EP 177: Psychedelics: From Prohibition to Progress | Rick Doblin PhD

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This is Fleet Ball, your host. And today I'm having a conversation with Rick Doblin, Dr. Rick Doblin, the founder of MAPS, the organization that has really been responsible for opening the door to the possible rescheduling of psychedelic medicines like MDMA and psilocybin for therapeutic use in treating very difficult to treat severe depression, anxiety disorders, panic disorders, addiction and so on. And he has all but single handedly kept, kept the lights on and the hope alive since way back when MDMA in particular was scheduled as a Schedule 1 drug and made completely illegal for any use, even medical use. So, you know, he's done extraordinary work and we're going to be exploring the changing attitudes towards psychedelics, this psychedelic renaissance that we're in the midst of and the subset of that which is this quickly emerging field of psychedelic assisted psychotherapy, psychedelic assisted medicine, psychology. So it's a fascinating conversation with an incredible pioneer, Dr. Rick Doblin.

Welcome Dr. Doblin.

It's a pleasure to be here.

Well, it's really a pleasure to have.

You and I'm going to share a bit of your background, your bio for audience and then we'll jump right into the conversation. Sound good?

Yeah, sounds great.

All right, so Rick Doblin, Ph.D. is the founder and president of the Multidisciplinary.

Association for Psychedelic Studies, or MAPS as it's known. He received his doctorate in public policy from Harvard's Kennedy School of Government where he wrote his dissertation on the regulation of the medical uses of psychedelics and marijuana and his master's thesis on a survey of oncologists about smoked marijuana versus oral THC pill in nausea control for cancer patients. His undergraduate thesis at New England College of Florida was a 25 year follow up to the classic Good Friday experiment which evaluated the potential of psychedelic drugs to catalyze religious experiences. He also conducted a 34 year follow up study to Timothy Leary's Concord Prison experiment. Rick studied with Dr. Stan Sloth Grof and was among the first to be certified as a holotropic breathwork practitioner. His professional goal is to help develop legal contact for the beneficial uses of psychedelics and marijuana, primarily as prescription medicines, but also for personal goals for otherwise healthy people and eventually to become a legally licensed psychedelic therapist himself. He founded MAPS in 1986, and currently resides in Boston with his wife and puppy, with three empty rooms from his children, who have all graduated college and begun their life journeys. You can learn more about Rick by listening to his origin story and watching his TED talks.

Rick, I very much want to today explore the current research and the status of the clinical trials and the prospects for rescheduling and all of that. But I'd like to start with maybe your reflections on the recent Maps Psychedelic Science Conference in Denver, Colorado, which was just has to be a landmark event. I was very privileged to be there and there were more than 12,000 people there, I think. And it was just an incredible. I mean, it was a scientific conference and it was a happening in the true sense all at the same time. And. And you know, there was a lot. The whole kind of psychedelic renaissance was present, although it very much focused on the science. So I'm just curious about your reflections on it. You've had some time to gain perspective, like, what did it mean to you?

What.

How do you see this as a reflection of what's where the movement has come to and so forth.

Yeah, well, personally, it was one of the best days of my life. It was just thrilling to see everybody coming together. And I would say my fears about the world which we share in terms of climate change and nuclear weapons and rise of authoritarianism and all of that, after the conference, my fear and paranoia of the world sort of went down a little because I felt a lot of hope from that conference. And I think part of what made it so exciting was that there was people from all aspects of our culture. It wasn't just, you know, aging hippies from the 60s. You know, we had a lot of Republicans, we had a lot of veterans, we had government officials. We had scientist Tom Insel, who used to be the head of the National Institute Institute of Mental Health. He said the conference was a cross between Neuroscience conference and Burning Man.

We. We had Marian Goodell, who was the head of Burning Man. And just one of the things that's been so interesting is that she felt comfortable in a way that she never had to talk about her own psychedelic experiences and about.

Psychedelics at Burning Man. And so just this year, a couple weeks ago, at Burning man, there's been a documentary that's been made about Burning man, that they've been doing it for three years. This is the fourth and final year. And Marian decided that she wanted to put some segments in there about psychedelics and the psychedelic harm reduction that we do. The Zendo project at Burning Man. So it's sort of. The conference made it more comfortable for a whole wider range of people to speak out about psychedelics. You know, we had the best example I could think of bipartisan support, because after my opening talk, we had Rick Perry, the former governor of Texas, on Trump's cabinet secretary of energy. He gave a very stirring speech about the importance of us coming together on psychedelics across political boundaries. He was followed by, you know, Governor Polis, the Democratic governor of Colorado.

