Unshackle Medical Marijuana Research!

Discussion in 'Marijuana Legalization' started by RMJL, Sep 6, 2003.

  1. Urge Dr. Andrea Barthwell at the drug czar's office to unshackle governmental control on medical marijuana production and research by approving the UMass Amherst application for a license to produce marijuana for federally-approved research. Help end the monopoly on supply which is an intentional obstacle to research and FDA-approval.

    Go here to take action:


    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

    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


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