Rick Doblin - MDMA Therapy

Full transcript: Rick Doblin on London Real

10:47 This is London Real. I am Brian Rose. My guest today is Mr. Rick Doblin, who is the president and founder of MAPS, which is the Multidisciplinary Association for Psychedelic Studies, which you founded back in 1986 with the goal of making MDMA and FDA approved medicine, but the organization has subsequently morphed and grown in a big way. You now also study the effects of psilocybin, LSD, ayahuasca, ibogaine and marijuana for such things as post-traumatic stress disorder, PTSD, depression, end of life issues.

11:25 I think to sum it up best, your website does it great. It says, “MAPS envisions a world where psychedelics and marijuana are safely and legally available for beneficial uses and where research is governed by rigorous scientific evaluation of their risks and benefits.” Rick, you’re one of my favorite guests ever to be on this show. When I grow up, I want to be just like you. Welcome back to London Real.

11:50 It’s a pleasure to be here. It’s, and I’m hoping to grow up one day too. Oh really. Yeah, you turned 60 recently, right? Yeah.

11:58 Jeez, you look great for 60. Yeah, and you’re not slowing down at all, are you? No, no. In fact, our projections are that MDMA becomes a medicine in 2021. Okay, and at that point, then I need to switch gears and start my real career, which is as a psychedelic psychotherapist.

12:15 Oh, okay. All right, so that’s the end game. Yeah, that’s been the beginning since I was 18. Okay starting in ’72 to become a psychedelic therapist, and at the time I thought I would have to do it as an underground activity because I was a draft resister, and I thought I would have a criminal record, and I thought I would go to jail, and I thought I wouldn’t be able to have a normal career, but I could do psychedelic psychotherapy both because I needed therapy myself and I wanted to help others, and I felt that consciousness change was the key, was a highly leveraged area that if I could help promote technologies that supported consciousness change, and particularly sort of mystical unit of experiences that the political implications of those would contribute to helping us solve all sorts of other problems.

13:04 And luckily when President Carter was elected president in 1976. First thing he did when he was president, the very first day, was he pardoned all the draft resisters. So that’s when I started thinking maybe I can do this above ground, and so I’m still wanting to do that, and I just didn’t think it would take me till I was, you know, 68 years old or whatever to do to start my career. But, you know, and so you ultimately want to be a therapist? Yes, and does that mean you’re going to need to get any more training?

13:35 I know you have your PhD from the Kennedy School of Government. Does that mean you need additional degrees, or not necessarily? Yeah, well, that’s a degree in public policy. Okay, so that doesn’t do me any good. I have an undergraduate degree in psychology, and I’ve trained with Stan Grof, and so I’m certified as a holotropic breathwork practitioner.

13:53 Okay, which is using hyperventilation to induce altered states of consciousness that then repressed material and other material emerges, and people can work with that, but that’s not the same as a credential for actually doing therapy. Okay, do you use the breath therapy yourself? Yeah, occasionally. I mean, I generally prefer drugs. Okay, fair enough.

14:16 More effective. Well, there’s in a way, maybe we could say that it’s easier, in some ways and harder in others, because with the holotropic breathwork I have a lot of admiration, because what you’re doing is you’re hyperventilating and you’re encountering your own defenses, and then when difficult material emerges, you have to both continue to deal with it and then also remember to keep hyperventilating. Okay, so you’re sort of consciously overcoming your defenses.

14:48 Okay, which is very challenging. And so when you take a tab of LSD or MDMA or psilocybin or ibogaine or whatever, you know, you don’t have to worry about keeping the process going, going, right? You’ve kick-started it with the pharmacology, and then you just have to surrender and open up to it instead of produce it at the same time. Right, right. It’s always interesting to me when I hear people say, I go into a flotation tank and it’s almost like being in a psychedelic trip, or I meditate and it’s almost just like, well, it’s actually quite simple, just to get there if you want to get there.

15:19 And there is, I mean, when I go into an ayahuasca ceremony or a psilocybin setting, I mean I do know that I’m going to get there regardless, and then once I’m there, it’s just all about opening up to the situation I don’t have to try to keep myself there. Yeah, you know, which is, yeah, although some people prefer it, because then you’re more in control. So if things get really difficult, you just don’t breathe as deep, or you kind of stop breathing for a while and you focus on the emotions.

15:46 So, and I’ve had many people tell me that they’ve gone deeper with the holotropic breathwork than they have with LSD. Okay, and it’s because they’re in a supportive environment. They’re not doing, you know, LSD and drinking alcohol at a party and distracting themselves with a million things. They’re focused inward and they’re with people that are supporting them. So the model is there’s a breather and then there’s a sitter, one-on-one okay.

16:11 And the sitter’s job is to remind the breather when they stop breathing and also to protect their space so that they don’t need to worry about anybody intruding, or the phone or the door, or anything like that. And usually it’s done in group settings, so that you kind of get energy from other people, people as well when people are releasing their emotions so it’s quite an important preparation for it. Stan gives lectures about the theoretical model of where the mind can go during non-ordinary states of consciousness, and so I think people have benefited greatly from holotropic breathwork, and I have incredible admiration for Stan and Christina to developing it, because here they had these powerful tools of the psychedelics, and then when the research was shut down in a counter overreaction to the psychedelic ’60s, they found a way to continue.

17:05 Right? Yeah, you know that’s powerful that that happened. You know, for people that don’t know much about you, I was wondering if you could just bring them up to speed with kind of MAPS. I know you guys have had some big successes this year with some real great breakthroughs. I know a pending marijuana study, some real success on your MDMA for I believe it was some firefighters and post-traumatic stress disorder of people, and I just wonder if you could tell us kind of how things are going in the MAPS world, and then why are you here?

17:31 Why is London a stop that you’ve made now twice in the past year, and is Europe important to you guys? Yeah, well, maybe I’ll start with that. Okay. So there’s the European Medicines Agency, which approves drugs throughout the EU for over 300 million people, and then there’s the FDA that we work with in the United States, and the European Medicines Agency and the FDA are engaged in some senses in regulatory competition, where they’re trying to see. Now the focus is on how can they approve drugs in a more rapid manner while not missing possible toxicities, okay, and gaining evidence about their potential therapeutic benefits.

18:17 So what we’ve been thinking all along is that the FDA requires two large-scale phase 3 studies. Those are the multi-site SE-controlled pivotal studies to prove safety and efficacy. Right, which can take five or 10 years even to get to phase three. Yeah, yeah, and that’s already taken us. Well, sadly, it’s taken us 28 years to get to this point, and we’re now just in the a year or so away from finishing phase 2 with MDMA, and everything else is behind that, behind that.

18:48 Right? Yeah, and only MDMA for post-traumatic stress disorder. We’re now starting a new study with MDMA for autistic adults with social anxiety, and we’re starting another study for MDMA with people with life-threatening illnesses that have anxiety. Okay, so those are early phase two. Okay, and those will probably be five, six years before we’re ready to take them to phase three.

19:11 Wow, long life cycles. Yeah, so the idea of Europe, though, is that if we can do one of the large-scale phase three studies in the United States and one in Europe, then we cross-submit back to the foreign studies are accepted by FDA if they review the protocols beforehand, and similarly for the European Medicines Agency. So for the same cost of doing two large scale phase 3 studies in the United States, if we do one in throughout England and Europe and the other one in the United States, for the same amount of money we get 600 million people, more or less, that we can use these drugs in, rather than 300 million.