We had a dinner for veterans. We had over a thousand people at the veterans dinner, and many of them, of course, being Republicans and a bunch of them supporters of Trump. But we could align on the healing potential of psychedelics. It was so rich, the content. We had about 10 or so simultaneous tracks, and we're just starting now to release the videos from that conference. So we're going to make them available for all the people that were there and all the people that weren't there who are interested. But I just felt that it was a historical moment that in a way, I'll say something else about Burning Man. You know, Burning man is they provide the infrastructure, and then people with their villages bring all sorts of things. And so the conference felt like that in a way. We provided the core superstructure with the lectures. But we had, I think, over 30 or 40 events that were organized by other groups around the conference, and we just had the participation of so many people that really the community came together, and that's what made it so powerful. And, you know, we've had conferences, psychedelics highest conferences, in 2010, 2013, 2017, and this now is six years. We're going to do it again in 2025, also in Denver, also at the convention center. But I think the thing that most impressed me about the conference, somehow it felt like there was the state of grace, that all the breaks that could have happened went in our favor during the conference in terms of it working out smoothly. But I think it just really felt like all the elements of American culture and global culture were there. And that's what made me think we can integrate psychedelics into our culture without the backlash that happened in the 60s against the. In particular LSD and psilocybin, or the backlash that happened in the 80s against MDMA or Ecstasy. I think the conference gave me substantial hope that we will be able to sort of land this plane safely and reintegrate psychedelics into our culture without the kind of backlash, because we've taken psychedelics out of the culture wars and have genuinely got bipartisan support in part it's because support of the veterans. You know, two thirds of the patients and most of the people with PTSD are women from sexual abuse or sexual assault or domestic violence. But the veterans get the media attention. But we had representatives of all different groups there at the conference and I think people will be able to learn for years now, just looking at all the presentations that were made, we do think in 2025 it'll again be a different world. We hope that FDA will have approved MDMA assisted therapy for PTSD. By then, psilocybin will have gone through some phase three studies. So we think again, it'll be like looking at a new set of opportunities, new set of options. And.

I'll just say that for us, the conference was just monumental in terms of demonstrating really that the culture seems to be ready for a change.

Wow.

Yeah, in my experience, it definitely was kind of a meta cultural event and it was really quite astounding to be at the opening ceremonies and have former governor Rick Perry come up on stage and a lot of self effacing humor. It was obviously in front of a pretty liberal crowd for the most part, and, but it was really great. And then to listen to the president of the Colorado Senate talk about what Colorado is going through with decriminalization and get into the nuances that. I want, I want to revisit that a little bit later in our, in our, our conversation. But yeah, it just demonstrates that there's something going on in the culture that's very different from back in the 60s and 70s and it does give great hope. It seemed like for me, the overall vibe at the conference was one of tremendous hopefulness and inspiration. Absolutely. So, you know, based on this incredible response that you've received.

Both in terms of the professionals coming together in this way, but also the incredible large audience of interested people, I know you were turning people away. I think the conference was sold out in the end.

And you've spoken to this a little bit already, but I wonder if you could speak a little bit to the, maybe the parallels of the psychedelic renaissance, as it's being called, and you know, all the efforts at decriminalization and you know, your more than three decades of efforts, as well as the specific emergence of this psychedelic assisted psychotherapy and medicine field, which is very much evidence based and is going to be hopefully very rigorous and be all about, you know, the, the medicalizing that, not to use that in a negative sense, but of, of the benefits that people can probably receive from psychiatric medicines in a clinical setting. So I wanted These parallel evolutions of those two things.

