In 2020, the University of Wisconsin–Madison School of Pharmacy created the Pharmacy Experts Webinar Series to share the broad and deep knowledge of the School’s faculty and alumni who are researching and practicing at the top of their fields. In fall 2022, the School hosted its sixth installment, focused on the development of psychedelic therapies.
Watch as Associate Professor Lucas Richert, of the Social and Administrative Sciences Division, and Professor Paul Hutson and Assistant Professor Cody Wenthur, both of the Pharmacy Practice and Translational Research Division, discuss where psychedelic research is today, what projects are underway here at UW–Madison, and how the role of pharmacists factors in.
Professor David Mott: Good evening, everyone, and welcome to the sixth installment of our Pharmacy Expert Webinar Series. The title of our webinar tonight is Psychedelic Medicine, Pharmacy and Society. I want to thank you for taking time this evening to join us for this webinar on this very interesting and important topic that will describe the ongoing study in clinical testing of psychedelic substances, including significant health conditions.
The UW School of Pharmacy is at the cutting edge of this area of research and practice through the establishment of the UW–Madison Transdisciplinary Center for Research in Psychoactive Substances and the establishment of the Psychoactive Pharmaceutical Investigation Master of Science Program.
The implications of psychedelic medicine for pharmacists and pharmacy practice as well as the role of advanced training in this area will be discussed.
My name is Dave Mott, and I am the associate dean for advancement at UW School of Pharmacy, and I will host tonight’s webinar. This event is being sponsored by the UW School of Pharmacy Advancement Office. I want to acknowledge and thank Alissa Karnaky, our alumni relations and advancement coordinator, and Anna Reinhart, our event coordinator for their work, marketing and producing this event.
We have over 200 people signed up to join us for tonight’s webinar. Before we get started, I want to describe the process we will use for taking questions. First, the chat function is turned off for attendees.
Second, due to the number of attendees, we will not be taking verbal questions. Instead, please use the Q&A feature on Zoom to type and submit your questions as you think of them. Since some of the questions may be the same across individuals, please feel free to click on the thumbs-up icon to up vote for a question. Then during the Q&A session, I will read the questions with the most upvotes for the panelists to answer.
The webinar is being recorded and we will send you a link when the recording is available. We also will be sending you an evaluation of the webinar. So let’s get started. Our webinar presenters this evening, are Dr. Paul Hutson, Dr. Cody Wenthur, and Dr. Luc Richert.
Paul Hutson is a professor at the UW School of Pharmacy and is the director of the UW Madison Transdisciplinary Center for Research and Psychoactive Substances and an associate member of the Paul P. Carbone Cancer Center. Dr. Hutson completed an oncology pharmacokinetic fellowship at St. Jude’s Children’s Research Hospital in Memphis. He is board certified in oncology pharmacy. Dr. Hutson’s present clinical research is focused on the safety and novel therapeutic uses of psilocybin and other psychoactive medications. These include the study of MDMA for PTSD and psilocybin for depression and substance use disorder. Dr. Hutson holds an FDA investigational new drug exemption for psilocybin as well as other necessary states and federal possession authorization.
Dr. Richert is an associate professor at the UW School of Pharmacy and a historian of medicine and pharmacy who focuses on legal and illegal drugs, drug science and technology, pharmaceutical pricing and policy and mental health. Dr. Richert holds the George Urdang Chair in the History of Pharmacy within the UW–Madison School of Pharmacy, and he is housed within the Social and Administrative Sciences Division and mostly teachers within the School of Pharmacy. His books today have centered on the pharmaceutical industry, regulation, and the Food and Drug Administration. See A Prescription for Scandal, the boundaries that separate all manner of legitimate and illegitimate drugs, such as LSD, heroin, and amphetamines. See his book, Strange Trips, radical mental health and social professional movements in the U.S. Again, see his books Break on Through and cannabis as an intoxicant and therapeutic substance across the planet, see Cannabis: Global Histories.
Cody Wenthur is an assistant professor of pharmacy at the UW School of Pharmacy and director of the first of its kind, Psychoactive Pharmaceutical Investigation master of science program at the School of Pharmacy. Dr. Wenthur’s research focuses on ways to improve mental healthcare through the development of new therapeutic treatment approaches, specifically those that include opioids, dissociative hypnotics, psychedelics, and cannabinoids. His research is motivated by the staggeringly high reported rates of depression, anxiety, overdose and suicide, inadequate access to treatment and the failure of current therapeutic models meaningfully improve the daily life of those who dearly need it.
Thank you to our three panelists for joining us tonight.
Now it is my pleasure to turn the program over to Dr. Luc Richert, Luc?
Associate Professor Lucas Richert: Thanks to Dave Mott, Anna Reinhart and Alissa Karnaky for being involved in organizing this. And this is really an honor I think I can say for Paul and I to share with you as well as Cody some of our ideas.
