[MAPS] MAPS News: December 2006
Jag Davies
jag at maps.org
Mon Dec 11 18:33:21 CST 2006
To read this in hmtl (suggested), click here:
http://www.maps.org/news
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 at:
http://www.maps.org/catalog
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.
Put your money where your mind is, at: http://www.maps.org/catalog
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 Mexican Ibogaine 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: http://www.maps.org/catalog ***
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 will feature 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".
Rick Doblin's Financial Strategy Report from the Winter 2006-07 Bulletin is
available at:
http://www.maps.org/news-letters/v16n3/maps_20th_anniversary_fininancial_rep
ort.pdf
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.
For more information and to make a purchase:
http://www.maps.org/catalog/index.php?cPath=24
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: http://www.maps.org/catalog
On a related note, on November 19 the final available print, numbered 1/50,
in Alex Grey's signed and limited edition series of his portrait of Dr.
Albert Hofmann, 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:
http://www.maps.org/mmj/DEAlawsuit.html
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:
http://www.maps.org/volunteer.html
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 aren¹t 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,
it¹s 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, we¹ll 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:
http://www.maps.org/mdma
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 MAPS¹ Investigational New Drug (IND) file and also to cross-reference all
information in MAPS¹ 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 US
Institutional Review Boards [IRBs]) 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.
Learn more about Dr. Gasser's MAPS-sponsored LSD/end-of-life anxiety study:
http://www.maps.org/research/cluster/psilo-lsd
About $60,000 has already been raised for this study from the sale of Albert
Hofmann-signed art and books. Another $90,000 is needed for this study, and
restricted donations are welcome. Another way to support this research is by
purchasing either a print of Robert Venosa's portrait of Albert Hofmann, or
by purchasing a signed hardcover copy of Dr. Hofmann's LSD: My Problem
Child. MAPS¹ share of the proceeds from the sale of these collector's items
will be reserved for Dr. Gasser¹s MAPS-sponsored LSD research.
To learn more about supporting MAPS through the purchase of these items,
visit the MAPS Webstore: http://www.maps.org/catalog
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.
Learn more about this study here:
http://www.maps.org/research/cluster/psilo-lsd/#cluster
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 at MAPS' Ibogaine Research
page: http://www.maps.org/ibogaine
10. MAPS Team Inspects Mexican Ibogaine 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. Listen here:
http://audio.thisamericanlife.org/podcast/321.mp3
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.
Read Dr. Moreno's paper:
http://www.maps.org/w3pb/new/2006/2006_Moreno_22868_1.pdf
BBC News online published an article describing Dr. Moreno's research,
"Psychedelic Drug 'Hope for OCD'":
http://www.maps.org/sys/nq.pl?id=1122&fmt=page
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
at: http://www.maps.org/wwpe_vid
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. Reply to this email if
you'd 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 mental health professional 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 a brief description of your qualifications
to MAPS Director of Operations Valerie Mojeiko at: Valerie at maps.org
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 for 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 interview Doblin speculates on the possibility of conducting MDMA/PTSD
research with tsunami victims and discusses MAPS' psychedelic research
strategy. Read "Healing Highs":
http://www.maps.org/mdma/Thai-Newspaper-MAPS.pdf
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. Read the Prague Post's article:
http://www.maps.org/sys/nq.pl?id=1095&fmt=page
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: http://www.maps.org/media
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.
Problem is, none of the reporters had actually read the study, since 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: http://www.maps.org/sys/nq.pl?id=1091&fmt=page
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 ;)
Jag Davies,
MAPS Director of Communications
p.s. Here's that link to the MAPS Webstore again:
http://www.maps.org/catalog
Jag Davies
Director of Communications
MAPS
10424 Love Creek Rd.
Ben Lomond, CA 95005
831.336.HEAL
**********************************************************
Advocating Science over Politics,
Replacing Fear with Facts:
MAPS ~ The Multidisciplinary Association for Psychedelic Studies
Support our Cause: http://www.maps.org/catalog
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