153. Dr. Rick Doblin - Part 1: Psychedelics, MDMA Therapy, and the Future of Mental Health

Depression, PTSD, and trauma related disorders continue to challenge modern medicine, even as our understanding of the brain and consciousness rapidly evolves. New research suggests that certain therapies may help unlock deeper healing by combining neuroscience, psychology, and carefully guided experiences. In this episode of Extend, we sit down with Dr. Rick Doblin, founder of MAPS, to unpack the science and history behind psychedelic assisted therapy and its potential role in mental health treatment. We break down the research behind MDMA assisted therapy for PTSD, how psychedelics influence neuroplasticity and emotional processing, and why therapeutic context, preparation, and integration are essential for safe and meaningful outcomes. We also explore how psychedelic research is reshaping conversations around trauma, healing, and the future of psychiatry. Dr. Rick Doblin is the founder and executive director of MAPS (Multidisciplinary Association for Psychedelic Studies), the organization leading global research into psychedelic assisted therapies and working to develop evidence-based treatments for PTSD and other mental health conditions. What We Discuss: (01:55) The political origins of psychedelic prohibition (04:40) Ancient psychedelic traditions and the Eleusinian Mysteries (08:01) Dr. Rick Doblin's path to founding MAPS (10:34) Science, policy, and the future of psychedelic medicine (11:00) Expanding research on MDMA therapy (12:21) Psychedelic churches and religious freedom laws (15:42) Why context and safety shape psychedelic outcomes (16:20) Neuroplasticity and emotional processing (17:36) Bromo-LSD and non-psychedelic therapeutic compounds (20:39) Psychedelics and rewriting personal narratives (23:22) The Good Friday Experiment and mystical experiences (25:23) MDMA therapy and trauma processing (27:47) Psychedelics and alternatives to alcohol (30:30) Ketamine therapy and pharmaceutical incentives (36:16) MAPS, MDMA development, and commercialization (41:56) The FDA pathway for MDMA therapy (47:00) Global psychedelic research initiatives (56:51) Early LSD research in psychology …to be continued Thank You to Our Sponsors: Timeline: Timeline powered by Mitopure just dropped the price. Check it out at timeline.com/drshah http://timeline.com/drshah and get an additional 20% off your first month with code DRSHAH. Learn more about Dr. Shah: Website: drshah.com https://www.drshah.com/ Clinic: next-health.com https://www.next-health.com/ Instagram: darshanshahmd https://www.instagram.com/darshanshahmd Learn more about Dr. Rick Doblin: Website: maps.org http://maps.org Instagram: rickdoblinphd https://www.instagram.com/rickdoblinphd/ X: @RickDoblin https://x.com/RickDoblin

Speaker names marked ? are inferred from speaking time and the show’s known hosts — they are not voice-verified.

• 0:03Dr. Darshan Shah?

  Welcome to Extend 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're 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.

• 0:48Dr. Darshan Shah?

  Mental health conditions like PTSD, depression, and trauma remain difficult to treat with the traditional approaches used alone. There's emerging research that suggests that psychedelic assisted therapies may offer a new path forward by combining neuroscience, psychotherapy, and carefully-guided experiences. In this episode of Extend, 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 contexts for psychedelics and marijuana,

• 1:33Dr. Darshan Shah?

  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 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,

• 2:17Dr. Darshan Shah?

  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 so I truly hope you enjoy this episode and also the next episode. Thank you.

• 2:57Dr. Darshan Shah?

  Rick, thank you so much for doing this with me.

• 2:59Speaker 01

  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.

• 3:17Dr. Darshan Shah?

  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, but 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.

• 3:46Speaker 01

  Right.

• 3:46Dr. Darshan Shah?

  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.

• 3:56Speaker 01

  Well, and the word hallucinogen is a pejorative negative term because it's unreal, it's fake, it's hallucination, it's distortion, it's intoxication.

• 4:06Dr. Darshan Shah?

  Yeah.

• 4:06Speaker 01

  Yeah, but it was really political. The suppression was not based on the science, it was based on the politics.

• 4:12Dr. Darshan Shah?

  What do you mean by that? I would love to dive in kind of the history of psychedelics and specifically psychedelics and medicine, but let's talk about that.

• 4:19Speaker 01

  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 Haldeman says, did we know we are exaggerating the risks of these drugs? Of course we did. So it was

• 5:02Speaker 01

  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.

• 5:18Dr. Darshan Shah?

  Right, right.

• 5:19Speaker 01

  It's incredible how powerful these myths are. So I went to the, my, 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.

• 5:52Dr. Darshan Shah?

  Hmm. Like, what does that mean?

• 5:54Speaker 01

  Yeah, what's wrong with me? She said, well, your chromosomes must be so screwed up from all the LSD you took. And like, this was a smart woman at the Kennedy School of government.

