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Media > Newsletter: April 11, 2005



Greetings, MAPS members & friends!

The MAPS staff has just returned from a very productive trip to Israel, where we held a one-day conference on MDMA research and met with Ministry of Health & Israeli Anti-Drug Authority officials. We're back and focused on our many other responsibilities and will be preparing a special issue of the MAPS Bulletin about our Israeli adventure.

The news from MAPS:

1. Israeli scientists, regulators, and media supportive of starting MDMA/PTSD research

2. Design work begins for new Spain MDMA/PTSD study

3. Swiss psychiatrist Dr. Peter Oehen visits MAPS to discuss MDMA/PTSD research

4. MAPS clinical research monitoring team met in Boston March 11-13, started work on MDMA/cancer anxiety study.

5. MAPS receives $40,000 grant from a family foundation for MDMA psychotherapy research

6. MAPS assists Sandra Karpetas of Iboga Therapy House apply for Health Canada grant

7. April 22 deadline for prehearing statement in medical marijuana lawsuit v. DEA

8. Proposed vaporizer research waiting on Health & Human Services (HHS) review

9. Upcoming conferences: ASSA, MindStates

10. MAPS Benefit Auction: A success!

11. Where's my MAPS Bulletin?

And the details:

1. Israeli scientists, regulators, and media supportive of starting MDMA/PTSD research

MAPS president Rick Doblin, staffers Valerie Mojeiko and myself, and several MAPS-funded researchers and MAPS members traveled to Israel to help build support for a MAPS-sponsored Israeli MDMA/PTSD pilot study. The study will examine the effects of MDMA-assisted therapy for people with Posttraumatic Stress Disorder (PTSD) as a result of war or terrorism. The highlight of the trip was a one-day conference attended by Ministry of Health officials, Israeli Anti-Drug Authority officials, doctors, laypeople, and reporters interested in the study. The speakers were:

  • Dr. Michael Mithoefer, primary investigator of the MAPS-sponsored MDMA/PTSD study in South Carolina
  • June May Ruse, Ph.D., director of MAPS' MDMA/PTSD treatment manual project
  • Dr. John Halpern, primary investigator of the FDA-approved Harvard Medical school MDMA research in cancer patients with anxiety
  • Dr. Raphael Mechoulam, Israeli scientist who discovered THC in cannabis and decades later the brain's endocannabinoid system, and is now beginning research in Israel with cannabis in treating PTSD
  • Valerie Mojeiko, who discussed her proposed outcome study of the use of ibogaine in treating substance abusers
  • Dr. Udi Bastiaans, who discussed his Internet-based outcome study with ibogaine
  • Jose Carlos Bouso, Ph.D. candidate, primary investigator for the MAPS-sponsored MDMA/PTSD study in Spain that was shut down for political reasons but which we are now working to resume
  • Dr. Torsten Passie, psilocybin and ketamine researcher from Germany
  • Dr. Jordi Riba, ayahuasca researcher from Spain

The talks were filmed and will be available for downloading on the MAPS website within the next few weeks.

Prior to the conference, MAPS researchers met with officials from the Israeli Anti-Drug Authority and Ministry of Health, and members of both expressed support for the study. Dr. Moshe Kotler, Chair, Dept. of Psychiatry, Tel Aviv University, Sackler School of Medicine, and former chief psychiatrist of the Israeli Defense Forces, will be the study's principal investigator. In light of the latest scientific data and positive political response, Dr. Kotler has decided to go forward and submit the protocol for review to the ethics committee and Ministry of Health, seven years and three conferences after he was first contacted by MAPS about conducting MDMA/PTSD research.

The largest Israeli weekly newspaper, Yediot Ahronot, ran a very favorable story on the research, which was published the day after the conference in its weekly magazine. The article included a full-page image that is probably the most positive portrayal of the promise of MDMA that has ever been published. The image (see the link above) is of a weary man in the middle of a blood-red ocean, with several helicopters flying behind him. He's almost drowned but has been saved by a life preserver in the shape of an Ecstasy pill, complete with smiley face!

2. Design work begins for new Spain MDMA/PTSD study.

Jose Carlos Bouso, the Ph.D. candidate who began a MAPS-sponsored MDMA/PTSD dose-response pilot study in Madrid shut down for political reasons in May 2002, is now working on a revised protocol that he thinks can be approved before the end of 2005. The protocol as currently designed will involve 12 subjects who will receive a combination of about 8 hours of non-drug psychotherapy and two day-long MDMA sessions. Eight of the subjects will receive full doses of MDMA and 4 will receive threshold/placebo doses of MDMA.

