MAPS Members and Friends,
As the MAPS headquarters at Love Creek gets the ball rolling with our new office in California, we’re pleased to announce that we have made some major steps forward with our international clinical research agenda while our domestic MDMA and marijuana projects have received remarkably positive media coverage. MAPS’ vision of a society that integrates the medicinal and therapeutic potentials of psychedelics and marijuana – and the states of mind they engender – is one month closer to fruition, though we still have many years to go.
Here are this month’s headlines:
1. New MAPS Headquarters at Love Creek
2. SwissMedic Approves MDMA for MAPS-Sponsored MDMA/PTSD Study
3. Israel MDMA/PTSD Research a Step Closer to Starting
4. New Project: LSD-assisted Psychotherapy Research in Switzerland
5. MAPS-Sponsored Psychedelic Sanctuary at Portugal’s Boom Festival
6. Positive Coverage for MAPS in Two Boston Globe Feature Articles
7. MAPS Preparing for Possible Positive Recommendation in DEA Lawsuit for Medical Marijuana Production Facility
8. Institutional Review Board Approves Changes to Dr. Mithoefer’s MDMA/PTSD Study
9. Signed Edition of LSD: My Problem Child Now Available
10. Join MAPS at the She Shamans and Magic Mamas Conference, June 23-25
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1. New MAPS Headquarters at Love Creek
During the last week of May, MAPS staffers and volunteers packed up the MAPS office in Sarasota, FL, where it had been located for the last eight years, and set up our new office in Ben Lomond, CA. 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.
The Love Creek office staff consists of Valerie Mojeiko (Program Director and Clinical Research Associate), Julia Onnie-Hay (Educational Outreach Coordinator), Jag Davies (Director of Communications), and Sarah Hufford (Membership and Sales Manager). The MAPS staff will also be joined this summer by Louise, a volunteer intern from New York’s Barnard College.
MAPS is in the early stages of planning a “Welcome to California” benefit party in San Francisco sometime in late 2006.
Please direct correspondence to our new address: MAPS/10424 Love Creek Rd./Ben Lomond, CA 95005. The MAPS office can now be reached by phone at 831.336.HEAL (4325) and by fax at 831.336.3665. Mail sent to the old MAPS address will be forwarded to Love Creek for the next six months along with calls from the old MAPS phone number.
2. SwissMedic Approves MAPS-Sponsored MDMA/PTSD Study
Switzerland’s FDA equivalent, SwissMedic, has now fully approved Dr. Peter Oehen’s MAPS-sponsored MDMA/PTSD study. The protocol design had already been approved, and earlier this week we received approval for the source of the MDMA itself, which MAPS is purchasing from a Swiss manufacturer. Now that Dr. Oehen has received permission from SwissMedic and an Ethics Committee (the Swiss IRB equivalent), the only regulatory hurdle remaining is licensing from BAG, the Swiss DEA equivalent, which is expected within a month. Initiation of Dr. Oehen’s study will take place shortly thereafter.
3. Israel MDMA/PTSD Research a Step Closer to Starting
Approval from SwissMedic of the source of the MDMA for the Swiss MDMA/PTSD study will now enable MAPS to move forward with the export of MDMA from Switzerland to Israel. The import/export of the MDMA is the last regulatory step in the initiation of Dr. Moshe Kotler’s MAPS-sponsored MDMA/PTSD research at Beer Yaakov Mental Health Center in Tel Aviv, in subjects with war and terrorism-related PTSD.
4. New Project: LSD-assisted Psychotherapy Research in Switzerland
MAPS and Dr. Peter Gasser have started working together on the design of a study to investigate LSD-assisted psychotherapy in subjects suffering from anxiety associated with advanced-stage cancer and other life-threatening illnesses. MAPS has pledged to donate $50,000 for this study, which MAPS has already raised from the sale of art and books signed by Albert Hofmann. This study will complement Dr. John Halpern’s MAPS-initiated research investigating MDMA-assisted psychotherapy and Dr. Charles Grob’s Heffter-sponsored research investigating psilocybin-assisted psychotherapy, both with subjects suffering from anxiety associated with advanced-stage cancer.
Dr. Gasser’s study is in the early stages of protocol design. The current idea is for a preliminary 4 patient, open-label design to gather basic information on safety for this patient population and to develop a treatment approach. Though there has been substantial prior research with LSD in cancer patients that demonstrated safety and some degree of efficacy, that research was conducted over 35 years ago. For this study to follow modern drug development standards, we must start from scratch and build carefully. Our goal is to be able to start this study before January 11, 2007, Albert Hofmann’s 101st birthday.
5. MAPS-Sponsored Psychedelic Sanctuary at Portugal’s Boom Festival
As a result of MAPS’ work at Burning Man assisting the Rangers to provide psychedelic emergency services, MAPS has been asked to provide psychedelic emergency services at the Boom Festival in Portugal from August 3-9. The Boom Festival organizers awarded MAPS $9600 for travel and other expenses.
