A Dive with the Maestro behind MDMA Psychotherapy Research – Rick Doblin – HPP 62
Finding the best method of treatment for battling mental illness has always kept researchers and scientists on their toes. It is wonderful that we have all sorts of medicines specifically developed to target certain illnesses. However, these treatments are not always effective in the long term.
A new treatment possibility, most providers over the years have largely ignored, is psychedelics. MDMA-assisted psychotherapy could very well be the future. It could be a new treatment option for our patients who have been struggling and suffering for years with PTSD and other related illnesses.
Today, we are extremely honored to be joined by a very well respected researcher and scientist who has been at the forefront of psychedelic research for decades, fighting to legalize the use of psychedelics for future clinical practice. He is the founder of the multidisciplinary association for psychedelic studies (MAPS), Dr. Rick Doblin. We will be discussing all the interesting data that he and his team of researchers have gathered over the course of their research and we’ll learn the possibilities of when this treatment option will be available for the public, its cost and impact, the spiritual links of using psychedelics, and many more interesting topics.
Working with Psychedelics: Against All Odds – 03:40
“And so I just feel so lucky that I was able to grow up at a time in the 60s where I saw the flourishing of psychedelics then I saw the backlash. That’s where I decided to get involved. Then I saw MDMA, which I learned about in ‘82 as a therapeutic drug, although it was at the same time ecstasy. So it was clear there would be a second backlash”
Understanding MDMA and its History – 07:44
“So MDA, methylenedioxyamphetamine, which is a little bit more like an LSD-MDMA combination. And then MDMA, which is methylenedioxymethamphetamine. So MDA, which was referred to by non-medical users as the miracle drug of America, because it promoted this open heartedness and it had the psychedelic component”
Getting Involved: Delving into Research – 14:13
“So the thing that I missed by talking about the early work was that MDMA was used by Roman Catholic monks and Buddhist meditators. And it was used as a tool for meditation. Half doses in meditation helped people have a deeper quiet to keep states that they were otherwise unable to do. And then once you have that experience once, then you could get back there without the drug through practice. So that was like climbing up to the top of the tree and seeing where you need to walk”
The Inner workings of Psychedelic Treatment – 16:00
“In this case, it’s the therapeutic alliance and the relationship that really contributes to the growth. And so, therefore, it does make sense, I think, for the therapist to have the experience and I felt that there’s less resistance in psychiatry and psychotherapy for them taking MDMA than there would be for taking LSD or psilocybin”
Ongoing Research – 19:31
“And they take a look at your actual data, they compare it to your hypothetical data that you use for your power calculations. And if your actuals are not quite as good as you had hypothesized, you can still get the drug approved, you can still get statistical significance, but you would need to add more people to the study. What that means basically is the stronger the signal, the bigger the effect size, the fewer the number of people you need to see it. And so you can have studies sometimes pharma has studies of thousands of people. And you can get statistical significance for trivial differences”
The Therapy is the Treatment – 28:52
“And so what we’re proposing is that the drug is not the treatment. It’s the therapy that’s the treatment that the drug makes more effective. So the only people that can be directly working with patients are people that have been through the training program, run by the sponsor or authorized by the sponsor, and in learning the psychotherapy component”
MAPS for Public Benefit – 35:06
“What we figured out is that from a public benefit perspective, the real public benefit is helping people get over PTSD. So the training program, we’re thinking of operating at our cost. We’re not thinking of the training program as a profit center. And so that’s why we’re very much not trying to keep it within MAPS and that we’re doing all of it. And so we want to distribute the training as much as possible, but we want to hold up fast on the quality”
Understanding How Much this will Cost versus Traditional Treatments – 38:56
“and he’s looked at our data from phase two and has shown that he thinks that it’s cost effective within several years. So it is more expensive initially, than just giving somebody a pill or treating them one hour a week. But what we see at the VA is that sometimes people go to weekly therapy for decades and decades. So over time, this is going to be more effective plus it’s got better results”
The Experience with Psychedelics Over the Years – 48:12
“And so when I first did LSD, when I was 17, four years plus later. I was almost 18 when I did it. So almost five years later, I felt like this is what my bar mitzvah should have been. This is moving these kinds of energies and even though it was scary, and I couldn’t completely let go but I had the ego dissolution and the sense of being connected through historical time and evolution and all this, I thought, Ahuh! This is filling a hole in my spirit, that the sort of traditional rites of passage didn’t”
Keith’s Interesting and Moving Experience with Psychedelics – 57:19
“Because once I was offered the LSD, I said, how is it possible that two people can have the exact same hallucination? And then what is a hallucination? It just completely opened up my entire mind of what is reality? And how can we have a shared reality of something that’s supposedly not happening? And it really opened up a lot for me, that was, you know, my first sort of spiritual opening”
A Note to Skeptics – 01:03:13
“the whole scientific process that we’re engaged in, is about harnessing your skepticism to create methodologies that ideally eliminate experimenter bias, or subject bias. So I welcome the skeptics. I mean, it’s not for everybody. I think you’re right. I mean, It can trigger psychotic reactions, if people are not supported, and people can take psychedelics and be worse off. That doesn’t mean we need a drug war to criminalize them under threat of jail. But I do think that there’s justification for skepticism and that we should be held to the highest standards of proof, which is what the FDA is saying”
Dr. Rick Doblin, Dr. Will Van Derveer, Keith Kurlander
Dr. Rick Doblin 00:01
What psychedelics did when I first started taking it is giving me access to my emotions. They were really helping me to feel and even though these were difficult feelings, all of a sudden, it wasn’t just thoughts in my head. So it sort of opened up a new dimension of life for me, which was emotions, and really powerful emotions.
Dr. Will Van Derveer 00:25
Thank you for joining us for The Higher Practice Podcast. I’m Dr. Will Van Derveer with Keith Kurlander, and this is the podcast where we explore what it takes to achieve optimal mental health.
Dr. Will Van Derveer 00:41
Our guest today, Rick Doblin from the multidisciplinary association for psychedelic studies, is a perfect guest for this podcast about optimal mental health because Rick Doblin has been carrying the flag now for 35 years to support the ushering in of psychedelic medicine through psychedelic assisted psychotherapy research. I had the good fortune to meet Rick about 10 years ago when I was invited in to participate as a study physician and MDMA psychotherapist in an MDMA psychotherapy trial for chronic PTSD. And as a practicing psychiatrist to see the incredible results possible in a very short period of time for people with decades of suffering from trauma was mind blowing. So we are delighted to have a very busy guy, Rick Doblin here to speak with us today about an update on how things are going with MDMA psychotherapy and how Rick got interested in psychedelics in the first place. It’s a really fun conversation with Rick that went into some great personal direction. So without further ado, here’s the episode. Well, it’s a real pleasure to have you on the show, Rick?
Dr. Rick Doblin 02:07
Well, no, it’s been wonderful to see what you’ve done in this area and see what you’re moving on to as well. Great.
Dr. Will Van Derveer 02:15
Yeah. It’s been amazing to see the trajectory of what has happened ever since I met you. Like, I think that was nearly 10 years ago, something like that.
Dr. Rick Doblin 02:23
Yeah, and just to see how much more comfortable you’ve got.
