Viral Load Seminars in January and February, Eight U.S. Cities
Roche Diagnostics will present a free half-day seminar on
viral load in eight U.S. cities in January and early
February. The seminars will be in the morning, except the one
in Washington D.C., which is scheduled for the afternoon.
The cities and dates are: New York, January 6; Boston,
January 8; Chicago, January 9; Coral Gables, January 10; San
Francisco, January 13; Beverly Hills, January 16, Washington
D.C., January 21; and Atlanta, February 5.
For more information, contact The Organizing Secretariat,
3112 East Shadowlawn Avenue, Atlanta, GA 30305, 404/233-6446,
fax 404/233-2827, email kristina@meditech-media.com.
d4T+AZT - Unexpected CD4 Drop Seen in Study
On November 22 the National Institutes of Health issued a
Note to Physicians recommending that physicians closely
monitor the CD4 counts of patients taking a combination of
d4T plus AZT. The reason was that an ongoing study (ACTG 290)
found an unexpected decline in CD4 count of volunteers
assigned to that combination, who also had much prior
experience with AZT.
In ACTG 290, volunteers had CD4 counts at study entry between
300 and 600, and had a median of 34 months' use of AZT. Those
assigned to the d4T plus AZT combination arm had an
unexpected CD4 drop -- 20 cells at week 4, to 82 cells at
week 36. There were no unexpected CD4 declines in other arms
of the study (d4T alone, ddI alone, and ddI plus AZT). "No
significant differences in adverse events, serious laboratory
toxicities, or HIV-related clinical events" were found in any
of the groups. The ACTG has discontinued the d4T plus AZT
combination arm, and offered volunteers a new study arm with
d4T alone for eight weeks, with very close monitoring.
Another study (ACTG 298) also had a d4T plus AZT arm, but had
no unexpected decline. The only apparent difference is that
in this study, the volunteers had less than 7 days of prior
AZT experience.
No one knows why the CD4 decline occurred, and additional
research is being done to try to find out. Meanwhile, the research is being done to try to find out. Meanwhile, the
Note to Physicians does not make any recommendation on
whether or not to discontinue this combination, but advises
physicians to closely monitor CD4 counts of patients taking
it.
1592: Consensus Letter on Access to New Glaxo Drug
A consensus letter signed by dozens of AIDS organizations and
individuals calls on Glaxo Wellcome to establish an expanded-
access program for 1592, a promising HIV treatment now in
human trials.
The letter calls for three stages of access:
(1) A compassionate use/salvage therapy program "without
delay" for those in most urgent need;
(2) A larger expanded access program, designed to avoid
possible interference with recruiting for large-scale
clinical trials; and
(3) Accelerated approval (marketing approval based on viral
load and other measurements of the drug's activity, without
waiting for completion of long-term "clinical endpoint"
trials).
This letter has already been signed by 46 organizations,
including AIDS Healthcare Foundation, AIDS Project Los
Angeles, Gay Men's Health Crisis, National Association of
People with AIDS, San Francisco AIDS Foundation/BETA, ACT
UP/Boston, ACT UP/Golden Gate, ACT UP/Los Angeles, ACT UP/New
York, ACT UP/Philadelphia, AIDS Treatment News, Log Cabin
Republicans, Mothers' Voices, POZ Magazine, Project Inform,
PWA Health Group, and Treatment Action Group -- and over 100
individuals.
More organizations and individuals are needed. You can obtain
a copy of the letter from the Linda Grinberg Foundation, fax
310/471-4565 or phone 310/471-4108; leave your fax number or
mailing address.
Call for Research on Better Use of Existing Drugs in Advanced Disease
In its current newsletter, Project Inform is calling on the
AIDS community to advance two lines of research which are
especially important to persons with advanced disease:
resistance testing to tell which antiretrovirals are no
longer working for a patient, and alternative drug delivery
systems for those who cannot effectively take the drugs
orally.
Today, when a combination treatment starts failing, doctors
usually do not know which of the drugs may still be working.
