MAPS News – February 2009: Congress Asks Attorney General to Fix Bush’s DEA Wrongs
Dear MAPS Supporters and Friends,
Today, sixteen members of the United States Congress sent a letter to the newly appointed Attorney General Eric Holder on behalf of Professor Lyle Craker and MAPS’ proposed medical marijuana production facility! The letter requests that the Attorney General have the Drug Enforcement Administration (DEA) withdrawal the final order refusing Professor Craker a license to grow marijuana for Food and Drug Administration (FDA) approved research. Our friends at Americans for Safe Access orchestrated the letter signing. Among the signatories were Representatives Barney Frank, Ron Paul, and Dennis Kucinich.
Of equivalent excitement, Health Canada, Canada’s equivalent of FDA, has approved our protocol for an MDMA-assisted psychotherapy study in Vancouver, as a potential treatment for posttraumatic stress disorder (PTSD).
Our ibogaine research project is in jeopardy of having reduced enrollment due to: a lack of donations. The protocol is written to include 30 subjects at a cost of $1000 per subject. We have been unable to raise enough funds restricted to the ibogaine study at this time, and are planning to cap enrollment at 15 subjects if we don’t secure new funds. If you or someone you know is able to help fund the ibogaine study, please contact us immediately or donate online and note that the donation is for ibogaine research.
We have a special offer this month! We are giving away postcard sets of visionary artist Michael Brown’s (AKA Michael Divine) magnificent paintings Illume, The Three Jewels, One, and Surrender. We will give away a set of the four postcards to any current member who makes a donation of $20 or more, or any new member who donates $35 or more. As always, your generosity will support the psychedelic research renaissance as we work determinedly to legitimize the beneficial uses of psychedelics and marijuana.
Details about the Craker/Marijuana case, the Canadian MDMA/PTSD study, the ibogaine project, and much more are below.
Randolph Hencken, MA
MAPS Communications and Marketing Director
Here’s a sample of what is happening this month at MAPS:
- Congress and Professor Craker Respond to Bush Administration and DEAs Obstruction of Scientific Freedom
- Health and Human Services and National Institute on Drug Abuse Place Another Hurdle in Front of Marijuana Vaporizer Research
- Mimi Peleg Provides Guidance to Medical Marijuana Facility in Israel
- Ibogaine Study Enrolls Tenth Patient – Study Still Needs Funding
- Flagship US MDMA/PTSD Study Final Monitoring Visit
- MDMA-Assisted Therapy Helps Israeli Subject with PTSD from the 1967 Six-Day War
- Health Canada Approves MDMA/PTSD Protocol Design
- MAPS is Seeking Volunteer Grant Writer for MDMA/Studies
- Gift of the Month: Artist Michael Brown Postcards
* * * 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/ * * *
1. Congress and Professor Craker Respond to Bush Administration and DEA’s Obstruction of Scientific Freedom:
On January 30, 2009, lawyers for Professor Lyle Craker filed a motion of reconsideration in response to the Drug Enforcement Administration’s (DEA) final ruling, which was the Bush Administration’s parting blow to medical marijuana research. Professor Craker rebutted DEA’s final order with the support of MAPS and the American Civil Liberties Union (ACLU) on grounds that new evidence was introduced in the final ruling that was not included during testimony in the case.
On February 6, 2009, 16 members of the United States Congress sent a letter to new Attorney General Eric Holder urging him to have DEA “amend or withdrawal the Final Order in this matter to permit President Obama’s new Deputy Attorney General and DEA appointees to review Prof. Craker’s merits, once they are in office.” This letter was orchestrated by our sister organization Americans for Safe Access (ASA), who also distributed a press release. The 16 signatories are Representatives John Olver, Maurice Hinchey, Ron Paul, Tammy Baldwin, Raul Grijalva, Sam Farr, Robert Wexler, Ed Pastor, Neil Abercrombie, Gary Ackerman, Lynn Woolsey, William Delahunt, Barney Frank, Zoe Lofgren, Michael Capuano, and Dennis Kucinich.
The motion of reconsideration and Congressional letter are responses to the Bush Administration’s last-minute obstruction of legitimate science on January 14th, when DEA filed in the Federal Register its final ruling refusing to end the government monopoly over the supply of marijuana available for Food and Drug Administration (FDA)-sanctioned research. DEA’s final ruling rejected the nearly 2-year-old recommendation of DEA Administrative Law Judge Mary Ellen Bittner. Her February 12, 2007, recommendation stated that it would be in the public interest to end the National Institute on Drug Abuse (NIDA) monopoly on the supply of marijuana for legitimate scientific research. The DEA’s contradictory ruling continues its policy since 1970 of forcing the controversy over the medical use of marijuana to be resolved through political struggles rather than scientific research. NIDA’s monopoly fundamentally obstructs MAPS’ research aimed at developing smoked or vaporized marijuana into a prescription medicine.
MAPS is hopeful that the Obama Administration will honor its commitment to science over ideology. The Obama administration should support MAPS’ efforts to sponsor research aimed at gathering evidence about marijuana to present to FDA, and should stop DEA’s and NIDA’s obstruction of our attempts to transform marijuana into an FDA-approved prescription medicine.