• 6:03Dr. Darshan Shah?

  Yeah.

• 6:04Speaker 01

  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.

• 6:17Dr. Darshan Shah?

  Oh, my gosh.

• 6:18Speaker 01

  You can commit any crime you wanted because you're certifiably insane from doing five or six times of LSD.

• 6:24Dr. Darshan Shah?

  Wow.

• 6:24Speaker 01

  So these were the kind of propaganda. So it was really politics, not based on the science.

• 6:29Dr. Darshan Shah?

  Yeah, I was gonna say, these are myths, but they sounds like more like propaganda to achieve a political goal. Of the Nixon era, of the Nixon presidency, really.

• 6:37Speaker 01

  Yeah.

• 6:37Dr. Darshan Shah?

  That's when everything kind of unraveled.

• 6:39Speaker 01

  Yeah, but if we go back in history.

• 6:41Dr. Darshan Shah?

  Please, yes.

• 6:42Speaker 01

  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 the Eleusinian Mysteries for roughly 2,000 years, from 1600 B.C. to 396 A.D.

• 7:06Dr. Darshan Shah?

  Okay.

• 7:07Speaker 01

  And everybody that we know of in terms of the Greek culture, Socrates, Plato, Pythagoras, Aristotle, all these people participated in the Eleusinian Mysteries. It had a psychedelic component. They drank a potion called Kikion. And then they would walk a certain distance to Eleusis, 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.

• 7:40Dr. Darshan Shah?

  Yeah.

• 7:40Speaker 01

  In these ceremonies. And they were the 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 larger.

• 7:55Dr. Darshan Shah?

  Right.

• 7:56Speaker 01

  And something is continuing in some ways. And so for the first couple of 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.

• 8:29Dr. Darshan Shah?

  Wow.

• 8:30Speaker 01

  So that's really the first prohibition against psychedelics.

• 8:34Speaker 01

  Psychedelics have been used for thousands of years.

• 8:36Dr. Darshan Shah?

  Once again, it sounds political.

• 8:37Speaker 01

  Completely political. 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.

• 9:05Dr. Darshan Shah?

  Sure.

• 9:05Speaker 01

  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 reemergence in the 1960s in a big way in America. And again, the politics.

• 9:32Dr. Darshan Shah?

  It's crazy how history just keeps repeating itself over and over again.

• 9:35Speaker 01

  It does. 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.

• 9:47Dr. Darshan Shah?

  Right, right.

• 9:48Speaker 01

  And that was the motto, in a way, of the counterculture.

• 9:52Dr. Darshan Shah?

  Right.

• 9:52Speaker 01

  And that's not good from the power systems. 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?

• 10:08Dr. Darshan Shah?

  Yes.

• 10:09Speaker 01

  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 on 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. 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.

• 10:50Dr. Darshan Shah?

  Yeah.

• 10:51Speaker 01

  You know, for being creative. So I had this moment where I'm sitting, 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. I'm thinking, I'm going to figure out what, 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 masters and PhD from there. So what I felt that I've been doing is moving from individual therapy to cultural therapy.

• 11:29Dr. Darshan Shah?

  Right, right, absolutely.

• 11:30Speaker 01

  And that's why talking to you and the podcast, that's so important.

• 11:34Dr. Darshan Shah?

  It's so important, right? Because we are at a good moment now, I think, again, hopefully if 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. 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.

• 12:03Speaker 01

  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 that what is the real goal? The real goal for me is a more spiritualized humanity and 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's, 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.

• 12:42Speaker 01

  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.

• 12:57Dr. Darshan Shah?

  Forty years.

• 12:58Speaker 01

  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.

• 13:07Dr. Darshan Shah?

  Right. That's going to be huge.

• 13:09Speaker 01

  It's, 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.

• 13:26Dr. Darshan Shah?

  Sure.

• 13:27Speaker 01

  But there's nothing in the law that blocks them from doing that. So not only are we gonna do so, the sweet spot of MAPS is sort of the science politics.

• 13:35Dr. Darshan Shah?

  Yeah.

• 13:36Speaker 01

  Connection.

• 13:37Dr. Darshan Shah?

  That's such 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, you know, things like marriage therapy, or just even just, you know, expanding your mindset, becoming more creative, all those other uses of it that we all know can be extremely beneficial for humans.

• 14:06Speaker 01

  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.

• 14:14Dr. Darshan Shah?

  Right, right.

• 14:15Speaker 01

  You know, and I'll say, one of the things that's been really surprising is the rise of the psychedelic churches.

• 14:22Dr. Darshan Shah?

  Yeah, let's talk about that a little bit.

• 14:24Speaker 01

  Yeah, because what we've have, this is sort of 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.

