Greetings MAPS Members and Friends,
Looking over the past year’s email updates, you can see it’s been a momentous year for MAPS. This month is no exception…
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1. Over $275,000 in Grants Awarded to MAPS
2. Second MAPS Online Auction
3. Second Round of DEA Hearings Completed
4. MAPS/MPP File Amicus Curiae Brief in the New 9th Circuit Raich Case
5. MDMA Research Progresses
6. Ketamine-Psychotherapy Article Accepted for Publication
7. Ibogaine Outcome Study Protocol
8. LSD/Psilocybin Cluster Headache Study Moves Forward
9. Merchandise Available from MAPS
10. New edition of LSD: My Problem Child Available Now
11. MAPS Travels to Switzerland Next Month to Celebrate Albert Hofmann’s 100th Birthday–See you there!
12. Congratulations to Nicole on the Birth of Her New Baby Girl!
MAPS received a grant this month in the amount of $35,524.90, restricted to MDMA psychotherapy research. This grant is the final bequest from the estate of Lyn Ehrnstein, who helped establish Phoenix Research with Phyllis Ehrnstein and Ann Klein. Lyn Ehrnstein, a lawyer, was involved in the initial DEA Administrative Law Judge hearing in 1985 about the scheduling of MDMA. Lyn, Phyllis (who has also died) and Ann Klein have been supporters of MAPS ever since.
An anonymous Family Foundation awarded a grant of $40,000 for MAPS MDMA/cancer anxiety study. Dr. John Halpern is the Principal Investigator and the study will take place at Harvard Medical School-affiliated McLean Hospital.
John Gilmore, a member of MAPS’ Board of Directors, awarded MAPS an unrestricted grant of $200,000.
These generous donations provide crucial support for MAPS activities. Due to achieved and expected breakthroughs in permission for MDMA research in the US, Israel, Switzerland and Spain, MAPS is still seeking an additional $500,000 in grants for MDMA research in 2005-2006. We also need additional donations for operational expenses and other research and educational projects. Please consider making a special year-end tax-deductible contribution to MAPS.
The second-ever MAPS online auction, which took place right after Thanksgiving, raised about $8000 in the sale of 32 items. Thank you to everyone who donated to or purchased something in the auction.
From December 12-16, MAPS went to court for the second round of hearings in Prof. Craker’s lawsuit against DEA over the medical marijuana production facility at UMass Amherst, being heard before DEA Administrative Law Judge Mary Ellen Bittner. Dr. 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.
On December 12, 2005, the Washington Post published a tremendous article about the DEA hearings, on page A2. The article reported on two new developments, the most unexpected being a letter to DEA urging the licensing of Prof. Crakers facility sent by influential Republican strategist, Grover Norquist. The other development was the sending of a Congressional sign-on letter to DEA urging the licensing of Prof. Craker, signed by 38 Representatives; 36 Democrats and 2 Republicans.
Our lawyers are convinced that the DEA witnesses ended up helping our case substantially more than the DEA’s case. The hearings are now almost all over except for one additional witness who is scheduled to testify on January 17. The story of this final witness will help explain the DEA’s self-destructing case (though whether the DEA Administrative Law Judge Mary Ellen Bittner will recommend that Prof. Craker receive his license is too difficult to predict). To read the full report by Rick Doblin on the latest hearings, plus the Washington Post article, Congressional sign-on letter, Grover Norquist letter, transcripts of the hearings, and other documents, go here.
MAPS and MPP have filed an amicus curiae brief in the new 9th Circuit Raich v. Gonzales case over states’ rights to allow the use of medical marijuana. The lawsuit raises new legal issues since the US Supreme Court ruled in the previous Raich case that the interstate commerce clause of the US Constitution did not preclude the federal government from enforcing federal marijuana laws in States that had approved the medical use of marijuana. The MAPS/MPP brief argues that I. Asserting patients’ constitutional rights to use cannabis is the only reasonable alternative given the government’s obstruction of FDA-approved research into the potential therapeutic uses of cannabis and; II. Because the FDA drug development process is not working as congress intended, patients who follow their doctors orders to obtain cannabis through alternative means should be permitted to assert their constitutional rights to use cannabis. The full brief can be read here.
MAPS’ MDMA drug development effort is moving along swiftly. Dr. Michael Mithoefer, Principal Investigator of the MAPS-sponsored MDMA/PTSD psychotherapy study in Charleston, South Carolina, recently filed an Annual Status Report with his Institutional Review Board (IRB). There have been no drug-related Serious Adverse Events (SAEs) and the results on treatment efficacy are promising.
An article published in the December 27, 2005 issue of the Washington Post reported that in 2004 the Veterans Affairs Department spent $4.3 billion on PTSD benefit payments to a total of 215,871 veterans. If the results of the second half of our MDMA/PTSD study are as promising as the results of the first half, we will have data suggesting that it would be financially wise for the VA to fund the entire $5 million cost of MAPS’ Phase III studies to evaluate whether MDMA-assisted psychotherapy for PTSD should become approved by the FDA as a legally-available treatment. Realistically, however, we will need to complete our study before having any hope of obtaining support from any branch of the US government for MDMA/PTSD research, and then we’ll probably be rejected for the first several times. As we reported in last month’s email update, the National Institute of Mental Health (NIMH) rejected our application for a grant to develop a treatment manual for the use of MDMA-assisted psychotherapy in the treatment of PTSD.
