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Episode 97 - An unexpected hurdle for MDMA assisted therapy. What now?
15th July 2024 • Two Brad For You • Bradley van Paridon
00:00:00 00:57:34

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In June an independent advisory committee recommended the FDA not approve MDMA assisted therapy for PTSD. This came as a surprise to many working in and following the field of psychedelic assisted therapy. It also raised questions as to where the field is at and what challenges still exist.

To provide some context and perspective on this decision and some of the specific criticism raised during the hearing Henrik Jungaberle, a psychedelic and public health researcher in Berlin joined the show.

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Transcripts

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Bradley van Paridon: What is up Brad fans how you doing how you

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live in. If you've followed this podcast for any stretch of time,

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or if you follow the psychedelic research that's ongoing about

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the use of psychedelics for therapy, you probably have

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heard, either me or some other person in this space talk about

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the likelihood that MDMA so MDMA assisted therapy, for the

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condition of post traumatic stress disorder is likely going

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to be the first of these treatments approved by the FDA.

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But in a somewhat of a surprise decision Earlier in June, an

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independent advisory committee to the FDA, recommended against

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approval. Now, to be clear, this is not the final decision on

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this treatment or on other psychedelics. This is in fact,

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as the name suggests, an advisory committee, a panel of

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experts put together to make this pre decision, let's say, as

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a recommendation to the FDA. The final decision will be coming

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sometime later in August. And like I said, this decision was a

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bit of a shock to many in in this space, or who follow this

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space who follow the psychedelic research space. But as we'll

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hear from our guests today, maybe not totally unsurprising.

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For some context, the decision was being made on data that was

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put forward by a company called Lighthouse, which was formerly

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the maps organization Maps has been a pioneer in this space of

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psychedelic assisted therapy specifically with MDMA. And

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they've really, really been responsible for pushing, you

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know, trials, clinical trials, and and bringing this work with

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PTSD. Closer and closer to approval. They submitted data

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for multiple clinical trials. And and like I said, the

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committee decided to recommend against approval. The hearing

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included public testimony, and by some accounts, in the in the

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reporting on this, this was some pretty charged testimony, both

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for and against approval commentary from people who have

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been profoundly helped by this treatment, and people with

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serious concerns about safety. And the nature in which Lycos

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conducted some of their trials. And some of the behavior of the

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therapists involved in some of the trials, there was

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allegations of assault that happened during the during the

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trials. And so this leaves us at an interesting place in terms of

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where does where does this field go now. So to get an informed

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perspective, and some much needed context into how this

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research is performed, and some of the questions that are

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ongoing in this field, I reached out to Henrik young Abella, he

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is a psychedelic research public health researcher, based in

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Berlin, and one of the founders of the mind Foundation, a

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nonprofit organization, again, based in Berlin, that is working

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towards bringing psychedelic assisted therapy, to a medical

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framework to an approval framework in Europe. And also

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they have activities, workshops surrounding safe practice, in

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terms of of psychedelics, and how do we maximize psychedelics

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and its use in our modern culture in maybe outside of the

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clinic and these kinds of things. So Henrik has been on

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the on the show before, as have other people from the mind

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Foundation. And I just always like to point out that, my my

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thanks to them for being so generous with their time in

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coming on this show. And I really do appreciate their

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balanced approach to this, to this to this field, and to the

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end to some of these questions, because there is a lot of hype,

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as Henrik and I talked about, and there is, you know, maybe a

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and there's also some change going on in in the field itself,

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you know, from the 60s and 70s. You know, what are some ideas

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that maybe were prevalent there that came about in the first

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wave of psychedelics that Maybe don't fit a modern, modern

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context anymore or that have been proven to be or can't we

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can look at now and say, Well, maybe that's not the best way to

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do this, maybe that's not the most healthy way, or safest way

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to do that. So, like I said, very balanced take on these

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things. And one of the reasons, you know, aside from Henrik

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being very involved in this field and having a lot of

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knowledge of it, that that balance I really like. And I

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think it gives us an opportunity to look at the pros and cons and

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everything very truthfully, very honestly. That would be the

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other thing I would say about Henrichs approach to this. And

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the mind foundations approach to this is honesty and balance. So

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we talked about the decision itself, some of the specific

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factors where maybe there was where where maybe Lycos could

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have done better, where there was some potentially

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incongruent, or head scratching decisions or comments by the

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regulators, we talk about the very prominent issues that

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always come up in this field of placebo and therapy, I really

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enjoyed Henrichs comments on the therapy angle, again, speaking

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about things that maybe we want to we don't want to see in the

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therapy anymore, that maybe come from older ideas, or other

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schools of thought, original, you know, psychedelic schools of

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thought from previous times, that don't fit the modern view

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anymore, or don't really mesh with the medical framework. So I

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really, really enjoyed that part of the conversation. And we

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talked about hype, and just how do we, how do we have a good

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discussion about these things?

