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MAPS Bulletin Summer 2014: Research Edition
 
Media > Newsletter: February 9, 2007



Greetings, MAPS Members, Supporters, and Friends,

A buzz is brewing. Everyday, MAPS gets more and more calls from media outlets across the world that are fascinated by the renaissance in psychedelic research. (See Item #10 - Ecstasy, the New Prescription Drug?) Meanwhile, our global research initiative continues to make steady progress, recently highlighted by our MDMA/PTSD study passing its final interim safety review with flying colors.

Now that MAPS is increasingly gaining approval for important psychedelic drug development research, your support is more important than ever. Our approved studies need funding to proceed, to enable us to take advantage of the unique window of opportunity we've opened to perform the highly-demanded, long-supressed research necessary to create legal contexts for the beneficial uses of these substances. If you're not a MAPS member yet, or if your membership has expired, please consider joining MAPS! If you're already a member, please consider making a special gift.

The historic shift we are diligently orchestrating must be met with historic gifts of all sizes. To chip in, please visit the MAPS Web Store to make the largest gift you will feel good about giving.

Here's the headlines from MAPS for our February update:

1. US MDMA/PTSD Study Shows Promising Results at Data Safety Monitoring Review
2. Ongoing MAPS-Sponsored Swiss MDMA/PTSD Study in Switzerland Makes Progress
3. Leader of Swiss Zen Community Makes Generous Gift to MAPS
4. Swiss LSD/End-of-Life Anxiety Study Preparing for Ethics Committee Review
5. MAPS, Clusterbusters, and Dr. Andrew Sewell Move Forward with Proposed LSA/Cluster Headache Survey Study
6. No Ruling Yet in DEA Lawsuit for MAPS-Sponsored Medical Marijuana Production Facility
7. CaNORML and MAPS to Submit New Marijuana Vaporizer Protocol to PHS/NIDA
8. Dr. Abrams' Study of Cannabis for HIV-related Peripheral Neuropathy to be Published February 13th
9. Two International Peer-Reviewed Journals Publish Articles Advocating for Psychedelic-Assisted Therapy Research
10. MAPS in the Media: "Ecstasy, the New Prescription Drug?"
11. Third Annual Amazonian Shamanism Conference July 7-14 in Iquitos, Peru
12. Share the Spirit: 2007 MAPS Calendars for Only $5, Special Offer on Huichol Yarn Paintings

1. US MDMA/PTSD Study Shows Promising Results at Data Safety Monitoring Review

The Data Safety Review Board (DSMB) for Dr. Michael Mithoefer's MAPS-sponsored FDA Phase 2 pilot study evaluating MDMA-assisted psychotherapy for subjects with posttraumatic stress disorder (PTSD) met in late January for its final review, now that 15 out of 20 subjects have completed the experimental treatment. The DSMB recommended that the study continue without modification. Ironically, the DSMB's only safety concern was that those subjects who received the placebo might see a substantial increase in PTSD symptoms after tapering off of psychiatric medications. The DSMB is comprised of an M.D., a Psy.D. and a Pharm.D. not otherwise involved in the study.

Efficacy data at this stage is promising, so far making a strong case for continuing the research into FDA Phase 3 studies. We're already looking beyond the next five subjects and the completion of this initial study, to future research protocols. It's now clear that we need to evaluate more closely some of the conditions for which we will exclude subjects, such as HIV+, hep-C, or hypertension, even if controlled. All of these subjects can likely receive MDMA-assisted psychotherapy in a sufficiently safe manner to pass the risk/benefit test, expanding the pool of potential research subjects and enabling the research to have more direct applicability to real world users. We're just starting to work on a new protocol designed to evaluate subjects with these current exclusion criteria to see if we can safely relax any restrictions.

2. Ongoing MAPS-Sponsored Swiss MDMA/PTSD Study in Switzerland Continues to Look Promising

The good news from Switzerland this month is that the standard measure of PTSD symptoms, the CAPS outcome measurements, for the first subject in Dr. Peter Oehen's MAPS-sponsored MDMA/PTSD study, showed a substantial reduction in PTSD symptoms comparable to the average reduction in the US MDMA/PTSD study. If a therapeutic effect of similar magnitude can continue to be produced in the Swiss and US studies, we're on our way to Stage 3 studies.

