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self index.cfm
site_filepath /www/sites/mfapp/templates/main/
 
Alan Trachtenberg, Md  
     
     
MAPS Collection
GroupWise WebAccess Message Item                                                                                           
                                  Mail Message              

From:  Brandy Doyle
To:  Alan Trachtenberg
Date:  Thursday - January 22, 2004 6:42 PM
Subject:  MAPS News 1/22/04
AttachmentsMime.822 (9285 bytes)  [View][Save As]
Hello, MAPS members and friends!

In today's news from MAPS:

1. FDA replies to DEA regarding Dr. Michael Mithoefer¹s Schedule I license
for MDMA/PTSD study; DEA should respond soon
2. Dr. Mithoefer interviewed by Peter Jennings' Ecstasy documentary team
3. Initial planning meeting for MDMA/ cancer patient study
4. DEA says "No comment" on UMass Amherst license
5. Psychedelic Review now archived online
6. Rick Doblin interviewed in LA City Beat
7. MAPS wishes Albert Hofmann a happy birthday
8. MAPS¹ goals for 2004

We hope you enjoyed your winter holidays and your winter bulletins -- if you
did not receive your bulletin, please contact me. Also get in touch if you
have an address change or if you'd like to stop receiving these e-mail
updates.

Best wishes,
Brandy
--
Brandy Doyle
Director of Special Projects
MAPS
(941) 924-6277



1. FDA replies to DEA regarding Dr. Michael Mithoefer¹s Schedule I license
for MDMA/PTSD study; DEA should respond soon

On Thursday, January 15, 2004, FDA confirmed that DEA's request for a
consultation about Dr. Mithoefer's qualifications for a Schedule I license
arrived at FDA in early January and that FDA's recommendation has already
been sent back to DEA. DEA claimed it sent the request for consultation in
early October. 

According to the Code of Federal Regulations [section 304(a) of the Act (21
U.S.C. 824(a))] , DEA must issue Schedule I licenses to researchers with
FDA-approved protocols within 10 days of DEA receiving a recommendation from
FDA that an applicant is qualified to do the research, unless the applicant
can be denied on any of the grounds specified in section 304 (a), and has
either 1) lied on the application, 2) been convicted of a drug felony, or 3)
no longer has State registration to administer controlled substances. Since
none of these criteria apply to Dr. Mithoefer, we may be quite close to
being able to start this study.  However, there could be some delays caused
by the uncertain amount of time between when FDA sends its recommendation to
DEA and when DEA acknowledges receiving it, with interagency mail
notoriously slow. MAPS will now work to expedite this process however we are
able.

2. Dr. Mithoefer interviewed by Peter Jennings' Ecstasy documentary team

On Wednesday, January 14,  Peter Jennings' Ecstasy documentary team flew Dr.
Mithoefer, the primary researcher for MAPS' MDMA/PTSD study, to New York
City for a filmed interview for their upcoming special on Ecstasy. The
documentary, which will also include interviews with Rick Doblin, is
expected to air prime time in early to mid-March.

3. Initial planning meeting for MDMA/cancer patient study

On Friday, January 16, Rick Doblin and Harvard psychiatrist Dr. John Halpern
met with an oncologist to begin planning for a study of MDMA-assisted
psychotherapy for anxiety and depression in end-stage cancer patients. This
study, which would be conducted at Harvard Medical School's McLean Hospital,
is part of a long-term
strategy to bring psychedelic research back to Harvard post-Timothy Leary,
with the last clinical research with psychedelics at Harvard conducted in
1965! Planning for this study will move from the protocol design phase to
the approval process phase only after the MDMA/PTSD study is fully approved.
We hope to be able to start this study in the fall. An MDMA/cancer patient
study would expand MAPS' focus on MDMA to include another patient
population, and builds on promising past research with cancer patients that
evaluated LSD and psilocybin-assisted psychotherapy.