I’m guessing you are here because you have an interest in the compounds, substances and plants that constitute what is now an emerging psychedelic industry. You’ve likely heard about this psychedelic medicine on the pages of the New York Times or in the New Yorker or in Scientific American. Maybe you’ve seen Michael Pollan’s book How to Change Your Mind, or seen the documentary on Netflix.
I’m really looking forward to talking to Cody and Paul, who I have the pleasure of working with in the School of Pharmacy about a variety of different topics today, including clinical practice, some of the curricular offerings within the School of Pharmacy, some of the ethics involved in this emerging space, maybe some of the gaps in training, as well as some industry opportunities.
And we’re also as we have this conversation and address some of your questions, we’re going to try and get to grips with why this matters big picture for health, for the economy, and for the profession of pharmacy.
So Cody and Paul, I invite you whenever you’re comfortable to turn your cameras on and it’s nice seeing you. I hope you’re well.
Professor Paul Hutson: Doing well, thank you.
Assistant Professor Cody Wenthur: Getting there.
Richert: So Paul, I wonder if we could start with the story of the center and maybe just give us a big-picture overview of the center, and then after that we can maybe unpack the story of the PPI program as well.
Hutson: Sure. Thank you, Luc, and good evening, everybody. So the Transdisciplinary Center for Research and Psychoactive Substances was born about a year and a third ago, August last. And the reason that we put this center together was so that we could better identify and draw upon the resources of the University of Wisconsin–Madison campus, as well as other individuals and organizations within the state of Wisconsin and even the region to try to promote and further the research and scholarly work being done on psychedelics.
We have several studies going on now, and we had several studies going on at that time with psilocybin and MDMA for the treatment of PTSD in that case. And so the center did not precede our involvement with psychedelics. In fact, we did the first phase I, dose-escalation study in pharmacokinetic study in the United States, with psilocybin several years ago. But we felt that by creating the center, we would have a better, an itis if you will, assured resources, a resource for individuals on campus to take advantage of our expertise and just the availability of the formulation expertise at the School of Pharmacy, as well as some of the regulatory issues.
We first tried getting it approved, and we’re approved as the Center for Transdisciplinary Research and Psychoactive Substances. And then the chancellor’s office at the last-minute noticed that the acronym for that was WISC TRPS. And so we were asked if we would change the name to the Transdisciplinary Center instead.
But we are excited about the center. We’ve had two well subscribed, in fact sold-out symposia, one just ended last week, psychedelic symposia here on campus with experts from on campus and around the country, even from Canada, talking about the science and the cultural implications of psychedelics and antigen such as MDMA.
So we’re really excited about the future for the center, and I’m looking forward to working with Cody on the master’s program and with others on campus as well.
Richert: Thanks, Paul.
Wenthur: Yeah, so I’ll pick up the story there. Likewise, from the PPI side, as we affectionately call it, which stands for Psychoactive Pharmaceutical Investigation, we’re excited to work with the center. The PPI program really has two arms. There’s a master’s of science in pharmaceutical sciences with a focus in psychoactive pharmaceuticals.
And then there’s also a graduate certificate program that is a smaller subset of the courses. And the story of how those came about was really recognizing that we have, you know, over a century of expertise in training in the pharmaceutical sciences and advanced graduate education here at UW Madison, and indeed have been educational innovators in this space throughout that long history.
And so it was wonderful to see the expansion of some of our offerings into this professional master space with the deployment of the accelerated drug development master’s degree that continues to be an offering that the school has. And really, I think of the PPI program as a sister program to that advanced drug development program and an extension of lots of the principles that have been part of the School of Pharmacy for a long time.
Some of those principles that are really important to me and really, I think, set the program apart are that it is a highly interdisciplinary curriculum. So we are trying to develop and generate students who are going to make their way into critical roles, critical leadership and support roles within the psychedelic pharmaceutical industry as well as cannabis industry. And in order to do that in a way that reflects the complexities of this space, the curriculum includes not just content on drug development and project management but it also includes information on clinical applications and a strong focus on history and humanities, including ethical concerns that are coming in this space.
And I’m really happy to say that we’ve attracted in the three semesters that the PPI program has been out there, we’ve attracted an excellent cohort of students from a wide variety of backgrounds. There are many PharmDs in the program, but we also have nurses with varying nursing degrees, lots of psychiatric nurses. We have MDs, we have folks coming from biology, chemistry, psychology backgrounds. We have folks coming from a historical background and even JDs. And I think this is reflective of the fact that we’ve put together a curriculum that really provides, you know, that capstone, that additional highly specialized knowledge that someone can take and put on top of the degree that they already have and be an important player moving forward in the psychedelic pharmaceutical industry.
And we’ve got more than 50 master students and more than 20 capstone students at this time. As Paul said, we just finished up our symposium, and a really good chunk of those students made their way to the symposium. This is a course that can be completed, a degree rather, that can be completed entirely online if they want. Although certainly we do have students in person who we love to see.
But that symposium was an amazing time to see many of these students in person networking with the context we’ve got and the faculty on campus, so.
