1 00:00:00,000 --> 00:00:02,010 Bradley van Paridon: What is up Brad fans how you doing how you 2 00:00:02,010 --> 00:00:07,650 live in. If you've followed this podcast for any stretch of time, 3 00:00:07,860 --> 00:00:16,620 or if you follow the psychedelic research that's ongoing about 4 00:00:16,920 --> 00:00:20,340 the use of psychedelics for therapy, you probably have 5 00:00:20,340 --> 00:00:25,770 heard, either me or some other person in this space talk about 6 00:00:26,310 --> 00:00:31,230 the likelihood that MDMA so MDMA assisted therapy, for the 7 00:00:31,230 --> 00:00:34,410 condition of post traumatic stress disorder is likely going 8 00:00:34,410 --> 00:00:38,340 to be the first of these treatments approved by the FDA. 9 00:00:38,820 --> 00:00:45,300 But in a somewhat of a surprise decision Earlier in June, an 10 00:00:45,300 --> 00:00:51,150 independent advisory committee to the FDA, recommended against 11 00:00:51,180 --> 00:00:56,550 approval. Now, to be clear, this is not the final decision on 12 00:00:56,550 --> 00:01:00,330 this treatment or on other psychedelics. This is in fact, 13 00:01:00,360 --> 00:01:05,520 as the name suggests, an advisory committee, a panel of 14 00:01:05,580 --> 00:01:10,260 experts put together to make this pre decision, let's say, as 15 00:01:10,260 --> 00:01:15,180 a recommendation to the FDA. The final decision will be coming 16 00:01:15,180 --> 00:01:19,680 sometime later in August. And like I said, this decision was a 17 00:01:19,680 --> 00:01:24,240 bit of a shock to many in in this space, or who follow this 18 00:01:24,240 --> 00:01:28,380 space who follow the psychedelic research space. But as we'll 19 00:01:28,380 --> 00:01:31,560 hear from our guests today, maybe not totally unsurprising. 20 00:01:32,520 --> 00:01:38,340 For some context, the decision was being made on data that was 21 00:01:38,340 --> 00:01:44,040 put forward by a company called Lighthouse, which was formerly 22 00:01:45,000 --> 00:01:49,800 the maps organization Maps has been a pioneer in this space of 23 00:01:49,800 --> 00:01:54,780 psychedelic assisted therapy specifically with MDMA. And 24 00:01:54,780 --> 00:01:57,960 they've really, really been responsible for pushing, you 25 00:01:57,960 --> 00:02:03,660 know, trials, clinical trials, and and bringing this work with 26 00:02:03,810 --> 00:02:09,840 PTSD. Closer and closer to approval. They submitted data 27 00:02:09,840 --> 00:02:15,420 for multiple clinical trials. And and like I said, the 28 00:02:15,420 --> 00:02:21,420 committee decided to recommend against approval. The hearing 29 00:02:21,450 --> 00:02:27,150 included public testimony, and by some accounts, in the in the 30 00:02:27,150 --> 00:02:32,010 reporting on this, this was some pretty charged testimony, both 31 00:02:32,010 --> 00:02:36,660 for and against approval commentary from people who have 32 00:02:36,660 --> 00:02:41,820 been profoundly helped by this treatment, and people with 33 00:02:41,820 --> 00:02:49,680 serious concerns about safety. And the nature in which Lycos 34 00:02:49,740 --> 00:02:54,510 conducted some of their trials. And some of the behavior of the 35 00:02:54,510 --> 00:02:58,500 therapists involved in some of the trials, there was 36 00:02:58,890 --> 00:03:03,510 allegations of assault that happened during the during the 37 00:03:03,510 --> 00:03:10,050 trials. And so this leaves us at an interesting place in terms of 38 00:03:10,590 --> 00:03:15,570 where does where does this field go now. So to get an informed 39 00:03:15,660 --> 00:03:21,390 perspective, and some much needed context into how this 40 00:03:21,390 --> 00:03:25,110 research is performed, and some of the questions that are 41 00:03:25,110 --> 00:03:30,360 ongoing in this field, I reached out to Henrik young Abella, he 42 00:03:30,360 --> 00:03:35,520 is a psychedelic research public health researcher, based in 43 00:03:35,520 --> 00:03:39,420 Berlin, and one of the founders of the mind Foundation, a 44 00:03:39,420 --> 00:03:43,800 nonprofit organization, again, based in Berlin, that is working 45 00:03:43,800 --> 00:03:48,960 towards bringing psychedelic assisted therapy, to a medical 46 00:03:48,960 --> 00:03:52,860 framework to an approval framework in Europe. And also 47 00:03:52,860 --> 00:03:59,430 they have activities, workshops surrounding safe practice, in 48 00:03:59,430 --> 00:04:03,150 terms of of psychedelics, and how do we maximize psychedelics 49 00:04:03,180 --> 00:04:07,350 and its use in our modern culture in maybe outside of the 50 00:04:07,350 --> 00:04:12,270 clinic and these kinds of things. So Henrik has been on 51 00:04:12,270 --> 00:04:15,840 the on the show before, as have other people from the mind 52 00:04:15,840 --> 00:04:19,350 Foundation. And I just always like to point out that, my my 53 00:04:19,350 --> 00:04:22,380 thanks to them for being so generous with their time in 54 00:04:22,380 --> 00:04:27,240 coming on this show. And I really do appreciate their 55 00:04:27,900 --> 00:04:33,060 balanced approach to this, to this to this field, and to the 56 00:04:33,060 --> 00:04:36,090 end to some of these questions, because there is a lot of hype, 57 00:04:36,120 --> 00:04:42,570 as Henrik and I talked about, and there is, you know, maybe a 58 00:04:46,680 --> 00:04:50,550 and there's also some change going on in in the field itself, 59 00:04:50,580 --> 00:04:54,660 you know, from the 60s and 70s. You know, what are some ideas 60 00:04:54,660 --> 00:04:58,650 that maybe were prevalent there that came about in the first 61 00:04:58,650 --> 00:05:03,300 wave of psychedelics that Maybe don't fit a modern, modern 62 00:05:03,300 --> 00:05:07,800 context anymore or that have been proven to be or can't we 63 00:05:07,800 --> 00:05:10,140 can look at now and say, Well, maybe that's not the best way to 64 00:05:10,140 --> 00:05:13,110 do this, maybe that's not the most healthy way, or safest way 65 00:05:13,110 --> 00:05:19,620 to do that. So, like I said, very balanced take on these 66 00:05:19,620 --> 00:05:24,690 things. And one of the reasons, you know, aside from Henrik 67 00:05:24,690 --> 00:05:26,760 being very involved in this field and having a lot of 68 00:05:26,760 --> 00:05:31,200 knowledge of it, that that balance I really like. And I 69 00:05:31,200 --> 00:05:36,360 think it gives us an opportunity to look at the pros and cons and 70 00:05:36,360 --> 00:05:41,130 everything very truthfully, very honestly. That would be the 71 00:05:41,130 --> 00:05:44,910 other thing I would say about Henrichs approach to this. And 72 00:05:44,910 --> 00:05:51,000 the mind foundations approach to this is honesty and balance. So 73 00:05:51,210 --> 00:05:57,210 we talked about the decision itself, some of the specific 74 00:05:57,210 --> 00:06:04,620 factors where maybe there was where where maybe Lycos could 75 00:06:04,620 --> 00:06:08,310 have done better, where there was some potentially 76 00:06:08,340 --> 00:06:12,240 incongruent, or head scratching decisions or comments by the 77 00:06:12,240 --> 00:06:17,880 regulators, we talk about the very prominent issues that 78 00:06:17,880 --> 00:06:22,650 always come up in this field of placebo and therapy, I really 79 00:06:22,650 --> 00:06:28,800 enjoyed Henrichs comments on the therapy angle, again, speaking 80 00:06:28,800 --> 00:06:33,210 about things that maybe we want to we don't want to see in the 81 00:06:33,210 --> 00:06:36,330 therapy anymore, that maybe come from older ideas, or other 82 00:06:36,330 --> 00:06:40,380 schools of thought, original, you know, psychedelic schools of 83 00:06:40,380 --> 00:06:45,090 thought from previous times, that don't fit the modern view 84 00:06:45,090 --> 00:06:49,470 anymore, or don't really mesh with the medical framework. So I 85 00:06:49,800 --> 00:06:53,070 really, really enjoyed that part of the conversation. And we 86 00:06:53,070 --> 00:06:58,200 talked about hype, and just how do we, how do we have a good 87 00:06:58,200 --> 00:07:00,030 discussion about these things? 