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MAPS Bulletin Summer 2014: Research Edition
Media > Newsletter: May 19, 2005

Greetings, MAPS members and friends!

As MAPS staffer Brandy Doyle is transferring her tasks to me, this is my first edition of the MAPS Email News Update. Heres the news to report this month:

1. Israeli MDMA/PTSD study begins approval process
2. Professor Lyle Crakers prehearing statement filed; ACLU enters marijuana research dispute
3. Dr. Andrew Sewell completes a poster presentation of his case report series for the LSD/psilocybin cluster headache study.
4. MAPS-produced psychedelic emergency video on the way
5. Signed Albert Hofmann prints available now
6. MAPS' data monitoring team completes site visit in Charleston, SC to review Michael Mithoefers MDMA/PTSD data
7. Latest MDMA Literature Review posted to our website
8. New Director of Membership and Sales
9. Be here for him now: Requesting donations for Ram Dass
10. MAPS in the Media: Newsweek, St. Petersburg Times, BBC, MSNBC
11. Upcoming conferences: Mindstates
12. $20,000 grant awarded from Keeler Foundation for MDMA/PTSD research

And the details:

1. Israeli MDMA/PTSD study begins approval process

Dr. Moshe Kotler, Chair of the Department of Psychiatry at Tel Aviv University, Sackler School of Medicine, and former chief psychiatrist of the Israeli Defense Forces, submitted the protocol for our Israeli MDMA-assisted psychotherapy pilot study to a local ethics committee (called an Institutional Review Board (IRB) in the US)--the first step in the approval process. This study is to take place at Beer Yaakov Mental Health Center and will administer MDMA to people suffering from treatment-resistant posttraumatic stress disorder (PTSD) related to war or terrorism. Dr. Rael Strous, psychiatrist at Beer Yaakov Mental Health Center, is coordinating the protocol review process.

If passed by the local IRB, it will be submitted to a national IRB, an extra step that does not exist for studies in the US. Once it is passed by the local and national IRBs it will need to be approved by the Ministry of Health, the equivalent to the US FDA. The protocol will also be submitted to the FDA for review, to ensure that the data gathered will be reviewed by FDA as well as by the Israeli Ministry of Health. We're still months away from starting the study, but it's looking quite hopeful. MAPS met with representatives of the Ministry of Health and the Israeli Anti-Drug Authority during a trip to Israel in March. Officials from both agencies said they think in principle that the study should take place, with formal review of the protocol still required.

2. Professor Lyle Crakers prehearing statement filed; ACLU enters marijuana research dispute

Prof. Lyle Craker, University of Massachusetts-Amherst, filed a prehearing statement in his Drug Enforcement Administration (DEA) Administrative Law Judge (ALJ) hearing regarding obstruction of medical marijuana research, with assistance from lead lawyer Julie Carpenter of Jenner & Block, Allen Hopper of the The American Civil Liberties Union (ACLU), Drug Law Reform Project, and Emanuel Jacobowitz, Steptoe & Johnson, all working on a pro-bono basis. Prof. Craker is seeking a DEA license to establish a MAPS-sponsored facility to grow marijuana for federally-approved research. Dr. Crakers facility is necessary in order to break the federal monopoly on the supply of marijuana that can be used in FDA-approved research, a monopoly which is used to obstruct rather than facilitate research.

"Science, not politics, should govern medical research," says ACLU in challenge to the DEA's marijuana policy in a press release issued about the filing of the prehearing statement in Prof. Crakers lawsuit against DEA.

The next step in the process will be a conference between the ALJ and the lawyers for the two sides to discuss the possibility of additional prehearing statements and to set a date for the hearing itself, probably late this summer or early Fall.

3. Dr. Andrew Sewell completes a poster presentation of his case report series for the LSD/psilocybin cluster headache study

Dr. Andrew Sewell presented a poster entitled The Treatment of Cluster Headaches with Indole-Ring Hallucinogens on March 30th to the Harvard Department of Psychiatry for their annual Research Day. In it he described 37 patients who used psilocybin and 7 who used LSD to treat their medical condition, half at sub-psychedelic doses. The poster was received with polite interest, and will form the basis of a somewhat larger case series that will be published soon. Then the information from the case series will guide the development of a protocol for submission to the FDA and the McLean IRB. We hope to have this protocol approved later in 2005, before Albert Hofmanns 100th birthday on January 11, 2006.