• 14:41Dr. Darshan Shah?

  Right, right.

• 14:43Speaker 01

  Alright, so now, you don't have to do that. The law says you can discriminate against people based on your religion.

• 14:49Dr. Darshan Shah?

  Right.

• 14:50Speaker 01

  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.

• 14:58Dr. Darshan Shah?

  Sure, sure.

• 15:00Speaker 01

  So the concern now has been that the, 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.

• 15:13Dr. Darshan Shah?

  Yeah.

• 15:14Speaker 01

  And so there's hundreds of psychedelic churches throughout the United States.

• 15:19Dr. Darshan Shah?

  I did not know that.

• 15:19Speaker 01

  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 US Supreme Court. This was quite a while ago, and they won the use of peyote.

• 15:39Dr. Darshan Shah?

  Right.

• 15:39Speaker 01

  But it was limited to this one religion.

• 15:42Dr. Darshan Shah?

  Yeah.

• 15:42Speaker 01

  Then, a little bit more about 12 years ago, the ayahuasca, the Uniao de Vegetal, went also to the US Supreme Court.

• 15:50Dr. Darshan Shah?

  Uh huh.

• 15:51Speaker 01

  And they won again that they could practice their religion.

• 15:54Dr. Darshan Shah?

  Yeah.

• 15:55Speaker 01

  And then Santo Daimi, which is another ayahuasca church, went up to the Ninth Circuit, and then the government didn't appeal. And then there's a new psychedelic church, the Eagle and the Condor.

• 16:05Dr. Darshan Shah?

  Okay.

• 16:06Speaker 01

  That just was newly created. But my favorite, and again, favorite because of access, it's called the Church of Ambrosia.

• 16:16Dr. Darshan Shah?

  Oh, okay.

• 16:17Speaker 01

  It's a mushroom church.

• 16:18Dr. Darshan Shah?

  Uh huh.

• 16:19Speaker 01

  But it has other sacraments, too.

• 16:21Dr. Darshan Shah?

  Okay.

• 16:21Speaker 01

  It has 130,000 members. It's in Oakland, California.

• 16:26Dr. Darshan Shah?

  Okay.

• 16:26Speaker 01

  They sell 90 pounds of mushrooms per month, which is a very lot.

• 16:31Dr. Darshan Shah?

  Huge.

• 16:32Speaker 01

  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.

• 16:52Dr. Darshan Shah?

  Hmm.

• 16:52Speaker 01

  So Oregon has passed the Oregon Psilocybin Initiative, and 18,000 people have now received MDMA, I mean, psilocybin in Oregon in the last three or four years.

• 17:05Dr. Darshan Shah?

  Okay.

• 17:06Speaker 01

  And it's more than all of the people that have received psilocybin in clinical research in the last 25 years.

• 17:12Dr. Darshan Shah?

  Yeah.

• 17:13Speaker 01

  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.

• 17:46Dr. Darshan Shah?

  Uh huh.

• 17:46Speaker 01

  Psychedelics can be disorienting. They can take you and make you worse off.

• 17:50Dr. Darshan Shah?

  Right.

• 17:51Speaker 01

  Or they can make you better off, but it's the safe and supportive context that really matters. So really, when we were 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 neuroplasticity. One of the ways that they work is they, well, there is Gould Owen, a researcher at, 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 prosocial.

• 18:30Speaker 01

  She's done work with mice, and you give MDMA to a mouse and it releases oxytocin, and that promotes new neural connections in prosocial 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.

• 19:05Dr. Darshan Shah?

  You think so?

• 19:06Speaker 01

  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-psychedelic psychedelics happened, which was there's a disorder called cluster headaches.

• 19:23Dr. Darshan Shah?

  Oh, yes, I know cluster headaches.

• 19:24Speaker 01

  Okay, and it's terrible, it's worse than migraines sometimes.

• 19:27Dr. Darshan Shah?

  It's horrible, right?

• 19:28Speaker 01

  They call it suicide headaches. So this was in 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.

• 19:47Dr. Darshan Shah?

  Oh, wow.

• 19:47Speaker 01

  And so they contacted me and said, we don't want to be criminals anymore. Can you do research?

• 19:52Dr. Darshan Shah?

  Yeah.

• 19:53Speaker 01

  And I was doing a lot of work at McLean Hospital with looking at the risks of MDMA and other things.

• 19:58Dr. Darshan Shah?

  Right.

• 19:59Speaker 01

  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, their cluster headaches? 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.

• 20:33Dr. Darshan Shah?

  Okay.

• 20:33Speaker 01

  Only if nothing else works. So the two researchers, John Hopper in here and Torsten Passi 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.

• 20:47Dr. Darshan Shah?

  Really?