Richert: I mean, of course, it’s music to my ears that the humanities are built into this program. For those of you who are alumni listening, the history of pharmacy class has been part of the history of I mean the history of the School for over 100 years. And so there’s a long tradition of history being sort of embedded within curricular offerings within the School of Pharmacy.
And but I won’t belabor that. Instead, what I want to do is turn to some of the substances that you’ve already referenced, Paul, and maybe get you to reflect a little bit on some of the highlights or some of the sort of the early results with psilocybin that our audience should be aware of. And Cody, if whenever you feel you want to add your knowledge to this as well, please do. And not only psilocybin, maybe I can invite you to reflect on MDMA as well.
Hutson: Sure. Thank you, Luc. So first of all, when I first entered the space, I thought I was going to be dealing with a highly addictive substance because I grew up in the “this is your brain on drugs” generation. I was surprised to find that there really are no data for humans or animal trials that suggest that LSD or psilocybin are addictive in the way that we typically classify or define addiction. And instead, the data that initially were coming out in this new generation, if you will, of clinical research from New York University and Johns Hopkins painted a picture of remarkable response to individuals from a very limited number of doses, if not one, then maybe two or three, separated by about a month. And what the recent publications have shown in phase II and even phase III studies is remarkable.
There are two companies that are trying to develop psilocybin for the treatment of depression. One is Usona, which is in nearby Fitchburg, Wisconsin, and they’re looking at patients with major depressive disorder. And COMPASS Pathways is looking at a more difficult diagnosis, treatment-resistant depression, and they just published results in the New England Journal just a few weeks ago, if not last week, actually. And they found that there was a dramatic response to depression the day after the dose. And the duration of that was a little bit perhaps disappointing compared to some of the earlier studies that in pilot fashion had suggested a more durable effect. But again, they were treating individuals with treatment-resistant depression. And we still don’t know at this point what the effect of multiple doses would be, or higher doses. And so there’s still a lot more to learn about the use of psilocybin for depression.
The FDA petition by both the Usona and Compass Pathways has agreed that both of that psilocybin is appropriate for categorization as a breakthrough drug. And one of the things that this designation does is it basically puts the FDA staff on board to be all hands-on deck to help these companies move the drug forward through the regulatory process, to actually give active advice instead of passive advice for the design of the studies and the interpretation of what needs to happen next. And so there is, frankly, a substantial amount of interest and enthusiasm on the part of the FDA and others. And in my case as well, we have not really found a lot of barriers thrown up by either the DEA or the FDA in terms of moving this research forward. And that’s really gratifying and we’re very appreciative of it.
And then also there’s some really remarkable results coming out of work with substance use disorders, which Michael Bogenschutz at New York University. Before that, he was in New Mexico, this showing that there is a substantial and rapid drop in the number of heavy drinking days and overall drinking by individuals who had alcohol use disorder. And this is with two doses of psilocybin. And also there’s a study that was done by the Johns Hopkins University that showed a dramatic decrease in the number of cigarettes smoked by individuals with tobacco abuse. In fact, these individuals with an average of six failed attempts to stop smoking, had an 80 percent abstinence rate at six months. And it ticked up a little bit so that I think it was nine or 10 out of those initial 15 had a few cigarettes, and there was some creatinine in their urine, but a dramatic effect. And in fact, these individuals went cold turkey without patches or gum, and there were only two or the three doses administered to these individuals. And the results of this study were so remarkable that the F — sorry, the NIH recently granted a multisite study to Hopkins, New York University and University of Alabama Birmingham with Peter Hendricks to do a larger study of psilocybin for the treatment of tobacco abuse.
Now we’ve got some studies underway here based on our expertise with the use of psilocybin for the treatment of opioid use disorder in persons on, or are going to start on suboxone for that opioid use disorder. And we’re really excited to be ready to start a new study looking at the use of psilocybin for the treatment of methamphetamine use disorder.
Cody, did you want to talk about MDMA or did you want me to touch on that?
Wenthur: I’ll let you take over MDMA, but I do have a couple comments I wanted to add on the psilocybin piece, which was just, yeah, Paul’s noting that this is, you know, one to three doses that have relatively durable effects. All the conditions that he mentioned, certainly of great interest in showing significant and in some cases, quite remarkable results. But it’s also important to note that all of these drugs are being administered in the context of strong preparative work with a therapist support during the dosing session itself and integration with that same therapy team afterwards. So I think this is one of the really exciting things for psychopharmacology, psychopharmacy and psychiatry, is to see a new type of intervention or rather reemergence of and a type of intervention that we haven’t thought of in quite some time, and certainly have not implemented on scale, which is use of drugs as adjuvants or helpers for psychotherapy.
And so I think that’s a really important thing to think about when we’re thinking about how these substances are being administered and what the different types of expertise are that need to make sure — that need to be in the room to make sure that we’re doing this both safely and effectively.
