An Inside Look At the Long Battle to Legalize Psychedelics: Dr. Rick Doblin, Founder & Executive Director of MAPS
“I know it's hard for people to think about holding on if they're in despair, but there's the possibility of healing coming ahead. Don’t give up hope,” says Dr. Rick Doblin, who has devoted his career to getting MDMA and other psychedelics approved by the FDA. As you’ll hear in this episode of Raise the Line, he could be on the verge of seeing his decades-long dream come true. On the day host Shiv Gaglani spoke to Doblin (January 5, 2023) successful results from a Phase 3 clinical trial of MDMA to treat PTSD were released by the Multidisciplinary Association for Psychedelic Studies – an organization Doblin founded thirty-six years ago. This sets in motion a process that could result in FDA approval of MDMA for this use in 2024. That’s very good news for the millions of Americans with PTSD – and hundreds of millions worldwide – whose disease is resistant to other treatments. One of the next big steps is training therapists to incorporate these drugs into their work, something MAPS and other organizations are moving quickly to accomplish. Tune into this fascinating conversation about the political and social factors that have held up legalization of psychedelics for decades, other promising applications of MDMA, what fuels Doblin’s passion for normalizing the use of these promising medications, and the largest ever conference on psychedelics coming to Denver, Colorado in June. Mentioned in this episode: https://maps.org/ https://psychedelicscience.org/
Shiv Gaglani: Hi. I'm Shiv Gaglani. The New Year brought a landmark moment for the use of psychedelics and mental health treatment. Citizens of Oregon are now allowed to use psilocybin in supervised settings, a first in the United States. This adds momentum to a larger trend of acceptance in the clinical use of psychedelics that's been developing over the past several years in the U.S. But our guest today is not a newcomer to this issue. In fact, he's been leading an effort for the past thirty-six years to gain FDA approval for psychedelics as prescription medicines, and also for developing personal growth spirituality, and creativity.
Dr. Rick Doblin is the founder and executive director of the nonprofit Multidisciplinary Association for Psychedelic Studies, or MAPS, which he has grown from a one-man project to an international pharmaceutical company with nearly 200 full-time staff. MAPS is designing or sponsoring psychedelic psychotherapy drug development research in more than a dozen countries and has raised over $140 million in grants and donations. In 2017, MAPS received FDA breakthrough therapy designation for MDMA-assisted psychotherapy for post-traumatic stress disorder or PTSD.
Full approval for that use case is expected within the next two years. Last year, MAPS shared very promising results of its first Phase 3 clinical trial, which we’ll get into. We're actually speaking the day they released the press release on their second Phase 3 clinical trial, so we're really excited to get into that. So, Dr. Doblin, welcome to Raise the Line, and thanks for taking the time to be with us.
Dr. Rick Doblin: Yeah. Thank you so much. It's a pleasure.
Shiv Gaglani: Before we dive into the clinical trials, which I know our audience would love to hear about, let's learn more about you and your origin story. What got you interested in psychedelics in the first place?
Dr. Rick Doblin: Well, I would say that it was my bar mitzvah that failed to turn me into a man. (laughs)
Shiv Gaglani: (laughs)
Dr. Rick Doblin: So, what I mean by that is that the traditional rites of passage that our culture often offers in different ways, don't often have the power that they used to. I felt that I was left wanting more. When I first started taking psychedelics, when I was seventeen, they brought me to confront who I was, what was my place in the world, how do I deal with my emotions, and I felt like psychedelics were the bar mitzvah that I should have had. That's one part.
The other part is that I was raised by a very politically progressive parents. They helped me to understand that I was just a link in a chain and that the chain going back several generations had been immigrants. On my mother's side, from 1880, from Russia, escaping antisemitism. Then my grandfather on my dad's side came over in 1920 from Poland, also escaping. So, they were immigrants coming with nothing, and then the American dream, the opportunities here.
I was trained and given the freedom to look at deeper threats than finding enough money for food and shelter. I was told early on about stories of the Holocaust that just horrified me and I felt like, "How can people be so willing to dehumanize and murder others?" That that was a flaw in the human psyche...that we could do that to each other.
Then, I was a young boy during the Cuban Missile Crisis. I thought, "Okay, now the whole world could blow up." Kids these days have active shooter drills but this was drills in case the nuclear bombs fell. And then finally, I was in one of the last years of the lottery for Vietnam. That was my own country doing terrible things. So, I felt like, "What is my response to all of this?"