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How do we talk about these things with people who are

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skeptical who maybe are, let's say more conservative about

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these drugs, or have emotional reactions to the experience to

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the word drugs and the experiences that these drugs can

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can provoke? How does that hype influence, you know, the people

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in the trials, that may be a negative thing in terms of our

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ability to collect good, unbiased data? How does that

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hype affect the the people making the decisions about these

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things, you know, so very, very interesting conversation, a lot

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of good context, about the decision and where the field is

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at and the challenges but also the, still the promise of, of

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moving forward with these things in a safe and, you know,

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legitimate way. So many, many thanks again to Henrik, for

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coming on the show. And I would just like to direct everybody to

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the shownotes whether you're seeing this on the podcast on

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YouTube, or on our social media feeds, look at the captions,

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look at the look at the show notes, to find links to a lot of

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great reporting that's been done about this decision, to the mind

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Foundation, and then to also some of the research papers that

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Henrik and his collaborators are putting out regarding their

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trials with psilocybin and depression. And then just some

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of the other, you know, philosophical questions or you

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know, or big topics in the field that need to be discussed, need

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to be addressed in an open, honest way, in order for, you

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know, skeptics and true believers and everyone in

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between to sort of find the right balance in terms of hype

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and how we talked about these things and how they can be best

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used to achieve, you know, the lofty noble goals that we all

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hope we can achieve with these things, first and foremost,

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alleviating serious harms from mental health conditions that

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many people are, are suffering from. So reach out to us on the

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show to me at the show on social media at to Brad for you. And on

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email, to Brad for you@gmail.com, you can go to

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again, our website, which is linked in the bio of our social

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media or in the in the show notes. And you can find

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transcripts and ways to get in touch with us ways to throw a

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couple bucks at the show. If that's something you're inclined

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to do. Please also rate subscribe, follow all of those

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great things really help out the show a lot. We do. We I

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appreciate it very much. And that's it. That's all let's get

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to my discussion with Henrik Yuna Birla About the independent

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committee decision recommending against approval for MDMA

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assisted therapy for post traumatic stress disorder.

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Well, good morning, Henrik. Thank you for taking the time

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once again to join me on my show. It's great to see you. How

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are you today?

Unknown:

Good morning. It's a pleasure to be with you, Brad.

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It's it's good. I'm I'm fine. Excellent

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Bradley van Paridon: AM. So we're here to talk about the

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recent decision by an independent advisory committee,

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to the FDA regarding MDMA assisted therapy for PTSD, Post

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Traumatic Stress Disorder. Now, I think a lot of people were

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shocked when the committee recommended against approval. As

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we heard in the intro, this isn't the final decision. But I

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think it was a shock to a lot of people, I just want to ask you

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right away, you know, as someone who is not involved in the

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American system, you're coming from Germany from the European

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system, but working in the same field working towards the same

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goals of bringing psychedelics to, to a medical framework to to

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an approval framework. What was your reaction when you heard

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that news? Was it a surprise? Did you have some inclination

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that maybe it wasn't going to be as easy as maybe some of the

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reports? Were making it sound? Yeah,

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very good question. So it wasn't a surprise, it was

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also a little bit of a shock, but not unexpected. So we among

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the networks that we work in, were talking about, particularly

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a European perspective. So the European perspective was, what

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the data that the FDA accepts or does not accept, be enough to

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also bring it to Europe. And I heard a lot of voices around us

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that said, well, the studies are too small. And the data that

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they that maps or like us is delivering is might not be good

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enough. And we're not sure if the reporting on on SAE is and a

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is how it will be. So it was like people are hoping for an

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MDMA approval, but also hoping for something that is sound

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enough to also take it to Europe.

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Bradley van Paridon: So a lot of the reaction that I was reading,

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and maybe it's a skewed perspective, I don't know, this

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is why I'd like to ask you was that a lot of the critiques from

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the committee weren't necessarily about the compound

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itself. There was some safety and long term safety issues

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raised. But it was more about maybe the methodology or, you

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know, some laxness in the way that some of the data was

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recorded by the company Lycos itself. Is that a perspective

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that you got? Is it something you can agree with? Or how did

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you view some of the some of the decisions,

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let me give a little bit of context for the

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listeners. So we are just through a massive psilocybin

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research project. And it was really a heavy thing to adhere

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to all the rules that we have given ourselves. And also, we

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have failed in some cases. So managing a team in two study

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centers on our sites, and study centers that we're doing it for

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the first time, that's really a challenge. Yeah. Now, maps had a

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lot more study centers, and Maps has not been a drug development

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company before they entered into that race. Neither have we while

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our principal investigator is very experienced in more than 30

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studies. So it was to be expected that some

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irregularities would pop up. And, of course, as the

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frontrunner in the psychedelic space, it, it would be very good

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if maps would take care of particularly the the risk data

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to be really sound. And I don't know what the FDA will be coming

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up with, there's a chance of it being approved still. But there

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could also be a chance of them demanding a clearer registry, a

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clearer, clearer way of dealing with some of the unexpected or

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unpublished events. So I don't know if you want to talk about

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that, too. Obviously, there were some things events happening

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that are not formally to be reported to the FDA. But we had

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conversations over here, what we report something that happens,

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like five months after the study formally ended, and that is

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closely linked to the study what we report that And so the vast

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majority of voices that I hear is that we should, particularly

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in a situation where we, as researchers, drug developers,

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are to show to society and society is a pretty complex

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thing. It does not only exist out of psychedelic enthusiasts,

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so we have to deal with a lot of the conservative people in the

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systems now. And the best way from our viewpoint, to deal with

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skepticism is to be truthful, very open a little bit more. A

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little bit more, maybe looking at the risks, then you consider

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necessary because you don't want to hear the voices that tell

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you, Oh, you were hiding something? Yeah,

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Bradley van Paridon: so it's really about being maybe

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overcautious, in your opinion to sort of when you have such, I

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don't know, let's say, scrutiny is maybe the right word. But I

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think there's a there's a, it's on both sides, right. Like

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there's a real enthusiasm. But there's also still this sort of

