MAPS February Email Update:
Will the Government Sell Us Marijuana?
Dear MAPS Members, Supporters, & Friends,
I’m extremely pleased to announce that since our January update, the first subject has participated in an experimental session in MAPS’ Israeli MDMA/PTSD study–a decade after MAPS began working to sponsor this research–and the last subject (#21) in our U.S. MDMA/PTSD study participated in his first experimental session. In marijuana research, a new MAPS/CaNORML-sponsored vaporizer study protocol was submitted to the Office of Public Health and Science, and to the Office of the Secretary of Health and Human Services, more than four and half years into our challenging struggle to purchase ten grams of legal marijuana (See news items below.) These are exciting and important developments in our mission to help create a future where psychedelic medicines and medical marijuana will be available to all those who might benefit from them.
Other positive developments include the continued favorable coverage of our research in the national and international media. This month the San Francisco Chronicle published an opinion piece favorably mentioning our MDMA/PTSD research, and Switzerland’s most important and conservative newspaper, the Tages Anzeiger, published a extremely positive article about our LSD psychotherapy study. (See news items below.)
Every day it seems, more and more exciting advances in psychedelic research are developing, and new possibilities are sprouting up all the time. Last week a meeting between Rick Doblin, Ph.D., Dennis McKenna, and others took place to explore a possible collaboration between MAPS, the Heffter Research Institute, and the Cottonwood Foundation to seek permission to conduct clinical research with ayahuasca.
If you value the key role that MAPS is playing in the evolution of psychedelic and medical marijuana research, and it’s creative and persistent approach to drug development and drug policy reform, please consider supporting our work by making a tax-deductible donation today.
Or please visit the MAPS Webstore, where you can find a treasure trove of psychedelic art and thought-provoking books to feed your mind, delight your senses, and inspire your spirit.
MAPS is buzzing with exciting news. Here’s a sample of what’s happening:
- Volcano Vaporizer Study Protocol Resubmitted to NIDA-PHS
- Rick Doblin Testifies at U.N. NGO Consultation on International Drug Control Treaties
- The World Psychedelic Forum–March 21 to March 24–Seeking Volunteers
- Michael Mithoefer’s MDMA PTSD Study Approaches Conclusion
- MAPS Staff Monitors Swiss MDMA PTSD Study
- MAPS Study Initiation Visit for Swiss LSD Research
- Positive Swiss Media Coverage About LSD Research
- Ibogaine Outcome Studies Move Forward
- MAPS and Heffter Discuss Ayahuasca Research
- Shattered Lives Radio Interviews MAPS Staffer Lauren Anderson Payne About Medical Marijuana Facility
- MAPS Staffer Valerie Mojeiko Speaks at the University of Amsterdam
- Ketamine: Dreams and Realities, by Dr. Karl Jansen, Now Free Online
*** MAPS needs your generosity to empower staff, scientists, and volunteers to carry out pioneering research and educational projects. To donate, learn about the benefits of MAPS membership, or purchase merchandise, visit: store.maps.org/ ***
On January 16, 2008, MAPS Volcano vaporizer research protocol was resubmitted to HHS for the required scientific review by the National Institute of Drug Abuse–Public Health Service (NIDA-PHS). The submission included three supportive letters from peer-reviewers (see 1, 2, 3), confirming the scientific merit of the study and urging NIDA-PHS to approve it. The goal of this study is to gather further information about the chemical constituents that are contained in the cannabis vapor stream.
NIDA’s regulatory process has unfairly dismissed this research in the past, and MAPS has been trying to purchase ten grams of cannabis for this study since June of 2003 without any success.We’re embarrassed to admit that we’re the only people in America who are unable to purchase ten grams of marijuana after four and a half years of trying!
To recapitulate a bit, our initial vaporizer protocol was submitted to NIDA-PHS in June, 2003. Since we didn’t hear back from NIDA-PHS in over a year, we sued them for “unreasonable delay” under the Administrative Procedures Act. Although the suit was dismissed without prejudice, NIDA-PHS finally replied on August 15th, 2005, rejecting the protocol more than two years after it was submitted. Then, on September 9th, 2005, we promptly responded to NIDA-PHS’s rejection with specific objections to all their critiques. Outrageously, we’ve heard nothing back from NIDA/PHS for the last two years and five months! MAPS has gone ahead and submitted a new protocol, with three supportive letters from peer-reviewers, and we’ve modified the protocol to accept some of the critiques that NIDA-PHS made–even though we didn’t necessarily consider them to be improvements.
