leftspacer middlespacer rightspacer
Media Menu
Email Newsletter Archive

MAPS BULLETIN
MAPS Bulletin Winter 2013: 2013 Annual Report
 
Media > Newsletter: April 4, 2006



MAPS Members and Friends,

As our MDMA psychotherapy pilot studies gather steam and our DEA lawsuit moves forward, the MAPS office is preparing for a big physical shift -- to a new coast and a new community, in California's San Francisco Bay Area. If anyone knows of a home and/or office space that could be donated (the value of which is a tax-deductible donation to MAPS), or has suggestions for space that could be rented, please let us know at .(JavaScript must be enabled to view this email address) (first please read Item #11 "Relocating MAPS Headquarters!")

***Want to join MAPS? Renew your membership? Make a restricted donation? Click here to support MAPS' mission***

Here's the news:

1. $250,000 Donation to Harvard's McLean Hospital for Dr. Halpern's MDMA/Cancer Anxiety Study
2. FDA Reviewing Changes to Dr. Mithoefer's MAPS-Sponsored MDMA/PTSD Study; Recruitment Efforts Continue
3. Proposed MAPS-Sponsored MDMA/PTSD Research in Israel Gaining Momentum
4. Swiss MDMA/PTSD Study Preparing for Government Approval
5. Paper by Andrew Sewell, M.D., About LSD/Psilocybin Cluster Headache Research to be Published in Neurology
6. Final Legal Briefings in Progress for Prof. Craker's DEA Lawsuit for MAPS-Sponsored Medical Marijuana Production Facility
7. Angel Raich Returns to Ninth Circuit Court with "Right to Life" Medical Marijuana Case
8. Presentation at Royal College of Psychiatrists in London Sparks Interest in Renewal of Psychedelic Research in UK
9. MAPS Bringing Psychedelic Sanctuary to Portugal's Boom Festival
10. MAPS' Women's Entheogen Fund Sponsors Speakers for She Shamans conference
11. Relocating MAPS Headquarters!

1. $250,000 Donation to Harvard's McLean Hospital for Dr. Halpern's MDMA/Cancer Anxiety Study

In some fantastic news, philanthropist Peter Lewis has agreed to donate $250,000 directly to Harvard Medical School-affiliated McLean Hospital to fund the costs of Dr. John Halpern's study of MDMA-assisted psychotherapy in subjects with anxiety associated with advanced-stage cancer.

Dr. Halpern's MDMA/cancer anxiety study is already fully approved by the FDA, DEA, two Institutional Review Boards (IRB's, at Lahey Clinic and McLean Hospital) and the Massachusetts Dept. of Public Health. Now that the study is fully funded, Dr. Halpern is preparing to initiate the study and hopes to enroll the first subject within the next several months.

As we reported in the last email update, MAPS has withdrawn from direct sponsorship of this study. The McLean Hospital administration felt that MAPS long-term advocacy for MDMA psychotherapy research and general opposition to Prohibition would cause the results of the study to be challenged as biased if MAPS were to sponsor the study and they did not want McLean Hospital to be involved in a study funded by MAPS. Therefore, we decided that it would be best for MAPS to offer to withdraw from further direct financial sponsorship of Dr. Halperns research so that the study, which many people labored so long to start, could proceed. Sacrifices sometimes need to be made. In this case, we decided that the benefits of the study moving forward substantially outweigh MAPS' withdrawal from direct sponsorship. MAPS will still have access to the data generated by Dr. Halpern, as will any other organization that requests it.

2. FDA Reviewing Changes to Dr. Mithoefer's MAPS-Sponsored MDMA/PTSD Study; Recruitment Efforts Continue

The FDA is currently reviewing several proposed changes to Dr. Michael Mithoefer's MAPS-sponsored study evaluating MDMA-assisted psychotherapy as a treatment for PTSD. Were asking to add a third experimental session (currently there are two) and to provide supplemental dosing of half the initial amount administered 2 to 2 1/2 hours after the initial dose. We expect that these changes, if approved by both FDA and our IRB, will increase the effectiveness of the treatment without significantly increasing risk.

To accelerate the pace of the study, MAPS will be sending referral letters to mental health professionals in the greater Charleston, SC area this month. There are only eight more subjects needed for this study.

MAPS is seeking to raise additional funds for this study, in an amount to be determined once we learn whether our protocol changes have been accepted.

3. Proposed MAPS-Sponsored MDMA/PTSD Research in Israel Gaining Momentum

There are several developments to report concerning MAPS' government-approved MDMA/PTSD research protocol in Israel. MAPS Clinical Research Associate Valerie Mojeiko and MAPS Clinical Program Manager Amy Emerson, along with MAPS President Rick Doblin, conducted data monitoring visits on March 7 and March 12 to prepare for the initiation of this landmark study. They worked with the studys Principal Investigator Dr. Moshe Kotler, Chair of the Department of Psychiatry, Tel Aviv University, Sackler School of Medicine, and former chief psychiatrist of the Israeli Defense Forces, and with the Israeli co-therapists Dr. Rael Strous and Dr. Rakefet Rodrigez.