Dr. Will Van Derveer 02:26
I was pretty stiff when you met me. I might as well share that I was one of those people who had been taught in medical school that MDMA causes holes in the brain. And I was extremely skeptical about MDMA research. When I met Rick and had been invited to support the phase two trial we did in Boulder, and I think you put Michael Mithoefer 2011 paper in my hand and said, “well, you know, why don’t you just look at the paper and see what you think?” And I saw 83% response rate as durable at 12 months. I thought, well, that’s about four times better than what I can do with PTSD, at least. So I better listen to this. So yeah, it’s been a journey.
Dr. Rick Doblin 03:05
Yeah, that paper has had such an impact.
Dr. Will Van Derveer 03:08
It’s wonderful to see you again. And so why don’t we jump right in? First thing I’m curious about, it was 1985 or was it 86?
Dr. Rick Doblin 03:20
MAPS was 86.
Dr. Will Van Derveer 03:22
Dr. Rick Doblin 03:23
And I had a prior nonprofit before that, but I started in 1984 to gather the sort of psychedelic community together to prepare to sue the DEA once they moved to criminalize ecstasy. So MAPS was the second non profit.
Dr. Will Van Derveer 03:40
Got it. So over 35 years that you’ve been at it. I’m just so curious what it must feel like for you to see all of this hard work over decades of finally seeing the change in public perception around psychedelics and getting very close now to seeing the first schedule in psychedelic back and clinical use in your lifetime. How’s that feel?
Dr. Rick Doblin 04:01
Well it feels a bit extraordinary. To put it in context, I really decided in 1972 when I was 18, to focus my life on psychedelics. So it’s been 48 years. It took 10 years initially from 18 to 28 for me to get grounded enough for my psychedelic trips, to sort of put psychedelics at the forefront of what I did in the world, even though that was where I was heading to. So the more things that I think about how lucky I am to be a social justice activist that actually lives at the right time to see the change. So I think a lot of the people that were working for women’s rights to vote, or for gay rights, or for civil rights. These are multi generational struggles, and even now, we haven’t really overcome the Civil War, and that kind of racism and we’re seeing that sort of coming to the surface now and all these monuments to Confederate generals. And so I just feel so lucky that I was able to grow up at a time in the 60s where I saw the flourishing of psychedelics then I saw the backlash. That’s where I decided to get involved. Then I saw MDMA, which I learned about in ‘82 as a therapeutic drug although it was at the same time ecstasy. So it was clear there would be a second backlash. So then I saw the second backlash against that with MDMA, criminalized in ‘85. And now I’m seeing the opening up. And one of the things also that I’m most proud of in the entire history of MAPS and what we have accomplished is that in 2008, and near the end of 2007, we got approval for LSD research which was the first time in about 35 years that LSD research had been approved. And we did that a few months before Anita Hoffman and Albert Hoffman died. So they got to see not the sort of full flowering of the psychedelic Renaissance, but they got to see LSD research being approved by the Swiss medic and getting ready to start with our sponsorship in Switzerland before they died. So being Jewish, I’ve thought a lot about the whole stories of Moses and the ideas that Moses led the Jews out of slavery, but then he died before he entered the promised land. That God told him that because he had killed this overseer, he committed murder, and he wouldn’t be allowed into the promised land. So for me, the promised land is FDA approval of psychedelics and starting all these psychedelic clinics. So if I’m continuing to be lucky, I may be ushering us into this promised land.
Keith Kurlander 06:41
Your story is gonna get to be a little different than Moses, hopefully.
Dr. Rick Doblin 06:44
One thing I’ll just say about Moses is that there was an article by an Israeli psychologist and he talked about how the burning bush vision and all of that, Moses must have been high when he saw that and mana was something that was proposed as magic food. Psychologists propose that that was actually a psychedelic drug and that Moses was high on psychedelics. So I went to my father who’s been very supportive. He was a doctor, and he’s no longer alive. He died at 93. He was a pediatrician. But I said “Dad look at this. Moses was high”. This validates everything I’m doing; psychedelics, Judaism, it’s all from the very beginning. And he said, “Well, in order for me to believe that, first off, I’d have to believe in Moses”, because as it turns out, there’s no historical evidence or archaeological evidence that Jews built the pyramids, or that they traveled to all these communities through the Sinai desert and stuff. But in any case, yeah. I hope my story is different from moses.
Keith Kurlander 07:44
So we’re gonna mostly talk about MDMA because we cover different things in the podcast on psychedelics, and we thought, wow, we’ve got a kind of spear headers here on MDMA. And we thought a great starting point about MDMA is to just first talk about when it was being used legally for psychotherapy back in the late 70s and early 80s. Is that right? So when it was being used, what exactly were people using it for? Was it more of a psychoanalysis type or because back then trauma wasn’t a huge conversation yet, right? It wasn’t as big as it is now, in terms of using that language.
Dr. Rick Doblin 08:21
So I think we need to go back a little bit further into the 60s where there was a drug called MDM. So MDA, methylenedioxyamphetamine, which is a little bit more like an LSD MDMA combination. And then MDMA, which is methylenedioxymethamphetamine. So MDA, which was referred to by non-medical users as the miracle drug of America, because it promoted this open heartedness and it had the psychedelic component. It was very popular and in fact, in 1972 or in the late 60s, there were studies that were being done with MDMA for psychotherapy. When the Controlled Substances Act came down in 1970 and criminalized MDA, a bunch of chemists, particularly Sasha Shulgin, had been looking at ways to modify drugs that were illegal because at that time, the DEA had to specify that a specific molecule was illegal. And if you tinkered with it, then it was a new thing and it was legal. Now we have the analog bill that they’ve tried to make so that analogs are illegal if what they’re based on is illegal. It’s hard to enforce. But in any case, once MDMA was sort of rediscovered in the middle 70s, it was given by Sasha Shulgin and Ann Shulgin. They tried it themselves first, then they had a core group of 12 people that they use to test out new drugs, and they felt that everybody has a unique kind of response so that if they could get a group of 12, and get all their different responses, they can get a good sense of what this drug might be. And they felt that MDMA had this incredible therapeutic potential. And so then they turned it over to Leo Zeff. And we’ve published a book called The Secret chief revealed. Leo was the secret Chief, the leader of the underground psychedelic therapy movement. He was a clinical psych PhD, jewish, had his own copy of the Torah, very spiritual. And he was doing a lot of work with LSD and other drugs illegally underground. And he was planning to retire. And once he experienced MDMA, he thought that this had enormous therapeutic potential and then he would not retire. And then he ended up training 100 or so therapists and psychiatrists on how to work with MDMA. So what it was used for, and it was used under the name Adam. So it was kind of a scramble of MDMA, so that they didn’t want the word to get out what it really was because the fear was that that might become more easily criminalized, but also they wanted to sort of evoke the Garden of Eden and original state of innocence because there’s a way in which MDMA is like a truth serum and helps you accept yourself. You can be a better listener for critical comments, it reduces fear, all these different things. So it began to be used for couples therapy a lot. But also for personal growth. It was being used for people that were scared of dying, people who had cancer. It was being used for quite a wide range of things. And in fact, it was also being used for Vietnam vets who had PTSD. So while there wasn’t such a widespread cultural focus on trauma and PTSD that there is now, there are still large numbers of people that were still traumatized in the late 70s, early 80s by Vietnam. And what we don’t get enough attention to is that most of the people in America that are traumatized are women from sexual abuse or childhood sexual abuse, complex PTSD or adult rape and assault, things like that. So around almost two thirds of our subjects are women, but the vets get the most attention. So MDMA was used in a wide range of things. A lot of them were not particularly patients but for spiritual purposes, for personal growth, for vision quests, and it’s spread quite widely. MDMA, actually a lot of it came from MIT, from chemists there that made it at night in the labs, so the MIT group was one of the big distributors—And they ended up distributing from the middle 70s to the early 80s, somewhere in the neighborhood of half a million doses in these therapeutic personal growth contexts. And these were done in private homes and private settings. And so the DEA had no idea that this was going on. And the situation is that some of these people who had experienced these circles decided that more people should know about it, that they could make a lot of money. And so it became ecstasy. And it became more used in bars and clubs and recreational settings. That’s what attracted the attention of the DEA. And so when they moved to criminalize ecstasy in the summer of ‘84, they had no idea that it was used as a therapeutic drug as well. And so when we think about what it is that we could learn from that early experience with the therapeutic use of MDMA. First thing is, a lot of people don’t know and maybe a bunch of the people listening to this don’t know that MDMA was a therapy drug before it was a party drug. That’s really important to establish. Also, once it became illegal, even still, a lot of people, underground therapists, kept using it instead of MDMA. It’s a little bit easier to work with, it’s more gentle, it’s more grounded. It’s very profound. It really goes very deep in terms of self acceptance. I think that some of the main things that we can learn from that early experience are that, in pharma, they call it a pipeline and a pill, in a sense that you want a drug that has multiple different clinical indications because then it’s more efficient economically to develop it for multiple indications. So I’d say MDMA is, as is psilocybin and LSD: these are classic pipelines in a pill because the treatment is not really the drug. The treatment is the therapy, which the drug makes more effective. So all of the different things that psychotherapy can be good for, psychedelic assisted psychotherapy can be good for.