The only other thing I would add on psilocybin is just to note one other population where there’s been significant interest and indeed sort of kicked off some of the biggest interest was an area that Paul especially knows a lot about, which is end-of-life care. And so folks who were enrolled in trials at NYU and at Johns Hopkins a number of years ago were enrolled who were experiencing strong anxiety, depression and frankly, existential distress due to a life-threatening diagnosis. And the results in those trials were quite remarkable. And because they’ve been, you know, there’s been enough follow up over several years we also see really strong durability in those cases with something on the order of 70 to 80 percent of patients showing remission from their psychiatric diagnosis, their existential crisis up to four and a half years later for those individuals who haven’t succumbed to their terminal illness.
Hutson: Great points, Cody. And you mentioned MDMA and the MAPS organization, Multidisciplinary Association for Psychedelic Studies based in California has spearheaded work on MDMA, which has also been granted breakthrough drug status by the FDA for the treatment of posttraumatic stress disorder PTSD. And they recently published the results of their phase III study, and they’re putting together their package to send it to the FDA probably next year. Based on results that suggest that as an adjunct to psychotherapy, and again, this is both psilocybin and MDMA are really adjuncts to preparation and attendance by trained therapists that there was at least a doubling of the response rate, the remission rate, if you will of PTSD when MDMA was added to the active psychotherapy.
And one of the things to really remember is that the average individual in these studies had had PTSD for at least 14 years. And so you could consider that to be refractory to the other standard treatments. So the response rate that they had, which wasn’t complete, and none of these indications can we expect MDMA or psilocybin to be magic bullets that’s going to cure or even benefit everybody. That’s not going to be the case, but the responses can be dramatic, and in many cases they can be durable. So we’re really excited about this, but I really need to emphasize what Cody emphasized is, and that is that this is just part of a package.
And that these people whether they’re getting psilocybin or MDMA are being screened for appropriateness, they’re being prepared with multiple hours of intention setting and discussion about their family history, what kind of concerns they’ve got, how they’re going to be actually in this setting and treated. And they’re attended for the entire session. They may have overnight stay at the study site, and then there is at least one debriefing or integration session after the dose, a day after the dose, in some cases, multiple integration sessions to provide the support that these individuals need to maintain that response. So it’s part of the package, and it’s not just as simple as taking a capsule and hoping for the best.
Richert: It’s really important to think through the holistic nature of the therapy. I guess I wanted to make sure that we touched on psilocybin and MDMA as level setting for everyone here, especially since UW has been involved in some of the — from the very beginning examinations and investigations. But can I ask you two to reflect a little bit more, even more broadly on some of the different types of psychedelics that are being explored right now in this space? Just again, to sort of create a more general understanding for the audience of the types of the range of substances that are being investigated?
Hutson: Cody, why don’t you take that.
Wenthur: Sure. Paul, do you mind if I start?
Hutson: No, please, please go ahead.
Wenthur: Yeah, I think one compound that certainly deserves mention is ketamine, which is a compound that is approved as a Schedule III substance. It’s regularly used for anesthetic purposes. It too in its form as the S-enantiomer esketamine gained approval for treatment — for use in treatment-resistant depression back in 2019 but continues to see actually fairly widespread use as the racemate [assumed spelling] and through intravenous injection for the treatment of depression. And has some fairly robust measures now in meta-analyses indicating sort of a unique benefit in terms of suicidality as well, which is quite interesting.
And I think ketamine deserves a special mention because it’s from a pharmacologist perspective, maybe not a pure psychedelic, but certainly plays well in this space in that there are a number of ways that people give it. But one of the emerging trends is that folks are incorporating integration, preparation and other psychotherapies around it. And the other thing that it does that’s quite interesting is ketamine was developed, you know, from the sense that the dissociative properties are kind of adverse effects, right? Things to be avoided, but what it’s really doing is inducing neuroplasticity. And the reason that’s of interest is that psychedelics proper things like LSD, psilocybin, seem to also induce this neuroplasticity.
And so they’re pretty active questions including here at UW through a study that we’re doing called the RECAP study that we can talk about a little bit more about what the relative importance of the neuroplasticity versus the experience versus the combination of both looks like. So ketamine is one I would put a pin in as one to remember on the psychedelic board.
The other compounds that are gaining interest are compounds like DMT, that’s dimethyltryptamine and 5-methoxy dimethyltryptamine. These are both structurally quite similar to psilocybin, although they have different sources and different durations of action, different routes of administration generally. But you’ll see more and more companies trying to develop these compounds.
And then the last compound that I’m going to point out is mescaline. There hasn’t been as much clinical movement on mescaline right now, but there’s some interest I think especially north of the border in Canada. But I think it’s worth noting as certainly both a historical and very modern example of a psychedelic substance that’s being used outside the context of western clinical trials in the form of peyote in the Native American Church and has a long, long history of sacramental use in north and Mesoamerica. Again, in a context that’s quite different than the Western clinical trial model but nevertheless was one of the reasons that the FDA agreed to do this fast-track designation for some of these substances like psilocybin where there was a history of use in Oaxaca and other areas of Mexico that they agreed, showed a robust safety signal.