• 20:47Speaker 01

  You add this bromo molecule to LSD and it knocks out the psychedelic component.

• 20:52Dr. Darshan Shah?

  Ah, interesting. Okay.

• 20:53Speaker 01

  And so they said, here's what our plan is. We're going to do a study of bromo LSD for cluster headaches.

• 20:59Dr. Darshan Shah?

  Yeah.

• 20:59Speaker 01

  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. They 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.

• 21:31Dr. Darshan Shah?

  It worked.

• 21:32Speaker 01

  Not only did it work, it worked better than LSD or psilocybin.

• 21:35Dr. Darshan Shah?

  Really?

• 21:35Speaker 01

  Yeah.

• 21:36Dr. Darshan Shah?

  Oh, my gosh.

• 21:36Speaker 01

  Because you can give it in grams.

• 21:38Dr. Darshan Shah?

  Yeah.

• 21:39Speaker 01

  Whereas LSD is micrograms.

• 21:41Dr. Darshan Shah?

  Yeah, because of the, of the effects, right?

• 21:42Speaker 01

  Yeah. And psilocybin is milligrams. So whatever it does, it floods the brain and.

• 21:47Dr. Darshan Shah?

  Yeah.

• 21:48Speaker 01

  And it works. So that was the first example I'd ever seen of a non psychedelic psychedelic being helpful.

• 21:55Dr. Darshan Shah?

  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.

• 22:09Speaker 01

  Well, in certain cases, I think that's right. On the other hand, I would say, and this is the, 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.

• 22:25Dr. Darshan Shah?

  Yes, for sure.

• 22:27Speaker 01

  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.

• 22:37Dr. Darshan Shah?

  Right.

• 22:37Speaker 01

  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.

• 22:48Dr. Darshan Shah?

  Yeah.

• 22:49Speaker 01

  So that there is this storytelling aspect to it that I think is what really matters to us. Where's 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.

• 23:06Dr. Darshan Shah?

  Yeah.

• 23:07Speaker 01

  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.

• 23:19Dr. Darshan Shah?

  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, cluster headaches treatment, maybe there's a role for non psychedelic versions of like, for example, you know, ketamine or psilocybin for depression. I think, 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.

• 23:49Speaker 01

  Yeah. And I think why they have such long-term effect is because of this neuroplasticity.

• 23:54Dr. Darshan Shah?

  Absolutely.

• 23:55Speaker 01

  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.

• 24:06Dr. Darshan Shah?

  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, right, and I say, you really want to be careful because of what you were mentioning earlier, the context.

• 24:18Speaker 01

  Yes, yes.

• 24:19Dr. Darshan Shah?

  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, right? And so a bad trip can be something that follows you for many years.

• 24:39Speaker 01

  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.

• 24:50Dr. Darshan Shah?

  Sure.

• 24:50Speaker 01

  So it doesn't just go away.

• 24:52Dr. Darshan Shah?

  Yeah.

• 24:52Speaker 01

  And so I think that this, the long term impact of it is really important. One of the, 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.

• 25:15Dr. Darshan Shah?

  Yeah.

• 25:15Speaker 01

  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.

• 25:49Dr. Darshan Shah?

  Yeah.

• 25:50Speaker 01

  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 that. 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.

• 26:10Dr. Darshan Shah?

  Which one did they use? They used psilocybin?

• 26:12Speaker 01

  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.

• 26:37Dr. Darshan Shah?

  Got it. So that's the cautionary tale there is make sure you're doing it in a, 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 undergoing.

• 26:50Speaker 01

  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.

• 27:33Speaker 01

  The other woman said, I, 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. And then, so I think it just really highlights the fact that the context is important.

• 28:09Dr. Darshan Shah?

  Yeah.

• 28:09Speaker 01

  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, that can kind of watch over.

• 28:24Dr. Darshan Shah?

  Watch what's happening and yeah.

• 28:26Speaker 01

  Just in case. I mean, not always, but that is a good cautionary tale. 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.

• 28:40Dr. Darshan Shah?

  Right.

• 28:40Speaker 01

  So I like to use the word celebratory.

• 28:43Dr. Darshan Shah?

  Celebratory.

• 28:43Speaker 01

  Which is a little bit more positive.

• 28:45Dr. Darshan Shah?

  Yeah.

• 28:45Speaker 01

  But there's, and does it make it less sacred? If somebody uses it in, 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.

• 29:05Dr. Darshan Shah?

  No, that makes, that makes a lot of sense.

• 29:11Dr. Darshan Shah?

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• 29:56Dr. Darshan Shah?

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• 30:16Dr. Darshan Shah?

  Let me ask you then, you know, for the people that are using it as an alcohol replacement.

• 30:21Speaker 01

  Yeah.

• 30:21Dr. Darshan Shah?

