Rick Doblin revisits his 1972 draft resistance—later pardoned by Jimmy Carter in 1977—and MAPS’ 30-year push for MDMA-assisted PTSD therapy, achieving an 88% response rate in Phase 3 trials. He debunks flawed psychedelic studies (e.g., Johns Hopkins’ retracted primate research) and warns against hype, while leveraging Reagan-era data exclusivity (2024–29) to fund broader applications like couples therapy. FDA approval hinges on transparency and bipartisan support, with Doblin aiming for equitable access despite scaling challenges, ultimately framing psychedelics as tools to reduce trauma, nuclear risks, and environmental harm by 2070. [Automatically generated summary]
Yeah, I'm pretty extremely lucky that 51 years ago when I was 18 in 1972 and I decided to focus my life on psychedelics, that now I'm 69 all these years later and it still makes sense.
Well, back then it must have been a big risk because in the 1970s, when you focused your life on psychedelics, that was like right after that whole sweeping Schedule I psychedelics act was passed, right?
I thought that I would serve my country by going to jail.
Which is kind of a funny way to say it, but I had felt that I'm not a conscientious objector.
In order to do that, you have to be a pacifist.
And so I'm not a pacifist.
I think there are some times you need to fight and defend yourselves.
So the only options for me as I studied how to respond to Vietnam I didn't want to pretend I had bone spurs or run away to Canada or anything like that.
And I studied Tolstoy and Gandhi and nonviolent resistance and decided that the thing that I would do would be to not register for the draft.
And I was paying taxes.
I had a social security number.
I had a driver's license.
I was in high school.
I figured the government knows who I am and knows where I am and knows my age.
And so I assumed that I would go to jail and that that would be a way to drain the system of energy and to register my protest that way.
Martin Luther King actually said a great thing.
He said, the person that thinks the law is unjust and violates it and is willing to suffer the consequences as an example to others About the unjust nature of the law actually has the highest respect for the law.
He was trying to reframe civil disobedience as patriotism.
And it made sense to me.
And so when I talked to my parents about it, they were like, well, okay, you know, we don't think you should go to Vietnam either.
We don't think it's in America's best interest.
But you're never going to be a doctor or lawyer.
My dad was a doctor.
Because you'll be a felon.
And I'm like, that's a price I'll have to pay.
What am I going to do with my life?
I can't have a normal job in a way.
So then when I stumbled on psychedelics, I was like, great!
I could be an underground psychedelic therapist that doesn't need a license.
There's still some people that think it was a good idea that we got Saddam Hussein out of power despite all the horrible collateral damage and the million people that are innocent that wound up dying in Iraq because of that invasion, but nobody thinks Vietnam was good.
Well, one of the people also quite interested and supportive of psychedelic therapy is Daniel Ellsberg, who was the person that released the Pentagon Papers.
But the false flag began with the Gulf of Tonkin incident.
And so we're told that our ships were being attacked.
And he was, I've gotten to spend some time talking to him, and he said that he had just started the National Security Administration at that time, was looking at some of these cables and realized it didn't make sense, but he thought somebody above him knew more than he did.
And he didn't feel like he should say anything about it.
And then all these years later when he released the Pentagon Papers, And people think of him as a hero because he was willing to go to jail for decades and decades, potentially the rest of his life, which is what the government was trying to do for him.
Went all the way up to the Supreme Court and he won the case, or the New York Times also won the case.
But he thinks of himself not just as a hero, but that he should have had more courage early on.
And if he would have done something early on, maybe more people would have realized that this wasn't the way the government was saying it was.
But I do think that there is patriotism in civil disobedience.
Yeah, and I think it's really remarkable for me now that because I was not a pacifist and I was not a conscientious objector, I always felt that the freedom that I had was defended by our military in World War II. If we had lost and I'm Jewish, I probably would have been killed along with others.
So I always felt that the military was essential and it was protecting my freedom.
And so now, all these years later, to have so much work to be done with veterans and in the Veterans Administrations and with, you know, special operators and all sorts of people with PTSD, it feels right in a way that a draft resistor should form an alliance with suffering veterans.
Yeah, I think that's one of the best aspects, at least publicly, of what you guys are doing, is that you are working with all these soldiers.
And so you've got a lot of support from people that traditionally wouldn't be invested in psychedelics.
Which has really kind of opened up.
It used to be that a lot of people on the right thought of psychedelics as a way to waste your life and you're going to be a hippie and a loser.
But because of the benefits that it's been showing to people with PTSD and people coming back from all these various foreign conflicts, now you're getting support from veterans.
You're getting support from the people on the right and people that know veterans that have had incredible experiences with psychedelics.
Where it's completely changed their life and sort of reset their mind.
Yeah, just several days ago I was in Nashville with Sean Ryan doing his podcast and he is a former Navy SEAL and CIA contractor and he was just talking about how much he had benefited from his experience with Ibogaine in Mexico.
And how it's changed his views about things.
And we've heard this a lot.
But he still said that if he were to be attacked, if America was to be attacked, he would defend it.
It doesn't turn people, again, into pacifists, necessarily, in that same way.
And there's something noble and honorable about willing to serve your country and be willing to give your life to protect others.
I think it's a problem in some cases when the political leadership makes terrible choices.
And, you know, you've enlisted to do that.
I think the other part, last week I was in Dallas, and we had an event that Governor Rick Perry attended, and Marcus Capone, and Jeff George, who's the chair of the board of directors of our MAPS Public Benefit Corp., and then also Amy Emerson, who's the CEO of that.
We have Governor Perry's support because he's heard from so many veterans.
He's also talked about Marcus Luttrell, who lived with him at the State House when he was very emotionally damaged from his time in the military.
And then he saw Marcus get a lot better when he went down to Mexico and got Ibogaine.
And so Governor Perry...
There's people that I have never thought that I would find common ground with.
And one of the ones that I thought was the most far that I couldn't imagine building a bridge, I mean, one of our themes is Be the Bridge, but it was with Ted Nugent.
And I thought, you know, how would I build a bridge with Ted Nugent?
Well, Rocco Moon, his son, connected us, and Rocco is interested in being a psychedelic therapist.
And he's been doing a lot of work educating his dad.
And we had a really remarkable conversation.
And Ted actually said that he could be extremely effective for helping us because he's known as being so anti-drug.
Yeah.
And yet, even he can see that in a therapeutic setting for veterans, that's what he cares about the most, but others, that these things can be helpful.
So this idea of building bridges.
There was one point in time, one of the most important lessons I learned was actually...
From a Supreme Court Justice, where I was sitting next to him at Passover Seder.
This is Stephen Breyer.
And I had accepted a donation from Rebecca Mercer.
Now, Rebecca Mercer, her father and she, they own Cambridge Analytica, they own Breitbart, you know, she's very much a supporter of Republican causes.
And she gave us a million dollars and said that it was restricted to use in veterans.
And I thought this is really a good thing to do to take this.
But I've gotten more criticism from taking that donation from Rebecca Mercer than most anything I've done in the entire 37 years of MAPS. And so at this Passover Seder, my wife and I got there late.
Our friends were somewhere else.
There was this old couple sitting next to us.
And I didn't know who they were, and I thought, oh, this will be boring, you know.
And so I talked to this guy, and I said, well, everybody else was pretty much scientists.
And I said, are you a scientist?
He said, no, I'm a judge.
And then his wife started talking about how she had written a book about grieving parents who have illnesses, that their kids have fatal illnesses, and how to handle grief.
And so we had this incredible conversation about MDMA therapy and about how it can be helpful for grief and all.
And then after hours, Passover Seder steak, hours and hours, I finally realized that there was something more going on.
And I thought, this guy is not just a judge.
I think he's Stephen Breyer, the Supreme Court judge.
And I said, are you Stephen Breyer?
And he said, yes.
And I said, well, I have an ethical question to ask you.
You know, I have taken this resources from Rebecca Mercer, and she's very much supporting Trump and supporting Bannon and others.
And I said, what do you think about that choice ethically?
Was that a wise idea?
And he said...
That the essence of democracy is trying to find common ground with people with whom you may disagree on everything else.
And he said, in our hyper-partisan, polarized world, there's not nearly enough of that.
And so he supported that.
And so I felt that that was like the judgment of the Supreme Court.
Dave, he very much is in tune with that and speaks about that all the time.
It's very important to him because it's just too easy to just dig in your heels and embrace the conflict and push away any ideas that are connected to the other side.
If you can get someone who's a Republican, who's a Trump supporter to engage in psychedelics, understand the benefits of psychedelics for whether it's for soldiers or whether it's for grieving parents or anyone, if that can make it into their life and perhaps they can have an experience...
I think a psychedelic experience is one of the greatest ways that someone can relax any ideological, dogmatic ideas that they might have that restrict them from taking in some of the opinions of the left.
I'm very left-wing for the most part, other than support for the Second Amendment and some other things.
And just a general distrust of government.
I, you know, I was raised by hippies.
You know, I lived in San Francisco during the Vietnam War when I was a little kid.
I mean, we were, you know, my stepdad had long hair when I was a kid.
So I was, you know, but then I also grew up and I was a fighter.
So I was always around these like hard-nosed, like very tough, you know, no-nonsense people.
And a lot of them were very right-wing.
And, you know, I knew a lot of cops from martial arts and You know, people have these ideas about what, you know, what drugs are and that blanket term, which I really don't like the term drugs and drug users, what drug users are.
And one of, you know, one of the things that I'm kind of proud of is that if anybody wants to say that people who enjoy psychedelics People that enjoy marijuana are lazy and they don't contribute or they don't you know like what about me?
Like what about me?
Like I work hard and I work a lot and I work out a lot and I have a lot of friends that are very much like me and they're very open-minded people that are They embrace all cultures and ideas and all kinds of different things,
but they're also You know, these hard-nosed, determined, very disciplined people that you would sort of automatically, maybe callously, lump in with people who are cruel or unkind or not embracing other ideas.
And I just think that these ideas that we have of people It's so convenient to push people into one category or another and it's also very convenient to embrace one category and adopt their sort of predetermined pattern of ideas.
I mean the DMT experiences are by far the most profound and those are the ones that have really Every time I've done it, it's just completely made me rethink how I interface with people, what life is, and what that experience...
What is that?
Is that a well of souls you're entering into?
Is it another dimension?
Is it some sort of parallel dimension of Disembodied consciousness that you seem to be engaging with life forms, with things that know you, that can see your thoughts and see resistance and see bullshit in you.
I mean, every time I've done it, it's sort of just like, in one way or another, just removed one layer of the onion.
You know, one layer of bullshit that keeps you from just embracing the great mystery of this existence, whatever it is.
Of evolution and sort of from the single cellular organisms.
It's all in a still.
And that our prefrontal cortex, our brain, has kind of helped us focus on what we need as humans in our transition from birth to death.
But that when you sort of, well, we talk about the default mode network, which is sort of the part of the brain that's identified as the sense of self.
And the classic psychedelics weaken that part.
And then more information floods.
So I think we can get back through all of the intercellular knowledge that is stored in our bodies and connect with this deeper, unitive sense.
Yeah, it's also—they help so much to abandon preconceived notions and just sort of—we don't realize how much of the way we sort of see ourselves and see the world is kind of a convenient set of armor that we put on to try to protect us from uncomfortable thoughts and protect us from— You know, just mystery.
But there is a lot of mystery in life.
It's mostly mystery.
And I think psychedelics are the greatest mystery.
And there's something about them that's just The idea that it exists that you can smoke a thing and then 15 seconds later be transported into an impossible realm and that that exists and no one's discussing it.
Every day on the news they're talking about a million different things that seem so trivial once you've had a DMT experience.
But I realized that so much of our life is patterns, like you're saying, that we have these habits and we have these patterns and we take them as fixed.
But they're not actually fixed.
We have put them into motion.
And this 5-MeO, by bringing me back to this moment of creation...
It helped me realize that the new can enter at any moment.
And so I've actually felt that that experience, which I had one time back in 1985, has been a big part of our success to get to the place that we're at now with psychedelic research, with MDMA therapy,
because it helped me to realize that whenever I felt blocked or stuck, that I could try to find something new to enter into the picture, that there's this perpetual ability to connect with creation, to connect with the new.
