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MAPS Bulletin Summer 2014: Research Edition
Media > Newsletter: March 6, 2006

MAPS Members and Friends,

Things are moving fast now that our research is going global. I'll be sending out the email updates now that Valerie Mojeiko (who has written the email updates 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.***

Heres 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 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 from the case on the MAPS website.

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 grant from the National Institute on Drug Abuse (NIDA) for a methodologically state-of-the art study started with MAPS funding of the neurocognitive consequences of the use of Ecstasy. Now that the MDMA/cancer anxiety study is fully approved, MAPS is withdrawing from any further financial sponsorship. MAPS, independent of McLean and Dr. Halpern, still hopes to assist with seeking donors interested in now 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. Mithoefers 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.

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.

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.

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.

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.

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 .(JavaScript must be enabled to view this email address) 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.

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. 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.

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.

9. $7,500 Donation to 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 Davies, MAPS Director of Communications

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