Current News in Psychedelic and Medical Marijuana Research
Happy Autumn, MAPS members!
It's been a while since the last email update,
and we've been quite busy -- as you'll read here.
In this issue:
1. DEA agents inspect Dr. Mithoefer's office for MDMA diversion control
issues
2. Nov 16-17 meeting scheduled for MDMA/PTSD team to prepare to start
3. MAPS files FOIA request about retracted MDMA/Parkinson's study
4. Both MA Senators write DEA to support UMass Amherst facility application
5. Daily Hampshire Gazette reports on UMass Amherst project
6. MAPS awarded $30,000 grant from Marijuana Policy Project
7. Rick Doblin to receive Norman E. Zinberg Award at Drug Policy Alliance
conference
8. New MAPS bulletin in the works
1. DEA agents inspect Dr. Mithoefer's office for MDMA diversion control
issues
On October 28, 2003, several DEA agents finally inspected Dr. Mithoefer's
facilities in Charleston, South Carolina. This was part of DEA's review of
Dr. Mithoefer's July 2002 application for a Schedule I license to handle the
3.5 grams of MDMA needed for the entire study. The inspectors focused on
issues of diversion control and checked out the safe, the alarm system and
the forms and procedures that will be used to track the MDMA and placebo
capsules. The DEA agents were interested in helping Dr. Mithoefer understand
and follow their rules and were quite reasonable. Dr. Mithoefer was told he
will probably receive his license in several weeks to several months. This
is the last step before we can begin recruiting patients for the study.
While we won't believe it until Dr. Mithoefer has his Schedule I license in
hand, it may be the case that MAPS' 17+year effort to start MDMA-assisted
psychotherapy research is approaching a successful conclusion.
2. Nov 16-17 meeting scheduled for MDMA/PTSD team to prepare to start
On November 16, 2003, the entire team involved in the MDMA/PTSD study will
meet in South Carolina to review all the forms and procedures involved in
the study. Professional researchers who monitor clinical trials for a large
pharmaceutical company are volunteering their time to MAPS, monitoring all
data-gathering processing for the project. After this meeting, the study
should be ready to begin after Dr. Mithoefer receives his Schedule I
license.
3. MAPS files FOIA request about retracted MDMA/Parkinson's study
In the continuing story of Dr. Ricaurte et al.'s retracted MDMA
neurotoxicity study, MAPS has filed a Freedom of Information Act (FOIA)
request to NIDA, asking for more information about the taxpayer-funded
research. Specifically, we asked for a list of all other studies which used
the methamphetamine mislabelled as MDMA, as well as a list of the studies
which used the mislabelled MDMA (the two bottles supposedly were switched at
the pharmaceutical house). We asked for information such as doses, route of
administration, ambient temperatures, number and kind of animals used,
animal death rate, etc. We also asked for information about the studies in
which genuine MDMA was orally administered and injected into primates
without causing any dopaminergic neurotoxicity. We received a confirmation
letter from NIDA
(http://www.maps.org/mdma/retraction/foia.jpg) and now await further
communication.
4. Senators write DEA to support UMass Amherst facility application
Senators Kennedy and Kerry (a presidential candidate) wrote a strong letter
of support to DEA Administrator Karen Tandy, urging DEA to approve Dr. Lyle
Craker's Schedule I license application for the proposed UMass Amherst
medical marijuana production facility. The letter (view at
http://www.maps.org/mmj/kkletter102003.html), which offers the support of
both U.S. Senators from Massachusetts, adds much stronger political backing
to the UMass Amherst project. We are actively seeking to obtain support from
MA Gov. Mitt Romney and await the DEA's decision on Dr. Craker's license.
5. Daily Hampshire Gazette reports on UMass Amherst project
A great article was published about the UMass Amherst project in the
Daily Hampshire Gazette newspaper on October 28. That article is included at
the bottom of this email.
6. MAPS awarded $30,000 grant from Marijuana Policy Project
We have been awarded our full $30,000 grant request from the Marijuana
Policy Project (MPP). The grant will be used to support MAPS' work on the
vaporizer and the UMass Amherst projects. For more on these projects, go to
http://www.maps.org/mmj.
7. Rick Doblin to receive Norman E. Zinberg Award at Drug Policy Alliance
conference
MAPS president Rick Doblin has been awarded the Norman E. Zinberg Award for
Achievement in the Field of Medicine by the Drug Policy Alliance. He will
accept the honor at the 2003 Biennial Drug Policy Alliance Conference later
this week. The Zinberg Award "recognizes medical and treatment experts who
perform rigorous scientific research and who have the courage to report
their findings even though they may be at odds with current dogma."
