← Extend Podcast with Darshan Shah, MD
Extend Podcast with Darshan Shah, MD
153. Dr. Rick Doblin - Part 1: Psychedelics, MDMA Therapy, and the Future of Mental Health
01:03:37
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- [00:03]
A
Welcome to Xtend with me, Dr. Darshan Shah. A podcast dedicated to cutting edge science research tools and protocols designed to help you extend your health span. Having become one of the youngest doctors in the country at the age of 21 and trained and board certified at the Mayo Clinic, I've accumulated three decades of practice as a board certified surgeon and longevity expert. Over that time, I've discovered that a mere 20% of health knowledge yields 80% of the results. When it comes to your health span, we are living in a new era where we are creating a new healthcare system no longer focused on disease management, but achieving optimal health and vitality. Join me as I interview world renowned experts offering you a step by step guide to proactively avoid disease and most importantly, extend your health span. Mental health conditions like ptsd, depression and trauma remain difficult to treat with the traditional approaches used alone. There's emerging research that suggests a psychedelic assisted therapies may offer a new path forward by combining neuroscience, psychotherapy and carefully guided experiences. In this episode of xtend, I'm joined by a giant in the field, Rick Doblin, PhD. He's the founder and president of MAPS, the Multidisciplinary association for Psychedelic Studies. Since he founded MAPS back in 1986, Rick has dedicated 40 years to developing medical, legal and cultural contacts with psychedelics and marijuana, sponsoring the most advanced psychedelic assisted therapy research in the world. We're going to unpack the science, history and future of psychedelic therapy. We explore how MDMA assisted therapy works for ptsd, how psychedelics influence neuroplasticity and emotional processing, and and why preparation, context and integration are essential for safe and effective outcomes. So if you're serious about longevity, you need to understand this. You cannot separate mental health from your metabolic health. And you can't optimize performance while your nervous system stays dysregulated. What we're talking about is the frontier of healing, trauma, addiction and mental health at its root causes. This episode of Rick Doblin, who's a giant in the field, like I said earlier, is incredibly important because I get asked almost every single time I take stage or in my comments on podcasts, when are you going to talk about psychedelics? So I went right to the top. Rick Doblin breaks it down for us and he was gracious enough to give me two hours plus of his time. So we're going to split this episode up into two segments, part one and part two. It's that important. I don't want you to miss a minute of this conversation and and so I truly hope you enjoy this episode and also the next episode. Thank you, Rick. Thank you so much for doing this with me.
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B
Yeah, no, I'm so glad, because, you know, one of the sayings that I've learned a lot from recently is that politics is downstream from culture, but so is science. And so I think trying to educate the culture, educate people, is really critical, particularly for controversial research like psychedelics have been.
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A
Right. It's so incredible the work you've been doing for so many years in this field. And I just, you know, I met you in Dubai. I don't know if you remember, I immediately ran up to you after I said, please come on my podcast because it's such an important topic. And, you know, for years, we. I went to Medical School 30 years ago, and in medical school, and even after medical school, I was told that psychedelics, no go. You know, this is not something that we should consider.
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B
Right.
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Closest you're going to get to it is ketamine for anesthesia. And the otherwise, they're just drugs. You know, they got thrown into the bucket of the war on drugs for many years.
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B
Well, and the word hallucinogen is a pejorative, negative term because it's unreal, it's fake, it's a hallucination. It's distortion, it's intoxication.
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A
Yeah, yeah, yeah.
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B
But it was really political. The suppression was not based on the science. It was based on the Baltics.
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A
What do you mean by that? I would love to dive into kind of the history of psychedelics and specifically psychedelics and medicine, but let's talk about that.
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B
Okay, well, from the more recent history with the psychedelics really flowering during the 1960s in the United States, there's a fellow named John Haldeman who was Nixon's domestic policy advisor, and he's got this famous quote from, I think it was 1979 to Dan Baum, a reporter, and he said that the two main enemies of the Nixon White House were the hippies and the civil rights movement. He said since he couldn't stop them from protesting, he could criminalize the drugs that they were using and then use that to arrest the leaders, bust up the meetings, demonize them. And then John Erlkerman says, did we know we are exaggerating the risks of these drugs? Of course we did. So it was psychedelics connected to the anti war, anti Vietnam War protests, to the counterculture that caused the backlash. It wasn't because the science was showing that these were so dangerous or that they couldn't. And then There was all these myths about how psychedelics will hurt your chromosomes.
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A
Right, right.
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B
It's incredible how powerful these myths are. So I went to my wife. We've been married now since 1993, but our first date sort of was in 1989. And she wanted to talk to me about a mushroom trip she had in college. And so we went out to lunch and we had. I helped her, she says I helped her think about this mushroom trip. But then she said, I just want to let you know that I'd never want to have a real relationship with anybody like you.
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A
Like, what does that mean?
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B
I'm like, yeah, what's wrong with me? She said, well, your chromosomes must be so screwed up from all the LSD you took. Gosh, this was a smart woman at the Kennedy School of Government. And I'm like, you believe this? But it's just incredible, the myths. And then I was raised in the 60s and told that if you take LSD five or six times, that's enough to be certifiably insane.
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A
Oh, my gosh, you could commit any
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B
crime you wanted because you're certifiably insane from doing five or six times of lsd.
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A
Wow.
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B
So these were the kind of propaganda. So it was really politics, not based on the science.
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A
Yeah. I was gonna say these are myths, but it sounds like more like propaganda to achieve a political goal of the Nixon era, of the Nixon presidency, really. That's when everything kind of unravels.
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B
But if we go back in history.
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A
Please, yes.
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B
So the Western culture that we think of as Western civilization really goes back to the Greeks. And that's where democracy and philosophy and all these things were created. And one of the things that the Greeks had, the longest running mystery ceremony that we know of in the history of the world was. Was the Eleusinian mysteries for roughly 2000 years, from 1600 BC to 396 AD and everybody that we know of in terms of the Greek culture, Socrates, Plato, Pythagoras, Aristotle, all these people participated in the Eleusinian Mysteries that had a psychedelic component. They drank a potion called Kykeon, and then they would walk a certain distance to. And then they would have this ceremony that they could not talk about under pain of death. You couldn't say what was in it. And they were so, in their minds, enlightened that they permitted women and slaves to participate in this, not just the men in these ceremonies. And they were this core of their culture in a way. It's like the secret of life and death, sort of the Death, rebirth story that we're both our individual lives from birth to death, but we're part of something much more larger and something is continuing in some ways. And so for the first couple hundred years of Christianity, the sort of pagan ceremonies with psychedelics at Eleusis coexisted with the development of the Christian church. But eventually the Christian church was like, we don't want you to have these direct experiences. We are the intermediary between you and spirit and God. The priests are the intermediaries. And therefore they crushed the Eleusinian Mysteries in 396 is when they destroyed Eleusis.
