Project Psilocybin and the Future of the Psychedelics Industry
During The PSYCH Symposium in November 2020, a panel of leading experts,operating in psychedelics sector discussed the advancement of research on psilocybin.
The groundbreaking, rapid progress being made in a number of regions across the US and beyond, the panel examined the realistic steps being taken towards the development of psychedelic treatment centers and how the business world is preparing for it.
The panel featured:
Sara-Brittany Somerset, United Nations Correspondent, Global Drug Policy Analyst
Olga Chernoloz, Chief Scientific Officer, Wake Network
Matt Emmer, Director Of Operations & Business Development, Field Trip Health
This article contains selected highlights from the presentation as well as a selection of extracts taken from the discussion.
How Did You Enter The Psychedelics Industry?
I’m the Director of Operations and business development at Field Trip. But I’ll start with a personal intro. It was about eight years ago, that I first did personal work with psilocybin. And in that work, you notice recognized how incredibly transformative it was for me personally. But ever since then, I’ve been really looking towards opportunities to be able to share that benefit and the impact that it has more broadly. And my professional background hails from finance, business investment, but it’s really ever since eight years ago that I’ve been looking towards, really when things would open up enough for psychedelics and psilocybin to be made more available to a wider audience.
And that’s what ultimately led me to field trip health and field trip is really working to read the client mental health and well-being through our groundbreaking work in psychedelics and psychedelic enhanced psychotherapy. What we found is that existing mental wellness offerings have failed far too many people.
So, through our purpose-built health centres, and advanced research on plant-based psychedelics, our mission is to really help people with simple evidence-based approaches to heal and heightened engagement with the world. And an important note here is that while we’re building the infrastructure, we’re really building it in a way that delivers the treatments as effortlessly as possible.
Given that psychedelics are nonspecific amplifiers of consciousness, even minor environmental factors influencing a setting can have a big influence when undergoing treatment. So, what we’re really doing is trying to build purpose-built centres that will be able to deliver these healing modalities in the best possible way to our clients and patients.
Hello, everybody. I’m very pleased to join PSYCH today for this panel. I’m Olga Shernoloz Chief Scientific Officer at Wake Network, a vertically integrated medicine company focused on treating the most critical mental health and wellness issues that are so hard pressing, especially today in our industry, leading cultivation and clinical research teams are grounded in science and everything. Every single step in our operations is science-backed and science-driven. My background is in pharmacology, I’m a neuroscientist with a background in neuropsychopharmacology. So, this particular type of work is 100%. What I’ve been preparing myself, for I’ve worked for many years, Vietnam, teaching mental health, hospitals, working with a very difficult clinical population.
When I started seeing their research coming from the new wave of psychedelic clinical work, I could not believe myself of how promising it looked. And when I saw this data, I knew that I had to join this way, and creative and more evidence-based data that would harm our physicians with the knowledge and tools, so much needed to how clinical population who often is underserved by currently available options.
The New Wave of Scientific Data
We probably all know that back in the 50s, 60s and all the way up to 70s psychedelics were enjoying quite a prominent place in both medicinal and counter cultures. In reality, thousands of patients went through clinical trials back in 60s. Psilocybin and LSD were produced by pharmaceutical companies and were available as pharmaceuticals. Their research done back then was terrific in a way that it showed us the potential that these substances carry.
Back then it was mostly used for addictions. And we know that these substances, psychedelics carry incredible potential for helping people out of the addictive cycles. However, because of the way that the research was conducted, and especially because of the politicizing the cultural side of use of these substances, they were banned in 1971. And for a couple of decades were banished from the clinical research team. Back in 1999, the research into potential psychedelics started its revival in several key academic centers in the United States, European University, and john Hopkins university, who have carried out some incredibly important and very prolific studies with psilocybin and other psychedelics. So, now, in 2000s, we can say that it’s a revival and renaissance of the psychedelic research.
I think the sort of reemergence that we’ve seen in psychedelics is the result of a few converging trends. First, I think the increase in awareness of the importance of mental health globally, we see this in the rise of different preventative health measures and mindfulness more broadly, in conversations around, normalizing depression, and anxiety and many other mental wellness considerations. I think the second factor is the incredible acceleration of the global health, mental health crisis overall, and the cost that it’s had to our society, and the quality of life, that mental health conditions are causing for so many people.
And I think a third point here is what Olga, spoke to is that the research on psychedelics, which has really been advancing at a rapid rate over the last 15 years, and particularly just in these last few years, is really demonstrating incredible results. And anyone that looks at those results recognizes that there’s true potential to help, I think, a great number of people, but particularly people who haven’t been adequately served by existing offerings.
And I think that this is also coming in, following the global country acceptance of cannabis. And certainly, the impact that once stigmatized medicines, particularly plant-based medicines, are now being reevaluated across the globe and are sharing great promise. So, I think it’s the convergence of those different factors that have really led to the decrease in movement overall, but certainly, the passage of measure 109 in Oregon, which is really a first step at creating a regulated marketplace, so that licensed companies and individuals can provide these healing therapies, modalities to people in safe, professional environments.
