[MAPS] Help MAPS by Contacting Your Rep: Sept. 7 Deadline Only Two
Weeks Away
Jag Davies
jag at maps.org
Fri Aug 24 11:21:32 CDT 2007
MAPS Members, Supporters, and Friends,
Over the past few months, MAPS members, marijuana reformers, and a
surprisingly broad coalition of allies across the country have turned
the heat up on the US House of Representatives and the DEA. Together,
we are telling our elected leaders that we want the controversy over
medical marijuana resolved by science, rather than politics. As a
result, Congress is starting to ask DEA tough questions about
Professor Craker's case and the federal obstruction of medical
marijuana research.
But we're not in this just to create a stir. We're in this to conduct
long-suppressed FDA drug development trials with the marijuana plant,
and to bring it to market as a legal, prescription medicine if it
meets federal standards for medical safety and efficacy. The millions
of patients suffering from conditions that could benefit from
marijuana have a right to know whether smoked and vaporized marijuana
passes the FDA test.
So far, over 35 House members have signed on to Rep. John Olver's (D-
MA) and Dana Rohrabacher's (R-CA) Congressional Sign-On Letter in
support of Prof. Craker's application to the DEA, but with your help
several more will take a historic stand for marijuana research and
scientific freedom. With the final deadline of September 7
approaching fast, now is the time to show that there is public
support and political will behind this critical issue. There are
dozens -- if not hundreds -- of representatives that should support
this issue based on their statements and voting records. Yet, most
politicians will only consider signing a letter with a seemingly
controversial word like "marijuana" if their constituents ask them to
do so.
That's why you can play a critical role by contacting your
representative as soon as possible before the Sept. 7 deadline for
the Congressional Sign-on letter to DEA. (If your representative has
already signed, tell them you support their decision by saying "thank
you.")
To automatically email your House member click here: http://ga0.org/
campaign/umass
Although emails do have an impact, the most effective way to have a
powerful impact on your representative is to ask for a meeting with a
staffer in your member's district office. Personalized phone calls
and letters are also very effective. For instructions to contact your
representative by letter or phone, click here: http://www.maps.org/
mmj/DEAlawsuit.html#bipartisan
It has been over six years since Professor Lyle Craker, Ph.D.,
Director, Medicinal Plant Program, Department of Plant, Soil and
Insect Sciences, at UMass-Amherst, first applied to DEA for a
Schedule I license to manufacture marijuana exclusively for federally
approved research.
Why is the DEA and federal government going to such bizarre lengths
to stop MAPS and Prof. Craker? They know that if marijuana is brought
before the FDA, it is likely to be approved. The only way that the
government will change course is if individuals like you and me
express our strong support.
Thanks for all that you do.
Jag Davies
MAPS Director of Communications
PS. Here's those links again -
To automatically email your rep., click here: http://ga0.org/campaign/
umass
For instructions to contact your rep. by letter or phone, click here:
http://www.maps.org/mmj/DEAlawsuit.html#bipartisan
PPS. To support MAPS' work by making a donation or Webstore purchase:
http://www.maps.org/catalog
PPPS. For those of you who like talking points, I'm pasting below the
sets of arguments that we have been using to educate Congress about
this issue. For even more background information, don't forget about
MAPS' DEA Lawsuit page: http://www.maps.org/mmj/DEAlawsuit.html
**************************************************************
TALKING POINTS IN SUPPORT of JOHN OLVER'S (D-MA) and DANA
ROHRABACHER'S CONGRESSIONAL SIGN-ON LETTER
INTRODUCTION
Professor Lyle Craker, Ph.D., Director, Medicinal Plant Program,
Department of Plant, Soil and Insect Sciences, at the distinguished
University of Massachusetts-Amherst, has been attempting for six
years to obtain a DEA Schedule I license to manufacture marijuana
exclusively for federally approved research. The facility will be
entirely privately funded with a grant from a non-profit research
institution to UMass-Amherst.
In February 2007, following a comprehensive review of the available
evidence from the 2005 DEA law hearing, DEA Administrative Law Judge
Mary Ellen Bittner issued a decisive—but non-binding—recommendation
that Professor Craker's application be approved.
It is now up to the DEA to decide whether to accept or reject the
recommendation.
The goal of the Prof. Craker’s facility is to help resolve the
controversy over the medical use of marijuana through FDA-approved
scientific studies
~ This is a conservative approach. Support for Prof. Craker's
application does not even mean you are in favor of medical
marijuana, just that you are in favor of resolving this controversy
through privately-funded FDA-approved research.
~ If marijuana were to become a medicine, it would be produced by a
non-profit research organization.
Although federal law[1] requires adequate competition in the
production of Schedule I drugs, such as marijuana, to ensure an
adequate and uninterrupted supply for legal research, the federal
government has a monopoly over the supply of marijuana—but no other
Schedule I drug—and uses that monopoly to obstruct privately funded
research. NIDA and DEA have created a "marijuana exception" for
research.
~ NIDA’s monopoly only applies to marijuana, not to other Schedule I
or II drugs available to researchers for scientific use, like
methamphetamine, LSD, MDMA (ecstasy), heroin, or cocaine.
~ NIDA's monopoly makes very little sense given that the DEA has
licensed privately-funded manufacturers of virtually all other
Schedule I drugs.
