On this episode of Wellness Unmasked, Dr. Nicole Saphier breaks down a major new development out of the White House: an executive order aimed at accelerating research into psychedelic therapies for mental health.
What does this mean for patients struggling with treatment-resistant depression, PTSD, and addiction? And could substances like psilocybin, MDMA, and ibogaine represent the next frontier in medicine—or a risky leap too far?
Dr. Saphier explores the science behind how these compounds interact with key brain systems like serotonin, dopamine, and opioid receptors, why traditional treatments often fall short, and what the data really says about effectiveness and risk. From promising clinical results to serious safety concerns—including cardiac risks and long-term psychological effects—this episode separates hype from reality.
Plus, a closer look at how the new policy could fast-track access for veterans and others battling severe mental illness, and why caution is still critical as research evolves.
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Episode Transcript
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Speaker 1 (00:04):
Welcome to Wellness and mass I'm doctor Nicole Safire and
I have an interesting topic to talk to you about today.
I'm not sure if you've caught the press conference over
the weekend, but President Trump, straight from the Oval Office,
was working on Saturday morning and he had a lot
of people behind him, including Secretary Kennedy FTA, Commissioner Macarey,
and he also had Joe Rogan behind him. Now what
(00:25):
were they all doing in the Oval Office on a
beautiful Saturday, Well, it kind of felt like we were
being transported back to the seventies. Now what do I
mean by that, Well, because they were talking about psychedelic medications,
and this executive order is aimed at accelerating research and
access to medications like psilocybin, MDMA, LSD. I'm not sure
(00:47):
if you knew that, but yeah, we have been studying
these for decades in how that they may be able
to help us with addiction and refractory cases of mental illness. Now,
one that's specifically getting a lot of tension right now
from the Oval Office is I begin ibogain is a
little bit different than the others. While most psychedelics that
have been studied, like silos cybin and MDMA. They primarily
(01:11):
work through serotonin pathways, and they've been used for depression PTSD.
Ibogain has a much broader pharmacologic profile. Not only does
it interact with serotonin, but also opioid receptors and dopamine receptors.
So while before we can jump into what this executive
order even does, I want to take a step back
(01:33):
for a minute, because when we talk about mental health
and the potential treatments for it, we really are talking
about chemistry at the most basic level. I want to
make sure that we all understand it. It's always a
good refresher for me, and I want to make sure
that you understand it too. So again, at the most
basic level, our mood, our behavior, and even how we
process trauma, it's all influenced by a few key neurotransmitter systems.
(01:58):
Their proteins, their peptides, their hormones, chemicals, all happening in
our body and specifically in our brain. Serotonin. I know
you've heard me talk about this. It helps regulate mood, anxiety,
and just overall emotional stability. That's why so many antidepressant
anti anxiety medications target serotonin. Dopamine is another one. Now
(02:23):
it's tied to our reward centers, motivation reinforcements. When we
find ourselves addicted to something, it activates our dopamine pathways.
So if we take that drug, or eat that sugary substance,
or even exercise, all of these things release dopamine in
our body and it rewards us. It makes us feel good.
(02:45):
Sometimes those things are good for you, like exercise, and
some of the things they're bad for you, like illicit drugs.
And now the opioid system. We have opioid receptors in
our brain, which people don't talk enough about. They're stigmatized
in the sense of the opioid epidemic. But opioid system
(03:05):
in our brain plays a major role in pain, our
stress response, and even emotional bonding. So now when these systems,
all three of them, are just regulated, that's when we
start to see depression, post traumatic stress disorder like PTSD,
addiction conditions that can be incredibly difficult to treat because
(03:26):
it's not black and white, and for decades, most of
our medications that have been prescribed have focused on just
one of those pathways, primarily serotonin. As I mentioned, it's
the most popular and has been the most targeted by
big pharma. But what if that's not enough, What if
we need therapies that work across multiple systems at once. Well,
(03:46):
that's exactly why this conversation is gaining so much traction
right now, because, as I said, this weekend, the White
House announced an executive order aim to accelerate the research
and access to aikiadelic medications, those that can activate and
effect all three of those pathways, not just one. So
(04:08):
to understand why this is happening right now and why
there are such urgency, we have to understand the scope
of the problem. We are in the middle of a
mental health crisis. It didn't happen yesterday, It didn't happen
last year. We have been in the thick of it
even before COVID. COVID has made it much worse. More specifically, though,
we're in a crisis of treatment failure because we've had
(04:29):
mental illness for a long time. We've had access to
treatments for a long time, and what we're seeing is
they're not working because for a significant number of patients
what we currently offer it just isn't enough. It's just
not working. Like talk about depression. About a third of
patients with major depressive disorder will go on to develop
what we call treatment resistant depression, meaning they've tried multiple
(04:52):
medications appropriately and they're still not getting better. And I'm
not just talking about having the blues one day and
feeling find the next day. Depression can be debilitating. Depression
is when true depression is when it affects your day
to day life, maybe impacts your job, your relationships with
your family, your friends, whatever it may be. They are
(05:13):
all various different forms of depression and varying levels of severity.