Psilocybin Production & Applications
To be honest with you, to me as a pharmacologist, the molecule is a molecule regardless of how it is derived. But for many people, there is a definite benefit to using the naturally-derived compound, especially if they can be certain that it has been produced to the highest quality standard and that their safety is being thought of in the process. So, to me, the molecule is a molecule, but if we can produce in organic matter, the same compound, I think it might be better options for many consumers.
And my previous question was, how long can you continue to micro dose before you need to give your brain a break? Do you recommend one day on one day off? Or two days off two days on etc. What is the standard protocol for implementing psilocybin?
So, there are several standard protocols. And again, probably is the case because there has been no research in this field, and it hasn’t been optimized and it’s one of the other things that wake network is working on. So, we are working to test these different protocols, once that are circulating the internet and some other ones to see what might actually be the best dosing protocol. And whether it varies by the type of condition that you’re looking to gain through micro dosing. So, it’s very much in the works. But overall, I think it’s not just how frequently do you dose but how long do you continue micro dosing for. So, in my personal recommendation, I would not be micro dosing for a year without any breaks. So, I think three months on, couple weeks off would be a good idea. But for now, just sit tight and let us do the research and we’ll be able to give you the evidence-based data to tell what would actually works best.
I can’t wait. What some say psychedelics, anecdotal evidence supports that there is a low period that’s equally as low for the uplifting period, for example, taking MDMA will make you feel really good in the moment, but then you might feel a depletion of serotonin afterwards in which you become maybe more depressed. Do you think there’s a way to streamline these psychedelics so that you can minimize the downside and the adverse effects?
Sara Brittany, it’s not gonna be the same for every person who consumes it because we all are different, and our neurobiology is different. There is definitely room for improvement. And for some of the compounds that we are discussing and talking about, the ups and downs are more pronounced. Typically, with psilocybin there is less of a off period than, say with MDMA. But there is definitely room for improvement and through research and through probably medical chemistry work, we can see if we can truly tweak it or find some natural ways to remedy this problem.
Therapeutic uses of Ketamine
Field Trip has chosen to focus initially on ketamine. Can you tell us a little bit about the differences between ketamine and Esketamine and why field trip chose ketamine as its main modality for the time being?
Yeah, certainly. And just returning quickly to the last question that you posed, as Olga mentioned, that the different psychedelics are different, MDMA is known to have that recovery period afterwards, I know that anecdotally, as well as the research that Olga mentioned that psilocybin, as well as ketamine, tends to have less of that effect. So, I think a lot of people report with both ketamine and psilocybin that the days following are actually highly elevated, that I think the recovery period; it can be present, but I think it’s something that requires further work.
And especially if people have adequate support, and rest afterwards, doesn’t necessarily have to be part of the treatment experience.
As for ketamine, and Esketamine, it gets a little bit more technical. So, ketamine is a Chiral molecule, which means that there are two mirror images of the ketamine molecule, the R-ketamine and the Esketamine, the best way to explain that is you have your left hand and right hand, which look essentially identical, but they’re not the same, the same way that you can’t put a right glove on your left hand. They’re mirror images of one another. So, Esketamine, which was FDA approved through Spravato is the Esketamine, it isolated only, for instance, the right-handed side of the molecule, whereas the ketamine that we’re using has equal proportions of the two different molecules, the left-handed molecule and the right-handed molecule.
I think one of the main reasons for Spravato FDA approval process with the Esketamine is that ketamine has been used in hospitals for decades at this point. So, it’s a generic drug, you couldn’t necessarily develop the patent on it. It’s widely available for anyone who’s able to prescribe it. So, then Esketamine provided the opportunity to actually do the studies, go through the FDA approval process and then have intellectual property around the Esketamine So, one big difference between the two is as a result, that Esketamine Spravato is far more expensive to use in treatments than generic ketamine and then the other side of it is because it’s FDA approved, some insurance will reimburse and cover treatments of Spravato and Esketamine.
Our approach is to use the regular ketamine, they’re still researching it, there’s no evidence that Esketamine works better, or is more beneficial than regular ketamine. So, our view is that regular ketamine provides additional flexibility, especially since we’re looking to use it within a psychedelic medicine framework. So, rather than merely being a bio medical treatment, which the Esketamine spravato treatment is based off of. We are really trying to deliver a biomedical, psychosocial, integrated treatment approach, which is the basis of psychedelic medicine. And for our patients, we provide out of network insurance reimbursement coverage, that doesn’t cover the ketamine, which is relatively cheap, the medicine itself, and then we’re kind of shifting, we’re charging towards, the psychotherapy, the psychiatric consultation, which a number of our clients patients are able to receive insurance reimbursement for.
