MAPS Members, Supporters & Friends,
I am pleased to announce that tomorrow, September 19, a letter will be delivered to DEA Administrator Karen Tandy signed by 45 members of the U.S. House of Representatives. The letter urges her agency to accept DEA Administrative Law Judge Mary Ellen Bittner’s recommendation that would it be in the public interest to license Professor Lyle Craker’s proposed MAPS-sponsored medical marijuana production facility at UMass-Amherst. This letter demonstrates to DEA that there is a growing political will to end the federal government’s monopoly on the supply of marijuana that can be used in FDA-approved research.
As you know, MAPS is the only membership-based organization working to develop marijuana and psychedelics into legal, FDA-approved prescription medicines. If you think the world would be a better place if MAPS is empowered to implement its plans, please consider supporting our work by making a donation or Webstore purchase today at the MAPS Web Store.
Without further adieu, here’s the news:
1. Fall 2007 MAPS Bulletin in the Mail to MAPS Members
If you are a MAPS member, in the next 2-3 weeks you will receive the Fall 2007 issue of the MAPS Bulletin in your mailbox. This Bulletin is a special issue on the theme of “Psychedelics and Self-Discovery.” Thank you to the thoughtful and generous MAPS members and supporters who submitted articles for this issue. If you are not a MAPS member and would like to receive a printed copy of the tri-annual MAPS Bulletin, please consider joining MAPS today.
2. Forty-Five U.S. Representatives Send Letter to DEA in Support of Medical Marijuana Research
Tomorrow, a letter signed by 45 members of the U.S. House of Representatives will be delivered to U.S. Drug Enforcement Administration (DEA) Administrator Karen Tandy urging her agency to license UMass-Amherst professor Lyle Craker to establish the nation’s first privately funded research-grade marijuana production facility. The letter (pdf) was signed by forty-two Democrats and 3 Republicans.
The bipartisan letter, co-sponsored by Reps. John Olver (D-MA) and Dana Rohrabacher (R-CA), urges DEA to follow Administrative Law Judge Mary Ellen Bittner’s February, 2007 ruling in favor of Prof. Craker. The law judge’s ruling is non-binding and DEA has no deadline to decide whether to accept or reject it.
Prof. Craker’s case is the focal point of the effort to put marijuana through FDA clinical trials to determine whether it meets federal standards for medical safety and efficacy. If DEA accepts the recommendation, Prof. Craker’s proposed MAPS-funded facility would create the necessary independence of supply outside of the NIDA-controlled monopoly 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. NIDA’s monopoly has been the key obstruction to FDA drug development research for four decades.
This strong showing was possible because MAPS members expressed support for marijuana research to their Representatives. This strong showing was also possible because MAPS’ staff temporarily expanded to include Lauren Anderson Payne, JD, Kelly Burns, Liberty Coalition National Director Michael Ostrolenk, MD, and US Bill of Rights Foundation President Dane Von Breichenruchardt, who worked together with me (Jag Davies) to obtain support from organizations and Congressional Representatives.
Furthermore, this strong showing was possible because our organizational allies and their supporters provided additional support on Capitol Hill, essential know-how, public relations assistance and grassroots mobilization. These organizations include Americans for Safe Access (ASA), American Civil Liberties Union (ACLU), Marijuana Policy Project (MPP), Drug Policy Alliance (DPA), and National Organization for the Reform of Marijuana Laws (NORML), Interfaith Drug Policy Initiative (IDPI), Drug Reform Coordination Network (DRCnet), and Patients out of Time (POT). ASA was particularly helpful and provided a temporary office for Lauren to work from while in Washington, D.C.
MAPS has received recent financial contributions for this effort to pressure DEA to accept Judge Bittner’s ruling from the Marijuana Policy Project ($45,000) and the Drug Policy Alliance ($12,500). Philanthropist and MAPS Board member John Gilmore has also donated over $50,000 to date for Prof. Craker’s struggle.
On behalf of the MAPS staff, we thank you for helping us orchestrate the multiplicity of efforts that have created this incredible window of opportunity. For background on this case and the latest news, please visit MAPS’ DEA Lawsuit Page.
Last month, MAPS President Rick Doblin, PhD, gave a thorough interview about MAPS’ medical marijuana efforts on “Dr. Meg Jordan, Global Medicine Hunter” on the Health Radio network.
3. FDA Reviews US MDMA/PTSD Protocol Amendment
Michael Mithoefer, MD, and Annie Mithoefer, BSN, have enrolled 18 out of 20 subjects in their MAPS-sponsored study evaluating MDMA-assisted psychotherapy for subjects with chronic PTSD. Another two potential subjects are currently in the screening process. The completion of MAPS’ flagship FDA Phase 2 clinical research study is now in sight.
