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Newsletter: December 11, 2006

MAPS Members, Supporters, and Friends,

It’s the most wonderful time of the year — the time of year to make an end-of-the-year tax-deductible donation to MAPS! To make a donation, or purchase art, books, and merchandise, visit the MAPS Webstore.

As the world’s only non-profit psychedelic and medical marijuana pharmaceutical company whose mission is to develop these substances into legal prescription medicines and create a regulated network of psychedelic-assisted therapy clinics, MAPS needs your support to make this challenging but realizable vision a reality for ours and future generations.

Organizationally, the rapid growth in the number of approved research projects that MAPS is able to sponsor has dramatically increased our workload and funding needs. Managing this growth has required a substantial amount of time and a greater emphasis on building a collaborative core team that can develop the capacity to manage an increasing number of projects and details while also contributing to the gradual refinement and realization of our long-term vision.

Over the past year, MAPS has made substantial progress toward each of our major goals and objectives: 1) Developing MDMA-assisted psychotherapy into an FDA-approved treatment for posttraumatic stress disorder (PTSD) and for anxiety secondary to life-threatening illnesses; 2) Globalizing our MDMA-assisted psychotherapy projects, with government-approved studies in Switzerland and Israel; 3) Breaking the US government monopoly on the supply of marijuana for research, as a prerequisite to starting a marijuana drug development effort; 4) Initiating psychedelic research at Harvard for the first time since 1965, with a study of MDMA-assisted psychotherapy in advanced cancer patients with anxiety; 5) Restarting LSD psychotherapy research for the first time in 35 years.

MAPS has positioned itself at the center of the conflict between scientific exploration and the politically-driven strategy of the War on Drugs. Your support is needed to translate hard-won scientific freedom into new research results and possibilities.

Today’s the day to put your money where your mind is, at the MAPS Webstore.

And, here’s the news from MAPS for December…

1. Winter 2006-07 MAPS Bulletin On The Way; MAPS 2005-06 Financial Report Available Online
2. Robert Venosa’s Limited, Signed “Hofmann” Portrait Still Available; Grey’s Final “Hofmann” Portrait Print Raises $6,655 for MAPS and COSM
3. STILL Waiting for Recommendation from DEA Judge in Lawsuit for MAPS-Sponsored Marijuana Production Facility
4. Volunteers Needed for NIDA-Sponsored Medical Marijuana Safety Study at UC-San Francisco
5. Worldwide MAPS-Sponsored MDMA/PTSD Studies Make Progress
6. MAPS Transfers FDA-Approved MDMA/End-of-Life Anxiety Protocol for Harvard/McLean Study
7. Proposed Protocol Design for MAPS-Sponsored Swiss LSD Psychotherapy Study Finalized
8. Cluster Headache Research Team Develops Timeline for Initiation
9. MAPS-Sponsored Ibogaine Observational Case Study in Vancouver Set to Begin
10. MAPS Team Inspects Mexico’s Ibogaine Association Clinic, Prepares for Potential Study
11. Heffter- and MAPS-Sponsored Psilocybin/OCD Study Findings Published in Journal of Clinical Psychiatry
12. Working with Difficult Psychedelic Experiences Now Available for Download; A/V Production Assistance Needed
13. Are You a Mental Health Professional Familiar With Individuals Undergoing Spiritual Emergencies or Integrating Challenging Psychedelic Experiences?
14. MAPS in the Media: From Chicago to Bangkok to Prague
15. Anatomy of an Ecstasy Scare Story

*** Can you imagine a cultural integration of the use of psychedelics and the states of mind they engender? Join us today. ***

1. Winter 2006-07 MAPS Bulletin On The Way

The Winter 2006-07 MAPS Bulletin will arrive to MAPS members in about 2-3 weeks. This issue contains a Financial Strategy Report from MAPS President Rick Doblin, a feature on MAPS’ efforts at Burning Man, research reports and updates, mind-bending artwork, thought-provoking articles, and a special surprise gift for all members who have made a donation in the past year — our way of saying “Thank you”.
(No, not that kind of gift — don’t lick the paper!)