And so much of our life is on cruise control, is on these patterns.
You know, you fall into the patterns of the group that you hang out with.
You fall into patterns of accents and, you know, dress and the way people behave and think about things and the concepts that they adopt.
And when you have like a real breakthrough psychedelic experience, it just makes all that seem so trivial.
My DMT experience, my first 5-MeO experience, I've done both multiple times, but the first 5-MeO experience, I thought I fucked up.
I thought it's over.
There was a moment when you're entering into whatever that great white...
Field of Geometry is you know where where you go?
Oh my god am I dying?
Like it feels like there's no way I'm coming back from this like like I've gone so far and then that fear That fear subsided once the experience just fully kicked in.
Like, the fear was at the doorway to the experience.
Like, oh no, what have I done?
And then...
You go into that...
The weirdest thing about 5-MeO, too, is the lack of visuals.
It's just this great white pattern.
This thing where you don't have any memory, you're barely a conscious entity, and you're experiencing what seems to be like the source code of the universe.
I mean, it's just a gap.
I felt like I was shot through a rocket to the center of everything.
Yeah, I've heard really great things from people that have addiction problems, like people that are addicted to pills in particular, have gone to Mexico.
One of them was my friend, Ed Clay, who went down to Mexico because of a pill problem he had.
And then he wound up opening up an Ibogaine Center down there once he had been cured of it.
There is that phenomena where people, once they get healed, they want to help others.
And in particular, in the military, you're trained to leave nobody behind.
And many people have said that, that once they've gotten help, now they want to bring all their brothers to...
that there's something about this feeling that it can help not just them but many other people.
And I think the other part there's been about why Governor Perry is so interested in a sense is that there's been now around 800 Navy SEALs and others that have gone down to Mexico for Ibogaine for both PTSD, depression, traumatic brain injury, addiction, and he's heard just remarkable stories. addiction, and he's heard just remarkable stories.
But now that you mention, or that we're talking about Ibogaine, I just would like to say a bit of, we have a mutual friend, Aubrey Marcus, and I've been texting him this morning and it's a bit sad his father died.
And so he's sitting Shiva, which is this Jewish tradition where for a week after someone dies, people come over to the house and you just mourn for a week.
So I'll be there tomorrow morning.
But his father, Michael Marcus, actually helped start Ibogaine research.
And so I'd like to explain that just a tiny bit.
Michael had studied a bit of holotropic breathwork with Stan Grof.
So Stanislav Grof is the world's leading LSD researcher.
He's almost 92 years old, but he worked at Johns Hopkins.
He did LSD research in the Czech Republic, and when the Russians came in in 68 to crush their rebellion, he escaped and came to the U.S. But Michael got to know Stan and did work with him where once psychedelics were criminalized, Stan realized that you can catalyze similar experiences through hyperventilation without a drug.
I mean, it is like a drug.
It changes the chemistry in your brain.
And so I got to know Michael, and at one point he was a stock trader, and he felt like he was losing his edge.
And this is probably, you know, 15 more years ago.
And what he said was he wondered maybe a psychedelic experience could be helpful for him, and I suggested Ibogaine.
And he went down to Mexico for an Ibogaine experience, and it helped him.
And then he felt like he regained his confidence, and then he bet that there was going to be a massive stock crash.
He shorted the market, and then there was a major crash.
And then he contacted me and he said, this Ibogaine really helped him and he would like to know how he might pay it back.
And I said, well, we've got this project.
We're trying to start for a long time.
It's the first project where we're going to look at a clinic in Mexico and test people do before and after.
Just how are they doing?
It'd be a long-term follow-up because Ibogaine For no good reason at all, other than the drug war, is illegal in the United States.
And it's not a drug of abuse.
It helps treat drug of abuse, but it is legal in Mexico and in Canada.
And so just the day before, I had gotten a matching grant offer of $10,000 for a $20,000 study.
And I said, Michael, would you be willing to match this?
And he said, sure, yeah.
I said, great, now we're going to have this first Ibogaine study.
And then he said, what else do you have?
And I was like, well, okay, if you want to know more, I'd say the most difficult thing for us to fund, the most idealistic thing we're doing, this was at the time, was we're trying to start research in Jordan.
You know, we have research in Israel, we have research in Canada, we have research, but we've no research in the Arab countries.
And I thought, if we could do something in Jordan, and I had incredible connections in Jordan with the mayor of Amman, whose son-in-law actually had found LSD helpful for cluster headaches.
And anyway, I went to Michael and I said, the most idealistic thing, the most far-reaching at this point would be to do this study in Amman.
And he said, well, how much does that cost?
And I said, well, it's about $85,000, something like that, $90,000.
And he said, all right, I'll do that too.
And so that started the first project with Ibogaine.
And then we eventually did another long-term follow-up in New Zealand.
And now there are people now, there's a project in Spain with a group called ICERs.
And it's to take increasing amounts of Ibogaine to help people withdraw from methadone.
There's projects in Brazil with Ibogaine.
There's a company, Atai, that's one of the for-profit psychedelic companies that's working with Deborah Mass from Demaracks.
They've merged and they're interested in Ibogaine.
So Ibogaine is one of the classic examples of disastrous drug policy.
It turns out that there were LSD dealers in the 60s who got busted, and they happened to have Ibogaine.
And so the government made Ibogaine illegal.
But these LSD dealers, Howard Lotsoff, was also experimenting with opiates.
And when they tried Ibogaine, they felt no desire for opiates, and they went through the withdrawal without any pain.
It's just remarkable what opiates do for you when you go through the withdrawal.
It's terrible.
But if you have Ibogaine, you can go through it in a couple days and you have a lot of psychological experiences about why you might want to run away from your problems into opiates.
And so what that means is that there is this ability for our neurons to have new synaptic connections.
And that's what we mean is neuroplasticity.
Our brain is constantly being rewired.
Every time we do anything, we have memories, and the memories are encoded.
And sometimes they get encoded in harmful ways, like with trauma, with PTSD. The memories are so painful that they never really get fully processed, they never really get put into long-term storage.
There's a lot of changes in your brain when you have PTSD. But this idea that you can then rewire your brain once you experience them.
And so there's researchers at, Goul Dolan is at Johns Hopkins.
She's done studies in mice with MDMA and showed that it releases oxytocin, which is the hormone that we have for love and connection, nursing mothers, but it also promotes this new neural growth.
So Ibogaine does that, LSD does that, psilocybin does that, and what Goul has found, which is really interesting, Is that the longer you're in the psychedelic state, the longer afterwards this period of neuroplasticity lasts, where you can do more integration work, where you have this enhanced ability to reroute patterns in your brain.
And so Ibogaine opens up this period of neuroplasticity for several weeks after, because the experience can last for more than a day or two.
Well, so there's a fellow named Leo Zeff who is the, we called him the secret chief.
So he was the leader of the underground psychedelic therapy movement.
And he worked closely with Sasha Shulgin.
And Sasha Shulgin was the chemist that invented hundreds of psychedelics.
He worked for Dow in the 60s, and he invented a biodegradable insecticide.
And they rewarded him with his own lab to do whatever he wanted.
And so Sasha tried to do more psychedelics.
And they were like, well, maybe these are not going to lead to products.
So he realized he had to leave.
And he set up a lab at home, and he taught.
But they would have this process of inventing new drugs, new psychedelic drugs, looking for new therapy drugs.
And they would then – Sasha would take it into himself.
And then if he thought it was okay, he would give it to his wife, Anne.
They are now both – And they would do these together, and then they had a group of 12 people that would meet like once a month, and they would try these new drugs.
Sasha, by the way, did go to the Bohemian Grove, where he was a musician there, and so he was able to go, but he would test new drugs with people at Bohemian Grove.
They'd go for walks in the woods because you go to Bohemian Grove for a week or two.
And so it's not like you're there for a day or so.
But so this small group of 12 people decided that MDMA had incredible potential.
This is in the middle 70s.
And they gave this to Leo Zeff and Leo said, wow, he was about to retire.
He was a clinical psych PhD and he was getting up there in years and he was about to retire.
He trained a lot of people with LSD and other things.
And so he did not retire in order to bring forth MDMA. And so he really pioneered the use of therapeutic use of MDMA. And this is now MDMA being a therapy drug before it became ecstasy as a party drug.
And that a lot happened in Dallas at the Star Club, which is, you know, a public place where, you know, incredible stories of the Star Club.
There's going to be a documentary by Michael Caine is working on a documentary about the Star Club.
But that attracted Lloyd Benson, the senator from Texas.
He heard about this and then he complained to the DEA. And then the DEA moved to criminalize.
We knew that this public use of MDMA was going to eventually result in DEA crackdown.
This is Nancy Reagan and Ronald Reagan and all of that.
And so we had a jumpstart in a sense that the DEA didn't know we were there.
They only knew the party drug.
They didn't know the therapy parts.
But we knew that the DEA was there and they were coming after us.
So I started a non-profit before MAPS in 84 and that was to prepare and gather this community together in order to defend MDMA once the DEA moved.
And so Leo Zeff came to me and he said, you're starting to be an advocate and I'd like to offer you an IBM experience.
Because we need to own our own shadow, own our own weaknesses, own our own things that we're not comfortable with and also, you know, have spiritual connections and things like that.
And he said, if I can help you, this might help in your political work because then you'll see that we're mixtures of good and bad.
Everybody is and that you won't demonize the DEA and that you may be able to find a way To, you know, build a bridge.
And so he offered me this Ibogaine experience.
And I said, great, I would love to do this.
And so we had this whole long day to set aside to do this.
And Ibogaine in plant form takes a while to take an effect.
So Leo said, I'd like to give you a bunch of LSD at the same time.
It was 350 micrograms of LSD, which is a pretty hefty dose.
The first LSD experience that we know of, Albert Hoffman, April 19, 1943, was an amount that he thought would have no real effect because it would be so small, 250 micrograms, which is a major existential challenge.
So 350 micrograms is pretty good.
And so I actually got administered Ibogaine, a bunch of it in plant form, and then also the LSD at the same time.
And I could tell the differences between the drugs.
I could tell coming up on the LSD and moving towards this kind of ego dissolution and opening up and different my emotions and how am I going to do this political work and who am I and, you know, am I qualified and all of this.
And I sort of had a lot of experience with LSD, had never done Ibogaine before, and I was able to open up pretty well for the LSD. But then this sort of low guttural rumble started from the Ibogaine.
The LSD peaks around three hours or so.
And I could feel this Ibogaine building and building and building.
LSD is also very much in your head, very ethereal, more so than psilocybin mushrooms, which are more embodied.
And so this Ibogaine started coming up, this experience, and I started feeling like if I could just let go, if I could just fully have this experience, and if I didn't have these fears and anxieties, then I would be a better advocate, and I needed to, and so much was at stake.
But then I felt I couldn't let go because I was too scared.
And then I would be hating myself.
So I felt that there was this cycle of, oh, I'm not as good as I should be.
I wish I could let go.
I do have these emotions of fear.
And then I would feel that and get nauseous.
And then I would vomit.
And then I would feel relief for like a minute or so.
And then the swirl would begin.
And each of them is like 15 or 20 minute cycles and stuff.
And then I would get to this peak And then I would vomit again and over and over and over.
And for a Jewish person, the imagery that I had was that I was being crucified on the cross of self-perfectionism.
That I didn't want to be human in a way.
I wanted to be perfect.
I wanted to be more than I was.
And that this idea that I was not perfect, that, you know, it just...
Was this connection between self-criticism and self-hatred.
And I could see that.
And it just made me sick.
And I wished I could do more.
But I couldn't get out of it.
And I had like a 12-hour cycle of that.
Over and over and over.
I mean, you know, I was like dry heaving.
I had nothing left to throw up anymore.
And I just so saw this connection between wanting to be perfect, not wanting to be human, being super self-critical, leading to self-hatred and shutting myself down.
And so at the end of that day, I was so exhausted.
I called it transcendence through exhaustion.
You know, I just gave up.
