EPILOGUE

FDA Approval by 2021?

Is 2016 the Year of “Coming Out” for Past Psychedelic Users?

More than two years after MAPS founder Rick Doblin, PhD, first joined me on the program, he came back again to talk about progress in his organization’s mission to make MDMA the first FDA-approved psychedelic medicine in a therapeutic context.

An Optimistic Forecast

Rick Doblin, PhD

August 18, 2015

RLM: Thirty years ago, Rick Doblin told me he was going to get his PhD and then start a pharmaceutical company. He was going to dedicate his life to working on the legalization of medicines that have been heretofore illegal. He founded MAPS—the Multidisciplinary Association for Psychedelic Studies—a historic pharmaceutical company. Welcome, Rick.

Rick Doblin, PhD (RD): Richard, it’s great to be here, and thank you for such an introduction. I don’t want to think of myself as historic yet.

RLM: Perhaps you’re too young to be historic.

RD: I think getting MDMA-assisted psychotherapy approved as a prescription medicine by the FDA and European Medicines Agency will be historic. We are currently anticipating that will happen in 2021, so I’ve got an awful lot of work before the word “historic” would really qualify.

RLM: Some of us look at you that way already, Rick, because the work MAPS has done around the globe has been a breath of fresh air for those of us in the professions of psychology and psychiatry. Those of us who were around when MDMA was legal and saw the benefits to ourselves and to our patients look at what you’re doing as historic because there’s light at the end of what has been a very long tunnel of government suppression of information.

A Thirtieth Anniversary Celebration

RLM: As you recently said publicly at your wonderful lecture at the old Federal Reserve building in San Francisco, when introducing Stan Grof, we’re looking at having MDMA as a legally prescribed medicine in the year 2021. The whole audience stood and applauded because all these professions are waiting for this event. And that’s, I think, what makes it historic.

RD: Our thirtieth anniversary is 2016. I started MAPS one year after MDMA was criminalized in 1985. We were thinking of having an event in the Bay Area, where we’d follow the lead of the gay rights movement. What they achieved was largely because people came out and said they were gay. Instead of hiding in the shadows, people acknowledged who they were. We’re looking to possibly do a similar event of people with mainstream credibility, but who have been quiet about the influence of LSD on their lives. Maybe if a bunch of people were to do it together it might be less worrisome. We’re thinking about it as a big coming out as far as psychedelics’ influence on people’s lives.

RLM: I think that’s an excellent idea. I feel strongly that an extremely high percentage of the psychologists and psychiatrists that I know who experienced MDMA when it was legal, in their therapist’s office, will come out for what you’re talking about and go public.

RD: That’s fantastic.

Signs of Hope at the American Psychiatric Association

RD: I actually got the idea at the American Psychiatric Association annual conference this year in May in Toronto. About twelve thousand psychiatrists from around the world come to it. For the first year in many years MAPS and the Heffter Research Institute were able to get a three-hour seminar on psychedelic-assisted psychotherapy. Also, MAPS purchased a table in the exhibit hall where Big Pharma had all their tables—but they didn’t have tables. We had a $5,000 table, which was just a table. They had massive exhibits that cost hundreds of thousands of dollars. So we kind of felt like we had arrived with this seminar and our little table.

But what we didn’t predict was fantastic. The president of the American Psychiatric Association is president for just one year, and the last thing they do is preside over the conference that they have organized during the prior year. The president put an interview that he did with Ram Dass [Richard Alpert] on the schedule. There was an hour and a half with discussion after this interview. We were shocked to see that Ram Dass was having an honored place at the American Psychiatric Conference—Ram Dass being a psychologist rather than a psychiatrist and being associated with Tim Leary and Ralph Metzner at Harvard for psychedelic research.

During the interview, the president—the sitting president of the APA—announced that when he was nineteen years old he took LSD and had a profound spiritual experience. He dropped out of college, traveled around, studied Zen—became kind of an itinerant Zen monk—and then eventually he had a dream that told him to become a psychiatrist. He was basically saying that LSD was responsible for him becoming a psychiatrist, and he had kept this quiet. This was at sixty-five years old and at the pinnacle of his career, he felt safe enough to acknowledge the role of LSD in his life.

RLM: And that is why I think you’re going to get tremendous support from psychologists and psychiatrists in going public, because there are so many of us who are in our late sixties and seventies, like myself, who are old enough to have been administered these medicines while they were still legal. There are enough of us around who took LSD when it was legal. I took MDMA for the first time in the office of my therapist—Robert Kantor, who started the Pacific Graduate School of Psychology. He regularly used it with me while it was legal.