19:48 Okay, and is there anything where you can actually make the two agencies compete against each other? I mean, I maybe, maybe I shouldn’t ask you this. Oh, no, no, no. That’s actually kind of one of the thinkings. Yeah, that there’s the fundamental difference is that in England and the European Medicines Agency, because there’s a lot of national healthcare organizations, they care about costs of medicines more than the FDA does.

20:11 The FDA cannot look at cost when they approve a medicine. They can only look at safety and efficacy. Okay, but in Europe there’s more like comparative studies, because the nation pays for it at the end of the day, where, as in America, it’s handled by private insurance companies. Yeah, so now there’s kind of a focus on how do you get drugs to market sooner, so that the costs and the time are not so great, and we respond to patient needs. Also, how do you take drugs off the market sooner if they’ve been approved in a faster way?

20:44 But then once you start ramping up and now hundreds of thousands of people take them, you find out that there’s a one in 50,000 risk or something. So there’s an approach in Europe here that’s called adaptive designs, where you’re kind of learning as you’re going. So there is a little bit of a competition as to where which agency can move drugs through the system faster, particularly for what’s called breakthrough therapies, and those are drugs for serious or life-threatening illnesses, for patients for whom other medications have failed.

21:18 Okay, and for PTSD, that’s exactly where we’re at. It’s serious, life-threatening. There’s a higher incidence of suicide, and at the same time we work with people that have failed on finding relief from the current available pharmaceuticals. There’s only two that are approved for PTSD, Zoloft and Paxil, and neither of them are particularly effective. So what we’re hoping is to do a study here in England, particularly with fMRI with veterans.

21:49 This would be a study with 24 veterans with PTSD who are given MDMA, not directly as a therapy drug, but to understand what happens while they’re under the influence of MDMA and going in an fMRI scanner. Right? Smells like David Nutt to me. Yes, David Nutt’s involved in this. He’s like, he’s a big guy that uses fMRI.

22:12 They’ve had the psilocybin study here. That’s, is that his thing? Is that his niche? He’s very well he’s the editor of the Journal of Psychopharmacology. He’s an incredible neuroscientist, and Beckley Foundation, with Amanda Feilding, has worked with David Nutt on some of the studies with psilocybin, okay, that they are doing with fMRI.

22:34 And so I’ve just been I just spent the last day with Amanda at Beckley Foundation, and last night we kind of had a breakthrough where this study in England is about 188 lbs over two years to do this, 24 subjects, 188,000 PB. Oh, yes, yes, excuse me, sorry. Yeah, okay, over, I know the pounds are worth more than a dollar, but not that much for much, right? So over two years, 24 people, 188,000. Yes.

23:05 So MAPS and Beckley Foundation have agreed that we’re each going to pay 25% of it. Okay, and then we’re going to try to see if we can raise the other 50% from donors. I’m here for a screening, the London premiere of a movie documentary called Neurons to Nirvana. Yes, I saw the trailer for that. Looks very interesting.

23:23 It’s about the use of psychedelics treating medical disorders. Is that right? Well, but it’s about consciousness shift, and how the world is in a crisis, and a lot of it is because of narrow thinking and people identifying themselves with limited parts of who they are, so they would identify themselves as part of their religion or their nationality or their gender or their race or their football team or their football team, and then there’s the US and them, and then, you know, that leads to dehumanizing others and not being sympathetic with others, and greed, and okay so it’s a real macro, real macro look.

23:59 Yeah, at the effects of psychedelics, having breaking down some of these barriers. Yeah, and through the psychedelic unit of experience, which people, you sort of move through certain levels of consciousness, and with psychedelics, usually the first is kind of certain perceptual changes, not so much with MDMA, but with the classic psychedelics. There’s more visual changes, people’s imagination, there’s more fluid, their ego processing is breaking down.

24:29 That’s what David Nutt and Robin Carhart-Harris discovered with psilocybin, right, that it reduces activity in the default network, which is the filtering process, which was kind of surprising. We had both of them on the show, and I know, uh, people would always think that your brain would get more active, but it turns out it almost becomes less active, or the, like, the orchestration. It stops happening between these different parts of the brain. Yeah, well, the default mode network is sort of synonymous, in a way, with our ego.

24:56 Okay, and with the things that we need to do as a human being in the world, getting through the day. And so there’s so much information that our brains are perceiving all the time that we decide not to attend to because it’s not fundamental for the tasks that we have to do, or it’s not novel, we know it’s not dangerous. Right, so with psilocybin reducing activity in the default mode network, then the filtering systems are slowed down, and you get a flood of material that you’re perceiving all the time but don’t pay attention to.

25:30 Right? And that gives you the sense of sort of a broader consciousness, and the sense that there’s more going on in your brain all the time. Right? So you stop thinking about, I have to eat this, I have to make sure that guy doesn’t kill me, and you can start thinking about what is my relationship with the society? What is happiness?

25:47 Why are we here? Yeah, yeah, yeah. And you start feeling energy patterns connecting things, and you start feeling that there’s this unified force, not everybody, but this is often the reports, and these are why these drugs have been used for thousands of years too. People end up with this more sense of the connection of things, and once you realize that you’re part of nature, that you’re part of the human family, you’re part of life on Earth, and that’s more fundamental than your ego, which is kind of a later development.

26:19 Then you realize that people who may be a different race than you or a different religion than you have more in common with you than they have different, and that there’s certain political implications of that, and I think we saw that during the psychedelic ’60s, where that was the birth of the women’s rights movement and the environmental movement. And I mean women struggled to get the vote, you know, in 1920s, well before that, but I do mean that there was a lot of development of all these progressive social movements in the ’60s, and a lot of it came from when psychedelics go, right, when people had this unit of consciousness and what that meant to them. Right?

27:02 I listen to a lot of old Terence McKenna lectures, courtesy of the Psychedelic Salon. Lorenzo over there. He keeps finding these lectures. It’s like Terence never stopped talking, in a weird way. I know you knew Terence back in the day.

27:15 I know he had his own opinions on MDMA. You didn’t agree with a lot of them, but he had a romantic notion about, if it’s from nature it’s good, and if it’s from the lab it’s not so good, right. I’d like to think he would have changed his mind by now, but I’m not sure, but you know, he talks a lot of this dominator culture. He kind of puts it in that perspective. I don’t think he likes to say like male dominated, just like a dominator culture as opposed to a cooperating culture.

27:39 And you know, he’s got a lot of interesting theories about, you know, used to have the psychedelics ingested and the orgiastic behavior, and you know, people not knowing necessarily who their direct descendants were, and how it was more of a tribe. But you know, I look at sometimes the world, and it just feels like this ridiculous dominator culture. And sometimes, and maybe it’s because of my experience with psychedelics, you know, I just turn on MTV and I see, you know, gold chains and big cars, and then I turn on CNN and I see Putin moving into Ukraine, and I’m just like, is anyone else seeing this massive dominator culture that’s not making anyone happy?

28:11 Yeah, I don’t know. Yeah, I think tens of millions, hundreds of millions of people are seeing it and there’s this growing sense about economic inequality, and you know, and also you could say the good side of global warming and climate change is that people realize that the problems we have transcend normal national boundaries or religious boundaries, and so we have this growing globalization, in this growing sense that the challenges that we face require solutions that will involve cooperation among people who are nominally different from each other and live in different countries. And so I think there’s on the one hand, a growing sense of crisis: environmental crisis, economic crisis, military crisis, and at the same time the sense of our interrelatedness and how we have to focus more on the human aspects of cooperation, and also we read about the incredible technological developments that have been, in terms of energy, new sources of energy, new sources of food, new sources of products, so that it seems as if the planet is capable of supporting the number of people that we have, if we have a more equitable distribution of resources and a more sustainable society, and we focused not so much on perpetual growth, but on providing for basic needs in ways that, you know, last a long time and give people actually more leisure time.