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stigma and skepticism of this kind of, of these of these

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compounds, really. And I think that's, that's what you're

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speaking to, maybe we could give a little bit of context for the

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audience on this, about just a couple of the specific things

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because the one that that stood out to me was not reporting,

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like overly positive feelings. So feelings of euphoria, or I

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can't remember some of the other terms they use. But these

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outcomes, normally we think about reporting the adverse

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outcomes. So you know, hypertension, or, you know,

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feeling stressed or feeling anxious, scared, you know, these

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kinds of things. And yes, that speaks logically, that's

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something we should record. But one of the criticisms was not

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recording the overly positive side effects, let's say or

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outcomes. And the idea being that looks

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to the mind, which speaks to the mind of addiction

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researchers, for example, right, they are obviously concerned

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about what are people doing with the states? Are they trying to

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repeat them overly often and things like that?

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Bradley van Paridon: Yeah, well, so what is your what is your

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thought on that, then in terms of I think, I think I could

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guess that your your idea would be to, yes, record all of this

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data and presented all openly and, and truthfully. But I'm

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actually a little interested in your thought on that sort of

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criticism? Because for me, it seems like there's a body of

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other work out there on addiction with these compounds

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that can be referenced in this case. So again, I wonder if this

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is maybe I don't want to say, overly critical, but I'm just

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wondering where where this decision comes from? Because

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there's a lot of compounds that have similar things. And I don't

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know that they've necessarily been scrutinized in the same

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way. I don't know I could be wrong on that. Yeah.

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Matt cyclus has a double it and it has also a drug

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policy agenda. And Rick Doblin has been very outspoken about

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it. He wants to get rid of the current way that drugs are

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regulated. And I mean, doing that, at the same time, maybe

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for a long time in the same organization, and in two

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organizations that are now undergoing internal changes also

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towards commercialization is really a big endeavor to to get

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a clear message over to the regulators and to the

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politicians. I wouldn't do it. So just as an example, maybe

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others can, but I couldn't. I have been before we found that

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the mind foundation here in Europe, we, we did a lot of

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water, tea and drug policy and prevention in another

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organization called finder. And we agreed to kind of stop that,

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of course, we I talk about drug policy if somebody asks me, but

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it's not that we are pushing it out into the world. Because we

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need to focus on one thing, first step that was our opinion.

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So this is a challenge that that maps build itself for itself,

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and it might now come back to as a problem that wasn't fully

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resolved. So a lot of people seem to be concerned in the

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regulator space. Also people who are not really deep into the

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science of psychedelics that was obviously some some very

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coherent reaction from the field that there are some people who

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were that committee who have never really looked deeply into

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the delicacies of psychedelic research on blinding and so on.

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But nevertheless, this is exactly the kind of people we

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need to convince. So, uh, Um, and I mean, having that double

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message of, let's get all the drugs free. And let's have our

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therapy be approved on the market. This is a challenge.

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Bradley van Paridon: Yeah. So you know, the biting off more

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than one can chew perhaps. But I still, I want to stick maybe to

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this. And the other thing that jumped out to me and again, I

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can't We can't get into the minds of the regulators and what

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they were thinking exactly. But there was another criticism and

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it kind of follows the same with with the extra can

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actually can't by just talking to them. I mean, yeah,

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we are talking through the European regulators. And you get

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a lot also of them on scientific conferences, not necessarily all

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of them go to like psychedelic conferences, but some go to

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neuroscience conferences, psychopharmacology conferences,

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and then they talk, and then they write papers. And I mean,

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it's pretty much open out in the space to skepticism, and maybe

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also not so sciency decisions on side of the regulators that are

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more political, we can see it in the European Space, I'm sure we

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can see it in the FDA. Regulatory space too.

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Bradley van Paridon: Hmm. So there is a there is a you have

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some advance notice then maybe of what they're going to be

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looking at, and what they're going to be focused on what

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their concerns might be

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at the moment. So that's also a European, again, I

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don't know if you if this is helpful for the American

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perspective, but on the European side, we are, we've just

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finished that episode study that we were working on for more than

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three years, and we are heading towards a potential phase three

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approval study. So that means for almost two years, we are now

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talking to regulators. And we see how they evolve and how they

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perceive us American data, and what their skepticism is. And I

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would just I would just more half the very conservative

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people or not so much the conservative, like the the maybe

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people with emotional reactions to everything that others call a

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drug. In my mind, it's not this is not all rational. So a lot of

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people even if they have have Professor titles and work in, in

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regulatory bodies or universities, they have

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prejudice like all of us, and they have emotional, emotional

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attitudes that you need to speak to some people just are scared

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of drugs, still, no matter how advanced your own thinking about

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drugs, psychoactive substances may be, let's talk to the people

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who are afraid

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Bradley van Paridon: and ease their concerns. Yeah, because

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that was one of the things again, that stuck out to me and

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reading was, you know, there was a lot of commentary about, well,

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the addictive side. But also, you know, mixing if patients

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were to mix these with alcohol or something like that, and as I

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was reading this, I was like, I mean, but we've done this

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before, antidepressants, you know, lots of different drugs

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have that concern and have gone through approval. So in a way I

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was thinking, Well, how much is this just a not an understanding

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of, of the compounds themselves, or putting an extra sort of

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filter on it that might be you know, from stigma or something

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else about these drugs, because they are considered were once

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considered, you know, recreational? Like, that's their

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sort of, they didn't come through that typical

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pharmaceutical lens, but maybe at what point do we have to, you

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know, trust the patients trust the therapists, you know, rather

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than sort of try to over regulate all of these behaviors.