88 00:07:01,350 --> 00:07:04,230 How do we talk about these things with people who are 89 00:07:04,260 --> 00:07:07,980 skeptical who maybe are, let's say more conservative about 90 00:07:07,980 --> 00:07:13,320 these drugs, or have emotional reactions to the experience to 91 00:07:13,320 --> 00:07:17,400 the word drugs and the experiences that these drugs can 92 00:07:17,430 --> 00:07:22,080 can provoke? How does that hype influence, you know, the people 93 00:07:22,080 --> 00:07:25,140 in the trials, that may be a negative thing in terms of our 94 00:07:25,140 --> 00:07:30,120 ability to collect good, unbiased data? How does that 95 00:07:30,120 --> 00:07:34,350 hype affect the the people making the decisions about these 96 00:07:34,350 --> 00:07:38,250 things, you know, so very, very interesting conversation, a lot 97 00:07:38,250 --> 00:07:42,780 of good context, about the decision and where the field is 98 00:07:42,780 --> 00:07:48,870 at and the challenges but also the, still the promise of, of 99 00:07:48,870 --> 00:07:53,100 moving forward with these things in a safe and, you know, 100 00:07:53,100 --> 00:07:59,010 legitimate way. So many, many thanks again to Henrik, for 101 00:07:59,010 --> 00:08:03,930 coming on the show. And I would just like to direct everybody to 102 00:08:03,930 --> 00:08:07,680 the shownotes whether you're seeing this on the podcast on 103 00:08:07,680 --> 00:08:12,780 YouTube, or on our social media feeds, look at the captions, 104 00:08:12,780 --> 00:08:16,230 look at the look at the show notes, to find links to a lot of 105 00:08:16,230 --> 00:08:19,530 great reporting that's been done about this decision, to the mind 106 00:08:19,530 --> 00:08:24,390 Foundation, and then to also some of the research papers that 107 00:08:24,390 --> 00:08:27,630 Henrik and his collaborators are putting out regarding their 108 00:08:27,630 --> 00:08:31,440 trials with psilocybin and depression. And then just some 109 00:08:31,440 --> 00:08:35,610 of the other, you know, philosophical questions or you 110 00:08:35,610 --> 00:08:39,420 know, or big topics in the field that need to be discussed, need 111 00:08:39,420 --> 00:08:45,180 to be addressed in an open, honest way, in order for, you 112 00:08:45,180 --> 00:08:49,500 know, skeptics and true believers and everyone in 113 00:08:49,500 --> 00:08:53,940 between to sort of find the right balance in terms of hype 114 00:08:53,940 --> 00:08:57,240 and how we talked about these things and how they can be best 115 00:08:57,270 --> 00:09:02,280 used to achieve, you know, the lofty noble goals that we all 116 00:09:02,280 --> 00:09:05,670 hope we can achieve with these things, first and foremost, 117 00:09:05,700 --> 00:09:12,570 alleviating serious harms from mental health conditions that 118 00:09:12,570 --> 00:09:19,080 many people are, are suffering from. So reach out to us on the 119 00:09:19,080 --> 00:09:24,360 show to me at the show on social media at to Brad for you. And on 120 00:09:24,360 --> 00:09:27,810 email, to Brad for you@gmail.com, you can go to 121 00:09:27,840 --> 00:09:33,150 again, our website, which is linked in the bio of our social 122 00:09:33,150 --> 00:09:37,710 media or in the in the show notes. And you can find 123 00:09:37,710 --> 00:09:40,500 transcripts and ways to get in touch with us ways to throw a 124 00:09:40,500 --> 00:09:43,230 couple bucks at the show. If that's something you're inclined 125 00:09:43,230 --> 00:09:46,260 to do. Please also rate subscribe, follow all of those 126 00:09:46,260 --> 00:09:51,240 great things really help out the show a lot. We do. We I 127 00:09:51,330 --> 00:09:56,460 appreciate it very much. And that's it. That's all let's get 128 00:09:56,460 --> 00:10:01,950 to my discussion with Henrik Yuna Birla About the independent 129 00:10:01,950 --> 00:10:06,960 committee decision recommending against approval for MDMA 130 00:10:06,990 --> 00:10:10,380 assisted therapy for post traumatic stress disorder. 131 00:10:17,550 --> 00:10:20,370 Well, good morning, Henrik. Thank you for taking the time 132 00:10:20,370 --> 00:10:23,850 once again to join me on my show. It's great to see you. How 133 00:10:23,850 --> 00:10:24,480 are you today? 134 00:10:24,630 --> 00:10:26,790 Unknown: Good morning. It's a pleasure to be with you, Brad. 135 00:10:26,790 --> 00:10:29,130 It's it's good. I'm I'm fine. Excellent 136 00:10:29,130 --> 00:10:32,280 Bradley van Paridon: AM. So we're here to talk about the 137 00:10:32,310 --> 00:10:35,310 recent decision by an independent advisory committee, 138 00:10:36,000 --> 00:10:42,240 to the FDA regarding MDMA assisted therapy for PTSD, Post 139 00:10:42,240 --> 00:10:45,840 Traumatic Stress Disorder. Now, I think a lot of people were 140 00:10:45,840 --> 00:10:50,670 shocked when the committee recommended against approval. As 141 00:10:50,670 --> 00:10:53,460 we heard in the intro, this isn't the final decision. But I 142 00:10:53,460 --> 00:10:56,190 think it was a shock to a lot of people, I just want to ask you 143 00:10:56,190 --> 00:11:00,360 right away, you know, as someone who is not involved in the 144 00:11:00,360 --> 00:11:03,390 American system, you're coming from Germany from the European 145 00:11:03,390 --> 00:11:06,900 system, but working in the same field working towards the same 146 00:11:06,900 --> 00:11:11,700 goals of bringing psychedelics to, to a medical framework to to 147 00:11:11,700 --> 00:11:15,750 an approval framework. What was your reaction when you heard 148 00:11:15,810 --> 00:11:19,740 that news? Was it a surprise? Did you have some inclination 149 00:11:19,740 --> 00:11:22,980 that maybe it wasn't going to be as easy as maybe some of the 150 00:11:22,980 --> 00:11:25,650 reports? Were making it sound? Yeah, 151 00:11:25,980 --> 00:11:28,380 Unknown: very good question. So it wasn't a surprise, it was 152 00:11:28,380 --> 00:11:34,260 also a little bit of a shock, but not unexpected. So we among 153 00:11:34,260 --> 00:11:38,070 the networks that we work in, were talking about, particularly 154 00:11:38,100 --> 00:11:41,400 a European perspective. So the European perspective was, what 155 00:11:41,400 --> 00:11:48,420 the data that the FDA accepts or does not accept, be enough to 156 00:11:48,420 --> 00:11:52,770 also bring it to Europe. And I heard a lot of voices around us 157 00:11:52,800 --> 00:11:58,560 that said, well, the studies are too small. And the data that 158 00:11:58,560 --> 00:12:04,170 they that maps or like us is delivering is might not be good 159 00:12:04,170 --> 00:12:11,010 enough. And we're not sure if the reporting on on SAE is and a 160 00:12:11,010 --> 00:12:16,770 is how it will be. So it was like people are hoping for an 161 00:12:16,770 --> 00:12:20,610 MDMA approval, but also hoping for something that is sound 162 00:12:20,610 --> 00:12:22,410 enough to also take it to Europe. 163 00:12:22,650 --> 00:12:25,920 Bradley van Paridon: So a lot of the reaction that I was reading, 164 00:12:26,820 --> 00:12:28,980 and maybe it's a skewed perspective, I don't know, this 165 00:12:28,980 --> 00:12:34,770 is why I'd like to ask you was that a lot of the critiques from 166 00:12:34,770 --> 00:12:37,470 the committee weren't necessarily about the compound 167 00:12:37,470 --> 00:12:42,060 itself. There was some safety and long term safety issues 168 00:12:42,060 --> 00:12:46,740 raised. But it was more about maybe the methodology or, you 169 00:12:46,740 --> 00:12:50,760 know, some laxness in the way that some of the data was 170 00:12:50,760 --> 00:12:54,270 recorded by the company Lycos itself. Is that a perspective 171 00:12:54,270 --> 00:12:58,080 that you got? Is it something you can agree with? Or how did 172 00:12:58,080 --> 00:13:00,240 you view some of the some of the decisions, 173 00:13:00,360 --> 00:13:03,240 Unknown: let me give a little bit of context for the 174 00:13:03,240 --> 00:13:08,700 listeners. So we are just through a massive psilocybin 175 00:13:08,850 --> 00:13:15,150 research project. And it was really a heavy thing to adhere 176 00:13:15,150 --> 00:13:19,500 to all the rules that we have given ourselves. And also, we 177 00:13:19,500 --> 00:13:24,060 have failed in some cases. So managing a team in two study 178 00:13:24,060 --> 00:13:28,920 centers on our sites, and study centers that we're doing it for 179 00:13:28,920 --> 00:13:33,510 the first time, that's really a challenge. Yeah. Now, maps had a 180 00:13:33,510 --> 00:13:38,490 lot more study centers, and Maps has not been a drug development 181 00:13:38,490 --> 00:13:43,470 company before they entered into that race. Neither have we while 182 00:13:43,470 --> 00:13:46,650 our principal investigator is very experienced in more than 30 183 00:13:46,650 --> 00:13:52,050 studies. So it was to be expected that some 184 00:13:52,080 --> 00:13:56,250 irregularities would pop up. And, of course, as the 185 00:13:56,250 --> 00:14:02,490 frontrunner in the psychedelic space, it, it would be very good 186 00:14:02,490 --> 00:14:09,120 if maps would take care of particularly the the risk data 187 00:14:09,180 --> 00:14:13,710 to be really sound. And I don't know what the FDA will be coming 188 00:14:13,710 --> 00:14:18,450 up with, there's a chance of it being approved still. But there 189 00:14:18,450 --> 00:14:24,030 could also be a chance of them demanding a clearer registry, a 190 00:14:24,030 --> 00:14:30,330 clearer, clearer way of dealing with some of the unexpected or 191 00:14:30,360 --> 00:14:33,870 unpublished events. So I don't know if you want to talk about 192 00:14:33,870 --> 00:14:38,010 that, too. Obviously, there were some things events happening 193 00:14:38,670 --> 00:14:45,270 that are not formally to be reported to the FDA. But we had 194 00:14:45,270 --> 00:14:50,610 conversations over here, what we report something that happens, 195 00:14:50,940 --> 00:14:56,310 like five months after the study formally ended, and that is 196 00:14:56,310 --> 00:15:01,740 closely linked to the study what we report that And so the vast 197 00:15:01,740 --> 00:15:05,640 majority of voices that I hear is that we should, particularly 198 00:15:06,600 --> 00:15:10,890 in