Dec 15 2004

U.S. puts brake on ‘pot’ studies

Posted by J. Craig Canada in cultivation, lyle craker, research

U.S. puts brake on ‘pot’ studies

U.S. puts brake on ‘pot’ studies

Wednesday, December 15, 2004

AMHERST – Lyle E. Craker’s plans to grow marijuana in his University of Massachusetts laboratory to be used for medicinal studies have been put on indefinite hold by the U.S. Drug Enforcement Administration.

Craker filed an application with DEA in June 2001 to establish a facility on the Amherst campus to produce marijuana for U.S. Food and Drug Administration-approved research.

Last July, he and two other plaintiffs filed a lawsuit demanding that the DEA respond to his request. On Friday, he got his answer in a six-page “order to show cause” from the DEA denying his request.

“What we’re attempting to do is to test this plant to see if it actually has any clinical benefit,” said Craker, director of the medicinal plant program and member of the department of plant, soil, and insect sciences at UMass, yesterday. “Many people may be suffering from medical problems who we may be able to help.”

He said he plans to seek a hearing at which he will show cause why the DEA should not deny his application. Under his plan, the Multidisciplinary Association for Psychedelic Studies would fund the UMass cultivation.

The association and Craker were plaintiffs in the lawsuit filed in July.

Currently, the National Institute on Drug Abuse is the only agency allowed to oversee the cultivation of research-grade marijuana on behalf of the government. But many scientists have questioned the quality and quantity of the marijuana produced at the University of Mississippi for the institute.

In its order, the DEA said it found that the laboratory is producing a “sufficient quantity and quality” of marijuana to meet research needs.

“What this decision does is effectively close the doors on any foreseeable prospect of the Federal Drug Administration considering marijuana as medicine,” said Bruce E. Mirken, director of communications for the Marijuana Policy Project based in Washington, D.C.

The order also says that an additional facility is not needed because marijuana research has not progressed to Phase 2 of clinical trials because “current research must utilize smoked marijuana, which ultimately cannot be the permitted delivery system for any potential marijuana medication due to the deleterious effects and the difficulty in monitoring the efficaciousness of smoked marijuana.”

Rick E. Doblin, president of the Multidisciplinary Association for Psychedelic Studies, said the DEA is performing Phase 2 trials with marijuana.

He said his group wants to study the medicinal benefits of marijuana in two forms, smoked and by vaporizer.

“We want to develop marijuana into a prescription medicine, or have research that says it’s too risky,” Doblin said. “Our broader goal is to say we have a public health issue that is being addressed as a criminal justice issue.”

The DEA would not comment on the order to show cause, and said Craker has 30 days from receipt of the letter in which to respond and have a hearing date scheduled.

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