rate considered some sort of success?
>> An executive order from President Donald Trump
calls for fast tracking research and access to
psychedelic medicines for treatment of mental health
disorders, with $50 million in funding going to state
governments for the research into the
treatments, the FDA pinpointed three companies,
including Madison based Usona Institute, for its
new drug Application for psilocybin in major
depressive disorder. Usona says the designation is
reserved for therapies addressing critical
national health priorities and unmet medical needs.
The work of UW-Madison researchers will be part of
Usona application. The center for Psychedelic
Research has been looking at the promise of
psilocybin and other psychedelics with human
research subjects at its dosing lab on campus, we
met with Professor Paul Hutson there to learn more.
>> Psilocybin kind of works by itself. We're here
primarily to protect the subject, reassure them if
they get anxious. >> So we are sitting in a
room where patients or research subjects are
administered psilocybin. What happens.
>> When somebody is coming in for a psychedelic dosing
session with psilocybin, for example? They come
after about 3 or 4 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 sofa, 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, they would 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 that they got home safely. And then we
bring them back the next day, typically, and have a
1 or 2 hour debriefing and ideally bringing them back
2 or 3 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 the psychedelic treatments. And one of the
reasons why we don't expect that recreational use of
psychedelics is going to be anywhere near as
therapeutically effective as the more controlled,
somewhat more complex work with the therapists.
>> 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 a very, 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 hand,
they that same person might then be visited by friends
and deceased relatives. 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 individuals with
depression, sometimes treatment resistant
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. 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, that I was part
of the this is your brain on drugs generation. And so
that was a surprise. But it's really important to 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. >> What was your reaction
when you learned of this executive order? That kind
of gives the FDA fast track. >> So 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 the 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 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 an
academic and a private for 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 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
going to expand that capacity to meet the demand
from the psychedelic industry?
>> And Steil, this is really exciting news. I
imagine for someone like yourself.
>> It is really exciting. Yes, we have participated
in the development of psilocybin from about 12
years ago, and some of our work is actually going into
the the new drug application that Usona
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