But for many people, as I said, a third of
people with severe depression, the medications aren't working. These are
patients who cycle through medications for years. They're functioning, maybe
they're going to work, they're raising their family, but they're
not thriving. They may be surviving, but they're not thriving
(05:35):
and they're not getting better. But where this becomes even
more urgent, and this is what we talked about a
bit in the White House this past weekend, is PTSD.
Roughly six to eight percent of Americans will experience post
traumatic stress disorder at some point in their lives. Now
among veterans, that number jumps significantly into the double digits
(05:57):
depending on the conflict area, if they or in a
war zone or just around high stress environments. And the
reality is we just don't talk about it enough. Even
when we treat PTSD the right way with therapy, with medications,
a large percentage of our patients they just don't go
into remission. We rely on medications, very common ones, certually
(06:20):
in peroxytine, and they can help, but they're modest. These
are the SSRIs, you know, they're focusing on serotonin. Oftentimes
they can take weeks two months to work, and for
many patients they just do not get enough relief. Up
to half of patients with PTSD will not achieve meaningful remission,
meaning no matter what they do in terms of medications
(06:42):
and therapy, they're just not getting back to their baseline.
And somewhere in that range of thirty to forty percent
are what we consider treatment resistant. They are still having
a difficult time functioning despite all efforts of treating themselves.
That means they've done everything right and they're still struggling,
(07:02):
and the consequences they're not abstract. Among veterans, we see
about seventy to twenty suicides every single day in this country.
PTSD is a major contributor to that list. It's not
just about mortality or how many people are killing themselves
or how many people are dying. It's about quality of life.
Our veterans do everything for us. They put their lives
(07:25):
on their line for our freedom, and then they come
back and they're struggling, and they're trying everything they can
to get better, and it's just not working. These patients
tend to struggle more with substance use, chronic illness, unemployment,
social isolation. We see a lot of veterans are homeless
(07:47):
because of it. This is not just a psychiatric condition,
it's a full body, life altering disease. And even our
best therapies have limitations. Psychotherapy, for one, can be incredibly effective,
but it's time. I'm intensive, it's hardly accessible to everybody,
and dropout rates can be really high because it takes
a lot of work and a lot of time, and
(08:09):
it can be expensive. So then we're left with medications,
and medications require daily adherents. They often have a ton
of side effects themselves, and those side effects can lead
the patients to not wanting to use them. Maybe they
can't drive a car wall on them. Maybe they just
don't feel like themselves. Whatever, it is, a lot of
people stop the medications because they don't like taking them.
(08:32):
So now we're left with the group of patients, especially veterans,
who are still suffering despite doing everything medicine has asked
of them. That is exactly the population being targeted in
the conversations around new psychedelic research. It's not about replacing
first line treatments of what we're already recommendation. It's about
(08:52):
what comes next when those treatments fail, and this is
where the real conversation begins. The substances we're talking about locybin, MDMA,
lsd ibogain, they've been around for decades, nothing novel has
been produced. What's different now is how they're being used
now in clinical settings. They are not casual experiences. They're structured, supervised,
(09:15):
often combined with psychotherapy. It's not like people are going
out to the sweat hut out back and they're like, hey,
let's try some psychedelics and see how crazy we can get.
