What is up Brad fans how you doing how you live in. If you've followed this podcast for any stretch of time, or if you follow the psychedelic research that's ongoing about the use of psychedelics for therapy, you probably have heard, either me or some other person in this space talk about the likelihood that MDMA so MDMA assisted therapy, for the condition of post traumatic stress disorder is likely going to be the first of these treatments approved by the FDA.
But in a somewhat of a surprise decision Earlier in June, an independent advisory committee to the FDA, recommended against approval. Now, to be clear, this is not the final decision on this treatment or on other psychedelics. This is in fact, as the name suggests, an advisory committee, a panel of experts put together to make this pre decision, let's say, as a recommendation to the FDA. The final decision will be coming
sometime later in August. And like I said, this decision was a bit of a shock to many in in this space, or who follow this space who follow the psychedelic research space. But as we'll hear from our guests today, maybe not totally unsurprising. For some context, the decision was being made on data that was put forward by a company called Lighthouse, which was formerly the maps organization Maps has been a pioneer in this space of
psychedelic assisted therapy specifically with MDMA. And they've really, really been responsible for pushing, you know, trials, clinical trials, and and bringing this work with PTSD. Closer and closer to approval. They submitted data for multiple clinical trials. And and like I said, the
committee decided to recommend against approval. The hearing included public testimony, and by some accounts, in the in the reporting on this, this was some pretty charged testimony, both for and against approval commentary from people who have been profoundly helped by this treatment, and people with serious concerns about safety. And the nature in which Lycos
conducted some of their trials. And some of the behavior of the therapists involved in some of the trials, there was allegations of assault that happened during the during the trials. And so this leaves us at an interesting place in terms of
where does where does this field go now. So to get an informed perspective, and some much needed context into how this research is performed, and some of the questions that are ongoing in this field, I reached out to Henrik young Abella, he is a psychedelic research public health researcher, based in Berlin, and one of the founders of the mind Foundation, a nonprofit organization, again, based in Berlin, that is working towards bringing psychedelic assisted therapy, to a medical
framework to an approval framework in Europe. And also they have activities, workshops surrounding safe practice, in terms of of psychedelics, and how do we maximize psychedelics and its use in our modern culture in maybe outside of the clinic and these kinds of things. So Henrik has been on the on the show before, as have other people from the mind Foundation. And I just always like to point out that, my my thanks to them for being so generous with their time in
coming on this show. And I really do appreciate their balanced approach to this, to this to this field, and to the end to some of these questions, because there is a lot of hype, as Henrik and I talked about, and there is, you know, maybe a and there's also some change going on in in the field itself,
you know, from the 60s and 70s. You know, what are some ideas that maybe were prevalent there that came about in the first wave of psychedelics that Maybe don't fit a modern, modern context anymore or that have been proven to be or can't we can look at now and say, Well, maybe that's not the best way to do this, maybe that's not the most healthy way, or safest way to do that. So, like I said, very balanced take on these
things. And one of the reasons, you know, aside from Henrik being very involved in this field and having a lot of knowledge of it, that that balance I really like. And I think it gives us an opportunity to look at the pros and cons and everything very truthfully, very honestly. That would be the other thing I would say about Henrichs approach to this. And
the mind foundations approach to this is honesty and balance. So we talked about the decision itself, some of the specific factors where maybe there was where where maybe Lycos could have done better, where there was some potentially incongruent, or head scratching decisions or comments by the regulators, we talk about the very prominent issues that always come up in this field of placebo and therapy, I really enjoyed Henrichs comments on the therapy angle, again, speaking
about things that maybe we want to we don't want to see in the therapy anymore, that maybe come from older ideas, or other schools of thought, original, you know, psychedelic schools of thought from previous times, that don't fit the modern view anymore, or don't really mesh with the medical framework. So I really, really enjoyed that part of the conversation. And we talked about hype, and just how do we, how do we have a good discussion about these things?