Yeah. Well, let's start with what is our real goal? So our goal is transformation of human consciousness. Our goal is mass mental health and a spiritualized humanity. And what I mean by that is very similar to what the astronauts, some of them were talking about as they look back at earth from space when we were going to the moon, that we're all part of one system. And when you have that perspective, a slightly more cosmic perspective, it's harder to want to kill people who have a different tribe than we do, or different color skin, or different religion. So this idea of a spiritualized humanity means that we still retain all of the ways that we identify ourselves through our religion, our nationality, our, our race, our gender, our political orientation, our sexual orientation. All these different things are how we define ourselves. But we would have a deeper identification with the planet, with life on earth as a whole. And that should make us more willing to appreciate differences rather than be scared by differences. So that kind of cultural transformation needs a Two parallel strategies. One is medicalization of psychedelics to change key opinion leaders minds to provide access through medicine that would be covered by insurance. The other is drug policy reform to provide access for people to experience psychedelics potentially. You know, without having a diagnosis, you should just be like, I'm a human, that's my diagnosis. I'm going to die and I need to figure out what to do about death, what to do about life, how do I contribute to making a better world in this brief time that I have while I'm above the ground. And so I think what we see is reflected to go backwards to medical marijuana and marijuana legalization. So the very first medical marijuana states were 1996 were California and Arizona. Now that was now 27 years ago. We still do not have federal legalization of cannabis or, you know, ending the criminalization and putting it back to the states the way that we did with alcohol. But we do have, I think, 17 or so states that marijuana is legal for any purpose. And I think 38, 39, something like that, states where there's some form of medical access. So the theory of change is that people have been inundated with propaganda for, you know, decades and decades, decades, you know, almost a whole century of propaganda about drugs or more even. And they don't know what to believe. And so when the polling has been done about why somebody might vote for legalization of marijuana, one of the top factors is if they know a medical marijuana patient. So you know somebody, you trust them, they tell you a story. You believe it, and then that causes you to question a lot of the propaganda that you've received. So I think that the similar things will happen with psychedelics. So, you know, starting in the 60s and into the 70s, but then the backlash and stuff wiped out for decades. And then starting again 1990 with Rick Strassman doing a DMT study, with 1992 with Charlie Grove and Maps doing MDMA research and all of that, we've sufficiently educated people about the potential therapeutic and spiritual value of psychedelics. And I think that has caused them to change their attitudes about whether psychedelics should be available just outside of medical supervision. We're also coming in at a time of mental health crisis that we've never seen before, exasperated by the pandemic, but also just by climate change. You know, my, my children in their 20s are saying that a lot of their friends are thinking they never want to have kids because it's such a difficult world to bring them into. And they think the stresses are only likely to get worse over the next couple decades. And so I think this.

Parallel path of medicalization and legalization are mutually synergistic. The more that we can medicalized, the more people think, well, maybe prohibition is the wrong idea. And so our current projection is that roughly May or June of 2024, we think FDA approval will come for MDMA assisted therapy for PTSD. And there are already 700 or more ketamine clinics in the United States, ketamine being a treatment for depression and other things. We think over the next decade there'll be the growth of thousands and thousands and thousands of psych psychedelic clinics. I think upwards of 6,000. The reason I say that is just that. We have about 5 to 6,000 hospice centers in the United States. So any community that's large enough to have a hospice center is largely likely large enough to have a psychedelic treatment center or one or several. So I think by 2035, what changes things is people telling their stories. And that's why I'm so glad to be interviewing with you now too. We need a second all coming out. We need people to share their stories and that will destigmatize things. So unlike many for profit psychedelic companies.

Who are worried about legalization being bad for the business model, if you can buy mushrooms, you know, for 10 bucks or grow them yourselves while you buy them for a substantially amount more as pharmaceutical medicines, well, I think people will only pay the CO pays. They won't pay, you know, what the insurance companies pay to the pharma companies. But I do think that the legalization will destigmatize further, will help people better understand that these are not just recreational tools, that they are tools for therapy and spirituality. And also they'll make more people say, I want to go to the trained professionals who've been cross trained in ketamine, mdma, psilocybin, and they will decide which is the next one for me, what's the sequence. So I think the moves towards legal access outside of religion and outside of medicine are moving forward in a rapid way. And I think that that's happening because of the scientific research that has sort of validated people's thoughts and experiences, but in a scientific consensus generated manner, you know, as regulated by the fda. So I do think that that's happening first in the United States, more so than around the world, that the US really originated the drug war, expanded it dramatically around the world, and now a lot of people are stuck with that, and they're sort of looking at the US to dismantle it in different ways. The other thing I just want to mention about religious use is that that is also dramatically growing in the United States. The number of people that are sort of claiming that they have a psychedelic religion and that that should protect them from criminal prosecution is enormous. And I think many of these new religions would not meet the Supreme Court test for what is a legitimate religion. It's pretty rigorous. However, because of the incredible need that, that people have for new treatments for mental health, and because of the overall serious questioning about the value of prohibition, that has been discredited in a lot of different ways. And the fact that we have, you know, over 100,000 people die in America just over one year over opiate and fentanyl overdoses, that there's been no enforcement, really little to no enforcement against psychedelic religions, even if they might not meet the technical definition. So overall, I think we are in a situation where there's just a very good chance that we can mainstream psychedelics without the backlashes that have happened in the past.