When I first tried psychedelics, I had this idea that this sense of going beyond the ego, of connecting to everything, feeling part of something bigger...that if everybody felt that, then it would be more difficult to dehumanize others. That would be the antidote to fundamentalism, to genocide, to environmental destruction, this kind of unitive mystical experience that the classic psychedelic could give you. I also learned about their incredible therapeutic potential to help us see through our traumas, work through depression.
When I was eighteen years old, I went to the guidance counselor in my first year of college and said, "My psychedelic experiences are becoming a lot more important to me than my classes. Would you help me deal with them because I'm having a hard time. I'm not good with my emotions. I'm scared. I'm not able to process, to really let go." My guidance counselor gave me a book to read, which was Realms of the Human Unconscious: Observations from LSD Research by Dr. Stanislav Grof. It was reading that book that led me to decide, yes, I will focus my life on psychedelics. So, that's my origin story.
Shiv Gaglani: That's amazing. We had the pleasure of speaking to Jim Fadiman on Raise the Line, who I'm sure you well know.
Dr. Rick Doblin: Oh, great!
Shiv Gaglani: He's been dubbed the "Father of Microdosing" and hearing his origin story and reading his book "The Psychedelic Explorer's Guide" first got me personally interested in the field. But how do you go from being that eighteen-year-old getting interested in psychedelics and what it can do in terms of human flourishing to then go to Harvard’s Kennedy School and received your Doctorate in Public Policy. It was there you wrote your dissertation on how psychedelics could get FDA approval, which it seems like you've turned into reality in an incredible way. So, can you give us maybe a little context on how you went about adding the academic bent to it and legitimizing it?
Dr. Rick Doblin: I dropped out of college when I was eighteen. This was not too long after Timothy Leary’s “turn on, tune in, drop out.” I did feel that I was overdeveloped intellectually and underdeveloped emotionally and spiritually, and I felt that the world was like that, too. That we have all these technologies but as humans, we're still very primitive and we don't have the emotional and spiritual capacity to deal with the technologies that we have. Hence, we're destroying the world and wiping out the environment and species and things like that.
When I decided to focus on psychedelics and dropped out of college -- it was right after the backlash against psychedelics, the Controlled Substances Act of 1970 – it was because I wasn't mature enough. I had to do my own healing and that took me ten years but I always knew I would go back to school to study to become a psychedelic therapist. It took me ten years of getting grounded, building houses, being in the physical world, trying to put ideas in my head out into the world and seeing the flaws of my thinking.
Ten years after I dropped out, in 1982, I went back to school as a twenty-eight-year-old freshman in college. My first semester, I went out to Esalen in Big Sur, California to study with Stan and Christina Grof. I had done a workshop with Stan in 1972. So, for ten years, I was on my own, then I go back to start my school and during this workshop is when this woman Debbie Harlow came by Esalen. She wasn't in the workshop but she said there was this new drug called adam, and it was terrific, and it turned out that this was MDMA.
She told me about it and I initially was not that enthused. She said it helps you feel love, it helps you feel connection, helps you be a better listener, opens your heart. I figured, "Hey, I already am in love, and I'm a good listener and blah blah." And then, I saw a group of people sitting in a circle doing MDMA, and I was like, "But, hey, they're talking to each other. How profound can this be?" At that time a dose of LSD was 250 micrograms -- now, it's more like sixty or seventy micrograms -- so, this idea of going beyond ability to talk, dissolving your ego, that's where I thought the action was. So, when I saw people talking under MDMA, I was like, "It can't be that profound." But I like to say that I was stupid enough to underestimate it, but smart enough to buy some. When I took it home and did it with my girlfriend, I was just shocked how profound it was, how incredible.
I did go through this process of getting an undergraduate degree in Humanistic Transpersonal Psychology and Psychedelic Research. I graduated in 1987 and I wanted to get into a clinical psych PhD program to learn how to do psychotherapy outcome research, but nobody would let me in when I told them I wanted to study MDMA. That had just been criminalized in 1985, and psychedelic research had been wiped out by the FDA for almost two decades at that point. I didn't know what to do. I went home and decided I would smoke some pot and think about it.
During this period of being high -- my mind may have got this idea some other time -- I realized that I wanted too much too soon: that I wanted to do the research but the politics were in the way. I said, "Okay. Then I just have to study the politics." So, that's how I switched from training to be a therapist and applied to the Kennedy School.
I asked a drug policy expert named Mark Kleiman if he would be my mentor. He said, "Yeah, if you can get in.” So, I managed to get into the Kennedy School. I wanted to see how legit I can be. At the Kennedy School, there's a program for people that want careers in the federal government that was called the Presidential Management Fellowship. It’s highly competitive and I managed to get it and I wanted a job at the FDA. My application landed at the FDA just at the time that the group at FDA that regulated psychedelics was switching from the group that had blocked it for twenty years to a new group that was going to open it up, and I almost got the job. I went through all this vetting and at the last minute, the DEA said that they would refuse to work with me because I previously sued them.