29:41 That, but but the idea there is that there is an opportunity, I think, for the unit of consciousness, for the psychedelic experiences to be integrated into our culture. Now there’s a great need, whereas during the ’60s it was so new and so novel, and in many, many different ways our culture wasn’t prepared for it. Right? I’ve heard this talked about, and it was it was the tune in, turn on, drop out. Let’s walk away from the rest of society.

30:10 Let’s do our own thing. Let’s not integrate it. There were a lot of things that were potentially done wrong. Right, yeah. Even people talk about taking psychedelics in a very egotistical way.

30:18 I’ve read old documents about that where it wasn’t all about this, you know, ayahuasca big tribal love. It was ego trips, and yeah, a lot of being used for bad purposes, or I don’t know, maybe this just well, even it’s still that way too. You know, there’s a lot of shamanistic approaches that are about power and not so much about healing. Okay, you know, this is, I did not expect you to talk about this stuff today, because you know, so much of what you do is, I mean, you know, you’re at the front lines.

30:47 You know, you’re like on the front lines in the hand-to-hand combat, you know, battling these big organizations trying to get these trials done. I mean, if people had any idea the kind of work you do to get to phase one to phase two, and all the slowness, the fact that the federal government was against any kind of marijuana studies for a long time, which would seem so counterintuitive, based on some of the states’ legalizations. But it’s interesting to hear you talking about psychedelics in a really worldly, macro sense.

31:12 Is this new for you, or no? No, this is what motivated me as an 18-year-old. All right, you know, but then you get down to practicalities, and what’s your strategy, and what’s the next step, and you know, for me, the whole Kennedy School of Government at Harvard, you know, trying to get my MS and PhD, that was about trying to find practical steps to build bridges between this sort of idealistic, visionary hippie kind of thought that that if we can promote consciousness change and help people move from fundamentalist perspectives to more mystical perspectives and more tolerance, that the keys to human survival are here in our hands.

31:52 We have the technologies, but we don’t have the social skills or the spiritual basis to really manage what we have well. So that’s what made me think, when I was turning 18 and was this draft resister, and you know, what would I devote myself to, and it felt like the most highly leveraged area was consciousness change because it can ripple out and affect all the different projects. Okay, so I don’t often give the, you know, big picture in a way like that, because, you know, certainly if I were to start talking to the FDA like that, that, you know, they would, they would wonder.

32:29 Right, right. It’s interesting, though, because you have a film like Neurons to Nirvana, which is looking at that really big, you know, top bird’s-eye perspective, and then you’ve got the recent video I watched, which was talking about the Vietnam vet, and yes, on the verge of MDMA. Fantastic, that was a great job. It was really good. I just tweeted it out today, and I think he quoted just to quote him.

32:49 His name was Bob Walker. He said, “I did in three sessions what I couldn’t do in 30 or 40 years.” And it’s a great little documentary. It starts out, he’s in the diner with, I think, some of his Vietnam vets, and they’re just like, you know, there’s no cure for PTSD. You know, these memories are always going to be there.

33:04 There’s nothing you can do, and he goes on to talk about his story of, you know, MDMA and some of the studies, you know, that you guys are doing. Yeah, yeah, yeah. You know, we did have some meetings at the Pentagon where we were talking about working with MDMA with active duty soldiers, and one of their concerns was that people who, if they were to get involved directly, that the word would get out that in some ways this was an acceptable area of research, and that worry was that people would, me meaning soldiers or veterans, would decide that there was just no way that they could get into the clinical studies, that they’re only for a limited number of people, and they would go out and find, try to find MDMA on their own, and they might get adulterated MDMA and they might take it in a supportive, a nonsupportive setting and might end up worse off.

33:56 Okay, but the people depending on were like, this is a worry of ours, but that shouldn’t start, stop the research. Okay, and so what Bob Walker’s story is about is the opposite, in a way. It’s somebody that heard about our research, um, decided that it would be too complicated for him to be part of it. I mean, for our study right now, in 24 veterans, firefighters, in Charleston, South Carolina, we have over 500 people on the waiting list, and we only have six more people to go, so there’s an enormous need.

34:25 So what Bob Walker did was, it was hilarious, he said he was near college right? You know, so he found MDMA on his own, and then it helped him, and then he found out an underground psychedelic therapist and had three sessions with them, and that helped him, and now he’s cured of his PTSD, and it’s actually 50 years, not 30 or 40 years, cuz he was in Vietnam in ’64-’65, so he is just an incredible example of somebody who has been stuck, frozen in this traumatic replaying of the trauma for 50 years, almost, and with a few sessions of MDMA he was able to break those patterns. You’re, you’re quoted in that movie, and you said something really interesting and I’ve read a few books on the brain, but a lot of people think that, you know, a memory is like a piece in your own hard drive in your brain, and you just access it, and that’s the data, and you access again.

35:18 It’s, that’s the data, but, you know, a lot of people believe, and has probably been proven, that you actually recreate that memory every time you remember, which is why there’s a lot of selective memory and a lot of things going on, and you were saying that with the MDMA therapy you’re almost recreating that memory, but now in a kind of a different plane or a different medium. I was wondering if you could explain what you meant by that. Yeah, well, when you have a traumatic memory, when you have a traumatic incident, a lot of times because you have to respond very quickly and your life is at stake, or you know, you perceive it to be at stake, that the memories don’t get processed in the normal way that we process memories.

35:57 They get sort of stuck in this fear mode, and then when people, uh, survive the trauma that whenever they think back on it, the trauma is as if it’s still happening. It hasn’t really been cycled into long-term memory. It’s kind of like hovering there, and people are constantly triggered by whatever sounds that might have happened at the time of their trauma. You know, for soldiers, it’s loud noises, or, you know, if somebody was raped, it’s, you know, a dark alley or whatever, that there’s constant triggers that make it seem as if it’s still happening now, right?

36:38 And so under the influence of MDMA, with the fear response muted to the trauma, you can remember the trauma to a deeper, fuller extent, and a lot of times people recover memories that they had forgotten that were just so painful, but then when you’re looking at them from a perspective where your fear response is muted, and MDMA also facilitates increases activity in the frontal cortex, right, where we put things in context, and it promotes oxytocin and prolactin, research hormones of bonding and affiliation and love, that you can reroute the memory in your brain, and you can properly put it into long-term storage, so that when you recreate the memory, sort of rewrite the memory, that it’s rewritten without the fear, and you can learn from it and differentiate between then and now, so it can finally be processed just like any other event in your life.

37:36 Yeah, as opposed to just being kind of, it’s like almost frozen in time, yet still amplified. Yeah, yeah, very much. And so this new understanding of memory reconsolidation, that every time you remember something you have to actually recreate the memory, and which helps explain how for some people one MDMA experience can be sufficient, right, because it kind of finally resolves that piece, or finally processes that piece. Yeah, and then your initial response to it isn’t the fear and the panic.

38:07 So what the study that we’re trying to do here at Cardiff University, which, you know, now we have half the funds through MAPS and Beckley Foundation, and hopefully we’ve been rejected by the Wellcome Trust, by Forces in Mind Trust, by the traditional, why has but Wellcome has funded some of Nutt’s research the past. Not yet, they stay away from the psychedelics. Well, they, when we, David helped arrange for a meeting a couple years ago with Ben Sessa, and Dr. Ben Sessa here, who’s going to do the Cardiff study.