Rick Doblin’s Financial Strategy Report from the Winter 2006-07 Bulletin is now available.

2. Robert Venosa’s Limited, Signed “Hofmann” Portrait and MAPS Merchandise Available in MAPS Webstore; Grey’s Final “Hofmann” Portrait Print Raises $6,655 for MAPS and COSM

Twenty out of 50 of Robert Venosa’s limited edition portrait of Dr. Albert Hofmann are still available. Each print is signed by both Dr. Hofmann and Venosa, printed on archival, acid-free Somerset Velvet paper, and accompanied by a Certificate of Authenticity signed by the artist. Proceeds will be split evenly between the artists and MAPS-sponsored LSD research.

Looking for holiday presents that go toward a cause you care about? Look no further than the MAPS Webstore, where you’ll find an exclusive selection of psychedelic-related artwork, books, t-shirts, hoodies, not to mention the remarkable 2007 MAPS wall calendar.

On a related note, on November 19 the final available print in Alex Grey’s signed and limited edition series of his portrait of Dr. Albert Hofmann, numbered 1/50, sold for $6,655 in an Ebay auction. Proceeds were split evenly between MAPS-sponsored LSD and psilocybin research and Albert’s writings, and Alex and Allyson Grey’s Chapel of Sacred Mirrors (COSM). This amount is more than twice the amount any other print sold for, with the last ten prints selling for $3000 each.

3. STILL Waiting for Recommendation from Judge in Lawsuit for MAPS-Sponsored Marijuana Production Facility

It has now been seven months since lawyers representing Prof. Lyle Craker and the DEA filed final legal briefs in Prof. Craker’s MAPS-supported lawsuit against the DEA for refusing to issue him a Schedule I license for a MAPS-sponsored medical marijuana production facility at the University of Massachusetts-Amherst. Since we had originally been told that a recommendation from DEA Administrative Law Judge (ALJ) Mary Ellen Bittner would probably be issued within 3-6 months, a decision in this case could now come any day, although we have no way of know which day, or what the decision will be!

If the DEA ALJ issues a favorable recommendation, it will mark an extraordinary window of opportunity in the six year struggle by MAPS and Professor Craker to gain a Schedule I DEA license to grow research-grade marijuana for use by other scientists in privately funded, DEA- and FDA-approved studies. Professor Craker’s proposed MAPS-funded facility would create the necessary independence of supply to justify the time and expense for MAPS or other organizations to sponsor clinical research evaluating the risks and benefits of marijuana as a potential FDA-approved prescription medicine.

For extensive background on the case, visit MAPS’ DEA Lawsuit page.

4. Volunteers Needed for NIDA-Sponsored Medical Marijuana Safety Study at UC-San Francisco

The National Institute on Drug Abuse (NIDA) and the Community Consortium, a branch of the Positive Health Program of the University of California-San Francisco Medical Service at San Francisco General Hospital, are sponsoring a study to assess whether using vaporized marijuana affects the safety of prescribed opioids in patients treated for cancer-related pain. Anecdotal reports suggest that the combination of marijuana and opiates offers fewer side effects, reduces the amount of opiates that are needed, and in some cases reduces pain below that obtained by opiates alone. This study will be conducted by Dr. Donald Abrams and will assess the clinical safety of the concomitant use of marijuana and opioids by monitoring the short-term side effects associated with combined therapy. For more information, see MAPS’ Volunteer for Research page.