How do we talk about these things with people who are skeptical who maybe are, let's say more conservative about these drugs, or have emotional reactions to the experience to the word drugs and the experiences that these drugs can can provoke? How does that hype influence, you know, the people in the trials, that may be a negative thing in terms of our
ability to collect good, unbiased data? How does that hype affect the the people making the decisions about these things, you know, so very, very interesting conversation, a lot of good context, about the decision and where the field is at and the challenges but also the, still the promise of, of moving forward with these things in a safe and, you know, legitimate way. So many, many thanks again to Henrik, for
coming on the show. And I would just like to direct everybody to the shownotes whether you're seeing this on the podcast on YouTube, or on our social media feeds, look at the captions, look at the look at the show notes, to find links to a lot of great reporting that's been done about this decision, to the mind Foundation, and then to also some of the research papers that Henrik and his collaborators are putting out regarding their
trials with psilocybin and depression. And then just some of the other, you know, philosophical questions or you know, or big topics in the field that need to be discussed, need to be addressed in an open, honest way, in order for, you know, skeptics and true believers and everyone in between to sort of find the right balance in terms of hype and how we talked about these things and how they can be best used to achieve, you know, the lofty noble goals that we all
hope we can achieve with these things, first and foremost, alleviating serious harms from mental health conditions that many people are, are suffering from. So reach out to us on the show to me at the show on social media at to Brad for you. And on email, to Brad for you@gmail.com, you can go to again, our website, which is linked in the bio of our social media or in the in the show notes. And you can find transcripts and ways to get in touch with us ways to throw a
couple bucks at the show. If that's something you're inclined to do. Please also rate subscribe, follow all of those great things really help out the show a lot. We do. We I appreciate it very much. And that's it. That's all let's get to my discussion with Henrik Yuna Birla About the independent committee decision recommending against approval for MDMA assisted therapy for post traumatic stress disorder. Well, good morning, Henrik. Thank you for taking the time
once again to join me on my show. It's great to see you. How are you today?
Good morning. It's a pleasure to be with you, Brad. It's it's good. I'm I'm fine. Excellent
AM. So we're here to talk about the recent decision by an independent advisory committee, to the FDA regarding MDMA assisted therapy for PTSD, Post Traumatic Stress Disorder. Now, I think a lot of people were shocked when the committee recommended against approval. As
we heard in the intro, this isn't the final decision. But I think it was a shock to a lot of people, I just want to ask you right away, you know, as someone who is not involved in the American system, you're coming from Germany from the European system, but working in the same field working towards the same goals of bringing psychedelics to, to a medical framework to to an approval framework. What was your reaction when you heard
that news? Was it a surprise? Did you have some inclination that maybe it wasn't going to be as easy as maybe some of the reports? Were making it sound? Yeah,
very good question. So it wasn't a surprise, it was also a little bit of a shock, but not unexpected. So we among the networks that we work in, were talking about, particularly a European perspective. So the European perspective was, what the data that the FDA accepts or does not accept, be enough to also bring it to Europe. And I heard a lot of voices around us that said, well, the studies are too small. And the data that they that maps or like us is delivering is might not be good
enough. And we're not sure if the reporting on on SAE is and a is how it will be. So it was like people are hoping for an MDMA approval, but also hoping for something that is sound enough to also take it to Europe.
So a lot of the reaction that I was reading, and maybe it's a skewed perspective, I don't know, this is why I'd like to ask you was that a lot of the critiques from the committee weren't necessarily about the compound itself. There was some safety and long term safety issues raised. But it was more about maybe the methodology or, you know, some laxness in the way that some of the data was recorded by the company Lycos itself. Is that a perspective
that you got? Is it something you can agree with? Or how did you view some of the some of the decisions,
let me give a little bit of context for the listeners. So we are just through a massive psilocybin research project. And it was really a heavy thing to adhere to all the rules that we have given ourselves. And also, we have failed in some cases. So managing a team in two study centers on our sites, and study centers that we're doing it for the first time, that's really a challenge. Yeah. Now, maps had a lot more study centers, and Maps has not been a drug development
company before they entered into that race. Neither have we while our principal investigator is very experienced in more than 30 studies. So it was to be expected that some irregularities would pop up. And, of course, as the frontrunner in the psychedelic space, it, it would be very good if maps would take care of particularly the the risk data to be really sound. And I don't know what the FDA will be coming