Well, it's really fascinating that this is.

All happening against the backdrop of, you know, some really challenging times with the existential crisis of climate change, the increasing political divisiveness, ongoing conflicts around the world, and the mental health crisis, the opioid crisis here in our country and so forth. So in some ways there's some. Some real synergies there. And in other ways, it seems to be a magical moment that despite a very conservative world based on people getting real information, people are making different choices and beginning to accept Things they would have written off based on a political or emotional argument. And it's really quite amazing. Well, let's talk a bit about the research. So what would you say about the current state of the research? Maps has stewarded a lot of the research and the clinical trials. What do we know now? What are some of the more important findings that you would point to that will lead the way in the medicalization aspect of this?

Yeah, well, in several days later this week, the results of our second phase three study will be published in a major scientific journal. And we've given the New York Times an exclusive on that. So I think once that comes out, people will. We've already put out a press release saying that the second phase 3 study was very successful. But you know, people have not been able to look at the actual data. So we are the first and only psychedelic company that has completed any phase three studies ever. There were no phase three studies in the 60s. These were more academic research projects. And now we have two successful phase three studies. And you know, it looks likely that FDA will go ahead and say yes, we're not sure exactly how, what regulations. So I think that the work that's being done with psilocybin there was just. Usona just published a paper a couple days ago about a large phase two study that they've done for psilocybin for major depressive disorder. Compass Pathways is starting its phase three projects for MDMA for treatment, excuse me, psilocybin for treatment resistant depression. There's research in five meo, DMT for depression and other things. The FDA division of Psychiatry, which is the one that reviews most of the psychedelic protocols that said that over half of the protocols that they're getting these days are psychedelic related. So that's amazing. The innovation in psychiatry is coming from psychedelics right now. And the traditional medications are, have gone generic and they basically control symptoms. Whereas what we're talking about with psychedelic assisted therapy is going to the core root of the problem and trying to address it through experiencing, expressing.

What happened, no longer suppressing it. And then through the neuroplasticity that is created through psychedelics, through the integration process, making these short term experiences anchored into long term change. So there is more psychedelic research taking place now than at any time in the past. Even during the height of the 1960s, the main areas that are being looked at are ours for ptsd. Others are looking at depression and then also substance abuse. So, you know, the first time in 50 years that the National Institute on Drug Abuse has actually funded a Psychedelic study took place, I think maybe about a year ago or so. It was Matt Johnson and his project at Johns Hopkins. And it was psilocybin combined with cognitive behavioral therapy for nicotine cessation. And they got great results. So I think we're looking at anxiety related to death, addiction, trauma and depression are the main areas. And then the new areas that are being looked at are going to be in the nature of the mind body problem. So like irritable bowel syndrome, fibromyalgia, there's a whole host of physical illnesses that have a psychological component to it. And so that's going to be starting to be researched. And then there's about to be in the next couple weeks or month, a really interesting paper from Roland Griffiths and others at Hopkins and NYU about religious leaders who, from different religious traditions who receive psilocybin in a therapeutic setting. And the purpose was to see if they described them as being genuinely mystical and religious and valid and having an important meaning for their lives, which, which did occur. So the research with psychedelics, I think is.

At an unbelievable state. But, but I want to add one thing. When we talk about integrating psychedelics back into our culture, really it's a reintegration. But the, the last time psychedelics were fully integrated in Western culture was all the way back around 392 in Greece with the Eleusinian Mysteries that had run for around 2000 years and it was wiped out by the Catholic Church because they wanted to be the intermediary between people and God. But that's really the last time that psychedelics were fully integrated into culture. And that's the foundation of philosophy, of democracy. The Greeks, everybody that we know of, Pythagoras, Aristotle, Plato, all these people participated in the Eleusinian mysteries that had a psychedelic component. So I think we need to realize that the domination of religion and politics that squashed the Eleusinian mysteries then during the Middle Ages killed all the witches, many of whom had information about plant medicines. Then when the conquistadors come to North America, the first thing they do is they kill the shamans who are working with ayahuasca, peyote and mushrooms because they were the center of their communities. And there was only this brief flowering during the 60s.

