Why Are We So Easily Deceived About Psychedelics? Featuring Hamilton Morris

Is our time quickly becoming the era of “psychedelic McCarthyism”? If we’re not careful, that’s where it looks like we’re heading… In this episode of The Psychedelic Report, Dr. Dave Rabin sits down with Hamilton Morris for an in-depth discussion on the recent controversy surrounding MDMA-assisted therapy and the FDA's pivotal August 9th decision. Together, they address the backlash against MAPS/Lykos and how misinformation has fueled public skepticism and prevented this safe and powerful treatment from getting to millions of patients suffering from PTSD. 

Hamilton shares his experience from evaluation and investigation of the MDMA clinical trials and sheds light on the media's tendency to sensationalize allegations, including claims of misconduct during the trials. Hamilton and Dr Rabin emphasize the importance of relying on the scientific method, evidence-based data, and research, rather than sensationalized narratives, when assessing the safety and efficacy of MDMA-assisted therapy.

The conversation also explores the broader implications of the FDA's ruling and how the negative hype surrounding psychedelics has overshadowed their significant therapeutic benefits and is causing harm to patients in need. They call for a more balanced and responsible approach to discussing these therapies in both journalism and public discourse, advocating for truth and evidence over fear and speculation. 

This episode offers critical insights into the challenges facing psychedelic research today, highlighting the need for thoughtful engagement with the ongoing developments in this field.

• Instagram: https://www.instagram.com/hamiltonmorris/
• Hamilton’s Pharmacopeia: https://www.vicetv.com/en_us/show/hamiltons-pharmacopeia
• The Hamilton Morris Podcast: https://hamiltonmorris.buzzsprout.com/1870388
• Twitter: https://twitter.com/DrDavidRabin
• Instagram: https://www.instagram.com/drdavidrabin
• Web: https://www.drdave.io/

Episode Transcript

Speaker 1 (00:01):
The Psychedelic Reports.

Speaker 2 (00:03):
Psychedelic drugs have played their part in America's long strange
trip toward an understanding of mind.

Speaker 1 (00:09):
All during drugs The Psychedelic News, leading physicians, scientists, and
experts share their wisdom about psychedelic medicines and healing.

Speaker 3 (00:16):
Fifty years ago, psychedelic drugs were at the center of
America's counterculture.

Speaker 1 (00:21):
The brightest minds in psychedelic medicine the Psychedelic Report.

Speaker 3 (00:26):
We use the kedemy assisted psychotherapy model that happens to
have psychedelic effects that were not predicted when the drug
was first developed.

Speaker 1 (00:33):
From researchers to investors. I think the biggest mistake we
pat as the culture is the war of drugs.

Speaker 4 (00:38):
So physicians to shamans and non private pioneers psychedelic drugs.

Speaker 3 (00:43):
Recent research suggests some of them could have legitimate uses.

Speaker 1 (00:47):
The Psychedelic Needs bring you diverse perspectives from the front
lines of this exciting movement, The Psychedelic Report.

Speaker 3 (00:57):
The Psychedelic Report was brought to you by Apoll Neuroscience
and produced by Future Medicine Media. Welcome to the Psychedelic Report,
your single source of truth for the Psychedelic News. I'm
your host, doctor Dave Raven. I'm a neuroscientist and psychiatrist
trained in ketemine assisted psychotherapy as well as MBMA assisted therapy.

Speaker 2 (01:21):
Today, on this episode we bring on a special guest
who's been on the show before, and that's Hamilton Morris.
Hamilton was on The Psychedelic Report last in July of
twenty twenty three. Today, Hamilton and I dive into a
really interesting conversation as we always do, but from a
different perspective, which is really an attempt at answering the

(01:44):
question of why are we so easily deceived? And the
reason why I say it this way in particular is
because articles have come out in quite a few of
them since the FDA's decision on requiring more research on
MDMA assisted therapy, based from what they describe in large

(02:07):
part around safety concerns. And on October two, twenty twenty four,
an article by Jamie de Charme was published in Time
magazine discussing the risks of psychedelic medicine and that article
is called Safer Psychedelic Drugs May Be Coming. There has

(02:28):
been a big move to try to remove the psychedelic
experiences from psychedelic drugs and still continue to allow those
drugs to have some benefit to healing from mental illness.
It is still debatable whether that's possible. In many of
these publications, this one in time included, it is very

(02:51):
clear that the FDA's decision is being cited as evidence
that there is undue risk of psychedelic medicines even when
used properly, and that those risks are very significant. And
while as a psychiatrist, I will always tell you that
medicine has risk, it is risk that is not unique

(03:14):
to psychedelic medicine. Psychedelic medicine, like all medicines that we
use in mental health, have a specific toxicity profile, and
that toxicity profile for all medicines that we use, and
even including many psychedelic medicines that are not currently used,
have been studied at one time and their toxicity profile
as well understood, and the scientific evidence has shown across

(03:40):
at least dozens of very well done, peer viewed scientific
studies that psychedelic medicines like MDMA, as one example, because
that's what the FDA was just recently ruling on, is
safer than most other medicines that we use in mental
health health from a side effect profile, and when used properly,

(04:04):
the side effects are extremely manageable and do not last
after the fact. So because MDMA is also dosed only
three times over the course of twelve weeks, unlike an
SSRI like Prozac or zoloft, which are dose every day
and most other mental health medications in western psychiatry are

(04:25):
dosed every day, the side effect profile of these medicines
is actually much higher, and when compared to other drugs
of abuse, MDMA is still much safer, including drugs like
cocaine or opiates or benzodiazepines which are prescription and also
often drugs of abuse alcohol nicotine. These are all more

(04:47):
dangerous and more addictive and more heavily abused, and also
have a higher likelihood of causing death than MDMA, and
especially more than MDMA assisted therapy, which is extremely safe
and the evidence from the trials to date show that
it not only is it extremely safe, but it is
also extremely effective. And yet journals and publications like Time

(05:13):
magazine and The New York Times, I think the Wall
Street Journal and pretty much every other major publication has
been going back to an almost war on drugs narrative,
almost like a regressed narrative that perhaps these medicines, these substances,
these tools that have been used and studied for decades

(05:34):
are actually more dangerous than we thought, which couldn't be
further from the truth. And so we go to Hamilton Morris,
an American journalist, documentarian, and scientific researcher who is a
creator and director of the television series that many of
you have heard of because it's educated us on the

(05:57):
modern understanding of drugs called Hamilton's Pharmacopeia. In Hamilton's Pharmacopeia,
Hamilton Morris investigated the chemistry, history, and the cultural impact
of various psychoactive drugs for a number of years, and
he served as the correspondent and producer for Vice on
HBO until twenty twenty one. Hamilton is one of the

(06:19):
people who I turned to when I really want to
understand how chemistry works, and also when I want to
get the opinion of somebody who is really educated about
what's going on in the psychedelic world, in the medical
and scientific world, as well as in the underground. Hamilton

(06:39):
is a wealth of information. So I'm really excited to
share this conversation with you, Hamilton. It's always such a
pleasure to be able to have you on the show.
Thank you so much for joining me today.

