MAPS Members, Supporters & 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.
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 at the MAPS Web Store.
Here’s a sample of what’s going on at MAPS this July:
MAPS & Medical Marijuana
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.
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.
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, “Scientists Stir the Pot for Right to Grow Marijuana,” 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) …
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 NIDAwhich has a monopoly on the supply of research-grade marijuana but no other controlled substancemeaning 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.
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 protocol 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.
Upon hearing news of the Ethics Committee’s approval of MAPS’ LSD/end-of-life anxiety study, Amanda Fielding, founder of the Beckley Institute, 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.
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.
Another way we are raising funds for Dr. Gasser’s MAPS-sponsored LSD study is through the sale of 50 limited edition prints of Robert Venosa’s portrait of Albert Hofmann, signed by Albert and Robert. We’ve already sold 33 of the 50 prints.
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.
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.
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.
The Huffington Post’s Mary Clare Ditton published an interesting article on July 17 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.
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 offer our thanks to all of the contributors who make the Bulletin possible.
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.
On a related note, we have extended the deadline to July 20 for submissions for an upcoming special edition of the 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 Website. 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 the Visionary Congress Web site
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).
14. MAPS at Burning Man 2007: An Improved “Sanctuary” and Smaller Entheon Village
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, please visit the EV Website.
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.
The future is in our hands. Throw your weight behind MAPS’ work today.
Thank you for your support.
Jag Davies, MAPS Director of Communications