Dr. Will Van Derveer 14:13
Great, thank you for the background. So why don’t we fast forward from 1985 to today and tell us what’s happening with phase three? How many subjects have been completed so far? How did the interim analysis go?
Dr. Rick Doblin 14:28
One moment, just about the early days, and then we’ll do this pivot, which was in 1983, I contacted the Assistant Secretary General of the United Nations named Robert Mueller, who was a French resistance fighter. He’s like the mystic at the UN. And so he talked about how we need to have a global spirituality, and a lot of the conflicts between countries are religious based. Anyway, I contacted him and he said nothing about psychedelics. He referred me to a bunch of mystics. So the thing that I missed by talking about the early work was that MDMA was used by Roman Catholic monks and Buddhist meditators. And it was used as a tool for meditation. Half doses in meditation helped people have a deeper quiet to keep states that they were otherwise unable to do. And then once you have that experience once, then you could get back there without the drug through practice. So that was like, climbing up to the top of the tree and seeing where you need to walk. But then you need to walk back down into the forest and walk out. So there was that other kind of spiritual aspect to it, not just therapeutic.
Keith Kurlander 15:33
I think what I hear you saying right before we get to today is that although there were different indications that were very apparent in the early days of using it for psychotherapy, they were couples working with it, there were different things going on. It seems like that as we came forward in time, I don’t know whether this was a political choice or not. It seems like, wait a second, this is really, really good at trauma work. Let’s focus on that in the research. What happened there?
Dr. Rick Doblin 16:00
Well, that was a strategic decision. It was a political decision. And so I like to say that we don’t do science, we do political science. We do drug development science, of course. But it was 1982 actually that I met a veteran from Vietnam who had PTSD. And he talks about how the MDMA helped him to relax where he’d been shot by a bullet. And then he carried a lot of tension in his body, where he’d been shot and that contributed to his trauma and under the influence of the MDMA, his musculature relaxed, and also he was able to more deeply process that trauma of being shot. So the political calculations were first off, of all the psychedelics, which one was most likely to make it through the regulatory system first? And then the next question, which of the clinical indications would be paired with that psychedelic in order to try to move forward with something that was highly controversial? So the idea of MDMA was that it’s the most gentle of all the psychedelics, it’s the easiest to integrate, it’s the least likely to produce “bad” trips, or difficult experiences, although it really helps you process really difficult experiences. And then the other part is that part of our belief is that the training of therapists and the training of psychiatrists to work with psychedelics will be enhanced if they’ve done the drug themselves in a therapeutic setting as the patient. And so I felt that that’s not necessary. It’s not essential, but it’s not that everybody that’s done MDMA will be a better therapist than everybody that’s not. It’s just that each person will be more effective if they’ve done it. I know that’s not true with psychiatry, you don’t think you have to get electroconvulsive therapy to give it to people or you don’t actually have to take all your antipsychotic drugs yourself. But that’s where those drugs in the ECT or the treatment itself. In this case, it’s the therapeutic alliance and the relationship that really contributes to the growth. And so, therefore, it does make sense, I think, for the therapist to have the experience and I felt that there’s less resistance in psychiatry and psychotherapy for them taking MDMA than there would be for taking LSD or psilocybin.
Dr. Will Van Derveer 18:21
I agree with you from the perspective as a psychiatrist that MDMA is an easier entry point. For the audience, what Rick is referring to is a FDA approved training study where people like me and other future MDMA psychotherapists have an opportunity to undergo the protocol and experience MDMA assisted psychotherapy as the patient. To be brief, I’ll just say it was incredibly valuable as a training tool to know what that feels like and how open you can feel and how trusting you can feel and how little fear there is in that situation. And you know, not only as a training experience, but also as a personal expense. It was incredibly deep and valuable for me. So I think that’s a really important factor in training therapists. And we’re going to get to questions about training therapists in a few minutes but I’m very curious how all of this is going to work out as we expand things.
Dr. Rick Doblin 19:16
I don’t think that the company is doing psilocybin research to think that they have not tried to create opportunities for their trainees to experience psilocybin. But I still think for us, it’s very important. So that’s how we came to MDMA. Then how did we come to PTSD?
Dr. Will Van Derveer 19:31
Tell us a little bit about how far we’ve gotten in phase three, how the interim data analysis went and how many subjects have gotten through at this point?