Hutson: LSD is also being investigated. There are about 50 studies that are either underway or ready to start that are activated, but perhaps not accruing. One of the reasons that we’re not using LSD is that the effect of the LSD is longer than the psilocybin. Theoretically with the psilocybin there was even a substantial one. People can be done with their psychedelic episode experience and go home after an eight-hour session, and LSD lasts longer. It sits in the receptor longer. And so it’s a little bit less convenient, if you will, but there’s a lot of excitement about LSD as well.
Richert: That’s fantastic. And I think that helps sort of give a better sense of the overall landscape for everyone involved. What I suppose we should do now is pivot if we can to the implications for the pharmacy profession and for the pharmacist in the day-to-day practice. And maybe you had general remarks and comments that you wanted to make beforehand, whether or not that had to do with compounding whether or not that had to do with dosing in and out of pharmacy.
I just would like to hear your thoughts on this.
Hutson: Well, if I could start. One of the things that we determined in our study several years ago, the PK study, is that we could approximate the weight-based dosing, which was individualized for every patient with a 25-milligram oral dose. And that’s really what the studies are starting with that are going on not only here but internationally. So we’re proud of that.
There’s probably not going to be much formulation required of pharmacists if they’re using an oral formulation. But there are other novel administration routes for other products. I think that 5-MeO-DMT that Cody mentioned is going to be one of those that probably is going to be explored in different routes of administration because of its rapid onset. And DMT, which is inactivated by enzymes, by first pass effect may have some novel administration routes too.
But in the context of dispensing psilocybin, if we take that as an example, you know, the therapists aren’t going to be able to take a dose of psilocybin to somebody’s house and give it to them there. That’s not legal. So in those contexts where somebody might be dosed at their home or at some apartment building or a nursing home or something like that, somebody is going to have to pick that prescription up from a pharmacy. And unless the clinic site is actually licensed by the DEA to receive the psilocybin pharmacists are going to be involved in that dispensing process.
One of the other things that I think pharmacists need to anticipate is that these individuals that are getting it whether they’re going to be getting the psilocybin from them or some other source, are likely to be asking questions of the pharmacist. You know, what do you think about this psychedelic stuff that I’m hearing about and I’m planning on taking? I’ve been talking to these people about this preparation, and I just, or I just had this stuff. What do you think that’s going to do to me? And I think that it’s really important for the pharmacists and other clinicians as well that will be interacting with the patients, these treated individuals get a sense of what kind of support and encouragement that they’re going to be needing to be more informed about things like addiction risks and the side effects of these medications, which are really small compared to most of the other drugs that these individuals will be taking for the disorders that we’ve been talking about.
Cody, anything you wanted to add?
Wenthur: Yeah, definitely. So I completely agree with everything that Paul said. I think on kind of the pragmatic, you know, nuts and bolts side, the other things that pharmacists should be aware of are being ready to reference community resources for things like harm reduction. We’re seeing more people even before approval using psychedelics because they’re seeing this hype, right? And the level of adverse effects and risks are different in clinical trials versus use in the wild. And so I think it’s really important that pharmacists get good education on this so that they can give their patients really good advice. I think one of the other kind of nuts and bolts things that’s, you know, absolutely to mix metaphors, bread and butter [brief laughter] pharmacists, is thinking about drug, drug interactions and management of medication series and follow up.
So in many of these trials, patients have been tapering off maintenance therapy with SSRIs or other antidepressants in the case of both [brief laughter] the PTSD, but also obviously in depression. And thinking about how to manage that so that patients aren’t destabilized, if that becomes a standard of practice will be really important in figuring out interactions with MDMA particularly as there are special risks with things like MAOIs will be really critical. But beyond that, I actually think there’s a huge opportunity for pharmacy here. As Paul points out, the pharmacist is likely to be the source for medication access.
And if we think about access to mental healthcare right now across the United States, it’s not great. In fact, it’s bad. And community pharmacies are distributed across every portion of this country in urban areas and rural areas. And I think there’s a real opportunity for pharmacists to practice at the top of their license, particularly those pharmacies who are at, you know, independent community pharmacies where they’re an extremely trusted healthcare provider that’s had long-term relationships with these patients where they can follow up.
That’s a massive opportunity for us to get involved to help support therapeutic alliance, but also I think an opportunity to take advantage of the infrastructure that pharmacy has, to have safe dosing sites, and to work with the other clinicians that are going to be needed to help support the therapy. So I would really try and get pharmacists to think about how they can maximize their value in this new space, recognizing the importance of these long-term relationships, recognizing the incredible training that we get on drug safety as well as all of those, you know, sort of soft skills, right?
Relating to how we interact with our patients over the long term, and our ability to follow up as a pair of eyes in the community because as Paul pointed out, and I pointed out earlier, these aren’t magic bullets. The people who think there’s going to be one treatment and it’s done, and the person is ready for the rest of their life to go about their business are likely going to be extremely disappointed. And so having someone ready, engaged and able to refer and follow up and support is something pharmacists are absolutely ready to do.
