[MAPS] MAPS News: May 2006

[Jag Davies, MAPS]

If you would prefer to read this in html, click here:
http://www.maps.org/news/


MAPS Friends and Supporters,

Here's the latest news from MAPS:

1. Final Legal Briefs Submitted for Prof. Craker's DEA Lawsuit for
MAPS-supported Medical Marijuana Production Facility
2. Chemic Labs Still Awaiting Response to Appeal from PHS/NIDA
3. FDA Marijuana Statement Draws Backlash from Congress and Media
4. Israeli MDMA/PTSD Team Attends Training Session at US MDMA/PTSD Site
5. FDA Approves Changes to Dr. Mithoefer's MDMA/PTSD Study
6. MDMA/Cancer Anxiety Study at Harvard's McLean Hospital
7. Leading UK Medical Journal Calls for Resumption of Psychedelic Research
8. Strategies for Growth Discussed at MAPS Board of Directors Meeting
9. Next Stop for MAPS Office: Love Creek
10. Ebay Auction May 21-28 for Ticket to the 2nd Amazonian Shamanism
Conference in Peru 
11. Tickets Still Available for She Shamans Conference
12. Spring 2006 MAPS Bulletin
13. Thank You to Anonymous $20,000 Donor

*** Want to join MAPS? Renew your membership? Make a restricted donation?
Click here to support MAPS' mission today: http://www.maps.org/donate ***

1. Final Legal Briefs Submitted for Prof. Craker's DEA Lawsuit for
MAPS-supported Medical Marijuana Production Facility

On Monday, May 8, lawyers from the ACLU and two Washington D.C. law firms
submitted the final legal brief in Prof. Lyle Craker's MAPS-supported
lawsuit against the DEA for refusing to license a MAPS-sponsored medical
marijuana production facility. Prof. Craker¹s lawyers include lead attorney
Julie Carpenter (Jenner & Block), assisted by Allen Hopper (ACLU), and
Emanuel Jacobowitz (Steptoe & Johnson). DEA¹s legal brief was also filed on
May 8. The legal briefs build arguments based on laws, regulations and the
testimony presented in court before DEA Administrative Law Judge (ALJ) Mary
Ellen Bittner during oral arguments, but cannot introduce new evidence.
Prof. Craker's facility is a prerequisite to beginning MAPS-sponsored
clinical trials into the risks and benefits of marijuana as a potential
FDA-approved prescription medicine.

We estimate that Judge Bittner will make a decision in two to four months.
If ALJ Bittner issues an unfavorable recommendation, DEA wins and there will
probably be no privately-funded medical marijuana research effort ever
started until a more reasonable President is in office. If ALJ Bittner does
issue a favorable recommendation, we will need to organize a major
coordinated campaign to obtain letters of support from members of Congress,
especially Republicans, urging DEA Administrator Karen Tandy to accept the
favorable recommendation. Tandy will probably take several months to study
the recommendation before issuing her final ruling. That will be our period
of maximum opportunity, and it does seem within our reach for us to mobilize
sufficient pressure on DEA to force the acceptance of a favorable
recommendation. 

If ALJ Bittner does issue a favorable recommendation and Tandy rejects it,
we can still sue DEA in the DC Circuit Court of Appeals, but that will take
more time and money and will continue DEA's strategy of delay. Still, if DEA
rejects a favorable recommendation, we should be able to inflict a
significant blow to whatever remains of the credibility of DEA and ONDCP by
showing the hypocritical nature of their supposed objection to medical
marijuana on the basis of there not being enough research to prove that it
should become an FDA-approved prescription medicine. DEA rejection of a
favorable recommendation would also strengthen the case for state-level
reforms.

You can read the legal briefs, background information, media coverage, and
court transcripts from the case on the MAPS website at:
http://www.maps.org/mmj/DEAlawsuit.html

2. Chemic Labs Still Awaiting Response to Appeal from PHS/NIDA

It has now been eight months since Chemic Labs appealed PHS/NIDA's rejection
of their MAPS/CaNORML-sponsored application to purchase 10 grams of
marijuana from the government's lone production facility at the University
of Mississippi, and to import 10 grams from the Dutch Office of Medicinal
Cannabis. The 10 grams from NIDA and the 10 grams from the Dutch are needed
to complete research analyzing the particulate matter and cannabinoid (CBD)
and Delta-9-tetrahydrocannabinol (THC) content of marijuana heated with a
vaporizer, a non-smoking delivery system.

