Greetings, MAPS Members, Supporters, and Friends!
There’s a lot of significant developments to report, so off we go:
1. John Gilmore Donates $150,000 to MAPS
2. New Face in the MAPS Office: Troy Dayton
3. MAPS Team Conducts Inspection for US MDMA/PTSD Study; Milestone Passed
4. MAPS-Sponsored Continuing Medical Education (CME) Course in Spring 2008
5. MAPS-Sponsored LSD-Assisted Therapy Protocol Submitted to Swiss Ethics Committee
6. Swiss MDMA/PTSD Study: MAPS Clinical Research Corps Strike Again
7. Birthday Lunch for Albert Hofmann Proceeds, Minus Albert and Anita
8. MAPS Becomes a Sponsor for 2008 Gaia Media Conference
9. FDA IND For MDMA/Cancer Anxiety Study Transferred to John Halpern, M.D.
10. MAPS Awards Grants for Ongoing MDMA/Defense Mechanism Research, New MDMA/Asperger’s Internet Data Gathering Project
11. MAPS and Clusterbusters to Sponsor LSA/Cluster Headache Study
12. Deja Vu: STILL Waiting for Recommendation from Judge in Lawsuit for MAPS-Sponsored Marijuana Production Facility
13. Winter 2006-7 MAPS Bulletin Arrives; Corrections Due
14. 14. Mind States Costa Rica: June 13-17, 2007
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1. John Gilmore Donates $150,000 to MAPS
Philanthropist and MAPS Board Member John Gilmore has pledged $150,000 to MAPS for unrestricted operational expenses. On behalf of the MAPS community, Thank You, John, for providing MAPS with this crucial support at a time of momentous growth and opportunity!
2. New Face in the MAPS Office: Troy Dayton
MAPS’ new (and first-ever) Director of Development, Troy Dayton, began work at MAPS earlier this month. With MAPS’ increasing success in obtaining approval for psychedelic research, the amount of money needed to fund that research has increased dramatically.
Troy’s primary role is to help raise that money. He will be meeting with MAPS’ top few hundred donors to communicate MAPS’ plans and gather feedback. He is also reaching out to other supporters who can consider making significant charitable gifts to this historic effort. In addition, he is helping MAPS increase revenue through product sales and membership growth. Troy is splitting his time 50/50 with our friends at the Marijuana Policy Project, also in a development capacity.
Troy is a longtime friend of MAPS and drug policy reform. He spent the last three years as the associate director of the Interfaith Drug Policy Initiative, mobilizing religious leaders behind ending the War on Drugs. He helped found and currently serves on the board of Students for Sensible Drug Policy, which has over 100 chapters. He was the promotional director, fundraiser, and a script consultant for the film, BUSTED: The Citizen’s Guide to Surviving Police Encounters, now seen by over 1 million people. Troy also helped start Renewable Choice Energy, which recently made national headlines for making the largest sale of wind power in U.S. history.
CNN recently profiled Troy in a special on the science of happiness where he explained that his occasional use of MDMA helps maximize his mental health. The segment is posted on Youtube.
We are excited to have Troy’s passion and expertise at MAPS. I hope you get the chance to visit with him soon.
3. MAPS Team Conducts Inspection for US MDMA/PTSD Study; Milestone Passed
From January 3-6, 2007, MAPS’ clinical research team (Amy Emerson, Valerie Mojeiko, and Josh Sonstroem) was in Charleston, SC, conducting a monitoring inspection of Dr. Michael Mithoefer’s MAPS-sponsored IRB-, DEA-, and US FDA-approved MDMA/PTSD study. On January 5, the 15th subject participated in her third and final experimental MDMA-assisted psychotherapy session. On January 6, MAPS President Rick Doblin visited Charleston to meet with Dr. Michael and Annie Mithoefer and MAPS’ clinical research team to review the data, which looks very promising. An additional $125,000 will be required to complete this study.
4. MAPS-Sponsored Continuing Medical Education (CME) Course in Spring 2008
As part of our mission to disseminate accurate educational information about the risks and benefits of psychedelics, and to help us to find more co-therapist teams for our eventual FDA Phase 3 multi-site studies, MAPS is planning to sponsor a Continuing Medical Education (CME) course on clinical research with psychedelics in Charleston, South Carolina in the Spring of 2008. On January 7, MAPS President Rick Doblin, along with Dr. Michael and Annie Mithoefer, scouted locations for the course, which will be CME-certified and open to all mental health professionals. Details of the conference will be announced in the coming months.
