Hope, Healing, and the Next Chapter of Pyschedelic Medicine

Welcome to the Radical responsibility podcast. I'm Dr. Fleet Mahl and I'm excited to guide you on a journey of authentic transformation. In each episode, I'll bring you insights from leading experts to explore trauma recovery, mindfulness practices, positive psychology, and innovative breakthroughs in health, wellness and life optimization. This is a space for real conversations that inspire meaningful change, helping you find alignment with the person you were always meant to be. Let's get started. My name is Dr. Fleet Mall, your co host for this session and I'm really thrilled to be here today with none other than Rick Doblin. Welcome Dr. Doblin Fleet.

It's a pleasure to be here with you today.

Oh, it's really great to have you and been looking forward to this conversation. So Maps, under your direction has really been a pioneering force in psychedelic research and the efforts to kind of overturn what happened back in the 70s with the scheduling of all the psychiatric medicines as Schedule 1 drugs having no therapeutic or medical value. And your efforts led to the clinical studies on MDMA and psilocybin and others. And recently the FDA elected not to recommend rescheduling of MDMA at this time based on the advice of their or the recommendations from their advisory committee. So I'm curious about your thoughts on that. Where things stand now and given the complexities of the overall FDA approval process and DEA rescheduling, you know, strategies for seems like it's something that's inevitable, but this is clearly, I would imagine, a bit of a setback. So where are we and where do we go from here?

Well, I do believe it's inevitable because I do believe that even the data that we have was considered by the FTA advisory committee meeting to be inadequate to demonstrate safety or efficacy. They issued their report on June 4. The Dutch state Committee on MDMA was the Dutch equivalent of the FDA advisory committee, except for the fact that it had actual subject matter experts who knew more about psychedelics and psychedelic research than the advisory people did for the fda. They spent about a year reviewing the data and they published a book length report about their findings and they came to the opposite conclusion of the FDA advisory committee. They said that efficacy was proven, safety was proven, and since Lycos had pulled out of Europe after supporting some early pilot studies in phase two to prepare therapists for phase three, which Lycos decided not to do, pulled out of Europe, withdrew their application. The Dutch committee said that because efficacy and safety are proven, because there's such a major unmet medical need, there should be immediate implementation of what they call naturalistic studies, which is basically real world evidence, compassionate use, where therapists can give MDMA to PTSD patients, you do some measurements before and after, but there's no control group. So in that sense, it's like real world evidence. And so that's what's being discussed to really set up now in the Netherlands. So I think that we need to look at how did two different bodies come to two completely different conclusions within two days of each other? And I think the answer is that the FDA advisory committee really was composed of people that really didn't understand the data, the research. They were really much more influenced by media and public opinion. And for that, Lycos had adopted a traditional approach which they called the quiet period, which they wanted no interaction with media, no interaction with outside agencies, not even blocking me from even responding to criticisms about the therapeutic approach in scientific journals. So I think it was basically a situation where we had people on the advisory committee who didn't really understand the science, were much more influenced by the media than they were by the briefing package that they got from the FDA and who really didn't understand so much. So, for example, and then I'll get to where do we go from here? Which is really the key question. The advisory committee said that, oh, one big concern of theirs was this idea of functional unblinding. And you know, Lycos has hired a fellow, David Huff, who led the Spravato effort to make Spravato into a medicine for Johnson and Johnson for S Ketamine Spravato. And what he said in an interview in Psychedelic Alpha, that in his experience, even schizophrenia studies are not really blinded because the drugs that are tested have such a strong side effect profile that the researchers and the patients can tell whether they got the placebo or whether they got the active drug. Tom Loughran, who was the former director of psychiatry products, said something similar, that even in SSRI studies where you think it's a pill, it doesn't have like a psychedelic effect. You need to take it for weeks or months sometimes before it really changes one's mood. That would be easy to blind. But he said again, no, that the side effect profile of these drugs makes it so that a double blind is a theoretical approach, but in practice it fails more often than it succeeds. And we negotiated fully with the FDA in 2017, 2016, November 29, 2016, as we got permission to go to phase three because of the double blind and other issues, I decided to elect to go through a special protocol assessment process that took Eight months. And we negotiated every aspect of the design with fda and we discussed intensively how to address functional unblinding. And the solution that the FDA chose was MDMA with inactive placebo versus MDMA with full dose. I mean, therapy with inactive placebo, therapy with full dose mdma. And the reason that I, my dissertation, which I got from the Kennedy School of government at Harvard 2001, focused a lot on the double blind issue. And I thought the solution was going to be therapy with low dose MDMA versus therapy with full dose. And the challenge was going to be what's the dose that's high enough to start causing confusion? Microdose doesn't work because you don't really notice it. That's the definition of microdosing, just has subtle effects. So what's the dose that's high enough to start saying to people, well, maybe this is a full dose, but not so high that it has so much therapeutic potential that you'll never be able to tell the difference between the two groups. And what we discovered in 16 years of phase two study, starting in 2000, was that the lower doses did produce blinding. And I'm talking about 25 milligrams, 30, 40, 50. We're more likely to be confused with a fuller dose. But to our surprise, they had an anti therapeutic effect, meaning they activated people, but they didn't reduce the fear enough and they made them uncomfortable. So by anti therapeutic, I mean they still got better because it's with the therapy, but they didn't get as much. Those people that got low dose MDMA did not make as much progress as those people that got therapy without any MDMA at all with inactive placebo. So we went to the FDA and we said, hey, you know, we can give you blinding, but you're gonna make it easier for us to find a difference between the two groups. The other thing we discovered in phase two, to our surprise, was that the point, the tipping point, you could say, to where it went from being making people nervous to being very therapeutic was lower than we thought it was. 75mg did great for people. And so in one study that we had veterans, firefighters, and police officers, it was 30 milligrams for one group, 75 for another, and 125 milligram. And the 75 milligram actually did better than the 125. Now, when you randomize, not everything is equal. So there was more depression associated with the PTSD in the 125 group than in the 75 group. That may have contributed to the difficulties of treating the people in the 125. But in any case, 75 was really very profoundly effective. So we went to the FDA and said, you know, we'll give you blinding, but the real question is, if you can do this with therapy, why bother add a drug? And then the other thing we said is that the safety profile is better understood and better characterized with inactive placebo. Because if you have therapy with inactive placebo, whatever happens, you know, is due to severe or moderate to severe PTSD in therapy. We had one woman try to kill herself twice in the study. Another woman had severe suicidal ideation and checked herself into the hospital not to kill herself. And both were in the placebo group, meaning MDMA with inaccurate placebo. If they had been in a group that had gotten 25 or 30 or 40 milligrams of MDMA, people would say, oh, maybe that was the MDMA, made her uncomfortable. That's not background. Now, when we talk about background Factors for treating PTSD, the VA did a study, took them around six years, published it two years ago. 916 veterans comparing prolonged exposure with cognitive processing therapy, the two main non drug therapies used by the FDA to treat PTSD. 50% of the people dropped out of the study because the therapy was re traumatizing. Half the people didn't even make it through the study. So that just shows you how difficult it is to normally treat people with PTSD with any of these normal standard therapies. So FDA had other reasons as well. Dutch committee, as I said, was the opposite. So where do we go from here?

Just follow up on that for just a minute. A couple. Because I know there were a couple other objections raised by the committee.

Yeah, I'd be glad to go through them.

And we could just mention those briefly. The one that there was somewhere in the history of the clinical trials, there was one incident of inappropriate behavior on the part of a sitter or a guide or a therapist, which happens in psychotherapy all the time. So not that it should. And there's regulations. You have institutional repercussions, but it does happen. So isolating that as being a significant. It seems like they gave way too much significance to that.