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A
Wow.
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B
So that's really the first prohibition against psychedelics. Psychedelics have been used for thousands of years.
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A
Once again, it sounds political, completely political.
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B
And then what happened was over the Middle Ages, over time, we know about the burning of the witches. These were also people that were very much connected to plant medicines and psychedelics. And then the conquistadors, when they started coming into the New World, the first people that they wanted to kill were the shamans, because they were the core of the kings or the shamans. And so they said, oh, if you're under the influence of peyote, that's like the devil and the mushroom. So the sort of peyote and mushrooms went underground. So it's just this continual pattern where psychedelics can help you have a direct experience and different authoritarian kind of religious groups and others want to be the intermediary. And so it's been continual. And then we have this re emergence in the 1960s in a big way in America. And again, the politics.
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A
It's crazy how history just keeps repeating itself over and over again.
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B
It does well. And one of the things that was, you know, we're here right, in Cambridge, where Timothy Leary was. But one of the main things that Timothy Leary said was think for yourself and question authority. And that was the motto, in a way of the counterculture. And that's not good from the power system. They don't want you. So there was this whole kind of conflict. And so the challenge now, here we are in 2026, how do we bring forth psychedelics in a way that doesn't sort of trigger an immune response from the culture?
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Yes.
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B
And so that's been a lot of the work that I've been trying to do. And that's where I went from deciding in 1972, when I was 18, that I would focus my life in psychedelics and then deciding in 1988 that when I was unable to get into a clinical psych PhD program because I wanted to study psychotherapy outcome research and demonstrate that psychedelics would have potential there. But MDMA had been criminalized in 1985, so nobody would let me in to get A Clinical Psych PhD on psychedelic psychotherapy outcome research.
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And.
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And that's where I realized I should add under the influence of marijuana when I'm stuck. Marijuana is really good for thinking out of the box, for being creative. So I had this moment where I remember exactly where I was. I had just gotten these rejections from all the clinical psych PhD programs. And I'm sitting in Florida in my house, and I'm smoking marijuana, and I'm thinking, I'm gonna figure out what can I do? And I realized that the pattern I had was I want too much too soon. And in this case, I want to do the science, but the politics is blocking the science. So therefore, I have to switch to study the politics. And that's what led me to the Kennedy School to get my master's and PhD from there. So what I felt that I've been doing is moving from individual therapy to cultural therapy.
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Right, right, absolutely.
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B
And that's why talking to you in the podcast, that's so important.
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A
It's so important. Right. Because we are at a good moment now, I think, again, hopefully she doesn't repeat itself again. But, you know, you've been a huge proponent about pushing the science and then bringing this to clinical psychology as well.
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B
Yeah.
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And I think once we cross that bridge where these are actually looked at as therapeutic interventions, and, you know, they'll start off as prescriptions as well for those interventions. I think at that point, hopefully, it's a train that can't be stopped in the right direction.
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B
I think. So. I think that. But. But I would add that my work has been a little bit more controversial because I've had two parallel paths. And I'll say, what is the real goal? The real goal for me is a more spiritualized humanity, a more mentally healthy humanity, a way where we celebrate differences rather than use them to persecute people or to go after immigrants or anything like that. So it requires a shift in consciousness on a large level. And so what that means is we both have to do the science and medicalize, but we also have to work on drug policy reform. And it shouldn't be just for treating illness. It should also be preventative medicine. It should also be for wellness. So one of the really exciting things that MAPS is going to be doing, and it's basically, I started maps in 86. So now we're 40 years. 40 years into it. It's taken 40 years to reach this point where we're starting to do final design and fundraising for a study of MDMA for couples therapy.
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Right. That's gonna be huge.
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B
It's one of the best uses of it, but it's not a disorder. And so it's about wellness, it's about flourishing. It's about looking at the positive side of things. And so the FDA has never approved a drug in psychiatry for something that wasn't a DSM diagnosis, but there's nothing in the law that blocks them from doing so. Not only are we going to do so, the sweet spot of Maps is sort of the science, politics connection.
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A
That's great to realize that, because you are kind of playing both. I guess one's more like a means to an end as well. Once you get it into psychiatric intervention, then you can then take a step towards more global usage of it for other things like marriage therapy or just. Even just expanding your mindset, becoming more creative. All those other uses of it that we all know could be extremely beneficial for humans.
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B
Yeah. I mean, the medicine route, it has to make sense in its own right. We have to demonstrate safety and efficacy, but that's not the end goal.
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Right, right.
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And I'll say one of the things that's been really surprising is the rise of the psychedelic churches.
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Yeah, let's talk about that a little bit.
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B
Yeah. Because what we have, this is sort of the. The other side of the rise of the religious right. So now in America, you can discriminate against people based on your religion. So if you're. The classic case was a baker who didn't want to bake a cake for a gay wedding.
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Right, right.
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All right. So now you don't have to do that. The law says you can discriminate against people based on your religion.
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Right.
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So you can do all sorts of things now in the name of religion. You don't have to go to public schools. You can even get public money now in some places for religious schools.
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Sure.
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So the concern now has been that the support for religious freedom has grown in such a way that now people can say, I have a new religion with psychedelics as the center of it. And so there's hundreds of psychedelic churches throughout the United States, and there's no real persecution of it because of the fear that in courts, because of this rise of protection of your religious freedom, that it would be demonstrated that you do have the right to do it. So the Native American church Use of peyote has gone to the U.S. supreme Court. This was quite a while ago. And they won the use of peyote, but it was limited to this one religion. Then a little bit more, about 12 years ago, the ayahuasca, the Uno de vegetal, went also to the US Supreme Court and they won again that they could practice their religion. And then Santo Daimy, which is another ayahuasca church, went up to the 9th Circuit and then the government didn't appeal. And then there's a new psychedelic church, the Eagle and the Condor, that just was newly created. But my favorite and again favorite because of access. It's called the Church of Ambrosia. It's a mushroom church, but it has other sacraments too. It has 130,000 members. It's in Oakland, California. They sell 90 pounds of mushrooms per month, which is a very lot. And they don't have services. You go to the church, which is a storefront, to buy the mushrooms and then they give you a little booklet about how to have a spiritual experience. And then you take it home and you do it at home. So there's kind of both the medical route, the psychedelic churches route, and then there's the state level reforms. So Oregon has passed the Oregon psilocybin initiative and 18,000 people have now received MDM. I mean, psilocybin in Oregon in the last three or four years.