During oral testimony last December in Prof. Craker's DEA lawsuit (see link
at end of item),  Steve Gust, Asst. Director of NIDA, stated that the
PHS/NIDA review process takes 3-6 months -- already a very lengthy and
cumbersome delay compared with the FDA's 30-day review period for human
research protocols. Steve Gust also stated that the appeals process itself
could add another 3-6 months.  Neither of Steve Gust¹s estimated review
times have been accurate in regards to Chemic¹s application in that the
initial review took over two years, during which MAPS sued NIDA for
unreasonable delay. When the PHS/NIDA review was finally completed, Chemic
quickly responded to every point in the protocol critique and has since been
waiting over 8 months for a reply.

Steve Gust¹s testimony has been contradicted by the facts, which will
hopefully make an impression on DEA Administrative Law Judge Bittner. NIDA
is clearly doing its best to provide evidence supporting our argument in
Prof. Craker's DEA lawsuit that an independent source of supply is necessary
for clinical trials to take place.

Testimony of Steve Gust, Asst. Director of NIDA in Prof. Craker's lawsuit:
http://www.maps.org/mmj/legal/craker-dea/transcript1214.html

MAPS/CaNORML-sponsored vaporizer research:
http://www.maps.org/mmj/vaporizer.html

3. FDA Marijuana Statement Draws Backlash from Congress and Media

On April 20, the FDA abruptly issued a poorly documented and transparently
political statement denying the medical benefits of marijuana. Twenty-four
members of Congress, and numerous media outlets such as the New York Times,
the Chicago Tribune and the Economist joined the medical and public health
community in a backlash against the politicization of science by publishing
editorials critical of the FDA statement. The DEA's obstruction of Prof.
Craker's MAPS-sponsored medical marijuana facility is described in several
of these articles, raising the profile and importance of his MAPS-supported
DEA lawsuit.

Read the FDA Statement, letter from Congress, and related media coverage and
criticism at:
http://www.maps.org/mmj/DEAlawsuit.html

4. Israeli MDMA/PTSD Team Attends Training Session at US MDMA/PTSD Site

On May 5, MAPS brought Israeli psychiatrists Rael Strous, M.D., and Rakefet
Rodrigez, M.D., to Charleston, SC, to observe an MDMA/PTSD session conducted
by Dr. Michael and Annie Mithoefer as part of their MAPS-sponsored US
MDMA/PTSD study. Drs. Strous and Rodrigez are co-therapists in the
MAPS-sponsored Israeli MDMA/PTSD study to be conducted at Beer Yaakov Mental
Health Center near Tel-Aviv.

Drs. Strous and Rodrigez also worked with MAPS Clinical Research Associate
Valerie Mojeiko on Case Report Forms, study instructions and other aspects
of conducting the research in a manner that will enable MAPS to submit their
data to the FDA as well as to the Israeli Ministry of Health.

In addition to data monitoring, the therapy approach itself must be
standardized since the treatment we are investigating is MDMA-assisted
psychotherapy, not the simple administration of MDMA. To this end, MAPS is
developing an MDMA/PTSD treatment manual to ensure congruence throughout our
international drug development effort. Dr. Michael and Annie Mithoefer are
leading the effort to standardize the treatment approach and train other
therapist teams.

