May 22, 1999

U.S. Eases Curb on Medical Marijuana Research

By SHERYL GAY STOLBERG

WASHINGTON -- Despite intense interest in the medical benefits of marijuana, few scientists are studying it, because the government has always required that such work be paid for by scarce grant money from the National Institutes of Health.

That changed Friday when the Clinton administration eased the requirement, announcing that it would sell government-grown marijuana to privately-funded scientists.

The decision was issued as a regulation by the National Institute on Drug Abuse and is supported by General Barry McCaffrey, who as director of the Office of National Drug Control Policy has been the administration's most ardent opponent of the legalization of medical marijuana.

"Before, the problem was if you wanted marijuana, you had to not only show that it was high-quality research, you had to show that it was more important than other competing applications for NIH funding," said Chuck Blanchard, chief counsel for McCaffrey's office. "Now, as long as you are willing to show that it is high-quality research and also provide your own funding, you can have access to medical marijuana."

Under the ruling, marijuana studies will still be reviewed for their scientific merit, but it will become easier for state and local governments to pay for the research. Experts and government officials hope the studies could some day lead to the development of a new delivery system for marijuana, such as an inhaler, that would enable patients to benefit from its active ingredients without suffering the toxic effects of the smoke.

Some officials already say they hope to take advantage of the new rule. "This news today gives us great hope," said Mike Nevin, a member of the San Mateo County Board of Supervisors. About a year ago, he said, his board allocated $500,000 for studies of marijuana in cancer and AIDS patients. "We are hoping the federal government will grant us the ability to do this study," he said, "and we are willing to pay."

For years, the National Institute on Drug Abuse has paid a farmer at the University of Mississippi to grow marijuana for research, primarily studies on addiction. The government also provides the drug to eight patients under a "compassionate use" program authorized by the Food and Drug Administration, but that program has been closed to new participants since 1992.

In recent years, as interest grew in using marijuana as a medicine, scientists have tried, with limited success, to persuade the National Institutes of Health to pay for the studies. Only three studies have been approved so far; among them is one being conducted by Dr. Donald Abrams of the University of California at San Francisco, who said it took him five years to obtain approval to study marijuana in AIDS patients.

And even then, Abrams had to mask his true research interest; although he wanted to examine the effects of marijuana on the weight loss associated with AIDS, he pitched the study as one that would look at the potentially toxic interactions between marijuana and standard AIDS medications. "We designed a study that would appeal to the group of people funding the grant," he said.

Friday's decision comes two months after an exhaustive study by the Institute of Medicine, a branch of the National Academy of Sciences, concluded that the active ingredients in marijuana, called cannabinoids, appear useful for treating pain, nausea and the severe weight loss associated with AIDS. Two years ago, a review by NIH officials reached a similar conclusion.

"We have had several pretty distinguished groups now say that cannabinoids, not smoked marijuana, may have some real potential medical usage," said Dr. Steven Gust, special assistant to the director of the National Institute on Drug Abuse. "This is a first step towards ultimately developing purified forms of cannabinoids that may be FDA-approvable."

So far, there is only one cannabinoid-based drug on the market, Marinol, manufactured by Unimed Pharmaceuticals Inc. of Buffalo Grove, Ill. But some patients complain that the Marinol pills are too potent, leading researchers to theorize that an inhaler, similar to those used by asthma patients, might be a more effective form of treatment.

Recognizing that such a method might take years to develop, the Institute of Medicine report recommended that patients who did not respond to other therapy be permitted to smoke marijuana. But the regulation issued Friday said the government does not intend to approve "single-patient requests for marijuana," because they do not "produce use useful scientific information."

Advocates for legalizing marijuana as medicine had both praise and criticism for Friday's decision. "It is a tiny step forward, but far too tiny," said Ethan Nadelmann, director of the Lindesmith Center, which backed initiatives in California and Arizona to make marijuana legal for medical use. "It's an implicit acknowledgement that the government has blocked research into medical marijuana for explicitly political reasons for the last two decades."