With psychedelics again. But that was too controversial. The backlash came and now we're trying to 50, 60 years later have a successful landing. But I, I think it does help to think about. It's not the first time that psychedelics have been integrated into Western culture. It's really going to be the second time after the origins of our the Greeks and our history. So that suggests that if we can understand the dynamics, we have a good chance to reintegrate psychedelics in a major way without producing a backlash. That's the challenge.

I wonder if I could just inquire a little further about your research and your understanding of the state of the research in general. So there's no question people have extraordinary experiences on, on psychedelic medicines and they can be all around. People can have amazing blissful experiences of interconnectedness and so forth, or they can revisit traumas and have some pretty difficult journeys. But what I've watched of interviews post such sessions, people seem to be able to witness what they've been through with a newfound courage and perspective. So people have incredible experiences. What does the data show in terms of like comparing this type of psychotherapy with psychotherapy without the medicine, both in terms of immediate effect, but also in terms of lasting effect. So, you know, how long before there's a, you know, recurrence of depression or recurrence of addictions and so forth? So I wonder, what are you seeing in terms of how far the needle is really moving?

Yeah, quite a bit. And I think your focus on the durability of the results is absolutely critical because what we're talking about is labor intensive, meaning these are therapeutic interventions. It's not the same as giving someone a pill and then come back two months from now and I'll adjust your medication. So unless these outcomes are durable, insurance companies won't pay for them. So the durability has got to be a key factor. What we're finding is, first off, it's very difficult to do double blind studies with psychedelics. But the FDA and the European Medicines Agency have agreed with us that the way to do the research for phase three, the double line placebo controlled studies that are required, is that we compare our therapy with an inactive placebo versus our therapy with full dose MDMA. Around 90% of the people understand correctly, guess correctly whether they received MDMA or placebo. But there's a small amount of people that are confused. So it's not completely a failed double blind, even when you use an inactive placebo. But that gives us the opportunity to answer your question about how does this compare to therapy? Now, there was a recent study that was six years in the making done by the Veterans Administration, and it compared cognitive processing therapy with prolonged exposure. Those are the two main therapies used to treat PTSD inside the VA. And that study demonstrated that there was roughly 50% dropout rate in both prolonged exposure and cognitive processing therapy. These therapies are re traumatizing to a lot of people. They're directive, you got to go over and over your trauma. A lot of people can't handle that. The dropout rate that we had in our MDMA project was 8% in our first study. So MDMA first off keeps people in the treatment. Treatment, that's a really important point. The.

First phase two studies that we did from starting 2000 to 2016, we're working with treatment resistant people. People had gotten, initially people had gotten both therapy and medication that had failed. Over time we went to therapy or medication and in our phase three we dropped the idea of treatment resistance because if we kept that then it would only be approved for people that had previously failed other treatments. And so but what we showed is that in our first phase three study, now we had people that are the hardest to treat. One third of them had either behaviors to prepare for suicide, like going to a bridge and thinking about jumping off and not doing it, or actually attempted suicide. Around one third had this serious suicidal ideation and or behaviors to do this. People had PTSD an average of 14 years. Over 1/3 had PTSD over 20 years. We enrolled people that have previously attempted suicide. We had around 32% or so of people at the two month follow up no longer qualified for a diagnosis of ptsd. This is with the therapy with an inactive placebo, but when you add MDMA it more than doubles to 67% no longer qualified for diagnosis of PTSD at the two month follow up and 21% and additionally had what are called clinically significant reductions of PTSD symptoms, meaning they still had PTSD but the symptoms were reduced enough that that would positively impact their, their, their behaviors and their life. So we have focused on what the FDA wants us to do, requires us to do for approval. So that was the design. It was our therapy without MDMA versus our therapy with mdma. We have not funded direct head to head comparisons of MDMA compared to SSRIs for example. But almost everybody in our study has had them and still has moderate to severe ptsd. I think that the issue is going to be for the fda.

You know.

