Yes, being the son of Hollywood,
which is a cool story.
She was quite a woman.
Whenever you're ready.
So thank you, first of all, for
doing this with us.
Thank you for inviting me.
So we are sitting in a room
where patients
or research subjects
are administered psilocybin.
What happened?
When somebody is coming in for a
psychedelic dosing session with
psilocybin, for example.
After about three to four hours of
preparatory counseling and intention
setting with the therapists that are
going to be sitting with them.
They'll come in, they'll lie down
on the sofa after taking the
capsule of psilocybin,
and then the two therapists, which
would be sitting in the chairs that
we're in, facing the person
on the sofas, would watch and attend
them, reassure them if that was
something that needed to happen with
a hand on the shoulder, perhaps.
And then after about six hours,
be evaluated to make sure that they
were safe to go home. They'd go home
in the care of someone that they
trusted that could make sure they
got home safely.
And then they'd come back 24 hours
later, typically for some
debriefing, some integration of
their experience.
What do they experience?
That's hard to describe, and it's
going to be different for every
individual. And frankly, it's
probably different for every
medication that we're using.
There's a lot of hallucinogen
effects, like seeing sounds
and abnormal visions
of patterns
in the carpet, patterns in the wall.
But they also describe a noetic,
all-knowing sense of
knowledge, that they've experienced
something very profound.
On the other hand, they typically
describe it as being ineffable, very
difficult to explain.
Sometimes they feel like they've
come into the presence of a deity of
God.
Others feel very
alone, like they're in a canoe in
the middle of the ocean on a very
dark night and feel very isolated.
But then on the other, the
same person might then
be visited by friends and
deceased relatives, or at least
that's what some would describe.
And so it's really hard to...
Pin down a particular experience for
any individual.
What is the promise of
treatment with psychedelics for
things like depression or PTSD?
It's amazing, quite honestly,
what the effects of one dose of
psilocybin seem to have.
We see some really remarkable
results in the individuals with
depression, sometimes treatment
resistant to depression, and
that can occur within 24 hours.
And it seems to be durable in many
individuals.
Not all, not everybody responds like
that, just like any medication.
We also see in our own work
with methamphetamine.
But also other institutions looking
at alcohol, tobacco,
cocaine, some really remarkable
rapid responses in terms of
decreased uses of these drugs of
abuse.
Do you yet know why?
We don't know why these changes
happen, whether it be substance use
disorders or depression.
We feel that the conscious
psychedelic experience is
important. We don't know if there's
a particular level you need to
reach, that you need dial something
in.
We have evidence at this point
though that microdosing is not
effective and might
be very dangerous to the heart.
We think that perhaps it allows
people to
If you think of the mind in
a pressed patient as being rutted
and you're kind of forced into this
path that you can't, you know,
having a hard time getting out of,
perhaps the psilocybin experience
allows you to sort of smooth that
and reframe the way you see
yourself, the way you
use your use of
drugs of abuse, for example.
But we're not really sure, quite
honestly. We don't know if it's just
the psychedelic experience or some
biochemical effect that doesn't need
the psychedelics experience.
We're still studying that.
What was your reaction when
you learned of this executive order
that kind of gives the
FDA fast track?
The executive order does
several things, but the thing that I
think is going to have the greatest
impact on our work and the
psychedelic industry
as a whole is that it is going to
accelerate the rate at which the FDA
can evaluate drugs like
this.
And in particular, three companies
got these national program vouchers
that is going to accelerate even
more the speed at
which FDA is reviewing their
applications for approval.
The concern that I have, quite
honestly, is that...
The FDA will approve this
sooner than we were expecting.
And we don't really have the
capacity in terms of rooms, but
especially the therapists that are
going to attend to these individuals
to accommodate the demand that's
going to occur when that happens.
And this would be happening,
presumably, at research centers
across the country.
Once the drug is approved by the
FDA, it does not have to be at a
research center.
