[MAPS] MAPS News 07/07: "Scientists Stir the Pot"
Jag Davies
jag at maps.org
Tue Jul 17 21:41:03 CDT 2007
To read this in html (w/ hyperlinks), click here:
http://www.maps.org/news
MAPS Members, Supporters, and Friends,
The last time MAPS' research agenda was debated in a Congressional
hearing was 1996, when -- to our surprise -- C-SPAN broadcast a
Senate hearing in which Senator Orrin Hatch (R-UT) awkwardly
attempted to ridicule MAPS’ research efforts. <http://maps.org/mmj/
hatch1.shtml>
The tides are turning. Rather than attacking us, Congress is standing
up for us! Last Thursday, in the new Congress's first oversight
hearing on the federal government's role regarding medical marijuana,
Reps. Bobby Scott (D-VA) and Jerold Nadler (D-NY) grilled officials
from ONDCP and DEA on their role in obstructing Prof. Lyle Craker's
MAPS-sponsored medical marijuana production facility. Rep. Nadler
asked a series of pointed questions about NIDA's unique monopoly on
the supply of marijuana for FDA trials, Judge Bittner's recent ruling
in favor of MAPS and Prof Craker, and the DEA's timeline for issuing
a decision on whether to accept or reject Judge Bittner's
"Recommended Ruling" (see Item #1). DEA and NIDA’s obstruction of
medical marijuana research is becoming increasingly difficult for
those agencies to hide from politicians -- and from the public, as
evidenced by last month's article in Nature, "Scientists Stir the Pot
for Right to Grow Marijuana" (see Item #3).
Meanwhile, our other projects continue to make meticulous yet
substantial progress toward MAPS' unique goal of developing marijuana
and psychedelics into legal, government-approved prescription
medicines. Just last week, we learned that Dr. Peter Gasser's
historic MAPS-sponsored LSD therapy study has received final approval
from the Swiss Ethics Committee, effectively clearing the most
difficult hurdle in the approval process (Item #4).
As you have probably noticed, neither the government, the
pharmaceutical industry, nor any of the major health research
foundations are willing to fund this controversial research. 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 marijuana and psychedelics.
Please consider making a special tax-deductible gift today: http://
www.maps.org/catalog
Here's a sample of what's going on at MAPS this July:
MAPS & Medical Marijuana
1. Congress Bolsters MAPS' Medical Marijuana Research Effort
2. Leukemia & Lymphoma Society Passes Resolution Supporting MAPS-
Sponsored Marijuana Production Facility
3. Nature Raises Awareness for MAPS; JAIDS Publishes Promising Study
Psychedelic Research
4. MAPS-Sponsored LSD Therapy Study in Switzerland Receives Final
Ethics Committee Approval, Two New Donations
5. Beckley Foundation's LSD Research Project Obtains Government Approval
6. Seventeenth Subject Treated in MAPS' Flagship MDMA/PTSD Study
7. MAPS Responds to Ecstasy Use Meta-Analysis Study
8. MAPS-Sponsored Ibogaine Study Makes Progress, Huffington Post
Inside MAPS
9. Management Consultants Preparing MAPS for Next Stage of Growth
10. Spring/Summer 2007 MAPS Bulletin Published; Final Call for
"Psychedelics and Self-Discovery" Submissions
11. MAPS Founder and President Rick Doblin Interviewed on "Healthy Talk"
12. MAPS to Co-Host Women's Visionary Congress Later This Month
13. Call for Papers from "Rising Researchers" at 2008 World
Psychedelic Forum
14. MAPS at Burning Man 2007: An Improved "Sanctuary" and Smaller
Entheon Village
MAPS: Putting the 'MD' Back in 'MDMA' since 1986: http://www.maps.org/
catalog
MAPS & Medical Marijuana
1. Congress Bolsters MAPS' Medical Marijuana Research Effort
While the DEA is taking its sweet time mulling over whether to accept
or reject the recent DEA Administrative Law Judge ruling in favor of
Professor Lyle Craker's proposed MAPS-sponsored medical marijuana
production facility, MAPS is continuing to work with Congress to
demonstrate to DEA that there is public support and political will to
end the DEA's obstruction of medical marijuana research.
