[MAPS] News 05/07: One signature away from breaking NIDA monopoly!

[Jag Davies]

To read this online w/hyperlinks: http://www.maps.org/news


MAPS Members, Supporters, and Friends,

The fate of MAPS¹ quest to put marijuana through FDA clinical trials is in a
thrilling but precarious position ‹ the DEA¹s hands. After six years of
struggle since renowned agronomist Professor Lyle Craker first applied to
the DEA for a Schedule I license for a MAPS-sponsored research-grade
marijuana production facility, we are now just one signature away from
breaking the federal government¹s decades-long stranglehold on medical
marijuana research. On May 15, the case was officially transmitted to DEA
headquarters.

On May 16, a ³Dear Colleague² letter by Reps. John Olver (D-MA) and Dana
Rohrabacher (R-CA) was sent to all members of the US House of
Representatives, urging each member to add their name to their Congressional
Sign-On letter to DEA Administrator Karen Tandy urging the DEA to accept the
recent non-binding ruling by DEA Administrative Law Judge Mary Ellen Bittner
in favor of MAPS and Prof. Craker. To succeed at this critical juncture,
we¹ll need each supporter to contact his or her Congressional Representative
(see Item #2).

Meanwhile, the MAPS staff is continuing to refine the organization¹s
objectives as we prepare for the next stages of our psychedelic and
marijuana research agenda. MAPS has a valuable new addition to the Board of
Directors (Item #9) and will be undergoing a specialized management review
over the next two months (Item #10). These developments are a continuation
of our larger strategy to build a thoroughly efficient, sustainable research
and educational organization that will meet both its short-term and
long-term goals.

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.

Help bring MAPS¹ challenging but realizable vision to fruition for ours and
future generations by making a purchase or a charitable gift today:
http://www.maps.org/catalog

There¹s so much good news to report this month that the headlines are split
into four sections.

MAPS & Medical Marijuana

1. Marijuana Research in the Balance: Final Legal Filings Filed, Case
Transmitted to DEA Headquarters

2. Help MAPS and Marijuana Research Succeed by Contacting Your Congressional
Representative

3. $12,500 Grant from Drug Policy Alliance (DPA) for MAPS¹ Marijuana
Research Effort

4. New Studies Show Potential of Marijuana Vaporizer Research

MAPS-Sponsored Psychedelic Research

5. FDA Will Approve MAPS-Sponsored Swiss and Israeli MDMA/PTSD studies for
MAPS¹ Investigational New Drug (IND) Application

6. Ongoing Swiss MDMA/PTSD Study Makes Progress

7. Dr. Mithoefer to Present on MDMA Research at International PTSD
Conference

8. MAPS Preparing for Ibogaine Study in Mexico as Parallel Canadian Study
Continues; Laptop Donation Needed!

Inside MAPS 

9. Shawn Hailey Joins MAPS Board of Directors

10. MAPS Preparing for Professional Management Review

11. Fundraisers in San Francisco Area Raise Over $23,500 for MAPS

12. Thanks to Robert Barnhart and Anonymous Donor for $40,000 and $25,000
Donations

13. Call for Articles for Upcoming Special MAPS Bulletin

Upcoming MAPS Events

14. 3rd Amazonian Shamanism Conference: Healing Plants and Navigational
Tools

15. Mind States Costa Rica: Last-Minute Tickets Available

16. Women¹s Visionary Congress Tickets Sold Out

*** Your support is needed ‹ join the force today!
http://www.maps.org/catalog ***

MAPS & Medical Marijuana

1. Marijuana Research in the Balance: Final Legal Filings Filed, Case
Transmitted to DEA HQ

On May May 4, Prof. Craker filed the final brief in his MAPS-sponsored DEA
Administrative Law Judge case.  This brief is a strong response to the DEA's
"exceptions" to ALJ Bittner's recommendation that it would be in the public
interest for DEA to register Prof. Craker as a bulk manufacturer of
research-grade marijuana for his proposed MAPS-sponsored independent
production facility. It was prepared by an outstanding legal team led by
Julie Carpenter, Jenner & Block, Allen Hopper, ACLU, and Emanuel Jacobowitz,
Steptoe & Johnson, and assisted by Christina Alvarez, ACLU, and Lauren
Payne, MAPS. 

Read the ³Respondent¹s Response to the Government¹s Exceptions to Opinion
and Recommended Ruling, Findings of Fact, Conclusions of Law, and Decision
of the Administrative Law Judge² at:
http://www.maps.org/mmj/5.4.07_response_to_government_exceptions.pdf

On May 15, DEA Administrative Law Judge Mary Ellen Bittner transmitted the
case files to DEA, officially putting the ball in the DEA¹s court to decide
whether to accept or reject the Judge¹s non-binding ruling. Unfortunately,
there is no time limit for the DEA to issue its final decision, so we are
anticipating a wait of anywhere between 3 months and two years, based on
previous cases. 

