[MAPS] News 09/07: U.S. Reps Take a Stand for Marijuana Research

[Jag Davies]

To read this in html, click here:
http://www.maps.org/news

MAPS Members, Supporters, and Friends,

I am pleased to announce that tomorrow a letter will be delivered to  
DEA Administrator Karen Tandy signed by 45 members of the U.S. House  
of Representatives. The letter urges her agency to accept DEA  
Administrative Law Judge Mary Ellen Bittner's recommendation that  
would it be in the public interest to license Professor Lyle Craker's  
proposed MAPS-sponsored medical marijuana production facility at  
UMass-Amherst. This letter demonstrates to DEA that there is a  
growing political will to end the federal government's monopoly on  
the supply of marijuana that can be used in FDA-approved research.

As you know, MAPS is the only membership-based organization working  
to develop marijuana and psychedelics into legal, FDA-approved  
prescription medicines. If you think the world would be a better  
place if MAPS is empowered to implement its plans, please consider  
supporting our work by making a donation or Webstore purchase today  
at: http://www.maps.org/donate

Without further adieu, here's the news:

1. Fall 2007 MAPS Bulletin in the Mail to MAPS Members
2. Forty-Five U.S. Representatives Send Letter to DEA in Support of  
Medical Marijuana Research
3. FDA Reviews US MDMA/PTSD Protocol Amendment
4. Key Changes to MDMA/End-of-Life Anxiety Receive IRB Approvals,  
Awaiting FDA Approval
5. New MAPS-Sponsored Psilocybin/End-of-Life Anxiety Study Submitted  
to FDA
6. MAPS-Sponsored LSD Study Featured on Swiss TV News, Scheduled for  
Another Ethics Committee Review
7. MAPS Receives $35K Grant for Operational Expenses from Donor- 
Advised Tides Foundation Fund, $20K Donation from Anonymous Donor
8. Chemistry World Publishes Feature Article on Medical Research with  
Psychedelics
9. New Ayahuasca Study Confirms Therapeutic Potential
10. MAPS Facilitates Harm Reduction Services at Burning Man Festival
11. Audio Recordings of Presentations Available from Women's  
Visionary Congress
12. Horizons: A One-Day Psychedelic Conference in Manhattan, Oct. 27
13. Join MAPS at the International Drug Policy Reform Conference in  
New Orleans, Dec. 5-8
14. Join MAPS at the World Psychedelic Forum, March 21-24
15. Psychedelic Researcher John Beresford Dies


1. Fall 2007 MAPS Bulletin in the Mail to MAPS Members

If you are a MAPS member, in the next 2-3 weeks you will receive the  
Fall 2007 issue of the MAPS Bulletin in your mailbox. This Bulletin  
is a special issue on the theme of "Psychedelics and Self-Discovery."  
Thank you to the thoughtful and generous MAPS members and supporters  
who submitted articles for this issue. If you are not a MAPS member  
and would like to receive a printed copy of the tri-annual MAPS  
Bulletin, please consider joining MAPS today: http://www.maps.org/donate


2. Forty-Five U.S. Representatives Send Letter to DEA in Support of  
Medical Marijuana Research

Tomorrow, a letter signed by 45 members of the U.S. House of  
Representatives will be delivered to U.S. Drug Enforcement  
Administration (DEA) Administrator Karen Tandy urging her agency to  
license UMass-Amherst professor Lyle Craker to establish the nation's  
first privately funded research-grade marijuana production facility.  
The letter was signed by forty-two Democrats and 3 Republicans.

The bipartisan letter, co-sponsored by Reps. John Olver (D-MA) and  
Dana Rohrabacher (R-CA), urges DEA to follow Administrative Law Judge  
Mary Ellen Bittner's February, 2007 ruling in favor of Prof. Craker.  
The law judge's ruling is non-binding and DEA has no deadline to  
decide whether to accept or reject it.

Prof. Craker's ongoing six-year struggle is the focal point of the  
effort to put marijuana through FDA clinical trials to determine  
whether it meets federal standards for medical safety and efficacy.  
If DEA accepts the 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. NIDA's monopoly has been the key  
obstruction to FDA drug development research for four decades.

This strong showing was possible because MAPS members expressed  
support for marijuana research to their Representatives. This strong  
showing was also possible because MAPS' staff temporarily expanded to  
include Lauren Anderson Payne, JD, Kelly Burns, Liberty Coalition  
National Director Michael Ostrolenk, MD, and US Bill of Rights  
Foundation President Dane Von Breichenruchardt, who worked together  
with me (Jag Davies) to obtain support from organizations and  
Congressional Representatives.