Absolutely not, that is not what's happening. It's very controlled
and they obviously start out at very low dose. Now
they do appear to work by altering brain connectivity, loosening
(09:36):
rigid patterns of thought, and really allowing patients to process
trauma in a very different way. In simple terms, they
may help the brain do something it has been unable
to do on its own. Think like hypnotism, where you're
trying to get your brain to just forget certain things
so you can really work deeper and deeper. That's kind
(09:57):
of the goal in a lot of psychotherapy. But sometimes
we're just not able to get past that blockage in
our brain. So these medications in theory are getting past
that blockage. In depressions, psilocybin has shown rapid improvements, sometimes
after just one or two sessions, with effects lasting weeks
or even months in some patients. In PTSD, MDMA assisted
(10:22):
therapy has produced some of the most compelling data we've
seen in years. Patients with severe chronic PTSD, many whom
have failed other treatments, have shown significant reductions and symptoms
and in some cases no longer meeting diagnostic criteria of
severe depression with addiction. Compounds like ibogain and psilocybin are
(10:44):
being studied for their ability to reduce cravings and interrupt
those deeply ingrained behavioral patterns that sometimes are so difficult
to break in addiction, and underlying all of this is
something we're still trying to fully understand, which is neuroplasticity. Now,
these drugs appear to increase connectivity in the brain, allowing
(11:06):
people to break out of just these entrenched patterns and
just process experiences differently. That's fundamentally different from what our
current medications do. Our current medications are trying to blunt
the feelings of some of these hormones in the brain.
These psychedelics are trying to have your brain to think
(11:26):
a different way and maybe open itself up to experiencing
the trauma, working through the trauma, and maybe even make
psychotherapy give it a chance of being much more successful. Now,
for me, the use of psychedelics sounds incredibly drastic and dramatic.
I am a bit of a prude when it comes
to experimenting with certain medications. Between us, I've never even
(11:50):
tried a cigarette, let alone anything else, so certainly never
dabbled in the psychedelics back in the day, although I
did have friends in high school and college who I
knew they did. But yeah, it seems a little bit
scary to me, But I am starting to believe there
may be clinical use of some of these medications in
a very low dose, controlled environment after reviewing a lot
(12:12):
of the data. Now, while early data on psychedelics, you know,
in my opinion does look like it could be promising,
the risks are real and they're measurable. It does not
come without risks. I feel like these medications may be
considered as a last case resort when you have someone
who you're worried if you don't do something drastic, suicide
(12:34):
may be a very viable outcome for them, and you
want to do everything you can to avoid that. So
in a controlled clinical trials, from what I've read, ten
to twenty percent of participants report acute anxiety or like
a panic attack during the experience. I probably would be
one of those people. If I started hallucinating a little bit,
I'd probably be one of the twenty percent having a
(12:56):
panic attack. Now, this is sometimes referred to as ae
unquote challenging trip, you know, where you get a little
crazy when you're quote unquote tripping out. I guess even
in supervised settings, these can be very scary and can
be dangerous. Again, if it's not controlled. There are also
concerns about more serious psychiatric effects, particularly in vulnerable individuals
(13:18):
with case reports linking psychedelics to psychoses and mania, especially
in those with underlying risk factors like you no family
history of someone who had psychoses, or they themselves already
had some. Now on the medical side, some of the
compounds have very unique dangers. I will gain being one
of them, which is the one that we've been talking about,
(13:40):
mostly because it's been associated with cardiac arrhythmias or meaning
your normal heartbeat goes out of whack, and has been
linked to dozens of deaths globally, largely due to what
we call a QT prolongation, or essentially the electricity that
goes through your heart. It causes kind of a slow
(14:01):
slowing down of it being able to go through the
heart from the atrium to the ventricle, and this puts
your heart into an arrhythmia, and you can have a
heart attack and you can die. Has been well documented globally,
and other fatal heart rhythm and disturbances, and even with
more commonly studied agents like the silos ibin MDMA, averse
effects such as transient increase in blood pressure and heart
(14:24):
rate as well are also well documented. Now, long term
safety data remains very very limited. One condition that has
been observed is hallucinogen persisting perception disorder. It's a bit
of a tongue twister, but it's a rare but distressing
syndrome involving persistent visual disturbances. So even when you're not
(14:45):
on the medication anymore, you're still hallucinating. That can't be
good for anybody. You're essentially giving someone schizophrenia, psychoses, and
perhaps most importantly, while many of these studies are conducted
in highly controlled environments, the real world risk profile, especially
outside of medical supervision, it's not fully understood at all. Now.
(15:09):
The good news is specifically when it comes to some
of the cardiac the heart concerns. It has been shown
if you give these medications with magnesium. Magnesium is an
electrolyte that helps stabilize the cardiac rhythm, you see the
risk of cardiac issues drop drastically to like almost zero.
(15:30):
So that's a good thing. If someone has pre existing
cardiac illness or high risk for cardiac illness, obviously i'd
be very concerned with them still taking these medications even
with magnesium. Again, unless it is very, very dire and
refractory and they have just run out of all options.
What's important to note about this announcement from the White
(15:52):
House over the weekend. It doesn't mean that all of
a sudden, these psychedelic medications are accessible and available and
you can go to your local pharmacy or your doctor
or the commedian store and go pick it up. No,
absolutely not. The White House did not legalize psychedelics. Do
not believe the headlines. They didn't approve a new drug.
What they did was something more strategic and in many
(16:14):
ways will be more impactful because they issued an executive
order directing federal agencies like the FDA to move faster
on researching and developing psychedelic therapies for serious mental illness.
That includes prioritizing these medications at the FDA level, particularly
those that have already been labeled as breakthrough therapies, so
(16:37):
it essentially just puts them at the front of the
line for review so they're not lost in the shuffle.
It also expands access through what's called the right to
Try pathway. You may remember that President Trump in his
first term was a huge supporter of that, meaning patients
with severe treatment resistant conditions may be able to access
(16:57):
these therapies before full FDA approval. Now that's a big
shift because historically access to these treatments has been limited
almost entirely to clinical trials, So if you were not
enrolled in a clinical trial, you couldn't try the medication.
And unfortunately, just like we see in cancer care, a
lot of people don't qualify for clinical trials, so they're
(17:18):
out of luck. They don't get to try these potential
life saving medications, and in some cases patients traveling outside
of the United States. We can't give them to people here,
but sometimes people can leave the United States and go
get them. I mean, I've never understood that. Now there's
a real effort to bring this into a regulated, medically
supervised framework, because again I don't think people should be
(17:41):
walking around taking recreational psychedelics. I absolutely don't. I don't
care how responsible you are, how well you think you
can tolerate or manage it. It should be structured and
it should be under the supervision of a physician, and
not just any physician, but a physician who understands these medications,
(18:02):
these side effects, potential benefits, and how are they going
to maximize the benefit of using these medications. It can't
just be throw these medications and then let people deal
with it. They still need to be doing the work.
They still need to be going to therapy, they need
to make sure that they are in safe social environments
and so forth. And on top of that, there's a
heavy emphasis on collaboration between the FDA, the Department of
(18:25):
Health and Human Services under Secretary Kenney, and also the veterans'
hospitals and private researchers. So I guess in theory, we're like, oh, good,
everyone's going to work together. Everyone's going to care for
our veterans and treatment resistant PTSD because everyone stood in
the Oval office and if you stand there and you
take a picture, it makes it look like you actually care. Well,
(18:48):
so what we usually say, what put your money where
your mouth is. Well, good news. They actually did that too.
The order also includes fifty million dollars in federal funding
channeled through the arp H or whatever that is some
funding pathway to support research and build out the infrastructure
to ensure that our veterans and others who are suffering
(19:09):
with treatment resistant PTSD and mental health illnesses like depression
are first in line to get access, and currently these
psychedelics like silocybin MDMA sit in the most restrictive category,
a scheduled one. The Order is also laying groundwork for
rescheduling these drugs once sufficient data is there, and we
(19:31):
can only hope that that data shows benefit with a
very low risk profile. We're not there yet. We still
need more research, we still need more data, but they're
doing what they can to accelerate it and if there
is a benefit in these medications, to get it to
the people that need it. So when you step back
and look at the full picture, this is not about
bypassing the system. It's about accelerating it. We saw this
(19:53):
through Operation Warp Speed with COVID pandemic, and President Trump
is doing it again now with psychedelics for treatment refract
treat mental illness. As for all the advances we've made
in medicine, there are still millions of people who are
suffering quietly, persistently, and often without relief. Patients who have
tried the medications, they've done the therapy, they follow the recommendations,
and they're still struggling. That is who this is really about.
(20:16):
And here's where we have to stay grounded because while
innovation is important, speed can also be equally important when
lives are on the line. But in medicine, safety has
to come first. We cannot rush something because lives can
be lost. We have seen lives lost with the use
of psychedelics, so this is exciting, but we cannot allow
excitement or desperation to outpace the science. We see what
(20:39):
happens when that balance is lost. So the right approach
here is not to dismiss psychedelics, but it's also not
to embrace them blindly either. I'm certainly not there yet.
It's to do what we should always do, follow the data,
protect the patients, and try to move forward. And I
want to end on something that matters just as much
as anything that we discuss today. You're listening to this
(21:00):
and you're struggling, whether it's depression, anxiety, some sort of
trauma you faced. I assure you you are not alone.