What therapy is approved, how do we train the therapists? And so we're seeing MDMA as a tool and it can be used in different ways. So we are actually supporting studies to combine MDMA with cognitive processing therapy to combine MDMA with prolonged exposure. Once those combinations are developed, then, then we can See how well they work to MDMA with our own therapeutic method. But we don't feel the need to directly head to head compare MDMA to SSRIs, for example. And the FDA doesn't require that, and I don't think that insurance companies will require that either. But it's fair to say that almost everybody in our study had had access to pharmaceutical medicines and they still had moderate to severe ptsd. I think the big issue for us going forward is going to move to group therapy and how do we really explore whether group therapy can be as effective as individual therapy. So our first group therapy project has been FDA approved at the Portland, Oregon va, and there's going to be four therapists for six veterans with ptsd, each of them getting two MDMA experiences. But the first will be getting.

Everybody will get an MDMA experience individually before they do it together in a group. So I think that's one of the big lessons that we're going to have. There's also a little bit of an expansion between who's the patient. So there's an approach called cognitive behavioral conjoint therapy. Conjoint meaning couples or diets. And it's a treatment for ptsd. And you bring in the PTSD patient and their partner and you work with them both together. And we've added MDMA to that and have done six dyads where they both get mdma. And the results were phenomenal, better than anything they'd gotten before, both in reduction of PTSD symptoms and in strength of the relationship. There's been a project at Sunstone Therapies, which is outside of Rockville, Maryland. They're an expanded access site of theirs, but they've done work with cancer patients where they bring in the cancer patient and also their partner and they both get mdma. So we've moved from just treating two therapists, two people in the room, one a therapist, one doesn't have to be a therapist treating one person, to then two people treating two people getting mdma, one a patient and one a significant other, both with PTSD and also with anxiety related to cancer. And now we're moving into group therapy where everybody has ptsd. So I think over time we're going to be developing new.

Blended therapeutic modalities.

But I think it's fair to say effect size is a statistical.

Process that is designed to compare treatments across studies. So, you know, when you do statistical significance, that's one measure. Did your study reach 0.051 in 20 chance that was random. That then if you have two of those, the FDA will approve the drug. Potentially. I think that what we're.

Seeing.

Is that there will be.

Post approval.

You know, many different ways people can do this. But when you look at the effect sizes of SSRIs for the treating PTSD or the effect sizes of other therapies.

What you find is that the MDMA assisted therapy effect size is larger than any of them. So that's not a head to head comparison, but that's using the statistical methods of effect size to do a comparison. And so I think there's a lot we can learn from that. So it is our hope that MDMA assisted therapy for PTSD is.

Seemingly more effective than other approaches. I think the same will be true for psilocybin for depression and other indications. There's just remarkable therapeutic potential for psychedelics when combined with therapy.

So thank you for that, very thorough.

So let's talk about the rescheduling a.

Little bit to the extent that you can.

I understand you're hopeful that next year MDMA could be rescheduled for being prescribed by medical professionals for therapeutic use. And so you've had two successful phase three trials. So what does that process kind of involve without a whole lesson on the bureaucracy.

But what's, and, and where are we in. And, and then what's it likely to look like as that rolls out? Because the FDA is not approving the drugs alone, they're approving the drugs as part of therapy. Right. And so what's that going to look like? You know, if they, if you get the notice, the FDA has rescheduled it on, you know, January 1, 2024, which may not happen. But then how long is it before it might actually be able to be utilized and prescribed and so forth?

So the process is going to be. Was very much impacted by November 29, 2016. We got permission to go to phase three, but I knew that phase three would have a lot of challenges, particularly how to do double blind study. So we engaged in what's called special protocol assessment process. Most pharma companies don't do it because there's not that much unusual about what they're trying to do. But that's a process where you negotiate with every aspect with the FDA about every aspect of your design, your statistical analysis plan, your double blind and all the ancillary studies that they're going to want to see about safety and efficacy. So we engaged in a successful process and we managed to get what's called an agreement letter. So FDA is legally bound now to approve our drug, if we get statistical significance from these studies, if we have no new safety problems, and if we've gathered the data properly. So we are now gathering together all the data for submission to FDA probably in the next month or two. And that's for what's called the NDA, the new Drug Application. We have a six month review time and that is because we have breakthrough therapy status. It looks like this is a breakthrough therapy. However, the clock stops. The six month clock stops when FDA asks questions. So it'll be how quickly do we respond to these questions? But my guess is that around May or June of 2024 we should have FDA approval. Now that's not enough because the drug is still in schedule one. So the Drug Enforcement Administration waits for FDA approval and then they have 90 days to go ahead and reschedule. Whether it goes into Schedule 2 or Schedule 3 or Schedule 4 is not quite clear yet. But the DEA must reschedule and they've in the past taken forever to do that. That's why Congress passed these laws that require them to do do that within 90 days. Now that's not enough. The states need to reschedule as well. And so about half the states automatically reschedule following the dea. Another half have various different, their board of Public health or various different groups have to do this. Some places, like California, you need a new law signed by the government. So we are currently working with the people that worked on the psychedelic decrim law that just is now being sent to the Governor of California. And in it is this proposal that they will automatically reschedule MDMA once the FDA does. All right, so we're anticipating the launch of the product, the launch of the treatment near the end of 2024 after FDA approval, DEA approval and then state rescheduling. And our most, one of the most important things as far as whether the launch works out right, is going to be whether there's insurance coverage for it. And so we've had a series of discussions with insurance companies that are quite promising. So I think there's a real good chance that we will both get FDA approval and we'll be able to.