a situation where we, as researchers, drug developers, 199 00:15:11,310 --> 00:15:16,050 are to show to society and society is a pretty complex 200 00:15:16,050 --> 00:15:22,650 thing. It does not only exist out of psychedelic enthusiasts, 201 00:15:22,740 --> 00:15:26,370 so we have to deal with a lot of the conservative people in the 202 00:15:26,370 --> 00:15:31,470 systems now. And the best way from our viewpoint, to deal with 203 00:15:31,800 --> 00:15:40,740 skepticism is to be truthful, very open a little bit more. A 204 00:15:40,740 --> 00:15:46,320 little bit more, maybe looking at the risks, then you consider 205 00:15:46,320 --> 00:15:50,550 necessary because you don't want to hear the voices that tell 206 00:15:50,550 --> 00:15:53,310 you, Oh, you were hiding something? Yeah, 207 00:15:53,310 --> 00:15:55,110 Bradley van Paridon: so it's really about being maybe 208 00:15:55,110 --> 00:16:00,120 overcautious, in your opinion to sort of when you have such, I 209 00:16:00,120 --> 00:16:03,270 don't know, let's say, scrutiny is maybe the right word. But I 210 00:16:03,270 --> 00:16:06,390 think there's a there's a, it's on both sides, right. Like 211 00:16:06,390 --> 00:16:09,420 there's a real enthusiasm. But there's also still this sort of 212 00:16:09,510 --> 00:16:13,950 stigma and skepticism of this kind of, of these of these 213 00:16:13,950 --> 00:16:16,200 compounds, really. And I think that's, that's what you're 214 00:16:16,200 --> 00:16:19,080 speaking to, maybe we could give a little bit of context for the 215 00:16:19,080 --> 00:16:22,620 audience on this, about just a couple of the specific things 216 00:16:22,620 --> 00:16:27,540 because the one that that stood out to me was not reporting, 217 00:16:27,630 --> 00:16:32,340 like overly positive feelings. So feelings of euphoria, or I 218 00:16:32,340 --> 00:16:35,280 can't remember some of the other terms they use. But these 219 00:16:35,880 --> 00:16:38,820 outcomes, normally we think about reporting the adverse 220 00:16:38,820 --> 00:16:43,770 outcomes. So you know, hypertension, or, you know, 221 00:16:43,770 --> 00:16:46,950 feeling stressed or feeling anxious, scared, you know, these 222 00:16:46,950 --> 00:16:50,130 kinds of things. And yes, that speaks logically, that's 223 00:16:50,130 --> 00:16:53,910 something we should record. But one of the criticisms was not 224 00:16:53,910 --> 00:16:58,380 recording the overly positive side effects, let's say or 225 00:16:58,380 --> 00:17:01,320 outcomes. And the idea being that looks 226 00:17:01,320 --> 00:17:04,470 Unknown: to the mind, which speaks to the mind of addiction 227 00:17:04,470 --> 00:17:07,170 researchers, for example, right, they are obviously concerned 228 00:17:07,170 --> 00:17:10,770 about what are people doing with the states? Are they trying to 229 00:17:10,770 --> 00:17:14,130 repeat them overly often and things like that? 230 00:17:15,270 --> 00:17:17,460 Bradley van Paridon: Yeah, well, so what is your what is your 231 00:17:17,460 --> 00:17:21,000 thought on that, then in terms of I think, I think I could 232 00:17:21,000 --> 00:17:24,480 guess that your your idea would be to, yes, record all of this 233 00:17:24,480 --> 00:17:28,380 data and presented all openly and, and truthfully. But I'm 234 00:17:28,380 --> 00:17:32,220 actually a little interested in your thought on that sort of 235 00:17:32,280 --> 00:17:37,350 criticism? Because for me, it seems like there's a body of 236 00:17:37,350 --> 00:17:41,490 other work out there on addiction with these compounds 237 00:17:41,700 --> 00:17:44,580 that can be referenced in this case. So again, I wonder if this 238 00:17:44,580 --> 00:17:49,110 is maybe I don't want to say, overly critical, but I'm just 239 00:17:49,110 --> 00:17:51,960 wondering where where this decision comes from? Because 240 00:17:51,960 --> 00:17:54,960 there's a lot of compounds that have similar things. And I don't 241 00:17:54,960 --> 00:17:58,380 know that they've necessarily been scrutinized in the same 242 00:17:58,380 --> 00:18:00,300 way. I don't know I could be wrong on that. Yeah. 243 00:18:00,540 --> 00:18:03,960 Unknown: Matt cyclus has a double it and it has also a drug 244 00:18:03,960 --> 00:18:08,190 policy agenda. And Rick Doblin has been very outspoken about 245 00:18:08,190 --> 00:18:12,540 it. He wants to get rid of the current way that drugs are 246 00:18:12,540 --> 00:18:18,390 regulated. And I mean, doing that, at the same time, maybe 247 00:18:18,420 --> 00:18:20,880 for a long time in the same organization, and in two 248 00:18:20,880 --> 00:18:26,160 organizations that are now undergoing internal changes also 249 00:18:26,160 --> 00:18:30,630 towards commercialization is really a big endeavor to to get 250 00:18:30,630 --> 00:18:33,120 a clear message over to the regulators and to the 251 00:18:33,120 --> 00:18:40,140 politicians. I wouldn't do it. So just as an example, maybe 252 00:18:40,140 --> 00:18:44,550 others can, but I couldn't. I have been before we found that 253 00:18:44,550 --> 00:18:48,510 the mind foundation here in Europe, we, we did a lot of 254 00:18:48,510 --> 00:18:51,810 water, tea and drug policy and prevention in another 255 00:18:51,810 --> 00:18:59,730 organization called finder. And we agreed to kind of stop that, 256 00:18:59,760 --> 00:19:03,600 of course, we I talk about drug policy if somebody asks me, but 257 00:19:03,630 --> 00:19:09,150 it's not that we are pushing it out into the world. Because we 258 00:19:09,150 --> 00:19:13,860 need to focus on one thing, first step that was our opinion. 259 00:19:14,070 --> 00:19:19,410 So this is a challenge that that maps build itself for itself, 260 00:19:19,920 --> 00:19:25,410 and it might now come back to as a problem that wasn't fully 261 00:19:25,410 --> 00:19:30,540 resolved. So a lot of people seem to be concerned in the 262 00:19:30,540 --> 00:19:34,950 regulator space. Also people who are not really deep into the 263 00:19:34,950 --> 00:19:38,970 science of psychedelics that was obviously some some very 264 00:19:38,970 --> 00:19:42,780 coherent reaction from the field that there are some people who 265 00:19:42,780 --> 00:19:46,650 were that committee who have never really looked deeply into 266 00:19:46,650 --> 00:19:51,600 the delicacies of psychedelic research on blinding and so on. 267 00:19:51,630 --> 00:19:56,400 But nevertheless, this is exactly the kind of people we 268 00:19:56,580 --> 00:20:03,570 need to convince. So, uh, Um, and I mean, having that double 269 00:20:03,570 --> 00:20:07,650 message of, let's get all the drugs free. And let's have our 270 00:20:07,650 --> 00:20:13,290 therapy be approved on the market. This is a challenge. 271 00:20:15,540 --> 00:20:18,330 Bradley van Paridon: Yeah. So you know, the biting off more 272 00:20:18,330 --> 00:20:23,730 than one can chew perhaps. But I still, I want to stick maybe to 273 00:20:23,820 --> 00:20:27,600 this. And the other thing that jumped out to me and again, I 274 00:20:27,600 --> 00:20:30,240 can't We can't get into the minds of the regulators and what 275 00:20:30,240 --> 00:20:33,750 they were thinking exactly. But there was another criticism and 276 00:20:33,750 --> 00:20:36,180 it kind of follows the same with with the extra can 277 00:20:36,180 --> 00:20:38,910 Unknown: actually can't by just talking to them. I mean, yeah, 278 00:20:39,300 --> 00:20:43,440 we are talking through the European regulators. And you get 279 00:20:43,440 --> 00:20:48,240 a lot also of them on scientific conferences, not necessarily all 280 00:20:48,240 --> 00:20:52,050 of them go to like psychedelic conferences, but some go to 281 00:20:52,320 --> 00:20:56,730 neuroscience conferences, psychopharmacology conferences, 282 00:20:57,120 --> 00:21:01,740 and then they talk, and then they write papers. And I mean, 283 00:21:01,770 --> 00:21:06,870 it's pretty much open out in the space to skepticism, and maybe 284 00:21:06,870 --> 00:21:11,130 also not so sciency decisions on side of the regulators that are 285 00:21:11,130 --> 00:21:14,610 more political, we can see it in the European Space, I'm sure we 286 00:21:14,610 --> 00:21:17,850 can see it in the FDA. Regulatory space too. 287 00:21:18,690 --> 00:21:22,440 Bradley van Paridon: Hmm. So there is a there is a you have 288 00:21:22,440 --> 00:21:24,930 some advance notice then maybe of what they're going to be 289 00:21:24,930 --> 00:21:27,420 looking at, and what they're going to be focused on what 290 00:21:27,420 --> 00:21:29,820 their concerns might be 291 00:21:31,230 --> 00:21:34,170 Unknown: at the moment. So that's also a European, again, I 292 00:21:34,170 --> 00:21:36,000 don't know if you if this is helpful for the American 293 00:21:36,450 --> 00:21:39,420 perspective, but on the European side, we are, we've just 294 00:21:39,420 --> 00:21:42,750 finished that episode study that we were working on for more than 295 00:21:42,750 --> 00:21:46,740 three years, and we are heading towards a potential phase three 296 00:21:46,770 --> 00:21:53,370 approval study. So that means for almost two years, we