Dr. Rick Doblin 19:41
Okay. So for phase three, the agreement that we made with the FDA, that we have to do two 100-person phase three studies. And what FDA said was that they think that we can prove efficacy with smaller numbers than they want to see for safety. And so we have also agreed with FDA that we would do what’s called an interim analysis of each of the two phase three studies. So it’s kind of remarkable the situation is and it shows the power of the pharmaceutical lobby. Because often when you do a scientific experiment, you look at your prior data, you do your power calculations, you do your statistical analysis, you come up with how many subjects you think you’re going to need under certain conditions, and then you do the study. And then at the end of it, you uncover the data and you either failed or succeeded. But the interim analysis is for what’s called sample size re-estimation. And what that means is that you have an unblinded, independent data monitoring committee. And they take a look at your actual data, they compare it to your hypothetical data that you use for your power calculations. And if your actuals are not quite as good as you had hypothesized, you can still get the drug approved, you can still get statistical significance, but you would need to add more people to the study. What that means basically is the stronger the signal, the bigger the effect size, the fewer the number of people you need to see it. And so you can have studies sometimes pharma has studies of thousands of people. And you can get statistical significance for trivial differences. Because the FDA thinks, well, these are group averages between the placebo group and your test group. And maybe some people will respond more than others. Maybe one day you’ll figure out who they are. And then also, they leave it to the marketplace to kind of sort it out. So we agreed that we would do an interim analysis at 60 people out of the hundred who had reached their primary outcome measure. So we would have 60 people basically 30 and 30 from the placebo group, which is therapy without MDMA, versus therapy with MDMA, and we have to have all hundred people enrolled. And by enrolled it means just through screening, they don’t have to be actually treated yet. And we require people to taper off of their medications as well to be in the study. So people could be enrolled in there in a month or two of the tapering process to get off their psychiatric medication. So we had our interim analysis in March of 2020. There’s only two drugs that have been approved by the FDA for what’s called breakthrough therapy, designated breakthrough therapy, MDMA and a drug called Todd Maya, a repurposed sleeping pill from 30 years ago, and they thought it would help people not have nightmares. They did their interim analysis in February, and it failed for futility. And they spent well over a billion dollars and the drug didn’t work. So that backed out their breakthrough therapy drug and their stock went down and all that. We had our interim analysis in March. And what we learned is that we were doing great, that we didn’t need to add a single person to the study and that we had a 90% or greater probability of statistical significance once the study was completed, and we had the primary outcome data for all 100. Now that was in March, and we know the COVID and the lockdown happened shortly after that. So what FDA did is that they reached out to us and to a lot of other sponsors, and they said, we know that enrollment is going to be slower, or in some cases have stopped for a while. And so they gave us an option to end the first phase three study early. And so we sort of pulled all the different teams of therapists which we’re willing to continue, which of the patients that were sort of in the process, were willing to continue, which were not. And we decided that we would propose to the FDA that we would end the study with 90 subjects instead of 100. And that all 90 didn’t have to really go through the whole study as long as they had a baseline measure and they’ve been through at least one of the three MDMA sessions or the placebo sessions, the eight hour day long sessions, and then had an outcome measure after that, that we could end it like that. So that’s a bit of a risk you could say on our side because the 90% or greater probability of statistical significance was with all hundred people. And so we decided that we would end it with 90. And so the last data point is now coming in about two weeks. And we will have before the end of September, we’re going to know if the first phase three study was statistically significant.
Keith Kurlander 24:34
Wow, that’s coming up soon,
Dr. Rick Doblin 24:36
Very soon. And if so, and we think it’s very likely that it will be statistically significant, then the chances are that the second phase three study will be statistically significant as well and we can start really planning for commercialization. Now, we could screw up the second phase three study. It doesn’t mean automatically it’ll work but it will be the most important signal that we’ve had in the entire drug development program with MDMA. And we have now started enrollment for our second phase three study. But unfortunately, only four of the 11 sites in the United States are ready to start. So we’re starting enrollment there. I think Boulder, Fort Collins, New Orleans, and I think one of the San Francisco or LA sites is ready to start. The others I think are going to come online over the next month or so, a month or two. Not all of them may. We also have two sites in Israel and two in Canada, the Israeli sites are getting ready to start, but because of COVID, we anticipate that it will be a lot slower. And so now we’re assuming two years that the second phase three study will be done by the middle of 2022. We’re hoping to be approved before the end of 2022 or early 2023 assuming our data justifies that.
Dr. Will Van Derveer 26:00
Great and So the process with FDA after the completion of these two phase two studies, is it similar to the end of phase two meetings where you go in and you present the data and you have a conversation? Or what’s the process of getting MDMA off schedule one, if assuming that you have two statistically significant phase three studies?
Dr. Rick Doblin 26:20
Well, we need a whole lot of other studies too. So the FDA is wanting us to do animal toxicity studies, they want us to do studies with pregnant rats. And we already exclude people that are pregnant. So this is sort of what kind of precautions do we need to take? And we were doing pregnancy tests before every session for every woman who could conceivably become pregnant. So we have to combine all of the data from phase three from our other studies, and also what’s called CMC (chemistry, manufacturing and control) data that’s about the product itself. So we’re spending about 5.6 million to produce about 17 kilos of MDMA that could be used in a commercial post approval context. So all of that we submit to FDA in what’s called a new drug approval, or a new drug application (NDA). Because it’s a breakthrough therapy, we can do what’s called a rolling NDA. Meaning we can submit to them the CMC data about the product, we can submit them the animal toxicity data, the different things at different stages, but it will take the FDA probably six months or so to review all the data, then, most likely, and it’s not 100% sure, the FDA will call a public advisory committee meeting, and they will present the data and they will get the advisory committee meetings some recommendations. The FDA doesn’t have to accept the recommendations of the Advisory Committee. Sometimes they don’t, but there will probably be this public advisory committee meeting and that’s where you have members of the public but also key opinion leaders and various people sort of argue the case out from the data to this Advisory Committee, and these are appointed by the FDA. They have advisory committees throughout the FDA for all the different things. But we think that that would probably work really well, because we do have connections with key opinion leaders all over the world and they’re seeing the value of MDMA. Then what happens though, is let’s say the FDA says, Yes, they’ll approve the drug, then the FDA has a group called the controlled substances staff that works on controlled substances and trying to figure out what schedule should it go. Should it go from 1 to 2, or 1 to 3, or 1 to 4, or 1 to 5? Now, the DEA has their own evaluation of what schedule it should be. And so then the FDA controlled substance staff and the DEA meet together. And so there has to be a rescheduling. And we’re going to probably propose schedule three or schedule four.
Keith Kurlander 28:52
And Rick, I know what’s on a lot of people’s minds right now is first of all, what is this approval going to actually look like on the ground in terms of, is this have to be given in a psychiatrist’s office? Are you gonna have to have one therapist, two therapists, who they’re going to be. There’s a lot of questions people have right now about that. Where are we at with all that?
Dr. Rick Doblin 29:13
Right, so that’s called the REMS, the risk evaluation and mitigation strategies. So the thalidomide, which was the sort of quintessential bad drug. It was for morning sickness because of birth defects. The FDA was able to develop special requirements for special risks for the drug and they first did that with thalidomide. Now they do that for every drug and there needs to be these REMS. So we’re already preliminary negotiating this with FDA and DEA. And so what we’re proposing is that the drug is not the treatment. It’s the therapy that’s the treatment that the drug makes more effective. So the only people that can be directly working with patients are people that have been through the training program, run by the sponsor or authorized by the sponsor, and in learning the psychotherapy component. And then we’re also proposing that it’s like completely different than medical marijuana or medi drugs that you know, that are able to be taken home. This would only be administered under direct supervision of the therapists. Now, as far as whether it needs to be in the psychiatrists office or not, we’re also arguing with the FDA right now about whether there needs to be a doctor on site or a doctor on call. So for the study that was at Boulder, that was really well done. The doctor does the screening. And then, the doctor doesn’t actually need to be on site the entire time of the treatment. The doctor just needs to be at home.
Dr. Will Van Derveer 30:50
Yeah, that’s how it was for me as the study physician in Boulder. Right.
