August 9, 2024 • 34 mins
In this episode, Dr. Dave Rabin is joined by Dr. John J. Miller, a renowned clinical psychopharmacologist, to discuss the significance of the upcoming FDA decision on MDMA therapy for PTSD.
John J. Miller, M.D. is Medical Director at Brain Health in Exeter, New Hampshire and has served as the Editor-in-Chief for Psychiatric Times since February 2019. He has worked for 38 years as a clinical psychopharmacologist, most recently 17 years as a Staff Psychiatrist at Seacoast Mental Health Center in Exeter, NH. Dr. Miller completed his B.S. in Biochemistry at the University of MA/Amherst. And medical school and residency in Adult Psychiatry at the University of MA Medical School/Worcester. He is a Diplomate of the American Board of Psychiatry and Neurology. Since 1998 he has presented more than 3,000 lectures throughout the US on a wide range of psychiatric topics including PTSD. You can find Dr. Miller in his monthly editorials for Psychiatric Times that he has been authoring since March 2019.
Discover the history of PTSD treatment, the current limitations of existing medications, and the promising results of MDMA-assisted therapy trials. Learn about the bipartisan support from lawmakers and the urgent need for FDA approval to provide relief to millions suffering from PTSD.
Don't miss this insightful conversation on the potential paradigm shift in mental health treatment. Stay informed and advocate for change by tuning in to The Psychedelic Report.
Brain Health in Exeter, New Hampshire (http://www.brain-health.co)
Psychiatric Times (http://www.psychiatrictimes.com)
https://x.com/PsychTimes?ref_src=twsrc%5Egoogle%7Ctwcamp%5Eserp%7Ctwgr%5Eauthor
https://www.linkedin.com/in/jjmillermd/
https://www.linkedin.com/company/psychiatric-times/
www.apolloneuro.com
FDA petition for MDMA-assisted therapy
https://healingmaps.com/sign-the-petition-to-approve-mdma-therapy/
John J. Miller, M.D. is Medical Director at Brain Health in Exeter, New Hampshire and has served as the Editor-in-Chief for Psychiatric Times since February 2019. He has worked for 38 years as a clinical psychopharmacologist, most recently 17 years as a Staff Psychiatrist at Seacoast Mental Health Center in Exeter, NH. Dr. Miller completed his B.S. in Biochemistry at the University of MA/Amherst. And medical school and residency in Adult Psychiatry at the University of MA Medical School/Worcester. He is a Diplomate of the American Board of Psychiatry and Neurology. Since 1998 he has presented more than 3,000 lectures throughout the US on a wide range of psychiatric topics including PTSD. You can find Dr. Miller in his monthly editorials for Psychiatric Times that he has been authoring since March 2019.
Discover the history of PTSD treatment, the current limitations of existing medications, and the promising results of MDMA-assisted therapy trials. Learn about the bipartisan support from lawmakers and the urgent need for FDA approval to provide relief to millions suffering from PTSD.
Don't miss this insightful conversation on the potential paradigm shift in mental health treatment. Stay informed and advocate for change by tuning in to The Psychedelic Report.
Brain Health in Exeter, New Hampshire (http://www.brain-health.co)
Psychiatric Times (http://www.psychiatrictimes.com)
https://x.com/PsychTimes?ref_src=twsrc%5Egoogle%7Ctwcamp%5Eserp%7Ctwgr%5Eauthor
https://www.linkedin.com/in/jjmillermd/
https://www.linkedin.com/company/psychiatric-times/
www.apolloneuro.com
FDA petition for MDMA-assisted therapy
https://healingmaps.com/sign-the-petition-to-approve-mdma-therapy/
Mark as Played
Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
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. All during drugs The
Psychedelic News.
Speaker 1 (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 2 (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.
Speaker 2 (00:35):
I think the biggest mistake we pat as the culture
is the war of drugs. So physicians to shamans and
non private pioneers psychedelic drugs. 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 2 (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.
(01:21):
Today we're discussing an article recently published by CNN on
August fifth, twenty twenty four, entitled, with FDA decision looming,
Bipartisan group of lawmakers urge support for MDMA to treat PTSD.
This is a fascinating article and very detailed report discussing
how the impact of MDMA assisted therapy for PTSD is
(01:45):
so significant that politicians on both sides are coming forward
to urge President Biden to make sure that this treatment
gets over the line. The vote by the FDA on
MBMA assisted therapy clearance or approval is expected on August
eleventh of twenty twenty four, just a few more days away,
and with that decision looming, a decision that is critically
(02:07):
important for all veterans and any American with PTSD or
with suspected PTSD, which, as we discuss, could be as
many as fifteen percent of Americans. I have a very
special guest expert to join me to discuss the state
of affairs of PTSD treatment, the meaning of the approval
(02:27):
of something like MBMA assisted therapy for veterans, and what
it could mean if the FDA decides not to do
their diligence and trust the advisory committee that provided biased
information to them about the risks of MDMA therapy, which
from the study data, when practiced according to protocol, are
minimal and less than most current antidepressants available. Our special
(02:53):
guest today is doctor John J. Miller. Doctor Miller is
the medical director at Brain Health and Exeter in New Hampshire,
and has served as the editor in chief for Psychiatric
Times since February twenty nineteen. He has worked for thirty
eight years as a clinical psychopharmacologist, most recently seventeen years
as a staff psychiatrist at Seacoast Mental Health Center in Exeter,
(03:14):
New Hampshire. Doctor Miller completed his bachelors in Science in
biochemistry at U mass Amherst, and he completed medical school
and residency in adult psychiatry at UMSS Worcester. Doctor Miller
is also a Diplomat of the American Board of Psychiatry
and Neurology. Since nineteen ninety eight, doctor Miller has presented
more than three thousand lectures throughout the us on a
(03:36):
wide range of psychiatric topics, including PTSD post dramatic stress disorder.
You can find doctor Miller in his monthly editorials for
Psychiatric Times that he has been authoring since March or
twenty nineteen. Doctor John Miller, thank you so much for
taking the time out of your busy schedule to join
me today.
Speaker 1 (03:54):
Thank you, Doctor Revan. It's a pleasure to be here,
and I really enjoyed our last conversation and look forward
to having a discussion with you about such an important topic.
Speaker 2 (04:05):
I really appreciate that and have enjoyed my conversations with
you as well, especially given your expertise in the field
of PTSD and your background on this, which is relevant
today because we're just a few days away from the
FDA decision around MBMA assistant therapy as the newest, most
(04:27):
successful and promising treatment for PTSD and chronic PTSD as well,
and we have not had a lot of good treatments
for these over the years. So I was wondering could
you run through for us the brief history of PTSD
and kind of how we got here today.
