MAPS Members, Supporters & Friends,
The fate of MAPS’ quest to put marijuana through FDA clinical trials is in a thrilling but precarious position — the DEA’s hands. After six years of struggle since renowned agronomist Professor Lyle Craker first applied to the DEA for a Schedule I license for a MAPS-sponsored research-grade marijuana production facility, we are now one signature away from breaking the federal government’s decades-long stranglehold on medical marijuana research. On May 15, the case was officially transmitted to DEA headquarters.
On May 16, a Dear Colleague letter by Reps. John Olver (D-MA) and Dana Rohrabacher (R-CA) was sent to all members of the US House of Representatives, urging each member to add their name to their Congressional Sign-On letter to DEA Administrator Karen Tandy urging the DEA to accept the recent non-binding ruling by DEA Administrative Law Judge Mary Ellen Bittner in favor of MAPS and Prof. Craker. To succeed at this critical juncture, we’ll need each supporter to contact his or her Congressional Representative (see Item #2).
Meanwhile, the MAPS staff is continuing to refine the organization’s objectives as we prepare for the next stages of our psychedelic and marijuana research agenda. MAPS has a valuable new addition to the Board of Directors (Item #9) and will be undergoing a specialized management review over the next two months (Item #10). These developments are a continuation of our larger strategy to build a thoroughly efficient, sustainable research and educational organization that will meet both its short-term and long-term goals.
MAPS has positioned itself at the center of the conflict between scientific exploration and the politically-driven strategy of the War on Drugs. Your support is needed to translate hard-won scientific freedom into new research results and possibilities.
Help bring MAPS’ challenging but realizable vision to fruition for ours and future generations by making a purchase or a charitable gift today at the MAPS Web Store.
There’s so much good news to report this month that the headlines are split into four sections.
MAPS & Medical Marijuana
MAPS-Sponsored Psychedelic Research
***For MAPS memberships, special donations, merchandise, books, artwork, and more, visit the MAPS Online Store.***
MAPS & Medical Marijuana
1. Marijuana Research in the Balance: Final Legal Filings Filed, Case Transmitted to DEA HQ
On May May 4, Prof. Craker filed the final brief in his MAPS-sponsored DEA Administrative Law Judge case, the “Respondent’s Response to the Government’s Exceptions to Opinion and Recommended Ruling, Findings of Fact, Conclusions of Law, and Decision of the Administrative Law Judge.” This brief is a strong response to the DEA’s “exceptions” to ALJ Bittner’s recommendation that it would be in the public interest for DEA to register Prof. Craker as a bulk manufacturer of research-grade marijuana for his proposed MAPS-sponsored independent production facility. It was prepared by an outstanding legal team led by Julie Carpenter, Jenner & Block, Allen Hopper, ACLU, and Emanuel Jacobowitz, Steptoe & Johnson, and assisted by Christina Alvarez, ACLU, and Lauren Payne, MAPS.
On May 15, DEA Administrative Law Judge Mary Ellen Bittner transmitted the case files to DEA, officially putting the ball in the DEA’s court to decide whether to accept or reject the Judge’s non-binding Recommended Ruling. Unfortunately, there is no time limit for the DEA to issue its final decision, so we are anticipating a wait of anywhere between three months and two years, based on previous cases.
On the morning of Wednesday, May 23, MAPS President Rick Doblin, PhD, Prof. Lyle Craker and medical marijuana patient Angel Raich will hold a brief press conference on the sidewalk outside of DEA headquarters in Washington, DC, followed by a national teleconference at 1:15 pm.
2. Help MAPS and Marijuana Research Succeed by Contacting Your Congressional Representative
On May 16, a Dear Colleague letter by Reps. John Olver (D-MA) and Dana Rohrabacher (R-CA) was sent to all members of the US House of Representatives, urging each member to sign their Congressional Sign-On Letter to DEA Administrator Karen Tandy urging the DEA to accept the recent non-binding ruling by DEA Administrative Law Judge Mary Ellen Bittner in favor of MAPS and Prof. Craker.