Let me comment on that first, which. Totally. Right. Because that happened in 2016. We started in 2000. We've worked with around 400 people. So the fact that a therapist would engage in sexually, by definition, sexually abusive relationship of a patient after the MDMA sessions were over one time out of hundreds and hundreds and hundreds. Eight years ago. Yeah. That should never have happened. One is too many. But this idea that this is a rampant, you know, process, and everybody who goes through therapy with MDMA is vulnerable and that I'm a. You know, I was called a cult leader on par with Scientology and Nexium. I mean, it's massive exaggerations. But my wife helped me to understand this a little bit better, and she said that a lot of women are harassed or raped or, you know, it's not an uncommon thing for a woman to encounter this. So when this was raised at the advisory committee in such a way that was so powerful, the women on the advisory committee meeting were probably reminded of some of their own experiences, and that became more emotionally salient to them than the fact that it happened one time eight years ago out of, like, 400 people. So I think it was completely overblown in the implications for the therapy. And at the same time, what about people that commit suicide from PTSD reward ratio?

And as you said, one time of incidence of sexual abuse, one time is too many. And this is the human realm, and these things happen. We try to prevent it as much as we can. But on a purely scientific base, one out of that many eight years ago, it seems overly weighted to say the least.

Well, let me just add that in the Spravato studies for depression, some people committed suicide. We didn't have any of that. Not a single person in the MDMA group attempted suicide.

Maybe this is a minor. I don't know how to mischaracterize it, but they pointed there was some they felt underreporting of, not necessarily negative experiences, but the way people were characterized as having sort of positive trips, so to speak, versus somewhat negative or something. And there was some. They felt there was some underreporting of that. Am I characterizing that correctly?

Yeah. This idea that people might pass through. Now, let me just say 90% of the people had suicidal ideation, 40% had serious suicidal ideation. Roughly a third had positive behavior, which means they attempted suicide, or they bought a rope and thought about hanging themselves.

But didn't do it prior to the study.

You mean prior to the study. And once you look at this population, then this idea that sometimes people might go through a process where they're reliving some of their prior suicidal behaviors or ideations. And so the claim was, oh, every time that somebody felt suicidal, that was not reported as a adverse event. Now, I don't believe that's the case. I think that there was a real good reporting of the adverse events, but the fda. The letter that the FDA sent to Lycos to complete response letter. Lycos, I think, has not made that public, but I think if they did, that would be helpful for people. And then you can see whether FDA really decided that there was any of this underreporting. I don't think that's the case. Then the other part you said about the positive event adverse events. So the idea is that if you feel, you know, MDMA is known as the love drug and, you know, people can feel self compassion, they can feel joy. A lot of people have, you know, particularly traumatized people have not felt joy for a long time. So what the FDA said is that all these moments of joy or ecstasy or, you know, should have been recorded as a positive adverse event could. Because it could lead to people, you know, taking MDMA outside of the therapeutic setting and becoming addicted to MDMA or addicted to cocaine. That's. Somebody at the advisory committee talked about how you're going to give people MDMA and before you know it, they're going to do cocaine. I mean, outrageous. So I think that it's true, though, that Lycos did not gather this kind of information. Again, it's like these are intermediate signals of something else. The something else is becoming dependent on mdma. So there was no evidence that anybody became dependent on MDMA or, you know, and there was evidence that people drink alcohol less. You know, once you work through people's traumas, they have less of a need to escape in drug abuse. You know, there was a study in England with MDMA for alcohol use disorder. And most of the people in the study were running away from traumas. And you help them work through it. They don't need. So I think actually MDMA assisted therapy will be helpful for addiction is not going to create addiction. And yet FDA was like, oh, we don't have enough information on euphoria or other kind of positive adverse events that Lycos probably should have gathered that, but they didn't.

Well, it's really interesting how even how they're defining adverse effects, both positive and negative, because adverse effects can be very much part of the therapeutic process.

Yes, exactly. They're confused therapy. So when somebody goes through, there's suicidal ideation. So this is a different kind of a story. But this was someone that was, you know, going through MDMA therapy in an underground way. I heard this story and they were talking about. And earlier, actually, this is somebody who had a LSD trip that was really difficult. And then this is now 40 years later doing MDMA therapy to deal with the trauma of this LSD trip. And during the LSD trip, as the person was reliving it, they were talking about how, you know, they felt suicidal, and that's why it was so problematic. And so when you're doing the therapy, you're revisiting these thoughts and. But you're not, like, captive to them. It's like, oh, you know, yes, I was suicidal at that time. Does that feel right now? Did that feel right then? But you could look at it from the outside, oh, now he's got suicidal thoughts and that's an adverse event. And now this guy's at danger of committing suicide again. He actually did try to kill himself during the LSD trip and later is trying to. Four years later, still trying to work through it. And it was kind of a breakthrough with the mdma. Yeah, I think the FDA and others confused what's the therapeutic process with adverse events.

It'd be interesting when the FDA looks at trials on psilocybin, other classic psychelic psilocybin, or even LSD and others, because people, as part of the therapeutic process, people can have some really pretty difficult journeys, revisiting even unconscious memories and traumas and so forth. And they can have extraordinary transpersonal experiences that are part of the therapeutic back, but might be considered, you know, even beyond the euphoria, someone experiences an mda. So it's kind of hard the way they're framing it, how you can almost ever get there.

People at the advisory committee said, oh, my God, can't trust the results. 40% of the people had done MDMA before they got into the study. Well, then they said, they're biased now. These people liked MDMA or else they wouldn't have volunteered. They should have fewer side effects and they should get better results because they're all biased. Well, that's something to raise. However, in the debate, the discussions, the formal special protocol assessment process, the FDA didn't say, don't enroll people with prior experience with mdma. But in any case, those people that had prior experience with MDMA did not show greater benefits than those people that had never done MDMA. And those people had done prior MDMA didn't show fewer side effects than the 60%. But I think the most important thing to say is that these people had done MDMA and they still had ptsd. The healing is not in the drug. It's in the relationship you have with the drug in a therapeutic context. So that was a big criticism. Oh, 40% of your people had prior experience with MDMA. And theoretically we think, oh my God, they're biased and they're going to have better outcomes and fewer side effects. But when you look at the data, it wasn't that way at all. And yet that was this whole big confusion. Then the other a bunch of these people at the Advisor, one of them said, I kind of voted against this in part because your studies were not diverse. Well, the second phase three study had 50% non white people. I mean, they totally didn't even understand what they were talking about. The other thing I should add is that, and this relates now back to the unblinding is that the agreements we had with the FDA in 2017 to conclude the special protocol assessment with a legal agreement letter were with people at the FDA who had left the agency afterwards. And so the new director of psychiatry products was deputy director, but she was not director when we made these agreements. And so we now have a changing of the guard to more conservative people. But the agreements that you make should not be with individuals, they should be based with the organization. These are agreements with fda. The FDA changed the goalposts all of a sudden, said, oh, this design that we chose to do inactive placebo, now we don't believe the results of it. It's completely inappropriate for them to do that. And we thoroughly discussed functional unblinding. And what the FDA said was that there's two main ways to deal with this. When there is functional unblinding, which there is, as I said, in many studies, but also in psychedelics, in cannabis, and also all psychotherapy studies are not blinded. You know, you can't blind somebody to what kind of psychotherapy they're receiving. But the idea that people were somehow or other, you know, biased. The FDA said that random assignment is the first thing you want everybody similarly motivated. So that's easy to do. But then the other thing that they said is that you want independent raters to evaluate the outcomes. The outcome should not be evaluated by the research team or by the therapists. And so we had a very robust system of independent raters, over 20 raters, mostly trained by the Boston VA, with monthly inter rater reliability tests where they'd all watch a videotape of someone going through a PTSD interview for the clinician administered PTSD scale. So we had independent raters that were blinded to the condition and we had random assignment. And so those. Now the other thing to say, which somehow never got discussed, is that 25% of the people who got placebo either thought they had MDMA or were unsure. So that's not so bad. Blinding. 25% of the people who got the placebo couldn't tell or thought they had MDMA because they were in a situation to work on difficult issues. They were supported with music. Now it's not the other way around. So it's like 95% of the people that got MDMA knew they got MDMA. But when you look at the placebo people now, the other criticism you could make is, oh, these therapists are. The blinding doesn't work. And the therapists are now biased because now they know who gets MDMA and who doesn't and they're going to try harder with the people that get MDMA and they're not going to try so hard with the placebo people. Well, first off, that's totally not true. We have videotapes of all these therapy sessions. We've had adherence raters. That's not true. But the other thing is, if you look at the second phase three study, unbelievable. 46.7% in the placebo group no longer had PTSD. That's better than prolonged exposure, cognitive processing. There was an incredibly low dropout rate. And so the results in our control group that got therapy with inactive placebo, where 75% knew they had inactive placebo and 25% weren't sure or thought it was MDMA, the results were outstanding. So there's no evidence whatsoever that this blinding not working cause therapists to be biased in their effort and there's no good solution. That's the other big problem is what's a better approach? So we told the fda, you want blinding, you're going to make our job easier, we'll give it to you. And they said, no therapy with inactive placebo. Let's make your job harder to show a difference between the two groups. So for this current crop of people at the FDA to backtrack, it's really outrageous, I think, and you know, it's not only that, but it's expensive, it's not fair, it's not good to patients. And I think that the, you know, this is something that people are not aware of, but the FDA is actually considering a proposal to stop voting at the advisory committee level. They want to keep the advisory committee to get give advice, but the voting makes it seem like they have more credibility and more power than they really do. And the lack of knowledge in this group of people at the advisory committee was astonishing. In fact, the most outrageous was this one woman, supposedly the patient representative said, hey, why do we even need new. Therapies for ptsd. We have really good evidence based therapies for PTSD and they work great. And they're so much cheaper than this and they act faster. I mean, unbelievable. I mean, there's a million veterans receiving disability for PTSD from the va. We included people in our studies that had tried therapies, had tried medications. This idea from the patient representative that we don't need new treatments for PTSD is so out of touch. But those were the people that were asked by FDA to review and they really were out of their depth.

Yeah, that was one of the most shocking things, was the composition of the committee itself. So in light of where do we go from here? I don't know if there are ongoing discussions between Lycos and the FDA on how to go forward. I'm curious whether some kind of open placebo trial would be one possibility. Basically, people know they're getting a placebo and they know they're not getting a placebo. And so it makes that process transparent. And then you're looking at the data, it's similar to some of the effects you saw in there that people who didn't realize they got the placebo and some of those people who did realize they got placebo still had therapeutic effects in the situation. So I'm not sure whether that could work in this stuff, but some way around, because it seems like the way they're presenting this blinding issue almost is saying, you can't get there from here.

Well, what the fda, you know, the evidence needs to be presented to the fda, the data needs to present the fda. So Lycos is engaging in the next couple months with discussions about fda. There's been some leakage about what was in this letter published in Psychedelic Alpha, a newsletter for investors in Psych Dogs. And one of the things that they said was that Lycos is saying that, oh, we don't understand this therapy, so don't use it. Don't use the therapy that got these incredible results with mdma, but use MDMA with the evidence based therapy, like prolonged exposure or something like that. Then they said, not in the direction you're saying, but they would want like an active placebo of something. So they're considering low dose MDMA which we considered explored for 16 years and abandoned. But they may go back to that or they may go to, quote, psychological support, which is MDMA without therapy at all. So the concern I have is if they go in that direction based on kind of pressure from FDA or suggestions or requirements from fda, if you get it Approved. What's going to happen with insurance companies? They'll pay for the drug, but they're not going to pay for more therapy than was used in the phase three studies. Does Lycos care about that? I don't know. I think they care about selling the drug. And what's best for patients is a separate thing. So I'm worried that the design of the new phase three study will be to minimize the role of therapy, to use psychological support. I'm fine. If they want to use inactive, I mean, a low dose MDMA as a placebo. You know, all the work that's been done with psilocybin, a lot of it has been using niacin as an active placebo. Niacin gives you a flush and stuff, but it's not psychedelic in any way. Nobody is fooled by that. You know, if you give people a tranquilizer, the therapists are not going to be fooled and the people are not going to be thinking, oh, this is mdma. And if you give a stimulant like amphetamine, which doesn't have the heart opening properties of MDMA, but has some in that direction, you know, I think it'll act more like low dose MDMA could be compromising of the therapy. People could still get better. So I don't know that there's a better solution, but the FDA is going to say, oh, do something different. And Lycos will say, you know, tell us what to do.

Inevitably there will be another phase three trial. You think?

Yes. Oh, for sure. Not only were the. Well, first off, the FDA approach is essential. We need to go through the fda. It's critical to get insurance coverage, even if it's just for the drug. And at the same time, I think Lycos will succeed that they've got. I think this delay will be maybe three years. I don't know how long it'll actually be, but I think glycos will in the end succeed with something. And the other point is you don't need outstanding results like we had to succeed. You just need statistical significance. You know, whether insurance companies will pay for stuff if it's marginally effective is another question. The other issue about durability, which we do have very good durability, not we, but Lycos or maps, the PTSD patients have really good variability durability. I mean, and that's key for insurance coverage because it's labor intensive at the beginning and if it fades over time, they won't pay for it. But if it's durable, they Will. So I do think that Lycos will succeed with something in about three years. And what MAPS is trying to do is work on creating a nonprofit in Europe to see if we can raise money from donors. We might need up to a hundred million or something, but can we do that? And that would permit us to develop MDMA assisted therapy in Europe with open science, no patents, and turn it immediately into a generic. That's something. It's a long shot, but that's what NAPS will be working with others in Europe to do.

I'm curious. As we know, in Australia, the government recently this year approved both MDMA and psilocybin for prescribed therapeutic use. And it's currently being used by therapists, psychiatrists, psychotherapists that go through some kind of initial approval process and then they're able to use it with their patients. And I understand it was a bit of a different process there. The drug actually hasn't been registered, what you would call registered in Australia, which would require an FDA type clinical trial process, but rather it's been approved by some kind of governmental process that in my understanding was driven as much by consumer demand and tens of thousands of patient testimonials, as much by that as the science. Now, they certainly did reference clinical trials going on worldwide, but it seems like it was a different process altogether. And I'm wondering whether there's anything to learn from that or are there any other mechanisms in the US outside of complete legalization or decriminalization that could move the ball down the field?