Provide insurance for those people that are covered by insurance.

So I would imagine that part of the insurance approval have to do with expense. And as you meant, the way the clinical trials have been done is very expensive. So I know you're exploring group therapy as one vehicle to lower the cost on this, but it could still be considerably expensive. And I wonder if that's part of the consideration with the Insurance companies, and I'm curious not to get into a deep conversation about this, but with the dominance of the serotonin inhibitor drugs, the SSRIs and associated drugs for a long time, psychiatry, whether it's a pushback from that lobby or that part of the pharmaceutical business and how all that's going to kind of play out and what might be some of the obstacles that would actually have this really start rolling out and benefiting people.

Yeah, well, I think insurance coverage is going to be the key. And in particular there's loads of people who don't even have insurance. So how are we going to help them? And not all of them are, most of them are not wealthy and can't afford to do the self payment. But I think the SSRIs and the drugs that have been developed by Big Pharma for various mental illnesses, the innovation happened 20, 30 years ago and those drugs are now generics. So we do not experience any pushback. I do not see any signs whatsoever of pushback from pharma trying to block what we're doing. Big Pharma has in the past contributed to the Partnership for a Drug Free America or other anti drug groups, but I don't see that happening anymore either because the drug war has been discredited in a lot of people's eyes, not in everybody's eyes. So at the moment I really don't see the likelihood of pushback. I do see that the value of helping somebody with moderate to severe PTSD regain their life and no longer have a diagnosis of PTSD is extremely large.

Some of our estimates are the value to the person, their family, society is somewhere in the neighborhood of $70,000 over the first three years, offset medical expenses, things like that. So I, I do think that we have a very good chance to have insurance coverage.

Right from the very beginning. It's going to be a challenge. Again, what to do with people that don't have insurance. That's where we need a robust patient assistance program. But unlike all other pharma companies where you see their ads on TV and they say, oh, we can help you. If you can't afford the drug, just come to us, we'll give it to you. Well, we can give somebody free mdma, but if they can't afford the therapy, it doesn't do them any good. So for a proper patient assistance program, we'd need to pay for the therapy. That's also why we want legalization, so people will train them in peer support and self care so people can do this on their own without going to this. The other thing I do want to mention is that we have a standardized treatment manual. It's up for this in the public domain, available on our website. But and it describes our therapeutic approach. And we think that the way that we're going to be negotiating with FDA is that once this becomes a medicine, it's not going to be available for all therapists to prescribe it or to give it to their patients. It's only going to be for trained therapists. And the therapists need to be trained in the method that we've used in phase three. They don't need to be trained by us. We want this to be schools of psychiatry and psychotherapy as part of the core curriculum. But once people have learned the method that we have used in phase three, they can innovate if they want to. They're not going to be stuck to required to use only what we call our inner directed therapeutic method. They can, if they want, combine it with prolonged exposure, combine it with guided imagery, whatever. So the regulations will have most likely limitations on who can prescribe. There's probably will be special much, much shorter education for prescribers and then who can be in the room with the patient. And it will prohibit.

Doing it at home.

Without supervision of therapists. It won't be like a take home medicine and do on your own. So I think it can be regulated in a really good way. And I do think that therapists don't have to worry that they'll be constrained to just our method. But we do think they, and I think the FDA will agree that they should learn that method.

