MAPS Members, Supporters & Friends,
There’s a flurry of activity on the horizon to close out the year, and an incredible slate of studies that are set to begin in early 2008.
MAPS has four government-approved first-of-their-kind Phase 2 clinical studies evaluating psychedelic-assisted psychotherapy underway around the world. Several more are nearing approval — all seeking to make psychedelics available as prescription medicines. Plus, we’ve got DEA on the defensive in our medical marijuana lawsuit.
Keep an eye out on Thanksgiving weekend for the Washington Post Sunday Magazine’s cover story on Dr. Michael Mithoefer’s MAPS-sponsored MDMA/PTSD study, by editor Tom Shroder.
After years of inching toward legitimacy, medical research with psychedelics is now making once-unimaginable leaps and bounds, thanks to your valiant support.
As you consider your year-end contributions, please remember that we need your support to conduct these historic studies that will facilitate the integration of marijuana, MDMA, and psychedelics into both the modern pharmacopoeia and into society.
If you value MAPS’ unique and persistent approach to psychedelic and marijuana research and reform, please consider supporting MAPS by making a (tax-deductible) gift you feel good about at the MAPS Web Store.
1. Think You Could Write This Email Update Better Than Me? Apply For My Job!
This is a bittersweet monthly news update for me, since it will be the last before I take leave of MAPS for a new challenge.
In January, 2008, I’ll be taking a new position as Policy Researcher at the ACLU Drug Law Reform Project. As a division of the national ACLU, the Project’s goal is to end punitive drug policies that cause the widespread violation of constitutional and human rights, as well as unprecedented levels of incarceration. My responsibilities there will include staying abreast of relevant policy developments, drafting specific policy reform proposals that can be utilized in public education efforts, and playing a role in constructing the content needed to effectively communicate a compelling and convincing vision for workable alternatives to the failed “War on Drugs.”
While I am thrilled to have this new opportunity, I must admit it is difficult to tear myself away from MAPS at such a transformative and promising period in the organization’s development. It has been an honor to work so closely with the many committed, inventive, and courageous members of the MAPS community.
Are you a good candidate for the new position of Communications and Public Relations Director at MAPS? The Communications and Public Relations Director will be responsible for developing all written materials about MAPS, helping raise the profile of the organization, and advocating on the organization’s behalf in a variety of media formats. If you think a career at MAPS could be right for you, please take a close look at the job posting on Craigslist.
2. LSD Study Receives Ethics Committee Approval and SwissMedic Clearance
On October 30, Dr. Peter Gasser’s MAPS-sponsored study evaluating LSD-assisted psychotherapy for subjects with anxiety secondary to advanced-stage illness received final Ethics Committee (EC) approval. An EC is the Swiss equivalent of an Institutional Review Board (IRB), often the most difficult and time-consuming regulatory hurdle. On Thursday, November 8, we officially cleared the second major hurdle, when Swissmedic cleared the study to proceed. SwissMedic is the Swiss equivalent of the US Food and Drug Administration (FDA). Now there is just one more regulatory hurdle: Bundesamt fur Gesundheit, or BAG — the Swiss DEA equivalent. It is likely that the study will have full approval by Albert Hofmann’s 102nd birthday, on January 11, 2008.
3. MAPS-Sponsored Psilocybin/Melanoma Psychotherapy Study to Receive FDA Clearance
In September, MAPS submitted an application to FDA for a new study evaluating psilocybin-assisted psychotherapy for subjects with end-of-life anxiety secondary to advanced-stage melanoma. On October 18, we learned that the study will receive clearance from FDA, with only one clinical hold due to a request from FDA for a stability study of the psilocybin. The study was conducted earlier this month, and the results showed that the psilocybin is 100% pure. The results will be submitted to FDA soon. Earlier this month, we also submitted the protocol to an IRB, where it is currently under review.
The study will take place in the US and will evaluate nine subjects with anxiety secondary to advanced-stage melanoma. MAPS has been working with the researchers on protocol development for over one year. We will be able to post the protocol on the MAPS Website and disclose the names and institutional affiliations of the researchers after the study receives IRB approval.
The researchers for this study have generously offered to volunteer their time, which will reduce overall costs significantly. The estimated budget for this study is $50,000, all of which remains to be raised.
