[MAPS] MAPS News: March 2006

Tue Mar 7 10:48:05 CST 2006

If you would prefer to read this in html, click here:
http://www.maps.org/sys/nq.pl?id=791&fmt=std

MAPS Members and Friends,

Things are moving fast now that our research is going global. I'll be
writing the email updates now that Valerie Mojeiko (who has written them
since last May) has got her hands full monitoring MAPS' clinical research.

*** If you are not a MAPS member yet, or if your membership has expired,
please consider joining MAPS! If you are already a member, we can always use
additional support. Please consider making a special donation to support
your favorite project at http://www.maps.org/donate ***

Here's what we have to report this month:

1. Final Briefings Due April 27 in MAPS' Medical Marijuana DEA Lawsuit
2. Dr. John Halpern's MDMA/Cancer Anxiety Study
3. Dr. Mithoefer's MDMA/PTSD Study Gets Approval from Data Safety Monitoring
Board
4. Upcoming Data Monitoring Visits for Swiss and Israeli MDMA/PTSD Studies
5. Resumption of the Protocol Design and Approval Process for MAPS-Sponsored
MDMA/PTSD Research in Spain
6. Supreme Court Votes Unanimously to Allow Religious Use of Ayahuasca
7. Alex Grey's Albert Hofmann Portraits On Their Way
8. Merchandise and Visionary Artwork Available From MAPS
9. $12,500 in 2 large donations to the Women's Entheogen Fund
10. MAPS Receives $50,000 Grant

1. Final Briefings Due April 27 in MAPS' Medical Marijuana DEA Lawsuit

Lawyers from both sides of the case have filed motions to extend the
deadline to April 27 for the submission of final legal briefs in Prof. Lyle
Craker's MAPS-supported lawsuit against the DEA for obstructing a
MAPS-sponsored medical marijuana production facility. Prof. Craker's
facility (http://www.maps.org/mmj/mmjfacility.html) is a prerequisite to
beginning MAPS-sponsored clinical trials into the risks and benefits of
marijuana as a potential FDA-approved prescription medicine.

DEA Administrative Law Judge Mary Ellen Bittner is expected to make a
decision three to six months after the briefs have been submitted. You can
read background information, media coverage, and court transcripts on MAPS'
DEA Lawsuit page: http://www.maps.org/mmj/DEAlawsuit.html

If Judge Bittner issues an unfavorable recommendation, obtaining a license
for Prof. Craker's facility would require an Act of Congress or much more
political pressure on DEA than we have brought to bear to date. If Judge
Bittner issues a favorable recommendation, DEA Administrator Karen Tandy
would probably take several months to prepare her ruling. During this time,
MAPS would help initiate a major collaborative campaign to obtain letters of
support for Prof. Craker's license from many members of Congress, focusing
primarily on Republicans, using the letter of support we have already
obtained from Republican strategist Grover Norquist.

On March 2, MAPS learned that it was awarded a grant of $35,500 from the
Marijuana Policy Project (MPP) to cover legal expenses for the DEA lawsuit.

2. Dr. John Halpern's MDMA/Cancer Anxiety Study

The DEA has, after over one year, issued a license for Dr. John Halpern's
study of MDMA-assisted psychotherapy in subjects with anxiety associated
with advanced-stage cancer. The final regulatory approval has thus been
obtained. Additional approvals have already been received from two
Institutional Review Boards (IRB-McLean and Lahey Hospitals) as well as the
Food and Drug Administration (FDA) and the Massachusetts Department of
Public Health.

MAPS has donated over $94,000 to McLean Hospital over the last five years in
an effort to initiate the evaluation of MDMA-assisted psychotherapy. One
fruit of this support has been Dr. Halpern's $1.8 million, five-year grant
from the National Institute on Drug Abuse (NIDA) for a methodologically
state-of-the art study of the neurocognitive consequences of the use of
Ecstasy, started with MAPS funding in a subject population MAPS brought to
the attention of Dr. Halpern. Now that the MDMA/cancer anxiety study is
fully approved, MAPS is withdrawing from any further financial sponsorship
of that study. MAPS, independent of McLean and Dr. Halpern, still plans to
assist by seeking donors interested in donating directly to McLean Hospital.
We believe that this financial distance from MAPS, and more so the rigor of
the methodological design of the study itself, will enable the results of
the study to be viewed by skeptics as more objective. If the results of the
pilot study are promising, MAPS will again explore options for the support
of research at McLean Hospital.

