MAPS Members, Supporters, and Friends,
MAPS has been attempting for years to put marijuana through FDA-approved clinical trials to resolve the controversy over medical marijuana’s safety and efficacy, and to develop and distribute it as a prescription medicine if its meets the FDA’s standards.
In light of our recent hard-won victory in Prof. Craker’s lawsuit against the DEA, we’re ramping up for a lobbying campaign of unprecedented significance and scale. Shortly after March 26, when DEA’s lawyers submit their objections to DEA Administrative Law Judge Bittner’s recommendation that DEA issue a license to Prof. Craker for a MAPS-sponsored medical marijuana production facility, we are planning to initiate a new Congressional sign-on letter campaign aimed at pressuring DEA to accept Judge Bittner’s recommended ruling.
Meanwhile, MAPS’ psychedelic research agenda continues to make leaps (see Items 3-10).
If you are a MAPS member, we are deeply grateful for your support and glad to have you on our team. We couldn’t do our work without you. If you are not a MAPS member, please consider joining us. Reading updates about the burgeoning renewal of psychedelic therapy research is way more fulfilling when you know that you are helping to make it happen.
Please visit MAPS.org/donate to become part of this force today!
Read on:
1. Update on Craker/DEA Lawsuit for MAPS-Sponsored Marijuana Production Facility
2. MAPS and Chemic Labs Negotiate Vaporizer Protocol
3. Ninth Circuit Court Rejects Raich Medical Marijuana Right-to-Life Appeal
4. Ethics Committee Meeting for Historic Swiss LSD/End-of-Life Anxiety Study
5. Crucial Media Provision Approved on Appeal by IRB for Dr. Mithoefer’s MAPS-Sponsored MDMA/PTSD Study
6. Final Five Subjects Recruited for Dr. Mithoefer’s Flagship MDMA/PTSD Study
7. Second Subject Treated in Dr. Oehen’s Swiss MDMA/PTSD Study
8. MAPS Funds Secondary Study Measuring EEG/ERP for Subjects in Dr. Oehen’s MDMA/PTSD Study
9. MAPS-Sponsored LSA/Cluster Headache Study Submitted to IRB for Approval
10. Iboga Therapy House Now Recruiting Patients; MAPS-Sponsored Observational Case Study Poised to Begin
11. MAPS/Heffter-Sponsored Ketamine Research Published
12. Women’s Visionary Congress: Web Site and Registration Now Up!
13. Raffle for MindStates Costa Rica
14. Pioneering Psychedelic Researcher Duncan Blewett Passes On
For MAPS memberships, special donations, merchandise, books, artwork, and more, please visit MAPS.org/catalog
1. Update on Craker/DEA Lawsuit for MAPS-Sponsored Marijuana Production Facility
In light of our recent hard-won victory in Prof. Craker’s lawsuit against the DEA, we’re ramping up for a lobbying campaign of unprecedented significance and scale. MAPS must show DEA that there is substantial public support for scientific freedom in marijuana research. Thats why MAPS is coordinating a lobbying campaign aimed at pressuring DEA to actually accept Judge Bittner’s recommended ruling.
On March 26, DEA’s lawyers will submit their critique to DEA Administrative Law Judge (ALJ) Mary Ellen Bittner’s recommended ruling that DEA grant a Schedule I license to Prof. Lyle Craker for his proposed MAPS-sponsored marijuana production facility. On May 4, our lawyers will submit a reply to the DEA lawyers’ critique, and then within a few weeks the ALJ will formally submit her recommendation and the dueling comments from the two legal teams to DEA. The DEA has an unlimited amount of time to make a final ruling.
MAPS has already utilized over $250,000 in resources to help Prof. Craker win his lawsuit against DEA, mostly in the form of pro bono legal services. Now, we must harness the momentum from this victory to demonstrate to DEA that the public wants to see the safety and efficacy of marijuana determined by rigorous scientific research, not by the vested political interests of NIDA and DEA. The opportunity to resolve the controversy over medical marijuana through FDA-approved clinical trials hangs in the balance.
