The FDA Trip
Or How Psychedelic Research Was Revived in the 90's

Rick Doblin in conversation with RU Sirius


Even among such interested parties as anti-drug fanatics and hallucinatory enthusiasts, very few are aware that the US Food and Drug Administration (FDA) licensed some psychedelic experimentation during the past decade. Unless you subscribed to the FDA's own newsletter, or read MAPS, the magazine published by Rick Doblin's organization of the same name (spelled out: Multidisciplinary Association of Psychedelic Studies), it's unlikely you would have heard about it.

Doblin started his own hallucinatory Journey in 1971 with a dose of LSD. He was 19 years oldIn contrast to his bar mitzvah five years earlier, he found the psychedelic experience to be a satisfactory rite of passage into manhood. A decade later, at a Stanislav Grof workshop at Esalen, he experienced MDMA (Ecstasy), while it was still legal.

Very few who are deeply impressed by the psychedelic experience gravitate towards the oftentedious work of legitimating research into these compounds' properties and potentials. There are the scientists who want to do the research, of course And then there's Rick helping them deal with the excruciatingly slow and Byzantine processes of Government bureaucracy. Through his MAPS organization, Doblin has supported and supervised animal and human research, protocol design, and done fundraising and policy analysis, He also administered an FDA Drug Master File for MDMA. At the some time, he's been working towards a Ph.D. Degree in Public Policy at Harvard University's John F. Kennedy School of Government

I had long been carious about bow the liberalization of psychedelic research - which had been unofficially-but-entirely shut down since the countercultural explosion of the mid-sixties - had managed to fly under the political radar In the midst of the everescalating "drug war," so an interview with Rick Doblin seemed in order.

RU SIRIUS: Them was a liberalization of FDA policy around psychedelic drug testing and experimentation since the nineties. In your view, how did this change come about?

RICK DOBLIN: ...Through the courage and integrity of a small group of FDA officials who prioritized science over drug war politics.. These people were located in the FDAs Pilot Drug Evaluation Staff (PDES), created in 1989 to expedite FDA procedures for the evaluation of all drugs. Part of the portfolio of drugs they reviewed were the Schedule I drugs, including the psychedelics and marijuana. This group was disbanded in 1995 as a result of internal FDA politics having nothing to do with the PDES approval of psychedelic and medical marijuana research. A 1992 FDA PDES Advisory Committee meeting ratified the policy that the FDA could review psychedelics like all other drugs, and that scientific research into potential therapeutic benefits was appropriate This remains current FDA policy.
     FDA has not come under pressure from Congress or anywhere else for approving psychedelic research protocols, though there has been some pressure on medical marijuana research from the DEA. However, FDA was able to get Office of National Drug Control Policy (ONDCP) to tell DEA to back off. This was because ONDCP was stuck opposing state referendums in favor of marijuana, so they had to say that the FDA process was the right way to go. That made it difficult for DEA and ONDCP to get away with blocking FDA research. Now, Department of Health and Human Services guidelines do make it difficult to conduct marijuana research because the National Institute of Drug Abuse has a monopoly on marijuana for research. But this isn't the case with psychedelics.

RU: I read with interest your dissertation on the history of this liberalization process. It's clear that the psychedelic testing was really just A side issue for something called the "Pilot Drug" program. This was an attempt largely to de-bureaucratize and make more efficient the whole FDA review process. And while doing that, a couple of rather heroic anti-bureaucratic bureaucrats -- Dr. John Harter and Dr. Curtis Might -- decided to deal with a backlog of requests involving Schedule One drugs. Can you comment on the characters of these two men?

RD: Dr Harter was an extremely self-confident and independent person who loved the FDA and was deeply committed to public service. He was an innovator who empowered those around him while at the same time retained supervisory control. He wasn't pro-psychedelic, but rather proscience. His vision was to train me to understand how the FDA worked so that I could try to mobilize the demoralized psychedelic research community to submit protocols.
     Dr. Wright went to college during the 1960s and wasn't inherently afraid of psychedelics. He was blunt and direct, but fair, and thrived in the experimental environment created by Dr. Harter. He was a Trekkie who had programmed his FDA computer to make all sorts of Star Trek sounds, Still, he was also more proscience than pro-psychedelics. He was Dr. Harter's protegˇ and was being groomed by Dr. David Kesler to be the FDA regulator of tobacco.

RU: How did the retirement of Kesler effect FDA attitudes?

RD: There was a short period after he resigned in 1995 during which lower level FDA officials made it difficult to move forward with psychedelic and medical marijuana research. However, I filed a complaint with the ombudsman and the policies established by "Pilot Drug" were reaffirmed in 1999 by FDA upper management. The current FDA Commissioner Dr. Jane Henney, is supportive of psychedelic research. The main concern I have is that Bush is hying to politicize the FDA by forcing them to reevaluate RU-486, the abortion pill. The FDA may get defensive about other controversial drugs and may make it more difficult to mm forward with psychedelic psychotherapy research. I still think we will be able to get permission for MDMA-assisted psychotherapy research, We shall learn more some time after the MDMA/PTSD (Post-Traumatic Stress Disorder) protocol from the Medical University of South Carolina gets submitted to FDA in March or April. I'm optimistic.

