[MAPS] MAPS News: January 2007
Jag Davies
jag at maps.org
Mon Jan 15 23:06:09 CST 2007
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Greetings, MAPS Members, Supporters, and Friends!
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There's a lot of significant developments to report, so off we go:
1. John Gilmore Donates $150,000 to MAPS
2. New Face in the MAPS Office: Troy Dayton
3. MAPS Team Conducts Inspection for US MDMA/PTSD Study; Milestone Passed
4. MAPS-Sponsored Continuing Medical Education (CME) Course in Spring 2008
5. MAPS-Sponsored LSD-Assisted Psychotherapy Protocol Submitted to Swiss
Ethics Committee
6. Swiss MDMA/PTSD Study: MAPS Clinical Research Corps Strike Again
7. Birthday Lunch for Albert Hofmann Proceeds, Minus Albert and Anita
8. MAPS Becomes a Sponsor for 2008 Gaia Media Conference
9. FDA IND For MDMA/Cancer Anxiety Study Transferred to John Halpern, M.D.
10. MAPS Awards Grants for Ongoing MDMA/Defense Mechanism Research, New
MDMA/Asperger's Internet Data Gathering Project
11. MAPS and Clusterbusters to Sponsor LSA/Cluster Headache Study
12. Deja Vu: STILL Waiting for Recommendation from Judge in Lawsuit for
MAPS-Sponsored Marijuana Production Facility
13. Winter 2006-7 MAPS Bulletin Arrives; Corrections Due
14. Mind States Costa Rica: June 13-17, 2007
*** For MAPS Membership and Merchandise, Visit the MAPS Online Store:
http://www.maps.org/catalog ***
1. John Gilmore Donates $150,000 to MAPS
Philanthropist and MAPS Board Member John Gilmore has pledged $150,000 to
MAPS for unrestricted operational expenses. On behalf of the MAPS community,
Thank You, John, for providing MAPS with this crucial support at a time of
momentous growth and opportunity!
2. New Face in the MAPS Office: Troy Dayton
MAPS' new (and first-ever) Director of Development, Troy Dayton, began work
at MAPS earlier this month. With MAPS' increasing success in obtaining
approval for psychedelic research, the amount of money needed to fund that
research has increased dramatically.
Troy's primary role is to help raise that money. He will be meeting with
MAPS' top few hundred donors to communicate MAPS' plans and gather
feedback. He is also reaching out to other supporters who can consider
making significant charitable gifts to this historic effort. In addition, he
is helping MAPS increase revenue through product sales and membership
growth. Troy is splitting his time 50/50 with our friends at the Marijuana
Policy Project, also in a development capacity.
Troy is a longtime friend of MAPS and drug policy reform. He spent the last
three years as the associate director of the Interfaith Drug Policy
Initiative (IDPI), mobilizing religious leaders behind ending the War on
Drugs. He helped found and currently serves on the board of Students for
Sensible Drug Policy (SSDP), which has over 100 chapters. He was the
promotional director, fundraiser, and a script consultant for Flex Your
Rights' film, BUSTED: The Citizen's Guide to Surviving Police Encounters,
now seen by over 1 million people. Troy also helped start Renewable Choice
Energy, which recently made national headlines for making the largest sale
of wind power in U.S. history.
CNN recently profiled Troy in a special on the science of happiness where he
explained that his occasional use of MDMA helps maximize his mental health.
The segment is posted on Youtube: http://www.youtube.com/watch?v=Ugw6xeTuTCg
We are excited to have Troy's passion and expertise at MAPS. I hope you get
the chance to visit with him soon.
3. MAPS Team Conducts Inspection for US MDMA/PTSD Study; Milestone Passed
>From January 3-6, 2007, MAPS' clinical research team (Amy Emerson, Valerie
Mojeiko, and Josh Sonstroem) was in Charleston, SC, conducting a monitoring
inspection of Dr. Michael Mithoefer's MAPS-sponsored MDMA/PTSD study. On
January 5, the 15th subject participated in her third and final experimental
MDMA-assisted psychotherapy session. On January 6, MAPS President Rick
Doblin visited Charleston to meet with Dr. Michael and Annie Mithoefer and
MAPS' clinical research team to review the data, which looks very promising.
An additional $125,000 will be required to complete this study.
Dr. Mithoefer's IRB-, DEA-, and US FDA-approved MDMA/PTSD protocol:
http://www.maps.org/mdma/protocol/index.html
4. MAPS-Sponsored Continuing Medical Education (CME) Course in Spring 2008
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 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 the Spring of
2008. On January 7, MAPS President Rick Doblin, along with Dr. Michael and
Annie Mithoefer, scouted locations for the course, which will be
CME-certified and open to all mental health professionals. Details of the
conference will be announced in the coming months.
