EPISODE 322
The MDMA Therapy Revolution With Rick Doblin
Description
Rick Doblin is the founder of MAPS and has been pioneering psychedelic research for decades. He joins me to talk about the promising results MDMA assisted psychotherapy has shown in treating PTSD, a problem that has plagued humanity for eons. He addresses the current state of the clinical studies, and all of the intricacies that come with getting it approved as a medicine. As legalization is on the horizon, it brings revolutionary potential to heal the hearts and minds of even the most severely traumatized among us--ushering in a new era of mental health.
Transcript
AUBREY: We're in this kind of like this zeitgeist and timeline of our culture where we're in this almost like just photo opportunity mindset. Like, as long as you could see it and take a photo, that's what matters. That's what was real, but it doesn't matter. Were you really there? Did you really feel it? That's the interesting thing. I mean, it would be if you could take MDMA for three minutes. Yeah, that would be cool. But like, not nearly the same as a five hour journey. You're not going to work through the material. You're just going to be like, whoa, this is wild. And then you're done.
RICK: And that's why we actually add a supplemental dose to turn it into an eight hour journey instead of a five hour journey,
AUBREY: Right. Which is also why I think a boga is so effective. It's so long. Like it has you for a day, 24 hours up to. So, it's just patient. And like you're in it, you're sitting with it and you can wrestle around and try and negotiate with the Iboga, but you're there, you're not going anywhere, I think that's important.
RICK: And then there's another aspect of it too, which is this idea of neuroplasticity. So that these psychedelics do stimulate nerve terminal growth and new connections. And so there's something to be said for the length of time you're in the space. Because there is this physical brain change going on. And that can account for long term changes too. You've made new pathways, new routes.
AUBREY: Yeah, I mean this neuroplasticity, I imagine it like you're carving a new fresh set of tracks down fresh powder. And you can bomb the run one time, and you'll make a little mark in the snow, but really, the grooves that we have in our brain are from skiing for a lifetime down the same path, the moguls are huge. And so it's really easy to fall into these pathways. So if you can get eight hours to ski the same track of love, let's say, like a new way to love the world or a new idea about yourself, the more time you have to spend on those skis down that track, the deeper it's going to go. Like the more lasting the experience is going to be for you.
RICK: Yeah. And one of the things that sort of reinforces that idea is that we had a fellow in our study who had PTSD from Vietnam. So almost half a century of these PTSD tracks and he was still able to get better. That you can have hope, that you can be in these deep grooves of half a century, almost of PTSD patterns and you can get out of that still.
AUBREY: How was that for him? Because he probably gave up hope a long time ago.
RICK: I think he had. And I think that there was a lot. So a lot of the people that are volunteering for our studies really don't even want to give themselves permission to believe that it'll work, because they've been through so much stuff that hasn't worked. So they come in kind of a pessimistic way. Others have come in and said, this is my last chance. If it doesn't work, I'm going to kill myself. But what it's like for them to see that change is possible is amazing.
AUBREY: How stunning it must be for the facilitators to go through these experiences because deeply at the call to be a psychologist or psychiatrist or counselor or anything like that is this called a service that you want to help people and you really want to see that you're making a difference in people's lives. And now with this tool that's coming online, it must be overwhelmingly powerful for the therapist.
RICK: And one of the things that many of the therapists say, though, is that it's very hard for them to go back to their patients outside of the protocol. And not have this tool of MDMA to help them do the therapy. Now they've got to struggle through people that get blocked, the fear is too great, they can't make progress. And so we're building a lot of dissatisfied therapists who are having trouble going back to their normal approaches. Because we can only do this as part of a protocol. It's very limited.
AUBREY: It’s like you get used to a perfectly honed, handcrafted machete, and you're charting your way through the jungle and they're like, okay, back to the butter knife. You're like, come on, butter knife. Really? I could see how that could be difficult. But the good news is that, ultimately, and it's not for everybody and not all applications, but I mean, we are speeding to the reality in which this is going to be a viable tool and for the right situation for the right people to serve. So where are we at in this process? Like what's the latest up to the minute update of? Where we are in this legalization quest that's been going on since the 80’s. And here we are in 2021. And damn, we're close now.
RICK: Well, I was just reflecting when you talk about speeding, when you look at it now there's rapid progress, but my sense of it is that we're crawling. And we're finally to this place where it's speeding up a bit, but where we are at this exact moment is that in order to make a drug into a medicine, according to regulatory agencies, particularly the FDA, and we're also doing research right now in Israel, Canada, and the FDA. So our phase three studies for MDMA assisted therapy for PTSD are in three different countries. We're starting work in Europe in nine sites in six countries, including England. We've got projects in Australia, Brazil. We're trying to build stuff projects in South Africa, Somaliland, Rwanda, Bosnia, Armenia. One day we hope to be working inside refugee camps. But where we are now is that, on May 10th, we published our results from our first phase 3 study. And the results were phenomenal. Better than we could have even hoped.
AUBREY: Better than the phase 2?
RICK: Better than the phase 2.
AUBREY: Wow. If you were going to summarize the results, because I've talked about the phase 2 a bit, but I haven't talked about the phase 3 results.
RICK: Okay, well in phase 2 what we are doing is refining our method, figuring out if we could do a double blind study, what are the doses, who do we include, who do we exclude. So, when we combine all that in phase two, what we showed is that the control group, I'm reluctant a little bit to call it a placebo group since in our case it's therapy. So it's not just an inactive placebo pill, but people get 42 hours of therapy with a In the control group, either no MDMA or low dose MDMA. And so we lumped that together versus the people that get therapy with full dose MDMA. And what we showed there is that 23% of the people that were severe, chronic, treatment resistant PTSD an average of around 15 years of PTSD. That 23% no longer had PTSD at the two month follow up. So that's therapy without MDMA or therapy with low dose MDMA. And then what we showed is at the group that got MDMA, it was 56 percent no longer had PTSD. And of those that had PTSD, most of them of those that still had PTSD, most of them had what's called clinically significant reductions of PTSD symptoms. So their lives were changed, their PTSD symptoms were reduced, but they still had PTSD. And if we could have given them a fourth session or so.
AUBREY: Sure.
RICK: But what we did do is we waited and we didn't do anything more. And at the one year follow up, what we showed is that two thirds no longer had PTSD. So what that is phenomenal because what it showed is that people still keep getting better on their own afterwards and that 12 month follow up is going to be the key to insurance companies because the two month follow up is the key to whether FDA will approve it or not. We have to show statistically significant differences between the two groups and then the FDA will approve it. But since it's labor intensive, the question is, will insurance companies cover it? So to show that it's durable and people keep getting better is phenomenal. That gives us hope that this will be both introduced and adopted and we can really scale it now. So in phase three. Well, the last thing, what we learned in phase two is that the low doses of MDMA that we thought would be able to produce a double blind, that that would be the way we would do double blind studies. We would have therapy with low dose MDMA, therapy with full dose MDMA, and the challenge would be to find the dose of MDMA that was high enough to cause some confusion, but not so high that it had so much therapeutic potential that you could never tell the difference between the two groups. And that was what my dissertation at the Kennedy School of Government at Harvard was about.
AUBREY: And when you say confusion, you mean confusion for the administer of the medicine so it still remains blind.
RICK: Well, confusion for, there's what's called triple blind. So we normally think of double blind, but triple blind means confusion for the patient, confusion for the researchers, therapists and confusion for the people that do the outcome measures.
AUBREY: Right.
RICK: So we're able to get the outcome measures done in a blinded way because they do it all by telemedicine. We tell the patient, don't say, whether you think you got MDMA. It's just an hour long interview about their symptoms. So what we showed, unfortunately in a way for me, is that my dissertation was wrong and that I did not find the solution to the double blind problem. And that while the low doses, 25 milligrams, 30 milligrams, 40 milligrams did confuse some people as to whether they got low dose or full dose. And they confuse the therapists sometimes. Maybe 20% of the time there was confusion. But that's meaning they guessed wrong. But what we showed, which we did not expect, is that the low doses actually made people uncomfortable. And that it compromised the therapy. So that the people that had the therapy without any MDMA did a little bit better than the people that got the therapy with low dose MDMA. And so the best way to describe it is an airplane you're taking off and there's turbulence at the beginning and then you can get over the clouds and then it's smooth sailing, but MDMA is particularly for people who are heavily traumatized, who are struggling, have not been able to get over their trauma and the memories are overwhelming for them to have these 8 hour sessions, three 8 hour sessions, one month apart and twelve 90 minute non drug psychotherapy sessions. So for them to be in an 8 hour session to confront their trauma when they haven't been able to do it before and the MDMA gives them a little bit of focus, but it's not enough to reduce the fear, to quiet the amygdala. So what we discovered there was that the low dose did not really work, it had an anti therapeutic effect in a way, but again, people still got better. So for phase 3, we went to the FDA and also to the European Medicines Agency and we said there is no solution to the double blind problem. At least for MDMA for PTSD, this doesn't necessarily apply to psilocybin or LSD, but for MDMA for PTSD, there's no good solution for the double blind problem. And so we said to the FDA that we can give you a certain amount of confusion, a certain amount of blinding, but you're going to make it easier. If we do that, it will be easier to see a difference between the two groups because the therapy will be compromised a little bit. And the real question is, if you can do this healing work with therapy without a drug, why bother adding the drug? So what we really want to do is compare therapy at its best, which is without MDMA, with therapy with MDMA. And so the FDA agreed to that. And it is a big issue. And they brought this fellow named Bob Temple, who's like the old wise man at the FDA. He's been at the FDA since 1972. And actually 1972 is when I decided to focus my life on psychedelics, when I was 18. So he was already at the FDA, and he's the office of science policy, he's the expert in scientific methodology, and so they brought him into the final meeting that we had in what's called the special protocol assessment process where we negotiate the design of the phase three study. And he came and he said, there is a lot of sense in what they're saying to do MDMA with therapy versus inactive placebo with therapy. And so that's the design for phase three. And we had to do two, 100 person phase three studies. And because of COVID, we had trouble, once we hit COVID in the lockdown, enrolling more people, we couldn't do that. So we came to an agreement with the FDA that we would end the first phase 3 study at 90 patients. And so what we found was that the people that got placebo with therapy 32% no longer had PTSD. So it's a little bit better than the 23% and you can see how the argument that we made to the FDA that now, because the placebo group is doing better, it is harder to find a difference now because they're doing better, but that's the real test and that's what we wanted to do. But what we showed is that in the group that got MDMA and the way we designed it, the first session was 80 milligrams. It's followed two hours later by 40 milligrams, which extends it to about an eight hour session. The second session is a negotiation. It could be the 80 followed by 40 or it could be up to one 20 milligrams followed by 60 and about 90, 95% go up to the one 20 followed by 60. And then the third session is also a negotiation, but again, it's almost always the fuller dose, but we start with a little bit lower dose. It gets people adjusted. They still make a lot of progress. So what we showed is in the group that got therapy with MDMA 67% no longer had PTSD
AUBREY: After the two month one?
