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DISTRIBUTED BY GENA/aegis (714.248.2836 * 8N1/Full Duplex * v.34)
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
Published twice monthly
Subscription and Editorial Office:
P.O. Box 411256
San Francisco, CA 94141
800/TREAT-1-2 toll-free U.S. and Canada
415/255-0588 regular office number
fax: 415/255-4659
Internet: aidsnews@igc.apc.org
Editor and Publisher:
John S. James
Reader Services and Business:
Thom Fontaine
Tadd Tobias
Rae Trewartha
Statement of Purpose:
AIDS Treatment News reports on experimental and
standard treatments, especially those available now. We
interview physicians, scientists, other health
professionals, and persons with AIDS or HIV; we also
collect information from meetings and conferences,
medical journals, and computer databases. Long-term
survivors have usually tried many different treatments,
and found combinations which work for them. AIDS
Treatment News does not recommend particular
therapies, but seeks to increase the options available.
Subscription Information: Call 800/TREAT-1-2
Businesses, Institutions, Professionals: $230/year.
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Individuals: $100/year, or $60 for six months.
Special discount for persons with financial difficulties:
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a subscription, please write or call.
Outside North, Central, or South America, add air mail
postage: $20/year, $10 for six months.
Back issues available.
Fax subscriptions, bulk rates, and multiple subscriptions
are available; contact our office for details.
Please send U.S. funds: personal check or bank draft,
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VISA, Mastercard, and purchase orders also accepted.
ISSN # 1052-4207
Copyright 1994 by John S. James. Permission granted for
noncommercial reproduction, provided that our address
and phone number are included if more than short
quotations are used.