And many patients do not have enough options left to start
three or more different drugs which they have never used
before. What is needed is more widespread access to viral
tests to rule out those drugs which will not work because the
virus has already become resistant to them. Such testing
already exists, but it is experimental and expensive. There
must be more research, wider access, and eventually official
approval.
On the drug formulation issue, there is much effort today to
teach patients the importance of using their treatments
(especially protease inhibitors) as directed, to avoid blood
levels which are too low and can lead to rapid development of
resistant virus. But much less attention has been paid to the
problem that some patients cannot absorb the drugs properly,
especially those with advanced HIV disease and
gastrointestinal problems. Much more effort is needed on
developing intravenous formulations or other alternatives to
oral delivery.
These two areas will be important in AIDS activism in 1997
and beyond.
For more information, see "Closing the Gap: Next Steps in
Optimizing Therapy," in PI PERSPECTIVE #20, November 1996. It
is available from Project Inform, 800/822-7422 or 415/558-
9051, 10 a.m. - 4 p.m. Pacific time, or by fax 415/558-0684,
email pinform@hooked.net, or World Wide Web
http://www.projinf.org.
National Conference on Women and HIV -- Late Breaker Deadline March 21
The National Conference on Women and HIV will be held near
Los Angeles in May 1997. Although the regular deadline for
abstracts from persons who want to present at this meeting
has passed, late-breaker session abstracts will be accepted
until March 21. Grassroots and community-based people are
encouraged to make a presentation, which can be an oral talk,
slide presentation, or poster.
To reach the conference organizers, contact Alexandra Minnis,
800/845-2115 or 213/351-8196, or send email to
womenconf@aol.com, or check the Web site
http://www.womenhivconf.org.
Geneva AIDS Conference Seeks Community Planning Coordinator
The 1998 International Conference on AIDS seeks a full-time
planning coordinator, who will be based in Geneva from early
1997 through August 1998. This person must be fluent in both
French and English, and able to work in a team and under
tight deadline pressures.
If you are interested, send a CV/resume and cover letter to
the Conference, fax 41-22-372-98-20, email florian@hivnet.ch.
Vaccine Report Available
It is widely agreed that only a vaccine will be able to stop
the worldwide AIDS epidemic, and that an effective vaccine
could save tens of millions of lives. But little is happening
in vaccine development, with only a handful of companies
having comprehensive HIV vaccine programs, and government not
having provided the leadership which industry needs.
The AIDS Vaccine Advocacy Coalition, an activist group with
funding from the American Foundation for AIDS Research,
Broadway Cares, and Until There's a Cure Foundation,
interviewed scientists and officials confidentially at 23
companies with active or former HIV vaccine programs to find
out what is needed. They found little if any doubt that an
HIV vaccine will be possible, but much scientific uncertainty
about which approaches might work. This scientific unknown
emerged as the single greatest obstacle to an effective HIV
vaccine effort.
It is widely agreed that government must fund the basic
research effort to answer key questions, such as identifying
what immune responses are important against HIV. Then private
investors will have paths to follow toward product
development.
The AVAC report, INDUSTRY INVESTMENT IN HIV VACCINE RESEARCH,
is available for $9.95 from the AIDS Vaccine Advocacy
Coalition, 2215 Market Street, #501, San Francisco, CA 94114.
Comment
Fortunately one major obstacle -- lack of any one person in
government responsible for the vaccine effort -- has been
addressed since the report was written. On December 12 the
Office of AIDS Research announced that Nobel Prize-winning
virologist Dr. David Baltimore would be in charge of HIV
vaccine research at the U.S. National Institutes of Health.
Dr. Baltimore's appointment has been well received by the
AIDS community.
Individuals can help, by getting AIDS organizations involved.
So far few have even put vaccine development on their
lobbying agenda.
"The important thing is, are everyday people talking about
it?" said one communications expert recently, addressing a
different issue. Vaccine organizations building grassroots
support should ask what is required to move the issue toward
"the center of interpersonal discourse."
Reminder: AIDS Treatment News Reader Survey
Readers are reminded to return the one-page survey which
appeared in the last issue, #260.