Speaker 1 (06:52):
Thanks for having me.

Speaker 3 (06:54):
Yeah, it's my pleasure and always love our conversations and
really glad that you were able to make time to
come back on the show, especially given the state of
affairs of MBMA assistant therapy and the recent vote on
August ninth by the FDA that did not result in
clearance of MDMA assistant therapy for patients with PTSD, which

(07:16):
was I think based on most of our assertions and
folks who have our clinicians, researchers, people like yourself who
have been deep in the leads of the clinical research,
you know, following the papers for the last ten twenty
years and the research pathway and what's been going on.
This came as a huge surprise to many of us,

(07:37):
and I would love to start by just getting your
impressions and reaction to the vote and decision on August ninth.

Speaker 4 (07:46):
I was immensely disturbed by the vote. I was immensely
disturbed by the Advisory committee hearing. I've been disturbed by
the media coverage. I've been disturbed by the public discussion.
I've been disturbed by most of this and I know
that there was a period, maybe around twenty eighteen, where

(08:10):
the media coverage surrounding psychedelics became incredibly positive. One could
even argue that there was hype at play and that
the positive coverage was uncritically positive or exaggerated in some way.
And I think a lot of people started to assume
that that was the norm, and it was their responsibility

(08:32):
to be anti hype or to engage in critical psychedelia.
And I'm not against that. I think most people, at
least most people that I know that are interested in
psychedelics are not interested in them in such a way
that they need them to be good always or need
them to have no associated dangers. I don't think any responsible,

(08:55):
reasonable person who's interested in this domain wishes to hide
or or deny evidence that they have potential downsides or drawbacks,
or that they're inappropriate for some circumstances, both recreationally and clinically.

Speaker 1 (09:13):
So I thought this idea that.

Speaker 4 (09:15):
We need to fight against hype was a little overblown,
because most of the hype wasn't really that harmful to
begin with.

Speaker 1 (09:24):
You know, if the critique was.

Speaker 4 (09:26):
That, for example, Robin Carhart Harris's default mode network model
of psychedelic action was reductionist or something like that. Sure
it's fine to critique that, it's fine to examine the
validity of different models, but I don't think anyone who's
being substantially harmed by, you know, the way Michael Polland
interpreted Robin Harris's work or something like that. So that

(09:50):
was kind of what we were up against. Was at worst,
maybe a overly generous appraisal that was slightly sensation in
the positive direction, but really not that much. I mean,
I do really believe that these medicines have an enormous
amount to offer society in a variety of different ways.

(10:11):
But everyone became so critical during this so called hype
phase that the anti hype started to become louder and
stronger than the hype. And I think that both of
these positions are rarely informed by reason or evidence or logic.
For the majority of people, I think it's often about

(10:33):
this kind of hot take. Acxis like, is the what
makes me look smart, what makes me look like I'm
in the know. So if it makes you look smart
in the know to say, hey, you know, you thought
this MDMA stuff, this is a recreational drug that creates
holes in your brain and it's addictive. Well, wouldn't she
know it. That's not the case at all. In fact,

(10:55):
some brilliant scientists at prestigious universities their finding that this
is one of the most effective treatments for PTSD ever developed,
and it has this positive effect and that positive effect,
and this could revolutionize psychiatry. Right, So that makes you
look smart to say that. And then there's the flip
side where you can say, oh, you know these people,

(11:17):
they're just capitalists trying to create a monopoly selling snake oil,
and you know it's our responsibility to fight against this.
So I see people on every side making these arguments
that I feel are informed more by their desire to
look knowledgeable than to actually engage constructively with the evidence.

(11:40):
And when I saw this anti hype mounting, both in
the media and in public discussions, it alarmed me, in
part because I felt that anti hype is already the
status quo of our culture when it comes to psychedelics.
You know, people would would say like, Oh, no one's
talking about the harms, And all I could think is,

(12:03):
that's the only thing anyone ever talked about for for
fifty years, I mean, the idea of talking about the
benefits was unthinkable until recently.

Speaker 3 (12:14):
So you could get kicked out of your academic department
for talking about the evidence based benefits of psychedelic medicines
even twenty three years ago because it was so avant
garde and there was so much propaganda in the medical
space anti psychedelic propaganda.

Speaker 4 (12:30):
And even to this day, I mean, it's you know,
it's very common for the issue of whether or not
a researcher has used these drugs themselves to be dramatized
in one direction or another, where this idea that if
they'd used them, well, isn't doesn't that mean they're a
true believer that's biased in some way, or that they
should hide it and pretend that they've never used it,

(12:53):
because wouldn't it be terrible if people found out? And
when you think about this, it's just ridiculous in any
other domain, and with a clinician who's researching depression feel
afraid to admit that they've used SSRIs, No, they wouldn't
at all. In fact, they would probably, if anything, be
proud to say that because they would recognize that if

(13:14):
they were researching SSRIs, saying you know, and as a
person who's taken prozac on and off for ten years,
that that would give them a certain authority based on
their personal experience. Same thing with almost any other domain
of research. Right, would any you know, ethnomusicologist hesitate to
say that they'd listened to the music that they're studying

(13:35):
in different cultures because it might bias them in some way.
Of course not, it would be absurd. It would be
considered a prerequisite to have personal experience and understanding of
the domain that you're studying. So this is just another
example of something that is pretty inconsequential that's being sensationalized,
and everyone is kind of afraid to even talk about

(13:56):
it because of this legacy of fear surround this domain,
which is again comes back to why I think this
anti hype thing is really not a necessary force, because
it's already baked into our culture.

Speaker 3 (14:09):
Yeah, I couldn't agree more. And I think that that's
a major point to emphasize, is that if we're going
to describe the last four to five years of media
and public discourse around psychedelics as hype, which I think
is a general overstatement because most of it is really

(14:29):
just talking about the potential of these tools, which is
the first time that doctors, scientists, and experts have been
legitimized in being able to talk about and explore the
potential of these tools because they have been DEA schedule
on and still are preventing research, and because they have
been you know, aggressively anti hyped for so long fifty sixty,

(14:52):
seventy years, but especially aggressively since Nixon's you know, in
Reagan's laws in the seventies and eighties, like, we are
coming out of a legacy of ignorance about these substances
and the healing potential of these substances, to the point
where the legal policy today is, you know, the DEA
denoting that these are Schedule one drugs is stating effectively

(15:16):
that there is no medical or research purpose for these medicines. Meanwhile, opiates, cocaine,
and many other much more addictive, much more harmful substances
are actually Scheduled two and are able to be researched.
So we're really coming you know, in the psychedelic world.
I think it's important to note in a lot of ways,
we're coming out of the dark ages of not being

(15:36):
able to do large scale research easily not being able
to study these substances in patient populations easily to the
point where we finally thanks to you know, the work
of Maps and Rick and the team and many others
who have put forty years and hundreds of millions of
dollars into philanthropically, you know, funding this research. Despite all adversity,