We estimate that the odds of prevailing over DEA are 2-1 against us — in other words, more favorable than many of MAPS’ long-shot efforts. Even if we lose, we win in some important ways. If the DEA rejects the ALJ’s recommendation, it will highlight DEA obstruction of FDA-approved research and will help build support for state-level medical marijuana reform efforts.
Last week, our lobbying campaign received a big boost with news that MAPS has been awarded a grant of $45,000 from the Marijuana Policy Project (MPP). Over the next few weeks, we’ll be formulating a strategy. Then, well ask MAPS members and many others to contact their Congressional legislators to request that they write to DEA urging the agency to accept the ALJ’s recommendation.
2. MAPS and Chemic Labs Negotiate Vaporizer Protocol
On February 16, MAPS President Rick Doblin met with Joe St. Laurent and Scott Goodrich, the founders of Chemic Labs, the analytical laboratory that has conducted prior MAPS/CaNORML-funded vaporizer research. They discussed the development of a new vaporizer research protocol to submit to NIDA for review, once again seeking to purchase 10 grams from NIDA and seeking DEA permission to import 10 grams of high THC/high CBD marijuana from the Netherlands, with a cannabinoid content that NIDA doesn’t have available. The design work and the study itself, should we eventually obtain approval from NIDA, will be co-funded by MAPS and CaNORML, as have all our previous vaporizer research projects.
This new protocol seeks to analyze the constituents of the vapor produced in the Volcano vaporizer, from samples of NIDA marijuana that contain THC and samples of imported marijuana that contain both THC and CBD. During the meeting at Chemic, we reviewed in detail the critiques of the original vaporizer research protocol that the PHS/NIDA reviewers offered back in August 2005. We will make a few changes in the protocol so that this will be a new submission and we will respond in detail to each critique. The proposed methodology will call for testing at various temperatures, and will measure for carbon monoxide levels, cannabinoids and certain particulates.
PHS/NIDA’s handling of the original version of this protocol was another classic case of the dysfunctional nature of NIDA’s monopoly on research-grade marijuana. After waiting for more than two years for PHS/NIDA to review the protocol, during which time we unsuccessfully sued NIDA for unreasonable delay in the DC Circuit Court of Appeals, the critique that was finally issued contained several important misunderstandings and seemed to come from people who had barely even read the protocol. Chemic filed a response to the critiques in September 2005, which PHS/NIDA has totally ignored for more than 17 months. There seems to be no appeal process at all in the PHS/NIDA review of medical marijuana research proposals and there are certainly no deadlines that compel PHS/NIDA to respond within any reasonable period of time. This is in contrast to FDA, which must reply to protocol submissions within 30 days and has a clearly defined and prompt appeal process.
The new vaporizer protocol will be submitted to NIDA in April. Then, we anticipate a long wait. NIDA has successfully ignored Chemic’s response to its critiques but it will be more difficult for NIDA to ignore a new protocol submission.
3. Ninth Circuit Court Rejects Raich Medical Marijuana Right-to-Life Appeal
Earlier today, the Ninth Circuit Court of Appeals unanimously rejected (3-0) an appeal by medical marijuana patient Angel Raich, ruling that the 10th amendment does not protect her right to use medical marijuana and that there is no constitutional right to use marijuana to treat pain and suffering. MAPS and MPP submitted an amicus curiae brief for the appeal, as well as for Raich’s previous cases, detailing the federal government’s obstruction of medical marijuana research. Raich, a mother of two, uses marijuana to treat severe chronic pain, an inoperable brain tumor, wasting syndrome, and seizures.
Judge Harry Pregerson wrote, “We agree with Raich that medical and conventional wisdom that recognizes the use of marijuana for medical purposes is gaining traction in the law as well. But that legal recognition has not yet reached the point where a conclusion can be drawn that the right to use medical marijuana is fundamental and implicit in the concept of ordered liberty.”