And the last kind of piece I would say is I think there’s evidence that we can do this which is, if we look at the expansion of scope of practice of pharmacists, lots of the recent gains have been in the areas of public health and mental health. So it goes without saying that pharmacies have been indispensable portion of rapid response to what was a massive need for COVID vaccination. And also pharmacies now are places basically across the country where you can get naloxone without a prescription in response to another epidemic that intersects very closely with mental health, obviously the opioid overdose epidemic. And here in Wisconsin, we have expansion of the ability to provide long acting injectables, things like Vivitrol or Subutex or even long-acting antipsychotics.
And so again, I think these are really pieces of data that show pharmacists are ready, willing and able to step in and add value to support patients in a healthcare space where delivery of mental healthcare, in particular has been challenging to scale.
Hutson: Luc, if I could jump in. One of the problems that has been identified with both the research on psilocybin and also MDMA is that minorities are terribly, terribly underrepresented, even in Baltimore with a Black population there, the percentage of Black individuals in these pivotal studies that demonstrated the benefit of psilocybin in patients with end-of-life distress, 5 percent was the total number of Black participants in these studies. And it’s a recognized problem, and there are a lot of reasons for that.
There’s a lot of distress about the medical system and research by the Black and the American Indian populations, Hispanics as well. But there’s also another practical barrier in that there’s a lot of visits required for these preparatory sessions. There’s an eight-hour presence in the — after with a dose, and then they have to come back for one or more integration debriefing sessions. That’s a lot of back and forth.
If somebody doesn’t have a car or if they’ve got kids to take care of, if you’ve got a job that they can’t kind of jump away from, it’s a big barrier. And so one of the things that we’re really trying to work on is how in the state of Wisconsin, particularly in the underserved areas, whether it be urban or rural, we can use the skill sets of pharmacists as well as other healthcare practitioners to project the practice of psychedelic therapy in an appropriate fashion with trained individuals to underserved areas, whether that be on a reservation or in a rural setting. We think that this, that pharmacists are going to be one of the key components of that whole process.
Richert: Yeah. So important to underline that. And this is also a value that’s sort of built into the PPI program as well as the center I’m kind of proud to say, and hopefully I can get you guys to reflect on marginalized communities in a momentor two, but I wanted to make sure that we had an opportunity to ask a couple questions from the audience. We had a lot of people show up and ask questions.
And so before I ask any more questions that I’m burning to put to you, maybe I’ll just ask about for example, Alzheimer’s. There was a question from an audience member related to the use of psychedelics in Alzheimer’s and what the state of the research is there.
And then secondly, there’s a question about are there positive reports of people self-medicating outside of a clinical trial, outside of a pharmacist or a physician purview to treat their mental health conditions?
So I wonder if I can just put those two questions to you.
Hutson: Cody, did you want to pick one?
Wenthur: Yeah, I’ll take the latter question.
Wenthur: If you want to take the former.
Hutson: Okay. You go first then.
Wenthur: Okay. So in regard to the question of whether there are examples of people using psychedelics outside the purview of the healthcare system, certainly people are doing that. And I think the question specifically was, are people trying to, you know, treat existing mental health disorders in this way?
And again, yes, you certainly hear reports of folks trying to do this. It’s worth noting that outside jurisdictions, you know, in the U.S., so in other countries, there are places people will go to access psychedelics legally, and their frameworks may look different. Some of them, their retreat centers with support and other things, some of them are using it in a more sacramental or ceremonial type context, such as in the Amazonian basin and in the literature, right? What we see when people are asked about this, and it’s usually through questionnaires and survey type studies.
So the strength of evidence, you know, not as high as that of a randomized controlled trial, but observational data indicates that by and large people do report improved wellness, right? These rarely, if ever, look at clinical scales or outcomes. So improvement of the actual mental health disorder itself, I think we have far too thin a corpus to say anything about on that front.
But in terms of wellness, yeah, there’s pretty realistic reports. But I do want to underline something else that I said earlier, which is that the rates of challenging experiences and risks of harms, including, for example the risk of when you’re in a very vulnerable position being subjected to potential sexual abuse or other abuse by an untrusted individual, are significantly greater in that setting.
So I would say overall, the risks are higher and the level of evidence that we have for clinical outcomes is quite weak. But all of this is going to depend on the specific setting, right, in which folks are choosing to do this, and what the level of support is around that. Again, to use an example that I brought up earlier, groups like the Native American Church, for example, have very well-established protocols for group use, and have been doing this in a way that has supported their goals for very long periods of time.
And that’s true also in other well-regulated sort of sacramental or traditional approaches and may not be true for sort of independent psychedelic practitioners let’s call them, who may have a more variable outcome.
