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MAPS Bulletin Spring 2014: Special Edition: Psychedelics and Education
 
Media > Newsletter: May 11, 2006



MAPS Members and Friends,

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***

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. Craker's lawyers include lead attorney Julie Carpenter (Jenner & Block), assisted by Allen Hopper (ACLU), and Emanuel Jacobowitz (Steptoe & Johnson). DEA's 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 initiated 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.

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, 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 Gust's estimated review times have been accurate in regards to Chemics application in that the initial review took over two years, during which time 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 Gust's 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.

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.

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.

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 MDMA's 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.

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 Harvard's 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.

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 MAPS' 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 north 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 Ben Lomond 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 try to get them 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 email Julia, auction coordinator, at: .(JavaScript must be enabled to view this email address)

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.

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.

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.

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 Davies, MAPS Director of Communications























































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