August 28, 2024 • 40 mins
In this episode, Dr. Dave Rabin discusses the impact of the FDA's decision, the potential delays in accessing this crucial treatment, and the unethical behavior of certain organizations influencing the FDA. Dr. Rabin is joined by Jon Lubecky, a retired army sergeant and Veteran who took part in MAPS MDMA therapy trials, as he discusses the implications of this rejection and emphasizes the need for ongoing advocacy and hope for eventual approval. The episode also addresses the unethical behavior of Symposia, an organization accused of falsifying information to the FDA to obstruct MDMA therapy approval. Additionally, former Symposia member David Nichols reveals serious ethical violations within the organization, raising questions about their motives and funding. Through these discussions, the episode highlights the critical need for transparency, ethical practices, and continued efforts to ensure access to psychedelic treatments for those in need.
Rachel Nuwer’s Scientific American Article: https://www.scientificamerican.com/article/fdas-rejection-of-mdma-psychotherapy-for-trauma-draws-criticism-from/
Jon Lubecky’s Conversation with David Nickles on Breaking Points: https://www.youtube.com/watch?v=lttFB0c0cAo
Rachel Nuwer’s Scientific American Article: https://www.scientificamerican.com/article/fdas-rejection-of-mdma-psychotherapy-for-trauma-draws-criticism-from/
Jon Lubecky’s Conversation with David Nickles on Breaking Points: https://www.youtube.com/watch?v=lttFB0c0cAo
- Web: https://psychedelic.support/
- Twitter: https://twitter.com/DrDavidRabin
- Instagram: https://www.instagram.com/drdavidrabin
- Web: https://www.drdave.io/
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Episode Transcript
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Speaker 1 (00:01):
The Psychedelic Reports. Psychedelic drugs have played their part in
America's long strange trip toward an understanding of mind. All
during drugs The Psychedelic News.
Speaker 2 (00:11):
Leading physicians, scientists, and experts share their wisdom about psychedelic
medicines and healing. Fifty years ago, psychedelic drugs were at
the center of America's counterculture. The brightest minds in psychedelic
medicine the Psychedelic Report.
Speaker 1 (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 2 (00:33):
From researchers to investors. I think the biggest mistake we
pat as the culture is the war of drugs.
Speaker 1 (00:38):
So physicians to shamans and non private pioneers psychedelic drugs.
Speaker 2 (00:43):
Recent research suggests some of them could have legitimate uses.
The Psychedelic Needs bring you diverse perspectives from the front
lines of this exciting movement, The Psychedelic Report.
Speaker 1 (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 MDMA assisted therapy.
(01:22):
Today we discussed the disappointing FDA decision to reject MDMA
assisted therapy for approval for treating PTSD on August ninth,
twenty twenty four. This was a very surprising decision from
the FDA, given the preponderance of evidence to support MDMA
assisted therapy as the best available treatment for PTSD and
(01:44):
perhaps the most effective treatment ever developed for any mental
illness since the NIMH, the National Institutes of Mental Health,
was founded in nineteen forty nine to treat PTSD. We
have seen endless challenges in this forty year path of
MDMA assisted therapy to get from a poorly understood street
drug all the way through to the FDA's desk, with
(02:05):
substantial double blind, randomized, placebo controlled trials demonstrating safety and effectiveness.
This has been no small undertaking and the results being
so good akin to the discovery of antibiotics to treat
infections by Alexander Fleming in the early twentieth century, make
the FDA's denial even more bizarre. As a result, the
(02:27):
FDA decision on August ninth has drawn quite a bit
of criticism from experts in the psychedelic space, as well
as clinicians and researchers leading the charge to address the
unruly public health epidemic of mental illness. Rachel Knuher describes
this in her August thirteenth article and Scientific American entitled
FDA's rejection of MDMA psychotherapy for trauma draws criticism from
(02:51):
psychedelic experts, which we highly recommend you check out, and
we've linked it here for you in the show notes.
Since August ninth, there has been a lot of opennesscussion
about what this decision by the FDA means and what
was motivating it, because it certainly wasn't based in scientific
evidence from what this doctor can tell. This left a
lot of open questions for us to answer, like what
(03:14):
is the outcome of this decision, what are the next steps?
And how long is it going to take MDMA therapy
to get to the people who need it most, the
tens of millions of Americans suffering from PTSD who are
at the highest risk of suicide. Following the August ninth
FDA decision. Breaking Points hosted a conversation between John Lubecky
(03:35):
and David Nichols, formerly of Symposia, about what was motivating
the FDA decision. David Nichols, representing himself and in part
Symposia as a former leading member, was directly involved in
this construction of the false narrative that communicated fabricated safety
concerns not based in evidence or reality about the MAPS
(03:58):
MDMA trials to the At the end of this conversation,
he calls out Symposia for conducting ethical violations and cited
this as the reason why he defected from the organization.
Nichols was not specific about what those ethical violations that
Symposia were, but we can only guess given what they've
been falsifying in the reports to the FDA about the
(04:21):
MAPS trials. This is a very important moment to understand
in terms of the unprecedented nature of what MBMA Assistant
Therapy has had to go through to get to the
FDA's desk, and the disruption caused by the falsification of
information by Symposia to the FDA, which was cited by
Isiser the Institute for Clinical and Economic Review, who was
(04:44):
also manipulated by false information provided by Nichols and the
Symposia team. It is now very clear from the public
comments from folks and leadership at Symposia about how happy
they were when they were able to prevent MDMA assisted
THEIRS therapy from becoming available and legal as a treatment.
The Symposia team has also communicated publicly how excited they
(05:07):
are that the FDA, an objective government organization that is
responsible for protecting Americans, was able to be manipulated by
their tactics to act against the best interests of Americans
and act in their own best interests to protect what
they perceived as risk to them the FDA if they
approved MBMA assisted therapy. To this doctor's knowledge, this situation
(05:31):
of a radical extremist outside group like Symposia with no
experienced doctors or researchers on their staff preventing a safe
and effective treatment, as proven by rigorous, double blind, randomized
placebo controlled trials, from being approved and made available to
millions of patients in need, has never happened before and
sets a frightening precedent for the future of healthcare in America.
(05:56):
If a radical extremist group with no medical expertise can
prevent a treatment as incredible and revolutionary as MBMA assisted
therapy for PTSD from getting FDA approval? What will stop
similar organizations from doing the same for cancer treatments, autoimmune
disorder treatments, diabetes, you name it. I had a lot
(06:16):
of questions that I wanted to have answered about what
is actually going on, so I brought back John le Becky.
John le Becky is a retired Army sergeant and veteran
and former participant in the MAPS MDMA assistant Therapy trials.
John is one of many real life examples of the
truly life saving benefits of MDMA assisted therapy delivered via
(06:37):
the MAPS protocol. As a twelve year retiree of the
US Armed Forces, John worked with MAPS in the past
to help facilitate education of the federal government and military
decision makers on MDMA assisted therapy and why this is
such an important treatment that is game changing for Americans. Currently,
John spends much of his time providing public service to
(06:59):
the in war torn areas in the Ukraine. John, thank
you so much for joining us. It's always such a
pleasure to have you on the show.
Speaker 2 (07:07):
It's great for you to have me back on There's
been a lot that's been going on the past few weeks,
and hopefully we're gonna have a great discussion.
Speaker 1 (07:15):
Yeah, we always do, and I'm glad to have you back.
You have expertise in this area and familiarity beyond most
people I know, just given where and how you've worked
in the space as a veteran and having worked closely
with government on MDMA moving forward and education about this
important clinical tool for PTSD. And on August ninth, as
(07:40):
most people now know, the FDA declined approval clearance for
MBMA assistant therapy for PTSD, which was a real surprise
to most of us in the space who are clinicians
and scientists and researchers, and also a surprise I think
to a lot of veterans and people who were being
(08:00):
this as one of the best opportunities for treatment that
we've had since the founding of the NIMH in nineteen
forty nine to treat shell shock now known as PTSD.
So can we start by you just giving us a
little bit of an understanding of what happened on August
ninth and the impact of that vote so far.