There are people walking around beside you feeling the same thing,
and there are people who want to help you. Reach
out to someone you trust, a friend, a family member,
a physician, a therapist, whoever it may be. Not chat GPT,
(21:22):
make it be a real person, because no matter how
promising these new treatments may be, connection, real human connection
still matters, probably more than a lot, and it can
be life saving. I'm doctor Nicole Safire. Thank you so
much for listening to Wellness on MASS. Be sure to
listen to Wellness on Mass on iHeartRadio, Apple Podcasts, or
wherever you get your podcasts.
Welcome to Wellness and mass I'm doctor Nicole Safire and
I have an interesting topic to talk to you about today.
I'm not sure if you've caught the press conference over
the weekend, but President Trump, straight from the Oval Office,
was working on Saturday morning and he had a lot
of people behind him, including Secretary Kennedy FTA, Commissioner Macarey,
and he also had Joe Rogan behind him. Now what
(00:25):
were they all doing in the Oval Office on a
beautiful Saturday, Well, it kind of felt like we were
being transported back to the seventies. Now what do I
mean by that, Well, because they were talking about psychedelic medications,
and this executive order is aimed at accelerating research and
access to medications like psilocybin, MDMA, LSD. I'm not sure
(00:47):
if you knew that, but yeah, we have been studying
these for decades in how that they may be able
to help us with addiction and refractory cases of mental illness. Now,
one that's specifically getting a lot of tension right now
from the Oval Office is I begin ibogain is a
little bit different than the others. While most psychedelics that
have been studied, like silos cybin and MDMA. They primarily
(01:11):
work through serotonin pathways, and they've been used for depression PTSD.
Ibogain has a much broader pharmacologic profile. Not only does
it interact with serotonin, but also opioid receptors and dopamine receptors.
So while before we can jump into what this executive
order even does, I want to take a step back
(01:33):
for a minute, because when we talk about mental health
and the potential treatments for it, we really are talking
about chemistry at the most basic level. I want to
make sure that we all understand it. It's always a
good refresher for me, and I want to make sure
that you understand it too. So again, at the most
basic level, our mood, our behavior, and even how we
process trauma, it's all influenced by a few key neurotransmitter systems.
(01:58):
Their proteins, their peptides, their hormones, chemicals, all happening in
our body and specifically in our brain. Serotonin. I know
you've heard me talk about this. It helps regulate mood, anxiety,
and just overall emotional stability. That's why so many antidepressant
anti anxiety medications target serotonin. Dopamine is another one. Now
(02:23):
it's tied to our reward centers, motivation reinforcements. When we
find ourselves addicted to something, it activates our dopamine pathways.
So if we take that drug, or eat that sugary substance,
or even exercise, all of these things release dopamine in
our body and it rewards us. It makes us feel good.
(02:45):
Sometimes those things are good for you, like exercise, and
some of the things they're bad for you, like illicit drugs.
And now the opioid system. We have opioid receptors in
our brain, which people don't talk enough about. They're stigmatized
in the sense of the opioid epidemic. But opioid system
(03:05):
in our brain plays a major role in pain, our
stress response, and even emotional bonding. So now when these systems,
all three of them, are just regulated, that's when we
start to see depression, post traumatic stress disorder like PTSD,
addiction conditions that can be incredibly difficult to treat because
(03:26):
it's not black and white, and for decades, most of
our medications that have been prescribed have focused on just
one of those pathways, primarily serotonin. As I mentioned, it's
the most popular and has been the most targeted by
big pharma. But what if that's not enough, What if
we need therapies that work across multiple systems at once. Well,
(03:46):
that's exactly why this conversation is gaining so much traction
right now, because, as I said, this weekend, the White
House announced an executive order aim to accelerate the research
and access to aikiadelic medications, those that can activate and
effect all three of those pathways, not just one. So
(04:08):
to understand why this is happening right now and why
there are such urgency, we have to understand the scope
of the problem. We are in the middle of a
mental health crisis. It didn't happen yesterday, It didn't happen
last year. We have been in the thick of it
even before COVID. COVID has made it much worse. More specifically, though,
we're in a crisis of treatment failure because we've had
(04:29):
mental illness for a long time. We've had access to
treatments for a long time, and what we're seeing is
they're not working because for a significant number of patients
what we currently offer it just isn't enough. It's just
not working. Like talk about depression. About a third of
patients with major depressive disorder will go on to develop
what we call treatment resistant depression, meaning they've tried multiple
(04:52):
medications appropriately and they're still not getting better. And I'm
not just talking about having the blues one day and
feeling find the next day. Depression can be debilitating. Depression
is when true depression is when it affects your day
to day life, maybe impacts your job, your relationships with
your family, your friends, whatever it may be. They are
(05:13):
all various different forms of depression and varying levels of severity.
But for many people, as I said, a third of
people with severe depression, the medications aren't working. These are
patients who cycle through medications for years. They're functioning, maybe
they're going to work, they're raising their family, but they're
not thriving. They may be surviving, but they're not thriving
(05:35):
and they're not getting better. But where this becomes even
more urgent, and this is what we talked about a
bit in the White House this past weekend, is PTSD.
Roughly six to eight percent of Americans will experience post
traumatic stress disorder at some point in their lives. Now
among veterans, that number jumps significantly into the double digits
(05:57):
depending on the conflict area, if they or in a
war zone or just around high stress environments. And the
reality is we just don't talk about it enough. Even
when we treat PTSD the right way with therapy, with medications,
a large percentage of our patients they just don't go
into remission. We rely on medications, very common ones, certually
(06:20):
in peroxytine, and they can help, but they're modest. These
are the SSRIs, you know, they're focusing on serotonin. Oftentimes
they can take weeks two months to work, and for
many patients they just do not get enough relief. Up
to half of patients with PTSD will not achieve meaningful remission,
meaning no matter what they do in terms of medications
(06:42):
and therapy, they're just not getting back to their baseline.
And somewhere in that range of thirty to forty percent
are what we consider treatment resistant. They are still having
a difficult time functioning despite all efforts of treating themselves.
That means they've done everything right and they're still struggling,
(07:02):
and the consequences they're not abstract. Among veterans, we see
about seventy to twenty suicides every single day in this country.
PTSD is a major contributor to that list. It's not
just about mortality or how many people are killing themselves
or how many people are dying. It's about quality of life.
Our veterans do everything for us. They put their lives
(07:25):
on their line for our freedom, and then they come
back and they're struggling, and they're trying everything they can
to get better, and it's just not working. These patients
tend to struggle more with substance use, chronic illness, unemployment,
social isolation. We see a lot of veterans are homeless
(07:47):
because of it. This is not just a psychiatric condition,
it's a full body, life altering disease. And even our
best therapies have limitations. Psychotherapy, for one, can be incredibly effective,
but it's time. I'm intensive, it's hardly accessible to everybody,
and dropout rates can be really high because it takes
a lot of work and a lot of time, and
(08:09):
it can be expensive. So then we're left with medications,
and medications require daily adherents. They often have a ton
of side effects themselves, and those side effects can lead
the patients to not wanting to use them. Maybe they
can't drive a car wall on them. Maybe they just
don't feel like themselves. Whatever, it is, a lot of
people stop the medications because they don't like taking them.
(08:32):
So now we're left with the group of patients, especially veterans,
who are still suffering despite doing everything medicine has asked
of them. That is exactly the population being targeted in
the conversations around new psychedelic research. It's not about replacing
first line treatments of what we're already recommendation. It's about
(08:52):
what comes next when those treatments fail, and this is
where the real conversation begins. The substances we're talking about locybin, MDMA,
lsd ibogain, they've been around for decades, nothing novel has
been produced. What's different now is how they're being used
now in clinical settings. They are not casual experiences. They're structured, supervised,
(09:15):
often combined with psychotherapy. It's not like people are going
out to the sweat hut out back and they're like, hey,
let's try some psychedelics and see how crazy we can get.
Absolutely not, that is not what's happening. It's very controlled
and they obviously start out at very low dose. Now
they do appear to work by altering brain connectivity, loosening
(09:36):
rigid patterns of thought, and really allowing patients to process
trauma in a very different way. In simple terms, they
may help the brain do something it has been unable
to do on its own. Think like hypnotism, where you're
trying to get your brain to just forget certain things
so you can really work deeper and deeper. That's kind
(09:57):
of the goal in a lot of psychotherapy. But sometimes
we're just not able to get past that blockage in
our brain. So these medications in theory are getting past
that blockage. In depressions, psilocybin has shown rapid improvements, sometimes
after just one or two sessions, with effects lasting weeks
or even months in some patients. In PTSD, MDMA assisted
(10:22):
therapy has produced some of the most compelling data we've
seen in years. Patients with severe chronic PTSD, many whom
have failed other treatments, have shown significant reductions and symptoms
and in some cases no longer meeting diagnostic criteria of
severe depression with addiction. Compounds like ibogain and psilocybin are
(10:44):
being studied for their ability to reduce cravings and interrupt
those deeply ingrained behavioral patterns that sometimes are so difficult
to break in addiction, and underlying all of this is
something we're still trying to fully understand, which is neuroplasticity. Now,
these drugs appear to increase connectivity in the brain, allowing
(11:06):
people to break out of just these entrenched patterns and
just process experiences differently. That's fundamentally different from what our
current medications do. Our current medications are trying to blunt
the feelings of some of these hormones in the brain.
