Video: Explorations in Interdisciplinary Psychedelic Research: Regulation Panel

April 01, 2023

On April 1, 2023, The Harvard Psychedelics Project at Harvard Divinity School, a student organization, held the "Explorations in Interdisciplinary Psychedelic Research" conference gathering together faculty, researchers, and students from across Harvard University to explore their diverse, interdisciplinary, and promising research on psychedelics. Speakers came from across the University’s Schools, units, and departments, including the Dana Farber Cancer Institute, Harvard Business School, Harvard College, Harvard Divinity School, Harvard Graduate School of Arts and Sciences, Harvard Graduate School of Education, Harvard Law School, Harvard Medical School, Massachusetts General Hospital, and POPLAR at the Petrie-Flom Center. This third series of talks featured Suzannah Clark, Max Ingersoll, Logan Fahrenkopf, Jeffrey Breau, and Paul Gillis-Smith.

Explorations in Interdisciplinary Psychedelic Research: Regulation Panel

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SPEAKER 1: Harvard Divinity School.

SPEAKER 2: Explorations in interdisciplinary psychedelic research regulation panel April 1, 2023.

JEFFREY BREAU: All right, so our first speaker from the panel will be Glenn Cohen, who is the faculty director of the Petrie-Flom Center, the James A. Atwood, and Lesley Williams professor of law and deputy dean at Harvard Law School. He is one of the world's leading experts on the intersection of bioethics, sometimes also called medical ethics and the law, as well as health law. He also teaches civil procedure here. Thank you so much.

GLENN COHEN: Great. If it's OK to do it from here because I don't have any slides, I'm just going to keep sitting, which is good. Always fun to relax, lean into it. So when I say words like artistic inspiration, a salve for mental health crisis, when I say words like spiritual enlightenment, I know there's only one word people in the room think of, and that is lawyer, of course, right.

[LAUGHTER]

So you might wonder what it is the law has to contribute to this great discourse we're having today. And I'm going to try to convince you the answer is quite a lot. So I am the faculty director of POPLAR, the Project on Psychedelic Law and Regulation. Other people affiliated with include Mason, Kamal Shaker, Jeannie Sue Gerson. Leonard's also an affiliate. Logan's been working for us. And we've done a number of papers on the questions of legal regulation, the legal future of psychedelics.

I'm going to talk about two of them, one published, one still in progress, just give a little preview of that one. But if I want to give you a high level idea of where we're going, my own view is we're at a moment where there are three pathways for psychedelic use in America.

And while they are all burgeoning, there's going to be points where they come into friction with one another, one is a medicalized model, which brings it into the therapeutic relationship of psychiatrists of prescription, one is a religious model, spirituality and fellowship, and one, for lack of a better word word, is personal use. So we might use the word recreational, but I think that devalues what we're talking about.

And unfortunately, it is the case that the regulatory superstructure has to think about how these are going to intersect. And some of the decisions we're going to make are going to clamp down on one wall, they burge on another.

And I find it fascinating. It's an amazing moment to be doing this work. There's visionaries. I'm so honored to be sharing the dais with this man who saw this wall a long time ago and built towards it. But we're at a moment where Congress here is jointly from veterans and Indigenous populations on these subjects where they hear about mental health suffering but also hear from big pharma on the question. So it's a very interesting moment of strange bedfellows in some instances but also real possibilities.

So the first topic I want to talk about is intellectual property. And here I'm going to draw from a paper I wrote with Mason in the Harvard Law Review Forum. So patents, as many of you know, are a form of government granted monopoly. They give the holders the right to exclude others from making, using, or selling an invention for approximately 20 years from the date each patent application is filed. The public policy justification for such patents is that the right to exclude competitors incentivizes innovation and encourages inventors to disclose their inventions to the public instead of maintaining them as trade secrets.

We see companies like the British pharmaceutical firm Compass, Pathfinder Limited, seeking and obtaining patents to protect the formulations of psychedelic compounds and methods of producing and administering them. Such companies argue that patents are necessary to protect their investment not only in drug discovery but also because of the cost of commercialization, which may involve very expensive clinical trials, as you well know, and other requirements to obtain FDA approval, as well as buy in from the medical community thereafter.

This sudden influx of psychedelic patents has prompted criticism from stakeholders, including patients, Indigenous populations, journalists, lawyers, and the like. They contend the patents can exploit the traditional knowledge of Indigenous communities without permission or adequate acknowledgment and compensation. Others argue that psychedelic patents are making a small number of companies gatekeepers for the emerging psychedelic industry which could inhibit research, stifle innovation, and restrict access to needed therapies.

In addition, some commentators frame the medical landscape as a thicket, a dense web of interlocking patent rights that restrict the entry of competitors. Formed when patent holders pepper the field with numerous patents on the same product or closely related product, these patent thickets discourage researchers and manufacturers from entering the field out of fear of being sued for infringement or having to pay a high licensing fee to patent holders. In many cases the result will be that only large, well-capitalized firms will be able to navigate these murky regulatory waters surrounding psychedelic research and development.