To succeed at this critical juncture, we’ll need each supporter to contact his or her Congressional Representative here’s how:
To reach your Representative by phone, call the congressional switchboard at: (202) 224-3121 or (800) 962-3524.
To reach your Representative by mail, write to: The Honorable (full name)/House Office Building/United States House of Representatives/Washington DC 20515
Tell your Congressperson that you would like him or her to add his or her name to the Congressional Sign-On Letter sponsored by John Olver and Dana Rohrbacher urging the DEA to follow the DEA administrative law judge’s Recommended Ruling by granting a Schedule I license to Professor Lyle Craker, UMass-Amherst. If you feel comfortable, explain that you would like to see the controversy over medical marijuana resolved through privately-funded FDA-approved research, and that Prof. Craker’s case is the focal point of the struggle to evaluate whether medical marijuana meets the FDA’s standards for safety and efficacy. Individualized letters and phone calls are the best ways to get the attention of your legislators. Emails are helpful, but phone calls and especially personal letters or faxes carry significantly more weight. No matter what, always be courteous and succinct.
For complete background on the case, see the MAPS DEA Lawsuit page.
3. $12,500 Grant from Drug Policy Alliance (DPA) for MAPS’ Marijuana Research Effort
Last month, MAPS was awarded a grant of $12,500 from the Drug Policy Alliance (DPA), for our efforts to pressure DEA to accept Judge Bittner’s ruling on behalf of Prof. Craker.
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.
4. Two New Studies Show Potential of Marijuana Vaporizer Research
Two new studies, one from University of California-San Francisco, and the other from SUNY-Albany, provide strong evidence that vaporization has promising potential as a method of medical marijuana delivery. The first study, published online by the journal Clinical Pharmacology and Therapeutics, was conducted at UCSF by a team led by Donald Abrams, MD, and compared a commercially available vaporizer to smoking in 18 volunteers. The researchers found that, “vaporization of marijuana does not result in exposure to combustion gases, and therefore is expected to be much safer than smoking marijuana cigarettes.” Dr. Abrams was able to obtain permission from FDA to conduct his study based in part on data on the composition of the ingredients in marijuana vapor gathered in research sponsored by MAPS and CaNORML. That line of MAPS-sponsored research is currently blocked since NIDA has refused to sell marijuana for additional studies. Click here to read Dr. Abrams’ full report.
The second study, conducted by Mitch Earleywine, PhD, at SUNY-Albany, and published in Harm Reduction Journal, was based on an extensive survey of over 7,000 marijuana users. After adjusting for variables such as age and cigarette use, Earleywine found that vaporizer users were 60 percent less likely than smokers to report respiratory symptoms such as cough, chest tightness or phlegm, and that the effect of vaporizer use was more pronounced the larger the amount of marijuana used. Click here to read Dr. Earleywine’s full report.
MAPS hopes to eventually put vaporized marijuana through FDA clinical trials, but has been stalled since June 2003 because of NIDA’s monopoly on the supply of research-grade marijuana. Research into alternative delivery methods such as vaporization was one of the primary recommendations of the Institute of Medicine’s landmark 1999 report on medical marijuana.
Marijuana vaporization is an effective delivery method because it has the rapid action and easy dose adjustment of inhalation, but without the respiratory hazards associated with smoking. Unlike smoking, a vaporizer does not burn the plant material, but heats it just to the point at which THC and cannabinoids vaporize into steam.
MAPS-Sponsored Psychedelic Research
5. FDA Approves MAPS-Sponsored Swiss and Israeli MDMA/PTSD studies for MAPS’ Investigational New Drug (IND) Application
MAPS is currently sponsoring three pilot studies evaluating MDMA-assisted psychotherapy for subjects with treatment-resistant posttraumatic stress disorder (PTSD), in the US, Switzerland, and Israel. Last month, we learned that the data being generated from the Swiss and Israeli studies will be accepted by the US FDA.