The DEA is feeling the heat from the Congressional Sign-On Letter co-
sponsored by US Reps. John Olver (D-MA) and Dana Rohrabacher (R-CA),
urging the DEA to accept DEA Administrative Law Judge Bittner's
"Recommended Ruling" to license the proposed MAPS-sponsored medical
marijuana production facility. MAPS Government Relations Coordinator
Lauren Anderson Payne, JD, joined by our allies in Washington with
Americans for Safe Access (ASA) and the American Civil Liberties
Union (ACLU), has been working with dozens of Congressional
Representatives to clarify MAPS' agenda and to gain signatures for
the sign-on letter to the DEA.
If you haven’t contacted your Congressional Representative yet, we
need you to help by contacting your Representative -- here's how:
http://www.maps.org/mmj/DEAlawsuit.html#bipartisan
The DEA also felt the heat last Thursday at a US House of
Representatives Committee on the Judiciary hearing regarding the
DEA's regulation of medicine, when Reps. Bobby Scott and Jerrold
Nadler forcefully questioned ONDCP and DEA officials about Prof.
Craker's case. Rep. Nadler asked a series of pointed questions to
Joseph Rannazzisi, Deputy Assistant Administrator for DEA. First,
Nadler asked Rannazzisi why marijuana is the only Schedule One drug
for which the federal government has a monopoly on supply. Rannazzisi
cited international treaty obligations, a line of reasoning already
disproved in court. Then, Nadler asked if the DEA would make a
decision on Judge Bittner's ruling in favor of Prof. Craker by the
end of Bush's term. When Rannazzisi couldn't answer, Nadler asked how
long the DEA normally takes to process a recommendation from an
administrative law judge. Rannazzisi said it varies from case to
case, but Nadler wasn't satisfied, and continued the line of
questioning by asking whether it takes closer to one year, two years,
or five years. Rannazzisi asked to answer in writing following the
hearing. Nadler insisted that he wanted a commitment that the
decision would be made on Prof. Craker's application before the end
of Bush’s term in January, 2009.
2. Leukemia & Lymphoma Society Passes Resolution Supporting MAPS-
Sponsored Marijuana Production Facility
Prof. Craker's case also received a strong boost this month from the
Leukemia and Lymphoma Society, which issued a strong resolution on
"Medical Marijuana Use and Research" that explicitly resolves to
"encourage the federal government to authorize the Drug Enforcement
Administration to license privately funded production facilities that
meet all regulatory requirements to produce pharmaceutical-grade
marijuana for use exclusively in federally approved research." The
Leukemia and Lymphoma Society is the fourth largest health research
charity in the US, and is the world's largest voluntary health
organization dedicated to funding blood cancer research, education
and patient services. Read the Society's resolution: http://
www.maps.org/mmj/lnls-res.pdf
Other organizations that have written to DEA in support of Prof.
Craker's MAPS-sponsored medical marijuana production facility include
the National Association for Public Health Policy, Citizen Outreach
Project, Republican Liberty Caucus, Lymphoma Foundation of America,
Pain Relief Network, American Association for Social Psychiatry,
Americans for Tax Reform, American Medical Students Association,
California Medical Association, Texas Medical Association, The Drugs
and the Law Committee of the Association of the Bar of the City of
New York, Doctors for Open Government, United Methodist Church, New
Grady Coalition, Ethics in Government Group, Student Health Integrity
Project, Multiracial Activist, Coalition Against Prosecutorial
Misconduct, U.S. Bill of Rights Foundation, Liberty Coalition,
Citizens for Health, North Carolina Nurses Association, Wisconsin
Nurses Association, New Mexico Nurses Association. Mothers Against
Misuse and Abuse, The AIDS Institute. National Association of People
with AIDS, L.A. Gay & Lesbian Center, HIVictorious, Inc., and
Multiple Sclerosis Foundation.