Unknown:

Let me quickly talk about some of the complexities

Unknown:

in the kind of data that we do not have. So, there is a

Unknown:

transition between maybe self administered drug use and

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therapeutic drug use, obviously, after MDMA therapy, and also

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after psilocybin or the empty or five Meo DMT therapy. So, there

Unknown:

are several questions coming from that. Are we socializing

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patients into a certain subculture? Or are we

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socializing or modeling a certain kind of use or attitude

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towards these therapeutic compounds? Also, to be clear, I

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believe that MDMA has a can have a very therapeutic effect. So

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but even people who might have received it once, twice, three

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times in the study, May after some month, feel the need to

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have a refresher or want to do something or have a growth

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Motivation. So what are what are they doing? Those days after the

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studies phase is seriously under invested. And the data that we

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have here is scars. This is where were the where there is a

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field, where people often also, some people, a part of the study

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population may go to sub cultural or drug dealing

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structures. And this is where people get concerned. And it's

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a, it's a complex field, I mean, the, we have already talked

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about it. So free forming this, the the drug, the drug field and

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how drugs are provided in society. And maybe even a

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thinking that, how thinking more concretely about how to fulfill

Unknown:

the needs of people who might have a tremendous improvement

Unknown:

through psychedelic therapies, but then, after months, or years

Unknown:

fall back, or maybe even might have gone into might have tasted

Unknown:

some of the potential growth or and self self development

Unknown:

impulses that these substances can have on people. So this is

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something I would look at very clearly and talk to regulators

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about openly and they might react with. So that's what some

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of the European people we talked to have reacted with. Okay. We

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understand that we also see that in other drug trials, we, we

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feel that this is an open conversation, and we somehow

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through a follow up studies need to get an impression on what are

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people doing after therapy. And, of course, we also need to

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encourage people to report truthfully, and not build a

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relationship to study participants. That insinuates

Unknown:

Well, yeah, you've gone through a tremendous therapeutic

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process. Now you owe us not to report on what you do

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afterwards. This is, I think, not the way that we should go

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on.

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Bradley van Paridon: Hmm. Yeah, that's, that's a really good

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perspective, actually. And I didn't, I didn't consider that

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one, my initial reaction of reading the some of the

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committee findings and stuff. And I think that's a good point,

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because it's almost like you were saying before trying to do

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two things at once, because there is this movement. And I'm

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not saying that you guys are I mean, I think, like, I'm not

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putting words in your mouth, but the psychedelic community, on

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one hand, doing the medical approval process, and all of

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that, but there's also an opening up of the conversation

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about these compounds outside of a medical context, you know, and

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a lot of it pertains to growth, personal growth. And so yeah, I

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can see the point where someone who has gone through a

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therapeutic trial, a medical trial, tightly supervised

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everything like that, but they felt this, this, you know, maybe

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this power, you know, this sort of this, this feeling that can

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be provoked by the substances, and then would want to, you

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know, do that, again, maybe six months, a year later, that kind

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of thing, or they have another experience, or maybe they're

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even telling other people about that experience, maybe,

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maybe they are diving into the psychedelic subculture,

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or community literature, or space, or a workshop environment

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and book their tickets to the Amazon and talk to, to Brad

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about what they did in the Amazon, or talk to a newspaper,

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and then it's out here, and there needs to be some kind of

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reasonable commenting on that on some and talking to the

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regulators about that, if they do their job, they are reading

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that in the media and wherever we need to develop an

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understanding of what people are doing there, and what what

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future regulation needs might be.

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Bradley van Paridon: Yeah, it seems like it would have, you

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know, again, two parallel things happening at once. And it might

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be difficult to balance those. But I guess, the way you might

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one way you might address this is just longer, longer follow up

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with study participants to see behaviors and attitudes, you

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know, maybe a year, which is a lot of work to keep track of all

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of these people and a lot of money, like you said, building

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a lot of money too. So so in the study that we're just

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trying to build, we have 30 It's 32 weeks long. So even that it

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has two phases, the six week phase and the 26 week phase

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following but it's the same study and after that comes

Unknown:

follow up potentially for several years and you need to

Unknown:

finance that,

Unknown:

Bradley van Paridon: and build the relationships with

Unknown:

participants that that, like you said that they are

Unknown:

not trumping reporting truth and not dropping

Unknown:

Bradley van Paridon: out. So it's it is, it's a lot of work,

Unknown:

I think we know. Okay, then there's a couple specifics,

Unknown:

maybe, again, that I'd like to just talk to you about, and

Unknown:

maybe I just, you could start with, were there things that

Unknown:

really stood out to you in the decision that you were like,

Unknown:

yes, that's something we need to get a grip on? Or where there's

Unknown:

some things that you might say, we could push back a little bit

Unknown:

and say, Well, we already have this, I'm thinking specifically

Unknown:

of the placebo conversation, which which comes up all the

Unknown:

time. And then also the regulating the therapy angle, or

Unknown:

maybe regulating is the wrong word, because FDA doesn't

Unknown:

regulate therapy, I'm assuming it's similar in the in the

Unknown:

European context. But standardizing the therapy maybe

Unknown:

is a is a better word for that. And but what were maybe some of

Unknown:

the highlights for you, where you saw, yes, that's something

Unknown:

that we need to figure out a way to address.