(16:00):
they've finally given us this stage effectively to have this discourse,
to have this open conversation without everyone being so emotionally
charged about the propaganda and the false studies that came
out about NBA maybe making holes in your brain and
psychedelics being as dangerous as opious, which is clearly not true. Right,

(16:21):
And so I think that people who see what's happening
in the psychedelic media space over the last five years
prior to the June FBA Advisory Committee vote as over
hype or missing the majority of the discourse, which is
actually just people wanting to talk about this and talk
about the potential for you know, changing the way we
practice psychiatry, changing the way we treat our patients, and

(16:43):
really creating opportunities for healing the mental health many disorders
that are considered in the mental health epidemic to have
never been effectively treated before you're listening to the psychedelic report.
I think the other point that you made is really important.
That is a historical point that we've talked about a lot,
but most people forget, which is that in the history

(17:05):
of medicine, going back fifty to sixty seventy one hundred
years more than that, it was commonplace for doctors and
scientists to try the medicines that they developed. That was
standard course. People would try all the medicines, even just
once that they had developed, whether it's an antipsychotic or
an antidepressant or a psychedelic when they were first developed, right.

(17:29):
A lot of these effects that are known now about
psychedelics came from self experimentation and small group experimentation. Even antibiotics,
when they were first discovered and synthesized by Alexander Fleming
in the nineteen twenties, were experimented on themselves and other
people in small you know, small groups or individuals with infection.

(17:51):
Edward Jenner with a smallpox vaccine, right, tried it on
himself first treating cowpox.

Speaker 1 (17:56):
Right.

Speaker 3 (17:56):
So this is the history and legacy of medicine and
discouraging self experimentation, small group experimentation, and a safe environment.
To your point, I think is actually really destructive to
our advancement as a field for the good of our
patients and the good of our community. But one thing
that you mentioned that I think is really important to

(18:18):
talk that I want to circle back on, is when
you first started talking about the August ninth decision by
the FDA to deny clearance to MBMA assistant therapy despite
the preponderance of evidence from double blind, randomized facebo control
and trials that are at least as good as many
pharmaceutical companies trials big industry pharmaceutical companies that put their

(18:40):
drugs forward and get approval that have much greater risks
than MBMA assisted therapy delivered properly. You said you were
disturbed on a number of accounts, and I'm curious, could
you tell us a little bit about what is so
disturbing to you about this outcome and the interactions that
happened between the June FDA Advisory Committee vote and the

(19:01):
FDA decision on the ninth of August.

Speaker 4 (19:04):
Well, there had been a number of issues that MAPS
had to contend with in the years leading up to
this the main one being the abuse of one participant
in the Phase two trials, and that was something that
had really been I would go so far as to

(19:25):
say exploited in a way that wasn't really about protecting participants,
but trying to demonstrate that MAPS was dangerous. And I
predicted that that would be rehashed again. But what surprised
me was that there were a number of new allegations
that were made and I saw them as they were unfolding.

Speaker 1 (19:46):
So the first one was.

Speaker 4 (19:48):
That Niche Devno said that a MAPS therapist named Veronica
Gold had hinned down a patient while the patient screamed,
get your fucking hands off of me, but that Veronica
Gold would not stop. And when I heard that, I thought,
oh my god, that's as salt. That's a felony. That's

(20:10):
really serious. I mean you could even say it's false.
Imprisonment like that is a very very big deal to
do special, especially in the context of n fdhrial. Yeah,
it's a huge deal. So I thought, how on earth
did I not know about this? And why is this
the first time that this is being brought up? This
is extremely important and Niche had a citation for this claim.

Speaker 3 (20:33):
This is immediately niche of symposia.

Speaker 4 (20:38):
Yes, yes, she had a citation for this claim in
her presentation. So I immediately went to the citation to
see what it was that she was describing. And again,
immediately I saw that there was something a little bit off.
The first was that it wasn't MDMA psychotherapy in the account,
and this get your fucking hands off of me lyon

(21:01):
was not directed at the therapist but at the patient's
memory of their father, and so I thought, ooh, that's
not good. And then furthermore, there was no claim in
it about having pinned down the patient, which is really
the crux of this is the accusation of assault, and
it wasn't present at all. So you had something that

(21:22):
was not MDMA psychotherapy, not related to maps, being radically
misrepresented with the fabricated addition of a claim that the
therapist had assaulted their patient, and I thought, ooh, this
is really bad. This is a I mean, it's a
crime actually to lie to the FDA. The way that

(21:43):
that was done and it's being it wasn't a mistake.
This was being read from a script. Clearly if you
look at the video, this was prepared in advance. Then
more unusual claims emerged that Maps was a therapy cult,
which was another thing that I thought, that's a new angle.

Speaker 1 (22:00):
I haven't heard that one before.

Speaker 4 (22:01):
Maps has been around for quite a long time and many, many,
hundreds or thousands of people have interacted with Maps. You
would think that if they were a cult, someone would
have noticed by now.

Speaker 3 (22:15):
And so this was also published in an open letter
that Niche wrote to the FDA and then published openly
on subsac or something like that. Right, Yeah, And I
think it's also important to note that to your point,
Maps has been around for forty years. This is the
first allegation that anyone had ever heard of this, and

(22:36):
Niche herself and many of the other people who are
at symposia criticizing Maps now were actually Maps volunteers at
one point in the past for a short time.

Speaker 1 (22:46):
Yeah.

Speaker 4 (22:47):
Yeah, so this was a new one and also not
well supported. Then there was a lot of sophistry, a
lot of there's a lot of opinions, a lot of
things that are taken in a hyper literal way that
is just not really honest or constructive. It's like, you know,

(23:11):
people really love to harp on Rick making a comment
on I think just one occasion about wanting a world
with net zero trauma by twenty something.

Speaker 3 (23:21):
I think I might have been his ten talk even. Yeah,
but it was a very powerful comment. I remember to
try to like basically have real you know, the essence
of that commost had, like real trauma treatments available because
we're not doing anything about it right now, or just
like sweeping it under the rug and hoping that it's
going to solve itself.

Speaker 1 (23:38):
Right.

Speaker 4 (23:38):
And if you understand this comment as a hopeful aspiration,
there's nothing remotely bad about it. It's only when you
apply this hyper literal framework to everything that you can
deliberately misinterpret things to show that everybody is wicked and delusional.
And you know, it's just you see this sort of

(24:00):
thing all the time. Like there's a recent documentary about
Brian Eno that I was watching and he makes some
remark like I think if everyone in the world could
sing together and a choir, there would be world peace
or something like that, and you know, yeah, well, I
get what he's saying. Maybe it's true, but either way,
it's like it would it be a constructive response to say, like, exactly,
how is singing an a choir going to affect world peace.

(24:23):
I think that that's delusional and dangerous and reductive, and
how dare you?

Speaker 1 (24:27):
Like?