Unfortunately, the study is not currently designed to evaluate pain through the use of standardized pain measures. After discussions about the protocol between Dr. Abrams and Rick Doblin, Ph.D., based on a suggestion by MAPS Board of Directors member John Gilmore, Dr. Abrams and associates are considering adding a measuring of pain to the study. This would enable them to gather preliminary evidence about whether a combination of opiates and vaporized marijuana can reduce pain below the level of pain relief that can be achieved only from opiates. However, subjects arent enrolled in the study on the basis of a specific amount of pain; rather, they are enrolled on the basis of having a stabilized amount of opiates for pain. As a result, its not clear whether some subjects are still experiencing pain that is uncontrolled by their opiate use.

5. Worldwide MAPS-Sponsored MDMA/PTSD Studies Make Progress

In South Carolina (US), Dr. Michael Mithoefer’s flagship FDA Phase 2 MDMA/PTSD pilot study has enrolled 16 out of 20 subjects, with completion of the 15th subject scheduled for January. Once the 15th subject completes the final follow-up, well conduct a preliminary data analysis for our Data Safety Monitoring Board and for submission to FDA.

For the study’s final subjects, Dr. Mithoefer is seeking to “recruit” veterans with PTSD as a result of war-related trauma.

MAPS is also sponsoring parallel government-approved MDMA/PTSD studies in Switzerland and in Israel. These studies were just submitted last week to FDA for review and approval. Although these studies do not need to be approved by the US FDA in order to be conducted in their home countries (they have already been approved by their home country’s regulatory agency equivalent to FDA and by local ethics committees), FDA review and approval enables us to submit to FDA the data from these two studies as part of MAPS’ Investigational New Drug (IND) application for MDMA-assisted psychotherapy in the treatment of PTSD. Once accepted, the data from these studies will be used to help negotiate with FDA regarding the design of larger Phase 3 studies intended to gather data to determine whether or not MDMA meets the requirements necessary to be approved as a legal prescription medicine.

For more details about these studies, visit MAPS’ MDMA Research page.

6. MAPS Transfers FDA-Approved MDMA/End-of-Life Anxiety Protocol for Harvard/McLean Study

At the request of the administration at Harvard’s McLean Hospital, the protocol for Dr. John Halpern’s MAPS-initiated and Peter Lewis-funded study evaluating MDMA-assisted psychotherapy as treatment for end-of-life anxiety is being transferred from MAPS to John Halpern, M.D. Discussions concluded this last week with FDA about how to enact this transfer. The transfer is relatively simple and should be completed by early January 2007. This is the final step that is to occur before initiation of the study, which has full institutional and government approval.

MAPS is agreeing to relinquish sponsorship of the protocol and to permit Dr. Halpern to cross-reference all data, literature reviews, and other protocols in MAPS Investigational New Drug (IND) file and also to cross-reference all information in MAPS MDMA Drug Master File. In exchange, Dr. Halpern is agreeing to permit MAPS to cross-reference the protocol and all data that he submits to FDA from his study into his new IND.

7. Proposed Protocol Design for MAPS-Sponsored Swiss LSD/End-of-Life Anxiety Study Finalized

Dr. Peter Gasser’s proposed MAPS-sponsored study evaluating LSD-assisted psychotherapy for anxiety secondary to life-threatening illnesses will be submitted to a Swiss ethics committee (the Swiss equivalent to Institutional Review Boards) by the January 11, 2007 filing deadline — coincidentally also the date of Albert Hofmann’s 101st birthday. In the past month, many details were finalized, such as the budget and the protocol design, which will include a dosage of 20 micrograms for the active placebo, and 200 micrograms for the full LSD session.

Another $90,000 is needed for this study, and restricted donations are welcome. About $60,000 has already been raised for this study from the sale of Albert Hofmann-signed art and books. By purchasing one of these collector’s items — either a print of Robert Venosa’s portrait of Albert Hofmann or a limited, signed hardcover copy of Dr. Hofmann’s LSD: My Problem Child, you are not only making a good investment, but also empowering MAPS’ research mission. MAPS’ share of the proceeds from the sale of these collector’s items will be reserved for Dr. Gasser’s MAPS-sponsored LSD research.