are now 297 00:21:53,370 --> 00:21:57,630 talking to regulators. And we see how they evolve and how they 298 00:21:57,630 --> 00:22:03,390 perceive us American data, and what their skepticism is. And I 299 00:22:03,390 --> 00:22:08,430 would just I would just more half the very conservative 300 00:22:08,430 --> 00:22:13,440 people or not so much the conservative, like the the maybe 301 00:22:13,980 --> 00:22:19,260 people with emotional reactions to everything that others call a 302 00:22:19,260 --> 00:22:25,680 drug. In my mind, it's not this is not all rational. So a lot of 303 00:22:25,680 --> 00:22:29,910 people even if they have have Professor titles and work in, in 304 00:22:29,940 --> 00:22:33,330 regulatory bodies or universities, they have 305 00:22:33,330 --> 00:22:38,220 prejudice like all of us, and they have emotional, emotional 306 00:22:38,250 --> 00:22:42,780 attitudes that you need to speak to some people just are scared 307 00:22:42,810 --> 00:22:47,670 of drugs, still, no matter how advanced your own thinking about 308 00:22:47,730 --> 00:22:52,560 drugs, psychoactive substances may be, let's talk to the people 309 00:22:52,560 --> 00:22:53,490 who are afraid 310 00:22:54,570 --> 00:22:56,880 Bradley van Paridon: and ease their concerns. Yeah, because 311 00:22:56,880 --> 00:22:59,490 that was one of the things again, that stuck out to me and 312 00:22:59,490 --> 00:23:03,360 reading was, you know, there was a lot of commentary about, well, 313 00:23:03,360 --> 00:23:08,190 the addictive side. But also, you know, mixing if patients 314 00:23:08,190 --> 00:23:11,250 were to mix these with alcohol or something like that, and as I 315 00:23:11,250 --> 00:23:14,640 was reading this, I was like, I mean, but we've done this 316 00:23:14,640 --> 00:23:18,540 before, antidepressants, you know, lots of different drugs 317 00:23:18,570 --> 00:23:23,580 have that concern and have gone through approval. So in a way I 318 00:23:23,580 --> 00:23:26,430 was thinking, Well, how much is this just a not an understanding 319 00:23:26,430 --> 00:23:30,360 of, of the compounds themselves, or putting an extra sort of 320 00:23:30,360 --> 00:23:33,930 filter on it that might be you know, from stigma or something 321 00:23:33,930 --> 00:23:37,170 else about these drugs, because they are considered were once 322 00:23:37,170 --> 00:23:39,420 considered, you know, recreational? Like, that's their 323 00:23:39,420 --> 00:23:41,970 sort of, they didn't come through that typical 324 00:23:42,180 --> 00:23:46,170 pharmaceutical lens, but maybe at what point do we have to, you 325 00:23:46,170 --> 00:23:49,740 know, trust the patients trust the therapists, you know, rather 326 00:23:49,740 --> 00:23:52,800 than sort of try to over regulate all of these behaviors. 327 00:23:53,070 --> 00:23:55,770 Unknown: Let me quickly talk about some of the complexities 328 00:23:55,830 --> 00:24:00,450 in the kind of data that we do not have. So, there is a 329 00:24:00,450 --> 00:24:06,030 transition between maybe self administered drug use and 330 00:24:06,030 --> 00:24:11,460 therapeutic drug use, obviously, after MDMA therapy, and also 331 00:24:11,460 --> 00:24:17,520 after psilocybin or the empty or five Meo DMT therapy. So, there 332 00:24:17,520 --> 00:24:23,340 are several questions coming from that. Are we socializing 333 00:24:23,670 --> 00:24:29,040 patients into a certain subculture? Or are we 334 00:24:29,400 --> 00:24:35,220 socializing or modeling a certain kind of use or attitude 335 00:24:35,250 --> 00:24:39,210 towards these therapeutic compounds? Also, to be clear, I 336 00:24:39,210 --> 00:24:45,210 believe that MDMA has a can have a very therapeutic effect. So 337 00:24:45,240 --> 00:24:49,740 but even people who might have received it once, twice, three 338 00:24:49,740 --> 00:24:55,920 times in the study, May after some month, feel the need to 339 00:24:55,920 --> 00:24:59,490 have a refresher or want to do something or have a growth 340 00:25:00,480 --> 00:25:04,980 Motivation. So what are what are they doing? Those days after the 341 00:25:04,980 --> 00:25:12,210 studies phase is seriously under invested. And the data that we 342 00:25:12,210 --> 00:25:19,650 have here is scars. This is where were the where there is a 343 00:25:21,090 --> 00:25:27,030 field, where people often also, some people, a part of the study 344 00:25:27,030 --> 00:25:32,130 population may go to sub cultural or drug dealing 345 00:25:32,340 --> 00:25:37,080 structures. And this is where people get concerned. And it's 346 00:25:37,080 --> 00:25:40,800 a, it's a complex field, I mean, the, we have already talked 347 00:25:40,800 --> 00:25:47,910 about it. So free forming this, the the drug, the drug field and 348 00:25:47,910 --> 00:25:52,740 how drugs are provided in society. And maybe even a 349 00:25:52,740 --> 00:25:58,800 thinking that, how thinking more concretely about how to fulfill 350 00:25:58,800 --> 00:26:03,720 the needs of people who might have a tremendous improvement 351 00:26:03,720 --> 00:26:09,870 through psychedelic therapies, but then, after months, or years 352 00:26:09,870 --> 00:26:16,080 fall back, or maybe even might have gone into might have tasted 353 00:26:16,260 --> 00:26:21,810 some of the potential growth or and self self development 354 00:26:22,680 --> 00:26:28,530 impulses that these substances can have on people. So this is 355 00:26:28,560 --> 00:26:33,450 something I would look at very clearly and talk to regulators 356 00:26:33,480 --> 00:26:40,980 about openly and they might react with. So that's what some 357 00:26:40,980 --> 00:26:44,850 of the European people we talked to have reacted with. Okay. We 358 00:26:44,850 --> 00:26:51,090 understand that we also see that in other drug trials, we, we 359 00:26:51,090 --> 00:26:55,860 feel that this is an open conversation, and we somehow 360 00:26:55,860 --> 00:27:02,250 through a follow up studies need to get an impression on what are 361 00:27:02,250 --> 00:27:05,700 people doing after therapy. And, of course, we also need to 362 00:27:05,700 --> 00:27:11,760 encourage people to report truthfully, and not build a 363 00:27:11,760 --> 00:27:15,630 relationship to study participants. That insinuates 364 00:27:15,660 --> 00:27:18,210 Well, yeah, you've gone through a tremendous therapeutic 365 00:27:18,210 --> 00:27:22,740 process. Now you owe us not to report on what you do 366 00:27:22,740 --> 00:27:27,000 afterwards. This is, I think, not the way that we should go 367 00:27:27,000 --> 00:27:27,300 on. 368 00:27:28,470 --> 00:27:32,340 Bradley van Paridon: Hmm. Yeah, that's, that's a really good 369 00:27:32,340 --> 00:27:35,790 perspective, actually. And I didn't, I didn't consider that 370 00:27:35,790 --> 00:27:38,610 one, my initial reaction of reading the some of the 371 00:27:38,610 --> 00:27:40,800 committee findings and stuff. And I think that's a good point, 372 00:27:40,800 --> 00:27:43,110 because it's almost like you were saying before trying to do 373 00:27:43,110 --> 00:27:47,160 two things at once, because there is this movement. And I'm 374 00:27:47,160 --> 00:27:50,280 not saying that you guys are I mean, I think, like, I'm not 375 00:27:50,280 --> 00:27:53,070 putting words in your mouth, but the psychedelic community, on 376 00:27:53,070 --> 00:27:55,620 one hand, doing the medical approval process, and all of 377 00:27:55,620 --> 00:27:58,590 that, but there's also an opening up of the conversation 378 00:27:58,590 --> 00:28:01,620 about these compounds outside of a medical context, you know, and 379 00:28:01,620 --> 00:28:05,490 a lot of it pertains to growth, personal growth. And so yeah, I 380 00:28:05,490 --> 00:28:09,120 can see the point where someone who has gone through a 381 00:28:09,120 --> 00:28:12,090 therapeutic trial, a medical trial, tightly supervised 382 00:28:12,090 --> 00:28:15,060 everything like that, but they felt this, this, you know, maybe 383 00:28:15,060 --> 00:28:18,870 this power, you know, this sort of this, this feeling that can 384 00:28:18,870 --> 00:28:22,260 be provoked by the substances, and then would want to, you 385 00:28:22,260 --> 00:28:26,460 know, do that, again, maybe six months, a year later, that kind 386 00:28:26,460 --> 00:28:28,350 of thing, or they have another experience, or maybe they're 387 00:28:28,350 --> 00:28:31,170 even telling other people about that experience, maybe, 388 00:28:31,470 --> 00:28:35,070 Unknown: maybe they are diving into the psychedelic subculture, 389 00:28:35,070 --> 00:28:40,680 or community literature, or space, or a workshop environment 390 00:28:40,710 --> 00:28:47,190 and book their tickets to the Amazon and talk to, to Brad 391 00:28:47,220 --> 00:28:51,270 about what they did in the Amazon, or talk to a newspaper, 392 00:28:51,300 --> 00:28:56,130 and then it's out here, and there needs to be some kind of 393 00:28:56,130 --> 00:29:00,390 reasonable commenting on that on some and talking to the 394 00:29:00,390 --> 00:29:04,230 regulators about that, if they do their job, they are reading 395 00:29:04,230 --> 00:29:09,360 that