Medical marijuana: tribulations and trials.

Widespread use of smoked marijuana in the San Francisco Bay Area as a treatment for HIV-related anorexia and weight loss, as well as nausea related to prescribed therapy, prompted the design of a clinical trial to evaluate the safety and effectiveness of this controlled substance. The Community Consortium--the Bay Area's community-based HIV clinical trials organization--designed a first pilot evaluation of smoked marijuana compared to oral tetrahydrocannabinol (THC, synthesized as dronabinol or Marinol) in 1993. A legal source of marijuana could not be identified. Two subsequent applications to the National Institutes of Health were submitted in 1996 and 1997. During the intervening period, increasing numbers of people with HIV infection were obtaining marijuana for "medicinal use" from local Cannabis Buyer's Clubs. In November 1996, California voters endorsed the medical use of marijuana by approving Proposition 215. The federal government's attempt to oppose the voters' mandate led to public outrage. Organized medicine demanded more studies into marijuana's potential use as medicine. The consortium's 1997 proposal to evaluate the potential interaction between THC and widely-prescribed protease inhibitors was positively received. Funding and study-required marijuana cigarettes have been obtained from the National Institute of Drug Abuse, and the first subjects are being enrolled in the trial. When politically sensitive research proposals include sound science, they can prevail if investigators are willing to persist.