RICK: After the two month one. So we were only at 56% before in phase two, and now we're at 67% in phase three and we don't have the 12 month data yet. Because it's recent, we're going to tell you about it.
AUBREY: But you could make the logical conclusion that it's just going to increase from there.
RICK: Yeah, that's what we think and that's what we hope.
And now the other things to say about this though, and this is where, We get into a little bit of stigma of psychedelics and how the FDA regulates things, but statistical significance is the key. So this measure that I just told you is loss of diagnosis of PTSD, that's not how the FDA is going to decide whether to approve the drug, they decide on the basis of statistical significance. And what that means is there's a 1 in 20 chance that whatever the finding that you have is due to some random factor rather than to your intervention. And that's called 0.05. So basically nickel out of a dollar, 0.05. And if you are at that level or below, then you have statistical significance. Two of those studies are generally required to make a drug into a medicine. So, 0.05 times 0.05, assuming that they're independent studies, that's basically 1 in 400. So, you have a 1 in 400 chance it's due to random factors, and then you'll get the drug approved.
AUBREY: If it's at 0.05, which is the threshold.
RICK: Alright. So, the FDA has another measure that they call robust, very persuasive, and that's 0.001. means one in a thousand chances that it's due to some random factor. And under certain circumstances, if you get 0.001, one in a thousand chance, they will approve the drug on the basis of only one phase three study instead of two. So we were hoping. Yeah, okay, maybe we can get close to 0.001. What it turned out we got was 0.0001. It was utterly shocking. And so that also means that there's not a lot of variability. So that's a factor in statistics. So what it means is most everybody that got the therapy plus MDMA, did well and that there wasn't a whole big range of variability. So the other part that you look at, and this is again more for insurance companies, is it worth it, is called effect size. And so an effect size measure is designed to equalize studies treatments across studies because you can have statistical significance which is independent of your effect size. And the more subjects you have in a study, the more numbers you have, the easier it is to find statistical significance from smaller and smaller effects.
AUBREY: Sure.
RICK: So that's why you hear studies with thousands and thousands of people, and they'll find statistical significance from some minor effect that may not even be that clinically significant. So the SSRIs that were approved for PTSD, Zoloft and Paxil, have very small effect sizes or on the low end of medium. And that's the effect size of one is considered very large, and that's one standard deviation from the norm. So if you have moved people from the bell curve, if they're off one standard deviation from the norm, that's a very large effect. And that's 0.8 is considered a large effect size. So even 0.8 of standard deviation. And as I said, the Zoloft and Paxil were 0.3, 0.35, 0.4, and one was 0.56. So 0.5 is where it starts to be medium, 0.8 is large. And so there's two ways to figure out effect sizes. The normal way is called placebo subtracted. So you look at your control group, you look at your treatment group, you kind of do some math that in essence subtracts the effect of the control group. And so that's called placebo subtracted. And we had 0. 91, which is large. It was terrific, better than anything approved. But what it really means is that we've taken the therapy group that got inactive placebo and we've subtracted their benefits from the therapy with MDMA and we're left with just the effect of MDMA. But in actual practice, it's going to be MDMA plus therapy. That's our main story, it's really the therapy that the MDMA makes more effective. So when you look just at the group that got the MDMA plus therapy, we had a 2.1 effect size. Two standard deviations from the norm. Enormous. Now, the other part of this is dissociative subtype, which is considered the hardest group to treat. And we feel like because of the stigma of psychedelics, we have to work with the hardest cases. So we also let people into our studies that have previously attempted suicide.
AUBREY: Which no one would do for any other study on a drug like an antidepressant or anything like that.
RICK: Very rare that people, sometimes they'll do it, but very rare. And in PTSD it's pretty rare. So we feel like we work with the hardest cases. And what dissociative subtype means is that when you're traumatized, you're physically hurt, one of the classic strategies is to sort of pretend you're not there, is that you're not really there. You escape in your mind. Your body's in incredible pain, but you escape in your mind. And the problem with that is that it does help you get by the traumatic incident, but then it gets harder for you to get back engaged with the trauma because when it happens, your imprint is, I can't handle it. I'm running away. I'm going away in my mind. And so the traumatic incident, you have to reconnect it. And every time you try to reconnect, you get the painful memories, the fear, the anxieties. And so it reinforces itself. And so people get more and more dissociated over time sometimes as a result of trauma. So the dissociative subtype is considered the hardest group to treat. And what we showed, again, to our surprise is that they did better than the average of the other people. That something about MDMA is integrative. It helps people pull together their dissociated memories and it helps people remember their traumas. It reduces activity in the amygdala and you don't have the normal fear response. So what we showed was that it works in the hardest cases. Now all of this would be important but it's just about efficacy. So I have to talk now about safety because if you have great results, but half the people die because it's not safe or whatever, you're not gonna make something into medicine. We'll have to deal with this with ibogaine to demonstrate that it can be given safely. Which I think it can be with that under medical supervision without anybody ever dying. That's a different story. But again safety is important. So we had one person in our study who tried to kill herself twice during the study. Fortunately, did not succeed. We had another woman who had such severe suicidal ideation coming from this confrontation with her trauma that she had suppressed that in order to avoid self harm, she checked herself into an inpatient facility as a self protection. So all of these are considered serious adverse events. What we are happy to report, I guess, is that both of these people were in the placebo control group. We didn't have anybody in the MDMA group try to hurt themselves. And so what we showed also is that in cases of severe suicidal, serious suicidal ideation, we had more, five of those cases in the placebo group and only three of those cases in the MDMA group. So the safety record is excellent. The other criteria that the FDA looks at, and just to elaborate now on safety, so there are acute side effects from MDMA, and we monitor all of those. And there's–
AUBREY: Loving your family, enjoying life more, things like that.
RICK: Those are very, very helpful.
AUBREY: Maybe finding God in your own heart. These were very strange things. We shouldn't document these very rigorously. So people are aware that this might happen to you.
RICK: You might change all your relationships, end up happier. But what they do have is teeth, grinding, sweating, little muscle tension.
AUBREY: As the famous rapper once said, pop to Molly, I'm sweating.
RICK: Yeah. And it is more in the MDMA group than the placebo group, but it's short lived. It's not very problematic and it fades. So safety is good. Then the other thing that the FDA looks at is called the distribution of results. So we have 15 sites, two in Israel, two in Canada, 11 throughout the United States. And what they want to see ideally is that there's no statistical difference between the results you get in the different sites, meaning that if you have a few sites that are performing great and then the rest of the sites don't do that well, maybe that's because the therapists at these few sites are so great. That this thing is not going to scale that it's about the therapist skill.
AUBREY: Well, presumably because the same therapist for placebo and not, that would kind of equal out in that hypothesis
RICK: In their team. Yes. In their sites, yes. They would get better results for their placebo, but if the other therapists aren't as good, then they won't get as good results on either.
AUBREY: Yep.
RICK: And so what we were able to demonstrate statistically is that there is no effect by site. Meaning that the teams at the different sites did equally, more or less equally well. And the really good part of that is that it's either we could say because of three factors. First off, who comes in? Who do we choose to let into the therapy program? Then it's our therapy training. And then we think that the main factor really though is the MDMA. That sort of equalizes, helps. Even therapists who aren't as skilled get really good results as the ones who are more skilled. So, the fact that we had no effect by sight, we had a tremendous safety record, we had 1 in 10,000 statistical significance, we had very unusually large effect sizes. We applied to the FDA and we said that we want to go to a new drug approval with just one phase 3 study. We meet the criteria. The FDA said no. That they would not let us do that and that they want to see the second phase three study. And what they said was that we're convinced that you can demonstrate efficacy with fewer people than we want to see for safety. And so it's contrasted by what we just saw about the Alzheimer's drug that the FDA approved with great criticism on the basis of studies that were mostly failed but one marginally effective study. And they approved this drug and now they've had to pull back and there is an internal investigation at the FDA, but they were willing to approve this Alzheimer's drug with very minimal benefits and significant side effects that are worrisome and several failed studies. So in our case, I think it's, again, the stigma of psychedelics.
AUBREY: Sure.
RICK: And the FDA wants to see. So where we're at now is that we've enrolled about 35 people of the 100 in the second phase three study. And we anticipate that, what's called the interim analysis, so just to not get too detailed or scientific, but what it means is that the FDA is basically set up to help you succeed. Now, it might not seem that way, but they want you to succeed, and so you, at the very beginning, you look at what you think your effect size is. And you design in the statistical power calculations, how many people you're going to need to see a difference to have a certain percentage of likelihood of success. So what we've done is we've set the bar high that we want to make sure we have a 90% chance of success. And we set the effect size at .56. So we assumed a lower effect size. So at a .56 effect size to be 90% sure of succeeding and getting statistical significance, we come up with 100 subjects in each study. And what the FDA permits you to do is when the study is, you can debate where this goes, but for us, it's when the study is 60% done when we have 60% of the subjects have reached their two month follow up and the rest have been enrolled. So when we have all 100 enrolled, 60% we have their final data point at the two month. Then you have an independent committee that looks at the results and they'll tell me, the sponsor a number. All they tell me is a number and the number is either zero, meaning you don't need to add anybody to get statistical significance or you need to add X number of people or there's no number of people you can add. It fails for futility. And what that means is that the more subjects you add, the more you are able to find smaller and smaller effects. So if our effect size was less than 5,6. And we were in danger of not getting, no longer having a 90% chance of success, then we could add subjects. So in our first phase three study, we were told zero. We didn't have to add anybody. We think that's likely to happen in the second one. There's only two drugs that have been declared breakthrough therapy for PTSD by the FDA. The interim analysis that we had on our first phase three study was in March of 2020 and that's when we were told zero, but this other company Tonics Pharmaceuticals had a drug called Tonmaya, which was a repurposed sleeping pill. They thought they could help people not have nightmares. They were breakthrough therapy for PTSD on the basis of early preliminary data. They did their interim analysis and they were told, give up the study, it fails for futility. You're never going to find a difference, it didn't work. So they'd spent well over a hundred million dollars on this study and it completely failed. So, the next big point for us is going to be the end of March, early April, 2020. And that's when we get the interim analysis–
AUBREY: 2022
RICK: Excuse me, yeah, 2022. Yeah, that's when we get the interim analysis for this study. And we think that we will complete the study in October of 2022. It'll take us a month or two to analyze the data and then we submit that to the FDA. And then it'll take them around six months or so to analyze the data so that we–
AUBREY: And you were given breakthrough status.