All of us who have taken it are experientially aware of the profound positive effects that these medicines had on us and our patients. We’ve been waiting in the wings for decades for you to come along—and it happens to be you.

Setting Modern Psychiatry Straight

A New Model for Psychotherapy

RLM: We have to return to the legal use of these medicines, because modern psychiatry is adrift—the pharmaceutical companies are creating medicines that Robert Whitaker says are wreaking havoc with neurotransmitters [see chapter 5]. The medicines that are being used are not helpful—they may be making people suffer more, not less. And here we have these other medicines that thousands, if not tens of thousands, of us professionals have experienced to have positive effects.

RD: We believe therapists who want to work with these substances will be more effective if they’ve tried them themselves. In some ways that’s an obvious statement—if you want to study yoga, you go to somebody that practices yoga; or if you want to study meditation, you go study with somebody that actually meditates.

It makes intuitive sense that if you want psychedelic-assisted therapy you should ideally go to somebody that has had these experiences. Many younger psychiatrists and psychologists that grew up during this period of the backlash have received very little in the way of education about psychedelics, and the education they have received has been largely negative. They are taught that it causes psychosis—people go crazy—and that we have to deal with them at the hospitals.

From a view of integrating psychedelic-assisted psychotherapy into mainstream psychiatry and psychotherapy, MDMA is more likely to be adopted by mainstream psychiatrists and psychotherapists. We’ve already seen that to be the case in that we have FDA approval for a protocol. We’ve been able to bring in therapists from Israel, from the Veterans Administration, from the United States, and from England and give them MDMA experiences in a legal, controlled, and scientific way to help them be more effective when they work on our studies. I think there would have been several of those people that would not have volunteered for psilocybin or LSD but were willing to volunteer for receiving MDMA.

No Such Thing as a One-Dose Miracle Cure

RLM: What are the viewpoints of the professions of clinical psychology and psychiatry regarding the thousands of research studies that were done with LSD while it was legal that indicated profound benefits, particularly the research out of England on treating alcoholism?

RD: The consensus is that there were some remarkable recoveries but that when you look at the evidence, there were flaws with the meth-odological design in light of our modern understanding of randomized placebo-controlled double-blind studies. The follow-ups were showing that the benefits lasted six months, but they didn’t persist beyond that. The treatment model used back then was what I would characterize as a “one-dose miracle cure.” They tested whether you could give patients one overwhelming experience of LSD to try to produce a spiritual experience, bringing up from people’s unconscious, into awareness, what they were suppressing. This was supposed to help them see the consequences of what they were doing and then help them have this unitive, mystical, connective experience that they could draw strength from. This method could be insufficient without aftercare programs to help people start a new life and refrain from alcoholism on a long-term basis.

And while it did work with some people, the whole treatment model was unrealistically idealistic in the sense that it was this one-dose model. What we understand now is that to really change deep-seated patterns of addiction, personality patterns, pains, depressions, or anxiety, it usually takes more than one session and it takes a lot more focus on the integration process. When people look back at the evidence from prior studies, the results tend to get dismissed as being a psychedelic afterglow that fades over time.

Challenging the Annuity Model

RLM: I’m thinking now of Roland Griffiths, who was on this program. I know in his study they gave psilocybin once, and subjects have had positive results a year later.

If one dose can, on average, help people for six months, that’s phenomenal. When you compare that to the SSRIs and the various medicines that Big Pharma is giving us—where you have to take the medicine every single day for the rest of your life, thereby paying an annuity—to be able to take a medicine once and get a six-month result is truly phenomenal.

RD: Yeah—those were mostly healthy people looking for spiritual experiences, and they did work with cancer patients with anxiety. The research from the past suggests several things. It suggests that LSD and the classic psychedelics can be given safely. It is also preliminary evidence of efficacy sustained over a relatively short period of time and that with a more rigorous methodological design of the studies, and with greater focus on the integration process, these substances could be a remarkable new addition to psychiatry.

Instead of practicing psychiatry, many psychiatrists don’t even study psychotherapy at all and are agents of the pharmaceutical industry. They prescribe medications in fifteen-minute appointments with their patients. They don’t really understand psychotherapy. We’ve also seen that psychoanalysis has had a lot of assumptions that are not scientifically verified, and the “talking cure” only goes so deep for a lot of people. That model has fallen into disrepute among psychiatrists and has left them unprepared for psychedelic-assisted psychotherapy, because they really have to hone their skills in the psychotherapeutic process. So what we’re basically trying to do is introduce a new model that some psychiatrists and psychotherapists will be willing to do. It’s more labor intensive in the short run, but it has the benefits of easing suffering and costing less money in the long run.