  And that's very common now.

• 30:23Speaker 01

  Yeah.

• 30:23Dr. Darshan Shah?

  What are your, what are your thoughts on that?

• 30:25Speaker 01

  Interestingly enough, so I just, last week was at Brown University in Providence, Rhode Island, just like an hour from here.

• 30:33Dr. Darshan Shah?

  Yeah, I almost went to medical school there.

• 30:34Speaker 01

  Oh, oh, it's a good one.

• 30:36Dr. Darshan Shah?

  I ended up in Kansas City, but I did interview at Brown, yeah.

• 30:40Speaker 01

  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.

• 30:49Dr. Darshan Shah?

  Okay.

• 30:50Speaker 01

  So up till now, in the work that MAPS did and 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 hardest 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.

• 31:34Dr. Darshan Shah?

  That's right.

• 31:34Speaker 01

  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.

• 31:41Dr. Darshan Shah?

  Right.

• 31:42Speaker 01

  If you're using it as another form of escape, it's probably not going to 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

• 32:11Dr. Darshan Shah?

  Forever.

• 32:11Speaker 01

  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.

• 32:18Dr. Darshan Shah?

  Yeah, for sure.

• 32:19Speaker 01

  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.

• 32:44Dr. Darshan Shah?

  Yes.

• 32:45Speaker 01

  And then you can move forward.

• 32:46Dr. Darshan Shah?

  Right.

• 32:47Speaker 01

  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.

• 33:02Dr. Darshan Shah?

  Yeah, I mean, I think there's some major studies now that show ketamine assisted therapy versus this therapy alone.

• 33:08Speaker 01

  Yeah.

• 33:09Dr. Darshan Shah?

  Extremely powerful, more long lasting, much better result rate.

• 33:13Speaker 01

  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 of weeks ago saying that they're, I think it was the fourth quarter of 2025, they sold over $500 million.

• 33:38Dr. Darshan Shah?

  Of ketamine?

• 33:39Speaker 01

  Of ketamine. So they're on track to being a $2 billion annual sales of Spravato. 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, like our body, we're right-handed and left-handed, we're bilaterally symmetrical.

• 34:01Dr. Darshan Shah?

  Yes.

• 34:02Speaker 01

  And molecules break like that, like mirror images.

• 34:05Dr. Darshan Shah?

  They can become mirror images, right?

• 34:06Speaker 01

  Yeah, and so a molecule is called reseemic when it has both the right hand and left.

• 34:10Dr. Darshan Shah?

  Right.

• 34:11Speaker 01

  So all the, all the molecules, you know, MDMA, they're all reseemic. 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.

• 34:24Dr. Darshan Shah?

  Yeah.

• 34:25Speaker 01

  And then developed a new delivery system, nasal spray.

• 34:28Dr. Darshan Shah?

  Right.

• 34:28Speaker 01

  But ketamine itself is one of the world's essential medicines and it only costs a dollar or so.

• 34:34Dr. Darshan Shah?

  Yes.

• 34:35Speaker 01

  And when you inject it IM. Enter your muscular. It's better than Spravato.

• 34:41Dr. Darshan Shah?

  Yeah.

• 34:41Speaker 01

  But the problem is the incentives so that Johnson and Johnson is not incentivized by what's best for patients.

• 34:49Dr. Darshan Shah?

  No.

• 34:50Speaker 01

  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 the Spravato. 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. You're, the goal of doing ketamine assisted therapy is to make it so you don't need the ketamine or the therapy.

• 35:17Dr. Darshan Shah?

  Like, there's an end to this. You're done.

• 35:19Speaker 01

  Yeah, you worked through it. You've, you've kind of processed this, this

• 35:23Dr. Darshan Shah?

  Yeah.

• 35:23Speaker 01

  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.

• 35:38Dr. Darshan Shah?

  Sure, sure.

• 35:38Speaker 01

  So the, 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, two billion annual sales. And so they're separating drug from therapy.

• 35:50Dr. Darshan Shah?

  Yeah.

• 35:51Speaker 01

  And these companies just want to be drug companies.

• 35:53Dr. Darshan Shah?

  Right.

• 35:53Speaker 01

  In this case, the drug is psilocybin or even potentially MDMA or LSD. And it's, it's a race to the bottom.

• 36:00Dr. Darshan Shah?

  Yeah.

• 36:00Speaker 01

  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.

• 36:31Dr. Darshan Shah?

  Right, right.

• 36:33Speaker 01

  A 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.

• 36:39Dr. Darshan Shah?

  Right, but they don't.

• 36:40Speaker 01

  They don't make money on the therapy.

• 36:42Dr. Darshan Shah?

  Well, there's, you know, there's so many stories of pharmaceutical companies.

