No Way Out
Welcome to the No Way Out podcast where we examine the variety of domains and disciplines behind John R. Boyd’s OODA sketch and why, today, more than ever, it is an imperative to understand Boyd’s axiomatic sketch of how organisms, individuals, teams, corporations, and governments comprehend, shape, and adapt in our VUCA world.
No Way Out
Clean Slate: The Psychedelic Revolution in Healthcare with Maria Velkova
Maria Velkova, managing partner of Tabula Rasa Ventures, discusses the use of psychedelics in therapy and the work her organization is doing to support the space. She explains that psychedelic-assisted therapy is a novel care delivery model that combines traditional therapy with the use of psychedelic medicines. Velkova emphasizes the efficacy of these therapies, particularly for veterans who have high unmet needs. She also discusses the history of psychedelics and the negative connotations associated with them, as well as the current shift towards acceptance and understanding. The conversation explores the impact of psychedelics on the healthcare ecosystem and the potential for personalized, holistic, and disease-modifying approaches to mental health care. The conversation explores the role of money and investment in the psychedelic industry, the potential approval of MDMA-assisted therapy by the FDA, and the challenges and stigma surrounding psychedelic research and therapy. It emphasizes the need for capital to scale and provide broad patient access to innovative therapies.
As we await the FDA's decision on MDMA-assisted therapy, Maria shares promising Phase 3 trial results and discusses the broader applications of these treatments beyond veterans. Stay informed about the evolving landscape of psychedelic science, and gather valuable resources for further learning, including peer-reviewed journals and insightful platforms like Psychedelic Alpha and Double Blind. Maria also shares her top book recommendation, "The Myth of Normal" by Gabor Mate, and the impactful initiatives of Tabula Rasa and Energia, leaving us with a sense of hope and excitement for the future of mental health care.
Maria Velkova on LinkedIn
Tabula Rasa Ventures
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So, maria, thanks for coming on. No Way Out today. We're a service-disabled, veteran-owned small business. We are trying to build a bridge between helping veterans like ourselves more and more. Acceptable and more and more there's more and more knowledge and understanding around us is psychedelics. We've had a lot of guests on the show recently talking about psychedelics and you're doing some fascinating work, and what we'd like to do today is build the bridge from where we sit as veterans to what it is that you're doing with Tabula's Adventures and the things that you're doing in psychedelic therapies, and creating more, wider access, safe access and broader understanding for this type of therapy. So why don't you give us a little background on what you're working on now and then let's go from there?
Maria Velkova:Yeah, absolutely, and thank you so much for having me guys, and thank you so much for having me guys, um, and thank you so much for doing the important work you're doing. It all starts with awareness, as we like to say in therapy, or, you know, um, uh, working on on on traumas and reshaping, rewiring our blueprints of human existence. So thank you so much for doing this work, for spreading the word and for having me on the podcast to contribute a little bit about what I've been doing and how we're supporting the space. Maria Velkova, I am a managing partner of Tabula Rasa Ventures and we also have our nonprofit foundation which is called Energia, this novel care delivery model in mental health care where it is not just here's a prescription, go and take this SSRI for the rest of your life. Or, you know, here's your therapist. You speak to them for one hour every week, but really combining those two interventions interventions and assisting the therapeutic component of this therapy with these ancient, novel medicines is what a lot of people call them. They've been around for millennia, actually, but psychedelic assisted therapy and in modern times we have seen such incredible efficacy for a lot of people to really get back, reclaim their life and heal those traumatic moments that they've experienced serving our country. So that's the space where my business partner and I have been very active.
Maria Velkova:Our general thesis for our fund is building the future of human health, so it stretches beyond that. But really most of our work over the last five and a half years has been in the psychedelic therapeutic space, which is a true catalyst for rethinking how we do healthcare in our modern times. You know, the reactive symptom management, disease management, keeping the person at bay, versus the personalized, really truly holistic and disease modifying approach which psychedelic assisted therapy is. On the other hand, with our nonprofit foundation and very aligned to what you guys are doing here, we do a lot of impact initiatives, starting with education.
Maria Velkova:We've been around the world. World's leaders congregate once a year to discuss the most pressing needs and challenges that we're facing as a species and the impact of our troubles and challenges on the environment and etc. So really educating the global leaders who have a lot of power and say and what happens, and also even the middle East. We brought psychedelic education for the first time in the Arab world. We've done some work there and have connected specifically with organizations who work with veterans. So yeah, that's kind of like the introduction, happy to dive into any part that your audience might find interesting. So thank you once again for having me.