These psychedelics are trying to have your brain to think
(11:26):
a different way and maybe open itself up to experiencing
the trauma, working through the trauma, and maybe even make
psychotherapy give it a chance of being much more successful. Now,
for me, the use of psychedelics sounds incredibly drastic and dramatic.
I am a bit of a prude when it comes
to experimenting with certain medications. Between us, I've never even
(11:50):
tried a cigarette, let alone anything else, so certainly never
dabbled in the psychedelics back in the day, although I
did have friends in high school and college who I
knew they did. But yeah, it seems a little bit
scary to me, But I am starting to believe there
may be clinical use of some of these medications in
a very low dose, controlled environment after reviewing a lot
(12:12):
of the data. Now, while early data on psychedelics, you know,
in my opinion does look like it could be promising,
the risks are real and they're measurable. It does not
come without risks. I feel like these medications may be
considered as a last case resort when you have someone
who you're worried if you don't do something drastic, suicide
(12:34):
may be a very viable outcome for them, and you
want to do everything you can to avoid that. So
in a controlled clinical trials, from what I've read, ten
to twenty percent of participants report acute anxiety or like
a panic attack during the experience. I probably would be
one of those people. If I started hallucinating a little bit,
I'd probably be one of the twenty percent having a
(12:56):
panic attack. Now, this is sometimes referred to as ae
unquote challenging trip, you know, where you get a little
crazy when you're quote unquote tripping out. I guess even
in supervised settings, these can be very scary and can
be dangerous. Again, if it's not controlled. There are also
concerns about more serious psychiatric effects, particularly in vulnerable individuals
(13:18):
with case reports linking psychedelics to psychoses and mania, especially
in those with underlying risk factors like you no family
history of someone who had psychoses, or they themselves already
had some. Now on the medical side, some of the
compounds have very unique dangers. I will gain being one
of them, which is the one that we've been talking about,
(13:40):
mostly because it's been associated with cardiac arrhythmias or meaning
your normal heartbeat goes out of whack, and has been
linked to dozens of deaths globally, largely due to what
we call a QT prolongation, or essentially the electricity that
goes through your heart. It causes kind of a slow
(14:01):
slowing down of it being able to go through the
heart from the atrium to the ventricle, and this puts
your heart into an arrhythmia, and you can have a
heart attack and you can die. Has been well documented globally,
and other fatal heart rhythm and disturbances, and even with
more commonly studied agents like the silos ibin MDMA, averse
effects such as transient increase in blood pressure and heart
(14:24):
rate as well are also well documented. Now, long term
safety data remains very very limited. One condition that has
been observed is hallucinogen persisting perception disorder. It's a bit
of a tongue twister, but it's a rare but distressing
syndrome involving persistent visual disturbances. So even when you're not
(14:45):
on the medication anymore, you're still hallucinating. That can't be
good for anybody. You're essentially giving someone schizophrenia, psychoses, and
perhaps most importantly, while many of these studies are conducted
in highly controlled environments, the real world risk profile, especially
outside of medical supervision, it's not fully understood at all. Now.
(15:09):
The good news is specifically when it comes to some
of the cardiac the heart concerns. It has been shown
if you give these medications with magnesium. Magnesium is an
electrolyte that helps stabilize the cardiac rhythm, you see the
risk of cardiac issues drop drastically to like almost zero.
(15:30):
So that's a good thing. If someone has pre existing
cardiac illness or high risk for cardiac illness, obviously i'd
be very concerned with them still taking these medications even
with magnesium. Again, unless it is very, very dire and
refractory and they have just run out of all options.
What's important to note about this announcement from the White
(15:52):
House over the weekend. It doesn't mean that all of
a sudden, these psychedelic medications are accessible and available and
you can go to your local pharmacy or your doctor
or the commedian store and go pick it up. No,
absolutely not. The White House did not legalize psychedelics. Do
not believe the headlines. They didn't approve a new drug.
What they did was something more strategic and in many
(16:14):
ways will be more impactful because they issued an executive
order directing federal agencies like the FDA to move faster
on researching and developing psychedelic therapies for serious mental illness.
