Video: Bioethics, Legal Ethics, and Ethics of Care: An introduction to psychedelics and ethics

This event launched the CSWR and the Petrie-Flom Center's new “Psychedelics & Ethics” initiative, which brings together interdisciplinary scholars and practitioners to explore ethical questions surrounding psychedelics. The series seeks to create a forum for constructive conversations about the role of psychedelics in society, with an eye toward justice and care. This interdisciplinary panel featured experts Dr. Mason Marks, Dr. Christine Hauskeller, and Dr. Roman Palitsky, who respectively represent legal, philosophical, and spiritual care approaches to psychedelic ethics. This event took place on April 16, 2024 at Harvard Divinity School.

Bioethics, Legal Ethics, and Ethics of Care: An introduction to psychedelics and ethics. April 16, 2024.

[MUSIC PLAYING]

SPEAKER 1: Harvard Divinity School.

SPEAKER 2: Bioethics, Legal Ethics, and Ethics of Care: An introduction to psychedelics and ethics. April 16, 2024.

CHARLES STANG: Good evening. Welcome My name is Charles Stang. I have the pleasure to serve as the director of the Center for the Study of World Religions here at Harvard Divinity School. And I want to welcome you to this evening's panel on psychedelics and ethics, bioethics, legal ethics and ethics of care.

So as we open our event today, I want to remind us all that Harvard University is located on the traditional, ancestral and unceded land of the Massachusett, the original inhabitants of what is now known as Boston and Cambridge.

We pay respect to the people of the Massachusett Tribe, past and present, and honor the land itself, which remains sacred to the Massachusett people.

Tonight is the inaugural event in a new series the center is launching in collaboration with our colleagues at the Petrie-Flom Center for Health Care Policy, Biotechnology and Bioethics at Harvard Law School. Let me take this opportunity to thank Glenn Cohen, Petrie-Flom's director, and Susanna Baruch, its executive director, for their support of this event and the new series.

The series' aim is to bring together interdisciplinary scholars and practitioners to explore ethical questions surrounding psychedelics. We wish to create a forum for constructive conversations about the role of psychedelics in culture, society with an eye towards issues of justice, safety and care.

This evening, we'll be asking how ethical approaches from law, philosophy and spiritual care can help-- can help us best inform psychedelic studies and promote safer psychedelic use. To answer this and related questions, we'll be joined by experts Dr. Mason Marks, Dr. Christine Hauskeller and Dr. Roman Politsky.

They represent, respectively, legal, philosophical and spiritual care approaches to psychedelic ethics. So I'll introduce them in earnest in a moment. Before I do that, let me thank my colleagues at the CSWR, Laurie Sedgwick, our events coordinator. Thank you, Laurie. And Isabel Fredericks.

CHARLES STANG: She's manning the door. OK. Thank you, Isabel. And I want to thank especially Gosia Sklodowska, the center's newly appointed executive director who took the lead in organizing this evening's event.

And thank you to our two student researchers, Jeff Breau, Paul Gillis Smith, who also run our psychedelic reading group and our Zoom speaker series, Psychedelics and the Future of Religion. And thank you always to our AV folks for making our events available to those who are beyond our walls or beyond these walls.

And maybe this is a good time to acknowledge the more than 300 people who are joining us via Zoom. So we're delighted to have you, and we hope that the experience is smooth and seamless for you. So our collaboration with Petrie-Flom is as welcome as it is unexpected.

We're delighted and grateful that the Harvard Study of Psychedelics and Society and Culture brings the Harvard Divinity School and the Harvard Law School into closer dialogue. Petrie-Flom has been a terrific partner, and we're confident that this is just the beginning of a long collaboration.

What we're seeing now with psychedelics in some ways mirrors what happened in the early years of stem cell research, that is a rush to create legal and ethical frameworks that could inform research and applications beyond the academy.

We see something similar with psychedelics, an explosion of interest and enthusiasm, but perhaps too little regulation, that's open for debate, but certainly a very fast moving landscape. Discussions about psychedelics and ethics couldn't be more timely.

The Harvard Study of Psychedelics in Society and Culture will soon be launching a new website created in collaboration with our partners at Petrie-Flom and the Mahindra Humanities Center. It will be the central site for events, news opportunities and publications, and you'll see a slide about that new website in a moment.

If you're interested in following these kinds of events, you can sign up for the CSWR website, to our newsletter, but you can also, through that new website, sign up for listservs that are specifically about psychedelic related events across the three centers.

So without further ado, let me get on with the evening's event. I want to introduce our three experts. It is my delight to have them here with us and to introduce them. Our first speaker is Dr. Christine Hauskeller. She is a philosopher with training in sociology and psychology.

Her research interests include a range of topics in moral philosophy and empirical ethics, feminist philosophy and decolonizing approaches, Frankfurt School of Critical Theory, philosophy of medicine and the life sciences, especially psychedelic therapy, genetics and stem cell research and science and technology studies.

She's the co-editor of Psychedelics and-- I'm sorry, Philosophy and Psychedelics: Frameworks for Exceptional Experience, which I know the reading group dipped into earlier this year. And she's the principal investigator for the University of Exeter's Philosophy and Psychedelics Research Group.

We're delighted to have you, Dr. Hausler. Thank you. Our second speaker is Dr. Roman Politsky, who is assistant professor of Psychiatry and Behavioral Sciences and director of Research Projects and Spiritual Health at Emory University.

And he is faculty in the Emory Center for Psychedelics and Spirituality. His research applies a bio psycho social, spiritual approach to improving behavioral interventions by ensuring that the treatments we offer are responsive to care seekers cultural needs and strengths.

His work in psychedelic treatment research reflects these commitments by seeking to make psychedelic therapies rigorous, effective and accountable to the many patient populations who might benefit from them and to support those care seekers who may experience adverse effects.

Now, my understanding is I've actually just reversed the order of our speakers. Mason Marks will actually be speaking second and Dr. Roman Politsky third. But Mason Marks is the Florida Bar Health Law Section professor at Florida State University College of Law.

At Harvard Law School here, he is a visiting professor of law and the senior fellow and project lead of the Project on Psychedelics Law and Regulation, or POPLAR. That's at the Petrie-Flom center. And he is also a visiting fellow at the information society project at Yale Law School. So please join me in welcoming our three experts to this panel.

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CHRISTINE HAUSKELLER: Is this the slide you wanted to show?

CHARLES STANG: No, not that one.

CHRISTINE HAUSKELLER: OK. So I'm Christina Hauskeller. Thank you very much, Charles, for this introduction. Also, thank you very much for the invitation to be here. I very much appreciate the opportunity to discuss this topic with you because there is a--

As Charles said, there is a need-- OK, let's figure this out first. Is this better? Is that even better?

AUDIENCE: Better.

CHRISTINE HAUSKELLER: And how is that?

[LAUGHTER]

AUDIENCE: And you can use this--

CHRISTINE HAUSKELLER: OK. Yeah. Good. I think this works, yeah? OK. So I just stick like this, and then we'll be right. So the-- I've come to work on psychedelics just five years ago. And before this, I worked for 20 years on STEM cell research and genetics and philosophy of science and ethics.

So-- also very practical ethics. So for me, this topic brings together the things I did before that on critical theory and gender and political philosophy, and the things I have learned in 20 years on philosophy of life sciences and innovation. And it does this in the most exciting way.

So I try to give you some ideas of what I think the psychedelics discourse is missing in terms of a, somewhat, professionalization of ethics and connecting with the ethics discourses that are actually out there in the world--

--but that somehow because it was somewhat in this bubble, busy with itself and this strange places in which it existed, somewhat unclear. But first, let me start with what do I mean when I say ethics. So as you may know, the word ethics relates to the Greek word for ethos, and that can be translated with habit, character, attitude.

Often in ancient philosophy, ethics is the relationship to one's own life in relation to the other. It doesn't necessarily translate directly into moral philosophy. However, here, I don't want to distinguish this. I mean ethics as the ways in which we think about how can I live a good life, how can we live good lives--

--but also the question of what should I, what should we do. So it's the practical study of what is right and wrong in philosophy for the benefit now of the individual, of groups of humanity, but also wider life and the planet.

And in psychedelics, I think there is a range of ethical relevant concepts that come in. So there are the direct and immediate ones that have been articulated in biomedical ethics and care ethics in the last 50 years.

But there are also some longer term ethics that take a more global dimension that are equally relevant, and that is the ethics of technology and decolonial ethics.

And in an interesting way, they all sort of need to talk to each other if we want to really be serious about getting it right with psychedelics or at least as good as we maybe can. Because the psychedelic space is a very multifaceted space.

And currently, we talk about the medicalization of ethics, which is what brought it from the sort of underground or semi-underground into the open. So there are these semi-legalized uses of psychedelics that have been around de facto for quite a while.

And I would say that includes the religious communities that use psychedelics and sacraments, that includes the party and the rave scene. However, the law stood to them, the business around them is so lucrative and so transparent that I would say this is a semi-legal space at least.

And then, of course, the psychedelic tourism sector, people going to Peru, to Colombia, to Mexico, to Brazil. So this sort of medicine, medicalization, our Western medicalization now re-mobilizes these scenes in an interesting way and taps into all the knowledge on psychedelic uses that has been accumulated there over decades.

They are mutually informing each other without this being made open in most cases. But there are also very interested other parties, and that is regulators, that is venture capitalists and charitable donors--

--and that is the whole underground psychonaut scene that exists alongside all these others for some 150 years in the West, when people started speculating, what does nitrous oxide do to your mind, right? This bigger field which we have, which is interesting.

Now, I think there are two different-- when I say I talk about psychedelics, then the question is, what are you actually talking about? And I think there are two different ways we need to take into account that are in tension with one another. One is what I call the substance perspective.

Among the substances are the ones of which I put these lovely images here. Some of them come from the laboratory. Some of them grow in nature, come from animals. When we talk about substances, that seems to make it easier to talk about ethics because we have actual stuff, which we can, for instance, regulate.

We can say who owns it, what it is, we can try to define its chemical properties, et cetera. That's helpful in some way, but maybe it's not enough. There is the other perspective. And I think Luis Eduardo Luna for the permission to use his Pablo Amaringo paintings. There is the experience perspective.

Psychedelic experiences don't match to psychedelic substances. Not only that the same dose of the same substance doesn't induce the same effects in different people or even in the same person twice, but also in the sense that one can have psychedelic type experiences without any substance--

--and that some people don't respond very much or at all to some substances. So there is the idea that the psychedelic experience and the substance connect together is somewhat misleading, at least there is a large gray space.

Things such as holotropic breathwork can engender quite valid psychedelic experiences. On the other hand, there is a way in which we have a much harder time dealing with the experience side of things. When we have a substance, we think we have a thing, and we can talk about it somewhat clearly.

When we have an experience, especially one that is so weird and that our culture has for 600 years weirded to no end, yeah, then this becomes much more difficult. That is why it would be nicer if we could just attach the experiences to the substances because with substances, we can deal with experiences. It's so much harder.

But the experiences are really the stuff that even the medics would say is what makes it work. That then, however, asks these-- raises these interesting questions if we talk about experiences that our culture finds very hard to deal with, that it has persecuted--

--and excluded for centuries, that on the other hand, it now wants to mobilize via the vehicle of these substances that we can measure in nanograms to actually engender some sort of change that is very badly understood.

What is it we are actually doing? And what are the ethical challenges that attach to this? What's happening here? My [INAUDIBLE] appears on this slide. So when we think about ethics, one of the most obvious ethics to use, and this gets me back to the substance. How do we talk about substances? We can think about standard bioethics.

We can actually use principles that have been with us now for a very long time and have very much created the discourse around biomedical ethics, the four principles by Beauchamp and Childress.

But they actually help us to deal with a lot of the things and scandals that are now being reported from the psychedelic space. They address the duty to help and promote the good for society, the duty to avoid harming or injuring patients, the duty to ensure patients take informed--

--and voluntary decision, and the duty to ensure access and fair distribution of benefits and risks. That can be read very narrowly. And in a medical ethics context, this could be just about the relationship between care or personnel-- clinical personnel and medics and an individual patient.

But of course, in biomedicine, this is a larger and wider way of thinking. And we can stretch this quite widely, actually. These principles, like all these principles that moral philosophers have produced when it comes to application, it gets difficult.

But they are quite comprehensive to address a lot of the things that are currently debated. And it's important that we notice this. We don't need to invent ethics to discuss critically and take a position towards questions of maybe not taking very seriously patient autonomy--

--or designing research and clinical trials in ways that are actually not open and transparent enough. So in addition, of course, to this comes then a whole industry interest when we look on the biomedical side, and that is that medicine is embedded and cannot be--

--the medical ethics is so lovely to talk about me and my patient and how we want to care for each other. But there's actually a world around it, and that world is extremely influential. That world is hospital budgets, it is licenses, it is pharmaceutical industry interests, et cetera.

So in the end, medics measure not the-- there is the individual level, and then there is the health care level, and that is always patient and statistical data similar to clinical trials. And of course, at that level, often the individual can fall out of sight, let's put it this way.

So there are tensions between ethics and profits. The research for the best possible treatment, this ideal medical ethics scenario is very much in tension, often with what is the most cost effective new therapy. And in psychedelic research, that leads, for instance, to the idea that maybe we could just use 5-MeO DMT because it is so quick.

If it doesn't matter which psychedelic we use and it is really that we just somehow create this situation of huge connectedness in the brain, and then somehow we reassemble it in the discussion afterwards, then why would you need a substance that takes four--

--or eight hours where people need to sit there and make sure the patient is safe, et cetera? Why not just take DMT in a 10 minute rush that is decidedly more cost effective? I actually think this is quite the most brutal psychedelic treatment out there.

And I'm not particularly impressed by this way of thinking as can probably be easily engaged from how I presented it. But this is, of course, the tensions within which we operate and the degree to--

--which we let the medical research agenda be influenced by concerns that really come after this question of, OK, we've now got a good new treatment, how can it be put into practice and funded is instead turned the other way around.

We are now having people who think, OK, we know already that nobody will fund this if there is 50 hours of psychotherapy attached and every session takes 12 hours until the people have worked through this massive amount of LSD we have been giving them, yeah?

So no, we see routes to make this as cheap as possible from the onset and this, I think, is ethically problematic. Then, as I said also this ethics can enlighten us regarding some recent psychedelic scandals such as cases of sexual abuse--

--and harassment in clinical trials and in retreats, things about incomplete reporting of preparation or follow-up in clinical trials. On many of my slides, you will find a few literatures for further interest. I won't mention them. In case you're interested, they will be recorded and available to you.

Then the incomplete monitoring and reporting of serious events and clinical trials that has been-- people are trying to address this, but this is very fraught because we are not just talking about substance, we are talking about experiences.

And then there are people involved, and there is a narration and a storytelling involved. So these things are complex. Patients. Then there are patients, and that has been reported by Noorani and others for years seeking more support after trial participation.

So obviously, they come out of this, and they need more. They might either seek more drug treatments, particular risk, for instance, with ketamine, but also they might seek other support infrastructure. And then, of course, there's something that happened that is the high cost of psychedelic treatment, so it's something like $2,000 per psilocybin session.

When you think that these mushrooms grow basically everywhere on a windowsill, there is something slightly perverse about this. So we talk about costs on the one hand with the 5-MeO, and then you pair this with what I've just been saying about the psilocybin.

There's something wonky, and I just want to point it out that we need to look into this because I see my talk here as sort of setting out some research questions rather than answering them. So these are issues that need to be looked at, and they need to be looked at also in an ethical perspective, not just in a economic one or legal one.

But we have other ethics I have mentioned that could contribute to this, and that includes the ethics of technology and what does responsible technology development mean. And this is because psychedelics has a long-term agenda both into the past and into the future probably is something we should really seriously consider.

And we have not managed in any of the new biotechnologies to do this very well. With the stuff that was predicted in 2000s about stem cells or genetics and what they actually are now is so far off that at least should give us pause that make us realize our predictive capacities are somewhat limited.

But that doesn't mean we are left off the hook on responsibility. And there is a lot of things we can learn from these other developments that we might bring in here to think of what actually would it mean to think about how such a treatment could be equitably available--

--affordably available, affordable for different health care systems if that were found to be necessary. So this is a reference to Hans Jonas, obviously.

But then there is care and relational ethics, very important, not only because care ethics is generally important in medical ethics, but also because the relational view very much comes and links this to decolonial ethics, but also because psychedelic experience has so much themselves to do with relations.

So other than treatments, there is a way in which when you imagine-- so you have patients in a clinical trial on anything that is not a psychedelic, and you can observe them, and you can afterwards record what they say they do, yeah?

When there is an overwhelming experience of love that they exude after or during the experiment, you find yourself as a participant and sitter in a strange position, yeah?

So the relationships to nature, relationships to other people, to community, to oneself, that's exactly the stuff that probably needs to change to cure a lot of the mental illnesses for which these psychedelics are being trialed. But these relationships need to be brought in and discussed.

What do these relationships mean as an emotion in the moment, but also the changes in relationships that people report after psychedelic experiences? And then the decolonial ethics, there is this recognition of past violence and the prevention of new colonizations and this really is-- colleagues have been looking.

My colleague, Osiris González Romero, for instance, has been looking at the inquisition archives and how women were persecuted, how the missionaries reported on psychedelic use, and how then the inquisition and the conquistadors actually persecuted as witchcraft, the use of psychedelics and put people in prison and murder.

So there is a way in which we cannot disentangle even Indigenous today, uses of psychedelics, even the language in which they speak, which is filled with a lot of interesting words that stem from Catholic theology. And that's not by chance. That is because it was the Spanish. And so the teonanacatl and the Santa Rosa.

The language that is being used to name them in Indigenous language is probably very much, Osiris González Romero says, something that is a negotiation between the interests of keeping your practice protected and making it somewhat look OK to those people who actually don't like it, yeah?

So there is a lot of work we need to do to understand this history on psychedelics, but it also should prompt us to really think about the Indigenous knowledges involved in this and how we can include them.

So the colonization and the psychedelic arena includes the colonization of objects of psychoactive plants, of animals and plants, of Indigenous knowledges, rituals and practices of Indigenous peoples and of peoples minds, experiences, hopes and needs.

And with this, I mean maybe our current societies people's minds, hopes and needs because there is also a colonization that seems some of the practices around psychedelic therapy when they become very ideological and very charged with expectations of not just a psychedelic experience--

--but what degree of mysticism that has to entail, for instance, where we actually over reach, I think, and preach that for principles idea of patient autonomy, where we actually don't give enough autonomy to patients of interpreting the experiences they may be having.

And the methods used are the usual ones, extraction, oppression, appropriation, adaptation, synthetic reproduction, marketization and control of profits and onto all of those we need to work if we are serious about including psychedelic knowledges.

So I've written this article in this book about the way in which medicalization aims to place psychedelic drugs into the toolbox of psychology, and that there is an interesting paradox emerging when these experiences that seem to be indicative of the madness of someone.

Because if you hear voices and if you see spirits and elves, you better don't tell your doctor.

[LAUGHTER]

But in this case, this is all different, OK? But this is exactly the kind of experience the doctor will engender in the participant so that the participant then changes their mind. That's an interesting one.

So we use and induce states of what we've called madness before to cure what we've called madness before and somehow create health. This is phenomenal. But what it includes trying to do this is that we need to control the substances, and we need to control the experiences.

And whereas, with the substances, there are all these issues of colonization I've mentioned before, we need to turn them into drug products that can be mass produced chemicals held in most cases with these wonderful technology that we call patents.

And then we need to control the experiences, not too much, not too little, the right kind and stare it in the direction so that the outcome of the experiment is actually that the patient can use the psychedelic experience you've given them to let go of their addiction, of their PTSD, of their depression, and not something else.

You have a defined outcome that you need to measure at the end of this trial. If your patient came in for addiction treatment And is no longer depressed, this is nice, but it actually doesn't help you in your reporting.

So you need to do a lot of work to achieve the right outcome, which has some things of a degree of violence to it one might think. At least it's worth to look into it, talk to people, find out more about how people feel affected by this.

This is an interesting open question of patient autonomy and ethics goes in this. So what would it mean then to apply decolonizing practices? Respecting and crediting Indigenous knowledge and technologies, acknowledging this knowledge and a share in profits. Unclear how we would do this. Talking needed.

Then reconsider ownership practices, that is rights to land, to plants, and to animals, land use or monoculture such as, for example, the UDV wants to have a sole right to grow peyote cactus, OK. So there's something interesting happening when a state considers loosening legislation and decriminalizing psychedelics.

And then the churches that were actually using the psychedelics and had the sole authority to administer them legally within that place suddenly are against the decriminalization because it counters their-- contrary to their interests.

So we are finding interesting conundrums happening as soon as what was a sort of fixed landscape that the law provided, when this tumbles or when holes are poked into this here and there, you suddenly see what was-- what calling itself the psychedelic community, sort of getting into fractures and states of tensions and new conflicts arising.

And it would be very good if those would not lead to a lot of very negative outcomes. So it would be really good to do a lot of talking about what is really happening here and what these interests are. Then there are questions of laboratory modification and patenting rights, and then the technological extraction questions.

The question is, who owns the profits? And who owns the means of production? And who exactly is that? Can we and how can we recognize Indigenous contribution? So what happened with this slide? This is not the last slide. This is the last slide.

How can we get to be fair regarding these Indigenous contributions to contemporary psychedelics? So ayahuasca, yage, mushrooms, peyote, iboga and many, many more substances that Indigenous groups have been using--

--and are using that engender psychedelic states of consciousness, they have been used for many purposes, not just mystical experiences or spiritual experiences. There are other interesting uses.

So if you read, for instance, Davi Kopenawa's book, The Falling Sky, and it is about illness, and there is this weird story about this way in which there's somebody ill, and then you need to find the ill spirit animal, and then you need to cure the ill spirit animal. And only then can you cure the ill person.

And this you can only do, of course, if you have the mental capacity through the expanded consciousness of finding that spirit animal, finding the way to cure it, and finding the method to then cure your actual patient. But the whole concept is alien.

We shouldn't pretend to think that these Indigenous uses are any way similar to us having a vision of God. There is something very different happening, many different sort of utilizations. And to bring all this into one thing is really problematic.

There is a-- Indigenous people have been responding to the psychedelic conference thing when they were brought in as our token Indigenous person by having an Indigenous psychedelic conference. I've made the link here.

The first one was, I think, in 2017, then one in 2019, and I think there is one next year. So there is the Indigenous Ayahuasca Conference. The link is on this website. That is-- really have a look at this. I'm not invited, and that is totally OK, obviously, but it is something to--

--where there is people we need to talk to, yeah? We need to actually take notice and engage. This is really important. So when we think we can include just by having tokenistic participants, I think we make a great mistake--

--and it shows that we really haven't understood a thing about how great the differences are in a way and what the methods are and the interests of all parties to actually talk and sort them out. And this-- so we have the making of drug products.

And we have the psychedelic trips as medically and culturally controlled, and the diagnosis. There is a colonizationizing of both patients' minds and Indigenous practices, I think. And so the-- this is really not my last set of slides I sent you. I'm sorry about this.

I don't know how-- where this is going now. I think I stop at this point. So the ethics of decolonization would mean that moral culpability and compensation for past exploitation is reconsidered, that we think about how this can be done, that we prevent the continuation of inequalities in the present--

--and that we identify new practices of colonization that are actually ongoing now. I know. Shall I took it the next slide or not? It is risky. Yeah, no, I-- this is not my last slide. I end here. This is a lovely slide that I once made on [INAUDIBLE] book on relational ethics, which is a very good point to close.