Granting patent exclusivity enhances existing disparities. And the unique characteristics of psychedelics together with the regulatory environment surrounding them may increase the likelihood of issuing bad patents. There are patents granted on inventions that do not meet the patentability requirements or that were patented in bad faith to block competition. And this is a real problem because the people who work at the PTO, the Patent Trademark Office, they typically lack examiners with sufficient knowledge of these substances in their history.

There's been long standing prohibitions, of course, of drug use from people in the federal government. And the associated stigma and criminalization threatens one's professional reputation and employment prospects. And when you don't have patent examiners with detailed knowledge of psychedelic compounds in their history of indigenous as well as underground use, the chance of bad patents getting through is more likely.

Critics of psychedelic patents argue that many granted and recently filed patents would not stand up to scrutiny. While some of these could lack novelty, which is a requirement of the patent statute, others may lack non-obviousness because a person having ordinary skill in the field could have foreseen how to make them. Others would be invalid if they claim naturally occurrence psychedelic plants, or fungi, or phenomena exhibited by these organisms as patent subject matter. But unfortunately, even if patents might ultimately be invalidated if challenged, they can be used to cause significant offensive harm against challengers.

Patent holders can claim infringement by potential competitors, many of whom will be unable to mount an effective defense due to the prohibitively high cost of litigation. To use an evocative phrase of my colleague, Bob Mnookin, in another context, "Business decisions are often made in the shadow of law, such as the threat of such litigation by a patent holder may deter backers from investing in space."

Asymmetries of power resulting from abuse of the patent system are particularly relevant to this emerging industry where barriers to entry are already very high. And we view the history of ketamine as a bit of a cautionary tale, space in which large companies have monopolized the space.

We also see a race between those who want to push a psychedelic renaissance focused on naturally occurring substances and those who want to push one based on synthetic psychedelics and the ways in which existing IP law and the cost of the FDA processes sets up some tension and some preferences for one of the other. And one way to think about it is that IP will to some extent set the terms about what psychedelics we get, which are allowed outside of underground use, and which are readily available for the therapies we so desperately need. OK. Thank you very much.

[APPLAUSE]

JEFFREY BREAU: Thank you very much, Glenn. Our next speaker is Rick Doblin, PhD. Rick Doblin is the founder and president of the Multidisciplinary Association for Psychedelic Studies or MAPS. He received his doctorate in public policy from Harvard's Kennedy School of Government where he wrote his dissertation on the regulation of the medical uses of psychedelics and marijuana and his master's thesis on a survey of oncologists about smoked versus oral THC pills in nausea control for cancer patients. He also conducted a 34-year follow-up study to Timothy Leary's Concord prison experiment. Welcome to the stage, Rick Doblin.

[APPLAUSE]

RICK DOBLIN: Thank you very much. It's really a pleasure to be here. First off, I just wanted to make, oops, a comment about terminology. So, Max, just be careful about counterculture as a term. So I think that was one of the big mistakes of the '60s for people to identify as counterculture. And so the thrust of our work has been to try to become the culture instead of to be the counterculture.

And then, Glen, just were struggling for another word for recreational. And so I like the word celebratory. It doesn't have the kind of pejorative terms that recreational does.

So I'm just going to briefly give you an overview. Brevity is not my strength, but I will try my very best. And, of course, it's almost Good Friday coming right up, so 61 years of psychedelics at Harvard. What got me into psychedelics was 1972. And it was out of despair for the way the world was going, the Vietnam War. I was one of the last years of the lottery. I'd been traumatized at a distance from the stories of the Holocaust and also the Cuban Missile Crisis so we could blow up the whole world.

And so when I first started doing psychedelics, I got this sense that if we could identify not as our tribe as our culture, as our religion, as our gender, as our nationality, any of these things, if we could have a deeper sense of who we are, that would be the antidote to racism and genocide. And there's a great album by Rita Marley, Bob Marley's wife. It's Who Feels It, Knows It. So it's not just to say it. You've got to feel it. And often this is where psychedelics come in. And that they're the only way, but they're a major way, and they've been used for thousands of years.

So this theory of change was reaffirmed for me by Robert Mueller. This was 1983. And he was the assistant secretary general of the United Nations. He also started the UN university for peace in Costa Rica. And this was his idea about shaping a global spirituality.

And you can see that the Earth from space was on the cover of the book. And he was saying that astronauts a lot of times we're getting the overlook effect. So psychedelics aren't the only way. It's a lot cheaper to give somebody psychedelics though, than just shoot them up in space.

But the theory is this that mysticism is the antidote to fundamentalism. And I think that's going to be one of the major challenges, I think, particularly here at the Divinity School is, how do we take people who are, you could say, in some ways inspired by but also trapped by fundamentalism and literalism? And how do we help them realize that if they let go that, something deeper is this experiential sense. And it doesn't mean that they have to give away your cultural context or your terms, but you can see them in a different way. So this was, for me, very inspiring.