Furthermore, this strong showing was possible because our  
organizational allies and their supporters provided additional  
support on Capitol Hill, essential know-how, public relations  
assistance and grassroots mobilization. These organizations include  
Americans for Safe Access (ASA), American Civil Liberties Union  
(ACLU), Marijuana Policy Project (MPP), Drug Policy Alliance (DPA),  
and National Organization for the Reform of Marijuana Laws (NORML),  
Interfaith Drug Policy Initiative (IDPI), Drug Reform Coordination  
Network (DRCnet), and Patients out of Time (POT). ASA was  
particularly helpful and provided a temporary office for Lauren to  
work from in Washington, D.C., for several months.

MAPS has received recent financial contributions for this effort to  
pressure DEA to accept Judge Bittner's ruling from the Marijuana  
Policy Project ($45,000) and the Drug Policy Alliance ($12,500).  
Philanthropist and MAPS Board member John Gilmore has also donated  
over $50,000 to date for Prof. Craker's struggle.

On behalf of the MAPS staff, we thank you for helping us orchestrate  
the multiplicity of efforts that have created this incredible window  
of opportunity. For background on this case and the latest news,  
please visit: http://www.maps.org/mmj/DEAlawsuit.html

Last month, MAPS President Rick Doblin, PhD, gave a thorough  
interview about MAPS' medical marijuana efforts on "Dr. Meg Jordan,  
Global Medicine Hunter" on the Health Radio network. Click here to  
listen: http://www.healthradio.net/component/option,com_mtree/ 
task,viewlink/link_id,3866/Itemid,273

The full letter to DEA with all 45 signatures is also posted on the  
MAPS site: http://www.maps.org/mmj/signonfinal.pdf


3. FDA Reviews US MDMA/PTSD Protocol Amendment

Michael Mithoefer, MD, and Annie Mithoefer, BSN, have enrolled 18 out  
of 20 subjects in their MAPS-sponsored study evaluating MDMA-assisted  
psychotherapy for subjects with chronic PTSD.  Another two potential  
subjects are currently in the screening process. The completion of  
MAPS’ flagship FDA Phase 2 clinical research study is now in sight.

Several weeks ago, MAPS and Dr. Mithoefer submitted a protocol  
amendment to FDA, seeking approval to treat a 21st subject, a US  
veteran with PTSD from the Iraq War. We need FDA permission to  
deviate from our inclusion criteria that requires all PTSD subjects  
to be treatment-failures from both drug and non-drug treatments. The  
request to include a subject who is not a treatment-failure is due to  
the sad fact that this veteran, like several others with whom we have  
spoken, has been diagnosed with PTSD but has never been offered  
treatment by the military. We expect to hear from FDA in a few weeks.


4. Key Changes to MDMA/End-of-Life Anxiety Receive IRB Approvals,  
Awaiting FDA Approval

Dr. John Halpern of McLean Hospital/Harvard Medical School informed  
us that he recently received IRB approvals from McLean Hospital and  
from the Lahey Clinic Medical Center for a series of crucial changes  
to his protocol, "Phase II Dose-Response Pilot Study of +/-3,4- 
Methylenedioxymethamphetamine (MDMA)-assisted Psychotherapy in  
Subjects with Anxiety Associated with Advanced Stage Cancer." Dr.  
Halpern is the sponsor/investigator for this study, which MAPS helped  
to initiate.

Dr. Halpern will submit these changes to FDA later this week. If  
these changes are accepted by FDA,  this updated version of the  
protocol will enable recruitment from a much larger pool of potential  
subjects and will result in the study's first and subsequent 11  
subjects. The main changes include: inclusion of cancer patients  
still receiving cancer treatments but for palliative purposes only,  
removal of a cut-off score for the STAI (State Trait Anxiety  
Inventory), inclusion of the HADS (Hospital Anxiety and Depression  
Scale), and inclusion of other female co-psychotherapists.


5. New MAPS-Sponsored Psilocybin/End-of-Life Anxiety Study Submitted  
to FDA

Later this week, MAPS will submit an application to FDA this week for  
a new study evaluating psilocybin-assisted psychotherapy for subjects  
with end-of-life anxiety secondary to advanced-stage melanoma.