In Raich’s 2005 US Supreme Court case, Gonzalez v. Raich, medical marijuana suffered a judicial setback when the Court ruled that the federal government can continue arresting patients who use medical marijuana legally under their state laws. Almost a year ago, on March 27, 2006, Raich returned to the Ninth Circuit Court in Pasadena, California, with a new legal strategy. Her attorney, Prof. Randy Barnett, emphasized that the case was about Raichs “fundamental right to life,” arguing that her right to use marijuana is constitutionally protected under the 5th & 9th amendments and by the common law doctrine of medical necessity.
During oral arguments last year, Justice Arlen Beam cited the MAPS/MPP amicus curiae brief. However, the Judge did not cite the primary message of the brief — that the federal government has obstructed research, hence making state reform efforts necessary — instead, to our disappointment, he only focused on the brief’s acknowledgment that there is not enough current clinical research for the FDA to approve marijuana for prescription use.
With Raich’s appeal lost, one more potential door to federally-legal medical marijuana is firmly shut, making the route through FDA even more necessary than before. There is no constitutional refuge for medical marijuana patients. The federal government is using its full authority to crack down on medical marijuana users and providers, even in medical marijuana states, while also making sure patients stay criminals by obstructing FDA-approved research.
4. Ethics Committee Meeting for Historic Swiss LSD/End-of-Life Anxiety Study
On March 8, the Ethics Committee (Swiss IRB equivalent) for Dr. Peter Gasser’s proposed MAPS-sponsored LSD-assisted psychotherapy study met to review his protocol. The committee is writing him a letter with their decision later this week. During the meeting, Dr. Gasser answered questions for 40 minutes. According to Peter, the meeting went well, and the committee seemed comfortable with the doses and the size of the study. Most of the information they requested was about videotaping and protecting the privacy of the subjects. One member of the committee did express some worries about the overwhelming power of the LSD experience itself. These concerns were addressed by Dr. Gasser, who stressed the psychological preparation of the subjects, the controlled clinical setting, and the supportive relationship with the therapists as being the key ways that the power of the LSD experience can be utilized in a therapeutic and beneficial manner.
This was the first of three formal regulatory reviews for the protocol to obtain full government approval. Depending on the outcome of the Ethics Committee evaluation, and the subsequent reviews by SwissMedic (Swiss FDA) and BAG (Swiss DEA), we could be ready to begin the study by this summer. The study is budgeted at $180,000 – MAPS has already raised $50,000 so far, but we need your help to bring the final $130,000 to fruition. Once approved and completed, this study will be the first government-approved study in over 35 years evaluating LSD’s therapeutic applications.
5. Crucial Media Provision Approved on Appeal by IRB for Dr. Mithoefer’s MAPS-Sponsored MDMA/PTSD Study
After several years of effort, three rejections, and an appeal, the Institutional Review Board (IRB) for Dr. Michael Mithoefer’s flagship MAPS-sponsored US MDMA/PTSD study approved an amendment to the study’s protocol. The IRB decided that it will not object to subjects speaking with the media and/or documentary filmmakers following completion of each subject’s participation in the study. The IRB originally insisted that patients not speak with the media even after the entire study is complete. After years of careful consideration, the IRB has now determined that it has no jurisdiction to control subjects’ decisions about whether or not to speak to the media.
Now that the media policy has been resolved, we are ready to move forward with our 12-month follow-up evaluations, which the IRB has previously approved.
6. Final Five Subjects Recruited for Dr. Mithoefer’s Flagship MDMA/PTSD Study
Another encouraging advancement is that we may be close to enrolling the final five subjects needed to complete Dr. Mithoefer’s study. We’ve focused more attention on recruitment with ads on various psychedelic-related websites and websites for PTSD support groups and currently have more than five subjects going through the screening process. Two of these potential subjects are Iraq War veterans.
Fifteen out of 20 subjects have completed the experimental procedures and their final follow-up evaluation session. Efficacy data at this stage is promising, so far making a strong case for continuing the research into FDA Phase 3 studies.