5. MAPS-Sponsored LSD-Assisted Psychotherapy Protocol Submitted to Swiss
Ethics Committee
On January 9, MAPS' clinical research team visited Solothurn, Switzerland
to assist with final protocol design for Dr. Peter Gasser's LSD/end-of-life
anxiety pilot study. That same day, Dr. Gasser's protocol was submitted to a
Swiss Ethics Committee (Switzerland's Institutional Review Board [IRB]
equivalent). We anticipate that the Ethics Committee's review will take
several months. If approved, the protocol will then be submitted to
SwissMedic (Switzerland's FDA equivalent) for review, which may take another
month or two. We're anticipating that the study will have full government
approval, including Dr. Gasser's LSD research license from the Swiss
equivalent of the DEA, by June 1, 2007.
Once approved and completed, this will become the first government-approved
LSD-assisted psychotherapy study in 35 years. The study is budgeted at
$150,000 and MAPS has raised about $50,000 so far, with another $100,000 to
go.
For more background about Dr. Gasser's proposed MAPS-sponsored study:
http://www.maps.org/research/cluster/psilo-lsd/#lsd
6. Swiss MDMA/PTSD Study: MAPS Clinical Research Corps Strike Again
MAPS' clinical research team met on January 10 with Dr. Peter Oehen for a
monitoring visit to review all data-gathering procedures and inspect records
for the first subject in Dr. Oehen's ongoing MAPS-sponsored study evaluating
MDMA-assisted psychotherapy for subjects with treatment-resistant PTSD. The
second subject received her first experimental MDMA session on December 23,
and the first subject received her third and final experimental session on
January 4.
Dr. Oehen's government-approved MDMA/PTSD protocol is posted on the MAPS
website:
http://www.maps.org/mdma//swissmdmaptsd/protocol1608.pdf
7. Birthday Lunch for Albert Hofmann Proceeds, Minus Albert and Wife Anita
MAPS-sponsored researchers Peter Gasser, M.D., Peter Oehen, M.D., and
co-therapist Verena Widmer, along with Rick Doblin, MAPS' clinical research
team, and Dieter Hagenbach, Michael Gasser, and Lucius Werthmuller of Gaia
Media were scheduled to have lunch in Basel, Switzerland with Albert and his
wife Anita on January 11, 2007, to celebrate Albert's 101st birthday.
Unfortunately, Albert came down with pneumonia and the lunch had to proceed
without him and Anita. Albert still managed to send an inspiring message to
our gathering. We're all sending him our best wishes for the return of his
health.
Read Albert's 101st birthday message:
http://www.maps.org/Albert'sNote011107.htm
8. MAPS Becomes a Sponsor for 2008 Gaia Media Conference
MAPS has agreed to donate $5000 to Gaia Media to become a sponsor of their
next conference, scheduled to take place in Basel, Switzerland, on Easter
weekend in 2008. Gaia Media is the organization that put together the Spirit
of Basel symposium in honor of Albert Hofmann's 100th birthday in January,
2006. The 2008 conference will be about "the psychedelic revival, the
resurgence of shamanism, and the re-enchantment of the world." Stay tuned
for more details. To learn more about Gaia Media: http://www.gaiamedia.org
9. FDA IND For MDMA/Cancer Anxiety Study Transferred to John Halpern, M.D.
At the request of the administration at Harvard's McLean Hospital, the
protocol for Dr. John Halpern's MAPS-initiated study evaluating
MDMA-assisted psychotherapy as treatment for end-of-life anxiety has been
transferred from MAPS to Dr. Halpern as a sponsor/investigator. FDA approval
for Dr. Halpern's IND was finalized on January 11. This study, which will be
for subjects with end-of-life anxiety secondary to advanced-stage cancer,
has full institutional and governmental approval and has now started
recruitment. Dr. Halpern's study is fully funded by Peter Lewis, who pledged
$250,000 to McLean Hospital, Harvard University, to cover all costs of the
study. MAPS agreed 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. Learn more
about Dr. Halpern's study:
http://www.maps.org/news-letters/v16n3-html/mdma_cancer_usa.html
10. MAPS Awards Grants for Ongoing MDMA/Defense Mechanism Research, New
MDMA/Asperger's Internet Data Gathering Project
MAPS has donated $3000 to Pål-Ørjan Johansen and Terri Krebs for a project
that will seek to use the internet to search for reports of people with
Asperger's (a form of high-functioning autism) who have found MDMA to be
helpful in their learning to cope more effectively in social situations. If
we do find at least a handful of such reports, this could become another
area of research, if funding becomes available.