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Okay.
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And it's more than all of the people that have received psilocybin in clinical research in the last 25 years.
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Yeah.
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Colorado has just approved natural plant medicines. We've got other states that are starting to do it. New Jersey's putting $5 million into psilocybin research. New Mexico is approving psilocybin research. So there's state level reforms and then there's drug decriminalization in different ways. So there's a lot of ways to provide access. But what I think is really important for people to know is that it's the context that matters more than the substance. So we're not saying that psychedelics are automatically healing. Psychedelics can be disorienting. They can take you and make you worse off or they can make you better off. But it's the safe and supportive context that really matters. So really when we are trying to bring this forward, we're saying it's the psychotherapy as a medicine that makes the major difference. Now there's also interesting work trying to develop non psychedelic psychedelics. And so what I mean by that is that psychedelics promote A neuroplasticity. One of the ways that they work is they. Well, there is Gould Dolan, a researcher, she was at Hopkins, now she's at UC Berkeley. And she's done work with octopuses, giving octopuses MDMA and then they're more pro social. She's done work with mice and you give MDMA to a mouse and it releases oxytocin and that promotes new neural connections in pro social areas of the brain. So there's this whole neuroplasticity and people are thinking maybe if you've got a stroke or if you've had some kind of brain cancer or something like that, maybe you can have a pill that helps you route around the damaged parts of your brain without you getting psychedelic. Which I think is perfectly legitimate to try to. Yeah, I mean, I think what we need is clinicians need to have all the tools to help people in all different ways. And some people will want the subjective experience and some people won't. I'll say how my first understanding of non psychedelics happened, which was there's a disorder called cluster headaches.
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A
Oh, yes, I know. Cluster headaches.
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B
Okay. And it's terrible. It's worse than migraines sometimes.
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A
It's horrible. Right.
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They call it suicide headaches. So this was a 2003, and there's a group called Cluster Busters that is of cluster headache sufferers. And they had discovered inadvertently that if you take psilocybin or lsd, it can get you out of a cycle of cluster headaches and delay the return of the next cycle.
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Oh, wow. Okay.
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And so they contacted me and said, we don't want to be criminals anymore. Can you do research?
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Yeah.
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And I was doing a lot of work at McLean Hospital with looking at the risks of MDMA and other things. And they were interested in doing this work with cluster headaches. So the first thing that they did was get a bunch of people with their medical records and verified they had cluster headaches. And then where did they take LSD or psilocybin? Usually it was going to a party or something. And then how did that impact their cluster addicts? So the next step was going to be to do an actual study with LSD or psilocybin. And the people at McLean were like, oh no, Timothy Leary's been here. It's too controversial. We'll only do the research with LSD or psilocybin if it's the last resort, only if nothing else works. So the two researchers, John Halperin here and Torsten Passe, at the University of Hanover were working together on this and they said, there's Bromo lsd, which is a non psychedelic version of lsd. Really, you add this Bromo molecule to LSD and it knocks out the psychedelic component.
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Ah, interesting. Okay.
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And so they said, here's what our plan is. We're going to do a study of Bromo LSD for cluster headaches. And then it won't work. And because we have no idea why it works. But why should LSD or psilocybin work? It must have something to do with the part that gives you the psychedelic experience. I said, we'll do this project with Bromo lsd, it won't work. And then we'll come back and we'll do LSD or psilocybin. I said, great idea. So they did this project and I kept waiting, what's the results? What's the result? And they weren't telling me. I'm like, what's going on? Finally they said they didn't want to tell me because they thought I would be terribly disappointed because it worked.
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A
It worked.
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Not only did it work, it works better than LSD or psilocybin.
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A
Really? Yeah.
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B
Because you can give it in grams.
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Yeah.
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Whereas LSD is micrograms.
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Yeah. Because of the effects. Right?
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Yes, milligrams. So whatever it does, it fluctuates, floods the brain and it works. So that was the first example I'd ever seen of a non psychedelic psychedelic being helpful.
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A
So I mean, it just reinforces the point that these are molecules that have an effect on the brain way beyond the psychedelic experience. So maybe the psychedelic experience is a side effect of if you're using it for a treatment like this.
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Well, in certain cases I think that's right. On the other hand, I would say, and this is also why it's so good that we're talking and doing this public education part is what we like to say is that the regulators need data, but people need stories.
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Yes, for sure.
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And so this idea that when you have a psychedelic experience, you're sort of telling yourself a new version of the story of your life, you're seeing different parts of it, you're seeing different kinds of emotions, you're able to feel deeply, you're often able to see yourself through the eyes of other people, even if it's perpetrators or things like that. So that there is this storytelling aspect to it that I think is what really matters to us. Where is our place in the universe? People have all sorts of incredible imagery and metaphors that help in their healing process. So I think there will be a role for non psychedelic psychedelics, but I do think that the psychedelic component of it is going to continue for, you know, it's been thousands of years. It will continue because it helps us to reframe what is the story of our lives.
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A
Right, right. It's a very important component of it. But it just to me, this aspect of the non psychedelic psychedelics being used for something like treatment, headache, posture, headaches, treatment, maybe there's a role for non psychedelic versions of like, for example, you know, ketamine or psilocybin for depression. I think that's another way to look at these molecules a little bit differently and apply more science to it rather than just discounting them as a weird experience.
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B
I think why they have such long term effect is because of this neuroplasticity.
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Absolutely.
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I mean, because we can go to a movie and see a story or have a dream sometimes and see a story, but it's this neuroplasticity combined with the story that makes it have long term impact.
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So let's talk about that a little bit more. I'd like to dive a little bit deeper because when my patients ask me about recreational use of psychedelics.
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B
Right.
