WEBVTT 00:00.000 --> 00:05.000 Yes, being the son of Hollywood, which is a cool story. 00:05.000 --> 00:08.000 She was quite a woman. 00:08.000 --> 00:10.000 Whenever you're ready. 00:10.000 --> 00:13.000 So thank you, first of all, for doing this with us. 00:13.000 --> 00:15.000 Thank you for inviting me. 00:15.000 --> 00:23.000 So we are sitting in a room where patients or research subjects are administered psilocybin. 00:23.000 --> 00:26.000 What happened? 00:26.000 --> 00:31.000 When somebody is coming in for a psychedelic dosing session with psilocybin, for example, 00:31.000 --> 00:38.000 they come after about three or four hours of preparatory counseling and intention setting 00:38.000 --> 00:41.000 with the therapists that are going to be sitting with them. 00:41.000 --> 00:46.000 They'll come in, they'll lie down on the sofa after taking the capsule of psilocybin. 00:46.000 --> 00:53.000 And then the two therapists, which would be sitting in the chairs that we're in facing the person on the sofa, 00:53.000 --> 00:59.000 would watch and attend them, reassure them if that was something that needed to happen with a hand on the shoulder, perhaps. 00:59.000 --> 01:05.000 And then after about six hours, they would be evaluated to make sure that they were safe to go home. 01:05.000 --> 01:10.000 They'd go home in the care of someone that they trusted that could make sure that they got home safely. 01:10.000 --> 01:15.000 And then they'd come back 24 hours later, typically, for some debriefing, some integration of their experience. 01:15.000 --> 01:18.000 What do they experience? 01:18.000 --> 01:22.000 That's hard to describe, and it's going to be different for every individual. 01:22.000 --> 01:26.000 And frankly, it's probably different for every medication that we're using. 01:26.000 --> 01:37.000 There's a lot of hallucinogen effects, like seeing sounds and abnormal visions of patterns in the carpet, patterns in the wall. 01:37.000 --> 01:45.000 But they also describe a noetic, all-knowing sense of knowledge that they've experienced something very profound. 01:45.000 --> 01:49.000 On the other hand, they typically describe it as being ineffable, very difficult to explain. 01:49.000 --> 01:53.000 Sometimes they feel like they've come into the presence of a deity, if God. 01:53.000 --> 02:02.000 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. 02:02.000 --> 02:12.000 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. 02:12.000 --> 02:16.000 And so it's really hard to pin down a particular experience for any individual. 02:16.000 --> 02:25.000 What is the promise of treatment with psychedelics for things like depression or PTSD? 02:25.000 --> 02:31.000 It's amazing, quite honestly, what the effects of one dose of psilocybin seem to have. 02:31.000 --> 02:38.000 We see some really remarkable results in the individuals with depression, sometimes treatment resistant to depression. 02:38.000 --> 02:41.000 And that cannot occur within 24 hours. 02:41.000 --> 02:44.000 And it seems to be durable in many individuals. 02:44.000 --> 02:48.000 Not all, not everybody responds like that, just like any medication. 02:48.000 --> 02:57.000 We also see in our own work with methamphetamine, but also other institutions looking at alcohol, tobacco, cocaine. 02:57.000 --> 03:03.000 Some really remarkable, rapid responses in terms of decreased uses of these drugs of abuse. 03:03.000 --> 03:06.000 Do you yet know why? 03:07.000 --> 03:12.000 We don't know why these changes happen, whether it be substance use disorders or depression. 03:12.000 --> 03:17.000 We feel that the conscious psychedelic experience is important. 03:17.000 --> 03:22.000 We don't know if there's a particular level you need to reach, that you need to dial something in. 03:22.000 --> 03:30.000 We have evidence at this point, though, that microdosing is not effective and might be very dangerous to the heart. 03:31.000 --> 03:38.000 We think that perhaps it allows people to, if they think of the mind in a press patient as being rutted, 03:38.000 --> 03:43.000 and you're kind of forced into this path that you can't, you know, having a hard time getting out of. 03:43.000 --> 03:49.000 Perhaps the psilocybin experience allows you to sort of smooth that and reframe the way you see yourself, 03:49.000 --> 03:54.000 the way you see your use of drugs of abuse, for example. 03:54.000 --> 03:56.000 But we're not really sure, quite honestly. 03:56.000 --> 04:01.000 We don't know if it's just the psychedelic experience or some biochemical effect that doesn't need the psychedelic experience. 04:01.000 --> 04:03.000 We're still studying that. 04:03.000 --> 04:12.000 What was your reaction when you learned of this executive order that kind of gives the FDA fast track? 04:12.000 --> 04:19.000 So the executive order does several things, but the thing that I think is going to have the greatest impact on our work 04:19.000 --> 04:28.000 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. 