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Yes, being the son of Hollywood,

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which is a cool story.

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She was quite a woman.

4
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Whenever you're ready.

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So thank you, first of all, for

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doing this with us.

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Thank you for inviting me.

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So we are sitting in a room

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where patients

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or research subjects

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are administered psilocybin.

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What happened?

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When somebody is coming in for a

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psychedelic dosing session with

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psilocybin, for example.

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After about three to four hours of

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preparatory counseling and intention

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setting with the therapists that are

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going to be sitting with them.

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They'll come in, they'll lie down

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on the sofa after taking the

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capsule of psilocybin,

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and then the two therapists, which

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would be sitting in the chairs that

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we're in, facing the person

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on the sofas, would watch and attend

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them, reassure them if that was

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something that needed to happen with

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a hand on the shoulder, perhaps.

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And then after about six hours,

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be evaluated to make sure that they

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were safe to go home. They'd go home

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in the care of someone that they

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trusted that could make sure they

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got home safely.

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And then they'd come back 24 hours

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later, typically for some

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debriefing, some integration of

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their experience.

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What do they experience?

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That's hard to describe, and it's

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going to be different for every

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individual. And frankly, it's

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probably different for every

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medication that we're using.

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There's a lot of hallucinogen

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effects, like seeing sounds

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and abnormal visions

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of patterns

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in the carpet, patterns in the wall.

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But they also describe a noetic,

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all-knowing sense of

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knowledge, that they've experienced

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something very profound.

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On the other hand, they typically

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describe it as being ineffable, very

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difficult to explain.

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Sometimes they feel like they've

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come into the presence of a deity of

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God.

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Others feel very

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alone, like they're in a canoe in

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the middle of the ocean on a very

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dark night and feel very isolated.

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But then on the other, the

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same person might then

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be visited by friends and

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deceased relatives, or at least

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that's what some would describe.

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And so it's really hard to...

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Pin down a particular experience for

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any individual.

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What is the promise of

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treatment with psychedelics for

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things like depression or PTSD?

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It's amazing, quite honestly,

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what the effects of one dose of

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psilocybin seem to have.

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We see some really remarkable

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results in the individuals with

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depression, sometimes treatment

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resistant to depression, and

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that can occur within 24 hours.

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And it seems to be durable in many

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individuals.

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Not all, not everybody responds like

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that, just like any medication.

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We also see in our own work

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with methamphetamine.

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But also other institutions looking

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at alcohol, tobacco,

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cocaine, some really remarkable

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rapid responses in terms of

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decreased uses of these drugs of

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abuse.

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Do you yet know why?

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We don't know why these changes

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happen, whether it be substance use

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disorders or depression.

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We feel that the conscious

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psychedelic experience is

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important. We don't know if there's

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a particular level you need to

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reach, that you need dial something

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in.

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We have evidence at this point

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though that microdosing is not

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effective and might

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be very dangerous to the heart.

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We think that perhaps it allows

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people to

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If you think of the mind in

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a pressed patient as being rutted

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and you're kind of forced into this

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path that you can't, you know,

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having a hard time getting out of,

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perhaps the psilocybin experience

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allows you to sort of smooth that

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and reframe the way you see

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yourself, the way you

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use your use of

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drugs of abuse, for example.

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But we're not really sure, quite

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honestly. We don't know if it's just

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the psychedelic experience or some

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biochemical effect that doesn't need

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the psychedelics experience.

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We're still studying that.

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What was your reaction when

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you learned of this executive order

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that kind of gives the

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FDA fast track?

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The executive order does

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several things, but the thing that I

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think is going to have the greatest

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impact on our work and the

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psychedelic industry

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as a whole is that it is going to

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accelerate the rate at which the FDA

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can evaluate drugs like

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this.

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And in particular, three companies

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got these national program vouchers

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that is going to accelerate even

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more the speed at

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which FDA is reviewing their

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applications for approval.

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The concern that I have, quite

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honestly, is that...