Several weeks ago, MAPS and Dr. Mithoefer submitted a protocol amendment to FDA, seeking approval to treat a 21st subject, a US veteran with PTSD from the Iraq War. We need FDA 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 due to the sad fact that this veteran, like several others with whom we have spoken, has been diagnosed with PTSD but has never been offered treatment by the military. We expect to hear from FDA in a few weeks.
4. Key Changes to MDMA/End-of-Life Anxiety Receive IRB Approvals, Awaiting FDA Approval
Dr. John Halpern of McLean Hospital/Harvard Medical School informed us that he recently received IRB approvals from McLean Hospital and from the Lahey Clinic Medical Center for a series of crucial changes to his protocol, “Phase II Dose-Response Pilot Study of +/-3,4-Methylenedioxymethamphetamine (MDMA)-assisted Psychotherapy in Subjects with Anxiety Associated with Advanced Stage Cancer.” Dr. Halpern is the sponsor/investigator for this study, which MAPS helped to initiate.
Dr. Halpern will submit these changes to FDA later this week. If these changes are accepted by FDA, this updated version of the protocol will enable recruitment from a much larger pool of potential subjects and will result in the study’s first and subsequent 11 subjects. The main changes include: inclusion of cancer patients still receiving cancer treatments but for palliative purposes only, removal of a cut-off score for the STAI (State Trait Anxiety Inventory), inclusion of the HADS (Hospital Anxiety and Depression Scale), and inclusion of other female co-psychotherapists.
5. New MAPS-Sponsored Psilocybin/End-of-Life Anxiety Study Submitted to FDA
Later this week, MAPS will submit an application to FDA this week for a new study evaluating psilocybin-assisted psychotherapy for subjects with end-of-life anxiety secondary to advanced-stage melanoma.
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 and FDA 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.
6. MAPS-Sponsored LSD Study Featured on Swiss TV News, Scheduled for Another Ethics Committee Review
A major Swiss TV news report was broadcast earlier this month about Dr. Peter Gasser’s MAPS-sponsored study evaluating LSD-assisted psychotherapy for subjects with end-of-life anxiety secondary to end-stage illness. The report includes a new interview with Albert Hofmann, who rarely speaks publicly due to his fragile health. Click here to watch the broadcast (in German, translation in process) on the MAPS site.
Dr. Gasser’s protocol will be reviewed again on November 8 by the Swiss Ethics Committee (EC). The EC is reviewing a report about the protocol from a Swiss psychooncologist who raised issues about patient selection (cancer patients v. patients with a range of life-threatening illnesses) and the possibility of measuring any acute traumatic effects of the LSD experience. We expect that this meeting of the EC will resolve the final issues regarding protocol design.
The protocol has already been submitted to SwissMedic, the Swiss equivalent of the FDA. SwissMedic has begun its review and is waiting to consider the outcome of the EC meeting in November. After EC and Swissmedic approval have been obtained, we expect we’ll need an additional several weeks to obtain final approval from the BAG, the Swiss equivalent of DEA. We expect the study to be fully approved by January11, 2008, Albert Hofmann’s 102nd Birthday.
MAPS has already raised $$43,000 for this study from the sale of Albert Hofmann-signed art and books, but an additional $160,000 is still needed. In addition to general donations for operational expenses, MAPS also accepts restricted donations for specific research projects.
7. MAPS Receives $35K Grant from Donor-Advised Tides Foundation Fund, $20K Donation from Anonymous Donor
Earlier this month, MAPS received two critical donations for operational expenses. Last month, an anonymous donor contributed $20,000 directly to MAPS. Then, earlier this month, another anonymous donor generously contributed $35,000, through a fund at the Tides Foundation. We are deeply grateful to these two individuals for their support and generosity.
Because most large donations are earmarked for specific research projects, donations for operational expenses are especially helpful and appreciated.
8. Chemistry World Publishes Feature Article on Medical Research with Psychedelics
Chemistry World magazine recently published a comprehensive feature-length article about the “resurgence of medical hallucinogens.” MAPS President Rick Doblin is quoted throughout the article.
9. New Ayahuasca Study Confirms Therapeutic Potential
A study recently published in the Journal of Ethnopharmacology has demonstrated that the South American psychedelic plant brew ayahuasca can alleviate signs of anxiety, panic, and hopelessness. The international quintet of researchers conducting the study, which included noted DMT researcher Rick Strassman, MD, concluded that:
“While under the acute effects of ayahuasca, participants scored lower on the scales for panic and hopelessness related states. Ayahuasca ingestion did not modify state- or trait-anxiety. The results are discussed in terms of the possible use of ayahuasca in alleviating signs of hopelessness and panic-like related symptoms.”