I was willing to wear a suit and tie and give up drugs to go work inside the FDA. So, the DEA helped me not give up drugs. I'll have to thank the DEA for that. That's when I realized I need more credibility, and that's when I decided that I would go then on for the PhD.
Shiv Gaglani: Well, many people have a lot to thank that the DEA intervened at that point, I think, because of the work you've done since. Let's fast forward a bit to MAPS. What are some of the milestones MAPS has achieved? I'll let you talk about this last Phase 3 and then now the new Phase 3 studies because I think that's really exciting for our audience to learn about.
Dr. Rick Doblin: Super fast, I'll start in 1986 when I started MAPS. We had five protocols all rejected by the FDA. The first milestone was 1992, when the FDA reviewed our protocol to study the therapeutic use of MDMA and they decided that they needed to have a special advisory committee meeting to decide whether they would open the door to psychedelic research. They decided that they would do that, and that they would regulate psychedelics the way they regulated the other drug, which meant that we couldn't start with therapy, we had to start with a Phase 1 dose response safety study. That was with Dr. Charles Grob at Harbor-UCLA. That was 1992. That took through the nineties.
Then, in 2000, we started the first study with PTSD and that was in Spain. The heartbreaking part of that is we had just started the study and then we got some good publicity, and the Madrid anti-drug authority got upset and shut the study down. We weren't powerful enough to open the study up again.
It wasn't till around 2003-2004 that we were able to start MDMA research in the U.S. That took us until November 29, 2016, where we had what's called the end of Phase 2 meeting with the FDA. We've done six, Phase 2 studies in the U.S., Israel, Canada and Switzerland. The purpose Phase 2 is to figure out how to design Phase 3, which are the large scale placebo controlled randomized studies to prove safety and efficacy. So, we negotiated those designs in 2017 to 2018. We started the first Phase 3 study in May 10, 2020. We published the results in Nature Medicine, and the results were outstanding.
Then, we started the second Phase 3 study and we just sent out the press release this morning about that. The second Phase 3 study was successful. Similar results to the first Phase 3 study. The first one is called pivotal, the second is called confirmatory. Now, we're anticipating submitting the application to the FDA for what's called the new drug application by July or so of 2023 that we hope to have approval for by May or something of 2024. So, that's the overview but the results are incredible.
I'll just say very quickly that we felt that we had to work with the people that had the most extreme PTSD because of the stigma of psychedelics. We had to work with people that had PTSD for a long time, chronic PTSD, and severe PTSD in our first study. And what we showed is that at the two-month follow up, 32% of the people who got therapy without MDMA no longer had a diagnosis of PTSD -- so, the therapy was really pretty good by itself -- but 67% of people who got therapy plus MDMA no longer had a PTSD diagnosis, and another 21% had what is called clinically significant reductions of PTSD. So, we had an 88% response rate, which is great.
These people had PTSD on the average of over fourteen years, and one-third had PTSD for over twenty years.
One of the things we learned in Phase 2 is that our therapy works regardless of the cause of PTSD. The drugs that are approved by FDA for PTSD -- Zoloft and Paxil -- were better in women than in men and failed in combat related PTSD. But we showed that it worked equally in men and women, with complex PTSD from childhood, and with war-related PTSD, as well. So, in the second Phase 3 study, we decided that we would work with moderate to severe cases to just broaden it out so that it wouldn’t be just for the people with the most difficult PTSD, even though moderate is very debilitating. The results were tremendous, as well.
I think the message that I'd like people to hear is that while it's still going to take us time to get this out as a prescription drug -- if we are fortunate enough to get FDA approval -- people should have hope. Don't give up. There's a large number of people that commit suicide from PTSD or from depression. We had over 100,000 people in America die from opioid related overdoses with fentanyl. A lot of that is people running away from trauma...a lot of alcoholism or drug abuse is people running away from trauma. I really want people to understand that there are healing potentials, healing technologies that we are working on to become more available, to mainstream them and have them covered by insurance. I know it's hard for people to think about holding on if they're in despair or something, but there's the possibility of healing coming ahead.
Shiv Gaglani: That's a very important message and I hope it gets across to our audience and then their patients by way of our audience because it does seem imminent and hopefully, the FDA views these results in a very positive light.