RICK: We were given a breakthrough.
AUBREY: And that's going to mean that everything is expedited on the processing side. Isn't that one of the benefits of getting breakthrough status?
RICK: Yes. One of the benefits of that is that, normally there's like an eight month or longer review time. We'll have a six month review time. But the other benefit is more meetings with the FDA. So one of the things that we're meeting with them right now is called the REMS and that means risk evaluation and mitigation strategies. So the FDA has these policy tools that they can customize the requirements post approval for the specific risks of the drug. And this was developed initially for thalidomide. Which is the drug that people may remember as being given to women for morning sickness and causing terrible birth defects, where people would be born without limbs. And this was approved in Europe for morning sickness, and there was in the early 60s, the FDA, this woman, Frances Kelsey, blocked thalidomide from coming into the US. She was concerned by the safety signals, and in the end, she was the only person at the FDA ever to win a Presidential Medal of Honor.
AUBREY: Oh, wow.
RICK: It goes for blocking thalidomide and saving thousands and thousands of women and fathers from having these deformed babies. Years later, we discovered that the blood constricting effects of thalidomide are helpful in treating certain tumors and leprosy. So thalidomide, the epitome of a bad, dangerous drug is now an FDA approved drug. So proves that there's no good drug or bad drug. There's no such thing as a good drug or bad drug. It's how you use it. And so the FDA developed a set of procedures for thalidomide, which is that the pharmacist has to be educated. The patients have to get this educated. They want to make sure no pregnant woman ever gets this drug. And there's a patient registry. So everybody that ever gets thalidomide is tracked to make sure there's no inadvertent birth defects, however. So that was how these REMS began. And now there's negotiations, what we're saying to the FDA and also to the DEA, because they're concerned because it's a scheduled drug about diversion. What we're saying is that the real thing going on here is therapy, that the drug makes the therapy more effective. So therefore the treatment is MDMA assisted therapy. And once it's approved as a medicine, we want the only people that can treat patients to be therapists that have been through our training program to learn how to do the therapy. They don't have to actually do the therapy as they were taught post approval. They can innovate. We're not trying to control what they do later. The FDA doesn't control the practice of medicine so that once the drug is approved, therapists, physicians, they can prescribe what's called off label. Meaning it's not exactly what it was approved for, but we want the therapist to be trained. We also want a special training for the prescribers, so we're going to have like a two to four hour training for the prescribers or doctors, mostly just about the physical effects, and the training of the therapist is going to be about a hundred hours. Mostly thinking about our method, learning about that, watching videotapes of therapy sessions doing role plays, and all this supervised by our training team. So we have one training program right now that's, when we've gone virtual, we've got 310 people in it. We're going to start another one in September, so for anybody that's listening that's a therapist that might be interested in it.
AUBREY: How many spots did you get? Because I think there's going to be a lot of people who are listening to this that are going to be interested.
RICK: Well, we're going to try to do 500. We’ve got about 300 or so already chosen. It's going to start in September.
AUBREY: Ryan, we got to get this podcast out sooner. Otherwise our people are not going to get any spots in the therapy sessions.
RICK: Yeah. And we will keep doing this. I mean, so there'll be training on and on. So what we're saying to the FDA though, is that the REM should include this. It should also include something else, which is that. The only administration is under direct supervision of the therapists, meaning it's never going to be a take home drug. We're not going to say, so even if the therapists are trained, they're not going to be able to say, here, take this home. We have gone to telemedicine, you could say, for a lot of the preparation and integration sessions, but for the actual dosing with MDMA, we think that should be in person. And we believe in a two person therapy team. Again, we're trying to maximize therapeutic outcomes. There's going to be pressure over time, particularly from the insurance companies, to go to a one therapist model. But we feel there's a couple reasons why the two therapist model is better. And the way we want to handle the economics of it is that the first person is licensed to do therapy and the second person is more like an apprentice. And that they're getting their hours to do therapy to be a therapist, or they don't necessarily ever want to be a therapist. Maybe they could just be a massage therapist. You could combine MDMA with massage, or different ways to do things. But initially, probably these REMS will require two therapists in the room. We don't know. That's a negotiation. And what we're also saying is that there's certain safety concerns, particularly blood pressure, that MDMA can increase your blood pressure a little bit. We want people's hearts checked out, so there'll be a certain number of things that are required to be checked out by the prescriber. And then whether or not there'll be a patient registry is unclear yet, but there is a patient registry for GHB, which is a medicine for narcolepsy. There's a patient registry for ketamine, which is now for depression. We're arguing against it because it's more expensive. There's really no need for it, but we think there's a good chance we'll be required to have a patient registry. The other part of it is that there's going to be specialty pharmacies where the drug is not something that the patient picks up at the pharmacy, the drug is sent to the prescriber and the patient only gets the drug when they're in the psychedelic clinic. And handed a bowl or a goblet or whatever. So we don't put the pill in the person's hand because from the very beginning our method is about people healing themselves. We want to empower people to heal themselves. So we want them to do that initial reaching out to get the pill. So they are choosing to do it. It's their choice that we present it to them. We present this option. We'll have spent all these now 35 years, and it'll be more. And all is we've raised $115 million in donations so far to get to this point. But we've done a lot to present this option to people, but we want them to choose it. And that's a big part of the healing. So this is what I think was going to be the ramps. And so what we think now is by the second half of 1993, we've got a good chance of having approval.
AUBREY: 2023?
RICK: 2023. In the FDA, Israel and Canada, we're negotiating right now with the TGA, the therapeutic goods authority in Australia. They might go earlier. One of the benefits for us of Brexit, is that the English equivalent of the FDA called the MHRA, they want to demonstrate that they got something out of Brexit. And what they want to demonstrate is that they can go faster than Europe. And England did go faster on the vaccines. And so now they're trying to make it that on heart drugs, cancer drugs, and mental health, they may be having this ability to go even faster. So we think we might get approval in England before the rest of Europe, but Europe, we're thinking is going to be the end of 2024 right now. And in Australia, it may be that they'll approve compassionate use, which there's different ways you can do that where it's either on a named patient basis, or they just say, here's the protocol. Anybody can volunteer as soon as they meet these criteria. So where we're at is poised for a likely approval. I'd say the biggest concern that we have that would maybe knock us off track is several people in the MDMA group committing suicide, because that would increase the risk of profile of this going forward. We don't think that's going to happen. As I said, in phase two, nobody in the MDMA group tried to hurt themselves. In phase three, nobody tried to hurt themselves, but I'd say that's our biggest vulnerability. And so we're very careful about how we track people after the MDMA. When they might have now suppressed this trauma for a long time, the MDMA brings it to the surface, we're helping them deal with it. But we call them every other day for a week to check in with them. Every meeting that we have, they have to fill out this form called the Columbia Suicide Severity Rating Scale. So it's like 5 or 10 minutes, but it's just where are they at with their suicidal ideation, things like that. So we're tracking their emotional status very frequently, particularly related to suicidality. So I think that that's the main concern that we have. We don't think that anybody's gonna have a heart attack or anything like that. I mean, that's always possible. And the other big thing that the FDA and the DEA are concerned about, which has not been a problem, is this idea that we've given people MDMA, a party drug, ecstasy. And now after the therapy, they're going to want to go get addicted to it and use it all the time. That's the concern. What is the abuse liability of this drug? We're exposing people to a drug that people think makes you happy, makes you parties. And so what we find is that more than a few of the subjects in our study have said the same thing. They said, I don't know why they call this ecstasy.
AUBREY: Yeah, sure. It works.
RICK: It's work. They're dealing with their trauma. It's hard work and they have to go through a lot of pain and suffering, but it's like grief. You're crying, but it's crying in a way that's healing and cleansing catharsis. They're finally letting it out. Catharsis is the great word for it. We don't see people reporting going after ecstasy or MDMA on their own afterwards. It only stays in the blood for a few days. So there's really no way for us to verify this by blood tests or anything. It's not like cannabis that stays in your blood for a month or so. We take their word for it, but we don't see any evidence of this abuse liability. So overall, I think we've got a really good chance where of all the groups that are in phase three of all the psychedelic there's over a hundred now, psychedelic companies, for profit companies. Interestingly enough, there's not a single big pharma company that's working on psychedelic psychotherapy. Johnson Johnson did get the ketamine approved, but that was ketamine without therapy, which is sub optimal. But of all these companies, we're the only one in phase three. And there's Atai, that just went public, 2.8 billion dollar market cap MindMed, 1.8 market cap compass, 1.8 billion market cap. So what you can say, that we've done, is in 35 years of work with 115 million so far of donations, we've created well in excess of a billion dollars of public value. So we have no investors. So what we have is two companies. One is the nonprofit maps, and that's what I started in 1986 and that's when I was assuming that because it's a generic, that it would be generic as soon as it was made into a medicine. That it was invented by Merck in 1912, they never tested it in humans, it's in the public domain. I saw in the late 80s that, well, in 1986, when I started MAPS, another group called, with Howard Lotsoff and others, started a company called NDA International, and that was for Ibogaine. And that was to make Ibogaine into a medicine, and they did that in a for profit way. And what happened is they worked with Debra Mash, they ran out of money, she completed a study, she discovered a long lasting metabolite, and she thought that it was her right to patent that, and then they said, oh, we helped you get this started. So anyway, they went into long lawsuits. And this whole field of Ibogaine development was really tanked for decades by all these litigation, but I saw that happen. So I went to the lawyer, the patent lawyer for the Ibogaine people who got the use patent on Ibogaine for opiate addiction and other addictions. And I said, I want you guys to help me develop an anti-patent strategy so nobody could get use patents on MDMA for PTSD or anything. I didn't want to patent it. We didn't invent the idea. MDMA was used for PTSD in the late 70s and early 80s. So it just feels wrong. We didn't invent the idea. We didn't invent our therapeutic approach. It came from the early work with LSD, with Stan Kroff with Leo Zef, the secret chief, the leader of the underground psychedelic therapy movement. So I wanted to make sure nobody could patent the uses of it. So I just thought it would become generic and that would be fine because people would get it. But what I realized later on, years later, I'm amazed. I didn't know this earlier. My dissertation at Harvard was about, at the Kennedy School of Government, about the regulation of Schedule I drugs by the FDA. I took a class at Harvard Law School by the leading food and drug lawyer. And through all of this, I missed something very obscure, which was that in 1984, Ronald Reagan had signed a law to provide incentives for developing drugs that are off patent. And those incentives are called data exclusivity. And so what that means is that it's not a patent. No one can use our data immediately to market a generic for five years. And in Europe, it's 10 years. And if you do studies in pediatric populations, meaning initially 12 to 17 year olds. Which the FDA is requiring us to do. If we succeed with making MDMA into a medicine for adults, 18 or older, we have to do kids, 12 to 17 year olds who are traumatized. And the incentive there is first off, well, for us, the incentive is the closer you can treat people to the trauma, the better it is, the more value it is for their lives, their families. You get an extra six months data exclusivity for these pediatric population studies, and it doesn't even have to succeed. in kids. You just have to try in kids. And if the study fails, you still get the six months data extension. But chances are, I think it'll work. And then, that's five and a half years of data exclusivity. And the additional benefit you get is it blocks a generic competitor from submitting their application to the FDA until the five and a half years is over. So they can't have refined their process and submitted to FDA years before in anticipation and then five and a half years is over and then that day they can market the generic. So it takes the FDA at least six months or so on average to review a new generic drug. So chances are we're going to have six years of data exclusivity. In Europe I said it's ten. The beauty of it from our public benefit perspective is that we're not blocking anybody from doing anything. If they want to get their own data for MDMA for PTSD, they can. What they're probably more likely to do, and we already know this, is that they're going to try to develop new MDMA-like drugs that they could get patents on.
