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,
they come after about three or 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 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 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, if God.
Others feel 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, the same person might then be visited by friends and deceased relatives, or at least 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 cannot 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 to 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 they think of the mind in a press 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 see 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 psychedelic 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?
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's 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?
Well, 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-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 going to expand that capacity to meet the demand from the psychedelic industry?
Do you have any expectation that that demand is understood by the policymakers and people who dole out budgets?
I do not. I have not seen it really addressed by the policymakers.
It's going to cost anywhere from three to ten thousand dollars I estimate for each of these dosing sessions.
And 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 and 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 that they're waiting.
And I'm concerned that we don't have the ability to help them as soon as we would like to.
When the FDA approves the store, there will be some time that the companies have to scale up, if you will.
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.
This is your brain on drugs generation.
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.
We look 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.
Do you have any questions?
Did you list that success rate number?
Like 90%?
Or is that not psilocybin?
That is psilocybin.
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 were 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 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.
All right.
That's hurting us.
You have one.
How long does a treatment last?
So when somebody comes into the dosing room, they will be expected to stay for about eight hours.
And then again, they will be 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 the 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 are you?
That idea that, you know, okay, so the FDA approves to the cybin for the treatment of depression or other things.
And then people say, 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 high V, sprinkle it with something, and I wouldn't know the difference.
And so I'm 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 like clarifying question because you said you do a few sessions, so there's like a big kind of capital cost.
But once the package of sessions wraps, does that last years?
Do you know?
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, twelve 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.
That's how remarkable it is that one dose seems to have these really, really dramatic rapid effects and surprisingly durable too.
Great.
Thank you.
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 and knew that they had done this and had these remarkable results.
I mean, is their back kind of interaction?
Not yet.
But I think that's kind of what I think is what we're going to need to do.
The therapists that are here for psilocybin are not providing that much therapy.
They're providing reassurance and safety.
I think that to be sustainable that we're going to have to take people that are identified by their caregivers, whether it be a primary care physician or a psychiatrist psychologist referred to us, get screened, we dose them for eight hours, we have some integration.
But the mental health practitioners, we can't afford to put them in these chairs.
We need to have them meeting with them the days afters 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 going to have to have that warm handoff.
Yeah.
No.
We need to do the part that you very much displayed.
No, I think we can take from what we just did.
Oh, that.
I thought you meant asking separate questions.
No, no, no, no, no.
The clap.
Oh, so now?
Yep, whenever you're ready for it.
That's the.
Synchronize.
All right.
And then we can get 15 seconds of room to go.
So don't talk.
Okay.
Okay.