Speaker 4 (24:27):
It's just not a It's not a smart way to
respond to a statement like that, unless you're just trying
to prove that you're thinking is so rigid and literal
that you can't understand anything another person says anyway, So
there was a bit of that. Then there were just

(24:48):
a lot of comments that were superficially reasonable, but as
soon as you started to really think about them for
even a few seconds, you realized how decep if they were.
Like one that stood out to me was Brian Pace
made a comment at the end where he said, very dramatically.

Speaker 1 (25:08):
These harms will scale.

Speaker 4 (25:11):
And I was thinking about it and thinking, well, if
I had to guess, he's probably right, the harms probably
will scale. But crucially, there's something else that would also scale,
which would be the benefits, and the benefits outweigh the harms. Therefore,
the scaling of the harms is a necessary outcome of

(25:35):
the scaling of any real therapy that has both benefits
and harms. So it's just astically every single therapy, yeah,
every single therapy. Yeah, So whatever the case may be
whether it's ibuprofen or tail and al. There will be
some people that are harmed by using them, and the
more people that use them, the more those harms will scale.

(25:57):
But the benefits outweigh the harms. Therefore, it is socially
appropriate to allow the use of these medications. And this
is kind of the crucial dimension. I think this is
sort of emblematic of the thought process saying these harms
will scale and not looking at the bigger picture. It's

(26:17):
so myopically focused on harm that you don't think about.
First of all, you don't think about the harm that
comes from denying the benefit, which is another big harm.

Speaker 1 (26:27):
Right.

Speaker 4 (26:28):
There's a lot of people that could be experiencing this
therapy who will not have it, who are being harmed
as a result. That's a harm that no one at
symposia is talking about, of course, because they don't want
to acknowledge the benefits. So I think that there's a
lot of deceptive tactics at play that are dangerously reminiscent

(26:52):
of Macarthyism. I see this as psychedelic Maccarthyism. There's a
lot of fear that is being promoted, and I see
this all over the place.

Speaker 1 (27:03):
You know.

Speaker 4 (27:04):
I have a friend who I was talking to about this,
and he was saying, I see where you're coming from,
but you might want to be careful defending MAPS because
there might be some bad stuff that comes out about
them in the future, and you wouldn't want to be
defending them now if bad stuff were to come out
about them in the future. And he was saying this

(27:27):
to me in a friendly way. I understood what he
was saying when he said that, But this is a
very dangerous road to go down, because you have to
base your understanding of the world on evidence that exists.
So if I say that from everything that I've read
and everything that I've looked at, I do not see
evidence that the MAPS therapeutic protocol incentivized abuse, and then

(27:52):
later something comes out that shows that everyone was being
hypnotized and brainwashed to be use patients as much as possible.
Would I then have been a fool for saying what
I said that I don't think that their protocol incentivized abuse. No,
because I wouldn't have had access to that evidence. So
this is what I would encourage people to recognize is

(28:13):
not to allow people to frighten you by saying well,
what if what if something comes down the line that
shows this or that to be the case. Well, if
that happens, then any responsible person will respond accordingly and
change their opinion to suit the available evidence. But I

(28:34):
see a lot of this fear mongering, like when people
push back on Niche making the false claim about Veronica
Gold assaulting a patient. Again, a lot of these very
interesting deceptions were being used, where one was well, why
would you trust this woman's who's an abuser's account to

(28:54):
begin with? Well, they're trusting it when it comes to
framing it as abuse. So there's already a kind of
logical inconsistency there, and they're saying, oh, well, you know
we've got evidence, it's going to come out. Well, first
of all, if they have hidden evidence that a therapist
is assaulting patients, they should really prioritize getting that evidence

(29:16):
out there if they care about protecting patients. It's not
the kind of thing you want to hide. And I
would encourage anyone with that sort of evidence to come
forward and make it available so that people can use
it to inform their understanding of all of this. But
if they don't, if this evidence doesn't exist, then it

(29:36):
is totally unreasonable to try to frighten people into responding
on the basis of evidence that has never been presented exactly.

Speaker 3 (29:47):
And I think that's where I want to kind of
ground everybody in what evidence we actually do have today, right,
And I think you really do a great job of
summarizing and debunking some of the not evidence based hearsay
that has been propagated over the last several months through symposia,
the iSER group, which institute for what is it something Economic.

Speaker 1 (30:10):
Review but I don't remember either, Yeah.

Speaker 3 (30:12):
But iSER who only did all of their publications about
the potential harms of MDMA assisted therapy by citing symposia.
They didn't do any independent research. It was very clear
because symposia are articles, are all of their citations. And
these are the two pieces, in addition to the open
letters that Symposia wrote to the FDA that were primarily
influential from what we can tell, in the FDA's decision making,

(30:35):
because the FDA Advisory Committee and the FDA themselves were
approaching the study review and using terminology that was fed
to them about undue risk from symposia that was not
actually founded in the evidence. And you know, I've been trained.
I don't work with MAPS, I don't have any particular
allegiance to MAPS as an organization, but I am fascinated

(30:57):
by the incredible amount of scientific work they've done. And
I'm a scientist and a doctor, and so for me,
thinking about this is not about my personal relationship with
MAPS or anybody at MAPS, or my allegiance. It's about
what does the evidence say. And if you look at
the MDMA therapy protocol, which is public and has been
public for many many years on the MAP website, there

(31:19):
everything about the treatment is rooted in safety. Everything about
the treatment is rooted in safety. The entire basis of
the healing for how MDMA works in the MAPS protocol
is that MDMA is basically like molecularly amplifying safety in
the patient's body and brain to allow them to feel
safe enough to remake meaning around past traumatic events and

(31:42):
themselves and in relation to those events. And so safety
is the key. And there's nothing in that protocol, which
I've read many many times over and been trained in,
there's nothing in that protocol that incentivizes abuse. Everything's about consent.
Everything is about, you know, just providing a safe all
around spiritual, emotional, mental, physical, safe experience for the patient

(32:04):
and the person receiving care. So I think, first and foremost,
the allegations that the protocol incentivized abuse are completely unfounded
and there's zero evidence to support that. You're listening to
the Psychedelic report. The other piece is that we have multiple,
you know, nature large some of the best journals, most

(32:27):
reputable journals in the world, that have published this work,
and that have published the trial results from these map
space ory trials, which are if I'm not mistaken, I'm
pretty sure that some of the at least one of
those publications was cited in Science, which is the other
one of the other biggest, world's biggest and most reputable
scientific journals, as being one of the top one hundred

(32:49):
most important discoveries of our time of the last one
hundred years. Right, So this is acknowledged, and the results
are there. The evidence is there, and if you've done
deeper review like perhaps you have or I have than
most people into the results of these trials, everything was
reported as it.

Speaker 1 (33:07):
Was supposed to be.

Speaker 3 (33:07):
From what we can tell to the FDA, everything was disclosed,
if not more was disclosed than should have been. For instance,
functional blinding is not required. Unblinding is not required to
be disclosed to the FDA, but MAPS didn't because they
thought it was important to convey that information. But no
other pharmaceuticals that study mental health drug submit functional and
blinding data to the FDA because it actually can decrease

(33:30):
their chances of getting cleared. So maybe the overdisclosure was
one of the mistakes that MAPS made, but it wasn't
under disclosure.