AUBREY: Yeah, different analogs, go the Saussure Shulgin route, and try and figure it out.
RICK: Exactly, and then they'll patent something. So what we've got with this data exclusivity period is a new story to tell to donors. So MDMA is good for PTSD, but MDMA is good for people who have life threatening illnesses that are scared of dying. MDMA is great for social anxiety. We're doing studies now with eating disorders. There's been research in England by Ben Sessa and his team in MDMA for alcohol use disorder.
AUBREY: So for all of these, the primary studies that you're doing through phase three is for treatment resistant PTSD.
RICK: Well, not for treatment resistance. So for PTSD, severe PTSD, the FDA told us that if almost everybody is treatment resistant in our study, and they've had PTSD an average of over 14 years, one third had PTSD over 20 years. But they said, if we make the study specifically requiring treatment resistance, they would only approve it for treatment resistance.
AUBREY: Makes sense. Okay. So it's approved for PTSD. All people who prescribe it, even off label for these other things, because it's still going to be off label because you haven't gone through the full approval process. But they'll still go through your training, to be able to prescribe it. But once you go through the training, then there's data that's available to show that it treats all of these other different conditions.
RICK: Well, not really. So there’s early preliminary phase two data, early promising data. And so for a long time, the FDA wanted and succeeded in preventing pharmaceutical companies from sharing with their prescribers data from small phase two studies. You were prohibited from doing that because they thought that would be a way for pharmaceutical companies to increase sales but not do the full research to see if it's really necessary. But then the pharmaceutical industries and their lawyers sued under First Amendment rights that they have the right to share information that's in the public domain and the FDA lost. So where this line is, is that we can do these small phase two studies, we can say it looks useful in all these different areas. But we cannot knowingly sell or promote off label uses. We can share information.
AUBREY: Just open source the data from all this research that you're doing.
RICK: Yeah. And then the question that the prescribers will have is can they get insurance coverage for something that we've not proved? Will insurance companies pay for it? And medical malpractice, if something goes wrong and they're using it for something that's not been approved as the label.
AUBREY: Which is the case for all off label use. You could get called to the medical board and you could lose, whatever.
RICK: But the defense actually for malpractice came about, ironically, because of the chemotherapy. So that when chemotherapy came in, in the 50s and 60s, it was very dangerous to people and they used higher doses than they use now of the chemotherapy agents. And so there were a lot of people that were starting to experiment with chemotherapy and they were challenged by their medical boards and others to say that they were doing harm. And so the legal definition now is to protect yourself against medical malpractice is, you need a “significant minority of your peers.” So it doesn't have to be the leading view. But there has to be a significant minority means it has to be people with reputations of some kind.
AUBREY: You're not a lone wolf.
RICK: You're not alone. Exactly. So we think that there will be a lot of this off label prescription.
AUBREY: No doubt. It's going to work. That's my opinion. That's not officially. I'm just saying it's gotta fucking work.
RICK: Yeah. And I have to be more and more careful.
AUBREY: I can hear you and you are dancing through raindrops like a ninja wizard, Rick. And I appreciate that.
RICK: Well, the shocking thing for me is that we've had to hire somebody whose job is called, he's the compliance officer. So from a bunch of us, psychedelic rebels. Counterculture criminals, to have a compliance officer, just even the name of it. It's like, Oh, it makes me cringe. But anyway, we have to comply with what we can say to avoid getting in trouble with the FDA or getting in trouble with the DEA or state medical boards. So I think that what we want to do though, is look at other indications that are promising and then make them also do the phase three studies, so that they are fully approved and then the insurance companies will cover it. Now, I will say that another complicating factor is that all my training has been on how to make a drug into a medicine. I've not really been trained on how to commercialize a drug. And so unless you, if you get it approved and people don't use it, what have you really done? So–
AUBREY: I don't think that's going to be a great problem, but that's also my opinion. I feel like the word of mouth on this one's going to be pretty good.
RICK: I think. Because people respond to stories and when we have so many stories of people being healed.
AUBREY: Yeah.
RICK: So I think the chances are that it will be adopted, but what we are wanting to do to chart a path, we're working with this group called the psychedelic science funders collaborative. And there are a lot of people from tech and from other groups, other funders. And so this group is sort of helping them figure out with their philanthropic dollars where to put them in psychedelics. And so what they've done with us is we've hired the Boston consulting group to chart out the path to commercialization. And it turns out that David Bronner, who's on our board of directors, went to Harvard. His close friend Dan Grossman is a senior partner at BCG right now. And Dan is actually the one that gave David Bronner his first hit of LSD. So we went to Dan Grossman and David did it and he was very thrilled to work on a psychedelic project. He specializes in pharma. He got some of their great team and he said that it was a 2 million value that they're going to give us for three quarters of a million dollars. So we have this very interesting BCG report on the track to commercialization. And so this has led us to the challenge that we're in now, which is what they're suggesting is that if we were a normal pharmaceutical company and which we're not, of course, but if we were, and we recognize that we've got this six year limited period of data exclusivity for PTSD, what we want to do is hit the ground running with as many Therapist trained as possible with all of our team, with all of our negotiations with insurance companies as much as we can ahead of time with all of our government relations with, we have to actually reschedule in every single state. So if MDMA becomes a medicine, it's in schedule one right now, the DEA, cause they're not so thrilled always by making drugs that are scheduled into medicines they've been slow in this process in the past. So Congress passed a law a bunch of years ago, DEA must reschedule within 90 days. But then the states have to reschedule as well. So, here in Texas, and there's 25 states where it's automatic or automatic unless something happens. So in Texas I think it's the Commissioner of Public Health or it's automatic unless the Commissioner objects. And so we've had an incredible situation here in Texas in which a bill has been passed that actually provides state support for psilocybin for PTSD. Governor Rick Perry was one of the lobbyists for this because he's now come on board for the importance of psychedelics. And what it also provides is that the Commissioner of Public Health, they have to go ahead and do a survey of the literature on MDMA. So sort of prepare ahead of time. California, you have to have a special law. It's signed by the governor to reschedule a drug. So we're working with various other groups. There's a psychedelic decrim law in California now that's been through the Senate, the State Senate. It's being considered by the Assembly. It's for decriminalizing psychedelics throughout, in the whole state. But it also has this clause that if it does pass, that they will automatically DEA do. So we have to do all this work in the different states and what BCG is suggesting is that we're.
AUBREY: My Texas pride flared up a little bit right there. I don't know if you could see it. Probably the camera was off me, but it came through a little bit. I could feel my shoes turn into boots real quick and I got excited.
RICK: Well. Taxes are pretty incredible what's happening and so which I'll get to in a minute because I'm here because of a meeting with Congressman Dan Crenshaw that just happened in Houston. So, I'll just finish with the BCG and get to that. But so what they've suggested is that we need to spend between 70 and 80 million beforehand starting now to build a team of 60 or 70 people.
AUBREY: Well, there's one piece that I don't think it's been sufficiently explained. All of this makes sense if you're trying to maximize the revenue during the six year window and get the highest proliferation, which has a huge value to the human health of our world. So it's not just money, but is there another section of maps that is not nonprofit that is actually going to be able to reap the benefit of this?
RICK: Yes. And that's called the MAPS Public Benefit Corporation. So once I learned about this data exclusivity, in December of 2014, we created the MAPS Public Benefit Corporation. And what we want to do, we're innovating in terms of psychedelic assisted psychotherapy, but we also want to innovate in terms of how to market a pharmaceutical. And we don't want to be a profit maximizing marketer. I think that the profit motive in healthcare has made it so that in America, we have the highest per capita expenditures per person, but our outcomes on average in countries are down like 50. Because so much money is being siphoned off by insurance companies, by whether you get care or not. So what we wanted to do is demonstrate a new way where you maximize public benefit, not profit. So it is a for profit company. But it's not a traditional for profit company, and our structure is that the Public Benefit Corporation of MAPS is 100% owned by the non profit. So we have a pharma company, psychedelic pharma company, owned by a non profit drug legalization, harm reduction policy and advocacy group. What we're planning to do, where is this line between public benefit and profit? You can set it in any number of places. So, one of the challenges that we have is where do we set the price of the MDMA? And then what do we do with the resources? What BCG is suggesting is, at a price that what they said is that you look at the value to offset medical care, that if you help somebody deal with their problems and then they don't need a lot of more treatment, you've helped them. Then you also look at the benefit to society. Now they can go back to work. Now they can do a lot. And then you look at the benefits to their families.
AUBREY: And so you end up with a million dollar dose of MDMA using those criteria because it's enormous.