Having learned from our prior experience, we’re planning ahead for when we’ll sue NIDA-PHS in case of “unreasonable delay.” We have already had several discussions with our attorneys about this, and have a tentative date set for a lawsuit in August, 2008. During the DEA Administrative Law Judge (ALJ) hearings surrounding Professor Lyle Craker’s license, Steve Gust from NIDA’s Director’s office testified that it should take NIDA-PHS “three to six months” to review protocols—and another three to six months to review responses to any initial critiques. These timelines establish what is considered to be “reasonable,” according NIDA officials themselves, even though what’s “reasonable” for NIDA is unreasonable for the FDA, which reviews much more complicated protocols in just thirty days. Because Steve Gust’s statement establishes the new “reasonable” for the NIDA/PHS review, we’re going to wait seven months, and if there’s no response, we’ll initiate a lawsuit.
It’s important to note that while we’re arguing with NIDA-PHS about more vaporizer research, the FDA has already approved vaporizers for use in human clinical trials.
Journal Watch for Psychiatry–which has summaries and editorial comments on important studies from journals–included a comments about Donald Abrams’ and MAPS’ Vaporizor study from the journal Clinical Pharmacolological Theory that said “The virtual absence of exhaled CO may indicate the lack of other combustion products…that can cause lung damage and cancer…the system may facilitate medical use of marijuana…[that] has medical applications in treating nausea, pain and weight loss associated with certain serious medical illnesses.”
This is just another example of the importance of removing NIDA/PHS from medical marijuana research, which can be accomplished only if we can break NIDA’s monopoly on the supply of marijuana legal for use in federally-approved research.
On February 4th and 5th, MAPS President Rick Doblin participated in a United Nations-sponsored consultation with NGOs (non-governmental organizations) about international drug treaties and policies. The Consultation took place in Vancouver and was called “Beyond 2008: A Global Forum on the 1998-2008 Review of the United Nations General Assembly Special Session on Illicit Drugs.” The Special Session of the conference “culminated in the adoption of a political declaration committing a hundred and fifty states to the achievement of significant and measurable results in reduction of illicit supply and demand for drugs by the year 2008.” Back in 1998, the U.N.’s goal was a drug-free world in 2008. Now they just say, “significant and measurable results,” which seems less foolish than their previous goal.
Doblin said, “It was a very productive time, and there were some hints that the U.N. Staff are realizing that they need a little bit more realistic goals other than a drug-free world. It was a terrific opportunity to make important points about the renaissance of psychedelic research–which has been conducted in a manner that is entirely consistent with the international drug control treaties–and medical marijuana research, which has been fundamentally obstructed by the DEA, in part through an intentional misreading of the international drug control treaties. However, the international treaties are sufficiently flexible to permit the DEA to license Professor Lyle Craker to grow marijuana for medical research–as recommended by the DEA Administrative Law Judge–and it should decide to stop obstructing medical marijuana research.”
For more detailed background information see Suzanne Fournier’s article in The Province entitled “U.S.-style war on drugs a dismal failure and Canada shouldn’t try it, says former cop” and the Canadian Press article entitled “U.S. cities have taken note of Vancouver safe-injection site: conference”.
Doblin added, “The United Nations International Narcotic Control Board (INCB) recently came out with a statement denouncing the medical marijuana vending machines in California. The INCB is hypersensitive about the medical use of marijuana. The Vancouver Consultation gave reformers an important opportunity to engage them proactively about DEA obstruction of medical marijuana research .