The study will take place in the US and will evaluate nine subjects  
with anxiety secondary to advanced-stage melanoma. MAPS has been  
working with the researchers on protocol development for over one  
year. The protocol was submitted last month to FDA and to an IRB,  
with the review currently in process. We will be able to post the  
protocol on the MAPS Website and disclose the names and institutional  
affiliations of the researchers after the study receives IRB and FDA  
approval.

The researchers for this study have generously offered to volunteer  
their time, which will reduce overall costs significantly. The  
estimated budget for this study is $50,000, all of which remains to  
be raised.


6. MAPS-Sponsored LSD Study Featured on Swiss TV News, Scheduled for  
Another Ethics Committee Review

A major Swiss TV news report was broadcast earlier this month about  
Dr. Peter Gasser's MAPS-sponsored study evaluating LSD-assisted  
psychotherapy for subjects with end-of-life anxiety secondary to end- 
stage illness. The report includes a new interview with Albert  
Hofmann, who rarely speaks publicly due to his fragile health.

To see the report (in German, translation in process) please visit:  
http://www.maps.org/avarchive/telebasel_lsdstudy-sept07.wmv

Dr. Gasser's protocol will be reviewed again on November 8 by the  
Swiss Ethics Committee (EC). The EC is reviewing a report about the  
protocol from a Swiss psychooncologist who raised issues about  
patient selection (cancer patients v. patients with a range of life- 
threatening illnesses) and the possibility of measuring any acute  
traumatic effects of the LSD experience. We expect that this meeting  
of the EC will resolve the final issues regarding protocol design.

The protocol has already been submitted to SwissMedic, the Swiss  
equivalent of the FDA. SwissMedic has begun its review and is waiting  
to consider the outcome of the EC meeting in November. After EC and  
Swissmedic approval have been obtained, we expect we’ll  need an  
additional several weeks to obtain final approval from the BAG, the  
Swiss equivalent of DEA. We expect the study to be fully approved by  
January11, 2008, Albert Hofmann’s 102nd Birthday.

For background information about this study, please see:
http://www.maps.org/research/cluster/psilo-lsd/#swlsd

MAPS has already raised $$43,000 for this study from the sale of  
Albert Hofmann-signed art and books, but an additional
$160,000 is still needed. In addition to general donations for  
operational expenses, MAPS also accepts restricted donations for
specific research projects.

To make a restricted donation, or for purchase information regarding  
Albert Hofmann-signed books and art, please visit: http:// 
www.maps.org/catalog


7. MAPS Receives $35K Grant from Donor-Advised Tides Foundation Fund,  
$20K Donation from Anonymous Donor

Earlier this month, MAPS received two critical donations for  
operational expenses. Last month, an anonymous donor contributed  
$20,000 directly to MAPS. Then, earlier this month, another anonymous  
donor generously contributed $35,000, through a fund at the Tides  
Foundation. We are deeply grateful to these two individuals for their  
support and generosity. Since most large donations are earmarked for  
specific research projects, donations for operational expenses are  
especially helpful and appreciated.


8. Chemistry World Publishes Feature Article on Medical Research with  
Psychedelics

Chemistry World magazine recently published a comprehensive feature- 
length story about the "resurgence of medical hallucinogens." MAPS  
President Rick Doblin is quoted throughout the article. Click here to  
read: http://maps.org/media/chemworldsep07.pdf


9. New Ayahuasca Study Confirms Therapeutic Potential

A study recently published in the Journal of Ethnopharmacology has  
demonstrated that the South American psychedelic plant brew ayahuasca  
can alleviate signs of anxiety, panic, and hopelessness. The  
international quintet of researchers conducting the study, which  
included noted DMT researcher Rick Strassman, MD, concluded that:

"While under the acute effects of ayahuasca, participants scored  
lower on the scales for panic and hopelessness related states.  
Ayahuasca ingestion did not modify state- or trait-anxiety. The  
results are discussed in terms of the possible use of ayahuasca in  
alleviating signs of hopelessness and panic-like related symptoms."

To read the full study, see:
http://www.maps.org/media/ayahuasca-jep.pdf


10. MAPS Facilitates Harm Reduction Services at Burning Man Festival

 From Aug. 26-Sep. 2, as part of MAPS' educational outreach and harm  
reduction mission, for the fifth year in a row MAPS assisted Burning  
Man's Black Rock Rangers by coordinating a team of trained volunteers  
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. MAPS staffer Valerie Mojeiko coordinated the training of  
over 30 volunteers for Sanctuary, assisted by about eight core staff  
with psychedelic psychotherapy experience. Over 100 people going  
through difficult emotional and psychological experiences, some  
psychedelic-related, and some not, were cared in for Sanctuary over  
the course of the week-long event.