RICK: Well, yeah, what BCG actually suggested is that a pharma company that was profit maximizing would probably come in somewhere in the neighborhood of 15 to 20,000 a dose. And that's three MDMA sessions. So what they suggested to us is that we consider between one and six thousand. My guess is that we don't know we're going to end up on this. There's so many complications, but the other issue is, what is the real cost to the patients? So that's the co pays for those that are insured. So if we get insurance. You can have higher prices for the drug but you can cap people's co-pays by the number of visits, different things, so that people could pay five, six hundred dollars but the pharma companies could pay all this money for the drug and the therapy. So what about the one third of people that don't have insurance? The self pay people. So if you get this really high price, they're having to pay the whole thing. They're not just having to pay the co-pays. Now, some of them can afford it and some cannot, and some of them will not be able to afford it because of your high price, and you will lose them, and they won't get the healing. So what we're going to try to do is have a, what's called a very robust patient assistance program. And so we will provide the drug for free for people that can't otherwise afford it. The problem is that the treatment is drug plus therapy. And so we can provide the drug for free to people, but unless there's some way for them to pay for the therapy, they're not going to get the treatment. So what BCG is saying is that, ethically, there are a lot of trade offs. There's no easy answer, but if you charge a higher price and you make a bunch more money, then you're able to actually subsidize the therapy as well as the drug for people that can't afford it. The other part of this to add further complexity is, what are we really trying to do? Our goal is mass mental health, which we really need to get, and that's why on the one hand, we're working to work on drug development through the FDA. On the other hand, we're working through drug policy reform and legalization for people to be able to buy these drugs on their own, and you should be able to buy MDMA for 10 bucks or something like that. And you should be able to use it. If you have PTSD, if you want to try to heal yourself, or if you want your friends to sit with you, we would promote that. And so, we're not like, again, a normal pharma company where we see drug policy reform and legal access as a threat to our business model. We see it as an aid to our real mission, which is mass mental health. And we also see it as, this is my difference than I think a lot of the for profit companies, is that I tend to think that if it's legal, And it's easy for people to get, and we've trained them in harm reduction, and we've made our public, our treatment approach, all of that, that there's going to be even more people that are want to go for treatment by trained professionals in psychedelic clinics covered by insurance. So I think legalization is actually good for our business model. Most other companies either don't want to get into controversy or they think it's bad for their business model. But in any case, that's a big part of what we're doing. But the other part is, what does mass mental health really mean? For me, it means global and what you're talking about, seeing the earth from space or things like that to get this global perspective, that's really in a way, what got me into psychedelics in the first place is the political implications of a unit of mystical experience. That if you're a part of everything, how can you kill somebody because they're a different religion or how can you be racist or how can you destroy the environment because it's not really you, you're throwing it out. So that's what got me in when I was 18 years old. This idea of a crazy world, we're destroying ourselves. Can we help people realize that they're part of a bigger system and stop fighting each other in these ways? But what I mean by mass mental health now is what if we have a price makes it, and this is one of the things that BCG has presented to us, that there's a certain price that they think maximizes, well, they think we'd get way more money by, limiting the number of people that it can get at monopoly pricing. But there's one price that they suggested that would cut down the demand by 30%. And they say you can make up 10% of that by these patient assistant programs.
AUBREY: These are all models though.
RICK: These are all models, but the part of it is then. What do we do with the money? Let's say we do make this more money, but 20 percent of Americans who would get treated don't get treated. But what if we go down to South Africa or Somaliland and treat people at a fraction of the cost and and treat more people? So ethically, it's not clear. What's the public benefit? How do we define the public? But I think what we're probably gonna do and this is way premature, but I think we're gonna pick a price. Where we don't cut off 30% of the demand in the US we can still give it away for free. In South Africa, we can still do things like group therapy, which is, we're about to explore. So I think we'll end up with a price that doesn't cut out a lot of Americans, but anyway, that's some of the choices that we have to make. So we're also trying to globalize. And that's what I'm talking about now, but we want to go to Europe. So we need around 30, 35 million dollars to make MDMA into a medicine in Europe, which has got more people than the US. The reason it's so much less expensive in Europe than in the US is because they'll accept our US data. So we've already negotiated that. So it's like high leverage. It's leveraging our data to then go globalize. And then, at least according to this BCG report, in the middle of 2024 is when we will hit a sustainability point. Meaning that the income from the sale of MDMA by prescription will cover our staff. So right now we have about 125 staff. And two thirds are in the Public Benefit Corp and one thirds are in MAPS. People donate to MAPS, get a tax deduction. MAPS invests in the Benefit Corp. And they do the research. The Benefit Corp will sell MDMA. It'll be taxable. And then with the proceeds, we will then use it to further MAPS submission. So there, cause there's no investors. So it will take us around 30 or 40 million to reach this sustainability point in the middle of 2024. So what we've decided on at our board meeting at the end of June is to embark on a 150 million fundraising campaign, 50 million a year for three years. And we're looking at a whole series of options to do that. Our first option is philanthropy. And that we've gotten this far with philanthropy in 35 years, we've raised 115 million to say now. We want $150 million from philanthropy. Paul Allen, at one point the co-founder of Microsoft gave $25 million to the search for extra terrestrial intelligence. And I'm like, okay, that's great, but where's intelligence on earth? I mean, could you give $25 million? Maybe we can find some emotional and spiritual intelligence on earth. So we're hoping that we will raise this with philanthropy. We're also looking at a series of philanthropic debt, we're calling it, or loans. Where it'll be capped returns and we'll pay people out of the proceeds of selling MDMA. But they have to be willing to lose the money because what if we don't succeed? We have no collateral. We have no assets other than this drug development effort. The other form is partnerships with different for profit companies. Because we've built this incredible team of experts in psychedelic psychotherapy research and we have research sites and we know how to do it to meet the regulatory requirements. And so a lot of these for profit companies have set up on the basis of ideas. So to give you an example, in the last two years, MAPS has raised about 45 million dollars. The for profit psychedelic companies have raised over a billion dollars. From the capital markets on stories and none of them have evolved into phase three. None of them are even into phase three. And they also tend to contract out to what are called CROs, contract research organizations to do their research for them, which is very expensive. I think a key to our success has been, we've built internally our own research team. So we have a bunch of offers from different companies that are interested in partnering with us. And so we're exploring that and then the fourth thing we're looking at is IPO. So as I said–
AUBREY: For the public benefit?
RICK: For the public benefit court, we've built over a billion dollars of public value compared to these other market caps so we could raise two, 300 IPO, but what are the pressures of investors and even in a public benefit court where you maximize public benefit over profit, the line is not that settled in law, where you set that line so we could still have investors that say, “Hey, we don't like the fact that you're giving it all free to South Africa.” You should at least charge 10 bucks or whatever. They might say, okay. We bought into the public benefit, but you're too much on the public benefit side and not enough on the for profit side. So we're nervous, I would say about, and you could get aligned investors and things like that. It's mitigated. Anyway, we're looking at all these four different approaches.
AUBREY: You could also do, instead of an IPO, you could do private investment into the public benefit corp, where you can really select the investors, and it's not open to the public markets where some hungry, profit driven VC or something could just buy up a bunch of shares and start to assert leverage. So that's, I guess, a fifth option.
RICK: Yeah. And so thank you for that. And we can talk about that because we do want to explore options because we need the first 50 million before the end of this year or the end of 2021. So this is our plan and what we're able to tell donors why this public benefit corp in a way was set up is that there are so many different uses of MDMA that we would exhaust philanthropy to go one after another after another. But we're in the rare position of actually having a product where a nonprofit with a product that has good markups and yet can still treat. So our goal is really in the period of data exclusivity to have a million MDMA sessions. We're thinking about primarily the number one thing is the number of people treated, the amount of money is secondary. The number of people treated as first, we think we'll have roughly half a million people treated each getting on average two sessions, some will get three, some will get one every month. So that is really our metric that we're looking at is a million people treated in the US alone, not in these other countries. And to do that, we're going to need to train about 25,000 therapists. And so far we have just a couple hundred therapists fully trained. We have about 2,000 that are partially trained. And what I mean by that is that the next steps of the training are that we have a protocol where therapists can volunteer to take MDMA themselves under supervision. And so they understand to be a patient, what it's like to be a patient. And many of these therapists, as we scale, have never done MDMA before. Or some of them have done MDMA as ecstasy back when they were in college, but they say it's so totally different when they take it internally. And so, we are now scaling up our therapy training program, we are trying to scale up all of these commercialization people that we need. We're scaling up in Europe. So, it's a very difficult time.
AUBREY: Here's why I think it's not that difficult. And I think that it's complex, but the reason why it's not difficult or it's not stressful for me is because I know your heart and I know the heart of the organization. And so ultimately, whatever decision you guys make is going to be the best decision that possibly can be made. A decision is going to be made and ultimately that decision is going to be the best decision that you have with your heart fully online and your heart fully on board with the decision. And so while it's complex, I think it's also in some ways simple. It's like working with all the data and making the best decision. The beauty of this is that I've known you for a long time. I've met a lot of the different people in the organization. It's a heart led organization and whatever is decided is going to be decided for the right reason. And I can't help, but think that all of the seen and unseen assistance that comes to those who dedicate themselves to a path with heart is going to come to fruition. While it's complex, it's going to all fall into place, and it just really will. And I know that, I don't know, I would say that my message to you and all the maps is you can't do it wrong, whatever way you do, it's the best decision you could make. And in many ways, the divine intelligence behind that decision will reveal itself when it's revealed.
RICK: Thank you for that. There's a lot of that. Yeah. And I would add that the main learning I got from my Ibogaine experience. Which was one time in 1985, and I think, a lot of MAPS success has been to separate out self criticism from self hatred. And to be able to learn from mistakes. And so, if you're kind of a perfectionist, everything that is a mistake is super painful and that's also like you're not wanting to be human. You're wanting to be some perfect thing. But what I would add to your point that every decision we make will be the right one is that we will learn from all the decisions that we make. And we will constantly try–
AUBREY: That’s why do the right decisions. That was a thing that needed to be learned. Yes. If you make a decision that ultimately steers in a direction, it's just learning. It's just a way to learn. It's because of the motivation. I think the only wrong decisions are decisions made when you know better, but you're doing something else because you're greedy or you're doing something else because you have some other motivation, trying to impress somebody, that's when I could think, all right, that was a wrong decision. I knew better, but I did the other thing intentionally. And that's usually pretty rare. Most of the time we're really doing our best. And there's no doubt that you guys are going to do your best. I'm sure you'll learn, maybe prices will adjust and things will, you'll figure stuff out along the way, but I just have this immense faith. The longer I've gone in my own path, I have this immense faith in the intelligence and the assistance of humanity in the world. Like, I think the world really wants this, it really wants this. This is healing the heart. Like if you think of the heart of the planet, we are the planet, and this is healing the heart of the planet as us, as the kind of the stewards and also the ones that could either be stewards or destroyers, like we, as representative of earth, have to heal our heart to heal the earth. It's essential. It has to go that way. First, if we just heal the earth. Put all of this money into all these environmental things, but our hearts aren't healed. We're just going to destroy the earth again.