• 36:45Speaker 01

  Yeah.

• 36:46Dr. Darshan Shah?

  You know, CEOs that have retired and then come, 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?

• 36:57Speaker 01

  Although that's not so much true anymore because look at the cure for Hep C.

• 37:01Dr. Darshan Shah?

  Yeah, that is true.

• 37:02Speaker 01

  That's like $70,000, but it's so like 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, and look at all the orphan companies that have orphan drugs. So an orphan drug is, is defined as a, a drug for a disease that has 200,000 people or lasts 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.

• 37:44Speaker 01

  And you can charge enormous amounts of money. So a lot of the big moneymakers are now these orphan drugs.

• 37:49Dr. Darshan Shah?

  Yeah.

• 37:49Speaker 01

  Charging. So I think it's just, 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.

• 38:03Dr. Darshan Shah?

  Yeah. But that must be so incredibly frustrating for you because you've been for 40 years, you know, you've been running MAPS and you've been fighting for the use of responsible use of psychedelics for the treatment. You know, full stop treatment of, 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.

• 38:28Speaker 01

  Yeah.

• 38:28Dr. Darshan Shah?

  Subscription, right?

• 38:29Speaker 01

  It's enormously frustrating. And, and I think it's, to, to say what I think our biggest mistake was in, 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, 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 was in the public domain. And I learned about MDMA in 1982, but it was already a therapy drug for about six years.

• 39:03Dr. Darshan Shah?

  Sure.

• 39:03Speaker 01

  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

• 39:45Speaker 01

  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. And 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. Got it. So in 2014, when I realized this, we created the MAPS Public Benefit Corporation,

• 40:29Speaker 01

  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. Yes. 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

• 41:14Speaker 01

  money for Phase 1 and Phase 2 and Phase 3 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. 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 because we couldn't raise that much money that quickly.

• 41:45Dr. Darshan Shah?

  Yeah.

• 41:45Speaker 01

  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.

• 42:00Dr. Darshan Shah?

  Yeah.

• 42:01Speaker 01

  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.

• 42:13Dr. Darshan Shah?

  Got it.

• 42:14Speaker 01

  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.

• 42:32Dr. Darshan Shah?

  Okay.

• 42:33Speaker 01

  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.

• 42:50Dr. Darshan Shah?

  Ah, congratulations. That's great. Yeah.

• 42:52Speaker 01

  And they've also said that once this data exclusivity period is over, which is in the US, 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.

• 43:15Dr. Darshan Shah?

  Six years, right?

• 43:16Speaker 01

  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.

• 43:39Dr. Darshan Shah?

  Yeah. How many years away are we from MDMA completing its studies in this?

• 43:44Speaker 01

  Well, I would say that I don't really know because now the pharma company is independent and is negotiating with the FDA. But what I, what my guess is, is that about a year, well, in June of last year, RFK Junior, the head of HHS, said that he wanted to see some sort of approval for psychedelics within a year. Marty Makary, who's the doctor who's the head of FDA, said that psychedelics are a priority of them. Yeah. 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

• 44:29Speaker 01

  months instead of the normal six to eight or 12 months. Okay. And so there was 10 companies that had been selected by the FDA and then approved by HHS as getting these priority vouchers. Uh huh. 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. Right. And so what had 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. Oh darn. 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? Yeah.

• 45:09Speaker 01

  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, Smoke Benefit Corp., but then we had a disagreement about patent policy. And I said, you don't deserve the MAPS name anymore. Go ahead, 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, that there's these accusations. Because we feel that the therapists are more effective if

• 45:51Speaker 01

  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. Right. 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. And so there's been a review of the videotapes. And then I think within the next couple of 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

• 46:33Speaker 01

  research that they want to gather. But I think, and 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.

• 46:49Dr. Darshan Shah?

  Okay.

• 46:51Speaker 01

  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.

• 47:08Dr. Darshan Shah?

  It's painful.

• 47:09Speaker 01

  But you can do it. 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 of 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

• 47:53Speaker 01

  therapy for active duty soldiers with PTSD.

• 47:56Dr. Darshan Shah?

  Ah.

• 47:57Speaker 01

  It's incredible.

• 47:57Dr. Darshan Shah?

  Yeah, that's incredible.

• 47:58Speaker 01

  One at Walter Reed, which is combining MDMA with acceptance and commitment therapy. The other is in Texas, it's a place called Strong Star in Emory, in Atlanta, combining MDMA with prolonged exposure. So I think that this idea that people who have been stuck

• 48:15Speaker 01

  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.

• 48:29Dr. Darshan Shah?

  Yes.

• 48:29Speaker 01

  And that this works. So I, so my guess is that there'll be some kind of provisional access in certain limited ways with additional research. But, but again, these are just guesses. I don't know directly.