How to Help the Psychedelics Industry Progress
MAPS is the Multidisciplinary Association of Psychedelic Studies. And they’re the group that’s really spearheading workaround MDMA, as it applies to PTSD. And they’re currently in phase three FDA trials with MDMA for treating PTSD. And at this point, recently, they did a study looking at the cost of the MDMA assisted psychotherapy versus other prevailing treatment options for PTSD. And I think another important note here to make about psychedelic medicine is, it really aims to work to get to the root cause of some of these elements.
So, then you look at some of the studies done with the MDMA trials and existing treatment options seem to have less than a 15% effectiveness around relieving symptoms, whereas the MDMA trials are above 50%, on actually curing PTSD, meaning that people aren’t just coping with PTSD symptoms. But when their follow up, questionnaire is done, they no longer qualify for meeting the conditions of PTSD. So, as a result rather than needing to continue to take a pharmaceutical center on a weekly basis, or even on a daily basis, individuals are able to go through these treatment approaches, and hopefully not need to stay on ongoing treatment methods. So, from an insurance payer perspective, that means it’s more expensive upfront, because it involves both the medicines themselves, but also very intensive therapy, which is, I think, a core point or core part of these treatment approaches.
So, as a result, it’s difficult for insurance companies. The study that came out recently, and even backing up what the study says is that over a 30-year period, individuals treatment, would be expected to cost roughly $100,000 less using the MDMA therapy versus existing prevailing treatment options?
And the break-even point is that 3.1 years, and I think what’s fantastic about that there’s is now evidence and data showing that not only does this seem to work better at treating PTSD, and we hope that similar data and research will come out with psilocybin and other psychedelics, but that it will also be cheaper in the long run.
So, now you have a health benefit, you have a wellness benefit, and you also have an economic benefit. And I think what’s going to be so important is doing additional studies like this to make that case. And my sense is that it’s only a matter of time before, this is more widely accepted. I think that, one example is that even traditional therapy wasn’t previously covered by a lot of the insurance companies. And then a lot of data research was showing how helpful that is for individuals, that’s now covered by a lot of insurance companies. So, I think it’s a matter of time before psychedelic therapy is widely covered and that’s certainly our hope at Field Trip.
And I couldn’t agree more. And I think it all comes down to putting through these treatment modalities, putting them through scientific and clinical rigour required by their regulatory bodies. And probably even more so than for any other compound considering how much negative connotation, these compounds carry with them through the decades of prohibition. But in reality, from the data coming from these clinical trials, now, it appears that psychedelics, especially classic psychedelics, like psilocybin have exceptionally great safety profile, they are not addictive substances, people who use them for therapy, and especially in the clinical setting, with proper observation, the most frequent adverse events that they experience is increasing blood pressure, and it’s typically self-resolving. So, it’s a meditation class with a great safety profile. And I think once it goes through the regulatory approvals and is seen as a treatment option for the clinical community, the insurers will see the benefit on not only on the clinical side, but on the socio-economical side as well.
And I think that coverage by the insurance companies is only a matter of time and actually getting the approvals to these drugs in the first place. And I think that the approval of these medicines is not that far removed in reality, because the weight of the data coming from the clinical trials is such that even FDA has fast-tracked the approval of psilocybin through their breakthrough therapy designation, which means that the two companies now running their trials with psilocybin for various modalities of depression. And they would be able to run their trials in somewhat expedited way, it doesn’t mean that it will be any less rigorous, but it means that they will have more support from the FDA to actually put it through.
Yeah, and I think an important point here is the importance of education at all levels. I think we’ve spoke to in a previous conversation was that, when these substances were labeled schedule one, it was largely for political rather than scientific reasons. There was never strong scientific data to support that classification. So, now the research is more just returning to, I think recognizing scientifically with the data and research, really how these substances can be used beneficially.
And, that said, I think a lot of damage has been done in terms of the stigmas over the last few decades. And it will take time to reeducate individuals. I think that’s the broader population and society, but it also includes medical professionals, the insurance companies that we spoke to, and one anecdote,
I think that’s helpful to share is, here in our New York clinic, we’re doing ketamine assisted psychotherapy. And even, ketamine has some stigmas out there. So, one of our clients who came to seek treatment, prior to beginning treatment, our psychiatrist here spoke to that client’s existing psychiatrist, and that psychiatrist was initially a little bit sceptical about his patient seeking out ketamine assisted psychotherapy, but after the call between our psychiatrist and other psychiatrist, he actually said, Wow, I had no idea that there was a stat and research and after viewing the papers, he actually said, you know, what, not only I am supportive of this current patient coming, but I might actually send other patients to your centre, because this is really illuminating for me to actually recognise that this data exists and here are the results they’re being shown.
So, I think that’s such a classic example that even a lot of professionals in the medical field aren’t fully aware of this opportunity. And it’ll be important to educate on that front.
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