38:39 Okay. And Dr. Peter Owen, who did our Swiss MDMA PTSD study, and myself, we went to the Wellcome Trust. And what shocked me is that they started talking about their reputational risk of getting involved with, like, with MDMA research, and I was sitting there thinking, you guys have $20 billion, and you are cowards, and you are worried about your reputational risk. I mean, right, you’re the charity. They shouldn’t have a reputation.

39:08 You’re saying, well, they should. So what I told them is, this is a reputational opportunity, right? You could get involved on the ground floor of an area that looks very promising for the treatment of PTSD, and for understanding the way the brain functions and neuroscience. And yet, in the end, they fell off the other side and decided it was a reputational risk. Does it still surprise you that things like MDMA and LSD, fantastic acronyms, still get this fear response, or no?

39:37 It doesn’t surprise me, because I mean, even those of us who are advocates of psychedelics, you know, when I think about my next big LSD trip, it’s with a certain amount of trepidation. Definitely, you know, there’s the ego dissolution, there’s the surrendering, there’s all the different things that we’re keeping at bay from our normal consciousness, there’s thinking about death as we get older. So it takes a, it’s fearful, and then you think about a culture that had, you know, an explosion of psychedelics in the ’60s, combined with certain, you know, let’s leave the mainstream, and, you know, the kids, you know, no longer doing what their parents wanted them to do and turn into drop-outs, and you know, that profoundly frightened the culture, and then the political arena was threatened.

40:24 The propaganda that came on the back of that. Yeah, so people are stuck believing that, you know, LSD causes chromosome damage still, or brain damage, or when I try to tell people that LSD is one of the safest drugs physiologically that we know of, that people don’t overdose on LSD, and you can take enormous amounts of it. People have a hard time realizing that it’s got quite a reputation, you know, and and I’m one. We’ve had shows where we’ve talked about our before and after ayahuasca experiences.

40:52 We talked about experiences with DMT. It’s our most popular episode ever. We had a before and after DMT show with myself and Alexander Ward, and it’s been watched over 300,000 times, and that’s great. Really a surprise to me that something, you know, very well known in the community has been talked about and used for 10, 20 years, that we could make a video a year ago and it be watched, you know, 330,000 times. And it’s quite simply Alex and I talking about DMT, us going away somewhere and smoking it and coming back, and me talking about my very first experience with it.

41:23 And I see. So to get more people to listen to this, we should take this MDMA now. There’s no MDMA here. Just joking. Wait, later, but that would be good.

41:32 Yeah. People are very interested in how it changes the way we normally communicate and process, and it’s very subtle yeah. People are fascinated and terrified. Yeah, and terrified. And even LSD, to me, and I’m not a psychedelic veteran, but I’ve been, you know, in the space for a couple years.

41:49 It’s even the one where you’re just like, okay, wow, here we go, you know. Obviously, since it’s usually prescribed in micrograms, you’re not sure of the dose, et cetera. The mushrooms you know, there’s a certain amount that you eat, the ayahuasca, there’s a certain amount that you drink. You know, it’s, and so even for someone like me, it still has this kind of, you know, unknown, yeah, quality out there, which is important to realize that that is the case.

42:13 That there’s something about the way in which we tailor the reality that we perceive to our own preconceptions, and we limit ourselves, and we protect ourselves, but not always to our benefit, that we may protect ourselves from critical thinking, or from, you know, challenging our fundamental assumptions, and that isn’t really good for our human growth and development. And under LSD you really have to surrender. Again, it’s not like breath work, where you can slow it down.

42:43 Once you’ve done the LSD it’s going to happen, and you’re going to have an eight-hour experience, or so, so I think a certain amount of respect, if not fear, but a certain amount of respect for the difficulty of surrendering your own hold on reality in order to get a deeper perception. So I can understand why society is scared, but at the same time the fear has been massively amplified by the propaganda and by the suppression of research, so that we don’t have the examples that are of these drugs being used in appropriate situations, with proper support, helping people with problems. So that we’ve recently finished a study with LSD for subjects with anxiety related to end of life life-threatening illnesses.

43:33 Right. This isn’t Johns Hopkins study. That’s no, that’s was psilocybin sponsored by Heffter Research. Okay, so they’re focus on that. This was done in Switzerland.

43:42 Okay, and what we are most proud of is that this was 12 subjects. It was published in the Journal of Nervous and Mental Disease, and there’s a big, in March it was in the New York Times science section, and a really positive way. So this was the first study of LSD in over 40 years looking at its therapeutic use, and what we’re most proud of is that 11 of the 12 subjects had never done LSD before. Okay. So we’re showing that this isn’t just for hippies.

44:12 This is for people who are seriously struggling with issues related to their own mortality, and that in a supportive setting LSD, and we use 200 micrograms, which is not an overwhelming dose. When Albert Hofmann first did the first planned experience with LSD, he took an amount that he thought would be smaller than anything known at the time, and probably would have no impact on him. And that was 250 micrograms. Okay, and so we’re and he had a life-challenging experience, thought he was dying, and went through all sorts of experiences, and ended up feeling ennobled and enlivened by the whole thing.

44:54 But, you know, they took milk as an antidote. They thought that would help slow down the LSD. They didn’t really know, but that, what there is, is this sort of sense that at 200 micrograms, you’re bordering on the ego dissolution and the default mode network being, you know, pretty completely suppressed and this flood of material. So I think what we’re sort of saying is that, like, the society that we live in, a lot of times when people feel challenged, when their religious beliefs are challenged, or their sense of superiority is challenged, that instead of looking more deeply and accepting a lot of the limitations and broadening their worldview, they end up blocking and then projecting out.

45:47 So we see that most horrifically in World War II, where it’s the Jews or the evil, and, you know, the Germans are all good, and they’re projecting their shadow out on others. So I think the work of psychedelics, the work of becoming more mature, is the work that our culture needs to do in order to face the challenges that we have, and we don’t have a lot of emotional tools to facilitate that process, and that’s where I think the emergence of this psychedelic Renaissance, where now research is permitted again. There’s more research now than at any time since the late 1960s, right, with psychedelics, and I think it’s very promising.

46:33 And at the same time, what we’re hoping to do is to show people, and this is where I would say I differ with Terence McKenna okay, so that Terence had this idea that somehow or other these ideas that are catalyzed by psychedelics are inherently corrosive to ordered systems of government and ordered society, that we’re always going to be tearing down the old and building the new, and that there’s going to be a tension between the existing society and the sort of psychedelic scouts. Okay, you know, the psychonauts that go out to explore consciousness, and that there would be this inevitable suppression and tension, and that was kind of the view in the ’60s too, right? And so I think what I’m trying to demonstrate, and what I believe a lot of people are able to live out through their lives, is that people can have these psychedelic experiences and return home to their families and their work, and that they don’t have to go off and live on some remote island, or they don’t, that we can have these awarenesses and live in society, and we can have a society where it’s a healthier society, challenging its assumptions but growing in an organic way, and that the psychedelics will be an essential tool for that.

47:49 And if we look at the spread of ayahuasca throughout the Western world right now, not only as a tool for religious ceremonies and spiritual ceremonies, but also in kind of more quasi-therapeutic contexts. We see it’s like with the gay rights movement, where people always knew gay people. They just didn’t know they knew gay people, and once gay people started stepping out, then you think, wow, you can actually be, you know, more or less a normal, healthy, happy person and be gay.