7. Second Subject Treated in Dr. Oehen’s Swiss MDMA/PTSD Study
Dr. Peter Oehen’s MAPS-sponsored study evaluating MDMA-assisted psychotherapy for subjects with chronic posttraumatic stress disorder (PTSD) has been making swift progress. Last Thursday, March 8, the second subject in Dr. Oehen’s study underwent the second experimental treatment session. The third subject will undergo the first experimental session later this week, and the fourth and 5th subjects have already been recruited.
8. MAPS Funds Secondary Study Measuring EEG/ERP for Subjects in Dr. Oehen’s MDMA/PTSD
MAPS has committed $5,300 to Dr. Franz Vollenweider at the Psychiatric University Hospital in Zurich to co-sponsor a secondary study that will gather data for physiological assessments of subjects in Dr. Oehen’s MDMA/PTSD study. The additional study will use several different measures to assess the psychophysiology of PTSD by using EEG/ERP and other biological measures such as heart rate variability (HRV) and pre-pulse inhibition (PPI). These parameters will be measured before and after the MDMA-assisted psychotherapy to allow researchers to evaluate changes in various areas of the brain and body. We expect that this additional neurophysiological and biological data will document the efficacy of MDMA-assisted psychotherapy. The amendment to Dr. Oehen’s protocol to include Dr. Vollenweider’s research was previously approved by Dr. Oehen’s Ethics Committee (IRB) in September 2006.
For more on this study, see Dr. Oehen’s article in the Fall 2006 MAPS Bulletin.
9. MAPS-Sponsored LSA/Cluster Headache Study Submitted to IRB for Approval
Earlier today, R. Andrew Sewell, M.D., received conditional approval from an IRB, pending a few minor changes in the informed consent form, for his protocol for a case series of the effects of LSA-containing seeds (morning glory, Hawaiian baby woodrose, or Rivea corymbosa) on cluster headache. The study, funded by a donation to MAPS from Seth Hollub, collects reports from people with cluster headache who have tried to treat this extremely painful condition through the use of seeds that contain this psychedelic compound. For more on this study, see the study’s Memorandum of Understanding (MOU).
10. Iboga Therapy House Now Recruiting Patients; MAPS-Sponsored Observational Case Study Poised to Begin
MAPS Clinical Research Associate Valerie Mojeiko is in Vancouver, Canada this week to conduct a study initiation visit for the MAPS-sponsored observational case study evaluating the long-term efficacy of ibogaine-assisted therapy in participants seeking treatment for opiate addiction at the Iboga Therapy House. If you or someone you know isinterested in receiving ibogaine therapy, you can learn more about the Iboga Therapy House and apply to their program at www.ibogatherapyhouse.net
11. MAPS/Heffter-Sponsored Ketamine Research to be Published March 31
Evgeny M. Krupitsky, M.D., Ph.D., Chief of the Research Laboratory at St. Petersburg Regional Center of Addictions and Psychopharmacology, will publish “Single Versus Repeated Sessions of Ketamine-Assisted Therapy for People with Heroin Dependence” in the March 31 issue of the Journal of Psychoactive Drugs. Krupitsky and his team found that multiple sessions of ketamine-assisted psychotherapy were more effective than single sessions, helping take an important step forward from the “magic bullet, miracle cure” theory.
Unfortunately, since this research was conducted, all ketamine research in Russia has been halted by its increasingly repressive regime, although heroin-related harm has risen considerably in recent years.
12. Women’s Visionary Congress: Web Site and Registration Now Up!
The Women’s Visionary Congress is a gathering of healers, activists, researchers and artists who are redefining the use of entheogens. This is a rare opportunity to meet the women doing critical work in the entheogenic, medical cannabis and harm reduction communities. The event will feature 25 mostly women speakers including Val Corral, Earth and Fire Erowid, Amanda Feilding, Carolyn (Mountain Girl) Garcia, Kathleen Harrison, Mariavittoria Mangini, Hilary McQuie, Annie Mithoefer, Cindy Palmer, Steph Sherer and Annie Sprinkle. The V Congress is a benefit for the Women’s Entheogen Fund (WEF) which was created in 2002 to support the work of women who spend a significant portion of their professional lives researching psychoactive plants and chemicals. MAPS is the non-profit fiscal sponsor for WEF.