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And I say, you really want to be careful because of what you were mentioning earlier, the context. If you do it in a situation where you don't feel safe, where you're stressed, where there's something else going on that could be negative, the neuroplasticity, it doesn't discriminate between good and bad connections, just forms more connections between neurons.
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B
Right.
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A
And so a bad trip can be something that follows you for many years.
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B
Oh, decades and decades. I mean, in fact, there's a fair number of people that say that they don't like smoking marijuana because it brings them back to difficult trips that they had before.
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A
Sure.
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B
So it doesn't just go away. And so I think that this, the long term impact of it is really important. One of the first ever research that I did was when I was a college student at New College in Sarasota, Florida and you had to do a senior thesis and I did a 25 year follow up to the Good Friday experiment and that took place here in Boston in 1962. And that was the first study ever to see if psychedelics could produce a religious experience in religiously inclined people in a religious setting. So it was in Marsh Chapel at Boston University. Interestingly enough, Howard Thurman was the minister. He was an African American minister and he had studied with Gandhi, and he learned about nonviolent resistance. And then Martin Luther King got his PhD at Boston University. And Howard Thurman was his mentor. And so Howard Thurman understood the political implications of this mystical sense of connection. And so he was open to do this Good Friday experiment in his church on Good Friday when he was leading the ceremony. But I did a 25 year follow up. And I would say the most important finding in a way was the strength of the memories that people had for this experience that had happened 25 years before.
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A
Which one did they use?
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B
They used psilocybin. Yeah, yeah, the placebo. People mostly remembered it as this was an unusual experiment. And I saw things. I. Some of them said, I saw what was happening to others, and it so scared me. I never wanted to do psychedelics again. Others said, I wanted to do psychedelics as quickly as I could afterwards. These are all the placebo people, but they didn't remember that much. But something about the psychedelics imprints in your memory in a really profound way.
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A
Got it. So that's the cautionary tale there is. Make sure you're doing it in an environment, in a context where whatever you're trying to lock in, you want to make sure it's. You understand that you're locking in whatever experience you're in.
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B
Yeah, exactly. And it's too simple to think, oh, just take this pill. It's not about the pill, it's about the context. And so to highlight this even more, this is now about 20 years ago, and within one week, we got two reports. Two women with a very similar report. Both of them had taken MDMA at a rave at a party, and had remembered sexual assault in the past. One of them was with a bunch of friends who were just out to have a party, and she felt that they didn't want to hear about something that would be that quote, serious. And so she stuffed her feelings down. And then months later, she's still feeling worse. So she contacted us to say, yeah, I had MDMA in the wrong context. And now months later, I'm still feeling worse. The other woman said, similar story, but I was with a girlfriend. I started remembering the sexual abuse. We went off into the corner. I talked about it with her for an hour or so, worked through a lot of it and felt better, and then went back to the party. And then I realized that MDMA could be great for ptsd. And I thought I figured it out because everybody thinks it's just a party drug. People don't know it was a therapy drug. Before it became ecstasy as a party drug. So she did a Google search on MDMA for PTSD and discovered we were studying it.
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A
Yeah.
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B
And then I think it just really highlights the fact that the context is important and more important than the drug. And so I think it is wise to advise people to be very careful about the context. And usually that means like the designated driver to have somebody that's not high.
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Yeah.
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B
That can kind of watch over.
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Watch what's happening. And. Yeah.
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B
Just in case. I mean, not always, but that, that is a good cautionary tip. But. But I also tend not to use the word recreational. Do I use it? Because that's also a little bit pejorative. It's like, it's frivolous. It's. Even though recreation is key. So I like to use the word celebratory.
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A
Celebratory.
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B
This is a little bit more positive. But there's. And does it make it less sacred if somebody uses it for a deep spiritual purpose? Does it make it less sacred if somebody uses it at a party? And I don't think so. I think because the sacredness or the respect or the therapy, it's in the context, what you bring it to. It's not in the molecule itself.
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A
No, that makes a lot of sense. So I'm 52 right now, but I'm still pushing all of my limits. I'm running long distances, I travel across many time zones to support my work, and I just want to live my life to the fullest. Staying active as I age isn't just about willpower. It's about supporting my mitochondria, the powerhouses of my cells with the energy that they need to recharge my muscles and recharge my brain. Mitopure is a supplement that I take. It's backed by solid research showing that it can boost cellular energy, increase muscle strength and support overall healthy aging. Personally, I take Mitopure every single day. It's helped me continue my active lifestyle, whether it's a high intensity workout or keeping up with my kids. So if you are looking to support your body and want to feel younger from the inside out, my friends at Timeline are offering you a 10% discount on your first order. Go to timeline.com Dr. Shah to get started. That's timeline.com Dr. Shah, your future self will thank you. Let me ask you then, you know, for the people that are using it as an alcohol replacement.
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B
Right.
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A
And that's very common now.
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B
Yeah.
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A
What are your, what are your thoughts on that?
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B
Interestingly enough. So I just last Week was at Brown University in Providence, Rhode island, just like an hour from here. And they're almost went to medical school there. Oh, oh, oh. It's a good one.
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A
I ended up in Kansas City, but I did interview at Brown.
- [30:40]
B
They have a $2 million grant from the Veterans Administration to do a study, a dual diagnosis study of veterans with PTSD with alcohol use disorder.
- [30:49]
A
Okay.
- [30:50]
B
So up till now, in the work that MAPS did, in the phase three studies that we did, we were excluded by the FDA from working with people that had alcohol use disorder or any drug abuse disorder. We could only work with people that had ptsd. They could have coexisting depression, but not substance use disorders. So now people are realizing that many people have this dual diagnosis. Those are even the harder cases, and those are the ones that we want to work with. Well, we do work with people that have attempted suicide, so we want to work with the harder cases. So I think if you're using something as an alcohol substitute, if it's just another way to escape. So I would say ketamine, of all the psychedelics, is the most addictive because it's the most reliable escape. I think that's where people really need to be very careful. Because it's a dissociative anesthetic, if you're using it as another form of escape, it's probably not gonna do you any good. If you're using psychedelics as a substitute for alcohol, to get into the issues and work through them in a therapy way with the goal that you're not trying to do the psychedelics every day. In fact, you're trying. I'd say the fundamental difference between pharma drugs, SSRIs, and antipsychotics, all these, that they're meant to correct some sort of biochemical deficit. And the theory is you need to take them every day for a very long time, forever. And you know, and it's baked in that if you start trying to taper off of these, sometimes you have more problems too.