up with, there's a chance of it being approved still. But there could also be a chance of them demanding a clearer registry, a clearer, clearer way of dealing with some of the unexpected or unpublished events. So I don't know if you want to talk about that, too. Obviously, there were some things events happening
that are not formally to be reported to the FDA. But we had conversations over here, what we report something that happens, like five months after the study formally ended, and that is closely linked to the study what we report that And so the vast majority of voices that I hear is that we should, particularly in a situation where we, as researchers, drug developers, are to show to society and society is a pretty complex
thing. It does not only exist out of psychedelic enthusiasts, so we have to deal with a lot of the conservative people in the systems now. And the best way from our viewpoint, to deal with skepticism is to be truthful, very open a little bit more. A little bit more, maybe looking at the risks, then you consider necessary because you don't want to hear the voices that tell you, Oh, you were hiding something? Yeah,
so it's really about being maybe overcautious, in your opinion to sort of when you have such, I don't know, let's say, scrutiny is maybe the right word. But I think there's a there's a, it's on both sides, right. Like there's a real enthusiasm. But there's also still this sort of stigma and skepticism of this kind of, of these of these
compounds, really. And I think that's, that's what you're speaking to, maybe we could give a little bit of context for the audience on this, about just a couple of the specific things because the one that that stood out to me was not reporting, like overly positive feelings. So feelings of euphoria, or I can't remember some of the other terms they use. But these outcomes, normally we think about reporting the adverse
outcomes. So you know, hypertension, or, you know, feeling stressed or feeling anxious, scared, you know, these kinds of things. And yes, that speaks logically, that's something we should record. But one of the criticisms was not recording the overly positive side effects, let's say or outcomes. And the idea being that looks
to the mind, which speaks to the mind of addiction researchers, for example, right, they are obviously concerned about what are people doing with the states? Are they trying to repeat them overly often and things like that?
Yeah, well, so what is your what is your thought on that, then in terms of I think, I think I could guess that your your idea would be to, yes, record all of this data and presented all openly and, and truthfully. But I'm actually a little interested in your thought on that sort of criticism? Because for me, it seems like there's a body of other work out there on addiction with these compounds
that can be referenced in this case. So again, I wonder if this is maybe I don't want to say, overly critical, but I'm just wondering where where this decision comes from? Because there's a lot of compounds that have similar things. And I don't know that they've necessarily been scrutinized in the same way. I don't know I could be wrong on that. Yeah.
Matt cyclus has a double it and it has also a drug policy agenda. And Rick Doblin has been very outspoken about it. He wants to get rid of the current way that drugs are regulated. And I mean, doing that, at the same time, maybe for a long time in the same organization, and in two organizations that are now undergoing internal changes also towards commercialization is really a big endeavor to to get a clear message over to the regulators and to the
politicians. I wouldn't do it. So just as an example, maybe others can, but I couldn't. I have been before we found that the mind foundation here in Europe, we, we did a lot of water, tea and drug policy and prevention in another organization called finder. And we agreed to kind of stop that, of course, we I talk about drug policy if somebody asks me, but it's not that we are pushing it out into the world. Because we need to focus on one thing, first step that was our opinion.
So this is a challenge that that maps build itself for itself, and it might now come back to as a problem that wasn't fully resolved. So a lot of people seem to be concerned in the regulator space. Also people who are not really deep into the science of psychedelics that was obviously some some very coherent reaction from the field that there are some people who were that committee who have never really looked deeply into the delicacies of psychedelic research on blinding and so on.
But nevertheless, this is exactly the kind of people we need to convince. So, uh, Um, and I mean, having that double message of, let's get all the drugs free. And let's have our therapy be approved on the market. This is a challenge.
Yeah. So you know, the biting off more than one can chew perhaps. But I still, I want to stick maybe to this. And the other thing that jumped out to me and again, I can't We can't get into the minds of the regulators and what they were thinking exactly. But there was another criticism and it kind of follows the same with with the extra can
actually can't by just talking to them. I mean, yeah, we are talking through the European regulators. And you get a lot also of them on scientific conferences, not necessarily all of them go to like psychedelic conferences, but some go to neuroscience conferences, psychopharmacology conferences,
and then they talk, and then they write papers. And I mean, it's pretty much open out in the space to skepticism, and maybe also not so sciency decisions on side of the regulators that are more political, we can see it in the European Space, I'm sure we can see it in the FDA. Regulatory space too.