And so I ended up writing a letter to Robert Mueller. And I said, your book is great. I totally agree with it, but you don't say anything about psychedelics. And would you like to know about psychedelics? And can you help us bring back psychedelic research? And he said yes.

Now, this is-- you can't really read it, but I just want to say that I developed a proposal for Robert Mueller in 1984. And this was for something that is happening in a sense right now by the studies of religious leaders with psychedelics at Hopkins and NYU.

So this was an idea is can we take a bunch of people who are in training for different religions and have different groups and some of them get psychedelics and some of them don't, and then you do a cross analysis from all the people in the different religions? Because a lot of the imagery is not going to be from-- I would predict is not going to be from their own cultural context. It will be, but it will also be other cultural contexts. And then what kind of studies can we see? And is there such a thing as an underlying common mystical core?

And we don't think twice about it when we talk about languages. There's all these different languages. But we don't say Russian is better than English, and English is better than German. They're all coming from our common desire to communicate using sounds. So I think that that's one way to think about religion.

And we actually did scout the UN grounds for a potential psychedelic research site at the time because the UN is not technically in America. They've got their own little legal status. So we never got permission to do this at the time though or didn't do it. But this, I think, is what's really exciting about the work that's going on with psychedelics and spirituality.

This is our MAPS logo as interpreted by Alex Gray. But the important point is that the hands are in front and the psychedelic swirl images in the back, meaning that it's about therapy. It's not about the drug. The drug makes the therapy more effective. It's not like ketamine that's often administered without any therapy. This is therapy is administered with the adjunct of a psychedelic. And that's the message that we're trying to get across also to the FDA, to the DEA that this is really a therapy tool.

Now, this was Timothy Leary and I in 1990. And so this was a benefit for MAPS. And it was tremendous. And after his talk, I went up to him and I said, can you please give us some advice, those of us who are wanting to work with the government to try to do psychedelic research? You've been struggling for so long in this field of psychedelics, and you did this early work at Harvard. What advice would you have for those of us who want to do work with the government? So the first thing he said is fuck the government.

[LAUGHTER]

He said, I am so far past asking for permission for anything, but I'm glad you're doing it. And that's where he held up my hand. So I thought this was the passing of the torch in a way.

All right, now the Good Friday experiment, what shocked me is that it took place in the Marsh Chapel. And when you look at the inscription that's above the door to the Chapel-- now, the actual Good Friday experiment, the group was down in a basement Chapel. But Howard Thurman was above giving the lecture. And it was piped in downstairs.

But what I was shocked to read chiseled in there is, "Let this Chapel at the center of the university campus signify forever the centrality both of intellectual and experimental religion in education and also of devotion to God's righteous rule in human lives." So this phrase experimental religion that they put up their way before they even had the Good Friday experiment.

Now, the other part is that Howard Thurman, who is the minister here, studied with Gandhi. And he was very interested in the role of spirituality in political action, the political implications of the mystical experience. And Howard Thurman was also the mentor for Martin Luther King. And Martin Luther King got his PhD at Boston University. So we have from the person that really helped start this research in psychedelics and mystical experiences also helped introduce the whole concept of nonviolent resistance to the American Civil Rights Movement. It's really inspiring.

So one of the problems, though-- now I'll just say from my follow-up to the Good Friday experiment-- was that the results were affirmed that was shocking. People could remember very clearly what their psilocybin was. A lot of times the people that got the placebo, didn't have that much memories. But what I found was that there was a bit of an exaggeration of the benefits. It was written in Time Magazine. Everybody that had the psilocybin had a mystical experience like the saints of the ages, and that's not true-- not all of them did.

And then it turned out that one person was so moved by Howard Thurman's speech, which by the way, was recorded and is on the MAPS website. So if you want to hear Howard Thurman's Good Friday lecture, we still have it. And one part he's like, you have to tell people there's a man on the cross. You have to tell people there's a man on the cross.

And this one divinity student from Andover, Newton, said, yeah, I should do that. I should do that now. And I should tell the president. And I should leave this room, and I should go tell the president. And then he's like, well, the president is in Washington. I'll tell the president of the university.

So he's wandering down-- as you know, Commonwealth Avenue is not very-- it's not a quiet street. And so Walter Pahnke and Huston Smith got really nervous and went chasing after him. And they caught him, and he didn't want to go back indoors. Now he's outside, and he's got this mission to tell the president. So they injected him with thorazine. And that was completely missed. They never reported that. So there's a bit of an overemphasis on the benefits and a minimization of the risks.

But then their next step was going to be the Concord Prison Experiment. And this idea that you could have a mystical experience, but how you describe it is subjective. What you say about its benefits in a way are subjective. But if you can reduce recidivism, that's an objective external measure. And this would be a great way to show that psychedelics had transformative power.