- [32:19]
A
Yeah, for sure.
- [32:19]
B
So it's perfect for the pharma company. The difference that with psychedelics is psychedelics first off, combined with therapy and only used a few times embedded in a psychotherapy process to get to the root cause, to make it so that you can do memory reconsolidation, you can work through these traumas. It's not like they go away or they didn't happen, but they're not the foreground. They become part of the background, and then you can move forward. And so I think that's really what people need to be thinking about is that just to substitute one dependence or addiction for another is no good. But if you use the psychedelics to get into the issues, that can be helpful.
- [33:02]
A
Yeah, I mean, I think there's some major studies now that show ketamine assisted therapy versus just therapy alone is extremely powerful and more long lasting, much better result rate.
- [33:14]
B
Yeah. And I think this is my big. I'm glad you brought this up because this is my big fear of, and worry, I would say, of the way the whole psychedelic field is going in that the for profit companies are looking at Johnson and Johnson, which is marketed Spravato for ketamine. They just published something a couple weeks ago saying that they're. I think it was the fourth quarter of 2025, they sold over $500 million of ketamine. Of ketamine. So they're on track to being a $2 billion annual sales of Spravato.
- [33:45]
A
Jeez.
- [33:46]
B
Meanwhile, Spravato at 4, 500 or whatever they charge per dose is an isomer of ketamine. But ketamine itself. Maybe we should explain isomer. Every molecule is like our body. We're right handed and left hand, we're bilaterally symmetrical and molecules break like that, like mirror images.
- [34:05]
A
They keep you mirror images, Right? Yeah.
- [34:07]
B
And so a molecule is called racemic when it has both the right hand and left. So all the molecules we know, mdmal, they're all racemic and they're known to be useful for therapy. So what Johnson and Johnson did is they decided that they would work with one of the isomers of ketamine so they could patent it and then developed a new delivery system. Nasal spray.
- [34:28]
A
Nasal spray, right.
- [34:29]
B
But ketamine itself is one of the world's essential medicines and it only costs a dollar or so.
- [34:34]
A
Yes.
- [34:35]
B
And when you inject it immediately anterior muscular, it's better than Spravato. But the problem is the incentives. So that Johnson and Johnson is not incentivized by what's best for patients, they're incentivized by what's best for their shareholders. And what you see when you provide Ketamine or Spravato without therapy is that it only lasts a short time. And you keep needing to get more and more of this bravado and that's what they want. You keep coming more and more back to it. But when you do it with therapy, again, you're integrating the lessons. The goal of doing ketamine assisted therapy is to make it so you don't need the ketamine or the therapy, there's
- [35:18]
A
an end to this. You're done. Yeah.
- [35:19]
B
You worked through it. You've kind of processed this. Terrible things that have happened to you that you feel are overwhelming if you approach them. But then you learn you can approach them and then you don't need to run away for alcohol or numb the feelings. You've learned you can process them and then you can do that on your own without the therapy and without the ketamine.
- [35:38]
A
Sure.
- [35:39]
B
So the general concern I have is that the for profit psychedelic field is looking at Johnson and Johnson and saying, wow, that's great. You know, 2 billion annual sales. And so they're separating drug from therapy. And these companies just want to be drug companies.
- [35:53]
A
Right.
- [35:53]
B
In this case, the drug is psilocybin or even potentially MDMA or lst. And it's a race to the bottom. You know, they don't call it therapy, they call it psychological support or monitoring, or they prohibit people from doing therapy in these studies. And then they think, oh, we'll just sell this psilocybin. So Compass Pathways just put out their latest results just yesterday from their phase three study. But they're saying they understand that they've got this bare bones treatment and people will figure out how to embellish it. So the results are better. But that should be their responsibility.
- [36:32]
A
Right? Right.
- [36:33]
B
The pharma company is going to be making all this money charging off this drug. They should be the ones that try to optimize outcomes for patients.
- [36:39]
A
Right.
- [36:40]
B
But they don't, they don't make money on the therapy.
- [36:42]
A
Well, there's, you know, there's so many stories of pharmaceutical companies, you know, CEOs that have retired and then come and come clean and say, oh, we had a drug to cure this issue, but we squashed it because there's no money in curing disease. Right.
- [36:58]
B
Although that's not so much true anymore because look at the cure for Hep
- [37:01]
A
C. Yeah, that is true.
- [37:03]
B
Yeah, that's like $70,000. But it's. So the company can make a lot of money off that. So it's just easier to sell something that just controls symptoms over and over and over. But, but I think this. And look at all the orphan companies that have orphan drugs. So an orphan drug is, is defined as a drug for a disease that has 200,000 people or less per year. And these are rare drugs. So in general, pharma companies have not developed drugs for these rare diseases. But now you have seven year patent protection, even if it's not Patentable. If you're treating an orphan disease, you get the seven years, right, to have a monopoly to sell your drug and you can charge enormous amounts of money. So a lot of the big money makers are now these orphan drugs. So I think it's just the laziness or it's just people in pharma companies are just trained to think about the bottom line, not about what's best for patients. And they even ignore the fact that you can still make a lot of money if you cure something.
- [38:04]
A
Yeah, but that must be so incredibly frustrating for you because you've been, for 40 years, you've been running MAPS and you've been fighting for the use of, responsible use of psychedelics for the treatment, full stop treatment of these psychological issues. But then a pharma company comes along and makes billions of dollars by patenting one Isomer, but it's not a treatment, it's just like another prescription subscription. Right.
- [38:30]
B
It's enormously frustrating. And I think it's to say what I think our biggest mistake was in all of these years, and it relates to the pharma company that we launched and then had to take in investors and then eventually lost control over. The original vision was that in 1986 when I started MAPS, I thought that it would be a generic drug because MDMA was invented by Merck in 1912. The molecule is in the public domain. And I learned about MDMA in 1982, but it was already a therapy drug for about six years. So the therapeutic use was also in the public domain. So I assumed that MDMA would be generic and therefore it could only be developed through the FDA by donations, and then it would become a generic, which is great. 28 years later, after I got my PhD in 2001 and thought I knew everything about what I needed to know about drug development, which is kind of a dangerous moment when you think you know everything. But I learned because of Bromo lsd. So actually what happened is once Bromo LSD was determined to be better than LSD or psilocybin, the Harvard patent, Bromo LSD got it all right. And so it was 28 years later when I chanced into a meeting with the patent attorney for Harvard who did the Bromo lsd, and I said, you know, there's nothing like that for mdma. And he said, well, there is something you don't maybe know about this, but it's called data exclusivity.