Speaker 1 (04:43):
Yes, I'd be delighted too. It's really one of those
psychiatric or medical tragedies, which it's a diagnosis that continues
to fight for treatment and acknowledgment. But we can go
all the way back to good old Sigmund Freud. In
the late eighteen hundreds, he published a case series of
(05:04):
women diagnosed with hysteria and he proposed that childhood abuse
was the likely ideology. In fact, the paper was called
the Ideology of Hysteria, and it was very quickly scorned
and shunned, and he was humiliated by his colleagues to
the point that he retracted it. And that just in
that time, it puts into context how suppressed or oppressed
(05:26):
or disconnected we were from the effects of trauma. My
own grandfather was a medic in Germany and nineteen eighteen
World War One on the front lines, and you know,
he was gassed, He saw a lot of really bad
stuff and when he came back his life was changed,
which my grandmother's diary reflects. And back then they called
(05:48):
it shell shock and it was viewed as a weakness.
And if we jump ahead to World War Two, you know,
one of the quintessential themes there was George Pattern, General
George Pattern, who basically slapped a bunch of soldiers who
had been an incredible warfare and traumatic experiences and blood
(06:11):
and death, and he called them messissies because they were
basically suffering from PTSD, and Eisenhower ultimately reassigned him, which
was interestingly when he was reassigned to northern Europe, the
Germans thought that's where the D Day was going to occur.
So it has this interesting historical connection. But the good
news was people with PTSD have continued to advocate for themselves,
(06:37):
and the Vietnam veterans did an outstanding job saying, you know,
there's a lot here. You got to help us. This
is not right. We're trying to help each other. We
need your help. And finally, in nineteen eighty, not that
long ago, Diagnostic and Statistics Manual of Mental Illness the
third Issue finally recognized and introduced a diagnosis of post
(07:00):
traumatic stress disorder. And basically the definition has remained similar to today,
so I won't repeat it. But what did happen in the.
Speaker 2 (07:10):
Early twoes, So this was like nineteen eighties, nineteen.
Speaker 1 (07:15):
DSM three entered in nineteen eighty and that was when
the American Psychiatric Association finally recognized post traumatic stress or
as a real disorder. So forty four years ago not
a long time ago, you know, I had just graduated
from college, you know, so it's in our lifetimes. And
(07:35):
back then we had nothing to treat it, and we
talked about it, and you know, there was lots of approaches.
We didn't get our first drug approof of PTSD until
nineteen ninety nine, and that was aloft generic searchrali, which
is a serotonin reuptake inhibitor, and it showed benefit with
a lot of anxiety disorders as well as major depression
(07:58):
and other things. And Tafaiza's credit, they studied it aggressively
and they got approval, and a few years later paxil
prooxidy and got approval, And so here we are twenty
four years later, and those are the only two drugs
that are FDA approved for PTSD. And they're not really
that great. I mean, they work a little bit. They
(08:19):
help some people. They work better in people who've had
a single traumatic experience. They don't work well for people
who've had a lot of childhood trauma, or a lot
of military trauma, or a lot of just adult tough life,
living in dangerous places trauma. And that's the population that
suffers the most, and ultimately down the road a lot
(08:42):
of them end up with significant functional impairment and get
marginalized in homelessness and unemployment and divorces and financial issues
and difficulty functioning. And so it remains this huge unmet
need and probably around and two thousand and nine twenty ten,
(09:03):
one of our thought leaders in PTSD.
Speaker 2 (09:07):
Before you go on to Bessel, when you talk about
the unmet need, could you just give us an idea
because you mentioned very importantly that PTSD wasn't even a
diagnosis in psychiatry until nineteen eighty and subsequent to that
it has been heavily stigmatized. Even so, because it's a
new diagnosis and it is widely underreported, right, trauma that
(09:31):
itself is often stigmatized. So we have some idea of
the number of veterans and civilians who are who are
reported to have PTSD diagnoses. But how many people would
you guess or estimate, you know, nationwide to suffer from
symptoms of PTSD treated or untreated, because guest my guess
(09:53):
as a psychiatrist who see these kinds of folks is
you know, somewhere in the order of like you know,
forty to eighty million, But I don't know. I'm just
just guessing.
Speaker 1 (10:02):
Yeah, So I'll go to statistics percentages, which gives me
a frame around the what subset of the population. And
you know, based on papers that I've read, if you
look at an experience that would rise to the level
of meeting criteria for PTSD, which means you've had this
(10:24):
traumatic experience. It either affected you directly or someone close
to you directly, and those symptoms are persistent for thirty
days or longer, because by definition, thirty days are longer.
So when you look at the percentage people who've had
a traumatic experience like that, it's estimated to be fifty
percent of everybody in the United States. One and two.
(10:46):
If you look at the percentage that then go on
to develop post stress disorder, it's somewhere between ten and
fifteen percent, So that's one in ten people. Now, some
of that may be mild PTSD, but significant subset is
more impairing. And one of the difficulties with DSM in
(11:09):
psychiatric nosology is that a lot of severe personality disorders,
especially what we call a borderline personality. Up to ninety
percent of them had had severe childhood abuse most of
the time, sexual abuse, severe emotional abuse, physical abuse. And
so while their brains are wiring between the age of
(11:32):
two and fifteen, they're always in a state of being fearful, afraid, unsafe, unprotected,
and not surprisingly, that wired brain then gets carried throughout
life and we give them a label that unfortunately gets
stigmatized negatively. We're working on that, but the bottom line
(11:54):
is PTSD percolates throughout many DSM diagnoses. You see arbit
with major depression, you see a coll rbid with bipolar disorder.
If you have PTSD, you're more likely to have your
first psychotic episode of schizophrenia. So addiction exactly, Yeah, and
that's another whole podcast for you, right is addiction as
(12:15):
an attempt to self medicate PTSD. And then people focus
on the addiction and the actual reason for that dysphoria
or distressed is put into the background.
Speaker 2 (12:29):
You're listening to the psychedelic report that leads us up
to best el Vandercole yes.
Speaker 1 (12:35):
So he started at the Boston VA in nineteen seventy
eight and immediately started working with these raally traumatized vets
that he developed a passion to try to help and
continues to do that to today. You know his iconic book,
The Body Keeps the Score is a classic and I
recommend it to a lot of my patients to read,
as well as my colleagues. But he and a group
(12:58):
of his colleagues who strongly believed in the importance to
define complex PTSD, which was a subset of PTSD that
included increased functional impairment, significant negative kind of self judgment,
more severe interpersonal conflicts, and behaviors that could be aggressive
(13:23):
from a self protective sense, that those kinds of symptoms
complex PTSD should be differentiated in the DSM Diagnosis and
Statistics Manual as a separate diagnosis, and they lobbied hard,
but ultimately in twenty thirteen and again in twenty twenty
one when the DSM five came out in twenty thirteen
(13:47):
and d SM five TR in twenty twenty one, they
ignored the diagnosis of complex PTSD, and I professionally and personally,
I think it was an egregious error and it basically
continued to distance the subset that need help the most
from bringing attention and clinical attention in screening attention to
(14:09):
give them more visibility and to help them. Yeah, that
makes a lot of sense, and so enter MDMA assisted therapy. Yes.