And so they actually went into Concord Prison, took psilocybin with the prisoners-- they would have half the researchers get a placebo, have to take psilocybin. And they treated about 35 people. And they ended up releasing them. And then they tracked recidivism. And this was considered to be one of the most best examples of psychedelic therapy in the history of the psychedelic literature.

And when my paper about the Good Friday Experiment was published in the Journal of Transpersonal Psychology in 1991, I got a call from someone from the Department of Corrections here in Massachusetts. And he said they had a room with the files from interesting prisoners. Malcolm X was one of them.

But they had the prisoners from the Concord Prison Experiment. And that list was gone. Nobody had that list. So they let me go ahead and do that. Took a whole year to get permission from the governor. And the permission came with this scribbled-- it was permission, but somebody had scribbled, no psilocybin. We weren't asking to give psilocybin. It was like, no psilocybin, just to make sure.

So what I discovered unfortunately was that this was a completely flawed analysis and that it did not really work. And that there was one example that you could say is close to scientific fraud, which was that obviously the longer you're out of prison, the more likely you are to go back. So they compared their 35-plus people when they were an average of 10 months out of prison, and they compared it to the base rate of people that had been released from Concord Prison the years before but at 30 months. So it's obviously that there'll be more people going back to prison after 30 months.

And when you look at the actual paper that they wrote where their base rates, they tracked it over time. So the 10-month rates for each one of them were identical. But what happened was that Leary and Metzner and Dass, they all realized that you cannot just give somebody a psychedelic experience. You have to support them when they get out of prison the same way that we talk about integration after the psychedelic experience. And once they realize that, they started setting these up, and then they got kicked out of Harvard. And so that fell apart.

So the experiment has never really been done, but it's an example, I think, of Leary believing that since the world was demonizing psychedelics and exaggerating the risks and suppressing it denying the benefits, that he was justified to do the opposite. And so I think we have to be very careful. If there is going to be a backlash, I think it will come from us exaggerating the risks-- I mean, exaggerating the benefits and minimizing the risks.

Now, part of symbolism of the psychedelic renaissance is we had to start research at Harvard again because this is where things began. We also had to start research with LSD because that's the quintessential scary psychedelic. So in 2007, we did manage to start at McLean Hospital a study with MDMA for cancer patients. And one of the things that I'm most proud of in the entire history of 37 years of MAPS is that we managed to start LSD research in Switzerland in 2008 right before Albert Hofmann died and his wife, Anita.

So they were married 79 years, but they were able to see the very beginnings of LSD research starting again. But it was really also this symbolism of getting psychedelic research starting back at Harvard that I think helped cement this concept of the psychedelic renaissance.

Now, we have two successful phase three studies. And this is just the results of our first one, severe PTSD, that There's a whole strategic analysis. I won't get into it because of time. But there's a whole strategic analysis, like which drug, which condition is most likely to make it through the system? I thought MDMA being the most gentle. And we needed sympathetic patients. So I like to say we don't do science. We do political science. We have to be very careful of why we're doing this and what's the message that we're sending.

So this is severe PTSD often in veterans and others. Although the veterans get the media attention, but two thirds of the people with PTSD are women from sexual assault, usually. So the veterans get the media attention, and it's not quite a fair representation. But it's a way to get bipartisan support.

So what we showed is that therapy plus inactive placebo, which was the best way to do these double blind study, which the FDA agreed, one third of the people, 32%, no longer had PTSD at the two-month follow-up after three day-long therapy sessions and 12 90-minute non-drug psychotherapy, so 42 hours of therapy.

So it's pretty great that these people who had PTSD, an average of 14 years, one third over 20 years, one third of them almost had no-- they would not qualify for a diagnosis of PTSD at the two-month follow-up. But then you give MDMA, you add it to the mix, and it more than doubles to 67%. So it's astounding. And another 21% are treatment responders. they have clinically significant reductions of PTSD, but they still have PTSD. If we give them a four hour session or over time, so we basically have 88% responders, 12% non-responders. So this was our first phase three study.

Our second one-- we just released a press release January 5-- it was confirmatory. So you talk about your first as a pivotal study. Your second is confirmatory. So it has taken us from 1986 when I started MAPS. 85 was when MDMA was criminalized. So pretty much 37 years to get to this point of two successful phase three studies. And this was very, very successful and is being submitted to a major journal, and hopefully it'll be published in the next couple of months.

And then we've got the world's biggest conference on psychedelics coming up in Denver. I'd like to invite all of you to that. We've already got over 5,000 people coming. We've had three other psychedelic science conferences, 2010, 2013, 2017. And this is the one the theme is the doorway to the new world. And this new world is going to be not just MDMA but psilocybin and other substances becoming, I believe, prescription medicines in certain controlled contexts.