4. US MDMA/PTSD Study Nears Completion, Receives IRB Approval to Enroll Iraq Vet as Additional Subject
Dr. Michael Mithoefer’s flagship FDA Phase 2 study evaluating MDMA-assisted psychotherapy for subjects with posttraumatic stress disorder (PTSD) has completed treatment of 15 subjects. Three more subjects are currently undergoing the protocol, one is about to start, and a potential 20th subject will soon be screened.
Last week, we received IRB approval to enroll a 21st subject, an Iraq War vet with PTSD. We needed FDA and IRB permission to deviate from our inclusion criteria that requires all PTSD subjects to be treatment-failures from both drug and non-drug treatments. The request to include a subject who is not a treatment-failure is because this veteran was diagnosed with severe PTSD but never offered individual treatment by the military. Our protocol requires subjects to have attempted treatment without success.
5. FDA Approves Protocol Changes for MDMA/Cancer Anxiety Study
John Halpern, MD, would like to let the MAPS community know that his study, “Phase II Dose-Response Pilot Study of +/-3,4-Methylenedioxymethamphetamine (MDMA)-assisted Psychotherapy in Subjects with Anxiety Associated with Advanced Stage Cancer” went through major design revisions so that it could be available to a wider population of cancer patients. So far, we have been unable to recruit any subjects due to self-imposed limitations in our inclusion criteria. Specifically, the study now can include patients who may continue with cancer treatments for palliative purposes. In the former design, patients had to have completed all such treatments before enrollment. What changed since we initially designed the study many years ago was the nature of palliative care, which is now commonly offered almost to the point of death.
In addition, subjects can now be enrolled based on a clinical diagnosis of anxiety associated with advanced-stage cancer rather than a cut-off score on the State-Trait Anxiety Inventory (STAI), which is what we originally called for. We’re still using the STAI and we’ve also added the Hospital Anxiety and Depression Scale (HADS) as another outcome measure on recommendation from Sameet Kumar, PhD.
A variety of smaller modifications and improvements in design were also completed. The key point of interest for the MAPS community is that these changes have been approved by the study IRBs and by the FDA. Evaluation of our first study subject should occur soon.
6. Upcoming Washington Post Sunday Magazine Cover Story on MAPS-Sponsored MDMA/PTSD Study
On November 25, Thanksgiving weekend, Dr. Mithoefer’s study will be the focus of the cover story of the Washington Post Sunday Magazine. The article is written by the magazine’s editor, Tom Shroder, and sheds a positive light on this line of research. Keep an eye out!
7. MAPS Donation to Clusterbusters for McLean LSD/Psilocybin Research
MAPS President Rick Doblin, PhD, spoke at the second annual Clusterbusters conference in Austin, Texas, held from October 26-28. At a Clusterbusters business meeting after the conference, MAPS donated $26,000 to Clusterbusters for the protocol development and approval process for LSD/psilocybin cluster headache research. Clusterbusters and McLean Hospital, Harvard Medical School, have entered into an agreement calling for Clusterbusters to cover expenses related to protocol development and FDA, IRB and DEA approval for studies at McLean into the use of LSD and psilocybin in the treatment of cluster headaches. MAPS’ donation will further Clusterbusters’ funding of its contract with McLean Hospital. Dr. John Halpern is leading the LSD/psilocybin cluster headache research effort at McLean Hospital.
MAPS raised these funds in 2005 from the sale of Dean Chamberlain’s signed and numbered prints (1 -50) of his portrait of Albert Hofmann, at which time our only active project intending to study LSD and psilocybin was the cluster headache research. MAPS currently has for sale a larger and more limited edition (1-25) set of prints of Dean’s portrait of Albert, also signed by Albert, with funds from those sales going to support MAPS-sponsored LSD and psilocybin psychotherapy research in people with anxiety associated with end-of-life issues.
