports on experimental and 
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and found combinations which work for them. AIDS 
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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