Unknown:

Very interesting question. So again, from a

Unknown:

European perspective, and as an organization, that together with

Unknown:

other organization tries to set up a trial that tries to solve

Unknown:

some of the questions that you're raising. So yes, placebo

Unknown:

controlled trials are demanded. But there is there are a lot of

Unknown:

other trials that could be done. And we're trying in our

Unknown:

potential phase three, to do a comparative trial. So we are, we

Unknown:

are comparing against a standard of care. And so we have two to

Unknown:

two branches in this in the study. So both involve

Unknown:

psychotherapy. And on the one side, there is an antidepressant

Unknown:

being administered on the other side. So those have been being

Unknown:

administered. This is called a health technology assessment

Unknown:

study, which is designed to take these therapies into the public

Unknown:

health insurance space. And for that you need all you always

Unknown:

need to compare against the standard of care. So that could

Unknown:

have easily been demanded by the authorities in the United

Unknown:

States. They didn't do that. And then there's some incoherence on

Unknown:

the side of the FDA, of course, so they accepted. The unblinding

Unknown:

Rich studies, and they had a conversation for many years for

Unknown:

more than a decade, with, with maps. And so in a sense, there

Unknown:

is some under preparation of the Committee on we accepted that

Unknown:

and because we believe that these drugs have a therapeutic

Unknown:

role to play in the market, in the future, we accept some of

Unknown:

the deficiencies of of the of the study. So that that was a

Unknown:

little bit unsystematic. On the side of the FDA, I don't know

Unknown:

why they let it happen like that. We may hear from others

Unknown:

about the political stuff that happened in the background. And

Unknown:

just one of the things and then ongoing topic in psychedelic

Unknown:

research about is it psychotherapy, is it not

Unknown:

psychotherapy, how much psychotherapy, should we call it

Unknown:

psychotherapy. And maps have been Maps has been pretty

Unknown:

outspoken about it, but in a, again, European perspective away

Unknown:

that would be very unwise to do it in Germany, France,

Unknown:

Switzerland, some other European countries. They have under

Unknown:

defined their intervention, their psychotherapeutic

Unknown:

intervention and put in a bunch of ideas that emerged in the

Unknown:

1970s, which are not clearly defined and investigated. And so

Unknown:

they were opening up to all the criticism that then came out of

Unknown:

committee group without necessarily the need to do that.

Unknown:

So there were yours to be which they could have defined that

Unknown:

accompanying intervention much better. Everybody who knows some

Unknown:

of our papers, we, like our principal investigator get

Unknown:

Glinda. He just published first authored a paper in Lancet

Unknown:

psychiatry, with the title a psychedelic therapy is

Unknown:

psychotherapy. Now, of course, this is a very radical position

Unknown:

and others have contradicted but you on our side, opinionated,

Unknown:

certainly. We are more looking at the intersections of how can

Unknown:

we measure that what's happening I think what's what's happening

Unknown:

in psychedelic therapy has similarities to all kinds of

Unknown:

psycho therapies, and where are the exceptional effects. Instead

Unknown:

of saying it, there are two things, and we don't know how

Unknown:

they work together, which is actually a scientific. Lai is a

Unknown:

little bit too strong. But we have, we have 77 decades of data

Unknown:

on psychotherapy research that we can look at. And that we can

Unknown:

apply now. And it's happening more and more, I see more and

Unknown:

more study centers, applying, applying questionnaires and

Unknown:

concepts from psychotherapy research in Australia, in

Unknown:

Germany, in Spain, and also at the Johns Hopkins. So this could

Unknown:

have happened a little bit earlier. And defining the

Unknown:

therapy better is something that does the whole thing very well,

Unknown:

it

Unknown:

Bradley van Paridon: seems to me like this is exactly where a

Unknown:

comparative study comes in. Because if if you're comparing

Unknown:

to standard of care with a with a therapy that is, you know,

Unknown:

known, trusted by the community, by regulators, that kind of

Unknown:

thing, and all you're swapping out is, like you said, an

Unknown:

antidepressant versus the psilocybin treatment, that seems

Unknown:

like it would be a robust comparison as to what's going

Unknown:

on. Hopefully,

Unknown:

hopefully, we have very, very good feedback so far.

Unknown:

But it's also Admittedly, it's an expensive thing. And it's

Unknown:

something that takes a lot of resources and motivation on the

Unknown:

side of the study sites. And you need to you need to have people

Unknown:

in the study sites, then that are both trained

Unknown:

psychotherapists, and are open to the psychedelic substances.

Unknown:

And I mean, there has been kind of diffuse field, from again,

Unknown:

from, from our perspective, in the United States, where you

Unknown:

don't have such a, sometimes a little bit rigid system, like in

Unknown:

Germany, in Germany, the psychotherapy definitions are

Unknown:

very rigid, and what is reimbursed is, is a very well

Unknown:

defined in terms of psychotherapy, schools who have

Unknown:

hundreds of, of studies to, to apply with to the HTA

Unknown:

authorities to be reimbursed. And that kind of thing is not

Unknown:

present in the FDA regulatory space. So there are differences

Unknown:

between Europe and the United States. Okay.