Mark McGrath:Tell us about where we've been and where you see us at now as far as acceptance goes, because there's always been a very negative connotation of psychedelics, particularly in this country, with you know they think to the hippies and things like that and they think about mind control and they they put these things like LSD and others on schedule one. And you know where do you see us? Where we kind of know where we've been and we've had some other guests talk about how that's transitioned. But where do you see it now? Naturally in a positive light, because you have a, you know you have a fund that's creating more awareness and investment in this. But where do you see us now? Where are you really hopeful?
Maria Velkova:Yeah, definitely. I mean it's very important to to mention that. You know I refer to these as novel, ancient medicines because they have been used for millennia. Really, they entered our modern day. Framework of existence and human experience in the Western world is back in the 50s and 60s when researchers, scientific researchers, have started looking at these very powerful medicines. Albert Hoffman was the person who has discovered, for example, lsd. He's known to be the first recorded person to really experience a psychedelic LSD experience and he was working with pharmaceutical companies back in the day and that really sort of opened up, along with other small events where, you know, maria Sabino was sort of discovered by the Western world and she was serving psilocybin mushrooms in Mexico and all of these culminated in our interest into these.
Maria Velkova:They have been highly researched in controlled settings, meaning in a very safe way. They have been prescribed for various ailments very successfully mental health ailments, for example, for addictions, for couples, therapy, for anxiety and depression. However, all of this research started in the 50s and 60s around the Vietnam War, and the issue was that they leaked out into the public where they started being used underground. Allow you to feel deeply connected to yourself, to oneself, and also deeply connected to others and also deeply connected to nature. So all the hippies, as they were called, you know, were these people who are connected to themselves, to others and to nature and really didn't want to go halfway around the world to fight in a war. And, to you know, wars come with very, very traumatic experiences. I don't need to tell you guys or the audience I'm probably not the best one to speak but these people didn't want to go to war.
Maria Velkova:So the story is that President Nixon, you know, put into action the Controlled Drugs Act, which started the war on drugs as we know it in our culture, against these therapies, because a lot of the young people didn't want to go to war and were protesting against the Vietnam War.
Maria Velkova:Human existence is very complex and unfortunately there are still currently, as we speak, ongoing wars around the world, many wars around the world, which tear apart not only the material you know cities we live in, but our internal realities, and unfortunately these things are still happening. Hopefully, one day we will awaken and recognize that that's not the best way to resolve conflict. But yeah, nixon started the war on drugs and that's where a lot of propaganda and stigma that wasn't rooted in scientific evidence started being communicated to people. So all of this research just got canceled or a little bit of it went underground. However, in the past decade, there has been a rekindling of the interest in these therapeutics by prominent universities around the world who are doing experimentation and really showing who are doing experimentation and really showing the impact. If again, if delivered correctly, if used correctly, the impact on, as Gabor Mate says, traumas with a big T, but also traumas with a small T.
Brian "Ponch" Rivera:There's more to psychedelics than just healing. There's also a better understanding of how the brain works, and for me, you and I met down in Miami several years ago, I think, on accident down at Wonderland and what I've learned since participating in psychedelic assisted therapy is this thing called the free energy principle. There's Robin Carhart-Harris who's working on something known as entropic brain hypothesis and reduced beliefs under psychedelics, which is allowing us to understand how humans sense the external world, how we plan, how we adapt and how we learn. And this is very much aligned to what Mark and I and we're doing with the John Boyd's Observed Oriented Side Act Loop, which is very, very, very similar to what Carhartt Harris and Carl Friston are developing with their free energy principle and, of course, rebus and things like that.
Brian "Ponch" Rivera:We've had other guests come on the show to talk about how we can use that type of thinking in economics, how we can use it over here, how we can use it for war fighting. It's kind of a unifying theory potentially on how humans evolve, living systems evolve, um. So I want to hear you know we have a lot of guests come on here and we have a lot of friends that have podcasts to talk about psychedelic assisted therapies. Uh, I, I generally go on and talk on those shows when I can with my friends that have gone through this. I'm curious what kind of ecosystem are you seeing as an investor? What are psychedelics doing for the healthcare ecosystem?
Maria Velkova:Yeah, definitely. You know I'm trained academically. I studied pharmacology and bioscience, so I was really fascinated by how the body works on a molecular level from a very young age. Now I'm equally fascinated about how the human experience works and for me it's pretty fascinating that we don't really know. And thank you for bringing the scientific angle, because that's my bread and butter and I really am excited about not only the healing potential but how these compounds and medicines are helping us to understand how the human experience works. And I love how you said the entropic brain.