04:28.000 --> 04:40.000 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. 04:40.000 --> 04:48.000 The concern that I have, quite honestly, is that the FDA will approve this sooner than we were expecting. 04:48.000 --> 04:58.000 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. 04:58.000 --> 05:05.000 And this would be happening presumably at research centers across the country? 05:05.000 --> 05:11.000 Well, once the drug is approved by the FDA, it does not have to be at a research center. 05:11.000 --> 05:16.000 I think that they are right now, the ones that are best positioned to accommodate that. 05:16.000 --> 05:23.000 But frankly, it's going to be both an academic and a private for-profit enterprise as well. 05:23.000 --> 05:30.000 People will need to go to some of these clinics that will charge them out of pocket for the experience. 05:30.000 --> 05:39.000 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. 05:39.000 --> 05:49.000 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? 05:49.000 --> 06:00.000 Do you have any expectation that that demand is understood by the policymakers and people who dole out budgets? 06:00.000 --> 06:05.000 I do not. I have not seen it really addressed by the policymakers. 06:05.000 --> 06:13.000 It's going to cost anywhere from three to ten thousand dollars I estimate for each of these dosing sessions. 06:13.000 --> 06:19.000 And the insurance companies are going to be waiting for the FDA approval and what the FDA requires. 06:19.000 --> 06:28.000 But I haven't seen anything from the policymakers themselves that suggests that they are anticipating how to deal with this increased demand. 06:28.000 --> 06:34.000 And still, this is really exciting news. I imagine for someone like yourself. 06:34.000 --> 06:36.000 It is really exciting. Yes. 06:36.000 --> 06:42.000 We have participated in the development of the psilocybin from about 12 years ago. 06:42.000 --> 06:49.000 And some of our work is actually going into the new drug application that the USON Institute is going to be working on. 06:49.000 --> 06:52.000 So we're really excited that we can be part of that. 06:52.000 --> 06:57.000 But helping other companies, but also looking at the mechanism of why this happens. 06:57.000 --> 07:05.000 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? 07:05.000 --> 07:21.000 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? 07:21.000 --> 07:26.000 That they are just waiting for this to be approved so that they can take part? 07:26.000 --> 07:29.000 I know that they are. I know that they're waiting. 07:29.000 --> 07:39.000 And I'm concerned that we don't have the ability to help them as soon as we would like to. 07:39.000 --> 07:46.000 When the FDA approves the store, there will be some time that the companies have to scale up, if you will. 07:46.000 --> 07:57.000 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. 07:57.000 --> 08:00.000 Is there anything you want to add on this? 08:00.000 --> 08:09.000 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. 08:10.000 --> 08:13.000 This is your brain on drugs generation. 08:13.000 --> 08:15.000 So that was a surprise. 08:15.000 --> 08:21.000 But it's really important to make it clear that we do screen the individuals that we bring into our studies. 08:21.000 --> 08:26.000 And I think it's going to be important to screen the individuals that come to us after drug approval. 08:26.000 --> 08:36.000 We look to identify individuals that might be harmed by these treatments, such as with certain mental illnesses, some bipolar disorders, schizophrenia, for example. 08:36.000 --> 08:44.000 We're not sure that these people might actually be hurt by the effects of the psychedelic during this eight-hour session. 08:44.000 --> 08:46.000 Do you have any questions? 08:46.000 --> 08:50.000 Did you list that success rate number? 08:50.000 --> 08:54.000 Like 90%? 08:54.000 --> 08:56.000 Or is that not psilocybin? 08:56.000 --> 08:58.000 That is psilocybin. 08:58.000 --> 09:10.000 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? 09:10.000 --> 09:17.000 The efficacy is remarkably fast and remarkably consistent in a lot of individuals. 09:17.000 --> 09:26.000 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. 09:26.000 --> 09:36.000 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. 09:36.000 --> 09:42.000 We've got one small study that we were able to look at individuals with methamphetamine use disorder. 09:42.000 --> 09:52.000 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. 09:52.000 --> 10:07.000 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. 10:07.000 --> 10:09.000 You just spoke to losing your funding. 10:09.000 --> 10:20.000 I know that the university itself and all of its research has been the subject of some loss of funding and otherwise delays. 10:20.000 --> 10:23.000 Has that affected this work as well? 10:23.000 --> 10:33.000 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. 10:33.000 --> 10:34.000 We'll see. 10:34.000 --> 10:45.000 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. 