Although these protocols do not need to be approved by the FDA to be conducted in their home countries (they have already been approved by their home country’s regulatory agency equivalent to FDA and by local ethics committees), FDA review and approval enables us to submit to FDA the data from these two studies as part of MAPS’ Investigational New Drug (IND) application for MDMA-assisted psychotherapy in the treatment of PTSD. The data from these studies will be used to help negotiate with FDA regarding the design of larger Phase 3 studies intended to gather data to determine whether or not MDMA meets the requirements necessary to be approved as a legal prescription medicine.
To learn more about the MAPS-sponsored study in Israel evaluating MDMA-assisted psychotherapy for subjects with war- and terrorism-related PTSD, the protocol is posted on the MAPS Web site.
To learn more about the MAPS-sponsored MDMA/PTSD study in Switzerland, the protocol is also posted on the MAPS Web site.
6. Ongoing Swiss MDMA/PTSD Study Makes Progress
The ongoing MAPS-sponsored MDMA/PTSD study in Switzerland, led by Peter Oehen, MD, has completed treatment for two subjects and is currently treating the third and fourth subjects. In addition, two new subjects have qualified for the study and will begin treatment this summer.
7. Dr. Mithoefer to Present on MDMA Research at International PTSD Conference
Dr. Michael and Annie Mithoefer, the co-therapists for MAPS’ landmark US MDMA/PTSD study, were in Norway recently attending a workshop by Dr. Edna Foa, an internationally-recognized expert in the treatment of PTSD. The workshop was organized by Pal-Orjan Johansen, a Ph.D. candidate at the Trondheim Psychotherapy Research Program, Department of Psychology, The Norwegian University of Science and Technology, and Teri Krebs, B.S., Program in Neuroscience, Boston University.
While in Norway, Dr. Michael and Annie Mithoefer were also able to work with Pal and Teri, who are conducting a MAPS-sponsored study reviewing audio and video recordings and transcripts of subjects in the Mithoefer’s 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.
Dr. Michael and Annie Mithoefer were also able to discuss with Pal and Teri their MAPS-sponsored project using 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.
Drs. Mithoefer, Peter Oehen and Franz Vollenweider, will be presenting their MDMA/PTSD work at the European Conference on Traumatic Stress in Croatia next month.
8. MAPS Preparing for Ibogaine Study in Mexico as Parallel Canadian Study Continues; Laptop Donation Needed!
The Iboga Therapy House is now enrolling clients in MAPS’ IRB-approved long-term observational case study. Three subjects have been enrolled in the study so far and will be followed up on a monthly basis for a full year after their initial ibogaine treatment. The study will examine changes in substance use in 20 consecutive individuals undergoing ibogaine-based addiction treatment for opiate dependence at the Iboga Therapy House near Vancouver, Canada.
Meanwhile, MAPS is currently developing the protocol for a parallel MAPS-sponsored observational case study in Mexico under the direction of Principal Investigator John Harrison, PsyD (cand). The study would evaluate changes in substance use in 20 consecutive individuals undergoing ibogaine-based addiction treatment for opiate dependence at Mexico’s Ibogaine Association. The Ibogaine Association has been under new management since 2006, and has significantly upgraded the quality of services for its clients.
While on that note, we are looking for a laptop donation! We’re seeking a functional laptop less than three years old for the proposed MAPS-sponsored study in Mexico. It will be used primarily for email, word processing, and internet and can be either Windows or Macintosh. We don’t mind reinstalling the OS, upgrading RAM, and doing other light upgrades and maintenance to make it functional. Please write to josh [at] maps.org if you have a machine that you would like to donate.
9. Shawn Hailey Joins MAPS Board of Directors
We’re pleased to announce that longtime MAPS supporter Shawn Hailey is joining the MAPS Board of Directors as the fourth member. Shawn will actively work with MAPS President Rick Doblin and the other members of the Board of Directors to strengthen the organization, both by reviewing business and technical proposals, and by helping MAPS refine its long-term vision. We’re looking forward to Shawn’s increased input as we focus on meeting the challenges of success at this critical phase in the organization’s development.