48:19 So it’s like that now with psychedelics, but we’re behind the curve. So if the people in England who had taken ayahuasca or psychedelics and were making major contributions to society could just raise their hands, people would be shocked. Yeah, and I’ve heard this from many guests that have come on here, and the advice has been, and it might have been your, actually it was yours last time you were here. You said, come out of the psychedelic closet, and it’s, uh, it’s something I have tried to do over the last couple years, and it’s been difficult every step of the way for me.

48:47 It’s just because you think that there’s no going back. You know, you think, I used to work in the banking world, I like, there’s no way they’re letting me back. But the more I come out, the more, I mean, the percentage of guests that have sat in that chair that have either tried ayahuasca or are going to try it is shockingly high. Yeah, and you know, we had six-time Mr. Olympia Dorian Yates, considered one of the greatest bodybuilders of all time, and an hour into the show we’re talking to him, and he’s like, yeah, I drank ayahuasca when I was in Brazil, and I smoke DMT all the time, and you know, our jaws dropped.

49:19 You know, I have a UFC fighter in here, Dan Hardy, and he is talking about how it’s an important part of him as a fighter. You know, taking these psychedelic drugs, and you know, and he’s, it’s the opposite of what you would expect, you know, especially if you think it’s this tune-out society. He can use it and also still punch people’s heads for a living, you know, and it’s very complimentary to his life. And yeah, it also sort of questions the idea, challenges the idea that this is all about peace and love, and that you have these experiences, then we all become sort of naive, defenseless people that the real hardcore is going to take advantage of.

49:57 Right, so it’s not that way I mean, it really is not that way, and there are some of the veterans, you know, that work with MDMA to deal with the trauma of what happened to them during the war, and so part of the concern was, is everybody going to become sort of a peace-loving, you know, disarmament, now kind of person? And we don’t find that either, right? Although we do find, I think, that many of the people who have been in our studies with veterans with PTSD, as a result of the MDMA working through the traumas of being involved with friends getting killed and killing people, that they become more willing to postpone military action until the last resort.

50:43 They don’t become pacifists. At least we’ve not seen anybody really become a pacifist, but what they do say is that as they develop their ability to navigate their own emotions, that conflicts that previously would reach a point where there was no next steps. They were all blocked, and then you move to violence, right? Right, either against others or yourself. You know, there’s 22 veterans every day, on average, committing suicide.

51:10 Now, high numbers, that they’re more willing to engage in negotiations, and again, see violence as a last resort. And so I think that’s the kind of impact, as a culture, if it were more widespread, that we would see is that we don’t ignore the fact that we live in a dangerous world, but that we don’t resort to violence without it being other efforts have been tried for negotiations. And I think I did some work I talked about before with Robert Muller, who was the assistant Secretary General of the United Nations.

51:47 Okay, and he talked about, he wrote a book in ’83 called New Genesis: Shaping a Global Spirituality, and his view was that we have the United Nations to mediate conflicts between countries, but that a lot of those conflicts have a religious base, and so if we could have a global spirituality, where people, you know, look at the Earth from space and understand that we’re all in it together, that people move from fundamentalism to mysticism, that would be the basis for a more peaceful world, that people wouldn’t have one world religion. You could have your own traditions, your own views, but you might hold them more metaphorically than literally, and you might be more sympathetic to people with other religions, and that’s where I got a lot of the big picture view that working on psychedelics and consciousness change had a role to play in world peace.

52:38 Okay. And it was from the assistant Secretary General of the United Nations. So I feel that there’s appropriate fear and caution that our society should have about psychedelics, because they’re very powerful tools, and how they are used determines the outcomes more so than the drugs themselves. So the whole system of prohibition is based on the idea that these drugs themselves are inherently dangerous and bad, right? And that the whole system of prohibition ignores the relationship that we establish with the drugs, which is what really determines their outcomes.

53:16 Can you be specific when you say your relationship with the drugs? Yeah, so let’s say that somebody, um, takes MDMA and goes out to a rave, right? All right, if they’re thinking of this, this is a party drug. I’m going to go out and have fun with my friends, and we’ve had people that have talked about having that exact motivation. Their relationship was, this is a party drug, then they go out to a party with their friends, and women in particular have talked about how sometimes they remember prior sexual abuse, and it’s something that they see has been incorporated into their personality.

53:51 It affects their relationships with others. It affects their ability to be in loving relationships, and if they’re just there with a bunch of friends, and they think this is a pretty heavy topic to talk about, and my friends really are just here to party, right? And it’s loud, and there’s a thousand other people around. Yeah, yeah, so then they stuff the feelings, right, and they end up worse off than before, right? And then they become the parent who’s 50 who says MDMA is a party drug.

54:17 What are you thinking? Yeah, yeah, yeah, yeah, very much, and they end up in large ways too, not aware, you know, because we’re only now really starting to get a lot of media about the therapeutic use of these drugs, that people sometimes in their mind only think of them as a party drug. They only know about ecstasy or Molly, but they don’t know about Adam, which was the code name when MDMA was a therapy drug in the middle ’70s to the early ’80s. So that the context that you bring to the experience is more important than the drug itself.

54:50 The power of the mind can tailor and shape things more so than we realized, right? And so if your approach to MDMA is, I’m going to take this as a party drug, and I’m going to go to this party and have friends, with my, you know, party with my friends, but if something more serious comes up, I will take that as an opportunity and as a sign that I need to work on deeper issues, and we’ve had some situations where people have been like that, where they’ve said that they went to a rave. Prior sexual abuse came up, but they were with friends that supported them and sort of focusing in on that, which isn’t reckless partying, but or even fun partying, but is something very sober and problematic, and then they can often work through it in the next hour or so and then go back to the party.

55:40 So that the attitude really makes the difference. And if our society sees these things as the sign of losing control, that you take these drugs and they weaken your control, and that we need our control to function in society, to not rape and pillage and plunder then people resist the introduction of these drugs, and they think about criminalizing them. But if you have this attitude that this weakening of control in a supportive environment helps you to have a more balanced control later, once you’ve taken these split off parts of yourself and integrated them and acknowledged them, then you end.

56:21 So it’s letting go of control in order, once you’re not doing drugs, to have a deeper sense of control. Right? And like, just so people understand, with your MDMA studies, you know, it’s, they administer the MDMA, and it’s preceded by an eight-hour session with a therapist, where they can talk through a lot of these issues in a safe environment. And, you know, in my opinion, I don’t see how you could ever do MDMA in any other way, you know, if not doing that first.

56:47 You know, yeah. Well, there’s usually three sessions, each around 90 minutes long, of preparation where you build the therapeutic alliance, okay, between the person that’s coming for the treatment for PTSD or anxiety because of end of life, or social anxiety because of autism, autistic spectrum, that you get to know the therapist, they get to know you, and we always use a male-female co-therapist team, okay. And we feel that people get regressed to childhood sometimes, in certain moments of a parental model it’s kind of a parental model.

57:24 It’s also, so there’s several reasons for it, but one of them is that the the, well, the functioning of opposites, you know, so you have male-female working well together, that can help people feel reparented in some ways, and it could also help them to realize that if they can have sort of a union of the opposites inside themselves, okay, that if they can accept the fact that we’re all these polarities, and we just are on, you know, one level or another, right? But that inside every man is, you know, female sensibilities to some degree, and vice versa, that if they can see a model of successful communication between the two co-therapists then they can adopt that with themselves, and then also they can project onto, you know, parental issues onto one or the other.