Dr. John Halpern is still waiting for final DEA approval of his study of MDMA-assisted psychotherapy for anxiety associated with advanced stage cancer at Harvard Medical School’s McLean Hospital. Dr. Halpern received a message from a senior DEA official shortly before the holidays stating that approval is certain and will come fairly soon, but no definite timetable was given. We’re otherwise ready and eager to begin this historic study.
On December 27, 2005, we received a report from Swiss psychiatrist Dr. Peter Oehen saying that he has received final approval for his MDMA/PTSD study from the ethics committee. This study will be co-funded by MAPS and the Swiss Association for Psycholytic Therapy. Dr. Oehen will now submit his protocol to Swissmedic (the Swiss FDA) for a review process that we expect will take about a month. On January 10, MAPS Clinical Research Associate Valerie Mojeiko and MAPS President Rick Doblin will meet with Dr. Oehen in Solothurn, Switzerland for a prestudy monitoring visit.
In Israel, as we reported last month, Dr. Moshe Kotler, Chair, Department of Psychiatry, Sackler School of Medicine, Tel Aviv University and former chief psychiatrist of the Israeli Defense Forces, has received all approvals for his MAPS-sponsored MDMA/PTSD study, We are now working to schedule a visit by the Israeli co-therapists, Dr. Rael Strous and Dr. Rakefey Rodrigez, to Charleston, SC, to observe Dr. Michael and Ann Mithoefer conduct an MDMA/PTSD session. We are also planning a monitoring visit to Israel in early March, 2006. Fundraising efforts have now started for this study, seeking the necessary $75,000-100,000.
Dr. Evgeny Krupitsky’s MAPS and Heffter-funded research into the use of Ketamine-Assisted Therapy (KPT) in the treatment of heroin addiction has recently been accepted for publication in the Journal of Psychoactive Drugs (JPD), pending minor revisions that are in the process of being made. There will now be a second article about ketamine in the treatment of heroin addiction indexed in Medline! The first article was published in 2002 in the Journal of Substance Abuse Treatment (JSAT), showing that a single dose of KPT was more effective in promoting abstinence than low dose ketamine, which was used as an active placebo. This new article reports that multiple (three) KPT sessions are more effective than a single session. Taken together, these two papers are milestones in psychedelic research. The JSAT article demonstrated the efficacy of psychedelic psychotherapy in a double-blind controlled randomized clinical trial. Dr. Krupitsky’s new article is the first study comparing efficacy of multiple vs. single session approach (also within the evidence-based medicine paradigm study design).
MAPS’ outcome study of ibogaine in the treatment of addiction is moving closer to submission to a Canadian IRB. The protocol is only for the outcome study, not the treatments themselves, which will be provided legally on a fee-for-service basis by the Iboga Therapy House, directed by Sandra Karpetas. MAPS has hired Philippe Lucas to shepherd the protocol through the IRB. Philippe has previously obtained permission from the IRB for a clinical study of the therapeutic use of marijuana. We’re trying to get the documents ready to submit before the end of January 2006.
Dr. Andrew Sewell’s and Dr. John Halpern’s research into the use of LSD and psilocybin in the treatment of cluster headaches has reached a major milestone, in that Dr. Sewell’s colleagues recently submitted a case report series for publication with data from over 50 subjects. The information gathered from the case report series is forming the basis for designing a clinical study, with the protocol design phase well underway and making progress. MAPS has also been successful in fundraising for the clinical study, primarily through the sale of portraits of Albert Hofmann by artists Dean Chamberlain and Alex Grey, with portraits by Dean Chamberlain still available. MAPS has about $80,000 already in hand for the clinical study, though a substantial amount of additional funds will be necessary once the protocol is fully approved and ready to start.
It’s not too late to buy your 2006 psychedelic calendar from the MAPS bookstore. This calendar features 12 visionary or otherwise bizarre artists in full-color to psychedelic-ize your new year.
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.
This edition of the classic psychedelic text by Albert Hofmann Ph.D., which has been out of print in English for many years, includes a new foreword by LSD psychotherapy pioneer Dr. Stanislav Grof, as well as a new index, a new preface from the author, and 16 pages of photos, many of which are in color. It is available in our bookstore now. In addition to a Russian translation, MAPS has also discovered a Polish translation which is now available on our website. We are also working on a Chinese translation, to post online and possibly to be published on paper, the first few chapters of which will be posted online soon.
Join MAPS researchers and staff next month in Basel, Switzerland, where we will be celebrating the 100th birthday of Albert Hofmann, the man who discovered LSD and first synthesized psilocybin. The Spirit of Basel is presenting a symposium for the occasion, where MAPS will be bringing several speakers to discuss topics related to psychedelic psychotherapy, including Drs. Michael Mithoefer, John Halpern, Andrew Sewell, Charles Grob, and MAPS staffers Rick Doblin and Valerie Mojeiko. Before the symposium, we will also be visiting the University of Zurich and Solothurn to prepare for MAPS research with MDMA in Switzlerand.
Yesterday, at 8:24 AM, in Sarasota Memorial Hospital, MAPS staffer Nicole Tavernier-Luebcke gave birth to a baby girl, Rebecca Grace. Proud father David reported that Rebecca Grace weighed 9 lbs, 6 ozs, and was 21 1/2 inches. The baby was born by C-section and everything went smoothly. Nicole will be on maternity leave for the next several months.
Thanks for your support. Happy New Year!