Breaking through to Phase III Approval

RD: We will be completing our international series of Phase II pilot studies at the end of 2015, and we will have the primary outcome data from around 105 PTSD patients. We will be able to show that in our experimental conditions that are carefully controlled, with pure MDMA—with lots of preparation and integration, a male-female cotherapist team working with people for the full eight hours, and the whole time of their integration and preparation sessions—under those circumstances we’re able to deliver MDMA psychotherapy without any lasting negative side effects and with remarkable evidence of efficacy.

The evidence is so remarkable, in fact, that we considered applying to the FDA for what is so-called “breakthrough therapy designation.” This is a program to accelerate the development of drugs for serious and life-threatening illnesses for which there’s a large group of patients for whom other available treatments have not worked. Usually it’s for new cancer drugs that have a genetic basis for certain kinds of people with certain genetic histories, and that’s the way in which the FDA can accelerate that. There’s only been one drug for mental illness—for psychiatric purposes—that’s been approved under breakthrough therapy, and it was esketamine, an isomer of ketamine for suicidal refractory depression. So we think we’ve got about a fifty-fifty chance of getting this designation. However, after a meeting with our FDA consultant, we decided that it would be best to just go forward with a standard FDA End of Phase II meeting,^*35 since the remarkable results and high-profile nature of MDMA meant that our application to the FDA would still receive attention and guidance of senior management, and the designs of our Phase II studies weren’t exactly the kind that the FDA wanted to see for breakthrough therapy designation. We decided to take the standard approach.

The End of Phase II meeting is a good way to present the information to the FDA as part of the negotiations for Phase III, which is the studies that count to make a drug into a medicine—the large-scale, multisite, randomized placebo-controlled studies.

We’re anticipating starting those around early 2017. We will be completing them and hopefully getting approval by around 2021. We currently estimate those studies will cost around $22 million. We have raised already about half of the cost in actual money and also have pledges. We recently got $5 million pledged—a million a year for five years—from Dr. Bronner’s Magic Soaps.

There was a time, in recent history, when the people of the world believed the planet was flat; a handful of scientists were demonized for their belief that the world was round. Pythagoras is often credited for establishing the world as round.

There was a time, in recent history, when people believed that the earth revolved around the sun. Then came Galileo.

There was time, quite recently, when people believed that thunder was an expression of God’s anger and lightning bolts were thrown at us by God himself. Then came Benjamin Franklin.

There was a brief period in history, lasting about two thousand years, when people believed that sex was bad and dirty. Then came Kinsey.

We are living in a time when government leaders are still making policies based on self-interest, materialism, morality, ideology, and religion. To advance their irrational beliefs these misguided leaders have been waging a war that has extended to science itself and has cost the lives of patients—denied access to certain medicines called psychedelic—as well as untold numbers of people who have been criminalized for nothing more than ingesting something they were denied access to. We will look back on this period the same way we look back on the period when the world was thought to be flat.

During this present historic period of suppression of science, a small group of scientists around the world persevered in the face of career-consuming obstacles and have brought us life-changing information. It is our good fortune that these scientists have taken the time to sit for the interviews presented in this book and have spoken to us in language readily understandable. The data collected by these scientists clearly informs us that the medicines classified as psychedelic have huge potential both as a healing modality, perhaps only limited by our own creativity in using them, and also as an instrument for consciousness expansion. These psychedelic medicines also provide an avenue in the field of epigenetics, whereby we will go inside ourselves and self-sculpt our very genetic inheritance. We are also reminded, by the scientists, as well as our own observations, that the best of medicines can become a dangerous drug when taken improperly.

As we were editing this book, three thousand people from around the world—many of whom are scientists—gathered in Oakland, California, for the Psychedelic Science Conference sponsored by America’s MAPS and England’s Beckley Foundation. All of the scientists in this book presented one or more papers at the conference.

Information can be suppressed ad nauseam but not ad infinitum.

 

To support research into the therapeutic uses of psychedelic medicines, consider making a donation to MAPS, the Multidisciplinary Association for Psychedelic Studies, a 501(c)(3) nonprofit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana.