Regulating Psychedelic Medicine, FDA Approval, and Why We Need More Evidence

Podcast Highlights

• The commonalities and differences between cannabis and psychedelics.
• Why psychedelics should—or shouldn’t—be controlled and regulated.
• Using ketamine as a catalyst to improve psychotherapy and integration.
• The therapeutic potential of cannabis and psychedelics.
• Gaining FDA approval to legitimize psychedelic therapies.
• Mistakes, biases, and the need for more evidence for both psychedelic use and microdosing.
• Lifestyle changes, sleep, exercise, intermittent fasting, fish oil, and the danger of fads.
• Finding a middle ground between trusting and blaming big pharma.

Show Links

1. Field Trip Psychedelics Inc.
2. Professor David Nutt
3. Oregon Psilocybin Services Act
4. Canadian Cannabis Clinics
5. MAPS MDMA Trials
6. Usona Institute
7. COMPASS Pathways
8. Epidiolex - GW Pharma
9. Joe Rogan Experience - Paul Stamets
10. MindMed
11. Eleusis
12. Dana Larsen
13. Toronto Centre for Psychedelic Science
14. Thinking, Fast and Slow by Daniel Kaheneman
15. FoundMyFitness - Rhonda Patrick
16. Peter Attia
17. Ben Greenfield Fitness

Podcast Transcript

00:00 Paul Austin: Welcome to the Third Wave podcast. I'm your host, Paul Austin, here to bring you cutting edge interviews with leading scientists, entrepreneurs and medical professionals who are exploring how we can integrate psychedelics in an intentional and responsible way for both healing and transformation. It is my honor and privilege to bring you these episodes as you get deeper and deeper into why these medicines are so critical to the future of humanity. So let's go and let's see what we can explore and learn together in this incredibly important time.

00:37 PA: The Third Wave Podcast is brought to you by Magic Mind. Do you want more creativity, flow, and energy in your day to day routine, then go to magicmind.co and get the two ounce shot that contains 12 magical ingredients scientifically designed to improve your productivity. I've been using Magic Mind over the last couple of months. It has replaced my morning coffee. It has matcha, Lion's Mane and a number of other nootropics, and I can't say enough about it. It is so, so useful. So if you're interested in Magic Mind, go to magicmind.co and enter promo code, THIRDWAVE to get 10% off and try it for yourself. As long time listeners know yoga and meditation have played a huge role as complementary practices to my own responsible psychedelic use, and that's why we're excited to be working with Half Moon Yoga as a partner for the podcast. They carry everything from basic yoga supplies to more advanced things like bolsters and sand bags to meditation cushions that are super comfy to sit on. And right now they're offering a 15% discount to Third Wave listeners with the promo code, THIRDWAVE. I'd encourage you to check them out at shophalfmoon.ca if you're looking for tools to support your yoga or meditation practice.

01:51 PA: So Ronan let's start there because I think your background in the Cannabis industry is something that both you and your partners at Field Trip is what sets you apart from a lot of the other major players in the psychedelic space currently, and so I'd love to just start with talking about what are some of the commonalities and differences between Cannabis and psychedelics, in particular Psilocybin, Ketamine and MDMA, which are becoming medicalized within the next couple of years to treat clinical conditions.

02:20 Ronan Levy: Yeah, the overlap between Cannabis and psychedelics is on its face quite apparent but it doesn't run as deep as most people, I think would consider. Cannabis and psychedelics, especially Psilocybin are plant based medicines. If you look at David Nutt's research on the safety profiles and the harm profiles of Psilocybin and most psychedelics and Cannabis, they tend to be quite low, they tend to have a lot of therapeutic potential, they were both made illegal for more political than scientific reasons. The high level comparisons are quite evident on an initial blush, but that's to some degree where things end but not entirely. The big difference, I think, between psychedelics and Cannabis is Cannabis is really a product. It's a take home, you go to a dispensary, you sign up with your doctor or you get a prescription from your doctor, you take it home and you self-titrate, and you figure it out by yourself because there's no precision and dosing in Cannabis, but it's relatively safe and generally it's designed to, or not designed, but the experience is it helps resolve symptoms around chronic conditions but tends not to be a cure. It doesn't address the underlying cause by and large. It just help you manage the symptoms.

03:43 RL: On the other hand, psychedelics are much more of a service. We personally and our expectation... Or we personally believe, and our expectation is that the emergence of the psychedelics industry is going to be a lot more controlled and regulated in terms of where and how people can have psychedelic experiences. We look at the Oregon Psilocybin initiatives or Psilocybin initiative, which is proposing to create the Psilocybin Services Act, and I think that really speaks volume even in the name, which is, what they're proposing there is a system whereby people can have access to Psilocybin and psychedelic experiences, but it wouldn't be something where you could just buy it and take it home and do it yourself. The proposal contemplates having licensed site with licensed professionals to oversee the experience and we're big advocates for that kind of structure. We like it a lot, for two reasons. One is we think that structure minimizes the downside risk that the likelihood of having a bad trip or a hard trip that turns into a bad trip is minimized if you require people to do sessions with qualified professionals.

04:54 RL: In the same token, we think you can maximize the potential positive benefits of psychedelics by making sure that people are doing it in the right context. So it seems like a win-win. Even though it will limit access to some degree and probably make the cost of access higher than some may like, at least at this early stage in the development of the industry. We think a prudent approach that really maximizes success and minimizes downside is the way to go, and so that's really one of the big ways to see Cannabis and psychedelics in a different light, which psychedelics are about the experience, Cannabis is about the product, but for purposes of building the industry or the field of psychedelics, I think one of the big areas of overlap is that much like Cannabis, psychedelics are gonna require a whole new clinical infrastructure as well as a whole new supply chain, that really doesn't exist right now.

05:50 RL: So when we saw in Cannabis, you needed new licensed producers who could cultivate at large scale and in a compliant manner that meets all analytical testing requirements. That didn't exist before. Of course, there were underground growers of Cannabis, but scaling it in a safe way that met the analytical testing requirements was just challenging, and a lot of producers struggled to get there, and now after five or six years they're there but it was a learning curve, for sure. And similarly you needed a whole new clinical infrastructure just for Cannabis medicine because most physicians were not comfortable prescribing it. Cannabis didn't fit nicely in a box that most physicians could understand and feel comfortable with, and that's why there is a need for services and clinics like Canadian Cannabis Clinics, and we think that you're gonna see a lot of similarities in that respect with psychedelics. One of the big challenges that I think everybody in psychedelics at colleges is, how do you make this accessible and scalable? Because at least as looking at the protocols and the clinical trials that are going on through the FDA and what's generally encouraged within the community, it's a very high touch point. It's very labor-intensive to take someone through a psychedelic journey and then by virtue of that, it becomes very expensive.

07:09 RL: And even going beyond that and looking at what is likely to be the first route to legal access to psychedelics, which is through FDA approval of most likely MDMA in a MAPS trial, most psychiatrists who are gonna be equipped to prescribe and feel comfortable identifying the appropriate patients to treat with psychedelics, they either work in hospitals or they tend to be home operators. Sole proprietors in their house or on their couch, working with them, and so you can't treat a lot of patients with psychedelics in that model.

07:42 RL: And that's exactly why with Field Trip, our first focus is leveraging our experience building a large scale clinic network in a new therapeutic modality with psychedelics. And so we just opened our first Toronto-based psychedelic medicine clinic, which will be using Ketamine as its first agent. But we're treating Ketamine as a true psychedelic and we're making the experience a psychedelic experience, which means we don't look at the drug, we don't look at Ketamine as the end point. We don't see it as a solution in and of itself. We see it as a catalyst to make the psychotherapy and the integration much more effective. So it's psychedelic in that respect, and then very much when you have, say, a Ketamine experience, it is pretty consistent with what you'd have in terms of an experience on the classic psychedelics.

08:30 RL: So that's one area where the industry needs new a clinical infrastructure, needs the infrastructure to be built to support it. And just like Cannabis in the same token, the trials that are moving forward right now with MAPS and Usona and COMPASS Pathways, they're looking at MDMA and Psilocybin, but there are countless other psychedelics. And I think with a more robust offering of different psychedelic treatments, ones that are longer acting, shorter acting, different experiences, different target, different off-target receptor binding, all that kind of stuff is going to lead to greater therapeutic optionality. You'll have more than just MDMA or Psilocybin which is kind of like using a hammer, sometimes a scalpel is needed. And so we're investing both in more conventional drug development, looking at other psychedelic molecules as well as we started to build the first, as far as we know, legally compliant cultivation and research facility for Psilocybin-producing mushrooms in Jamaica, at the University of West Indies. Really with a view to understanding scalable cultivation, so we don't have to make the mistakes of the Cannabis industry, should there be a market for the mushrooms themselves as opposed to synthetics.

09:38 RL: If you look at the Cannabis industry, again, as a model in the research that's happened on Cannabis and hemp, we've identified close to 100, I think the last number I heard was a 130 novel minor cannabinoids that we didn't know existed, many of which have their own therapeutic potential. And when you look at Psilocybin-producing mushrooms, of which there are roughly 200 species, most of which have never been studied with any degree of rigor or depth, you kind of got to believe that nature is hiding some wonderful molecules in these fungi that have a lot of potential as well. And so that's the kind of work we'll be doing in Jamaica. So in that respect, in terms of having to build a whole new infrastructure to support this coming industry, I think that's one of the biggest parallels between Cannabis and psychedelics, but it's going to be a very different execution.

10:27 PA: Well, there are a few themes that are coming up here, and I think probably the most critical theme to focus on for this conversation is the advent of personalized medicine. When you spoke about in particular there are over 200 species of mushrooms that we don't yet know a lot about, there are also all these other chemicals, psychedelic chemicals like 2C-I and 2C-B, and various DMT molecules that could be utilized for very specific purposes. We're seeing right now the main focal point of the psychedelics based on FDA approval, by and large.

11:00 PA: Obviously, there's stuff going on with decrim, obviously there's stuff going on in Canada, which is a different process, but probably has some overlap with FDA approval, but by and large, a lot of the media, a lot of the attention focuses on FDA approval. Now, I think the upside of that is we do extensive clinical trials, we know that for general indications like PTSD, treatment resistant depression, major depressive disorder, that MDMA and Psilocybin work for that. However, what the industrial model that the FDA represents doesn't do a great job of is the personalized medicine approach. So I'd be really curious to hear your thoughts on how do you see this industry developing over the next 10 years, in particular in a post-COVID era where a lot of this clinical research is going to become incredibly slow because people can't actually meet up in person for who knows how long.

11:51 RL: Over the course of the next 10 years, my personal belief, maybe it's more hope than belief, is that you're gonna see two complementary parallel systems creating access to psychedelics. One is going to be the purely medical, synthetic FDA drug development and approval routes designed to clinical diagnoses like depression, like anxiety, like PTSD, like anorexia. Anything that fits within the pretty square parameters of conventional psychology and psychiatry. And then you're gonna have a separate system which is focused more on natural products designed to be accessible by people who want it from a more wellness perspective. People who don't have a clinical diagnoses, but see the potential of psychedelics to help them process trauma or improve their creativity, or improve their empathy. And so I think you're gonna see those kind of overlapping systems, and that's also an analogy to Cannabis, where you see products like Epidiolex, which is produced by GW Pharma, that has approval from the FDA for the treatment of Dravet syndrome and childhood epilepsy.

13:03 RL: But then you have access, both adult usage and medical too with the natural products, and I think 30 states now have some degree of medical laws, and 12 have adult use, I think was the last number I checked and so I think you're gonna see something very similar to that in terms of psychedelics, but in a much more controlled setting, like I touched upon. In terms of the personalized medicine consideration versus the industrial and industrialization of medicine, I don't see that as much of a concern here. At the end of the day, I view psychedelics as a catalyst to deeper experience, deeper understanding, deeper awareness, and the personalization comes in the therapy, it comes in the people you work with who provide those experiences, so I think if you have a two-track parallel system, one for wellness and one for more conventional medical treatment and care, you'll have a sufficient degree of personalization. Certainly, I think it'd be better if there is a more robust suite of psychedelics that have approval or legalization happen around them, so you can have more tailored, more nuanced, better triaged experiences than just MDMA or Psilocybin, but I think the personalization really comes in terms of the people you work with creating the environment, the setting and the therapeutic execution and protocols than the drug itself or the necessity for predefined approval processes.

14:33 PA: I wanna dive deeper a little bit into a point you made, which I love the comparison, the parallel clinical track and what we're seeing now in the States with decriminalization. And as an American, as someone who has lived in America for most of my life and who has lived abroad in Thailand and Portugal and Turkey, various other countries, what I've come to understand that's very specific about the American healthcare system is that it's not very accessible for people who have low income, and what we know is people who struggle with clinical issues, depression, PTSD, addiction, also tend to come from lower socioeconomic backgrounds, and so I think one question that I would have for you or one question just to generally consider is if the majority of people who come from a low socio-economic background already have these clinical conditions, how are they going to afford clinical therapy in an insurance system, particularly in the United States, that won't cover these alternative therapies?

15:32 RL: And I think that's one of the reasons that even though it has its limitations and problems with it, the FDA approval route to legalization is one of the best ones, because what happens when you get FDA approval is that the evidence becomes, it's not totally infallible, we've seen mistakes happen in the past, but it is as robust and evidence-based as you can get for new products, and with that, you maximize the likelihood for insurance coverage, especially when you consider that, for instance, with Psilocybin, the anti-depressant effects can last for up to five years according to one of the more recent studies that came out of NYU or with MDMA, in the MAPS phase two trial, they're showing that roughly 70% of patients that they're treating with MDMA assisted psychotherapy with chronic severe PTSD, have total resolution of all symptoms associated with PTSD, and when you just do the cost analysis of, yes, it may be expensive to have a person to go through one or two MDMA assisted psychotherapy sessions up front.

16:43 RL: But when you consider the cost savings over the lifetime of that patient, keeping them off SSRIs or benzos or other antipsychotic drugs or anti-depressive drugs, and all of the other lost productivity and social consequences and opportunity costs of not treating that person and providing the best possible care at the beginning, it starts to become pretty persuasive from an insurance coverage perspective, that all of these insurers should be interested in providing this kind of coverage because it's going to be cheaper for them in the long run to make sure that these patients get healthy and treated and address these disorders. So that's one of the things that makes the FDA route so appealing is that you're gonna have as much evidentiary and clinical support as you can to make a persuasive case for broader insurance coverage.

17:39 PA: And that's my hope, right? I'm very optimistic about that, that that will be the case, and I think that's why we just don't know, and one thing that COVID has brought up a major concern for me, and particularly with the United States is Donald Trump, and I don't wanna get too deep into politics 'cause I don't think it's necessarily all that relevant, but there is basically an opportunity for Donald Trump to be in office for four more years, and it looks like the American healthcare system is going to fall apart because of COVID. And so this has also been a shift where the psychedelics space has had a number of assumptions that they've built our entire foundation on, and now in a post-COVID world, I seriously question some of those assumptions and how true they will become because from my perspective, and again, this is just America, the American, in particular, cities like New York, San Francisco, LA, Miami, Chicago have such significant income inequality, that they could easily become disaster zones.

18:39 PA: I also just question how reasonable it is to put any sort of trust in the federal government, whether it's the FDA or not, as it's sort of falling to pieces before our eyes. So I'd love to use that as just sort of a lead-in in terms of pre-COVID, post-COVID, how has in particular Field Trip Ventures, how has your approach changed, how are you shifting and adapting as a business as a result of COVID, and if you wanna get any thoughts on what I just brought up, which is a lot, feel free to dig into that as well.

19:09 RL: I don't know enough about the nuances of the American healthcare system to offer a great deal of insight other than to offer whether you like the execution of the American healthcare system and whether you think FDA approval is overly bureaucratic or inappropriate in a pre or post-COVID world. I don't think it matters. The one thing that the FDA process does impose is rigor in terms of science and clinical data, and where it goes from that is an entirely separate conversation, especially in a post-COVID world, what's the relevance and influence of the FDA in American healthcare, I can't really opine. But at the end of the day, the rigor that they provide and demand to get through that process is what's going to legitimize psychedelic therapies more than anything on a broad-based basis. How that gets implemented, where you get care from, the coverage, particularly in the US now that Bernie Sanders is no longer on the campaign trail, I have no idea. That's for people, way smarter and way closer to it, to sort of figure out and decide. But I do think the rigor of the FDA process is never a bad thing. It's never bad to be that rigorous when it comes to this kind of stuff.

20:23 RL: In terms of how it's evolving our business model, it hasn't changed it substantially. It gave us an opportunity to advance some digital therapeutic efforts that were somewhat sidelined or lowered down on the priority list when we were focusing on opening our first clinic in Toronto, and New York is under construction. And we had hoped we'd be opening soon, but construction has been delayed as well. But our plan is still this type of care requires... For the best possible outcomes, requires very high touch point, very engaging, very thoughtful and accessible services, and we think that's gonna lead to the best outcomes. That being said, we do recognize that access is a challenge both in terms of delivering physical services right now in the COVID area. And so actually today, we announced the availability of our virtual psychedelic therapy. Now, we're not providing Ketamine through the mail; that's something that our clinical team has decided that is not appropriate, at least for our patients, and we know that some other groups are doing it and respect their willingness, but from our perspective, we're focused on patient outcomes and we don't think that doing at-home Ketamine in terms of a self-styled offering is necessarily the right approach, so that we're open-minded and then we'll follow the evidence.

21:46 RL: But our virtual psychedelic therapy is gonna leverage breath work, which is we think a lower risk activity, but one that eschews the ultimate goal of using psychedelics in the first place, which is to open the mind, create an altered state of consciousness, slow down the default mode network, reduce the impact of the ego such that the effects of therapy can be more efficient and create more impact. And so our virtual psychedelics therapy offering, you'll have access to breath work sessions, which you'll be invited to do in advance in the comfort of your own home, and then you'll join a teleconference with one of our therapists to do the integration work after the fact.

22:30 RL: So COVID has accelerated our digital therapeutic offerings. It's also accelerated the development of our app, which we're working on right now, which is really designed to take all of these protocols because with our field trip clinics, we really built both the space and our protocols from the ground up. We took nothing for granted. We brought in experts from a wide variety of academic and medical psychological backgrounds to really build our protocol from the ground up using evidence-based approaches and the wisdom and experience of a broad base of expertise. And what we're doing with our app is essentially, to the extent possible, taking those tools and protocols that we've developed for in-clinic patients and opening it up to people who may not have access to in-clinic experiences because either they're not in the right jurisdiction or they don't have the ability to afford the care, which is still going to be a challenge.

23:26 RL: But from a harm reduction basis, we believe that the best way to maximize the benefits of psychedelics and minimize the potential risks around them is making sure that people have at least the right tools, and the right understanding, and the right processes to go through if they're gonna go out and do it on their own or do it with friends, which is something we don't necessarily advocate for, but we recognize is going to happen. So making sure that people are as equipped as possible is really what we're trying to build through our app as well. So that's how COVID has changed the evolution of our business, but by and large, it really hasn't changed what we're doing. It just meant that we accelerated certain projects while other projects like the buildout of our clinics experienced some temporary delays.

24:07 PA: Yeah, education. Education is critical, regardless of whether it's the clinical route or with friend's route or by yourself at home. And we've noticed with Third Wave is education is central to generating mainstream acceptance. That's probably because we've had the science around psychedelics since the 1950s. None of the science is all that new. There is some science that's new, but a lot of it isn't. What is new is the ability to openly speak about it through a decentralized platform, aka the internet, which then allows more and more accessibility for some people to understand truth and not be sort of scared away by myths or stigma, or whatever else it might be.

24:51 RL: Yeah, it's certainly challenging some of the dogma and the myths and the misunderstanding. It's a challenge for sure, and education is going to be essential. And I think one of the big challenges that we have, all of us, is, "How do we stop psychedelics from being the new CBD from the Cannabis industry?" Not that there's anything wrong with CBD. It does seem to be a very potent therapeutic model or therapeutic drug that's quite safe and effective, but it's gotten out of control. Even last year, I saw people selling CBD-infused clothing, and it's just become almost absurd, right?

[laughter]

25:29 RL: And I can foresee that kind of mania emerging around psychedelics. And so I think all of us... It's incumbent upon all of us to make sure that the evidence is objective, the conversation and education is objective, that psychedelics are not a cure-all, they're not a panacea, they're not going to solve every problem on the planet, but if implemented well and done carefully, they can really start to move a lot of the big challenges that we're facing as a species, as inhabitants on this planet with limited resources. So I think the impact can be huge, but we've gotta be, I think, modest and humble in the way we communicate that.

26:14 PA: So let's talk about microdosing.

26:16 RL: Sure.

26:17 PA: I think microdosing might flip some of those assumptions on its head. Microdosing I've compared somewhat to the CBD of the Cannabis space, because technically, microdosing is sub-perceptual, and we know not from clinical research necessarily, but by looking at the impact that it's having on, at this point, hundreds of thousands of people, we know psychedelics are anti-inflammatory, we know that chronic inflammation is linked to lifestyle choices, so poor diet or exercise or sleep, and we know that psychedelics activate serotonin receptors, 90% of which are in the gut. So there's a lot of things that point to microdosing having some level of efficacy, just like fish oil might, just like ashwagandha might, just like any other herbal supplements could help with. Paul Stamets has also spoken extensively about this, how microdosing helps with neuroplasticity. He was quoted on the Joe Rogan podcast as saying that any startup that doesn't microdose will be at a competitive disadvantage, which will be interesting to see how that goes.

27:14 PA: And obviously microdosing, we see companies like Mindmed, that are trying to get clinical approval for microdosing LSD for ADHD. There's companies like Eleusis that are looking at microdosing for Alzheimer's and other things like that. And microdosing represents that trickster energy in the psychedelic space because you have an individual like Dana Larsen, who has a mushroom dispensary now out of Vancouver, where if you send him a doctor's note that you have a clinical condition, he will sell you microdosing supplements, and the Canadian government and Vancouver government is doing nothing about it. I would ask you from less of a "This is my position" and more of like an honest objective approach, how does microdosing challenge some of those assumptions that you hold?

28:01 RL: And the answer is, I don't think it challenges any of my assumptions yet. I'm open-minded to the potential of microdosing, but personally and as a business, our view is to follow the evidence, and we'll support whatever the evidence suggests is good and not support where the evidence doesn't exist, or suggest some sort of negative impact. So I'm inclined to believe there's a good rational basis for why microdosing does seem to help a lot of people, and I won't be surprised if the evidence really supports that. But the evidence just isn't there. I think Thomas and Rotem from the Center for Psychedelic Studies at the University of Toronto did the first somewhat academic study on microdosing, just soliciting responses I think through Reddit and people's practices and their therapeutic outcomes. But that's very, very observational and very preliminary, so it'll be really interesting to see the more clinical work coming out of Eleusis, coming out of Mindmed, all of those companies.

29:05 RL: But I'm open-minded to it. I do take every kind of comment with a little bit of a grain of salt around it, just because I wanna try to be objective as much as possible and not create the hysteria, as you pointed out, where microdosing may become the new CBD, it's good for everything. It's surely a maybe, and there's lots of reasons it could be, but on the same token, psychedelics aren't without their risks, even on a sub-perceptual level. The Psilocybin is a fairly promiscuous molecule in terms of its binder, receptor binding, and there's the 5-HT2B liability, which seems to suggest that when you engage that receptor, which Psilocybin can engage, it creates risks around...

29:52 PA: Heart valve function.

29:52 RL: Heart valve function, yeah, and it's not entirely harmless. It may be. Maybe these amounts, such small amounts over a long time don't create the 5-HT2B liability, but it's not a slam dunk. So when you start microdosing or you take it from the perspective that Paul Stamets has offered, you are taking some risk. Admittedly, I think most people would conceive of it as relatively small, but it's not nothing. And humans are prone to errors, so even the best experts don't always know what they're talking about. I still relish the about-face that public health groups in Canada, the US, have done about the diet plan, and then what we should be eating and how grains were so central. And they're like, "Oh yeah, no, we made a mistake on that."

30:41 PA: "Actually... " [chuckle]

30:42 RL: "Maybe fats are okay." And so it's like... We definitely live in a society where expertism is becoming a problem. We see an expert, we see a documentary, we listen to a podcast, and it resonates with our own beliefs, then therefore we accept as facts, the opinion of so many experts who are writing books and creating podcasts and all this kinda stuff. And the truth is, is a lot of the time, they're not experts, they're just people who research a particular subject on a fairly superficial basis and created a book and B: Evidence changes. Experts don't know everything, and the universe is infinitely complex. And even when we think we know something, there's always surprises around the corner. So I think everything... We just need to be very open-minded and be willing to change our minds, to quote the name of two books in the psychedelic sphere, to some degree, when the evidence presents itself and continue to be rigorous and demanding answers and evidence and understanding.

31:43 PA: All of those are fantastic points, so thank you for bringing those up. I'm not a medical professional. I am an amateur in every way possible. [chuckle] I'm a social entrepreneur and an activist.

31:56 RL: Yep.