Yeah, well, there's a program called expanded Access, which is compassionate use. Basically, Lycos did have an expanded access protocol where you get mdma similar in the phase three design, but there's no control group and the data is only for safety, not for efficacy, because there's no control group. And Lyco, for financial reasons, shut that down. It takes a bit of time to manage that, staff time and money. So that's not going to happen in Australia it is more like this compassionate access. You know, Canada, they call it special protocol. Yeah, so there's compassionate use in Canada and in Australia it's, you know, patient by patient. It is compassionate use in the US There, the big hope, and this might take six months or so to resolve is what's called right to try. So there's a bunch of laws in 39 states, I think, that say that patients have a right to try drugs that are being developed by pharma if they've tried other medications and they haven't worked and there's an experimental drug, then they should have a right to try, meaning that they can contact the pharma company and see if they will provide access to the drug outside of the fda, not for research at all, but just as again, as a compassionate use. Now, right to try is prohibited right now from being applied to controlled substances, meaning schedule drugs. And there was a lawsuit about two weeks ago against the DEA by Katherine Tucker and others to try to expand right to try to control substances. And the outcome of that lawsuit will be known in about six months or so. So then it's a promising opportunity if the lawsuit works. Other than that, you know, there's state level reform. So for example, in November, just less than two months from now, there's going to be a ballot initiative in Massachusetts to legalize plant psychedelics, similar to what passed in Colorado and expanding on what passed before in the Oakland psilocybin initiative, which was just for psilocybin. Now, the problem from my point of view is that people have this romantic attachment to plants, but when you add synthetics like MDMA or psilocybin and you do the polling, then people don't vote for it. Not enough. So access to MDMA through these state level reforms is not likely to happen for quite some time because people again are focused on plant psychedelics and not synthetics. So right now there is no place in the entire world where people can legally access MDMA outside of a therapeutic protocol. Now, if you want to go to psilocybin experiences, you can go to Jamaica, you can go to Costa Rica, you can go to the Netherlands, you can go to Oregon, you can go to Colorado, you may be able to go to the Massachusetts eventually, but there's no place for MDMA where it's legal without being in a protocol, unfortunately.

I'm wondering about the role of maps and kind of advocacy in Australia. I think there was a. You mentioned this blind period that the traditional blind period during the FDA process.

Quiet period.

I'm sorry? Quiet period. Right. Quiet period.

Disaster. And not only did Lycos quiet, but then they blocked maps and me from speaking, which was very damaging.

Yeah. So I'm wondering if you had been allowed to have stronger advocacy that might have, because as you said, you think that advisory committee was strongly influenced by public opinion or different political views. And so public opinion. And there does seem to be a sea change of political or public opinion in this country around psychedelics and psychedelic medicines and in certainly when you hear from the veteran community and so forth. So I'm wondering If about MAP strategies and with other organizations within the psychedelic space in terms of advocacy that could marshal enough public opinion and consumer demand to say, look, you know, there's plenty of evidence that these things are helping people and this is something we want. I mean, similarly, you know, it's really citizen demand that has opened up the whole field of alternative medicine and even supplements, all the rest. At one point the FDA and the medical establishment really tried to shut down the whole world of supplements and all that. At one point, I think studies showed that citizens were spending 65, 70% of their medical dollars on alternative medicine. And I'm sure that freaked out the establishment, but it really was consumer demand that has really changed that landscape. So I'm just curious about that whole process.

Yeah, I don't think any of that's going to work for synthetics like mdma, unfortunately. How do you get that? You know, it gets mediated through state level reforms of some way, drug decriminalization or just, you know, there was 19 senators and 61 members of Congress that sent a letter to the FDA and to the President Biden saying approve MDMA. But FDA doesn't want to be swayed by politics and Lycos didn't do enough to respond to the issues that were raised at the advisory committee meeting.

Well, it's interesting. MDMA certainly has a history of being used recreationally, as we all know, but in many ways it could be considered a little more benevolent and less risky than many of the more powerful psychedelics that even the plant derived ones. Yeah.

Oh, very much so, yeah. People don't have panic reactions as much, you know, to MDMA as they do for psilocybin. There are people that have committed murders or committed suicide under the influence of psilocybin. It's really rare, but that kind of thing you don't see under mdma. It's more gentle, filled with self compassion. So I think that the concerns there are less. I think it should be legalized and the consequences will be mostly beneficial with some negative outcomes. But I think the negative outcomes will be way less than the negative outcomes from the drug war. I mean, people have died from ecstasy contaminated with fentanyl. That's directly related to the drug war. That's not problems with Ecstasy, that's problems or mdma. That's problems with the underground markets.

Yeah, that's a whole other conversation. The collateral damage of criminalization and the drug war seems so nonsensical. You mentioned before the, you know, possible, what you're doing in your possible efforts. You could be making in Europe. And I'm wondering curious about kind of maps. I know you do think globally in terms of where all this is and you know, even for humanitarian reasons that how opening up both the therapeutic use of psychedelics and maybe the more well educated sort of personal growth use and safe and well educated personal growth use while shifting, you know, our views around this could really address some of the really pressing humanitarian issues we have globally from the effects of all kinds of trauma and as well as the mental health crisis and all kinds of things that are going on not just in the US but globally. And I'm curious about maps involvement with that and some of your ideas around that. What if transformation isn't just about thinking differently, but feeling differently? Science shows us that true change happens when we align not just our minds but but also the neural networks in our hearts and guts. This heart mind connection is the key to deeper healing, resilience and expanded awareness. That's why I created the Heart Mind All Access, membership and Community. A space designed to help you rewire your nervous system, cultivate heart intelligence and live with greater clarity and purpose. With over 1000 hours of transformational teachings mind specifically curated to meet your needs. You'll learn from world renowned meditation teachers, neuroscientists and experts in neuroplasticity, all sharing powerful tools to help you shift your mindset and heartset, regulate your emotions and unlock your full potential. You'll also gain unlimited access to every summit and course we've ever produced, a treasure trove of wisdom worth over to $10,000 in growing plus live gatherings and an inspiring global community to support your journey. If you're ready to step into a more heart centered, connected and conscious life, I invite you to join us. Click the link to learn more and start your journey today.