RICK: Yes, exactly.
AUBREY: Well, it'll never change. This is the fountainhead. This is the point upstream that we need to address before anything downstream is ever going to be cleaned up. So anybody listening, like I love all of the initiatives that are out there for, agricultural reform and biodiversity of soil and all of the different things. It's all super important. Very much so. The most important thing, and I've always maintained this, is the healing of the human mind and the human heart. And I don't know anything on planet earth that does that better than these medicines, particularly this MDMA assisted psychotherapy session. For me, speaking as me, now, I've been blessed to be in the room in some of these underground treatments, and I've seen it. I've seen things happen there and I've been in all the ayahuasca sessions. I've been in countless mushroom and DMT sessions and buffo ceremonies. I have never seen healing as profound as when there's a male and female therapist taking somebody in the blindfold with the music through an MDMA assisted psychotherapy process. I've never seen anything close to it. And that's, I mean, Iboga can be pretty fucking profound too. But like, I think, out of all the things, those are the two that, and everything is profound and beautiful. And I'm a huge advocate of all of the medicines. It's unimaginably profound. And these are people, some have classic PTSD, some have just garden variety trauma that we all carry. Everybody has a number on that trauma scale, very few people are coming in with a goose egg of trauma, like we all have shit we carry, but no matter what it is, every time I've seen it, I've seen it really change people's lives in a fundamental way, and that could be someone who's gone to Burning Man for five years and taken plenty of MDMA out on the play. I had good experiences, but there's something different when the blindfolds off and you're looking at fire and fireworks and music and you're dancing and there's people, it's a lot of external input and stimulation. But when you have the blindfold on all of that. Inner vision goes right into your heart and right into your psyche and it's absolutely unbelievable what this treatment has to offer.
RICK: And it’s such a subtle shift from normal processing. With MDMA so that it's easier to integrate as well. So it's easier to take the lessons from MDMA and build it into your life.
AUBREY: Yeah, because it's not coming to you as a vision of a man with a crocodile head speaking to you in mystical, like riddles, they're like, what does that even mean? It's like talking to you like, oh man, like really just sitting with the truth that you're creating, that your truth. That's often just right behind the veil of accessibility.
RICK: Yeah. And on the theme of the world wanting this that is what brought me here. So to Houston in the last few days on Friday a friend of mine Sri Kulkarni was from the state department for many years, an expert in national security. He left the state department to run for office and he ran for office in Houston in 2018. He got like 44% of the vote. Or 46, something like that. He ran for office again in 2020 didn't win, but he's about the most progressive person, extremely progressive and he ran his campaign Houston is a majority minority, and he ran his campaign in multiple different languages, and he's very, you could say, left wing progressive Democrat. He introduced me to Dan Crenshaw. Who is also from Houston, a member of Congress, but is a former Navy SEAL, is a very staunch Republican. And I think this is one of the best parts of America, and maybe one of the best parts of Texas, is that although you see the fights between the Texan Republicans and Democrats right now, this progressive person introduced me to somebody on the other side of the political spectrum who cared about PTSD. And what's happened is that Dan Crenshaw has heard from a lot of Navy SEALs who have had PTSD or traumatic brain injury and have gone to the VA and have not gotten the treatments that they needed. And have then gone down to Mexico for Ibogaine and 5 Methoxy-DMT. Or some of them have gone down to South America for Ayahuasca. Or some of them have done underground MDMA treatments. And he's also spoken with people that were veterans that were in our study. And has heard about the healings that they've received. So, now Dan Crenshaw is one of our strongest allies for psychedelic research. Particularly MDMA research for PTSD. And he's partnering with Tim Ryan, who's a member of Congress from Ohio, who's one of the more progressive Democrats. And we're trying to work with them on two different bills for Congress. One would give 25 million to the Department of Defense for psychedelic research for PTSD and traumatic brain injury. And the other would give 25 million to the VA. Now, we don't know if these bills will succeed, but we again have this bipartisan support. And so what Dan does every year, this was his third annual healthcare innovation summit. And he invited me to be one of the people that he interviewed. So he interviews like four people from different healthcare innovative companies and he'll have several hundred people there and it'll be broadcast and stuff. And so Dan invited me to be in this event on Friday. And it was tremendous that the first speaker was the former commissioner of the FDA who just left a few months ago. So I was involved with doing the vaccines and he won this Crenshaw award. Dan Gibbs, his mother died of cancer, I think when he was around 10 years old. And so he's always been very interested in healthcare and promoting innovation. And so this event, on the one hand, I'm like surrounded by Texas Republicans, and I know about the Texas Democrats, at least from the house, leaving the state. It was warm and friendly, it went great. And I think in part, there was a veteran who had been in our study, John Lubecki, who spoke along with me about his personal testimonial. And there was one sweet moment too, when I started my talk I just wanted to say, look, that we're here because of philanthropy and we're here because we've created bipartisan support. We've been able to take this out of the political sphere in a way. And I said, we've received funds from Rebecca Mercer. We know family owned Cambridge Analytica and Breitbart and big Trump and Bannon supporters. Elizabeth Koch, who herself is not conservative, but from the Koch family. Charles Koch is, she's apolitical or so. Her father is Charles Koch. We've gotten funds from the Rockefellers, the Buffetts, the Pritzkers. And as I was describing this, I was sort of, and we've gone all the way to George Soros. And so there was this neat kind of moment where Dan tried to make a joke of like, Oh, George Soros, but he kind of, it was like, it's still okay. That he's in a partnership in a way that this mission is not just Rebecca Mercer, it's George Soros.
AUBREY: And it’s almost like it's bringing the higher parts of all humanity forward.
RICK: Yeah, it felt like that. And then there was this one woman who's running for Congress and she's a therapist and she used to work at the Houston VA and she was very sympathetic. Her husband is a vet and she talked about PTSD and EMDR and it was just a delightful conversation. And then she said that she was actually running against a Republican. And I'm like, Oh, okay, that was okay. I wonder if you've got a chance of getting elected or not. And it was just great. We exchanged cards. I go home and I'm writing her a sort of thank you note and just to say, keep in touch. Turns out she's running as a Republican against a Republican and she's farther to the right than the Republican that's in. And yet we had a delightful conversation. So what's coming out of this is that. The state of Texas is going to be funding a psilocybin PTSD study. And it's at Baylor Medical and potentially connected to the Houston VA. And the woman Lynette Avril, who was the researcher there, has a good chance of getting this funding. What she's talked about is a separate arm that we would fund through philanthropy that would do MDMA for PTSD. And then we would compare psilocybin versus MDMA.
AUBREY: That’s great.
RICK: And then the other part of, and this gets back to the state of Michigan now. I'll just say that we have, in addition, I've just talked about MDMA and mostly for PTSD, but we're trying to become experts in PTSD. And there's a lot of people that may not want to do the hard work of the therapy. It is painful. And so cannabis has been used by a lot of veterans and others for PTSD. It helps them not have nightmares. Focuses more on the present and so we've completed the first study ever, controlled study of cannabis for PTSD and we got a 2.2 Million dollar grant from the state of Colorado from their marijuana taxes and it took us seven years to get permission to do this study even after we had FDA permission the National Institute on Drug Abuse that until recently had a monopoly on the supply of federally legal marijuana. They didn't want to sell us the marijuana. Eventually we got approval. It took us three years to do the study and we were comparing four different groups of 76 veterans 19 in each group. And one group got marijuana with THC. We wanted high THC, the highest THC NIDA had was 12%, we tested it twice, it was 9%. Another group had 12% CBD, another group had, it was supposed to be 12% THC, 12% CBD, but the best they could do was 8% THC, 8% CBD. Then the other group–
AUBREY: There's a lot of weed cultivators out there right now like, oh man. I could have given you that 15%, easy.
RICK: That's totally right.
AUBREY: I mean, we were like, come on, man, I got you, Rick.
RICK: Yes. But we were limited. Well, since 1968, this monopoly, this federal monopoly at the university of Mississippi growing under contract to the government has been existing. We've tried since 2000 to end the monopoly and actually it just ended a couple of months ago when they gave four licenses, but the fourth group had alcohol washed cannabis. So what it does is it takes out all the terpenes and all the cannabinoids. So you still smoke something, but it's really got no active ingredients in it. So those were the four groups. And what we did was work through the study and there was this one guy that was very interested in becoming a public spokesperson to say what happened to him. Because he was able to get over his PTSD. He felt that this was tremendous, that this cannabis worked great. And even more importantly, he said he was on opiates for pain. And he was able to stop using the opiates and substitute the cannabis for the opiates. And he's a veteran and he got a lot of media attention and it was a great story that he told. And at the end of the study, when we uncovered the blind, it turned out he was in the placebo group. It was just a shocker to him, a shocker to all of us. It shows the power of the mind. If you think you're getting healing, you can do incredible work on your own without active ingredients.
AUBREY: Yeah.
RICK: That's what we showed in a way in the MDMA study where 32% of the people that got therapy without MDMA, they knew they pretty much knew they didn't have MDMA, but this placebo effect in the cannabis really shocked us. And so all the four groups got better, but the group that got the least amount of the benefit was the group that had CBD. And we think about CBD so much as anti anxiety, anti pain. They showed the least benefit. The next group was the THC CBD combination. Then the group that got the second most benefit was the placebo group. And the group that got the most benefit had THC, but they weren't that much more beneficial than the placebo. So, what we showed is safety. We demonstrated safety. Nobody hurt themselves. This was nobody had any kind of problems that we could tell on a safety, but we failed in terms of efficacy. So we're going to redo this study with money from the state of Michigan. So friends of ours at the marijuana policy project. Particularly Rob Campia, who lives here in Austin.