- [39:56]
A
Oh, what's that?
- [39:57]
B
Data exclusivity was actually signed into law by Ronald Reagan in 1984, in the hacks Waxman laws about FDA, what it means is that it's incentives for developing drugs that are off patent. So you have exclusive use of your data, but another company can develop its own data. So you don't have a patent. You can't block other people. But if you get a head start, then you can have a monopoly position for a period of time.
- [40:23]
A
Got it.
- [40:23]
B
So in 2014, when I realized this, we created the MAPS Public Benefit Corporation, which is because I didn't want to do a normal pharma company where you maximize profits. Public benefit corporations are a modification of capitalism where you prioritize public benefit. And minority shareholders cannot sue the management if you're not maximizing profits because you've got public benefit objectives. And so the idea was now MAPS people make donations to Maps. Maps invests in this public benefit company, and we're the 100% owner of it. And once MDMA becomes a medicine, then we're going to be able to have an income stream during this period of data exclusivity. So we won't have to constantly go back to donors and say, keep giving us more money and more money. So that was the plan. And then by 2018 and 19, we'd raised all the money for phase one and phase two and phase three research. But the mistake that we made is we believed the experts saying that we needed to prepare for commercialization. And I didn't know anything about commercialization. And so they said, you need to raise 60 or 70 million dollars right away. You should have started last year. And public benefit means not just getting it approved, but getting it to people. And you need this commercialization infrastructure. So that's where we started to take in investors. Cause we couldn't raise that much money that quickly. Okay, but the mistake that we made is we did not quantify what we meant by public benefit and then link that to bonuses, stock options and salaries of the management so that they would be incentivized by public benefit. And once we started doing that, there had been too much separation. And so the company was now more independent and they refused to participate in these developing these public benefit metrics.
- [42:14]
A
Got it.
- [42:14]
B
So now they're incentivized the same way. Now, the good thing I'll say is that I did bring in several new investors to take over from these investors who didn't want to do public benefit. So these two new investors are investing from their foundations, not from their funds. And they're not doing it primarily to make money. And what they've indicated is that MDMA should be generic. Once it's approved, let's say by the fda, it should be generic in all of India, in all of Africa and in other countries too. So now Lebanon has been added to that.
- [42:51]
A
Oh, that's. Congratulations. That's great. Yeah.
- [42:53]
B
And they've also said that once this data exclusivity period is over, which is in the U.S. it's five years, then for pediatric studies, you get six months, and it's really important to treat people closer to the trauma. So then you get five and a half years of data exclusivity, and then it takes the FDA six months or more to evaluate the data package from the generic competitor. So it's around six years. Six years. The company, it's now 10 years in Europe, though Europe did data exclusivity after, and they realized that they wanted to provide a longer period of time. So it's 10 years in Europe. But they've said that they will not try the traditional pharma company patent tricks of patenting stuff so you can sue generics to block generics. So I'm somewhat hopeful in that sense.
- [43:39]
A
Yeah. How many years away are we from MDMA completing its studies and this.
- [43:44]
B
Well, I would say that I don't really know because now the pharma company is independent and is negotiating with the fda. But my guess is is that about a year. Well, in June of last year, RFK Jr, the head of HHS, said that he wanted to see some sort of approval for psychedelics within a year. Marty Makari, who's the doctor, who's the head of fda, said that psychedelics are a priority of them. What's just happened, this just came public a week ago or so, is that the FDA has developed what they call priority vouchers, which are for national priorities. And this priority voucher will mean that the FDA will do an accelerated review process in just several months instead of the normal six to eight or 12 months.
- [44:33]
A
Okay.
- [44:34]
B
And so there was 10 companies that had been selected by the FDA and then approved by HHS as getting these priority vouchers. And then it went to the White House and One of these 10 companies, only one was psychedelic. It was compass pathways with psilocybin for treatment resistant depression.
- [44:53]
A
Right.
- [44:53]
B
And so what it came out just last week is that somebody in the White House said, no, we don't want to give this priority voucher to psilocybin, to compass pathways. So they were knocked out of it.
- [45:02]
A
Oh, darn.
- [45:03]
B
So there's a little bit of a resistance yeah. Okay. But to get back to your question, when will we have something with MDMA? It was in August of 2024 that the FDA rejected the new drug application from at the time it was called Lycos to it was maps, Public Benefit Corp. But then we had a disagreement around patent policy, and I said, you don't deserve the Maps name anymore. Go ahead and change the name. And they changed it to Lycos, and then now they've changed it to Resilient. But this idea was that there is the rejection that happened, and then a review of all the videotapes to see if there was any sort of bias that was there. There's these accusations because we feel that the therapists are more effective if they've done the drug that they're giving to their patients. And so traditional psychiatrists would say, I give electroshock to my patients. I don't need to take it. Or I take antipsychotics, or I don't need to take it. And I'll say, you're totally right. But when it's psychedelic therapy, the therapist is part of the treatment, and if they understand better what's going on, they'll be more effective. So anyway, all these accusations about bias because they'd taken the drugs and they believe it worked. So there's been a review of the videotapes, and I think within the next couple months, there will probably be some announcement from the FDA about, here's the path forward. And I think that they will say there is more research that they want to gather. But I think this, again, is just my guess that it'll be focused more on safety and that they will accept the efficacy which we demonstrated. One of the big issues at the FDA rejection was that they didn't gather information on positive adverse events.
- [46:50]
A
Okay.
- [46:51]
B
Now, the point of positive adverse events is that they think, oh, you might like the drug, and therefore you're likely to abuse it after therapy. We had a bunch of the people in our studies said, I don't know why they call this Ecstasy, because when you take MDMA to work on your traumas, it's painful.
- [47:09]
A
It's painful, but you can do it.
- [47:11]
B
It's not party drug. So we don't see that much of people going to use it. But in any case, I think there'll be some sort of discussion by the FDA in a couple months about what's next to get full approval and there'll be some kind of partial approval. My guess is, and the reason I say that is that I believe that the efficacy has been determined. And one reason to say that is that it's throughout. There's MDMA research throughout the Veterans Administration. You know, I just mentioned the $2 million grant to do MDMA with veterans with PTSD and alcohol use disorder. There's a $10 million grant that the Department of Defense has given two $4.9 million grants for MDMA assisted therapy for active duty soldiers with ptsd. It's incredible.
