Background
Since the summer of 1992, MAPS has been working with Dr. Donald Abrams, Professor of Medicine, University of California, San Francisco and Assistant Director, AIDS program, San Francisco General Hospital. We have been trying to secure permission to conduct a study to compare the effectiveness of smoked marijuana and the oral THC capsule in promoting weight gain in patients suffering from the AIDS wasting syndrome. The oral THC capsule is already available by prescription for the treatment of the wasting syndrome, but thousands of anecdotal reports suggest that smoked marijuana is more effective in some patients.
In the summer of 1994, after two years of intensive review and redesign, the FDA approved the protocol (IND#43,542). Dr. Abrams' study was the first in over a decade that the FDA had approved to investigate the therapeutic potential of marijuana. Since FDA approval, however, research has been prevented for lack of a legal supply of marijuana. Attempts made early in the summer of 1994 to import high-potency marijuana from the only legally licensed marijuana grower in the Netherlands were blocked by the Drug Enforcement Administration. On April 19, 1995, the National Institute on Drug Abuse (NIDA), which has a monopoly on the domestic supply of marijuana for research purposes, rejected Dr. Abrams' August 1994 request for marijuana, despite the fact that NIDA has previously supplied every FDA-approved marijuana research protocol.
The Crucial Meeting
At a July 19, 1995 meeting near Washington, D.C. which the Marijuana Policy Project and MAPS helped arrange, Dr. Alan Leshner, Director of NIDA, met with a group of medical marijuana patients, medical marijuana activists, and drug policy analysts. The meeting focused on objections to Dr. Leshner's decision not to provide NIDA marijuana to Dr. Abrams' study. Dr. Leshner scheduled the meeting, held in the midst of NIDA's National Conference on Marijuana Use, at the request of a coalition of protesters who organized a silent demonstration at the conference and handed out a booklet of information to all the attendees entitled "What NIDA Won't Tell You About Marijuana." Not surprisingly, Dr. Leshner defended his decision to block medical marijuana research.
The Current Strategy
According to Dr. Leshner, the only way Dr. Abrams' study can obtain a legal supply of marijuana from NIDA is if the protocol is reviewed and approved by the National Institutes of Health (NIH). Unfortunately, the NIH only reviews protocols in the context of grant applications. Though private funding for the study had been obtained, Dr. Leshner is now requiring go through with a request for government funding. Despite the low probability of success, Dr. Abrams is proceeding to submit a revised protocol to NIH. MAPS has donated $4,000 and the Drug Policy Foundation has donated an additional $1,000 to Dr. Abrams and associates to help cover costs associated with the preparation of the NIH grant application. The NIH application deadline is January 1, 1996. The NIH review process itself takes about six months.
MAPS is also working to build support for the creation of a non-profit medical marijuana pharmaceutical company that would apply for legal permission to grow marijuana for research purposes. Such a project is estimated to cost $250,000 to establish. Once these funds are pledged, the application process will be initiated.
As long as patients report that the medical use of marijuana eases their suffering more effectively than legally obtainable medications, MAPS will continue to work towards medical marijuana research.
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