Aresearcher at the University of Massachusetts at Amherst is seeking the U.S. Drug Enforcement Administration’s permission to grow cannabis that could be used to develop legal prescription drugs, but the request is being opposed by the University of Mississippi, the sole source sanctioned by the government to grow marijuana for such purposes.
In an administrative hearing on the dispute held last week, the University of Massachusetts argued that Mississippi’s product is of insufficient potency and that the government has released too little of it to researchers. The DEA argued that the supply is ample, and that other researchers have found the crop sufficient to meet their scientific needs.
In December the agency turned down the request to grow cannabis from Lyle E. Craker, a professor of plant and soil sciences at Amherst who is an expert on the production of medicinal plants. He has appealed and is now represented by the American Civil Liberties Union.
Last week’s hearing was before an administrative-law judge. Although the judge’s decision will not bind the DEA, officials of the ACLU said they hope that winning their appeal will persuade the federal agency to reconsider its denial. A decision is expected by January.
The hearing began just two months after the U.S. Supreme Court ruled that the federal government may block state governments from allowing patients to use marijuana for medical purposes. During oral arguments in that case, Gonzales v. Raich, at least one justice, Stephen G. Breyer, suggested that patients who wanted to receive cannabis should persuade the Food and Drug Administration to approve the plant for medical use. Mr. Craker and his supporters say the goal of the Massachusetts project is to provide the scientific evidence to do just that.
However, some scientists have said that the DEA and the National Institutes of Health have blocked some marijuana research because they are biased against studies that do not focus on the plant’s health hazards for patients and recreational users.
Mr. Craker and his supporters want to expand research on both benefits and risks. “The DEA’s refusal to permit me to grow marijuana for research necessarily prevents an accurate assessment of this plant’s potential medicinal properties,” he said.
An Alternative Source
Mr. Craker has been seeking the DEA’s permission to grow marijuana since June 2001, with the expectation that his research would be financed by the Multidisciplinary Association for Psychedelic Studies, a nonprofit, Washington-based group that supports research on the medical and “spiritual” uses of marijuana. The federal agency’s decision to deny his request in December came after Mr. Craker and the association sued the agency for dragging its feet.
The Amherst project would study optimal growing conditions to cultivate marijuana useful for medical studies. The growing plot would be located behind locked doors, under artificial lighting, in the horticulture department’s building. The actual medical studies would be conducted at other institutions.
The psychedelic-studies association has proposed sponsoring research into whether marijuana could be used, for example, to relieve the nausea that patients with cancer and AIDS suffer as a side effect of medications they take. The Food and Drug Administration has already permitted the use of a marijuana extract in pill form, called Marinol, to treat such symptoms. But some patients with nausea can have trouble keeping those pills down.
The association argues that a second source of marijuana is needed because the National Institutes of Health and the Department of Health and Human Services rejected applications from at least two other researchers for access to the Mississippi marijuana, which the department controls. (One of those decisions was reversed after the scientist changed his study to focus on cannabis’s risks rather than its potential benefits.)
The association’s president, Richard E. Dublin, said that he had invited Mr. Craker to participate because of his expertise and because he is not an advocate for legalizing marijuana for recreational use. “I’m very much against recreational use, and I have never used it,” Mr. Craker said in an interview.
In addition, Mr. Dublin said, Mr. Craker was a senior, tenured faculty member who would be protected from any potential political backlash over the research.
Potency at Issue
Mr. Craker and Mr. Dublin’s association argue that the marijuana available from Mississippi is not sufficient for the studies because it is too weak. They are seeking a content of 7 percent to 15 percent by weight of tetrahydrocannabinol, or THC, the plant’s psychoactive ingredient. The Mississippi pot typically has a content of about 4 percent or less, although the facility has produced some marijuana with a content of 10 percent.
Few clinical studies have been conducted on the medical benefits of marijuana. But some patients who have been given the government-sanctioned pot have complained that either it had no effect or they had to smoke it for long periods to experience any, Mr. Craker said.
He and the association also argue that the Mississippi pot generally has too many seeds and stems to be useful for their research. The THC typically is concentrated in the plant’s leaves and buds, while seeds tend to explode when heated.
In its pre-hearing documents, the DEA defended the Mississippi marijuana. The agency argued that researchers at the University of California at San Diego who used it in their preliminary clinical studies said it was of sufficient quality for their purposes. The university installed a custom-made de-seeding machine that has operated effectively, the agency argued.
The DEA has also raised health concerns about giving research subjects high doses of THC.
Mr. Craker has already won support from Massachusetts’ Congressional delegation, including its senators, Edward M. Kennedy and John F. Kerry. In a 2003 letter to the agency’s administrator, the two Democrats called the Mississippi contract an “unjustifiable monopoly.”
The University of Mississippi has contracted with the National Institutes of Health since 1968 as the sole source of government-approved cannabis. The university currently has an inventory of more than one ton and a full-time staff of 10 that cultivates the marijuana on a 14-acre, outdoor plot surrounded by a double row of security fences.
http://chronicle.com Section: Government & Politics Volume 52, Issue 2, Page A34