I think that they are, right now,
the ones that are best positioned
to accommodate that.
But frankly, it's going to be both a
academic and a private
for-profit enterprise as
well. People will need
to go to some of these
clinics that will charge them out of
pocket for the experience.
The personnel demands to have
the two therapists sitting in the
room for eight hours is going to be
one of the most critical things that
we have to deal with.
How are we going to, in a
system where mental health
professionals are hard enough to
find, how are we to expand
that capacity to meet the demand
from the psychedelic industry?
Do you have any expectation that
demand is understood by
the policy makers and people
who dole out budgets?
I have not seen it really addressed
by the policymakers.
It's going to cost anywhere from
$3,000 to $10,000, I estimate,
for each of these dosing sessions.
The insurance companies are going to
be waiting for the FDA approval and
what the FDA requires, but
I haven't seen anything from the
policymakers themselves that
suggests that they are anticipating
how to deal with this increased
demand.
And still, this is
really exciting news, I
imagine, for someone like yourself.
It is really exciting, yes.
We have participated in
the development of the psilocybin
from about 12 years
ago. And some of our work is
actually going into the new
drug application that
the Uson Institute is going to be
working on.
So we're really excited that we can
be part of that.
But helping other companies, but
also looking at the mechanism
of why this happens.
We've got several studies that were
just asking the foundational
question. Why does it work, and how
does it work, how can we perhaps
make it better?
Do you have a sense that
patients who currently suffer
from severe
depression or PTSD or
alcohol abuse or any
other of these kinds of conditions
that could be helped, that they are
just waiting for this to be
approved so that they can take part?
I know that they are.
I know they are waiting.
I'm concerned that we don't have the
ability to help them
as soon as we would like to.
When the FDA approves this, there
will be some time that the companies
have to...
But being able to scale up the
capsules is going to be very
different from the clinical
treatment sites to be able to find
the space and the personnel to
actually help them with the dosing.
Is there anything you want to add on
this?
I think that one of the things that
really surprised me when I first got
into this was
that the psilocybin and LSD
treatments are not addictive.
I was part of the This Is
Your Brain on Drugs generation, and
so that was a surprise.
But it's really important to make
it clear that we do screen
the individuals that we bring into
our studies, and I think it's going
to be important to screen the
individuals that come to us after
drug approval.
To identify individuals that might
be harmed by these treatments, such
as with certain mental illnesses,
some bipolar disorders,
schizophrenia for example, we're
not sure that these people might
actually be hurt by the effects of
the psychedelic during this
eight-hour session.
Marisa, do you have any questions?
Did you list that success
rate number,
like 90% or
is that
not psilocybin?
Oh, that is civil society.
So I did have a question that I
didn't ask because, I
don't know why, but what is the
efficacy of psilocybin
for some of these people?
The efficacy is
remarkably fast and
remarkably consistent in a lot of
individuals. We see that at
the usual dose that we're using,
that up to 60%, sometimes more
individuals can have a
remission of their depression.
In some cases, we see a similar
remission rate or abstinence rate
in tobacco, for example,
or alcohol.
Not studies that we've done here,
but really reliable studies.
We've got one small study that we
were able to look at individuals
with methamphetamine use disorder.
And in the three individuals that we
are able to study before we lost our
funding, these
individuals had a 90% drop
in their methamphetamine use after
two doses.
So again, there's something about
the substance use disorders that
seems to be responding very well in
a controlled administration of
psilocybin, not recreational use
necessarily, but in the process
that we're doing it, some remarkable
results.
You just spoke to losing your
funding. I know that the
University itself and
all of its research has
been the subject of some
loss of funding and and otherwise
delays.
Has that affected this work as well?
Not really.
We have not had federal funding.
It's not been very easy to
get federal funding for the
psychedelics for whatever reason.
And that may change in
the near future. We'll see.
Most of our research has been funded
by donors.