58:19 Plus it’s a sense of safety. So a lot of times for post-traumatic stress disorder, we’re working with people who survived childhood sexual abuse or adult rape and assault, and to have a male-female team makes them feel more comfortable than if it was just a male, or sometimes perhaps just a female. Okay, then the other is that there’s eight-hour sessions, so it’s a very long time, and sometimes one person needs to go to the bathroom or get something to eat or just take a little break, and so you always want somebody there with them.

58:49 Okay, and you’re on phase two there in the States with those studies, and those are proceeding. Yeah, yeah. So what we’re, we’re talking about is a sequence of studies and leading towards FDA approval and European Medicines Agency approval around 2021. Okay, and the basic scenario is that, first off, you do with a drug trying to make, what pharmaceutical companies do to make a drug into a medicine is you first off develop some molecule, then you do preclinical studies in animals, and you get all sorts of toxicity information.

59:27 Then you start with humans who are healthy volunteers in what’s called phase one studies, and that’s where you look at toxicity, and you look at what does the drug actually do? Now, if it’s a super toxic drug, like anti-cancer drugs you don’t start in healthy volunteers because it’s so toxic, right? So those are like phase 1A studies where you start actually with patients, but that’s rare, that the drugs that you want to test, you know, are so toxic that you can only work with patients.

1:00:01 So in general the phase two is where you start the small pilot studies with the patients, and you’re trying to figure out the doses, you’re trying to figure out what’s your treatment method, you’re trying to figure out who is your ideal patient population, and you’re trying to figure out methodological issues, like how do you do a double blind study, right? You know, how many times is this a, that somebody gets every day, or do they get it once a week or once every month? Like in our MDMA studies, usually it’s once a month.

1:00:31 Okay, so you figure all this out in phase two, and you’re also figuring out the magnitude of the effect and the variance, right? So how strong of an effect is it? How easy is it to see the signal throughout all the noise? And that helps you design the statistics to figure out the phase three studies and how they should be, and the phase three studies are what count for improving safety and efficacy to make the drug into a medicine, which means in 2021, if all goes as planned, then you could be prescribed this in a psychotherapy session in the future.

1:01:05 Everyone could have that option. Yes, that is the end goal. Yes. And we talked a little bit earlier before about the regulatory competition between the European Medicines Agency and the FDA. So there’s another program which is called expanded access, and what that means is it’s like compassionate access, so I described how we have over 500 people on our waiting list, for now less than six spots in our study with veterans, so that once you start phase three, and you have your phase three studies underway, if you have a drug that is for serious or life-threatening illness, and it’s for people who failed on other medications, you ask for expanded access, which means that patients can seek treatment outside of your clinical trial, and patients can pay for it.

1:01:57 Ah, okay, so we can be training hundreds of therapists and be treating thousands of patients before MDMA becomes a prescription medicine. Okay, in this expanded access approach, okay, which is during the phase three trial, which is during phase three. If you start slowing down phase three, they take away your expanded access. Okay, okay, and they do look at your books. You can’t make a profit, but you can sell things at cost.

1:02:22 Okay, and the safety data accounts. Okay, all right, but they don’t count any of it for efficacy data, so if it doesn’t work it doesn’t matter, because again, it’s not controlled placebo control double blind studies. That’s what we need in phase three. Okay, that’s the purpose of phase three. The purpose is, is these controlled highly scientifically methodologically rigorous studies, because you’re not doing double blind studies now.

1:02:47 You dup, no, no, we are doing double studies now but they’re just much more rigorous in phase three. Um, not necessarily. I mean, what you basically want to do is test out everything in a small scale in phase two that you’re going to do in phase three. You don’t really want to do new things in phase three because the stakes are so high. Okay, right?

1:03:07 Like, to give you an example, right now we’ve got studies that are underway. We finished a study with 12 people in Switzerland. We finished a study with 20 people in Charleston, South Carolina. These are MDMA for PTSD, and now we’ve got studies underway in Israel for 10 people, in Canada will be six people, and in Charleston will be 24 vets and firefighters, and in Boulder, Colorado, would be 23 subjects. So these are relatively small numbers, and we’re trying to finish these phase 2 studies but we are testing out comparing MDMA versus inactive placebo, comparing MDMA with various low-dose MDMA.

1:03:49 We’re refining our methods. So what we’ve learned is that, like, the double blind problem in particular is exceptionally challenging from a scientific methodological point of view, and in some ways it’s an impossible challenge, because the therapist is giving therapy to someone and it’s pretty obvious if they’re not taking the drug. Yes, and double blind study means that the people giving the drug don’t know about it, and the patients don’t know about it, so you can be very objective, but in this case you know if someone’s on MDMA or not.

1:04:21 Yeah, you totally know. And so what we tried to do was called dose response, which was to use low doses of MDMA that might fool the patient and the therapists. Right? And what we’ve found is that, um, the more that there is this confusion between the doses, the more therapeutic efficacy there is. So meaning that if you give somebody 10 milligrams of MDMA, they’re barely going to notice, and you’re still going to be able to tell the difference, and the MDMA is not going to hardly do anything for them.

1:04:55 Okay, all right, but as you march up further, and we’ve done studies with 30 mg, 40 mg, 25 mg, 75 milligrams, 100, 125, that as you go higher in the doses you end up causing more confusion, but you also end up starting to help people. Right? And so that makes it difficult to show a difference between the full dose and whatever your comparison is going to be, if you’re also helping people with the comparison. Okay, I think I understand. Yeah.

1:05:23 So that, so that it’s, um, so there’s this trade-off, and we’ve been spending years trying to figure out where is this right place where we get enough confusion between the doses, so that it’s double blind but not so much therapy. Okay. And what we’ve been finding is that at the 25-30 mg dose that there may indeed even be an anti-therapeutic effect. That it gets people, people are coming to work on their trauma, they get a drug that they notice a little bit what’s happening, but it doesn’t really reduce the fear response to their emotions.

1:06:02 Okay, and they start working on their trauma, and then it gets to be too painful. Okay, and so this is the the problem with the traditional non-drug psychotherapies for PTSD is when people start talking about their trauma to work through it, it’s just this trigger, that it’s like it’s happening now, and they can’t do it. So you’re potentially doing damage to some of those patients by bringing up those subjects without them having a sizable enough dose of MDMA.

1:06:29 Yeah, sometimes it gets to be difficult for them, and some people want to drop out of the study. Right? Okay, and that’s where it becomes yeah, and there’s large numbers of people that drop out of prolonged exposure and cognitive processing therapy, which are the non-drug psychotherapies right for PTSD. So when you have people that are dropping out, they’re, you know, it’s not a fair comparison in a way, and particularly if it’s anti-therapeutic. So what the FDA has said to us, and what I for the longest time, you know, I’ve had the view that we wanted to be the opposite of the pharmaceutical industry.

1:07:10 Yeah you built your organization on that, right? Yeah, yeah. I mean, we hired patent attorneys to develop anti-patent strategies, so nobody could patent MDMA for anything, right? So it’s all in the public domain, and so, you know, I, in some ways that’s been really, really good, but we share our protocols, we share the data, but in some ways it was really bad, and that I missed a trick that the pharmaceutical companies do, which I’ve just recently managed to do and that trick is that when the regulators who you worked with retired, you hired them.