And so I'm very proud that Josh Gordon, who's the head of NIMH, is going to be coming. Michael Pollan's coming, Deepak Chopra. There was actually a really hilarious thing. I'll say it was on Fox News Sports. And it was about Aaron Rodgers, who's a football quarterback. And I was just with him the other day in Austin. And he's had ayahuasca experiences.

And so this was like Fox News Sports team debating, is this a good idea? Is this a bad idea? What is this? But to see the Fox people come on, oh, no, it's just for medicine, it's not-- it was fantastic. So I would like to invite you all to this conference. And it's just a pleasure to see that the Devin skull is really comfortable and law school that all of this is moving forward in an above ground way. And I will say I think it is becoming the culture, not the counterculture.

[APPLAUSE]

JEFFREY BREAU: Thank you so much, Rick. A Wonderful example of the past of Harvard meeting the present and hopefully helping create the future. We are now going to turn-- our next two presenters will be on Zoom. Our next presenter is Dr. Mason Marks. Let's see if he's able to-- just on-- here we go.

Yep, so Dr. Mason Marks is the Florida bar health law section professor at the Florida State University College of Law. At Harvard Law School, he is a senior fellow and project lead of the Project on Psychedelics law And Regulation, POPLAR, at the Petrie-Flom Center for health law policy, biotechnology, and bioethics. I welcome to the virtual stage Mason Marks.

MASON MARKS: Perfect. All right, thank you so much. So thank you, everyone. Thank you, Jeffrey. Thank you, Paul and Professor Staine for organizing this event. It's really great to be with you. I'm going to talk a little bit more about the work that we're doing at the project on psychedelics law and regulation. Glenn Cohen talked about a couple of the projects we've been working on, and I'll talk about two more.

We started POPLAR in 2021 because we were watching these academic programs crop up around the country and around the world, but they were all focused on the medical applications for psychedelics. And we observed that there was a lack of work being done on a legal and ethics side. And so that is really the necessity through which POPLAR was born. And I really want to thank Tim Ferriss and Matt Mullenweg for supporting our research through the Saisei Foundation.

We just really see the law as one of the primary obstacles to scientific progress in this area. So I'm really excited to be a part of exploring the legal landscape. And that's what I want to talk about first is to provide you with an overview of the psychedelic legal reforms that are sweeping across the country, what I like to refer to as the psychedelic legal renaissance. And most of the action is on the local and state level. I'll give you an overview of that. And I'll talk a little bit about what's going on at the federal level, but it's not quite as comprehensive.

So I recently published an article called The Varieties of Psychedelic Law in the journal Neuropharmacology where I break down five different categories of psychedelic legislation that we're seeing. There are others that exist in other countries, but these five are really the types that we're seeing in the US and certain hybrid approaches, combinations of these different categories. And the first is decriminalization, which involves either the reduction or elimination of criminal penalties associated with various activities like producing, possessing, consuming, or sharing psychedelics.

And decriminalization really exists along a spectrum. So on one end of the spectrum, you might see complete elimination of criminal penalties, and on the other might see criminal penalties remaining in place but a legislature or a city council issuing a policy that it won't enforce those penalties. And so that might more accurately be described as deprioritization rather than full decriminalization.

This trend really started in the US in 2019 when Denver became the first US city to decriminalize psilocybin producing mushrooms. And several other cities like Oakland, California, Santa Cruz, California, Ann Arbor, Michigan, and Cambridge and Somerville, Massachusetts, followed suit shortly thereafter. And they added other substances in addition to psilocybin.

Massachusetts really has become a leader in this area. There are about 15 cities now that have decriminalized psychedelics to some extent. I believe Massachusetts has five. And that is thanks to the efforts of activists like those at a group called Bay Staters for Natural Medicine and other groups like them around the country, like Spore in Colorado and Discriminator Seattle in Washington State. These groups have are volunteering their time to educate lawmakers about psychedelics and to advise them on decriminalization policies.

At the state level, we only have two states that have decriminalized psychedelics to varying extents, Oregon and Colorado. Oregon was the first state where voters passed a ballot initiative, Measure 110, in November of 2020, which partially decriminalized psychedelics or the possession of small amounts, personal use amounts not only of psychedelics but of other controlled substances, like cocaine and heroin, for example. And it reduced the penalty from a misdemeanor to a civil infraction or a $100 fine that people can avoid by agreeing to go through a substance use treatment assessment process.

The second state to implement decriminalization was Colorado where voters passed Proposition 122 or the Natural Medicine Health Act last November. And this is another ballot initiative. So far, decriminalization has not been very palatable to state legislatures. And we've only seen these types of laws come into being through ballot initiatives or voters approved them.

In Colorado, the decriminalization went a little bit farther instead of limiting penalties to people who possess more than personal amounts. In Colorado, proposition 122 remove criminal penalties for production and even sharing of psychedelics and not just psilocybin but psilocybin, mescaline, ibogaine, and dimethyltryptamine.