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The FDA will approve this

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sooner than we were expecting.

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And we don't really have the

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capacity in terms of rooms, but

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especially the therapists that are

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going to attend to these individuals

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to accommodate the demand that's

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going to occur when that happens.

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And this would be happening,

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presumably, at research centers

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across the country.

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Once the drug is approved by the

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FDA, it does not have to be at a

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research center.

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I think that they are, right now,

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the ones that are best positioned

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to accommodate that.

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But frankly, it's going to be both a

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academic and a private

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for-profit enterprise as

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well. People will need

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to go to some of these

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clinics that will charge them out of

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pocket for the experience.

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The personnel demands to have

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the two therapists sitting in the

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room for eight hours is going to be

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one of the most critical things that

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we have to deal with.

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How are we going to, in a

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system where mental health

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professionals are hard enough to

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find, how are we to expand

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that capacity to meet the demand

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from the psychedelic industry?

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Do you have any expectation that

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demand is understood by

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the policy makers and people

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who dole out budgets?

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I have not seen it really addressed

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by the policymakers.

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It's going to cost anywhere from

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$3,000 to $10,000, I estimate,

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for each of these dosing sessions.

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The insurance companies are going to

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be waiting for the FDA approval and

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what the FDA requires, but

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I haven't seen anything from the

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policymakers themselves that

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suggests that they are anticipating

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how to deal with this increased

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demand.

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And still, this is

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really exciting news, I

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imagine, for someone like yourself.

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It is really exciting, yes.

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We have participated in

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the development of the psilocybin

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from about 12 years

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ago. And some of our work is

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actually going into the new

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drug application that

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the Uson Institute is going to be

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working on.

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So we're really excited that we can

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be part of that.

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But helping other companies, but

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also looking at the mechanism

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of why this happens.

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We've got several studies that were

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just asking the foundational

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question. Why does it work, and how

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does it work, how can we perhaps

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make it better?

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Do you have a sense that

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patients who currently suffer

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from severe

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depression or PTSD or

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alcohol abuse or any

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other of these kinds of conditions

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that could be helped, that they are

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just waiting for this to be

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approved so that they can take part?

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I know that they are.

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I know they are waiting.

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I'm concerned that we don't have the

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ability to help them

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as soon as we would like to.

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When the FDA approves this, there

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will be some time that the companies

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have to...

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But being able to scale up the

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capsules is going to be very

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different from the clinical

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treatment sites to be able to find

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the space and the personnel to

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actually help them with the dosing.

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Is there anything you want to add on

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this?

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I think that one of the things that

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really surprised me when I first got

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into this was

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that the psilocybin and LSD

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treatments are not addictive.

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I was part of the This Is

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Your Brain on Drugs generation, and

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so that was a surprise.

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But it's really important to make

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it clear that we do screen

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the individuals that we bring into

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our studies, and I think it's going

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to be important to screen the

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individuals that come to us after

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drug approval.

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To identify individuals that might

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be harmed by these treatments, such

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as with certain mental illnesses,

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some bipolar disorders,

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schizophrenia for example, we're

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not sure that these people might

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actually be hurt by the effects of

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the psychedelic during this

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eight-hour session.

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Marisa, do you have any questions?

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Did you list that success

275
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rate number,

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like 90% or

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is that

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not psilocybin?

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Oh, that is civil society.

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So I did have a question that I

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didn't ask because, I

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don't know why, but what is the

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efficacy of psilocybin

284
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for some of these people?

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The efficacy is

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remarkably fast and

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remarkably consistent in a lot of

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individuals. We see that at

289
00:09:18,530 --> 00:09:20,569
the usual dose that we're using,

290
00:09:20,570 --> 00:09:22,589
that up to 60%, sometimes more

291
00:09:22,590 --> 00:09:24,449
individuals can have a

292
00:09:24,450 --> 00:09:26,489
remission of their depression.

