MAPS News 9/24/03: A historic day
Hello, MAPS members-
We have wonderful news!
Yesterday (Tuesday, September 23, 2003), the Institutional Review Board reviewing Dr. Mithoefer’s MDMA/PTSD protocol made its final decision — and approved the study! This is a historic moment for MAPS and for MDMA research. The approval marks the end of a three-month process with this IRB, and a 22-month IRB process overall. Dr. Mithoefer and MAPS have been struggling to obtain IRB approval since November 2001, when the FDA approved the study. This is the eighth IRB to which we’ve tried to submit the protocol. Five refused to accept it for review (after varying periods of consideration), one approved it then revoked that approval for political reasons, and another finally tabled the review, after spending months formally reviewing the study and having made it clear, through unreasonable demands, that the committee did not want to approve it. Along the way, we also established a MAPS IRB, but fortunately, we didn’t need to use it.
The last remaining step before we can begin the study is for Dr. Mithoefer to obtain a DEA Schedule I license. DEA received Dr. Mithoefer’s application more than 15 months ago. We hope to receive a license somewhat quickly now that IRB approval has been obtained, but you can never tell with DEA. After Dr. Mithoefer does obtain a Schedule I license, we can finally begin the study, using MDMA-assisted psychotherapy to treat Posttraumatic Stress Disorder.
Thanks for making this progress possible! We’ll keep you updated as events unfold.
Best wishes,
Brandy
—
Brandy Doyle
Director of Special Projects
MAPS
(941) 924-6277
MAPS E-Bulletin 9.19.03
By Brandy Doyle
Salutations, MAPS community!
We’re pleased to offer the fourth edition of the MAPS email news update. We’ve been happy to receive a very positive response to this new forum for communicating with MAPS members, and we plan to continue the updates as a regular service. With recent events progressing so rapidly, we’re committed to providing you with the latest news in psychedelic and medical marijuana research. Also note that you can log on to https://maps.org to check the “What’s New” section, and the main pages about MDMA (https://maps.org/research/mdma/) and marijuana (https://maps.org/mmj/) for up-to-date information on events at MAPS.
In this issue:
1. Hopefully final re-review of MDMA/PTSD study protocol set for next week
2. Retracted MDMA study claiming that MDMA could cause Parkinson’s evokes widespread criticism of sensationalism and bias
3. Drug Policy Alliance, NORML, DrugSense, and DRC-Net action alerts result in over 2000 faxes sent to Drug Czar urging support for the MAPS-sponsored UMass Amherst marijuana production facilty
4. MAPS volunteers provide psychedelic emergency services at 2003 Burning Man
1. Hopefully final re-review of MDMA/PTSD study protocol set for next week
The Institutional Review Board (IRB) reviewing Dr. Michael Mithoefer’s MDMA/PTSD study protocol has scheduled its re-review of the protocol and informed consent form for Tuesday, September 23, 2003. The announcement follows an exchange of comments and responses between the IRB and the MDMA/PTSD team. On August 25, 2003, Dr. Mithoefer’s team responded to the IRB’s concerns with additional comments, a revised protocol and revised informed consent form. The IRB and MAPS have arranged for the MAPS MDMA/PTSD protocol development team to be available by phone during the time of the IRB meeting in case any new issues arise, so that we can respond and perhaps resolve them on the spot.
After IRB approval has been obtained, Dr. Mithoefer still needs to obtain a Schedule I license from the Drug Enforcement Administration before the study can begin. We anticipate that DEA approval will take place within two months after IRB approval. DEA has delayed responding to Dr. Mithoefer’s application for a Schedule I license for well over a year, but will have no excuses left once IRB approval has been obtained.
For more information on the MDMA/PTSD study and other information on MDMA research, go to https://maps.org/research/mdma/index.html.
2. Retracted MDMA study claiming that MDMA could cause Parkinson’s evokes widespread criticism of sensationalism and bias
A widely-publicized NIDA-funded Johns Hopkins study, published September 27, 2002 in the prestigious journal Science, claimed that MDMA causes dopamine damage and can be linked to Parkinson’s diseas. In a shocking development, the study was recently retracted by authors George Ricaurte et al. They now report that the drug used in the study was actually methamphetamine instead of MDMA, supposedly due to mislabelled bottles, and that subsequent research with oral and then the injection of genuine MDMA failed to replicate the original findings. MAPS estimates that roughly $1 million was spent and about 25 monkeys were sacrificed in these experiments. The retraction confirms that more attention should have been paid to the exaggerations, omissions, and political agenda of the original study, which MAPS and several scientists had criticized in the New York Times and the Washington Post when it was first published, and in a letter MAPS sent to Science one week after the paper appeared but which took Science eight months to publish.