Speaker 1 (33:39):
Yeah.

Speaker 4 (33:39):
Yeah, And I see that as a pattern where many
of the things that MAPS is getting criticized or are
actually instances of them having done the right thing. So
they weren't required to videotape those sessions, they weren't required
to have the male female therapist diad. These were all

(33:59):
things that were done out of concern for patient safety,
and when you look at some of these criticisms, they're
very odd. So, you know, there were three articles that
were retracted from the journal Psychopharmacology.

Speaker 1 (34:15):
With the claim being that.

Speaker 4 (34:18):
MAPS had not had included a participant in their data
set who had a sexual relationship with a therapist after
the conclusion of the therapy in the phase two trial.
In the phase two trial, yes, and so, first of all,
I'm not sure that I think it would have been

(34:40):
better if they had removed those data points. I could
see that being something that would be criticized as well, saying, oh,
so you're cherry picking your data so if something bad
happens to a participant, you just delete them from the
data set.

Speaker 1 (34:51):
Huh.

Speaker 4 (34:52):
I could easily see them being criticized for that. I
actually don't know. Maybe you do what is right in that.
I think disclosing it is obviously the right thing to do,
but I don't know about whether cutting them out of
the data set is the appropriate thing to do or not.

Speaker 3 (35:09):
That's a great thing to talk about because within I
believe seven to fourteen days after the August ninth decision
by the FDA to not clear MDMA assisted therapy, there
were I believe or two articles that have been published
on the Phase two trial, And just to make sure
everybody's up to speed here, the Phase two trial results

(35:32):
were not the focus of the FDA's consideration for clearance.
The Phase two trials had already been reviewed by the
FDA and published on years before the FDA on August
ninth was really supposed to be focused on the Phase
three trials. Which are much the larger, bigger trials that
were demonstrating safety and efficacy in the community with newly

(35:53):
trained therapists, under which case there were no reported abuses
from what we can tell. So in the Phase two
trial there were. What's really interesting about this is that
within seven to fourteen days after the FDA's decision on
August ninth, there were at least two papers that were
published on the Phase two trial. They were retracted from
the journal after being published years before. And what's really

(36:17):
surprising to me is is what you just brought up,
which is that what is what is the actual due
course here? Right? And typically my understanding of this is
from working in clinical trials and publishing is that and reviewing,
you know, as a reviewer of different for different journals publications,

(36:38):
if there was understood to be or or anticipated to
be a significant influence to the data set, that shifted it,
for example, into statistical significance from the people the subjects
who went through this trial site in Canada with the
abusive therapists, right, even though there was one abuse, but

(36:59):
there were a few people who ended up being treated
by those people in the context of the trial. The
first thing to do is to look at the data
set with those people in there, then take them out,
take out that whole study site, because we know that
that's the therapist at that study site. We're not acting
according to protocol, right, we have evidence of that, and
you take them out of the analysis, and then you

(37:21):
rerun the analysis without those subjects and their data in there,
and then you rerun and compare it to with And
what's interesting is if you actually look at that, which
my understanding is the lead authors are now working on
doing this and then resubmitting it, the results don't change, right,
So you can you can extract all the three or
four five people who are research subjects who went through

(37:44):
this particular research site in Canada. You pull them out
of the study results so that they're not included in
the analysis, which actually is the appropriate thing to do. Now,
once you know that they're not conducting the research ethically
and follow like they're conducting research infractions basically according to
FDA guidelines, you pull it out. If you relook at
the data, oh wow, look at the data, it's still

(38:05):
showing statistically significant improvement at all time points that were assessed, right,
So that would show you that despite this one case
of a study site not following protocol that the results
are still valid, right, And so I think that is
really the takeaway from this is that all treatments have risk,

(38:26):
and all treatments there are more people who die of
tilenol every year tilenyl overdoses every year in the United
States than MDMA. There are thirteen million estimated MDMA users
every year, right, So you think about that number of
people and then how many people are using talentol and
there are way way more people dying of tilenol use

(38:47):
and opiates especially than of MBMA. So it's really not
about risk, it's about relative risk. And when we think
about MDMA as a treatment, we also have to consider,
you know, and the risks of it. If we really
want to talk about the risk, it's we have to
understand that what is the alternative that Symposia is advocating

(39:11):
for here, right, that all the icer that these parties
that are opposing directly the clearance of MBMA to be
a legal medicine to address the epidemic of PTSD in
the United States that really heavily targets veterans and abused
and battered women. You know, these really vulnerable populations. What

(39:31):
happens when they don't get access to legal treatment of
this variety, they go to the underground, and the underground
has been the major source black market drug dealers. Underground
therapists have been who are not licensed therapists have been
the major source of Americans and we'll just talk about

(39:52):
America for now getting access to psychedelica sist therapy, and
what the legalization process that has been engaging with the
FDA on is to ensure that there are safeguards in
treatment when MDMA is administered, and currently that's not the case.

(40:12):
So it's actually directly the opposite of what Symposia is saying,
because the whole purpose of the MBMA assisted Therapy protocol
and making MDMA a legal, regulated medicine means that people
like me and all of the best licensed therapists in
the country who have a license to risk no longer
have to risk that license and can provide care when

(40:35):
if MDMA is decriminalized but not legalized through the FDA
and the DEA. The unfortunate side effect of that, and
what's going to happen now because the FDA did not
approve it, is that underground use of MDMA is going
to skyrocket, and most of that underground use is provided
by non safe, non trained or untrained, poorly trained, unlicensed providers.

(40:57):
So if we see that in fractions are possible with
trained providers, look at what can happen with unlicensed, untrained providers.
Of note, the only known issue that occurred in the
phase in the MDMA studies of an abuse occurred by
an unlicensed provider. When MDMA is still illegal as the

(41:19):
FDA has allowed it to be, who is going to
be providing care? It's not me. I can't legally provide
MBMA assist to therapy. I can lose my license. It's
a federally illegal drug still. But guess who can Joe
on the street, who had a few MDMA experiences of
his own and thinks he's a shaman, can now go
and tell you I can give you this care and
take advantage of you and abuse you because he has

(41:40):
no therapy training, has no idea what he's doing, and
it actually puts more people at risk to only provide
these medicines to the underground with no safeguards, and to
me as a clinician where my treatments are also entirely
focused on safety, as most clinicians are. It is astounding
that the FDA would prevent this from going through knowing

(42:02):
that this is currently being used in the underground and
with great risk, and knowing that if they don't approve it,
underground use is going to skyrocket. Right, it's actually increasing risk,
increasing the potential for damage done from these medicines, rather
than the opposite, which is putting the safeguards in place.