• 48:42Dr. Darshan Shah?

  Yeah.

• 48:43Speaker 01

  But, but that's my thing. Now, meanwhile, though, MAPS is doing work around the world.

• 48:47Dr. Darshan Shah?

  Right.

• 48:47Speaker 01

  And so I'd say that the, in, 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.

• 49:09Dr. Darshan Shah?

  Okay.

• 49:10Speaker 01

  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.

• 49:29Dr. Darshan Shah?

  Right.

• 49:29Speaker 01

  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.

• 49:41Dr. Darshan Shah?

  Yeah.

• 49:41Speaker 01

  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.

• 49:54Dr. Darshan Shah?

  Right.

• 49:55Speaker 01

  So what this study in Israel is 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.

• 50:07Dr. Darshan Shah?

  Got it.

• 50:07Speaker 01

  So it's called non-inferiority.

• 50:09Dr. Darshan Shah?

  Okay.

• 50:10Speaker 01

  And because it's not as powerful of a statement, you're not saying one is more

• 50:14Dr. Darshan Shah?

  Yeah.

• 50:15Speaker 01

  valuable than the other, more useful than the other. You need smaller numbers of people.

• 50:18Dr. Darshan Shah?

  Sure.

• 50:19Speaker 01

  So this is 168 people. So thanks 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 too resilient. The pharmaceutical and we're no longer involved in that.

• 50:35Dr. Darshan Shah?

  Got it.

• 50:36Speaker 01

  But because we're a nonprofit, what we're focusing on is global humanitarian projects.

• 50:41Dr. Darshan Shah?

  Right.

• 50:42Speaker 01

  That are non monetizable.

• 50:43Dr. Darshan Shah?

  Right.

• 50:44Speaker 01

  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.

• 50:54Dr. Darshan Shah?

  Lebanon, right?

• 50:56Speaker 01

  And, you know, we're doing a lot of work, I mentioned in Israel, we were in Dubai. We're, 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 Somali land.

• 51:09Dr. Darshan Shah?

  Yeah.

• 51:09Speaker 01

  In Africa, we want to do work in Rwanda and South Africa and Kenya. So this is kind of the, the edge that I'm working on now is the global access.

• 51:20Dr. Darshan Shah?

  Got it. Yeah, it sounds like, you know, you, 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.

• 51:32Speaker 01

  Well, I would say that we, one of the key things that I realized, looking at the history with that, you know, we talked about how psychedelics were wrapped up with the counterculture in the sixties and the anti Vietnam War. And so there was this political backlash.

• 51:46Dr. Darshan Shah?

  Right.

• 51:46Speaker 01

  So in this new era of the psychedelic renaissance, I realized that it was absolutely essential that we get bipartisan support.

• 51:54Dr. Darshan Shah?

  Sure.

• 51:54Speaker 01

  And that's where the work with the veterans came in too.

• 51:57Dr. Darshan Shah?

  Yes.

• 51:58Speaker 01

  Because, and we have managed to get bipartisan support.

• 52:01Dr. Darshan Shah?

  Yeah.

• 52:02Speaker 01

  So I think that there are headwinds, but they're not as.

• 52:05Dr. Darshan Shah?

  Not as bad as before.

• 52:06Speaker 01

  Not as bad as before in any way, because we do have some, a lot of support in the Trump administration.

• 52:13Dr. Darshan Shah?

  Yeah.

• 52:13Speaker 01

  For moving now, I'm not sure who in the White House slowed down this compass priority voucher, but it still is moving forward.

• 52:21Dr. Darshan Shah?

  Yes.

• 52:22Speaker 01

  But there are headwinds, but I think they can be overcome.

• 52:24Dr. Darshan Shah?

  Yeah. And you're right. I mean, with the current administration, there's definitely a priority put on some of these.

• 52:29Speaker 01

  Yeah.

• 52:30Dr. Darshan Shah?

  Methods that were not there before, and also a deprioritization of giving the pharma industry even more power than they already have.

• 52:37Speaker 01

  Yeah.

• 52:38Dr. Darshan Shah?

  Which is already, which is also helpful too.

• 52:40Speaker 01

  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.

• 52:48Dr. Darshan Shah?

  Yes, I saw that. Mm hmm.

• 52:50Speaker 01

  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?

• 53:08Dr. Darshan Shah?

  Right, right. I love that.

• 53:10Speaker 01

  All these kind of like, you know, do you want to fall in love again? MDMA for couples therapy, something like that. So it's been pretty fun to just play around with that. 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.

• 53:32Dr. Darshan Shah?

  Right, exactly. It's not something that's done anywhere else in the world that I know of, and it's done here. Yeah, and I think also, you know, 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.

• 53:53Speaker 01

  Yeah.