in the media and wherever we need to develop an 396 00:29:09,360 --> 00:29:12,060 understanding of what people are doing there, and what what 397 00:29:12,060 --> 00:29:14,760 future regulation needs might be. 398 00:29:14,910 --> 00:29:16,860 Bradley van Paridon: Yeah, it seems like it would have, you 399 00:29:16,860 --> 00:29:20,880 know, again, two parallel things happening at once. And it might 400 00:29:20,880 --> 00:29:25,350 be difficult to balance those. But I guess, the way you might 401 00:29:25,380 --> 00:29:28,740 one way you might address this is just longer, longer follow up 402 00:29:28,770 --> 00:29:32,400 with study participants to see behaviors and attitudes, you 403 00:29:32,400 --> 00:29:35,280 know, maybe a year, which is a lot of work to keep track of all 404 00:29:35,280 --> 00:29:37,650 of these people and a lot of money, like you said, building 405 00:29:38,520 --> 00:29:42,240 Unknown: a lot of money too. So so in the study that we're just 406 00:29:42,240 --> 00:29:49,050 trying to build, we have 30 It's 32 weeks long. So even that it 407 00:29:49,050 --> 00:29:53,010 has two phases, the six week phase and the 26 week phase 408 00:29:53,010 --> 00:29:56,640 following but it's the same study and after that comes 409 00:29:56,640 --> 00:30:00,090 follow up potentially for several years and you need to 410 00:30:00,090 --> 00:30:00,690 finance that, 411 00:30:01,410 --> 00:30:02,580 Bradley van Paridon: and build the relationships with 412 00:30:02,580 --> 00:30:04,620 participants that that, like you said that they are 413 00:30:04,680 --> 00:30:07,200 Unknown: not trumping reporting truth and not dropping 414 00:30:07,200 --> 00:30:11,130 Bradley van Paridon: out. So it's it is, it's a lot of work, 415 00:30:11,130 --> 00:30:16,170 I think we know. Okay, then there's a couple specifics, 416 00:30:16,170 --> 00:30:19,230 maybe, again, that I'd like to just talk to you about, and 417 00:30:19,230 --> 00:30:23,640 maybe I just, you could start with, were there things that 418 00:30:23,640 --> 00:30:25,800 really stood out to you in the decision that you were like, 419 00:30:25,800 --> 00:30:29,550 yes, that's something we need to get a grip on? Or where there's 420 00:30:29,550 --> 00:30:32,010 some things that you might say, we could push back a little bit 421 00:30:32,010 --> 00:30:35,070 and say, Well, we already have this, I'm thinking specifically 422 00:30:35,070 --> 00:30:37,440 of the placebo conversation, which which comes up all the 423 00:30:37,440 --> 00:30:43,410 time. And then also the regulating the therapy angle, or 424 00:30:43,680 --> 00:30:46,470 maybe regulating is the wrong word, because FDA doesn't 425 00:30:46,470 --> 00:30:49,590 regulate therapy, I'm assuming it's similar in the in the 426 00:30:49,590 --> 00:30:53,370 European context. But standardizing the therapy maybe 427 00:30:53,370 --> 00:30:57,420 is a is a better word for that. And but what were maybe some of 428 00:30:57,420 --> 00:31:01,110 the highlights for you, where you saw, yes, that's something 429 00:31:01,110 --> 00:31:03,660 that we need to figure out a way to address. 430 00:31:05,070 --> 00:31:07,230 Unknown: Very interesting question. So again, from a 431 00:31:07,230 --> 00:31:11,790 European perspective, and as an organization, that together with 432 00:31:11,820 --> 00:31:18,330 other organization tries to set up a trial that tries to solve 433 00:31:18,330 --> 00:31:24,240 some of the questions that you're raising. So yes, placebo 434 00:31:24,240 --> 00:31:28,680 controlled trials are demanded. But there is there are a lot of 435 00:31:28,680 --> 00:31:31,830 other trials that could be done. And we're trying in our 436 00:31:31,860 --> 00:31:36,750 potential phase three, to do a comparative trial. So we are, we 437 00:31:36,750 --> 00:31:42,900 are comparing against a standard of care. And so we have two to 438 00:31:43,500 --> 00:31:47,490 two branches in this in the study. So both involve 439 00:31:47,490 --> 00:31:51,180 psychotherapy. And on the one side, there is an antidepressant 440 00:31:51,840 --> 00:31:54,390 being administered on the other side. So those have been being 441 00:31:55,350 --> 00:31:58,500 administered. This is called a health technology assessment 442 00:31:58,500 --> 00:32:03,810 study, which is designed to take these therapies into the public 443 00:32:03,810 --> 00:32:08,220 health insurance space. And for that you need all you always 444 00:32:08,220 --> 00:32:13,530 need to compare against the standard of care. So that could 445 00:32:13,530 --> 00:32:17,820 have easily been demanded by the authorities in the United 446 00:32:17,820 --> 00:32:21,480 States. They didn't do that. And then there's some incoherence on 447 00:32:21,480 --> 00:32:28,200 the side of the FDA, of course, so they accepted. The unblinding 448 00:32:28,230 --> 00:32:33,660 Rich studies, and they had a conversation for many years for 449 00:32:33,660 --> 00:32:39,330 more than a decade, with, with maps. And so in a sense, there 450 00:32:39,330 --> 00:32:44,010 is some under preparation of the Committee on we accepted that 451 00:32:44,010 --> 00:32:48,390 and because we believe that these drugs have a therapeutic 452 00:32:49,020 --> 00:32:53,250 role to play in the market, in the future, we accept some of 453 00:32:53,250 --> 00:32:58,320 the deficiencies of of the of the study. So that that was a 454 00:32:58,320 --> 00:33:02,640 little bit unsystematic. On the side of the FDA, I don't know 455 00:33:02,670 --> 00:33:07,560 why they let it happen like that. We may hear from others 456 00:33:07,560 --> 00:33:12,780 about the political stuff that happened in the background. And 457 00:33:12,780 --> 00:33:16,620 just one of the things and then ongoing topic in psychedelic 458 00:33:16,890 --> 00:33:19,890 research about is it psychotherapy, is it not 459 00:33:19,890 --> 00:33:22,560 psychotherapy, how much psychotherapy, should we call it 460 00:33:22,560 --> 00:33:27,210 psychotherapy. And maps have been Maps has been pretty 461 00:33:27,210 --> 00:33:33,870 outspoken about it, but in a, again, European perspective away 462 00:33:33,870 --> 00:33:40,710 that would be very unwise to do it in Germany, France, 463 00:33:40,740 --> 00:33:46,710 Switzerland, some other European countries. They have under 464 00:33:46,710 --> 00:33:49,920 defined their intervention, their psychotherapeutic 465 00:33:49,950 --> 00:33:53,940 intervention and put in a bunch of ideas that emerged in the 466 00:33:53,940 --> 00:34:02,010 1970s, which are not clearly defined and investigated. And so 467 00:34:02,010 --> 00:34:05,460 they were opening up to all the criticism that then came out of 468 00:34:06,090 --> 00:34:11,490 committee group without necessarily the need to do that. 469 00:34:11,670 --> 00:34:16,470 So there were yours to be which they could have defined that 470 00:34:17,340 --> 00:34:21,720 accompanying intervention much better. Everybody who knows some 471 00:34:21,720 --> 00:34:27,360 of our papers, we, like our principal investigator get 472 00:34:27,360 --> 00:34:32,490 Glinda. He just published first authored a paper in Lancet 473 00:34:32,490 --> 00:34:39,300 psychiatry, with the title a psychedelic therapy is 474 00:34:39,960 --> 00:34:44,610 psychotherapy. Now, of course, this is a very radical position 475 00:34:44,610 --> 00:34:53,190 and others have contradicted but you on our side, opinionated, 476 00:34:53,190 --> 00:34:58,170 certainly. We are more looking at the intersections of how can 477 00:34:58,170 --> 00:35:01,500 we measure that what's happening I think what's what's happening 478 00:35:01,530 --> 00:35:07,200 in psychedelic therapy has similarities to all kinds of 479 00:35:07,200 --> 00:35:11,700 psycho therapies, and where are the exceptional effects. Instead 480 00:35:11,700 --> 00:35:15,570 of saying it, there are two things, and we don't know how 481 00:35:15,570 --> 00:35:21,180 they work together, which is actually a scientific. Lai is a 482 00:35:21,180 --> 00:35:28,350 little bit too strong. But we have, we have 77 decades of data 483 00:35:28,350 --> 00:35:32,460 on psychotherapy research that we can look at. And that we can 484 00:35:32,640 --> 00:35:35,280 apply now. And it's happening more and more, I see more and 485 00:35:35,280 --> 00:35:39,930 more study centers, applying, applying questionnaires and 486 00:35:39,930 --> 00:35:43,500 concepts from psychotherapy research in Australia, in 487 00:35:43,650 --> 00:35:50,340 Germany, in Spain, and also at the Johns Hopkins. So this could 488 00:35:50,340 --> 00:35:55,680 have happened a little bit earlier. And defining the 489 00:35:55,680 --> 00:36:00,270 therapy better is something that does the whole thing very well, 490 00:36:00,630 --> 00:36:00,810 it 491 00:36:00,810 --> 00:36:02,370 Bradley van Paridon: seems to me like this is exactly where a 492 00:36:02,370 --> 00:36:06,150 comparative study comes in. Because if if you're comparing 493 00:36:06,150 --> 00:36:08,940 to standard of care with a with a therapy that is, you know, 494 00:36:08,940 --> 00:36:12,960 known, trusted by the community, by regulators, that kind of 495 00:36:12,960 --> 00:36:15,660 thing, and all you're swapping out is, like you said, an 496 00:36:15,660 --> 00:36:20,040 antidepressant versus the psilocybin treatment, that seems 497 00:36:20,040 --> 00:36:23,610 like it would be a robust comparison as to what's going 498 00:36:23,610 --> 00:36:25,050 on. Hopefully, 499 00:36:25,140 --> 00:36:29,010 Unknown: hopefully, we have very, very good feedback so far. 500 00:36:29,130 --> 00:36:33,000 But it's also Admittedly, it's an expensive thing. And it's 501 00:36:33,030 --> 00:36:36,990 something that takes a lot of resources and motivation on the 502 00:36:36,990 --> 00:36:42,360 side of the study sites. And you need to you need to have people 503 00:36:42,390 --> 00:36:46,320 in the study sites, then that are both trained 504 00:36:46,350 --> 00:36:50,670 psychotherapists, and are open to the psychedelic substances. 