4. MAPS-produced psychedelic emergency video on the way

As part of MAPS educational mission, we have created a pilot instructional video about how to deal with difficult psychedelic experiences, to be shown as part of a Unitarian Universalist drug education course for young people. This pilot video was made possible by a grant from the Unitarian Universalists for Drug Policy Reform (UUDPR). While the target audience for this video is high school students, it is applicable for anyone who may encounter people who use psychedelics. The video, which illustrates a party scene where a young man becomes overwhelmed by his psychedelic experience and two concerned partygoers step in to help, is being produced by MAPS staffer Jagdeep Davies, with narration by Rick Doblin. The video was pilot-tested at one Unitarian congregation and with the feedback received we will refine the video. When completed, we will reproduce it on DVD and VHS to distribute from our website to parents, schools, and psychedelic users. If you are interested in sponsoring the development of the psychedelic emergency video, please contact: .(JavaScript must be enabled to view this email address)

5. Signed Albert Hofmann prints available now

We are pleased to present a special signed, numbered limited edition of prints of Dean Chamberlain's light painting portrait of Albert Hofmann. This portrait was made in 1997 at Albert's home in Switzerland and is signed by Albert and Dean. Deans series of portraits can be seen at: http://www.deanchamberlain.com

This edition of prints was created to help fund MAPS-sponsored LSD and Psilocybin research as well as to commemorate Albert's 100th birthday next year. 50% of the profits from the sale of these prints will go towards this research, with a minimum of $25,000.

There are only 50 of these beautiful archival pigment prints. Eleven have already been sold.

The image is 11"x14" and is printed on fine-art matte paper. The price of the prints started at $1500 and will increase as the edition sells out. Prints #1-20 are $1000, Prints #21-30 are $1500; Prints #31-40 are $2000 and Prints #41-50 are $2500. Recently Albert's signature on a single sheet of blotter acid art sold at auction for $3000.

Dean Chamberlain developed his light painting technique, which involves working with his camera and subject in completely dark spaces, in 1977. These images are created entirely in the camera, with no computer manipulation. Using extremely long exposures in sessions that often extend to four or five hours, he moves through the composition space with a flashlight and colored gels, illuminating each individual element, not so much photographing a moment but painting with light through time and space. Dean considers this portrait of Albert to be one of his best photographs.

Prints are available for sale at the MAPS online bookstore: http://www.maps.org/cgi-bin/thatsanorder_LE?bookstore

6. MAPS' data monitoring team completes site visit in Charleston, SC to review Michael Mithoefers MDMA/PTSD data

Clinical Program Manager Amy Emerson, who monitors studies professionally for a major pharmaceutical company, is offering her services pro bono to MAPS as the leader of our monitoring team. I assisted her in sifting through the hundreds of pages of paperwork on this site visit as MAPS Clinical Research Associate. MAPS has assembled this team to monitor our clinical trials to ensure that the data gathered in each of our studies is properly and thoroughly recorded. Double- and triple-checking these many binders full of data is an important part of ensuring that our results are communicated effectively to, and accepted by, the FDA as we take the steps to turn MDMA into a prescription medicine. Monitoring is especially important for the foreign MDMA/PTSD studies we are working to start in Israel, Spain and Switzerland since we also intend to submit the data from those studies to FDA.

7. Latest MDMA Literature Review posted to our website

MAPS staffer Ilsa Jerome has completed and posted the latest MDMA Literature Review update to our website. It contains papers found between March 2004 and January 2005 and focuses on issues relevant to estimating the risks and benefits of clinical trials with MDMA. Sections include clinical trials, studies in ecstasy users and non-human animal and in-vitro studies. This is the third update to the comprehensive literature review.

Ilsa writes: This year neither clinical trials nor studies in ecstasy users produced any "novel" results, though several studies in ecstasy users suggest that psychological problems are more closely associated with drug use generally, and are not uniquely related to use of any one drug, and more findings of impaired visual memory in ecstasy users rather than in verbal memory. Findings from a study and a conference report of ecstasy users in naturalistic settings are intriguing as well. This year's crop of non-human animal studies are where the most interesting findings are, from findings concerning different measures of serotonin function to findings of long-term effects in young rats, and a nine-study opus on the neurochemistry behind immunological changes produced by MDMA.

You can check out the newest update on the website, with links up on the MDMA page. You can view it in HTML (http://www.maps.org/research/mdma/litupdate3) or as a PDF (http://www.maps.org/research/mdma/protocol/litupdate3.pdf). For those who want to scroll down through the entire document in HTML without relying on a navigational bar, we also have a version that allows this (http://www.maps.org/research/mdma/litupdate3/noframes.html).

