Bradley van Paridon: 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?
Unknown: Good morning. It's a pleasure to be with you, Brad.
It's it's good. I'm I'm fine. Excellent
Bradley van Paridon: 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,
Unknown: 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.
Bradley van Paridon: 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,
Unknown: 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,
Bradley van Paridon: 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
Unknown: 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?
Bradley van Paridon: 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.
Unknown: 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.
Bradley van Paridon: 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
Unknown: 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.
Bradley van Paridon: 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
Unknown: 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
Bradley van Paridon: 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.
Unknown: 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.
Bradley van Paridon: 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,
Unknown: 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.
Bradley van Paridon: 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
Unknown: 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,
Bradley van Paridon: and build the relationships with
participants that that, like you said that they are
Unknown: not trumping reporting truth and not dropping
Bradley van Paridon: 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.
Unknown: 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
Bradley van Paridon: 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,
Unknown: 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.
Bradley van Paridon: 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
Unknown: 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.
Bradley van Paridon: 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.
Unknown: 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.
Bradley van Paridon: 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
Unknown: 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.
Bradley van Paridon: 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.
Unknown: 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.
Bradley van Paridon: 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
Unknown: 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,
Bradley van Paridon: 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.
Unknown: Thank you for your questions and for the
opportunity to speak here. Thank you
Bradley van Paridon: 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
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Brad for you. Big thanks as always to the frequency for the
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