1:07:48 Okay, all right, you know, so I never even thought of that. That’s what, you know, we always talk about how the revolving door of regulators to industry, right, and how that’s kind of a bad thing. And right, all right. So it turned out that the person that was the head of the FDA division of Psychiatry Products retired, and the next guy that’s there, he didn’t have the 15-year history with us. He raised some of the early safety concerns that we already have been addressed, we worked with him and his staff and brought the old issues to their attention, and then they’re back in the same place.

1:08:29 All right, but that’s all that I thought. So then I was out in December in California. Dr. Richard Rockefeller, who, one of our supporters, was the former chairman of the board of advisers of Doctors Without Borders, and got sensitized to whole populations being traumatized, and started looking at ways to help that. Started coming to understand, look at what MDMA does. So anyway, he gave a talk at the Commonwealth Club, which is sort of a public forum in San Francisco, and while I was there a friend referred a young woman, a friend of his, to one of our board of directors, a fellow named John Gilmore, who helped start the Electronic Frontier Foundation, which looks at the internet and trying to keep net neutrality and kind of keep censorship off the internet.

1:09:23 Anyway, this young woman was a lawyer, and she wanted to switch from corporate law to something else, so I happened to go to lunch with her and with John Gilmore when I was in town, and it turned out she said that she knew about MAPS, and that she was really interested, and that her father had recently retired from the FDA. Okay, and I was like, wow, so he was a pharmacologist working for the division of Psychiatry Products, and so we started working with him, and then he said that there was somebody else that recently retired, which was the former director, and that maybe he’d be willing to work with us. Okay, so you’re starting to use some people that used to work with these regulatory agencies, and we’re getting great advice from them, and so I do see that there’s some wisdom in what the pharmaceutical companies said, but what we’ve learned is that there are two approaches to the double blind.

1:10:11 One is the sort of regulatory approach, and the other is the scientific approach. They’re not always different, but in this case the regulators have recognized that there is a lot of problems with double blind, not just for psychedelics but for other medicines for psychiatric indications. Okay, that there are side effects that people can distinguish, that there’s so there might be a better way of doing this, going the future. No, in fact there’s no way to do this.

1:10:41 So according to what we’ve been told, we should accept the fact that we are not able to design a successful double blind experiment, and what that does is it places greater emphasis on the independent raters, that we have to have people that evaluate the outcomes that are not invested in the outcomes, they’re not the therapists. Okay, so that we can design our studies comparing MDMA, whatever we decide is the most effective dose, versus an inactive placebo, and that as long as we have independent raters that evaluate the progress people are making, and we’re moving more and more towards telemedicine and taking advantage of Skype and the internet, that the raters will be a team of raters that will be sort of calibrated among themselves to have inter-rater reliability.

1:11:35 Okay, and then they will see patients on a random basis, and they won’t even know this patient, they might never have seen them before. They won’t track them now, we have independent raters who track people through the whole study. Okay, gives them their baseline. This is a potential problem you see with this. Well, this is the solution.

1:11:51 Okay, the solution is to, the accept the, and this is what’s going to permit us to move to phase three. So this is where I’m saying is that we have to be starting to do these things in phase two, where we’re enhancing the independence of our independent raters, okay, and the lack of knowledge they have about where the patients are in the treatment process, so that their evaluations will be considered more reliable. Okay, and then that will be the antidote to the problem of trying to do successful double blind.

1:12:23 It’s like, almost, you’re building this huge infrastructure in order to be able to welcome in this potential phase three, and it not only involves therapists that have to be trained in this MDMA administration, but independent raters, and this whole other piece. Yeah, well, there’s a lot of things, you’ve always known this, you’ve been building infrastructure for years, Rick. Yeah, but it keeps getting more complicated, which is, you know, things that we thought were fixed turn out to be variable.

1:12:51 Right? Okay, and then we have to control them. Okay, so we’re controlling more and more things. That’s why they pay you the big bucks, that’s why they pay me the big bucks. Yeah.

1:13:00 Although I would say that I finally got my salary, well, I finally got my salary up to $75,000 a year. Congratulations, and that is a lot of money, and you know, I think, you know, maybe with a Harvard PhD I should be able to do more, but what I really, I love to do this, and so it’s not, you know, I have to have enough to send my kids to college and do stuff but it’s not really about the money. And unfortunately, you know, my wife is one of those successful women who earns more than I do, and I’m like, you know, not, my masculinity is not challenged.

1:13:41 Let me just say that I’m grateful for what she does. Thank God. I mean, like, the position you’re in is such an important place to be, and every time I see your tweets, and every time I read your articles, and every time, honestly, I see anything in the news about PTSD or MDMA research, I think of MAPS, and I think most people do recognize. Yeah, and the big breakthrough that we’re making now is with the military. Okay, so that’s since the last time I was here.

1:14:06 In a weird way, a blessing in disguise. In a weird way, these crazy wars that the US has got involved with has actually accelerated the adoption of these psychedelics. Yeah, it’s true that there’s a society in crisis, and if we can respond to that crisis, if we can show that psychedelic-assisted psychotherapy now, in general everybody’s in a crisis about dying, so that’s where one of the main areas that Heffter is doing research with is psilocybin for end of life for cancer.

1:14:34 Right, we’re, we’re broadening not just cancer but life-threatening illness, and we’ve just finished the LSD study as I described, and we’re starting one with MDMA. But okay, so, so we need to show, by virtue of the fact that psychedelics have been suppressed for so long, that these have useful benefits to the mainstream, to the very people that are suppressing these drugs, that they’re hurting themselves. So you need to, you’re saying that the soldiers is such a small percentage of the population that you need, it’s something to appeal to everyone, which is end of life issues to make.

1:15:06 Well, I think we need a series of areas, and the other main one is the treatment of addiction. Right? Okay, because, you know, people have again this simplistic idea that certain drugs are good or bad, right? And so, and the drugs that are illegal are those that are bad, and they have a high potential for abuse according to the law, right? So if we can show that psychedelics, well used, help people with addictions to alcohol, tobacco, to opiates, to cocaine, then people are going to start to question it.

1:15:37 It’s not the drugs, it’s how they’re used. Right? So we need, and you’re doing some preliminary studies with LSD, psilocybin, or with ibogaine as well? Well, what we’re doing is just observational studies of ibogaine and ayahuasca in the treatment of addiction. Okay, so, you know, we only have limited resources.

1:15:56 We’re focusing on trying to develop MDMA for PTSD, that’s going to take 18 million or so, 18 million from here to the finish line. Okay, dollars, dollars yeah, not pounds, dollars. And we do already have about 6 and a half million of that that we’ve received in bequests. Okay, so you know, we’ve got one-third of what we need. Okay, and the more that we get positive data the better, and the breakthroughs with the military are hopeful, because what we’re trying, even though the military, the veterans are a small percentage of the population, they’re held in high regard by most of the population.

1:16:40 Right? And there’s the perception of a national scandal, and a national obligation to provide proper health care to people who risk their lives for the country. Right? Yeah, no, was perfect when you were here last time. You know, when you take an MDMA study of a, you know, firefighter.

1:16:59 I mean, it’s almost the most marketable study you can give, because you take something that doesn’t have really an LSD history, in buzzword, you take someone that you know is revered by the society, and it must be a much easier study to get pushed through. Yeah, very, very much so. And so that’s been part of what I learned at the Kennedy School, is this sort of strategic analysis of how you choose the patients that you work with, and how you choose the drug-patient combination, and then how you try to communicate through the media and through the regulatory agencies and others what we’re doing.