• 53:53Dr. Darshan Shah?

  That's also going to weaken that industry.

• 53:55Speaker 01

  Well, I would just say that a lot of what Trump says doesn't actually

• 54:00Dr. Darshan Shah?

  That's true, too.

• 54:01Speaker 01

  take place. And so, you know, there was going to 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, but I mean, there is value in large prices to pharma companies to support innovation.

• 54:24Dr. Darshan Shah?

  That's true, too, yeah.

• 54:25Speaker 01

  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 hundred, 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.

• 55:10Dr. Darshan Shah?

  So that's like a $2 billion.

• 55:12Speaker 01

  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.

• 55:54Speaker 01

  And so it really, if you start out with a drug that we know works, like psychedelics.

• 55:59Dr. Darshan Shah?

  Exactly.

• 55:59Speaker 01

  And you just go direct.

• 56:01Dr. Darshan Shah?

  Yes.

• 56:01Speaker 01

  A couple hundred million dollars.

• 56:03Dr. Darshan Shah?

  Yep. So it's a lot lower. It's $200 million to get something approved if you're not counting the opportunity cost and you're not counting the failures.

• 56:11Speaker 01

  Yeah, even less than 200 million. You know, 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.

• 56:21Dr. Darshan Shah?

  Sure.

• 56:22Speaker 01

  From a statistical point of view.

• 56:24Dr. Darshan Shah?

  Right.

• 56:24Speaker 01

  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 it's used by the pharma company, this $2 billion number to justify charging high prices.

• 56:52Dr. Darshan Shah?

  Charging higher prices.

• 56:53Speaker 01

  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.

• 57:04Dr. Darshan Shah?

  Yeah, and we do need to fund the innovation as well. And so that, you know, if you go to any of these campuses for these drug companies are massive. And where I live, there's a few pharma companies 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.

• 57:23Speaker 01

  Yeah.

• 57:23Dr. Darshan Shah?

  But I do, you know, to your point, you know, opportunity cost of money should not be factored into the drug development cost. That doesn't make sense.

• 57:31Speaker 01

  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.

• 57:41Dr. Darshan Shah?

  That's true. Well, I mean, it's very hopeful that we can start using psychedelics for treatment of these psychological problems that we people have been struggling with for, you know, since the beginning of psychology, right? And is

• 57:55Speaker 01

  Yeah.

• 57:55Dr. Darshan Shah?

  Was there ever a time in psychology where psychedelics were used more frequently?

• 58:00Speaker 01

  Well, I would say that, so again, here we are in Cambridge. The psychology building is the William James Building.

• 58:08Dr. Darshan Shah?

  Well.

• 58:08Speaker 01

  So it was in the 1890s that William James started experimenting with nitrous oxide.

• 58:14Dr. Darshan Shah?

  Oh.

• 58:14Speaker 01

  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.

• 58:25Dr. Darshan Shah?

  Oh.

• 58:25Speaker 01

  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 filmyest screen from our normal consciousness is not really taking full consciousness into account. And I think it was 1896 is when Arthur Hefter 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.

• 58:56Dr. Darshan Shah?

  Right.

• 58:56Speaker 01

  And that there is a story that the book that reports it, the footnote basically goes nowhere. But they claimed that the chief visualist Fantasia, which is one of the most incredible Disney movies, had participated in a mescaline experience.

• 59:14Dr. Darshan Shah?

  Interesting.

• 59:14Speaker 01

  In Germany in the 20s.

• 59:16Dr. Darshan Shah?

  Interesting.

• 59:16Speaker 01

  And that the visions that he got from mescaline helped him to create Fantasia.

• 59:21Dr. Darshan Shah?

  Yeah.

• 59:22Speaker 01

  So.

• 59:23Dr. Darshan Shah?

  Makes sense.

• 59:24Speaker 01

  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.

• 1:00:08Speaker 01

  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, is that this whole concept of people hitting bottom, you know, 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.

• 1:00:43Dr. Darshan Shah?

  Right.

• 1:00:43Speaker 01

  And he felt, you know, 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.

• 1:01:08Dr. Darshan Shah?

  Yeah, exactly. And so now here we are picking it up again.

• 1:01:11Speaker 01

  Yeah.

• 1:01:12Dr. Darshan Shah?

  And, you know, I think most people out there have heard of many of the psychedelic options out there, both in plant medicine and also, you know, the chemical compounds like LSD and MDMA. And 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.

• 1:01:39Dr. Darshan Shah?

  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 ingrained emotional patterns into something new. Number four, context determines outcomes.

• 1:02:24Dr. Darshan Shah?

  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.

• 1:02:47Dr. Darshan Shah?

  Thank you so much for listening to the podcast today. Please remember to subscribe if you liked 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.