CA NORML News
Feb 12th, Washington, DC. In response to a lawsuit brought by medical cannabis research advocates, Drug Enforcement Administration (DEA) Administrative Law Judge Mary Ellen Bittner ruled that the agency should stop blocking approval of a private cannabis research production facility at the University of Massachusetts.
In an 87-page ruling, Judge Bittner found that the public interest would be served by ending the government's monopoly on marijuana supplies (Text of ruling).
The lawsuit was sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS), which is sponsoring the U Mass project, with legal assistance from the ACLU.
“This is a major step to getting us to do the scientific research that the government has been blocking for the past 30 years," said MAPS Director and NORML board member Rick Doblin. "For decades, politicians have said that marijuana has no proven medical value while scientists have been denied the ability to prove otherwise,"
At present, the only legal source of marijuana in the U.S. is the government's research farm at the University of Mississippi, controlled by the National Institute on Drug Abuse (NIDA). However, NIDA tightened restrictions on access to its marijuana following passage of Prop. 215, refusing to make it available even by sale for certain FDA-approved medical marijuana studies.
In response, MAPS filed an application by U. Mass. Prof. Lyle Craker, a medicinal plant horticulturist, to establish a DEA-licensed cannabis research farm to supply researchers interested in medical cannabis R & D. After three and a half years of regulatory delay, the DEA rejected Prof. Craker's application in December, 2004, precipitating the MAPS lawsuit.
Judge Bittner sided with Prof. Craker in every major contention, rejecting the government's claims that present marijuana supplies are adequate, that international treaty forbids alternative marijuana suppliers, and that the University of Massachusetts failed to offer adequate security.
The DEA is not bound by Judge Bittner's decision and is not expected to issue a final reply to it for several months. Past DEA administrators have rejected other administrative law judge decisions, notably Judge Francis Young's 1988 ruling that marijuana should be rescheduled for medical use.
Nonetheless, the decision is expected to stir up pressure against the DEA within the new Democratic Congress, where supporters of medical marijuana have moved into leadership positions.
The establishment of a private producer of marijuana is crucial to conducting the kinds of FDA efficacy studies that the government has demanded in order to allow medical marijuana. Although NIDA has allowed its marijuana to be used in studies by California's state-sponsored Center for Medicinal Cannabis Research, the results of these studies cannot be used for FDA approval, since that would require a new drug application from the manufacturer. NIDA has indicated that it has no interest in filing a new drug application for its marijuana. Therefore another, private manufacturer is needed to begin the process of new drug approval.
In effect, the government has created a Catch-22 situation, in which it insists that FDA studies are needed to approve marijuana, while at the same time it blocks the studies.
Among the studies that NIDA has blocked is one on marijuana vaporizers sponsored by California NORML and MAPS. The study, designed by Chemic Labs of Canton, Mass., is aimed at developing a smoke-free delivery system for medical cannabis. Because the government has declared that smoking is an unacceptable delivery form, the development of a smoke-free alternative is essential to winning FDA approval of herbal cannabis for medicine. In 2004, Chemic Labs asked to purchase 10 grams of marijuana from NIDA for a vaporizer study. For comparison purposes, Chemic applied to import another 10 grams of high-CBD marijuana from a licensed supplier in the Netherlands. After an 18 month regulatory delay, the applications were denied by NIDA and DEA.
In light of Judge Bittner's decision, Chemic Labs is planning to re-submit the vaporizer research proposal shortly.
Drug reform advocates are hopeful that the Congress will hold hearings on the government's obstruction of medical marijuana. However, prospects of actually passing legislation remain dim so long as the Bush administration remains in power.
Text of Judge Bittner’s ruling is available online at: http://www.maps.org/ALJfindings.PDF.