Speaker 2 (08:20):
So I do want to clear some things up. They
did not say no, this is over, go home, pack
your bags. They are not requiring new Face one or
Face two trials. We actually until Licos Therapeutics, which is
currently either already has or in the very near future,
will be requesting a meeting with the FDA for clarification
(08:42):
and reconsideration. Now part of that meeting is they get
a big letter, but not everything's in the letter, and
so the meeting will allow MICOS to sit down and
ask questions, get very specific on things. But what the
FDA said is we require more research. Is what the answer,
frankly has been for the past twenty years. Every second
(09:04):
of research gets us closer to the end goal. This
is not over, not by a long shot. The momentum
is building and as I've been saying, and I believe
I said this after the ad COM when we talked,
this will be approved one day. And this is where
I want to take a minute. This was devastating, not
just to the veteran community, this was devastating to everyone
(09:28):
who saw this as a ray of hope. You know,
I try to be as clear as I can. While yes,
I have been cured of PTSD and can very much
demonstrate that this doesn't work for everyone. There are people
that you know. Even in the LECOS data, thirty percent
of people did not go into remission. But it's a
(09:49):
ray of hope because seventy percent did. And so it
wasn't just veterans, it was sexual assault survivors, domestic violence survivors.
You know, as a twelve year old kid who has
PTSD because they live in an abusive household and one
of their parents suffers from addiction, who's hoping that when
(10:10):
they turn eighteen they can make the nightmares go away.
And this is why I think it's critically important for
everyone to realize this isn't the end of the road.
There is always hope this will be approved, and it
really sucks that the people who suffer from PTSD are
(10:30):
delayed yet again. But I'm not going anywhere. I'm going
to continue to fight until you know psychedelic assistant therapy
is approved by the FDA and available in the VA
through health insurance, through Medicaid, through Medicare, through all the
ways we pay for health coverage, and that there's programs
for people who don't have health insurance, because that's the
(10:53):
future I work.
Speaker 1 (10:54):
Towards absolutely same, and I appreciate you starting with that,
because I think that's really important for people to understand
is that this isn't over and that the results are
so significant from MDMA is just a therapy that this
will get approved eventually. However, all that being said, we're
talking about what kind of delay here. You know, what
(11:15):
is from what you know, what is the FDA asking
of licos currently from what we know, and what do
we think the delay is going to be in terms
of when people actually get access to this treatment.
Speaker 2 (11:28):
FDA has said they want another Phase three trial. Now,
one of the questions that I don't think is currently
known is what trial size that that would require that
they're looking for as a number of participants, what specific
data that was missing from the first two needs to
be collected, and also, frankly, how many Phase three trials.
(11:51):
So if you remember the quote phase three trial, it
was actually a Phase three trial and a confirmatory trial.
Now the question is do they want one confirmatory trew
with a thousand participants? Do they want two with five
participants each? Because it's its tiny niche thing. These are
some questions that we frankly don't know the answer to.
Yet I do know as most people saw both like
(12:12):
this and maps had a major downsizing to conserve funds.
They also brought in apologize. I'm not sure it was
like Chief Medical Officer or something like that, to help
figure out a way forward. Now, one of the things
on the reconsideration, I mean, the reconsideration can frankly be anything.
(12:34):
FDA could completely reverse their decision. FDA could say, Okay,
we don't need a full clinical phase three trial, we
need more data. We'd like you to take the data
you have, add in these parameters or wait this differently.
Or it could be something like sending out surveys to
phase three participants to fill out to gather more data
(12:55):
on certain things. And then also what things can be
pushed off post approval. You know, one of the things
like how long do you have to stay until you
can drive a car has not been answered. That's something
that can easily be done in post approval by having
people spend the night gathering the data, coming up with
an answer, and then implementing. But there's still a lot
(13:18):
of open questions. There's also been some very recent developments
since the decision. Specifically, the entity that was attacking MDMA
assistant therapy and licos. It has been reported on the
record that two members left over a year ago due
(13:41):
to ethical violations at Symposia that have yet to be
answered for We have no idea whether it's financial or
sexual or somebody sharpened the pencils wrong. But the longer
that everybody remained silent on this raises a lot of questions.
Especially can considering ISISER had Symposi on their advisory committee
(14:03):
and why AISER would want a writing professor on an
advisory committee on MBMA assistant psychotherapy. It's completely beyond me,
But I think Ier and Symposia Business Insider, some of
the other people who had a willful and biased yellow
journalism attack against this have a lot of answers that
(14:27):
they need to give, or frankly, they shouldn't be listened to.
Speaker 1 (14:33):
You're listening to the Psychedelic Report, So I just want
to fill in the gap here of what we're talking about,
which is that from what we can tell, and anybody
who's interested in this more and the Deep Dive can
listen to the past three or four episodes of the
Psychedelic Report, including one of our episodes. It's John. But
ultimately what we're talking about here is something that's unprecedented
(14:55):
in the field of clinical research and drug development with
the FDA, which is that, from my understanding, for the
first time in the history of the FDA, we are
seeing a radical anti capitalist organization known as Symposia with
a P that has falsified information and put it into
(15:19):
letters that they have written directly to the FDA and
the FDA Advisory Committee in an effort to prevent the
approval and clearance of MDMA assisted therapy by the FDA.
And this is fascinating for a lot of reasons and
also very detrimental and destructive to all the work that's
been done to try to move this therapy along, because
(15:41):
ultimately the results in the clinical trials are so robust
and so significant and profound that we're seeing basically a
repair process start to take place for a lot of
people with PTSD and chronic PTSD that we've never seen
before in the history of psychiatry. The precedent that the
f DA is now setting for psychedelic assistant therapies to
(16:03):
be approved is unreasonably high, given the fact that I actually.
Speaker 2 (16:08):
Think that potentially showing the alt left and the radical
anti capitalists, Marxists, whatever you want to call them. A
pathway to block medications that people desperately need to live
will be replicated, not just in the psychedelic space. I
think that attack had more to do with if it's
(16:29):
FDA approved, who would be treated, and their belief that
those people should not be treated, those people being veterans, yes, veterans,
first responders, anybody who does not politically agree with them,
you know, Jewish hostages, you name it. Anybody that the
alt left dislikes or views as an oppressor.
Speaker 1 (16:49):
Doesn't deserve the right to heal from the MBMA therapy
or anything.
Speaker 2 (16:53):
But I also think that that showing I mean, look,
these are the people who set up tent cities, and
these are people who are riding at the DNC. Once
shown a pathway to inflict damage, we will see this
over and over again with lots of medications. Because you know,
as Niche stated, you know in a podcast with Symposia
(17:16):
that mental illness is a symptom of capitalism, and if
you heal mental illness, then there's no reason to overthrow capitalism. Well,
diabetes is it, frankly of capitalism. So does that mean
we should now ban insulin. I mean the same argument
equally applies. And the crazy part is all of the
people who have openly stated they are non prohibitionists that
(17:39):
they you know, in the debate between me and mister Nichols,
he openly stated that he frequently uses psychedelics. So it's
not about safety and efficacy, they openly stated. But their
argument is this will cause sexual assault and this will
cause suicide.
Speaker 1 (17:56):
As if that's not happening more already in the underground
and unregulated environments.
Speaker 2 (18:01):
And that's the issue. Look if this was the Family
Research Council or evangelicals who are like drugs are bad, okay,
and their argument was this is dangerous, this is why
we should ramp up enforcement and put people in jail,
et cetera. You know, the drug war mantra. That would
make logical sense. But coming at the FDA and scaring
(18:23):
the FDA, because the FDA, if they say yes and
something goes wrong, they get in trouble. If they say no,
the people who bear the consequences aren't their friends. SYMPOSI
is not going to bear any real consequence for this.
The FDA isn't. But I guarantee you I'm going to
be going to more funerals because of it, and that's
(18:43):
kind of the issue, you know, the VA. I've had
my issues with them. They've actually been really good recently.
Shout out to doctor Elman Hall again under Secretary for
Health for taking this seriously. But a lot of the
problems of the VA kind of boiled down to it's
easier to do nothing than to do the right thing,
and that's how a lot of times paperwork doesn't get
(19:04):
done right and et cetera. And this is the hazard
of any bureaucratic organization, not just the VA, but it
also happens at FDA. And for the FDA, it was
politically easier to say no, we want more research than
knowing what is going to happen if they don't, because
(19:27):
they're not going to get blamed. If suicide rates stay
the same, they're not going to get blamed, you know.