Shawn and his twin brother, Kim, worked for almost 2 decades to build a software company focused on computer chip design and manufacture, before taking their company public. As a result, Shawn has extensive experience in managing growth and offers that experience to MAPS as we enter our own growth phase. For a fascinating, though somewhat technical, account of the history of Shawn and Kim’s company, Meta-Software, see this 1997 interview.
10. MAPS Preparing for Professional Management Review
Over the months ahead, the MAPS staff will be participating in a management review project with The Management Center, a nonprofit that helps progressive advocacy organizations get results in pursuit of their missions. The Management Center is funded by philanthropist Peter Lewis to provide professional management assistance to the organizations to which he contributes. We are deeply grateful to Peter for this fantastic opportunity.
11. Fundraisers in San Francisco Area Raise Over $23,500 for MAPS
Our fundraising events last month were a major success. On Friday, April 27, we held an intimate meeting of the minds with 15 distinguished psychedelic guests over an 8-course meal at the home of MAPS patron member Richard Miller in Tiburon, CA. On Saturday night, April 28, we held an all-night party with a spectacular line-up of guest speakers, DJs and visual artists at the home of MAPS patron member Richard Wolfe in San Francisco. Together the two events brought in over $30,000 with a profit of nearly $24,000 after costs. Special thanks to False Profit
12. Special Thanks to Robert Barnhart and Anonymous Donor for $40,000 and $25,000 Donations
MAPS is deeply grateful to longtime MAPS supporter Robert Barnhart for making a $40,000 charitable gift to MAPS in the last month. In addition, MAPS also received a $25,000 donation from an anonymous donor.
13. Call for Articles for Upcoming Special MAPS Bulletin
For the following MAPS Bulletin, we’re getting down to basics in a special theme issue. And we want to hear from YOU.
Have psychedelics been important to your personal development? How so?
Please share your stories with us for the upcoming special edition of the MAPS Bulletin, Psychedelics & Self-Discovery.
We are looking for articles that are between 400-1500 words. Articles may be submitted anonymously if that makes you more comfortable (although, all things being equal, we do prefer for people to write under their real names when possible). If possible, please send a high-quality photo of yourself to go with the article. Please email your submission to Sarah [at] maps.org by June 22.
Upcoming MAPS Events
14. 3rd Amazonian Shamanism Conference: Healing Plants and Navigational Tools
“The Third Annual Amazonian Shamanism Conference: Healing Plants and Navigational Tools” will take place once again in Iquitos, Peru, from July 7-14. Shamans, curanderos, scientists, and psychonauts will gather for lectures, discussions, and experiential workshops. Special guests will include Dennis McKenna, Peter Gorman, Alan Shoemaker, Richard Grossman, Jimmy Weiskopf, Kevin Furnas, and many more. Traditional healers will also give presentations and participate in panel discussions.
15. Mind States Costa Rica: Last-Minute Tickets Available
The upcoming Mind States seminar will be held June 13-17 in Costa Rica. To purchase tickets or check out the latest developments, visit mindstates.org.
16. Women’s Visionary Congress Tickets Sold Out
Tickets have sold out for this summer’s Women’s Visionary Congress: Consciousness, Healing, and Social Justice, at Wilbur Hot Springs in Calousa county, California. The Congress is co-sponsored by MAPS and the Sybil Society, and is a fundraiser for MAPS’ Women’s Entheogen Fund (WEF).
Now that our applications to conduct psychedelic research are finally being granted, the biggest thing limiting progress is no longer the government. It is our ability to fund the research and the work that goes into it.
The future is in our hands. Throw your weight behind MAPS’ work today.
Thank you for your support.
Director of Communications
The Multidisciplinary Association for Psychedelic Studies
MAPS :: 10424 Love Creek Road :: Ben Lomond, CA 95005