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DEA judge's ruling could help medical marijuana research

The federal government's system for evaluating requests for marijuana for clinical study has hindered investigation of the drug's safety and effectiveness, the opinion states.

By Amy Lynn Sorrel, AMNews staff. March 19, 2007.

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A decision last month by a Drug Enforcement Administration judge could make way for a scientific answer to the controversial question of whether medical marijuana should be made available as a prescription drug, proponents say.

In only the second ruling of its kind, DEA Administrative Law Judge Mary Ellen Bittner found that it would be in the public interest to allow a university researcher to grow cannabis in a licensed facility for use in privately funded, government-approved studies to test its potential clinical benefits.

As a schedule I controlled substance, cannabis can be researched only with federal approval. With the National Institute on Drug Abuse in control of the supply for U.S. studies, some doctors and scientists worry that the government's tight grip may be stifling the kind of research used to test other drugs with therapeutic possibilities.

In 2005, scientist Lyle E. Craker, PhD, a professor in the department of plant and soil sciences at the University of Massachusetts Amherst, appealed the DEA's denial of his application for a schedule I license to grow research-grade cannabis for private medical studies.

In her nonbinding decision, Bittner recommended that Dr. Craker's application be granted. She ruled the existing supply of marijuana inadequate for legitimate research.

"NIDA's system for evaluating requests for marijuana for research has resulted in some researchers who hold DEA registrations and requisite approval from the Dept. of Health and Human Services being unable to conduct their research because NIDA has refused to provide them with marijuana," the 87-page opinion states.

Bittner also concluded that there was no danger that the marijuana Dr. Craker would cultivate would end up in the wrong hands -- a standard that the DEA uses when considering license applications.

Dr. Craker said cannabis should not be treated differently from other medicinal plants he has studied over the last 25 years. "All I want to do is the science, and we want to supply the material to run an honest clinical trial to determine if the drug has benefits or not," he said. "We need to put it to the test, and if it doesn't pan out, OK, but certainly society could benefit from knowing that."

Although the decision is not binding, the recommendation, along with increasing state efforts to decriminalize medical marijuana, could help pressure the federal government to take down the political obstacles hindering the science, proponents say.

If the Food and Drug Administration, through clinical studies, could determine whether marijuana is a safe and effective drug, individual states would not have to pass laws decriminalizing its use by patients with serious illnesses, said Allen Hopper, an attorney at the American Civil Liberties Union's Drug Law Reform Project, which helped defend Craker's case.

Eleven states allow medical marijuana use. New Mexico is attempting to become the 12th. Its Senate approved a bill in February that is now headed to the House.

Take II

The first time a DEA judge overturned an agency decision regarding medical marijuana came in 1998.

In that ruling, Administrative Law Judge Francis L. Young granted a petition by the National Organization for the Reform of Marijuana Laws to have the DEA downgrade marijuana from a schedule I to a schedule II controlled substance. The administration rejected the decision.

"But that was before a single medical marijuana statute had been passed, and what the petition sought to do in that case was to leapfrog over the FDA without it having the opportunity to say it has effective medical use," Hopper said. In contrast, last month's ruling is a significant step toward letting science, rather than the government, be the judge, he said.

American Medical Association policy calls for further adequate clinical research into the safety and efficacy of cannabinoid treatments in seriously ill patients.

DEA spokesman Steve Robertson said the agency is reviewing the decision but declined to comment further. The government maintains that no sound scientific studies exist to support marijuana's medical value.

That notion was recently challenged, however, in a study funded by the University of California's Center for Medicinal Cannabis Research, the only state-funded, government-approved trial with NIDA approval.

The study, conducted at the University of California, San Francisco, and published in February's issue of Neurology, found that smoked cannabis relieved chronic neuropathic pain in AIDS patients.

The research builds on a 1999 report by the Institute of Medicine. That report analyzed existing clinical studies on the medical value of marijuana and shared similar conclusions about its therapeutic potential for AIDS and other seriously ill patients.

UCSF professor of clinical medicine Donald I. Abrams, MD, who led the study, agrees that federal interference has hindered necessary research. An oncologist, Dr. Abrams said he has seen marijuana help cancer and AIDS patients for whom conventional pain treatments do not suffice.

"The lack of evidence is because not enough people want to get involved in researching marijuana, and you do what you think is an elegant study, and the government tells you it's flawed," Dr. Abrams said.

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