I heard about the results of the first Phase 3 trial through two Osmosis connections that I'll give a quick shout-out to. The first is, James Acer, one of the chiefs of staff at MAPS. He is actually the cousin of one of our longtime teammates, Hillary Acer. So, he presented some of those results when I talked to him. The second is our board member, Mitch, who's very instrumental to Osmosis' growth and the fact that now we reach millions of students and professionals all around the world. I know that his wife, Dr. Rachel Yehuda at Mount Sinai, is one you're collaborators and good friends.
Dr. Rick Doblin: Oh, yes! Yeah!
Shiv Gaglani: So we definitely are excited from a personal perspective and obviously for what it means for our providers and patients. So, what advice would you give to our audience of healthcare professionals students if they're interested in getting into this career and/or in general, what career advice would you give them?
Dr. Doblin: Well, the most important thing I would say is that what we're talking about is really therapy. It's not psychedelics by themselves. It's therapy that the psychedelics make more effective. So, we really want to work with trained therapists. There's a lot of different opportunities for training. Learn how to be a good therapist, and then take some of these specialized trainings that we offer that the other groups that are working with psilocybin will offer.
There's a Jungian archetype that I think many of your people might be aware of called the "wounded healer.” It's about people that have had various wounds and have learned how to heal themselves, and those are the people that have the most compassion and capacity to heal others because they've done it themselves, in certain ways. I think people should really think about going through their own therapy.
There's another big issue, which is, you wouldn’t go to a meditation teacher that never meditated, or a yoga teacher that didn't do yoga. So, I'd say that the best training that you could get is to have your own psychedelic experiences and see how hard they can be, or how opening they can be, or what results come from that, or what the fears are. We do have several approved protocols from the FDA where we can give MDMA to therapists as part of their training.
Right now, there are certain places like Oregon, which has just opened up a program for people to access psilocybin. And a similar program -- but for a wider range of psychedelics -- was approved on the ballot in Colorado this recent election. So, there's other places around the world where you could go for legal experiences. I’d encourage people to really do their own work and to really pay a lot of attention to your dreams. Jung, as far as we know, never did a psychedelic but he had just incredible access to his unconscious through his dreams and through other meditations. So, I think the key thing is therapists are their own instrument. You need to refine your instrument and face your own fears, do your own work, and that will really build the strength for you to work and help with other people.
Shiv Gaglani: Absolutely, and we have certainly have a lot more wounded healers now than we did even three years ago given all the stressors that people went through with the pandemic. Are you finding that in the work you do at MAPS in these clinical trials, that you're getting former nurses, doctors and therapists who've maybe experienced PTSD or been burned out leaving the workforce? One of the things we're most excited about is how you keep these healers in the workforce without having them burn out or commit suicide.
Dr. Rick Doblin: Well, if you're paying attention to what's going on in the world right now -- with climate change, species extinction, violence, authoritarianism -- we're all exposed to enormous amounts of stress and fear and anxiety. So, there's no such thing really as a "healthy normal.” We all have our own issues and we’re in an unhealthy system.
One of the benefits of COVID-19 is people have realized how we're all connected. Viruses just spread globally, incredibly. One of the other parts is that people have realized just how prevalent mental illness is. There's more of an appreciation for the need to treat anxiety, depression, fear or phobias. They say it's darkest before the dawn. There's a lot of challenges right now, and at the same time, that's creating opportunities.
That's why I think we're able to bring back psychedelics now, in large part because of the veterans. We have bipartisan support, and we've been able to do this without getting it wrapped up in the culture wars. The backlash fifty years ago was about psychedelics being used by hippies protesting Vietnam. It was the classic “counterculture versus the culture”: the culture wins and smashes the counterculture, which wipes out psychedelic research. Now, we're trying to bring it back for everybody, regardless of their political persuasion, and I think we've pretty much succeeded in making this a bipartisan issue working with psychedelics for mental health.
So, I'd just like to encourage people to think about this as a modality. The key issue for scaling is the number of therapists. There's twelve million PTSD patients in America. We're hoping to train 25,000 therapists in this decade. So, to the extent that people that are listening want to really become psychedelic therapists, I think it’s an enormous opportunity for a career.
Shiv Gaglani: Absolutely. You mentioned MAPS offers this training and you're trying to train 25,000 over the next decade. What other kinds of scaling limitations are there to bring this to the twelve million PTSD patients in the U.S., not to mention the ones with depression or alcohol-use disorder?
Dr. Rick Doblin: Well, and all over the world. There's 350 million people with PTSD in the world at least, and that doesn't count all these refugees from Ukraine and all that's going on elsewhere. There's just an enormous amount of need. One of the things that Rachel Yehuda has done, which is very instructive, is looked at multi-generational trauma and epigenetics in PTSD. So, that's a major issue...that you could pass on certain aspects of trauma, like your set points for anxiety and depression, to the next generation. This helps explain why conflicts can go on for 1,000 years between different groups. There's this multi-generational aspect.