Maria Velkova:Robin Carhart-Harris is one of the leading experts and researchers in this space and I always like to make the analogy of when babies are born. They don't have frameworks of human existence. We put those there. We meaning the parents, the peers, the educational system, society, culture. We're born as tabula rasa, which means clean slates, and really get conditioned into living in this world. You know, if you think about the story of Tarzan, he was raised by gorillas and monkeys, so his conditioning was not that of our modern human experience. And also it's very important to state that different parts of the world have different types of culture and conditioning, so we're not the same and we really become byproducts of our world that we live in and that we are directly thought about or not, or indirectly.
Maria Velkova:I'm reading probably one of the most incredible books I've ever come across. It's called the Myth of Normal by Gabor Maté. Highly, highly highly recommend it. It's very fascinating. Fascinating, um, but it's helping me learn about my own self as well.
Maria Velkova:Um, and to your point, um, these as as as I always say, um, our, our world, external world, the human world, not not natural world, but anything that's not made by nature, anything that's made by man, whether it be a desk or a house, or a financial system or a healthcare system or, you know, government. These things are a reflection of our internal environments. So our internal environments, as I said, get shaped by our experience of being alive. And for veterans, again, just to stay relevant to our audience in this podcast they can be stimulated by positive things that happen, but also negative things that happen. And when negative things happen, the brain goes into fight or flight, in survival mode, and it imprints this experience into our human experience, or blueprint of existence, or default mode network, whichever phrase you want to use to describe it and long past that experience, it still gets lodged in there if it's not properly processed emotionally processed, but anyway. So the point that I wanted to make is that what we put out into the world is a direct reflection of our internal environment, our internal environment and what I'm seeing in how the psychedelic ecosystem is being built and how it's impacting our healthcare system. It's truly reflected of the people that are building this ecosystem, and many of us come from very different life experiences, from very different situations. You know, there's not only entrepreneurs or doctors, there's also lawyers, there's bankers, there's political figures. It's such a diverse tapestry of individuals that are building this ecosystem and most of them have had their own lives impacted by these therapies, or at least impacted by them bringing awareness and consciousness to this blueprint of human experience. So I see a lot more collaboration in the psychedelic space.
Maria Velkova:My background I used to work in big pharma. That's probably helpful to mention. But I see a lot more collaboration. I see a lot more intentionality that's grounded in something bigger than than than ourselves. You know, not like competition. I need to be the best. I need to make. You know the, the, the, which is so true, we live in a capitalist world, but, you know, the main intention is to bring healing to to others that we have experienced ourselves, um, and I don't see that as much in other industries, you know, certainly not in the pharmaceutical industry, which I have direct experience of, but also through all of the individuals that I have crossed paths with and work directly with, for example, the. You know, wall Street and the financial system definitely, certainly doesn't have this, this air and nature of collaboration and and working to it together towards a purpose that's bigger than ourselves and that's reflecting in how we build our businesses.
Mark McGrath:Ponch and Maria, to be clear, you've spent zero time in the military, correct Yourself? That is correct. So I've not heard such a beautiful explanation of John Boyd's orientation as you just gave a few minutes ago. You absolutely nailed it out of the park and, as Ponch has said before on other episodes with guests, so you nothing of John Boyd. Yet at the same time, you know everything, because you just beautifully described how orientation is our, our inner computation, our inner understanding of what it is that we deal with in in reality. And it was, I think all three of us would agree. That's, that's one of the values of of psychedelics, to help us understand that reality better. So, punch, would you, would you agree?
Brian "Ponch" Rivera:I was thinking the same thing, I was just listening to it like, oh my gosh, this is exactly what orientation is and it scales Absolutely. So a couple of things unpacked there. Pharmaceutical industry has an orientation. That orientation, from my perspective, is you want to maintain a customer. You get them addicted to something. You want a customer for life. In the psychedelic space, you don't have a customer for life, right? I?
Maria Velkova:mean you don't do psychedelics every single day, you don't want yeah.
Brian "Ponch" Rivera:So there's a conflict here that Wall Street may need to look at, which is hey, how do we make money off of something that makes people healthy versus how do we make money off of something that keeps people addicted to like a benzodiazepine or something like that? Right, something that keeps people addicted to like a benzodiazepine or something like that, right?