We are already using this survey to help decide what to
publish in this newsletter. Let us hear from you about what
you do or do not want us to cover.
Medical Marijuana: Legal Issues for Physicians, Others
by Bruce Mirken
On November 6 voters in California and Arizona passed ballot
initiatives intended to allow medical use of marijuana by
those suffering from illnesses for which the herb may provide
relief. Unfortunately, considerable doubt remains about the
practical effect of the measures, particularly regarding
possible dangers to physicians who recommend use of cannabis --
an important issue, since such doctor recommendations are
required in order for patients to invoke the new laws.
In Arizona, organizers of the campaign for Proposition 200 (a
far-reaching measure which also commits the state to placing
nonviolent drug offenders in treatment programs instead of
prison) do not expect the law's medical marijuana provision
to get much immediate use. Campaign coordinator Sam Vagenas
said that he expects the combination of prosecutors'
hostility toward the new law and the state's harsh drug laws,
which make marijuana possession a felony in most cases, to
stifle use of Prop. 200 until a test case is decided by the
courts. "We expect this to be litigated," Vagenas noted, "and
we do not expect a lot of usage until that litigation
occurs."
In California the situation is quite different. Even before
the passage of Prop. 215, the state's relatively mild
marijuana possession laws and the at least tacit cooperation
of some local authorities allowed a number of medical
marijuana buyers' clubs to exist. Despite state Attorney
General Dan Lungren's much-publicized raid on one such
operation in San Francisco, a number of clubs continue to
operate.
This does not mean, however, that patients, doctors or
distributors of medical cannabis face a clear path. A major
unresolved question is whether doctors will face reprisals
for recommending marijuana, a Schedule I drug which they are
not legally allowed to prescribe. Prop. 215 was written to
protect doctors, both by requiring only a "recommendation" of
marijuana rather than a formal prescription and by barring
the state from taking action against doctors for making such
recommendations. These provisions, however, do not give
physicians complete protection.
The California Medical Association, which opposed Prop. 215
on the grounds that there is insufficient study data
supporting therapeutic use of marijuana, has issued an
information sheet for doctors that urges caution and cites
possible dangers. The CMA warns that physicians acting under
215's provisions "may be subject to serious liability" under
federal drug laws which are not affected by the measure.
"Federal law," the CMA notes, "establishes a clear
prohibition against knowingly or intentionally distributing,
dispensing or possessing marijuana" and "gives an extremely
broad scope to the terms 'distribute' and 'dispense.'" The
CMA cites one particular federal court decision, the 1977
case of United States vs. Davis, which seems to allow federal
prosecution of doctors for "creating the means" for
individuals to obtain illegal drugs. This and other cases,
the CMA argues, suggest possible criminal liability even for
"physicians who, in good faith, are trying to protect their
patients' health." And even if doctors are not prosecuted
they might face other federal sanctions, such as action to
revoke the physician's Drug Enforcement Agency registration,
making it impossible for him or her to prescribe legal
controlled substances ranging from morphine to anabolic
steroids.
Although the CMA believes the safest course for doctors is
not to recommend marijuana at all, the organization suggests
that those who choose to make such recommendations use
statements such as these:
1) That the patient has [a specific medical condition] for
which there is evidence that the use of marijuana is
sometimes medically warranted.
2) That in the physician's medical judgment, the patient
would benefit from the medical use of marijuana.
3) That, because federal law prohibits dispensing,
distributing, possessing and cultivating marijuana, the
physician cannot legally prescribe marijuana for the
patient." The CMA document notes that use of such statements
does not guarantee that doctors will be safe from federal
sanctions, but "may reduce the likelihood of such liability."
Many doctors are giving recommendations to their patients,
and on Dec.4 a doctor's testimony produced the first known
Prop. 215-related dismissal of marijuana possession charges
in a case in Amador County. But many health care providers
are approaching the new law cautiously. Michael Weinstein,
president of the AIDS Healthcare Foundation, a major
nonprofit provider of HIV/AIDS medical services in Los
Angeles County, said that AHF is allowing its doctors to make
their own decisions regarding recommending marijuana, but has
asked them not to put such letters on AHF letterhead.