5. MAPS-Sponsored LSD-Assisted Therapy Protocol Submitted to Swiss Ethics Committee
On January 9, MAPS’ clinical research team visited Solothurn, Switzerland to assist with final protocol design for Dr. Peter Gasser’s LSD/end-of-life anxiety pilot study. That same day, Dr. Gasser’s protocol was submitted to a Swiss Ethics Committee (Switzerland’s Institutional Review Board [IRB] equivalent). We anticipate that the Ethics Committee’s review will take several months. If approved, the protocol will then be submitted to SwissMedic (Switzerland’s FDA equivalent) for review, which may take another month or two. We’re anticipating that the study will have full government approval, including Dr. Gasser’s LSD research license from the Swiss equivalent of the DEA, by July 1, 2007.
Once approved and completed, this will become the first government-approved LSD-assisted psychotherapy study in 35 years. The study is budgeted at $150,000 and MAPS has raised about $50,000 so far, with another $100,000 to go.
6. Swiss MDMA/PTSD Study: MAPS Clinical Research Corps Strike Again
MAPS’ clinical research team met on January 10 with Dr. Peter Oehen for a monitoring visit to review all data-gathering procedures and inspect records for the first subject in Dr. Oehen’s ongoing MAPS-sponsored study evaluating MDMA-assisted psychotherapy for subjects with treatment-resistant PTSD. The second subject received her third and final experimental session on January 4.
7. Birthday Lunch for Albert Hofmann Proceeds, Minus Albert and Anita
MAPS-sponsored researchers Peter Gasser, M.D., Peter Oehen, M.D., and co-therapist Verena Widmer, along with Rick Doblin, MAPS’ clinical research team, and Dieter Hagenbach, Michael Gasser, and Lucius Werthmuller of Gaia Media were scheduled to have lunch in Basel, Switzerland with Albert and his wife Anita on January 11, 2007, to celebrate Albert’s 101st birthday. Unfortunately, Albert came down with pneumonia and the lunch had to proceed without him and Anita. Albert still managed to send an inspiring message to the gathering. We’re all sending him our best wishes for the return of his health.
8. MAPS Becomes a Sponsor for 2008 Gaia Media Conference
MAPS has agreed to donate $5000 to Gaia Media to become a sponsor of their next conference, scheduled to take place in Basel, Switzerland, on Easter weekend in 2008. Gaia Media is the organization that put together the Spirit of Basel symposium in honor of Albert Hofmann’s 100th birthday in January, 2006. The 2008 conference will be about “the psychedelic revival, the resurgence of shamanism, and the re-enchantment of the world.” Stay tuned for more details.
9. FDA IND For MDMA/Cancer Anxiety Study Transferred to John Halpern, M.D.
At the request of the administration at Harvard’s McLean Hospital, the protocol for Dr. John Halpern’s MAPS-initiated study evaluating MDMA-assisted psychotherapy as treatment for end-of-life anxiety has been transferred from MAPS to Dr. Halpern as a sponsor/investigator. FDA approval for Dr. Halpern’s IND was finalized on January 11. This study, which will be for subjects with end-of-life anxiety secondary to advanced-stage cancer, has full institutional and governmental approval and has now started recruitment. Dr. Halpern’s study is fully funded by Peter Lewis, who pledged $250,000 to McLean Hospital, Harvard University, to cover all costs of the study. MAPS agreed to relinquish sponsorship of the protocol and to permit Dr. Halpern to cross-reference all data, literature reviews, and other protocols in MAPS Investigational New Drug (IND) file and also to cross-reference all information in MAPS MDMA Drug Master File. In exchange, Dr. Halpern is agreeing to permit MAPS to cross-reference the protocol and all data that he submits to FDA from his study into his new IND.
10. MAPS Awards Grants for Ongoing MDMA/Defense Mechanism Research, New MDMA/Asperger’s Internet Data Gathering Project
MAPS has donated $3000 to Pal-Orjan Johansen and Terri Krebs for a project that will seek to use the internet to search for reports of people with Asperger’s (a form of high-functioning autism) who have found MDMA to be helpful in their learning to cope more effectively in social situations. If we do find at least a handful of such reports, this could become another area of research, if funding becomes available.
MAPS also awarded another grant of $6000 to Pal-Orjan Johansen and Terri Krebs to expand their work reviewing transcripts of subjects in MAPS-sponsored MDMA/PTSD research, in order to code and compare the psychological defense mechanisms used in both non-drug therapy sessions and in the experimental MDMA-assisted therapy sessions. This study is designed to identify process variables that may help explain how MDMA can be a useful adjunct to psychotherapy.