4. DEA says "No comment" on UMass Amherst license

On December 29, 2003, MAPS received a letter regarding the UMass Amherst
project from Ms. Laura Nagel, Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration. The letter acknowledged
MAPS' letter of November 21, 2003, but said only that "the DEA cannot
officially comment on the merit of any specific application." No timetable
was given regarding when DEA will officially reply to Prof. Craker's
application, for which DEA's public comment period ended September 22, 2003.
Once again, we see evidence that DEA's primary strategy is to delay
responding as long as possible. DEA fears that acceptance may eventually
lead to FDA approval of the prescription use of marijuana, while a refusal
to approve the application will expose the hypocrisy of the ONDCP/DEA line
that more research into the medical use of marijuana is required before
patients can legally receive marijuana under a doctor's recommendation or
prescription.

5. Psychedelic Review now archived online

MAPS has completed scanning of the entire collection of the issues of The
Psychedelic Review, the journal started by the Harvard psychedelic research
team of Ralph Metzner, Richard Alpert and Timothy Leary. Issue #1 was first
published in June 1963 and the final issue, #11, was Winter 1970/1971. MAPS
had some issues scanned by a commercial scanning company and others by MAPS
staffer Mercedes Paulino. This historic collection is available in PDF
format at http://maps.org/psychedelicreview/. Each issue is available as a
complete PDF or broken down by article.


6. Rick Doblin interviewed in LA City Beat

Check out the profile of Rick Doblin in the January 8 LA City Beat:
http://www.maps.org/media/lacb010804.html. Interviewed by Dennis Romero,
Rick discusses the reasons he became interested in psychedelic research and
in MDMA (Ecstasy).


7. MAPS wishes Albert Hofmann a happy birthday

Dr. Albert Hofmann, who discovered LSD and first synthesized psilocybin,
turned 98 on January 11, 2004. On behalf of the MAPS community, MAPS member
Costa Haralambis brought flowers to Dr. Hofmann's home in Basel, Switzerland
that day. MAPS also created a special web page honoring Dr. Hofmann, and
visitors to that page sent Dr. Hofmann birthday greetings through MAPS. To
see the Dr. Hofmann page, go to http://www.maps.org/people/ah/ah.html   To
see a slideshow with photos from Dr. Hofmann's birthday, go to
http://www.maps.org/slideshows/ah98/ . To hear a recording of piano music
played for Dr. Hofmann on his birthday by Dr. Rolf Verres, go to
http://www.maps.org and click on ³piano music² near the top of the page. To
see a slideshow with other photos of Dr. Hofmann, go to
http://www.maps.org/slideshows/ah/ .

8. MAPS' Goals for 2004.

The following is admittedly an ambitious list of MAPS' goals for 2004 but
it's not beyond reach with focused and efficient effort, a pinch or two of
luck, and courage on the part of several Institutional Review Boards (IRBs).
Actually obtaining these goals will require a substantial broadening of
support for MAPS and its research agenda well beyond our current community.
Fortunately, the science is on our side.

1.   Obtain final approval for US MDMA/PTSD study by end of February 2004,
final approval for Israeli MDMA/PTSD study by Fall 2004, and final approval
for Harvard MDMA/cancer patient study before the end of 2004.

2. Raise $500,000 for MDMA research by the end of 2004, of which $185,000 is
the remaining needed for the US PTSD study, $75,000 for the Israeli PTSD
study, $225,000 for the Harvard/cancer patient study and $15,000 for the
ongoing MDMA literature review.

3. Either obtain DEA approval for the UMass Amherst marijuana production
facility or initiate major lawsuit against the DEA.

4. If DEA approval is obtained for the UMass Amherst marijuana production
facility, start campaign to raise $500,000 for the facility and $2 million
for associated research projects. Campaign to reach goal within one year
after DEA approval has been obtained.

5. Obtain HHS approval by the end of April to purchase NIDA marijuana for
the continuation of the vaporizer research or initiate a lawsuit.

6. Obtain DEA approval by the end of April to import high-potency marijuana
from the Dutch Office of Medicinal Cannabis for the continuation of the
vaporizer research or initiate a lawsuit.

7. Increase MAPS' membership to 2500.

8. Publish second edition of The Secret Chief.

9. Publish four issues of the MAPS Bulletin and send out 12 monthly email
updates.

10. Take time to celebrate the occasional triumphs, study the occasional
failures, and keep on working hard.