Dr. Rick Doblin 30:54
Yeah, that’s where we really set the precedent too that the doctor doesn’t need to be on site. So we’re still arguing that out with the FDA. For certain new studies, they’re trying to make it so there needs to be a doctor now in the building, but they’re used to like institutional studies, where there’s hospital settings, doctors in the building, but they’ve agreed for the Bronx VA study that we’re trying to get approved there that as long as there’s a doctor in the building, the lead therapist doesn’t need to be an MD PhD. The lead therapist can be a licensed therapist and the second person doesn’t need to be licensed. He can be a student who has to have some mental health training that is not fully defined. So to answer your question about whether there needs to be a two therapists team, so far, the answer is going to be yes. And the FDA will want us if we want to move to just one therapist, we’ll have to do other studies with just one therapist to demonstrate. Now, the reason we are doing two therapists, and we realized that it increases the cost substantially, but we think that it’s a controversial drug. There have been instances in the past where the therapist administering MDMA to their patients, their patients are in an open trusting way, have developed sexual relationships. This was in the 80s. And it was kind of scandalous. So we want to make sure that that doesn’t happen, particularly in the early stages when you’re starting to roll something out. And we also think that two therapists are better than one. We don’t think that they’re twice as good. Where we want to get to is no doctor on site, but a doctor on call. We want there to be a two therapy team, but the one therapist should be only licensed to therapy, not MD, PhD. And the other, we would like to ideally be working for free or for a little amount of money to be supervised by the first person to get their own approval to be a lead person if they’re a licensed therapist. But we’re also realizing the FDA wants the second person to have a bachelor’s degree and we don’t think that that’s necessary. So we would ideally in the future imagine somebody could be a massage therapist, or a music therapist or acupuncturist or any number of different things that may or may not require a college degree. So once the drug is approved initially, it will be a two person team. The therapist will need to be through our training program. And this will also be true for psilocybin, I think as well. And we hope we will not need a doctor to be on site. Now the big modification for this is going to be once we start looking at group therapy. And we think that group therapy is going to be a very important thing for us to try to develop and implement. And so the question will be what is going to be the ratio of the therapists to the patients. We don’t want there to be two. If it’s a group of four, we don’t want there to be eight therapists. The whole point is to try to reduce the cost of it and to see if there’s benefits that come from the group supporting each other. We are concerned with PTSD in particular, either for military related PTSD or sexual abuse. There’s a lot of guilt and shame and people are sometimes reluctant to talk about that in a group setting. Now in a group setting makes them more likely because somebody else opens up and that gives them courage so that there can be that. But the only group therapy project that’s been done so far was done with psilocybin. But it was done with group preparation and group integration, but individual sessions. So that does save a bit of money, but it’s still individual sessions. So I think we will be going forward after approval. Hopefully even before that to start some of these group therapy studies. And you look at Ayahuasca ceremonies or Native American church peyote ceremonies, they have large groups with only a few shamans eating it but at the same time, most of these people don’t have severe PTSD. They don’t require that kind of direct support as much.
Keith Kurlander 35:06
And then Rick in terms of training, so let’s say over the next 10 years, we have thousands or tens of thousands of therapists that need to be trained in this. Is the idea right now that MAPS is gonna hold all that?
Dr. Rick Doblin 35:19
Well, we are going to set the standards for training, we are training more trainers. But the ideal situation for us to scale up is that we would authorize different groups to run their own training. So for example, at the bronze VA with Rachel Yehuda, she wants to not only do an experiment there with treating veterans, the experiment would be comparing two sessions versus three sessions. Eventually she wants to do a group therapy program, but she also wants to train therapists throughout the VA system. And so it’s more likely that therapists throughout the VA system, if the VA decides that this training should be widespread. They would rather house the training and run it themselves, rather than have them all come to us. So we would authorize them to do the training. They would sit in some of our own training sessions, we would say, Yes, we think you’re good enough to train others. And then another part of this is a protocol where we have it so that therapists can volunteer to take MDMA, as part of their training which Will went through as well. The situation that Will went through was we were training people for phase three, where there is a control group, and then there’s the experimental group. And so the protocol that Will went through was four days where you have either MDMA or placebo for a day-long session, then you have a day of integration. Then you have the crossover, you get whatever you didn’t get the first time you get the second, the third day and then a fourth day of integration. So for going forward for treating people post approval or for expanded access, there aren’t going to be control groups. So we’re now negotiating with FDA to get approval for a two day program instead of a four day program. But the FDA has been balking at that. And so we’re in the midst of a formal dispute with FDA about getting this new protocol approved. But it would always be voluntary. I’ll say we’re never going to require anybody to take MDMA. We think that MDMA helps people understand, going through it helps them understand what it is. So we did a survey of 79 people that went through it. That’s the summary of most everybody. And so we’re still negotiating with FDA on that, but we would authorize different groups. So let’s assume, for example, that some of the expanded access sites who are actually treating PTSD patients, and we’re supervising them on their first patient, the first step would be once people (therapists) have actually experienced working with a PTSD patient under supervision and they’ve done that several times, then we think they would be able to have a protocol to give MDMA to other therapists. They would know enough about how the PTSD therapy works, then they could give it to healthy volunteers. So yeah, we think that because of the scale of need for therapists and for training, that’s the real issue for scaling. And so we would have our own training but we would also be authorizing other centers around the country. And also because we’re public benefit, not profit oriented for the public benefit corporation. What we figured out is that from a public benefit perspective, the real public benefit is helping people get over PTSD. So the training program, we’re thinking of operating at our cost. We’re not thinking of the training program as a profit center. And so that’s why we’re very much not trying to keep it within MAPS and that we’re doing all of it. And so we want to distribute the training as much as possible, but we want to hold up fast on the quality.
Keith Kurlander 38:56
The flip side of this question is, this sounds like a very expensive service to be able to offer as the providers if you have a doctor involved, you have the therapists, long hour sessions, so many sessions. So obviously a lot of patients are like, am I going to be able to afford this? What is this going to look like? And just where are we at with your thoughts on how much is this going to cost the patient?
Dr. Rick Doblin 39:16
Well, we think that it will cost around $5,000 for each MDMA session and for the preparation and integration and screening. So for a three session model, with three day long sessions with 12, 90 minute non drug psychotherapy sessions, it’s 42 hours of therapy with two therapists. So the cost will vary according to where the therapists are. Sometimes therapists in New York will charge one price, therapists in New Orleans will charge another price. But more or less, we’re hoping it will be in the neighborhood of 15,000 or less for the full program. Now, some people post approval will only need one session, some will need two sessions, some only four sessions. So we think the standard model will be two sessions. That’s what Rachel Yehuda wants to test out at the Bronx VA. Two sessions versus three sessions. We know that people get better from the third session, but maybe at the one year follow up, people who got two sessions only are going to be more or less similar to the people that got three because we see that people learn how to heal themselves, and they can keep getting better over time. So we don’t know if that’s true. But we do think most of the people will heal faster if they have three sessions, but maybe the standard model with two sessions worth $10,000. So the big question is going to be insurance coverage. So we’re working with a fella, Eliot Marsay, who is a healthcare economist at UC San Francisco. And he’s got a private consulting company, and he’s looked at our data from phase two and has shown that he thinks that it’s cost effective within several years. So it is more expensive initially, than just giving somebody a pill or treating them one hour a week. But what we see at the VA is that sometimes people go to weekly therapy for decades and decades. So over time, this is going to be more effective plus it’s got better results. So the other part for the veterans, let’s just say is that if you are disabled with PTSD, the average lifetime cost of that to the VA for your disability payments is million, million and a half dollars. So if we have a $15,000 treatment, and let’s say, from our phase two data at the one year follow up, two thirds no longer had PTSD. It’s enormously cost effective for the VA or the Department of Defense to offer this. But the other part that I think directly addresses your question about the cost is that we believe that the drug war, fundamentally counterproductive, doesn’t help reduce drug abuse. It’s racist, it is not useful. It’s always been for suppression of minorities, and that MDMA is the most inherently therapeutic of all the psychedelics. Not that it is automatic. But we believe that people should have access to this without having to go through MAPS, without having to go through medicine or without having to pretend that it’s now their religious freedom to use MDMA, not that it’s necessarily pretend, and that’s true for other psychedelics like ayahuasca and native peyote have been approved really straight. So we’re working to do harm reduction at Birmingham and elsewhere to help people who take in these drugs illegally. And we’re also now helping in Denver and in Oakland where they decriminalized mushrooms and other plant psychedelics to help them implement that. So Sarah Gail, who’s from our boulder site who Will knows, and she was in charge of the zendo program. She’s part of a commission for the City Council of Denver to monitor and to prepare for how their mushroom the Crim law enforcement priority goes into effect. So they’ll be educating police at hospitals. So all of this is to say that we anticipate that at some point after the country has legalized marijuana on a federal basis, and after we’ve got maybe a decade of psychedelic clinics rolled out that we will move to a post prohibition world of licensed legalization for psychedelics so that people can have access on their own. And we’ll try to train them to help each other and to do peer support. And I think that will address the cost in a certain way. But I think the hardest cases are going to go to the clinics. And that’s where it’s going to be really important that we do try to get insurance coverage. And so, that’s our challenge is to really show cost effectiveness.