293
00:09:26,490 --> 00:09:28,009
In some cases, we see a similar

294
00:09:28,010 --> 00:09:29,849
remission rate or abstinence rate

295
00:09:29,850 --> 00:09:31,689
in tobacco, for example,

296
00:09:31,690 --> 00:09:33,229
or alcohol.

297
00:09:33,230 --> 00:09:34,449
Not studies that we've done here,

298
00:09:34,450 --> 00:09:36,549
but really reliable studies.

299
00:09:36,550 --> 00:09:38,749
We've got one small study that we

300
00:09:38,750 --> 00:09:40,089
were able to look at individuals

301
00:09:40,090 --> 00:09:42,449
with methamphetamine use disorder.

302
00:09:42,450 --> 00:09:43,969
And in the three individuals that we

303
00:09:43,970 --> 00:09:45,589
are able to study before we lost our

304
00:09:45,590 --> 00:09:47,429
funding, these

305
00:09:47,430 --> 00:09:49,369
individuals had a 90% drop

306
00:09:49,370 --> 00:09:51,269
in their methamphetamine use after

307
00:09:51,270 --> 00:09:52,389
two doses.

308
00:09:52,390 --> 00:09:54,229
So again, there's something about

309
00:09:54,230 --> 00:09:56,109
the substance use disorders that

310
00:09:56,110 --> 00:09:58,209
seems to be responding very well in

311
00:09:58,210 --> 00:10:00,169
a controlled administration of

312
00:10:00,170 --> 00:10:02,149
psilocybin, not recreational use

313
00:10:02,150 --> 00:10:03,989
necessarily, but in the process

314
00:10:03,990 --> 00:10:05,849
that we're doing it, some remarkable

315
00:10:05,850 --> 00:10:07,179
results.

316
00:10:07,180 --> 00:10:08,939
You just spoke to losing your

317
00:10:08,940 --> 00:10:10,779
funding. I know that the

318
00:10:10,780 --> 00:10:13,019
University itself and

319
00:10:13,020 --> 00:10:15,199
all of its research has

320
00:10:15,200 --> 00:10:17,099
been the subject of some

321
00:10:17,100 --> 00:10:19,259
loss of funding and and otherwise

322
00:10:19,260 --> 00:10:20,260
delays.

323
00:10:20,920 --> 00:10:23,429
Has that affected this work as well?

324
00:10:23,430 --> 00:10:24,489
Not really.

325
00:10:24,490 --> 00:10:26,209
We have not had federal funding.

326
00:10:26,210 --> 00:10:28,049
It's not been very easy to

327
00:10:28,050 --> 00:10:29,169
get federal funding for the

328
00:10:29,170 --> 00:10:30,869
psychedelics for whatever reason.

329
00:10:30,870 --> 00:10:32,789
And that may change in

330
00:10:32,790 --> 00:10:34,369
the near future. We'll see.

331
00:10:34,370 --> 00:10:35,709
Most of our research has been funded

332
00:10:35,710 --> 00:10:36,809
by donors.

333
00:10:36,810 --> 00:10:38,749
And the problem now is

334
00:10:38,750 --> 00:10:39,989
that there are enough companies that

335
00:10:39,990 --> 00:10:41,329
are trying to move into this space

336
00:10:41,330 --> 00:10:43,249
because of the evidence that,

337
00:10:43,250 --> 00:10:44,749
in general, this field is very

338
00:10:44,750 --> 00:10:46,589
promising, that what used

339
00:10:46,590 --> 00:10:48,389
to be donors now are turning to

340
00:10:48,390 --> 00:10:49,829
investors. And they're not looking

341
00:10:49,830 --> 00:10:51,729
so much at small academic studies

342
00:10:51,730 --> 00:10:53,749
as supporting

343
00:10:53,750 --> 00:10:55,669
larger companies that might have a

344
00:10:55,670 --> 00:10:57,289
return on their investment.

345
00:10:57,290 --> 00:10:59,069
So that's been a discouragement that

346
00:10:59,070 --> 00:11:01,129
the money that has supported our

347
00:11:01,130 --> 00:11:03,129
research through donors has

348
00:11:03,130 --> 00:11:04,130
faded away a bit.

