Happy Summer, MAPS members!
This is the second edition of our newly-created email update for members. We have several items of encouraging news to report:
- In medical marijuana news:
- Grant awarded for vaporizer study with humans
- MAPS working to import Dutch cannabis for research
In MDMA research news:
- MAPS continues debate over Ricaurte research
- MAPS donates money for effort to start MDMA cancer study at Harvard
- MAPS-assisted researchers seek NIDA grant for MDMA/memory study
And in community news:
- Upcoming conference on altered states and spirituality
Please contact us if you’d like to be removed from the list, or you’d like to update our records with a new email address.
— Brandy Doyle
Director of Special Projects
IN MEDICAL MARIJUANA NEWS:
MAPS has primarily been working on two fronts in the effort to make marijuana into a prescription medicine. The first strategy has been to break the NIDA monopoly on marijuana for research, by establishing an independent source of high quality marijuana, which would offer a higher potency product and guaranteed availability to researchers. This is why we’re trying to start a marijuana production facility at UMass Amherst (see http://maps.org/mmj/mmjfacility.html). Though establishing our own domestic source offers greater benefits, we’re also working to establish an independent source by importing Dutch cannabis, as reported below.
The second major strategy has been to conduct medical marijuana research with vaporizers, which would meet FDA’s preference for non-smoked delivery systems. While vaporizers are the most politically desirable route, since they don’t involve smoking, we plan to continue to include smoked marijuana in future studies, as we would be surprised if there are significant differences in safety and efficacy for most patients.
We have news on this front as well:
GRANT AWARDED FOR VAPORIZER STUDY WITH HUMANS
On June 24, 2003, California’s Center for Medicinal Cannabis Research (CMCR) approved Dr. Donald Abrams’ Phase I vaporizer research protocol and grant application, amounting to slightly more than $137,000. The study will compare subjective effects, cannabinoid blood levels and carbon monoxide levels in exhaled breath in subjects on six different days, three days smoking 400 mgs of marijuana of either 1.7 % THC, 3.5% THC or 7% THC, and three days vaporizing 400 mgs of marijuana of either 1.7 % THC, 3.5% THC or 7% THC.
The protocol now goes to FDA for its review, finally. The big question is whether the FDA will want more data than MAPS and California NORML have already gathered on the Volcano (http://www.vapormed.de) or will accept the data we have already submitted, which is more than FDA has about what is in marijuana smoke post-combustion. We should hear from FDA within 4-6 weeks or so.
Also reviewing the protocol will be NIDA (since NIDA pot is being requested), DEA (supposedly to see what it can do to prevent the diversion of research supplies), and the Research Advisory Panel of California (which reviews all Schedule I research in California). The key review will be by FDA, since it will decide whether or not MAPS and California NORML need to raise more funds for additional vaporizer research. For more on vaporizer research, see http://maps.org/mmj/vaporizer.html
MAPS WORKING TO IMPORT DUTCH CANNABIS FOR RESEARCH
MAPS has completed negotiations with the head of the Dutch Office of Medicinal Cannabis for the importation of ten grams of high THC, high CBD marijuana for use in the next phase of the vaporizer research project. Chemic Laboratories, where the project will be conducted, has submitted an application to the DEA for an import license. This request to the DEA is, to our knowledge, the first attempt to import the marijuana plant from the Netherlands, through the newly established Office of Medicinal Cannabis. Chemic Laboratories has also submitted a request to NIDA for ten grams of its best quality product for the vaporizer project.
IN MDMA NEWS:
CONTINUED DEBATE OVER RICAURTE STUDY IN SCIENCE
On June 6, 2003, Science published an exchange of letters about MDMA neurotoxicity between Mithoefer and colleagues, who are the MAPS MDMA/PTSD research team (Mithoefer et al. 2003), and Ricaurte and colleagues (Ricaurte et al. 2003). These letters addressed Ricaurte et al.’s study recently published in Science, which made the dubious claim that MDMA could cause Parkinson’s Disease. To see the letters, as well as MAPS’s press release and the New York Times and Washington Post articles that reported critically on Ricaurte’s paper, go to http://maps.org/research/mdma/studyresponse.html.
While Science doesn’t publish replies to letters, the MAPS MDMA/PTSD research team wrote a response to Ricaurte et al.’s letter, and published it online at: https://maps.org/mdma/mithoefer-ricaurte6.19.03.pdf. The reply has been sent directly to Ricaurte et al. and they have been invited to respond if they wish.
