One of the drug warriors' favorite arguments against state medical marijuana laws and initiatives is that the medical use of marijuana has not been approved by the FDA and that more scientific research must be conducted. What they don't say is that marijuana is treated differently than all other drugs.

The federal government, through the National Institute on Drug Abuse (NIDA), retains a monopoly on the supply of marijuana that can be used in FDA-approved research and has twice refuse to supply it to privately-funded FDA-approved studies. Over two years ago the Medicinal Plant Program at UMass Amherst applied for a license to produce marijuana for research purposes only to be given the run around by the DEA. Finally, in July this year the DEA officially announced the program's application. A decision is expected shortly after the end of the public comment period on September 22, 2003.

The DEA has indicated that it probably won't approve the application so we have to act now to stop the cycle keeping medical marijuana from sick and dying patients.

As a doctor and senior member of the Office of National Drug Control Policy, Barthwell holds authority over this issue. Through news articles she has become a vocal part of the Drug Czar's campaign against medical marijuana. Her most recent article explicitly says that "If a substance has the proven capacity to serve a medical purpose, then it will be accepted."

Yet, Dr Barthwell, along with the Drug Czar, continues to support the governmental stranglehold on marijuana production hindering such research. See Dr Barthwell's article here:

http://www.mapinc.org/drugnews/v03/n1148/a02.html

NIDA produces only low-potency material with stems included meaning that patients have to inhale more smoke to get any of the beneficial effects, decreasing the chance FDA will approve it. The UMass team wants to produce a small quantity of high-potency marijuana. As long as NIDA retains its monopoly on the supply of marijuana that can be used in research, no rational sponsor will invest money in the research required to get marijuana approved as a medicine. Your help is needed to break the government's monopoly on the supply of marijuana in order to unshackle medical marijuana research.

Write Dr. Andrea Barthwell, Deputy Director for Demand Reduction, Office of National Drug Control Policy, urging her to recommend that the DEA approve the Umass/Amherst license. You can use the NORML provided tool at: http://capwiz.com/norml2/issues/alert/?alertid=3171511&type=CU

Fax Dr. Andrea Barthwell, Deputy Director for Demand Reduction, Office of National Drug Control Policy, urging her to recommend that the DEA approve the UMass license. Use the DPA provided tool at: http://actioncenter.drugpolicy.org/action/index.asp?step=2&item=11290

The non-medical use of marijuana was criminalized (taxed out of legal existence) in the US in 1937 but medical use was still permitted until 1941, when marijuana was officially taken out of the United States Pharmacopeia and National Formulary. Since that time, all legal production of marijuana for medical research has been funded (monopolized) by the federal government.

The federal government does not retain a monopoly on the production of any other Schedule I drug, with multiple private producers having DEA licenses to manufacture MDMA, psilocybin, etc., for sale for use in federally-approved research. In fact, the laws regulating the licensing of producers of Schedule I drugs specifically require adequate competition, the opposite of a monopoly. Title 21 of the Code of Federal Regulations, Section 1301.33(b), states: "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 that that consistent with maintenance of effective controls against diversion solely because a smaller number is capable of producing an adequate and uninterrupted supply."

At present, the National Institute on Drug Abuse (NIDA) contracts to Dr. ElSohly at the University of Mississippi to grow marijuana at an outdoor, fenced facility with 24-hour armed guards. The product that is grown is seeded, leafy, low-potency material with stems included. The product is sent to Research Triangle Institute in North Carolina for rolling into standardized cigarettes, usually with about 4% THC, with the highest potency available (in small quantities) being 7% THC. A medical marijuana potency study conducted by MAPS and CaNORML showed that the most popular varieties of marijuana offered to patients at Buyers' Clubs around the country were in the range of 12-15% THC, substantially reducing the amount of smoke or vapors (if vaporizers are used) that patients need to inhale to obtain the desired dose of cannabinoids. The low potency of NIDA's material has been criticized by patients and researchers as being one reason why NIDA's material is undesirable for a serious drug development research program.

Furthermore, NIDA has twice refused to provide marijuana to FDA-approved medical marijuana research protocols, claiming it didn't like the design of the studies. As long as NIDA retains its monopoly on the supply of marijuana that can be used in research, private sponsors of medical marijuana research:

1) cannot select the exact strain of marijuana with the exact mix of cannabinoid content that the sponsors consider most likely to be safe and efficacious,

2) cannot manufacture the drug they wish to research and thus are not in control of either availability and cost, and

3) cannot guarantee to supply the exact drug that was researched for possible prescription use since NIDA is legally authorized to grow marijuana for research but cannot supply it on a prescription basis.

No rational sponsor will invest millions of dollars in medical marijuana research while it remains dependent for its supply of research material on NIDA, whose institutional mission is diametrically opposed to exploring the beneficial uses of marijuana and which cannot in any case legally provide marijuana for prescription use.

Prof. Craker originally submitted his application to DEA on June 25, 2001, with his facility to be funded by the Multidisciplinary Association for Psychedelic Studies (MAPS, www.maps.org), a non-profit research and educational organization working to develop marijuana into an FDA-approved prescription medicine. For the first year, DEA claimed to have "lost" the application and refused to accept the resubmission of a photocopy because it didn't have an original signature.

Then, DEA returned the original application to Prof. Craker with a DEA date stamp showing it had been received when it was sent and was never lost! Prof. Craker resubmitted the original application and, for the second year, DEA unsuccessfully tried to encourage Prof. Craker and the UMass Amherst administrators to withdraw the application. DEA also claimed that it was prohibited from licensing the privately-funded UMass Amherst facility due to US international treaty obligations. This claim was refuted in a legal analysis submitted to DEA that was prepared pro bono by DC law firm Covington & Burling and the ACLU Drug Policy Litigation Project. DEA's claim is also refuted by the example of the April 1998, British Home Office licensing of privately-funded GW Pharmaceuticals to produce marijuana for medical purposes, without a peep of protest from the International Narcotic Control Board which monitors compliance with international drug control treaties. (In 2002, GW Pharmaceuticals produced 5-6 tons of dried material, substantially more than the 25 pounds Prof. Craker is seeking to produce.)

Finally, on June 25, 2003, DEA posted an announcement of Prof. Craker's application in the Federal Register, even though it should have posted it shortly after the license was submitted. Public comments, limited to people who have applied for or possess a similar license, must be submitted by Sept. 22,2003, with a decision from DEA expected shortly thereafter.

If DEA rejects the application, which is what it has indicated will probably take place, a lawsuit will be initiated and yet another DEA Administrative Law Judge hearing will result about the medical use of marijuana. Alternatively, if enough political pressure can be brought to bear on DEA and ONDCP, DEA will approve the license. Then, as Ex-DEA Administrator Asa Hutchinson stated on November 28, 2001 "the question of whether marijuana has any legitimate medical purpose should [will] be determined by sound science and medicine."

A history of the efforts of MAPS and Dr. Craker to obtain a DEA license for the UMass Amherst production facility, with extensive supporting documents, can be found at: http://www.maps.org/mmj/mmjfacility.html