11. MAPS and Clusterbusters to Sponsor LSA/Cluster Headache Study
MAPS and Clusterbusters have agreed to sponsor Andrew Sewell, M.D., to conduct a survey study of LSA (lysergic acid amide) in the treatment of cluster headaches. LSA is found in the seeds of common plants that are legal to buy and possess, such as Morning Glory and Hawaiian Baby Woodrose. There is considerable anecdotal evidence that LSA, like LSD and psilocybin, is more effective than current leading treatments in terminating extremely painful cluster cycles, which can last for weeks or longer.
This project is funded by a $10,000 donation to MAPS by Seth and Kari Hollub. Seth is also volunteering his time to manage the technical aspects of MAPS’ website and server, a job for which MAPS previously paid $15,000 a year.
12. Deja Vu: STILL Waiting for Recommendation from Judge in Lawsuit for MAPS-Sponsored Marijuana Production Facility
It has now been more than eight (8) months since lawyers representing Professor Lyle Craker and the DEA filed final legal briefs in Prof. Craker’s MAPS-supported lawsuit against the DEA for refusing to issue him a Schedule I license for a MAPS-sponsored medical marijuana production facility at the University of Massachusetts-Amherst. Since we had originally been told that a recommendation from DEA Administrative Law Judge (ALJ) Mary Ellen Bittner would probably be issued within 3-6 months, we are still expecting a decision in this case any day.
If the DEA ALJ issues a favorable recommendation, it will mark an extraordinary window of opportunity in the six year struggle by MAPS and Prof. Craker to gain a Schedule I DEA license to grow research-grade marijuana for use by scientists in privately funded, DEA- and FDA-approved studies. DEA Administrator Karen Tandy would then need to decide whether to accept or reject the ALJ recommendation. If DEA accepts a favorable recommendation, Professor Craker’s proposed MAPS-funded facility would create the necessary independence of supply to justify the time and expense for MAPS and other organizations to sponsor clinical research evaluating the risks and benefits of marijuana as a potential FDA-approved prescription medicine.
If there is a favorable recommendation, we’re poised for action with the new Congress, to try to create sufficient pressure on DEA to accept the recommendation. We’ll need all supporters to contact their Congressional Representatives, so look out for an important announcement soon!
On the other hand, an unfavorable recommendation would be a paralyzing blow to efforts aimed at resolving the medical marijuana controversy through FDA-approved scientific research, although, ironically, it would actually encourage marijuana policy reform at the state and local levels to protect medical marijuana patients and their physicians.
13. Winter 2006-7 MAPS Bulletin Arrives; Corrections Due
MAPS members should now have received a copy of the Winter 2006-7 MAPS Bulletin, featuring a financial strategy report from MAPS President Rick Doblin, Ph.D. As Rick explained in his detailed report, MAPS is moving into a new phase of its growth and development and needs substantial resources to fund our expanding research agenda. If you know someone who might be interested in supporting MAPS, please let the MAPS office know and we’ll send him/her a complimentary copy of the Bulletin!
Also included in the mailing was a free calendar for our recent donors. If you would like to purchase a 2007 MAPS Calendar, they are now reduced to $10.
Our apologies to Robert Venosa, whose portrait of Dr. Albert Hofmann on the inside front cover suffered from some significant printing problems. The proper image, brighter and uncropped, has now been posted on the MAPS site. On that note, less than 20 out of the 50 prints are left in Robert Venosa’s signed, limited edition series. MAPS’ proceeds from the sale of these portraits will be restricted for Dr. Peter Gasser’s MAPS-sponsored LSD psychotherapy research. Credit is also overdue to Devin Breen, the multi-talented photographer, filmmaker and artist whose uncredited photograph of Entheon Village provided an ideal wraparound cover for the Winter issue. See more of Devin’s work at devinbreen.com.
14. Mind States Costa Rica: June 13-17, 2007
Mind States 2007 will feature presentations by Joe Coleman, Erik Davis, Earth & Fire Erowid, Stanislav Grof, Jon Hanna, Liz McIntyre, Mark Pesce, Sasha & Ann Shulgin, and Margaret Wertheim, and morning Holotropic Breathwork sessions facilitated by Sheelo Bohm. Registrants receive 10% off of the conference’s “early bird” ticket price until February 15.
The eco-resort where this conference will be held is on a 2,000 acre sanctuary of virgin rainforest set at the juncture of two rivers near the town Horquetas of Sarapiqui. Swim by natural waterfalls or in the pool, relax in a hot tub, enjoy refreshing beverages at the bar, challenge one of the presenters to a paddle boat race, marvel at the botanical gardens, or arrange a zip-line canopy tour, horseback ride, white water rafting trip, or massage through the resort. To get a sense of this event, view this YouTube clip.
Best Wishes for 2007.
Jag Davies,
MAPS Director of Communications