Speaker 4 (42:21):
Of course, yeah, I mean, it's all mind boggling when
you start to consider these factors. So underground, unregulated use
can also then further interfere with medical approval. I'm very
much in favor of anyone using whatever drugs however they want,
But the reality is we live in a very immature

(42:42):
society where if something bad happens, it will be used
as evidence that MDMA is intrinsically dangerous. They won't say, hey, look,
this happened in an underground treatment situation, maybe we should
rethink this and make it available to licensed practitioners. They're
going to say, this is why it's dangerous. So you're
creating a more dangerous framework that also interferes with the

(43:04):
introduction of a safer framework and Crucially, if somebody is
harmed in an underground setting, they have a very little recourse.

Speaker 1 (43:13):
What are you going to do?

Speaker 4 (43:14):
Realistically, that puts a huge amount of burden on the
patient because if they report the therapist to someone, they're
going to potentially go to prison. So you have to
deal with all of this legal baggage associated with how
do I even respond to something to a dangerous practice

(43:35):
if I see it being conducted. You really have no options, right,
what is going to happen if you go to the
police and you say, hey, my unlicensed to MDMA psychotherapist
spooned me during a session. It's just not going to
solve anyone's problems.

Speaker 3 (43:50):
Yeah, most of the time they'll do nothing.

Speaker 4 (43:52):
They'll do nothing, or they'll arrest the therapist and maybe
even pursue some kind of I mean, the whole thing
would be a mess. It would be a really bad situation,
Which is why having a review board and an associated
institutional body that can be reported to where patients can

(44:12):
make clinicians aware of whatever adverse outcomes they may experience
and the therapy can be tailored accordingly, is very important.
And I think this also looks at drug approval as
a sort of monolithic binary of like it's approved and
then that's it. But that's not the way things work.
There's post marketing surveillance, and it's actually routine. If let's

(44:37):
say worst case scenario, Let's say it turns out that
MVMA in fact is intrinsically dangerous and it creates an
epidemic of sexual abuse. Let's say that that happened. Obviously
I would bet a lot of money that it wouldn't.
But if it did happen, there's still a regulatory framework
in place to respond to that and withdraw it from

(45:00):
the market, which would happen.

Speaker 1 (45:01):
Right.

Speaker 4 (45:02):
It's not as if that would be the end and
we would all be condemned to a world where everyone
is being sexually abused by MDMA therapists. It would just
be taken off the market. And this happens all the time, right.

Speaker 1 (45:15):
You Know. There was a diet.

Speaker 4 (45:16):
Drug somewhat recently called lord casserin. There was a very
small number of people that got cancer and it appeared
that it may potentially be mildly carcinogenic, and the pharmaceutical
company voluntarily withdrew it because they didn't want to deal
with lawsuits and didn't want to sell a dangerous medication,

(45:38):
and that's all it took, right, is they did this
on their own. And there's going to be all sorts
of rems in place, there's going to be all sorts
of safeguards that are introduced, and if they don't work,
then the framework will be adjusted accordingly, as it always
has been. And the flip side is also that when

(46:01):
there are instances of a drug behaving a certain way
in clinical trials, both positive and negative, you don't really
know exactly how people are going to respond until larger
numbers of people begin using it, and then you can
make a more informed assessment. So saying it's too dangerous
to even try this, well, that's preventing a better understanding

(46:25):
of the benefits and the harms. Like this is how
we learn exactly how efficacious and safe an intervention is.
This was became a kind of big issue recently with
the Parkinson's treatment called PEMA answerin where there was some
preliminary evidence of increased mortality in the Parkinson's patient population,

(46:45):
and this was used as evidence that it shouldn't be approved,
And then there were patient advocacy groups that campaigned for
the approval and everyone, myself included, was a little wary, wondering,
you know, are they being pressured to approve this drug
for the wrong reasons. The drug approved and as it
turns out, is very very well tolerated, and if anything,
appears to have benefits that were greater than anticipated for

(47:10):
a number of patients with Parkinson's. So that's just you know,
that's just to say that for all of the what
if things are worse than we realize, there is also
the what if things are better than we realize or
things are as they currently appear. Both are very important
perspectives to acknowledge, and I think it's really tragic for anyone.

(47:33):
I mean, if you're someone that's skeptical of this therapy,
then this is how we learn more about it exactly.

Speaker 3 (47:40):
And we don't want to put obstructions in the way,
especially if we respect science and care about evidence backing
and supporting the decisions we're making, which I would say
most of our listeners and most of the people do
if you ask them. We need to create the fertile
ground to be able to let these plants grow and

(48:03):
blossom so we can see what they look like. Right,
we could see what they produce and right now that's
being obstructed like there's no soil or there's no water,
right and we can't even begin to explore what improvements
we could make because of all the outside influences in
bureaucracy that we've been spending decades to overcome. You're listening

(48:25):
to the Psychedelic Report. I want to move on to
a question I've been beaning to ask you for a while,
but I think just to get everybody kind of back
up to speed on the evidence that we are saying
is available today that is actually informing how we can
make decisions and understand this better. You know, what the
FDA's decision on August ninth is saying to everyone with

(48:49):
PTSD in the US who are currently being undertreated or
not adequately treated, which is over seventy percent of Americans
with PTSD are not receiving adequate treatment, and it's likely
more than that. What the FDA is actually saying by
denying approval of MDMA assistant therapy in this manner with

(49:09):
minimal explanation or justification around you know, and focusing on
these safety claims as they're saying that despite all the
evidence to support the MDMA assisted therapy delivered properly is safe,
which the evidence does support to date. That they believe
it's safer to continue to live a life with PTSD,

(49:30):
knowing the hospitalization rate, knowing the suicide rate, knowing the
failure rate of the medications and the high side effect
rates and the medications that most of these folks are taking,
knowing the community impact, the social impact of untreated PTSD.
They're saying it's safer to live with PTSD than it
is to receive MDMA assistant therapy from trained providers. And

(49:53):
that could not be more false. That is just a
completely false state, and that the FDA is as a sentiment,
is putting out by denying approval. And to put this
in context, this would never happen and never does happen
in a non psychedelic medical space. It's unprecedented. If you

(50:14):
look at surgery as one example, right, surgery has known risks.
It has known risks like death, infection, tons of other issues.
You can cut nerves by accident, right, There's all these
different problems that can arise that are expected as a
result of undergoing surgery. It's something that all doctors and
surgeons a supposed to communicate to their patients, this is

(50:35):
what could happen and what does happen to a certain
percentage of people. Same with anesthesia. When you get put
under for surgery, there are certain risks you'd get dementia
when you come out, you might not be the same
when you come out. Doesn't happen that commonly, but it
does happen. It happened to my uncle. Right, people have
these kinds of things happen even with safe medications and
safe administration that's been tried and true or thought to

(50:57):
be tried and true. If you set aside the normal
risks of surgery and anesthesia, which are significant in and
of themselves, like dire like life ending potential risks or
life changing morbidity and disability that could be caused by
normal surgical conduct, and then you introduce the concept that, oh,

(51:17):
by the way, there's an estimated four thousand surgical errors
every year that happen, which is not counting the abuses
that surgeons are. Not all surgeons, of course, but a
few surgeons are known to have perpetrated against patients that
are under anesthesia who can't defend themselves in an ultimate vulnerability. Right,