Unknown:

Bradley van Paridon: And then I think this goes along with

Unknown:

defining the therapy a little better. And one of the things

Unknown:

you mentioned at the beginning of just, you have these

Unknown:

different sites, you know, doing these trials, and you kind of

Unknown:

trying to monitor them, but they have independence on you know,

Unknown:

they're not being monitored all the time. And I think we have to

Unknown:

bring up the safety concerns that were that were that were

Unknown:

brought up in the trial, as well, some allegations of abuse

Unknown:

during therapy, that kind of thing. And I think that these

Unknown:

kind of flow together that it's it's difficult to monitor all

Unknown:

these sites, you have to vet all these people, but also with an

Unknown:

undefined therapy. Some things like touch, comforting touch,

Unknown:

these sorts of concepts in therapy can lead to maybe this,

Unknown:

you're opening yourself up basically to to potential

Unknown:

mishaps. So is that a fair read on it? Or how do you view that,

Unknown:

that that situation, even

Unknown:

if we would think about our organization, which is a

Unknown:

small organization, to be able to monitor all the study centers

Unknown:

ourselves, we wouldn't do it, we would hire contract research

Unknown:

organization, particularly to have a second perspective and to

Unknown:

have somebody in the study, a process that has a lot of a lot

Unknown:

more experience than we do we have never done a study with 15

Unknown:

study centers. So theoretically, I can imagine that we could do

Unknown:

it, of course, we believe we have, we have trust in that

Unknown:

whatever we can talk to people but but trust is not enough. We

Unknown:

need to have these processes in place. That is one one thing.

Unknown:

And the other thing is the personalities of some of the

Unknown:

study therapists in maybe the maps trials also other trials.

Unknown:

We took we will take care and have taken care in the episode

Unknown:

study that overly enthusiastic psychedelic therapists or ex

Unknown:

underground therapists would not become part of the study teams.

Unknown:

There is there is a bias, big bias that is coming in there.

Unknown:

And I am not sure that there is a clear policy on the site of

Unknown:

Lycos Weiser clear policy on the site of Lycos maps there

Unknown:

Because, because it also from from so a Greek is very

Unknown:

outspoken about it. And this is also his, his his big magic, he

Unknown:

is very open. And he is he is very authentic in what he says.

Unknown:

And and he also believes a lot of the underground therapists

Unknown:

will become legal therapists. And I believe that this will

Unknown:

happen that that some people will transcend to the legal

Unknown:

space. But there are also some ideas and some, some attitudes

Unknown:

that we don't want to see in the legal space. So building

Unknown:

relationships with your patients that are based on on the

Unknown:

movement that we have seen in the 1970s, which is called anti

Unknown:

psychiatry. So instead of changing psychiatry to become

Unknown:

more humane, more open, less rigid, more psychotherapeutic

Unknown:

just work on the fact that patients the patient role, so

Unknown:

part of the anti psychiatry, psychiatry movement was

Unknown:

destroying the patient doctor role. So because some authors

Unknown:

thought this is in itself, unhealthy, or almost unethical,

Unknown:

and we need to go to a completely different

Unknown:

relationship, and then come people into the space who define

Unknown:

that relationship as Shaman. And somebody's looking for healing,

Unknown:

even even using unreflectively for term healing is at least

Unknown:

demanding. I mean, people project all kinds of religious

Unknown:

fantasies into it, and what does it do to the expectation of

Unknown:

clients? And what does it do to the relationship of therapist

Unknown:

and client. So this is a broad field, obviously, now, we don't

Unknown:

know how far you want to go into it. But but some of the, of the

Unknown:

founding ideas of psychedelic therapy in the 1960s and 70s,

Unknown:

particularly when they were legalized, or not viable in an

Unknown:

open multicultural, ScienceBase society, where we actually have

Unknown:

a dialogue on epistemologies and truth and if something works,

Unknown:

and we invite the patient to be able to go to a certain body if

Unknown:

she feels mistreated by a patient. So this all has to be

Unknown:

living in the therapist, too. And the patient's need to know

Unknown:

it, we sort of invite people into some pseudo modern

Unknown:

shamanistic relationship.

Unknown:

Bradley van Paridon: Yeah, I mean, I think you know, me that

Unknown:

that really speaks to me, and I agree with a lot of that, and,

Unknown:

but I think it is a, it's, it's a difficult, it's a difficult

Unknown:

process, it's like, you know, shedding shedding the old skin

Unknown:

and trying to trying to re work things for for a modern time.

Unknown:

But this maybe then brings us to just overall the hype

Unknown:

surrounding this, because I think, you know, with some of

Unknown:

the maybe some of the therapists, some of the

Unknown:

underground practitioners, let's say, people who were were in

Unknown:

this field, in the beginning, maybe when it was really

Unknown:

stigmatized, you know, or even then became illegal. There's

Unknown:

this defensiveness to it, like a, like a, we, we uncovered this

Unknown:

truth, and then the man tried to shut us down. So you know, like,

Unknown:

there's there can be a real evangelistic kind of attitude

Unknown:

towards it. And that's just one aspect of hype. There's also,

Unknown:

you know, hype for the participants that maybe see that

Unknown:

those attitudes, and then there's the expectation that,

Unknown:

you know, was brought up in the trials, and then how does this

Unknown:

hype affect the scrutiny that then gets put onto the field by

Unknown:

those who are looking at this and saying, Well, this just

Unknown:

looks so weird, this just looks so you know, it can't be right,

Unknown:

you know, that kind of thing. So that's a lot to throw at you

Unknown:

right there, those three angles of hype, I think, but how do we

Unknown:

then move forward? How do you think about it moving forward in

Unknown:

terms of having these conversations, like we're having

Unknown:

now or with the media or with skeptics, or with, you know,

Unknown:

true believers? How do we balance all of these ideas and

Unknown:

make sure that, you know, we're not throwing babies out with

Unknown:

bathwater, but also, you know, reflecting a safe modern

Unknown:

approach to all of this? Yeah.