Maria Velkova:So walk us through the conflict there and how this resolves over time. Yeah, definitely Two things. One, I'm very happy the message is being repeated because it's fundamentals of existence. It's true. That's why it's being repeated with different words and language, but really that same message. Every single human is experiencing the same thing.
Maria Velkova:And with that I also would like to say that you know malintentions. It's really systemic. You know it's so big that we don't even realize. You know how it's impacting how we show up in the world. So I certainly know that, like many of our systems are very, very broken. But also in every system, there's always, you know, a handful of individuals who honestly, to be to be fair, have had very horrible trauma themselves and are projecting it in a way that's not healed, and have malintentions maybe.
Maria Velkova:But generally, even in the pharmaceutical industry, the people I've worked with are the sweetest, nicest individuals. It's just you get, when you're so deep into a certain lens of experience and you don't take a step back to look around wait a minute like what am I doing here? It's it's. You get lost in it. And we all experience that in small ways or even on day to day. Um, something happens or you feel like you said the wrong thing or you feel like you let someone down and you get so deep in it and you don't look up to see. Okay, you know, everything is made up and you're the author of your own experience and you have, every moment of every day, the opportunities to start fresh and change your life, if you choose so to do so, your life, if you choose so to do so.
Maria Velkova:So yeah, in the pharmaceutical industry which has been built over centuries it was or not pharmaceutical industry, but more generally, our legacy healthcare systems they were built initially to be reactive on purpose, you know to to be able to contain infectious diseases. You know that's how it all started with cholera, with these infectious diseases that you needed to be reactive. Or you know there is some. You know car accident and you need to be reactive. You know car accident and you need to be reactive. And I think it wasn't intentionally built, to some respect, just to make money. You know our healthcare legacy healthcare system has worked wonders and miracles. You know, several decades ago, our life expectancy was, you know, in our 40s 50s and that has continuously been increasing. However, we are getting to a point where that's not enough and reactive disease management is no longer enough and our science is evolving to understand better what health means.
Maria Velkova:So when I mentioned that our fund invests into the future of human health, our four pillars that we look at are very much aligned to psychedelic assisted therapy which is personalized. It's not like you go once a year, 15 minutes, to the doctor's office and they tell you, okay, great or not, what can you find out in 15 minutes about health? You can't really find out anything. You only find out if something's wrong. So this future of health, which psychedelic assisted therapy is the catalyst, very big catalyst is personalized.
Maria Velkova:The patient, the person, gets to sit with a therapist for multiple hours of therapy during the preparation phase of the intervention, during the dosing and during the integration. It's also disease modifying. It goes to the root cause. It doesn't just numb your feelings of anxiety and depression. It actually helps you process the root cause that these are coming from, in order to be able to then go on with your life without needing to take medicine every day. It's also holistic. It's not just like, oh, there's a symptom, here's a drug for it.
Maria Velkova:You go and you look at your life holistically Again. Gabor Mate's book the Myth of Normal paints a beautiful picture about that. You know, most doctors don't ask the patient how is your life situation? A lot of autoimmune disease, neurological disease, cardiovascular disease, asthma these are all triggered by mental health, because if you're constantly living in stress and anxiety it creates actual physical ailments. But most doctors don't ask you know, are you living in a safe environment? Do you have anything really traumatic that happened to you in your life? So, like psychedelic assisted therapy is really holistic because it looks at the full picture of your life, and also democratized. Again, a lot of people are not happy that we live in a capitalist world and that's not per se impossible to change, but it's so ingrained in how we operate in the Western world Everything is linked to that that it takes many, many, many, many, many, many decades for such massive systemic change to occur. And the healthcare system too. You know that's a big system. The financial system too, our governance systems. When they're so big and so ingrained in our human existence, it takes a long time to change.
Maria Velkova:But what I'm seeing in the psychedelic space is that there's a lot of initiative. How do we get these therapies which really work to as many patients as possible? So there are different programs. There's different support programs that help. For example, you mentioned Jesse Gold with Heroic Hearts. It's a nonprofit organization. They are helping veterans to be able to experience psychedelic-assisted therapy outside of the US.
Maria Velkova:And, yeah, so democratize. How do we get these therapies which actually work, which target the root cause, which are personalized, which are holistic to as many patients and people as possible? And there's many different paths for that to happen. One is the medicalization path, which is, you know, going through the Native American church, where that's their sacrament, or even taking people outside of jurisdictions where these medicines are scheduled, to indigenous tribes where they're being practiced, and these folks are so gracious to be able to share their indigenous wisdom with us as well. And so, yeah, that's how I'm seeing.
Maria Velkova:You know, the psychedelic assisted therapy and the psychedelic ecosystem, differentiating from our health care system, is a true catalyst. How do we look at health, not just disease management? Do people so, when you're pitching the fund and the investment other than well, we don't have the money, but what are the objections that you venture capital funds? The way that works is that my family are immigrants to the US and my business partner's family are refugees from the Crimea back in the 90s, so we don't come from family wealth, and how we are able to invest capital into these projects is by going out there and educating investors people with money to entrust us with their capital in order to put it into the right projects and the right companies that are aligned to what they believe in. Again, this is touching capital, so there's still a lot of stigma out there. A lot of people don't believe that the FDA will approve these therapies. I beg to disagree, although we're approaching a very important date in just 10 days a week and a half.
Maria Velkova:Yeah, 10 days Exactly when the FDA will give their first you know decision on whether they are approved or not or anything in between MDMA-assisted therapy, which is the first classic psychedelic assisted therapy going through the system. So you know when money is involved. You know some people have surplus or you don't even have to have surplus, but some people really believe in these therapies and they're crucial for innovation. Where they're giving philanthropic donations. But you know, if I come in and ask you, okay, can you give me quarter million dollars, and there's absolutely no guarantee you're ever going to see that money back. But it might help to bring these new therapies forward. Not a lot of people can part with that kind of money and to build a completely new healthcare system for behavioral health, for mental health, it takes capital to be able to scale it and provide broad patient access. So there's still pushback, there's stigma, but a lot of people do believe in it. You know their lives have been touched by it. But with anything so innovative although, again, these have been around for a very long time but anything that's innovative, I mean, if you think, crypto, uber back in the day, like all of these new concepts of building businesses, they're risky, but that's how innovation happens, and certain investors have an appetite for the very risky stuff because they know for a fact and they see certain things that they know that this will be successful or has a high potential to be successful. But there's other people who are a little bit more risk averse and once we show a proof of concept and that this works and it's all the way through the FDA approval process, it's already being deployed and administered in our healthcare systems. More and more capital starts to flow in. Capital has different tastes for risk, let's say, and different people have different tastes for risking their capital. So in the four and a half years that I have been in this space, it has been an interesting time, not only for psychedelics, but venture capital, meaning risky investments in general.
Maria Velkova:In 2021, when there was a 0% interest rate and literally money was being printed because of the COVID pandemic, our whole world went into a very unique situation that's never happened before on the scale that it has happened and into the connected scale it has happened in our human existence. So there was surplus capital, a lot of money was being invested into more risky stuff, but then, as our economic systems shifted with the COVID pandemic, money became much more tight for everyone. I mean, we saw the layoffs, you know a lot of unemployment was affected. So when money is tight was affected. So when money is tight, then less money goes into the riskiest and most um, innovative stuff. Um, so, yeah, it's, it's, it's, it's been through a cycle.
Maria Velkova:Um, typically, um, venture capital goes through cycles. Uh, we're seeing, uh, an interest rekindle, right. Uh, again, I think we're very far into critical mass with the research, with these therapies, that there's no going back. Way too many people's lives have been transformed by these therapies for the system to say no where there's no other options for patients. But again, it is a massive system so it takes time. It takes time to change it at the root, at the fundamentals.
Brian "Ponch" Rivera:So you brought up an upcoming date. We'll try to get this podcast released before then I think it's August 11th as FDA is looking at approval for MDMA AT, which is MDMA-assisted therapy, and I got to note a letter here actually in front of me that went to President Biden, vice President Harris as well, and it says Phase 3 clinical trials of MDMA-AT resulted in 71% of participants no longer qualifying for a PTSD diagnosis, 71% right 86% of the participants experiencing clinically significant improvement in their symptoms. So this is in a letter that went to the president of the United States signed by many, many veterans in the last couple of weeks. And again, the president doesn't have anything to do with the approval of the FDA approval. Can you tell us what you're sensing coming out of the? I think we had a little bit of a rough, is it ICER? Did I get that right a couple of months ago?
Maria Velkova:ICER and the FDA advisory committee.
Brian "Ponch" Rivera:Yeah, yeah. So can you kind of give us your perspective on what you think is going to happen in the next couple of weeks?
Maria Velkova:Oh gosh, if I had a crystal ball. But I can give you my perspective based on all of the data I do have. So just for a little bit of context typically any drug that goes through the FDA approval process, any drug from Big Pharma, from psychedelics the FDA appoints an independent advisory committee of experts to look at the submission, the clinical data that was submitted, and to give their opinion. Now the FDA doesn't always have to follow, they don't have to follow the advisory committee recommendations. They can make their own assessments. So for psychedelic-assisted therapy and more specifically for MDMA-assisted therapy, which is closest to approval and it's currently this year, has been reviewed by the FDA. That advisory committee happened about two months ago. That happened. That advisory committee happened about two months ago.
Maria Velkova:Everyone has been so excited because I'm not going to repeat the results but typically with the current drugs antipsychotics and SSRIs less than 20% 25, depending on which statistics you look at percent of patients actually receive any benefit at all. And the 71% that you said lost their diagnosis of PTSD. That can be analogous to remission in oncology. So the cancer could come back, but it's not there any longer for a long time. So this is what MDMA assisted therapy resulted in for patients that were in the clinical trials and we are having the long-term follow-ups to show for how long they didn't qualify for the PTSD diagnosis but it's anywhere between six months to 12 months and for some people even longer.
Maria Velkova:So the big surprise was that during the advisory committee actually the sentiment was very negative. Now, a lot of very good feedback was shared. I don't want to discredit that, but I think the focus of the advisory committee was not at the bottom line here. So one of the main issues that the advisory committee raised was around the placebo effect, or being aware whether you're on MDMA or not. The way that the clinical trials were ran was that one of the groups of patients received MDMA-assisted therapy. The other group of patients received placebo, basically no pharmaceutical treatment and just therapy.
Maria Velkova:So it's quite Because these are consciousness-expanding compounds, you can definitely tell if you're on a psychedelic or MDMA or not. So this unblinding in the clinical trial meaning patient can guess whether they're on the drug or not one of the main critiques that almost like overpowered the entire. You know it's a full day discussion between these experts. Now for me, you know, okay, great. Yes, that could skew the results. However, lycos slash MAPS, who is the company that's developing this therapy? Lycos slash MAPS, who is the company that's developing this therapy? They actually showed in the data that the outcome of the efficacy was so large that actually it could not have been just because the patient and these are people who have been struggling with PTSD for a decade or longer you can't just think yourself into remission. If it was that easy, you know, we wouldn't have PTSD, wouldn't be such a big issue in our in our world.
Mark McGrath:So they showed with data. Isn't it worth pointing out too. You know we're partial to veterans, we come from that world, but trauma and PTSD is not limited to veterans by by any means. There's, there's I don't know postpartum depression, there's sexual assault trauma.
Mark McGrath:there's wide categories of trauma that it really does help a wide I mean the band of people that can be helped is you know, veterans is a huge, obviously a huge chunk of one that's very near and dear to our hearts, and there's, there's a lot more, and so so people's understanding and awareness would be would be well served, I think.
Maria Velkova:Yeah, definitely. And the trials for MDMA assisted therapy of course included a lot of veterans, but also sexual assault victims as well, so it was a diverse patient population that went through the clinical trials. So, yeah, I mean, I'm a trained scientist, I'm trained as a scientist, my orientation, like you guys said, is a scientist and I was in the pharmaceutical world and so I know that it is important. The scientific method is important for a reason to be able to truly say whether something worked or not, and you know the no hypothesis etc. But you know, the funny thing is that in big pharma, something called real world evidence, which means evidence or data from the real world outside of a clinical trial, from everyday life, is the holy grail. It's so important to have real world evidence. If you call it anecdotal evidence meaning it wasn't originally a therapy, wasn't originally researched in a clinical trial, but like that data is coming from real world experiences of people, it's like, oh no, that's not good enough. Okay, it's pretty much the same thing, we're just calling it different words. But either way, these trials did not only have you know evidence from the real world, these trials had evidence from controlled clinical settings, which is the standard of getting a drug approved by the FDA. But the advisory committee, you know, picked so much on the clinical trial design which, by the way, was designed in partnership between the FDA and MAPS slash Lycos. The FDA said, okay, this is the trial design that we're using. And they picked on the trial design so much for such a big percentage of the advisory committee meeting of the day that it's like, do we care that they might be unblinding or do we care that 71% of patients went into remission. These are patients who, again, for decades, have not had relief from PTSD at all. So I feel like, you know, that's why psychedelic assisted therapy is a catalyst into how do we actually look at health care, because it has shown really substantial true science proof, scientifically efficacy and and really great results for for these patients.