Co-sponsored by The Sibyl Society and MAPS, the V Congress will take place at Wilbur Hot Springs in Northern California from July 27-29th. Tickets are $375 and include the cost of all events, meals, camping and yoga classes. A limited number of rooms are available at the Wilbur Hot Springs Hotel for an additional cost. This event is open to both women and men. For more information and to register, visit the V Congress Web site or call MAPS Membership and Sales Manager Sarah Hufford at (831) 252-0023.
13. Raffle for MindStates Costa Rica
Want to win a trip to the Mind States Costa Rica seminar, June 13-17, 2007? Try your luck and support MAPS by purchasing a ticket for the MindStates raffle! Raffle tickets are $20.00 each, and winning tickets are worth approximately $2,100 in event costs and airfare. Ten percent of the price of each raffle ticket goes to MAPS.
To purchase a raffle ticket, click here.
Winner(s) airfare (up to $700), attendance fee, food, and resort room costs will all be covered. Seminar presenters include Joe Coleman, Erik Davis, Earth Erowid, Fire Erowid, Stanislav Grof, Jon Hanna, Liz McIntyre, Mark Pesce, Alexander Shulgin, Ann Shulgin, and Margaret Wertheim, with Holotropic Breathwork offered by Sheelo Bohm.
14. Pioneering Psychedelic Researcher Duncan Blewett Passes On
On February 24, Duncan Blewett died at Nanaimo Hospital, British Columbia, after two years of loving post-stroke care at his home on Gabriola Island. Dr. Blewett was an athlete, husband, father, PHD from University of London (UK), WWII veteran, founding chairman of University of Saskatchewan’s department of Psychology, and one of the earliest western scientists to study the effects and therapeutic applications of psychedelics. Blewett published numerous books, such as Handbook for the Use of Lysergic Acid Diethylamide-25: Individual and Group Procedures and The Frontiers of Being.
Handbook for the Use of LSD-25… is available in electronic format in the Free Books section of the MAPS website.
Blewett and a team of forward-thinking research psychologists were recruited to work at the U. of Saskatchewan’s (later known as the U. of Regina’s) Weyburn Hospital by Dr. Humphrey Osmond in the early 1950s, where they conducted a wide variety of patient studies and observations. Osmond, of course, is known for introducing Aldous Huxley to psychedelics (as described in The Doors of Perception) and for coining the term “psychedelic,” in addition to his myriad research.
According to the Gabriola Sounder, Duncan “lived his life fabulously in the moment to the very end: the power of his joy will resonate on for many lifetimes … The afterlife just got a little lighter.”
Following Duncan’s death, longtime friend and associate Prof. Larry Schor wrote:
“Duncan was a trickster, a magician, an alchemist. In his company and under his spell, you could almost witness reality and imagination dancing together on the head of a pin. With Duncan by your side, you were always capable of more. More love. More compassion. More courage. One of his favorite quotes was of the Chinese philosopher Mencius, who said, ‘The ways are but two, love and want of love.’ For Duncan, the only path was love.”
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The power is in our hands to create our future, and to determine the future of psychedelics.
Now that MAPS’ agenda is gathering momentum, your support is more important than ever. If you are a MAPS member, we are deeply grateful for your support and glad to have you on our team. We couldn’t do our work without you. If you are not a MAPS member, please consider joining us.
For MAPS memberships, special donations, merchandise, books, artwork, and more, visit MAPS.org/catalog
Happy Spring!
~Jag
Jag Davies
Director of Communications
MAPS
10424 Love Creek Rd.
Ben Lomond, CA 95005
(831) 336-HEAL