Ms. Laura Nagel
Deputy Assistant Administrator
Office of Diversion Control
Drug Enforcement Administration
US Department of Justice
Washington, DC 20537
Dear Ms. Nagel,
I'm writing to respond to the comment you received from Dr. Mahmoud ElSohl= y,the Director of NIDA's Marijuana Project at the University of Mississippi.= Dr.ElSohly submitted his comment in response to DEA's Federal Register notic= e ofJuly 24, 2003 (FR Doc. 03-18866) announcing the application from Prof. LyleCraker, UMass Amherst, for a license to bulk manufacture marijuana. The public comment period ended on September 22, 2003, and MAPS obtained Dr.ElSohly's letter through a Freedom of Information Act (FOIA) request.
Prof. ElSohly objected to the licensing of a facility at UMass Amherst on the grounds that his facility, funded by NIDA, produces materials that "are enough, both qualitatively and quantitatively, to satisfy any possible needs of the research community."
Unfortunately, that statement is false. For example, Chemic Labs requires marijuana with higher levels of THC and CBD than Dr. ElSohly can provide. Chemic Labs is conducting MAPS-sponsored laboratory research into the constituents of vapors produced when marijuana has beenheated but not burned in a device known as a vaporizer. As you are probably aware, Chemic Labs has applied to DEA for a permit to import 10 grams of marijuana from the Dutch Office of Medicinal Cannabis of the SIMM 18 variety. This product contains 13.2% THC and 7.6% CBD, cannabinoid levels that NIDA does not have available.
In a rather humorous indication of just how unaware NIDA and Dr. ElSohly are about what some members of the research community require, Dr. ElSohly acknowledged that he and NIDA didn't consider it a significant issue that for over twenty years, low-potency material was provided that included seeds and sticks! At least Dr. ElSohly said that seeds and sticks have supposedly been eliminated from current production.
Even assuming that NIDA could satisfy any possible needs of the research community, NIDA's monopoly serves to obstruct privately-funded research. As long as NIDA and Dr. ElSohly retain a monopoly on the supply of marijuana, sponsors of privately-funded research are prevented from choosing the strain of marijuana they would prefer to research. Different strains have different ratios of the cannabinoids, THC and CBD, with NIDA offering low-potency, low-quality material.
NIDA's monopoly also makes privately-funded sponsors dependent on NIDA for price and availability. This is problematic since NIDA has twice refused to provide marijuana to protocols it didn't like even though FDA approved the protocols. Furthermore, NIDA is limited by law to providing marijuana for research but cannot provide it for prescription use. As a result, NIDA's monopoly forces sponsors to conduct research with a plant strain provided by NIDA that cannot be guaranteed to be available for prescription use.
No rational private sponsor will invest the millions of dollars needed to conduct the research required by FDA with the limitations imposed by NIDA's monopoly on supply. Dr. ElSohly also didn't comment on how NIDA's monopoly is inconsistent with US law requiring competition in the production of scheduled materials for use in research.
Federal law makes clear that the importation and bulk manufacture of Schedule I and II substances must be provided "under adequately competitive conditions." 21 U.S.C. 823 (a) (1). Federal regulations also provide:
"In order to provide adequate competition, the 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." 21 C.F.R. 1301.33 (b).
I look forward to DEA's decision regarding Prof. Craker's application. I hope DEA acts to facilitate medical marijuana research so that this controversial issue can be resolved through the conduct of FDA-approved scientific research rather than through yet another lawsuit against the DEA and further political rather than medical initiatives.
Rick Doblin, Ph.D.
Multidisciplinary Association for Psychedelic Studies
MAPS Rick Doblin 3 Francis Street Belmont, MA. 02478-2218
617 484-8711, Fax: -8427 www.maps.org firstname.lastname@example.org