March 17, 2004
City, State, Zip
Your help is urgently needed to catalyze necessary FDA-approved research into the risks and benefits of the medical use of marijuana.
I'm writing you now because the Drug Enforcement Administration (DEA) has requested letters from physicians willing to recommend that DEA issue a license for a privately-funded medical marijuana production facility at the University of Massachusetts, Amherst. The facility would be under the direction of Prof. Lyle Craker, Director of the Laboratories for Natural Products, Medicinal and Aromatic Plants, Department of Plant and Soil Sciences, and would produce marijuana exclusively for federally-approved research. The facility would be funded by MAPS, the non-profit research and educational organization that I founded and direct.
Prof. Craker originally applied for his license on June 26, 2001. On October 20, 2003, Senators Edward Kennedy and John Kerry wrote a letter to the DEA expressing their support for the UMass Amherst facility. In February 2004, DEA contacted Prof. Craker and asked for letters of support from physicians, to arrive at DEA before April 9, 2004.
At present, the National Institute on Drug Abuse (NIDA), an organization with an institutional mission diametrically opposed to the medical use of marijuana, has a monopoly on marijuana that can be used in research. NIDA does not have a monopoly on the supply of any other Schedule I drug. As a result of NIDA's unique monopoly on marijuana, private funders have not been willing to invest in medical marijuana research aimed at developing marijuana into an FDA- approved medicine. NIDA's marijuana can legally be used only for research but not prescription use, it's product is low- potency, it's review process is exceedingly time-consuming and NIDA has twice refused to even sell marijuana to FDA- approved researchers, preventing those studies from taking place. If DEA does grant a license to grow marijuana to Prof. Craker at UMass Amherst, FDA-approved medical marijuana research will flourish.
Enclosed are two copies of a pre-printed sample letter and pre-addressed labels to DEA and Prof. Craker. Since DEA has a history of losing documents related to the UMass Amherst application (DEA pretended for a year to have lost the application itself), a copy of your letter to DEA should also be sent to Prof Craker. If you have time, writing your own letter or just typing our sample letter on your letterhead would be more effective but is not necessary.
A complete history of the UMass Amherst application, with supporting documents, can be found on the MAPS website at: http://www.maps.org/mmj/mmjfacility.html If you have questions, I can also be reached at 617 484-8711. Thank you for reading so far and for considering this request to take the time to send these letters.
Rick Doblin, Ph.D.
SAMPLE LETTER TO DEA
City, State, Zip
Ms. Helen Kaupong
Drug Enforcement Administration
700 Army Navy Drive
Arlington, VA 22202
Dear Ms. Kaupong;
I'm a physician and am writing to recommend that the DEA grant a license to produce marijuana exclusively for federally-approved research to Prof. Lyle Craker, Director of the Laboratories for Natural Products, Medicinal and Aromatic Plants, Department of Plant and Soil Sciences, UMass Amherst.
In my view, we need more scientific research, both government-funded and privately-funded, into the risks and benefits of the medical uses of marijuana.
At present, marijuana for research is currently available only from the National Institute on Drug Abuse (NIDA). However, NIDA can legally only provide marijuana for research but not for potential prescription use. In addition, NIDA cannot be relied upon to provide marijuana for all FDA-approved protocols, has a time-consuming review process and a low-potency product. In order to stimulate privately-funded research investigating whether marijuana could become an FDA-approved prescription medicine, DEA should license Prof. Craker's privately-funded growing operation.
OPTIONAL: The strongest letters would be from doctors who also say that they are deterred from seeking permission to conduct research due to NIDA's monopoly and would consider conducting research if the UMass Amherst facility were to be established.
By issuing a license to Prof. Craker, the DEA will demonstrate that it is interested in facilitating, rather than obstructing, the resolution of the question of marijuana's potential medical uses.
cc. Prof. Lyle Craker
UMass Dept. Plant and Soil Sciences
Stockbridge Hall-Room 12A
Amherst, MA 01003
COPY OF LETTER FROM SENATORS KENNEDY AND KERRY TO DEA
United States Senate
Washington DC 20510
October 20, 2003
Ms. Karen Tandy
Drug Enforcement Administration
2401 Jefferson Davis Highway
Alexandria, VA 22301
Dear Ms. Tandy,
We are writing to express our strong support for the application by the University of Massachusetts Amherst for registration as a bulk manufacturer of marijuana for distribution to researchers in clinical investigations authorized by the Food and Drug Administration and non-clinical investigations at DEA-licensed laboratories.
We believe that the National Institute on Drug Abuse facility at the University of Mississippi has an unjustifiable monopoly on the production of marijuana for legitimate medical and research purposes in the United States. Federal law makes clear that the importation and bulk manufacture of Schedule I and II substances must be provided "under adequately competitive conditions." ( 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).)
Federal law clearly requires adequate competition in the manufacture of Schedule I and II substances. The current lack of such competition may well result in the production of lower-quality research-grade marijuana, which in turn jeopardizes important research into the therapeutic effects of marijuana for patients undergoing chemotherapy or suffering from AIDS, glaucoma, or other diseases.
The University of Massachusetts Amherst is one of the nation's most distinguished research universities, and it is highly qualified to manufacture marijuana for legitimate medical and research purposes with effective controls against diversion. We urge you to grant the university's application for registration as a bulk manufacturer.
With respect and appreciation,
Edward M. Kennedy
John F. Kerry