I just beat myself up so much.
I just gave up and I had the most blissful night.
It was so beautiful.
It was like no struggle, completely open, everything.
And I realized that what I needed to do was keep the self-criticism because that is the drive for quality.
You need access to the self-critical part of your mind.
But if it's connected to self-hatred, you don't listen as much because then you're a bad person.
So I sort of I severed the connection between self-criticism and self-hatred.
I accepted myself as a flawed human being that had a lot of room to grow and that I made friends in a way.
I made an ally out of the self-critical part of my brain.
And it, I think, has helped me to learn and grow because we're doing things that have never done before.
We're doing things I've never done before, nobody's never done before, bringing this through the FDA, psychedelic psychotherapy.
And we're constantly making mistakes.
I like to say that I'm just a fuck-up who just keeps on trying.
But I told myself this story.
This was the most beautiful night all night.
I was just super alert, didn't sleep at all, and just saw the stars.
But I told myself a story, and so much is governed by stories, as you know.
But the story was that I was telling myself is that I had not earned this.
I hadn't had a breakthrough.
I just exhausted myself.
So I said, when the sun comes up, I'll be back stuck in this nauseous space.
I don't know why I told myself that story, but I did.
And the sun comes up, and then I was like stuck and nauseous again, and I couldn't move for a day.
I actually had to sit there or lie there, really, in a fetal position.
I think the stories we tell ourselves, I mean, that's sort of PTSD or depression.
And that's what we're saying about you get in these grooves.
And that's where the psychedelics can shake things up.
And the neuroplasticity is what really permits you to see it in a different way.
So I spent the whole next day just curled in a puddle, basically.
Occasionally they'd bring me a banana to eat or something like that.
And then by the third day, finally, I was able to stand up without being nauseous, and a friend came and picked me up and ended up driving me away.
And as we were driving, I'd only been there once.
This was at a house I'd never been to before, and we were going back to familiar ground in the same way.
And I had this sense in my mind that I knew what was around the corner.
And I would say, oh, I think we're going to see this.
And a couple times we did.
And so what I think happened is that I was taking it in peripherally, but I wasn't paying attention to it when I was going there.
It wasn't like I was, you know...
Telepathic in a way or anything like that.
It was just that all these experiences had sort of been there but hadn't registered.
And I think I cleared out a lot of space in my mind from this constant self-criticism.
So I had more openness in space and I could remember things.
It was the fourth day that I could finally drive.
But I felt that ever since then, I've had this Increasing ability to be self-critical without it being so connected to self-hatred and so painful.
And I really feel that that I begin to experience, although I've not done it since.
Because it was pretty heavy and exhausting and painful.
And I've had other psychedelic experiences since.
But that, I think, was one of the pivotal ones in my mind.
And so here we have an opioid epidemic.
Over 100,000 people died last year with overdoses, connected sometimes with fentanyl and others.
And a tool that can be tremendously helpful is something that is not being studied at all in the United States, and we're forcing people to go to other countries.
So MAPS is developing what's called an investigator brochure.
And what that means is that any time a pharmaceutical company wants to develop a drug through the FDA, you have to summarize the world's literature in the peer-reviewed journals, and you look at it from a safety and efficacy perspective.
And so we prepare this brochure for the FDA, and it will bring us to what is the latest science.
It'll include the study that ICERS is doing in Spain with Ibogaine for Helping people withdraw from methadone or the studies in Mexico also for opiate addiction.
And then we will propose a new study.
Ibogaine is in some ways one of the most dangerous of the psychedelics in that there are a small group of people that can have problems with the heart.
And so some people have died from taking ibogaine.
But if you do it under medical supervision, particularly for people who are in weaker physical states because of drug addiction, that nobody needs to die and you can reverse it if something does happen.
So we are probably going to propose And we're working with Joe Barsuglia and Martin Polanco, who have developed a company to try to make Ibogaine into a medicine.
Well, there's two tracks, again, and that's one track.
But the other track is from a policy point of view.
So MAPS, our nonprofit, we have a policy and advocacy team.
So if ever there was a drug that we could make a strong case that should be removed from Schedule I. Schedule I is a drug, high potential for abuse, no accepted medical use.
It's the worst drugs, according to our scheduling system.
You know, if we make MDMA into a medicine, what's going to happen is that we'll have what's called bifurcated scheduling.
And that means is that our particular product in this particular capsule for PTSD would move out of Schedule I, potentially Schedule III or Schedule IV, but MDMA itself would still stay in Schedule I. So getting MDMA out of Schedule 1 so that it's hopefully more accessible, not just for medicine, is part of our goal as well.
Drug policy reform, post-prohibition world.
But Ibogaine...
There's no reason for it to be in Schedule 1 or Schedule 2. Schedule 2 is drugs that have a high potential for abuse but also have a medical use.
So I think we need to have a two-pronged strategy with Ibogaine.
One is to try to work through the FDA to make it into medicine, but other is to try to make the case that it never should have been criminalized in the first place, and it's not a drug of abuse.
And at a time where we have so many people dying from opiate overdoses, and so many other people suffering even if they're not dying from this that this is something that a logical rational country would make this available and we should have clinics right here in Austin and all over the country because we have a massive problem and and yet it's this remnant of the drug war which and again I would say Nixon well John Ehrlichman who was Nixon's domestic policy advisor It came out in the
late 70s, and he said that the Nixon White House had two main enemies.
Those were the blacks for civil rights and the hippies, the anti-war.
And what Ehrlichman said is, we realized that if we could criminalize the drugs that they did, we could bust them up, we could arrest their leaders, we could bust up their meetings.
And then Ehrlichman said, did we know we are exaggerating the risks of those drugs?
Of course we did.
So I think we could make a good scientific and rational case Now that Ibogaine never should have been criminalized and it should be legally available, but by trained therapists in proper circumstances so that the safety is fine.
But I think what has happened and what we've seen with medical marijuana leading to marijuana legalization, changing people's attitudes, We see that a lot of the psychedelic research with MDMA and psilocybin has led to Oregon decriminalizing drugs and making the Oregon psilocybin initiative with a sort of state legal program that they're trying to implement with local guides.
Colorado in November, the last election, legalized natural plant medicines.
So I think with Ibogaine we will see a similar kind of a thing, that there will be a lot of, hopefully, research over the next couple years and that will change people's attitudes and then maybe we can remove Ibogaine from Schedule I. And then the bigger question is, you're saying like, you know, nobody really looks back and thinks Vietnam was a good idea.
Yeah, so nobody looks back and thinks Vietnam was a good idea, you said.
But I think it's going to be the same way for the drug war.
Yeah, for sure.
And so I think we will think of it as a massive tragic experiment that has been exported all over the world, caused enormous violence, and I think the The idea of Ibogaine removing, getting it removed from Schedule 1 could be really important.
But I have a little pee joke, if I could tell you.
People will know that you just went out to pee and come back, but that's what brought this to mind.
So I actually was very lucky.
I had prostate cancer.
And it was caught early.
But I had prostate surgery and now I'm fine.
But it affects your ability to control your bladder for a while.
So I had to wear and still do these sort of basic depends and pads and all this kind of stuff.
But there was a time shortly after the operation.
This is very short.
I was at Burning Man.
And we have a village at Burning Man.
We do psychedelic harm reduction there.
So a group of us were in this Sort of cuddle-puddle in this, you know, I was not doing MDMA at the time, but other people were.
And it was like 3 in the morning, and we'd been there for hours, and we're just, like, 14 of us or something just talking, and this one woman goes out to pee and comes back, and, you know, other people do that.
And then this woman turned to me and said, I don't understand.
So, back to this idea that in the future we're going to look at the drug war as being an overall negative thing and a mistake.
For sure, I think the biggest thing is going to be this blanket definition of drugs.
You know, that there's, especially things, when you have things like psilocybin in Schedule I, Where it can help people in so many ways, and we're denying that help.
And I think one of the keys, just like Rocco was the key to get the TED, I think that someone's son having a bad experience with opiates, someone in a great position of power, someone who's a politician or a governor or someone like that, who sees a big turnaround from someone using Ibogaine or using psilocybin.
It's when people see members of their family or somebody that they care about that's suffering, that gets better, that's when change really happens.
And I think it's sad that it takes that, that you can't sort of look at the world and think, you know, those might not be me or my friends, but something new should change.
And I think that the way in which we have – drugs have become scapegoats.
So they become the shadow.
They become the source of all the problems.
And the fundamental mistake, I would say, of the drug war – has been to say that certain things themselves are good or bad.
These are bad drugs, and they have to be illegal.
These are okay drugs, or these are good drugs.
Of course, good drugs have included tobacco and alcohol.
But we make the thing itself good or bad, and what we miss is that it's about the relationship that we have with the thing.
And that it's not the substance, it's the relationship.
And so by focusing on the thing, then we say, oh, we've got to reduce the supply.
We've got to do all this kind of work to make it so difficult or expensive for people to get to.
And then we have to threaten them.
There's a man named Carl Hart who is on our… Yeah, I know Dr. Carl Hart.
Yeah, he's fantastic.
He's on our board of directors.
And he's a neuroscientist.
And he is, you know, in New York City, and he's a drug policy reformer.
And one time we were talking about drugs, and I said, you know, I think that the more dangerous the drug, the more important it is that it be legal.
And he said he liked to say that and that he believed that also.
And what I mean by that is that the dangerous drugs are ones which, when people get into problems with them, we need to offer them help as soon as possible.
And then we stigmatize them and drive them away.
The more dangerous drugs also get mixed with other things.
So like fentanyl mixed with opiates and that's where you have the overdoses.
So people don't get pure drugs.
They don't get support.
They don't get help.
They're not treated as humans.
They don't get really access to treatment as much.
We just punish, punish, punish.
So our goal is to make drug users, particularly these people, feel worse off so that they're an example So nobody will want to do it.
But that's not a really good example.
People won't do that.
So I think this idea of the more dangerous the drug, the more important it is that it be legal, I think makes a lot of sense.
And we need to really offer treatment on demand and peer support.
And when we think about drug policy too, you know, people don't understand as much lost opportunities.
You can see things that have gone wrong, but lost opportunities are like invisible.
But when I think about MDMA having been criminalized in 1985 by the DEA on an emergency basis for bogus reasons about neurotoxicity, but they used that as a rationale, then the hearings that we had going on with the DEA administrative law judge, they said that it should stay as a medicine.
And the DEA overruled them, and we sued them twice in the appeals courts and won, and on the third time, DEA lawyers figured out how to Satisfy the courts to keep it illegal.
And that's why, again, in 86, I started maps to go through the FDA. But that when I think of the number of suicides that have happened in both veteran communities and everywhere since 1985, Hundreds and hundreds of thousands, I think, of lives.
Oprah is a big person responsible for that, actually.
So, there was...
It started on MTV and went to Oprah.
This was around 2001. So what had happened was that there was a young woman, her mother worked at a drug abuse treatment center, and she had problems with cocaine, she had problems with marijuana, she had problems with ecstasy, other things.
And so they arranged, and this was for this MTV show, that this woman would go and do a brain scan, a spec scan, which is blood flow in the brain, and then they would reveal the results to her live on TV. And this was at this drug abuse treatment center that her mother worked at, and they revealed the results, and the results showed these holes in the brain.
And it was a graphically manipulated image.
So spec scans show blood flow through the brain, and there's certain areas that light up when you have more blood flow than others.
And so they took an arbitrary cutoff.
Any place that had lower than a certain amount of blood flow, they showed as a hole.
And it was just complete propaganda.
It was to scare this young woman to supposedly do it.
She'd done all these other drugs and ecstasy anyway.
So short time after that, Oprah decides that she's going to do a show.
And she contacts me and us because we are now advocates and she knew about what we're doing and we're trying to start MDMA research.
Her team says that they want to do two shows on ecstasy.
It's such a big thing.
They want to do one on the risks and one on the benefits.
I'm like, great.
Sounds great.
And they say, well, we're going to do the one on the risks first.
And they brought this woman who had all these holes in the brain, supposedly, to be on the show.
If you had all the holes in the brain that they showed, you wouldn't be walking and talking.