Wow. Thank you for asking that because that's really a lot of the areas that I'm working on right now, which is I'll just say from an advocacy point of view though, just to mention that in June 16th to 20th of 2025 we're going to have the world's largest conference on psychedelics ever. In Denver. We had Psychedelic Science 2023 that was in Denver, 12,400 people. So we anticipate even more people for this upcoming conference in June in Denver to bring the community together to share ideas and things like that and to bring people from all over the world. And we're talking about potentially a track from the global psychedelic societies because there are psychedelic societies all over the world now as far as our Humanitarian projects. I saw something, some information not too long ago that talked about the lag between drugs that are approved by FDA or by EMA and the time these drugs reach the Third World. And often it's well over a decade or more. And so there is massive amounts of trauma, especially in poorer countries. You know, there's an estimate that there could be a billion climate refugees by 2050. And these will all be traumatized people who will be destabilizing societies. There'll be trauma all over the place. So I think it's really important that we think globally. I think one of the things that Lycos ignored at its peril was this idea that it's only about the data, which means that they ignored the culture, and it's only about the US which means they shut down Europe. So we have a series of small pilot studies that we're trying to start. And MAPS is also doing international trainings. So we are recently had trainings in Bosnia and Sarajevo. We've had trainings in Iceland. So the first example of a program, humanitarian projects, is in Somaliland in Africa. And there's Dale Armstrong, who's a U.S. psychiatrist, that sort of adopted this area of Somaliland, building a medical clinic, things like that. And so we trained a bunch of Somaliland therapists, and then they got permission from their government to import 2.1 grams of MDMA for a protocol to give MDMA to therapists as part of their training, because these are people that have no psychedelic history. And it was just amazing how much MDMA helped them personally and how much this experience prepared them for working with PTSD patients. And now that's in the process of designing the next study with Somaliland people with PTSD in Bosnia. We're working with the team there that wants to. We've trained them. They want to do a study with survivors of the Srebrenica massacre about 30 years ago, where around 8,600 or so men and boys, Muslim men and boys, were all murdered. So this would be for women and survivors of that. There's a project in Denmark that we're working to start to help the people start there. That would be with Syrian refugees in Denmark, second generation, the ones that speak English, less religious than their parents, and are believing that they're going to stay in Denmark. We're talking about a project we've been approached in Rwanda. We haven't had any resources for that yet. We're talking about a training in Ukraine and to try to bring MDMA to Ukraine. And they're terrible time of massive culture wide trauma. And so if we can do these and maybe one or two other humanitarian projects, the goal is to do them to train the trainers, meaning to help the therapists there learn how to train another therapist and then to go for like a $100 million grant a year and a half or two years or so from now to really globalize access in humanitarian ways. Because these are things the pharma company's not going to do. And yet the need is great. And people may have heard about the study with octopuses where Gould Dolan, a neuroscientist at Hopkins and now at Berkeley, but she gave MDMA to octopuses. MAPS provided the MDMA and octopuses became pro social. They're solitary creatures, but under the influence of mdma, they wanted to hang out with other octopuses. So it gets pro social, evolutionary, conserved and pre verbal. So I think that what we're going to find is that MDMA is going to work cross culturally in all these different contexts. We'll have to figure out what's the therapeutic context, things like that. But that I think is one of the more exciting things that MAPS is going to be working on is to really to globalize access to highly traumatized populations that maybe don't have a lot of resources. There's something else that Maps is going to do with this. We're trying to start this nonprofit in Europe that would end up trying to say, let's follow the Dutch position, naturalistic studies, and then negotiate it with the EMA and MHRA in England. If they would accept people treated in naturalistic studies as equivalent to a phase three study. Then there's something else that's really interesting for me, which is MDMA for couples therapy. So couples therapy is not a disorder. People think, well, the FDA has never approved a drug in psychiatry for something that's not a clinical disorder. But there's nothing in the law that prevents them from doing that. And the advantage of FDA approval is that then you have insurance coverage potentially. So going to start a study in California with MDMA for couples therapy. That's going to be really exciting. Then the other thing is maps is doing 12.9. We've got a $12.9 million grant from the state of Michigan for cannabis for PTSD in 320 veterans. And so FDA is blocking us from doing that study, not permitting us to study smoked marijuana or vaporized marijuana for reasons that are not very good. So we've just launched a formal dispute with lawyer scientists against the FDA two weeks ago, trying to unblock this study with, you know, the way people with ptsd, veterans with PTSD use cannabis. Some of them will do it edibles, but most will smoke or vaporize. So, you know, I find it very amusing in the meeting we had with the FDA after they blocked it to try to see if we could come to an agreement before we do this formal dispute, which will cost 300,000 or so in legal fees. We were talking about this project and the woman from FDA said, I hate the word medical marijuana because it's not medical until we say it is. She said that at a meeting where she's blocking us from doing research with marijuana. Mind boggling.

So in terms of your global efforts with mdma, so is does Lycos control the patent for mdma?

No. No. So first off, MDMA was invented by Merck in 1912. So the molecule is in the public domain. I hired patent attorneys in the late 1980s, early 1990s to help maps develop an anti patent for the uses, which is we publish stories about all different uses of MDMA on the website. Nobody can say they invented it. MDMA for postpartum depression, MDMA for fibromyalgia, all these different things people have said they've received Helix. What Lycos is trying to do is to patent the particle size of the MDMA molecule to optimize it going through high throughput encapsulation machines. That's the patent that they're going to try to get. And this is in the public domain already for them to block generics. Whether they'll get that or not, I don't know. If they do get that, I think it's easy to not infringe on that patent and do things in other ways. There's a challenge in that when you're a pharma company, you can in your either data exclusivity or one patent is expiring, you got another one. You want to delay generics as long as you can, so you sue them for infringing. And the FDA is once that those kind of suits happen, the FDA is automatically blocked for two and a half years from issuing a license to the generic to give time for the court lawsuit to work it out. Now, in Australia, if you are a generic company and you're sued for infringing on the patent and it turns out you don't infringe on the patent, the company has to pay. The innovator company has to pay your legal fees, but they have to pay fines because of all the money that they made when it should have been a generic. There's no such law like that in the US So the other part of this is that when you are a generic manufacturer and you have not been sued in 45 days, you can go to the courts for summary judgment, that you'll never be sued. But the condition is you have to make your entire package of the FDA available to the competitor, the innovator company, for them to look at and see if there's any evidence of infringement. I said to the company that when I was still on the Lycos board that we should make a good faith effort to see if they infringe before we sue during these 45 days. That was not well received, unfortunately. So I do think that the effort by Lycos to patent particle size is something. It'll probably take a year and a half or so to figure out if they get it. Now, there's a company called Tiran Biosciences. What Lycos has done is MDMA hydrochloride, which is MDMA with a certain kind of salt. They're trying to claim that even though salts can act differently, that the patent that they've asked for on particle size, which they generated from working with MDMA hydrochloride, should apply to all the different salts that MDMA can be combined with or manufactured with. So there's another company, Taran Biosciences, that has patent MDMA with a different salt, and it is claiming that it will not be covered by the Lycos, Pat. And that they want to, you know, as soon as possible, make MDMA into a generic. So, you know, I don't know how that's all going to play out, but I do think that the problem is with philanthropists. The situation is with philanthropists, they're not looking to monopolize situations, they're looking to heal people.

Exactly.

Investors. They're looking not so much to heal people, but to use healing people as a way to make money. And so, you know, how will patents be enforced? How will they be applied for? But my, I'm not a patent attorney, but my sense is that there's a good chance that the salt that Terran Bioscience has combined with MDMA would not infringe on the Lycos patent, although Lycos claims that its work will apply to all the different salts too. So we'll have to see what the FDA does.

I mean, let's see how this plays out. And it's, I mean, as fascinating as that is systemically, I mean, there's so many. There's the economics and the business interest, there's the politics, there's the cultural forces and then there's the actual science. And then most importantly there's the need of people who are suffering. And that should, I think most of us, we should predominate.

What I would say is the need is really critical, but it's the culture that really is where the cultural change has to take place. That's where I think Lycos fell down, is to think it's a rational process. We've evolved to the point where FDA will just look at the data, culture doesn't matter and they have quiet period when the culture was starting to erupt with negativity and then the decision was made, oh, let's not apply, not reply. And that's what I think. Built and built and built and that's what led to the negative outcomes.

Well, speaking of the culture somewhat, I guess parallel trajectories and forces and trends. On the one hand the, the efforts to reschedule Schedule 1 psych medicines for therapeutic use and the medicalization of those to create distribution systems and third party payment with insurers and that whole world and then this psychiatric renaissance that's going on and the widespread semi above ground, semi below ground use by people for personal growth. I mean some recreational obviously and some of it may not be, but a lot of people really looking spiritual growth, personal growth and going all around the world to do it as well. And then here in the U.S. some as you mentioned in, in Oakland, California, in Colorado, possibly in Massachusetts, in Oregon, there's, there's these efforts at decriminalization and some active decriminalization and policy making happening. And so I wonder what you, how you see these two parallel worlds operating. Is there can there be a mutual benefit that'll move things down the field or are they at cross purposes sometimes or.