Hutson: Yeah. And one of the other things I wanted to add, Cody, in that harm reduction is that in a series of 11 reported deaths associated, not necessarily caused, but associated with psilocybin mushroom ingestion, not the pure drug, but the mushrooms, 10 of those 11 were associated with accidents. So people taking it by themselves in a secluded place, whether it’s because that’s the way where they prefer, or they’re afraid of being caught are at risk, and these accidents included stepping out into traffic or stepping off of a balcony or off of a roof. And so it’s really important that if somebody is going to be taking this on a recreational out extra clinical study sort of fashion, that they make sure that they’ve got somebody to protect them from doing something that’s going to harm them.
In the context, Luc, then, of the question about Alzheimer’s disease. I’m not familiar with any studies that are looking at psilocybin, but Eleusis was a company that was looking at LSD for the treatment of Alzheimer’s. And I don’t think that they reported out their results yet, and they were recently purchased by another company that I can’t recall the name of. But my understanding is that they’re going to be continuing with that work. And so we’re really excited to see what the results of that study are, because again, that neuroplasticity possibly the opportunity to create new synapses. I’m not terribly optimistic, but I’m hopeful that we might see some improvement or at least stabilization.
Richert: I think I want to stay on the topic of the role of the pharmacist.
Richert: And so I wanted to ask you both what type of roles can or should pharmacists and pharmacies have in jurisdictions where there’s a form of decrim or a given regulatory framework in place? So that’s the one question about the pharmacist’s role. And then the second has to do with, I think, scalability of this industry. So the question is, do you see inpatient pharmacies dispensing substances as well?
This is more, a little more speculative, but are you seeing inpatient pharmacies dispensing these substances for use in daily clinics? So those are the two questions for you guys.
Hutson: Which one do you want, Cody?
Wenthur: I’ll switch. I’ll take the former question first.
Richert: Nice [brief laughter].
Hutson: You go.
Wenthur: Yeah. I think in jurisdictions where decriminalization has occurred, and even in those where it hasn’t one of the things, you know, that I often hear as someone who’s like raised my hand and said, yes, I’m a pharmacist, yes, I’m willing to talk about psychedelics, is people saying that’s something I haven’t encountered with other healthcare professionals.
And I think there is a perception, a misperception that simply providing information about compounds is tacitly endorsing their use, and that you’re somehow putting your license at risk by providing good, reliable information to individuals. And I think as decriminalization proceeds, that’s something we need to be willing to do. Pharmacists are the most accessible healthcare provider. And so if you’re saying, I’m not willing to discuss benefits and risks of these compounds with you at all, if a patient opens up, one, I think you’re putting your long-term relationship and trust with that patient at risk.
And two, I think you’re exposing them to the risk of getting misinformation from a less well-informed source. So that’s one thing that I think is really important for the role of pharmacy, is we are the drug experts, and we need to act as such for the classes of compounds that our patients are going to be interacting with.
The other important role that I think is really important is directing folks toward resources for harm reduction, as we’ve mentioned several times. So in addition to that risk of accidents as Paul pointed out, which is probably best mitigated by giving good information about sort of who, when, where, what, why during the dosing session should, you know, be occurring to minimize risks. If you’re doing — if a patient is doing this out in the wild with no integration, they may become destabilized. And there are resources like the Zendo Project and the Fireside Project that are active and free for patients to access that would be really helpful for pharmacists to have in their back pocket to refer patients to, as ways to have them access integration and psychedelic support.
Hutson: What was the second question [brief laughter]? Sorry [brief laughter].
Richert: About inpatient pharmacies.
Hutson: Inpatient bottlenecks. Yes. That’s going to be a problem because we have limited capacity for dosing sessions for dosing sites, and we have limited number of therapists, if you consider that we’ve got two therapists doing the preparation for the subject multiple sessions before the dose, and then they have a full day sitting with the subject doing psychotherapy, and then they come back and do debriefing and integration. That is a huge demand on their time. There’s a huge demand on that dosing room. And so there’s going to be a huge demand for PTSD with MDMA and psilocybin for depression and other indications in the next few, three years, three, four years at most. And we’re going to have to figure out a way to make this more efficient. I think that whether we can do multiple people at the same time like they do with Ayahuasca ceremonies, or maybe have one therapist with one patient and a centralized person watching several rooms at once, we’re not sure.
The FDA’s going stipulate some REMS in elements to assure safe use most likely in terms of what they expect when it’s first approved. Hopefully we can make this a little bit more efficient.
Wenthur: Yeah. I think the other thing I would just say on scalability with relationship to the potential role of the pharmacist is, as Paul points out, the language is still being written, kind of what the requirements are for those two people. And I don’t think every pharmacist is going to get advanced training to be a therapist, for example. I’m sure there will be some folks for whom they’re very excited to do that, and they will get additional credentialing in that space.
But I think the other opportunity for pharmacists and pharmacy training is, who’s that second person in the room? So pharmacists are already a doctorate level degree. And I think with proper thoughts about how we incorporate this into our curricula we could make a very strong case for them to be that second person for oversight without any additional training. Where that falls, we will see. But I think it is worth thinking about as a profession and advocating for, given all the wonderful training and expertise we know we have to support patient and drug safety.
