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Dea and The Umass Amherst Medical Marijuana Production Facility

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Dea and The Umass Amherst Medical Marijuana Production Facility

Marijuana

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alienship550
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12 maps • volume xiii number 1• spring 2003

DEA and the UMass Amherst Medical


Marijuana Production Facility: An Update
Rick Doblin, Ph.D.
DEA Finally Replies After 18 Months

Since 1992, MAPS has been working to sponsor a privately-funded medical marijuana drug
development research program. In late 1999, MAPS and Prof. Lyle Craker, Director of the Medicinal
Plant Program, Department of Plant and Soil Sciences, UMass Amherst, began working together to
establish a Massachusetts Department of Public Health and Drug Enforcement Administration
(DEA)-licensed medical marijuana production facility. The facility is to be funded by a grant to
UMass Amherst from MAPS and is intended to produce high-potency marijuana for use exclusively
in federally-approved scientific research. In June 2001, Prof. Craker submitted his license applica-
tion to the DEA, with full support from the UMass
Amherst administration. For a complete, documented
“The fundamental history of this effort, see http://www.maps.org/mmj/
question posed to the mmjfacility.html
On December 16, 2002, several DEA agents went
DEA by Prof. Craker’s to UMass Amherst to meet with Prof. Craker and sev-
application for a license eral senior members of the UMass Amherst adminis-
tration. Unfortunately, it turned out that the pur-
to produce marijuana is pose of the meeting was to persuade Prof. Craker and
whether or not the DEA UMass Amherst to withdraw the application, which
they declined to do.
will open the door to a On March 4, 2003, DEA responded in writing for
privately-funded medical the first time to Prof. Craker’s application, more than
20 months after the application was originally sub-
marijuana drug mitted (it had been “lost” for over a year). The let-
development program.” ter, from Frank Sapienza, Chief, Drug and Chemical
Evaluation Section, stated that DEA was inclined to
reject the application because it believed that NIDA
can supply marijuana “acceptable to the research community.” The testimony of Dr. Ethan Russo,
who wrote to DEA to say that he found the quality of NIDA material to be substandard, was
discounted since Dr. Russo “has not been registered by the DEA to conduct research with mari-
juana.” Ironically (at least to us), Dr. Russo was not registered with DEA to conduct human clinical
research with marijuana (though he is registered with the DEA to conduct laboratory research with
marijuana) because NIDA and the Public Health Service (PHS) didn’t like his privately-funded,
FDA-approved protocol and refused to sell him marijuana, effectively preventing his study from
taking place.

MAPS Response

MAPS responded in writing to the DEA letter by pointing out that while the poor quality of
maps • volume xiii number 1 • spring 2003 13

NIDA material is an important consideration, grow a variety of strains of marijuana as part of


there are other fundamental reasons why DEA its privately-funded research into the medical
licensing of the UMass Amherst facility is neces- uses of marijuana extracts. Unfortunately, DEA
sary to facilitate medical marijuana research. As support for NIDA’s monopoly seems to be more
long as NIDA retains its monopoly on the supply about controlling medical marijuana research
of marijuana that can be used in research, pri- than about controlling drug diversion, DEA’s pri-
vate sponsors of medical marijuana research 1) mary responsibility.
cannot select the exact strain of marijuana with MAPS has asked the Marijuana Policy Project,
the exact mix of cannabinoid content that the the Drug Policy Alliance, the National Organiza-
sponsors consider most likely to be safe and ef- tion for Marijuana Laws, and Patients Out of Time
ficacious, 2) cannot manufacture the drug they to write letters to the DEA. These letters will point
wish to research and thus are not in control of out, among other things, that as long as the DEA
either availability and cost, and 3) cannot sup- defends NIDA’s monopoly, funders will not invest
ply the exact drug that was used in research for in scientific research they perceive as politically
possible prescription use since NIDA is legally obstructed but will continue to prioritize state
authorized to grow marijuana for research but and federal legislative approaches and state ini-
cannot supply it on a prescription basis. tiatives. MAPS has also been in contact with Sena-
MAPS also emphasized a procedural reason tor Edward Kennedy and his staff, who we are
why DEA support for NIDA’s monopoly on supply hoping will eventually take an active role in sup-
serves to obstruct medical marijuana research. port of the UMass Amherst facility. DEA support
At present, NIDA will not sell marijuana to a of NIDA’s monopoly effectively discourages pri-
researcher with a privately-funded and FDA-ap- vately-funded research, making federal calls for
proved protocol unless the protocol is also ap- more research ring hollow.
proved by a NIDA/PHS review process. Since NIDA
has a monopoly on the supply of marijuana, but
not any other Schedule I drug such as MDMA,
LSD or psilocybin, this additional review process Marijuana Research in Israel
exists only for marijuana research and has twice
been used to prevent privately-funded, FDA-ap- MAPS is also working to facilitate
proved protocols from taking place. medical marijuana research in Israel. The
As a result of NIDA’s monopoly, no rational Israeli Ministry of Health has approved a
sponsor will invest millions of dollars in medical small number (about ten) of physician-
marijuana research while it remains dependent recommended patients for legal access to
for its supply of research material on NIDA, whose marijuana for medical purposes. MAPS has
institutional mission is diametrically opposed to agreed to donate $10,000 to cover the
exploring the beneficial uses of marijuana and costs of a researcher to periodically evalu-
which cannot legally provide marijuana for pre- ate the health status of these patients.
scription use. Maripharm, a Dutch-government licensed
The fundamental question posed to the DEA medical marijuana growing company, is
by Prof. Craker’s application for a license to pro- considering donating the necessary mari-
duce marijuana is whether or not the DEA will juana for the study. This project is tenta-
open the door to a privately-funded medical mari- tively scheduled to begin in mid-2003.
juana drug development program. This is the
model adopted by GW Pharmaceuticals in En-
gland, licensed by the British Home Office to

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