- [47:58]
A
Yeah, that's incredible.
- [47:59]
B
One at Walter Reed, which is combining MDMA with acceptance and commitment therapy. The other is in Texas at a place called strongstar, and Emory in Atlanta, combining MDMA with prolonged exposure. So I think that this idea that people who have been stuck for decades sometimes can still get better. We had somebody who had PTSD from Vietnam in our study, and they were still able to get better. So I think that there's enough of a sense of unmet medical need. Yes. And that this works. So I. That. So my guess is that there'll be some kind of provisional access in certain limited ways with additional research. But again, these are just guesses. I don't know directly, but that's my thing now. Meanwhile, though, Maps is doing work around the world.
- [48:47]
A
Right.
- [48:48]
B
And so I'd say that the. In some ways, I think what is some of the most important work that's being done with psychedelics anywhere in the world is being done in Israel. And so we have MAPS Israel, which is a separate nonprofit in Israel, but it's the only study of which I'm aware of any psychedelic. That's a direct comparison of individual therapy versus group therapy, because the theory is that individual therapy works really well. The FDA insists that everything begin with individual therapy. But group therapy could potentially be close to as good, maybe even better, or maybe similar, but a lot less costly if you can use the group to support each other. So this is going to be the first study ever, and it started in screening and enrolling to do direct comparison of individual versus group. And from a statistical point of view, just to educate people a little bit, is that when you have two effective therapies, individual versus group, to find a statistical difference between them requires large numbers of people. The smaller a difference you're looking for, the larger number of people that you need.
- [49:55]
A
Right.
- [49:56]
B
So what this study in Israel has designed is called a non inferiority study. It's not looking for one to be superior to the other. It's looking to be that they're more or less in the same range. So it's called non inferiority.
- [50:10]
A
Okay.
- [50:10]
B
And because it's not as powerful of a statement. You're not saying one is more valuable than the other, more useful than the other. You need smaller numbers of people. So this is 168 people. So it takes about three years. So I think that the globalization is what I'm working on now. So MAPS has left the development of MDMA into a medicine through the FDA to resilience the pharmacopolita. And we're no longer involved in that.
- [50:36]
A
Got it.
- [50:36]
B
But because we're a nonprofit, what we're focusing on is global humanitarian projects that are non monetizable. And so that's where I mentioned before we started talking, we just got a $800,000 grant. It'll be in sequences to bring MDMA healing to Lebanon.
- [50:55]
A
Lebanon, right.
- [50:56]
B
And you know, we're doing a lot of work. I mentioned in Israel, we were in Dubai. We're going to be inviting people from the Abu Dhabi Department of Health to send therapists to the training in Lebanon. We've got projects in Somaliland, in Africa, we want to do work in Rwanda and South Africa and Kenya. So this is kind of the edge that I'm working on now is the global access.
- [51:20]
A
Got it. Yeah. It sounds like there's a lot of, I would say, headwinds in the United States to getting anything done here with the FDA and the politics of everything.
- [51:32]
B
Well, I would say that one of the key things that I realized looking at the history that we talked about, how psychedelics were wrapped up with the counterculture in the 60s and the anti Vietnam War, and so there was this political backlash. So in this new era of the psychedelic renaissance, I realized that it was absolutely essential that we get bipartisan support.
- [51:54]
A
Sure.
- [51:55]
B
And that's where the work with the veterans came in too. And we have managed to get bipartisan support. So I think that there are headwinds, but they're not as.
- [52:06]
A
Not as bad as before.
- [52:07]
B
Not as bad as before in any way. Because we do have some. A lot of support in the Trump administration for moving now. I'm not sure who in the White House slowed down this Compass priority voucher, but it still is moving forward. Yes, but there are headwinds, but I think they can be overcome.
- [52:25]
A
Yeah. And you're right, I mean, with the current administration, there's definitely a priority put on some of these methods that were not there before. And also a deprioritization of giving the pharma industry even more power than they already have, which is also helpful too.
- [52:41]
B
Yeah, yeah. One of the joke things that we've done is one of the things that the current administration is considering is stopping pharma ads on tv.
- [52:49]
A
Yes, I saw that.
- [52:51]
B
I think they're mainly doing that not because they care about pharma, because they want to weaken media. They don't want independent media, and they get a lot of money from pharma ads. But we've done some fake pharma ads just for fun. Like, have you asked your doctor about MDMA yet? Right, right.
- [53:09]
A
I love that.
- [53:10]
B
All these kind of like, you know, do you want to fall in love again? MDMA for couples therapy, stuff like that. So it's been pretty fun to just play around with that.
- [53:19]
A
But.
- [53:19]
B
But I agree probably that it's not such a good idea to advertise drugs to. In a public setting. We should focus on the doctors. And, you know, it's only America and New Zealand, I think, that permit direct ads to consumers.
- [53:33]
A
Right, exactly. It's. Yeah, it's not something that's done anywhere else in the world that I know of and is done here. Yeah. And I think also, you know, the, the pharma industry is going to hit a major battle with Trump's new plan as well, to, you know, giving the United States most favored nation pricing for a lot of these drugs, too.
- [53:53]
B
Yeah.
- [53:54]
A
That's also going to weaken that industry.
- [53:57]
B
Well, I would just say that a lot of what Trump says doesn't actually.
- [54:01]
A
That's true, too, take place.
- [54:03]
B
And so, you know, there was gonna be a 10% cap on credit card interest. That's gone. That's not happening. So I think he's throwing out a lot of things. But whether that will actually, you know, come about, because there is. It's hard to say this, but I mean, there is value in large prices to pharma companies to support innovation.
- [54:24]
A
That's true, too.
- [54:26]
B
So one of the things that's. Well, here's another. Pharma companies will tell you that it costs around $2 billion to make a drug into a medicine. And so I could never raise $2 billion. So I looked at where did that number come from. And it's done by the Tufts center for the Study of Drug Development. And the most important thing to say is that they amortize all the failures into the few successes. So if you're a pharma company and you've had, you know, a thousand drugs that you've manufactured and then a hundred that go into animal studies and, you know, and by the time you get into the ones that are approved, you've had enormous amount of failures and so they amortize all the cost of the failures into the.