On the morning of Wednesday, May 23, MAPS President Rick Doblin, PhD, Prof.
Lyle Craker and medical marijuana patient Angel Raich will hold a brief
press conference on the sidewalk outside of DEA headquarters in Washington,
DC, followed by a national teleconference at 1:15 pm.

For complete background on the case, see:
http://www.maps.org/mmj/DEAlawsuit.html

2. Help MAPS and Marijuana Research Succeed by Contacting Your Congressional
Representative

On May 16, a ³Dear Colleague² letter by Reps. John Olver (D-MA) and Dana
Rohrabacher (R-CA) was sent to all members of the US House of
Representatives, urging each member to sign their Congressional Sign-On
Letter to DEA Administrator Karen Tandy urging the DEA to accept the recent
non-binding ruling by DEA Administrative Law Judge Mary Ellen Bittner in
favor of MAPS and Prof. Craker.

To succeed at this critical juncture, we¹ll need each supporter to contact
his or her Congressional Representative ‹ here¹s how:

To reach your Representative by phone, call the congressional switchboard
at: (202) 224-3121 or (800) 962-3524.

To reach your Representative by mail, write to: The Honorable (full
name)/House Office Building/United States House of
Representatives/Washington DC 20515

Tell your Congressperson that you would like him or her to add his or her
name to the Congressional Sign-On Letter sponsored by John Olver and Dana
Rohrbacher urging the DEA to follow the DEA administrative law judge's
Recommended Ruling by granting a Schedule I license to Professor Lyle
Craker, UMass-Amherst. If you feel comfortable, explain that you would like
to see the controversy over medical marijuana resolved through
privately-funded FDA-approved research, and that Prof. Craker¹s case is the
focal point of the struggle to evaluate whether medical marijuana meets the
FDA¹s standards for safety and efficacy.  Individualized letters and phone
calls are the best ways to get the attention of your legislators. E-mails
are helpful, but phone calls and especially personal letters or faxes carry
significantly more weight. No matter what, always be courteous and succinct.

For complete background on the case, see:
http://www.maps.org/mmj/DEAlawsuit.html

3. $12,500 Grant from Drug Policy Alliance (DPA) for MAPS¹ Marijuana
Research Effort

Last month, MAPS was awarded a grant of $12,500 from the Drug Policy
Alliance (DPA), for our efforts to pressure DEA to accept Judge Bittner¹s
ruling on behalf of Prof. Craker.

DPA is the leading organization in the US working to end the war on drugs
and envision new drug policies based on science, compassion, health and
human rights. We are grateful to have DPA as an ally in the struggle to
create rational alternatives to prohibition-based policy.

Learn more about DPA on their Web site: http://www.drugpolicy.org

4. Two New Studies Show Potential of Marijuana Vaporizer Research

Two new studies, one from University of California-San Francisco, and the
other from SUNY-Albany, provide strong evidence that vaporization has
promising potential as a method of medical marijuana delivery. The first
study, published online by the journal Clinical Pharmacology and
Therapeutics, was conducted at UCSF by a team led by Donald Abrams, MD, and
compared a commercially available vaporizer to smoking in 18 volunteers. The
researchers found that, "vaporization of marijuana does not result in
exposure to combustion gases, and therefore is expected to be much safer
than smoking marijuana cigarettes." Dr. Abrams was able to obtain permission
from FDA to conduct his study based in part on data on the composition of
the ingredients in marijuana vapor gathered in research sponsored by MAPS
and CaNORML. That line of MAPS-sponsored research is currently blocked since
NIDA has refused to sell marijuana for additional studies.

Dr. Abrams¹ study is available online at:
http://www.maps.org/media/vaporizer_epub.pdf

The second study, conducted by Mitch Earleywine, PhD, at SUNY-Albany, and
published in Harm Reduction Journal, was based on an extensive survey of
over 7,000 marijuana users. After adjusting for variables such as age and
cigarette use, Earleywine found that vaporizer users were 60 percent less
likely than smokers to report respiratory symptoms such as cough, chest
tightness or phlegm, and that the effect of vaporizer use was more
pronounced the larger the amount of marijuana used.