Read the government-approved MAPS-sponsored Israeli MDMA/PTSD protocol here:
http://www.maps.org/mdma/israel_protocol_3.16.05.pdf

Read MAPS' MDMA/PTSD treatment manual here:
http://www.maps.org/research/mdma/ptsd_study/treatment-manual/053005/treatme
nt-manual.pdf

5. FDA Approves Changes to Dr. Mithoefer's MDMA/PTSD Study

The FDA has granted approval for several key changes to Dr. Michael
Mithoefer's MAPS-sponsored study evaluating MDMA-assisted psychotherapy as a
treatment for PTSD. The changes include (1) adding a third experimental
session to the two that are currently included in the protocol to test
whether a third session adds significantly to the therapeutic process, (2)
providing supplemental dosing of half the initial amount of MDMA
administered 2 to 2 .5 hours after the initial dose in order to prolong the
plateau of MDMA¹s therapeutic effectiveness, and (3) doing without an ER
doctor on standby in the next room since Dr. Mithoefer has become a
board-certified ER doctor as well as a board-certified psychiatrist. Now
that the Data Safety Monitoring Board (DSMB) and the FDA have approved these
changes to our protocol, the only remaining regulatory hurdle before these
changes can be implemented is Institutional Review Board (IRB) approval,
which we estimate will take about a month. Mithoefer is currently treating
the 13th patient out of 20, and is continuing efforts to recruit the
remaining subjects.

Dr. Mithoefer's MAPS-sponsored MDMA/PTSD protocol:
http://www.maps.org/mdma/protocol/index.html

6. MDMA/Cancer Anxiety Study at Harvard's McLean Hospital

The MDMA/cancer anxiety psychotherapy pilot study, to be conducted by John
Halpern, M.D., at Harvard¹s McLean Hospital, is now fully-approved and
fully-funded. Preparations are underway to begin the study this summer.

7. Leading UK Medical Journal Calls for Resumption of Psychedelic Research

The prospects for resumption of psychedelic research in the UK took an
auspicious turn this month when an influential British medical journal, the
Lancet, published an editorial encouraging research into the potential
therapeutic benefits of psychedelic drugs. The editorial also calls for a
new legal structure that makes this research easier and less burdensome to
conduct. The Lancet editorial was inspired by a commentary published in the
British Journal of Psychiatry by Ben Sessa, M.D., in June 2005. The Lancet
editorial received positive coverage in London's biggest newspaper, the
Guardian. 

The Lancet Editorial:
http://www.maps.org/sys/nq.pl?id=811&fmt=page

Dr. Ben Sessa's commentary in the British Journal of Psychiatry:
http://www.maps.org/w3pb/new/2005/2005_Sessa_22760_1.pdf

Guardian Unlimited reports "Lancet Calls for LSD in Labs":
http://www.maps.org/sys/nq.pl?id=812&fmt=page

8. Strategies for Growth Discussed at MAPS Annual Board of Directors Meeting

MAPS held its annual Board of Directors meeting on April 23 to review
individual projects and to chart the course for future growth. MAPS Board
members John Gilmore and Rick Doblin were present, and the third member of
the Board of Directors, Marybeth Home, contributed via telephone. Most of
MAPS¹ staff was present, as were guests Annie Harrison, Richard Wolfe and
Rob Kampia, Executive Director of the Marijuana Policy Project (MPP). The
meeting began with some good financial news: MAPS' income and assets both
reached record highs in Fiscal Year 2005-06, as our agenda shifted from the
decades-long struggle to obtain permission for research to actually
conducting research studies. MAPS needs to raise an additional $250,000 for
its series of Phase II MDMA/PTSD studies in the US, Switzerland and Israel
that will be conducted over the next year and a half to two years. If those
studies generate promising data, large-scale Phase III trials for
MDMA-assisted psychotherapy and/or approval for Prof. Craker's medical
marijuana production facility and the subsequent initiation of FDA trials
with marijuana could each demand ten-fold growth in revenue over the next
two to five years, according to MAPS President Rick Doblin.

At the meeting, MPP Executive Director Rob Kampia discussed tactics with
MAPS for coordinating pressure on the DEA in the event that DEA ALJ Bittner
recommends that DEA issue a license to Prof. Craker for a MAPS-sponsored
medical marijuana production facility.

MAPS staff members also reviewed their job positions and discussed plans for
pro-active educational outreach from the new California-based office (see
next item).

9. Next Stop for MAPS Office: Love Creek

Intent on expanding MAPS' educational outreach mission to the San Francisco
area, but avoiding the high costs of the city itself, the MAPS team has
secured a new home/office complex in the town of Ben Lomond, about one hour
south of San Francisco and 20 minutes east of Santa Cruz.

