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 marijuanawas officially taken out of the United States Pharmacopeia and National Formulary.

Since that time, all legal production of marijuana for medical research has beenfunded (monopolized) by the federal government.

The federal government does not retain a monopoly on the production of anyother Schedule I drug, with multiple private producers having DEA licenses tomanufacture MDMA, psilocybin, etc., for sale for use in federally-approved research.

In fact, the laws regulating the licensing of producers of Schedule I drugsspecifically require adequate competition, the opposite of a monopoly. Title21 of the Code of Federal Regulations, Section 1301.33(b), states: "Inorder to provide adequate competition, the Administrator shall not be requiredto limit the number of manufacturers in any basic class to a number less thatthat consistent with maintenance of effective controls against diversion solelybecause a smaller number is capable of producing an adequate and uninterruptedsupply."

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 toResearch Triangle Institute in North Carolina for rolling into standardizedcigarettes, usually with about 4% THC, with the highest potency available (insmall quantities) being 7% THC. A medical marijuana potency study conducted byMAPS and CaNORML showed that the most popular varieties of marijuana offered topatients 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. Thelow potency of NIDA's material has been criticized by patients and researchersas being one reason why NIDA's material is undesirable for a serious drugdevelopment research program.

Furthermore, NIDA has twice refused to provide marijuana to FDA-approvedmedical marijuana research protocols, claiming it didn't like the design of thestudies. As long as NIDA retains its monopoly on the supply of marijuana thatcan be used in research, private sponsors of medical marijuana research 1)cannot select the exact strain of marijuana with the exact mix of cannabinoidcontent 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 controlof either availability and cost, and 3) cannot guarantee to supply the exactdrug that was researched for possible prescription use since NIDA is legallyauthorized to grow marijuana for research but cannot supply it on aprescription basis. No rational sponsor will invest millions of dollars inmedical marijuana research while it remains dependent for its supply ofresearch material on NIDA, whose institutional mission is diametrically opposedto exploring the beneficial uses of marijuana and which cannot in any caselegally provide marijuana for prescription use.

Prof. Craker originally submitted his application to DEA on June 25, 2001, withhis facility to be funded by the Multidisciplinary Association for PsychedelicStudies (MAPS, www.maps.org), a non-profitresearch and educational organization working to develop marijuana into anFDA-approved prescription medicine. For the first year, DEA claimed to have"lost" the application and refused to accept the resubmission of a photocopybecause it didn't have an original signature. Then, DEA returned the originalapplication to Prof. Craker with a DEA date stamp showing it had been receivedwhen it was sent and was never lost! Prof. Craker resubmitted the originalapplication and, for the second year, DEA unsuccessfully tried to encourageProf. Craker and the UMass Amherst administrators to withdraw the application.DEA also claimed that it was prohibited from licensing the privately-fundedUMass Amherst facility due to US international treaty obligations. This claimwas refuted in a legal analysis submitted to DEA that was prepared pro bono byDC 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 HomeOffice licensing of privately-funded GW Pharmaceuticals to produce marijuanafor medical purposes, without a peep of protest from the International NarcoticControl Board which monitors compliance with international drug controltreaties. (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'sapplication in the Federal Register, even though it should have posted itshortly after the license was submitted. Public comments, limited to people whohave applied for or possess a similar license, must be submitted by Sept.22,2003, with a decision from DEA expected shortly thereafter. If DEA rejectsthe application, which is what it has indicated will probably take place, alawsuit will be initiated and yet another DEA Administrative Law Judge hearingwill result about the medical use of marijuana. Alternatively, if enoughpolitical pressure can be brought to bear on DEA and ONDCP, DEA will approvethe license. Then, as Ex-DEA Administrator Asa Hutchinson stated on November28, 2001 "the question of whether marijuana has any legitimate medical purposeshould [will] be determined by sound science and medicine."

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

Back to Top