Well, with this particular FDA approval and then the rescheduling that will follow. Is this specifically for treating PTSD alone or once it's approved, will physicians be able to describe, prescribe it off label for therapists to use with addiction, anxiety disorders, which are all kind of often interrelated with PTSD, but not always.

Yeah. So the, in 1986, the FDA approved a Marinol, the oral THC pill for nausea control. And the DEA put out a rule saying they wanted to block off label prescriptions because it's a controlled substance. There was so much outcry from the pharmaceutical industry and others that they had to withdraw that. So there is no way that the DEA or FDA can block off label prescriptions. However, the problem is that insurance companies tend not to pay for off label use. And so the drug is going to be quite expensive. The therapy is quite expensive. Again, it's expensive to insurance companies. People are Just going to pay the co pays. But I think that there's going to be very little off label prescription because people would have to pay the full price of the drug and also the therapy on their own. What that means is that we should be doing we meaning the maps, Public Benefit Corp. As many other studies as we can to get MDMA approved for other uses so that then insurance companies will cover them. And I'll just mention that one of the best uses I believe is going to be couples therapy. And even though it's not a disease in the dsm, we've been instructed that it might very well be possible for the FDA to approve MDMA for couples therapy so that we can get insurance coverage for it. But we'll have to come to agreement on what is the primary outcome measure and what are the secondary measures. And for that, you know, it's not whether a couple stay together. Some of them could make a smart decision to get divorced. So it has to be more about communication styles. But, but I do feel that the off label prescriptions for group therapy will be possible because it's still for PTSD, but off label for other indications. And MDMA has potential for a wide range of things. We call it MDMA assisted psychotherapy or MDMA assisted therapy. So whatever therapy is good for MDMA can be helpful. Same was true with psilocybin and others. So that's going to be a challenge is how do people afford off label indications and how quickly are we to review, you know, conduct the studies to get FDA to approve them?

Well, that's the current situation with ketamine. Since it's being used off label, it's largely not covered by insurance, I think. Is that the case?

Yes. And one of the things though, that ketamine was approved as a medicine strictly on its pharmacological properties, right? Not at all on, not with therapy at all. So there's no insurance coverage for therapy associated with ketamine, even though it'll work better when you combine therapy with ketamine than ketamine alone. But yeah, because it wasn't approved with therapy, the insurance companies won't cover it.

We're just about out of time here, Dr. Doblin. I just want to maybe as a final question.

You know, again, I, as I said it was fascinating listening to the president of the Colorado Sen. Talk about their, you know, Colorado decriminalized plant medicines broadly. I think he said, now we got work out the policies of how we're going to deal with all this. And you know, so this has to do with the whole kind of decriminalization movement. And he said it's not going to be like it was with marijuana. You know, marijuana, at least the decriminalization for recreational use has been largely driven by economics, taxation. It's a business and very profitable business for many. And he said he feels the plant medicine is going to be rolled out in a different way with different motivating, different economic structures. So I'm just curious about your thoughts on that, since you've been a proponent of. Of both.

Yeah, well, I, I actually think that the most people will be treated with PTSD by small private practice therapists working out of their homes or small offices. You know, there is some thought that there'll be major medical centers that will offer MDMA assisted therapy for ptsd, but I, I think most of the prescriptions will come from the way most therapists actually practice, which is in small private practice contexts. And I think that that's going to be something that we really need to facilitate and make it easier for them to both store the drugs and get.

You know, DEA licenses to do that and get insurance coverage. So I, I think the way ahead is very promising, but that there'll be a lot of work to try to make it fit within.

Existing structures. We are making it optional for people to spend the night, but in phase three, much of our patients were treated in a facility and then spent the night in that facility. And then the next morning, the therapists come back for integrative psychotherapy. It doesn't for facilities that operate during the day. There's not that much extra cost for keeping people overnight, but in some places, institutions there could be. So we've made that to be optional, but I do think that this will roll out, I think, pretty smoothly.

Well, Dr. Rick Doblin, thank you so much and congratulations on seeing your work of many, many decades coming to fruition. Congratulations on the extraordinary Denver conference and that rescheduling really does seem to be on the horizon at this point. So thank you so much for your many decades of work and for being part of our summit.

But thank you, Fleet. I really appreciate the opportunity because we're very interested now in public education. Now that we've got the data, what we really need is the public education.

Great.

Thank you so much. Be well.

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