|Rick Doblin, founder of MAPS|
In the 1950s and throughout the next decade scientists were eager to test the 'mind-manifesting' properties of psilocybin and LSD, with up to 1000 articles appearing in medical journals in little over ten years. A cultural example of where this research was heading can be found in a 1960 Paris Review magazine interview with the great literary artist and intellectual Aldous Huxley; where only three years before his death he spoke freely of how this field of scientific exploration could develop. Talking of LSD specifically, Huxley remarked:
In the intervening years since Huxley's analysis, science has also discovered the potential mind-healing benefits of 'recreational' substances such as cannabis and MDMA. Leading this renewed charge is the Multidisciplinary Association for Psychedelic Studies [MAPS] - a US organisation determined to bring credibility and mainstream attention to this often poorly understood arena of scientific endeavour."While one is under the drug one has penetrating insights into the people around one, and also into one’s own life. Many people get tremendous recalls of buried material. A process which may take six years of psychoanalysis happens in an hour—and considerably cheaper! And the experience can be very liberating and widening in other ways. It shows that the world one habitually lives in is merely a creation of this conventional, closely conditioned being which one is, and that there are quite other kinds of worlds outside. It’s a very salutary thing to realize that the rather dull universe in which most of us spend most of our time is not the only universe there is. I think it’s healthy that people should have this experience."
After investing over $2 million and 24 years of dedicated effort, MAPS has completed two successful pilot studies of MDMA-assisted psychotherapy in patients with chronic, treatment-resistant post-traumatic stress disorder [PTSD] in the US and Switzerland, with additional pilot studies underway or in the approval process in Israel, Jordan and Canada. MAPS suggests that the US is still about 10 years and $10 million away from the prescription approval of MDMA for PTSD. In mid-2010, MAPS published the results of the world's first randomized pilot study into the safety and efficacy of using MDMA-assisted psychotherapy to help individuals with chronic, treatment resistant PTSD. The findings intimated:
Rick Doblin, Ph.D., is the founder and Executive Director of MAPS. In early December 2010, he travelled to Australia to deliver the keynote speech at the EGA 2010 Psychedelic Symposium; where he was joined by leading local researchers and health professionals at the University of Melbourne to discuss the future for psychedelic drugs research. On the eve of the conference, Rick kindly gave up some of his time to exclusively talk to The Trip Out Corner.This pilot study demonstrates that MDMA-assisted psychotherapy with close follow-up monitoring and support can be used with acceptable and short-lived side effects in a carefully screened group of subjects with chronic, treatment-resistant PTSD. In this group, MDMA-assisted psychotherapy compared with the same psychotherapy with inactive placebo produced clinically and statistically significant improvements in PTSD symptoms as measured by standard symptom scales. This difference was immediate and was maintained throughout the time period. There were no drug-related serious adverse events and no evidence of impaired cognitive function as measured by neuropsychological testing.
Q: What moves or actions do you believe need to happen in Australia for scientific psychedelic drugs research (with MDMA, LSD etc) to begin?
R. Doblin: From a risk/benefit perspective, which is what the Australian regulatory agencies will consider as well as the Institutional Review Board (IRB) or Ethics Committee, psychedelic research can be justified under certain circumstances. Numerous studies have been approved around the world. For research to take place in Australia, a sponsor needs to come forward who wants to see a certain study conducted and is willing to pay for the study.
The sponsor could be a scientist who donates his or her time and has grant money for the remaining expenses, the Australian military that wants to explore MDMA for PTSD in veterans, or a non-profit research organization such as MAPS, or even a for-profit pharmaceutical company (not likely since these drugs are off-patent, will be generic drugs and aren't likely to make a profit for the manufacturer).
Regardless of whether the study is of psychedelic psychotherapy with LSD or MDMA or another psychedelic in patients, or a neuroscience study in healthy volunteers, a key factor will be who exactly will be with the subject when they are administered the test drug. The therapists/researchers will need to persuade the regulators that they can provide sufficient support for the subjects.
An institutional, university or hospital setting is helpful but not essential.
The drugs can be imported or perhaps manufactured in Australia.
Then, whoever wants to conduct the research needs to be prepared for a lengthy, multi-year process.
MAPS wants to help start MDMA/PTSD research in Australia, ideally in veterans with PTSD. We'd need to find a male/female co-therapist team, a setting in which the therapy can take place, and funding.
Q: How far off do you believe Australia is from legalising cannabis (either medical or recreational), or decriminalising its use and minor sales?
R. Doblin: I don't know the political dynamics well enough to say. I can say that developing cannabis as a legal prescription medicine through the conduct of scientific, drug development research will take about ten years.
Legalizing cannabis for medical sales has been done in the Netherlands, Israel and 15 US states by political means without the conduct of scientific, drug development research. That could be quick.
Q: I note that MAPS has prepared a submission in early November 2010 to test the efficacy of using cannabis as a treatment for PTSD in the USA. What are the practical difficulties of beginning such a program? Is the Food and Drug Administration [FDA] supportive of such programs? What about the Drug Enforcement Agency [DEA], considering US federal authorities have recently pointed out (during the Prop. 19 debate) that using cannabis is still a criminal matter.