Maria Velkova:So there was a lot of negativity around the advisory committee. There's still a lot of stigma and trauma and you know, if we look on any layer of our human existence personal or in our family, or in our community or in our whatever system, healthcare system change is scary and change is hard and change takes a lot of commitment and it doesn't happen overnight. You know, if you try to change your behavior. But like for addictions, for example, like it's, it's scary because, like you know that the alcohol or whatever the person is addicted to, shopping food, it gives them comfort, it provides a safe space because they're so used to it and getting off of that is scary. Or changing a job Even changing a job, even moving to a new city, change is scary and it takes time. So I'm not surprised that a lot of the experts on the advisory committee were still stigmatized. This is a very new approach to therapy, so there was a lot of negative comments. A lot of people were very shocked and disappointed that we didn't look at the big picture and the bottom line, which is, you know the percentages of the efficacy and the results that you mentioned, but this is still not you know the final results.
Maria Velkova:So on August 11, the FDA will consider all of the data, it will consider the advisory committee recommendations, it would consider ICER's recommendations, it would consider everything that has been presented about MDMA-assisted therapy to make that decision and there's three possible outcomes. One, it gets approved, which means that a trained professional can prescribe this nationally for PTSD specifically. Two, they can say no, it's not approved and that's it, which would be a really really big loss because the unmet need for these patients is immense, there's no other therapies and because behavioral health, psychiat, psychiatry and mental health are such difficult conditions, because maybe we're looking at them wrong or have been looking at them wrong big pharma is not developing any drugs for these ailments. So what I think personally with my lens of experience and I cannot I don't have a crystal so I can't tell you what the outcome is going to be but I think a straight up no is extremely unlikely and if there's a straight up no, it would be extremely disappointing to a lot of people who are suffering. Believe that the outcome will be a straight up no because, again, as I mentioned, the MDMA assisted therapy trials were designed together with the FDA, though FDA is on board.
Maria Velkova:I have spoken with the leadership team of Lycos and also with Rick Goblin, who is the main person who started this whole 40 year long process of getting MDMA approved, and they've spoken to FDA.
Maria Velkova:You know that's normal for any drug developer to be in communications with the FDA to make sure that they're doing what they're supposed to do in order to increase the probability to approve these therapies.
Maria Velkova:So I don't think it's going to be a straight up no, there is a small chance it could be just a yes. I think the most likely scenario will be maybe they need more data. There were certain things in the trials that could have been improved, but this is the first team, the first psychedelic assisted therapy, going through this process, so there's a lot of learning involved, and so I think the most probable outcome is that the FDA might ask to do another phase three clinical trial where they take into account they meaning Lycos takes into account all the feedback of how the trials can be improved to make sure that everything's like great, but it doesn't necessarily need to be in an actual phase three trial. A lot of this data that was missing on on the safety, for example, or like these small little tweaks this can be done post launch, meaning after approval, as well, so there is a chance that it could be um, it could be a yes, but I guess we're gonna have to wait and see.
Mark McGrath:I mean, you're a scientist and we've heard the phrase in the last couple of years trust the science. The science is settled. As you know, science is always meant to be challenged and developed and in this case, with this particular therapies, I mean, the science is overwhelming, right, the support for helping people, you know, and if I was going to explain to a non-scientist, I would explain that this is actually, you know, the evidence is overwhelming that this, this helps people, you know, resolve their trauma, as you say, go into remission important point to mention is science in the way that we practice.
Maria Velkova:It is a man-made you know, we, we created science which is the study of, of of some of the natural world, or or of of a disease or something like we. We created that um and uh. Our science is limited by our tools and understanding and our knowledge. Science evolves with the evolution of discoveries. It evolves with our tools getting better for measuring stuff. I always like to say you know, before we can, us almighty humans could measure and use x-rays in a medical setting.
Maria Velkova:Yeah, x-rays have been there since the beginning of eons, you know, like since the beginning of time. The x-ray is an energetic wave. Before we could measure it and then manipulate it for healthcare purposes, x-rays were there since the beginning of time. So just because we can't measure something yet also doesn't make the science is absolutely, completely right. We've we've come up with a system to measure things in a way that is, um, uh, very helpful and important, uh, to to say whether something is true or not. Well, it's not even true or not. The know-how hypothesis means that this could not be disproven. It's not. This is an absolute truth.
Mark McGrath:Um it's evolving, so right, yeah, and it evolves.