MAPS' data monitoring team also viewed the extensive renovations taking place at the treatment facility where MDMA will be administered during the study at Beer Yaakov Mental Health Center in Tel Aviv. While in Israel, MAPS President Rick Doblin and MAPS Clinical Research Associate Valerie Mojeiko also attended a conference sponsored by the Israeli Anti-Drug Authority that included a talk by Prime Minister Ehud Olmert.

To help train the Israeli co-therapists, MAPS is bringing them to Charleston, SC, to observe an MDMA/PTSD session conducted by Dr. Michael and Annie Mithoefer as part of their MAPS-sponsored study. This training session is tentatively scheduled for May 5.

Weve also made some progress in fundraising for the Israeli MDMA/PTSD study. Mr. Martin Gruss has agreed to donate $25,000, restricted to Dr. Kotler's study, as a result of discussions with MAPS member Ami Shinitzky, who donated $10,000 to the study last month. MAPS is still seeking to raise an additional $65,000 for this study.

4. Swiss MDMA/PTSD Study Preparing for Government Approval

Immediately prior to their arrival in Israel, MAPS Clinical Program Manager Amy Emerson and MAPS Clinical Research Associate Valerie Mojeiko conducted a monitoring visit in Switzerland for Dr. Peter Oehen's MAPS-sponsored MDMA/PTSD study. Dr. Oehen's protocol has been approved by an Ethics Committee (Switzerland's equivalent of an Institutional Review Board [IRB]) and by Swissmedic (Switzerland's FDA equivalent). The Informed Consent (IC) form has been revised to incorporate changes requested by SwissMedic, with the revised IC under review by Dr. Oehen's Ethics Committee, which must approve the new language for the IC. MAPS anticipates the initiation of Dr. Oehen's study in June.

MAPS is also seeking to raise an additional $115,000 for this study. The budget is $150,000, with $25,000 to be donated by the Swiss Medical Association for Psycholytic Therapy and $10,000 already donated by Vanja Palmers.

MAPS plans to submit the Israeli and Swiss protocols to the FDA so that data gathered in these studies will be evaluated and considered by FDA as part of MAPS overall effort to develop MDMA into an FDA-approved prescription medicine. The data from these studies will also be submitted to their respective national regulatory authorities and to the European Medicines Agency, as part of the MAPS strategy to obtain approval for MDMA as a prescription medicine both in the US and throughout Europe.

5. Paper by Andrew Sewell, M.D., About LSD/Psilocybin Cluster Headache Research to be Published in Neurology

A paper by Andrew Sewell, M.D., coauthored by John Halpern, M.D., and Harrison G. Pope Jr., M.D., describing MAPS-sponsored LSD/psilocybin cluster headache research has been accepted for publication in Neurology, the official journal of the American Academy of Neurology.

Anecdotal evidence suggests that ingesting psilocybin or LSD can terminate cluster attacks in the same manner as sumatriptan (Imitrex), and--more significantly--can end cluster periods and extend remission periods so that no more cluster attacks occur, a quality shared by no conventional medication. MAPS supported Andrew Sewell, M.D., and John Halpern, M.D., in collecting and analyzing hundreds of case reports from Erowid.org and Clusterbusters, an organization run by and for people with cluster headaches dedicated to promulgating the use of psilocybin as a treatment for cluster headache. Neurology is a top specialty journal read by most neurologists throughout the world, so news of this discovery will for the first time be widely disseminated among doctors. The paper should see print in about six to nine months.

Based on this data, Drs. Sewell and Halpern are currently developing a protocol for a randomized, dose-response study of psilocybin and LSD in people with episodic cluster headaches. Currently, there is no legal research with LSD in humans taking place in the world, and we hope that this will be the first study to renew human research with LSD. Due to the previously expressed concerns of the McLean administration, MAPS will not be funding research at McLean until the McLean administration decides that such funding is welcomed.

6. Final Legal Briefings in Progress for Prof. Craker's DEA Lawsuit for MAPS-Sponsored Medical Marijuana Production Facility

MAPS and lawyers from the ACLU and two Washington D.C. law firms are working to meet the April 27 deadline 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. The legal briefings will build arguments based on the evidence presented in court before DEA Administrative Law Judge 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.

Judge 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.

On a related note, Rick Doblin will be the featured lunchtime speaker on April 6 at the Fourth National Clinical Conference on Cannabis Therapeutics in Santa Barbara, CA. He will be speaking about DEA and NIDA's obstruction of privately-funded medical marijuana research and Prof. Craker's proposed production facility.