So the ways in which we need relational epistemologies and talking, my actual last slide is about discourse ethics, about the ways in which going back to this first slide with all these different stakeholders. We need to find ways of doing research in those different--

And with those different communities to then actually keep talking and develop new ways of discourse that at this point, we actually haven't got. There was a lot of movement in the 1990s on bottom up ethics and bottom up discourse ethics and somehow it has all gone away. It has really vanished from the landscape.

We need something similar now, but something that actually maybe works better than it did then because the problem with it was it had great social acceptance, but no influence on politics. We need to find ways of having such discourses that actually change the way we do things, not only how we talk. Thank you.

[APPLAUSE]

MASON MARKS: All right. OK. Well, Hello. I'm Mason Marks. I'm a law professor. And I'm going to try to make this talk not too much-- not too legal, more on the ethics side. But this is a great moment for me to be joining you.

I'm kind of celebratory moment because I just ran across campus from the law school where we finished teaching a course on psychedelic law, my colleague, Professor Glenn Cohen. It's the second time I've offered this course. I taught it last semester at Florida State University.

And it's exciting because legal academia, the legal profession, are fairly conservative. And when I was in law school, I graduated in 2015, we couldn't have imagined anything like a course on psychedelic law. And so we literally just had our last class session. And I ran over here.

And so it's exciting to be with you to talk more about psychedelic law. And I'm going to take this opportunity to talk a little bit about a new paper that just came out last week that I wrote with Professor Cohen, along with Dr. Rebecca Brendel and Carmel Shachar, who is also at the law school.

And I'll just take you through the process of writing this paper. It's an exciting time to be thinking about psychedelics from a legal and ethical perspective because it's largely uncharted territory. There was a lot of work obviously done in the '50s and '60s--

--but in terms of the revival of interest in researching psychedelics and administering them in a clinical context, we're kind of trying to figure out what to do as we go along.

And informed consent is one of those areas where so far, it's largely been addressed in the research context because there are many, many clinical trials that have been ongoing, especially in the past few years. But right now we don't have any FDA approved classic psychedelics.

So we don't have informed consent happening in the clinic with a much more diverse patient population. We have very narrow patient populations with strict exclusion criteria. And we wanted to think about how informed consent might look in the real world.

And so I'll just take you through our process of writing this paper. Our first step was to look at what people were doing in the research context. And so we went to clinicaltrials.gov where you can find information about clinical trials that are recruiting--

--or that are ongoing or are completed, and you can search for psilocybin or MDMA. And some of those trials, I'd say a very small percentage of them, actually have informed consent documents that you can read.

So down on the left-hand corner, there were only two related to psilocybin. There were quite a few more with MDMA. So we downloaded those forms. We looked at them. We saw what kinds of questions are they asking people.

And I should back up just a little bit. What is the purpose of informed consent? Plays a couple of different functions. One function being ensuring that patients or in this case, research participants, understand the potential risks and benefits of a treatment that they are about to receive.

Also, that they understand what alternatives are available to them if they choose not to participate in the study or in the treatment. Because that's part of the ethics of clinical practice. We believe that people should fully understand what they're getting themselves into.

There's also sort of a liability role as well for clinicians that they have a duty to inform patients of the risks and benefits and alternatives and if they don't, then perhaps they have not met the duty of care that they owe to patients. So we looked at the informed consent forms that were available to us.

And we started thinking about the challenges of informed consent when it comes to psychedelics. Are there things that are unique about these substances that require a different approach, or are they the same in many ways to other medical treatments?

In many ways, they are the same, and we wanted to focus on things that are different. So there are many types of adverse events that clinicians are going to be very experienced explaining to patients. They're not going to have any trouble explaining to patients, like, a headache or palpitations, anxiety, depression.

These are things that aren't really going to pose a challenge. So we left these more commonplace aspects and informed consent out of the equation and try to identify things that are different. I'm not going to go into this list in detail because we'll kind of get into it as I talk through each of the elements on the next slide.

So our goal was really to identify what are the fundamental core elements of informed consent when it comes to psychedelics? And this is what we came up with, a list of seven items. Again, I'm not going to go through this list. Right here I have a slide for each one, and I'll go into greater detail there.

So the first is acute and chronic perceptual changes. And one of the challenges of informed consent to psychedelics is the profound nature and the unusual nature of their effects, one of them being these changes to perception, whether it's visual perception, auditory perception.

There's also the added complexity that it's very difficult to predict how any particular individual will react. And so how do you inform them of that, of the risks, one of which is what's believed to be a very rare, as far as we can tell, effect adverse event where these perceptual changes persist, perhaps indefinitely--

--or perhaps even permanently. There's a condition called HPPD. We don't really know how common it is, but you can imagine how distressing and potentially disabling it might be if you had shapes, colors, snow, some kind of distortion in your visual field that was permanent.

And so we felt that this was something that really needed to be conveyed to patients, both the profound and unusual nature of the short-term perceptual changes, as well as the risk of the potential prolonged changes. It's very difficult to assess from the patient's perspective.

We can't even give them a percentage. There are procedures that are commonly done in health care, like cardiac catheterization, that carry a very real risk of death. You might be able to tell a patient there's a 1% chance that you might die.

But we can't really give them a percentage in this case, and so that's a real challenge. And we just have to be honest about that. Another unusual feature of psychedelics is the possibility of personality change or altered metaphysical beliefs.

And we don't know a lot about this, but there is some data to suggest, for example, that some people might come out of the experience feeling that the world is a bit more deterministic and that we have less of a role in choosing our own path in life. So is that something that you want to sign up for?

We don't even know if that's really going to happen. It's very difficult to evaluate whether it's worth it for someone to take that risk. But it has to be mentioned, not only the potential changes, but also the uncertainty that surrounds that.

And one could argue that many other medical procedures, surgery, certainly various psychiatric procedures or medications might change personality. But this feels different in some way. It's like a core fundamental belief about how the world works, which it seems to be unusual.

A very controversial topic, hopefully for obvious reasons, is the limited role of touch. And part of the reason this is controversial is that there are some schools of thought in the psychedelic ecosystem that believe that touch, far beyond the hand being held here, are appropriate, perhaps even necessary to the therapeutic process.

There are some in the psychedelic space that believe that it's possible to regress patients back to an earlier period in their lives where they experienced trauma, perhaps where they were not given physical touch and nurturing from their parents, and then that the therapist could provide that touch, serve in that role.

That's a very controversial claim. And I would say that most researchers looking into the therapeutic applications of psychedelics do not hold that view and would argue that touch should be very limited to holding a hand, lightly touching one shoulder.

I think it's widely accepted that this can be very helpful during a psychedelic experience because they can be quite anxiety provoking for some people, disorienting. And so it perhaps can help reorient people and provide some comfort in this very limited role.

And that's something that needs to be discussed and agreed upon during the informed consent process before the psychedelic is administered and not something that is kind of decided on the fly when someone is under the influence of the drug.

So something we discussed in the paper is developing different approaches to having a clear and easy system for communicating, I want to stop being touched, during the experience. OK. Another very important one is potential for patient exploitation and abuse.

There are documented and alleged cases of patients or clients being abused both physically and financially. And by the way, I should say many of these things that I've mentioned so far did not appear in the clinical trial informed consent documents and this was one of them, which was a bit surprising.

And some people have pushed back a bit on this when I've discussed it with them and said, how do you expect the clinician to tell a patient you're at increased risk of being abused by me, your clinician? And I don't think that's how this would actually play out.

One possibility is to have a different staff member engage in the informed consent discussion. But more likely, I think that the clinician could merely explain that there have been cases of abuse. There is a risk of abuse, coercion, exploitation because of the vulnerable state that people are in under the influence of psychedelics.

And these are the steps that we've taken to protect you from that. And so instead of making the patient feel less safe, it could actually promote open discussion about this and make people feel safer.

Another aspect of this is the possibility that people may remain in a state of increased vulnerability to persuasion for an extended period of time beyond the duration of the acute psychedelic effects.

And another criticism I've received is that, well, people are vulnerable to abuse under anesthetics, when they take benzodiazepines and other commonly prescribed medications. That may be true, but I suspect that psychedelics can have a more prolonged effect perhaps, and this needs to be studied in greater detail.