349
00:11:05,870 --> 00:11:06,870
That's hurting us.

350
00:11:07,930 --> 00:11:08,769
How come it doesn't?

351
00:11:08,770 --> 00:11:09,770
A treatment.

352
00:11:18,100 --> 00:11:19,859
So when somebody comes into the

353
00:11:19,860 --> 00:11:21,719
dosing room, they will be

354
00:11:21,720 --> 00:11:22,939
expected to stay for about eight

355
00:11:22,940 --> 00:11:24,719
hours. And then again, they will

356
00:11:24,720 --> 00:11:26,659
sent home with someone that they

357
00:11:26,660 --> 00:11:28,039
trust, that we trust, that they'll

358
00:11:28,040 --> 00:11:29,079
take care of them.

359
00:11:29,080 --> 00:11:30,699
Although we don't let them go home

360
00:11:30,700 --> 00:11:33,019
in a abnormal,

361
00:11:33,020 --> 00:11:34,319
compromised state. They're able to

362
00:11:34,320 --> 00:11:35,779
walk out, they're clear.

363
00:11:35,780 --> 00:11:36,839
We just don't want them to start

364
00:11:36,840 --> 00:11:37,840
driving.

365
00:11:38,480 --> 00:11:40,659
So it's about an eight hour session.

366
00:11:40,660 --> 00:11:42,659
And then we bring them back the next

367
00:11:42,660 --> 00:11:44,619
day typically and have a

368
00:11:44,620 --> 00:11:46,639
one or two hour debriefing and

369
00:11:46,640 --> 00:11:48,679
ideally bringing them back.

370
00:11:48,680 --> 00:11:50,199
Two or three more times.

371
00:11:50,200 --> 00:11:51,859
We think that that debriefing

372
00:11:51,860 --> 00:11:53,859
session, that ability to work with

373
00:11:53,860 --> 00:11:55,659
those people with whom they've got a

374
00:11:55,660 --> 00:11:57,579
therapeutic alliance, is critically

375
00:11:57,580 --> 00:11:59,219
important to really maximize the

376
00:11:59,220 --> 00:12:00,699
effects of these psychedelic

377
00:12:00,700 --> 00:12:01,559
treatments.

378
00:12:01,560 --> 00:12:02,939
And one of the reasons why we don't

379
00:12:02,940 --> 00:12:04,719
expect that recreational use of the

380
00:12:04,720 --> 00:12:06,239
psychedelics is going to be anywhere

381
00:12:06,240 --> 00:12:08,459
near as therapeutically effective

382
00:12:08,460 --> 00:12:10,459
as the more controlled,

383
00:12:10,460 --> 00:12:12,119
somewhat more complex work with the

384
00:12:12,120 --> 00:12:13,120
therapists.

385
00:12:13,590 --> 00:12:15,209
Interesting, thank you.

386
00:12:15,210 --> 00:12:16,729
I'm good, where else are you?

387
00:12:18,569 --> 00:12:20,769
That idea that, you know,

388
00:12:20,770 --> 00:12:23,109
okay so the FDA approved psilocybin

389
00:12:23,110 --> 00:12:24,909
for the treatment of depression or

390
00:12:24,910 --> 00:12:26,909
other things and then people said,

391
00:12:26,910 --> 00:12:28,369
great I'll just take a bunch of

392
00:12:28,370 --> 00:12:30,429
mushrooms and be cured, right?

393
00:12:30,430 --> 00:12:31,979
That's very, very different.

394
00:12:31,980 --> 00:12:33,899
Yeah, and so

395
00:12:33,900 --> 00:12:35,259
I'm really concerned that that will

396
00:12:35,260 --> 00:12:36,559
be the case, that people will be

397
00:12:36,560 --> 00:12:38,899
buying mushrooms off the streets,

398
00:12:38,900 --> 00:12:40,579
and frankly, you could sell me a

399
00:12:40,580 --> 00:12:41,879
bunch of dried mushrooms from

400
00:12:41,880 --> 00:12:43,819
Hy-Vee, sprinkle it with something,

401
00:12:43,820 --> 00:12:45,599
and I wouldn't know the difference.