505 00:36:51,180 --> 00:36:59,370 And I mean, there has been kind of diffuse field, from again, 506 00:36:59,370 --> 00:37:02,670 from, from our perspective, in the United States, where you 507 00:37:02,670 --> 00:37:06,120 don't have such a, sometimes a little bit rigid system, like in 508 00:37:06,120 --> 00:37:08,820 Germany, in Germany, the psychotherapy definitions are 509 00:37:08,820 --> 00:37:14,100 very rigid, and what is reimbursed is, is a very well 510 00:37:14,100 --> 00:37:17,190 defined in terms of psychotherapy, schools who have 511 00:37:17,190 --> 00:37:24,210 hundreds of, of studies to, to apply with to the HTA 512 00:37:24,210 --> 00:37:27,750 authorities to be reimbursed. And that kind of thing is not 513 00:37:27,750 --> 00:37:32,640 present in the FDA regulatory space. So there are differences 514 00:37:32,640 --> 00:37:35,250 between Europe and the United States. Okay. 515 00:37:35,250 --> 00:37:37,380 Bradley van Paridon: And then I think this goes along with 516 00:37:37,380 --> 00:37:40,410 defining the therapy a little better. And one of the things 517 00:37:40,410 --> 00:37:43,920 you mentioned at the beginning of just, you have these 518 00:37:43,920 --> 00:37:47,100 different sites, you know, doing these trials, and you kind of 519 00:37:47,100 --> 00:37:50,040 trying to monitor them, but they have independence on you know, 520 00:37:50,040 --> 00:37:52,860 they're not being monitored all the time. And I think we have to 521 00:37:52,860 --> 00:37:57,540 bring up the safety concerns that were that were that were 522 00:37:57,540 --> 00:38:01,350 brought up in the trial, as well, some allegations of abuse 523 00:38:01,380 --> 00:38:04,410 during therapy, that kind of thing. And I think that these 524 00:38:04,410 --> 00:38:06,930 kind of flow together that it's it's difficult to monitor all 525 00:38:06,930 --> 00:38:09,630 these sites, you have to vet all these people, but also with an 526 00:38:09,630 --> 00:38:13,980 undefined therapy. Some things like touch, comforting touch, 527 00:38:13,980 --> 00:38:17,970 these sorts of concepts in therapy can lead to maybe this, 528 00:38:18,390 --> 00:38:21,660 you're opening yourself up basically to to potential 529 00:38:21,690 --> 00:38:26,310 mishaps. So is that a fair read on it? Or how do you view that, 530 00:38:26,340 --> 00:38:28,500 that that situation, even 531 00:38:28,500 --> 00:38:33,120 Unknown: if we would think about our organization, which is a 532 00:38:33,120 --> 00:38:38,430 small organization, to be able to monitor all the study centers 533 00:38:38,430 --> 00:38:44,430 ourselves, we wouldn't do it, we would hire contract research 534 00:38:44,430 --> 00:38:49,920 organization, particularly to have a second perspective and to 535 00:38:49,920 --> 00:38:55,320 have somebody in the study, a process that has a lot of a lot 536 00:38:55,320 --> 00:38:58,560 more experience than we do we have never done a study with 15 537 00:38:58,920 --> 00:39:04,170 study centers. So theoretically, I can imagine that we could do 538 00:39:04,170 --> 00:39:10,110 it, of course, we believe we have, we have trust in that 539 00:39:10,110 --> 00:39:13,710 whatever we can talk to people but but trust is not enough. We 540 00:39:13,710 --> 00:39:17,940 need to have these processes in place. That is one one thing. 541 00:39:18,330 --> 00:39:21,750 And the other thing is the personalities of some of the 542 00:39:22,320 --> 00:39:28,290 study therapists in maybe the maps trials also other trials. 543 00:39:29,190 --> 00:39:33,930 We took we will take care and have taken care in the episode 544 00:39:33,930 --> 00:39:41,670 study that overly enthusiastic psychedelic therapists or ex 545 00:39:41,670 --> 00:39:46,440 underground therapists would not become part of the study teams. 546 00:39:46,680 --> 00:39:50,640 There is there is a bias, big bias that is coming in there. 547 00:39:51,690 --> 00:39:55,920 And I am not sure that there is a clear policy on the site of 548 00:39:55,920 --> 00:39:59,970 Lycos Weiser clear policy on the site of Lycos maps there 549 00:40:01,380 --> 00:40:04,260 Because, because it also from from so a Greek is very 550 00:40:04,260 --> 00:40:09,000 outspoken about it. And this is also his, his his big magic, he 551 00:40:09,000 --> 00:40:13,980 is very open. And he is he is very authentic in what he says. 552 00:40:14,010 --> 00:40:19,710 And and he also believes a lot of the underground therapists 553 00:40:19,710 --> 00:40:24,840 will become legal therapists. And I believe that this will 554 00:40:24,840 --> 00:40:29,580 happen that that some people will transcend to the legal 555 00:40:29,580 --> 00:40:35,550 space. But there are also some ideas and some, some attitudes 556 00:40:35,580 --> 00:40:40,530 that we don't want to see in the legal space. So building 557 00:40:40,530 --> 00:40:46,350 relationships with your patients that are based on on the 558 00:40:46,350 --> 00:40:49,980 movement that we have seen in the 1970s, which is called anti 559 00:40:49,980 --> 00:40:54,600 psychiatry. So instead of changing psychiatry to become 560 00:40:54,600 --> 00:40:58,770 more humane, more open, less rigid, more psychotherapeutic 561 00:41:00,030 --> 00:41:05,760 just work on the fact that patients the patient role, so 562 00:41:05,790 --> 00:41:09,420 part of the anti psychiatry, psychiatry movement was 563 00:41:09,420 --> 00:41:15,390 destroying the patient doctor role. So because some authors 564 00:41:15,390 --> 00:41:20,730 thought this is in itself, unhealthy, or almost unethical, 565 00:41:20,910 --> 00:41:23,610 and we need to go to a completely different 566 00:41:23,640 --> 00:41:27,900 relationship, and then come people into the space who define 567 00:41:27,900 --> 00:41:33,480 that relationship as Shaman. And somebody's looking for healing, 568 00:41:33,960 --> 00:41:43,950 even even using unreflectively for term healing is at least 569 00:41:43,950 --> 00:41:48,960 demanding. I mean, people project all kinds of religious 570 00:41:48,960 --> 00:41:55,800 fantasies into it, and what does it do to the expectation of 571 00:41:55,830 --> 00:42:01,800 clients? And what does it do to the relationship of therapist 572 00:42:01,830 --> 00:42:06,120 and client. So this is a broad field, obviously, now, we don't 573 00:42:06,120 --> 00:42:11,730 know how far you want to go into it. But but some of the, of the 574 00:42:11,790 --> 00:42:18,840 founding ideas of psychedelic therapy in the 1960s and 70s, 575 00:42:18,840 --> 00:42:24,060 particularly when they were legalized, or not viable in an 576 00:42:24,120 --> 00:42:30,330 open multicultural, ScienceBase society, where we actually have 577 00:42:30,330 --> 00:42:35,220 a dialogue on epistemologies and truth and if something works, 578 00:42:35,220 --> 00:42:42,210 and we invite the patient to be able to go to a certain body if 579 00:42:42,210 --> 00:42:47,460 she feels mistreated by a patient. So this all has to be 580 00:42:47,520 --> 00:42:51,630 living in the therapist, too. And the patient's need to know 581 00:42:51,630 --> 00:42:56,700 it, we sort of invite people into some pseudo modern 582 00:42:56,700 --> 00:42:59,490 shamanistic relationship. 