Hello, MAPS members and friends!
In today’s news from MAPS:
1. FDA replies to DEA regarding Dr. Michael Mithoefer’s Schedule I license for MDMA/PTSD study; DEA should respond soon
2. Dr. Mithoefer interviewed by Peter Jennings’ Ecstasy documentary team
3. Initial planning meeting for MDMA/ cancer patient study
4. DEA says “No comment” on UMass Amherst license
5. Psychedelic Review now archived online
6. Rick Doblin interviewed in LA City Beat
7. MAPS wishes Albert Hofmann a happy birthday
8. MAPS’ goals for 2004
We hope you enjoyed your winter holidays and your winter bulletins — if you did not receive your bulletin, please contact me. Also get in touch if you have an address change or if you’d like to stop receiving these email updates.
Best wishes,
Brandy
—
Brandy Doyle
Director of Special Projects
MAPS
(941) 924-6277
1. FDA replies to DEA regarding Dr. Michael Mithoefer’s Schedule I license for MDMA/PTSD study; DEA should respond soon
On Thursday, January 15, 2004, FDA confirmed that DEA’s request for a consultation about Dr. Mithoefer’s qualifications for a Schedule I license arrived at FDA in early January and that FDA’s recommendation has already been sent back to DEA. DEA claimed it sent the request for consultation in early October.
According to the Code of Federal Regulations [section 304(a) of the Act (21 U.S.C. 824(a))] , DEA must issue Schedule I licenses to researchers with FDA-approved protocols within 10 days of DEA receiving a recommendation from FDA that an applicant is qualified to do the research, unless the applicant can be denied on any of the grounds specified in section 304 (a), and has either 1) lied on the application, 2) been convicted of a drug felony, or 3) no longer has State registration to administer controlled substances. Since none of these criteria apply to Dr. Mithoefer, we may be quite close to being able to start this study. However, there could be some delays caused by the uncertain amount of time between when FDA sends its recommendation to DEA and when DEA acknowledges receiving it, with interagency mail notoriously slow. MAPS will now work to expedite this process however we are able.
2. Dr. Mithoefer interviewed by Peter Jennings’ Ecstasy documentary team
On Wednesday, January 14, Peter Jennings’ Ecstasy documentary team flew Dr. Mithoefer, the primary researcher for MAPS’ MDMA/PTSD study, to New York City for a filmed interview for their upcoming special on Ecstasy. The documentary, which will also include interviews with Rick Doblin, is expected to air prime time in early to mid-March.
3. Initial planning meeting for MDMA/cancer patient study
On Friday, January 16, Rick Doblin and Harvard psychiatrist Dr. John Halpern met with an oncologist to begin planning for a study of MDMA-assisted psychotherapy for anxiety and depression in end-stage cancer patients. This study, which would be conducted at Harvard Medical School’s McLean Hospital, is part of a long-term strategy to bring psychedelic research back to Harvard post-Timothy Leary, with the last clinical research with psychedelics at Harvard conducted in 1965! Planning for this study will move from the protocol design phase to the approval process phase only after the MDMA/PTSD study is fully approved. We hope to be able to start this study in the fall. An MDMA/cancer patient study would expand MAPS’ focus on MDMA to include another patient population, and builds on promising past research with cancer patients that evaluated LSD and psilocybin-assisted psychotherapy.
4. DEA says “No comment” on UMass Amherst license
On December 29, 2003, MAPS received a letter regarding the UMass Amherst project from Ms. Laura Nagel, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. The letter acknowledged MAPS’ letter of November 21, 2003, but said only that “the DEA cannot officially comment on the merit of any specific application.” No timetable was given regarding when DEA will officially reply to Prof. Craker’s application, for which DEA’s public comment period ended September 22, 2003. Once again, we see evidence that DEA’s primary strategy is to delay responding as long as possible. DEA fears that acceptance may eventually lead to FDA approval of the prescription use of marijuana, while a refusal to approve the application will expose the hypocrisy of the ONDCP/DEA line that more research into the medical use of marijuana is required before patients can legally receive marijuana under a doctor’s recommendation or prescription.
5. Psychedelic Review now archived online
MAPS has completed scanning of the entire collection of the issues of The Psychedelic Review, the journal started by the Harvard psychedelic research team of Ralph Metzner, Richard Alpert and Timothy Leary. Issue #1 was first published in June 1963 and the final issue, #11, was Winter 1970/1971. MAPS had some issues scanned by a commercial scanning company and others by MAPS staffer Mercedes Paulino. This historic collection is available in PDF format at http://maps.org/psychedelicreview/. Each issue is available as a complete PDF or broken down by article.
6. Rick Doblin interviewed in LA City Beat
Check out the profile of Rick Doblin in the January 8 LA City Beat: https://maps.org/media/lacb010804.html. Interviewed by Dennis Romero, Rick discusses the reasons he became interested in psychedelic research and in MDMA (Ecstasy).
7. MAPS wishes Albert Hofmann a happy birthday
Dr. Albert Hofmann, who discovered LSD and first synthesized psilocybin, turned 98 on January 11, 2004. On behalf of the MAPS community, a MAPS member brought flowers to Dr. Hofmann’s home in Basel, Switzerland that day. MAPS also created a special web page honoring Dr. Hofmann, and visitors to that page sent Dr. Hofmann birthday greetings through MAPS. To see the Dr. Hofmann page, go to https://maps.org/people/ah/ah.html To see a slideshow with photos from Dr. Hofmann’s birthday, go to https://maps.org/slideshows/ah98/ . To hear a recording of piano music played for Dr. Hofmann on his birthday by Dr. Rolf Verres, go to https://maps.org and click on ‘piano music’ near the top of the page. To see a slideshow with other photos of Dr. Hofmann, go to https://maps.org/slideshows/ah/ .
8. MAPS’ Goals for 2004.
The following is admittedly an ambitious list of MAPS’ goals for 2004 but it’s not beyond reach with focused and efficient effort, a pinch or two of luck, and courage on the part of several Institutional Review Boards (IRBs). Actually obtaining these goals will require a substantial broadening of support for MAPS and its research agenda well beyond our current community. Fortunately, the science is on our side.
1. Obtain final approval for US MDMA/PTSD study by end of February 2004, final approval for Israeli MDMA/PTSD study by Fall 2004, and final approval for Harvard MDMA/cancer patient study before the end of 2004.
2. Raise $500,000 for MDMA research by the end of 2004, of which $185,000 is the remaining needed for the US PTSD study, $75,000 for the Israeli PTSD study, $225,000 for the Harvard/cancer patient study and $15,000 for the ongoing MDMA literature review.
3. Either obtain DEA approval for the UMass Amherst marijuana production facility or initiate major lawsuit against the DEA.
4. If DEA approval is obtained for the UMass Amherst marijuana production facility, start campaign to raise $500,000 for the facility and $2 million for associated research projects. Campaign to reach goal within one year after DEA approval has been obtained.
5. Obtain HHS approval by the end of April to purchase NIDA marijuana for the continuation of the vaporizer research or initiate a lawsuit.
6. Obtain DEA approval by the end of April to import high-potency marijuana from the Dutch Office of Medicinal Cannabis for the continuation of the vaporizer research or initiate a lawsuit.
7. Increase MAPS’ membership to 2500.
8. Publish second edition of The Secret Chief.
9. Publish four issues of the MAPS Bulletin and send out 12 monthly email updates.
10. Take time to celebrate the occasional triumphs, study the occasional failures, and keep on working hard.