Well, I think that Lycos feels that they're at cross purposes, but I think they're mutually supportive. So as I said, it's really about the culture. I mean psychedelic research was blocked for more than two decades. That's not because of the science from the 1970 Controlled Substances act, that's because of politics, that's because of culture, that's because of the fear engendered in people about psychedelics. So I think that the culture is the critical factor and that that's something that we constantly be needing to be educating people about things like that and that this idea of how do we do this public education, the most important thing is people telling their Stories about having their own healing experiences. So what we really need is sort of a psychedelic coming out of all sorts of people that have benefited from psychedelics, you know, speaking in public about it. So to help people understand more from people that they trust about benefits, to balance off all the negativity. So I'm very much hopeful that over time, what will happen is more and more research will come out, more and more positive research will come out, and there'll be this sort of return to hope over fear in the public. And that's what we really need to be counting on.

I'm curious, you mentioned education. So it seemed to me that, you know, if we're going to get this positive cultural shift in attitudes towards psychedelic medicines and eventually decriminalization or even legalization in certain areas, and more availability, not only in medically prescribed therapy, but for people to explore on their own. And, you know, there's a feeling among many people that natural plants, anybody should have access to those. That along with a reason, all the reasons why we maybe think that's the way it should be if we want it that way. It seems like it's incumbent upon the movement to really do a lot of education so that we have a very well educated public, because these medicines can be powerful, they can be destabilizing in some cases. Overall, compared to a lot of things, they're pretty benevolent, even compared with alcohol in many cases. But still the idea of creating an educated consumer so that you avoid a lot of, you know, so you really focus on harm reduction through education. I guess it may be what I'm. The point I'm making here.

Yeah, so normally the way that this sort of public education gets done is with advertising dollars. You know, there's no product. So that that doesn't happen. The way that we've done it in the past is through doing science. Because in our culture, science gets widely reported and that's earned media that you don't have to pay for. So concentrating resources on doing the science and then getting the media to report about it is what's been essential. But there are still so many people that have not heard these stories that don't. This is just another. This is a while ago, but the very first date I ever had with my wife. Now We've been married 31 years, but this was now in 1989. She was a student at Harvard's Kennedy School of Government. And we had this lunch together. And at the end she said, you know, I just want to tell you I'd never want to have a relationship, a real relationship with anybody like you. And I'm like, why is that? You know? And she said, well, you've done so much lsd, your chromosomes are all screwed up. I'm like, it was kind of funny. I said, it may be premature, but let me defend my sperm here. The point I'm trying to make is that she, an intelligent woman, believed the propaganda about LSD causing chromosome damage, which it does not do in any way that affects childbirth. So how do we really do this Public education? That's a big part of the Psychedelic Science 2025 conference that we're going to have in June. But. Well, and that's why I'm talking to you. I think podcasts are really helpful, but we need documentaries on therapists. There's multiple documentaries that we're trying help. There's a feature film that's being made about the book Acid Test, lsd, Ecstasy and the Power to Heal, about our MDMA movie that was going to be with Participant Media, but then Participant Media shut down. So I don't know if they're going to find the funding or not, but I think I took a class at Harvard School of Public Health by the guy that introduced, helped introduce designated drivers into the American culture. And he did that through TV shows and movies, having somebody be the designated driver. So that's what we are trying to do. In terms of your public education question, the more we can get stories in media, even fictional stories, the more people will be educated. I mean, there's just such an enormous reservoir of fear and misinformation that people have. So we have to do whatever we can for public education. And I think it's really important that you're pointing your finger at that. And that is something that we really need to figure out how to do. But without, you know, now, you know, lycos will do some science, but they're going to shy away, I think, from public education. I think it's really through the science that we've been able to make the progress that we have. And now I think some documentaries of patients telling their stories will be really effective. Well, yeah, that's the key. We've got a population that, well, you hear one story of one boundary violation by a therapist and that becomes the dominant story.

Yeah, I've been involved in criminal justice reform and prison work for a long time. And they talk about incident driven politics. You know, you have, for example, community corrections, which has proven to work. It's vastly inexpensive compared to incarcerating people. But you have one person on parole that messes up and suddenly you're going to change the whole policy and spend a gazillion dollars locking everybody up. When actually it's been proven that statistically it makes total sense to keep a lot of people in the community. So that incident driven politics kind of affects a lot of things. I'm curious about this idea. You know, so we're training therapists and I think it really important in terms of the therapeutic use of psychedelic medicines that the training be really good, the standards be really good. I know MAPS has a training program for the therapists involved in your clinical trials. CIIs and Naropa both have master's level professional programs. I think Andrew Weil at the University of Arizona is developing one for physicians and so forth. So, you know, developing excellent training. And there's probably some training being developed for non clinical guides as well. I'm curious about in states where there's an effort at decriminalization even around the plant medicines, the idea of, of almost, you know, requiring a citizen's license of sort, citizens use license. I mean even with the, you know, the way marijuana has been, you know, legalized recreationally, that someone be required to go through some kind of just like to get a driver's license, go through some kind of training and take a test, at least pass the test. And of course people could game it and this happened still on, on the whole, people would get some basic education, harm reduction education. So if they're going to use psychedelics for personal exploration, growth, they would at least be more well informed if there wasn't something like this.

I think that's a phenomenal idea. Yeah, we definitely. So in the training of therapists, you know, one of the key controversial aspects of it is therapist self experience. Mm. A drug that they're gonna give to the patients. Now, for example, you would probably never take ice skating lessons from somebody that never ice skated. You would never go to an ayahuasca shaman that had never done ayahuasca. You wouldn't go take flying lessons from somebody that never flew a plane. Now psychiatrists will say, oh, I give ect, electroconvulsive therapy, and I give antipsychotics to my patients and I don't need to take them myself. And in that case they're right, they don't. Because what they're talking about is that the ECT is the therapy, the antipsychotics are the medicine, they're the therapy. But in psychedelic assisted therapy, the therapist is part of the treatment, they're part of the medicine. They're part of what's helping people get better. I think they're more important than the MDMA. That's what we said, that 40% of the people in our study had done MDMA, but they still had PTSD. So I think this idea of how do we train therapists and this idea of having them have their own self experience is really important. I think the harm reduction, what we want to do is sort of expand the culture. So how do we move to a post prohibition world? And also how do I sort of balance two different things? One is MDMA should become a medicine administered only under direct supervision of therapists who are specially trained with all of that covered by insurance on the one hand. And on the other hand I'm saying, hey, it should be legal for people to just be able to get on their own as a fundamental human right to explore that consciousness. That will be a lot less risky. I mean, a lot riskier to just have people. But I think that the drug war is worse. But what I really liked was your focus on a license. And I think that is the key and we don't hear about it enough. I've talked about licensed legalization and the idea here is that let's say you're a drunk driver and you get pulled over for DUI and you lose your driver's license. Well, you can go to a liquor store, you can go to a bar and you can still get alcohol, you can still get into your car, drive drunk and kill people. But if you had a license to buy alcohol, and this license was basically simple to get, the main point is that you could lose it if you misbehave. And we all know how quickly people can check our credit cards for us to pay for stuff. It takes seconds, it's extremely fast. So I like the idea very much. But there's very few people talking about a license to do cannabis, a license to do alcohol, and then you would have different licenses to do psychedelics and all these drugs. And I think furthermore, heroin, cocaine, all these drugs should be made legal with licenses and with proper support and with harm reduction and opportunities for treatment on demand. When you treat people as humans, a lot of these people will want treatment. They don't necessarily want to stay addicted to drugs. But when you push them underground, you push them away from help, that's not the way to get the best results. And then you fuel this vast criminal underground. And so I think licensed legalization is kind of this midway between, oh, people think, oh, everybody can get it for Any reason, and that's too dangerous. But the license makes it so that if people misbehave under the influence of the drug, you've now made it harder for them to get that drug. And that just makes logical sense. The one main argument I've heard against this idea of is that then we know how governments switch all the time and policies switch. So if you have a license, then you've got a list of all the people that are using this drug, say it's marijuana or mdma. And then government shifts, and now all of a sudden the new government which hates MDMA or marijuana is a list of all the people that used it in the past. Now, they still can go after credit card records to see where people have shopped. You know, there's still a lot of information for them to tell who's who. But that's the one of the main reasons, I think I've heard, against license legalization. But I'm curious where you started thinking about that, because there's not that many people that think about that.