583 00:42:59,580 --> 00:43:02,100 Bradley van Paridon: Yeah, I mean, I think you know, me that 584 00:43:02,100 --> 00:43:06,810 that really speaks to me, and I agree with a lot of that, and, 585 00:43:06,990 --> 00:43:11,220 but I think it is a, it's, it's a difficult, it's a difficult 586 00:43:11,220 --> 00:43:13,980 process, it's like, you know, shedding shedding the old skin 587 00:43:13,980 --> 00:43:18,450 and trying to trying to re work things for for a modern time. 588 00:43:18,780 --> 00:43:22,200 But this maybe then brings us to just overall the hype 589 00:43:22,200 --> 00:43:24,810 surrounding this, because I think, you know, with some of 590 00:43:24,810 --> 00:43:26,490 the maybe some of the therapists, some of the 591 00:43:26,580 --> 00:43:31,470 underground practitioners, let's say, people who were were in 592 00:43:31,470 --> 00:43:33,450 this field, in the beginning, maybe when it was really 593 00:43:33,450 --> 00:43:37,230 stigmatized, you know, or even then became illegal. There's 594 00:43:37,230 --> 00:43:41,940 this defensiveness to it, like a, like a, we, we uncovered this 595 00:43:41,940 --> 00:43:44,610 truth, and then the man tried to shut us down. So you know, like, 596 00:43:44,610 --> 00:43:49,020 there's there can be a real evangelistic kind of attitude 597 00:43:49,020 --> 00:43:53,730 towards it. And that's just one aspect of hype. There's also, 598 00:43:53,970 --> 00:43:56,970 you know, hype for the participants that maybe see that 599 00:43:56,970 --> 00:43:59,820 those attitudes, and then there's the expectation that, 600 00:43:59,850 --> 00:44:03,210 you know, was brought up in the trials, and then how does this 601 00:44:03,390 --> 00:44:07,830 hype affect the scrutiny that then gets put onto the field by 602 00:44:07,830 --> 00:44:10,050 those who are looking at this and saying, Well, this just 603 00:44:10,050 --> 00:44:13,290 looks so weird, this just looks so you know, it can't be right, 604 00:44:13,290 --> 00:44:16,950 you know, that kind of thing. So that's a lot to throw at you 605 00:44:16,950 --> 00:44:20,730 right there, those three angles of hype, I think, but how do we 606 00:44:20,730 --> 00:44:23,970 then move forward? How do you think about it moving forward in 607 00:44:23,970 --> 00:44:27,090 terms of having these conversations, like we're having 608 00:44:27,090 --> 00:44:30,690 now or with the media or with skeptics, or with, you know, 609 00:44:30,690 --> 00:44:34,260 true believers? How do we balance all of these ideas and 610 00:44:34,260 --> 00:44:38,220 make sure that, you know, we're not throwing babies out with 611 00:44:38,220 --> 00:44:41,850 bathwater, but also, you know, reflecting a safe modern 612 00:44:41,850 --> 00:44:43,560 approach to all of this? Yeah. 613 00:44:44,040 --> 00:44:47,220 Unknown: Well, let me say first, that even true believers or 614 00:44:47,220 --> 00:44:51,300 people who are over enthusiastic are not bad people. Yeah, of 615 00:44:51,300 --> 00:44:54,570 course, we have been over enthusiastic in our lives, in 616 00:44:54,570 --> 00:44:59,310 many ways. So, so, but we have to we have to definitely think 617 00:44:59,310 --> 00:45:03,570 about how have built a system around disruptive pharmacology a 618 00:45:03,570 --> 00:45:09,150 system. And I don't think that some of the ideas that I hear 619 00:45:09,180 --> 00:45:12,180 when I go to psychedelic conferences, that we have to 620 00:45:12,180 --> 00:45:18,720 break down the system and, and kind of create an archaic 621 00:45:19,260 --> 00:45:25,890 situation where everybody heals herself himself. And people just 622 00:45:25,890 --> 00:45:32,610 provide trip sitting to somebody else. This is profoundly naive 623 00:45:32,610 --> 00:45:38,550 and misunderstanding, the nature of people who are deep into 624 00:45:38,550 --> 00:45:42,150 mental health issues. So there's a spectrum, obviously, and we 625 00:45:42,150 --> 00:45:46,110 cannot treat everybody the same. There are people who perfectly 626 00:45:46,500 --> 00:45:49,830 can self administer psychedelics, and never take any 627 00:45:49,830 --> 00:45:54,510 harm from it. But there are people who are severely into 628 00:45:55,230 --> 00:45:59,580 suicidal and other severe mental health issues, and they need 629 00:45:59,580 --> 00:46:04,500 somebody to really know who really knows what they do. So 630 00:46:04,560 --> 00:46:07,980 how do we go on? Oh, first of all, we also see in Europe very 631 00:46:07,980 --> 00:46:14,760 raised strongly the hype is kind of gone, investors and donors 632 00:46:14,790 --> 00:46:19,950 are more looking at is this really doing something where I'm 633 00:46:19,950 --> 00:46:26,670 supposed to invest or donate to. So more looking at good science. 634 00:46:26,730 --> 00:46:31,920 So also with with foundations and organizations coming up in 635 00:46:31,920 --> 00:46:37,770 Europe that are really looking at founding more basic research, 636 00:46:37,800 --> 00:46:42,930 and various strict and good science, it's not a surprise, 637 00:46:42,960 --> 00:46:46,110 I'm a scientist, of course, I'm advocating for science, but but 638 00:46:46,860 --> 00:46:51,240 also from from the, from the viewpoint of a citizen from the 639 00:46:51,270 --> 00:46:56,580 viewpoint of a person who philosophically thinks that a 640 00:46:56,580 --> 00:47:01,680 pluralistic society that tries to be open, needs to have ways 641 00:47:01,710 --> 00:47:06,450 of communicating truth, and debating truth with each other. 642 00:47:06,600 --> 00:47:11,460 And it cannot be done on on the basis of cult of subjectivity. 643 00:47:12,720 --> 00:47:18,480 So only judging the world from that would be a very radical 644 00:47:18,480 --> 00:47:23,280 stance from your own subjective psychedelic experience. Somehow, 645 00:47:23,280 --> 00:47:27,150 you need to go into that negotiation process with your 646 00:47:27,150 --> 00:47:30,750 peers and with people from society. What is really true? 647 00:47:30,750 --> 00:47:34,740 And should we build our relations to our children and to 648 00:47:34,740 --> 00:47:39,390 our colleagues and and to our communities? On the basis of 649 00:47:39,390 --> 00:47:43,950 that? And so why, why do I say that, because I think the hype 650 00:47:43,950 --> 00:47:47,220 has a has a big operative gives us provides us with a big 651 00:47:47,220 --> 00:47:54,360 opportunity to rethink again, to maybe consolidate the studies to 652 00:47:54,360 --> 00:48:00,120 be a little bit more patient to talk to other funders who may 653 00:48:00,120 --> 00:48:05,760 come in, after the hype, funders. So I'll own example, 654 00:48:05,760 --> 00:48:09,870 just just to be clear what's happening over here, we are 655 00:48:09,870 --> 00:48:13,320 running a clinic, the OB clinic, Berlin, and it took me one and a 656 00:48:13,320 --> 00:48:19,800 half years to find a new group of people, do we first 657 00:48:19,800 --> 00:48:23,310 investment round in the clinic that we needed, but we now found 658 00:48:23,340 --> 00:48:29,820 wonderful people who have been following the whole hype circle, 659 00:48:30,060 --> 00:48:36,780 or hype Phase II phase since 2014 15, and said, We're 660 00:48:36,780 --> 00:48:39,930 waiting. Let's wait, let's wait, it's going to show are they 661 00:48:39,930 --> 00:48:44,370 still present? Are the people here? Will this studies show any 662 00:48:44,370 --> 00:48:48,540 results that are published in higher level mega high level 663 00:48:48,540 --> 00:48:56,520 journals. And so we now find found, just in our case, a group 664 00:48:56,520 --> 00:49:00,030 of people who came in late so this is an opportunity, this is 665 00:49:00,030 --> 00:49:06,060 a chance also to have investor relationships that are not 666 00:49:06,510 --> 00:49:11,850 illusionary where investors drive you to results on the 667 00:49:11,850 --> 00:49:17,310 basis or based on on assumptions for where they think this is a 668 00:49:17,310 --> 00:49:22,290 wonder drug. And the people that I'm funding are only speaking 669 00:49:22,290 --> 00:49:26,700 some kind of strange scientific code, because society doesn't 670 00:49:26,700 --> 00:49:31,230 understand the nature of the wonder drug. This is not how we 671 00:49:31,230 --> 00:49:34,710 should go. It's not it's not this is not true. These are not 672 00:49:34,710 --> 00:49:41,730 wonder drugs. We have had now about 500 patients in our clinic 673 00:49:41,730 --> 00:49:46,350 and we see considerable improvements but we also failed 674 00:49:46,350 --> 00:49:50,940 on many people. That's so clear. And if you're if you're really 675 00:49:50,940 --> 00:49:56,580 looking at every day to day processes of therapy with 676 00:49:56,580 --> 00:50:00,210 ketamine, or in the studies with five MEO and or psilocybin When 677 00:50:01,110 --> 00:50:04,530 you fail a lot, and, of course, people are not just healed, 678 00:50:05,100 --> 00:50:09,630 there are all kinds of intermediary results that you 679 00:50:09,630 --> 00:50:12,570 get, and people want to go on, and you need to transfer them to 680 00:50:12,570 --> 00:50:16,650 another doctor, or you need to transfer them to a clinic, 681 00:50:16,650 --> 00:50:22,560 because through your therapy, they got the DS, D stabilized 682 00:50:22,560 --> 00:50:25,260 and things like that. These are all realities that we can now 683 00:50:25,260 --> 00:50:26,550 talk about after the hype. 684 00:50:26,880 --> 00:50:30,150 Bradley van Paridon: So again, it's it's getting as much data 685 00:50:30,150 --> 00:50:34,050 and presenting it as openly as possible, you know, and also, 686 00:50:34,080 --> 00:50:37,950 and also talking about hype in a way. Yep, balance of hype, and 687 00:50:37,950 --> 00:50:39,420 also talking, frankly, about 688 00:50:40,650 --> 00:50:45,060 Unknown: non clinical use, and how could we build a model in 689 00:50:45,060 --> 00:50:49,290 our societies for non clinical use of these substances? That is 690 00:50:49,290 --> 00:50:53,610 not the same as recreational use institutionalizing non clinical 691 00:50:53,610 --> 00:50:59,250 use would do it, what would the studies be? So this is a little 692 00:50:59,250 --> 00:51:03,240 bit further in the future. But if we need it, we should do 693 00:51:04,260 --> 00:51:08,190 produce a data about that or begin to produce a data about 694 00:51:08,190 --> 00:51:11,280 it. And I think we need it, there is a there is a case for 695 00:51:11,280 --> 00:51:16,860 non clinical salutogenic and clinical and preventive use of 696 00:51:16,860 --> 00:51:21,360 these substances. And that fits well into some of the needs of 697 00:51:21,480 --> 00:51:27,660 patients after therapy. Now, and this is, this is the first 698 00:51:27,660 --> 00:51:31,920 fascinating stuff that we can now begin to talk about. Yeah, 699 00:51:31,950 --> 00:51:36,390 yeah, I'm, even before the first psychedelic has been approved. 