But they do appear to have this effect on neuroplasticity. They promote neuroplasticity, new neural connections in the brain that may prolong this period of increased vulnerability. OK. I'm going to try to speed through these.

Generally in psychiatry, there is a trend towards increasing data collection. There's an entire field, a subset of psychiatry called digital phenotyping.

It's not exclusive to psychiatry, but it involves measuring pretty much everything a patient does through wearables like an Apple Watch or a Fitbit, smartphone apps where people might enter in how they're feeling at certain intervals every few hours.

There are helmets that have been created that measure circulation in the scalp in order to draw conclusions about brain activity. There's one called kernel that's being utilized in psychedelic clinical trials. But a lot of this information is going to be extremely sensitive--

--because imagine the sensitivity of the information that one might share with a therapist or psychiatrist, that will be sensitive. But there does appear to be this disinhibition effect of psychedelics where people potentially gain access to memories that are repressed--

--or subconscious information that they can't typically access that comes to the surface. And so there is reason to believe this could be particularly sensitive. And so patients should be informed of the risk of sharing data for research and other purposes.

And this actually was mentioned in one clinical trial informed consent document, which said you should be aware that you could be fired if your employer found out that you were taking psychedelics.

And I was impressed by that because we have to remember that in many jurisdictions that are offering psychedelics like Oregon and soon Colorado, these substances are still federally illegal. They are Schedule I controlled substances.

So any data that you collect in addition to being sensitive is literally evidence of a federal crime, a felony. And what's happening in these states is data is being collected by the state and stored in a centralized database.

It's just a fact of life, especially in health care, that data breaches have become commonplace. This information will inevitably get out there. This needs to be explained to patients in the informed consent process.

Perhaps more than in other fields of health care, many researchers in the psychedelic ecosystem are working with private entities because for decades, there has not been federal funding for this research.

So researchers tend to partner with companies that are investing in the development of products. Also, you often hear that people doing this work did so because they had a personal experience with psychedelics, and I think that may be more the case with psychedelics and many other drugs.

I know there are-- perhaps someone might be involved in a Prozac clinical trial and be so impressed with the results of Prozac that they start becoming-- they become a brand ambassador for Prozac. And they're at all the conferences for Prozac.

I could see that happening potentially, but you see that all the time in psychedelics. There are clinical trial participants. I'm going to rush through the remainder. I'm almost finished. But you see clinical trial participants becoming brand ambassadors for psychedelic companies.

You see them lobbying on their behalf, becoming paid lobbyists, paid activists. So the point here is that perhaps more than in other fields, we think it's important for the clinician to disclose any potential--

--or actual conflicts of interest, financial conflicts of interest, other relationships, whether it's with a company, a psychedelic training program, whatever. OK. Last point I want to make is that because it's so difficult to understand what it means to experience these perceptual changes--

--or in some cases, to have a mystical experience where one feels connected to other people or to nature or to have some kind of divine experience, we think there could eventually be a role for technology to aid in this.

It's not a perfect solution, but there may be some way to use virtual reality and augmented reality to just give people who have never used psychedelics before some idea of what they might experience so that it may not be quite as disorienting or frightening when it actually happens.

There you go. We have a demonstration right here with Oculus 3. That's AR, right? So there you go. All right. And then just lastly, another role of technology is to create an interactive informed consent process.

There's evidence to show that when the informed consent process involves open-ended questions, quizzes to confirm patient understanding, maybe some multimedia experiences, some role playing--

--we want to introduce those kinds of tools into the informed consent process to really help people understand something that is very difficult to understand until you actually experience it. And I won't go into this, but this is just a supplement to our article that shows some of the language.

Well, in this case, it was language that was not included because the topic of personality change was not addressed in this particular sample. And we provide some language to fill the gap. And I'll just leave you to look that up in JAMA Psychiatry.

But I was quite surprised that some of these things were either omitted, underemphasized, or they were phrased in such a way that it didn't seem as though patients would really understand what the experience might actually be like. So I think there's a lot of room for improvement. And thank you very much.

[APPLAUSE]

OK. Can everybody hear me OK. All right. So my name is Roman Politsky. I just want to have a little preface about myself and my part on the panel. First, I have no conflicts to disclose. Second, I'm primarily trained as a clinical psychologist, even though I have an MDiv.

I don't think of myself really as a scholar of religion. I'm just lucky enough to be able to work with and learn from scholars of religion on a regular basis. And so the perspective that I'll be speaking from today is from clinical psychological science, because that's really what I feel equipped to do.

And from that perspective, I'll just talk about two issues. The importance of spiritual integration and psychedelic assisted therapies, and relatedly, the ethical considerations that arise when integrating spirituality and psychedelic care.

Because of course, if we're going to address spirituality, we suddenly become aware of myriad ethical concerns and demands. In particular, I'll talk about two things, the importance of non-imposition and respect for autonomy in psychedelic care and adverse effects in psychedelic therapies.

We could be talking about a lot more things and the previous speakers talked about, many of them. These are the two that I will focus on. So I'll introduce an acronym at this point. I apologize for that. The acronym is SERT. It stands for spiritual, existential, religious and theological.

And it comes from work done at the Danielson Institute in development of relational spirituality and psychotherapy as a model. In psychedelics, we often talk about these mystical type experiences, these transformational transient experiences that impart some deep sense of knowledge and having made contact with something real, and these are important.

But I have come to prefer this SERT framework because I find it to be more inclusive of the kinds of experiences that can arise on a psychedelic and also because they can account for some of the individual, interpersonal, social--

--and cultural dimensions of life that are really important before, during and after the psychedelic experience and which can be impacted by the psychedelic.

To wit, here is a miniature non-comprehensive literature review of different studies with different compounds, different indications, different populations that seem to demonstrate what we would call a dose response relationship between psychedelic dosing--

--and SERT impacts so the higher the dose of the psychedelic, the more likely people are to report a strong SERT impact. And here is another mini literature review, different studies, different populations, different compounds--

--that observe a dose response relationship between SERT impacts on one hand and the tendency for participants to report some kind of a benefit from that intervention. So when I look at this from a clinical science perspective, this looks a lot like mediation.

A mediation is any time that you have a treatment, in this case psychedelics, that affects its outcome, so, for example, depression by means of some kind of a third variable, in this case, SERT impacts.

And in ordinary psychotherapy, when you can identify mediation, it's a pretty good idea to begin to address it in your therapy model. So, for example, let's take something like the bond between the therapist and the client.

If you have a therapy, whether it's cognitive behavioral therapy or psychoanalysis, then that therapy can increase the bond between the therapist and the client, and that therapy is more likely to succeed. And that's why we build alliance into many of our clinical models.

Now, the jury is still out about this mediation hypothesis in psychedelics. We need more data to know whether SERT impacts actually mediate their effects. But there's another reason to address certain psychedelic care--

And that is that we do have ample evidence that psychedelics seem to produce these SERT experiences in the people who take them, and that the people who have these SERT experiences attribute a lot of importance to them.

So what would it look like to address SERT in our models of psychedelic assisted therapy? Last summer, my colleagues and I published a paper in JAMA Psychiatry that made some of the arguments that I have previously made.

And what we also did is we created a sort of non-prescriptive, a kind of a descriptive map of the different points of contact that can arise between the psychedelic therapy and various aspects of SERT in care.

And this model begins with the treatment, which we often think of as a kind of a package deal. There are some preparation sessions that include meetings with facilitators or therapists. The care seeker can prepare for the experience. There's some psychoeducation that happens.

Then some dosing experience or experiences followed by integration sessions that can help the care seeker internalize the experience and maximize their benefits from it.

So this package deal is applied to the care seeker, and that is often how we think of interventions, that we have a treatment, and we bring it to the care seeker. But I find it very useful to think of who is the care seeker and what is important to them.

And we can think about this on an individual and interpersonal level. So we can think about the genetics, the symptoms, the worldviews that the care seekers have. But these are in relationship to a social and community domain that might include their attachment relationships.

It can include their roles in their communities. And these, of course, exist in relationship to a cultural and collective domain that includes human geographies, economy, history, culture. I don't think I'm telling anybody in this room anything new, right? We all kind of know this stuff.