It was just big holes in her brain.
So nobody seemed to put it together.
Here, this woman, she seems fine, but this is her damaged brain.
And we told Oprah's team, don't show this.
This is fake.
This is not real.
And they did it anyway.
And they had one woman who was a 24-year-old woman that was a raver, but she had positive experiences about MDMA. So they said, okay, she would be the one that would sort of say something positive about MDMA. And then Oprah said to her, do you know what you might be doing to your brain with all these holes in the brain?
We'd like to offer you a brain scan.
And if your brain scan looked like hers, would you, I think it was Lynn Smith was her name that had the holes in the brain, would you stop using if your brain looked like that?
And she said, well, I'd be willing to do a brain scan.
But the very next day she contacted MAPS. She contacted us and said that, should she do this brain scan?
And I said, you definitely should do it, but do it with different people.
Don't do it with the people.
But definitely do this brain scan and then you'll be on the show again and you can show what the results are.
So she did the brain scan and then she wrote me back and she said, well, no holes and they've canceled the next show.
There's no show on the benefits and they're not bringing me back.
But then years later, over a decade later, when Oprah was just a short time from closing her show, but she had O Magazine.
So she decided she would assign a senior editor to do a story on MDMA and the therapeutic use.
And it was like Oprah doing Atonement.
I said, would you be willing, though, to do another show on your TV show and bring this woman back who had all these holes in the brain and let's see what she's doing now?
And she actually did show some signs of brain damage in that she was working for the Partnership for a Drug-Free America.
And she was...
As the exhibit of, oh, you know, MDMA is terrible.
So do you think they scared her with the holes in the brain to the point where she thought that drugs were ruining her life and she wanted to save other people?
And I think that she wanted to get back in the good graces with her mother, that then she gets supportive and then she gets a job and this whole thing.
And so Oprah said, no, she's not willing to do another show, but this article would go forward in O Magazine.
And the article was great.
And the woman who was the reporter ended up going for an underground MDMA experience, which I helped arrange.
And it was very successful.
And that's how the article ends.
But it's great because it didn't make a big deal of, oh, this is illegal underground.
It was just like, here's what happened to her.
The MDMA. But it was, in some ways, propaganda in the positive way.
It was like, can a single pill save your life?
You know, before it's like, this is going to cause holes in your brain.
Now, one pill is all you need, a magic pill, and then you're going to be better for everything.
Ignores the whole point that it's about the therapy and the context and the relationship.
It seems like, unfortunately, because of those kind of television shows and because of up until podcasts and the internet, you had a limited sort of ability to fully express the pros and the cons and explain...
The nuance of what these experiences are about.
You're instead dealing with this sensationalist perspective where they're just trying to highlight whatever the most wildest aspects of the experience, pro or con, would be so they can get a lot of people to pay attention to it.
And I think that like long form podcasts where you can have the whole story, you can get the whole story out unedited by people that are wanting to do it.
But I will say in terms of educating people about psychedelics, what we're doing is a lot of maps is about public education.
And so we're hosting the world's largest conference on psychedelics ever.
And it's going to take place June 19th to the 23rd.
We also have some police officers who are – we have one.
Sarko Gregarian is a full-time police officer in Winthrop near Boston, but he's also a psychotherapist.
And he's been through our training program in order to give MDMA therapy to other police officers.
We just had an incredible – the first psychedelic conference in Iceland.
And Sarko came and also did his – police chief came.
And we met with the Minister of Justice in Iceland.
The conference was phenomenal, the second old conference in Iceland.
And now the Minister of Justice is interested in having Iceland fund a study to give MDMA to prisoners to work with them to see about dealing with their traumas to reduce recidivism, also with victims of crime.
To help them deal with their PTSD and also with prison guards and police.
So we have this opportunity in Iceland to potentially make it an example of a countrywide approach.
Our new big vision, and I'll get back to the Psychedelic Science Conference in just a second, but our new big vision is a world of net trauma by 2070. So this idea of every year we're adding to the burden of trauma that people are experiencing.
And then it lasts.
There are some people that get better, but there's many people that get stuck in PTSD. And then there's multi-generational PTSD. There's what's called epigenetics, which is, you know, biological evolution takes place over long periods of time.
But what turns the genes on and off is epigenetics above the genes.
That can change from your own experience.
And there's a woman, Rachel Yehuda, at the Bronx VA that has done studies with Holocaust survivors and their children and has identified an epigenetic mechanism by which this is passed on.
From parent to child and it could be either from the father or the mother line.
It's in either of our genetics.
So this idea that we are increasing the burden of trauma by, there's some estimates that by 2050 that if climate change continues as it does that there will be about a billion climate refugees from droughts and poor crops and you know lack of water and all this so that it feels like The humanity is going to be burdened more by trauma.
We have incredible problems with mental health because of both the COVID and other things.
So that what we want to do is reduce the burden of trauma every year and get to net zero trauma.
And it will take multi-generations.
And the end goal is mass mental health and a spiritualized humanity.
And that's the hope for the future.
And we will be talking about this at the Psychedelic Science Conference.
So it's going to be at the Denver Convention Center.
We have the entire Denver Convention Center.
We already have, yes, be part of the breakthrough.
Yeah.
And we've got over 5,000 people coming.
We hope there'll be about 10,000.
And we'd also like to say that we have a special discount code for people who are listening.
So it's psychedelicscience.org.
And if you just put in Rogan20, it's a 20% discount.
Yeah, but Denver and Colorado is very progressive.
The mayor's going to help us open the conference.
We've got the support of the governor.
We're actually doing a project with the Denver police.
Because mushrooms are the lowest enforcement priority, and we want to educate police on what happens when you encounter somebody with a difficult trip.
You know, you could make it worse for them, or you could try to treat them in a certain way so that you calm them down and, you know, they don't need to be tased or, you know, however.
So we're trying to educate police on how to de-escalate people with difficult psychedelic experiences.
So the conference...
This is our fourth psychedelic science conference that we call it, where we bring everybody together.
The first was in 2010, and we had about 400 people, something like that.
But that was enormous for us.
And that was in San Jose.
The second one was in 2013, and we had, at this point, about 1,000 people.
And that was in Oakland.
And then in 2017, we had another one, and that was over 2,000 people.
And that now is still the world's largest conference.
We had like 2,500.
And now this one we think is going to be way more.
And the theme of it, why we've waited so many years between 2017 now, is that we are now at the doorway to a new world.
And what I mean by that is that we are at an incredible moment in time where there have been Probably two and a half or more billion dollars have gone into for-profit psychedelic companies.
Well, some of them were trying to develop new drugs.
A lot of them were trying to set up networks of clinics.
We also have ketamine, which has now been S-ketamine.
An isomer of ketamine has been approved for a treatment of depression.
You know, we ended up...
In November 29, 2016, we had what's called an End of Phase 2 meeting with the FDA about our research with MDMA-assisted therapy for PTSD. So it took us 30 years, from the start of MAPS, 1986 to 2016, where we presented our data to the FDA and they said, yes, you can go into Phase 3. Phase 3 is the final stage of research where you need to do safety and efficacy.
And if you prove that to the satisfaction of the FDA, you get permission to So some of the new for-profit companies, Compass Pathways is one, and USONA is a non-profit, are trying to develop psilocybin into a method, a treatment with therapy, Compass for treatment-resistant depression, USONA for major depressive disorder.
And so a bunch of these companies are trying to develop new drugs.
And I think some of them are thinking, well, the classic psychedelics like LSD, MDMA, psilocybin, MDMA, we wouldn't say classic, but the classic psychedelics like, you know, Ibogaine, Mescaline, psilocybin, LSD, DMT, all these are in the public domain.
And so there's no patents on them.
So people have tried to say, well, we'll patent the manufacturing process or we'll do something.
But there's also use patents.
But the use of psychedelics for therapy in different conditions is also in the public domain.
So a lot of these companies are going to try to develop new molecules that they can patent.
I understand that we're trying to undo 53 years of criminalization, but I just think that that's a bad strategy and you're getting in bed with some demons.
And so if somebody develops some new molecule and, you know, for us, it's going to cost us hundreds of millions of dollars to make MDMA into a medicine.
And so we've done that in an incredible set of ways.
And I think this is why what I explained to you just a couple weeks ago and why you were so gracious to invite me back now is because I talked about this crossroads that we're at.
And so MAPS has raised about $145 million in grants and most of it donations in our history.
And we have gotten enormous value in people's donated time, expertise of all sorts.
And it's hard to even put a dollar number on that, but it's been tremendous.
And so we have used that to do this MDMA research.
A couple years ago...
With the rise of all these for-profit psychedelic companies, it became more difficult for us to raise donations because people were like, why should I donate now?
I can just invest over here and you've got a story now.
Your story is that it looks like you're moving into phase three.
Maybe you can get investors.
And so we didn't want to sell equity at the time.
And so we do have, as I said, about $145 million in grants and donations and a lot of free donated time.
But we also have $43 million in what's called a royalty share.
So it is money from investors.
They're mission-aligned investors.
Ryan Zuer organized it as the lead one called Vine Ventures.
And they have about 3.8% of North American revenues from MDMA once we make it into a medicine for about 8 to 10 years afterwards.
And if we don't give them a certain amount of money back, then it continues.
But they don't have ownership, and they don't control what we do, and we can end up prioritizing public benefit over profits.
So we also have around $20 million in a loan that's potentially convertible into equity if we don't repay the loan.
And we've got a couple of years there.
But we have reached this spot where we have the nonprofit MAPS, which has about 35 people, Is the 100% owner of the MAPS Public Benefit Corp., which is about 135 people, something like that.
And so we have this situation.
We also tried to do something new with pharma so that And something new with capitalism.
So that capitalism, when you have for-profit companies, you're supposed to maximize profits.
And if minority shareholders don't like the fact that the management isn't maximizing profits, they can try to throw them out.
And so that produces a prioritization of profits over people, profits over social benefit.
And so capitalism has been modified in a way with the public benefit corporation.
So that's a new corporate structure, maybe 20 years old, but relatively new.
And there's thousands, you know, not hundreds of thousands, not tens of thousands, I don't think, but there's thousands of these public benefit corporations.
And what you do is you can maximize public benefit over profit so that you cannot be sued by minority shareholders to try to force out the executives because you're not maximizing profits because your goal is public benefit over profit.
So we want to create a new model for how pharma drugs can be distributed.
So we have this It's a remarkable moment where we have the nonprofit is 100% owner of a for-profit but public benefit pharmaceutical company.
But we need to raise additional capital.
We are now at a place where we recently announced that our second Phase III study was successful.
And was confirmatory.
Our first Phase III study was incredibly successful.
And to give you a sense of how successful, and we published this in Nature Medicine, the FDA looks at statistical significance.
So there's efficacy and safety.
So efficacy is determined by basically statistical significance.
And you have to have.05, which means 1 in 20 chance that it's random, that it's not from what you think it was.
You know, that your intervention, your experiment said, yes, it's statistically significant.
That means it's 1 in 20 or lower chance that your finding is random.
And you have to have two of those.
And so if you have 1 in 20 and then you multiply them another 1 in 20, it's 1 in 400 chance that these two independent studies have produced results that are random, and then the FDA will approve it.
Our first study was 1 in 10,000 chance that it was random.
It was just incredible.
Now how do you do that?
How do you get such great statistical significance?
You get it because you have a big difference between the two groups and you also have not that much variability.
So what it means is the people that got MDMA Pretty much of them got major benefits, and the people that got the therapy without MDMA, so I should say, the people got therapy with MDMA, did great, pretty, not very much variability, it doesn't work for everybody, but we had 88% responders.
We had 67% no longer had a diagnosis of PTSD. These are severe PTSD patients that had PTSD an average of 14 years, one-third over 20 years, and then we had Just another 21% had what's called clinically significant response.
And they still have PTSD, but over time they might get better.
If they could have had a forced session, they might get better.
And we had a great safety record.
We had actually nobody in the MDMA therapy group tried to kill themselves, tried to hurt themselves.
We enroll people that have previously attempted suicide.