Hmm. So there is a there is a you have some advance notice then maybe of what they're going to be looking at, and what they're going to be focused on what their concerns might be
at the moment. So that's also a European, again, I don't know if you if this is helpful for the American perspective, but on the European side, we are, we've just finished that episode study that we were working on for more than three years, and we are heading towards a potential phase three approval study. So that means for almost two years, we are now talking to regulators. And we see how they evolve and how they
perceive us American data, and what their skepticism is. And I would just I would just more half the very conservative people or not so much the conservative, like the the maybe people with emotional reactions to everything that others call a
drug. In my mind, it's not this is not all rational. So a lot of people even if they have have Professor titles and work in, in regulatory bodies or universities, they have prejudice like all of us, and they have emotional, emotional attitudes that you need to speak to some people just are scared of drugs, still, no matter how advanced your own thinking about drugs, psychoactive substances may be, let's talk to the people who are afraid
and ease their concerns. Yeah, because that was one of the things again, that stuck out to me and reading was, you know, there was a lot of commentary about, well, the addictive side. But also, you know, mixing if patients were to mix these with alcohol or something like that, and as I was reading this, I was like, I mean, but we've done this before, antidepressants, you know, lots of different drugs
have that concern and have gone through approval. So in a way I was thinking, Well, how much is this just a not an understanding of, of the compounds themselves, or putting an extra sort of filter on it that might be you know, from stigma or something else about these drugs, because they are considered were once
considered, you know, recreational? Like, that's their sort of, they didn't come through that typical pharmaceutical lens, but maybe at what point do we have to, you know, trust the patients trust the therapists, you know, rather than sort of try to over regulate all of these behaviors.
Let me quickly talk about some of the complexities in the kind of data that we do not have. So, there is a transition between maybe self administered drug use and therapeutic drug use, obviously, after MDMA therapy, and also after psilocybin or the empty or five Meo DMT therapy. So, there are several questions coming from that. Are we socializing patients into a certain subculture? Or are we socializing or modeling a certain kind of use or attitude
towards these therapeutic compounds? Also, to be clear, I believe that MDMA has a can have a very therapeutic effect. So but even people who might have received it once, twice, three times in the study, May after some month, feel the need to have a refresher or want to do something or have a growth Motivation. So what are what are they doing? Those days after the studies phase is seriously under invested. And the data that we
have here is scars. This is where were the where there is a field, where people often also, some people, a part of the study population may go to sub cultural or drug dealing structures. And this is where people get concerned. And it's a, it's a complex field, I mean, the, we have already talked about it. So free forming this, the the drug, the drug field and
how drugs are provided in society. And maybe even a thinking that, how thinking more concretely about how to fulfill the needs of people who might have a tremendous improvement through psychedelic therapies, but then, after months, or years fall back, or maybe even might have gone into might have tasted some of the potential growth or and self self development impulses that these substances can have on people. So this is something I would look at very clearly and talk to regulators
about openly and they might react with. So that's what some of the European people we talked to have reacted with. Okay. We understand that we also see that in other drug trials, we, we feel that this is an open conversation, and we somehow through a follow up studies need to get an impression on what are people doing after therapy. And, of course, we also need to encourage people to report truthfully, and not build a
relationship to study participants. That insinuates Well, yeah, you've gone through a tremendous therapeutic process. Now you owe us not to report on what you do afterwards. This is, I think, not the way that we should go on.
Hmm. Yeah, that's, that's a really good perspective, actually. And I didn't, I didn't consider that one, my initial reaction of reading the some of the committee findings and stuff. And I think that's a good point, because it's almost like you were saying before trying to do
two things at once, because there is this movement. And I'm not saying that you guys are I mean, I think, like, I'm not putting words in your mouth, but the psychedelic community, on one hand, doing the medical approval process, and all of that, but there's also an opening up of the conversation about these compounds outside of a medical context, you know, and
a lot of it pertains to growth, personal growth. And so yeah, I can see the point where someone who has gone through a therapeutic trial, a medical trial, tightly supervised everything like that, but they felt this, this, you know, maybe this power, you know, this sort of this, this feeling that can be provoked by the substances, and then would want to, you know, do that, again, maybe six months, a year later, that kind of thing, or they have another experience, or maybe they're
even telling other people about that experience, maybe,
maybe they are diving into the psychedelic subculture, or community literature, or space, or a workshop environment and book their tickets to the Amazon and talk to, to Brad about what they did in the Amazon, or talk to a newspaper, and then it's out here, and there needs to be some kind of reasonable commenting on that on some and talking to the regulators about that, if they do their job, they are reading that in the media and wherever we need to develop an
understanding of what people are doing there, and what what future regulation needs might be.
