HELP UNSHACKLE MEDICAL MARIJUANA NOW

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.