8. New Director of Membership and Sales

We are happy to introduce the newest member of the MAPS staff, Julia Onnie-Hay. Julia will be taking over Valeries previous position as Director of Membership and Sales, as Valerie is promoted to Program Director. Julia first started volunteering with MAPS five years ago as a gardener at Arcturus (aka the MAPS House) while she was studying religions of the African diaspora for a B.A. in Cultural Anthropology at New College of Florida. Julia was a student in Rick Doblins 2001 class on Drugs and Drug Policy (along with MAPS staff members Brandy, Valerie, and Jag) at New College, and also led a group of student drug policy reformers as co-founder and president of a student chapter of NORML.

9. Be here for him now: Requesting donations for Ram Dass

While we dont normally ask for donations on behalf of individuals, we are passing this information along from a friend of Ram Dass:

Last fall Ram Dass journeyed back to India for the first time since the early 80's. He may have thought he would never make it back to his Guru's ashram at Kainchi after a near-fatal stroke in 1997 but he did, wheelchair and all. His care at the ashram was overseen with great affection by the devotees of his Guru there, and it was a transformative time for him. He had a cold and a minor infection while there but he seemed to have recovered.

On the return trip from Delhi to California he traveled for 35 hours, spent one day at home, then turned around and flew to Maui to run a long-scheduled retreat. At the end of the retreat he came down with a high fever and was hospitalized with a urinary tract infection that got into his kidneys and bloodstream (the same kind of thing that killed the Pope).

It took several weeks of doctors trying to find the right antibiotic and a very pain-filled time in the Maui hospital for him to get better. Since then he has been recovering and living on Maui in a rented house. He is much better, has been really applying himself in physical therapy, and in as good Spirit as ever. However, he couldn't travel for a considerable time, and his 2005 speaking schedule has had to be mostly cancelled, along with it the income he depends on.

Friends have been working to raise the necessary funds to pay for Ram Dass' care and living expenses, both short and long term, so he won't have to travel and so people can come to him instead of the other way around.

Being the focus of fundraising has proved humbling for Ram Dass, who has always raised money for everyone else. In some ways it is his Guru's latest and fiercest Grace, and one can only believe that overall it is another change for the best.

A foundation is being utilized for contributions to Ram Dass' ongoing teaching. If you feel moved to contribute to Ram Dass' care and teaching, please send donations to the Center for Spiritual Studies, 57361 Hillcrest Drive, Yucca Valley, CA 92284, tel (760) 365-2333. The Center for Spiritual Studies is a California 501(c)3 with Federal Tax ID # 23-7356960. For more information please contact: Raghu/ Mitchell Markus .(JavaScript must be enabled to view this email address)

10. MAPS in the Media: Newsweek, St. Petersburg Times, BBC, MSNBC

On May 2, Newsweek published a story about MDMAs potential in treating PTSD with mentions of the Mithoefers study in Charleston, SC and the proposed study using MDMA in advanced stage cancer patients with anxiety at Harvard. The International Edition of Newsweek published A Psychedelic Cure, a piece similar to the one in the domestic edition but with greater discussion of proposed studies of MDMA-assisted psychotherapy in Spain and Israel. The St. Petersburg Times ran a front page article, Party pill gets tryout in therapy," reporting on MAPS mission of decriminalizing MDMA for therapeutic purposes. Rick Doblin spoke to a worldwide audience on BBC radio, and also held his ground on the conservative MSNBC program "Scarborough Country." To keep abreast of the latest media mentions of MAPS, go to http://www.maps.org/media.

11. Upcoming Conference: Mindstates

Buy your ticket now for Mind States VI "Technology & Transcendence." MAPS President Rick Doblin will be speaking, along with an impressive lineup of psychedelic luminaries. Dont forget to come by the MAPS table and visit with staff: Brandy, Julia, and Valerie. Tickets are available now for $275, $300 at the door. Inquire about discounted work-trade tickets; they are $60 or $120, depending on the amount of time worked. The past two conferences have sold out in advance.

12. MAPS receives $20,000 grant from Keeler Foundation for MDMA/PTSD research

The Robert T. Keeler Foundation awarded MAPS a $20,000 grant for Dr. Michael Mithoefers MDMA/PTSD research. FDA approval of our requests to offer open-label MDMA to the placebo subjects, after they have completed their final follow-up, session has added a cost of approximately $100,000 to the study. Further grants are still needed.

Thank you for reading!

Valerie Mojeiko

MAPS Program Director and Clinical Research Associate

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