7. Angel Raich Returns to Ninth Circuit Court with "Right to Life" Medical Marijuana Case

In June 2005, medical marijuana suffered a judicial setback when the US Supreme Court ruled in Gonzalez v. Raich that the federal government can continue arresting patients who use medical marijuana legally under their state laws. On March 27, 2006, Raich returned to the Ninth Circuit Court in Pasadena, California, with a new legal strategy. Her attorney, Prof. Randy Barnett, emphasized that the case was about Angel's "fundamental right to life," arguing that her right to use marijuana is constitutionally protected under the 5th & 9th amendments and by the common law doctrine of medical necessity.

During oral arguments in Raich's new Ninth Circuit case last month, Justice Arlen Beam cited the MAPS/MPP amicus curiae brief. However, the Judge did not cite the primary message of the brief -- that the federal government has obstructed research, hence making state reform efforts necessary -- instead, to our disappointment, he only focused on the brief's acknowledgment that there is not enough current clinical research for the FDA to approve marijuana for prescription use. For more information, here's a full report on the oral arguments by Dale Gieringer, Ph.D.

8. Presentation at Royal College of Psychiatrists in London Sparks Interest in Renewal of Psychedelic Research in UK

On Friday, March 31, a group featuring Ben Sessa, M.D., gave a presentation at London's Royal College of Psychiatrists entitled "The Healing Potential of Non-Ordinary States of Consciousness." Dr. Sessa, who hopes to one day conduct psychedelic research in the UK, spoke specifically about the potential uses for psychedelics in modern medicine. The presentation was a sold-out success, and the presenters were congratulated for bringing this important topic to the minds of British doctors, many of whom at the meeting were enthusiastic to see increased awareness about this issue within the medical profession. Dr. Sessa has been invited to present at a number of medical schools and universities around the UK over the next few months.

Dr. Sessa said of the event: "Britain has a rich history in the very beginnings of the psychedelic movement -- from Sandison and Osmond to, of course, Aldous Huxley. It would be great to see Britain getting back on the map again with this important, and too long neglected, area of medicine."

We are heartened by this evidence of growing international support for the renewal of psychedelic research. While MAPS has yet to sponsor research in the UK, we are considering it as a potential location for Phase III MDMA/PTSD clinical trials and for Phase II LSD/psilocybin cluster headache trials.

9. MAPS Bringing Psychedelic Sanctuary to Portugal's Boom Festival

MAPS will be coordinating psychedelic emergency services at the Boom Festival in Portugal August 3-9. We will be sending a team consisting of Jose Carlos Bouso, M.D., and John Halpern, M.D., probably along with Leah Martin and Sandra Karpetas of Vancouver's Iboga Therapy House, and other volunteers.

10. MAPS' Women's Entheogen Fund (WEF) Sponsors Speakers for She Shamans Conference

MAPS is contributing $1000 from the Women's Entheogen Fund (WEF) for travel expenses for speakers at the She Shamans and Magic Mamas conference, June 23-25 at Isis Oasis in Geyserville, CA. 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.

11. Relocating MAPS Headquarters!

We're elated to announce that the MAPS headquarters will be relocating to the San Francisco Bay Area in the summer of 2006!

The decision to leave Sarasota -- the city that has served as the home base for the MAPS office from 1985-88 and from 1998 to the present -- was not easy, but considering MAPS' growing staff, the relative plethora of educational outreach opportunities in the Bay Area, and the welcoming and open-minded community we've worked with there, the decision was made with enthusiasm. We are relishing the challenges of expanding MAPS' educational mission, as we simultaneously gain momentum for our clinical research agenda, over the coming years in California. MAPS President Rick Doblin will continue to operate out of his office in Belmont, MA.

If you or anyone you know would like to make a tax-deductible donation of an office, live/work space, or a large residence that could accommodate an office and housing for employees in San Francisco, Oakland, Berkeley, or a neighboring area, please respond to this email or write to .(JavaScript must be enabled to view this email address) We would be looking for a dog-friendly house with 3-4 bedrooms, with perhaps a large private space that could serve as a MAPS office. For an office space, we would need at least 750-1000 sq. ft. Since we don't have a retail operation, though, it won't be necessary to find a space that is easily accessible to the public if the office is separate from the house in a commercial area.

MAPS staffers will be in San Francisco from April 19 to April 25 to run a MAPS table at the NORML conference, attend the MAPS Board of Directors meeting, and to scout out potential offices, homes, and home offices. Also, if you have any leads on any of the above that may be available for rent starting June 1, please contact us as well.



Wishing you an astonishing April,

Jag Davies, MAPS Director of Communications























































Give Our Veterans Hope
1 in 7 Iraq and Afghanistan veterans suffer from PTSD, in many cases leading to suicide. We owe it to our veterans to stop this epidemic.

Tell the Pentagon to fund MAPS' groundbreaking work to treat PTSD.