But if ozempic is used incorrectly, they are going to
get blamed for approving it. And I think part of
the big issue is symposia use the fear of sexual
assault and increased suicide to spook the FDA. Knowing that
(19:50):
five hundred people have gone through trials, they're talking about
one person, and they don't talk about the rampant sexual abuse. Look,
if you're getting your m d m A and it's
not from lycos or like the DEA, there is a
zero chance it has fentanyl in it.
Speaker 1 (20:09):
Right or something or something.
Speaker 2 (20:12):
And this is the issue. And all the people who
demand that veterans not have access to this will go
use MDMA because the law doesn't affect them, because they
just ignored it. But people like police officers, firefighters, truck drivers,
you know, members of the military, veterans, others. Most people
(20:34):
won't be able to afford this if it's not FDA approved.
But that's the whole point. This goes all the way
back to the sixties. The counterculture, anti war left found
psychedelics and thought they were fun. This is their thing. Well,
here's the funny part. Republicans and Conservatives have always done psychedelics.
They just don't make it their whole life.
Speaker 1 (20:54):
Yeah, you said it, and I think you know it
can't be ignored. The precedent like the president that's being
set right now with you know what the FDA is
communicating to our society, to America can't be swept under
the rug. Like we need to talk about this right,
And you bring up a key point, which is if
(21:16):
this was allowed to happen, Now, where an outside organization
that is providing information with no evidence to the FDA
that is supposed to be objective in every right and
looking out for patients, not just looking out for themselves,
but looking as an organization of the federal government, but
looking out for there for the patients and the community
(21:36):
of Americans as public servants that they serve. Technically speaking,
you know that they can be influenced by a group
of non doctors and non researchers that call themselves a
psychedelic watchdog organization could literally replace with anything watchdog organization
and influence any government organization that's supposed to be looking
(21:57):
out for us and for our communities time we pay
our taxes.
Speaker 2 (22:01):
Right, they'll put the FDA put their own personal reputation.
They protected that rather than protecting American citizens. And I
don't think you can look at it any other way, right,
because the FDA should have asked the very questions we've
talked about here. Okay, what happens if we don't, because
otherwise the system is inherently corrupted by people who want
(22:24):
to use these drugs. Who one of their motivating factors.
Let's be honest, all right, Rick Doblin love them to death.
Do you know what what's his FDA dissertation, how to
legalize drugs to the FDA? You'd think the FDA probably
read that. Yeah, and a lot of other people did.
And there's a lot of people who realized, wait, this
isn't going to be like ketamine. This isn't going to
(22:46):
be like other prescription drugs where I can just go
to a doctor and get a prescription for thirty pills
and get it filled at the CBS or Walgreens or wherever.
This is going to be highly controlled. And who got mad?
They were like, but that wasn't the point. It was
to legalize drugs through the FDA, not to actually heal people.
And so they get mad and they threw a temper tantrum.
(23:07):
And the thing is, it's easy to throw a temper tantrum.
Most of the left, you know, the far all left
their demands. They don't face the consequences of any of
what they demand.
Speaker 1 (23:19):
Right. It's always a lot easier to tear stuff down
than it is to rebuild it again. Right, Like something
literally that took forty years to get through to the
FDA's death was torn down in three months, six months.
Speaker 2 (23:33):
And I've had my pirsial reputation attacked by symposia. I've
had my family's reputation attacked by symposia. And you know what,
I'll be honest. My ex wife and my kid have
nothing to do with my work, but they have both
been attacked. Why because it was about, you know, honestly,
me being a good spokesman and me I'm willing to
(23:55):
put my reputation on the line to get this done.
They thought that if they had tacked me, I would run. Well,
where was my last time we talked? I tend not
to run away.
Speaker 1 (24:07):
Yeah, the last time we did an interview, I was
really impressed. You were in the Ukraine providing service to
the community there, which is clearly a sign that you
have done a lot of self work to able to
put yourself back in those environments.
Speaker 2 (24:19):
Well, and I'll tell you after we spoke, I went
down to the lines and hopefully we have time for
this because this is actually really interesting and good story.
And I do a lot of support supporting stabilization points
so they can get equipment that they need to be
able to help people like I'm not a surgeon, I'm
not a doctor, I'm not an MD, I'm not even
(24:40):
a medic. I do have some medical training from the military,
and so I went down there with my partner Anna,
who is the field director for Frontline Medics shout out
to them Frontlinemedics dot org. It was originally just to
go check out and meet like the battalion doctor and
check the place out and see if I wanted to
help support it. Casualties start coming in. It's been about
(25:01):
four or five days there. I will tell you I
saw more blood, more dead bodies, more artillery impacts in
that period of time than I did the whole time
I was in Iraq. Wow. And I came back on
July tenth for the press conference at the Capitol. Actually
got off the plane and went straight to the press
conference because I found out on my trip home that
(25:24):
I was exposed to chemical weapons while I was down there.
So I did the press conference and then I went
to Walter Reed to get checked out. I'm fine. It
was low level, it was secondary exposure. But I still
don't have nightmares either about either out there or Iraq.
And it's funny because one of the nights, I woke
up because I'm an old guy and I had to
(25:46):
get up and pee, and I'm walking out of the
hooge and I walked past another Iraq veteran. He was
an Aussie and served in Iraq, and he was shaking.
I woke up laughing because I had a funny ass dream.
There was some shelling off in the distance and stuff.
So I go, I take care of this and I
go back to sleep, and I talked to him in
the morning. I'm like, how'd you sleep? He's like, like
(26:06):
shit because of all the shelling. I slept like a
baby and had a hilarious dream. Wow. So I'm not
saying that if you just go do MDMA, that'll happen
to everybody. But I shouldn't be alive. So I lived
my life to prove that others can. If I can
get figxed, so can anybody else.
Speaker 1 (26:29):
Yeah, you having pleasant dreams in that kind of environment
is very different than the dreams you might have had
in the past.
Speaker 2 (26:37):
Well, especially, I would have those dreams in a completely
safe and peaceful environment, and I'd still wake up with
nightmares thinking I was in a combat zone. Like if
I get awoken over there, startled because something went boom. Okay,
it went boom and you were startled a wake. That's
different than being startled awake because something went boom and
(26:57):
you're sitting in Charleston, South Carolina, on a lake. And
that is the kind of stuff that symposia poses. This
is why people like Jules Evans and others are now saying, well,
the data doesn't show suicide was reduced. How about you
ask the five hundred people who went through MDMA assistant
therapy how many of them believe that they're alive today?
(27:19):
Because I'm an n of one and I get that
I would be dead by suicide if I had not
gone through MDMA assistant Therapy, point blank. And I know
I'm not the only one. I'm just, frankly one of
the fuse willing to come on a podcast and talk
about it.
Speaker 1 (27:36):
You're listening to the Psychedelic Report, you know, getting back
to what you were talking about earlier, you know, with
symposia and the precedent that's being set here for manipulation
of a federal organization, the FDA that's supposed to be
looking out for all of our best interests, which is
alarming in and of itself and cannot happen again. This
(27:57):
is going to be appealed bypsychos with the FDA. We're
going to see what happens. But ultimately there is you know,
some interesting information has come to light since, which is
you had a conversation, very pointed conversation on breaking point,
I believe, with David Nichols, who used to be with
(28:18):
David Nichols who used to be a leader at Symposia
and resigned I think a year ago. Can you summarize
a little bit of that conversation for us and what
was brought to light because I found it very interesting.
Speaker 2 (28:29):
I'm assuming you're referring to the statement towards the end,
and I will say it was expertly moderated by by
Ryan Grimm, who he wrote a book with a drug dealer,
he worked for MPP. It's not like he's an opponent
of any of this. He probably supports d grim We
haven't exactly talked about that, but just to say this
(28:51):
was if there was any bias, it was probably on,
you know, in the drug war. So mister Nichols openly stated,
we'rerdly enough, completely unprompted in the middle of nothing, just
kind of blurted out that he had left Symposia, and
is it over a year ago? I know Lily, who
(29:11):
he also works with, left, and I believe April of
twenty twenty three. Nichols left after that due to ethical
violations at Symposia that were reported and that management refused.