Yeah, it seems like it would have, you know, again, two parallel things happening at once. And it might be difficult to balance those. But I guess, the way you might one way you might address this is just longer, longer follow up with study participants to see behaviors and attitudes, you know, maybe a year, which is a lot of work to keep track of all of these people and a lot of money, like you said, building
a lot of money too. So so in the study that we're just trying to build, we have 30 It's 32 weeks long. So even that it has two phases, the six week phase and the 26 week phase following but it's the same study and after that comes follow up potentially for several years and you need to finance that,
and build the relationships with participants that that, like you said that they are
not trumping reporting truth and not dropping
out. So it's it is, it's a lot of work, I think we know. Okay, then there's a couple specifics, maybe, again, that I'd like to just talk to you about, and maybe I just, you could start with, were there things that really stood out to you in the decision that you were like,
yes, that's something we need to get a grip on? Or where there's some things that you might say, we could push back a little bit and say, Well, we already have this, I'm thinking specifically of the placebo conversation, which which comes up all the time. And then also the regulating the therapy angle, or maybe regulating is the wrong word, because FDA doesn't regulate therapy, I'm assuming it's similar in the in the European context. But standardizing the therapy maybe
is a is a better word for that. And but what were maybe some of the highlights for you, where you saw, yes, that's something that we need to figure out a way to address.
Very interesting question. So again, from a European perspective, and as an organization, that together with other organization tries to set up a trial that tries to solve some of the questions that you're raising. So yes, placebo controlled trials are demanded. But there is there are a lot of other trials that could be done. And we're trying in our potential phase three, to do a comparative trial. So we are, we are comparing against a standard of care. And so we have two to
two branches in this in the study. So both involve psychotherapy. And on the one side, there is an antidepressant being administered on the other side. So those have been being administered. This is called a health technology assessment study, which is designed to take these therapies into the public health insurance space. And for that you need all you always need to compare against the standard of care. So that could have easily been demanded by the authorities in the United
States. They didn't do that. And then there's some incoherence on the side of the FDA, of course, so they accepted. The unblinding Rich studies, and they had a conversation for many years for more than a decade, with, with maps. And so in a sense, there is some under preparation of the Committee on we accepted that and because we believe that these drugs have a therapeutic role to play in the market, in the future, we accept some of the deficiencies of of the of the study. So that that was a
little bit unsystematic. On the side of the FDA, I don't know why they let it happen like that. We may hear from others about the political stuff that happened in the background. And just one of the things and then ongoing topic in psychedelic research about is it psychotherapy, is it not psychotherapy, how much psychotherapy, should we call it
psychotherapy. And maps have been Maps has been pretty outspoken about it, but in a, again, European perspective away that would be very unwise to do it in Germany, France, Switzerland, some other European countries. They have under defined their intervention, their psychotherapeutic intervention and put in a bunch of ideas that emerged in the
1970s, which are not clearly defined and investigated. And so they were opening up to all the criticism that then came out of committee group without necessarily the need to do that. So there were yours to be which they could have defined that accompanying intervention much better. Everybody who knows some of our papers, we, like our principal investigator get Glinda. He just published first authored a paper in Lancet psychiatry, with the title a psychedelic therapy is
psychotherapy. Now, of course, this is a very radical position and others have contradicted but you on our side, opinionated, certainly. We are more looking at the intersections of how can we measure that what's happening I think what's what's happening in psychedelic therapy has similarities to all kinds of psycho therapies, and where are the exceptional effects. Instead of saying it, there are two things, and we don't know how they work together, which is actually a scientific. Lai is a
little bit too strong. But we have, we have 77 decades of data on psychotherapy research that we can look at. And that we can apply now. And it's happening more and more, I see more and more study centers, applying, applying questionnaires and concepts from psychotherapy research in Australia, in Germany, in Spain, and also at the Johns Hopkins. So this could have happened a little bit earlier. And defining the therapy better is something that does the whole thing very well, it
seems to me like this is exactly where a comparative study comes in. Because if if you're comparing to standard of care with a with a therapy that is, you know, known, trusted by the community, by regulators, that kind of thing, and all you're swapping out is, like you said, an antidepressant versus the psilocybin treatment, that seems like it would be a robust comparison as to what's going on. Hopefully,
hopefully, we have very, very good feedback so far. But it's also Admittedly, it's an expensive thing. And it's something that takes a lot of resources and motivation on the side of the study sites. And you need to you need to have people in the study sites, then that are both trained psychotherapists, and are open to the psychedelic substances.