So as long as I've been practicing for psychiatry for
thirty eight years, and throughout that time, we've never had
great treatments pharmacologically. You know, some of the best treatments
(14:31):
for PTSD of all types have been eye movement desensitization
and reprocessing what we call EMDR, and dialectic behavior therapy.
With Marshall Lenihan, who had her own traumatic experiences one
got her PhD to learn how to help herself and
ended up developing DBT as a tool to work with
(14:52):
other people who've been traumatized to work on a lot
of these behavioral and emotional and self regular tis to
read symptoms. And today DBT has the best evidence base
for helping people with what we call borderline personality disorder.
But underneath that really is the symptoms of post traumatic
stress disorder complex postmatitrust disorder. So we have a MDR,
(15:15):
we have DBT, we have cognitive behavioral therapy, exposure therapy,
and in the right hands with the right therapists, they
can be very helpful. But what's missing is tools in
our case as psychiatrists medications that may help facilitate the
therapists in either treating symptoms to allow a more aggressive
(15:39):
therapeutic approach, or in the case of that MDMA, which
I personally think is a really smart strategy early in
the treatment, to give them an actogen. You MDMA, which
is sometimes called it an actogen, releases a lot of serotonin.
It improves the ability of social comfort, It makes people
(16:02):
more able to access what otherwise are difficult, painful traumatic memories.
And when that's done, in the case of the clinical
trials for MDMA, after three intensive therapy sessions of a
two therapists to get to know each other, so now
you have trust and relationship, and then you just have
three sessions where you take MDMA which helps facilitate the
(16:26):
unmasking or the bringing to the surface material that had
been stuck. And then that becomes the foundation of the
next nine sessions which are intensive all with the same therapists,
safe environment, et cetera, to then process and reconsolidate those memories.
(16:49):
And this is a simplistic example, but from what we
call the amigdala, you know, stored of a visceral, raw
reptilian emotion, where it just pokes through and it's overwhelming
to reframe it from being stuck there to storing it
in the pre framal cortex where it becomes part of
our biographical memory, and then it makes sense and we
(17:09):
can remember it without the amygdola flipping on our fight
or flight in all of the other really difficult symptoms
of PTSD. So the model I started following probably fifteen
years ago, and you know, through my own research, when
I read, after I read the vote by the Advisory Board,
(17:31):
I was really perplexed. So I did the fourth vote, Yeah,
the June fourth vote by the Advisory Board, and the
Advisory Board voted nine to two that it did not
show good enough efficacy versus harm and ten to one
that did not have better benefits than risks. And I
was really disturbed, surprised, and frustrated by that. And I
(17:56):
don't know the answer to this, But the question I
asked myself was what background did those Advisory board members
have on PTSD, on the big picture, on the fact
that MDMA was registered as a new drug application in
two thousand and one, that was twenty three years ago.
(18:16):
So the FDA started working with maps and the people
looking at MDMA for PTSD twenty three years ago, and
in twenty seventeen, which is seven years ago, the FDA
awarded fast track status. In all the documentation from twenty seventeen,
there was this ongoing collaboration where from my reading, a
(18:40):
lot of the issues that were raised by the Advisory
Board had already been talked about in processed through that
correspondence between the FDA and MAPS over those seven years
that the clinical trials were being done. And so it
left me confused. And I think the way I made
(19:01):
sense of it, or still make sense of it, not
that I agree with it, is that it seems like
the missing link with the FDA is having a lack
of awareness and understanding of the fact that this treatment
is really a psychotherapy treatment. And you know, there are
fifteen sessions, very long sessions with a skilled clinicians who
(19:22):
are trained to work on helping someone rise above the
difficulty and pain and suffering at PTSD, and the purpose
of the MDA is very specific. It's at the early
part of treatment to kind of shake the traumatic experiences
loose so that they'll be more easily accessed and then
(19:44):
allow for those final nine sessions to help the person
who's suffering to help them reintegrate. And as the study showed,
there was a significant improvement in the CAPS five score
in the Shann disability score. And so the bottom line
is in the.
Speaker 2 (19:59):
CAPS five is a no joke, serious survey assessment of
PTSD or requires. It can't be just done online. You
have to have somebody administer it. And it's a very
extensive questionnaire, well validated and well validated.
Speaker 1 (20:13):
And the other part of the study, the studies that
I was really oppressed that it was multi ethnic, so
you crossed a whole line of cultural and racial and
gender demographics. And in addition to that, the majority of
people met criteria for severe PTSD. I think it was
like sixty five or seventy percent had severe and the
(20:35):
other thirty percent had moderate. So you're not talking about
people with mild PTSD. You're talking about really impaired individuals.
And these are the people that untreated are going to
end up disenfranchised, homeless, incarcerated, divorced, suicidal, suicidal, or tragically
commit suicide. And a turn to substances is a way
(20:58):
to try to self medicate something they feel they can't control,
but they know they need help for and so you
put it all together. It was a disappointing finding that
from my window, it seems like they didn't utilize all
the data that should go into such an important decision.
My biggest concern is that if the FDA does not
(21:21):
vote to approve it regardless, and they've done this before.
They did this with one of the monoclinal antibodies for Alzheimer's,
that will unanimously denied approval, but the FDA, based on
other factors in their bucket of information, ended up approving it.
So ultimately, the FDA is just taking the Advisory Board's
decision as an opinion or a recommendation. But my hope
(21:46):
is the FDA looks at the big picture and all
of the information they have and all of the input
from credible sources, because if they do vote to deny approval,
my fear is it's going to delay necessary, essential, compassionate
treatment to people with severe PTSD, possibly for decades. Yeah,
(22:07):
it's not fair. It's just not fair to the people
who are suffering. It's not fair to the clinicians who
know what needs to be done and who just need
the tools to do it.
Speaker 2 (22:20):
You're listening to the psychedelic report. Yeah, it's in the
complete disservice of patients and veterans which are disproportionate per
capita rates of PTSD and suicide rates. So this, you know,
the effect on the vulnerable patient population that just finally
(22:40):
now received their diagnostic code, right, just forty four years
ago to be able to have an understanding of what's
going on that will be paid for and covered as
treatment of an illness only had two medications, right, it's
a sum up what we've been talking about. Two medications
that work that maybe inducesion in like thirty percent of people,
(23:01):
and they don't work that great, and they have lots
of side effects, right, Like Paxel has known severe withdrawal
effects that make it very very hard to stop taking both.
So often packs will have black box warnings, which is
the most severe label n FT eight can give to
any drug for increased rates of suicide right in young people,
in children and teens who are taking people under twenty four.