(51:39):
you take out the abuse, the sexual abuse, the physical abuse,
all those things, and you just focus on people making
mistakes that were not predicted, preventable errors. We're talking like
four thousand at least nationwide every year, right The consequence
of one of those preventable errors could be death. This

(52:00):
is not a consequence we're talking about with MDMA. There
were no death consequences of MBMA. This is not one
of the issues that we're talking about. And yet surgery
is approved. Surgery is allowed, it is cleared, it is available,
it's regulated. And the reason why surgery and all medical
practices that have a risk that require administration of a

(52:21):
doctor or a clinician to administer are allowed to continue
is not because of the FDA. It's because there are
these other organizations called medical boards that regulate the practice
once it's in the community, once it's been disseminated. The
medical boards regulate the practice and discipline people who have

(52:44):
one or multiple reported violations so that there are actual consequences,
meaning that if you have multiple infractions as a surgeon
or a doctor that have been reported, you can actually
lose your ability to practice medicine. There's a real consequence
there that's losing your life livelihood that you spend decades
training how to do. That's a real consequence. That consequence

(53:06):
does not exist in the underground. In the underground, could
some people potentially be jailed for abusing patients by administering psychedelics, sure,
but that is ultimately not what happens most of the time.
What happens most of the time is all of the
abuses that occur in the underground space go unreported because
people are embarrassed to talk about them and there's no

(53:28):
disciplinary body to actually do anything about it other than
traditional law enforcement, and interactions with traditional law enforcement can
be re traumatizing in and of themselves, so people tend
to avoid reporting these abuses and fractions in the underground,
and so they're just allowed to propagate because there's no
disciplinary body to step in. And so that's kind of

(53:49):
where things are today. Just to kind of like in
terms of across the field of medicine, that's really really
important to understand, and if you're not a practitioner in medicine,
most people don't necessarily understand the risks they take when
they go undergo anesthesia or surgery, and that the risks
of MBMA assistant therapy are actually significantly lower, which is great.

(54:09):
That's the way many of us thought the FDA would
be looking at this. And yet you described earlier use
this word deception, and I really want to ask you,
do you think or do you believe from what you've
seen that the FDA was actually deceived in this vote
that resulted in not approving MBMA assisted therapy. In this context, I.

Speaker 4 (54:34):
Know that they were being exposed to false information.

Speaker 1 (54:38):
That's what I can.

Speaker 4 (54:40):
Say based on the fact that if you look at
the Advisory Committee hearing, there are instances of completely fabricated
claims being presented, as well as traumatic misrepresentation of information
with the explicit goal of manipulating regularly. So there's no

(55:01):
question that they were exposed to that that they were intimidated.
I mean, the very public commentary period was odd in
that I think there were twenty people who were selected
in a lottery to comment, and five of them were
Symposia affiliates, So that's pretty remarkable. And I assume that

(55:24):
they simply don't know. I mean, most people in the
psychedelic world don't know all of this internal drama. They
don't know exactly what's going on. You have to be
pretty immersed in this, which clearly these people were not.
And it would be very easy if you didn't know
the history, to think, oh, these are just some concerned

(55:44):
academics who really care about patient safety or something like that.
But I think it's very clear that they were being
pressured in a lot of ways that could have influenced
the decision, and earlier when we were talking about the
kind of you know, the potential for harm. I also

(56:06):
think it's worth mentioning that even though this is technically
speaking an experimental intervention, the risk profile of MDMA is
extremely well known. This is a drug that's been used
by probably over ten million people, and even under the
most dangerous imaginable circumstances, it tends to be pretty safe.

(56:27):
Used in a completely unregulated environment, used where people don't
understand the dose or purity or even identity, Even under
those circumstances, it tends to be pretty well tolerated. So
the idea that this would be unacceptably dangerous under the
safest imaginable conditions is bizarre in and of itself.

Speaker 3 (56:48):
Yeah, I would tend to agree, and I think one
of the things that we've been reporting on here that's
really interesting is the falsified reports from group like Symposia
Niche and iSER that were presented to the FDA prior
to June. It was June eleventh initial Advisory Committee vote

(57:11):
expressing that there are way number one, there are way
more risks than you know that are being that are
not being reported. At number two, you shouldn't trust maps
because they're under reporting the risks, both of which were falsified.
And the FDA is a is a governmental organization, they
are inherently risk averse, and their entire decision about medicines

(57:34):
getting approved or cleared is around or technology is around
safety first and efficacy second. And so part of what
is so surprising to me about this situation, which I
would get the sense of surprising to you as well,
is that is how easily people were deceived and manipulated
by these falsified claims. Rather than saying, oh, this is interesting,

(57:55):
I'm really surprised to hear that people are starting to
bring this kind of commentary forth because it was new
as of like twenty twenty three, Like we didn't really
have early twenty four, nobody was really talking about these
overstating these abuse issues and all this kind of stuff,
and then all of a sudden it starts to generate
a huge media outpouring through the symposia and ICER paths

(58:17):
that they were taking to pass on this information. You know,
it's a really unprecedented situation in the history of medicine
that there is a group of people suffering with PTSD
in need. Many of them are veterans and abused and
battered women who desperately need care, who have two times
if not more, the suicide rate of the average American,

(58:38):
which is tragic and avoidable, and they have no available
treatments to actually solve their problem at work. And yet
there's a group, an outside group or two groups if
we're talking about ICER and symposia, that are actively working
to oppose access to a novel treatment that actually has

(58:59):
evidence to work to these vulnerable populations that are suffering.
And I've never seen that from my studies of the
history of medicine. Typically it's actually there are radical groups
of patients patient advocacy groups that are lobbying the FDA
heavily to get treatments through. But I've never seen the opposite,
where there are groups opposing treatments to the detriment of

(59:22):
those in need, and also publishing publicly on social media
at ted in these different areas that they are proud
of themselves for doing so and see themselves as heroes
protecting people, which is exactly the opposite of what's actually happening.
So there seems to be some delusional character here in
terms of the way these folks are thinking about this.
But why do you think people are so easily deceived?

(59:43):
Not just the FDA getting just using the language of
symposia and what was fed to them in these letters,
but also the general public. Right, the general public is
starting and the media are starting to adopt this narrative
that MBMA is not safe and the FDA is legitimate
and their decision and all these things, and it's just
a big echo chamber of repeating the same stuff that
the FDA said. But the FDA is clearly being influenced

(01:00:06):
by outside forces that are deceiving based on false, fied
information that is not cited from real sources. So, you know,
why do you think people are so easily deceived in
this situation when everybody was so excited about the forty
years of work bringing this over the line?