402
00:12:45,600 --> 00:12:47,039
And so I am really concerned about

403
00:12:47,040 --> 00:12:48,959
adulteration of magic

404
00:12:48,960 --> 00:12:51,299
mushrooms and what that

405
00:12:51,300 --> 00:12:53,699
risk might be down the road.

406
00:12:53,700 --> 00:12:56,779
All the drug that we're using is

407
00:12:56,780 --> 00:12:58,719
synthetically prepared and

408
00:12:58,720 --> 00:13:00,699
very pure. Of course.

409
00:13:00,700 --> 00:13:03,479
I guess one more clarified question,

410
00:13:03,480 --> 00:13:05,319
because you said

411
00:13:05,320 --> 00:13:07,299
you do a few sessions,

412
00:13:07,300 --> 00:13:09,219
so there's like a big capital

413
00:13:09,220 --> 00:13:11,699
cost, but once the

414
00:13:11,700 --> 00:13:13,240
package of sessions wraps,

415
00:13:14,820 --> 00:13:16,820
does that last years?

416
00:13:22,590 --> 00:13:24,349
We don't really know yet how long

417
00:13:24,350 --> 00:13:26,129
these effects, these beneficial

418
00:13:26,130 --> 00:13:27,729
effects on substance use disorders

419
00:13:27,730 --> 00:13:29,190
or depression will last.

420
00:13:30,310 --> 00:13:31,609
In our studies, we typically can

421
00:13:31,610 --> 00:13:32,649
only watch them so long.

422
00:13:32,650 --> 00:13:34,089
We only have so much money to watch

423
00:13:34,090 --> 00:13:35,469
them. And so typically we're looking

424
00:13:35,470 --> 00:13:37,089
for one or two months.

425
00:13:37,090 --> 00:13:38,429
But the companies that are looking

426
00:13:38,430 --> 00:13:40,209
at it will be expected by the FDA to

427
00:13:40,210 --> 00:13:41,749
do some long-term studies and to

428
00:13:41,750 --> 00:13:42,969
better understand the question of

429
00:13:42,970 --> 00:13:44,329
how durable these effects.

430
00:13:44,330 --> 00:13:46,269
We also don't know how important

431
00:13:46,270 --> 00:13:47,889
it is for perhaps a booster to be

432
00:13:47,890 --> 00:13:49,789
administered six months, 12 months

433
00:13:49,790 --> 00:13:50,769
down the road.

434
00:13:50,770 --> 00:13:52,209
Or how many doses in quick

435
00:13:52,210 --> 00:13:54,029
succession a week apart, a month

436
00:13:54,030 --> 00:13:55,789
apart is going to maximize the

437
00:13:55,790 --> 00:13:56,949
therapeutic effect.

438
00:13:56,950 --> 00:13:58,269
The FDA is going to be receiving

439
00:13:58,270 --> 00:14:00,349
these applications primarily with

440
00:14:00,350 --> 00:14:01,969
just one dose though.

441
00:14:01,970 --> 00:14:03,589
It's how remarkable it is that one

442
00:14:03,590 --> 00:14:05,049
dose seems to have these really,

443
00:14:05,050 --> 00:14:07,409
really dramatic, rapid effects and

444
00:14:07,410 --> 00:14:08,410
surprisingly durable too.

445
00:14:10,020 --> 00:14:10,859
Thank you.

446
00:14:10,860 --> 00:14:12,679
Yeah, that is interesting.

447
00:14:12,680 --> 00:14:14,559
And this isn't for, we can

448
00:14:14,560 --> 00:14:15,699
stop recording.

