Krissy Oechslin is assistant director of communications for the Marijuana Policy Project, www.mpp.org.
A handful of drug policy reformers found themselves in the heart of darkness recently as they observed hearings at the DEA's Arlington, Virginia, headquarters concerning a proposal to grow research-grade marijuana at a private facility. While it was heartening to have an opportunity to engage in a dialogue -- albeit one set in a courtroom -- with our opponents, the hearings made it clear that the DEA will employ any logic, however twisted, to quash efforts to make marijuana available as a medicine.
First, a bit of background: Dr. Lyle Craker applied in June 2001 for a DEA license to grow marijuana at the University of Massachusetts-Amherst, where he studies medicinal plants. The marijuana would have been used in clinical trials with the ultimate goal of FDA approval of marijuana as a prescription medicine. The DEA took more than three years -- until December 2004 -- to reject Dr. Craker's application (and even that was only under the force of a court ruling citing unreasonable delay); Dr. Craker is now appealing the DEA's decision.
The DEA cited three factors in rejecting Dr. Craker’s proposal: 1) Smoked marijuana will never be FDA-approved because it is too harmful to health. 2) No pharmaceutical companies have applied to the FDA to develop marijuana-based drugs, so there is no need to permit another facility to produce research-grade marijuana. 3) International treaty obligations forbid private marijuana production facilities such as the one proposed by Dr. Craker.
These arguments, as you may have guessed, are all false. 1) Declaring that smoked marijuana could never meet FDA standards is putting the cart before the horse -- the DEA is jumping to a conclusion based on research that has not yet been conducted because they won’t permit it. 2) No companies have applied to the FDA because they know the DEA almost never permits research on the medical benefits of marijuana. 3) There is no basis under international law for restricting the supply of marijuana for research purposes. In fact, a pharmaceutical company in England grows its own marijuana to produce an extract for sale to patients, and it has not gone afoul of international treaty obligations.
The U.S. has a single source of marijuana for research purposes: a farm at the University of Mississippi, grown under contract for the National Institutes on Drug Abuse. That marijuana, though, can never be used in FDA trials because it is under no requirement to contain specific levels of marijuana's individual chemical components, which would be necessary for FDA-approved research.
Why, then, should we go to all this trouble? The absence of FDA approval is one of the most frequent, seemingly logical arguments raised by opponents of medical marijuana. Supreme Court Associate Justice Stephen Breyer told medical marijuana patient Angel Raich to take her case to the FDA during her recent Supreme Court battle, and the drug czar's office points to the lack of FDA approval as a reason to continue arresting and incarcerating people with cancer and AIDS.
FDA trials could also uncover and refine new uses for marijuana, better delivery methods (such as vaporization), and controls over its prescription and dispensing.
But because the Amherst facility is still a proposal, not a reality, no researchers have any plans to use the marijuana that Dr. Craker might someday grow. And without commitments from researchers, there would be no funding for Dr. Craker’s proposed facility.
Fortunately, MAPS -- the Multidisciplinary Association for Psychedelic Studies -- is ready and willing to pony up for the Amherst production center. MAPS sees itself as a nonprofit pharmaceutical company, funding not just research into the uses of illicit drugs (like marijuana, MDMA, and psilocybin) but also, as in the Amherst case, the production of the drugs themselves so research can begin.
It would seem obvious, then, that a private facility to produce marijuana for medical research is desperately needed. Obvious to everyone but the DEA.
Through the administrative law hearings, which were held the last week of August and will continue at the end of September and again in December if necessary, the DEA attorneys’ line of questioning indicated that they just don’t “get it.” Dr. Craker’s proposal was raked over the coals in search of every single flaw, every possibility that hadn’t been thought out ahead of time -- never mind the fact that many details have not yet been determined simply because the DEA has not granted him the license.
The DEA seems to think the marijuana supplied through the University of Mississippi is just fine, even though it’s not suitable for FDA trials. It's also notoriously difficult to obtain and of such low quality that some patients in the few ongoing DEA-approved and studies have complained and even dropped out. But this is all irrelevant: Even if the federal marijuana was top-notch and handed out freely to researchers, it is essentially useless for FDA trials. The DEA is using the Mississippi marijuana as a red herring.
The DEA’s intransigence may, in fact, help our cause. It says far more about the federal government's empty rhetoric than we ever could. Though Dr. Craker may never get approval to grow marijuana for research purposes, the DEA’s true motives have been revealed and the FDA is no longer a reasonable avenue for pushing the medical marijuana issue. Congress and state legislatures can -- and must -- act to keep people out of jail for using marijuana under the advice of a doctor, with or without FDA approval.
Of course, there’s still the possibility that the DEA’s administrative law judge will rule in favor of Dr. Craker’s proposal. Even then, though, the DEA is under no obligation to follow rulings from its administrative law judges: DEA Administrative Law Judge Francis Young ruled in 1988 that marijuana should be available as medicine and that it would be “unreasonable, arbitrary and capricious” for the DEA to forbid the seriously ill from using marijuana. The DEA, apparently, missed that memo.
For more information about Dr. Craker’s proposal, legal documents in the case, and transcripts of the DEA administrative law hearings, please visit www.maps.org/mmj/.