Dr. Will Van Derveer 43:36
And then for the one third of people who still haven’t experienced the full resolution of their PTSD at the 12 month follow up, do you anticipate that there’ll be availability for people to have booster sessions of MDMA psychotherapy if beyond the two or three session protocol?
Dr. Rick Doblin 43:54
Yes. So the big question that we didn’t discuss in terms of the reps, we talked about doctor insider, doctor on call, the qualifications of the therapist, the training requirements. There’s a possibility, and this we see with ketamine and we see it with GHB’s, that there could be what’s called a patient registry. So right now, there’s not a patient registry. And it’s possible that the FDA could say that there’s a lifetime limit on the number of MDMA sessions that people could get. And if so, they would probably put it at eight or 10, somewhere like that. So we’re trying to argue against the patient registry, but I think we’re likely to end up with one, which means that then we track how many sessions each patient has gotten. What we feel though is that some people will need more than two sessions, some people will need three, some people could need four. Some people could need two and then two years later need another one. But we think that if people have eight sessions, let’s say and it didn’t work for them for their PTSD, we’re not saying it works for everybody, then that should be enough. Now, I’ve taken MDMA about 120 times in my life since 1982. I keep learning new stuff when I take it. But I’m not curing PTSD. It’s about my relationship with my wife and things like that. So I think there’s other ways people can learn more from these experiences. But in terms of treating PTSD, I think that it’s very important that there be this opportunity, as you say, for a sort of a supplemental session years or if they get re-traumatized. Well, I will say one thing is one of the vets that was in our study has developed a certain resilience, once you heal from PTSD and you learn how to process trauma. So this fellow John Becky, he’s spoken publicly about this is that after he was through the program, and this happened about a year ago, his house is part of a group of houses that are on a small pond, and there was someone who was doing the landscaping and they were on a riding mower. They were on the mower trying to get to the grass closest to the pond. The riding mower fell over, became unbalanced and trapped the guy underneath it. John came and brought him out from underwater and gave him mouth mouth and the guy died in John’s arms. And so he didn’t sleep that night, but he called Michael Mithoefer and worked through some stuff and he didn’t develop PTSD. So he had a certain resilience. About three months ago, he was at an event trying to reach a politician to talk about MDMA. After the event, he went outside and there was somebody a few blocks away that he saw just a block or so away, it looked like giving CPR to somebody. So we went over to see and help out, it turned out that he took over doing CPR for this guy, but he had been shot in the chest by sort of a drive by shooting. And this guy also died in John’s arms. The second person died while John’s giving CPR, within a year. And luckily he called me about it and I was on the phone with Michael Mithoefer. So we talked him through it and he did not develop PTSD. All of this to say is that there’s a certain resilience that people develop, but some people will not be that resilient, something will happen, the PTSD will come back. And yes, they will be able to get other treatments. Now, the other thing to say is that of the one third that still has PTSD, almost all of them had what’s called clinically significant reduction in PTSD symptoms. It’s not that they got no benefits, their benefits were just relatively smaller than the others, and they ended up still qualified for a PTSD package. But if they were to get a four-session, maybe they would be below the level.
Dr. Will Van Derveer 47:48
Right. I’m glad to hear that there will be at least some opportunity beyond the two to three sessions for people who need that and for people who relapse or who get a new trauma. I mean, I think that’s really important. And that can be very devastating to recover from PTSD and then have a new trauma and not have access to the thing that helped you reclaim your life. Yeah. So thanks for explaining that.
Keith Kurlander 48:12
I think for the last portion of this show, we should get a little personal with you, because I’m really curious. I kind of see you as one of the psychedelic kings of the planet. And I’m just curious, you know, you mentioned your hundred and twenty times with MDMA. And I’m curious about what role psychedelics played in your life, because obviously, you must care about them for some reason?
Dr. Rick Doblin 48:39
At one point, this was around 1984. And I decided in 1972 to focus my life on psychedelics when I was 18. So I was at Aslan, studying with Stan grof. And Aslan is at the edge of the cliffs, overlooking the Pacific Ocean, and I was just thinking, I wonder what my life would be like if it wasn’t organized on psychedelics, what would I be doing? And I felt this kind of vortex of emptiness and fear, like pulling me over the edge of the cliff in the unknown. I would be lost. So, I don’t know. But psychedelics have been sort of the center of my life starting from age 18. You know, I needed to integrate a lot of experiences. So for 10 years from 18 to 28, I was building houses and getting grounded in the physical world. I took so much psychedelics, I was kind of spacey. I didn’t properly understand that you need to integrate your psychedelic experiences. I just thought the more you take, the faster you evolve. And sadly, that’s not the case. And it can actually make you worse, but what they’ve meant to me, I think I can explain it by saying that when I was 13, and my bar mitzvah took place, and in the morning after my bar mitzvah, I’m lying in bed at home, and I’m thinking, where’s God? I mean, I’m the same person as before. This rite of passage did not work for me. It didn’t turn me into a man. It didn’t make me feel more spiritual. Okay, it was a party and I got presents and that was good. And I read from the Torah and I did all this Hebrew stuff but I didn’t feel like this ritual which I feel in the past. For thousands of years, these kinds of Rites of Passage connected with Judaism with Christianity, probably worked for a lot of people. But somehow or other in the modern culture for me, it didn’t work and I felt this emptiness. And I actually remember waiting every morning for a week after my bar mitzvah thinking, maybe a lot of people got Bar Mitzvah this day, God is slowly coming around to me. I’m in the second list, not the first list, and nothing is happening. Nothing, nothing, nothing. And then the next week comes by and a whole group of new people get Bar Mitzvah or Bat Mitzvah, like, okay, it’s not gonna happen. And so when I first did LSD, when I was 17, four years plus later. I was almost 18 when I did it. So almost five years later, I felt like this is what my bar mitzvah should have been. This is moving these kinds of energies and even though it was scary, and I couldn’t completely let go but I had the ego dissolution and the sense of being connected through historical time and evolution and all this, I thought, Ahuh! This is filling a hole in my spirit, that the sort of traditional rites of passage didn’t. And then what I really thought too is that I was very much super shy in high school. I could hardly talk to a girl and was very much in the world of ideas. So I was reading books. I was very political. I thought the Beatles were stupid. Because the Beatles were initially all these love songs. I want to hold your hand. I was like the Vietnam war, the world’s on fire, the civil rights people getting assassinated, who cares if I want to hold your hand?
Keith Kurlander 51:53
That was before they took LSD.
