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News (Media Awareness Project) - US: Web: Help Unshackle Medical Marijuana Now
Title:US: Web: Help Unshackle Medical Marijuana Now
Published On:2003-08-29
Source:DrugSense Weekly
Fetched On:2008-01-19 15:36:44
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 cannabis that can be used in
FDA-approved research and has twice refused to supply it to
privately-funded FDA-approved studies. Over two years ago the Medicinal
Plant Program at The University of Massachusetts/Amherst applied for a
license to produce cannabis for research purposes only to be confronted by
a series of dilatory tactics by the DEA.

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

Or send an email or letter to Dr. Barthwell through:
http://capwiz.com/norml2/issues/alert/?alertid=3171511&type=CU

But we suggest that you modify and personalize your message when using
either of the above links so that Dr. Barthwell knows that you personally
care about the issue.

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 OPED 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 OPED, which was printed in a number of
newspapers, here: http://www.mapinc.org/author/Barthwell

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 U.S. 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 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, 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 U.S. 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
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