Our team of therapists will consist of Peter and Verena Oehen from Switzerland (MDMA/PTSD researchers), Andrew Sewell from Harvard (LSD/Psilocybin in cluster headache researcher), Jose Carlos Bouso from Spain (MDMA/PTSD researcher), Sandra Karpetas (Ibogaine researcher) and several others from Vancouver, Canada, along with about fifteen other volunteers.
6. Positive Coverage for MAPS in Two Boston Globe Feature Articles
On May 15, the Boston Globe published “A Good Death,” an article by Scott Allen that discusses one cancer patient’s experience with the underground therapeutic use of MDMA to help her deal with anxiety and pain. The piece also describes Dr. John Halpern’s MDMA-assisted psychotherapy research at Harvard’s McLean Hospital, which MAPS helped design and obtain funding for. This study will examine the potential therapeutic benefits of MDMA in people who suffer from anxiety as a result of advanced-stage cancer. Allen’s article had originally been written for the Boston Globe’s Sunday Magazine, but the editors deemed the article too positive, shortened it, and instead placed it as the lead article in Monday’s Health/Science section with an article on drug addiction published immediately next to it!
On May 28, the Boston Sunday Globe published “Weed Control,” an article by Jessica Winter describing the proposed MAPS-sponsored medical marijuana production facility at the University of Massachusetts-Amherst, the current government monopoly on marijuana grown for research, and the MAPS-supported lawsuit filed against the DEA to end this monopoly. The piece describes MAPS’ involvement in developing the proposed facility and features quotes from MAPS President Rick Doblin. The article, with multiple graphics, was the lead article in the “Ideas” section, which contains the editorials, op-eds and other feature articles.
7. MAPS Preparing for Possible Positive Recommendation in DEA Lawsuit for Medical Marijuana Production Facility
As we reported in May’s email update, lawyers from the ACLU and two Washington D.C. law firms have 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, with a recommendation from DEA Administrative Law Judge Mary Ellen Bittner to DEA Administrator Karen Tandy expected within three to six months. We are now focusing our attention on preparing to pressure the DEA to accept Judge Bittner’s recommendation if she actually recommends that the DEA should issue a Schedule I license to Prof. Craker for his marijuana production facility. Prof. Craker’s proposed facility would end the government’s six decades-long monopoly on the production of marijuana for research purposes and would create the necessary independence of supply to justify the time and expense for MAPS to sponsor clinical research evaluating the risks and benefits of marijuana as a potential FDA-approved prescription medicine.
MAPS has re-hired Kelly Burns, who worked with us on our Congressional sign-on letter campaign last Fall, to obtain letters of support to DEA for Prof. Craker’s facility from prominent medical and public health organizations. DEA has already received letters of support for Prof. Craker from Americans for Tax Reform, the Lymphoma Foundation of America, the National Association for Public Health Policy, the United Methodist Church, the American Medical Students Association, and several state nurses’ associations.
Visit MAPS’ DEA lawsuit page to read the legal briefs, letters of support, Congressional sign-on letter, media coverage, court transcripts from thecase, and more.
8. Institutional Review Board Approves Changes to Dr. Mithoefer’s MDMA/PTSD Study
Dr. Michael Mithoefer has received Institutional Review Board (IRB) approval for several key changes that FDA had recently approved to his ongoing 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), FDA, and IRB have all approved these changes to our protocol, they will be implemented for the study’s remaining six subjects.
9. Limited Signed Hardcover Edition of LSD: My Problem Child Now Available
For those of you who have purchased a signed copy of Dr. Albert Hofmann’s long-out-of-print autobiographical book, LSD: My Problem Child — Reflections on Sacred Drugs, Mysticism, and Science, we have good news: the limited edition of 100 hardcover copies have now been signed by both Dr. Hofmann and Dr. Stanislav Grof (who wrote the foreword), bound into the hardcovers, and shipped to the new MAPS office. Your copy will be shipped to you shortly.
Dr. Albert Hofmann has signed 100 copies of a special hardbound edition of his book, with the profits to be allocated entirely to MAPS-sponsored LSD and psilocybin research. The price will increase in tiers (copies 1-20:$250 / 21-40:$300 / 41-60:$350 / 61-80:$400 / 81-100:$500). All of the 20 copies at $250 each are already sold and we are currently selling the next group of 20 at $300 each.
If you are interested in purchasing one for your collection, you can now purchase it directly from our online store.
10. Join MAPS at the She Shamans and Magic Mamas Conference, June 23-25
Join MAPS Educational Outreach Coordinator Julia Onnie-Hay and a heap of gifted female activists, spiritual explorers, and psychedelic pioneers at the She Shamans and Magic Mamas Conference, June 23-25 at Isis Oasis in Geyserville, CA. People of all genders are welcome at She Shamans.
MAPS is contributing $1000 from the Women’s Entheogen Fund (WEF) for travel expenses for conference speakers. MAPS established WEF in 2002 to facilitate women’s involvement in psychedelic research. Participants at the conference will discuss potential uses for the additional unallocated $5000 that WEF has recently received, the first unrestricted donations ever made to the fund. In turn, the conference will donate a portion of any profits to WEF.
Have a Joyous June,
Jag Davies,
MAPS Director of Communications