The leaders of Supposia refused to look into or even investigate,
which leads me to believe that this was something more
(29:32):
than somebody sharpened the pencils wrong or posted an offensive meme.
But again, I don't know. Nobody knows because Symposia hasn't
said anything as vocal as they are, I mean, Sas
Francisco I think deleted a Twitter account. You know, I
can't monitor Niche or Brian because they have me blocked
because I asked them for evidence. But yeah, so there's severe,
(29:55):
credible allegations of misconduct at Symposia that no one knows
what it's about. It could be financial, It could you know,
like I said, it could be covering up a sexual assault.
It could be you know, inappropriate conduct with participants that
they've been interviewing. We honestly don't know what it is,
and I think they should come forward. I also think
they should come forward and clearly state all their funding,
(30:17):
specifically if they're being funded by any pharmaceutical companies as
a Sarrive manufacturers, anyone in the psilocybin space, I begain
space any other competing products, because you're actually required to
do so when you testify before the FDA, and that
was not done. I mean, at the very least Brian Pace.
(30:38):
It's well known he's a professor at OSU teaching about
psilocybin and mushrooms and things like that. That should have
been disclosed, I mean, but they have never said where
any funding comes from. And given the meteoric rise, it
looks like they had a PR firm working for them,
and I'd like to know who was paying them.
Speaker 1 (30:56):
Yeah, me too, I think a lot of people would
like to know.
Speaker 2 (31:00):
I'm just demanding what they have demanded of the ghost
of me.
Speaker 1 (31:04):
Yeah, what you're asking is not unreasonable, right, And the
fact that they deny it, the evidence for their claims
and the evidence for you know, what they're stating, is
clear indicator that something strange is afoot. This is a
really important philosophical understanding for people to take away from this,
(31:24):
which is that this is a very clear case of
moral relativism. And we see this all the time, where
there is an organization or a person who talks about
ethics all the time and talks about how important it
is for everybody to have high integrity and to be
moral and to always be considerate of everyone, and et cetera,
(31:45):
et cetera, et cetera, And the narrative that they put
out is always very focused on morality and ethics, and
then when you look at their actions, their actions are
to the exact contrary or opposite.
Speaker 2 (31:57):
I'll be honest, I don't view this as moral relativism.
I view it simply as projection. Given the lack of
facts and the fact that they just kind of randomly
make things up about me and my kid. It's funny.
It's projection. They accuse others of what they themselves do.
Moral relativism is, hey, I can kill a thousand people
(32:18):
because you killed a thousand of my people. I think
this is far more of just projection, because show me
what they accuse people of, and I can show you
what they've.
Speaker 1 (32:28):
Done right, and you're exactly right. I would argue that
it's both. You know, on one hand, The moral relativistic
issue here is that they believe, because of their political stance,
that they can decide who deserves the right to heal
and who doesn't, and what's right and wrong, and so
then they act on that. So that's the moral relativistic perspective.
(32:50):
But you're exactly right, they are engaging in unethical behavior
and slander and you know, falseification of information and probably
other things. Which is which are the reasons why David
Nichols and one of their other folks left, And they're
talking about how great and ethical and morally superior they are, right,
(33:12):
And so this is a clear red flag for anybody
who's listening. When you hear this kind of talk, you
should ask yourself the question, is this what this person
is saying? Saying it for a reason because a lot
of people will try to overly justify their own moral
superiority and ethical superiority to make up for the fact
(33:32):
that they are not actually being ethical themselves exactly.
Speaker 2 (33:36):
You know, it gets interesting because as a participant is
someone who's gone through this since day one, I have said,
regardless of what you've done, you should have access to heal.
I believe that people who are formally INCARCERATD should should
absolutely have this and it would reduce recidivism and a
whole bunch of problems. And I don't care what crime
(33:57):
they committed. If the government has decided they should be released,
then they're released. And the only reason I don't believe
in doing it while incarcerated is it causes ethical problems
with consent. But I have never once said this person
shouldn't be allowed to heal because of any reason. I
(34:17):
believe everybody has the right to the opportunity to heal, period,
whether that's with MBMA, sole c ibon, I begain SSRIs,
going to church, yoga, I don't care. But denying people
the ability to heal because of your political beliefs is abhorn.
It's just like the Vietnam generals who killed as many
(34:39):
as they could because those people didn't agree with you
their politics, right, The Soviets killed a lot of people
because they didn't agree with their politics. And this is
what scares me. This is why I call these bar
left Marxists the alt left. They want to destroy this
country just as much as the alt right. And they
(35:00):
believe that by controlling a medicine that cures mental illness.
They can force people to adopt their ideology because here's
something I believe that that treatment should be very patient centric.
And what I mean by that is I entirely understand
why a person of color may want a person of
color as a therapist. They have a similar light, lived experience,
(35:22):
They can understand more in ways that I, frankly, as
a white dude, cannot understand. I understand why somebody who's
LGBT may want somebody from that community to be their therapist,
as I also understand that a veteran may not want
somebody who's Muslim and dresses in traditional Muslim garb, or
somebody a straight person, or even an LGBT person who
(35:45):
is raped by a man to have to do group
therapy and accept LGBT in all of this when those
are their triggers. No, no, no, you have to accept
these political beliefs to get treated, rather than saying what
does the patient need to get better?
Speaker 1 (36:03):
Exactly.
Speaker 2 (36:04):
Never once had an anesthesiologist ask me my political beliefs
before they put me under for surgery.
Speaker 1 (36:10):
Right, And that's a key point that you really hit on,
which is that everyone deserves the right to heal. This
is the entire premise of the history of medicine. And
this is the philosophy of the Board of Medicine, you know,
our nonprofit educational organization. And if you go back in history,
you know and look at Hippocrates, my Monodies, the two
(36:31):
forefathers of Western medicine, and into ancient tribal and Eastern
medicine cultures. They all agree on the same core basic principles,
which is that regardless of your political beliefs, regardless of
who you are, regardless of what you've done, regardless of
the crimes you committed, you deserve the right to heal.
And if you need to be prosecuted for your crimes,
you can be prosecuted after that if it's an especially
(36:53):
if it's an emergency situation that requires emergency healing. Right,
we don't deny people emergency care. It's you know, there
are lots of rules against that.
Speaker 2 (37:03):
So if I deny the enemy medical attention, even if
they were just shooting at me, it's a war crime. Right,
So why isn't it a war crime what Symposia did.
Speaker 1 (37:14):
Right, It wasn't in the context of war, but it
certainly is denying.
Speaker 2 (37:19):
But isn't it if we're talking about veterans healing from PTSD.
If I deny my opponent medical treatment that is desperately
need needed and they die, that's a war crime. If
you are injured in war and you are prevented from healing,
that is still a connected as a war crime.
Speaker 1 (37:40):
Yeah, it's just on civilian soil.
Speaker 2 (37:42):
Like when I was in Iraq, I didn't ask if
people were insurgents before it gave medical attention. If I
come across a wounded Russian soldier, I'm gonna treat them.
I go feed Russian villages that are loyal to the
Russians in the dawnbos where I have to take my
American flag off and hope they don't call it and artillery.
But they deserve a right to eat. Yeah, they deserve
(38:04):
a right to have access to doctors that we bring
with us. And you know, it's funny, it's the military
that taught me that, which is who they hate. And
I think a lot of it has to do with
they want to denegrate the military and the service of
millions of people because they view what we do and
they know they don't have the courage to do it.
(38:27):
So it boils down to they hate us because they
ain't them.
Speaker 1 (38:30):
I love the way you put that, and I love
the use of humor because it's one of our most
important coping strategies as human beings. But what you're saying
is so important and it's so good to hear this
from you and refreshing at the same time, because it's
the most important takeaway from any conversation when we're face
to face as human beings, which is really remembering always
(38:52):
that we're all human first, and we all have the
same core wants, needs, and desires for survival and thriving
as human beings on this earth. Despite all of the
rest of the perceived differences between us. We're all human first, always,
from the moment we're born to the moment we die,
and we have certain inalienable rights that are critical to
(39:12):
preserve the sanctity of humanity, not just for ourselves, but
for our entire community to be able to continue to
exist together, you know, and survive on this earth. So
I really appreciate you bringing it back to that, and
you know, what we really need to remember as we
move forward through these challenges that we're facing in the
(39:33):
mental health space and the you know, PTSD community, in
particular around psychedelic therapy getting over the line. So I
just wanted to thank you again for taking the time
to join me today. I really appreciate our conversations and
is there anything you want to leave folks with before
we wrap?