Speaker 4 (01:00:23):
Yes, switch right, Yeah, And I think that both of
us have a certain privilege as a result of having
thought about this so much. And when you've spent so
much time reading about this area, it's easy to have
a defined perspective because you know all of the contours

(01:00:44):
of the case. So for me to understand it, I
think it's most helpful for me to look to the
way I respond to things I don't know very much about.
And one example that comes to mind would be COVID
lab league stuff. Right, So I just don't know enough
about viral genetics and the politics of the Wuhan Institute

(01:01:05):
of Virology to have an informed take on this. So
sometimes some I'll read an article written by somebody and
they'll say, I mean, oh, just look at the fear
in cleavage site and look at this amino acid, and
isn't it obvious this is a clear signature of some
kind of genetic manipulation.

Speaker 1 (01:01:22):
And I'll think, oh, wow, I was such a fool.

Speaker 4 (01:01:25):
For believing the government media narrative that this came from
this wet market in Wuhan. How could I be so
easily deceived? Then someone else will make an equally compelling
argument saying, what is with these ridiculous conspiracy theorists.

Speaker 1 (01:01:40):
This is all made.

Speaker 4 (01:01:40):
These people have no idea what they're talking about. The
evidence clearly supports a natural zoonotic origin whatever. And then
I'll think, oh my god, I'm a crazy conspiracy theorist.

Speaker 1 (01:01:50):
How did I get convinced? And I go back and forth.

Speaker 4 (01:01:52):
And the reason that I'm like that is because I
don't really know. I don't know enough, because I'm not
a virologist and I'm not an epidemiologist, and I don't
have the tool set to make a truly informed assessment.
So I can be very easily swayed in one direction
or another if somebody who seems authoritative makes a compelling case.

(01:02:16):
And I think this is the same position that a
lot of people are in with MDMA, where someone will say,
look at the results of this trial, this is maybe
the most effective treatment for PTSD that's ever been developed,
and they'll think, Wow, that's amazing. And then someone else
will say, but they're suppressing negative results, and they're manipulating
the data, and they're incentivizing abuse of patients, and this

(01:02:40):
is aults and they're a cult. And then that same
person will say, oh my god, how is I so
stupid to buy into the monopolistic lies of this big
pharma company, you know. And so I think this is
really the issue is that the majority of people, even
ones who are aware of this area, are not full

(01:03:00):
immersed in it, and for that reason, they're easily swayed
in one direction or another. And the amount of research
required to navigate even the simplest aspects of this is
not insignificant. Like if we were to just even drill
into this question that we were talking about earlier, about

(01:03:21):
the psychopharmacology retractions, you need to first create a timeline
of events to even begin to assess the timing of
all of this. So if you have if the idea
is that they suppressed information, well you have to make
a timeline of what maps knew and when they knew it.
And that in and of itself is a complicated issue

(01:03:43):
because at the time of the data submission they were
aware that a trial participant had had an extra therapeutic
sexual relationship with a therapist. They were not aware of
any misconduct in the trial because it hadn't been reported
so at the time that they were submitting their data.
This idea that a patient had been mistreated in the

(01:04:06):
therapy during phase two was not available or hadn't been
presented to them. That didn't come until over three years later.
So that's another important thing to acknowledge, is that it's
easy to retrospectively look back at what we know now
and say, how could they have submitted this data. Well,

(01:04:27):
they didn't have this complaint that actually was not formally
made to Maps. They were only aware that there had
been a sexual relationship, now that a therapist had spooned patient.
So these are and then, as we were saying earlier,
then there's a question of is it more or less
ethical to remove a data point like that from a

(01:04:48):
data set? And you know, what is the appropriate intervention?
Is it that you make a correction or put a
note on the publication? And are we even sure that
the editors weren't aware? I mean, and that's often the case,
is like I would see people saying these things like, oh,
Maps really fucked up with their trial design.

Speaker 1 (01:05:06):
How could they do this?

Speaker 4 (01:05:07):
Well, they had approved it with the FDA, and the
FDA moved the goalposts, So.

Speaker 1 (01:05:13):
It's not that they fucked up with their trial design.

Speaker 4 (01:05:15):
It's that there was an inconsistency in the expectations that
was really on the FDA more than maps. So again,
these are the point really here is that this stuff
is complicated, and if you're not making a serious effort
to review all of the evidence and the timing of

(01:05:38):
that evidence and when it emerged, it's very hard to
produce an accurate picture of events and how we got
to this current place.

Speaker 3 (01:05:49):
Yeah. Absolutely, And to that point, if you're the kind
of person who's listening to this and you're you know,
reading what's coming out of IER and symposia and the FDA,
you know, I think what we would encourage you to
do is to not take that at face value, but
to take it as one data point, right, and then
to go back and look at everything else. Go back
and review the clinical trials, go back that are published

(01:06:13):
and available, Go back and review the MAPS protocol itself
published and available on their website, and go back and
douce do some research, like actually look into this and
find other data points to support what it is that
is actually happening, so you can build a framework for
yourself to understand the landscape. Because, as you said, Hamilton,

(01:06:34):
this is complicated, right. None of this stuff is as
simple as it might appear on the surface. It's certainly
not one sided. Every medicine has risks. The real question
is are those risks being blown out of the water
and over emphasized by certain parties who have a vested
interest in MDMA not becoming a legal medicine for the
people who are in need. And that's what actually seems

(01:06:57):
to be happening, especially from the standpoint of folks who
have reviewed all the evidence. It really, you know, the
reports from Symposia iSER and the FDA's decision really seem
to be unfounded and highly misguided and not in the
best interest of patients in the slightest And so we
are wrapping up on time for today, and I really

(01:07:18):
just wanted to thank you so much for taking the
time out to have this insightful conversation with me and
enlighten our listeners to you know, what's going on in
the space around this, because again, it's very complicated and
it needs more understanding and more light shed on it.
But I think, you know, I also want to end
with something hopeful, which is that I don't think there's

(01:07:41):
any question in many of our minds that MBMA will
not be approved for PTSD at some point, you know,
the FDA did not say no, this is denied. They
said we want to see more information, and what they're
going to require to see may take years, but is
going to happen. It's going to get through Aly. The
results from the trials are so profound compared to the

(01:08:03):
treatments we currently have available with just three doses of
medicine rather than medicine every single day, and with way
fewer side effects in our current medicines and way better
success rates, that this is going to get approved and
become available at some point. We're just trying to figure
out the when and the how, and so that's the
good news is it will eventually come through. The bad

(01:08:25):
news is we're not sure when and how that's going
to happen.

Speaker 1 (01:08:28):
But there's a lot of.

Speaker 3 (01:08:29):
Great people working on it, so you being one of them,
And thank you so much for your time today. I
really appreciate it.

Speaker 4 (01:08:35):
Oh yeah, thank you, and I hope this is constructive
for listeners.

Speaker 3 (01:08:40):
Thanks for listening to The Psychedelic Report. Visit us at
the Psychedelic Report dot com. This show is recorded weekly
on Clubhouse with a live audience. The Psychedelic Report was
brought to you by a poly Neuroscience and produced by
Future Medicine Media. While I am a doctor, I'm not

(01:09:02):
your doctor, So please don't take anything you hear on
The Psychedelic Report as personal medical advice because we don't
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