We did have one woman try to kill herself twice during the study, but she was in the placebo group.
She got therapy without MDMA. We had another woman, it was so difficult for her to confront her trauma that she checked herself into a hospital to not self harm.
She also was in the placebo group.
So the results were phenomenal.
And science, the journal Science, one of the most important journals in the world in science, at the end of every year, they publish a list of what they think are the top 10 scientific breakthroughs of the year.
And they chose our study in Nature Medicine as one of the world's top 10 breakthroughs of the year.
It was phenomenal.
And we had special appreciation for what science was willing to do.
Because you talked about beforehand about holes in the brain.
So 20 years before, science had published this article that they never should have published.
And this was by researchers at Johns Hopkins that had been funded by the Nationalist on Drug Abuse.
And what they claimed is that MDMA could hurt dopamine.
This was a study in primates.
And they said, oh, my God, MDMA can hurt dopamine.
And it could cause Parkinson's.
And this could be a real danger.
Now, this was around 2002, 2003.
And they had, since 1985, it had all been about MDMA supposedly hurting serotonin and causing holes in the brains from serotonin.
And we had done studies in primates before with these same researchers where none of the primates died from overdoses.
There didn't seem to be any problems with dopamine.
But the narrative of the anti-drug people and the National Institute of Drug Abuse about serotonin neurotoxicity was sort of Diminishing.
People weren't showing problems.
And so what they were saying was, well, you're reducing your cognitive reserves.
And so you don't show problems now, but when you get older, you're going to show problems.
So what we first proposed in 1992 is when we got permission for the first study with MDMA. And people had been using 5-HTP after MDMA. But there is a benefit to using 5-HTP. It boosts your serotonin levels quicker, correct?
Yes, yes.
It can be helpful.
But what we do in a therapy context, so the FDA, we said, should we try administering with 5-HTP or something like that?
They said, don't do that.
Let's do everything under observation and see what the problems are.
And if you see problems, then we should figure out how to mitigate the problems.
So the key thing that we do is to say to people that when you take MDMA, it's a two-day experience.
It's not a one-day experience.
And the second day is for rest and for reflection.
And they have no obligations, no appointments, nothing that you need to do.
Just take the second day and rest.
And that's where people would take 5-HDP if they wanted to.
But we don't see this dip in mood.
Anymore in the MDMA group than in the group that gets therapy without it.
So people talk about suicide Tuesdays or, you know, this depression after you've used up serotonin.
But I think the rest part is part of the therapeutic process.
So we have never felt the need to recommend that people do 5-HTP. I don't think it's a bad idea to do.
I mean, if people wanted to do it, it can be helpful.
But we just feel that the rest is just as helpful and it's more therapeutic.
So this idea of serotonergic neurotoxicity and holes in your brain and time bomb theories just wasn't working anymore.
It wasn't persuading people.
It wasn't persuading the FDA. So NIDA funded this study, Una McCann and George Riccardi, and it was in primates.
And as it turned out, a bunch of the primates died of overdoses and they published the paper in Science that said that MDMA could cause Parkinson's, it could hurt dopamine.
And the editor of – Science is published by the American Association for the Advancement The president of that was Alan Leshner.
He used to be the head of NIDA. And he fanned the fears of MDMA and he did that in Congress and it was great because then he got more money for NIDA. He got over a billion dollars a year.
So he published a press release about this article and it said that taking MDMA was like playing Russian roulette with your brain.
So it didn't seem right, this article.
We knew that we'd given MDMA two primates for research and nobody died of overdoses.
None of them did.
So we wrote a letter to the editor and we questioned it.
They didn't give it the way people take it, which is orally as well.
Also, you get more neurotoxicity in crowds for some reason when animals or people are together than when they're alone.
And when the temperature is higher, there's more neurotoxicity.
So they tried giving more MDMA to primates with higher temperatures, more crowded in the cages, and they couldn't replicate the results.
But they kept defending it in public.
And finally, a year later, they said that – and this was super embarrassing – they had to retract the study because they were puzzled why they couldn't replicate the results.
And so they took some of the tissue from one of the animals that had overdosed and died.
And they discovered that they had mistakenly given methamphetamine instead of MDMA. And that the bottles, they said, that were labeled MDMA actually had methamphetamine in them.
And so they got these bottles from a group called Research Triangle Institute in North Carolina.
They provide all the Schedule I drugs for all the NIDA-funded researchers.
So the Hopkins people blamed the people at Research Triangle Institute and said they switched the labels on the bottles.
The people from Research Triangle Institute said they never do that.
They always test it.
They have quality control.
They think that it got switched something or other at the site at Johns Hopkins.
The National Institute of Drug Abuse didn't want to find out what was going on, or if they did want to find out, they never made it public.
So it's never clear how did this happen.
But they had to retract this data and retract their papers.
And it was the high watermark of neurotoxicity fears.
And at the same time, Peter Jennings was doing a documentary called Ecstasy Rising.
And this was the first documentary that really had a bunch of people talking about the benefits.
And he also talked about this...
The other thing about methamphetamine versus MDMA is that, you know, for people that know about Adderall and other things, 10-15 milligrams is a hefty dose.
But MDMA, it's 125 milligrams, is a full dose.
And so they were giving the wrong drug in MDMA quantities.
And that's why they knocked off a bunch of these primates.
And that's why they claimed that they saw this dopaminergic problems.
And so ever since then, and that's been 20 years ago now— Do you have speculation that was sabotage?
Somebody sabotaged it somewhere.
I don't think it was from research trying to listen to it.
Do you think it's accidental sabotage, or do you think it— I think that the researchers wouldn't have done that intentionally, but maybe somebody in the lab did it or something.
But I do think that the researchers were fundamentally irresponsible to put the paper out because they should have known that there was prior primate studies where dopamine hadn't been damaged.
The other thing is in the late 1980s, early 1990s, we were trying to Talk about, yeah, MDMA, serotonergic neurotoxicity.
And so I went to George Riccardi, the same researcher that did the primate study with the methamphetamine instead.
And I said, I want to buy you some monkeys.
You've just done studies in rats.
Can you study this in monkeys, in primates?
And he said he did.
And again, there was no evidence of overdoses or dopamine.
Also, this was before brain scans came in.
And so the most sophisticated way that was available at the time to look at what's going on in the brain was to do spinal taps and to take spinal fluid and look for metabolites of neurotransmitters in the brain.
And I felt like I could not...
I wouldn't recommend try to get other people to volunteer for it unless I did it myself.
So I was the first one to get a spinal tap.
And it was really hard.
But the imagery that I did, and again, this is kind of this idea about storytelling.
So the story I was telling myself as this big needle is going into my spine to try to draw out the spinal fluid was that if a woman could give birth to a child, I could at least give birth to my spinal fluid.
It was like way less painful, much shorter, but I could do it.
And so the imagery was I'm giving my birth to my spinal fluid to these researchers so that we can understand what's really going on with MDMA and hopefully make it into a medicine.
And it didn't hurt terribly.
And there was spinal headaches that you get afterwards.
So a couple days afterwards I had headaches.
But I felt like I could enroll other people.
I could encourage other people to do it.
So I was going to a new college in Sarasota, Florida, which, by the way, DeSantis is now trying to kill and has fired the president.
I mean, this was the symbol of what he called the most woke school in a bunch of transgender people, a bunch of open-minded people.
It started as a private school in the 60s, merged with the state when they ran out of money.
So he fired the president, he stacked the board of trustees, and he wants to turn it into a conservative school.
He's doing it for political purposes.
To try to show that he's anti-woke and that he is wanting to – what's going on in public education in Florida is really frightening.
George Soros is actually interested in trying to help out at New College because George Soros actually, even though he's the boogeyman for a lot of the right wing, he funded the Central European University in Florida.
I think we're good to go.
I think we're good to go.
And so I got about 35 people or so to get spinal taps, not just from New College, but from all over.
And the spinal tap showed that there was no problems with dopamine.
There was a little bit less serotonin metabolites, but also lower serotonin has been linked to risk-taking behavior.
And so taking drugs is risk-taking behavior, particularly when they're heavily criminalized.
So it was not evidence that it was serotonin neurotoxicity from MDMA, but it cleared dopamine.
So these researchers should never have ignored their prior data.
They were just so willing to demonize MDMA to get more grant money.
Yeah, that seems to be the case with a lot of scientific studies, isn't it?
It's a real problem when you're not just trying to find out what the truth is.
You're trying to find data that would reinforce whatever idea that you went into it looking to find in the first place and throw out information that is contrary to that.
Working with Cruder tools, but there was a lot of work with LSD in the 60s for alcohol use disorder, and it proved to be quite effective when supported, so that these substances can be extremely helpful, again, used in a careful way, So the Good Friday experiment was an attempt to understand, can psychedelics produce a mystical experience?
And Walter Pankey was a doctor and a minister, and he was getting a PhD at Harvard.
And he was interested in looking at the spiritual potential of psilocybin and he worked with Timothy Leary and they did this experiment and they did it with a Reverend Howard Thurman.
So Howard Thurman was an African-American minister at Boston University's Marsh Chapel.
And Howard Thurman is someone who deserves a lot more attention because he studied with Gandhi.
He studied nonviolence with Gandhi.
And then he became Martin Luther King's mentor.
And Martin Luther King got a PhD at Boston University.
And Howard Thurman was his mentor.
So Howard Thurman really helped the...
American Civil Rights Movement adopt the strategy of nonviolence that he got from Gandhi.
And that's what we see in all of the stories about people being beaten by police, trying to protest different things, and they try to react.
So nonviolent resistance was a key to the American Civil Rights Movement.
And Howard Thurman was very interested in this connection between the mystical experience and political action.
So the mystical experience, you move beyond your sense of, I'm, you know, this biographical person.
You know, I'm my tribe.
I'm my country.
I'm my religion.
There's something deeper.
That we're a part of humanity.
We're part of energy.
I mean, if you look at the quantum level, right?
We're all energy.
We're all connected in these different ways.
So when you feel that, and Rita Marley has this incredible album about Marley's wife, and it's called...
Who feels it, knows it.
Who feels it, knows it.
So you can say this, and I can say this, and people can hear it, but if you have an experience that you feel it, then you know it.
And so Howard Thurman was very interested in this idea of...
What are the political implications of this mystical experience?
And so Walter Pankey was willing to work with him.
And Howard Thurman said, I will let you come to my church, Marsh Chapel, on Good Friday, and you can do an experiment with 20 divinity students from Andover Newton Theological Seminary, and you can Give them all a pill and half will be psilocybin, half will be placebo, which was nicotinic acid, which gives you a flush.
And so this was done and it was considered to be the most eloquently designed experiment ever done on whether psychedelics could produce a mystical experience.
And it showed that nine out of the 20 people had a mystical experience, eight out of the nine had the psilocybin, and then they did some long-term, like six-month follow-ups, and they said it impacted their lives in certain ways.
And then Walter Pankey died in a terrible scuba diving accident in 1971. And so a lot was ended with him.
And then the 1970 and the backlash against psychedelics.
So now it's in the 80s and I'm an undergraduate.
I dropped out of college for 10 years from 1972 to 1982. And you have to do a thesis, a senior thesis at New College.
And I wanted to do psychedelic research, but psychedelic research was wiped out at the time, nothing to do.
You couldn't get permission to give psychedelics.
But I thought, if I go back to the Good Friday experiment, that I could do a long-term follow-up that is just asking people what happened to them when they took the psilocybin and how do they think about it now.
And I wouldn't have to get permission from the FDA or the DEA. I would just have to get permission from what's called an Institutional Review Board, which our college had, just about the safety of the subject.
But I'm just asking them questions.
So that was the only way that I could do psychedelic research.
And it was incredible because in the mystical literature, the real test of the validity of a mystical spiritual experience is called the fruits test.
Means, what are the consequences in your life?
What are the fruits of the experience?
Does it make you more peaceful, more loving?
Does it make you more, reduce your fear of death?
Does it give you a more spiritual sense of how we're connected?
So that's the fruits test.
And so what I, you know, because people can describe all sorts of things, but what impact does it have in your life?