That includes prioritizing these medications at the FDA level, particularly
those that have already been labeled as breakthrough therapies, so
(16:37):
it essentially just puts them at the front of the
line for review so they're not lost in the shuffle.
It also expands access through what's called the right to
Try pathway. You may remember that President Trump in his
first term was a huge supporter of that, meaning patients
with severe treatment resistant conditions may be able to access
(16:57):
these therapies before full FDA approval. Now that's a big
shift because historically access to these treatments has been limited
almost entirely to clinical trials, So if you were not
enrolled in a clinical trial, you couldn't try the medication.
And unfortunately, just like we see in cancer care, a
lot of people don't qualify for clinical trials, so they're
(17:18):
out of luck. They don't get to try these potential
life saving medications, and in some cases patients traveling outside
of the United States. We can't give them to people here,
but sometimes people can leave the United States and go
get them. I mean, I've never understood that. Now there's
a real effort to bring this into a regulated, medically
supervised framework, because again I don't think people should be
(17:41):
walking around taking recreational psychedelics. I absolutely don't. I don't
care how responsible you are, how well you think you
can tolerate or manage it. It should be structured and
it should be under the supervision of a physician, and
not just any physician, but a physician who understands these medications,
(18:02):
these side effects, potential benefits, and how are they going
to maximize the benefit of using these medications. It can't
just be throw these medications and then let people deal
with it. They still need to be doing the work.
They still need to be going to therapy, they need
to make sure that they are in safe social environments
and so forth. And on top of that, there's a
heavy emphasis on collaboration between the FDA, the Department of
(18:25):
Health and Human Services under Secretary Kenney, and also the veterans'
hospitals and private researchers. So I guess in theory, we're like, oh, good,
everyone's going to work together. Everyone's going to care for
our veterans and treatment resistant PTSD because everyone stood in
the Oval office and if you stand there and you
take a picture, it makes it look like you actually care. Well,
(18:48):
so what we usually say, what put your money where
your mouth is. Well, good news. They actually did that too.
The order also includes fifty million dollars in federal funding
channeled through the arp H or whatever that is some
funding pathway to support research and build out the infrastructure
to ensure that our veterans and others who are suffering
(19:09):
with treatment resistant PTSD and mental health illnesses like depression
are first in line to get access, and currently these
psychedelics like silocybin MDMA sit in the most restrictive category,
a scheduled one. The Order is also laying groundwork for
rescheduling these drugs once sufficient data is there, and we
(19:31):
can only hope that that data shows benefit with a
very low risk profile. We're not there yet. We still
need more research, we still need more data, but they're
doing what they can to accelerate it and if there
is a benefit in these medications, to get it to
the people that need it. So when you step back
and look at the full picture, this is not about
bypassing the system. It's about accelerating it. We saw this
(19:53):
through Operation Warp Speed with COVID pandemic, and President Trump
is doing it again now with psychedelics for treatment refract
treat mental illness. As for all the advances we've made
in medicine, there are still millions of people who are
suffering quietly, persistently, and often without relief. Patients who have
tried the medications, they've done the therapy, they follow the recommendations,
and they're still struggling. That is who this is really about.
(20:16):
And here's where we have to stay grounded because while
innovation is important, speed can also be equally important when
lives are on the line. But in medicine, safety has
to come first. We cannot rush something because lives can
be lost. We have seen lives lost with the use
of psychedelics, so this is exciting, but we cannot allow
excitement or desperation to outpace the science. We see what
(20:39):
happens when that balance is lost. So the right approach
here is not to dismiss psychedelics, but it's also not
to embrace them blindly either. I'm certainly not there yet.
It's to do what we should always do, follow the data,
protect the patients, and try to move forward. And I
want to end on something that matters just as much
as anything that we discuss today. You're listening to this
(21:00):
and you're struggling, whether it's depression, anxiety, some sort of
trauma you faced. I assure you you are not alone.
There are people walking around beside you feeling the same thing,
and there are people who want to help you. Reach
out to someone you trust, a friend, a family member,
a physician, a therapist, whoever it may be. Not chat GPT,
(21:22):
make it be a real person, because no matter how
promising these new treatments may be, connection, real human connection
still matters, probably more than a lot, and it can
be life saving. I'm doctor Nicole Safire. Thank you so
much for listening to Wellness on MASS. Be sure to
listen to Wellness on Mass on iHeartRadio, Apple Podcasts, or
wherever you get your podcasts.
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