Speaker 2 (39:51):
Just honestly what I started with, it's not over till
it's over. This is going to be approved at some point.
I'm not saying it's going to be next week or
next month. As a matter of fact, it won't be.
It could be yours. But when it is finally approved,
I will gladly pop the cork on some champagne. And
I hope everybody who's listening to this and everyone who's
(40:11):
alive today is around to see it.
Speaker 1 (40:14):
Agreed. Thanks John, 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,
(40:38):
I'm not your doctor. So please don't take anything you
hear on The Psychedelic Report as personal medical advice, because
we don't know you. If you have questions about anything
you hear on this show, Please consult with your doctor.
The Psychedelic Reports. Psychedelic drugs have played their part in
America's long strange trip toward an understanding of mind. All
during drugs The Psychedelic News.
Speaker 2 (00:11):
Leading physicians, scientists, and experts share their wisdom about psychedelic
medicines and healing. Fifty years ago, psychedelic drugs were at
the center of America's counterculture. The brightest minds in psychedelic
medicine the Psychedelic Report.
Speaker 1 (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 2 (00:33):
From researchers to investors. I think the biggest mistake we
pat as the culture is the war of drugs.
Speaker 1 (00:38):
So physicians to shamans and non private pioneers psychedelic drugs.
Speaker 2 (00:43):
Recent research suggests some of them could have legitimate uses.
The Psychedelic Needs bring you diverse perspectives from the front
lines of this exciting movement, The Psychedelic Report.
Speaker 1 (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 MDMA assisted therapy.
(01:22):
Today we discussed the disappointing FDA decision to reject MDMA
assisted therapy for approval for treating PTSD on August ninth,
twenty twenty four. This was a very surprising decision from
the FDA, given the preponderance of evidence to support MDMA
assisted therapy as the best available treatment for PTSD and
(01:44):
perhaps the most effective treatment ever developed for any mental
illness since the NIMH, the National Institutes of Mental Health,
was founded in nineteen forty nine to treat PTSD. We
have seen endless challenges in this forty year path of
MDMA assisted therapy to get from a poorly understood street
drug all the way through to the FDA's desk, with
(02:05):
substantial double blind, randomized, placebo controlled trials demonstrating safety and effectiveness.
This has been no small undertaking and the results being
so good akin to the discovery of antibiotics to treat
infections by Alexander Fleming in the early twentieth century, make
the FDA's denial even more bizarre. As a result, the
(02:27):
FDA decision on August ninth has drawn quite a bit
of criticism from experts in the psychedelic space, as well
as clinicians and researchers leading the charge to address the
unruly public health epidemic of mental illness. Rachel Knuher describes
this in her August thirteenth article and Scientific American entitled
FDA's rejection of MDMA psychotherapy for trauma draws criticism from
(02:51):
psychedelic experts, which we highly recommend you check out, and
we've linked it here for you in the show notes.
Since August ninth, there has been a lot of opennesscussion
about what this decision by the FDA means and what
was motivating it, because it certainly wasn't based in scientific
evidence from what this doctor can tell. This left a
lot of open questions for us to answer, like what
(03:14):
is the outcome of this decision, what are the next steps?
And how long is it going to take MDMA therapy
to get to the people who need it most, the
tens of millions of Americans suffering from PTSD who are
at the highest risk of suicide. Following the August ninth
FDA decision. Breaking Points hosted a conversation between John Lubecky
(03:35):
and David Nichols, formerly of Symposia, about what was motivating
the FDA decision. David Nichols, representing himself and in part
Symposia as a former leading member, was directly involved in
this construction of the false narrative that communicated fabricated safety
concerns not based in evidence or reality about the MAPS
(03:58):
MDMA trials to the At the end of this conversation,
he calls out Symposia for conducting ethical violations and cited
this as the reason why he defected from the organization.
Nichols was not specific about what those ethical violations that
Symposia were, but we can only guess given what they've
been falsifying in the reports to the FDA about the
(04:21):
MAPS trials. This is a very important moment to understand
in terms of the unprecedented nature of what MBMA Assistant
Therapy has had to go through to get to the
FDA's desk, and the disruption caused by the falsification of
information by Symposia to the FDA, which was cited by
Isiser the Institute for Clinical and Economic Review, who was
(04:44):
also manipulated by false information provided by Nichols and the
Symposia team. It is now very clear from the public
comments from folks and leadership at Symposia about how happy
they were when they were able to prevent MDMA assisted
THEIRS therapy from becoming available and legal as a treatment.
The Symposia team has also communicated publicly how excited they
(05:07):
are that the FDA, an objective government organization that is
responsible for protecting Americans, was able to be manipulated by
their tactics to act against the best interests of Americans
and act in their own best interests to protect what
they perceived as risk to them the FDA if they
approved MBMA assisted therapy. To this doctor's knowledge, this situation
(05:31):
of a radical extremist outside group like Symposia with no
experienced doctors or researchers on their staff preventing a safe
and effective treatment, as proven by rigorous, double blind, randomized
placebo controlled trials, from being approved and made available to
millions of patients in need, has never happened before and
sets a frightening precedent for the future of healthcare in America.
(05:56):
If a radical extremist group with no medical expertise can
prevent a treatment as incredible and revolutionary as MBMA assisted
therapy for PTSD from getting FDA approval? What will stop
similar organizations from doing the same for cancer treatments, autoimmune
disorder treatments, diabetes, you name it. I had a lot
(06:16):
of questions that I wanted to have answered about what
is actually going on, so I brought back John le Becky.
John le Becky is a retired Army sergeant and veteran
and former participant in the MAPS MDMA assistant Therapy trials.
John is one of many real life examples of the
truly life saving benefits of MDMA assisted therapy delivered via
(06:37):
the MAPS protocol. As a twelve year retiree of the
US Armed Forces, John worked with MAPS in the past
to help facilitate education of the federal government and military
decision makers on MDMA assisted therapy and why this is
such an important treatment that is game changing for Americans. Currently,
John spends much of his time providing public service to
(06:59):
the in war torn areas in the Ukraine. John, thank
you so much for joining us. It's always such a
pleasure to have you on the show.
Speaker 2 (07:07):
It's great for you to have me back on There's
been a lot that's been going on the past few weeks,
and hopefully we're gonna have a great discussion.
Speaker 1 (07:15):
Yeah, we always do, and I'm glad to have you back.
You have expertise in this area and familiarity beyond most
people I know, just given where and how you've worked
in the space as a veteran and having worked closely
with government on MDMA moving forward and education about this
important clinical tool for PTSD. And on August ninth, as
(07:40):
most people now know, the FDA declined approval clearance for
MBMA assistant therapy for PTSD, which was a real surprise
to most of us in the space who are clinicians
and scientists and researchers, and also a surprise I think
to a lot of veterans and people who were being
(08:00):
this as one of the best opportunities for treatment that
we've had since the founding of the NIMH in nineteen
forty nine to treat shell shock now known as PTSD.
So can we start by you just giving us a
little bit of an understanding of what happened on August
ninth and the impact of that vote so far.
Speaker 2 (08:20):
So I do want to clear some things up. They
did not say no, this is over, go home, pack
your bags. They are not requiring new Face one or
Face two trials. We actually until Licos Therapeutics, which is
currently either already has or in the very near future,
will be requesting a meeting with the FDA for clarification
(08:42):
and reconsideration. Now part of that meeting is they get
a big letter, but not everything's in the letter, and
so the meeting will allow MICOS to sit down and
ask questions, get very specific on things. But what the
FDA said is we require more research. Is what the answer,
frankly has been for the past twenty years. Every second
(09:04):
of research gets us closer to the end goal. This
is not over, not by a long shot. The momentum
is building and as I've been saying, and I believe
I said this after the ad COM when we talked,
this will be approved one day. And this is where
I want to take a minute. This was devastating, not
just to the veteran community, this was devastating to everyone
(09:28):
who saw this as a ray of hope. You know,
I try to be as clear as I can. While yes,
I have been cured of PTSD and can very much
demonstrate that this doesn't work for everyone. There are people
that you know. Even in the LECOS data, thirty percent
of people did not go into remission. But it's a
(09:49):
ray of hope because seventy percent did. And so it
wasn't just veterans, it was sexual assault survivors, domestic violence survivors.