We incorrectly reported last month that the second subject had undergone the first experimental session, when in fact this session will take place on February 15. The 2nd, 3rd, and 4th subjects have been swiftly recruited, and Dr. Oehen reports that, "Inquiries from prospective patients and therapists are continuously coming in."

3. Leader of Swiss Zen Community Makes Generous Gift to MAPS

MAPS member and leader of the Swiss Zen Buddhist community, Vanja Palmers, has made a generous donation of $50,000 to MAPS to support MAPS-sponsored MDMA/PTSD research and help MAPS meet the growing opportunities to promote psychedelic research. Upon making this important gift, Vanja wrote, "The revival of psychedelic research is one of the most hopeful developments in our troubled times." Thank you, Vanja, for your generosity and inspiration.

While MAPS' Clinical Research team was in Switzerland last month working on the Swiss MDMA/PTSD and LSD/end-of-life anxiety studies, they were graciously hosted by Vanja at Felsentor, the Zen meditation center he helped build in the mountains outside of Lucerne. Much thought was given to the opportunities and challenges facing MAPS' staff and membership. In late January, when Vanja pledged to donate $50,000 to MAPS, he lamented that he couldn't receive a tax deduction. To remedy that, we've arranged for Vanja to make his donation directly to the Swiss Medical Association of Psycholytic Therapy (SAePT), which is co-sponsoring the Swiss MDMA/PTSD study along with MAPS. $40,000 of Vanja's donation will be used for the MDMA/PTSD study, $10,000 for MAPS' unrestricted operating expenses.

4. LSD/End-of-Life Anxiety Study Preparing for Ethics Committee Review

The protocol and informed consent for Dr. Peter Gasser's proposed MAPS-sponsored study evaluating LSD-assisted psychotherapy for subjects with clinical anxiety secondary to life-threatening illness was submitted to an Ethics Committee (a Swiss IRB) last month. MAPS' clinical research team will submit Case Report Forms and other additional materials requested by the Ethics Committee before the February 14 deadline, for review at its March 8 meeting. This will be the first substantive review of the protocol. Depending on the outcome of the ethics committee evaluation and the subsequent reviews by SwissMedic (Swiss FDA) and BAG (Swiss DEA), we could be ready to begin the study this summer.

The study is budgeted at $150,000 - MAPS has already raised $50,000 so far and we are looking to you to help fill this $100,000 gap. Once approved and completed, this study will be the first government-approved study in over 35 years evaluating LSD's therapeutic applications.

Albert Hoffman, the Swiss chemist that discovered LSD, turned 101 last month. He longs to see the day when, as he is fond of saying, his problem child will become a wonder child. It will be a great triumph for our movement for the father of LSD to see the renewal of LSD research in his lifetime.

5. MAPS, Clusterbusters, and Dr. Andrew Sewell Move Forward with Proposed LSA/Cluster Headache Survey Study

MAPS and Clusterbusters and Andrew Sewell, M.D have all agreed to collaborate to conduct a survey study of LSA (lysergic acid amide) in the treatment of cluster headaches. The three parties agreed on January 29 to a Memorandum of Understanding outlining the guidelines for the study.

LSA is found in the seeds of common plants that are legal to buy and possess, such as Morning Glory and Hawaiian Baby Woodrose. There is considerable anecdotal evidence that LSA, like LSD and psilocybin, is more effective than current leading treatments in terminating extremely painful cluster cycles, which can last for weeks or longer.

6. No Ruling Yet in DEA Lawsuit for MAPS-Sponsored Medical Marijuana Production Facility

It has now been more than nine (9) months since lawyers representing Professor Lyle Craker and the DEA filed final legal briefs in Prof. Craker's MAPS-supported lawsuit against the DEA. MAPS and Prof. Craker have been engaged in a six year struggle to end the government monopoly on the supply of marijuana that can be used in legal FDA research to develop marijuana into an FDA-approved medicine. Prof. Craker is suing DEA for refusing to issue him a Schedule I license for a MAPS-sponsored medical marijuana production facility at the University of Massachusetts-Amherst. Prof. Craker needs a Schedule I DEA license to grow research-grade marijuana for use by scientists in MAPS-sponsored and FDA- and DEA-approved studies.