3. Nature Raises Awareness for MAPS; JAIDS Publishes Promising Study
On the media front, Nature published an excellent article about MAPS'
campaign to break the federal government's illegal monopoly on the
supply of research-grade marijuana. MAPS is seeking to produce
marijuana for use in privately funded clinical studies that would
determine whether marijuana meets the FDA's standards for safety and
efficacy. The article states:
"Even after researchers have Food and Drug Administration approval
for their studies and clear their work with the DEA, NIDA can refuse
to supply them with the product. This effectively allows NIDA to
dictate the research agenda along political instead of scientific
lines, critics charge. "The role that NIDA plays in marijuana
research is unique," says Rick Doblin, founder and president of the
Multidisciplinary Association for Psychedelic Studies (MAPS) ... "
Read "Scientists Stir the Pot for Right to Grow Marijuana": http://
www.maps.org/sys/nq.pl?id=1381&fmt=page
In other marijuana research news, the Journal of Acquired Immune
Deficiency Syndromes (JAIDS) published a study earlier this month
comparing smoked marijuana with Marinol, an oral form of THC that was
approved by the FDA in 1992. The study found that smoked marijuana
was eight times more effective than Marinol. The study found that
"Smoked marijuana ... has a clear medical benefit in HIV-positive
[subjects] by increasing food intake and improving mood and objective
and subjective sleep measures."
Ironically, the biggest limitation to this study was that the
research material was from NIDA—which has a monopoly on the supply of
research-grade marijuana but no other controlled substance—meaning
that the marijuana was not medical quality, only 2.0% and 3.9% THC.
In contrast, the marijuana smoked for medical purposes in state where
it is available to patients has been documented to be between 12% and
20%. The other limitation to the study is that to develop marijuana
into a legal prescription medicine, the research material used in
clinical trials must have the same chemical "fingerprint" as the drug
being brought to market. Since NIDA cannot guarantee that the same
research material will be available for prescription use if FDA
clinical trials determine that marijuana meets its guidelines for
safety and efficacy, the data generated from this study cannot be
used toward federal approval. The goal of MAPS' quest for an
independent source of supply is to put smoked and vaporized marijuana
through FDA trials and bring it to market as a prescription medicine.
Psychedelic Research
4. MAPS-Sponsored LSD Therapy Study in Switzerland Receives Final
Ethics Committee Approval, Two New Donations
On July 12, Peter Gasser, MD, received final approval from the Ethics
Committee (Swiss IRB equivalent) for a MAPS-sponsored study to
evaluate the safety and efficacy of LSD-assisted psychotherapy for
subjects with end-of-life anxiety secondary to life-threatening
illness. Dr. Gasser originally submitted his proposal on January 10,
2007, received conditional approval in March, and has been working
closely with the Ethics Committee in the meantime to refine the
protocol design to address the committee's concerns. On July 13, Dr.
Gasser submitted the protocol to SwissMedic, the Swiss equivalent of
FDA. Thankfully, like FDA, SwissMedic must respond to the application
within 30 days.
Obtaining Ethics Committee approval is the first of three formal
regulatory reviews for the protocol to obtain full government
approval. After SwissMedic approves the study, Dr. Gasser will submit
an application to the BAG (Swiss DEA) for a license to possess and
administer the LSD to be used in the study. We were previously
informed by a staff member at the BAG that its review process should
take about a week, so we are still planning to begin the study by the
Fall of 2007. When fully approved, this will become the first
government-approved study investigating LSD's therapeutic benefits in
human subjects in over 35 years. For more information and background
on Dr. Gasser's proposed LSD study, visit: http://www.maps.org/
research/cluster/psilo-lsd/#swlsd
Upon hearing news of the Ethics Committee’s approval of MAPS’ LSD/end-
of-life anxiety study, Amanda Fielding, founder of the Beckley
Foundation, donated 5000 Euros (about $6880) to the study, and Vanja
Palmers, a leader of the Swiss zen community, pledged to donate
$10,000 to the study. These donations will not be routed through MAPS
but will be made directly to the Swiss Medical Association for
Psycholytic Therapy.