RU: So the approval of psychedelic testing did not turn out to be a controversial element of this otherwise controversial FDA program called Pilot Drug. Did it surprise you that psychedelic testing and experimentation could fly beneath the political radar in the middle of the War on Drugs?

RD: I was totally shocked. We all tend to think that our corner of the world is the most important and that people am deeply aware of what we are up to. I certainly thought that there would be more organized opposition to the renewal of psychedelic research. The saving grace, as I see it in retrospect, is that we were just doing basic safety studies. Trying to show benefits through psychedelic-assisted psychotherapy protocols is inherently more controversial and may generate a more aggressive reaction. However, the passage of the state medical marijuana initiatives forced the federal authorities to adopt the rhetoric that medical uses of marijuana should be settled through research rather than at the ballot box. As a result, it has become more difficult for federal authorities to obstruct and prevent psychedelic research.

RU: Let's talk a bit about drug policy in the broader sense. At the Ecstasy conference in San Francisco, you advocated putting unusually tight restrictions on prescribing psychedelic drugs for therapeutic purposes. In a different context, you said you thought that drug prohibition doesn't work and should be lifted. Contradictions?

RD: No, I don't think so. Use for therapy under medical supervision with insurance reimbursement and the full approval of FDA should probably always be heavily regulated. Some may be familiar with Dr. Rick Ingrasci's sexual abuse of patients under the influence of MDMA and ketamine back in the early 1980's, for instance. However, people shouldn't have to go to doctors to use MDMA, unless they want to - at least after their first experience under supervision to eliminate idiosyncratic reactions and major releases of underlying psychological dynamics of a challenging nature that require more skilled management. The two approaches can coexist, medical use under supervision and legalization for non-medical purposes, with the intersection being the first session under supervision, then a license to purchase independently.

RU: Any truth to the rumor that Hillary Clinton has been quietly helpful in getting lbogaine experiments approved?

RD: No. This is supposedly due to the fact that the head of the Democratic Party in Dade County, Florida is Joe Geller. His wife, Deborah Mash, is a leading advocate for the research into lbogaine as a one for drug addictions. So it's true that Deborah had a chance to meet with Hillary. However, it's almost certain that the FDA approved the Ibogaine project without any White House influence. In any case, around the same time FDA approved several other similar protocols, definitely without While House influence. If Hillary was really actively supportive she should have forced NIDA to fund Ibogaine clinical trials in humans, which NIDA almost did but then backed away from. Or she should have forced National Institute of Health (NIH) to fund Deborah's grant application (submitted with $50,000 worth of pilot data conducted with funds supplied to Deborah from MAPS). But Deborah's grant was rejected. I see no evidence that Hillary did anything whatsoever, nor do I credit her with being willing to support such controversial issues even if she believed in them.
     Our main allies are people within the FDA who value science over drug war politics. These allies are not psychedelic enthusiasts but have a strong sense of the importance of the scientific quest.

RU: You didn't include yourself in your dissertation, but in truth, this has been a Heisenbergian experiment for you. You have been deeply involved in this process through your MAPS organization. Given the broad range of folks interested in psychedelics, from hippies and radicals to cautious therapists and brain scientists, how do you think about and experience your own role?

RD: I experience myself as a Jew who grew up in the shadow of the Holocaust, who saw that cultural insanity and scapegoating based on the abilities of leaders to play on deep inner psychological processes in individual citizens was a direct threat to my life. As a product of the sixties, I also saw some of the same general processes in my own country, in relation to racism and Vietnam. In response. I became a draft resister who was prepared to go to jail instead of Vietnam. Then, I found psychedelics to be tools that could help me deal with those same psychological processes within myself and felt that, if used wisely and widely, psychedelics could substantially improve the mental health of individuals and nations.
     I decided in 1972, at age 18, to become an underground psychedelic psychotherapist in order to respond to the need to develop the psychological maturity of individuals and nations, hopefully to balance our overdeveloped scientific and intellectual capabilities that, unchecked, can lead to disaster. After President Carter pardoned all the draft resisters on his first day in office, I decided to by to become a legal psychedelic researcher and therapist. I fundamentally rejected the position that psychedelic users were inherently part of a counterculture. In many ways, I have traditional values and lifestyle, and know that psychedelics can be integrated into a regular middle-dass life with family and a job that requires hard work and attention to details. As I walk my son to kindergarten every morning, I feel more convinced than ever that I have been fortunate to be able to combine psychedelics with the pursuit of the American dream.
     My role is a lobbyist (that degraded term) for the integration of psychedelics into our culture and as the director of a non-profit pharmaceutical company seeking to move psychedelics and marijuana through the FDA.


Back to the Media Page