700 00:51:37,410 --> 00:51:39,780 Bradley van Paridon: Yeah, as you know, I think yeah, I also 701 00:51:39,780 --> 00:51:43,800 agree with with that, that that mindset. And I think a lot of 702 00:51:43,800 --> 00:51:46,980 what you said just in that, that answer there to be about 703 00:51:46,980 --> 00:51:50,550 communicating truth and finding a way to, you know, a kind of 704 00:51:50,550 --> 00:51:53,730 injury negotiation that applies to so much of what I feel is 705 00:51:53,730 --> 00:51:56,790 going on in in our world right now outside of psychedelics, 706 00:51:56,790 --> 00:52:01,770 politics, and just people in general. So I really enjoyed 707 00:52:01,770 --> 00:52:04,530 hearing your your perspective on that. I have one more for you, 708 00:52:04,560 --> 00:52:08,010 if it's alright, if we have time. And just a quick comment 709 00:52:08,010 --> 00:52:11,880 maybe on this is the other part as me a biologist, that I'm 710 00:52:11,880 --> 00:52:14,280 super fascinated when it comes to these psychedelics is 711 00:52:14,280 --> 00:52:17,280 understanding more exactly how they're working in the brain, 712 00:52:17,280 --> 00:52:19,680 right? Like these so called mechanistic studies, I just 713 00:52:19,680 --> 00:52:23,790 covered one on the podcast about MDMA and empathy was an animal 714 00:52:23,790 --> 00:52:26,640 study about does it increase empathy or not, you know, and I 715 00:52:26,640 --> 00:52:29,730 thought that was really fascinating. So where do you see 716 00:52:30,030 --> 00:52:35,250 basic research on how these things are working in the brain? 717 00:52:35,850 --> 00:52:38,700 fitting into, you know, again, this sort of pushing for 718 00:52:38,700 --> 00:52:43,080 acceptance approval? How will it help us, you know, to reach that 719 00:52:43,080 --> 00:52:47,310 goal? And what is there still a disconnect in terms of okay, 720 00:52:47,310 --> 00:52:50,070 brain chemicals are doing this, but what does that mean for the 721 00:52:50,070 --> 00:52:52,590 subjective experience? Because I feel like that's always going to 722 00:52:52,590 --> 00:52:54,570 be a tricky thing for us to manage. 723 00:52:55,530 --> 00:52:57,240 Unknown: Yeah. So scientifically, and 724 00:52:57,240 --> 00:53:00,840 philosophically, it's very hard to bring these third person and 725 00:53:00,840 --> 00:53:03,450 first person perspectives together. But this is exactly 726 00:53:03,450 --> 00:53:09,990 where I see a lot of research should emerge in the future. I 727 00:53:09,990 --> 00:53:13,080 see, I see no basic contradiction between a therapy 728 00:53:13,080 --> 00:53:18,000 where we have a biological effect, which we do. And when we 729 00:53:18,000 --> 00:53:20,760 have a psychotherapeutic effect, because psychotherapeutic 730 00:53:20,760 --> 00:53:25,080 effects are also biologically managed, or biologically 731 00:53:25,080 --> 00:53:30,240 mitigated, now, people have strange and strange things about 732 00:53:30,270 --> 00:53:34,500 what psychotherapy is, but our behavior is biologically rooted, 733 00:53:34,530 --> 00:53:37,680 and we we need to bring these perspectives together. So there 734 00:53:37,680 --> 00:53:45,090 was a time between maybe 2002 1017 18 When it was already 735 00:53:45,120 --> 00:53:51,840 enough to have some nice graphs about biological effects and and 736 00:53:52,020 --> 00:53:55,740 maybe also systemic biology effects house brain centers, 737 00:53:55,980 --> 00:53:59,790 communicate with each other. But we need to get we need to repeat 738 00:53:59,790 --> 00:54:04,980 that stuff. We need to show the relevance of that stuff in, in a 739 00:54:04,980 --> 00:54:09,480 mechanistic way. Yeah. Is it so for example, if it's true that 740 00:54:09,480 --> 00:54:12,510 people get a get go through a phase where they where they 741 00:54:12,510 --> 00:54:19,290 think less in a less rigid way? How is that upheld in the next 742 00:54:19,320 --> 00:54:24,810 hours and days? How is the window of change learning window 743 00:54:24,840 --> 00:54:30,090 being used canonbury to be used? So get much more down to the 744 00:54:30,840 --> 00:54:35,130 also clinical behavioral side of these mechanistic effects? 745 00:54:35,160 --> 00:54:39,270 That's how I would imagine it. But definitely, Brad, you're not 746 00:54:39,270 --> 00:54:42,390 talking to a neuroscientist. You're talking to somebody who 747 00:54:43,050 --> 00:54:48,690 is trained in psychotherapy who has has a medical psychology 748 00:54:48,690 --> 00:54:53,970 background. So I am obviously more interested in the 749 00:54:53,970 --> 00:55:01,200 intersection of these behavioral and clinical stuff and And the 750 00:55:01,200 --> 00:55:04,110 biological effect. So let's look at these interactions would be 751 00:55:04,110 --> 00:55:06,810 my, my obvious answer. Yeah. 752 00:55:06,810 --> 00:55:08,610 Bradley van Paridon: And I think that that speaks to it. I mean, 753 00:55:08,610 --> 00:55:11,370 this this is a lot of my wife is a neuroscientist, and this is a 754 00:55:11,370 --> 00:55:13,590 big debate that goes on in a lot of that stuff. You can look at 755 00:55:13,590 --> 00:55:16,260 just the brain and what's going on. But you have to relate it to 756 00:55:16,260 --> 00:55:20,340 behavior in order for it to be meaningful enough to see how 757 00:55:20,340 --> 00:55:20,670 that 758 00:55:20,700 --> 00:55:23,730 Unknown: yeah, and we'll have we'll have substances if if some 759 00:55:23,730 --> 00:55:28,560 of the approval programs will succeed, we'll have substances 760 00:55:28,560 --> 00:55:31,710 on the market where the provider claims it's basically a 761 00:55:31,710 --> 00:55:36,210 biological effect. And we have very little other regulatory 762 00:55:36,210 --> 00:55:39,720 stuff around it. And we have the opposites. These are healthy 763 00:55:39,720 --> 00:55:45,000 models, and we'll then find out through monitoring them. When we 764 00:55:45,000 --> 00:55:49,020 have to look at maybe we are overdoing it with psychotherapy, 765 00:55:49,530 --> 00:55:54,840 and the others are right, or maybe it's just says patient 766 00:55:54,840 --> 00:55:58,260 populations that go well with one approach and the others, not 767 00:55:58,290 --> 00:56:02,310 we we should have should look at that in the future. Well, 768 00:56:02,340 --> 00:56:04,350 Bradley van Paridon: great. Thank you so much for your time, 769 00:56:04,350 --> 00:56:09,360 I always appreciate your very grounded open perspective on 770 00:56:09,360 --> 00:56:12,600 these things. So when I saw the FDA decision, even though it's a 771 00:56:12,600 --> 00:56:16,710 European American context, it's a bit different. I love to hear 772 00:56:17,280 --> 00:56:19,860 what you've what you have to say very illuminating. As always, 773 00:56:20,160 --> 00:56:22,140 thank you so much for taking the time. I really, really 774 00:56:22,140 --> 00:56:22,770 appreciate it. 775 00:56:23,040 --> 00:56:24,750 Unknown: Thank you for your questions and for the 776 00:56:24,750 --> 00:56:26,370 opportunity to speak here. Thank you 777 00:56:29,640 --> 00:56:31,950 Bradley van Paridon: all right, many thanks to Henrik union 778 00:56:31,950 --> 00:56:35,310 Burleigh and the mind foundation for for for coming on the show. 779 00:56:35,640 --> 00:56:39,330 And please rate subscribe, review wherever you get your 780 00:56:39,330 --> 00:56:43,590 podcasts. Check us out on YouTube on social media at to 781 00:56:43,590 --> 00:56:47,550 Brad for you. Big thanks as always to the frequency for the 782 00:56:47,550 --> 00:56:51,240 music special in the mood for the logo. Check the show notes 783 00:56:51,240 --> 00:56:56,460 for all relevant reporting and articles that I use to to to 784 00:56:56,460 --> 00:57:00,360 inform this episode. And for some of that research that 785 00:57:00,360 --> 00:57:03,810 Henrik and his collaborators at mind and in Germany are doing 786 00:57:04,950 --> 00:57:08,850 really great to really great to hear from you all please reach 787 00:57:08,850 --> 00:57:13,020 out social media email at to grandview@gmail.com or add to 788 00:57:13,020 --> 00:57:17,430 Brad's view on the socials. And and until next time, please have 789 00:57:17,430 --> 00:57:21,510 a good summer. Enjoy yourself. Stay safe, and we'll see you 790 00:57:21,510 --> 00:57:21,900 next time.