The study is budgeted at $180,000 - MAPS has already raised $75,000
so far, but we need your help to raise the final $105,000 so this
historic study can move forward. Please consider making a special
gift to help move this study along: http://www.maps.org/catalog
One way we are raising funds for this study is by selling a signed,
limited edition hardcover edition of Albert Hofmann’s
autobiographical LSD: My Problem Child. One hundred percent of the
proceeds from sales will be restricted for Dr. Gasser’s LSD study.
Sixty-one out of 100 copies have been sold; #’s 61-80 are available
at $400, and #’s 81-100 are available at $450. For more information
and to order online: http://www.maps.org/catalog/product_info.php?
cPath=22_27&products_id=102
Another way we are raising funds for Dr. Gasser's study is through
the sale of 50 prints of Robert Venosa’s portrait of Albert Hofmann,
signed by Albert and Robert. We’ve already sold 33 of the 50 prints
-- take a look and get yours by visiting: http://www.maps.org/catalog/
product_info.php?cPath=24_39&products_id=119
5. Beckley Foundation's LSD Research Project with Human Subjects
Obtains Full Government Approval
Dr. Peter Gasser and MAPS had been vying for the title of "first
legal human LSD research study in over 35 years," but we have been
beaten to the punch by Amanda Fielding's Beckley Foundation, which is
sponsoring a US study that will administer two modest doses of LSD to
12 healthy LSD-experienced participants while measuring its effects
on experience, brain waves, and perceptual tasks. I guess MAPS and
Dr. Gasser will have to settle for the title of "first legal LSD
therapy research study in over 35 years." We'll take it.
Congratulations to our allies at Beckley!
Beckley's initial pilot study will look at dose-related changes in
consciousness using electroencephalography (EEG). It will investigate
the hypothesis that LSD induces increased synchronization in the
electrical activity between neurons, and that this enhanced neural
synchrony, plus increased integration of activity between cortical
regions, will be linked with changes in cognition. In particular, new
neurocognitive measures will be applied to study attention and
temporal integration on perceptual tasks. The recruitment phase of
the study is already underway.
6. Seventeenth Subject Treated in US MDMA/PTSD Study
On June 26, the 17th subject out of 20 completed the first
experimental session in Dr. Michael Mithoefer's MAPS-sponsored study
evaluating MDMA-assisted psychotherapy for subjects with treatment-
resistant post traumatic stress disorder (PTSD). We are still
actively seeking to enroll in the study at least two US veterans with
PTSD from the Iraq or Afghanistan wars.
This Phase II clinical study is the first-ever FDA-approved human
study evaluating MDMA's therapeutic applications. Efficacy data is
extremely promising so far, making a strong case for continuing
research into FDA Phase III studies. To view and learn more about Dr.
Mithoefer's protocol, see: http://www.maps.org/mdma/protocol/index.html
7. MAPS Responds to Ecstasy Use Meta-Analysis Study
For the second time in just a few months, the media chose to report
on studies claiming that ecstasy use harms memory. In the most recent
incident, the media coverage varied considerably, sometimes offering
sensationalized and inappropriate headlines. The newest study is a
meta-analysis by a team of researchers from the University of
Hertfordshire.
A meta-analysis seeks to analyze data from groups of studies,
treating them as if they were one large study. The meta-analysis
never looked at studies that contained people who reported using any
less than 16 tablets. Coverage may be based on the finding of a lack
of a relationship between ecstasy dose and memory impairment.
However, this is only one way of interpreting this result. Another
interpretation is that the lack of relationship indicates that
something else other than ecstasy is behind the effect. Furthermore,
while meta-analyses can overcome problems with studies, such as those
examining memory in ecstasy users and controls, that have small
sample sizes, they can't fix problems inherent in study design. In
this case, all studies looked at ecstasy users and controls long
after they began using substances, and many of these studies were
unable to pair ectasy users with people who used as many substances
or who used them as intensively as did the ecstasy users.