Congratulations, Rick!
8. New MAPS bulletin in the works
A number of you have written to ask whether you've missed the latest MAPS
bulletin. Due to all the exciting developments at MAPS over the past few
months, we've (unfortunately) had to postpone the latest issue. However,
that issue is now in the works, and we expect to send it to the printers
soon. It's a good one -- full of the research updates, conference reports,
personal accounts and book reviews that you expect from MAPS. Look for it
soon!
Thanks as always for your continued support! Please reply to this email if
you have an address change or if you'd like to stop receiving the email
updates. And read on for the Daily Hampshire Gazette article on the UMass
Amherst project.
Best wishes from MAPS,
Brandy
--
Brandy Doyle
Director of Special Projects
MAPS
(941) 924-6277
Senators back UM medical marijuana
By Marey Carey, Staff Writer
Daily Hampshire Gazette
http://www.gazettenet.com)
Tuesday, October 28, 2003 -- Both U.S. senators from Massachusetts, Edward
M. Kennedy and John Kerry, have written a letter to the federal Drug
Enforcement Administration urging approval of an application by the
University of Massachusetts to grow high-quality marijuana for medicinal
research.
Backers of the proposal by plant and soil sciences professor Lyle Craker say
support from Kennedy and Kerry, along with the recent refusal by the Supreme
Court to consider penalizing doctors for recommending medicinal marijuana,
put UMass in a much better position to win DEA approval than previously.
UMass would be only the second legal grower of marijuana for research
purposes. The University of Mississippi has supplied the National Institute
on Drug Abuse with marijuana for 30 years.
In their Oct. 20 letter addressed to DEA administrator Karen Tandy, Kennedy
and Kerry wrote, ''We believe that the National Institute on Drug Abuse
facility at the University of Mississippi has an unjustifiable monopoly on
the production of marijuana for legitimate medical and research purposes in
the United States.''
According to Kennedy and Kerry, the current lack of competition ''may well
result in the production of lower-quality research-grade marijuana, which in
turn jeopardizes important research into the therapeutic effects of
marijuana for patients undergoing chemotherapy or suffering from AIDS,
glaucoma, or other diseases.''
Kerry and Kennedy also said in their letter that UMass is ''one of the
nation's most distinguished research universities, and it is highly
qualified to manufacture marijuana for legitimate medical and research
purposes with effective controls against diversion.''
Craker first applied to the DEA in June 2001, for permission to grow, in a
secure building on the Amherst campus, an initial 25 pounds of high-potency
marijuana, which would be supplied to government-approved researchers. The
project would receive funding from the Multidisciplinary Association for
Psychedelic Studies (MAPS), a Florida-based nonprofit research and
educational organization that seeks to develop marijuana as a prescription
medication approved by the U.S. Food and Drug Administration.
Massachusetts Congressmen John Olver, Barney Frank, James McGovern, William
Delahunt and Michael Capuano, who support Craker's proposal, wrote to the
DEA urging its approval in June, 2002. But then DEA administrator Asa
Hutchinson responded in a July 1, 2002 letter addressed to Frank that
increasing the numbers of marijuana growers could put the United States in
violation of international treaties and that the University of Mississippi
supply has proven adequate for 30 years.
Rick Doblin, president of the Multidisciplinary Association, said Monday
that supporters of the University of Massachusetts proposal believe
Kennedy's and Kerry's support is a crucial turning point.
''I think the letter from Kennedy and Kerry shows that there is law on the
other side - the law saying we need a competitive environment - to try to
get the data to see whether we can justify to the FDA that marijuana is safe
and efficacious so that it should be a medication. I think the DEA loses
more credibility by trying to protect the government monopoly and obstruct
research,'' Doblin said.
Doblin said he has approached Gov. Mitt Romney's administration to ask for
the governor's support. ''As a venture capitalist in the past, he is dubious
of government monopoly and sympathetic to private industry,'' Doblin said.
''If Romney comes out and says that it's time for a plan, let science have
its day, I think that will be have the final step. Then we would have
bipartisan support in Massachusetts.''
Romney spokeswoman Nicole St. Peter said Monday of the Romney
administration's position on the UMass proposal, ''We do not have enough
information about this project to form a decision at this time.''
Mary Carey can be reached at .(JavaScript must be enabled to view this email address).
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