AIDS Treatment News
Viral Load Seminars
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 firstname.lastname@example.org.
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
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
The letter calls for three stages of access:
(1) A compassionate use/salvage therapy program "without delay" for those in most urgent need;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
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
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 email@example.com, or World Wide Web http://www.projinf.org.
National Conference on
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 firstname.lastname@example.org, or check the Web site http://www.womenhivconf.org.
Geneva AIDS Conference Seeks
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 email@example.com.
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.
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
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.
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 Researchby 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
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.
A much shorter index for 1996 only appears below.
|AIDS Treatment News Index, 1996|