DEA Quiet After Letters from Senators and Congressmen: MAPS News – May 2009
Dear MAPS Members, Supporters, and Friends,
We are perplexed about the status of Dr. Lyle Craker’s application for a license to grow marijuana for research. The final order ruling against Dr. Craker took effect on May 1st. However, May 1st has come and gone and we haven’t received any word from DEA. Based on conversations between our attorneys and the Department of Justice (DOJ), and Senator Durbin’s staff and DEA, we have learned that DEA review of our Motion to Reconsider is still pending, and that it is relatively common for such matters to take place after final orders have become effective. On April 29, Senators Kennedy and Kerry sent a letter to Deputy Attorney General David Ogden requesting that he take immediate action to delay DEA’s final decision. Professor Craker’s lawyers have also been proactive and have an appeal pending in the U.S. First Circuit Court of Appeals in case DEA’s Final Order is upheld.
It is a fundamental obstruction of science to allow the National Institute of Drug Abuse to have a monopoly on the supply of marijuana available for legal research. The government does not have a monopoly on any other Schedule 1 substance. We believe that science and justice will prevail over the ideology that is blocking legitimate inquires into the medical risks and benefits of marijuana. We have hope that the ignorance of the past will wash away in the near future and those in power at DEA, DOJ, and NIDA will allow MAPS to move forward with our planned marijuana production facility. We need access to quality marijuana in order to do the research necessary to prove marijuana in its organic form can become an FDA-approved prescription medicine.
This month our free gift is a music CD from the musical group Entheogenic. We have a limited supply of the 2002 self-titled album Entheogenic and the 2008 album Flight of the Urubus. We will give one of these albums to any current member who donates $20 or more or to any new member who donates $35 or more. We encourage you to order quickly while supplies last.
Randolph Hencken, MA
Director of Communications and Marketing
Here’s a sample of what is happening this month at MAPS:
- May 1 Comes and Goes Without DEA Action – Craker’s Marijuana Production Application Still Pending
- Rick Doblin, Mike Corral Visit Israel to Help Medical Marijuana Program
- MAPS Spring Bulletin is in the Mail
- High Times Features MAPS President Rick Doblin
- MDMA/PTSD Paper Completed and Sent for Friendly Review
- MDMA Data Analysis Nearly Ready for FDA Submission
- Canadian Study Awaits MDMA Import License
- MAPS at First Annual Students for Sensible Drug Policy West Coast Conference
- The Beckley Foundation’s Global Cannabis Commission Report
- National Geographic Television Gets MAPS help with Documentary on LSD and Psilocybin
- Psycomp Academic, a New Tool for Psychedelic Research Enthusiasts
- Gift of the Month: Entheogenic Music CD
* * * Dues-paying MAPS members are empowering staff, scientists, and volunteers to carry out pioneering research and educational projects. To donate, learn about the benefits of MAPS membership, or purchase books, clothes, art, and other merchandise, visit: store.maps.org * * *
On January 14, 2009, DEA issued a Final Order rejecting DEA Administrative Law Judge Bittner’s February 12, 2007, recommendation that Prof. Craker receive a license to grow marijuana for federally-licensed research. Prof. Craker’s facility would be built at the University of Massachusetts Amherst and would be sponsored by MAPS. Ending the federal monopoly on the supply of marijuana for research would be the beginning of a serious drug development effort aimed at transforming marijuana into an FDA-approved prescription medicine.
May 1, 2009, was the effective date of DEA’s final ruling rejecting Prof. Craker’s license. However, we have still heard nothing from DEA in response to Prof. Craker’s Motion to Reconsider. Based on conversations between Allen Hopper, Prof. Craker’s ACLU attorney, and Teresa Wallbaum, Acting Deputy Chief for Policy and Appeals, US Department of Justice, Criminal Division, Narcotic and Dangerous Drug Section, and also additional conversations between Senator Durbin’s staff and DEA officials, we have learned that DEA review of the Motion to Reconsider is still pending and that DEA intends to issue a written order adjudicating the Motion. We also learned that it is not rare for Motions to Reconsider, like the one filed here, to be resolved even after so-called final orders have become effective. In other words, there is still some possibility that DEA may grant in part or in whole the still-pending Motion to Reconsider, which could significantly change the final order. As the saying goes, It’s good to be the King, since you can ignore your own deadlines.
On May 11, 2009, Prof. Craker’s lawyers filed an update in the First Circuit Court of Appeals. We have asked for a delay in consideration of our case until after we learn how DEA responds to our pending Motion, which they may accept or reject. On February 13, 2009, in a prescient defensive maneuver, Prof. Craker’s attorneys filed a placeholder notice of appeal in the U.S. Court of Appeals for the First Circuit in Boston, preserving Prof. Craker’s right to appeal just in case DEA eventually denies the Motion to Reconsider; such a denial would effectively end the administrative proceedings and retroactively finalize the already-published final order denying his application. On March 12, the Court granted Prof. Craker’s attorneys’ request that the appeal be docketed but no further action be taken until such time as DEA rules on the Motion to Reconsider. The Court also ordered Prof. Craker’s attorneys to file an update every 60 days about the status of the case, with May 11 being the due date for the first update. If DEA denies the Motion to Reconsider, the appeal process is already started and a briefing schedule will be set. If DEA grants in part or in whole the Motion to Reconsider, the attorneys will focus on presenting new information to DEA and can further postpone (or completely eliminate the need for) the appeal. We are hoping that new leadership at DEA appointed by President Obama will thoroughly review the administrative proceedings, perhaps allow the submission of additional information, and eventually grant Prof. Craker’s application for a license to grow medical marijuana for FDA-approved research.