Richert: So that leads me into an answer for a question myself, which is the idea of expertise and evidence is something that ultimately led to myths around psilocybin and other psychedelic substances in the 1950s and 1960s. In the absence of expertise and the absence of hard evidence you and I suppose with certain researchers at Harvard University and other places being a bit too casual and liberal with their use of substances, it really tainted an entire field with a negative brush.
And so authors in history write about the ghost of Timothy Leary hanging over the heads of modern day contemporary psychedelic researchers like yourselves. So one thing that we need to be cautious of or think through when we’re thinking about this moment, is the way we operate, the way we conduct ourselves, the types of rules and the regulations that are established that are going to govern the different substances. It’s all too easy to come up with misinformation and fear mongering around different substances when people are playing fast and loose with these substances in various research settings. So psilocybin was considered to be addictive because conditions were enabled, conditions were set so that people could make those claims. There was a lack of evidence, hard evidence from the lab, and psilocybin was not alone.
LSD was considered addictive, extremely dangerous. Same with 5-MeO-DMT and other substances. So that’s just an answer to a question that was in the chat. Another question that I think I’m most probably [brief laughter] able to answer is how to prevent unchecked human greed and worship of the almighty dollar impacting this industry and polluting ultimately the massive untapped beauty and potential of the psychedelic space.
It’s a provocative question that comes from one of our — one of the individuals in the audience. And I would say that the industry now is grappling with these questions about how to move forward with ethical patenting, with notions of reciprocity and redistribution, working collectively with indigenous groups who use plants in a sacred way. So specific companies are developing models where they are giving back a percentage of their profits to a given group.
Other companies from the very beginning are trying to incorporate on their boards of directors and on their research staff, individuals from communities, whether that’s reservations or other groups. And so I don’t know if that is necessarily a satisfying answer to the question, but maybe other — maybe you can add on the thoughts.
Wenthur: Yeah. The only thing I would add there, two things maybe, are that we do see some pretty influential actors in this space who have explicitly not for profit models, right? And so I think that is fairly unique or at least very rare within pharma and a good sign. That’s not to say there aren’t ways in which there can be slippage of that, but I think holding folks accountable for the sort of value statements and principles that they’ve laid out is something that’s really important. And I think the mechanism for doing that, frankly, is to develop a workforce of individuals who have good information who have strong ethical compasses and who have been trained basically to understand what the ethical challenges and pressures are surrounding pharmaceutical drug development in general, and those that are particularly relevant to this space.
And so to me, that’s one of the things that I think is going to be so valuable about the PPI program is to try and ensure that just as we have codes of ethics for practitioners, I think it’s vitally important that we have codes of ethics for pharmaceutical scientists as well especially as human suffering and need is so great.
Hutson: We have time for one more question?
Richert: We might just. The last question I have for you two is what’s, I mean, happening? What’s next? So what kind of things should you be promoting for our audience, or what else key — what other key information you want to get out there?
Hutson: Why don’t you tell them about RECAP, Cody?
Wenthur: Sure. So he’ll be the spokesman for RECAP though I am just one of many players at the center who is involved in this. So Paul Hutson, who’s with us today, is involved. Randy Brown, Chris Nicholas, Chuck Raison, John Dunne, Matthew Banks, Richard Lennertz, you can see that there are more than a few psychedelic researchers hanging out here at UW. All of us have been involved in this study. And the idea is to ask the question whether the memory for the psychedelic experience is essential for individuals to report long-term changes and outcomes in behavior following the preparation, dosing and integration session. I think that’s a really central question in the field, right? Is the psychedelic experience necessary?
And we’re really trying to probe what the necessity of access consciousness is in terms of long-term change. If that’s not an exciting question for you, you’re a very different person than me, because that’s, I think, pretty cool and pretty exciting and pretty unique to UW. We’re very fortunate to have other centers and a broad array of expertise. Things like the Center for Sleep and Consciousness, the Center for Healthy Minds and others that we can tap into to provide unique value and one of the reasons I think our Transdisciplinary Center really is so unique and valuable.
Richert: We can keep talking and talking. I know we could, because it’s so fascinating. But I have to turn it over again to Dave Mott.
Mott: All right, Luke, thank you very much. Paul, Cody, thank you very much. Luc, I agree with you. I could have sat and listened to you guys for well into the evening. So thank you very much. I also want to thank our attendees for attending the webinar this evening, and please look for an email with a link to an evaluation survey so we can obtain your feedback about tonight’s webinar.
Also please check out the School of Pharmacy’s YouTube channel to watch the previous five pharmacy experts’ webinars that are available. So in other alumni engagement activities, please check out the latest edition of DiscoverRx, the School of Pharmacy’s digital publication for information about the school and our amazing alumni.
Also please look for information to participate in the next installment of our virtual trivia night to raise funds for the Pharmacy Alumni Association scholarships. And that virtual trivia night will take place on February 7th. So we hope to see everyone at that event.
So that’s a wrap for our webinar. So everyone please stay safe and healthy.
Have a nice evening and On, Wisconsin. Goodnight, everyone.