You know, as a twelve year old kid who has
PTSD because they live in an abusive household and one
of their parents suffers from addiction, who's hoping that when
(10:10):
they turn eighteen they can make the nightmares go away.
And this is why I think it's critically important for
everyone to realize this isn't the end of the road.
There is always hope this will be approved, and it
really sucks that the people who suffer from PTSD are
(10:30):
delayed yet again. But I'm not going anywhere. I'm going
to continue to fight until you know psychedelic assistant therapy
is approved by the FDA and available in the VA
through health insurance, through Medicaid, through Medicare, through all the
ways we pay for health coverage, and that there's programs
for people who don't have health insurance, because that's the
(10:53):
future I work.
Speaker 1 (10:54):
Towards absolutely same, and I appreciate you starting with that,
because I think that's really important for people to understand
is that this isn't over and that the results are
so significant from MDMA is just a therapy that this
will get approved eventually. However, all that being said, we're
talking about what kind of delay here. You know, what
(11:15):
is from what you know, what is the FDA asking
of licos currently from what we know, and what do
we think the delay is going to be in terms
of when people actually get access to this treatment.
Speaker 2 (11:28):
FDA has said they want another Phase three trial. Now,
one of the questions that I don't think is currently
known is what trial size that that would require that
they're looking for as a number of participants, what specific
data that was missing from the first two needs to
be collected, and also, frankly, how many Phase three trials.
(11:51):
So if you remember the quote phase three trial, it
was actually a Phase three trial and a confirmatory trial.
Now the question is do they want one confirmatory trew
with a thousand participants? Do they want two with five
participants each? Because it's its tiny niche thing. These are
some questions that we frankly don't know the answer to.
Yet I do know as most people saw both like
(12:12):
this and maps had a major downsizing to conserve funds.
They also brought in apologize. I'm not sure it was
like Chief Medical Officer or something like that, to help
figure out a way forward. Now, one of the things
on the reconsideration, I mean, the reconsideration can frankly be anything.
(12:34):
FDA could completely reverse their decision. FDA could say, Okay,
we don't need a full clinical phase three trial, we
need more data. We'd like you to take the data
you have, add in these parameters or wait this differently.
Or it could be something like sending out surveys to
phase three participants to fill out to gather more data
(12:55):
on certain things. And then also what things can be
pushed off post approval. You know, one of the things
like how long do you have to stay until you
can drive a car has not been answered. That's something
that can easily be done in post approval by having
people spend the night gathering the data, coming up with
an answer, and then implementing. But there's still a lot
(13:18):
of open questions. There's also been some very recent developments
since the decision. Specifically, the entity that was attacking MDMA
assistant therapy and licos. It has been reported on the
record that two members left over a year ago due
(13:41):
to ethical violations at Symposia that have yet to be
answered for We have no idea whether it's financial or
sexual or somebody sharpened the pencils wrong. But the longer
that everybody remained silent on this raises a lot of questions.
Especially can considering ISISER had Symposi on their advisory committee
(14:03):
and why AISER would want a writing professor on an
advisory committee on MBMA assistant psychotherapy. It's completely beyond me,
But I think Ier and Symposia Business Insider, some of
the other people who had a willful and biased yellow
journalism attack against this have a lot of answers that
(14:27):
they need to give, or frankly, they shouldn't be listened to.
Speaker 1 (14:33):
You're listening to the Psychedelic Report, So I just want
to fill in the gap here of what we're talking about,
which is that from what we can tell, and anybody
who's interested in this more and the Deep Dive can
listen to the past three or four episodes of the
Psychedelic Report, including one of our episodes. It's John. But
ultimately what we're talking about here is something that's unprecedented
(14:55):
in the field of clinical research and drug development with
the FDA, which is that, from my understanding, for the
first time in the history of the FDA, we are
seeing a radical anti capitalist organization known as Symposia with
a P that has falsified information and put it into
(15:19):
letters that they have written directly to the FDA and
the FDA Advisory Committee in an effort to prevent the
approval and clearance of MDMA assisted therapy by the FDA.
And this is fascinating for a lot of reasons and
also very detrimental and destructive to all the work that's
been done to try to move this therapy along, because
(15:41):
ultimately the results in the clinical trials are so robust
and so significant and profound that we're seeing basically a
repair process start to take place for a lot of
people with PTSD and chronic PTSD that we've never seen
before in the history of psychiatry. The precedent that the
f DA is now setting for psychedelic assistant therapies to
(16:03):
be approved is unreasonably high, given the fact that I actually.
Speaker 2 (16:08):
Think that potentially showing the alt left and the radical
anti capitalists, Marxists, whatever you want to call them. A
pathway to block medications that people desperately need to live
will be replicated, not just in the psychedelic space. I
think that attack had more to do with if it's
(16:29):
FDA approved, who would be treated, and their belief that
those people should not be treated, those people being veterans, yes, veterans,
first responders, anybody who does not politically agree with them,
you know, Jewish hostages, you name it. Anybody that the
alt left dislikes or views as an oppressor.
Speaker 1 (16:49):
Doesn't deserve the right to heal from the MBMA therapy
or anything.
Speaker 2 (16:53):
But I also think that that showing I mean, look,
these are the people who set up tent cities, and
these are people who are riding at the DNC. Once
shown a pathway to inflict damage, we will see this
over and over again with lots of medications. Because you know,
as Niche stated, you know in a podcast with Symposia
(17:16):
that mental illness is a symptom of capitalism, and if
you heal mental illness, then there's no reason to overthrow capitalism. Well,
diabetes is it, frankly of capitalism. So does that mean
we should now ban insulin. I mean the same argument
equally applies. And the crazy part is all of the
people who have openly stated they are non prohibitionists that
(17:39):
they you know, in the debate between me and mister Nichols,
he openly stated that he frequently uses psychedelics. So it's
not about safety and efficacy, they openly stated. But their
argument is this will cause sexual assault and this will
cause suicide.
Speaker 1 (17:56):
As if that's not happening more already in the underground
and unregulated environments.
Speaker 2 (18:01):
And that's the issue. Look if this was the Family
Research Council or evangelicals who are like drugs are bad, okay,
and their argument was this is dangerous, this is why
we should ramp up enforcement and put people in jail,
et cetera. You know, the drug war mantra. That would
make logical sense. But coming at the FDA and scaring
(18:23):
the FDA, because the FDA, if they say yes and
something goes wrong, they get in trouble. If they say no,
the people who bear the consequences aren't their friends. SYMPOSI
is not going to bear any real consequence for this.
The FDA isn't. But I guarantee you I'm going to
be going to more funerals because of it, and that's
(18:43):
kind of the issue, you know, the VA. I've had
my issues with them. They've actually been really good recently.
Shout out to doctor Elman Hall again under Secretary for
Health for taking this seriously. But a lot of the
problems of the VA kind of boiled down to it's
easier to do nothing than to do the right thing,
and that's how a lot of times paperwork doesn't get
(19:04):
done right and et cetera. And this is the hazard
of any bureaucratic organization, not just the VA, but it
also happens at FDA. And for the FDA, it was
politically easier to say no, we want more research than
knowing what is going to happen if they don't, because
(19:27):
they're not going to get blamed. If suicide rates stay
the same, they're not going to get blamed, you know.
But if ozempic is used incorrectly, they are going to
get blamed for approving it. And I think part of
the big issue is symposia use the fear of sexual
assault and increased suicide to spook the FDA. Knowing that
(19:50):
five hundred people have gone through trials, they're talking about
one person, and they don't talk about the rampant sexual abuse. Look,
if you're getting your m d m A and it's
not from lycos or like the DEA, there is a
zero chance it has fentanyl in it.
Speaker 1 (20:09):
Right or something or something.
Speaker 2 (20:12):
And this is the issue. And all the people who
demand that veterans not have access to this will go
use MDMA because the law doesn't affect them, because they
just ignored it. But people like police officers, firefighters, truck drivers,
you know, members of the military, veterans, others. Most people
(20:34):
won't be able to afford this if it's not FDA approved.