8. Cluster Headache Research Team Develops Timeline for Initiation

Last week, Clusterbusters President Bob Wold, along with Clusterbuster member Dan Bemowski, met in Boston with MAPS President Rick Doblin and researchers John Halpern, M.D.,and Andrew Sewell, M.D., to discuss the initiation of Clusterbuster-sponsored research at Harvard’s McLean Hospital examining LSD and psilocybin as treatment for cluster headaches, a rare and debilitating condition. One key outcome of the meeting was the development of a timeline that calls for full study initiation by November 2007.

9. MAPS-Sponsored Ibogaine Observational Case Study in Vancouver Set to Begin

The Iboga Therapy House in Vancouver, Canada, is now enrolling patients for ibogaine treatment. MAPS is sponsoring an IRB-approved long-term observational case study that will examine changes in substance use in 20 consecutive individuals undergoing ibogaine-based addiction treatment for opiate dependence at Iboga House. Learn more by reading MAPS’ Ibogaine Research page.

10. MAPS Team Inspects Mexico’s Ibogaine Association Clinic, Prepares for Potential Study

Last week, MAPS Clinical Research Associates Valerie Mojeiko and Josh Sonstroem, along with John Harrison, Psy.D., visited an ibogaine treatment facility in Mexico where MAPS is exploring sponsorship of an observational case study similar to the MAPS-sponsored study in Vancouver. Ibogaine is legal in Canada and Mexico, although it remains illegal in the US.

Incidentally, last week’s “This American Life” on National Public Radio included a feature story about a former heroin addict who has been treating people addicted to heroin with ibogaine.

11. Heffter- and MAPS-Sponsored Psilocybin/OCD Study Findings Published in Journal of Clinical Psychiatry

The long-awaited paper about the Heffter and MAPS-sponsored study conducted by Francisco Moreno, M.D., Univ. of Arizona-Tucson, investigating the safety and efficacy of psilocybin for subjects with treatment-resistant Obsessive-Compulsive Disorder (OCD), has now been published in the Journal of Clinical Psychiatry. MAPS’ contribution to this study was the world’s most expensive gram of psilocybin, which cost $12,250. Today’s BBC News features an article describing Dr. Francisco Moreno’s Heffter- and MAPS-sponsored research.

12. Working with Difficult Psychedelic Experiences Now Available for Download; A/V Production Assistance Needed

Working with Difficult Psychedelic Experiences is now available for DOWNLOAD!

This MAPS-produced 20-minute pilot educational video explains the principles of psychedelic emergency harm reduction services and teaches some basic methods about how peers can help transform challenging psychedelic experiences into opportunities for growth, self-knowledge, and healing.

In 2007, we’ll be re-shooting and re-editing portions of the video for a new version with wider distribution, and we’re looking for assistance with all aspects the video’s production: editing, lighting, camera, audio, or make-up skills and/or equipment would be greatly appreciated. Please contact us if you would like to help!

13. Are You a Mental Health Professional Familiar With Individuals Undergoing Spiritual Emergencies or Integrating Challenging Psychedelic Experiences?

At MAPS, we occasionally receive inquiries from individuals seeking a sympathetic therapist as they integrate challenging psychedelic experiences and/or undergo periods of spiritual emergency. If you are a licensed mental health professional, therapist, or psychiatrist, and would like for MAPS to refer such individuals in your area to you, please send your contact info and qualifications to MAPS Director of Operations Valerie Mojeiko at: .(JavaScript must be enabled to view this email address)

14. MAPS in the Media: From Chicago to Bangkok to Prague

Last week, MAPS President Rick Doblin was in Bangkok, Thailand, to testify in a medical MDMA case. The defendant paid all of Doblin’s expenses and donated $5,000 to MAPS. While in Thailand, Doblin took the opportunity to do an interview with The Nation, Thailand’s largest English-language daily. In the article Doblin speculates on the possibility of conducting MDMA/PTSD research with tsunami victims and discusses MAPS’ psychedelic research strategy.