Dr. Rick Doblin 51:58
You know, what’s the point of it? So, what psychedelics did when I first started taking it is giving me access to my emotions. Like they were really helping me to feel. And even though it was difficult feelings, all of a sudden, it wasn’t just thoughts in my head. So it sort of opened up a new dimension of life for me, which was emotions, and really powerful emotions.
Dr. Will Van Derveer 52:22
Wow. Thanks for sharing that.
Keith Kurlander 52:23
Yeah, thanks for sharing that. I have a similar story, Rick. A similar childhood as you. The bar mitzvah story and my first psychedelic experience opening up an emotional whirlwind that I didn’t actually know how to deal with.
Dr. Rick Doblin 52:38
Yeah. If we have a moment, I’ll just share what happened when I was 21. So when I turned 21, I finally had a girlfriend. We were actually living together, but she was away for a couple months studying pottery in England. And so I thought, Okay, I’m going to be alone on my 21st birthday. What should I do? I should take LSD and I thought that would be a great way to celebrate becoming an adult. So this was again now 1974 when I was turning 21. And that was in the golden days when there was such a thing called records. And so I had put these records on the record player and you stack a bunch of the records up. And you know, when you’re doing LSD, you get very intensely focused. And I was at the end of a dead end street. I could make this long, but I’ll try to make this short. I was at the end of a dead end street, and I was in Sarasota, Florida, which is an hour south of Tampa, Florida. My girlfriend’s father had been in the Air Force in World War II and he was part of the group that was dropping the atomic bombs on Hiroshima and Nagasaki. He would have been in the third plane, my girlfriend’s father, and he actually brought over the guy that was in the first plane that dropped the bomb on Hiroshima. And so I met him and we had some conversation. And Tampa, Florida is sort of the center of where we run our wars from. We think the wars are run from The Pentagon, a lot of the planning is in the Pentagon. But operationally a lot of it is run out of Tampa and they have underground bunkers for airplanes with nuclear weapons and so I knew all of that, right. So I’m taking LSD. I’m 21 years old, I’m listening to music, I’m at the end of this dead end street. I’m having a great time. And then there was quiet. And I was just super absorbed in this quiet. And then I heard this sound that sounded to me like an air raid siren. Somehow or the other I interpreted the sound as an air raid siren. And I thought, immediately, what a tragedy. I’m just turning 21 and I have my whole life ahead of me, but the Russians are dropping the bomb on Tampa. And I was like, why is there air raid siren there wasn’t air raid siren this time of the day. Normally, it had to be the Russians dropping the bomb, and my life was gonna be over. And I thought well, okay, as long as my life’s gonna be over pretty soon what I need to do is cram a whole lifetime of life into the next few minutes before I incinerate so I thought okay, what I’m going to do is I’m going to walk out of the house. And I’m going to walk down the street in the direction of Tampa. And I’m going to just watch the bomb as it explodes and obliterates. And actually, there was a line in a Grateful Dead song that sort of came to me one of the lines was, “I don’t know, but I’ve been told in the heat of the sun man died of cold”. So I don’t believe your mind can control everything. It’s not all about us. But I thought okay, so as I’m walking down the road, and I’m thinking I’ve only got a few minutes left to live, I was just suddenly aware of all of the beauty of all the different shades of green of all the plants around. There were flowers. I planted passion flowers in front of my house, and I was just overwhelmed by the beauty of nature and then the clouds and the beauty of the white clouds and blue sky and then the sounds of the birds and the sounds of everything. So I just felt like my consciousness opened up in this beautiful way. So I wasn’t terrified with fear. I was just taking in life at a rate that I had never had such depth of appreciation or so many perceptions so quickly, of so nuanced, you know, okay, it’s a blur of green and it’s just nature but now everything was separate. So I was joyous and it was the contemplation of death under the influence of psychedelics made me super aware. And then the air raid siren stopped. And then I heard guitars start, and I heard the drums start, and I was like, Oh my god, I am so stupid. That was the next album that I put up, that I had misinterpreted as this air raid siren. And once I realized that I was not going to die, that my life was not over. The bombs are not dropping in Tampa, I wasn’t able to sustain that level of awareness of everything around me. My awareness sort of narrowed, and so I was left with, okay, I’m a jerk. I’m stupid. But also, this connection between awareness of death, psychedelics and hyper awareness of life. Well, that was a bit worldly experience at age 21 that sort of carried me through my life. And it’s just told me that there are these deeper levels of awareness.
Keith Kurlander 57:19
Thanks for sharing that. It’s a great story. I want to share a really quick story here about my first LSD experience when I was 18. I think you’re gonna really appreciate it Rick. So my first experience was in a college dorm with one other person and this completely changed the way I thought for the rest of my life. What happened was we both were on LSD, and there was an aluminum tin foil roll on the ground. And we both were sitting there and all of a sudden we both watched this aluminum foil turn into an accordion worm and leave the room. And we only knew we both had the exact same hallucination after because we were so mystified by that we’ve just started talking about it. And that changed my life. Because once I was offered the LSD, I said, how is it possible that two people can have the exact same hallucination? And then what is a hallucination? It just completely opened up my entire mind of what is reality? And how can we have a shared reality of something that’s supposedly not happening? And it really opened up a lot for me, that was, you know, my first sort of spiritual opening. My second experience isn’t as glorious. My second experience is the opposite, where it opened up my trauma. And that’s why I’m so excited about what you’re doing, because I believe that how we can really help heal this planet is when we make these medicines available with the caveat that yeah, we need to have providers around that are going to help you with troubling experiences when they arise because they’re coming eventually for anyone that uses these medicines.
Dr. Rick Doblin 58:25
I mean, we all have trauma encoded, just through the process of being bored. But I’m curious what conclusion did you come to about how you both had the same hallucination?
Keith Kurlander 59:03
My conclusion at that point in time was okay, if this is possible, this means that there’s another space that I’m not aware of where the mind operates, where we can have shared realities where we can connect. Our minds can connect in ways and get entangled. That was just sort of my initial thoughts. While our minds can get entangled in some way, that is not in a spoken space, where we can have shared experiences that are in sort of an unseen realm and that people can get entangled. And this is now of course sent me years later and understanding entanglement and quantum entanglement in a whole new way later in life.
Dr. Will Van Derveer 59:51
So let’s see. Any directions you would recommend people who are just beginning to hear this conversation about the possibilities of healing with psychedelics, favorite books or ways? Where should people go for more information?
Dr. Rick Doblin 1:00:07
Well, I would say, Stan Grof who was sort of my mentor and trainer, Michael Mithoefer and others. Really the sort of premier psychedelic therapists that helped create transpersonal psychology. He sort of summarized his life’s work in a two volume series called the way of the psychonaut and cyclopedia for inner journeys. And so I would recommend that people read that. I will say that it’s a little bit difficult for me in that my mentor, who I think is brilliant, who’s an incredible therapist, and who has really got this encyclopedic mind, a little bit of this book is about transit astrology that he thinks is reflective of inner psychological dynamics. So that for me is a bridge too far. But there’s part of the book that’s about that as well. But I think that that would be the one book I would recommend “The way of the psychonaut”. There’s another book that’s really beautiful by Claudio Naranjo written in ‘72 called “The healing journey”. And it’s about several different drugs. It’s exquisite. Claudia was also a really renowned researcher and therapist. There’s a movie I would recommend that people see. A documentary called “Trip of Compassion”. And I think it’s on Vimeo, or Netflix or something. And it’s the best documentary ever made about MDMA assisted psychotherapy for PTSD. And it’s about three of our Israeli subjects. And it’s got English subtitles, a bunch of it is in English, and it’s very powerful. And it’s three different stories and you see their actual therapy videos. Also they’ve recreated the trauma situation. So you see actors recreating what they’re thinking of, and then they interview family members as well. And they have nothing to say about politics or science. It’s really focused on the therapy. So “Trip of Compassion” would be a great one for people to see. You know there’s been a book called “The Secret chief revealed”. And that’s by Myron Stolaroff about Leo Zap, who is the secret chief. He was a clinical psych PhD. He’s the one that really introduced MDMA into treatment in the middle 70s or early 80s. He trained 100 or so therapists and psychiatrists, and this is his reflections of his experience with different drugs and how to work with them as sort of the leader of the underground psychedelic therapy movement. So that book is also available from MAPS at our bookstore and website.
