DEA
Blocks
Private
Marijuana
Research
Grow,
Path
to
FDA
Approval
12/17/04
The Drug Enforcement Administration (DEA) has at long last acted on a nearly four-year-old request by an academic researcher to grow marijuana to test it for medical uses -- but only to deny it. In a letter faxed December 10 to University of Massachusetts-Amherst plant biologist Dr. Lyle Craker, who first submitted the request in 2001, the agency denied his request for a license to grow high-quality marijuana, saying that pot produced at a government-contracted facility in Mississippi is sufficient to supply research needs. Approving the application "would not be consistent with the public interest," the DEA said. But according to the Multidisciplinary Association for Psychedelic Studies (http://www.maps.org), which was prepared to fund Craker's research grow, and the Marijuana Policy Project (http://www.mpp.org), which helped generate congressional support for the project, the Mississippi weed is both low quality and difficult to obtain for medical marijuana research purposes, especially because access is controlled by the National Institute of Drug Abuse (NIDA), an organization whose mission is researching the dangers of marijuana -- not its possible medical benefits. What is worse, said MPP communications director Bruce Mirken, is that the DEA denial makes eventual Food and Drug Administration (FDA) approval of marijuana as a medicine virtually impossible. "Before the FDA allows a product to be put on the market, it wants clinical data to ensure that it is safe and effective and it wants that research to have been done on an identical product," Mirken explained. "The product's sponsor has to provide large amounts of information about its composition, how it was manufactured -- or, this case, grown. By law, NIDA's Mississippi marijuana cannot be prescribed; it's only available for research, not for sale. If the only marijuana you can obtain to do research cannot be made available as the end product, you are at a dead end." That the DEA would turn down the license request is little surprise given the agency's handling of Dr. Craker's application over the years. He first submitted it in July 2001, but the DEA failed to act at all for more than 18 months, and then only sent agents to U-Mass to attempt to persuade Dr. Craker to withdraw the application. After that came only further inaction, despite a dogged campaign by MAPS and Dr. Craker to get movement, including letters from both Massachusetts senators, John Kerry and Edward Kennedy, supporting the application. It was not until Craker and MAPS filed suit against the DEA in federal court in June of this year asking that the agency be ordered to explain its foot-dragging that the agency acted at all. Instead of explaining to the federal appeals court in Washington why it had refused to act, the DEA issued the denial last week. According to the DEA, the government-grade Mississippi operation provides researchers with "marijuana of sufficient quantity and quality to meet all their legitimate and authorized research needs in a timely manner." "There is one key problem in advancing medical marijuana research, and that is the government's monopoly on research marijuana and the ability of the drug czar and the DEA to use that monopoly to restrict research into the medical uses of marijuana," said MAPS executive director Rick Doblin. "FDA and NIDA are not the problem, the drug czar and the DEA are. They have decided that marijuana research is a fundamental threat to their propaganda. They exaggerate the risks in order to sustain a cruel and counterproductive policy and they suppress research that would challenge the propaganda," he told DRCNet. The DEA also cited the supposed dangers of smoked marijuana in rejecting the application, a position that led MAPS and MPP to accuse the agency of reaching conclusions before the clinical trials were undertaken and ignoring research with vaporized marijuana, not to mention flat-out lying about the state of current marijuana research. The agency's order said: "Current marijuana research has not progressed to Phase 2 of the clinical trials because current research must use 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." "The DEA's statement is simply false," said Doblin. "Phase 2 trials of marijuana -- which look at both safety and efficacy -- are underway now at the University of California, as is a study of vaporizer technology, which allows use of inhaled marijuana without smoking. The DEA is saying that we can't ever go to the FDA with marijuana because it has to be smoked, and that is simply not true. It is appalling that the DEA claims further research on medical marijuana is not in the public interest." A MAPS study of vaporizer technology has been stalled for 17 months by the federal government. "I am disappointed that the DEA seems to have decided that marijuana cannot be a medicine before the research has even taken place," Dr. Craker said. "We intend to appeal this decision and will keep trying to pursue vitally important research on medical uses of marijuana." For Doblin, there is a silver lining to the cloud. "The rejection of the application is a good thing," he argued. "For more than three years, the DEA tried to do nothing, but with the lawsuit we were able to force them to articulate their reasons for opposing this license. And those reasons are so pathetically weak and illogical that we are on good ground fighting them at the next level, the administrative law judge hearings. Now people will be able to see how the DEA is saying we don't need the research, they will block it. Their options are narrowing and narrowing, and we will ultimately prevail." Read all about Dr. Craker and MAPS' effort to obtain a DEA license, including the DEA's rejection letter, court filings, and much, much more at the MAPS medical marijuana research facility page, http://www.maps.org/mmj/mmjfacility.html online.
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