AUBREY: Was it close? I mean, was it indicated, was it trending positive? Is that the–
RICK: All trended positive, but the THC was a bit more than the placebo, but not that much more. So, the state of Michigan, when they legalized marijuana the initiative language says they have to spend 20 million a year for two years to fund research in veterans for veterans health and reducing veteran suicides. And it's only for FDA approved studies and it's only to nonprofit organizations or to academic researchers. So we've just submitted a 17 and a half million dollar grant to do a large number of veterans and we'll have one site at the Tampa Veterans Administration, one site in Phoenix, Arizona with Sue Sisley. Which will be unaffiliated with the VA there and two sites in Michigan, one affiliated with the VA and one not. And then we've said that there'll be two more sites that we'll add. We're not sure where they are. But what we're hoping, potentially, if we get the grant, is that one of these sites would be at the Houston VA as well. That this would be a Texas study. And it will take a couple of years and then we'll see, and the one thing we're going to do, well, two things we're going to do differently than the first study. The first thing is, we're going to use better marijuana. Number one, better marijuana. Of the people that just got the licenses to grow domestically from the DEA, none of them are going to have the marijuana developed enough and standardized enough in time for this experiment. So we're going to import either from Israel, Canada, or Australia. And so we're talking with different companies in those countries. So far nobody has been able to import flour. yet for research. So this is going to be flour, smoked. We'll let people have vaporizers, but they can use vaporizers or smoke, whichever they want. It'll take us a couple years to do the study. And we think that cannabis is more about symptom reduction than it is about cure. But that's enough for a lot of people. In the future, as we think about things, we ask people to withdraw from all of their psychiatric medications to be in the MDMA study. So if they're on SSRIs or any kind of drugs, that mutes the effect of MDMA. They have to withdraw. And that can take months sometimes. It's five half lives plus a week. But if they were to substitute cannabis instead of these SSRIs it can help with a lot of the symptoms, but you only need to stop smoking the day before you get MDMA. It's not going to have this lingering effect the way SSRIs do. So I could imagine in the future a fair number of people who are reluctant to taper off their medicines, even though they still have major PTSD, they're still worried about being stabilized that maybe one day we'll be able to bring them cannabis to use and then we'll switch to the MDMA to get the heart of the problem. And then at the end they won't need more MDMA. And if they want to smoke pot, they'll do it for something other than PTSD.
AUBREY: Yeah.
RICK: So that's in a way the long term vision. And so we'll see about this cannabis project. And we're very much hoping that one of the sites can potentially be in Texas. We'll see. We don't know if we're going to get the grant. We'll find out in a couple of weeks, a little early indication but we're hopeful. And so I think this meeting with Dan Crenshaw was just so good to really build these. People can be aligned on treating suffering. And we can do that without getting trapped into partisan situations. And there was to give an example of why I think this is so important. I was at a Passover dinner and this was a couple years ago. And it was a bunch of scientists. And I was sitting next to this older couple who I didn't know, my wife and I were sitting next to this older couple who I didn't know, and I said to the guy, are you a scientist? He said, no, I'm a judge. Okay, he's a judge. And then his wife started sharing that she's writing a book about grief, about parents who've lost a child, and how you cope with the grief of that, because that's among the most painful emotional things could happen to you, a lot of relationships break up. And so I was saying that's like PTSD and we had this long conversation about MDMA therapy and MAPS and what we're doing and marijuana and the government monopoly and all this kind of stuff. It was a tremendous conversation. Something finally clicked in my head and I realized that this guy wasn't just a judge. He was a Supreme Court judge.
AUBREY: Oh wow.
RICK: He was a US Supreme Court judge. And so I was like, Oh my God. So I said, "Can I ask you an ethical question?” And he said, “sure.” So I said, “Here's my ethical question.” I've taken a million dollars in donations from Rebecca Mercer and almost most of the people that support MAPS are more progressive. And of all the things I've done at this point it was only 33 years. But I said of all the things I've done in the 33 years of MAPS, the thing I've got the most criticism for is taking money from Rebecca Mercer. People are demonizing her and they say it makes her look good and I should have done any of that. But I said, I think it was one of the best things I ever did because we need bipartisan support. And so I just wonder ethically, was she, “a toxic donor” or what do you think I should have done? And what he said was so relieving. He said the essence of democracy is finding common ground with people with whom you may disagree on every other issue. And he said in this hyper partisan era that we're in there's not enough of this finding common ground. So he said I think you did exactly the right thing.
AUBREY: I would echo that for sure.
RICK: Yeah, and it felt right to me. That is so right and that's what we need to do. And so–
AUBREY: To not do it seems so wrong. No, we don't want this million dollars It's gonna help revolutionize mental health and ease the suffering and saves countless lives because it's coming from you like, what the fuck?
RICK: Yeah. And I think there's also this way where we think in simple ways, like people are all good or all bad, or this is black and white. So Rebecca Mercer, she's done things I don't agree with, but she's done things that are good too. I mean, I want to give her an opportunity to do something that we all agree with. So yeah, I really felt that that was the right thing and so I think this meeting with Dan Crenshaw was sort of in that spirit and that's what got me to Houston and to here–
AUBREY: There's a lot of good news that has been coming out of this podcast. I'm really pleased. This has obviously been something I've been passionately tracking for a long time as we kind of wrap up this year.
RICK: There are a few more things that I want to share just on this theme of good news. And also on this theme of trying to reach out to people what Elizabeth Coke has these events that she calls unlikely collaborators. So for me, one of the most unlikely collaborators is the police. I've always thought of the police as they're the predator and I'm the prey because of my drug use, not because I'm a big criminal, but–
AUBREY: Understandable.
RICK: But they're the predator and I'm the prey. And so it's been hard for me to–
AUBREY: No one celebrates the cop walking around burning man. I'm just saying. You're like, oh shit, that's a cop, for real.
RICK: Yeah. And so actually there was one time years ago where I spoke to this woman, Valerie Mocheco, who's the deputy director of MAPS. And she was at the MAPS office in California and I was calling her and she said that there were police all over the place and that there was a murder down the road and a pregnant woman had been killed. And I just thought, what would it be like? To be the police officer, to have to see this pregnant woman murdered. And I had this sympathy in a way for this police. And then coincidentally, later that day, I get a call from somebody from Vancouver. And what he said is that he's a therapist and he's interested in Ibogaine. And that we had been involved with Ibogaine research. We were trying to start some stuff in Vancouver. And he wanted to know how we were doing some Ibogaine stuff. And then he said, well, I really need to tell you, I'm a police officer. I'm a therapist for police officers. And I was like, do you have police with PTSD? And he said, yeah, we do. I said, well, let's work with them. So I was opened up through this series of coincidences. So years later, what I felt is we really need to build the relationship with the police. And so there's a senior retired DEA official. Tony Coulson, who is now a consultant for us. And the reason is, in part, what started this was that his son went to Iraq, has PTSD, and uses cannabis to help him with his PTSD. And it changed the mind of the father. So Tony arranged for us to give a presentation at the International Association of Chiefs of Police. So it's like 10,000 police chiefs and their senior staff from all over the world. This was in Orlando. And going through the marketplace, the hall was like a terrifying thing because there's all these new straight jackets and new handcuffs and new batons and new technology to track people and new ways to spy on what they're saying through these mechanisms to hear what somebody's saying a long distance away and all this kind of police technology. I'm like, Oh my God, but what had happened ironically was that President Trump decided that this was his group, and so two days before the conference, he announced he was going to speak there. And they set his time exactly the same time as our talk. And I'm like, damn, this is going to be bad. It's going to diminish the people that come to see us. So we get there, and it's John Lubecki who is there, Sanjay Gelfand, who's one of our therapists, Tony Colson, and myself. And so, we get to this place, there's thousands and thousands of people in line to see President Trump. We get to our room, 350 people that it could have capacity, and there's only 20 people there. And we're like, well, okay, these are the 20 people that really want to be here. And we gave our presentation, and afterwards, a police officer came up to me. He was sitting in the front row. He said, I'm a full time police officer, but I'm also a therapist and I would like to go through your training program so I can give MDMA therapy to the police. Cause there's a lot of police that actually are committing suicide. That it's not just veterans committing suicide. There's now an estimated 17 veterans a day, we hear 22, 20, but it seems like it's around 17 a day as the official numbers. It's probably an underestimate, but he said he wanted to go through our training program to help police. He also told me that veterans have preferential hiring at law enforcement. So you get people that are traumatized from being a veteran and then they come in a highly traumatizing group. So I said, we would love to have you in our training program. Sarko Gagarian is his name. He's been through our early training program. He's from Massachusetts. He's introduced me to his police chief several times. And we said, there's one more part of the training program which we'd like to talk about, which is that we give therapists an opportunity to volunteer to receive MDMA as a patient as part of their training. And so we'd like to give you that opportunity. And so Sarko was able to get permission from his police chief to do a federally legal study where he gets MDMA himself. Now there is a book by Michael Pollan, how to change your mind. And it's been incredible.
AUBREY: I interviewed him too.
RICK: Oh, good. It's incredible. He's written a new one just to say it's about plants, the changing your mind with plants. And he looks at opium, caffeine, and mescaline. But Netflix is doing or, there's going to be a documentary about his book. And one of the episodes is on MDMA. And so this police officer was filmed getting MDMA. And it may be a part of this documentary.
AUBREY: That's beautiful. So, yeah, I can imagine a world where the problem with the cops enforcing these things is that, people we inherently know when we're afraid of the cops, that if they come and mess with us, they're not doing it for our own good. Right? Like they're enforcing laws that they have to enforce that don't really make any sense because we're just manipulating the sovereignty of our own consciousness. And this should be one of our enabling–
RICK: Fundamentally legal.
AUBREY: Yeah, it should be fundamentally legal, like the ability to experiment and explore this in a safe container, obviously not driving a vehicle or doing something that would endanger someone else. So we get this kind of idea, like this is inherently unjust. And so we project that injustice upon the police when they're just doing their job. It's the laws that are unjust. They're the ones that are enforcing them. So I've always imagined a world where the police didn't have unjust laws to enforce. Then you would be stoked that the police were there because all they were there to do is prevent people from hurting each other, which is great. You'd be like, Oh, sweet. The cops are here. Amazing. Like I feel safer. Now, of course there's the human beings and they can be prejudiced. They can be biased. Some are of course, many aren't of course. But that environment where that's the reality, I think, we're approaching, closer to that reality, hopefully. And it's got to be a tough time. I have a lot of sympathy for the police as well, because of some of the actions of police officers, probably all police have been cast in the worst light that they ever have. In history probably for a long time. And so I'm sure that's increasing the suicidality, just like the veterans that came back from Vietnam and the country hated them and they're like, fuck, I'm just trying to do my best. I thought I was serving my country in the best way. And now I'm being hated for it on top of this incredibly traumatizing experience that I would have. So I can imagine that this is a time where I just see universal compassion as the universal solution. Like no matter what, whatever political party, whatever agenda, like whatever thing, we're not going to heal with non healing mindsets. And we're not going to heal with trying to cast someone out and judge them and separate them. Like we want an inclusive world where we all come together. Well, let's start that, by grabbing everybody and say, come on. Like, we're all in this together.
RICK: That's so right, Aubrey. Yeah, and to my surprise, my nephew has become a police officer. So my sister's oldest is now a Washington DC police officer and he's a reasonable guy. He's doing it for the right reasons and he wants to be protecting people. And luckily Washington DC has legalized marijuana and decriminalized psychedelics and other drugs.