In addition to several technical issues, our reply addresses the last sentence in the Ricaurte et al. letter, which states that there is not sufficient data “to conclude that clinical MDMA research can be conducted without running the risk of monoaminergic brain neural injury.” Our reply points out that it is impossible to prove that there is no risk inherent in MDMA research (or any other drug, or activity). Nor did we make that claim. Most importantly, Ricaurte et al. failed to cite any evidence contradicting our arguments that the currently existing body of scientific research demonstrates that there is a minimal and acceptable risk from the clinical use of MDMA.
One statement in the Ricaurte letter was so misleading that we have contacted Science to request a correction, which the letters editor has agreed is necessary. In Ricaurte et al.’s published study, they claim that two out of ten animals died, but in their letter they state only one out of ten died. This issue is important because the researchers claim that they administered a “common recreational dose regimen” to the animals, meaning that their research is relevant to human usage. However, in their letter, they state that their findings only apply to the rare “binge user,” a term they do not define. They then state that the three other studies we cited, which used actual humans were heavy users of MDMA and showed no reduction of dopamine levels, didn’t include any or enough subjects with similar use patterns to their theoretical binge user, further retreating from their claim that they administered a common recreational dose regimen.
MAPS STARTS PROTCOL DEVELOPMENT FOR MDMA RESEARCH WITH CANCER PATIENTS
On June 9, 2003, MAPS donated $15,000 to McLean Hospital, affiliated with Harvard Medical School, to enable Dr. John Halpern to develop a protocol for the use of MDMA-assisted psychotherapy in the treatment of anxiety and depression in end-stage cancer patients. The donation will support a portion of Dr. Halpern’s time from now until the end of December 2003, and supports work related to obtaining approval for the study from an Institutional Review Board (IRB), FDA, and DEA. If this project is approved, it will represent the first psychedelic research at Harvard since 1965 and will signal the beginning of the post-Leary era.
FDA has recently approved a study by Dr. Charles Grob using psilocybin-assisted therapy for cancer patients. These studies build on earlier research with cancer patients and LSD. To read early studies, check out the Hofmann Collection, a bibliography of PDFs of virtually all the early LSD and psilocybin research, at https://maps.org/wwwpb/.
MAPS HELPS RESEARCHERS APPLY FOR NIDA MONEY TO STUDY MDMA AND MEMORY
In May 2002, MAPS donated $11,500 to Dr. John Halpern to gather pilot data for a study of the effects of MDMA on memory. On May 29, 2003, Dr. Halpern submitted a grant application to NIDA, reporting on the pilot data and requesting nearly two million dollars, over five years, to expand the study.
This research began about a year ago, after a MAPS member had previously contacted us about a population of people who he thought would be ideal for such a study, a group of MDMA users who had taken virtually no other drugs. All existing studies have been in polydrug users, making it difficult to attribute any findings to MDMA itself. This new, unique group makes Dr. Halpern’s study one of the most important ever conducted on MDMA and memory.
If Dr. Halpern’s application is approved, MAPS’s initial seed money will be leveraged into a nearly two million dollar grant. This would break MAPS’s previous record, in which a $10,000 grant and five years of staff time led to a one million dollar NIDA grant to Dr. Donald Abrams, for the first study in 15 years giving marijuana to patients.
Dr. Halpern expects to hear NIDA’s decision in October. For more about the memory study, see http://maps.org/news-letters/v13n1/13110hal.html.
ALTERED STATES AND THE SPIRITUAL AWAKENING CONFERENCE
The ASSA Conference, held in San Francisco July 11-13, 2003, is “an attempt to bridge the gap between multiple generations of the same community and help gurus pass their wisdom to students.” Priced to be available for students and younger people, and held in the intimate loft space of False Profit, the group hosting the event, Altered States and the Spiritual Awakening will foster dialogue between different generations and different communities interested in altered states.
From the conference literature: “One of the primary goals of this conference is to bring together experts in multiple forms of altered states. We seek to cover three main spheres of knowledge: transpersonal and para-psychology, entheogens, and counsciousness exploration through external (technological) means. While all of the fields share certain commonalities, they all provide unique insights into how we can enrich the human psyche and deepen understanding of our existence.”
Presenters include: Morgan Brent, PhD, Etzel Cardena, PhD, Dr. Concrescence, Erik Davis, Frank Echenhofer, PhD, Earth Erowid, Fire Erowid, Ruth Inge-Heinze, PhD, Robert Jesse, Jon Klimo, PhD, Stanley Krippner, PhD, Luis Eduardo Luna, PhD, Maria Mangini PhD, FNP, CNM, Justine E. Owns, PhD, Daniel Pinchbeck, Beverly Rubik, PhD, Ann Shulgin, Stuart Sovatsky, PHD, Charles T. Tart, PhD, and Robert L. Van de Castle, PhD.
To register or for more information, go to http://www.assacon.com.