Speaker 1 (23:23):
For that box warning, I'll give it context. Any drug
that's an antidepressant gets that warning, right, And then it
was based on the FDA reviewing ten thousand patients at
the time. It was in the nineties, so it was
SSR eyes at Center Eyes and there fortunately were no suicides,
but there was the highest signal for people under the
age of twenty five for suicidal thoughts and behaviors. So
(23:47):
we insocietry have never really believed that to be a
good decision by the FDA's perspective. But to your other point,
ssriyes have lots of side effects, and not to mention,
you know, Paxel has one of the most severe withdrawals,
but all of them do, right, because you basically is
(24:07):
in the long year on at the higher dose, the
worse it is. But you also have cognitive dulling, You
have emotional bunting. You have people who become a little apathetic,
which other people around them know and they think it's
they're not depressed. It's like, no, it's not that you're
not depressed. Your brain's a little blunted because you know,
you're blunted when your race eratonin in your brain circuitry,
(24:28):
you're lowering dopamine, which is the cognitive motivational interest in
our transmitter. And not to mention, about seventy percent or
more have significant sexual dysfunction.
Speaker 2 (24:39):
Yeah, exactly, and those are very very significant side effects
that MDMA assisted therapy delivered under protocol does not have. Right.
And MDMA, you know, again bringing it full circle you're
talking about earlier, this would be only the third medication
FDA cleared medication that is really being cleared as a
(25:01):
therapy accelerant, right. Yeah, Like, it's not the MDMA alone
that is having the effect. It's the MDMA that is
neurochemically amplifying the safety cascades in our insult cortex and
olympic system that tells the amigala, hey, you don't need
to be blowing up right now, we're not under threat.
(25:22):
We can divert resources back to the empathy, recovery healing systems, right,
and is basically helping people feel safe enough to remake
meaning around past traumatic events.
Speaker 1 (25:33):
Yeah, I love I love your use of the word
accelerants because you know that one of the biggest challenges
in psychiatry is the delayed effect of any kind of treatment,
be it pharmac and therapy or medication therapy. And to
have a drug like MDMA, which at the end of
the sixth session that you're done with the MDMA and
(25:54):
now you're going to dig into the real work and
the MDMA has been there to amplify, to accelerate, to
allow that traumatized brain to access the roadblocks so that hopefully,
over the next several months they make gains. And as
(26:14):
the trials have shown, a lot of gains have been
made with this protocol.
Speaker 2 (26:18):
Right, And so it makes sense why so many clinicians
and researchers are upset and surprised and screaming about making
sure the FDA makes the right decision and evaluates the
whole data set on this study and understands and actually
looks at the outcomes and actually looks at the risks
(26:40):
and evaluates them objectively, because it seems like the committee,
the advisory committee that voted on June fourth, was not
objective and didn't have the expertise in PTSD or psychedelics
or the context of PTSD and what we have to
date that's not working and who's suffering to basically make
(27:00):
a statement with their vote that says we believe it's
safer to continue to live with PTSD than it is
to receive MDMA assisted therapy from a trained profession.
Speaker 1 (27:09):
You know, I would say, ask any family member of
someone with PTSD if they believe that statement.
Speaker 2 (27:14):
And I don't know a smile person who believes that statement.
But if you're a clinician or a person with PTSD
or a family member, you definitely know.
Speaker 1 (27:21):
If you live it, you see it. It would be
like saying, let's not give people with schizophrenia antipsychotic medications,
And it's like, why would you not do that? Look
at what they do. They decrease hospitalization, they decrease suicide,
they increase functionality. The earlier you treat, the better their outcome.
So let's get them on board, let's use them. And
I really do I think it's a fair analogy for
(27:43):
MDMA and the context of PTSD.
Speaker 2 (27:46):
Except a VMA has even way less side effects than
any psychotic medication like that.
Speaker 1 (27:50):
Well yeah, and you're only using it for three section.
The analogy is meant to be in terms of providing
a good treatment that's needed.
Speaker 2 (27:58):
Exactly with that significant side effect profile and the psychotics have,
we still don't deprive patients and physicians of using them.
And so what this really brings to mind for me,
you know, is the FDA vote on August eleventh, which
we just realized as the Sunday. But maybe so maybe
it's August twelfth, but sometime coming up real soon in
(28:20):
the next few days is critical. CNN just published an
article that's been around a few different places in the
news right now that is entitled, with FDA decision looming,
bipartisan group of lawmakers urged support for MBMA to treat PTSD,
And it's a really nicely written piece about bipartisan support
(28:43):
for this treatment and moving this forward. And you know,
I think it's interesting to see this in the public
media and the political environment in such a big way.
But it does impact so many people, and in my
in mind know base, you know, to me, this seems
relatively unprecedented, right where and correct me if I'm wrong here.
(29:07):
I love to hear your your thoughts because you've been
at this a lot longer than I have. But when
we think about, you know, what's happened over this journey
with MDMA assistant therapy. There was a radical anti capitalist
group that doesn't believe the veterans have a right to heal.
But regardless, they are a group that is directly advocating
(29:28):
and lobbying the FDA Committee and the FDA to reject
MDMA assistant therapy to treat all these people who are
suffering a need that we just talked about, and I've
never heard of that happening before, where there's some a
group actually trying to shut down a treatment from getting out.
I've heard about protesting to make it out out, but
not the opposite. And then we also have clinicians now
(29:49):
coming out and researchers saying, hey, you got to pay
attention to this. This is really important, Like, we have
to get this over the line. It's significant, and if
we don't, it's going to be really really bad, right,
like what you were saying earlier. And then we also
have now politicians on both sides urging the president to
ensure that this goes through. This is unprecedented, right.
Speaker 1 (30:10):
It is unprecedented. And I think an important piece of
all this is it's a paradigm changing treatment in medicine,
and institutions have a hard time with paradigm changes. I
studied as a biochemist before I went to medical school,
and one of my favorite quotes about science and scientists
and developing our knowledge base is that old scientists don't
(30:35):
adopt new paradigms. They simply die off. You know. Hopefully
that doesn't happen. Hopefully that people will objectively look at
all the new information and even though you know they've
been doing the same thing for thirty forty fifty, sixty
seventy years, the wisdom in them or the collective goal
of moving forward with science and with medicine and with
(30:57):
healing and with helping people, that we am race the
new paradigm changer, because in fact, it's going to make
a huge difference in in quality of life and functionality,
and everyone wins.
Speaker 2 (31:11):
I completely agree with you, and you know, I think
your background insight has just been really informative and educational.
I've learned a lot from our conversation and I really
appreciate you taking the time to join me today. You know,
I just wanted to end with you know, the FDA
decision again is just a few days away, and listeners
are going to be wondering do we just sit on
(31:33):
our hands the whole the whole time we're waiting for
this announcement or is there anything we can do? And
I wanted to finish by just asking you, you know,
is there anything people can do who are listening to
try to help?