Yeah, it just occurred to me, and it's come up around other things. There are many things that we do in society that we don't need training for or have a license for, and maybe they're just considered a natural human. Right. But where there's a lot of issues. I mean, one that has come out probably get in trouble saying this, but one has come up for me is it's the whole world of recreational bicycling, you know, and I've been a recreational bicyclist. Not avid, but have been. But, you know, we're asked to share the roads, and if drivers misbehave, somebody can get their license number and they will quickly be in trouble and report and be in trouble. A bicyclist completely, you know, off the grid. There's no way to track nothing.

Right.

And so, you know, if people had to get a license to some education around riding a bicycle on the roads, had to have a little license plate that would help pay for the, you know, the thing. But, you know, I mean, even today, now we got kids out on the streets with electric scooters, no license required. You know, I see families, a bicycle going down the street, pulling a little trailer behind it with an infant in it out in the street, mixed with cars, and it's legal, you know, so there's a lot of these things that are kind of nonsensical and, you know, and it's. Again, you know, I'm not, you know, I have a part of my brain is a bit of a, you know, not an anarchist, but so a little bit of a living. And so the idea of overregul society and having to have permits to do everything is not that attractive either. But with some of these things that, you know, where there are risks involved, how do we try to reduce harm and assure that the consumer is well educated, I think is the point. And also I think you framed it quite beautifully. How do we envision a post prohibition world and what does that look like? And how do we do that safely so that we're not continuing these cycles of backlash and then problems and so forth and it'll never be able to be perfect, but everything we can do to make it as good and as risky as possible.

Yeah, I think what we need is pure drug. Well, first off, we need honest drug education at schools, which we should not have. Then we need pure drugs so that people are not dying from contaminated drugs where they know the doses. They're not taking a drug that all of a sudden is twice as strong as they thought it was. Then we need harm reduction trainings for people to provide peer support for each other when psychedelic experiences often can get difficult. But it's not a sign that it's a bad trip. You need to work on what's difficult. And then also so we do, you know, the Zendo project at Burning man, we have hundreds of volunteers to provide peer support to people that have difficult trips. This year we had over 400 people come for help. Even in a sort of sophisticated environment of Burning man, where people, you presume are comfortable with psychedelics. 400 people said that they had experiences that were deeper and more profound or more troublesome than they thought. And they came for assistance with this group of peer support. And then we need treatment on demand for those people that do get addicted to something, whatever it happens to be, and they can get treatment if they want it. And those I think will make post prohibition world work. But the drug war is so counterproductive and so negative that we can switch right away if we could, even without all these policies in place, that would still be a benefit to society. But I do want to encourage you to sort of keep talking about the license ideas because it's a really good one.

Well, I'll be there in Denver in June, so I'll see if I can get anybody interested there. I was there last year and it was quite an amazing event. So I wonder about, you know, we're talking about cultural change and even in political change and mindset change, heart Set change. And so a lot of the psychedelic medicines can produce transpersonal experiences that have in many cases changed someone's mindset, heart set, worldview. And so I'm wondering about the role of that, if there's some, you know, I mean, back in the 60s, many of us had the idea if we could just give all the influential people and leaders in the world, lsd, the whole world change will all be beautiful. It didn't quite work out that way. But still I think there is the idea that there's something in the world of psychedelics that is related to changes in consciousness that could be positive for the world. Care about the environment, care about others, profound interconnectedness, you know, all kinds of things. And so I'm curious about your thoughts about that long range or even in the short term.

Well, that's what really motivated me at 18 in 1972 to devote my life to psychedelics. Now that was at the. So to help normalize this, I want to talk about the astronauts going to the moon. And we just got a quote I just read earlier today about one of the first private funded spacewalk in history, Billionaire guy, and he said, oh, you know, from up here the Earth looks like this incredibly beautiful thing. We have got a lot of problems on earth, but from up here it just looks like this super rare beautiful thing. The astronauts, some of them, Edgar Mitchell in particular, talked about seeing the Earth from space and how that changed his mindset. So I think this idea that you see the Earth as one thing, you don't see the religions, you don't see the borders, you don't see the races, you don't see the genders, you just see that we're all living on this one little miraculous little planet that somehow has life on it and we're not aware of life anywhere else, but we're all part of the same thing. And if you can see it that way, the astronauts have said that's changed their opinion. So the psychedelic mystical experience, feeling that you're part of everything, going beyond your ego sense, which is there to protect this body, but going beyond it, you see this body as part of billions of years of history. And you know that there were more like Anson and Anthill than, you know, you know, unique individuals. That there's this sentence that if we're all in it together, how do you dehumanize other people because we're all the same. How do you say, oh nature, let's just throw trash out because it's out? Well, there's no out in nature. You know, and we're all responsible for global warming and how do we deal with it? So I do think that there's been a couple studies have shown that psilocybin mystical experiences lead to nature relatedness, increased nature relatedness. And there's some other studies that talk about, you know, this relationship between the mystical experience and therapeutic outcomes. The more you feel connected in this way to everything, the more people are able to get over depression, anxiety, ocd, addiction. So I think that this kind of cultural change, consciousness shift, clearly we're in danger as a species. You know, the amount of extinctions that are going on now is unprecedented. And the. What we're doing to the environment and the rapid change that is happening now is also unprecedented. And the way I would look at it is, let's just talk about Galileo in Copernicus. You know, so there was the thing that the Earth was the center of the universe, right? And then Galileo and Copernicus were like, no, that's not the case. Galileo was arrested, was under house arrest by the church because they didn't like this idea that the Earth was not the center of the universe. Father Bruno, who was both into plant medicines and into studies of Copernicus, was burned at the stake by the church. And at the time that the Inquisition sentenced him, he said, your fear in sentencing me is greater than my fear in being sentenced. The people's worldview was so integral to who they were, and it was so shattering that, oh, you know, we're not the center of the universe. So I think what we have now is this crisis. E.O. wilson said it really well. He said that real problem with humanity is that we have Paleolithic emotions with medieval institutions, with godlike technologies. God have the emotions and spiritual capacity to deal with the world that we've created through our minds, through our science. And so we need this evolution of consciousness. And I think that we're at a stage in humanity where through the Internet and through satellites and through where everybody is, and through global warming, people are thinking more globally. And then I want to talk about humanistic psychology and Abraham Maslow. So most people are taught in school about the hierarchy of needs, this triangle, this hierarchy of needs. It starts with your survival needs and your belonging needs and then your self esteem, and it goes on and on. And the highest point that people are taught is self actualization, that this is almost like the libertarian dream, that, you know, you become your full self. That's this hierarchy of needs. And this was in the 60s, the mid-60s, that Abraham Maslow developed this. However, in the end of the 60s, he changed it. And people are not taught what he changed, but what he changed is above. Self actualization is something new. And he called it self transcendence. It is this exact thing you're talking about, this mystical, the sense we're big, connected to something bigger than ourselves. That's, I think, the consciousness shift that humanity needs to make. You know, many of people, humanity are down at this lower level of survival because we have inequitable access to resources, we have exploitation and we have greedy. Many, many people are barely surviving in poverty. So it's hard to think about self transcendence when you're starving to death or, you know, so you have to satisfy these needs. But if we were to get to more and more people that believed in self transcendence, there are enough resources to make everybody have a comfortable life. There's more than enough food that we can produce, there's more than enough shelter. That the capacity that humans have to take care of everybody and to take collective action against nuclear weapons, against global warming, all of that is there. The opportunity is incredible. But we need this consciousness shift. And I think that psychedelic in the proper context can play a major role in this sort of consciousness shift. But it's not the only way. So I was at a meeting the other day and somebody was debating, oh, is MDMA a psychedelic? And like, oh. And they said, oh, no, MDMA is not a psychedelic. You know, only the classic psychedelics that dissolve your ego. Lsd, psilocybin, things like that are. And I said, no. You know, what I've been doing to try to normalize psychedelics in people's minds is to broaden the definition of psychedelic, which it was meant to mean mind manifesting. And so hyperventilation is psychedelic. Dreams are psychedelic. You know, all of this is. And we all have some connection to our dreams, or, you know, just the thought that through altering your breathing, you can have a psychedelic experience. What it means is it's in ourselves. It's not this. These experiences in this drug. And it's also something you can get from looking at Earth from space. So I think that this consciousness shift is necessary for human survival. And whether we're going to make it or not is really uncertain. You know, people are talking about AI is going to destroy the world or, you know, but we are the ones that program AI. So it's not AI destroying things, it's us. If that's what happens. I do think we need this consciousness shift. And when I. Well, I'll Say, Alberto, Albert Einstein had this great quote as well, which was, the splitting of the atom has changed everything except our mode of thinking. And hence we drift towards unparalleled catastrophe. What shall be required if mankind is to survive is a whole new mode of thinking. Now, what is that new mode of thinking? I think it's collective, it's mystical, it's how we're all in it together. That's the consciousness shift that we need. And psychedelics can help with that.