31:57 PA: And I'm also very in-tune with human behavior and behavioral psychology. And I understand why people do things, and I understand what makes people tick. And from running Third Wave for the past five years and really being at the forefront of everything microdosing-related, the strongest lesson that I've learned is that, and this is backed by Daniel Kahneman in "Thinking, Fast and Slow," behavioral psychology, people do not make decisions based on research; people make decisions based on feeling and emotion, and they rationalize it after the fact with research.

32:29 RL: Yep.

32:30 PA: And so one question that I continue to bring up in the psychedelic space and I continue to fall flat with hearing a reasonable response is, why has microdosing become popular if there's no clinical evidence around it? And people just don't have a response for that. I continue to go back to that when we have people who emphasize, "It's clinical, it's clinical, it's clinical," and I go, "Yeah, maybe." But making that such a core central assumption, it essentially, what I think is it creates a tail risk within the psychedelic space, because if that doesn't work out and you don't create other areas that will help psychedelics to become integrated in mainstream, then you're potentially putting all of your eggs in one basket, and if that basket doesn't work because, for example, the United States falls apart because Donald Trump becomes a dictator of some sort, then we're kind of fucked. This is sort of where I always am taking the honest approach, it's like, "We want this to be successful. How do we ensure that it becomes successful, regardless of who's in power, and regardless of all these other things?" So that's the last thing that I will say about.

[chuckle]

33:46 RL: Yeah, it's interesting on that subject. I remember just last year, there was a study that came out around fish oil, which I think so many of you touched on, and Vitamin D, and whether those supplements actually do anything. And if you read the headlines, which many of us are pretty disposed to do and just make conclusion based on the headline and not read on, all of them said, "Fish oil and Vitamin D don't do anything." But if you actually read the articles, and kudos to the reporters who actually put the content in there, they showed something like, I'm making up the statistic, 'cause I don't remember exactly what it was, but it said that for fish oil in particular, for people who didn't eat the recommended amount of fish on a weekly or monthly basis, it reduced the risk of, I think heart attack and cancer, but something like 40%, some absurdly high number that most public health advocates should be screaming from the rooftops not because it is massive and profound that it does work, it does create impact, not for everybody, it works for specific section of the population, but it's just like, how do people miss that? How do we get sucked into headlines and say they don't do anything, but you just have to read the article that says, they don't do anything to find out that actually it does a whole lot.

35:00 RL: And I think there's certainly that same risk given some of the perspective, given the ardent emotional support that people put behind microdosing right now that even when some of the research comes out, it's going to be flipped in two directions; the people who believe are going to spin it to say it's amazing, and the people who don't believe or have political reasons for opposing are gonna say it's the work of the devil, and I think it's up to people like you and I to really try and be objective and balanced on it.

35:29 PA: Well, I think what you're speaking to again like fish oil, it really comes down to inflammation balancing out Omega 3s to Omega 6s. And this is why I go back and what you have emphasized in this conversation is, it's not so much about the psychedelic experience, it's a fantastic catalyst. Really, what happens through the psychedelic experience is a lot of stuff, but one of the main impacts is, what I've noticed is a change in lifestyle, and what we know from health and well-being is lifestyle choices are everything; sleep, number one; diet, number two; exercise, number three. When we look at how are we keeping chronic inflammation low, 'cause we again know how much inflammation is tied to everything when it comes to health and well-being, depression, addiction, anxiety, you name it, inflammation is tied to it. I'd be curious to hear from your perspective, from Field Trip's perspective, how are you approaching that relationship between psychedelic use and actually making concrete lifestyle changes, whether that's through preparation or through your integration process?

36:28 RL: Personally, I think all of us at Psychedelics are pretty active and progressive in terms of adopting different habits and practices into our own lives and testing out different approaches to see what works for us. I think everyone in our office had started intermittent fasting in the months and weeks leading up to COVID.

36:49 PA: Yes, it's so good, it's so good.

36:51 RL: Yeah, yeah, and personally, I think the evidence is reasonably strong. The personal difference for me is that I find my attention and my awareness and ability to concentrate is higher when I'm fasting, and that may be entirely anecdotal, but okay, it doesn't matter, it works for me. The challenge though, especially with patients in our clinics, is that doctors are held to a different standard in terms of their ability to recommend things and having the evidence to back it up. And so certainly lifestyle change and talking about proper sleep and proper exercise and making commitments around that is going to be part of the process. Most of the current fad du jour, even though they may be so legitimate, like intermittent fasting, like bulletproof coffee, like all of these things. They're not suitable for everyone. It's just like the fish oil conversation, it's like fish oil does something for a certain group and it can do a lot for a certain group, but for other people, I don't know about fish oil specifically, but it may not be positive, but it could potentially be negative and so there's a group of people for whom intermittent fasting is not a good idea, potentially.

37:57 RL: And so we've gotta be a little bit more dogmatic in terms of what we recommend to our patients, particularly because our patients starting in Toronto are going to be patients who have treatment-resistant conditions, who are coming after trying just about everything. These are relatively high risk patients, and so you've gotta be very, very thoughtful about what you recommended to them and what practices to encourage, but certainly mindfulness, awareness, trying to sleep well, these ones are obvious, and certainly we'll be trying to track that as well. And even recently, there's a study that came out that showed that insomnia had an impact on the ability of Ketamine to be an antidepressant. So clearly sleep is a factor, and I don't think anyone's going to debate that, but other practices or somewhat more nouvelle practices, we've just gotta be thoughtful about.