But that's the whole point. This goes all the way
back to the sixties. The counterculture, anti war left found
psychedelics and thought they were fun. This is their thing. Well,
here's the funny part. Republicans and Conservatives have always done psychedelics.
They just don't make it their whole life.
Speaker 1 (20:54):
Yeah, you said it, and I think you know it
can't be ignored. The precedent like the president that's being
set right now with you know what the FDA is
communicating to our society, to America can't be swept under
the rug. Like we need to talk about this right,
And you bring up a key point, which is if
(21:16):
this was allowed to happen, Now, where an outside organization
that is providing information with no evidence to the FDA
that is supposed to be objective in every right and
looking out for patients, not just looking out for themselves,
but looking as an organization of the federal government, but
looking out for there for the patients and the community
(21:36):
of Americans as public servants that they serve. Technically speaking,
you know that they can be influenced by a group
of non doctors and non researchers that call themselves a
psychedelic watchdog organization could literally replace with anything watchdog organization
and influence any government organization that's supposed to be looking
(21:57):
out for us and for our communities time we pay
our taxes.
Speaker 2 (22:01):
Right, they'll put the FDA put their own personal reputation.
They protected that rather than protecting American citizens. And I
don't think you can look at it any other way, right,
because the FDA should have asked the very questions we've
talked about here. Okay, what happens if we don't, because
otherwise the system is inherently corrupted by people who want
(22:24):
to use these drugs. Who one of their motivating factors.
Let's be honest, all right, Rick Doblin love them to death.
Do you know what what's his FDA dissertation, how to
legalize drugs to the FDA? You'd think the FDA probably
read that. Yeah, and a lot of other people did.
And there's a lot of people who realized, wait, this
isn't going to be like ketamine. This isn't going to
(22:46):
be like other prescription drugs where I can just go
to a doctor and get a prescription for thirty pills
and get it filled at the CBS or Walgreens or wherever.
This is going to be highly controlled. And who got mad?
They were like, but that wasn't the point. It was
to legalize drugs through the FDA, not to actually heal people.
And so they get mad and they threw a temper tantrum.
(23:07):
And the thing is, it's easy to throw a temper tantrum.
Most of the left, you know, the far all left
their demands. They don't face the consequences of any of
what they demand.
Speaker 1 (23:19):
Right. It's always a lot easier to tear stuff down
than it is to rebuild it again. Right, Like something
literally that took forty years to get through to the
FDA's death was torn down in three months, six months.
Speaker 2 (23:33):
And I've had my pirsial reputation attacked by symposia. I've
had my family's reputation attacked by symposia. And you know what,
I'll be honest. My ex wife and my kid have
nothing to do with my work, but they have both
been attacked. Why because it was about, you know, honestly,
me being a good spokesman and me I'm willing to
(23:55):
put my reputation on the line to get this done.
They thought that if they had tacked me, I would run. Well,
where was my last time we talked? I tend not
to run away.
Speaker 1 (24:07):
Yeah, the last time we did an interview, I was
really impressed. You were in the Ukraine providing service to
the community there, which is clearly a sign that you
have done a lot of self work to able to
put yourself back in those environments.
Speaker 2 (24:19):
Well, and I'll tell you after we spoke, I went
down to the lines and hopefully we have time for
this because this is actually really interesting and good story.
And I do a lot of support supporting stabilization points
so they can get equipment that they need to be
able to help people like I'm not a surgeon, I'm
not a doctor, I'm not an MD, I'm not even
(24:40):
a medic. I do have some medical training from the military,
and so I went down there with my partner Anna,
who is the field director for Frontline Medics shout out
to them Frontlinemedics dot org. It was originally just to
go check out and meet like the battalion doctor and
check the place out and see if I wanted to
help support it. Casualties start coming in. It's been about
(25:01):
four or five days there. I will tell you I
saw more blood, more dead bodies, more artillery impacts in
that period of time than I did the whole time
I was in Iraq. Wow. And I came back on
July tenth for the press conference at the Capitol. Actually
got off the plane and went straight to the press
conference because I found out on my trip home that
(25:24):
I was exposed to chemical weapons while I was down there.
So I did the press conference and then I went
to Walter Reed to get checked out. I'm fine. It
was low level, it was secondary exposure. But I still
don't have nightmares either about either out there or Iraq.
And it's funny because one of the nights, I woke
up because I'm an old guy and I had to
(25:46):
get up and pee, and I'm walking out of the
hooge and I walked past another Iraq veteran. He was
an Aussie and served in Iraq, and he was shaking.
I woke up laughing because I had a funny ass dream.
There was some shelling off in the distance and stuff.
So I go, I take care of this and I
go back to sleep, and I talked to him in
the morning. I'm like, how'd you sleep? He's like, like
(26:06):
shit because of all the shelling. I slept like a
baby and had a hilarious dream. Wow. So I'm not
saying that if you just go do MDMA, that'll happen
to everybody. But I shouldn't be alive. So I lived
my life to prove that others can. If I can
get figxed, so can anybody else.
Speaker 1 (26:29):
Yeah, you having pleasant dreams in that kind of environment
is very different than the dreams you might have had
in the past.
Speaker 2 (26:37):
Well, especially, I would have those dreams in a completely
safe and peaceful environment, and I'd still wake up with
nightmares thinking I was in a combat zone. Like if
I get awoken over there, startled because something went boom. Okay,
it went boom and you were startled a wake. That's
different than being startled awake because something went boom and
(26:57):
you're sitting in Charleston, South Carolina, on a lake. And
that is the kind of stuff that symposia poses. This
is why people like Jules Evans and others are now saying, well,
the data doesn't show suicide was reduced. How about you
ask the five hundred people who went through MDMA assistant
therapy how many of them believe that they're alive today?
(27:19):
Because I'm an n of one and I get that
I would be dead by suicide if I had not
gone through MDMA assistant Therapy, point blank. And I know
I'm not the only one. I'm just, frankly one of
the fuse willing to come on a podcast and talk
about it.
Speaker 1 (27:36):
You're listening to the Psychedelic Report, you know, getting back
to what you were talking about earlier, you know, with
symposia and the precedent that's being set here for manipulation
of a federal organization, the FDA that's supposed to be
looking out for all of our best interests, which is
alarming in and of itself and cannot happen again. This
(27:57):
is going to be appealed bypsychos with the FDA. We're
going to see what happens. But ultimately there is you know,
some interesting information has come to light since, which is
you had a conversation, very pointed conversation on breaking point,
I believe, with David Nichols, who used to be with
(28:18):
David Nichols who used to be a leader at Symposia
and resigned I think a year ago. Can you summarize
a little bit of that conversation for us and what
was brought to light because I found it very interesting.
Speaker 2 (28:29):
I'm assuming you're referring to the statement towards the end,
and I will say it was expertly moderated by by
Ryan Grimm, who he wrote a book with a drug dealer,
he worked for MPP. It's not like he's an opponent
of any of this. He probably supports d grim We
haven't exactly talked about that, but just to say this
(28:51):
was if there was any bias, it was probably on,
you know, in the drug war. So mister Nichols openly stated,
we'rerdly enough, completely unprompted in the middle of nothing, just
kind of blurted out that he had left Symposia, and
is it over a year ago? I know Lily, who
(29:11):
he also works with, left, and I believe April of
twenty twenty three. Nichols left after that due to ethical
violations at Symposia that were reported and that management refused.
The leaders of Supposia refused to look into or even investigate,
which leads me to believe that this was something more
(29:32):
than somebody sharpened the pencils wrong or posted an offensive meme.
But again, I don't know. Nobody knows because Symposia hasn't
said anything as vocal as they are, I mean, Sas
Francisco I think deleted a Twitter account. You know, I
can't monitor Niche or Brian because they have me blocked
because I asked them for evidence. But yeah, so there's severe,
(29:55):
credible allegations of misconduct at Symposia that no one knows
what it's about. It could be financial, It could you know,
like I said, it could be covering up a sexual assault.
It could be you know, inappropriate conduct with participants that
they've been interviewing. We honestly don't know what it is,
and I think they should come forward. I also think
they should come forward and clearly state all their funding,
(30:17):
specifically if they're being funded by any pharmaceutical companies as
a Sarrive manufacturers, anyone in the psilocybin space, I begain
space any other competing products, because you're actually required to
do so when you testify before the FDA, and that
was not done. I mean, at the very least Brian Pace.
