For decades, the federal government has been the nation's only legal producer of marijuana for medical research. Working with growers at the University of Mississippi, the National Institute on Drug Abuse has controlled both the quality and distribution of the drug for the past 36 years.
But for the first time the government's monopoly on research marijuana is under serious legal challenge. The effort is being spearheaded by a group that wants to produce medicines from currently illegal psychedelic drugs and by a professor at the University of Massachusetts who has agreed to grow marijuana for the group if the government lets him.
In a hearing due to start today before an administrative law judge at the Drug Enforcement Administration, professor Lyle Craker and his supporters will argue for a DEA license to grow the research drugs. It is the climax of a decades-long effort to expand research into marijuana and controlled drugs and of Craker's almost five-year effort to become a competing marijuana grower.
"Our work is focused on finding medicinal uses of plants, and marijuana is one with clear potential," said Craker, director of the medicinal plant program of the university's Department of Plant, Soil and Insect Sciences in Amherst, Mass., and editor of the Journal of Herbs, Spices and Medicinal Plants. "There's only one government-approved source of marijuana for scientific research in this country, and that just isn't adequate."
The DEA, which has to license anyone who wants to grow marijuana, disagrees.
The agency, as well as the National Institute on Drug Abuse, which formally runs the marijuana research program, argues that it is not in the public interest to have more than one source of marijuana, in part because it could lead to greater illicit use. What's more, they said in legal briefs, the Mississippi program supplies all the marijuana that researchers need. Agency officials declined to comment further.
In his suit against the DEA for a license to grow marijuana, Craker has backing from 38 members of Congress, the two senators from Massachusetts, numerous medical societies and even Grover Norquist, the president of the conservative Americans for Tax Reform.
The effort has been organized by Richard Doblin, president of the Multidisciplinary Association for Psychedelic Studies (MAPS) and a longtime advocate of medical research into controlled drugs. It was Doblin who recruited Craker after the association concluded it would never get a dependable supply of government marijuana.
"Dr. Craker has no goal here except to advance scientific research into marijuana, and our goals are the same," said Doblin, whose group is also sponsoring research into other controlled drugs, including MDMA (better known as "ecstasy") and the psychedelic mushroom psilocybin.
"By controlling who can research marijuana and how they can do it, the DEA has greatly limited promising research that could lead to [government] approved medications," Doblin said.
The problems, he said, are not limited to winning approval to buy the Mississippi marijuana. Doblin and other researchers contend that the government marijuana is low in quality and potency and could never be a stable source of basic ingredients if the Food and Drug Administration ever did approve a marijuana-based medication.
Marijuana, or cannabis, is now listed as a Schedule I drug -- with no medicinal use -- under the Controlled Substances Act. Its use was initially restricted in 1937 and eliminated from medicinal practice in 1942. On its Web site, the DEA lists marijuana as the most frequently abused illicit drug in America.
Since the 1970s, however, researchers have found potential uses for marijuana, or its active ingredient THC, in relieving nausea and vomiting associated with chemotherapy and to help with appetite loss in AIDS patients. A synthetic form of marijuana's active ingredient has been made into a prescription drug, Marinol.
Doblin said there are potentially many other medicinal uses of marijuana, including the treatment of multiple sclerosis and AIDS-related neuropathy. He also said researchers believe that if they can perfect a method of "vaporizing" marijuana -- allowing it to be inhaled rather than smoked -- it would be easier to administer as medicine.
But because of fears of illicit use, he said, the agency has essentially blocked the research. "I believe the DEA policy is one of delay, and they've succeeded in essentially blocking marijuana development for 30 years," Doblin said.
In its filings with Administrative Law Judge Mary Ellen Bittner, the DEA disputes the charge that it is standing in the way of marijuana research.
It says that medical marijuana research is underway in California using its Mississippi supply, and that the drugmaker Mallinckrodt Inc. has a contract with the Mississippi supplier to produce extracts of cannabis for its drug development program. In addition, DEA lawyer Brian Bayly told the law judge in August, when the first five days of testimony were heard, that the quality and potency of the government's marijuana was acceptable to the researchers his agency surveyed.
The hearing is expected to continue through the week, with a decision several months later. If Craker and his team prevail, however, the DEA is not obliged to give him a license or change its policies. And as a result, Craker and his team plan to continue lining up political support, such as the Nov. 22 letter sent by Norquist to the DEA.
"The use of controlled substances for legitimate research purposes is well-established, and has yielded a number of miracle medicines widely available to patients and doctors," Norquist wrote. "This case should be no different. It's in the public interest to end the government monopoly on marijuana legal for research."