Nestled in the redwood forest of the Santa Cruz mountains, with a babbling
brook named Love Creek running alongside the home and workspace, the office
staff feels blessed to have found such a peaceful spot within such close
range of the Bay Area.

MAPS is renting the new office starting June 1. The MAPS office will be
moving from Sarasota to the Love Creek location during late May and early
June, with one MAPS staffer remaining in Sarasota throughout May.  Although
response may be slower than usual during the last week of May and the first
week of June, we will continue to process donations as usual since May is
the end of MAPS' fiscal year. Product sales may be slower than usual, but
we'll still try to ship books and merchandise out as quickly as we can. The
main MAPS phone number (941-924-6277) will remain active during and after
the move and staffers will also be available via email. Beginning June 1,
please send mail to the Love Creek office (MAPS, 10424 Love Creek Rd, Ben
Lomond, CA, 95005-9467).  Mail received at the Sarasota office after June 1
will be forwarded to the new office.

The MAPS staff is planning to host an open house at the Love Creek location
and a welcome party in San Francisco, at dates to be determined later.

10. Ebay Auction May 21-28 for Ticket to the 2nd Amazonian Shamanism
Conference in Peru 

Support MAPS and your own personal psychedelic research by bidding on a
ticket to the 2nd Amazonian Shamanism Conference: A Gathering of Healers and
Scientists. This gathering is a unique way to explore your interest in
ayahuasca, healing, and the shamanistic traditions of the Amazon rainforest.
About a hundred or more psychonauts, healers, and scientists will meet in
the jungle city of Iquitos, Peru for ten days of panels, lectures, dinners,
and ceremonies. 

MAPS' E-Bay auction starts on Sunday, May 21st at noon Standard Pacific
Time, and ends on Sunday, May 28th at noon Standard Pacific Time. The
starting bid will be $250, half the normal registration fee. For further
information about the auction, please e-mail Julia, auction coordinator, at:
julia at maps.org 

2nd Amazonian Shamanism Conference website:
http://www.soga-del-alma.org/ConferenceSite/

11. Tickets Still Available for She Shamans Conference

Tickets are still available for the She Shamans and Magic Mamas conference,
June 23-25 at Isis Oasis in Geyserville, CA. MAPS is contributing $1000 from
the Women's Entheogen Fund (WEF) for travel expenses for conference
speakers. Participants at the conference will discuss potential uses for the
additional unallocated $4000 that WEF has recently received, the first
unrestricted donation ever made to the fund. In turn, the conference will
donate a portion of any proceeds to WEF. In case you're wondering, people of
all genders are welcome at She Shamans.

She Shamans conference website:
http://www.sheshamans.com

12. Spring 2006 MAPS Bulletin

If you're a MAPS member, the Spring 2006 MAPS Bulletin should be arriving in
your mailbox shortly, if it hasn't already. The Spring 2006 Bulletin is also
now posted online at:
http://www.maps.org/news-letters/v15n4-html/index.html

Notice that magical Dean Chamberlain portrait of the Shulgins on the inside
front cover? MAPS is still offering signed portraits of Sasha and Ann
Shulgin and of Laura Huxley by artist Dean Chamberlain. MAPS' 50% share of
the proceeds from the sale of the Shulgins' portrait are restricted to
MAPS-sponsored MDMA psychotherapy research, while our 50% share of the
proceeds from the sale of Laura Huxley's portrait are restricted to research
into psychedelic-assisted psychotherapy in people struggling with the
mystery of death. 

Sasha and Ann Shulgin portrait by Dean Chamberlain:
http://www.maps.org/catalog/product_info.php?cPath=24_29&products_id=46

Laura Huxley portrait by Dean Chamberlain:
http://www.maps.org/catalog/product_info.php?cPath=24_29&products_id=45

13. Thank You to Anonymous $20,000 Donor

MAPS received a $20,000 donation for general operating expenses from an
anonymous donor last week.

>From everyone at MAPS, thank you for your generosity! We couldn't be doing
what we do without you!


And thanks to everyone who has read to the end!


Have A Multidisciplinary May,

~Jag 


-------------------------------
Jag Davies
MAPS Director of Communications
jag at maps.org
-------------------------------




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