Marijuana-for-AIDS Study The first domestic study of marijuana's effects on AIDS patients is expected to begin in May in San Francisco. While this preliminary study is designed to focus on whether marijuana is safe enough for AIDS patients to use, it is the first clinical trial in 15 years that would obtain any data whatsoever on marijuana's medical effectiveness. On September 18, 1997, the National Institute on Drug Abuse (NIDA) announced that it would give Donald Abrams, M. D.
, a grant to study marijuana's safety as a medicine for people with AIDS. Dr. Abrams, an AIDS researcher at the University of California at San Francisco, has been trying since 1994 to obtain government permission to study medicinal marijuana. MPP and the Multidisciplinary Association for Psychedelic Studies (MAPS) have been working to remove the government's bureaucratic hurdles that blocked the research. Unfortunately, the federal government would not allow Dr. Abrams' research to proceed until the design was changed from primarily an efficacy study to primarily a safety study.
That is, the study that Abrams proposed in 1994 would have focused on marijuana's ability to increase the appetite of patients suffering from AIDS wasting syndrome (which causes patients to lose significant amounts of body weight). The approved study, however, will focus on the potential health risks of marijuana in people with AIDS who are also on other medications. If, as MPP predicts, the approved study determines that marijuana's risks are negligible - or at least acceptable - the path will be cleared to study marijuana's medical efficacy in greater depth. About the Study The federal government, through the National Institutes of Health, will provide Dr.
Abrams with $978, 000 and a supply of marijuana. A total of 63 AIDS patients who have used marijuana in the past and who are present taking protease inhibitors will participate. They will each be paid $1, 000 to stay in a hospital for 25 days and either smoke marijuana, take a synthetic version of marijuana's primary active ingredient (THC) in pill form, or take a placebo. The three groups of 21 subjects will be compared in terms of HIV levels, hormone levels, and other immune-system measures. The effects of marijuana and THC on the protease inhibitor metabolism will also be examined. Some preliminary data on caloric intake will also be recorded, but it will not be detailed enough to answer definitively any questions about marijuana's medical efficacy for AIDS patients.
Because of limited hospital space, only three patients at a time will be studied. Therefore, the study will take about a year and a half to complete. How the Government Thwarted the Original Proposal Dr. Abrams' original proposal was approved by the FDA in 1994. The original study - which was to be privately funded - would have been completed more than two years ago and would have obtained preliminary data on marijuana's ability to increase the appetite of patients suffering from AIDS wasting syndrome. But the federal government has a monopoly on the legal supply of marijuana for research, and NIDA rejected Abrams' first proposal.
(This cannot happen to synthetic drugs developed by pharmaceutical companies, which can begin their research as soon as the FDA approves. ) After nearly a year of stalling, NIDA Director Alan Leshner finally told Abrams that he would need to submit a grant application to NIH, of which NIDA is a part. Leshner argued that because "marijuana is money," NIH would have to conduct a lengthy peer review, which it does whenever anyone applies to NIH for a grant. So Abrams submitted a grant application in April 1996 - and it was rejected four months later. NIH said that the first study should focus almost exclusively on marijuana's safety as opposed to efficacy. Abrams complied and submitted a third proposal in April 1997.
This approved version is costing the federal government nearly $1 million, whereas the original version would have cost the government nothing except for the supply of marijuana. Of course, the government is happy to spend $1 million in order to delay the efficacy research - and thereby the FDA's approval of marijuana as a prescription medicine - for as long as possible. The only way to ensure that useful medicinal marijuana research is conducted as soon as possible is to get NIDA out of the marijuana distribution business and allow studies to be conducted with non-government marijuana. Or, at the very least, NIDA should be required to provide its marijuana to all FDA-approved studies, whether funded by taxpayer dollars or private citizens. MPP helped convince an NIH advisory group and the American Medical Association to recommend just that. MPP will continue to try to change the policies that block, delay, and otherwise thwart medicinal marijuana research.
In the meantime, MPP is pleased that Dr. Abrams has finally been permitted to study marijuana with AIDS patients. MPP, MAPS, and Abrams are hopeful that the results will be favorable and he will be allowed to study marijuana's medical efficacy in the near future. MPP strongly cautions the media and the government to avoid misconstruing the results of Abrams' approved study: While it will collect some preliminary data on marijuana's effectiveness, it is not designed to prove or disprove marijuana's medical efficacy. Therefore, if the results do not show any effectiveness, this will not mean that marijuana has no medical value. Only the next study would answer that question..