The next category that I want to talk about is called supported adult use. And I'd like to draw a comparison to recreational cannabis or what might more accurately be called adult use cannabis regulation. This is really the dispensary model that exists in many US states, including Massachusetts where people go to a retail store, and they purchase cannabis. And they can do so for any reason. They don't need a medical diagnosis. They don't need a doctor's prescription.

The supported adult use of psychedelics, like psilocybin, is similar in many ways because people don't need a medical diagnosis or prescription. However, they can't take the product home. They have to utilize it at a special center, a service center, or healing center where a licensed psychedelic facilitator is there to support them ensure their comfort and safety.

So Oregon was the first state, again, to implement this type of legislation. Voters approved measure 109, the Oregon Psilocybin Services Act, alongside the decriminalization ballot initiative measure 110, again, in November of 2020. And since then there's been a two-year rulemaking process where the Oregon Health Authority has been creating rules for this emerging industry that it published in December.

Colorado is a little bit later, came along a little bit later. Alongside the decriminalization provision of the Natural Medicine Health Act, there was also a framework for supported adult use passed last November. And the governor recently appointed members to a Colorado natural medicine advisory board in January. And that board will start meeting this month on the 13th to start advising regulators in Colorado on these rules, which will take shape over the next 12 to 18 months. And these service centers should open later this year in Oregon, but they are still several years in the future for Colorado.

Now, there are some other states that have this type of legislation. Under consideration currently, Illinois, for example, has a similar type of hybrid bill that combines decriminalization with a supported adult use framework. So we'll see what happens with that bill and similar bills in other states.

The third category is medical use. This is really the closest to traditional health care where someone needs a particular medical diagnosis. They need a physician's recommendation or prescription. And we're seeing bills like this in various states. Like New York, there is a proposal.

Connecticut actually enacted this type of legislation. Unlike supported adult use, which arguably conflicts with federal laws, like the Controlled Substances Act, medical use legislation often dovetails fairly nicely with federal laws and FDA regulations. So in Connecticut, for example, they are leveraging the FDA's existing expanded use program. And that allows one to provide access to a controlled substance an experimental or investigational drug that is not yet FDA approved.

The fourth category of legislation we're seeing is best characterized as clinical research. And this is really just where a state provides some funding and support to open a clinical trial in the state. Texas is perhaps the best example of this where research is getting underway in Houston at the Houston Medical Center and VA utilizing, I believe, it's psilocybin in a veteran population with PTSD.

And the final category that I'll touch on, I call, policy analysis. This is probably the most conservative approach to psychedelic legal reform. Really what happens is the legislature might provide some money to create a task force or a work group to study the feasibility of further psychedelic legislation. And we've seen this type of legislation under consideration in states like Hawaii as well as Washington State, which now has this type of bill under consideration by the legislature.

One of the projects that we have in the works which should come out any day now actually in the Boston University law review is a law review article about the regulation of microdosing where people take small doses of a psychedelic, typically a dose that doesn't cause any perceptual changes. And in this article, we address how microdosing is regulated currently under state, local, and federal law and how that perhaps should change in the future.

The second thing I want to talk about in my remaining couple of minutes is the reform of controlled substance regulation. Our colleague at POPLAR, Carmel Shaha, and I recently published an article in Nature Medicine called drug scheduling limits access to essential medicines and should be reformed.

And in this piece, we talk about how we like to think of schedule one, which is the most heavily restricted category of controlled substance, as a regulatory black hole. And that's because once substances are placed into schedule one, they almost never come out. And that's due to an informational asymmetry where very little, often low quality evidence is required to put a substance into schedule one. But you need a mountain of very high quality evidence to take it out. And due to this informational asymmetry, substances get trapped there.

And I know that Rick Doblin is very familiar with this because in the 1980s, he urged the Drug Enforcement Administration, the DEA, not to put MDMA into schedule one. And they went ahead and did that anyway. And it's taken all these years since then and tens or hundreds of millions of dollars to be on the brink of potentially taking MDMA out of schedule one.

And part of the problem is that over the years, many people, including courts and legislators and regulators, have confused the requirements and the purpose of scheduling with the FDA approval process. And oftentimes they're treated as the same. And they actually serve different purposes and have different requirements. There are some efforts to try to change that.

The one I'll just mention briefly is the Breakthrough Therapies Act under consideration by Congress, which is being sponsored by Senators Booker and Paul. And what that would do is that would help address this information asymmetry. Right now you really need data from phase two or more likely phase three clinical trials, if not full FDA approval, to take a substance out of schedule one. And the Breakthrough Therapies Act would reschedule substances that are designated breakthrough therapies by the FDA.

So psilocybin and MDMA have both been designated breakthrough therapies, which means that they could represent a significant improvement over existing treatments. And to get that designation, you only need safety data from phase one clinical trial. So that would significantly reduce that barrier and could help take substances that could arguably be life-saving for many people out of schedule one, get them into researchers hands, and get them into the hands of clinicians and patients sooner.

