MAPS Letter to Dr. Nora Volkow - September 16, 2003 on U Mass Amherst Medical Marijuana Project|
September 16, 2003
Dr. Nora Volkow
Dear Dr. Volkow,
I'm writing you on behalf of the Multidisciplinary Association for Psychedelic Studies (MAPS, www.maps.org), a non-profit research and educational organization working to develop Schedule I drugs such as marijuana and MDMA into FDA-approved prescription medicines. As you probably know, NIDA has a monopoly on the supply of marijuana, but no other Schedule I drug, that can be used in FDA-approved medical research. What you may not realize is that NIDA's monopoly stands squarely in the way of an objective assessment of the potential medical uses of marijuana.
I'm writing you now because you have a unique opportunity to contribute to the ending of NIDA's politically-sustained monopoly on the supply of marijuana. MAPS urges you to submit a comment from NIDA to the Drug Enforcement Administration (DEA) supporting the June 25, 2001, application from Prof. Lyle Craker, UMass Amherst, for a license to establish a privately-funded marijuana production facility to produce high-potency marijuana for use exclusively in federally-approved research. DEA finally published notice of Prof. Craker's application in the Federal Register on July 24, 2003, more than two years after Prof. Craker submitted his application to DEA. DEA's public comment period ends September 22, 2003. At the least, we ask that NIDA refrain from submitting a comment opposing Prof. Craker's application. MAPS is the organization that is offering to fund Dr. Craker's facility.
Bill McColl, Director of the Office of National Affairs for the Drug Policy Alliance, will be attending the Sept. 18, 2003 meeting of the National Advisory Council on Drug Abuse and plans to address you about this issue during the public comment period. I'm hoping that your actions will be consistent with your inspiring statement in the August 19, 2003, New York Times interview, "If you want to be a scientist, you cannot allow politics to get in the way of your objectivity."
Previous NIDA Directors have wanted NIDA to get out of the business of being the nation's marijuana supplier. As a result, NIDA's monopoly would no longer exist if not for politically-motivated resistance by the Office of National Drug Control Policy (ONDCP) and the Drug Enforcement Administration (DEA).
NIDA's monopoly obstructs privately-funded medical marijuana research by preventing sponsors of research from choosing the specific strain of marijuana they prefer to study and from having control over issues of price and availability (NIDA has twice refused to supply marijuana to FDA-approved research projects). In addition, NIDA can legally only provide marijuana for research, not for possible prescription use, a situation that no sponsors can work with since all pharmaceutical drug development research needs to be conduced with the same drug that FDA will be asked to approve for prescription use.
Furthermore, U.S. laws that regulate the production of Schedule I drugs (21 C.F.R. 1301.33(b)) state that, "*In order to provide adequate competition,* the [DEA] Administrator shall *not* be required to limit the number of manufacturers in any basic class to a number less than that consistent with maintenance of effective controls against diversion *solely because* a smaller number is capable of producing an adequate and uninterrupted supply." [emphasis added] In other words, the laws governing the licensing of manufacturers of Schedule I drugs specifically address the possibility of monopolies and are written so that monopolies do not exist.
I look forward to hearing from you regarding this issue.
Rick Doblin, Ph.D.