~ Currently, there is no competition for the production of
marijuana because the Drug Enforcement Administration (DEA) has
permitted only one person, Prof. El Sohly at the University of
Mississippi, to produce marijuana for research purposes, under
contract to the National Institute on Drug Abuse.
It is not in the public interest for the DEA to put politics over
science and medicine.
~ DEA has created a Catch 22 for researchers by denying that
marijuana is a medicine because the FDA has not approved it while
simultaneously obstructing the very research that would be required
for FDA to approve marijuana as a medicine
~ (*When appropriate*)Like research into global warming and the
morning after pill, this is another example of Republicans putting
ideology over science.
The U.S. Supreme Court ruled in Gonzales v. Raich that the federal
government can arrest medical marijuana patients and enforce federal
marijuana laws even in states where it is legal. Patients, doctors
and scientists are in a catch-22 because the Supreme Court has
insisted that they to go to the FDA, but the DEA, NIDA and the
federal government have systematically obstructed their ability to
perform FDA-approved research.
~ Justice Breyer stated in oral arguments during the Raich case that
medical marijuana patients should go through the FDA's regulatory
process to get marijuana approved as a prescription medicine, rather
than focusing on courts and referendums.
~ This means that rigorous scientific evaluations of medical
marijuana are now needed more urgently then ever.
Members of Congress and Major Medical Organizations Already Support
Prof. Craker
~ Organizations that have written to DEA in favor of Prof. Craker's
application included the Leukemia and Lymphoma Foundation, the
Multiple Sclerosis Foundation, the Lymphoma Foundation of America,
the National Association for Public Health Policy, the United
Methodist Church (over 8 million members), Americans for Tax Reform,
the American Medical Students Association, several state nurses'
associations, the Massachusetts Dept. of Public Health, and the
California and Texas State Medical Associations, the two largest US
state medical associations. For a full list see: http://www.maps.org/
mmj/DEAlawsuit.html#4
~ Massachusetts Senators Kerry and Kennedy, and 38 other members of
the US House of Representatives have previously written to DEA in
support of Prof. Craker's application in 2004 and 2005.
~ Organizations supporting some form of physician-supervised access
to medical marijuana include the American Academy of Family
Physicians, American Nurses Association, American Public Health
Association, the New England Journal of Medicine and many others.
NIDA’s monopoly deters privately-funded researchers from proposing or
conducting medical marijuana research. Financial sponsors will not
invest millions of dollars into research studies until there is
reliable access to a supply of high-quality research material that
can be used both in research and -- if the research should prove
successful -- as an FDA-approved prescription medicine. NIDA is an
inappropriate gatekeeper to the only source of marijuana for
researchers.
~ Human studies on any Schedule I drug must gain approval from US
FDA. With marijuana, researchers must go through an additional
review process through HHS/NIDA that exists for no other drug.
~ NIDA’s monopoly results in lengthy delays or refusals in providing
research material. The HHS/NIDA review has no deadlines and no formal
appeals process, in contrast to the FDA's 30-day deadline.
~ NIDA has refused to provide marijuana to 2 FDA-approved studies.[2]
~ On July 27, 2005, more than two years after the simple protocol was
submitted to NIDA, it refused to sell 10 grams (!) for one laboratory
study of marijuana vaporizers, preventing it from taking place.
~ For researchers whose protocols it approves, NIDA provides
inferior, low-potency marijuana with limited cannabinoid profiles,
with researchers unable to optimize the strain of marijuana they
prefer to use for costly drug development efforts.
~ To put the nail in the coffin -- NIDA cannot guarantee that the
same material will be available for prescription use should FDA
determine that safety and efficacy has been proven. This makes any
drug development effort using NIDA marijuana a futile exercise.
In Summary: There are three main problems with the current NIDA-
supplied marijuana for research: (1) Conflict of Interest, (2)
Quantity, and (3) Quality. The Conflict of Interest point refers to
NIDA’s mission being at odds with scientific research into
marijuana’s potential for use as a medicine. The Quantity point
refers to the fact that NIDA can deny marijuana to researchers and
put restrictions on amounts – so researchers are at the whim on NIDA
for their supply. Quality refers to the seeds and low-potency and
incomplete cannabinoids point.
But isn't there already lots of research with marijuana? The research
that the federal government is obstructing is the very research that
seeks to determine whether medical marijuana can be developed into a
legal, prescription medicine. Prof. Craker’s case is the focal point
of the struggle to bring medical marijuana before the FDA, to
actually determine once and for all whether it meets FDA's standards
for medical safety and efficacy.
· Medical Marijuana States: Your state passed a law approving
the use of marijuana as a medicine with a doctor’s recommendation.
Your state will benefit greatly from medical marijuana research.
· Non-medical marijuana states: Roughly 75% of Americans believe
“adults should be allowed to legally use marijuana for medical
purposes if their doctor prescribes it...”
[1] See 21 U.S.C. § 823 (a) (1); see also 21 C.F.R. § 1301.33 (b).
[2] NIDA refused to provide marijuana to two FDA-approved protocols
(Dr. Abrams, UC San Francisco, marijuana for AIDS wasting syndrome-
IND #43-542; Dr. Russo, U. Montana, marijuana for migraines-IND #58,
177).
Jag Davies
Director of Communications
The Multidisciplinary Association for Psychedelic Studies
MAPS :: 10424 Love Creek Road :: Ben Lomond, CA 95005
************************************************************
Your Support is Needed! http://www.maps.org/catalog
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