Unknown:

Well, let me say first, that even true believers or

Unknown:

people who are over enthusiastic are not bad people. Yeah, of

Unknown:

course, we have been over enthusiastic in our lives, in

Unknown:

many ways. So, so, but we have to we have to definitely think

Unknown:

about how have built a system around disruptive pharmacology a

Unknown:

system. And I don't think that some of the ideas that I hear

Unknown:

when I go to psychedelic conferences, that we have to

Unknown:

break down the system and, and kind of create an archaic

Unknown:

situation where everybody heals herself himself. And people just

Unknown:

provide trip sitting to somebody else. This is profoundly naive

Unknown:

and misunderstanding, the nature of people who are deep into

Unknown:

mental health issues. So there's a spectrum, obviously, and we

Unknown:

cannot treat everybody the same. There are people who perfectly

Unknown:

can self administer psychedelics, and never take any

Unknown:

harm from it. But there are people who are severely into

Unknown:

suicidal and other severe mental health issues, and they need

Unknown:

somebody to really know who really knows what they do. So

Unknown:

how do we go on? Oh, first of all, we also see in Europe very

Unknown:

raised strongly the hype is kind of gone, investors and donors

Unknown:

are more looking at is this really doing something where I'm

Unknown:

supposed to invest or donate to. So more looking at good science.

Unknown:

So also with with foundations and organizations coming up in

Unknown:

Europe that are really looking at founding more basic research,

Unknown:

and various strict and good science, it's not a surprise,

Unknown:

I'm a scientist, of course, I'm advocating for science, but but

Unknown:

also from from the, from the viewpoint of a citizen from the

Unknown:

viewpoint of a person who philosophically thinks that a

Unknown:

pluralistic society that tries to be open, needs to have ways

Unknown:

of communicating truth, and debating truth with each other.

Unknown:

And it cannot be done on on the basis of cult of subjectivity.

Unknown:

So only judging the world from that would be a very radical

Unknown:

stance from your own subjective psychedelic experience. Somehow,

Unknown:

you need to go into that negotiation process with your

Unknown:

peers and with people from society. What is really true?

Unknown:

And should we build our relations to our children and to

Unknown:

our colleagues and and to our communities? On the basis of

Unknown:

that? And so why, why do I say that, because I think the hype

Unknown:

has a has a big operative gives us provides us with a big

Unknown:

opportunity to rethink again, to maybe consolidate the studies to

Unknown:

be a little bit more patient to talk to other funders who may

Unknown:

come in, after the hype, funders. So I'll own example,

Unknown:

just just to be clear what's happening over here, we are

Unknown:

running a clinic, the OB clinic, Berlin, and it took me one and a

Unknown:

half years to find a new group of people, do we first

Unknown:

investment round in the clinic that we needed, but we now found

Unknown:

wonderful people who have been following the whole hype circle,

Unknown:

or hype Phase II phase since 2014 15, and said, We're

Unknown:

waiting. Let's wait, let's wait, it's going to show are they

Unknown:

still present? Are the people here? Will this studies show any

Unknown:

results that are published in higher level mega high level

Unknown:

journals. And so we now find found, just in our case, a group

Unknown:

of people who came in late so this is an opportunity, this is

Unknown:

a chance also to have investor relationships that are not

Unknown:

illusionary where investors drive you to results on the

Unknown:

basis or based on on assumptions for where they think this is a

Unknown:

wonder drug. And the people that I'm funding are only speaking

Unknown:

some kind of strange scientific code, because society doesn't

Unknown:

understand the nature of the wonder drug. This is not how we

Unknown:

should go. It's not it's not this is not true. These are not

Unknown:

wonder drugs. We have had now about 500 patients in our clinic

Unknown:

and we see considerable improvements but we also failed

Unknown:

on many people. That's so clear. And if you're if you're really

Unknown:

looking at every day to day processes of therapy with

Unknown:

ketamine, or in the studies with five MEO and or psilocybin When

Unknown:

you fail a lot, and, of course, people are not just healed,

Unknown:

there are all kinds of intermediary results that you

Unknown:

get, and people want to go on, and you need to transfer them to

Unknown:

another doctor, or you need to transfer them to a clinic,

Unknown:

because through your therapy, they got the DS, D stabilized

Unknown:

and things like that. These are all realities that we can now

Unknown:

talk about after the hype.

Unknown:

Bradley van Paridon: So again, it's it's getting as much data

Unknown:

and presenting it as openly as possible, you know, and also,

Unknown:

and also talking about hype in a way. Yep, balance of hype, and

Unknown:

also talking, frankly, about

Unknown:

non clinical use, and how could we build a model in

Unknown:

our societies for non clinical use of these substances? That is

Unknown:

not the same as recreational use institutionalizing non clinical

Unknown:

use would do it, what would the studies be? So this is a little

Unknown:

bit further in the future. But if we need it, we should do

Unknown:

produce a data about that or begin to produce a data about

Unknown:

it. And I think we need it, there is a there is a case for

Unknown:

non clinical salutogenic and clinical and preventive use of

Unknown:

these substances. And that fits well into some of the needs of

Unknown:

patients after therapy. Now, and this is, this is the first

Unknown:

fascinating stuff that we can now begin to talk about. Yeah,

Unknown:

yeah, I'm, even before the first psychedelic has been approved.