The full study is available on the MAPS site.
10. MAPS Facilitates Harm Reduction Services at Burning Man Festival
From Aug. 26-Sep. 2, as part of MAPS’ educational outreach and harm reduction mission, for the fifth year in a row MAPS assisted Burning Man’s Black Rock Rangers by coordinating a team of trained volunteers at Burning Man’s “Sanctuary.”
Sanctuary is a project led by the Black Rock City Rangers to provide a safe space for people who are undergoing emotional or psychological crises or who need non-medical assistance. MAPS volunteers lend their support and are trained to work with visitors undergoing psychedelic emergencies. MAPS staffer Valerie Mojeiko coordinated the training of over 30 volunteers for Sanctuary, assisted by about eight core staff with psychedelic psychotherapy experience. Over 100 people going through difficult emotional and psychological experiences, some psychedelic-related, and some not, were cared in for Sanctuary over the course of the week-long event.
11. Audio Recordings of Presentations Available from Women’s Visionary Congress
From July 27-29, 2007, MAPS co-sponsored the Women’s Visionary Congress, a unique gathering of women working to reform psychedelic and marijuana policy and to re-define society’s understanding of these drugs. For those of you who were unable to attend, or for those of you who were there and would like to listen to a particular presentation again, we have good news: the audio recordings are available on the MAPS Website.
Of particular relevance to MAPS’ work is Panel #4, moderated by MAPS Clinical Research Associate Valerie Mojeiko. The panel featured Annie Mithoefer, BSN (MAPS-sponsored MDMA/PTSD therapist), Amy Emerson (MAPS’ volunteer clinical monitoring expert), and June May Ruse (co-author for MAPS’ MDMA/PTSD treatment manual).
12. Horizons: A One-Day Psychedelic Conference in Manhattan, Oct. 27
Join MAPS President Rick Doblin, MAPS-sponsored researchers Michael Mithoefer and Andrew Sewell, artists Alex & Allyson Gray, Drug Policy Alliance Executive Director Ethan Nadelmann, and others at “Horizons: Contemporary Perspectives on Psychedelics” on October 27 at Judson Memorial Church in Greenwich Village from 1-6 pm. Proceeds from the conference will be donated to MAPS and the other non-profit organizations involved with the event.
For information on the conference, speaker bios, and tickets, please visit the Horizons Website.
13. Join MAPS at the International Drug Policy Reform conference in New Orleans, Dec. 5-8
This December 5-8, MAPS will be joining hundreds of other drug policy reformers in New Orleans for the biennial International Drug Policy Reform conference, hosted by the Drug Policy Alliance (DPA). Myself (Director of Communications Jag Davies) and Director of Development Troy Dayton will be attending the conference to present MAPS’ work. DPA is the leading organization in the US working to end the War on Drugs and envision new drug policies based on science, compassion, health and human rights. We are grateful to have DPA as an ally in the struggle to create rational alternatives to prohibition-based policy.
To get a sense of the conference, check out my review of the 2005 conference in the Spring 2006 MAPS Bulletin.
14. Join MAPS at the World Psychedelic Forum, March 21-24
Along with Gaia Media, MAPS will be co-sponsoring the World Psychedelic Forum, which will be held in Basel, Switzerland from March 21-23, 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. For more information and to register, please visit psychedelic.info.
Gaia Media will be hosting a talk in Basel on January 26 featuring Rick Doblin, MAPS-sponsored MDMA/PTSD researcher Peter Oehen, MD, MAPS-sponsored LSD/end-of-life anxiety researcher Peter Gasser, MD, and MAPS Patron Member Vanja Palmers. Stay tuned in for more details.
15. Psychedelic Researcher John Beresford Dies
Early psychedelic research pioneer John Beresford died on September 2. Beresford, who was born in Britain, resigned his post as an Assistant Professor of Pediatrics at the New York Medical College in 1961 to found the Agora Scientific Trust, the world’s first research organization devoted to investigating the effects of LSD.
Now that psychedelic research is being approved, the formidable challenge is funding it. Since these drugs are off-patent and would not be used on a daily basis, no for-profit pharmaceutical company has demonstrated any interest in sponsoring psychedelic research. Because of Drug War ideology, there is currently no government funding for this research. Plus, most foundations and philanthropists are averse to controversy. Because of the Drug War, this area of study is 35 years behind schedule. For historical reasons, unfortunately, psychedelics remain highly controversial. This means society must rely on people like you.
You can help make up for lost time by making a tax-deductible donation today.
Thank you for your generosity and foresight.
Jag Davies, MAPS Director of Communications