AUBREY: Yup.
RICK: So, but yeah, I have now a police officer in my own family. Which is kind of amazing.
AUBREY: The world is changing rapidly. And it's a world that we can always point at the difficulties of it. Whether it's the difficulties of over exertion of control that a lot of people are worried about. Or division or environmental causes. There's a lot of things where if you focus on it, there's a lot of trouble that's out there looking at it. But people are dramatically underestimating. The impact that the legalization of these medicines is going to have. It's like, just fucking can't hang on middle of 2023, everybody, let's just keep it together for a little bit longer everyone. Come on, we can do this. We could do this. And then we got some assistance.
RICK: All right. So let me chart out just a little bit of the future. Okay. So 2023, we will make MDMA into a medicine. There's already about 300 ketamine clinics, several in Austin throughout the United States. And a lot of the more enlightened providers are providing ketamine with therapy. There are still a bunch of people that just saying here, it's proved us as a physiological thing. We don't give it with therapy, but more and more of the providers are providing it with therapy.
AUBREY: I had Dr. Dave Rabin on the podcast. It was phenomenal.
RICK: Oh, good. Yes. He talks about his wearable technology and things.
AUBREY: I think he's gone through your protocol for MDMA assisted psychotherapy as well. And he uses a lot of those same principles in his ketamine assisted psychotherapy.
RICK: Yeah. Because a lot of the people we've trained have wanted to put this into practice now, set up clinics. A lot of them are running ketamine clinics and doing that. So what we anticipate though, is that the therapists really don't want to be a ketamine therapist or an MDMA therapist or a psilocybin therapist. They want to be a psychedelic therapist. They want to have a tool chest of all these different psychedelics that they can use. And we want to cross train people in these. And so what we think is going to happen is that once MDMA becomes approved, there's going to be starting to be psychedelic clinics that are set up. They'll initially probably be MDMA and ketamine a year or so later, there'll be psilocybin. And I think in the decade after approval, they'll end up being around 6,000 of these clinics in the United States. And the reason I say 6,000 is that we have around 6,000 hospice centers. So when you think about communities that are large enough to have a hospice center to help people have a more peaceful death, they can be large enough to have a psychedelic clinic. And I think that we will in the end have hundreds of thousands of people working at these psychedelic clinics. And over time, the same way with what we've seen with medical marijuana has changed people's attitudes about marijuana and they've moved towards legalization. But I think medical psychedelics over a decade or so, and people hearing all these stories, they'll end up realizing that it's not, this is a good drug or a bad drug or a party drug or a therapy drug. It's how it's used and people will be able to realize that there is this fundamental human right to explore. And that there's so many people that don't have a diagnosis that still can benefit for personal growth, for spirituality, for couples therapy. MDMA is great for couples therapy, but it's not a disease that the FDA would approve. So I think that what we'll have is these clinics will eventually, we'll start with patients. And we'll then bring in family members. And we've already moved to that in a little direction. There's a therapy for PTSD called Cognitive Behavioral Conjoint Therapy. And so conjoint is couples or dyads where one has PTSD but it affects the relationship. And they bring both people into the therapy. So in 2014, Richard Rockefeller, who was the son of David Rockefeller, but he was a doctor. He was chairman of the Board of Advisors of Doctors Without Borders and he saw Kosovo and Serbia and so many people traumatized and he knew there were not enough therapists and psychiatrists. So he started contacting me about MDMA for therapy and his cousin was Senator Jay Rockefeller and he was on the Senate Veterans Affairs Committee. And they got us, finally, after starting in 1990 to do work inside the VA we got permission to work with this woman, Candace Monson, who developed Cognitive Behavioral Conjoint Therapy. And so we did these six dyads blending that with MDMA. So both of the people with PTSD in the relationship got MDMA. And it was phenomenal. The results were better than anything with Cognitive Behavioral Conjoined Therapy without MDMA. Both for the person with PTSD, but both for the strength of the relationship for all the measures that they used. And so now we're trying to do a larger study with Cognitive Behavioral Conjoint Therapy with and without MDMA to kind of demonstrate that. We want to incorporate that into the VA. So anyway, it starts with patients, then goes to their family members. Then eventually, I think, these clinics will be able to take people who just want personal growth experiences for a range of different things. And then I think 2035, we hope that we'll have moved to legalization, and I'm calling it licensed legalization, where it's a little bit different than the way it is now. And that I think that we regulate alcohol too lightly. And what I mean by that is, let's say you are using alcohol and you get into a fight at a bar. Okay, you get into trouble for that, but the next day you can go into the bar and get more alcohol. Or you're a drunk driver. You get pulled over for driving under the influence. You lose your driver's license. You can still get alcohol, get in your car and kill people. So we should make it a little bit harder for people to get drugs that they've misbehaved on. So I think if you have a license, kind of like a credit card and then it's easy to get, it's easy to lose if you misbehave and then it makes it a little bit harder. There'll always be a black market. But anyway, I think 2035, we moved to license legalization. And then I hope in the big picture by 2050, we have enough people that are in this understanding of the way to use psychedelics for personal, emotional, and spiritual growth, that we'll have enough of a humanity in that way that it'll kind of be more of a spiritualized humanity to kind of turn us more towards saving the planet from mass weapons and from climate change and from prejudice and stuff. So, that's the big picture, the longterm plan. And as a final statement, I just want to say about the veterans, is that since 1990, we have tried to start research inside the VA. And we were able to do this study with Cognitive Behavioral Conjoint Therapy, but it was outside the VA. We had to pay for it. They wouldn't refer vets to us. And so we are now within weeks of having a study inside the Bronx VA with Rachel Yehuda, who's a top PTSD researcher. And she's also an expert in the epigenetics of trauma. And so what that means is that there's multi generational trauma, that parents can pass trauma around to their kids. And it doesn't change the genes, but it changes what turns on certain genes and certain genes that can be responsible for anxiety, depression. And it may be that therapy changes the epigenetic mechanism so that you can break the cycles of trauma. So, she's now gotten about seven and a half million dollars of philanthropy. Some from Bob Parsons, who's a Vietnam vet. Who's 70 years old, who's found healing in psychedelics, and he was the founder of GoDaddy, and he does a lot of support for vets. The Stephen and Alexandra Cohn Foundation. I gave her 2.1 million for MDMA research. So she's got around 7.5 million worth of philanthropy to do MDMA PTSD research inside the Bronx VA. We also have a study that's going to be starting within a couple weeks in the Loma Linda VA. A small study just to train their therapist. That's funded by Bob Parsons. And then we're going to be doing a group therapy study. So this is to say that group therapy is one of the new areas that we really need to research. Can we bring down the cost of the treatment through group therapy? Could groups support each other? Can it be more effective? I think we don't know. Maybe it'll be less effective where people aren't getting as much individual attention, but then they can get group support. So that is funded by the Stephen and Alexander Cohn Foundation, and that'll be at the Portland, Oregon VA. So we're now moving into the VA. The big next step for us is active duty soldiers. We haven't treated a single active duty soldier. We have treated active duty police, but we've not treated an active duty soldier. And we think that may also happen in the next couple months. We're working with a fellow, Bob Kaufman, at the he's a psychiatrist, expert in PTSD at Walter Reed in D.C and they have access potentially to active duty soldiers. So, this is a time of incredible breakthroughs. Things that have taken decades and decades to get us to this point. And so to start research inside the VA, if we can get active duty soldiers, finally start group therapy. I think it's enormously promising where we're at. And I'm looking forward to how we get the resources that we need to sort of cross into what we're calling the bridge to sustainability. And the bridge to globalization and the bridge to commercialization. So that kind of brings it all around.
AUBREY: As we wrap up here, for people listening who maybe it's themselves who have PTSD and they're listening to this podcast. Maybe it's their uncle, their brother, their son, somebody's listening and they know somebody they're like, wow, I'd really like to get them enrolled in one of these programs, we get these questions all the time. What advice do you have for that person listening that has a family member that they would really love to have this experience?
RICK: Because the key to our timetables and everything is how quickly can we recruit people for our second? Phase three study. If we can recruit people faster, then the drug can be available faster to more people. So they would go to the MAPS website and under participate, if you want to participate as a patient, you click on that. And then there's a series of questions that it asks you. One of them early on is going to be your zip code. So that we have two sites in Israel, two in Canada, and 11 throughout the United States. And we want people to be within an hour, an hour and a half drive of the site. Because there's about 16 or 17 visits. Some of them will turn virtual, but still there's a lot of visits. We want this to be not so stressful. It's already going to be stressful for people to deal with this. So if you live near one of these sites, go through this program, it'll tell you. They'll then say who to contact at that site, the study coordinator. So you go to maps.org, you go to participate, you fill out these questions about who you are and what your issues are. And hopefully you'll live near one of these sites. If not, I'd say the main message for people is don't give up hope. That's the most important thing. Hang on. It's coming. As I said about the Vietnam vet who was able to get help no matter how long you're stuck, there's still the hope of healing. I should say it doesn't work for everybody. About 85 to 90% have either no PTSD or a clinically significant reduction of PTSD symptoms. So, it doesn't work for everybody. It seems to work for a vast majority of the people, of the hardest cases. So don't give up hope, if you can't get into an MDMA study, you could try ketamine. That would be something that there's more ketamine clinics and accessibility. People can learn about our treatment method. It's called the treatment manual. So you go to research, you go to MDMA at the bottom of the page treatment manual that will teach you about our therapeutic approach, which you can apply even without drugs is how to approach trauma. So I'd say yeah, don't give up hope. It would be. Very sad for people to–
AUBREY: We’re so close. Yeah. Thank you so much, Rick, for everything that you've been doing for so many years. And it's because of your work and the work of a lot of other brave souls that I can genuinely look anybody in the eye and say that I have faith and I have hope for all of us because it's going to take a massive global healing. And I believe that that's what's on the horizon.
RICK: I think so. And I also want to give an acknowledgement to your father because he was an early donor for MAPS and he was very supportive of the MDMA research and the Ibogaine research.
AUBREY: And my own personal research. I wouldn't have gone on my first vision quest. When I was 18 years old and out in New Mexico, I wouldn't have had that first psychedelic experience that changed my life if my father didn't set it up. So even though he's come on difficult times of late, like his impact on the world through me and through his supportive maps go on forever. So thank you for that.
RICK: That's great, Aubrey. Thank you for this opportunity to educate people.
AUBREY: Yeah, absolutely. For anybody listening, maps.org. If you want to donate, you want to participate. And thank you so much, Rick. It's been a real pleasure. Thank you, everybody. Goodbye.