Weinstein reaffirmed AHF's support of 215 but said the
foundation did not want to "be first in line" to be a test
case.
What no one knows at this point is whether federal
authorities will aggressively enforce marijuana laws against
doctors or others. Officially the Justice Department is
saying very little so far. According to spokesman Gregory
King, "The Attorney General has stated on several occasions
that federal law still applies and that prosecutorial
judgments will be made on a case-by-case basis. The
Department of Justice is currently reviewing other
alternatives that might be appropriate responses." King
flatly declined to specify those "other alternatives."
There are some indications that government's approach may be
overtly hostile. Federal "drug czar" Gen. Barry McCaffrey
insisted at a Dec. 2 Senate hearing that Prop. 215 had
nothing to do with the medical needs of sick people and was
part of a dangerous "national strategy to legalize drugs."
Bizarre as McCaffrey's statements may seem to Californians
who support the measure, a Washington, D.C source familiar
with Clinton Administration thinking on the matter (who spoke
to AIDS Treatment News on condition of anonymity) said that
such ideas are in fact driving the government's decisions
about how to react to the California and Arizona laws.
Although a few states, including Connecticut, have long had
statutes providing for medical use of marijuana without
arousing the federal government, the source said that federal
drug enforcers are genuinely alarmed by the recent
initiatives. Policy makers "think George Soros (a New Yorker
who contributed heavily to the Arizona and California
campaigns) just sent a bunch of money to help out drug
dealers," the source said. As for the idea that marijuana may
have legitimate benefits for people fighting terrible
illnesses, "They don't get it. They don't get it at all."
The source added that the federal government is unlikely to
prosecute patients using marijuana for fear of a public
relations backlash, and for that reason the government almost
certainly will not attempt to challenge the laws in court,
since such a case would have to be built around the arrest of
a medical marijuana user. But prosecution of distributors,
which might include the buyers' clubs, remains a possibility.
A number of other possible actions are under active
consideration, including an effort to draft a Federal bill
aimed at effectively nullifying the two initiatives. Such
legislation, the source predicted, "would just zoom through
this Congress."
Californians for Medical Rights, the organization that
sponsored Prop. 215, is working on strategies to protect
doctors, according to campaign manager Bill Zimmerman. The
group has begun discussions with both the CMA and state
legislators aimed at drafting legislation to bolster the new
law and produce "some clarification from the federal
government as to what they will and won't do," Zimmerman
said. And if the government tries to punish physicians by
revoking their DEA registrations, Zimmerman said, "They might
be subject to a lawsuit by the doctor for depriving them of
the right to make a living. Since all that the initiative
requires is a recommendation, there could be a First
Amendment free speech issue as well. We're going to have a
first-rate team of lawyers in place to make the arguments and
file the lawsuits if necessary."
Marijuana and Research
by John S. James
The Current issue of SYNAPSE, a newspaper published by
medical students at the University of California San
Francisco, reports a case which may be an early test of
California's Proposition 215. Alan Martinez, a 40 year old
nurse's aide from Santa Rosa who uses marijuana for epilepsy
which he has had since age 19, was arrested in August for
growing plants in a windowsill box; his lawyer had the case
postponed until after the November election, when California
voters made clear that they do not want medical marijuana
treated as a crime. Martinez, who says he was largely
disabled while using conventional epilepsy drugs alone, spoke
publicly for the proposition during the campaign. ("Man with
Epilepsy Cites 'Medical Use' in Marijuana Case," SYNAPSE,
December 5, 1996.)
Martinez called for research on medicinal uses of marijuana.
A medical expert interviewed for the SYNAPSE article said it
was plausible that marijuana could affect the threshold for
seizures, although the question was unanswered because no
large studies had been done in people.
Ironically, one of the most extreme opponents of the medical
marijuana initiative -- California Attorney General Dan
Lungren -- is also calling for research. Lungren wants the
U.S. FDA to determine what if any medical uses of marijuana
are legitimate -- presumably hoping for a short list giving
him authority to keep prosecuting anyone who uses marijuana
for any other diagnosis. In the past, opponents of medical
marijuana have often used the lack of research to justify
their opposition -- while any research which could possibly
establish an accepted use was blocked by Federal authorities.