And I mean, there has been kind of diffuse field, from again, from, from our perspective, in the United States, where you don't have such a, sometimes a little bit rigid system, like in Germany, in Germany, the psychotherapy definitions are very rigid, and what is reimbursed is, is a very well defined in terms of psychotherapy, schools who have hundreds of, of studies to, to apply with to the HTA authorities to be reimbursed. And that kind of thing is not
present in the FDA regulatory space. So there are differences between Europe and the United States. Okay.
And then I think this goes along with defining the therapy a little better. And one of the things you mentioned at the beginning of just, you have these different sites, you know, doing these trials, and you kind of trying to monitor them, but they have independence on you know, they're not being monitored all the time. And I think we have to bring up the safety concerns that were that were that were brought up in the trial, as well, some allegations of abuse
during therapy, that kind of thing. And I think that these kind of flow together that it's it's difficult to monitor all these sites, you have to vet all these people, but also with an undefined therapy. Some things like touch, comforting touch, these sorts of concepts in therapy can lead to maybe this, you're opening yourself up basically to to potential mishaps. So is that a fair read on it? Or how do you view that, that that situation, even
if we would think about our organization, which is a small organization, to be able to monitor all the study centers ourselves, we wouldn't do it, we would hire contract research organization, particularly to have a second perspective and to have somebody in the study, a process that has a lot of a lot more experience than we do we have never done a study with 15 study centers. So theoretically, I can imagine that we could do it, of course, we believe we have, we have trust in that
whatever we can talk to people but but trust is not enough. We need to have these processes in place. That is one one thing. And the other thing is the personalities of some of the study therapists in maybe the maps trials also other trials. We took we will take care and have taken care in the episode study that overly enthusiastic psychedelic therapists or ex underground therapists would not become part of the study teams. There is there is a bias, big bias that is coming in there.
And I am not sure that there is a clear policy on the site of Lycos Weiser clear policy on the site of Lycos maps there Because, because it also from from so a Greek is very outspoken about it. And this is also his, his his big magic, he is very open. And he is he is very authentic in what he says. And and he also believes a lot of the underground therapists will become legal therapists. And I believe that this will happen that that some people will transcend to the legal
space. But there are also some ideas and some, some attitudes that we don't want to see in the legal space. So building relationships with your patients that are based on on the movement that we have seen in the 1970s, which is called anti psychiatry. So instead of changing psychiatry to become more humane, more open, less rigid, more psychotherapeutic just work on the fact that patients the patient role, so part of the anti psychiatry, psychiatry movement was
destroying the patient doctor role. So because some authors thought this is in itself, unhealthy, or almost unethical, and we need to go to a completely different relationship, and then come people into the space who define that relationship as Shaman. And somebody's looking for healing, even even using unreflectively for term healing is at least demanding. I mean, people project all kinds of religious fantasies into it, and what does it do to the expectation of
clients? And what does it do to the relationship of therapist and client. So this is a broad field, obviously, now, we don't know how far you want to go into it. But but some of the, of the founding ideas of psychedelic therapy in the 1960s and 70s, particularly when they were legalized, or not viable in an open multicultural, ScienceBase society, where we actually have a dialogue on epistemologies and truth and if something works, and we invite the patient to be able to go to a certain body if
she feels mistreated by a patient. So this all has to be living in the therapist, too. And the patient's need to know it, we sort of invite people into some pseudo modern shamanistic relationship.
Yeah, I mean, I think you know, me that that really speaks to me, and I agree with a lot of that, and, but I think it is a, it's, it's a difficult, it's a difficult process, it's like, you know, shedding shedding the old skin and trying to trying to re work things for for a modern time.