On April 29, 2009, Senators Kennedy and Kerry sent a letter to Deputy Attorney General David Ogden requesting that he take immediate action to delay DEA’s final decision regarding Prof. Craker’s application for a license to grow marijuana for research. This follows a similar letter sent on April 15 by Congressmen John Olver and Sam Farr requesting that Ogden intervene on behalf of Prof. Craker by asking DEA to cease going forward on its May 1 deadline. Since there has still been no final negative action by DEA, it appears these letters may have had an impact.
Now we’re back in waiting mode, with no deadline for DEA to file its decision regarding our Motion to Reconsider. Delay has always been DEA’s preferred strategy. Until there is new leadership at DEA appointed by President Obama, delay is now our preferred strategy as well.
From April 19 to April 22, 2009, MAPS President Rick Doblin went to Israel to work with Ministry of Health-approved medical marijuana producer Yohai Golan and Golan’s investors. Rick’s efforts in Israel involved consulting with the Ministry of Health about the possibility of allowing production facilities to sell marijuana to Ministry of Health-approved patients in order to create a sustainable system. Currently, the Israeli government has only given Golan, and several other producers, permission to give away the medicine they grow, but not to sell it. Rick is hopeful that the Ministry of Health will eventually permit sales of marijuana, but he recognizes that the wheels of bureaucracy turn slowly.
On Tuesday, May 12, 2009, Mike Corral–an experienced medical marijuana grower from the Wo/mens Alliance for Medical Marijuana–arrived in Israel to consult with three different growing facilities on techniques to maximize yield while reducing costs. An anonymous donor funds Mike’s work in Israel through MAPS.
The Spring 2009 MAPS Bulletin is now in the mail to dues-paying MAPS members. This Bulletin is a special 72-page edition about psychedelics and ecology edited by David Jay Brown. The Bulletin features articles from Kathleen Harrison, Stanley Krippner, PhD, David Luke, PhD, Ralph Metzner, PhD, Gregory Sams, Valerie Corral, Dragonfly de la Luz, Mark Schroll, PhD, Donald Rothenberg, Dale Pendell, John Allen, MBA, Mark Van Thillo, Shena Turlington, Sam Mickey, Kim Dawson, Daniel Pinchbeck, Michael and Violet Divine, Louise Reitman, Sara Huntley, and Lily Ross.
Rick Harlow, Penny Slinger, Michael Divine (formerly known as Michael Brown), Luke Brown, and Sara Huntley each contributed amazing art to this edition – most of which is for sale through MAPS with proceeds benefiting our research projects.
An electronic copy of the Bulletin is available online both as individual articles and as a single PDF file. You may also wish to check out our podcast in which David Jay Brown discusses the theme of this issue.
If you aren’t yet a MAPS member and would like to own a hard copy of the Bulletin, it isn’t too late to become a member and receive one as part of your membership.
The April edition of High Times featured an in-depth interview with MAPS President Rick Doblin. This excellent article is available as a PDF on the MAPS website.
MAPS is pleased to share that after months of work, our research team has completed a scientific paper that reports the remarkable results from our US MDMA/PTSD pilot study. Dr Michael Mithoefer, Annie Mithoefer, BSN, Ilsa Jerome, PhD, Mark Wagner, PhD, and MAPS President Rick Doblin, PhD, with assistance from statistician Yvonne Michel PhD, spent tremendous effort preparing the paper for submission to a peer-reviewed journal. We have now sent out the paper to several friendly reviewers for informal critique. We will incorporate the feedback we get from these reviewers and then submit the paper to a peer-reviewed scientific journal. This is a major milestone for MAPS and the legitimacy of psychedelic psychotherapy. When the paper is published in a peer-reviewed journal, MDMA-assisted psychotherapy will gain credibility among the scientific community and subsequently the general population. We have not yet released the paper to our readership, but keep checking back on our monthly email update to read about the results of this historic study.
On May 29, 2009, we will submit a preliminary dataset to FDA containing basic safety information from our US MDMA-assisted psychotherapy pilot study. Over the past several months MAPS Clinical Research Associate Valerie Mojeiko has been working diligently with a team of consultants from the pharmaceutical industry to prepare this preliminary data set, and to develop a streamlined collection of standard operating procedures to use in future data sets. This submission to FDA is the first of several data reports from our first pilot study and will provide the scientific justification for future protocols that we will submit to FDA.