MAPS also awarded another grant of $6000 to Pål-Ørjan Johansen and Terri
Krebs to expand their work reviewing transcripts of subjects in
MAPS-sponsored MDMA/PTSD research, in order to code and compare the
psychological defense mechanisms used in both non-drug therapy sessions and
in the experimental MDMA-assisted therapy sessions. This study is designed
to identify process variables that may help explain how MDMA can be a useful
adjunct to psychotherapy. For details on this study:
http://www.maps.org/news-letters/v15n3-html/mdma_pilot_outcome.html
11. MAPS and Clusterbusters to Sponsor LSA/Cluster Headache Study
MAPS and Clusterbusters have agreed to sponsor Andrew Sewell, M.D., to
conduct a survey study of LSA (lysergic acid amide) in the treatment of
cluster headaches. 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.
This project is funded by a $10,000 donation to MAPS by Seth and Kari
Hollub. Seth is also volunteering his time to manage the technical aspects
of MAPS' website and server, a job for which MAPS previously paid $15,000 a
year.
12. Deja Vu: STILL Waiting for Recommendation from Judge in Lawsuit for
MAPS-Sponsored Marijuana Production Facility
It has now been more than eight (8) months since lawyers representing
Professor 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, we are still expecting a
decision in this case any day.
If the DEA ALJ issues a favorable recommendation, it will mark an
extraordinary window of opportunity in the six year struggle by MAPS and
Prof. Craker to gain a Schedule I DEA license to grow research-grade
marijuana for use by scientists in privately funded, DEA- and
FDA-approved studies. DEA Administrator Karen Tandy would then need to
decide whether to accept or reject the ALJ recommendation. If DEA accepts a
favorable recommendation, Professor Craker's proposed MAPS-funded facility
would create the necessary independence of supply 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 soon!
On the other hand, an unfavorable recommendation would be a paralyzing blow
to efforts aimed at resolving the medical marijuana controversy through
FDA-approved scientific research, although, ironically, it would actually
encourage marijuana policy reform at the state and local levels to protect
medical marijuana patients and their physicians.
For extensive background on the case, visit MAPS' DEA Lawsuit page:
http://www.maps.org/mmj/DEAlawsuit.html
13. Winter 2006-7 MAPS Bulletin Arrives; Corrections Due
MAPS members should now have received a copy of the Winter 2006-7 MAPS
Bulletin, featuring a financial strategy report from MAPS President Rick
Doblin, Ph.D. As Rick explained in his detailed report, MAPS is moving into
a new phase of its growth and development and needs substantial resources to
fund our expanding research agenda. If you know someone who might be
interested in supporting MAPS, please let the MAPS office know and we'll
send him/her a complimentary copy of the Bulletin!
Also included in the mailing was a free calendar for our recent donors. If
you would like to purchase a 2007 MAPS Calendar, they are now reduced to
$10. Visit the MAPS Webstore for this and other exciting MAPS merchandise:
http://www.maps.org/catalog
Our apologies to Robert Venosa, whose portrait of Dr. Albert Hofmann on the
inside front cover suffered from some significant printing problems. View
the proper image, brighter and uncropped:
http://www.maps.org/news-letters/v16n3-html/inside_front_cover.html
Less than 20 out of the 50 prints are left in Robert Venosa's signed,
limited edition series. MAPS' proceeds from the sale of these portraits will
be restricted for Dr. Peter Gasser's MAPS-Sponsored LSD psychotherapy
research (see item #5). For purchasing and order information, see:
http://www.maps.org/catalog/product_info.php?cPath=24_39&products_id=119
Credit is also overdue to Devin Breen, the multi-talented photographer,
filmmaker and artist whose uncredited photograph of Entheon Village provided
an ideal wraparound cover for the Winter issue. See more of Devin's work at:
http://www.devinbreen.com
14. Mind States Costa Rica: June 13-17, 2007
Mind States 2007 will feature presentations by Joe Coleman, Erik Davis,
Earth & Fire Erowid, Stanislav Grof, Jon Hanna, Liz McIntyre, Mark Pesce,
Sasha & Ann Shulgin, and Margaret Wertheim, and morning Holotropic
Breathwork sessions facilitated by Sheelo Bohm. Registrants receive 10% off
of the conference's "early bird" ticket price until February 15. For more
information, see: http://www.mindstates.org
The eco-resort where this conference will be held is on a 2,000 acre
sanctuary of virgin rainforest set at the juncture of two rivers near the
town Horquetas of Sarapiqui. Swim by natural waterfalls or in the pool,
relax in a hot tub, enjoy refreshing beverages at the bar, challenge one of
the presenters to a paddle boat race, marvel at the botanical gardens, or
arrange a zip-line canopy tour, horseback ride, white water rafting trip, or
massage through the resort. To get a sense of this event, view:
http://www.youtube.com/watch?v=Ouk0FneZc3c
Best Wishes for 2007,
Jag
Jag Davies
Director of Communications
MAPS
10424 Love Creek Rd.
Ben Lomond, CA 95005
831.336.HEAL
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