So I figured I can do a long-term follow-up, and that's the fruits test.
And Walter Pankey would have done it if he hadn't died.
But nobody else was doing it.
So I ended up...
Trying to figure out how to do it.
I went to Andover Newton School, and I said, nobody knew who the subjects were in the study.
So I went to the school, which is outside of Boston, and I said, I'd like to put a note in the alumni newsletter.
Would you be willing to do that?
And they said no.
They refused.
I said, this is the most important experiment ever in the history of mystical experiences and psychedelics with your students.
And I just want to ask them questions.
Would you let me put something in the alumni newsletter?
And they said no.
This is now 1986. And so I was like, God, I was blocked.
Tim Leary, nobody had the list.
So I went to their library and I thought maybe I'll see some books or something on this experiment.
Nothing.
The thesis that was done at Harvard, nothing.
They had zero about this experiment.
It's like cultural amnesia.
But I'm wandering through the library, and I notice that they've got some books of the alumni, and one of them had the list of all the students that were in school in 1962, and their names and their addresses.
I was like, wow, this is a bonanza!
So I photocopied it all, and then there was like 350 of them, and I wrote a postcard to every single one of them, and that led me to three of them wrote back, saying that they were in the study.
And over years and years, it took me, but I identified 19 out of the 20. I was able to go see them in person and interview them.
And this really validated my theory of change.
So my theory of change also, which you've shared a bit, is that if you have these spiritual connections, these spiritual experiences, that will make you Think about the world in a different way.
Think about others in a different way.
And so what people said is that their mystical experiences really did reduce their fear of death, made them feel more connected to other people from different faiths, made them more ecumenical in a way, deepened their faith in their own religion.
It didn't turn them away, but they saw it in a more symbolic rather than literal way.
But what I discovered, so it validated the results, but what I discovered is a big mistake, that one of the persons in the study had heard the...
Howard Thurman, by the way, the audio of that service is up on our website.
If you go Good Friday Experiment, you can listen to Howard Thurman's Good Friday Experiment speech, you know, his sermons and stuff from 1962. One of them Was you have to tell people there's a man on the cross.
You must tell people there's a man on the cross.
And one of the students under the influence of psilocybin said, yeah, I got to tell people there's a man on the cross.
I'm going to do it right now.
And I'm going to run out of this room and I'm going to run down the road and I should tell the president.
But the president is in D.C. So I'll tell the president of the university.
And he goes running down the street and Walter Pankey and Houston Smith go, you know, running after him.
It's a busy street on Commonwealth Ave in front of the Marsh Chapel.
And they finally catch him.
And he doesn't want to go inside.
He's outside.
He's tripping.
He's like, got this mission.
And they give him a shot of Thorazine.
To tranquilize him, to bring him back inside.
And they never mentioned that at all.
Completely not mentioned it.
So I had this decision when I'm going to write this follow-up study.
You know, I said, I can't hide that.
So I did report that.
And what was going on, I think, was In the culture was this exaggeration of the risks and suppression and minimization of the benefits.
And I think what Timothy Leary did in response was the opposite.
He's like, okay, I can exaggerate the benefits.
One dose, you're enlightened, you know more than everybody else.
You know, I think I had, I don't know if you ever saw the podcast, I had Alex Berenson on, who wrote a book called Tell Your Children, and it's all about the dangers of marijuana.
And I had him on with Dr. Mike Hart, who is a cannabis doctor in Canada.
And, you know, one of the things that he was talking about was people, for whatever reason, When they have a high dose of marijuana, there's something that happens to some of them where they have like a schizophrenic break.
And I have heard of it.
I know people who have had this.
And the pro-marijuana people do not want to acknowledge this danger.
They want to paint marijuana as a completely innocuous substance that no one should worry about.
And I think it's way too powerful for that.
And I think too many people are psychologically or physiologically vulnerable.
We're not all the same.
And if someone is particularly vulnerable, whether it's towards schizophrenia or whatever mental illness it might be, there's something about these experiences that seem to send them over the edge.
And that's something that we should be concerned with.
I think there are some, and it could be biological.
We don't know.
It could be that they're just so...
Okay, it could be that they're so resisting the experience.
So Stan Grof actually talked about work with obsessive compulsives that he did with LSD, and he had some that he could give over a thousand micrograms of LSD, enormous amounts of LSD, and they could still play chess.
So there's a way where you can control your mind so much that even psychedelics won't happen.
To understand the influence that media had on you when you were a child, it's almost impossible for you to wrap your head around.
But I want you to try.
The kids of today, you kids with your internet and your Google and being able to watch whatever you want to watch on television at any given time.
When I was a kid, when you saw something on television, everybody talked about it.
Those Just Say No commercials.
This is your brain on drugs.
Any questions?
It's someone frying an egg.
Well, it led to a lot of funny stand-up comedy bits.
Bill Hicks had a funny bit about it.
But it also led to a lot of people thinking, literally, you're gonna fry your brain with drugs.
And it worked.
It worked on us.
It worked on a lot of fucking people.
Like, the influence that they had by being able to do those kind of things and put them on television back then, It sets things back.
Everything takes a whole generation for people to get over.
If we go back to the early days of cannabis prohibition, when you watch the Reefer Madness films, and you find out about this whole Harry Anslinger, William Randolph Hearst connection, and that it actually had a lot to do with commodities, like hemp.
There's so many aspects to it that you would have never guessed.
But the point is that that propaganda from the 1930s turned something that had thousands of years of human use, demonized it, created a new name for it, used a Mexican slang name for tobacco.
And then you've got to get into the 60s before marijuana is popular again.
Literally, it has to burn through a generation of propaganda.
Their children have to learn from their parents' mistakes and realize that their parents are dumbasses, and then they experiment with things, and they have to learn from other people that are doing it.
And then it goes to a point where it's at now.
We're now, because of the internet, these conversations are just everywhere.
There's so many maps videos.
The work that you guys have done is so extraordinary and so important.
Guys like Dr. Karl Hart, all these different people, Michael Pollan and his amazing book, all these people that are talking about these experiences, now there's just this flood of information.
So you can't demonize it the same way, but it's very important that the people that are on this side Don't bullshit anybody.
And all these people will be at Psychedelic Science, too.
And I think that the trap that we have to avoid falling into is, and where the backlash will come from now if there is, is if we exaggerate the results and minimize the risks.
It should be honest across the board, and I think if it is, there'll be an understanding by most people that you should be able to make educated, informed decisions as to what to do with your consciousness because there might be a significant benefit available if you do that.
In the stand-up comedy community, there was a group of guys who died from fentanyl-laced cocaine, I believe.
That was what it was proven to be.
Was it, Jamie?
I think, pretty sure.
It's a real problem.
It's a real problem.
So I talked to them about it and I explained that we have stuck our heels in the sand.
We've dug our heels in on something that is objectively not just ineffective, but very detrimental to society as a whole, and that's having drugs be illegal.
Because if you have drugs illegal, you're not going to stop people from taking drugs.
What you're going to do is funnel all the cash to criminals.
It's what happened in Prohibition, the 1900s in America, and it's what's happening right now in Mexico.
Okay, so that gets me to the Concord Prison Experiment.
That was the other thing that Timothy Leary did.
So what he said was that...
Yeah, people talk about their mystical experiences and then maybe they can say how that's changed their lives, but that's sort of subjective.
But if we can give psilocybin to prisoners and then help them have these pro-social experiences, work through their traumas, and then when they're released, then we can reduce their recidivism.
They will now be ready to make a new re-entry into society and that that's an objective thing.
So the next thing that Timothy Leary decided to do was the Concord Prison Experiment.
And this was a tremendous experiment, and they gave about 35 people psilocybin experiences inside prison.
Timothy Leary and others, the researchers would go into the prison, and half the researchers would also take psilocybin.
And with the prisoners in prison.
And this was a way to try to help them to reduce the experimenter-experimentee kind of idea.
And the Concord Prison Experiment was considered to be one of the most successful psychedelic experiences and studies of the 60s that ever there was.
And unfortunately, all the records were lost of who was in the experiment.
So after I did the Good Friday Experiment follow-up, after 25 years and found 19 out of the 20, I went to Tim and others and like, do you have any idea who was in the Concord Prison Experiment?
They had no records whatsoever.
So I didn't think I could do anything.
1991, I published a paper in the Journal of Transpersonal Psychology about the Good Friday Experiment.
And there was an editorial in the Boston Globe about it, op-ed.
And I got a call afterwards from a fellow, Michael Forcier, and he said that he worked for the Department of Corrections, and they had a special room where they collect the records of their famous and interesting prisoners.
Like they had Malcolm X and his records and others.
And they had the records of all the people from the Concord Prison Experiment.
And he said, would you like to do a follow-up study?
I said, I would love to do it.
And it took us a whole year to get permission.
We had to go all the way up to the governor.
It was Governor Weld at the time.
And the paper that came back was hilarious that said that we got permission because somebody had scribbled on it, no psilocybin.
Like, we were not planning to give psilocybin.
We were just going to look at their prison records, but they were like, no psilocybin.
Well, I have had a lot of good conversations with DEA people and police because what they're taught about drugs, if they believe it, nobody would ever do these drugs.
So I've tried to explain to them, and I could, oh, I did it when I was legal.
But you try to do it in a way where you don't encourage them to react in a negative way.
So I did this follow-up to the Concord Prison Experiment.
All right, so while I'm doing this experiment and tracking people's criminal justice system records in the decades—this was like a 34-year follow-up—it started becoming clear to me that the experiment wasn't a success.
And I was the one that was wanting to do the follow-up to bring attention to it because I thought it was a success.
But what I discovered was a trick that Leary had done to try to make the results look good.
And the trick is simple.
Just think about this.
When you're in jail, the first day that you get off jail, nobody goes back to jail.
But if you look two years out, more people will have had a chance to commit crimes and go back to jail.
So the longer you're out of jail, the more likely you are to go back.
So the group of people that had been in this experiment had been – on average, they'd been out of jail 10 months when they looked at their recidivism.
Some had been longer.
Some had been shorter.
And the researchers, Ralph Metzner and Tim Leary, they had done a base rate study of all the people that got released from the Concord Prison Experiment in the years before they did it, and they published their results.
So they compared it.
It was a little bit historical, so things don't always say the same exactly in history, but that was the best that they could do to compare it.
But what I discovered is that they had published the results of this base rate study in a really obscure journal, a British criminology journal, And, you know, I had to go down in the dusty libraries of Harvard Law Library, the Widener Library to even find this journal.
And when I read it, what I learned is that they had taken data from people that were out of prison for 30 months and compared it to people that were out of prison for 10 months.
Complete scientific fraud.
And so then I'm like, shit, how is it that all the people that hate psychedelics didn't discover this?
And everybody has thought, including me, that this is a great experiment and tremendously successful.
For someone to not go back to a life of crime after they've been incarcerated is a tremendous ask.
And I think that if you're measuring the success of a psychedelic experience for the normal person, if a normal person doesn't have a pattern in their life of committing crime and being incarcerated, The problem with becoming sort of institutionalized and you become accustomed to certain patterns of behavior, to ask someone to just stop doing that forever, it's a huge life shift.
Like even if they had a positive net benefit of their psychedelic experience, asking them to not commit crime.
If you know a guy who's been in jail a couple of times, And, you know, he grows up in a terrible neighborhood and there's crime all around him.
His parents are committing crime.
It's normal to just do crime.
And if you have a psychedelic experience, getting you to stop doing any crime ever again is a big ask.
And Leary and Ralph Metzner, they realized that what they needed to do was to provide support and aftercare after people got out of prison.
And just as they realized that, they started creating support groups.
That's where they got kicked out of Harvard.
And so those support groups fell apart.
And so what kind of an experiment we would need to do today would be to both...
See, this was an overvaluation of the psychedelic experience by itself.
And it didn't really understand the social support that you need and all the cultural determinants of people that go back to prison.
And so the experiment that needs to be done is...
Helping people have these psychedelic experiences, move through their traumas, kind of have these powerful, positive experiences of connection, but then the support that you need afterwards.
Just the same way in our research, you do the therapy with MDMA. And then you do integrative work without the MDMA afterwards.