Speaker 1 (31:44):
Well? I think we're seeing some of that with you know,
the Congress and the Senate where my guests is the
reason that they're you know, lobbying President Biden to get
involved and to support the approval of this treatment is
because the senators and the congress people are getting a
lot of calls from their constituents saying, we really need
(32:07):
this treatment. You know, my son, my daughter, my husband,
my wife needs this treatment. So certainly the lot or
the noise from the general population that does have an impact.
And the article you reference today is an example of that.
But we as clinicians and I certainly you know, apply
(32:28):
to you and your efforts in your podcast and all
that you do to try to move our treatment paradigms
forward are important. But it's one of those cases where
we have to verbalize and we need to ourselves as
treats and clinicians and our patients, you know, go through
our channels to advocate and make it clear why this
(32:51):
is important. And I know in my own case, you know,
I write an editorial every month and hopefully that gets
read and hopefully that inspires people to talk more about it,
like your podcast. So it's kind of a nervous week
coming up because I've been excited about this model for
years and was really expecting it to just move through
(33:15):
based on the quality of the data, you know, simply
based as a scientist, based on the quality of the data.
And when I ever heard the outcome of the advisory
board vote, I was very confused and disturbed, which is
why I did a deeper dive into it, and I
actually went back and read the PowerPoint that was given
to all of the people on the ad board. And
(33:37):
so here we are, as you said, let's make it happen.
Speaker 2 (33:42):
I love that. That's a great place to end, and
I just want to thank you again, doctor John Miller.
Speaker 1 (33:48):
Thank you for having me and keep up your good work.
Speaker 2 (33:51):
Thank you you too. Thanks thanks for listening to The
Psychedelic Report. Visit us at the Psychedelical for This show
is recorded weekly on Clubhouse with a live audience. The
Psychedelic Report was brought to you by apoly Neuroscience and
produced by Future Medicine Media. While I am a doctor,
(34:15):
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.
Speaker 2 (00:03):
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The Psychedelic Report was brought to you by Apoll Neuroscience
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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.
(01:21):
Today we're discussing an article recently published by CNN on
August fifth, twenty twenty four, entitled, with FDA decision looming,
Bipartisan group of lawmakers urge support for MDMA to treat PTSD.
This is a fascinating article and very detailed report discussing
how the impact of MDMA assisted therapy for PTSD is
(01:45):
so significant that politicians on both sides are coming forward
to urge President Biden to make sure that this treatment
gets over the line. The vote by the FDA on
MBMA assisted therapy clearance or approval is expected on August
eleventh of twenty twenty four, just a few more days away,
and with that decision looming, a decision that is critically
(02:07):
important for all veterans and any American with PTSD or
with suspected PTSD, which, as we discuss, could be as
many as fifteen percent of Americans. I have a very
special guest expert to join me to discuss the state
of affairs of PTSD treatment, the meaning of the approval
(02:27):
of something like MBMA assisted therapy for veterans, and what
it could mean if the FDA decides not to do
their diligence and trust the advisory committee that provided biased
information to them about the risks of MDMA therapy, which
from the study data, when practiced according to protocol, are
minimal and less than most current antidepressants available. Our special
(02:53):
guest today is doctor John J. Miller. Doctor Miller is
the medical director at Brain Health and Exeter in New Hampshire,
and has served as the editor in chief for Psychiatric
Times since February twenty nineteen. He has worked for thirty
eight years as a clinical psychopharmacologist, most recently seventeen years
as a staff psychiatrist at Seacoast Mental Health Center in Exeter,
(03:14):
New Hampshire. Doctor Miller completed his bachelors in Science in
biochemistry at U mass Amherst, and he completed medical school
and residency in adult psychiatry at UMSS Worcester. Doctor Miller
is also a Diplomat of the American Board of Psychiatry
and Neurology. Since nineteen ninety eight, doctor Miller has presented
more than three thousand lectures throughout the us on a
(03:36):
wide range of psychiatric topics, including PTSD post dramatic stress disorder.
You can find doctor Miller in his monthly editorials for
Psychiatric Times that he has been authoring since March or
twenty nineteen. Doctor John Miller, thank you so much for
taking the time out of your busy schedule to join
me today.
Speaker 1 (03:54):
Thank you, Doctor Revan. It's a pleasure to be here,
and I really enjoyed our last conversation and look forward
to having a discussion with you about such an important topic.
Speaker 2 (04:05):
I really appreciate that and have enjoyed my conversations with
you as well, especially given your expertise in the field
of PTSD and your background on this, which is relevant
today because we're just a few days away from the
FDA decision around MBMA assistant therapy as the newest, most
(04:27):
successful and promising treatment for PTSD and chronic PTSD as well,
and we have not had a lot of good treatments
for these over the years. So I was wondering could
you run through for us the brief history of PTSD
and kind of how we got here today.
Speaker 1 (04:43):
Yes, I'd be delighted too. It's really one of those
psychiatric or medical tragedies, which it's a diagnosis that continues
to fight for treatment and acknowledgment. But we can go
all the way back to good old Sigmund Freud. In
the late eighteen hundreds, he published a case series of
(05:04):
women diagnosed with hysteria and he proposed that childhood abuse
was the likely ideology. In fact, the paper was called
the Ideology of Hysteria, and it was very quickly scorned
and shunned, and he was humiliated by his colleagues to
the point that he retracted it. And that just in
that time, it puts into context how suppressed or oppressed
(05:26):
or disconnected we were from the effects of trauma. My
own grandfather was a medic in Germany and nineteen eighteen
World War One on the front lines, and you know,
he was gassed, He saw a lot of really bad
stuff and when he came back his life was changed,
which my grandmother's diary reflects. And back then they called
(05:48):
it shell shock and it was viewed as a weakness.
And if we jump ahead to World War Two, you know,
one of the quintessential themes there was George Pattern, General
George Pattern, who basically slapped a bunch of soldiers who
had been an incredible warfare and traumatic experiences and blood
(06:11):
and death, and he called them messissies because they were
basically suffering from PTSD, and Eisenhower ultimately reassigned him, which
was interestingly when he was reassigned to northern Europe, the
Germans thought that's where the D Day was going to occur.
So it has this interesting historical connection. But the good
news was people with PTSD have continued to advocate for themselves,
(06:37):
and the Vietnam veterans did an outstanding job saying, you know,
there's a lot here. You got to help us. This
is not right. We're trying to help each other. We
need your help. And finally, in nineteen eighty, not that
long ago, Diagnostic and Statistics Manual of Mental Illness the
third Issue finally recognized and introduced a diagnosis of post
(07:00):
traumatic stress disorder. And basically the definition has remained similar to today,
so I won't repeat it. But what did happen in the.
Speaker 2 (07:10):
Early twoes, So this was like nineteen eighties, nineteen.