I think what we're going to really hope for is that not only will we train therapists but we're also very interested in drug policy reform. These drugs should be legal, they should be available to people in some sort of licensed, legalization or other format. What we need to do is embed in the wider culture this idea of how to handle psychedelic experiences, and how to work with your own inner energies.
We talk about psychedelic harm reduction or training people for preparing for their own issues. We have a psychedelic fundamentals course that people might want to go through the MAPS website, which is a good educational introduction to psychedelics. Our treatment manual, particularly for your audience, is up on the MAPS website. It describes our therapeutic approach. So, if you just go to maps.org and you put in treatment manual, you'll see the sixty-page document that describes how our therapists deliver the therapy.
There are many other ways to do it, too. We're now working with researchers inside the VA to blend MDMA with prolonged-exposure cognitive behavioral therapy. We're hoping to start studies with EMDR and MDMA. MDMA is a tool that can help many different therapeutic modalities. For students or people wanting to learn this, just learn any way you can and then bring that into what you learned about psychedelics. The other big category that we're just at the beginning of is studying group therapy. We haven't started that yet, but we'll start at the Portland, Oregon VA in a couple of months.
Shiv Gaglani: That's awesome. Well, we're really excited to follow the journey. We'll link out to those resources in our show notes and encourage our audience to go check it out as well because it's definitely an interesting space that captured the public's imagination in large part because of the great research you and your team have been doing.
I'm respectful of your time, so is there anything else that you want to get across to our audience about you, MAPS, and psychedelics in general?
Dr. Rick Doblin: Well, how does social change really happen? Let's look at gay rights, gay marriage...it's because people came out. So, we need a massive psychedelic coming out. For those people that are listening that have had positive or maybe even negative experiences with psychedelics, I think it's important to share them with others to help normalize this.
We are having the world's largest conference on psychedelics ever, June 19th to 23rd, 2023 in Denver. We have the entire Denver convention center and we're hoping for up to 10,000 people. You can go to psychedelicscience.org and get all the information about the conference. We want it to be this coming out in the culture. Everybody has a role to play and if you learn what you can, and then even try to find the people that are the most frightened of psychedelics and see if you can help them balance what they know...replacing fear with facts.
Shiv Gaglani: Well, that's incredible. We'll definitely look for that conference and encourage our audience to attend that. My background -- just so you know -- I started med school at Hopkins for two years, then left to start Osmosis and grew that to a couple of million users. Now, I'm going back to Hopkins, in large part because I want to go work and do some elective research at the Center for Psychedelic Studies there with Roland Griffiths, who I know you know well. I know Roland Griffiths has Stage 4 cancer.
Dr. Rick Doblin: Oh. Yeah. Wow. Do you have any particular thoughts about what you want to study? Or what you'd like to research?
Shiv Gaglani: I love the psilocybin research for end-of-life care. It was very exciting to me to learn about having people go through ego death and accepting death more and how would that change their anxiety around it. But, certainly, substance-use disorders and couples therapy are kind of top of mind for what MDMA, plus other psychedelics, could potentially help people with.
Dr. Rick Doblin: Oh, that's great. MDMA for a couple's therapy is fantastic.
Shiv Gaglani: Yeah, for sure. So again, I’m really thrilled to have you on the podcast, Dr. Doblin, and appreciate all of the work you've been doing over the past several decades to get us to this point.
Dr. Rick Doblin: Well, I'm so proud that you're going back to studying more about psychedelics, that's great.
Shiv Gaglani: For sure, I'm sure I'll be in touch and hopefully Osmosis can be a conduit to get this even more mainstream within the healthcare professional audience.
Dr. Rick Doblin: I'll say that one of the things at the Psychedelic Science conference is we're going to have a special dinner to honor Roland, and we're hoping that he could be there. We don't know if he will be able to be there or not, but we're going to have a tribute to Roland at Psychedelic Science.
Shiv Gaglani: That would be very special. He, you, Dr. Yehuda, and several others have made a huge mark in the field.
Dr. Rick Doblin: Yeah.
Shiv Gaglani: Well with that Dr. Doblin, thanks for taking the time to be with us today and more importantly, for the work that you've done over the past decades, to raise the line and strengthen our healthcare system.
Dr. Rick Doblin: It's great that we're celebrating on the day that we sent out this press release about our second study. Very timely.
Shiv Gaglani: Very timely. Thank you again.