IRB Services, the Canadian IRB that we are working with, has approved the changes to our MDMA/PTSD protocol that were made by Health Canada. MAPS’ Canadian MDMA-assisted psychotherapy PTSD study is now at the stage of seeking to import the research-grade MDMA into Canada. MDMA has never been legally imported to Canada before, so the process is a little slow. MAPS is working with a pharmacist who has applied for the license to import and we hope the approval will take place swiftly but we have no idea how long this process will actually take. When the license to import has been obtained, we can go forward with obtaining the specific import/export permits to ship the MDMA from the manufacturer in Switzerland to the pharmacist in Canada. Once the MDMA arrives in Canada, we can start enrolling subjects.
On Friday May 8, Valerie Mojeiko and Josh Sonstroem of MAPS Clinical Research Team, went to Vancouver to conduct a pre-study site visit. They met with co-therapists Ingrid Pacey, MD and Andrew Feldmar, PhD along with other site staff. This visit was necessary to ensure that data will be collected in manners compliant with FDA and Health Canada guidelines and that procedures will follow the protocol and IRB rules.
We are seeking a research assistant to help with this study 10-20 hours per week who lives in Vancouver and has prior research experience. Please view our job posting for more information.
On the weekend of April 24th-26th, a number of MAPS staff, a researcher and a board member were in attendance at the first annual Students for Sensible Drug Policy West Coast Conference. The conference took place in Berkeley, California, at the Martin Luther King Student Union. The theme of the conference-“The Perfect Storm for Reform”- alludes to the dramatically increasing momentum in the drug policy reform movement as of the last few years.
MAPS was given center stage for the Psychedelic Research panel on Saturday afternoon. John Harrison, PsyD Candidate, shared his research and experiences studying the use of ibogaine for opiate addiction. Brian Wallace, MAPS’ intern, who works as Event and Outreach Coordinator, presented on recent findings of the Mithoefer MDMA/PTSD study to a roomful of eager conference attendees. MAPS is very excited that the next generation of drug policy reformers are consistently interested in the work we are doing.
MAPS would like to thank the numerous volunteers who dedicated their personal time that weekend to table for us at the event. We deeply appreciate your time and effort in this area, and hope to connect with you at events in the near future.
Amanda Feilding, Director of The Beckley Foundation, commissioned a team of the world’s leading drug policy analysts to prepare a comprehensive overview of the latest scientific evidence surrounding cannabis and the policies that control its use from a global perspective. In reviewing the evidence, the authors come to some striking conclusions, many of which challenge the received wisdom concerning cannabis. Foremost among these are that cannabis is less harmful than alcohol and tobacco, that many of the harms associated with cannabis arise from prohibition itself, particularly discriminatory enforcement against the young and ethnic minorities, and that control policies, whether draconian or liberal, have little effect on the prevalence of use.
In the light of these conclusions, the authors highlight the need to consider whether a regulated cannabis market might be the best way to minimize these harms. The Report is already influencing policy discussions as exemplified by the recent declaration from the former Presidents of Brazil, Colombia and Mexico entitled ‘Toward a Paradigm Shift’ calling for the relaxation of penalties for cannabis. With its review of policy options, the Report forms a blueprint for nations seeking to develop a more rational and effective approach to the control of cannabis, one that minimizes the harms associated with cannabis use.
We have been helping National Geographic Television prepare a documentary special about LSD and Psilocybin. MAPS-sponsored Swiss LSD researcher Peter Gasser, MD, has agreed to be interviewed about his study of LSD-assisted psychotherapy in subjects with anxiety associated with life-threatening illnesses. We will inform you about the airtime, but it will probably be around October 2009.
MAPS’ ally PsyComp Academic is a new free access resource for education pathways into research with psychedelic compounds.
Psycomp identifies postgraduate and postdoctoral positions relevant to psychedelic research as they arise. Examples of the types of research opportunities are pharmacology, neuroscience, cognitive sciences, anthropology, chemistry, botany, etc.
PsyComp is an evolving project and, when fully developed, will feature a searchable database of Undergraduate-level courses offering an opportunity to study subjects directly related to the psychedelic compounds.
Many great advances in our understanding of psychedelics have been achieved by highly-specialized non-professional researchers, and for those not wishing to attend an accredited institution Psycomp’s autodidact section will contain course materials and presentations donated by psychedelic researchers and educators. PsyComp is also developing a YouTube channel of video seminars and lectures. Together with links to online courses, Open Courseware and online books, this will provide a ‘virtual classroom’ for psychedelic home study.
This month we are pleased to offer a music CD from the inspiring musical group Entheogenic. Entheogenic donated their 2002 album Entheogenic and their 2008 album Flight of the Urubus. We will give one of these albums to any current member who donates $20 or more or to any new member who donates $35 or more. Order quickly while supplies last.
Entheogenic describes themselves as having a mission to create the perfect visual soundscapes to help enhance and illuminate the mind within the entheogenic experience. This music is a must have for anyone who appreciates fusions of eastern and western vocals with tribal sounds and electronic melodies, harmonies, and beats.
You should also visit MAPS on youtube and myspace and facebook.
Hey you — don’t forget to tell all your friends to sign up for this newsletter!