One of the arguments against Proposition 215 during the
campaign was that before marijuana could be accepted as a
medicine, it would have to be proved safe and effective, like
other drugs. But FDA approval of the efficacy of an herb
would be very unusual; the FDA usually approves chemicals
which can be uniformly manufactured. Other herbs are used in
medicine without FDA approval.
What Marijuana Research Is Needed?
Today, with rapidly growing support for medical marijuana
research, we need to think carefully about what research is
needed. Some of the claimed benefits of marijuana can be
physically measured -- intraocular pressure in glaucoma,
weight gain in wasting, or amount of vomiting in chemotherapy
or with other severe digestive conditions. Because some of
these benefits are short-term, they could be tested quickly
and at little cost.
But medical marijuana is usually used for RELIEF -- which is
often inherently subjective and very difficult to measure
scientifically. And ultimately, does it really make sense to
try to quantify short-term subjective relief -- as opposed to
trusting persons who are seriously ill to try different
possible treatments and select what works for them? Do we
have to try to measure relief anyway, even if it does not
make medical or scientific sense to do so, because of
political demand?
Another question in marijuana research is what do we want to
compare. One possibility would be smoked marijuana vs.
dronabinol (Marinol(R)), a legal prescription drug which
contains THC (tetrahydrocannabinol), the main active
ingredient of marijuana. And yet, what would be the value of
knowing that, on the average, marijuana worked a little
better, or dronabinol worked a little better, or (more
likely) that the trial was not big enough to tell
definitively? Anyone who knows patients knows that dronabinol
works much better for some, and marijuana for others; how
useful are gross averages, when the drugs are working for
different people? (A better trial design might compare three
arms: marijuana vs. dronabinol vs. CHOICE by the patient and
doctor of whichever of the two worked best for that person.
But -- except as a pilot study to work out the practical
problems in researching marijuana -- is there really a
medical reason for such a trial?)
The marijuana research we most recommend would be development
of pharmaceutical THC in an inhalable form. Almost all
descriptions of why marijuana worked for someone when
dronabinol does not, cite either:
(1)the ability to control
the dose through smoking, or
(2) difficulty using the (oral)
Marinol due to gastrointestinal problems (or
(3) the
exorbitant price of Marinol, if insurance will not pay, but
that is another issue).
An appropriate form of THC supplied
with a device to heat it (not burn it) would provide both of
the medical advantages of marijuana over dronabinol, with no
risk of infection from contaminated marijuana, or of harm
from combustion products in the smoke.
The fact that a very similar marijuana delivery system has
long been used ("hash oil," which is illegal but clearly does
deliver the drug in a way acceptable to users) shows that
developing a pharmaceutical heat-and-inhale delivery system
would not be difficult technically. And the existing approval
of dronabinol provides legal precedent; only the drug
formulation and delivery would be different. Then the medical
marijuana issue might ease, to the benefit of both sides. The
California and Arizona propositions may have opened the door
politically to practical research, which would ask why some
patients need marijuana and how else their needs might be
met.
AIDS Treatment News 28 - Page Index
A 28-page index to AIDS Treatment News from January 1994
through December 1996 will be mailed automatically to all who
currently subscribe at the regular (non-subsidized) rates,
probably early in January. (Those who are now paying a
subsidized rate -- $45 per year or less -- who have ever
previously subscribed at the full rate will also receive the
index without charge.)
This index differs from others in that every entry includes
the title and date of the article, so that you can tell
immediately which ones are likely to be important for you.
Also, every entry represents the judgment of our editor that
the article should be included under that particular heading.
We developed this format in-house to be the most useful
reference for AIDS Treatment News.
An online version of this index will be available at the
AIDS Treatment News back-issue site,
http://www.immunet.org/atn.
Copyright 1996 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.
This article was provided by AIDS Treatment News. It is a part of the publication AIDS Treatment News.