MAPS Research Associate Ilsa Jerome, PhD, has analyzed the study and
written an in-depth commentary and review:
http://www.maps.org/sys/nq.pl?id=1375&fmt=page
8. MAPS-Sponsored Ibogaine Study Makes Progress, Huffington Post
The Iboga Therapy House is currently enrolling clients in MAPS' IRB-
approved long-term observational case study. The study will examine
changes in substance use in 20 consecutive individuals undergoing
ibogaine-based addiction treatment for opiate dependence at the Iboga
Therapy House near Vancouver, Canada. Two subjects have been treated
and the third subject is now being screened.
This study is intended to gather information to evaluate whether
ibogaine-assisted therapy helps people who are dependent on opiates
to stop using opiates, use less, or practice moderated use after the
therapy. For one year after therapy we will be collecting data from
participants in the study, enabling us to examine whether ibogaine-
assisted therapy facilitates positive changes or improvements in
quality of life that result in decreased harms associated with
chronic or mismanaged opiate use.
People with substance abuse problems have found that psychedelic
doses of iboga, an African root used for centuries, can significantly
reduce symptoms of opiate withdrawal and eliminate substance-related
cravings for an extended period of time. The US is one of only a few
countries in the world where ibogaine is scheduled, but in Canada,
Mexico, and other countries, there are clinics where ibogaine is
legally administered to individuals. Yet, there is still no data from
prospective research published in a peer-reviewed journal reporting
any long-term follow-up data that could be used to evaluate
ibogaine's efficacy in reducing addiction-related harm.
To enroll in the study or learn more about the Iboga Therapy House:
http://www.ibogatherapyhouse.net
The Huffington Post's Mary Clare Ditton published an interesting
article yesterday about a new ibogaine treatment center in Barcelona.
The article discusses the MAPS-sponsored study in Vancouver as well
as the parallel ibogaine study that MAPS is developing in Mexico:
http://www.huffingtonpost.com/mary-clare-ditton/a-home-for-ibogaine-
in-ba_b_56563.html
Inside MAPS
9. Management Consultants Preparing MAPS for Next Stage of Growth
In late July, MAPS will be working intensively with management
consultants from The Management Center who will be assisting MAPS to
prepare for our next stage of growth and to cultivate a thoroughly
efficient, sustainable organization that will meet both its short-
term and long-term goals. The Management Center is funded by
philanthropist Peter Lewis to provide professional management
assistance to the organizations to which he contributes. The
management consultants have reviewed communications between MAPS
President Rick Doblin and MAPS Program Director Valerie Mojeiko,
visited Rick in his office, and will be coming to the MAPS office in
Ben Lomond, CA next week to interview the staff and observe the Board
of Directors meeting.
10. Spring/Summer 2007 MAPS Bulletin Published; Final Call for
"Psychedelics and Self-Discovery" Submissions
The Spring/Summer 2007 issue of the MAPS Bulletin has been published
and is available online. We would like to give our thanks to all of
the contributors who make the Bulletin possible. To read the online
edition: http://www.maps.org/news-letters
All MAPS members receive a subscription to the print edition of the
tri-annual MAPS Bulletin. If you would like to have this one-of-a-
kind psychedelic resource delivered to your mailbox, please consider
joining MAPS as a member today: http://www.maps.org/catalog
On a related note, we have extended the deadline to July 20 for
submissions for an upcoming special edition of the MAPS Bulletin,
"Psychedelics and Self-Discovery." If psychedelics have played an
important role in your personal development, we'd like to hear what
you have to say. We are looking for articles that are between
400-1500 words. Articles may be submitted anonymously if that makes
you more comfortable (although, all things being equal, we do prefer
for people to write under their real names when possible). If
possible, send a high-quality photo of yourself to go with the
article. July 20 will be the final deadline.
11. MAPS Founder and President Rick Doblin, PhD, Interviewed on
"Healthy Talk"
Earlier this month, Rick appeared as a special guest and gave a
lengthy interview on "The Deborah Ray Healthy Talk Show." To listen,
the show is archived on the MAPS site: http://www.maps.org/media/
deb1.mp3
The interview with Rick begins halfway through the show.