3. Data Safety Monitoring Board Reviews Dr. Mithoefer's MDMA/PTSD Study

On February 6, MAPS' Data Safety Monitoring Board (DSMB) met to review
records for the six new subjects who have enrolled since their last meeting
in Dr. Michael Mithoefer's study evaluating MDMA-assisted psychotherapy as a
treatment for PTSD. With data from a total of eleven subjects before them,
the DSMB reported that they did not have any concerns about the safety of
the study, and recommended that it continue without modification. The DSMB
is comprised of an M.D., a Psy.D., and a Pharm.D. not otherwise involved in
the study. Dr. Mithoefer has successfully treated 11 out of an eventual 20
subjects, and is currently treating the twelfth.

The DSMB also reviewed and approved three protocol changes that Dr.
Mithoefer and MAPS will initially submit to FDA and then, if approved, to
our Institutional Review Board (IRB). Dr. Mithoefer is seeking permission
to: 
1) Increase the number of MDMA experimental sessions from two to three, to
evaluate whether this extra session will enable subjects to make more
therapeutic progress.
2) Administer supplemental doses of 1/2 the initial dose of MDMA 2 to 2 1/2
hours after the initial dose, in order to prolong the relatively short
plateau of MDMA's full therapeutic effectiveness.
3) Since Dr. Mithoefer has recently renewed his Board certification in ER
medicine, we have asked to do without the additional Board-certified ER
doctor sitting in the next room.

In comparison, Dr. Peter Oehen's study in Switzerland has been designed and
approved for three MDMA experimental sessions and the use of supplemental
doses. Dr. Kotler's study in Israel has been designed and approved with
supplemental dosing but just two MDMA experimental sessions.

MAPS' FDA- and IRB-approved MDMA/ PTSD protocol:
http://www.maps.org/mdma/protocol/index.html

4. Upcoming Data Monitoring Visits for Swiss and Israeli MDMA/PTSD Studies

MAPS Clinical Research Associate Valerie Mojeiko and MAPS Clinical Program
Manager Amy Emerson will perform data monitoring visits for MAPS-sponsored
MDMA/PTSD research studies in Switzerland and Israel early this month. They
will work with Dr. Peter Oehen, M.D., in Solothurn March 2-4 and will be
joined by MAPS President Rick Doblin to work with Dr. Rael Strous, M.D., and
principal investigator Dr. Moshe Kotler, M.D., in Tel Aviv March 7-12.
During these visits, they will prepare for the initiation of these historic
studies. Standardized data monitoring is a key component of MAPS drug
development plans for obtaining approval from the FDA and the European
Medicines Agency for the prescription use of MDMA for the treatment of PTSD.

In addition to standardized data monitoring, the therapy approach itself has
to be standardized since the treatment we are investigating is MDMA-assisted
psychotherapy, not the simple administration of MDMA itself. As a result,
MAPS is developing an MDMA/PTSD treatment manual:
http://www.maps.org/research/mdma/ptsd_study/treatment-manual/053005/treatme
nt-manual.pdf

On a related note, Vanja Palmers donated $10,000 this month to Dr. Oehen's
MDMA/PTSD study. $115,000 is still needed for the Swiss study and $90,000 is
still needed for the Israeli study.

Swiss MDMA/PTSD Protocol:
http://www.maps.org/mdma/swissptsd/protocol011806.pdf
Israeli MDMA/PTSD Protocol:
http://www.maps.org/mdma/israel_protocol_3.16.05.pdf

5. Resumption of the Protocol Design and Approval Process for the
MAPS-sponsored MDMA/PTSD Research in Spain

Jose Carlos Bouso, Ph.D. candidate, has completed almost all of the work on
his dissertation and has returned to the design and approval process for his
MAPS-sponsored MDMA/PTSD study. This study was the world's first
government-approved MDMA psychotherapy study, and six patients were treated
in 2001-02. However, in response to positive reports about the study that
appeared in the Spanish media, the Madrid Anti-Drug Authority pressured the
hospital into withdrawing permission. The Ministry of Health has not
withdrawn permission, and we are hopeful that since we have now obtained
government approval for MDMA/PTSD studies in the US, Switzerland, and
Israel, it will be politically feasible to resume research in Spain within
the next year. As a result of the political suppression of his initial
study, Jose Carlos had to initiate and complete another study for his
dissertation before he was able to return his attention to his MDMA/PTSD
study.