8. Israeli Medical Marijuana Production Facility Moves Forward, Receives Major Donation
MAPS is currently involved as a consultant for a small, legal medical marijuana production facility in Israel. The facility, directed by Israeli medical marijuana advocate Tsachi Cohen, has been authorized by the Israeli Ministry of Health to provide marijuana to over 150 patients formally approved by the Ministry. MAPS is working to provide technical assistance to create an organic, hydroponic, standardized production facility, which will start small and give marijuana away for the next several months. Once a successful track record has been established, the Ministry will determine whether to permit the facility to produce medical marijuana on a commercial basis.
Earlier this month, the anonymous donor who donated $10,000 in seed money to the Israel production project three months ago made another major donation of $24,000. Of the $24,000, $5000 has been spent on a security fence and $5000 will go the Ministry of Health for costs associated with processing applications and another $8000 or so will go to lights, ventilation, wiring of the production facility. MAPS President Rick Doblin and Vancouver Island Compassion Society founder Philippe Lucas (who MAPS brought to Israel in August to provide technical assistance) are two of the three non-Israeli members of the Board of Directors.
9. Introducing the Cottonwood Research Foundation
In another sign of the increasing interest in psychedelic research, a new non-profit organization was recently founded in the US, the Cottonwood Research Foundation. President Rick Strassman, MD, asked us to share the following message:
“Rick Strassman, MD (University of New Mexico), Steven Barker, PhD (Louisiana State University), and Andrew Stone (Stone Design) are pleased to announce the formation the Cottonwood Research Foundation as a non-profit entity in New Mexico, for which donations are now tax-exempt. We established the Cottonwood Research Foundation in order to fill a need we perceived in the current landscape of psychoactive medicinal research.
1) As established clinical and basic research scientists, Drs. Strassman and Barker will be designing and implementing most aspects of the research agenda;
2) We will be primarily focusing on naturally occurring materials, such as the hallucinogenic tryptamines, including DMT and related compounds. We will be further assessing the function of endogenous tryptamines in normal and altered human states of consciousness;
3) Related to this is our interest in the DMT-containing Amazon plant brew ayahuasca; 4) As such we will utilize indigenous traditions and knowledge gained regarding the use of ayahuasca and other botanical hallucinogens;
5) Our long-range goal is the acquisition and development of land in northern New Mexico in which to build a campus wherein clinical research with these medicines can occur and be applied to a range of human concerns, establish academic departments that can explore the implications and utilization of these medicines and related states of consciousness (such as religious studies, anthropology/shamanism, therapeutics, psychology), and provide training to researchers and practitioners regarding optimal application of this knowledge.
Your donations are greatly appreciated.”
10. Last Chance to Purchase Original Pablo Amaringo Painting – November 15!
As you may have noticed in the inside front cover of the previous MAPS Bulletin, MAPS is offering an original Pablo Amaringo painting for $8,000, with half of the proceeds going to MAPS-sponsored psychedelic research. We’ve already sold one painting for $12,000!
Unfortunately, this offer will only be available until this Tuesday, November 15, when the painting will be put back on the free market.
11. 2008 World Psychedelic Forum – Buy Your Ticket from MAPS!
Along with Gaia Media, MAPS will be co-sponsoring the 2008 World Psychedelic Forum, which will be held in Basel, Switzerland from March 21-24.
12. Join MAPS, SSDP, MPP, LEAP, ACLU, and Many Others at the International Drug Policy Reform Conference in New Orleans
This December 5-8, MAPS will join hundreds of other drug policy reformers in New Orleans for the biennial International Drug Policy Reform conference.
At the conference, I will give two formal presentations on MAPS’ work. First, on Dec. 6, I will describe MAPS’ efforts to develop marijuana into an FDA-approved prescription medicine in a panel on the DEA’s “war on medical marijuana.” Second, on Dec. 8, I will summarize the current status of MAPS’ psychedelic drug development research as part of the panel, “Physically, Mentally, Emotionally Better: Psychedelics as Healing Agents.”
If you are a MAPS supporter who will be attending, we are looking for volunteers to help staff the MAPS table during the conference. If you are interested, please contact us or just look for the MAPS table when you get there.
For decades the government was the biggest obstacle to research. Now that long-awaited research is finally being approved, the formidable challenge is funding it. At present, there is no funding available from governments, pharmaceutical companies, or major foundations. That means that for the time being, the future of psychedelic and marijuana research rests in the hands of people like you.
Thanks for everything!