- [55:10]
A
So that's like the $2 billion.
- [55:13]
B
Well, that's one of the reasons. The other reason is that they permit the pharma companies to talk about the opportunity cost on the money. So it takes a long time to develop a drug. And they figured it out, the last one I've seen, and they may have changed this, but it was 12% per year. So let's say it's a 15 year period of time from you develop a new molecule, you figure out what it's for. So they're charging all the interest on that money. If you had invested it in the stock market or got 12% wherever, and instead you put it into developing a drug. So the opportunity cost is enormous. Then there's. Opportunity cost is almost 50% of this. Then you add the cost of the failures. And so it really. If you start out with a drug that we know works like psychedelics.
- [55:59]
A
Exactly.
- [56:00]
B
And you just go direct.
- [56:01]
A
Yes.
- [56:02]
B
A couple hundred million dollars.
- [56:04]
A
Yeah. So it's a lot lower. This is $200 million to get something approved. If you're not counting the opportunity costs and you're not counting the failures.
- [56:12]
B
Yeah. Or even less than 200 million, particularly. But the other part that really matters is how strong is the effect. We talked about that before. The stronger the effect, the fewer people you need to show it.
- [56:22]
A
Sure.
- [56:23]
B
From a statistical point of view. So our two phase three studies that were approved by the FDA were 100 people each. So the Compass Pathways has done two phase three studies. I think they've had well over a thousand people. And so SSRI studies sometimes have thousands and thousands of people in it because the effect is so small. So I think it's used by the pharma company, this $2 billion number, to justify charging higher prices. But I do think that a lot of what pharma companies do is a gamble and it doesn't work. And so there is some justification for a reward for innovation.
- [57:05]
A
Yeah. And we do need to fund the innovation as well. And so if you go to any of these campuses for these drug companies, they're massive. And where I live, there's a few pharma companies that have massive campuses. Most of them are science. Most of the space is used for science, actually. So something has to fund that. I get it. But I do, to your point, opportunity costs of money should not be factored into the drug development costs. That doesn't make sense.
- [57:32]
B
Yeah. It only makes sense because they think of themselves primarily as business, not as healers, not as trying to solve disease, but as trying to return shareholder value.
- [57:41]
A
That's true. Well, I mean, it's very hopeful that we can start using psychedelics for treatment of these psychological problems that people have been struggling with since the beginning of psychology. Right. And was there ever a time in psychology where psychedelics were used more frequently?
- [58:01]
B
Well, I would say that. So again, here we are in Cambridge. The psychology building is the William James building. So it was in the 1890s that William James started experimenting with nitrous oxide. And he talked about nitrous less in a therapeutic context, but more in a spiritual context. That nitrous would give him the sense of the multiple different kinds of consciousness. And he's got this famous statement saying that anybody who doesn't take into account the other states of consciousness that are separated by the filmiest screen from our normal consciousness is not really taking full consciousness into account. I think it was 1896 is when Arthur Heffter did the first synthesis of mescaline from peyote. So there was some research that was done in the 20s and 30s, and it was often just for creativity. And there is a story that the book that reports it, the footnote basically goes nowhere. But they claimed that the chief visualist on Fantasia, which is one of the most incredible Disney movies, had participated in a mescaline experience.
- [59:14]
A
Interesting.
- [59:15]
B
In Germany in the 20s.
- [59:16]
A
Interesting.
- [59:17]
B
And that the visions that he got from mescaline helped him to create Fantasia.
- [59:22]
A
Yeah. So makes sense.
- [59:24]
B
It could very well be, but it wasn't really deeply integrated into psychiatry or psychotherapy. It was only when it started to be. 1943 is when Albert Hoffman had self contaminated himself as he was resynthesizing LSD. And then the first study in the US was 1949. But in the 50s and 60s, there was an enormous amount of work on psychedelics for a whole range of conditions, including alcohol use disorder. Probably one of the more famous incidents is Bill W. Who started Alcoholics Anonymous actually in the 30s. He took belladonna, which is a disorienting psychedelic, but that helped him get over his alcoholism. And then it was in the 50s when he heard about LSD, that after he was already sober and had started AA, then he took LSD. And he thought that this has to play a major role in aa because what he said was that this whole concept of people hitting bottom, but once you've hit bottom, that's when you're ready to look at things. But you've destroyed your family, you've destroyed your work situation. You've destroyed your health a lot. And he thought with LSD you can precipitate the emotions of hitting bottom when you still have a little bit of an intact family system and job. And he felt the surrendering to the higher power and all these things, but he felt unable really to integrate this into aa. And eventually he left AA because he didn't want a cult of personality. But he also was frustrated. And so it was really through the 50s and 60s that therapeutic uses of psychedelics started being developed, and then it was squashed by the Controlled substances Act of 1970.
- [61:09]
A
Yeah, exactly. And so now here we are picking it up again. And I think most people out there have heard of many of the psychedelic options out there, both in plant medicine and also the chemical compounds like LSD and MD and ME. I'd love to kind of like go through all of them with you because I feel, you know, people are hearing a lot, they are asking a lot of questions and people are suffering and they need options. And I think access is becoming easier now. Here are my top five takeaways from my episode with Rick Doblin. Number one, Psychedelic therapy is about structure, not just substance. Preparation. A guided session and integration afterwards are what make these therapies effective and not dangerous. It's not just a drug alone. Number two, MDMA assisted therapies show strong promise for PTSD in clinical settings. It helps patients process traumatic memories in a safer and more supported way. Number three, Neuroplasticity is a key mechanism. Psychedelics may temporarily increase the brain's ability to form new connections, helping you shift deeply ingrain emotional patterns into something new. Number four, Context determines outcomes, set and setting, your mindset, environment and therapeutic support. These all play a critical role in whether the experience is healing or destabilizing. Number five, Integration is where lasting change happens. The real impact comes after the experience, when insights are processed and they're applied to everyday life. Thank you so much for listening to the podcast today. Please remember to subscribe if you like this episode and give us a good review and share a link with your friends. It really helps to support all of our efforts. I also want to remind you that the information shared on this podcast is for educational purposes only and is not intended to replace professional medical advice, diagnosis or treatment. Please consult with your healthcare provider or physician before making any decisions or taking any action based on what you hear today, especially if you have any underlying health conditions or on any medications. Your doctor knows your personal health situation the best and it's always important to seek their guidance.