And that's what makes it last.
And so what we're going to try to do in Iceland will be, with the Minister of Justice, it will be the proper kind of experiment.
And so it would be both work inside prison and then support afterwards.
And so I think there is this tendency, yeah, to overvalue the psychedelic experience and separate it out from the therapy and from the aftercare and from the integration.
So I felt like I had to report and debunk this experiment that was considered to be one of the best examples of the power of psychedelic therapy.
Well, that raises another issue, which is that we're now in about...
Starting research in about eight different VAs with different studies with MDMA. Actually, one thing I did last night, which was tremendous, and what I really like to do, because I got here early so I could be here on time today, is that I love to smoke pot and go wandering around cities after midnight.
No, I heard somebody across the street yelling about crack.
But I get to the Texas State House, and I'm just like, it's gorgeous, it's beautiful.
I noticed that there was a lot of scaffolding on it.
But I thought, here...
Not quite the middle of the night, but well after midnight.
In a place where so much conservative policies are coming out of it.
The Texas legislature is currently considering a rider to allocate $2.1 million to a study of MDMA at the Houston VA with veterans with PTSD. And two years before,
they have allocated a similar amount of money for a psilocybin study in veterans with PTSD. At the Houston VA. And Lynette Avril, who's going to be the principal investigator, she hasn't started the psilocybin study quite yet because she got pregnant and had a child and now she's getting back to it,
but it's going to Baylor College of Medicine and the Houston VA. So I just had this feeling of the legislature is under repair with all of the scaffolding, but in this place out of which so much conservative policies are coming, so is support for psychedelics.
And it just gave me such a warm feeling.
And again, it's like not demonizing everything's all bad.
But it was really a nice way to feel the grandeur of the building and to think that, yeah, we need to do a lot of renovation of our policies.
And this work that's being done, yeah, Governor Perry is helping with it.
I think the Michael Pollan's book, How to Change Your Mind, and then the Netflix series, the four series about that, has changed lots of people's minds.
So the moment that we're at is just this incredible moment.
So now we have two successful Phase III studies.
We have a non-profit that is 100% owner of a public benefit corp.
We do have Some money from investors, but our challenge now over the next couple months is where do we get the money to get us to two different points.
The first point is from here to FDA approval.
We think that's going to be potentially, if all goes well, something like June 2024. But then there's going to be about another year and a half or a bit more, potentially, until we reach what's called sustainability.
And so sustainability is when income from the sale of MDMA equals what all of our costs are, and then we start amassing resources for more research, for more studies, for work that MAPS is doing.
Because MAPS would still be the...
So what we have this chance to either keep MAPS as the sole owner of the Public Benefit Corp or we may have to turn it into a publicly traded company if we don't find the philanthropy that we need and we need to take investors and these investors want us to turn this into...
You're mixing something that could potentially change the way the whole world looks at life.
And you're mixing them with something that doesn't give a fuck about anything other than profit.
And that's just what the nature of that thing is.
That's the nature of corporations and capitalism.
They constantly want to make more money.
Every quarter, every year, more money, more money.
And they're trying to figure out a way to benefit their stockholders.
That's their primary concern.
Unless you've got some...
Well, it would have to be private.
It would still have to be some genius benefactor or some Elon Musk type character who comes along and decides to fund it, which could happen and would save you from that.
But if you just went public, my worry is that you're getting involved in You're getting involved in commerce with psychedelics and that just doesn't feel like the way to do it.
It feels like all that stuff should be completely legal and we should kind of wait until you guys and the way your work kicks in and all the influence and the people that vote get an understanding of what the real landscape is.
Now, there's a fellow that, Jeff George, he's the chair of the board of the MAPS Public Benefit Corp.
And he used to be the CEO of Sandoz, which is one of the world's largest generics, but also Sandoz was where Albert Hoffman invented LSD and where Albert also first synthesized psilocybin.
So Jeff has got incredible pharmaceutical experience and he's been trying to help educate me about that we have a tremendous opportunity in a way, if we do need to take investors and do need to become a publicly traded company, that we could be an example for the entire pharmaceutical industry.
That we could be an example of a public benefit psychedelic pharmaceutical company with majority control.
Hopefully we could remain a majority control owner of a nonprofit.
And so I appreciate your reaction to this because he said there may be several different ways in which there could be benefits from going public.
Well, we are currently developing a budget in the range of $75 million to FDA approval.
And then after FDA approval, there is going to be another raise that we're going to need to make to get to this sustainability point.
But once we have FDA approval, there's many options that we will have that were not so much open to us now.
So, for example, we've been approached by people, a big company in Korea that was interested in buying the rights for Asia for MDMA. So we're trying to narrow them down to Korea.
But we could, with FDA approval, it'll be pretty clear that other countries will give reciprocity, that we can make it.
So we might be able to sell rights to different countries so that we can keep the nonprofit, the 100% owner of the Public Benefit Corp.
We would have more options to do royalty shares because then there are people that, the mission-related people that have, through Ryan Zura, that have given us this $43 million They're gambling that we may get it approved.
And then the royalties come only if we get it approved.
Post-approval, we'll be able to get a much better deal.
Our valuation will be higher.
We could get loans, potentially, on this income form that looks like...
Okay, so, well, the downside for me is right now, the potential downside is right now, With MAPS as the 100% owner of the Benefit Corp, net zero trauma by 2070 is the new vision.
And what that means is we've talked about working with prisoners.
But I want to work with refugees.
I want to work with people in Rwanda that have been traumatized by genocide.
I want to go all over the world and try to globalize MDMA-assisted therapy in a way where we go where the trauma is, not necessarily where the money is.
And that we put this global perspective of net zero trauma by 2070, mass mental health, spiritualized humanity, you know, we're destroying the environment, we've got incredible proliferation of nuclear weapons, you know, whether humans survive is not a sure thing.
And so I think if we're more stable, if we're not seeing the world through all these filters of pain and past traumas, so I think one of the upsides, you could say, of having the public benefit corp be wholly owned by the nonprofit is that we can focus on public benefit and that that's the thing.
I think that when you start having publicly traded companies, you could say there's no one, it's not pure public benefit or pure returns to investors.
And so I think that with all the money from philanthropists, it will be towards public benefit.
We're not going to be trying to prioritize giving returns.
The returns to the donors are in a better world.
That's the return.
And that's, I'd say, the advantage.
The risk, depending on where the capital comes from and what kind of conditions they put on it, is that we start now maybe need to think about more returns to investors and where do we go for the money rather than where do we go to reduce the trauma.
So, but I think we can have a good example of a public benefit corp, hopefully at least majority owned by the nonprofit, that can do an enormous amount of good in the world.
But I just think that we could do an enormous amount of good plus if it's funded by philanthropy.
So I think the worst loss of public benefit for us would be to run out of money and to never make it into a medicine at all.
So if we have to take money from investors, I think we should do that.
And I hope that some of those wealthy hippies decide to donate to make it into a philanthropy.
But I do think that it's our obligation to make it into a medicine one way or another.
And if we do take it from investors to do it in structured in such a way where It's still within a public benefit structure, and so we will try to develop metrics to evaluate public benefit.
We will try to ensure governance controls so that it does stay more focused on public benefit.
But, you know, it would be a lot easier if we could do this, in a way, through philanthropy.
And also, we are the leading—there's hundreds of psychedelic for-profit companies and a few non-profits, but we're the only one that has completed Phase 3. So we have two successful Phase III studies.
I'd like us to be a model for the entire field.
And again, what you're saying about telling the truth or underestimating risks or overresting benefits, I would like us to be a model.
And that was my dream from...
When I first started MAPS in 1986, because I assumed, erroneously, that MDMA would immediately become generic if it was made into a medicine.
Because I knew it was invented by Merck in 1912, and so the molecules in the public domain.
And I also knew that the use of MDMA for PTSD was going on before I even knew about MDMA. You know, I worked with the first person with PTSD. I talked about it in my TED Talk.
In 1984 is the first person that I actually saw suicidal with MDMA, no other options, and she was able to get better.
And Marcella is her name, and now she's one of our lead therapists and trains other therapists.
But I thought it would be coming generic.
I did my PhD, I got it in 2001, focused on how to FDA regulation of psychedelics and marijuana.
I took a class at Harvard Law School around 96 from the leading pharmaceutical expert, Peter Burton-Hutt.
He wrote the textbook, Food and Drug Law.
And he later became on my dissertation committee.
He's with Covington Burling.
He's in his 80s.
He represents us pro bono.
But throughout my entire education, I still thought that MDMA would immediately become generic.
It wasn't until 2014 that I went to a party, in a way, and ran into a patent lawyer.
So my wife was head of what's called Foundation for Belmont Education, which is a local group that raises money to supplement the money that goes into public education.
And so she was president.
She had to give a little talk.
And it's mostly a lot of food and silent auction and stuff.
So I'd worked all that day.
And I thought, okay, great.
I'm just going to get super high.
I'm going to get the munchies.
I'm going to go eat all this food.
I don't have to talk to anybody.
My wife can do the speech, and I'm done working.
So this moment where I was done working and just going to munch on all this food is where I ran into a patent attorney who I had known.
He was from locally, and he had previously gotten patents for Bromo LSD, which is a non-psychedelic version of LSD. And bromo LSD... What's the benefit of it?
For cluster headaches.
So people that have cluster headaches had discovered that LSD or psilocybin breaks the cycle of cluster headaches.
Cluster headaches are suicide headaches.
They're way worse than migraines.
And there's not many good treatments for it.
They had approached me around 2004, 2005, saying, we don't want to be criminals anymore.
What can we do?
And I started doing work with them at Harvard.
And they did medical records of all these people.
They had terrible cholesterol headaches, then they didn't, and intervening was LSD or psilocybin.
So over nine days, you'll do the psilocybin or the LSD. I mentioned about this project in Jordan that Michael Marcus helped fund.
It was because a young Jordanian came by to McLean Hospital at Harvard to learn about the cluster headache study, and it turned out that his cycle began, and they weren't giving Psilocybin or LSD at the time, they were just studying it.
And so his cluster headaches started and they referred him to me.
And so I thought, okay, I'll give him LSD. But I thought, he's never done LSD before.
And I said, we have no idea why LSD works.
We have no idea why psilocybin works.
And I thought he's scared of these drugs.
You have to give it in a fairly, you know, it's not microdosing.
So I thought maybe give him MDMA too.
At the same time, the MDMA will calm him down and maybe whatever LSD does, it won't be blocked by the MDMA. I didn't know, but I thought let's give it a try.
And it worked.
It worked.
And it was incredible.
So anyway, he goes back to Jordan.
And after a bunch of months, he said, you know, my life has changed.
I feel much better.
It was a terrible burden.
I've met this girl.
And we've fallen in love.
We're going to get married.
And I would like you to come to the betrothal ceremony.
Turned out her father was the mayor of Oman.
And I'm like, great!
Now we can do research in Jordan.
We can finally get into an Arab country to do Arab-Israeli stuff.
So that's what I talked to Michael Marcus about, and that's why he supported that project.
But in any case, the Harvard people said, oh, Timothy Leary was here, and this is like, we're not going to let you do psychedelic research unless it's the last resort.
So Torsten Pasi, John Halpern were the two that were doing this.
Torsten was at Hanover University in Germany, and they said, all right, let's do Bromo LSD. We don't know why it works, but Bromo-LSD is a non-psychological version of LSD, and we'll give it to a bunch of people, and it won't work, and then we'll come back to Harvard and say, we've got to start giving LSD or psilocyme to people.
So, I say, great idea, great plan.
So, I keep waiting for the results, and waiting for the results, and waiting for the results, and they're not telling me, they're not telling me, they're telling me, I'm like, what is going on here?
Finally, they told me that they thought I would be terribly disappointed, but Bromo-LSD worked.
And not only did it work, but it worked better than LSD or psilocybin.
Anyway, so Harvard then gets a patent on Bromo LSD. For cluster headaches with the University of Hanover.
And a fellow, Kerry Turnbull, is now trying to move this through the FDA. So the patent attorney for Harvard was also part of this, you know, local.