Neither is it new that we can identify certain influences at each and every one of these domains. So at the individual level, we can think about the religious or existential beliefs that care seekers have about their mental health concerns.

We might think about a person's role in their community and the resources it offers, but also the demands that it makes on them. And we can think about the inter-religious histories that we live within and the legacies of collective resilience and trauma that we carry.

And these are also sites for SERT influence, both shaping how we think about these histories and also being shaped by them. In psychedelic assisted therapies, this can all inform assessment. And not to say that we need a 300 item questionnaire about all of these different things--

--but when we think about things like risks and vulnerabilities or maximizing patient resources in these therapies, these can inform how we think about these so that we can better tailor psychedelic therapies to the needs of care seekers. Again, this can happen at all the different levels.

For example, at the individual level, we might think about engaging their own SERT understanding of their experience, of their mental health history or their developmental trajectory. Did they disaffiliate? Did they grow up in a religious household? Did they recently convert?

At the relational level, I think this is where something like ceremony and ritual can become very important and relevant. And I'll just pause here at this cultural and collective level just to sort of take a step back.

We use the word history a lot, and I just want to emphasize that history is not just something that is abstract, something that is in the past either for our care seekers or for ourselves. Many of us wake up into history. We live with history.

We navigate history the same way as we navigate any other aspect of our lives. And so being able to address that and to recognize also that we are not the experts on our care seekers ways of knowing about the world, which invites us to take a very high degree of epistemic humility--

--and historic sensitivity to practice cultural inclusion in a non-appropriative way in order to support collective resilience among care seekers and their communities. So all of that can be ways that we think about SERT integrated psychedelic care.

A lot of opportunities here. But also, each and every one of these points of contacts is a site where ethical challenges can come up as well. For example, each one of these domains is a potential site of worldview and cultural imposition.

So that brings us to the plan for today's talk, and the part that I'll talk about next, which is the priority of non-imposition and respect for autonomy. I think we've already heard a little bit about the role of suggestibility in these therapies.

And so, yes, taking a psychedelic can incur new beliefs, shifted values, changes in metaphysical perspectives. I just add one more thing here that the suggestibility maybe does not begin when you take the psychedelic, but it begins when the care seeker walks through the door--

--and says, please help me deal with a problem that I've had a hard time managing on my own. And that is when they put themselves into your hands, especially when this experience involves something radically different from the ordinary types of experiences that they've had.

And this is one reason that we think about who are the clinicians and what is their training, what is their competency in non-imposition. Some of this work relies, again, this isn't new, decades of work, in spiritually integrated psychotherapies, which definitely no time to go over that today.

But I'll just mention this one really, I think useful paper, clinical and religious competencies in psychology. So there have been standards developed for psychologists and for other allied and mental health professions that address the importance of spiritual and religious competencies really as a part of cultural competence in care.

And these usually involve two things. One is that it is an ethical impetus to address spiritual and existential and religious concerns when they arise for patients rather than ignoring them. And the other is to do so in a way that does not impose on their values and that treats them with respect.

Clinical psychologists are still working on this one. It's not yet a consistent part of clinical training, but there is a group of professionals who are experts at this, I think, and these are spiritual health clinicians or chaplains.

So these are professionals who are trained to respond to relevant distress with a focus on autonomy and non-imposition of values. These are clinicians who are highly seasoned, three years of post-master's clinical experience, over 1,600 hours of clinical training and residency and board certification.

And I think that they can add a lot to our competencies in this kind of care. And the last aspect of non-imposition and respect for autonomy I'll talk about are the very clinical care models that we select. And I'll draw here on what I think is a wonderful paper essay by David Goodman, "The Mcdonaldization of Psychotherapy."

And in this article, Goodman describes a scenario where a patient comes into an office and says, well, you know, I've been feeling a lot of x, and their therapist says, well, x isn't really a feeling x is a thought. Have you thought about telling me how you really feel, right, and then what you think about it.

And then the patient responds and sort of processes it in that way. And I think the subtext for a lot of therapies is that succeeding in the therapy is predicated on taking on this way of seeing the mind and the world that the therapy invites.

So Goodman writes, "Different therapeutic orientations are different languages that human beings have for understanding their suffering, meaning identity and healing. Treatment practices in their respective languages carve out the horizons of possible experience.

In psychotherapy, the language about my experience shapes, orients, and ultimately mediates my self-experience." So therapy models often have either explicit or implicit views on some very important questions. How does my mind work? What is real? Are my thoughts real?

Are my feelings real? Are my behaviors more real? What is realistic as a goal in therapy? And what should I want in general in life? Am I a unified being or am I made up of parts? What caused my suffering, and what does it mean? So these all have tremendous relevance.

And I think that in psychotherapies, we're only really beginning to grapple with these issues, largely in the domain of culturally competent care because that is where a lot of these concerns tend to come up. And so I'll just add, I think it's important to recognize that certain position can be an adverse effect in itself.

It can contribute to adverse effects, and it can make adverse effects worse. So going back to this map for the talk, that is what I'll be talking about next, which are adverse effects and psychedelic therapies.

Generally speaking, barring some clinical rule outs and some medical rule outs, psychedelics are often described as safe for most people. Adverse events are reported at relatively low rates, but this might be an undercount.

And this is based on data from some systematic reviews, from epidemiological studies and recent increasing reports which you've heard about of patients and participants in trials coming forward and saying, well, you didn't report this as an adverse effect, but this isn't feeling right.

And a lot of this is really due to a few issues. One is that historically clinical trials with psychedelics have relied on passive monitoring to gauge adverse effects. Passive monitoring is when you ask somebody, well, did anything negative happen?

And you wait for them to tell you which picks up on a lot fewer adverse effects than asking specifically about certain adverse effects that can arise in therapy if we know what they are. Low frequency of adverse effect assessment and low frequency of follow-up, means we don't catch as many.

Another one is this focus on the acute dosing, right? Was there an adverse event during the psychedelic experience? But what about the days, weeks and months that follow after the psychedelic? Could those be related to the psychedelic experience?

A heterogeneity in the way that we assess adverse effects in trials means that it's hard to get a common picture of the prevalence, the incidence of these adverse effects that we just heard about.

And also importantly, a restricted criteria of adverse effects that we've inherited largely from pharmacology research where we assess important adverse effects. But we miss two really key components of psychedelic therapies.

One is they are often psychotherapies or they include some kind of facilitation, and psychotherapy on its own has a rate of adverse effects which are important to measure in psychedelic assisted therapy research. And the other is this piece that we just talked about, these SERT impacts. And when things go well, they really can lead to benefits.

But what happens when they go poorly? What do adverse effects look like in these different domains of a care seeker's life? And for an illustration, I'll just point folks here to a brilliant essay by Rachel Peterson, "A Theological Reckoning with Bad Trips" published in the Harvard Divinity Bulletin that discusses what a spiritual adverse effect can look like.

So we've been working for quite some time on developing a framework for assessing adverse events in psychedelic assisted therapy trials. And so these are adverse events. It's a clinical trials framework, but what we've tried to do is to really address these different domains of a care seeker's life.

That's yielded a expansive map, I would say, a set of criteria that we think is feasible to assess in a clinical trial, but that addresses many more of these domains. So this is coming from a multidisciplinary group that includes clinicians, researchers, psychiatrists, psychologists, chaplains and individuals with lived experience of adverse effects.

So I hope you brought lunch. We're going to go through all of these. No.

[LAUGHTER]

We can talk about them some other time. Also, this is up as a preprint. I'll just bring up one that I think is relevant to today's conversation, and that is this domain of psychospiritual adverse effects. And again, these are coming from reports and experiences that we have heard, we have seen, we know people can experience.

We just don't know the rates or the seriousness of these. So one is heightened existential distress, right, loss of coherence, meaning or purpose, increased death anxiety. Religious or spiritual struggles on one's own, but also struggles and tensions that can arise with one's community of faith and one's religious community or secular community.