Yeah, we clearly seem to be at a real inflection point. Maybe decades or centuries earlier, a shift in consciousness would have been nice, but now it seems somewhat existential that we need this now to address the very complex problems we're facing. And so the psychedelic experience, in whatever form, whether it's through breath work or nature experiences or psychiatric medicine, seems some kind of transpersonal experiences seems to be so necessary to create that collective individual and collective shift in consciousness. Maybe just one last question. I'd have. So if the FDA had approved mdma, you know, my question is kind of. I'm going to narrow it a bit, but where would we be now? What would we be doing? And, you know, envisioning, hopefully, the way it works out. They don't just narrowly approve just the drug, and it doesn't. Some of the dangers of how lycos and FDA may approve it, but hopefully if it works out the way you would like it to work out in three years and the outcome you were hoping for now occurs, but let's say it had occurred, one of the challenges is to roll this out in any way that's equitable, that's distributable, that's accessible, that's not too expensive, that insurance will cover, that can be widely distributed. And so one of the. One of the suggestions has been group therapy as opposed to just individual therapies. And, you know, and then at what level of licensure is required to be a guide? And, you know, in the main clinical trials, you had two licensed clinicians there. That would be extraordinarily expensive. So what would you. What do you envision would be happening right now if it had been approved now and over the next six months to a year? And what would you envision that needs to happen then?

Well, okay, so let's just say FDA had approved. One of the first things that would have been done and should have been done a while ago, and this is so clearly commercial, is a dose response safety study of people on SSRIs with PTSD, giving them higher doses of MDMA so we require we Lycos maps. The research with MDMA requires people to taper off of their psychiatric medications. It's true that they blunt the effect of mdma. There's a lot of underground evidence and anecdotal reports and some theoretical reasons to think that when you do higher doses of MDMA you overwhelm the blunting effects. But you don't get serotonin syndrome. So that's just from a purely commercial point of view. There's loads of people that don't really want to taper off their medicines in order to get treated for PTSD with mdma. Ketamine you can give to people on their medicines. More and more it's turning out psilocybin you can give to people on their medicines. That's one thing. Another thing that would be happening and I'll get to group therapy. But the FDA has blocked Lycos and MAPS before that from studying adolescents with PTSD or people under 18 with PTSD. So far it's only been 18 or over. And if it was approved, it was only approved for 18 or over. However, the FDA indicated that if they would approve it, then they would require studies in adolescents which are called pediatric studies. I think that's really, really important. The closer you can treat people to the trauma, the less damage there is, the, the more benefit there is. And so I think there would be adolescent studies happening if FDA happened. As far as group therapy. Now there is this incredible project that's being developed in Israel for group therapy, for exploring that there's a study, the Dutch, well, excuse me, the Australian government is now funding research with 200 people in group therapy with climate related PTSD from floods in England. They are going to do two therapists for three people. And at the Portland, Oregon VA there is group therapy taking place right now. And it's four therapists for six people with ptsd. And there they get one MDMA session individually and then a group session. In the Israel study, it'll be group sessions. In the Australian study, I'm not sure. So I think there would be even more work. But there is some work with group therapy. The other thing is that the FDA is a signal if they approve it, it's a signal to countries all over the world that it's okay. So our international global humanitarian projects are made more difficult now because FDA did not say approval. So just to give you an example, in Armenia, which you know has leftover terrible laws from Russia, in Ukraine, the story is similar. You cannot do research with drugs in Schedule 1 now in Ukraine, they're going to have a meeting in November. There's. They have such PTSD problems because of the Russian invasion that they're willing to think about different modifications of their existing systems. So there's going to be a meeting in November in Ukraine about ending this prohibition of research with MDMA or psilocybin or other Schedule 1 drugs. But if FDA said yes, it would be rescheduled and then that would be easy. Armenia, you can't do stuff with Schedule 1, but I haven't heard about real efforts to try to change that. Everywhere we go in Somaliland, Rwanda, Kenya, South Africa, we are going to do a training of therapists in Abu Dhabi and Dubai. There's an enormous amount of PTSD in the Arab world as well. And we want to treat everybody, Healing for all. But now that FDA didn't say yes, it may be a while before the people in Abu Dhabi and Dubai are ready for us to do that, to do trainings and to start work. A lot of people are ready to go second after fda, but they don't want to go first. So that's the real setback from fda, is that if they would have gone first, then so many other countries would have gone second, and we could have, but we will still be able to do things around the world. But I do think that you're putting your finger on group therapy as I think the key factor for access. And I just heard a story this morning from some of the Israeli teams that, you know, I've always felt that individual therapy is going to be more effective than group therapy, but that the group integration process can be so supportive that that can kind of make up for it. But what I heard from one of the Israelis this morning was that they saw a group session that they thought was so profound for the people in the group that they're questioning whether group therapy is inferior to individual therapy. They think it might even be as good or better in certain circumstances. So I think that is the main area of research that is still happening, even though FDA said no. But what is more difficult is the global humanitarian projects. And what is not happening is the pediatric studies or the dose response safety study with people on SSRIs.

Well, we'll hope for the best with how this rolls out with the fda. And thank you so much for the incredible work you've been doing for many decades. This has been incredibly educational, illuminating. This will thank you so much.

Thank you for having me. Because another thing that is so clear with the FDA rejection is that we need more public education. And that's. I want to thank you for trying to help, you know, do more of that.

Absolutely. Absolutely. Thank you. Be well. Thank you for joining me on the radical Responsibility podcast. Remember, real change happens when we commit to our growth, face our challenges with compassion, and stay open to transformation. If you found this episode helpful, I encourage you to subscribe and help us spread the message of healing and personal empowerment. Stay grounded, stay present, and stay true to you. Take care.