There are several media articles about DEA’s ruling on the MAPS in the media page.
2. Health and Human Services and National Institute on Drug Abuse Place Another Hurdle in Front of Marijuana Vaporizer Research:
On January 23, 2009, Gregory Goldstein, Health and Human Services (HHS) Senior Public Health Advisor, Office of the Assistant Secretary of Health, sent a letter to Chemic Laboratories. The letter requires Chemic to do a validation study showing that Chemic could reliably measure various cannabinoids. HHS is suddenly requiring this validation study before it will even review Chemic’s November 6, 2008 reply to the June 18, 2008 Public Health Service’s (PHS) and National Institute on Drug Abuse’s (NIDA) critique of Chemic’s January 16, 2008 protocol. In this way, HHS/NIDA avoided responding to the substance of Chemic Labs’ reply by insisting on a preliminary validation study. This latest message is part of a five and half year tactic of blocking MAPS-sponsored vaporizer research, since a validation study had not been mentioned before in the previous communications and critiques.
In the January 23, 2009 message, HHS provided a list of questions for Chemic Labs to use as guidance for the validation study, but in their own words the questions are “not inclusive of all aspects of method validation.” Therefore, we could spend $50,000 or more on this validation study and HHS could claim that we did not meet all of the requirements and could request additional expensive validation data, all before reviewing the vaporizer protocol itself, which would only cost an estimated $25,000.
What makes this especially frustrating is that a validation study isn’t truly necessary for the sort of academic study we’re seeking to conduct. A validation study is more appropriate for developing the Volcano vaporizer as an FDA-approved medical device, which MAPS isn’t seeking to do. We’re exploring collaborating with Dutch scientists from the University of Leiden, who are already studying the constituents of the vapors produced by the Volcano vaporizers. We may perhaps be able to conduct a cross-validation study at less than half the cost of the validation study.
We are wary of conducting a validation study, or even a cross-validation study, without HHS/NIDA having reviewed and approved the vaporizer protocol itself. We’ll get back to HHS after we determine if we can make a case for a cross-validation study, then we’ll ask for the vaporizer protocol itself to be reviewed and approved first before we spend money on any sort of a validation study.
3. Mimi Peleg Provides Guidance to Medical Marijuana Facility in Israel:
On Monday, January 26, MAPS funded Mimi Peleg of Wo/Mens Alliance for Medical Marijuana (WAMM) in Santa Cruz, CA, to travel to Victoria, British Columbia, Canada to meet with Philippe Lucas, founder of the Vancouver Island Compassion Society (VICS). Mimi and Philippe are advising a MAPS-supported medical marijuana production facility in Israel, licensed by the Israeli Ministry of Health. MAPS donated $15,000 as a matching grant to Yohai Golan’s medical marijuana production facility that is giving marijuana away for free to Ministry of Health-approved patients under the Israeli Health Minister’s guidelines. MAPS is also sponsoring Mimi Peleg and WAMM’s founder and president Val Corral to visit Israel next month for in-person consultation. An anonymous donor is covering expenses and Val and Mimi’s trip to Israel.
4. Ibogaine Study Enrolls Tenth Patient – Study Still Needs Funding:
The 10th subject has now been enrolled in the MAPS-sponsored ibogaine outcome study taking place at the Pangaea Biomedics treatment center in Playas de Tijuana, Mexico and conducted by Principle Investigator John Harrison PsyD Candidate. While enrollment is happening rapidly, donations are lacking for us to be able to evaluate all 30 patients called for in the protocol. This study is inexpensive compared to other studies that MAPS conducts, with a budget of just $1000 per patient for a total cost of $30,000. The cost is low since this is an observational study of subjects who are paying for their own treatment, rather than a MAPS-sponsored controlled clinical trial in which MAPS would need to cover all expenses of the treatment as well as the evaluation. Until we receive donations for this study, we are going to be capping enrollment at 15 subjects.
This will become the first study ever conducted and reported in the public domain regarding long-term outcomes of ibogaine treatment of opiate addiction. Ibogaine has been reported for several decades to have sometimes-miraculous abilities to set opiate and other addicts free from their addictions, but there still have been no prospective studies published looking at long-term outcomes. Depending on the results, this study could help give legitimacy to the now alternative treatment found outside of the US, or underground within the US.
We would very much like to enroll all 30 subjects originally intended for the study. We once again ask the MAPS community to help us find people who would like to support this research by making donations restricted to the project.
5. Flagship US MDMA/PTSD Study Final Monitoring Visit:
On January 20-22, MAPS’ clinical research monitoring team, Valerie Mojeiko and Josh Sonstroem, went to Charleston, South Carolina to conduct a closeout visit for MAPS’ flagship US MDMA/PTSD study. The data from this study is now ready to be submitted to FDA.
With this ending also comes the beginning of the “long-term follow up” extension to this study. During this extension, subjects who were enrolled in the original study will be retested on primary outcome variables one year or more after completion. In the initial study, the last measurement of PTSD severity was taken two months after the last experimental session. Since this study took over four years to conduct, some of the data from the long-term follow-up will be from subjects who were treated over four years ago. The value of the long-term follow-up study will be substantially enhanced as a result of the extra length of time since treatment for most of the subjects. MAPS is pleased to have the help of volunteers Scott Martin MD and Mili Ballard to coordinate this long-term follow-up study.