Undermining of a person's spiritual or existential worldview. Religious or spiritual abuse that can take place within the context of psychedelic care and kind of going back to the very beginning, religious or spiritual imposition.

So as Dr. DeMarks' talk makes clear, understanding adverse effects is really important for something like informed consent. And I wish that I could tell you the incidence of these occurrences, but we don't have the data on these. We haven't been measuring this.

Something I'm really excited about is that now this framework is being used in one ongoing study and two or three planned clinical trials. So hopefully in a little while I'll be able to share, you know, the extent to--

--which some of these might not be all that serious, some of these might not occur, but some of these might be quite serious, and this might not include adverse effects that are still relevant to care seekers.

So going back to the start, when I began, I pointed out that if we're going to address spirituality, we suddenly become aware of a range of ethical concerns and demands. And now I would actually argue that this is a good thing because in fact, the ethical issues have been there all along.

This is what happens when we start to look at religion and spirituality and existential issues that kind of pry open the door, and we see a lot of ethical turmoil that we just haven't been giving adequate attention to. As a colleague of mine once said, we're not adding religion here. We're just not taking it out. Thank you.

[APPLAUSE]

CHARLES STANG: --back up. What happened to the lights? Is that by design? Hi, [INAUDIBLE]. Good to see you. Thank you all so much. We are going to take an extra 15 minutes to field some questions. In light of the time, though, I ask that you try to make your question brief and make it a question.

And I will ask our panelists also to be as brief and to the point as they can in responding. So the floor is open. Who would like to pose a question to our panelists? Yes.

AUDIENCE: For those with an interest or background in [INAUDIBLE] studies at Harvard Divinity School, spirituality, et cetera, who might be interested in approaching therapy use of psychedelics, all of you have mentioned a number of different considerations with implications for what type of practical [INAUDIBLE] Do you have any recommendations for audience members who are interested in that topic?

MASON MARKS: [INAUDIBLE] there's room for every field in this-- I think there's great potential for every field to get involved. Actually, that would be of great benefit. But what I usually tell my law students is just get involved, like, just write an article. Fake it till you make it.

[LAUGHTER]

And that would be my advice, no matter what your field is.

CHRISTINE HAUSKELLER: I agree. It is a really interdisciplinary enterprise. I've not been in anything that interdisciplinary, and I've been around a bit. So there's many ways in which people can participate. But I did understand, was it also a question about how people should be trained to actually work in clinical trials?

Because this is sort of, of course, something that is very much in development. There are very few accredited programs that do anything of the kind, and that has to do with the legality, that has to do with the way in which this has been operated, but also because it's really unclear how you would do this.

And I mean, as long as we have relatively homogeneous populations, which we currently work with in those clinical trials, by and large, maybe things such as spirituality seems still manageable, which could be very different if you imagine a US population right now.

So there are many questions we really haven't thought through and have no practical solutions for. And this is why this research effort is so important. There are lots of things that really need to be actually discussed thoroughly before stepping out and doing a lot of nonsense which one could with this. This can do harm.

CHARLES STANG: Roman, do you want to respond to that?

ROMAN POLITSKY: If I understood the question right, how do you get involved in the care part? I think there's two considerations. There's the legal and then there's doing good work. How do you get good quality training? And those are not necessarily going to overlap.

The-- so I've talked about spiritual health clinicians and chaplaincy. This is an ongoing kind of struggle, right? There have been recommended guidelines by the FDA, right, that don't include chaplains, that I don't think that's a good recommendation.

But I think that's excellent training. There's great training programs out there. The legality piece is I think is a whole other story and--

CHARLES STANG: OK. Thank you. Other questions? Yes. Go ahead.

AUDIENCE: Thank you all so much for being here. My question is specific to the publication that you shared, Dr. Marks, but I appreciated [INAUDIBLE] from all of you. Just thinking about the impact of informed consent on expectancy effects and the way that can be accounted for going forward.

But also, Dr. Marks, if you encountered that in your review, I'd also be curious [INAUDIBLE].

MASON MARKS: It's a real concern. I don't really have an answer because I think that's something we identify that there is a risk that the way you design informed consent will shape the experience to some degree. And so, I mean, I hate to point out my own example, but the--

--we're using the virtual reality or the augmented reality that significantly alter the types of experience that one would expect. And we don't know. We have to do more research to find out. But that's certainly a very valid concern.

About training, I would just say be cautious. There are a lot of people who want to sell training to you. So have to be cautious.

AUDIENCE: Good afternoon. My name is [INAUDIBLE] student, faculty student at the Graduate School of Education. And I just wanted to lift up a question. Do you think the route of legality is what needs to happen [INAUDIBLE] and plant-based medicine or intuition?

Do you think that can hinder the actual work that needs to be done? So I just wanted to get your thoughts on all that.

CHRISTINE HAUSKELLER: Did you ask for whether we should decriminalize it or legalize it?

AUDIENCE: Yeah, [INAUDIBLE] around that concept altogether.

CHRISTINE HAUSKELLER: That [INAUDIBLE] several levels of discussion, and I keep it very brief. But one is, of course, the criminalization of drugs. The war on drugs is a political project that has so many layers that have nothing to do with the actual danger of the related drugs that, yes, we need absolute decriminalization of drugs.

But with psychedelics, when you think then about how they could become something that in society could do more harm-- more good than harm, then we actually lack. And this is why we need to do this work. It's public education.

There's a lot of anxiety that those 50 years of legal limbo have created. There is levels of anxiety that maybe are not so necessary and others that I think we have not appreciated fully. So I think it's high time to think--

--but I think there can be no doubt that whilst we need to decriminalize the question of how to legalize, which is the next one, it's actually tricky, and it's [INAUDIBLE].

CHARLES STANG: We've been asked to repeat the questions for those folks who are joining us online. So I just want to repeat the last question, which is about, if I understood it correct, to comment broadly on whether legalization is the strategy we should be pursuing. Mason, Roman, do you want to respond to that last question?

MASON MARKS: I-- it's really important to distinguish between decriminalization and legalization. I think I agree that criminalization does not appear to be of any benefit. So I think I agree with that. And the question is then how to-- in what manner to regulate in addition to decriminalizing?

CHARLES STANG: Could you just very briefly spell out the difference between decriminalization and legalization for those who may not be familiar with the distinction?

MASON MARKS: Yeah. There are differing views, but I would say that the majority perspective is that decriminalization means to reduce or eliminate criminal penalties or their enforcement, whereas legalization is typically used to describe regulation of manufacturing, distribution, sales.

CHARLES STANG: Thank you. Question from Zoom.

AUDIENCE: Yeah, from Zoom. Directed to Mason, but I think any of you may respond. What is your view of whether or not a patient should be able to change one's consent for touch during a session? Perhaps they initially say no, but then during the session, they're having difficulty with welcome [INAUDIBLE] touch.

CHARLES STANG: Just briefly to repeat that then the question is to Mason but open to any of our panelists. What do you think about a patient's ability to change his or her view on being touched in the process of the therapy? Hope I got that.

MASON MARKS: The general rule should be that they should only be able to de-escalate, to reduce the degree of touch unless there is-- it's a question of safety, medical safety. Some people believe that it would be cruel to deprive that person of touch if that's what they say they want in that moment. But of course, could be very perilous. Harmful.

ROMAN POLITSKY: A phrase I really like for this is a Ulysses protocol where it kind of goes back to the story of Ulysses and the Sirens. Ulysses gets the other sailors to tie him to the mast, and he can't go off. And that way, he can hear the calls of the Sirens.

And so it's kind of building your parachute in the consent process, which maybe can even be nuanced. It could be part of the discussion of like, well, if I would rather have no touch, but if I really, really ask for touch, maybe it's OK to hold my hand.

That can be something a person can consent to beforehand, but after they've made their position clear.

CHARLES STANG: There's a question over here.

AUDIENCE: I had a question about the slide that talks about [INAUDIBLE] spiritual adverse impact. And I was struck that some of those things could also be positive. So, for example, having anxiety about death [INAUDIBLE] contemplate death every day or having a shaking up of the undercurrent in your beliefs.