Meanwhile, the Czech Republic’s largest English-language daily, The Prague Post, reported earlier this week in “Long, Strange Trip” on MAPS-sponsored long-term follow-up research with patients who were treated with LSD as part of a government-sponsored program between 1956 and 1974 in communist Czechoslovakia. Dr. Stanislav Grof was among the primary psychiatrists who conducted this research program, in which more than 420 patients underwent at least 5,100 LSD-assisted psychotherapy sessions, before he moved to the US in 1967. Earlier this year, MAPS provided a $2,000 grant to R.M. Crockford, a Canadian journalist who worked in Prague to locate and interview Czech LSD patients and report on the long-term outcomes of this therapy program.
Back in good ol’ Midwest America, MAPS’ psychedelic research agenda and harm reduction project at Burning Man was featured in Chicago’s Conscious Choice magazine.

15. Anatomy of an Ecstasy Scare Story

If you pay attention to the news, you may have noticed a lot of headlines last week about Ecstasy causing brain damage even in first-time users. Apparently, however, none of the reporters had actually read the study — as it turns out, the researchers actually failed to find any sign of brain damage, and so far they’ve failed to publicly report any signs of memory impairment as well. Some news articles actually repeated claims that Ecstasy use could lead to depression even though the study reported reduction in depressive symptoms in Ecstasy users.

The study findings don’t indicate that ecstasy use repairs the brain, which might be the exact opposite of brain damage. What they do say, however, is that there isn’t any brain damage after low ecstasy use. There (may be) some data on memory tests, but whatever it is has not yet appeared in public. So there may be findings about memory loss, but the only ones the public can see now, in a conference presentation, do not support memory impairment in ecstasy users. While MDMA is not without its risks, the attempt to claim that Ecstasy causes significant brain damage after a single use is not born out by research, even research that media reports claim supposedly support such a claim.

MAPS Clincal Research Associate Ilsa Jerome, Ph.D., provides an analysis in this special report.

Jerome writes that, “After examining the few published reports and conference presentations, there is little to no published data supporting the worries of the researchers or the media. All the measures they used for detecting signs of damage to serotonin neurons failed to find these signs, and the significance of the one change they did find is not clear. Furthermore, the only publicly available data from these studies concerning memory in ecstasy users refutes claims of memory impairment in ecstasy users. Hence the news coverage, and even the researchers themselves, misrepresent what the researchers actually found; little to no indication that a few doses of ecstasy harm the brain.”

*@*@*@*@*@*@*@*@*@*@*@*@*@*@*@*@*@*@*@*@*@*@*@*@*@*@*@*@*@*@*@*@*@*@*@*@*@*@*@*@*@*@*

MAPS has faced many uphill struggles, and will face many more, as we conduct psychedelic and medical marijuana research and communicate our findings to the public. As you consider your year-end charitable donations, keep in mind both the stark reality and ripe opportunities for change that are within our reach. MAPS President Rick Doblin was in Thailand last week, where the recently-deposed government used death squads as a method of drug-control, murdering at least 2,500 drug dealers and users. The new government is exploring new, more humane policies, although both in Thailand and throughout the globe the potential remains for catastrophic human rights abuse in the name of the War on Drugs. Unfortunately, this global system of punitive, prohibition-based drug policies has been primarily perpetuated by the US.

This means that we have a responsibility to develop and implement new approaches to drug policy that are both more effective and humane. Now that MAPS finally has the opportunity to conduct highly-demanded research that could help people deal more effectively with war- and terrorism-related trauma, fear of death, and other conditions, we may be able to offer much-needed healing to the public at large. Please consider a generous donation to enable us to shift society’s perspective about drugs from excessive fear toward realistic hope…

Have a happy “X”-mas and a new year full of cheer wink

Jag Davies,
MAPS Director of Communications

p.s. Here’s that link to the MAPS Webstore again: http://store.maps.org/

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