12. MAPS to Co-Host Women's Visionary Congress This Month
Here in California, later this month MAPS will be co-sponsoring the
Women's Visionary Congress, a unique gathering of women working to
implement realistic alternatives to the War on Drugs and to re-define
society's understanding of psychedelics. Tickets are sold out, but
the transcripts and more info will be posted at: http://
www.visionarycongress.org
13. Call for Papers from "Rising Researchers" at 2008 World
Psychedelic Forum
Along with Gaia Media, MAPS will be co-sponsoring the World
Psychedelic Forum, which will be held in Basel, Switzerland from
March 21-23, 2008. Thomas Roberts, PhD, has issued a call for papers
for a session called “Rising Researchers” (not for the WPF 2008 in
general).
To be eligible to submit a proposal, researchers should not yet be
well established in psychedelic research. This includes both people
near the start of their careers and also established scholars who
intend to extend established careers to include psychedelic research.
Typically, papers might be based on dissertations or theses,
elaboration of already published papers, papers under submission, or
preliminary reports of work in-progress. Descriptions of psychedelic
courses or shorter instructional units within other courses and their
syllabuses are also welcome. Papers should have scientific,
scholarly, artistic, or practical merit. Methods might include
experimental, surveys, comparative, anthropological, archeological,
clinical, philosophical, historical, etc. Proposals should include
the following and be emailed to troberts at niu.edu by August 1st. The
sooner the better. Please send an abstract of less than 200 words.
Please use non-technical language for a general, educated audience.
Do not include graphics in this proposal. Please include the address
of proposer, both email and postal; organizational affiliation, if
any; title of proposed paper; do you plan to use PowerPoint slides or
other visuals? Also explain the source of proposal, e.g.,
dissertation, unpublished research, syllabus, etc. If this is a
dissertation, thesis, or derived from a published paper, please
include its bibliographic information. The time limit per paper is 12
minutes. This session will be in English. To submit a proposal in
German, please contact Dr. Torsten Passie at dr.passie at gmx.de
14. MAPS at Burning Man 2007: An Improved "Sanctuary" and Smaller
Entheon Village
As part of MAPS' educational outreach and harm reduction mission, for
the fifth year in a row MAPS will assist and coordinate in providing
mental health services at Burning Man's "Sanctuary." Sanctuary is a
project led by the Black Rock City Rangers to provide a safe space
for people who are undergoing emotional or psychological crises or
who need non-medical assistance. MAPS volunteers lend their support
and are trained to work with visitors undergoing psychedelic
emergencies. Thank you to all of the people who have submitted
applications to volunteer. We are extending the deadline for any
medical professionals who are interested in participating. Although
we are not providing medical assistance in the Sanctuary, we are
especially in need of psychiatrists, medical doctors, and nurses who
can recognize any potential crises that may have a medical basis so
that they can be referred to the medic tent. If you are a medical
professional and interested in working one or more 6 hour shifts in
the Sanctuary, please contact kernel at maps.org
MAPS will also play a small role in Entheon Village 2007, which will
be created at this year's Burning Man by a new group of
organizations. Our efforts in coordination with the folks who
organized Entheon at last year's 20th anniversary celebration for
MAPS have attracted several other camps that want to combine forces
and work together at this year's camp. Entheon Village will be
focused primarily on this year's theme of ecological responsibility.
It will provide residence for many of the volunteers who assist the
Rangers at Sanctuary, host a Zendo provided by a group of zen
meditators from Switzerland, will have a large renewable energy grid
demonstration, offer visionary art, lectures, workshops, movie
presentations, and provide holotropic breathwork sessions. For more
information about Entheon Village: http://www.entheonvillage.com
************************************************************************
**
With the support of a small base of dedicated individuals, MAPS has
been able to position itself at the center of the conflict between
scientific exploration and the politically-driven War on Drugs.
Help us translate hard-won scientific freedom into new research
results and possibilities: http://www.maps.org/catalog
Cheers,
Jag
Jag Davies
Director of Communications
The Multidisciplinary Association for Psychedelic Studies
MAPS :: 10424 Love Creek Road :: Ben Lomond, CA 95005
Tel. 831.336.HEAL (4325) :: Fax. 831.336.3665
***********************************************
Your Support is Needed! http://www.maps.org/catalog
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