A pharmaceutical company typically spends some $230 million and a decade or longer to win approval from the Food and Drug Administration for a new medicine. But Rick Doblin, president of the Multidisciplinary Association for Psychedelic Studies (MAPS), expects to complete the process within two years at a cost of about $500,000. To be sure, the drug he has in mind–marijuana–is not exactly new.
Encouraged by the FDA's 1992 approval of MDMA research with human subjects (see Trends, February 1993), Doblin asked the agency's Pilot Drug Evaluation Staff what it would take to make marijuana available by prescription. With the FDA's guidance, MAPS developed a research plan, including a large, multi-site clinical study and a series of individual trials, to test marijuana's effectiveness in treating AIDS wasting syndrome. In October the FDA approved a protocol for the large study, to be supervised by Donald Abrams, research director of the San Francisco Community Consortium, which coordinates AIDS research in the Bay Area.
Doblin says the protocol was submitted, revised, and approved within a week. "The FDA has expedited this," he says. "The FDA is being extremely helpful." He attributes what he calls "a monumental shift at the FDA" to the waning of the drug war and the influence of Commissioner David Kessler. He says Kessler seems sympathetic to patients seeking legal access to marijuana.
Other medical-marijuana advocates disagree, seeing the research as a stalling tactic. They note that the Community Consortium's scientific advisory committee rejected the FDA-approved design as unethical because it involved giving a control group marijuana from which THC had been removed. "FDA planned to give people with AIDS phony pot and watch them starve to prove what everyone already knows: marijuana gives you the munchies," said Robert Randall, president of the Alliance for Cannabis Therapeutics.
Yet some sort of control group is necessary to measure marijuana's effects. Partly because of this methodological problem, MAPS plans to use a $50,000 grant it received from a Dutch research group for a smaller pilot study. Doblin says the study, which would compare marijuana of various potencies with a synthetic THC pill, could begin this spring if the FDA continues to cooperate. He predicts the research will help raise money for further studies. "What we have to do," he says, "is demonstrate that this is an idea that can actually be implemented."