MAPS' MDMA/PTSD research in Spain:
http://www.maps.org/mdma/spain/index.html

6. Supreme Court Votes Unanimously to Allow Religious Use of Ayahuasca

It is possible to fight the DEA and win! As reported by the Washington Post
and the New York Times on February 21, the US Supreme Court unanimously
sided with a Brazil-based church, O Centro Espirita Beneficiente Uniao do
Vegetal (UDV) in a landmark case that allows for the religious use of
ayahuasca, which contains the psychedelic drug DMT. New Chief Justice John
Roberts said that the Bush administration had not met its burden under the
Religious Freedom Restoration Act (RFRA) to show that it could ban "the
sect's sincere religious practice." The Chief Justice had also been
skeptical of the government's position in the case last fall, suggesting
that the administration was demanding too much, a "zero tolerance approach."
The Bush administration had argued that the drug in ayahuasca not only
violates a federal narcotics law, but a treaty in which the US promised to
block the importation of drugs such as DMT. This may not be the last word on
the case, however, considering that the justices have sent the case back to
a federal appeals court, which could consider more evidence if the
Department of Justice wants to continue the case. Nevertheless, the Supreme
Court ruling was clear, decisive and unanimous in rejecting all the
arguments put forward by the Department of Justice lawyers.

UDV website: http://www.udv.org.br

Read the Washington Post article here:
http://www.maps.org/sys/nq.pl?id=786&fmt=page

Read the New York Times article here:
http://maps.org/sys/nq.pl?id=787&fmt=page

7. Alex Grey's Albert Hofmann Portraits On Their Way

Albert Hofmann has now signed and returned all 50 copies of the portrait of
him by visionary artist Alex Grey. Profits from the sales of the portraits
will be divided between MAPS, with funds restricted for LSD and psilocybin
research and for supporting Albert's writings, and with Alex and Allyson's
Chapel of Sacred Mirrors. For those of you who
purchased the portraits, we expect them to be mailed this month. If you made
a deposit and have not yet paid in full, please contact Julia at maps.org as
soon as possible.

The portrait numbered 1/50 will be auctioned on eBay, after all the other
portraits have been distributed. We will announce the start of this auction
in the next email update.  To see a copy of the portrait and read an article
by Alex Grey about it, click here:
http://www.maps.org/sys/nq.pl?id=790&fmt=page

Chapel of Sacred Mirrors: http://www.cosm.org

8. Merchandise and Visionary Artwork Available From MAPS

The MAPS online store has been revamped, and now is as good a time as ever
to support psychedelic research by decorating your home with visionary
artwork or by sporting a MAPS hoodie or water bottle at
http://www.maps.org/store

Also, it's still not too late to buy your 2006 psychedelic calendar from the
MAPS online store. This calendar features 12 pieces of visionary and
psychedelic-inspired full-color artwork that are guaranteed to
psychedelic-ize your 2006. See http://www.maps.org/calendar

MAPS is also 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 Laura Huxley's portrait are restricted to MAPS-sponsored research
into psychedelic-assisted psychotherapy in people struggling with the
mystery of death. MAPS' 50% share of the proceeds from the sale of Ann and
Sasha Shulgins' portrait are restricted to MAPS-sponsored MDMA psychotherapy
research.

Shulgins' portrait: http://www.maps.org/pioneers/shulgins.html
Laura Huxley portrait: http://www.maps.org/pioneers/huxley.html
Dean Chamberlain's website: http://www.deanchamberlain.com

9. $12,500 in Two Large Donations to the Women's Entheogen Fund

Two large donations, totaling $12,500, were made last month to the Women's
Entheogen Fund (WEF) in honor of former MAPS employee Carla Higdon, who
passed away last month. The WEF facilitates women's involvement in
psychedelic research.

10. MAPS Receives $50,000 Grant

Shawn Hailey has awarded MAPS with a grant of $50,000 for general operating
expenses. Thanks, Shawn!

Thanks to everyone for reading, and have a happy March!
Jag 

--
Jag Davies
Director of Communications
www.maps.org