And the problem now is
that there are enough companies that
are trying to move into this space
because of the evidence that,
in general, this field is very
promising, that what used
to be donors now are turning to
investors. And they're not looking
so much at small academic studies
as supporting
larger companies that might have a
return on their investment.
So that's been a discouragement that
the money that has supported our
research through donors has
faded away a bit.
That's hurting us.
How come it doesn't?
A treatment.
So when somebody comes into the
dosing room, they will be
expected to stay for about eight
hours. And then again, they will
sent home with someone that they
trust, that we trust, that they'll
take care of them.
Although we don't let them go home
in a abnormal,
compromised state. They're able to
walk out, they're clear.
We just don't want them to start
driving.
So it's about an eight hour session.
And then we bring them back the next
day typically and have a
one or two hour debriefing and
ideally bringing them back.
Two or three more times.
We think that that debriefing
session, that ability to work with
those people with whom they've got a
therapeutic alliance, is critically
important to really maximize the
effects of these psychedelic
treatments.
And one of the reasons why we don't
expect that recreational use of the
psychedelics is going to be anywhere
near as therapeutically effective
as the more controlled,
somewhat more complex work with the
therapists.
Interesting, thank you.
I'm good, where else are you?
That idea that, you know,
okay so the FDA approved psilocybin
for the treatment of depression or
other things and then people said,
great I'll just take a bunch of
mushrooms and be cured, right?
That's very, very different.
Yeah, and so
I'm really concerned that that will
be the case, that people will be
buying mushrooms off the streets,
and frankly, you could sell me a
bunch of dried mushrooms from
Hy-Vee, sprinkle it with something,
and I wouldn't know the difference.
And so I am really concerned about
adulteration of magic
mushrooms and what that
risk might be down the road.
All the drug that we're using is
synthetically prepared and
very pure. Of course.
I guess one more clarified question,
because you said
you do a few sessions,
so there's like a big capital
cost, but once the
package of sessions wraps,
does that last years?
We don't really know yet how long
these effects, these beneficial
effects on substance use disorders
or depression will last.
In our studies, we typically can
only watch them so long.
We only have so much money to watch
them. And so typically we're looking
for one or two months.
But the companies that are looking
at it will be expected by the FDA to
do some long-term studies and to
better understand the question of
how durable these effects.
We also don't know how important
it is for perhaps a booster to be
administered six months, 12 months
down the road.
Or how many doses in quick
succession a week apart, a month
apart is going to maximize the
therapeutic effect.
The FDA is going to be receiving
these applications primarily with
just one dose though.
It's how remarkable it is that one
dose seems to have these really,
really dramatic, rapid effects and
surprisingly durable too.
Thank you.
Yeah, that is interesting.
And this isn't for, we can
stop recording.
But I would think that,
let's say you had a
subject here, a test subject,
and they were also in the care of
a psychiatrist, right?
And knew that they had done this
and had these remarkable results.
I mean, is there that kind of
interaction?
Gosh.
Not yet, but I think that's
kind of what I think is we're going
to need to do, Frederick.
The therapists that are here for
psilocybin are not providing that
much therapy, they're providing
reassurance and safety.
I think to be sustainable,
that we're gonna have to take people
that are identified by their
caregivers, whether it be a primary
care physician or a psychiatrist or
psychologist, refer to us,
get screened, we dose them
for eight hours, we have some
integration.
The mental health practitioners,
we can't afford to put them in these
chairs.
We need to have them meeting
with them the days after and
reinforcing this down the road,
having their one hour meetings and
seeing eight people per day as
opposed to sitting in the chair.
So I think to be sustainable,
we're gonna have to have that warm
handoff.
We need to do the part that you very
much display.
No, I think we can take from what
we just did.
Oh, that?
I thought you meant asking separate
questions. No, no, no.
Oh, so now?
Yep, whenever you're ready for it.
That's tough.
Alright, and then we can get 15
seconds of room to tell them we
should be good.
So, so don't talk?
Yeah, cut.