The main reason we think that we can now obtain approval is that Jose Carlos Bouso has found a private hospital that is seriously interested in having the study conducted in its facility. This private hospital is not as vulnerable to political pressure from the Anti-Drug authorities as the public hospital where the study was previously conducted. In addition, the scientific consensus about the risk/benefit ratio for the use of MDMA in clinical research has changed substantially from several years ago. The risk of neurotoxicity is now generally considered to be minimal and we have promising efficacy data from Dr. Mithoefer's MDMA/PTSD pilot study. The most important factor of all is Jose Carlos Bouso's continued committment to conducting MDMA/PTSD research, in the face of initially overwhelming political opposition.

MAPS has pledged an initial $25,000 to fund the Spain study and is in the early planning stages of a benefit to raise additional funds.

3. Swiss psychiatrist Dr. Peter Oehen visits MAPS to discuss MDMA/PTSD research

Dr. Peter Oehen, a member of a group of Swiss psychiatrists who were permitted to offer LSD and MDMA-assisted psychotherapy in Switzerland from 1988-1993, will be visiting with Rick Doblin on April 8-9 and then with Dr. Michael and Annie Mithoefer in Charleston, SC. Dr. Oehen is exploring the possibility of conducting MDMA/PTSD research in Switzerland with a protocol design similar to the ones that MAPS will be using in the US, Israel and Spain studies. Since MAPS is developing MDMA within a non-profit context, we make our protocols, informed consent forms and literature review available to any research team in the world to use as is or modify as they choose. We're excited about the possibilities for the globalization of MDMA/PTSD research.

4. MAPS clinical research monitoring team met in Boston March 11-13, started work on MDMA/cancer anxiety study.

MAPS has assembled a team to monitor our clinical trials to ensure that the data gathered in each of our studies is properly and thoroughly recorded. There are hundreds of pages of paperwork on every subject in every study, and managing this mountain of data is an important part of ensuring that our results are communicated effectively to, and accepted by, the FDA and the larger scientific community. The monitoring team consists of Amy Emerson, who monitors studies professionally for a major pharmaceutical company, and MAPS staffers Valerie Mojeiko and Ilsa Jerome, Ph.D.

The team met on March 11-13 with Dr. John Halpern, Rick Doblin and Jill Stammer (who will help with data collection) for an initial site visit and began the process of developing written procedures and Case Report Forms for the conduct of the study. The team will also monitor the MAPS-funded studies in South Carolina and (when approved) Israel and Spain and perhaps also Switzerland.

MAPS' MDMA/cancer anxiety study can begin once DEA issues a Schedule I license, which we expect will occur within a month or so.

5. MAPS receives $40,000 grant from a family foundation for MDMA psychotherapy research

On March 10, 2005, MAPS was informed that it had been awarded a $40,000 grant from a family foundation for our MDMA psychotherapy research efforts.

We still have a fundraising mountain to climb of about $500,000 for all our MDMA research projects already approved or on the immediate horizon, so if you have any leads for additional grants, please let us know.

6. MAPS assists Sandra Karpetas of Iboga Therapy House in applying for Health Canada grant

On February 28, Sandra Karpetas of the Iboga Therapy House, an ibogaine clinic in Vancouver providing free ibogaine treatments to addicts that was shut down due to lack of funds, applied for a Canadian government grant from Health Canada to provide ibogaine detoxification services to 20 people as a pilot project. The grant is part of the Drug Strategy Community Initiatives fund, created under the leadership of Health Canada in April 2004 to facilitate the development of community-based solutions to substance abuse. MAPS staffer Valerie Mojeiko assisted in writing and editing the grant application, and if the clinic reopens, MAPS will provide guidance and funding for an evaluation component of the clinic's services. MAPS will also serve as the organization that administers the grant. A decision about the grant is expected before the end of June.

7. April 22 deadline for prehearing statement in medical marijuana lawsuit v. DEA

On February 28, 2005, DEA filed its prehearing statement in the Administrative Law Judge hearings about DEA's refusal to grant a license to Prof. Lyle Craker, UMass Amherst, to establish a MAPS-sponsored facility to produce marijuana exclusively for federally-approved research. Prof. Craker's prehearing statement is due April 22, 2005, with our pro-bono lawyers (Julie Carpenter of Jenner & Block, Emanuel Jacobowitz of Steptoe & Johnson, and Allen Hopper of the ACLU Drug Law Reform Project) and Rick Doblin making progress on the statement and the gathering of witnesses for the hearing itself. We intend to show to the DEA Administrative Law Judge that it is in fact in the public interest to break the government monopoly on the supply of marijuana that is legal for research, since the monopoly is used to obstruct research, and that US international treaty obligations do not prevent DEA from issuing a license to Prof. Craker, as the DEA contends.