6. MDMA-Assisted Therapy Helps Israeli Subject with PTSD from the 1967 Six-Day War:
MAPS President Rick Doblin PhD is delighted to share the success of a recent MDMA-assisted psychotherapy session in Israel. Rick was told a remarkable story during a check-in with the therapy team that is conducting our Israeli MDMA-assisted psychotherapy for the treatment of Posttraumatic Stress Disorder (PTSD) study.
Several weeks ago, the Israeli therapists successfully treated a patient who had suffered from PTSD for over 40 years, since the Six-Day War in 1967. On his second MDMA session, the gentleman became acutely aware of fears he was still harboring within him since the war. He requested to leave the treatment room for a walk outside on the hospital grounds. The therapists escorted him outside as he had a breakthrough catharsis leading to dramatic healing. Ironically, planes were flying overhead on the way to bomb Gaza.
With so much new trauma being created, it may seem underwhelming to speak of treating only 12 subjects each in our Israeli and proposed Jordanian studies. Yet if successful, these pilot projects will lead to larger-scale studies. Furthermore, as Charles Mackay, author of Extraordinary Popular Delusions and the Madness of Crowds (published in 1841), observed, “Men, it has been well said, think in herds; it will be seen that they go mad in herds, while they only recover their senses slowly, and one by one.”
The MAPS team is honored and humbled to help someone who has suffered for so long. We hope that in the near future MDMA-assisted psychotherapy will be available legally to all who suffer from PTSD. We believe that in the future, our successes in the laboratory will translate into a more peaceful world.
Rick shared, “in the midst of war, we are developing the technologies of peace and healing.”
7. Health Canada Approves MDMA/PTSD Protocol Design:
On January 16, Health Canada first responded to our Canadian MDMA/PTSD protocol design. They accepted almost all elements of the protocol but had some items they wanted changed. We also asked for a change in the kind of previous treatments for PTSD the subjects will be required to have tried and failed.
On January 20, we submitted our replies, accepting some changes and making our best argument for why it was important to include people who were free from substance abuse histories for the last 6 months rather than for the last 12 months, as Health Canada had suggested. In addition, we asked to be able to include subjects who failed on other psychotherapy and either tried and failed, or refused medication. Health Canada had suggested including only subjects who had failed on other psychotherapy, and had tried and failed to obtain relief from medication – excluding subjects who refused to try medication.
On February 3, we heard from Health Canada that our responses had been accepted and that our protocol design had been fully approved (Hooray!). This shows yet again that it is possible to negotiate with regulatory agencies that put science first.
On January 12, we heard from Health Canada’s chemistry reviewers. We’ve been gathering our replies ever since, which included obtaining a new analysis of the heavy metals and residue on ignition of the MDMA. In addition, Health Canada had a series of questions about the capsules, the lactose filler, and the bottles in which the capsules will be stored.
On February 2, Professor Rudolph Brenneisen from Switzerland provided MAPS with documents regarding the chemical make-up of the MDMA that will be imported to Canada from Switzerland. Ironically, the last bit of information we need to gather is the batch number of the lactose!
We expect to submit the required chemistry information in the next few days. Once the protocol is approved, we can start the process of obtaining the import/export permits for the MDMA from Switzerland, and can then start the study itself.
8. MAPS is Seeking Volunteer Grant Writer for MDMA/Studies:
We are seeking an experienced grant writer to guide MAPS in applying for a grant from the US National Institute of Health (NIH) to write a treatment manual documenting our therapeutic method. This manual will outline techniques and procedures for providing MDMA-assisted psychotherapy in the treatment of posttraumatic stress disorder. It will be a valuable tool in training researchers for phase 3 studies. The ideal candidate for this position has experience writing grants, especially grants with the NIH and/or treatment manuals. We are hoping to find someone to work on a volunteer basis, but we are also accepting applications from people who are offering their services on a fee basis.
We are also seeking a grant writer to assist MAPS in submitting grants to major foundations that fund health-related scientific research. Now that we have completed our US MDMA/PTSD study and have compelling data, we have a powerful story to tell, backed for the first time ever by data from an FDA-approved study. We’re hoping the time is ripe for major foundations to support MDMA/PTSD research, since it is no longer so controversial, and developing new treatments for PTSD is perceived as a national priority due to so many vets returning from Iraq and Afghanistan with PTSD.
9. Gift of the Month: Artist Michael Brown Postcards:
This month we are giving away postcard sets of visionary artist Michael Brown’s (AKA Michael Divine) magnificent paintings Illume, The Three Jewels, One, and Surrender. We will give away a set of the four postcards to any current member who makes a donation of $20 or more, or any new member who donates $35 or more. Michael’s artwork is truly fantastic and your financial contribution will help MAPS legitimize the beneficial uses of psychedelics and marijuana.
You should also visit MAPS on youtube and myspace and facebook.
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