The World Psychedelic Forum will be held next month in Switzerland, at the Congress Center in Basel, from March 21 to 24. The theme this year is “Consciousness Change: A Challenge of the 21st Century.” Along with Gaia Media, MAPS is helping to cosponsor the event by donating $5000, and we’ll be bringing Stan Grof M.D., Michael Mithoefer, M.D., Annie Mithoefer, R.N. Sameet Kumar, Ph.D., Valerie Mojeiko, B.A, and Rick Doblin, Ph.D. as speakers. Other speakers include Albert Hofmann, Ph.D., Alex Grey, Kathleen Harrison, Dennis McKenna, Ph.D., Ralph Metzner, Ph.D., Jeremy Narby, Ph.D., Daniel Pinchbeck, and Christian Rätsch, Ph.D. To find out more about the conference see: www.psychedelic.info.
If you planning to come to Basel and are interested in volunteering at the MAPS table selling memberships, art, and books, (and meeting a lot of other interesting MAPS members) please email Valerie at MAPS.
Dr. Michael Mithoefer’s MAPS’ sponsored MDMA/PTSD study has screened and enrolled its final subjects–numbers 20 and 21–and the treatment phase for all twenty-one subjects will be completed by June, 2008. We now have two Iraq war vets with PTSD in the study.
The media has been quite favorable in its coverage of Mithoefer’s study. We reported in December about Tom Shroder’s positive cover story in the Washington Post Sunday Magazine about Mithoefer’s MDMA research. This month there was a favorable opinion piece in the San Francisco Chronicle that contrasted the FDA’s recent approval of a drug for fibromyalgia with the therapeutic use of MDMA for PTSD, and there was also a great article posted by Scott Thill on Alternet called “Breaking the Drug Taboo: Group of Traumatized Veterans Get Ecstasy Treatment” that focused on the large social concern about veterans and PTSD. The idea that MDMA has potential therapeutic benefits is increasingly becoming an accepted concept in the mainstream media. We believe that this idea will become even more widely discussed after we complete Mithoefer’s pilot study and report the promising results.
June Blewitt just generously donated $5000 towards the study in honor of her late husband, Duncan Blewitt, leaving $90,000 still needed to be raised to complete the study.
On January 23, 2008 MAPS Clinical Research Associate Valerie Mojeiko and MAPS’ Clinical Research Assistant Josh Sonstroem completed a monitoring visit with Peter Oehen, M.D. and colleagues in Switzerland to access the progress with their MDMA PTSD pilot study. Dr. Oehen’s study is testing the safety and efficacy of using MDMA-assisted psychotherapy in twelve patients with treatment-resistent posttraumatic stress disorder. (PTSD). The monitoring visit went well and Dr. Oehen has now successfully enrolled six subjects. Everything was in good order and there were no serious adverse events related to the study drug.
On January 28th, MAPS’ Clinical Research Associate Valerie Mojeiko and MAPS’ Clinical Research Assistant Josh Sonstroem returned from their study initiation visit for Dr. Peter Gasser’s LSD/end-of-life anxiety study. They found that Dr. Gasser and his colleagues are prepared to begin their clinical trials, and are in the process of interviewing their first potential subject. MAPS staff delivered protocol documents to the Swiss team and confirmed that they had all of their regulatory documents in order. MAPS is extremely grateful to see this government-approved psychotherapeutic study with LSD being conducted in Switzerland–where Albert Hofmann (who celebrated his 102nd birthday last month) invented LSD and has been able to see with his own eyes the renewal of LSD psychotherapy research.
A very favorable article (entitled “Using LSD to Treat the Fear of Dying”) about Dr. Peter Gasser’s LSD/end-of-life anxiety study was published in the January 12, 2008 edition of Tages Anzeiger, the most conservative and important paper in Switzerland. The article was prominently mentioned above the fold on the first page of the paper, and it took up two-thirds of the page on the back of the front section of the paper, under the topic area Science/Knowledge. The tone of the article was respectful and supportive toward the renewal of LSD research, and it even suggested that there might be potential therapeutic benefits. There was also a question and answer interview with Dr. Peter Gasser. The article was about as prominent and as positive as it could possibly have been!
The article appeared the day after Albert Hofmann’s 102nd birthday. Albert is quoted in the article as saying, “My life’s greatest wish is now being fulfilled: LSD is finally becoming a medication again.” The renewal of LSD psychotherapy research has now been featured on Swiss television and in several newspapers–all in a positive, supportive manner. This article seems likely to build further public support for LSD research in Switzerland.