Maria Velkova:It evolves with our tools and I think we know so little about the brain itself, like the material, the structural signaling pathways in the brain and neuronal connections and which parts of the brain. We know very little about the mind. You know psychiatry. We know very little about that In the intersection of both. Literally no one knows how that happens. No one knows how serotonin signaling in the brain creates human experience, and we're starting to learn that to our earlier points.
Maria Velkova:Psychedelics are really helping us to understand that with, you know, the default mold network. You know babies are born tabula rasa, clean canvas. We condition them to exist in a certain way as humans in our modern world. So that's thought, that's put there, and then we start living our lives from this autopilot existence, which is very important for survival. We can't be going outside of our house and thinking like, am I going to get killed by a lion in every moment of our day? Because that's yeah, what kind of life would that be?
Maria Velkova:But actually, you know, going back to veterans and PTSD more generally, that's what people live in. They live in a state of like constantly being afraid for their life and their survival. So, yeah, like our understanding is evolving, but it's much bigger than just like, oh, there's too much serotonin or there's too little serotonin. It's so much more than that and we're only starting to understand how all of that interconnects. Now Just to like touch on the point of science. But to your point, yes, these trials were done in the most scientific way and they have shown positive, extremely positive results.
Mark McGrath:Overwhelmingly so, overwhelmingly so. So, as we close here and we encourage people to have a you know, as you say a clean slate, a clean canvas in their mind and open up and and make the effort to learn more about these things, what are some of the uh resources that you would direct people to to go and and learn more and uh, crunch their learning curve on? Uh, on the wider use of psychedelics.
Maria Velkova:Yeah, I mean, there's a lot of opinions out there and there's as many opinions as there's humans on this planet, because our blueprints are as different as our experiences and no two humans have had that same exact experience. As a scientifically trained person, I really look uh, I, I really look to peer reviewed articles. You know something that's scientifically proven or not, or like at least being researched in a, in a, in a scientific manner? Um, so peer reviewed journals. There's a lot of papers being published. They're very difficult to read. So actually one of my favorite resources is Psychedelic Alpha. It's a very, very sort of balanced reporting on the psychedelic industry, on the psychedelic research, on every aspect of it. Psychedelic research, um, on every aspect of it. Um, josh hardman is is someone who I really respect and the way he writes and it's um, uh, you know there's it's difficult to write from um in a non-biased way because we're naturally just biased, like to our own experience. Um, but psychedelic alpha is definitely one awesome source. Um, there's tons of podcasts out there, um, that are really awesome. Um, you know Andrew Huberman from, from the big, big podcasters like Andrew Huberman, um, he doesn't only speak about psychedelics but, um, he has a couple of really awesome podcasts to talk about how these things work. And, yeah, again, my go-to is Psychedelic Alpha. There's other sort of media like. Double Blind is a really incredible resource. It's a magazine about psychedelics and they have a very different sort of lens of reporting, but it has a lot of integrity. They're reporting there. Also, lucid News is another very well-balanced resource where people can learn more and more about the psychedelic space, and Ken Jordan, the founder of Lucid News, rest in peace. He actually passed away recently.
Maria Velkova:No-transcript, well, and of course, we want them to go to your website as well, so we'll have links to those. Yeah, my LinkedIn I'm pretty active. I do share a lot of articles and you know our link with the AIs and everything. Our LinkedIn or Instagram or social media is primed for seeing certain content and I've been priming mine for like five years, so I get to see a lot of the great knowledge sources in media, so I share that a lot. So, maria Velkova, on LinkedIn, instagram as well, maria V Velkova, that's a little bit of a different lens. Linkedin is my business, purely my business cap on. But you'll see my very diverse interests on my Instagram. For example, I love creative costume design, so I don't only post the scientist business stuff, but also some more fun stuff. I share a lot of accounts, different accounts that dive into more kind of like self-healing, really positive messaging as well, really profound stuff. I share books. There Again, the Myth of Normal by Gabor Mate. This book is like I can't even put it down. It's so great and it explains.
Mark McGrath:Put that one on the list and it explains in a great way yeah. And then, of course, we'll link to a tabula rasa link and also uh. Energia.
Maria Velkova:On tabula rasa you can see the companies we invest in Um and also on Energia, you can check out some of our impact initiatives globally that I mentioned at the beginning of the podcast. So yeah, those two.
Mark McGrath:Awesome. Well, hey, we want to thank you for coming and spending time and talking about this with us, Maria, we really appreciate it. Yeah, thank you.
Maria Velkova:My pleasure. Thank you, guys, and thank you for your work, yeah.