Speaker 1 (07:15):
DSM three entered in nineteen eighty and that was when
the American Psychiatric Association finally recognized post traumatic stress or
as a real disorder. So forty four years ago not
a long time ago, you know, I had just graduated
from college, you know, so it's in our lifetimes. And
(07:35):
back then we had nothing to treat it, and we
talked about it, and you know, there was lots of approaches.
We didn't get our first drug approof of PTSD until
nineteen ninety nine, and that was aloft generic searchrali, which
is a serotonin reuptake inhibitor, and it showed benefit with
a lot of anxiety disorders as well as major depression
(07:58):
and other things. And Tafaiza's credit, they studied it aggressively
and they got approval, and a few years later paxil
prooxidy and got approval, And so here we are twenty
four years later, and those are the only two drugs
that are FDA approved for PTSD. And they're not really
that great. I mean, they work a little bit. They
(08:19):
help some people. They work better in people who've had
a single traumatic experience. They don't work well for people
who've had a lot of childhood trauma, or a lot
of military trauma, or a lot of just adult tough life,
living in dangerous places trauma. And that's the population that
suffers the most, and ultimately down the road a lot
(08:42):
of them end up with significant functional impairment and get
marginalized in homelessness and unemployment and divorces and financial issues
and difficulty functioning. And so it remains this huge unmet
need and probably around and two thousand and nine twenty ten,
(09:03):
one of our thought leaders in PTSD.
Speaker 2 (09:07):
Before you go on to Bessel, when you talk about
the unmet need, could you just give us an idea
because you mentioned very importantly that PTSD wasn't even a
diagnosis in psychiatry until nineteen eighty and subsequent to that
it has been heavily stigmatized. Even so, because it's a
new diagnosis and it is widely underreported, right, trauma that
(09:31):
itself is often stigmatized. So we have some idea of
the number of veterans and civilians who are who are
reported to have PTSD diagnoses. But how many people would
you guess or estimate, you know, nationwide to suffer from
symptoms of PTSD treated or untreated, because guest my guess
(09:53):
as a psychiatrist who see these kinds of folks is
you know, somewhere in the order of like you know,
forty to eighty million, But I don't know. I'm just
just guessing.
Speaker 1 (10:02):
Yeah, So I'll go to statistics percentages, which gives me
a frame around the what subset of the population. And
you know, based on papers that I've read, if you
look at an experience that would rise to the level
of meeting criteria for PTSD, which means you've had this
(10:24):
traumatic experience. It either affected you directly or someone close
to you directly, and those symptoms are persistent for thirty
days or longer, because by definition, thirty days are longer.
So when you look at the percentage people who've had
a traumatic experience like that, it's estimated to be fifty
percent of everybody in the United States. One and two.
(10:46):
If you look at the percentage that then go on
to develop post stress disorder, it's somewhere between ten and
fifteen percent, So that's one in ten people. Now, some
of that may be mild PTSD, but significant subset is
more impairing. And one of the difficulties with DSM in
(11:09):
psychiatric nosology is that a lot of severe personality disorders,
especially what we call a borderline personality. Up to ninety
percent of them had had severe childhood abuse most of
the time, sexual abuse, severe emotional abuse, physical abuse. And
so while their brains are wiring between the age of
(11:32):
two and fifteen, they're always in a state of being fearful, afraid, unsafe, unprotected,
and not surprisingly, that wired brain then gets carried throughout
life and we give them a label that unfortunately gets
stigmatized negatively. We're working on that, but the bottom line
(11:54):
is PTSD percolates throughout many DSM diagnoses. You see arbit
with major depression, you see a coll rbid with bipolar disorder.
If you have PTSD, you're more likely to have your
first psychotic episode of schizophrenia. So addiction exactly, Yeah, and
that's another whole podcast for you, right is addiction as
(12:15):
an attempt to self medicate PTSD. And then people focus
on the addiction and the actual reason for that dysphoria
or distressed is put into the background.
Speaker 2 (12:29):
You're listening to the psychedelic report that leads us up
to best el Vandercole yes.
Speaker 1 (12:35):
So he started at the Boston VA in nineteen seventy
eight and immediately started working with these raally traumatized vets
that he developed a passion to try to help and
continues to do that to today. You know his iconic book,
The Body Keeps the Score is a classic and I
recommend it to a lot of my patients to read,
as well as my colleagues. But he and a group
(12:58):
of his colleagues who strongly believed in the importance to
define complex PTSD, which was a subset of PTSD that
included increased functional impairment, significant negative kind of self judgment,
more severe interpersonal conflicts, and behaviors that could be aggressive
(13:23):
from a self protective sense, that those kinds of symptoms
complex PTSD should be differentiated in the DSM Diagnosis and
Statistics Manual as a separate diagnosis, and they lobbied hard,
but ultimately in twenty thirteen and again in twenty twenty
one when the DSM five came out in twenty thirteen
(13:47):
and d SM five TR in twenty twenty one, they
ignored the diagnosis of complex PTSD, and I professionally and personally,
I think it was an egregious error and it basically
continued to distance the subset that need help the most
from bringing attention and clinical attention in screening attention to
(14:09):
give them more visibility and to help them. Yeah, that
makes a lot of sense, and so enter MDMA assisted therapy. Yes.
So as long as I've been practicing for psychiatry for
thirty eight years, and throughout that time, we've never had
great treatments pharmacologically. You know, some of the best treatments
(14:31):
for PTSD of all types have been eye movement desensitization
and reprocessing what we call EMDR, and dialectic behavior therapy.
With Marshall Lenihan, who had her own traumatic experiences one
got her PhD to learn how to help herself and
ended up developing DBT as a tool to work with
(14:52):
other people who've been traumatized to work on a lot
of these behavioral and emotional and self regular tis to
read symptoms. And today DBT has the best evidence base
for helping people with what we call borderline personality disorder.
But underneath that really is the symptoms of post traumatic
stress disorder complex postmatitrust disorder. So we have a MDR,
(15:15):
we have DBT, we have cognitive behavioral therapy, exposure therapy,
and in the right hands with the right therapists, they
can be very helpful. But what's missing is tools in
our case as psychiatrists medications that may help facilitate the
therapists in either treating symptoms to allow a more aggressive
(15:39):
therapeutic approach, or in the case of that MDMA, which
I personally think is a really smart strategy early in
the treatment, to give them an actogen. You MDMA, which
is sometimes called it an actogen, releases a lot of serotonin.
It improves the ability of social comfort, It makes people
(16:02):
more able to access what otherwise are difficult, painful traumatic memories.
And when that's done, in the case of the clinical
trials for MDMA, after three intensive therapy sessions of a
two therapists to get to know each other, so now
you have trust and relationship, and then you just have
three sessions where you take MDMA which helps facilitate the
(16:26):
unmasking or the bringing to the surface material that had
been stuck. And then that becomes the foundation of the
next nine sessions which are intensive all with the same therapists,
safe environment, et cetera, to then process and reconsolidate those memories.