So there isn't a lot happening right now at the federal level. There's some early activity, like the Breakthrough Therapies Act. Congress now has a psychedelic caucus to educate members of Congress about psychedelics. And a psychedelic task force is also forming. I'm encouraged by that. I think there will be a lot of exciting developments in the future.

And I just want to wrap up by saying that I think Harvard really is the leader in this area. I don't think any other university has the depth and breadth of programs on psychedelics that span the law, religious use, and medical use and others quite so effectively. So I think the future is very bright for psychedelics research at Harvard. And I hope you all will participate in that. Thank you so much.

[APPLAUSE]

JEFFREY BREAU: Thank you, Mason. Our final speaker today, our final panelist today is William Leonard Picard. William Picard is alleged to-- or Leonard Picard is alleged to have produced 90% of the world's LSD. I believe that is a quote from the DEA.

[LAUGHTER]

He is a former drug policy fellow at Harvard's Kennedy School of Government, research associate in neurobiology at Harvard Medical School, and deputy director of the drug policy analysis program at the University of California Los Angeles. With two life sentences without parole, he served 20 years in maximum security federal prisons before being released in 2020. I am very honored to welcome Leonard Picard to the virtual stage.

[APPLAUSE, CHEERING]

WILLIAM LEONARD PICARD: Yes, good afternoon, and lovely to be with you all, and especially with colleagues Glenn Cohen and Mason Marks and Rick Doblin. Lovely to see you all. I must appear virtually, not being permitted to travel on this occasion. But we'll do a brief historical aspect of what all came before the medicalization paradigm and some projections on possible futures, what may come. So let's share a screen and proceed into a number of slides in the historical aspects, and then we will return to possible future scenarios.

Imagine yourself 20 years ago. What were you doing in psychedelics? I was kneeling in this field in Kansas with a gun placed to my head explaining my brains were going to be blown out for making 90% of the world's LSD. Of course, I disagreed with this idea.

But I had arrived in the field after running through the night with the police helicopters overhead with down-looking infrared and finally into a little barn, at which case I prayed through the night and in the morning was surrounded and kneeling on the field. 90% of the world's LSDs, that's hundreds of millions of doses, during the past 20 years, allegedly.

But what were the historical events that brought me to my knees in that field in Kansas? It all started with this fellow, Augustus Stanley Owsley of a Kentucky political family. Owsley produced during his lifetime 500 grams of LSD in the early '60s. That's a million doses, quite a large batch at the time. Went out all over San Francisco and Northern California.

But he was superseded by this fellow, Nicky Sand, Nicky Sand the chief chemist of the brotherhood of eternal love and a friend of Rick's before he passed as well as my own in my youth. Nikki, a wonderful blotter, photograph of Nicky, produced 150 million doses in the course of his career, about 13 kilograms of pure LSD that went out across not only Northern California but across America and the world and Italy, France, Thailand, and South America, a revolution at the time.

The Kansas Lab was alleged by the government to produce that quantity each year for 20 years. Nicky, Owsley, and myself were all students of this wonderful individual Sasha Shulgin and Anshul, authors of the seminal text speckle and tickle.

Sasha was the lone voice crying in the wilderness in the '80s and the '70s, the leading medicinal chemist pharmacologists in the world in terms of entheogens and an inventor of hundreds analogs of great consequence, the early promoter of MDMA for underground therapy, and the inventor of 2CP and DIPT and a wonderful constellation of very interesting compounds. Saw Shannon in a blotter holding a molecule MDMA, a beloved throughout the world for their contributions.

But before all of this occurred, I found myself at Kennedy School just down the street from the [? divi ?] school up all night having extraordinary experiences learning and drug policy, alleged by the government to have issued during this period on occasion interesting blotters. This is a album covered blotters. It's the Grateful Dead album covers. 50 doses, you can see the little lines that break each dose apart, each containing about 100 micrograms of LSD.

But mostly at the Kennedy School studying under this wonderful, wonderful teacher, the leading drug policy analyst in the United States and also Rick's mentor as well as mine, an early influence on the structure of MAPS and his progress through DEA and FDA regulations.

But back to the field in Kansas, which led me here, 30 foot walls, no horizons, no flowers, no children, no dogs, no streams, no mozart, just gravel, walls, steel, a rather horrific environment, especially with these grad students in criminology, quite interesting fellows that one learned to be very polite around. There were killings, stabbings.

I'm speaking here of extreme regulation. Remember, psychedelics are still schedule one. They are truly illegal. And possession of large quantities can lead you to this. This was my home for 20 years most of the time, 60 square feet, good for meditation and yoga and writing.

During this period, I reflected back on some early work at the Kennedy School and the prediction of the fentanyl epidemic in 1996 under Mark Kleiman, in which we anticipated the next major drug of abuse would be fentanyl. That work was picked up by Rand Corporation in 2019 while I was still incarcerated and published in their seminal work, the future of fentanyl and other synthetic opioids.