But this maybe then brings us to just overall the hype surrounding this, because I think, you know, with some of the maybe some of the therapists, some of the underground practitioners, let's say, people who were were in this field, in the beginning, maybe when it was really stigmatized, you know, or even then became illegal. There's this defensiveness to it, like a, like a, we, we uncovered this
truth, and then the man tried to shut us down. So you know, like, there's there can be a real evangelistic kind of attitude
towards it. And that's just one aspect of hype. There's also, you know, hype for the participants that maybe see that those attitudes, and then there's the expectation that, you know, was brought up in the trials, and then how does this hype affect the scrutiny that then gets put onto the field by those who are looking at this and saying, Well, this just looks so weird, this just looks so you know, it can't be right,
you know, that kind of thing. So that's a lot to throw at you right there, those three angles of hype, I think, but how do we then move forward? How do you think about it moving forward in terms of having these conversations, like we're having now or with the media or with skeptics, or with, you know, true believers? How do we balance all of these ideas and make sure that, you know, we're not throwing babies out with bathwater, but also, you know, reflecting a safe modern
approach to all of this? Yeah.
Well, let me say first, that even true believers or people who are over enthusiastic are not bad people. Yeah, of course, we have been over enthusiastic in our lives, in many ways. So, so, but we have to we have to definitely think about how have built a system around disruptive pharmacology a system. And I don't think that some of the ideas that I hear when I go to psychedelic conferences, that we have to break down the system and, and kind of create an archaic
situation where everybody heals herself himself. And people just provide trip sitting to somebody else. This is profoundly naive and misunderstanding, the nature of people who are deep into mental health issues. So there's a spectrum, obviously, and we cannot treat everybody the same. There are people who perfectly can self administer psychedelics, and never take any harm from it. But there are people who are severely into suicidal and other severe mental health issues, and they need
somebody to really know who really knows what they do. So how do we go on? Oh, first of all, we also see in Europe very raised strongly the hype is kind of gone, investors and donors are more looking at is this really doing something where I'm supposed to invest or donate to. So more looking at good science.
So also with with foundations and organizations coming up in Europe that are really looking at founding more basic research, and various strict and good science, it's not a surprise, I'm a scientist, of course, I'm advocating for science, but but also from from the, from the viewpoint of a citizen from the viewpoint of a person who philosophically thinks that a pluralistic society that tries to be open, needs to have ways of communicating truth, and debating truth with each other.
And it cannot be done on on the basis of cult of subjectivity. So only judging the world from that would be a very radical stance from your own subjective psychedelic experience. Somehow, you need to go into that negotiation process with your peers and with people from society. What is really true? And should we build our relations to our children and to our colleagues and and to our communities? On the basis of
that? And so why, why do I say that, because I think the hype has a has a big operative gives us provides us with a big opportunity to rethink again, to maybe consolidate the studies to be a little bit more patient to talk to other funders who may
come in, after the hype, funders. So I'll own example, just just to be clear what's happening over here, we are running a clinic, the OB clinic, Berlin, and it took me one and a half years to find a new group of people, do we first investment round in the clinic that we needed, but we now found wonderful people who have been following the whole hype circle, or hype Phase II phase since 2014 15, and said, We're waiting. Let's wait, let's wait, it's going to show are they
still present? Are the people here? Will this studies show any results that are published in higher level mega high level journals. And so we now find found, just in our case, a group of people who came in late so this is an opportunity, this is a chance also to have investor relationships that are not illusionary where investors drive you to results on the basis or based on on assumptions for where they think this is a
wonder drug. And the people that I'm funding are only speaking some kind of strange scientific code, because society doesn't understand the nature of the wonder drug. This is not how we should go. It's not it's not this is not true. These are not wonder drugs. We have had now about 500 patients in our clinic and we see considerable improvements but we also failed
on many people. That's so clear. And if you're if you're really looking at every day to day processes of therapy with ketamine, or in the studies with five MEO and or psilocybin When you fail a lot, and, of course, people are not just healed, there are all kinds of intermediary results that you get, and people want to go on, and you need to transfer them to another doctor, or you need to transfer them to a clinic, because through your therapy, they got the DS, D stabilized
and things like that. These are all realities that we can now talk about after the hype.