The study retraction has received wide coverage, with stories in the Washington Post, the New York Times, NPR’s “All Things Considered,” ABC National News, as well as scientific journals such as Nature, The Scientist, The New Scientist, British Medical Journal, and others. Newspapers around the country picked up the story from the AP and Reuters wire services. The San Francisco Chronicle even published an op-ed rebuking Ricaurte’s team for their flawed methodology and dishonest assessment of its results. Most of the articles about the retraction, and the retraction itself, can be found on the MAPS website at https://maps.org/research/mdma/studyresponse.html. The MAPS website has been visited by more people than ever before as a result of this publicity, since MAPS is mentioned in many of the articles.
The problematic research of the NIDA-funded team is not only politically fueled, but has had a detrimental impact on public policy. One of the most unfortunate consequences of the Science study was its impact on the debate over the recently-passed and Constitutionally-dubious RAVE Act, in which Congressional representatives were motivated in part by exaggerated fears of ecstasy’s toxicity.
Many questions remain unanswered by the retraction. It is still unclear which studies published by the Ricaurte team may have used the mislabelled vials of methamphetamine and MDMA, thus needing to be retracted as well. On September 17, 2003, The Scientist reported that a study published in the European Journal of Pharmacology will also be retracted soon. Also unknown are the design details of the studies with genuine MDMA that failed to find dopamingeric neurotoxicity, such as doses, routes of administration and ambient temperatures. This information is needed to properly assess the risk that MDMA can cause dopaminergic neurotoxicity, since the retraction by Ricaurte et al. lacks the grace and wisdom of a simple retraction and makes a feeble effort to claim that MDMA could still cause Parkinson’s. On September 18, 2003, MAPS sent a letter to NIDA director Nora Volkow requesting the prompt release of additional information about Ricaurte et al.’s research. (https://maps.org/mdma/retraction/volkowletter091803.html) To read the response to the study from the scientific community and the media, go to: https://maps.org/research/mdma/studyresponse.html You can read the retraction itself at: http://maps.org/media/science9.5.03.html
3. Pressure builds for DEA to approve UMass Amherst pot farm application
Almost 2,000 faxes have flooded the Office of National Drug Control Policy (ONDCP, the Drug Czar’s office) to demand that the DEA grant the license for a MAPS-sponsored medical marijuana production facility at UMass Amherst. Coordinated by action alerts from the Drug Policy Alliance, NORML, Drug Sense, and DRC-Net, the faxes responded to the DEA’s July 24, 2003 announcement of the license application in the Federal Register. While the DEA requested comments only from other license applicants or holders, not the general public, a strong outpouring of public support may sway the ONDCP’s recommendation to the DEA. MAPS members are requested to contact the Drug Czar’s office to register their views. To do so, check out: http://actioncenter.drugpolicy.org/action/index.asp?step=2&item=11290
These events follow an incredible two years since Dr. Craker’s application was initially filed, on June 25, 2001. The DEA first claimed to have “lost” the application, then returned it nine months later with no cover letter or explanation, and later visited UMass Amherst in an attempt to persuade the administration to drop the project. The comment period for the application ends September 22, 2003, after which the DEA must rule on the application.
On September 16, 2003, MAPS wrote to NIDA director Nora Volkov, asking her to submit a comment to the DEA supporting Dr. Lyle Craker’s application for a Umass Amherst medical marijuana facility. To read our letter to NIDA director Nora Volkov, go to https://maps.org/mmj/volkowletter091603.html.
Currently, NIDA has a monopoly on the supply of research marijuana, though not on any other Schedule I research drug. The UMass Amherst facility would break this monopoly, allowing researchers to opt for a higher potency, higher THC product than the low-grade marijuana grown by NIDA. The facility would also enable researchers to move forward in cases where NIDA blocks already-approved studies by refusing to supply them with marijuana, as has already happened twice. An independent source of supply of high-potency marijuana is a necessary prerequisite to a serious MAPS-funded medical marijuana drug development program of research aimed at obtaining FDA approval for the use of marijuana as a prescription medicine.
4. MAPS team provides psychedelic emergency services at 2003 Burning Man
MAPS’ team lent a hand at the 2003 Burning Man festival, working alongside event staff to provide a safe space for participants in need of emotional support. A number of those served were undergoing difficult psychedelic experiences, and the MAPS team helped to create a supportive environment for people to work through these states. Our group included MAPS staff members Rick Doblin and Brandy Doyle, Harvard psychiatrist Dr. John Halpern, Iboga Therapy House coordinator Sandra Karpetas, an underground psychedelic therapist, and several psychedelic-experienced peer volunteers. Look for a full report on the Burning Man project in an upcoming MAPS bulletin.
These are exciting and challenging times! The support of the MAPS membership has never been more necessary, or more appreciated. Thank you for helping us get this far. With hard work and persistence, science and compassion can win out over misinformation and fear.
As always, please reply to this message if you’d like to update your contact information or be removed from the email list.
Best wishes,
Brandy
— Brandy Doyle Director of Special Projects MAPS (941) 924-6277