I was released shortly thereafter. Rand quoted the fentanyl prediction at the Kennedy School as the first prediction and recommendations for prevention of an epidemic that was 20 years in the future was considered science fiction in '96 but unfortunately became the tragedy it is today.

Released in 2020, I entered a world where billions of dollars and thousands of distinguished researchers had eyes upon psychedelics. And I encountered now working with the venture firm in New York City, great organizations, such as Cybin, Compass, which is run afoul of American view in terms of its control of the patents for psilocybin, the still extraordinary collection of individuals,

Gilgamesh, which is a ibogaine analog firm. Much of the new structure is made by Dolly Sims Lab, a chair of chemistry at Columbia manufactured overseas now valued at about $80 million and other firms, hundreds of firms. Frankly 300 to 500 psychedelic firms have appeared in the last three years as a result of not only Rick's work but Rowland's work, seminal efforts at Hopkins.

Of course, DARPA got into the mix and is now offering, oh, goodness $20 or $30 million of grants to develop substances that are not psychoactive that have effects on neuroplasticity. They may have healing effects, but the long night of the soul is not necessarily required to have these effects. So the hypothesis goes. The community is still divided upon it.

The most interesting developments that I can see presently are in artificial intelligence. In the firm that I worked for, which a number of startups, Celera, Sci.bio, Gilgamesh, a number of firms that rely upon artificial intelligence and computational chemistry in order to create novel compounds. And so this leads us into what is the question of the future? What outcomes will we see in the next 5 to 10 years? Or ultimately, which way are we going? Let me get off screen sharing now so we might get a good look at each other.

The future based on what we see in terms of artificial intelligence in terms of drug development, the wide variety of MDMA analogs and DMT analogs by firms, such as Tactigen and Redwood City and Beckley Scitech at Oxford, we will see tens of thousands of new analogs based on the classical legacy compounds, DMT mescaline, LSD psilocybin. We'll see intravenous use, sublingual use, buccal use.

Every conceivable variety of variations on these molecules is being developed as we speak. And stakeholders are claiming patent rights for every molecular variation, even those dreamed purely in silico by artificial intelligence platforms, such as Schrodinger.

We have four possible futures I could anticipate based on experience that we may be moving toward. The first future was all is well. Things will go smoothly. The 300 clinical trials will play out quite easily. We'll have wonderful new medicines all well and good. I trust that will be what will occur.

The second possibility is we'll have an untoward event. Something unusual may happen on the street. Or something unusual may happen in the clinic. There may be a behavioral acting out. This thing was seized upon by the government in the '60s to create the great darkness of the next 30 years and the oppression and laws and heavy regulations that occurred as a result of it.

So the second alternative in the future is we see an unusual event occur clinically or on the street, something worthy of media in which case there may be a blow-back media wise. Right now we're in a honeymoon phase, very positive things. We all have great hope.

For Rick Shepherd, those are MAPS. Those of the hundreds of firms doing such wonderful research. And we have the momentum and the distinguished eyes upon this and the funding upon it. So the future is likely bright, but there may be an awkward moment in the next few years.

The third possible future is an increase in regulation doing such awkward moment, increase in moving backwards in time perhaps 10 years. I don't consider that very likely. I consider that the regulations will continue to soften barring an awkward event, such as more tolerance of the decriminalization movement, more federalisation on the hill of the Booker Rand Paul Breakthrough Act allowing rescheduling to schedule too more research in that.

But all of these futures, the fourth future is complicated by the variety of analogs that are occurring. We'll see analogs that are marvelously new medicines. We'll see analogs that are little horrors, new beasts like fentanyl. So future is caught between these two extremes.

Likely, the positive aspects will prevail, but there may be little horrors that come along. An example is in bomb the hallucinatory variant on 2CB that turned out to be something of a killer In India and parts of Europe. We'll see development of new religious cults like under the Religious Freedom Restoration Act. So those in the dev school that want a good PhD thesis might consider RFRA evolving from legacy compounds and also from new analogs, a new God molecule that attracts attention from congregations.

In closing, I can only point out that in the past, medicalization has led to maybe 20,000 or 30,000 individuals receiving psychedelics. That's about to change. There'll be hundreds of thousands, if not millions. But in the past, in the underground, there were 2 billion doses distributed around the world in the last 40 years. And that continues at the rate of 200 to 300 million doses a year in the illicit underground market.

We trust that the medical market will expand broadly around the world bringing marvelous new medicines. Let me close with those thoughts and with all honor to our distinguished panelists and all honor to the many gathered here today to advance this dream. Thank you.

[APPLAUSE]

JEFFREY BREAU: Thank you, Leonard, and thank you to all of our panelists.

SPEAKER 2: Sponsors, the Harvard Psychedelics project at HDS, the Center for the Study of World Religions at HDS, and Harvard Divinity School.