MAPS has already raised $100,000 of the $200,000 required to complete this important study. The renewal of LSD psychotherapy research marks the culmination of the first phase of the renaissance of psychedelic research. Now MAPS will focus on trying to generate promising results in all of our Phase 2 studies.
A Mexican Institutional Review Board (IRB) has almost completed reviewing MAPS’ Mexican Ibogaine outcome study. The Mexican study–which will be exploring ibogaine’s ability to reduce opiate withdrawal symptoms and break addictive cravings–has been approved in concept, and we should be able to begin this study soon. The study will take place at a clinic run by Clare Wilkins.
Meanwhile, North of the border, the Canadian Ibogaine outcome study that MAPS is also sponsoring has now enrolled its fifth out of twenty subjects at the Iboga Therapy House in Vancouver, Canada.
Rick Doblin of MAPS met with Dennis McKenna, of the Heffter Research Institute, clinical psychologist Andrew Feldmar, Ph.D., psychiatrist Ingrid Pacey, M.D., Ken Tupper of British Columbia Ministry of Health, Philippe Lucas of the Vancouver Island Compassion Society (VICS), and others to discuss different options for moving forward with clinical ayahausca research. Specifically, the group discussed the possibility of looking into ayahausca’s potential ability to help breast cancer survivors who have completed treatment but are still anxious about its recurrence, and also investigating the use of ayahuasca in the treatment of addiction.
MAPS and Heffter will explore the possibility of a collaborative study on the use of ayahausca in the treatment of addiction, perhaps as a small open-label exploratory study in three or four subjects. MAPS will explore whether to seek permission in Canada from Health Canada to do a small pilot study with ayahausca for breast cancer survivors with anxiety about a recurrence. There hasn’t been any clinical psychedelic psychotherapy research in Canada since the early 1970s. (The Vancouver House Ibogaine outcome study that MAPS is currently sponsoring in British Columbia is an observational study only, not government-approved clinical research.)
February 12 was the one-year anniversary of DEA Administrative Law Judge Mary Ellen Bittner’s historic ruling in which she found that it would be in the public interest for the DEA to license Prof. Craker to produce marijuana for federally approved research, breaking NIDA’s monopoly on the supply of marijuana legal for research. Since Judge Bittner’s ruling, the DEA has predictably opted for its strategy of delay and has not yet issued a final ruling in response to Judge Bittner’s recommendation.
On January 28th MAPS Program Director Valerie Mojeiko addressed an audience of over two hundred and fifty psychology students and faculty, as well as others interested in MAPS’ research, at the University of Amsterdam. Her powerpoint presentation is available as a ZIP file online. Ms. Mojeiko spoke about MAPS’ current research into the use of LSD and MDMA in psychotherapy and about the principles of psychedelic emergency work. The talk was co-sponsored by Stichting Open, a Dutch foundation that is seeking to stimulate academic research into psychedelic substances.
Dr. Karl Jansen’s Book Ketamine: Dreams and Realities is now available in electronic format, for anyone to download, as part of MAPS’ policy to try to disseminate valuable information for free. This book is a gold mine of fascinating and vital information about the dissociative anesthetic ketamine, which is known to produce short-lived psychedelic experiences in sub-anesthetic doses, and may have important therapeutic value. This is by far the most comprehensive book on the subject. We anticipate that making the text available on the internet will provide access to this information to a larger number of people without reducing sales of the paper book edition.
Wishing you all a happy Valentine’s Day! May everyone’s hearts be filled with love and peace. Kristin Gorenflo (aka Saratonin) sent MAPS this Valentine’s Day greeting.
There’s an old story about someone who is having a conversation with God. “It’s a huge mess down here on Earth, God,” the person says, “people down here really need help. There are so many problems. Why, oh why, don’t you send help?” To which God replies, “I did. I sent you.”
If you love MAPS as much as we do, and value the vitally important research that it’s now initiating all over the world to help make psychedelic drugs into prescription medicines, please consider making a generous donation to MAPS today.
Onward and Upward,
David Jay Brown, M.A.,
MAPS Guest Editor