38:47 PA: Rhonda Patrick, for any listeners who want great research on fasting, Rhonda Patrick is a great resource, FoundMyFitness. Because there has been clinical research that's proven that fasting basically improved longevity and lifespan in particular, because it helps with mitochondrial plasticity. And so that's where I go... Yeah, and there's plenty of research to support, making sure that people know about things that might be perceived as being on the edge, but genuinely fall in line with better lifestyle choices and decisions. I don't think anyone's gonna argue with eating more fruits and vegetables.

39:25 PA: Or you might have some people who argue say, "Don't eat butter." But now there's a lot of research that shows that the fat-soluble vitamins, particularly in grass-fed butter, help significantly with health and well-being. I also feel like, and again, I'm just speaking as an individual, that it is incumbent on those who are leading this process in psychedelics to make sure that in the integration process, that there's reasonable advice given about lifestyle changes, because what I've noticed a lack in the psychedelic space is too much of an emphasis on mindfulness and not enough of an emphasis on, "Look, dude, if you just ate healthier and slept more and went outside to do some high-intensity interval training and spent some time in the sun you'd be healthier, way healthier." So I also feel like there needs to be a rebalancing of priorities when it comes to the integration process.

40:20 RL: One of the fallacies that all of us who are doing intermittent fasting fall prey to is, I think I'm not fully versed in this, so please feel free to correct me, but I think the evidence shows that intermittent fasting reduces a lot of the markers of inflammation and all of this kind of stuff. But I don't know that anyone has actually ever studied to see if people who intermittent fast on a regular basis actually live longer. We're using those markers as a proxy for longevity, but I don't think we know with certainty, 'cause just like 20 years ago, if you asked a doctor about your cholesterol level, that was a marker for poor health. But that seems to have changed because it didn't create a nexus to necessarily longer or healthier lives.

41:03 RL: And even though there's good reason to believe that these markers may have a nexus to longer or healthier lives, I don't think that's fully been established in many respects, just because some of these practices, at least that can be studied in a rigorous clinical setting, haven't been around long enough to be studied in that way to show that, "You, Paul, are now going to live 10 years longer, because you intermittent fasted since you were 30-years-old." I'm not sure that evidence exists, so even with that, I think we need to have a grain of salt. For me, it's fine. I'm not discouraging people to do it, because if it does make you feel better and you feel clear-headed and you have more energy, then that's perfectly sufficient rationale for doing it, but to be convinced you're gonna live longer as a result, I think we still need to take that with a degree of caution, because I'm not sure that the evidence quite supports that statement.

41:54 PA: There's some really good evidence that shows that fasting will significantly reduce cancer rates. So if you look at it from that perspective, in particular, it's not just intermittent fasting, but it's longer like three to seven day fasts. Dr. Peter Attia has done some fantastic podcasts on this in particular about the relationship between fasting. Ben Greenfield is another one, who's an investor, from what I understand, of Field Trip. So he has some fantastic resources on this as well, and I think this is sort of what I was getting into earlier in the podcast, Ronan, is personalized medicine, right? Where the opening that psychedelics allow us is this intuitive understanding of our needs like you're emphasizing everyone's needs are different. I'm different than you who's different than a 60-year-old woman who's different than an 80-year-old man who's different than, etcetera, etcetera.

42:42 PA: Sort of what I was hinting at earlier is with our industrial model of healthcare, everyone has given up their power to a doctor to tell them, "This is best for you, this is best for you, this is best for you." And I think the opportunity with psychedelics is for every individual to go, "Based on this and this and this, and more or less based on how I feel, based on my intuitive understanding of myself, I know that this is best for me compared to this is best for me." So I think that's also what I was sort of hinting at, it's like how do you then create a system for psychedelics, like a new healthcare system that allows people that process of intuition to really understand themselves better to make those decisions?

43:22 RL: That's a fair question and I certainly think that psychedelics and their ability to help us tap into our emotions and our intuitions and internal dialogue is certainly going to enhance people making informed decisions around their own healthcare, but I also acknowledge that we're also terribly prone to making poor decisions around our healthcare and the presence of information that when it comes to our own lives, one of the reasons that I think doctors are so important is because they do offer a degree of objectivity. It's the same reason that even though I have lots of issues with lawyers and how many of them practice, being a lawyer myself, is they can offer a degree of objectivity.

44:05 RL: My coach talks about true intelligence being the perfect integration of our emotions with our logic. We were gifted with both. Too many people in our society only operate in their brain and purely rational, and then totally discount or repress their emotions, and I think that creates perverse outcomes, and sometimes, especially when we're dealing around conflict, our health, we operate too much in our motions around fear or anger, and you need someone. You need that objective voice like a physician to say, "Take what your instinct says, but also weigh it with what the evidence does to make a truly informed decision." For some people, I think that's gonna create the best outcomes, but if you leave it totally personalized where people are self-selecting, I think... I don't know. But I understand the circumstances where that could lead to really bad outcomes.