449
00:14:15,700 --> 00:14:17,679
But I would think that,

450
00:14:17,680 --> 00:14:21,159
let's say you had a

451
00:14:21,160 --> 00:14:23,079
subject here, a test subject,

452
00:14:23,080 --> 00:14:24,979
and they were also in the care of

453
00:14:24,980 --> 00:14:26,259
a psychiatrist, right?

454
00:14:26,260 --> 00:14:28,259
And knew that they had done this

455
00:14:28,260 --> 00:14:30,199
and had these remarkable results.

456
00:14:30,200 --> 00:14:31,519
I mean, is there that kind of

457
00:14:31,520 --> 00:14:32,319
interaction?

458
00:14:32,320 --> 00:14:33,320
Gosh.

459
00:14:33,700 --> 00:14:35,859
Not yet, but I think that's

460
00:14:35,860 --> 00:14:37,159
kind of what I think is we're going

461
00:14:37,160 --> 00:14:38,160
to need to do, Frederick.

462
00:14:39,720 --> 00:14:41,279
The therapists that are here for

463
00:14:41,280 --> 00:14:43,119
psilocybin are not providing that

464
00:14:43,120 --> 00:14:44,159
much therapy, they're providing

465
00:14:44,160 --> 00:14:46,299
reassurance and safety.

466
00:14:46,300 --> 00:14:48,699
I think to be sustainable,

467
00:14:48,700 --> 00:14:50,319
that we're gonna have to take people

468
00:14:50,320 --> 00:14:51,559
that are identified by their

469
00:14:51,560 --> 00:14:52,999
caregivers, whether it be a primary

470
00:14:53,000 --> 00:14:54,719
care physician or a psychiatrist or

471
00:14:54,720 --> 00:14:56,839
psychologist, refer to us,

472
00:14:56,840 --> 00:14:58,679
get screened, we dose them

473
00:14:58,680 --> 00:14:59,839
for eight hours, we have some

474
00:14:59,840 --> 00:15:00,840
integration.

475
00:15:03,119 --> 00:15:05,338
The mental health practitioners,

476
00:15:05,339 --> 00:15:07,079
we can't afford to put them in these

477
00:15:07,080 --> 00:15:08,059
chairs.

478
00:15:08,060 --> 00:15:10,399
We need to have them meeting

479
00:15:10,400 --> 00:15:11,859
with them the days after and

480
00:15:11,860 --> 00:15:13,519
reinforcing this down the road,

481
00:15:13,520 --> 00:15:15,319
having their one hour meetings and

482
00:15:15,320 --> 00:15:16,619
seeing eight people per day as

483
00:15:16,620 --> 00:15:17,719
opposed to sitting in the chair.

484
00:15:17,720 --> 00:15:19,500
So I think to be sustainable,

485
00:15:20,560 --> 00:15:21,919
we're gonna have to have that warm

486
00:15:21,920 --> 00:15:22,920
handoff.

487
00:15:25,610 --> 00:15:27,289
We need to do the part that you very

488
00:15:27,290 --> 00:15:28,109
much display.

489
00:15:28,110 --> 00:15:30,129
No, I think we can take from what

490
00:15:30,130 --> 00:15:31,130
we just did.

491
00:15:34,970 --> 00:15:35,949
Oh, that?

492
00:15:35,950 --> 00:15:37,529
I thought you meant asking separate

493
00:15:37,530 --> 00:15:38,909
questions. No, no, no.

494
00:15:41,570 --> 00:15:43,439
Oh, so now?

495
00:15:43,440 --> 00:15:44,440
Yep, whenever you're ready for it.

496
00:15:45,949 --> 00:15:46,949
That's tough.

497
00:15:47,460 --> 00:15:49,179
Alright, and then we can get 15

498
00:15:49,180 --> 00:15:50,179
seconds of room to tell them we

499
00:15:50,180 --> 00:15:50,669
should be good.

500
00:15:50,670 --> 00:15:52,169
So, so don't talk?

501
00:16:08,180 --> 00:16:09,180
Yeah, cut.