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, we are still expecting a decision in this case any day. If the DEA ALJ issues a favorable recommendation, DEA Administrator Karen Tandy would then need to decide whether to accept or reject the ALJ recommendation. If DEA accepts a favorable recommendation, Prof. Craker's proposed MAPS-funded facility would create the necessary independence of supply outside of the NIDA-controlled monopoly to justify the time and expense for MAPS and other organizations to sponsor clinical research evaluating the risks and benefits of marijuana as a potential FDA-approved prescription medicine.

If there is a favorable recommendation, we're poised for action with the new Congress, to try to create sufficient pressure on DEA to accept the recommendation. We'll need all supporters to contact their Congressional Representatives, so look out for an important announcement sometime soon. If there is an unfavorable recommendation, we'll do our best to spread the word that the FDA drug development route is fundamentally obstructed by NIDA's monoply, stressing even more the need for state and local reforms.

7. CaNORML and MAPS to Submit New Marijuana Vaporizer Protocol to PHS/NIDA

Dale Gieringer, Ph.D., of California NORML and MAPS have agreed to co-sponsor the submission of a new vaporizer protocol to the National Institute on Drug Abuse (NIDA). Unlike all other scheduled substances, NIDA maintains a monopoly on supply of research-grade marijuana that can be used in government-approved studies. Our new protocol is designed to analyze the constituents of a marijuana vaporizer, a non-smoking delivery system that eliminates the products of combustion that patients would inhale after burning marijuana. When completed, the protocol will be submitted to NIDA, seeking approval to purchase a small amount of marijuana (about half an ounce), and to DEA, seeking approval to import the same amount of marijuana, with a cannabinoid profile that NIDA does not offer.

NIDA's review of our previous vaporizer protocol was a classic demonstration of a bureaucracy's ability to utilize delay and outright inaction as unethical but effective political tools.

On June 24, 2003, the original MAPS/CaNORML-sponsored protocol was submitted to NIDA by Chemic Labs, with a request to purchase 10 grams for the research. The protocol was also submitted to DEA, with a request to import 10 grams with a cannabinoid profile that NIDA doesn't offer. Chemic received no response from NIDA for over two years, even after MAPS (unsuccessfully) sued NIDA for unreasonable delay in the DC Circuit Court of Appeals. On August 15, 2005, just one week before Prof. Craker's lawsuit against DEA began and 26 months since the original protocol was submitted to NIDA, a letter arrived at Chemic from Assistant Secretary for Health Joel Egertson, reporting that the NIDA/Public Health Service (PHS) reviewers had rejected the protocol for supposed weaknesses in the design. On September 9, 2005, Chemic responded to the critiques in a letter to Mr. Egertson, expecting that its appeal would be acknowledged and a response would be issued based on a careful review of the scientific issues under discussion. A year and five months have since passed with no response. Apparently, there is absolutely no appeal process, and no avenues for scientific debate, in the NIDA/PHS review of requests to purchase marijuana for legal research.

For the new protocol, we plan to accept some of the critiques of the PHS/NIDA reviewers, even though we don't agree with the rationale for the changes. Our goal is to submit a protocol that should be approved on the merits as judged from the perspective of the PHS/NIDA reviewers. We therefore expect considerable delays inside NIDA in responding to the protocol. However, with a new Democrat-controlled Congress overseeing NIDA's performance, we are hoping that NIDA's response to the new vaporizer protocol will be as consequential for NIDA as it is for MAPS and CaNORML.

Our intention is to bring the issue of federal obstruction of marijuana research into the foreground. This particular line of research has been obstructed by NIDA for more than three and a half years. NIDA's monopoly on the supply of marijuana inhibits not just FDA trials aimed at developing it into a prescription medicine, but also basic harm reduction research that could potentially benefit both medical marijuana patients and non-medical users of marijuana.

8. Dr. Abrams' Study of Cannabis for HIV-related Peripheral Neuropathy to be Published February 13th

The long saga of Dr. Donald Abrams' double-blind study of smoked marijuana for HIV-related peripheral neuropathy is coming to a powerful conclusion. On Monday, February 13, the respected journal Neurology will publish the results of his study, which will demonstrate that marijuana can be a safe and effective medication for many people with this condition. Keep an eye out for some interesting op-eds in the media next week.

This study, funded by the University of California's Center for Medicinal Cannabis Research (CMCR), is evidence of marijuana's therapeutic potential and should lead to further studies. Yet, no researchers are continuing Dr. Abrams' promising research. CMCR has not been refunded by the CA legislature, and NIDA's monopoly and arbitrary review process deters any private sponsor from investing in a medical marijuana drug development effort.

