UMASS AMHERST APPLICATION FOR A DEA LICENSE
TO GROW MARIJUANA FOR MEDICAL RESEARCH

By Rick Doblin, Ph.D., October 27. 2003

PROBLEM: MEDICAL USE OF MARIJUANA DECIDED BY ELECTIONS AND COURTS, NOT FDA-APPROVED SCIENTIFIC RESEARCH.

As a direct result of NIDA's monopoly on the supply of marijuana (but no other Schedule I drug) that can be used in FDA-approved research, the issue=20of the potential medical uses of marijuana is not being resolved by privately- funded scientific research approved and reviewed by FDA. Instead, it is primarily being decided by privately-funded state initiatives and legislative actions, and by U.S. Supreme Court rulings.

NIDA's monopoly on the supply of marijuana prevents potential sponsors of research from choosing the strain of marijuana they would prefer to research (primarily a choice between varieties with different ratios of the cannabinoids, THC and CBD, with NIDA offering low-potency, low-quality material), makes sponsors dependent on NIDA for price and availability (NIDA has twice refused to provide marijuana to protocols it didn't like even though FDA approved=20the protocols), and forces sponsors to conduct research with a specific plant strain that cannot be guaranteed to be available for prescription use (NIDA is limited by law to providing marijuana for research but cannot provide it 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.

CONSEQUENCES: UNDERMINING FDA, DIMINISHED FEDERAL CREDIBILITY.

FDA's drug review and approval system is undermined as this issue increasingly spirals out of federal control, with the needs of patients and physicians for the best scientific information on potential treatments not being met. Furthermore, the overall credibility of federal government drug control agencies (ONDCP/DEA/NIDA) is diminished by the contradiction between calling for more research, on the one hand, and obstructing privately-funded research on the other.

Credibility problems will increase if this issue becomes the subject of a lawsuit leading to a DEA Administrative Law Judge hearing. The ALJ will probably not look favorably on DEA flouting US laws mandating competition in the legal production of Schedule I drugs or on any attempt by DEA to claim that private production of marijuana runs counter to US international treaty obligations. The British Home Office licensed GW Pharmaceuticals to grow marijuana in April 1998 and the International Narcotic Control Board (INCB) has not and will not object. Furthermore, if there is one thing most members of Congress agree upon regarding this issue, it is that research on the therapeutic benefits of marijuana is needed.

SOLUTION: PRIVATELY-FUNDED PRODUCTION FACILITY

DEA should approve the application from Prof. Craker, Director of the Laboratories for Natural Products, Medicinal and Aromatic Plants, Department of Plant and Soil Sciences, UMass Amherst, for a license to establish a privately- funded production facility to provide high-potency marijuana exclusively for use in federally-approved research.

If the UMass Amherst facility is approved, NIDA would no longer be the sole provider of marijuana for medical research. FDA, DEA and local Institutional Review Boards (IRBs) will still be required to approve all clinical research protocols, but privately-funded protocols will not need to be reviewed and approved by NIDA/PHS, a requirement that currently exists only for marijuana but not for privately-funded research with any other Schedule I drugs. ONDCP/DEA/NIDA could finally say that the issue of the medical use of marijuana is being treated like the medical use of any other drug.

CONSEQUENCES OF SOLUTION: MEDICAL MARIJUANA AND YOUTH MARIJUANA USE

Suggestive evidence, funded by ONDCP, supports the position that increased medical marijuana research and even FDA approval of marijuana as a prescription medicine would have a minimal effect on decisions by youth regarding marijuana use. In 1997 and 1998, ONDCP provided additional money for the National Household Survey on Drug Abuse (NHSDA) to increase sample size in California and Arizona. The NHSDA reported in 1998 that, 'In response to propositions passed by voters in California and Arizona in 1996 for the legalization of some illicit drugs for certain medical uses, the NHSDA sample was supplemented in those states in 1997 and 1998 to measure the potential impact of these voter initiatives.' The report noted that samples sizes for California were also large enough in 1995 and 1996 'to allow examination of longer term trends for that state.' The results of these surveys failed to demonstrate any significant link between the substantial amounts of favorable publicity and public support for the medical use of marijuana and subsequent non-medical use patterns of marijuana by youths in those two states The report noted that, in California, 'rates [of marijuana use] for both youths and adults have been stable since 1995.' In Arizona, marijuana use for all age groups combined declined from 6.1% in 1997 to 5.1% in 1998. In addition, among Arizona youths aged 12-17, 'there were significant increases in the percentage reporting great risk in using marijuana once or twice a week (from 46.6 percent to 52.7 percent).'

CONCLUSION: WHAT IS 21st CENTURY MEDICINE?

Whether 21st Century medicine will include the prescription use of the marijuana plant, either smoked or with the use of vaporizers, a newly invented non-smoking delivery system that works with the marijuana plant itself to eliminate combustion products and reduce particulate matter, is an issue that should most appropriately be decided by FDA. While more federal money for research would facilitate FDA-approved studies, NIH has not put out a special request for proposals for research into marijuana's medical uses. The only clinical studies currently being conducted in patients are funded by the State of California (Center for Medicinal Cannabis Research) or California's San Mateo County. Additional sums for a realistic FDA-approved drug development effort are needed and can be provided by the private sector within a non-profit drug development context (MAPS). However, privately-funded research is contingent upon sponsors having an independent source of supply as would be provided if DEA approves Prof. Craker's application for a license for a privately-funded production facility.

Multidisciplinary Association for Psychedelic Studies
MAPS Rick Doblin 3 Francis Street Belmont, MA. 02478-2218
617 484-8711, Fax: -8427 www.maps.org rick@maps.org