The study is available online at:
http://www.harmreductionjournal.com/content/pdf/1477-7517-4-11.pdf

MAPS hopes to eventually put vaporized marijuana through FDA clinical
trials, but has been stalled since June 2003 because of NIDA¹s monopoly on
the supply of research-grade marijuana. Research into alternative delivery
methods such as vaporization was one of the primary recommendations of the
Institute of Medicine¹s landmark 1999 report on medical marijuana
<http://books.nap.edu/html/marimed/>.

Marijuana vaporization is an effective delivery method because it has the
rapid action and easy dose adjustment of inhalation, but without the
respiratory hazards associated with smoking. Unlike smoking, a vaporizer
does not burn the plant material, but heats it just to the point at which
THC and cannabinoids vaporize into steam.

MAPS-Sponsored Psychedelic Research

5. FDA Approves MAPS-Sponsored Swiss and Israeli MDMA/PTSD studies for MAPS¹
Investigational New Drug (IND) Application

MAPS is currently sponsoring three pilot studies evaluating MDMA-assisted
psychotherapy for subjects with treatment-resistant posttraumatic stress
disorder (PTSD), in the US, Switzerland, and Israel. Last month, we learned
that the data being generated from the Swiss and Israeli studies will be
accepted by the US FDA.

Although these protocols do not need to be approved by the FDA 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. 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.

To learn more about the MAPS-sponsored study in Israel evaluating
MDMA-assisted psychotherapy for subjects with war- and terrorism-related
PTSD, the protocol is posted on the MAPS Web site at:
http://www.maps.org/mdma/israel_protocol_3.16.05.pdf

To learn more about the MAPS-sponsored MDMA/PTSD study in Switzerland, the
protocol is posted on the MAPS Web site at:
http://www.maps.org/mdma//swissmdmaptsd/protocol1608.pdf

6. Ongoing Swiss MDMA/PTSD Study Makes Progress

The ongoing MAPS-sponsored MDMA/PTSD study in Switzerland, led by Peter
Oehen, MD, has completed treatment for two subjects and is currently
treating the third and fourth subjects. In addition, two new subjects have
qualified for the study and will begin treatment this summer.

7. Dr. Mithoefer to Present on MDMA Research at International PTSD
Conference

Dr. Michael  and Annie Mithoefer, the co-therapists for MAPS' US MDMA/PTSD
study, were in Norway recently attending a workshop by Dr. Edna Foa, an
internationally-recognized expert in the treatment of PTSD. The workshop was
organized by Pal-Orjan Johansen, a Ph.D. candidate at the Trondheim
Psychotherapy Research Program, Department of Psychology, The Norwegian
University of Science and Technology, and Teri Krebs, B.S., Program in
Neuroscience, Boston University.

While in Norway, Dr. Michael and Annie Mithoefer were also able to work with
Pal and Teri, who are conducting a MAPS-sponsored study reviewing audio and
video recordings and transcripts of subjects in the Mithoefer's 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.

Dr. Michael and Annie Mithoefer were also able to discuss with Pal and Teri
their MAPS-sponsored project using 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.

Drs. Mithoefer, Peter Oehen and Franz Vollenweider, will be presenting their
MDMA/PTSD work at the European Conference on Traumatic Stress in Croatia
next month.

Learn more about Dr. Mithoefer¹s landmark MDMA/PTSD study on the MAPS Web
site: http://www.maps.org/mdma/protocol/index.html
 
8. MAPS Preparing for Ibogaine Study in Mexico as Parallel Canadian Study
Continues; Laptop Donation Needed!

The Iboga Therapy House is now enrolling clients in MAPS¹ IRB-approved
long-term observational case study. Three subjects have been enrolled in the
study so far and will be followed up on a monthly basis for a full year
after their initial ibogaine treatment.  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. 

Learn more about the Iboga Therapy House at:
http://www.ibogatherapyhouse.net

Meanwhile, MAPS is currently developing the protocol for a parallel
MAPS-sponsored observational case study in Mexico under the direction of
Principal Investigator John Harrison, PsyD (cand). The study would evaluate
changes in substance use in 20 consecutive individuals undergoing
ibogaine-based addiction treatment for opiate dependence at Mexico¹s
Ibogaine Association. The Ibogaine Association has been under new management
since 2006, and has significantly upgraded the quality of services for its
clients.

Learn more about the Ibogaine Association at:
http://www.ibogaine-therapy.net/

While on that note, we are looking for a laptop donation! We¹re seeking a
functional laptop less than three years old for the proposed MAPS-sponsored
study in Mexico. It will be used primarily for email, word processing, and
internet and can be either Windows or Macintosh. We don¹t mind reinstalling
the OS, upgrading RAM, and doing other light upgrades and maintenance to
make it functional. Please write to josh at maps.org if you have a machine that
you would like to donate.