10:46.000 --> 10:57.000 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. 10:57.000 --> 11:04.000 So that's been a discouragement that the money that has supported our research through donors has faded away a bit. 11:04.000 --> 11:05.000 All right. 11:05.000 --> 11:06.000 That's hurting us. 11:06.000 --> 11:07.000 You have one. 11:07.000 --> 11:10.000 How long does a treatment last? 11:11.000 --> 11:23.000 So when somebody comes into the dosing room, they will be expected to stay for about eight hours. 11:23.000 --> 11:29.000 And then again, they will be sent home with someone that they trust that we trust that they'll take care of them. 11:29.000 --> 11:33.000 Although we don't let them go home in a abnormal compromised state. 11:33.000 --> 11:35.000 They're able to walk out. They're clear. 11:35.000 --> 11:37.000 We just don't want them to start driving. 11:38.000 --> 11:40.000 So it's about an eight hour session. 11:40.000 --> 11:50.000 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. 11:50.000 --> 12:01.000 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. 12:02.000 --> 12:13.000 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. 12:13.000 --> 12:14.000 Interesting. 12:14.000 --> 12:15.000 Thank you. 12:15.000 --> 12:16.000 I'm good. 12:16.000 --> 12:18.000 Where are you? 12:18.000 --> 12:26.000 That idea that, you know, okay, so the FDA approves to the cybin for the treatment of depression or other things. 12:26.000 --> 12:30.000 And then people say, great, I'll just take a bunch of mushrooms and be cured, right? 12:30.000 --> 12:32.000 That's very, very different. 12:32.000 --> 12:33.000 Yeah. 12:33.000 --> 12:38.000 And so I'm really concerned that that will be the case that people will be buying mushrooms off the streets. 12:38.000 --> 12:45.000 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. 12:45.000 --> 12:53.000 And so I'm really concerned about adulteration of magic mushrooms and what that risk might be down the road. 12:53.000 --> 12:59.000 All the drug that we're using is synthetically prepared and very pure. 12:59.000 --> 13:00.000 Of course. 13:00.000 --> 13:10.000 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. 13:10.000 --> 13:18.000 But once the package of sessions wraps, does that last years? 13:18.000 --> 13:22.000 Do you know? 13:22.000 --> 13:30.000 We don't really know yet how long these effects, these beneficial effects on substance use disorders or depression will last. 13:30.000 --> 13:34.000 In our studies, we typically can only watch them so long, we only have so much money to watch them. 13:34.000 --> 13:37.000 And so typically we're looking for one or two months. 13:37.000 --> 13:44.000 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. 13:44.000 --> 13:50.000 We also don't know how important it is for perhaps a booster to be administered six months, twelve months down the road. 13:50.000 --> 13:56.000 Or how many doses in quick succession a week apart a month apart is going to maximize the therapeutic effect. 13:56.000 --> 14:01.000 The FDA is going to be receiving these applications primarily with just one dose though. 14:01.000 --> 14:09.000 That's how remarkable it is that one dose seems to have these really, really dramatic rapid effects and surprisingly durable too. 14:09.000 --> 14:10.000 Great. 14:10.000 --> 14:11.000 Thank you. 14:11.000 --> 14:12.000 That is interesting. 14:12.000 --> 14:15.000 And this isn't for, we can stop recording. 14:15.000 --> 14:30.000 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. 14:30.000 --> 14:32.000 I mean, is their back kind of interaction? 14:32.000 --> 14:34.000 Not yet. 14:35.000 --> 14:39.000 But I think that's kind of what I think is what we're going to need to do. 14:39.000 --> 14:44.000 The therapists that are here for psilocybin are not providing that much therapy. 14:44.000 --> 14:46.000 They're providing reassurance and safety. 14:46.000 --> 15:01.000 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. 15:01.000 --> 15:08.000 But the mental health practitioners, we can't afford to put them in these chairs. 15:08.000 --> 15:18.000 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. 15:18.000 --> 15:23.000 So I think to be sustainable, we're going to have to have that warm handoff. 15:23.000 --> 15:24.000 Yeah. 15:24.000 --> 15:25.000 No. 15:25.000 --> 15:28.000 We need to do the part that you very much displayed. 15:28.000 --> 15:33.000 No, I think we can take from what we just did. 15:33.000 --> 15:36.000 Oh, that. 15:36.000 --> 15:38.000 I thought you meant asking separate questions. 15:38.000 --> 15:40.000 No, no, no, no, no. 15:40.000 --> 15:41.000 The clap. 15:41.000 --> 15:43.000 Oh, so now? 15:43.000 --> 15:45.000 Yep, whenever you're ready for it. 15:45.000 --> 15:47.000 That's the. 15:47.000 --> 15:48.000 Synchronize. 15:48.000 --> 15:49.000 All right. 15:49.000 --> 15:51.000 And then we can get 15 seconds of room to go. 15:51.000 --> 15:53.000 So don't talk. 15:53.000 --> 16:08.000 Okay. 16:08.000 --> 16:09.000 Okay.