9. Two International Peer-Reviewed Journals Publish Articles Advocating for Psychedelic-Assisted Therapy Research

Ben Sessa, M.D., a British psychiatrist working toward the resumption of psychedelic research in England, has recently published two papers related to psychedelic-assisted psychotherapy research in two international peer-reviewed academic journals. "From Sacred Plants to Psychotherapy: The History and Re-Emergence of Psychedelics in Medicine," appears in the current issue of the Quarterly Journal of Mental Health. "Is there a case for MDMA-assisted Psychotherapy in the UK?" appears in the Journal of Psychopharmacology, and draws on evidence from MAPS-sponsored FDA Phase 1 and Phase 2 research studies.

10. MAPS in the Media: "Ecstasy, the New Prescription Drug?"

On January 23, Amanda Schaeffer of the Washington Post's Slate Magazine published an overwhelmingly positive description of MAPS' MDMA drug development efforts in a front page article entitled "What a Long, Strange Trip It's Been: Ecstasy, the New Prescription Drug?" The article discusses the government's exaggeration of MDMA's risks, and its history as an adjunct to therapy.

If you haven't checked out the ever-expanding MAPS in the Media section recently, there's a lot of fascinating coverage about MAPS' work. In particular, we've received glowing reviews about the Dec. 7 article in Chronicle of Higher Education, "Researchers Explore New Vision for Hallucinogens".

To be as effective as possible at garnering earned media to spread our important message, as Director of Communications I'm gearing up to implement a transition from a reactive mode (responding to incoming media calls) to a proactive role (reaching out to reporters and pitching stories). This change in strategy will require additional financial resources for the staff time and the technology needed to make the most of media opportunities, so please consider helping MAPS' operational expenses by making a special gift today.

11. Third Annual Amazonian Shamanism Conference July 7-14 in Iquitos, Peru

"The Third Annual Amazonian Shamanism Conference: Healing Plants and Navigational Tools" will take place once again in Iquitos, Peru, from July 7-14. Shamans, curanderos, scientists, and psychonauts will gather for lectures, discussions, and experiential workshops. Special guests will include Dennis McKenna, Peter Gorman, Alan Shoemaker, Richard Grossman, Jimmy Weiskopf, Kevin Furnas, and many more to be announced. Traditional healers will also give presentations and participate in panel discussions.

12. Share the Spirit: 2007 MAPS Calendars for $5, Special Offer on Huichol Yarn Paintings

If you haven't picked up a 2007 MAPS calendar yet, or if you would like to share some with your friends, we're reducing the price to only $5. The MAPS wall calendar features the works of Dean Chamberlain, Alex and Allyson Grey, Roberto Venosa, Martina Hoffmann, and other visionary artists, and is a great way to spread word about MAPS' mission. We've also reduced the price of our beautiful authentic Huichol yarn paintings to $125.

Thanks for your support! Working together, we are coming closer to creating legal contexts for the beneficial uses of psychedelics and marijuana.

Sincerely,

Jag Davies
Director of Communications
MAPS
10424 Love Creek Rd.
Ben Lomond, CA 95005
(831) 336-HEAL
www.maps.org

UPCOMING MAPS-SPONSORED CONFERENCES:

The Women's Visionary Congress: Consciousness, Healing and Social Justice
July 27-29 at Wilbur Hot Springs, California
A fundraiser for the Women's Entheogen Fund (WEF), co-sponsored by MAPS and the Sybil Society, this event will be open to both women and men. Featuring over 20 female speakers, including Carolyn ("Mountain Girl") Garcia, Kathleen Harrison, and Steph Scherer, founder and executive director of Americans for Safe Access.
Look for Registration Information and Details in Next Month's MAPS Update!

Continuing Medical Education with MAPS
As part of our mission to disseminate accurate educational information about the risks and benefits of psychedelics, and to help us to find more co-therapist teams for our eventual FDA Phase 3 multi-site studies, MAPS is planning to sponsor a Continuing Medical Education (CME) course on clinical research with psychedelics in Charleston, South Carolina in early 2008.
More information soon!

Give Our Veterans Hope
1 in 7 Iraq and Afghanistan veterans suffer from PTSD, in many cases leading to suicide. We owe it to our veterans to stop this epidemic.

Tell the Pentagon to fund MAPS' groundbreaking work to treat PTSD.