Inside MAPS 

9. Shawn Hailey Joins MAPS Board of Directors

We¹re pleased to announce that longtime MAPS supporter Shawn Hailey is
joining the MAPS Board of Directors as the fourth member.

Shawn will actively work with MAPS President Rick Doblin, PhD, and the other
members of the Board of Directors to strengthen the organization, both by
reviewing business and technical proposals, and by helping MAPS refine its
long-term vision. We¹re looking forward to Shawn¹s increased input as we
focus on meeting the challenges of success at this critical phase in the
organization¹s development.

Shawn and his twin brother, Kim, worked for almost 2 decades to build a
software company focused on computer chip design and manufacture, before
taking their company public. As a result, Shawn has extensive experience in
managing growth and offers that experience to MAPS as we enter our own
growth phase. For a fascinating, though somewhat technical, 1997 interview
with Shawn and Kim about the history of their company, Meta-Software, see:
http://silicongenesis.stanford.edu/transcripts/hailey.htm

10. MAPS Preparing for Professional Management Review Process

Over the months ahead, the MAPS staff will be participating in a management
review project with The Management Center, a nonprofit that helps
progressive advocacy organizations get results in pursuit of their missions.
The Management Center is funded by philanthropist Peter Lewis to provide
professional management assistance to the organizations to which he
contributes. The MAPS staff is very thankful to Peter for this fantastic
opportunity. 

11. Fundraisers in San Francisco Area Raise Over $23,500 for MAPS

Our fundraising events last month were a major success. On Friday, April 27,
we held an intimate ³meeting of the minds² with 15 distinguished psychedelic
guests over an 8-course meal at the home of MAPS patron member Richard
Miller in Tiburon, CA. On Saturday night, April 28, we held an all-night
party with a spectacular line-up of guest speakers, DJs and visual artists
at the home of MAPS patron member Richard Wolfe in San Francisco. Together
the two events brought in over $30,000 with a profit of nearly $24,000 after
costs. Special thanks to False Profit <http://www.false-profit.com/> and
DogStar Catering <http://www.dogstarcatering.com/> for their collaboration
with MAPS on these two events ‹ and an extra special thanks to everyone who
came out to support the psychedelic community! Watch the MAPS email news
update for an announcement about our next San Francisco area event,
tentatively scheduled for this fall in an historical psychedelic Victorian
mansion in the Haight-Ashbury district.

12. Special Thanks to Robert Barnhart and Anonymous Donor for $40,000 and
$25,000 Donations

MAPS is deeply grateful to longtime MAPS supporter Robert Barnhart for
making a $40,000 charitable gift to MAPS in the last month. In addition,
MAPS also received a $25,000 donation from an anonymous donor.

13. Call for Articles for Upcoming Special MAPS Bulletin

For the following MAPS Bulletin, we¹re getting down to basics in a special
theme issue. And we want to hear from YOU.

Have psychedelics been important to your personal development? How so?

Please share your stories with us for the upcoming special edition of the
MAPS Bulletin, ³Psychedelics & Self-Discovery.²

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 ³real²
names when possible). If possible, please send a high-quality photo of
yourself to go with the article. Please send your submission to Sarah
Hufford <sarah at maps.org> by June 22.

Upcoming MAPS Events

14. 3rd Amazonian Shamanism Conference: Healing Plants and Navigational
Tools

"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. Traditional healers will also
give presentations and participate in panel discussions.

Conference Web Site: http://soga-del-alma.org/ConferenceSite

15. Mind States Costa Rica: Last-Minute Tickets Available

The upcoming Mind States seminar will be held June 13-17 in Costa Rica. To
purchase tickets or check out the latest developments, visit
http://www.mindstates.org

16. Women's Visionary Congress Tickets Sold Out

Tickets have sold out for this summer¹s Women¹s Visionary Congress:
Consciousness, Healing, and Social Justice, at Wilbur Hot Springs in Calousa
county, California. For complete information go to:
http://www.visionarycongress.org


***************

Now that our applications to conduct psychedelic research are finally being
granted, the biggest thing limiting progress is no longer the government. It
is our ability to fund the research and the work that goes into it.

The future is in our hands. Throw your weight behind MAPS' work today:
http://www.maps.org/catalog

Thank you. 

Best Wishes,
Jag



Jag Davies
Director of Communications
The Multidisciplinary Association for Psychedelic Studies
MAPS :: 10424 Love Creek Road :: Ben Lomond, CA 95005
**********************************************************
Advocating Science over Politics,
Replacing Fear with Facts:
Your Support is Needed! http://www.maps.org/catalog

 

 





 




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