So he was there at this party.
And so I go to him, again, keep in mind, I'm super stoned, just munching on all this food.
And I'm like, oh, it's very interesting.
How's this going with the patent for bromo LSD? And I said, too bad there's nothing like that for MDMA. And he said, well, there is something.
It's called data exclusivity.
I'm like, data exclusivity?
What's that?
He said, well, it turns out in 1984, Ronald Reagan signed a bill to provide incentives to develop drugs that are off patent.
And what it means is that if you are the first to produce the evidence to make a drug into a medicine, even if there's no patents, you have exclusive use of your data for five years.
Now, it's different from a patent in that another person, another company, can develop their own data.
So it doesn't block anybody like a patent would block anybody.
Then, if you do studies in pediatric populations, so the FDA has right now forbidden us to do studies in people that are younger than 18. We can only work with 18 or older.
We've had a mother with a daughter who'd been terribly raped and was mute and wanted to be in the study, and the FDA said no.
But what they did say is that if you succeed in adults, if we do give you permission to work in adults, you must do studies in adolescence, and you get an extra six months date exclusivity.
So that's five and a half years.
Then it blocks the FDA from reviewing a generic applicant's file until the five and a half years is over, and it takes FDA an average of two years to review a file.
So there's this period of data exclusivity that we would have a monopoly potentially on the sale of MDMA for PTSD. And Europe, the European Medicines Agency, after Ronald Reagan signed this in 1984, they said, yeah, this is a good idea.
We should provide incentives for drugs that are off patent.
So it's 10 years data exclusivity in Europe.
So everything changed.
I thought, how is it that I took the class from the expert, I read the textbook, my whole dissertation is on it, and I never even heard about this.
And the reason is pharma doesn't use it.
They only want drugs that they have patented.
And we've had a bunch of potential biotech investors tell us that they don't really want to invest because they don't like the fact that data exclusivity isn't as long as a patent.
But that changed everything for me.
Now, that's why we created the MAPS Public Benefit Corp, because now it's not going to necessarily go generic.
We can then have this period of time where we can make an income, and then what I can tell...
Now, I'll say that the DEA then has to reschedule, and that will take a maximum of 90 days.
DEA, by law, must reschedule within 90 days after FDA has said yes.
So there will be this five and a half years, and then it could be a year and a half, two years, or six months, or who knows how long it'll take the FDA to actually review this file.
But I think that we have this period of time where we have this opportunity for income.
So that's the story to the donors has been, and the story to the investors and donors is, if you help us make MDMA into medicine, we're not going to be coming to you for money all the time because we will be able to make money to use to more research.
MDMA is not just good for PTSD. It's tremendous for couples therapy.
It's tremendous.
We think it would be tremendous for eating disorders, for postpartum depression.
Of course, we have to do all the research to see if this is really the case.
It has to be data-driven, but We have this opportunity to become self-sustaining.
And so that's the situation that we were able to tell both donors and then also investors, that we can return money during this period of data exclusivity.
Okay, so we've done this very patiently, step by step.
And so there's a big methodological problem from a scientific perspective.
You have to do double-blind studies.
And that's required.
You need randomized, placebo-controlled, double-blind studies.
That's the gold standard for Phase III studies.
So, well, Jamie, you may get these edibles and nothing happens, you know, but most people that get MDMA or LSD know they've got it, or psilocybin.
So the double-blind doesn't work too well in these kind of studies.
So the FDA offers what they call special protocol assessment.
And that's a process where you can opt in once you've been approved to go to phase three and you negotiate every aspect of the design with the FDA and all the other material and other scientific studies, all the other data that they want to see in the review package.
And the goal is to have these special protocol assessment negotiations to end up with what's called an approval letter.
An agreement, yeah, a formal agreement that they agree with this special protocol assessment.
Often you don't get that and Big Pharma doesn't use this a lot of times anyway because it delays things by quite a long time.
But they often don't need to do it because they're not doing something novel, they're not doing something controversial, they're not doing something that's a challenge with the double blind.
So we decided to elect to do this.
So we went through this special protocol assessment, and it took us eight months.
And in the end, we did get an agreement letter.
And the FDA brought in the old wise man of the FDA, a fellow named Bob Temple.
Who was at the FDA since 1972, their Office of Science Policy.
And what we said to them is, it was kind of funny, we said to them that there's a quote from an early president of Harvard, which says, never forget, there's always a Harvard man on the wrong side of every issue.
All right.
So I opened the meeting and I said, this is the quote and the person on the wrong side is me because my dissertation was, I thought I solved the double blind problem.
And it would be therapy with low dose MDMA versus therapy with full dose MDMA. And people would be confused about what they got.
And our challenge would be to find the dose of MDMA. The low dose that was high enough to cause confusion, but not so high that it caused so much benefits that we'd never be able to see the difference between the two groups.
So over the course of from 2000 to 2016, when we did all these phase 2 studies, we tested inactive placebo, 25 milligrams, 30 milligrams, 40 milligrams, 50 milligrams, 75, 100, 125, and 150. And what we discovered, which was again a little bit difficult for me to discover, is my dissertation was wrong.
I was not right.
I was partially right, is a better way to say it.
That it did cause confusion between the low dose and the high dose, but it made people uncomfortable.
So the low doses, it's like turbulence when you take off of an airplane.
At the very beginning there's more turbulence, and then when you get above clouds or so, your cruise control is smooth.
So early small doses of MDMA, they have an activating effect without as much of the fear reduction.
So what we showed is that people who got these low doses, they all still got better, but they didn't get as much benefit as if we gave them an inactive placebo.
If they got therapy with nothing, they did better than if they got therapy with low dose.
And we discovered that the 75 milligram dose group was actually surprisingly helpful and beneficial.
So it's a narrow range between when you're in the turbulent zone to when you're getting benefits, when you're cruising.
So there's no practical way to do that.
So we went to the FDA at this final meeting for this special protocol assessment, and we said, I'm wrong.
We'll do whatever you want.
You tell us what you want us to do.
But we can give you blinding, but you're going to make it easier for us to tell a difference between the two groups.
Because the people with the low dose don't do as well as the people that got nothing.
And the real challenge is to show if we can do this with therapy, why bother add a drug?
So we said to the FDA, we suggest you make it harder for us to find a difference by letting us use inactive placebo.
And what they said is that oftentimes, what Bob Temple helped them come to this conclusion, is that oftentimes the double-blind doesn't actually work anyway.
Like there's sexual side effects from SSRIs.
So you can learn from side effect profiles that people talk to you.
If you're doing an experiment and you're collecting adverse events, they'll tell you what the problems are and you'll say, oh, this is probably this or that.
So they said there's two main ways to reduce experimental bias.
The first is random assignment.
That means everybody is similarly motivated, they come from the same kind of background, they all fit the inclusion criteria, and then they're all willing to do whatever and then half get your treatment, half get the control.
The other is a robust system of independent raters to evaluate the outcomes.
We don't want the therapist to say how well people did, because they will most likely, over 90% of the time, they can tell who got MDMA, who didn't.
There still is some confusion.
Sometimes people are not responding very much.
Maybe like, Jamie, they have something biological where MDMA doesn't do that much, or they're...
They're controlling or something.
But most of the time, people are able to tell the difference.
But the question is also that the side effect profile will be better if it's no MDMA as well.
So when I said that we had one woman try to kill herself twice and she had the placebo, it's from the therapy.
If she had gotten low-dose MDMA, Maybe it's this low-dose MDMA that made her uncomfortable.
But now we know if you have severe PTSD and you go into therapy and you're starting to uncover things, that's a risk because you've got some balance.
It's difficult.
It's not healthy.
But when stuff comes to the surface, it can make you really disturbed.
So Bob Temple came and said, we will approve this idea of therapy with inactive placebo.
So we got an agreement letter from the Special Protocol Assessment.
So we have a situation now, to address your question, how likely is it that it's going to be approved, is that the FDA is legally bound to approve our drug if we get statistical significance, which we've got in spades, tremendous, If we have an excellent safety record, which we do, and if we've gathered the data in a proper way so that the FDA considers it valid.
And we've recently had a big inspection by FDA and Health Canada.
We've had loads of people from the Public Benefit Corp who did a phenomenal job to try to respond to all the questions from the FDA, and we got some findings but nothing serious, so we know that they're going to consider the data to be valid.
So I do think that the chances are they cannot say we don't like your design because the double line didn't work because we have prior agreement to use that design.
There's no safety issues that they can point to of significance.
I mean there's acute effects from MDMA. Most of it was like sweating or muscle tension or these are transitory side effects from the MDMA. All more from the MDMA than placebo.
I think the other big factor that makes me somewhat confident is that we have bipartisan support.
It's not a political issue.
So much in America is politicized, is part of the culture wars.
But we have managed somehow, well, consciously, intentionally, and a lot of it is working with veterans and others, is to take the psychedelics out of the culture wars.
So I don't think there's going to be political efforts to...
There's actually, I won't mention names or anything, but there is a member of Congress that has PTSD, that's a Republican, That wants to go through, if possible, a study in the open, a legal study, then to publicize the effects of MDMA therapy for PTSD. It's amazing.
So I think that we're in good shape.
I think how it gets regulated is going to be more of an issue than if it gets approved.
Well, the other similar substances, the next one in the line is psilocybin, and they're going to have to generate their own data.
So we got breakthrough therapy designation in 2017. Right after we completed the special protocol assessment, we got breakthrough therapy, and we were the first one for any kind of psychedelics.
A year or two later, the psilocybin, Compass got breakthrough therapy for psilocybin for treatment-resistant depression, and then USONA got breakthrough therapy for psilocybin for major depressive disorder.
So I think that the psilocybin people are going to be the next through the FDA system.
They're just starting their Phase III studies.
So I think by 2026 maybe psilocybin will be there.
So we're opening the door politically, but they have to come through with their own data.
And then there will be other people trying to work with 5-MeO to make that into a medicine, potentially for depression or something.
Ibogaine hopefully we can get.
So I think that we are the leading example.
That's why I would like to ideally do it through philanthropy.
But I think that we've got a real hope that this will be approved.
So we'll see who responds in terms of philanthropy or what hardcore capitalists think that you could save the world with this idea and make a shitload of money.
Well, before I get to the rest of this, just about kids.
So I've got Eden is 28, Lila is 26, and Ellie is 24. But when they were their bar mitzvah age, and this is where I'm curious more how you're going to teach your kids, is that I remember my bar mitzvah as being a massive disappointment.
So when each of our kids turned 13, my wife and I, we went to them and we said, if you want marijuana or MDMA, we think you're old enough for it and we'll do it together and you can have it.
And all of them were like freaked out, like, no, no, we're not ready!
Do drugs with my parents!
No way!
It turned to be the best anti-drug strategy we could have thought of.
Just give it to them, and they're like, oh no.
Now, they did come around later, I will say.
So I'm curious, for your own kids, are you going to say, don't do it when you're teenagers, but do it later?
Yeah, and I think that once we talked about it a couple weeks ago, why you invited me back is because you wanted to help us highlight this crossroads that we're at.
I've got another quick thing to get your reaction to.
Okay.
So Dan Grossman is also on the board of the MAPS Public Benefit Corp.
And he is from the Boston Consulting Group.
So he's a managing director, senior partner, and he does a lot of biofarm stuff.
So I'll just say that there's various theories of pricing.
So once we make it into medicine, whether we do it even in a public benefit with only philanthropy or if it's investors, we still are going to be looking at how do we price the drug.
And there's interesting ways to do this.
So the first is called price to value.
And when you consider the value, and this is how insurance companies will often look at it, it's both to the individual, the family, and the society.
So there are substantial values in taking people who have moderate to severe PTSD. They can't work, things like that.
And so the key challenge that we have is that when you look at pharmaceutical ads on TV, They'll say, oh, if you can't afford the drug, you know, we'll give it to you.
You know, we have a patient assistance program, you know, and apply to us.
So our situation is fundamentally different because the treatment is therapy augmented by the drug.
So if we give people MDMA, it's not going to do them any good whatsoever if they can't afford the therapy.