(16:49):
And this is a simplistic example, but from what we
call the amigdala, you know, stored of a visceral, raw
reptilian emotion, where it just pokes through and it's overwhelming
to reframe it from being stuck there to storing it
in the pre framal cortex where it becomes part of
our biographical memory, and then it makes sense and we
(17:09):
can remember it without the amygdola flipping on our fight
or flight in all of the other really difficult symptoms
of PTSD. So the model I started following probably fifteen
years ago, and you know, through my own research, when
I read, after I read the vote by the Advisory Board,
(17:31):
I was really perplexed. So I did the fourth vote, Yeah,
the June fourth vote by the Advisory Board, and the
Advisory Board voted nine to two that it did not
show good enough efficacy versus harm and ten to one
that did not have better benefits than risks. And I
was really disturbed, surprised, and frustrated by that. And I
(17:56):
don't know the answer to this, But the question I
asked myself was what background did those Advisory board members
have on PTSD, on the big picture, on the fact
that MDMA was registered as a new drug application in
two thousand and one, that was twenty three years ago.
(18:16):
So the FDA started working with maps and the people
looking at MDMA for PTSD twenty three years ago, and
in twenty seventeen, which is seven years ago, the FDA
awarded fast track status. In all the documentation from twenty seventeen,
there was this ongoing collaboration where from my reading, a
(18:40):
lot of the issues that were raised by the Advisory
Board had already been talked about in processed through that
correspondence between the FDA and MAPS over those seven years
that the clinical trials were being done. And so it
left me confused. And I think the way I made
(19:01):
sense of it, or still make sense of it, not
that I agree with it, is that it seems like
the missing link with the FDA is having a lack
of awareness and understanding of the fact that this treatment
is really a psychotherapy treatment. And you know, there are
fifteen sessions, very long sessions with a skilled clinicians who
(19:22):
are trained to work on helping someone rise above the
difficulty and pain and suffering at PTSD, and the purpose
of the MDA is very specific. It's at the early
part of treatment to kind of shake the traumatic experiences
loose so that they'll be more easily accessed and then
(19:44):
allow for those final nine sessions to help the person
who's suffering to help them reintegrate. And as the study showed,
there was a significant improvement in the CAPS five score
in the Shann disability score. And so the bottom line
is in the.
Speaker 2 (19:59):
CAPS five is a no joke, serious survey assessment of
PTSD or requires. It can't be just done online. You
have to have somebody administer it. And it's a very
extensive questionnaire, well validated and well validated.
Speaker 1 (20:13):
And the other part of the study, the studies that
I was really oppressed that it was multi ethnic, so
you crossed a whole line of cultural and racial and
gender demographics. And in addition to that, the majority of
people met criteria for severe PTSD. I think it was
like sixty five or seventy percent had severe and the
(20:35):
other thirty percent had moderate. So you're not talking about
people with mild PTSD. You're talking about really impaired individuals.
And these are the people that untreated are going to
end up disenfranchised, homeless, incarcerated, divorced, suicidal, suicidal, or tragically
commit suicide. And a turn to substances is a way
(20:58):
to try to self medicate something they feel they can't control,
but they know they need help for and so you
put it all together. It was a disappointing finding that
from my window, it seems like they didn't utilize all
the data that should go into such an important decision.
My biggest concern is that if the FDA does not
(21:21):
vote to approve it regardless, and they've done this before.
They did this with one of the monoclinal antibodies for Alzheimer's,
that will unanimously denied approval, but the FDA, based on
other factors in their bucket of information, ended up approving it.
So ultimately, the FDA is just taking the Advisory Board's
decision as an opinion or a recommendation. But my hope
(21:46):
is the FDA looks at the big picture and all
of the information they have and all of the input
from credible sources, because if they do vote to deny approval,
my fear is it's going to delay necessary, essential, compassionate
treatment to people with severe PTSD, possibly for decades. Yeah,
(22:07):
it's not fair. It's just not fair to the people
who are suffering. It's not fair to the clinicians who
know what needs to be done and who just need
the tools to do it.
Speaker 2 (22:20):
You're listening to the psychedelic report. Yeah, it's in the
complete disservice of patients and veterans which are disproportionate per
capita rates of PTSD and suicide rates. So this, you know,
the effect on the vulnerable patient population that just finally
(22:40):
now received their diagnostic code, right, just forty four years
ago to be able to have an understanding of what's
going on that will be paid for and covered as
treatment of an illness only had two medications, right, it's
a sum up what we've been talking about. Two medications
that work that maybe inducesion in like thirty percent of people,
(23:01):
and they don't work that great, and they have lots
of side effects, right, Like Paxel has known severe withdrawal
effects that make it very very hard to stop taking both.
So often packs will have black box warnings, which is
the most severe label n FT eight can give to
any drug for increased rates of suicide right in young people,
in children and teens who are taking people under twenty four.
Speaker 1 (23:23):
For that box warning, I'll give it context. Any drug
that's an antidepressant gets that warning, right, And then it
was based on the FDA reviewing ten thousand patients at
the time. It was in the nineties, so it was
SSR eyes at Center Eyes and there fortunately were no suicides,
but there was the highest signal for people under the
age of twenty five for suicidal thoughts and behaviors. So
(23:47):
we insocietry have never really believed that to be a
good decision by the FDA's perspective. But to your other point,
ssriyes have lots of side effects, and not to mention,
you know, Paxel has one of the most severe withdrawals,
but all of them do, right, because you basically is
(24:07):
in the long year on at the higher dose, the
worse it is. But you also have cognitive dulling, You
have emotional bunting. You have people who become a little apathetic,
which other people around them know and they think it's
they're not depressed. It's like, no, it's not that you're
not depressed. Your brain's a little blunted because you know,
you're blunted when your race eratonin in your brain circuitry,
(24:28):
you're lowering dopamine, which is the cognitive motivational interest in
our transmitter. And not to mention, about seventy percent or
more have significant sexual dysfunction.
Speaker 2 (24:39):
Yeah, exactly, and those are very very significant side effects
that MDMA assisted therapy delivered under protocol does not have. Right.
And MDMA, you know, again bringing it full circle you're
talking about earlier, this would be only the third medication
FDA cleared medication that is really being cleared as a
(25:01):
therapy accelerant, right. Yeah, Like, it's not the MDMA alone
that is having the effect. It's the MDMA that is
neurochemically amplifying the safety cascades in our insult cortex and
olympic system that tells the amigala, hey, you don't need
to be blowing up right now, we're not under threat.
(25:22):
We can divert resources back to the empathy, recovery healing systems, right,
and is basically helping people feel safe enough to remake
meaning around past traumatic events.