44:54 PA: I love that we're discussing this 'cause what's coming up for me is well, it's like, look, look at the American healthcare system the past 40 years. A lot of the doctors have been basically bought out by pharmaceutical companies. That's what got us in this mess in the first place, so I think that's some of my challenge and struggle that a lot of people have in the psychedelic space and again, Canadian healthcare is probably different, European healthcare is probably different, but a lot of people in America are very distrustful of, in particular, psychiatrists because they've been pill pushers for a pharmaceutical industry that has been bought out by people who just don't give a shit about our own health and well-being and I think that's the tricky challenge.

45:33 RL: I think there's aspects of that, for sure, but I think it's also reflective of what I talked about, which is, we've gone from a society that valued emotions and intuitions to one that purely valued data and evidence. And certainly data and evidence is incredibly important, but it is a very logical and rational thing, and it fits nicely within a scientific sphere because you have the evidence that X leads to why this molecule does X, which leads to these outcomes on a statistical basis. It's very easy to accept that blindly, and I think that's what happened in a lot of our medical practices. But let's give credit where credit is due. Until recently, by and large, people in the US have been... They've lived longer and healthier lives. And the challenges and the shrinking of those lives has largely been driven by, as you talked about, poor lifestyle choices, so less about pill popping, and more about eating poorly, gun violence and suicide. These are the things that are driving the average lifespan in the US down. So as much as there's been some poor execution on the pharmaceutical industry, particularly around the opioid crisis, it would be, I think, shortsighted to put all of the blame on the failing American healthcare system on pharmaceutical companies, I think there are a lot of things at play that have led to some of the challenges that exists right now.

46:56 RL: And I think we just live in a society that's too quick to blame big pharma and too quick to blame government. It's easy and sometimes I certainly fall prey to skepticism around government agencies, and are they acting in our best interest? But then I realized that I have friends who work at the most senior levels of some of those government agencies in Canada, and I know those people are genuinely well-intentioned trying to do the right thing, acting in what they genuinely believe to be your best interest. The challenge is two-fold, one is it's hard, as you said, it's not one-size-fits-all, what's my best interest is not the same as your best interest Paul, it should create a solution that's one-size-fits-all, doesn't always work. And secondly, they're just people, they make mistakes, they have biases, they are uninformed or over-informed, and regulation, in particular, is a hammer when you need a scalpel, right? It's so so hard to draft regulations in a thoughtful, effective way that doesn't create perverse outcomes. And so that's why a lot of the things that can be attributed to government, and some people may point to conspiracy theories and all that kind of stuff. I don't believe in a lot of those conspiracy theories.

48:06 PA: Me neither.

48:07 RL: But I do see those perverse outcomes happening, despite the fact that they were motivated by truly the most altruistic of intentions, by very informed people. And we just gotta be careful about where we allocate blame and who is responsible and really ask people to take responsibility for themselves. But that doesn't mean that you can do it on your own and that you are perfectly equipped to make decisions about your own healthcare without some degree of objective advice and information.

48:36 PA: And hopefully, with the rise of algorithms and whatnot, a lot of that advice can be purely objective. So rather than coming from an individual, I think, this is again my hope with personalized medicine is if we understand certain biomarkers, we understand certain qualitative data, we understand certain things about the history of the patient, then that can be inputted into a machine which actually gives a clear objective output about this is best for you. I think the unfortunate side effect of being human is we all, like you were saying earlier, we all have biases, and sometimes those biases are hard for us to understand and deal with.

49:09 RL: Absolutely and we're very often not very good at making decisions in our own best interest, especially when we're operating out of places of fear or anger, which tends to be a lot of the places that people operate out of when it comes to managing their health.

49:25 PA: Great. Well, Ronan, thanks for sticking in it and going toe to toe. I don't often get the chance to do this in the podcast. It was fun to go back and forth with you. Just so our listeners know where to find out more about Field Trip, what would be some website, all that sort of stuff, for our listeners?

49:40 RL: So I just wanna make one correction from the beginning of the podcast, which is we are no longer Field Trip Ventures, we are Field Trip Psychedelics Inc. We've moved away from the name Ventures because people confused us as a venture fund, but we're very much an operating company. But if you'd like to learn more about us, if you wanna learn more about our clinics, our virtual care, visit fieldtriphealth.com, and if you'd like to know more about the company more broadly, fieldtripdiscovery.com are the two websites, or you can find us on Instagram or Twitter or Facebook or LinkedIn or all of those places. But we're all over the web now, so I'm sure you can find us if you want to.

50:15 PA: Well, Ronan, thanks again for hopping on, it was an honor to interview you. Thanks for all the work that Field Trip is putting in and you guys have an excellent company. You've been operating in the space now for quite some time, and I know I'm speaking for myself and Third Wave, we're really excited to see how things continue to develop, in particular, with all the clinics.

50:34 RL: Thank you for having me. It's been great chatting with you. I enjoyed going to toe to toe as well. It's been a good conversation. I like to get the old brain working on these things every once in a while, so I appreciate the opportunity, Paul, it's been a pleasure, and I look forward to crossing our paths many, many times in the future.