So again, it's it's getting as much data and presenting it as openly as possible, you know, and also, and also talking about hype in a way. Yep, balance of hype, and also talking, frankly, about
non clinical use, and how could we build a model in our societies for non clinical use of these substances? That is not the same as recreational use institutionalizing non clinical use would do it, what would the studies be? So this is a little bit further in the future. But if we need it, we should do produce a data about that or begin to produce a data about it. And I think we need it, there is a there is a case for non clinical salutogenic and clinical and preventive use of
these substances. And that fits well into some of the needs of patients after therapy. Now, and this is, this is the first fascinating stuff that we can now begin to talk about. Yeah, yeah, I'm, even before the first psychedelic has been approved.
Yeah, as you know, I think yeah, I also agree with with that, that that mindset. And I think a lot of what you said just in that, that answer there to be about communicating truth and finding a way to, you know, a kind of injury negotiation that applies to so much of what I feel is going on in in our world right now outside of psychedelics, politics, and just people in general. So I really enjoyed hearing your your perspective on that. I have one more for you,
if it's alright, if we have time. And just a quick comment maybe on this is the other part as me a biologist, that I'm super fascinated when it comes to these psychedelics is understanding more exactly how they're working in the brain, right? Like these so called mechanistic studies, I just covered one on the podcast about MDMA and empathy was an animal study about does it increase empathy or not, you know, and I
thought that was really fascinating. So where do you see basic research on how these things are working in the brain? fitting into, you know, again, this sort of pushing for acceptance approval? How will it help us, you know, to reach that goal? And what is there still a disconnect in terms of okay, brain chemicals are doing this, but what does that mean for the subjective experience? Because I feel like that's always going to be a tricky thing for us to manage.
Yeah. So scientifically, and philosophically, it's very hard to bring these third person and first person perspectives together. But this is exactly where I see a lot of research should emerge in the future. I see, I see no basic contradiction between a therapy
where we have a biological effect, which we do. And when we have a psychotherapeutic effect, because psychotherapeutic effects are also biologically managed, or biologically mitigated, now, people have strange and strange things about what psychotherapy is, but our behavior is biologically rooted,
and we we need to bring these perspectives together. So there was a time between maybe 2002 1017 18 When it was already enough to have some nice graphs about biological effects and and maybe also systemic biology effects house brain centers, communicate with each other. But we need to get we need to repeat that stuff. We need to show the relevance of that stuff in, in a mechanistic way. Yeah. Is it so for example, if it's true that people get a get go through a phase where they where they
think less in a less rigid way? How is that upheld in the next hours and days? How is the window of change learning window being used canonbury to be used? So get much more down to the also clinical behavioral side of these mechanistic effects? That's how I would imagine it. But definitely, Brad, you're not talking to a neuroscientist. You're talking to somebody who is trained in psychotherapy who has has a medical psychology
background. So I am obviously more interested in the intersection of these behavioral and clinical stuff and And the biological effect. So let's look at these interactions would be my, my obvious answer. Yeah.
And I think that that speaks to it. I mean, this this is a lot of my wife is a neuroscientist, and this is a big debate that goes on in a lot of that stuff. You can look at just the brain and what's going on. But you have to relate it to behavior in order for it to be meaningful enough to see how that
yeah, and we'll have we'll have substances if if some of the approval programs will succeed, we'll have substances on the market where the provider claims it's basically a biological effect. And we have very little other regulatory stuff around it. And we have the opposites. These are healthy
models, and we'll then find out through monitoring them. When we have to look at maybe we are overdoing it with psychotherapy, and the others are right, or maybe it's just says patient populations that go well with one approach and the others, not we we should have should look at that in the future. Well,
great. Thank you so much for your time, I always appreciate your very grounded open perspective on these things. So when I saw the FDA decision, even though it's a European American context, it's a bit different. I love to hear what you've what you have to say very illuminating. As always, thank you so much for taking the time. I really, really appreciate it.
Thank you for your questions and for the opportunity to speak here. Thank you
all right, many thanks to Henrik union Burleigh and the mind foundation for for for coming on the show. And please rate subscribe, review wherever you get your podcasts. Check us out on YouTube on social media at to Brad for you. Big thanks as always to the frequency for the music special in the mood for the logo. Check the show notes for all relevant reporting and articles that I use to to to
inform this episode. And for some of that research that Henrik and his collaborators at mind and in Germany are doing really great to really great to hear from you all please reach out social media email at to grandview@gmail.com or add to Brad's view on the socials. And and until next time, please have a good summer. Enjoy yourself. Stay safe, and we'll see you next time.