Speaker 1 (25:33):
Yeah, I love I love your use of the word
accelerants because you know that one of the biggest challenges
in psychiatry is the delayed effect of any kind of treatment,
be it pharmac and therapy or medication therapy. And to
have a drug like MDMA, which at the end of
the sixth session that you're done with the MDMA and
(25:54):
now you're going to dig into the real work and
the MDMA has been there to amplify, to accelerate, to
allow that traumatized brain to access the roadblocks so that hopefully,
over the next several months they make gains. And as
(26:14):
the trials have shown, a lot of gains have been
made with this protocol.
Speaker 2 (26:18):
Right, And so it makes sense why so many clinicians
and researchers are upset and surprised and screaming about making
sure the FDA makes the right decision and evaluates the
whole data set on this study and understands and actually
looks at the outcomes and actually looks at the risks
(26:40):
and evaluates them objectively, because it seems like the committee,
the advisory committee that voted on June fourth, was not
objective and didn't have the expertise in PTSD or psychedelics
or the context of PTSD and what we have to
date that's not working and who's suffering to basically make
(27:00):
a statement with their vote that says we believe it's
safer to continue to live with PTSD than it is
to receive MDMA assisted therapy from a trained profession.
Speaker 1 (27:09):
You know, I would say, ask any family member of
someone with PTSD if they believe that statement.
Speaker 2 (27:14):
And I don't know a smile person who believes that statement.
But if you're a clinician or a person with PTSD
or a family member, you definitely know.
Speaker 1 (27:21):
If you live it, you see it. It would be
like saying, let's not give people with schizophrenia antipsychotic medications,
And it's like, why would you not do that? Look
at what they do. They decrease hospitalization, they decrease suicide,
they increase functionality. The earlier you treat, the better their outcome.
So let's get them on board, let's use them. And
I really do I think it's a fair analogy for
(27:43):
MDMA and the context of PTSD.
Speaker 2 (27:46):
Except a VMA has even way less side effects than
any psychotic medication like that.
Speaker 1 (27:50):
Well yeah, and you're only using it for three section.
The analogy is meant to be in terms of providing
a good treatment that's needed.
Speaker 2 (27:58):
Exactly with that significant side effect profile and the psychotics have,
we still don't deprive patients and physicians of using them.
And so what this really brings to mind for me,
you know, is the FDA vote on August eleventh, which
we just realized as the Sunday. But maybe so maybe
it's August twelfth, but sometime coming up real soon in
(28:20):
the next few days is critical. CNN just published an
article that's been around a few different places in the
news right now that is entitled, with FDA decision looming,
bipartisan group of lawmakers urged support for MBMA to treat PTSD,
And it's a really nicely written piece about bipartisan support
(28:43):
for this treatment and moving this forward. And you know,
I think it's interesting to see this in the public
media and the political environment in such a big way.
But it does impact so many people, and in my
in mind know base, you know, to me, this seems
relatively unprecedented, right where and correct me if I'm wrong here.
(29:07):
I love to hear your your thoughts because you've been
at this a lot longer than I have. But when
we think about, you know, what's happened over this journey
with MDMA assistant therapy. There was a radical anti capitalist
group that doesn't believe the veterans have a right to heal.
But regardless, they are a group that is directly advocating
(29:28):
and lobbying the FDA Committee and the FDA to reject
MDMA assistant therapy to treat all these people who are
suffering a need that we just talked about, and I've
never heard of that happening before, where there's some a
group actually trying to shut down a treatment from getting out.
I've heard about protesting to make it out out, but
not the opposite. And then we also have clinicians now
(29:49):
coming out and researchers saying, hey, you got to pay
attention to this. This is really important, Like, we have
to get this over the line. It's significant, and if
we don't, it's going to be really really bad, right,
like what you were saying earlier. And then we also
have now politicians on both sides urging the president to
ensure that this goes through. This is unprecedented, right.
Speaker 1 (30:10):
It is unprecedented. And I think an important piece of
all this is it's a paradigm changing treatment in medicine,
and institutions have a hard time with paradigm changes. I
studied as a biochemist before I went to medical school,
and one of my favorite quotes about science and scientists
and developing our knowledge base is that old scientists don't
(30:35):
adopt new paradigms. They simply die off. You know. Hopefully
that doesn't happen. Hopefully that people will objectively look at
all the new information and even though you know they've
been doing the same thing for thirty forty fifty, sixty
seventy years, the wisdom in them or the collective goal
of moving forward with science and with medicine and with
(30:57):
healing and with helping people, that we am race the
new paradigm changer, because in fact, it's going to make
a huge difference in in quality of life and functionality,
and everyone wins.
Speaker 2 (31:11):
I completely agree with you, and you know, I think
your background insight has just been really informative and educational.
I've learned a lot from our conversation and I really
appreciate you taking the time to join me today. You know,
I just wanted to end with you know, the FDA
decision again is just a few days away, and listeners
are going to be wondering do we just sit on
(31:33):
our hands the whole the whole time we're waiting for
this announcement or is there anything we can do? And
I wanted to finish by just asking you, you know,
is there anything people can do who are listening to
try to help?
Speaker 1 (31:44):
Well? I think we're seeing some of that with you know,
the Congress and the Senate where my guests is the
reason that they're you know, lobbying President Biden to get
involved and to support the approval of this treatment is
because the senators and the congress people are getting a
lot of calls from their constituents saying, we really need
(32:07):
this treatment. You know, my son, my daughter, my husband,
my wife needs this treatment. So certainly the lot or
the noise from the general population that does have an impact.
And the article you reference today is an example of that.
But we as clinicians and I certainly you know, apply
(32:28):
to you and your efforts in your podcast and all
that you do to try to move our treatment paradigms
forward are important. But it's one of those cases where
we have to verbalize and we need to ourselves as
treats and clinicians and our patients, you know, go through
our channels to advocate and make it clear why this
(32:51):
is important. And I know in my own case, you know,
I write an editorial every month and hopefully that gets
read and hopefully that inspires people to talk more about it,
like your podcast. So it's kind of a nervous week
coming up because I've been excited about this model for
years and was really expecting it to just move through
(33:15):
based on the quality of the data, you know, simply
based as a scientist, based on the quality of the data.
And when I ever heard the outcome of the advisory
board vote, I was very confused and disturbed, which is
why I did a deeper dive into it, and I
actually went back and read the PowerPoint that was given
to all of the people on the ad board. And
(33:37):
so here we are, as you said, let's make it happen.
Speaker 2 (33:42):
I love that. That's a great place to end, and
I just want to thank you again, doctor John Miller.
Speaker 1 (33:48):
Thank you for having me and keep up your good work.
Speaker 2 (33:51):
Thank you you too. Thanks thanks for listening to The
Psychedelic Report. Visit us at the Psychedelical for This show
is recorded weekly on Clubhouse with a live audience. The
Psychedelic Report was brought to you by apoly Neuroscience and
produced by Future Medicine Media. While I am a doctor,
(34:15):
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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