After the prehearing statements are submitted, there may be supplemental statements submitted by DEA and on behalf of Prof. Craker. Then the judge will set a date for the hearing, probably before the end of Summer 2005. The decision by the US Supreme Court in the Raich v. Ashcroft medical marijuana case should be issued before the DEA hearing. It's considered likely that the Supreme Court will assert federal authority over state medical marijuana laws. This will make the FDA-approved research process the only way for patients to obtain marijuana legally from a federal perspective, increasing the need for the DEA to license the UMass Amherst facility.

8. Proposed MAPS and CaNORML-sponsored vaporizer research waiting on Health & Human Services (HHS) review and DEA license More than 21 months after submission, Chemic Laboratories' proposed vaporizer study is still awaiting review of its application to purchase ten grams of marijuana from NIDA and import ten grams of marijuana from the Dutch Office of Medicinal Cannabis. The protocol itself needs to be reviewed by NIDA/Public Health Service scientists in a process which has no time limit and has already been delayed for more than 1 3/4 years.

MAPS' lawsuit against NIH/NIDA/HHS in the DC Circuit Court of Appeals, arguing unreasonable delay, failed to convince the court to compel NIH/NIDA/HHS to justify the delay. The case was dismissed without prejudice, meaning that we can resubmit the lawsuit after another period of time goes by without response. Fortunately, the DC Circuit Court of Appeals did require the DEA to justify why it had taken 3 1/2 years and had still not responded to Prof. Craker's application to grow marijuana for research. Rather than try to justify its inaction, DEA rejected Prof. Craker's application on December 10, 2004, which has enabled us to sue DEA in the above-mentioned Administrative Law Judge hearing.

In another bureaucratic manuever, DEA stated on December 10, 2004 that Chemic needed a research license in addition to its analytical lab license. Chemic immediately applied for the research license and is still waiting almost four months later. The criteria to receive a research license are identical to that required for an analytical laboratory license.

In early March, Chemic received word from the DEA that its application for a research license was being processed and received word from HHS that its protocol was being reviewed. We anticipate positive decisions on both of these reviews in April or May. As far as we can tell, DEA is probably planning to improve its position in the Administrative Law Judge hearing by granting Chemic its research license and approving the protocol. Denying Chemic permission to purchase 10 grams of marijuana from NIDA after almost two years would clearly demonstrate that NIDA's monopoly is insufficient to facilitate privately-funded medical marijuana research.

9. Upcoming conferences: ASSA, MindStates

The Bay Area will host two upcoming conferences for the psychedelic community: the Altered States & the Spiritual Awakening (ASSA) conference and the Mind States Conference. The ASSA conference, now in its third year, will be held April 15-16. Speakers include Stan Grof, Rick Doblin, Ralph Metzner, and several others. To learn more, go to .

The Mind States conference has moved from Berkeley to San Francisco this year, and will be held May 27-29 at the Palace of Fine Arts Theater. Three full days of speakers (11 a.m. to 11 p.m.) include several psychedelic researchers, like Charles Grob, Julie Holland, Franz Vollenweider and Rick Doblin. Go to for more info.

10. MAPS Benefit Auction: A success!

Thanks to the generous donations and generous bidding of MAPS supporters and friends, we raised just about $20,000 with the first-ever online MAPS Benefit Auction. Some of the highest-selling items were a set of prints by Dean Chamberlain ($2650), a guitar donated by The Cure ($1025), and a beautiful Huichol yarn painting ($1500). We made a total of $2065 on glassware donated by chemist Sasha Shulgin. If you were bid out, don't worry- we hope to continue this project in the future.

11. Where's my MAPS Bulletin?

No, we didn't lose your address. We are putting the finishing touches on a very full issue that we hope to have to the mailing house in a few weeks. Our apologies for the long delay.

Thanks for your continued support! Please email us with any address changes or if you'd like to be removed from the list!

Best wishes,
Brandy
--
Brandy Doyle
MAPS Projects and Communications Director

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