(30:38):
It's well known he's a professor at OSU teaching about
psilocybin and mushrooms and things like that. That should have
been disclosed, I mean, but they have never said where
any funding comes from. And given the meteoric rise, it
looks like they had a PR firm working for them,
and I'd like to know who was paying them.
Speaker 1 (30:56):
Yeah, me too, I think a lot of people would
like to know.
Speaker 2 (31:00):
I'm just demanding what they have demanded of the ghost
of me.
Speaker 1 (31:04):
Yeah, what you're asking is not unreasonable, right, And the
fact that they deny it, the evidence for their claims
and the evidence for you know, what they're stating, is
clear indicator that something strange is afoot. This is a
really important philosophical understanding for people to take away from this,
(31:24):
which is that this is a very clear case of
moral relativism. And we see this all the time, where
there is an organization or a person who talks about
ethics all the time and talks about how important it
is for everybody to have high integrity and to be
moral and to always be considerate of everyone, and et cetera,
(31:45):
et cetera, et cetera, And the narrative that they put
out is always very focused on morality and ethics, and
then when you look at their actions, their actions are
to the exact contrary or opposite.
Speaker 2 (31:57):
I'll be honest, I don't view this as moral relativism.
I view it simply as projection. Given the lack of
facts and the fact that they just kind of randomly
make things up about me and my kid. It's funny.
It's projection. They accuse others of what they themselves do.
Moral relativism is, hey, I can kill a thousand people
(32:18):
because you killed a thousand of my people. I think
this is far more of just projection, because show me
what they accuse people of, and I can show you
what they've.
Speaker 1 (32:28):
Done right, and you're exactly right. I would argue that
it's both. You know, on one hand, The moral relativistic
issue here is that they believe, because of their political stance,
that they can decide who deserves the right to heal
and who doesn't, and what's right and wrong, and so
then they act on that. So that's the moral relativistic perspective.
(32:50):
But you're exactly right, they are engaging in unethical behavior
and slander and you know, falseification of information and probably
other things. Which is which are the reasons why David
Nichols and one of their other folks left, And they're
talking about how great and ethical and morally superior they are, right,
(33:12):
And so this is a clear red flag for anybody
who's listening. When you hear this kind of talk, you
should ask yourself the question, is this what this person
is saying? Saying it for a reason because a lot
of people will try to overly justify their own moral
superiority and ethical superiority to make up for the fact
(33:32):
that they are not actually being ethical themselves exactly.
Speaker 2 (33:36):
You know, it gets interesting because as a participant is
someone who's gone through this since day one, I have said,
regardless of what you've done, you should have access to heal.
I believe that people who are formally INCARCERATD should should
absolutely have this and it would reduce recidivism and a
whole bunch of problems. And I don't care what crime
(33:57):
they committed. If the government has decided they should be released,
then they're released. And the only reason I don't believe
in doing it while incarcerated is it causes ethical problems
with consent. But I have never once said this person
shouldn't be allowed to heal because of any reason. I
(34:17):
believe everybody has the right to the opportunity to heal, period,
whether that's with MBMA, sole c ibon, I begain SSRIs,
going to church, yoga, I don't care. But denying people
the ability to heal because of your political beliefs is abhorn.
It's just like the Vietnam generals who killed as many
(34:39):
as they could because those people didn't agree with you
their politics, right, The Soviets killed a lot of people
because they didn't agree with their politics. And this is
what scares me. This is why I call these bar
left Marxists the alt left. They want to destroy this
country just as much as the alt right. And they
(35:00):
believe that by controlling a medicine that cures mental illness.
They can force people to adopt their ideology because here's
something I believe that that treatment should be very patient centric.
And what I mean by that is I entirely understand
why a person of color may want a person of
color as a therapist. They have a similar light, lived experience,
(35:22):
They can understand more in ways that I, frankly, as
a white dude, cannot understand. I understand why somebody who's
LGBT may want somebody from that community to be their therapist,
as I also understand that a veteran may not want
somebody who's Muslim and dresses in traditional Muslim garb, or
somebody a straight person, or even an LGBT person who
(35:45):
is raped by a man to have to do group
therapy and accept LGBT in all of this when those
are their triggers. No, no, no, you have to accept
these political beliefs to get treated, rather than saying what
does the patient need to get better?
Speaker 1 (36:03):
Exactly.
Speaker 2 (36:04):
Never once had an anesthesiologist ask me my political beliefs
before they put me under for surgery.
Speaker 1 (36:10):
Right, And that's a key point that you really hit on,
which is that everyone deserves the right to heal. This
is the entire premise of the history of medicine. And
this is the philosophy of the Board of Medicine, you know,
our nonprofit educational organization. And if you go back in history,
you know and look at Hippocrates, my Monodies, the two
(36:31):
forefathers of Western medicine, and into ancient tribal and Eastern
medicine cultures. They all agree on the same core basic principles,
which is that regardless of your political beliefs, regardless of
who you are, regardless of what you've done, regardless of
the crimes you committed, you deserve the right to heal.
And if you need to be prosecuted for your crimes,
you can be prosecuted after that if it's an especially
(36:53):
if it's an emergency situation that requires emergency healing. Right,
we don't deny people emergency care. It's you know, there
are lots of rules against that.
Speaker 2 (37:03):
So if I deny the enemy medical attention, even if
they were just shooting at me, it's a war crime. Right,
So why isn't it a war crime what Symposia did.
Speaker 1 (37:14):
Right, It wasn't in the context of war, but it
certainly is denying.
Speaker 2 (37:19):
But isn't it if we're talking about veterans healing from PTSD.
If I deny my opponent medical treatment that is desperately
need needed and they die, that's a war crime. If
you are injured in war and you are prevented from healing,
that is still a connected as a war crime.
Speaker 1 (37:40):
Yeah, it's just on civilian soil.
Speaker 2 (37:42):
Like when I was in Iraq, I didn't ask if
people were insurgents before it gave medical attention. If I
come across a wounded Russian soldier, I'm gonna treat them.
I go feed Russian villages that are loyal to the
Russians in the dawnbos where I have to take my
American flag off and hope they don't call it and artillery.
But they deserve a right to eat. Yeah, they deserve
(38:04):
a right to have access to doctors that we bring
with us. And you know, it's funny, it's the military
that taught me that, which is who they hate. And
I think a lot of it has to do with
they want to denegrate the military and the service of
millions of people because they view what we do and
they know they don't have the courage to do it.
(38:27):
So it boils down to they hate us because they
ain't them.
Speaker 1 (38:30):
I love the way you put that, and I love
the use of humor because it's one of our most
important coping strategies as human beings. But what you're saying
is so important and it's so good to hear this
from you and refreshing at the same time, because it's
the most important takeaway from any conversation when we're face
to face as human beings, which is really remembering always
(38:52):
that we're all human first, and we all have the
same core wants, needs, and desires for survival and thriving
as human beings on this earth. Despite all of the
rest of the perceived differences between us. We're all human first, always,
from the moment we're born to the moment we die,
and we have certain inalienable rights that are critical to
(39:12):
preserve the sanctity of humanity, not just for ourselves, but
for our entire community to be able to continue to
exist together, you know, and survive on this earth. So
I really appreciate you bringing it back to that, and
you know, what we really need to remember as we
move forward through these challenges that we're facing in the
(39:33):
mental health space and the you know, PTSD community, in
particular around psychedelic therapy getting over the line. So I
just wanted to thank you again for taking the time
to join me today. I really appreciate our conversations and
is there anything you want to leave folks with before
we wrap?
Speaker 2 (39:51):
Just honestly what I started with, it's not over till
it's over. This is going to be approved at some point.
I'm not saying it's going to be next week or
next month. As a matter of fact, it won't be.
It could be yours. But when it is finally approved,
I will gladly pop the cork on some champagne. And
I hope everybody who's listening to this and everyone who's
(40:11):
alive today is around to see it.
Speaker 1 (40:14):
Agreed. Thanks John, 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,
(40:38):
I'm not your doctor. So please don't take anything you
hear on The Psychedelic Report as personal medical advice, because
we don't know you. If you have questions about anything
you hear on this show, Please consult with your doctor.
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