MAPS Comments on DEA's "Order to Show Cause"
DEA finally rejected the application from Prof. Lyle Craker, UMass Amherst, seeking a license to establish a MAPS-sponsored facility to produce marijuana for federally-approved research, 3 and 1/2 years after the application was initially filed. DEA acted under pressure from MAPS' July 21 lawsuit arguing "unreasonable delay" and the DC Circuit Court of Appeals Nov. 22 decisionwhich gave DEA until Dec. 22 to reply. Just as we'd hoped, the lawsuit forced DEA to issue its ruling, which we can now challenge in the context of Administrative Law Judge hearings.
DEA's "Order to Show Cause" says that we have 30 days to submit an appeal for an Administrative Law Judge (ALJ) hearing and that if we don't, the application will be rejected. We will, of course, appeal and will launch yet another ALJ hearing. The "Order to Show Cause" gives DEA's explanations for its decision. After reading how weak and fallacious DEA's arguments are, it's easy to understand why DEA didn't want to issue this ruling and had to be sued in order to force it to do so, 3 and 1/2 years after the application was initially filed.
DEA considers the application to be not consistent with the public interest. My favorite DEA rationale is that despite our claim that NIDA's monopoly obstructs our efforts to do research, DEA says that its rejection of the application doesn't violate the public interest since "Current marijuana research has not progressed to Phase 2 of the 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." [See 8 (a) on page 4 of DEA's Order.]
Basically, DEA is saying that since it can prejudge the outcome of FDA-approved research and knows that smoked marijuana "ultimately cannot be permitted," therefore denying us the opportunity to do the research in the first place isn't against the public interest. What makes this all the more ludicrous is that the DEA lawyers don't even understand the FDA drug review process enough to know that there are currently several Phase II studies with smoked marijuana underway and already approved by DEA!
DEA focus on "smoked marijuana" also ignores the whole concept of vaporization as an alternative non-smoking delivery system that MAPS has already studied. Vaporization uses the marijuana plant and heats it to less than the temperature of burning, sufficient to generate a steam that contains cannabinoids but without the products of combustion which are of health concern. For the last 17 months, DEA has been blocking our efforts to import 10 grams of marijuana from the Dutch, and HHS/NIDA has been blocking our efforts to purchase 10 grams of marijuana from NIDA, both requests seeking marijuana for further laboratory research with vaporizers.
DEA's claims that US international treaty obligations prevent it from issuing the license to UMass Amherst are false, as the example of GW Pharmaceuticals proves. GW is a private producer of marijuana in England, which is also a signatory to the same international treaties that the US has signed. The International Narcotic Control Board (INCB), which monitors compliance with the treaties, has never once objected to the British Home Office licensing of GW's production facility, which took place more than six years ago in 1998. For a document submitted July 24, 2002, to DEA Administrator Asa Hutchinson analyzing US international treaty obligations, written by Peter Barton Hutt and Alexei M.Silverman of DC law firm Covington & Burling (which helped on the Ashcroft v. Raich case pro-bono), and Graham Boyd, American Civil Liberties Union, Drug Policy Litigation Project, see mmj/treatyanalysis.pdf.