So I just-- it strikes me that it's probably really difficult to qualify and define an adverse experience in that nuance, right?

CHARLES STANG: So just to repeat that briefly, the allegedly adverse effects, SERT effects can also be viewed in certain cultural contexts as potentially beneficial. So how would you respond to that, Roman?

ROMAN POLITSKY: It's a terrific question. And actually, a lot of this research was informed by research on meditation-related adverse effects where this stuff can also come up. I think it should be up to the care seeker. I don't think that it is up to us to impose a narrative of what is and is not adverse.

And so if they say that this has been a harm for them, I don't think it's our story to tell.

CHRISTINE HAUSKELLER: I think this-- there a lot of these questions that really need to be addressed and probably the ethics review board practices and separating out roles. I mean, we know that clinical trial participants don't like to tell the clinical trial team that something didn't work for them.

This is very well known. We don't need to go into psychedelics to find out about this. So it needs other people to do this, just like it needs other people to ask for consent. And this is in other parts of medicine perfectly well established that the trials in psychedelics seem not to follow such protocols. It's maybe where one should pick up.

ROMAN POLITSKY: I'll just add kind of on that topic. There's a wonderful essay by Robert Sharf. I think it's Is mindfulness Buddhist? And Why It Matters. I hope I got that name wrong-- that aim right.

[LAUGHTER]

But he usefully points out that the goals of a contemplative practice are not always the same as the goals that a care seeker comes in with when they're asking for some kind of a clinical support.

AUDIENCE: [INDISTINCT SPEECH]

CHARLES STANG: OK. Just to repeat. Hold on, Christine. Just to repeat. The question is about group therapy models versus individual therapy models and one aspect of group therapy would be driving down the cost of care. Question is, what do our panelists think about group therapy in the context of psychedelic assisted therapy.

CHRISTINE HAUSKELLER: Probably that you have three people in a room of which one has a psychedelic eyeshades and headphones is the weirdest thing about this whole endeavor ever because there is no other use of psychedelics, not in religious uses, not in raves, not in Indigenous uses, where anything such as two people watching one person being high ever happens.

[LAUGHTER]

So I think probably group therapy should for many reasons, of all we know about the effects of psychedelics, be the route to go. Only that this is not how medicine so far has worked and because you need to report the effect of this one individual who is itself responsible for their disease--

--and needs to get out of this disease somehow by themselves on a string. And so as long as we have this model, actually, this is how medical research seems to tend to operate. There are some attempts now to group research, and it's high time.

MASON MARKS: I think that's right. I mean, that's how these substances are used traditionally in Indigenous communities. It's a social occasion. Might involve an entire village. And AA is a model for that, you know, peer support. And that does appear to be underappreciated in even in Oregon.

And that the system for groups is a bit awkward there. So that's underexplored, I think. And also collaborative business structures, cooperative business structures as well. So not just in the actual administration, but in the production.

AUDIENCE: I have two-- I guess it's a two-part question. One is when it comes to the underground versus the [INAUDIBLE]. It's not seemingly a good amount of diversity, whether it's [INAUDIBLE]. But in the underground, there's a lot more [INAUDIBLE] because the illegality is hidden [INAUDIBLE].

How do you become more inclusive or connected with affinity groups that we have? Seems like no matter how you kind of slice it, it's going to be polarization between different groups saying segregate or keep [INAUDIBLE] from this because I've [INAUDIBLE].

CHARLES STANG: You're really going to challenge me. Well, hold on-- you may want to ask a second one, but I'm going to forget the first before, so let me try to paraphrase it. The psychedelic underground is more diverse than the psychedelic overground or above ground.

How do we ensure that the legal above ground spaces are more diverse and can treat more diverse populations well? Question two.

AUDIENCE: Secondary question is, what about-- you were talking about levels of certifications for people and well, there's so many people don't have access to the ability to [INAUDIBLE] financially a doctorate degree or to become a psychiatric mental health [INAUDIBLE]

How do we [INAUDIBLE] spaces where we're having-- there's more communal and available for us as regular folk who aren't as high [INAUDIBLE]. These things are grown from the Earth. We have [INAUDIBLE] access to them. [INAUDIBLE]

CHARLES STANG: Got it. OK. So I think closely related, the psychedelic underground does not require the same kind of accreditation. Accreditation narrows the kinds of populations that can become accredited. How do we break that open to make more diverse caregivers, both above ground and below ground? I hope I got it.

[LAUGHTER]

Go.

ROMAN POLITSKY: I probably won't be able to answer both because it would take so much attention. These are really, really important questions. These are the questions that we should be talking about. Just briefly, I think when we talk about legal--

--and clinical structural systems, we have to think about the tools that make those systems respond, and those might be different tools than would make underground systems respond. And so I think some of the work in adverse effects that we've been doing, you know, a critical shortcoming is because of the homogeneity of populations in trials.

We don't really know the adverse effects-- the full range of adverse effects that can occur, especially in the domains of cultural imposition and things like that. We know that in Indigenous spaces, the existence of psychedelic therapy itself can be a site of cultural harm--

--and grief because these are extracted from community practices and then sold at high cost, for example. And I think about the license-- about the clinical education piece, that answer for me, personally from my clinical standpoint, is a little bit easier.

I think two people can get together. One of them has a problem, and they talk about something and that person with a problem feels better. We don't have to call that therapy. We don't have to regulate that. That should exist, right?

But if that person says that they're a clinician, they're a therapist, and they are going to provide a treatment, then I think that person needs to be accountable in some way. And I think that's the system that I think about.

CHRISTINE HAUSKELLER: I would like to add something to this. And this is the clinical research is working with people who most people who have experience with psychedelics would say shouldn't take them. So people who don't have severe mental health issues are in a different space.

And this is a large part of the underground and to actually mix this up-- so there is a question whether we should take the medicalization for the whole thing. This is why I stressed these other groups being in existence. So what does medical research actually do?

It looks at a very particular limited use of psychedelic experiences to engender particular effects in people with defined conditions. And because they are particularly vulnerable, because of their conditions, this is very important that this is done right, yeah?

But this doesn't mean that there's anything desirable about this particular discourse, which is a very Western, very psychotherapy focused discourse to actually rule the roost over psychedelics. And I think this is where we should draw the line and think about, wait a minute, this is just this bit and then there's that.

CHARLES STANG: Mason, do you want to respond? And then I'm afraid this will-- we'll have to continue the conversation downstairs over the reception.

MASON MARKS: What's happening in Colorado right now is really a case study in what you're describing, a lack of representation and diversity. It had great promise. I'm talking about the Natural Medicine Health Act, which was a ballot-- a voter ballot initiative voters approved in late 2022.

And the reason it had such promise is it created-- it did these two things we're talking about. It decriminalized, and it legalized simultaneously. So it had a regulated side of the law and a decriminalized side.

And what was so interesting about the decriminalized side is it seemed to sort of prop up and legitimize the underground and give them a way to come out of the shadows. They could provide spiritual guidance, harm reduction services.

As long as they didn't charge for the substance, they could charge for the services. But almost immediately after voters approved that, the legislature swooped in, started chipping away at those rights. They could advertise the underground--

--or the decriminalized facilitators could advertise as long as it wasn't paid advertisement in the original law. So that meant at least they could speak about it on social media. That was removed, so they could not advertise at all.

And there's a new bill right now before the legislature to make-- to prohibit even discussing illicit substances on social media unless it's a licensed cannabis or psilocybin company. So they're chipping away at that.

And it could have really created some real equity for these sort of legacy underground communities versus the licensed medical framework.

CHARLES STANG: I generally don't think of my role here as editorializing, but I just want to highlight that this last exchange, I think is enormously important, and I'm so glad that it came up. So thank you for that question that it surfaced this, and thank you for your responses.

I'm afraid we are over time. That's the bad news. The good news is that we have a reception downstairs where you can continue to pose questions to our panelists. So please join me downstairs and also join me in thanking one more time our three wonderful panelists.

[APPLAUSE]

SPEAKER 2: Sponsor, Center for the Study of World Religions.

SPEAKER 1: Copyright 2024. The President and Fellows of Harvard College.