11. Audio Recordings of Presentations Available from Women's  
Visionary Congress

 From July 27-29, 2007, MAPS co-sponsored the Women's Visionary  
Congress, a unique gathering of women working to reform psychedelic  
and marijuana policy and to re-define society's understanding of  
these drugs. For those of you who were unable to attend, or for those  
of you who were there and would like to listen to a particular  
presentation again, we have good news: the audio recordings are  
available. To listen to a panel, please visit: http://www.maps.org/ 
avarchive/wvc_audio.html

Of particular relevance to MAPS' work is Panel #4, moderated by MAPS  
Clinical Research Associate Valerie Mojeiko. The panel featured Annie  
Mithoefer, BSN (MAPS-sponsored MDMA/PTSD therapist), Amy Emerson  
(MAPS' volunteer clinical monitoring expert), and June May Ruse (co- 
author for MAPS' MDMA/PTSD treatment manual).


12. Horizons: A One-Day Psychedelic Conference in Manhattan, Oct. 27

Join MAPS President Rick Doblin, MAPS-sponsored researchers Michael  
Mithoefer and Andrew Sewell, artists Alex & Allyson Gray, Drug Policy  
Alliance Executive Director Ethan Nadelmann, and others at "Horizons:  
Contemporary Perspectives on Psychedelics" on October 27 at Judson  
Memorial Church in Greenwich Village from 1-6 pm. Proceeds from the  
conference will be donated to MAPS and the other non-profit  
organizations involved with the event.

For information on the conference, speaker bios, and tickets, please  
visit: http://www.horizonsnyc.org/index.html


13. Join MAPS at the International Drug Policy Reform conference in  
New Orleans, Dec. 5-8

This December 5-8, MAPS will join hundreds of other drug policy  
reformers in New Orleans for the biennial International Drug Policy  
Reform conference, hosted by the Drug Policy Alliance (DPA). MAPS  
Director of Development Troy Dayton and I will be attending the  
conference to present MAPS' work. 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.

If you are a MAPS supporter who will be attending, we are looking for  
volunteers to help staff the MAPS table during the conference. If you  
are interested, please contact me by replying to this email.

For more information about DPA and the 2007 International Drug Policy  
Reform conference: http://kessjones.com/conf07/

To read my review of the 2005 conference in the Spring 2006 MAPS  
Bulletin, see: http://maps.org/news-letters/v16n1-html/ 
building_a_movement.html


14. Join MAPS at the World Psychedelic Forum, March 21-24

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. Gaia Media is the organization that put together  
the Spirit of Basel symposium in honor of Albert Hofmann's 100th  
birthday in January, 2006.

For more information and to register: http://www.psychedelik.info/

Gaia Media will be hosting a talk in Basel on January 26 featuring  
Rick Doblin, MAPS-sponsored MDMA/PTSD researcher Peter Oehen, MD,  
MAPS-sponsored LSD/end-of-life anxiety researcher Peter Gasser, MD,  
and MAPS Patron Member Vanja Palmers. Stay tuned in for more details.


15. Psychedelic Researcher John Beresford Dies

Early psychedelic research pioneer John Beresford died on September  
2. Beresford, who was born in Britain, resigned his post as an  
Assistant Professor of Pediatrics at the New York Medical College in  
1961 to found the Agora Scientific Trust, the world's first research  
organization devoted to investigating the effects of LSD.

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

Now that psychedelic research is being approved, the formidable  
challenge is funding it. Since these drugs are off-patent and would  
not be used on a daily basis, no for-profit pharmaceutical company  
has demonstrated any interest in sponsoring psychedelic research.  
Because of Drug War ideology, there is currently no government  
funding for this research. Plus, most foundations and philanthropists  
are averse to controversy. Because of the Drug War, this area of  
study is 35 years behind schedule. For historical reasons,  
unfortunately, psychedelics remain highly controversial. This means  
society must rely on people like you.

You can help make up for lost time by making a tax-deductible  
contribution today at: http://www.maps.org/donate

Thank you for your generosity and foresight.

Best Wishes,
Jag


Jag Davies
Director of Communications
The Multidisciplinary Association for Psychedelic Studies
MAPS :: 10424 Love Creek Road :: Ben Lomond, CA 95005
*********************************************
MAPS: Putting the 'MD' Back in 'MDMA' Since 1986
Your Support is Needed! http://www.maps.org/donate






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