Keith Kurlander 1:02:41
What would you say to the skeptics right now? Obviously, we’re talking about changing a way of culture, the view around these really valuable medicines. We still have a lot of skeptics out there that are, this is going to trigger psychosis and you know, all that kind of old language around it and thoughts And you know, again, my personal experience. I’ve been around the block with all this. And I’m a huge proponent of psychedelic assisted psychotherapy. I’m not sure about just handing them to everyone and everyone. I’m just wondering your thoughts of what you would say to those skeptics?
Dr. Rick Doblin 1:03:13
Well, be skeptical. That’s the first thing I’d say. I mean, the whole scientific process that we’re engaged in, is about harnessing your skepticism to create methodologies that ideally eliminate experimenter bias, or subject bias. So I welcome the skeptics. I mean, it’s not for everybody. I think you’re right. I mean, It can trigger psychotic reactions, if people are not supported, and people can take psychedelics and be worse off. That doesn’t mean we need a drug war to criminalize them under threat of jail. But I do think that there’s justification for skepticism and that we should be held to the highest standards of proof, which is what the FDA is saying. I will say that Jeffrey Lieberman, who is the head of Psychiatry at Columbia, The former president of the American Psychiatric Association, and an expert in schizophrenia. And Elias, one of his lead psychiatrists, they’re interested in doing a study of MDMA for schizophrenia, not for bipolar, not for Frank psychosis, but it may be because MDMA can be integrative. But if they do that study, it would be done on an inpatient basis, not an outpatient basis. So there could be a lot of proper supervision. But I think for skeptics, we welcome skeptics. So for example, part of our training program that we were just describing before is giving MDMA to therapists who volunteer to take it as a patient, so they understand what the drug does, but we don’t require them. And the reason that we don’t require that is precisely because we want to welcome skeptics who don’t want to do MDMA, but want to see the rest of the therapy training program.
Keith Kurlander 1:04:53
Right. And they want to see the results, but they don’t necessarily want to do it.
Dr. Rick Doblin 1:04:58
Yeah, and that’s okay. I don’t think that they will be as effective with their patients if they had never done MDMA. But they could still be very effective. I just think their effectiveness would be increased if they knew subjectively. So I think the skepticism people would have and I think even maybe perhaps you were alluding to this a bit would be more about like legalization or going beyond prohibition. So the controlled clinical settings, with a doctor hopefully on call that on site with medical screenings, the safety profile, the risk benefit for that is much better than the risk benefit of people taking it on their own. They’re not screened by those who know what context they are taking. But nevertheless, I think that the risk benefit analysis of prohibition is so negative that we should make it available and that’s why we need to really focus on honest drug education to children as they’re growing up, not dare that scare them with bogus stories. And we also then need pure drugs so people are not getting adulterated drugs, and we need harm reduction, education for people in emergency rooms and for the police and all of that. And then I think there will still be casualties, mopping that’s perfectly safe. But I think we can have way more benefits than downsides.
Keith Kurlander 1:06:18
We like to end the same way with everyone. And I’d love to hear your take on this, which is if you had a billboard that every human being will see one time in their life, it has a paragraph on there, what do you want to tell them?
Dr. Rick Doblin 1:06:30
Your mind is deeper than you realize and you’re a lot more irrationally motivated than rationally motivated. And that it would be very helpful for you to do a deep dive into your mind into your unconscious and your subconscious and psychedelics, as Stan Grof has said, LSD is a nonspecific amplifier of the unconscious. But while we talk about this as psychedelics, everybody does it every night in dreams. It’s a natural part of what we do is to alternate between different modes of consciousness. And that this is something that the final billboard would say, and there are thousands of psychedelic clinics all over right nearby you, you can go there.
Keith Kurlander 1:07:15
Great, I like that. And in our lifetime, we very well may see that and we’re close. So thanks for championing this work, Rick, so appreciative of you and what you’re doing and having you on the show.
Dr. Rick Doblin 1:07:28
Yeah, and thanks for the opportunity to share the Word with more people, particularly the therapists and others.
Dr. Will Van Derveer 1:07:35
Yeah. Thanks Rick for the inspiring example of taking such a big stand and seeing it through over so many years and congratulations on the amazing results that you’re getting.
Dr. Rick Doblin 1:07:48
Yeah, we got a few steps to go. Right.
Keith Kurlander 1:07:54
Yeah. You seem really busy in good ways right now talking to very influential people, which is really how you’re gonna make this happen.
Dr. Rick Doblin 1:08:01
Yeah, I think it’s happening. And I think we’ve gotten over the ghost of Timothy Leary. And that if you take these drugs, you’re gonna drop out of society and live on a commune and eat what you eat. Yeah, it’s a different narrative now that these can inspire people to contribute to society and help it become more healthy. Because I think collectively, the human species is enormously destructive of the planet, of each other. And we need to evolve in order to survive, and I think psychedelics are a big part of that evolution.
Keith Kurlander 1:08:40
Yeah, Rick, where did you grow up?
Dr. Rick Doblin 1:08:41
Keith Kurlander 1:08:42
In Chicago? And did you grow up in a religious orthodox family or conservative?
Dr. Rick Doblin 1:08:47
I am a conservative family. Yeah, so I was born in Chicago and grew up in Oak Park, then we moved to Skokie. And I thought the whole world was Jewish. Skokie was like this Jewish little island. I remember when I was six my parents were explaining to me that not only was the whole world not Jewish, but we are this miniscule minority fraction of 1%. And that got me really scared. I was like, Oh my god, what if Jesus is the Messiah? What if they’re right and we’re wrong? Whatever. But, yeah, I grew up in Chicago. Then we moved when I was about 12. And my parents had a house designed by a student of Frank Lloyd Wright’s. A very open house, which influenced me a lot.
Dr. Will Van Derveer 1:09:42
It’s been a real pleasure, Rick.
Keith Kurlander 1:09:43
Yeah. Great connecting Rick. Thanks for taking the time.
Dr. Will Van Derveer 1:09:50
Wow, I had never heard that story before. Although I’ve known Rick for a while of his experience with LSD and music and believing that the end of the world is about to happen and so many different interesting directions that this conversation went in, and especially grateful for Rick Doblin for the unwavering commitment to see through something that we think is going to play a huge role in the healing of humanity. Psychedelic assisted psychotherapy is on the way. If you are a therapist in the audience, and you’re just finding out about this now, it’s something you’re definitely gonna want to read about and get prepared for because there’s a revolution coming of psychedelic medicine in the world of psychotherapy. Well, we look forward to connecting with you again on The Higher Practice Podcast where we explore what it takes to achieve optimal mental health.