R. Doblin: The key problem is obtaining cannabis from the National Institute on Drug Abuse [NIDA], a federal agency part of the National Institutes of Health, which has a monopoly on the supply of cannabis legal for FDA-regulated studies.
FDA is supportive of science over politics. We are likely to obtain FDA approval for the study, if not at first, then after some negotiations about protocol design. NIDA is not sympathetic to letting marijuana in plant form become a medicine and is almost certain to delay the review process for at least a year and then reject the study.
If FDA and NIDA say yes, DEA will have to give approval as long as the researcher doesn't have a criminal record that would make diversion of the drug to non-medical purposes an issue of concern to DEA. However, DEA has been protecting NIDA's monopoly for decades in order to block research.
Q: You're delivering the keynote address at the EGA 2010 Psychedelic Symposium in early December at the University of Melbourne. As you have pointed out, psychedelic drugs research is now operating in 18 countries. Would you say internet communications has aided a seeming renaissance in this fledgling field?
R. Doblin: Yes, to some degree it has. Researchers can more easily communicate with each other across borders. International collaborative work has been greatly enhanced by the internet. However, what's more important is that the basic science has clearly demonstrated that in carefully controlled settings with screened patients, the risk/benefit ratios can be favorable and research can be ethically conducted. If that wasn't the case, the internet wouldn't matter.
Q: What are some of the common bulwarks or obstacles (cultural, institutional or otherwise) against this kind of research?
R. Doblin: Symbolic politics in which psychedelics are symbols of rebellion, liberalism, change, and reckless hedonism.
Fear that sending accurate information about illegal drugs that would include beneficial uses and contexts as well as risks would compromise government and private sector anti-drug messages.
Lack of funding from pharmaceutical industry, government and major health care foundations.
Resistance to research by regulatory agencies.
Q: Your 'mentor' (so to speak) in this field of research was the groundbreaking Stanislav Grof. I came to be interested in this area after reading several of his books. Would you say his work was ahead of its time, and thus Grof himself missed out on recognition in the wider spheres of influence away from science?
R. Doblin: His work in the 1950s and most of the 1960s wasn't controversial, it was mainstream. He wasn't ahead of his time then, he was part of his time. Then there was a backlash and his work was criminalized. Stan would certainly be more widely appreciated if psychedelics weren't so controversial. He will be more widely appreciated when much of the world, which is behind the times, works through the fears that catalyzed the backlash and returns to the 21st century.
Q: How can you explain the paradox that the world's leading psychedelic drugs trials are conducted in the country with the world's greatest prison population (and most of them are there due to drugs related crimes)?
R. Doblin: America is a land of many diverse power centers, with scientific freedom valued by the FDA coexisting with a punitive, reactionary, racist drug war.
Q: Were any states or territories in Australia more pronouncedly receptive or hostile to your argument and presence?
R. Doblin: I can’t say until I come to Australia and then I will only be in and around Melbourne. I don't understand Australian politics well enough at this point.
Q: How did you find the media reception and reaction to your visit to Australia?
R. Doblin: Interested and open, so far. I will need to see how the stories are presented before I can say if the topic is treated fairly in a thoughtful and balanced manner. The Australian government's anti-drug ads in the media seem extreme and unlikely to be effective.
R. Doblin: Our focus on scientific methodology is the key to regulatory approval. In addition, there is a widespread perceived need for new treatments for PTSD and for anxiety associated with end-of-life. Furthermore, there are lots of aging baby boomers in positions of power who used psychedelics in their youth and know their risks and benefits and can make informed, rational decisions about appropriate uses. Finally, there are lots of people for whom psychedelics have been beneficial who have money to donate to research.
Q: With Prop 19 narrowly defeated in California, advocates are confident of similar legislation succeeding in an American state in the next two to five years. Can you account for the massive increase in support for drugs decriminilization and the turn against a "War on Drugs"? A number of months ago, leading Australian drug expert Dr. Alex Wodak confidently (and correctly) predicted that Prop 19 would just fail, but noted that with the continuing economic downturn in the US, support would perhaps only increase. Do you share similar sentiments?
R. Doblin: Yes. In 2012, marijuana legalization initiatives will likely be on the ballot in California and Colorado and will likely pass.
Q: And finally, what is the most common misconception about MDMA?
R. Doblin: That it is a recreational drug that some people think has therapeutic potential. Actually, it was a therapeutic drug before it was popularized and became 'Ecstasy', with a half million doses used in therapeutic contexts between 1976 and 1985. MAPS is just working to bring back the therapeutic uses into legal contexts.
Image courtesy: MAPS (Copyright)
Image courtesy: Psychonaught (Wikimedia Commons)
Image courtesy: Erik Fenderson (Wikimedia Commons)
Image courtesy: Stanislav Kozlovskiy (Wikimedia Commons)