Unknown:

Bradley van Paridon: Yeah, as you know, I think yeah, I also

Unknown:

agree with with that, that that mindset. And I think a lot of

Unknown:

what you said just in that, that answer there to be about

Unknown:

communicating truth and finding a way to, you know, a kind of

Unknown:

injury negotiation that applies to so much of what I feel is

Unknown:

going on in in our world right now outside of psychedelics,

Unknown:

politics, and just people in general. So I really enjoyed

Unknown:

hearing your your perspective on that. I have one more for you,

Unknown:

if it's alright, if we have time. And just a quick comment

Unknown:

maybe on this is the other part as me a biologist, that I'm

Unknown:

super fascinated when it comes to these psychedelics is

Unknown:

understanding more exactly how they're working in the brain,

Unknown:

right? Like these so called mechanistic studies, I just

Unknown:

covered one on the podcast about MDMA and empathy was an animal

Unknown:

study about does it increase empathy or not, you know, and I

Unknown:

thought that was really fascinating. So where do you see

Unknown:

basic research on how these things are working in the brain?

Unknown:

fitting into, you know, again, this sort of pushing for

Unknown:

acceptance approval? How will it help us, you know, to reach that

Unknown:

goal? And what is there still a disconnect in terms of okay,

Unknown:

brain chemicals are doing this, but what does that mean for the

Unknown:

subjective experience? Because I feel like that's always going to

Unknown:

be a tricky thing for us to manage.

Unknown:

Yeah. So scientifically, and

Unknown:

philosophically, it's very hard to bring these third person and

Unknown:

first person perspectives together. But this is exactly

Unknown:

where I see a lot of research should emerge in the future. I

Unknown:

see, I see no basic contradiction between a therapy

Unknown:

where we have a biological effect, which we do. And when we

Unknown:

have a psychotherapeutic effect, because psychotherapeutic

Unknown:

effects are also biologically managed, or biologically

Unknown:

mitigated, now, people have strange and strange things about

Unknown:

what psychotherapy is, but our behavior is biologically rooted,

Unknown:

and we we need to bring these perspectives together. So there

Unknown:

was a time between maybe 2002 1017 18 When it was already

Unknown:

enough to have some nice graphs about biological effects and and

Unknown:

maybe also systemic biology effects house brain centers,

Unknown:

communicate with each other. But we need to get we need to repeat

Unknown:

that stuff. We need to show the relevance of that stuff in, in a

Unknown:

mechanistic way. Yeah. Is it so for example, if it's true that

Unknown:

people get a get go through a phase where they where they

Unknown:

think less in a less rigid way? How is that upheld in the next

Unknown:

hours and days? How is the window of change learning window

Unknown:

being used canonbury to be used? So get much more down to the

Unknown:

also clinical behavioral side of these mechanistic effects?

Unknown:

That's how I would imagine it. But definitely, Brad, you're not

Unknown:

talking to a neuroscientist. You're talking to somebody who

Unknown:

is trained in psychotherapy who has has a medical psychology

Unknown:

background. So I am obviously more interested in the

Unknown:

intersection of these behavioral and clinical stuff and And the

Unknown:

biological effect. So let's look at these interactions would be

Unknown:

my, my obvious answer. Yeah.

Unknown:

Bradley van Paridon: And I think that that speaks to it. I mean,

Unknown:

this this is a lot of my wife is a neuroscientist, and this is a

Unknown:

big debate that goes on in a lot of that stuff. You can look at

Unknown:

just the brain and what's going on. But you have to relate it to

Unknown:

behavior in order for it to be meaningful enough to see how

Unknown:

that

Unknown:

yeah, and we'll have we'll have substances if if some

Unknown:

of the approval programs will succeed, we'll have substances

Unknown:

on the market where the provider claims it's basically a

Unknown:

biological effect. And we have very little other regulatory

Unknown:

stuff around it. And we have the opposites. These are healthy

Unknown:

models, and we'll then find out through monitoring them. When we

Unknown:

have to look at maybe we are overdoing it with psychotherapy,

Unknown:

and the others are right, or maybe it's just says patient

Unknown:

populations that go well with one approach and the others, not

Unknown:

we we should have should look at that in the future. Well,

Unknown:

Bradley van Paridon: great. Thank you so much for your time,

Unknown:

I always appreciate your very grounded open perspective on

Unknown:

these things. So when I saw the FDA decision, even though it's a

Unknown:

European American context, it's a bit different. I love to hear

Unknown:

what you've what you have to say very illuminating. As always,

Unknown:

thank you so much for taking the time. I really, really

Unknown:

appreciate it.

Unknown:

Thank you for your questions and for the

Unknown:

opportunity to speak here. Thank you

Unknown:

Bradley van Paridon: all right, many thanks to Henrik union

Unknown:

Burleigh and the mind foundation for for for coming on the show.

Unknown:

And please rate subscribe, review wherever you get your

Unknown:

podcasts. Check us out on YouTube on social media at to

Unknown:

Brad for you. Big thanks as always to the frequency for the

Unknown:

music special in the mood for the logo. Check the show notes

Unknown:

for all relevant reporting and articles that I use to to to

Unknown:

inform this episode. And for some of that research that

Unknown:

Henrik and his collaborators at mind and in Germany are doing

Unknown:

really great to really great to hear from you all please reach

Unknown:

out social media email at to grandview@gmail.com or add to

Unknown:

Brad's view on the socials. And and until next time, please have

Unknown:

a good summer. Enjoy yourself. Stay safe, and we'll see you

Unknown:

next time.

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