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.

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:
http://actioncenter.drugpolicy.org/action/index.asp?step=2&item=11290

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.

MORE ABOUT THIS ISSUE:

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

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:
http://actioncenter.drugpolicy.org/action/index.asp?step=2&item=11290


Take Action:
http://actioncenter.drugpolicy.org/action/index.asp?step=2&item=11290