1:17:34 And so you’re selling at the end of the day, like everyone else, you know, but before we got a little bit of time left, you had a breakthrough this year with a marijuana study, and I know it’s something that last time you talked about, you kind of throwing your hands up, and you’re like, this isn’t going anywhere, and it’s frustrating, and I was just wondering what’s going on with that. Yeah, okay. Let me, before I backtrack, I’m not sure quite how much time we have, but I just want to say the breakthrough with the military, and then we’ll do the breakthrough with marijuana.

1:17:59 Yeah, we got a half hour. So okay, good. Okay, so the breakthrough with the military has been, again, through Richard Rockefeller, through his cousin Senator Jay Rockefeller, who’s on the Senate Veterans Affairs Committee, and through this massive sense of crisis, and so what Senator Rockefeller has done is met personally with the head of the VA and urged him to look into MDMA research, and written letters to the Assistant Secretary of Defense for Health Affairs, somebody who has a $50 billion budget, and encouraged them to look at MDMA.

1:18:32 So, because there’s such a high rate of suicides of veterans, 22 on the average a day, because there’s such a national crisis, finally after over 20 years, we’ve been able to get the cooperation of the Department of Defense and VA, and so what the VA, we now got three different studies that were trying to develop, where MAPS will fund small proof-of-concept studies, and then the data will be used to submit for Department of Defense grants for these studies. So, so one of them is um, a couples therapy approach to treating PTSD that’s been developed, where one of the couple is a vet with PTSD. Okay interesting.

1:19:17 We have the ability from the FDA to train therapists by administering MDMA to them in a scientific protocol. And we gather certain information about healthy volunteers taking MDMA in the therapeutic setting, but we can train therapists by giving them MDMA, and so we’ve now started to train VA therapists by administering MDMA to them. Wow, you can do that legally? We can do that legally. Okay, yeah, and then once they’ve experienced MDMA, they can better understand how to blend their approaches that they’ve developed without drugs with MDMA.

1:19:55 How do we blend them? So we’re now working on blending MDMA with a couples therapy approach. Right? And wow, that’s, it’s exciting. And then there’s another approach, which is prolonged exposure, where people are trained to talk about their trauma and talk about it over and over and over and over until they’re desensitized to it.

1:20:20 Okay, now the problem with that it works for some people, but the problem is that a lot of them are interested in blending with MDMA, and maybe MDMA will give people enough of training to work with the pain that then they’ll be able to go through prolonged exposure. Okay, and maybe that will be more efficient and effective than our approach, which is three sessions of MDMA, right, with non-drug psychotherapy every week over a three-and-a-half-month period. If there’s some way to give somebody an MDMA experience of at least 8 hours, maybe four or five hours, they do prolonged exposure and the other time they leave people free to wander in their minds as they will in our non-directive approach.

1:21:28 You know, maybe there’s a way to, to enhance it. We don’t know if that’s the case, but we’re willing to fund a pilot study with prolonged exposure, and then there’s another therapy called cognitive processing therapy, and some of the people that have developed that through the military have said that they want to see if they can take their treatment-resistant subjects, and administer MDMA to them. Okay, how many years before the Department of Defense cuts you a check for an MDMA study?

1:21:58 Cuz that’s, that’s, that’s headline news. Yes, that would be headline news, and, well, we’re wondering that ourselves. Um, that I think maybe a year and a half, two years. Okay, possibly. And one of the subjects in our study, we saved the Veterans Administration a million-and-a-half dollars.

1:22:15 Okay, because there’s a backlog of people who have PTSD, the VA can’t see them all. One of the subjects in our study, um, about a year and a half ago, before he entered the study, applied for disability payments, and he was somebody who, several days a week, couldn’t even leave the house, so he couldn’t hold a job. Right? And time goes by, time goes by, nobody called him. Over a year went by, and he still hadn’t been called for his appointment, and so he saw our study, and he volunteered for our study, and after two MDMA sessions he felt cured.

1:22:53 Now our study is three MDMA sessions, so he was on his way, driving for the third MDMA session, when he got a call from the VA: finally, we’re ready for your appointment. And this was an appointment for him to describe his symptoms and see if he could get disability payments, and the average cost to the VA is around a million and a half dollars lifetime cost. Okay, cuz these are kids in their, you know, early 20s, right? Right, right, most of them and if they get disability payments, they go for the rest of their lives.

1:23:24 So, so he passed on that. He passed on that. He said that, he, you know, there’s something about, um, the military ingrained in you about leaving nobody behind. You all take care of each other, sure. And so he started feeling like he didn’t really need the money, but there were other people that did, and that he wanted the pride of working.

1:23:46 He and so he turned, but he said he knew everything he needed to say to describe his symptoms to get lifetime disability payments. Okay, and he decided not to do that. All right. And did you give this evidence to, we told, yeah, we told this to the military. What did they say?

1:24:02 They said this is really important. Okay, they didn’t say here’s, you know, half the money, we’ll give it to you for your research, but they noted it, as they noted it, and they said we are now open to, to possibly funding some studies. So we start, the military is not ready to fund studies in active duty soldiers. Okay, but they’re willing because I think they are worried that if they take MDMA they become pacifists, maybe, and they’re, but they’re willing to support studies that we start with the VA.

1:24:27 Okay, so we’re a couple years away, I think, from Department of Defense funding, but we’re only three, four months away from starting these studies, in maybe six months, depending on how long it takes to design the protocols, in starting these proof-of-principle studies in direct collaboration with the VA. So that’s our big break. That’s very powerful. You know, in part of that video that I tweeted earlier, the Verge video, you know, it’s interesting, cuz the story isn’t about this PTSD guy that goes into one of your sessions.

1:24:54 It’s about a guy that heard about your session and then went and got the drugs from a college campus, I guess illegally, and took them. And yet you’re still promoting that part of me, when I saw that video, was like, wow, Rick’s taking a chance, because if he promotes this video and then he tries to go through the front door to these organizations, they’re going to be like, well, you know, Rick, you’re trying to subvert, you know, the clinical studies. Well, we’re not trying to.

1:25:19 I mean, we do feel that the public education, which is what we’re doing right now, you know, about the results, about that, there’s hope that that’s really important, and the fact that there’s 22 veterans a day on average committing suicide, maybe some of them will not do so, and they’ll think, okay, there’s hope, and maybe some of them will say, I’ll wait for 2021, I’m not going to kill myself now. Right? And some of them may try to find therapy in other ways.

1:25:47 And so I actually just got an email this morning from Jim Fadiman, who is an early psychedelic researcher who did work with, um, masculin and LSD for creativity, and, you know, he in the ’60s, and he saw the Verge video, and he’s like, are you going to have to issue a statement, you know, because this was somebody that took MDMA on his own, and that was a concern of the Pentagon. Right? And as I say in the video, though, that that is happening, and I feel it’s our obligation to try to say, to give hope to some of these people that might otherwise commit suicide, and at the same time, that shouldn’t be a reason to slow down the research or not do the research.

1:26:27 That should be a reason to expedite the research, so that the massive amount of people that need help that don’t have spots in our studies can maybe get expanded access, compassionate treatment, or get a slot in our studies. So it is a delicate situation. The other point, though, why I thought it was important for us to promote that, is that that was a Vietnam vet. Right? That was somebody, 50 years ago, had trauma and he’s been stuck.

1:26:54 Yeah, and so that’s the power of the MDMA and psychedelics in general, that it can take people who’ve been stuck for decades and decades and decades and give them a new perspective. Right? And that they shouldn’t give up hope. Right? It is part of your very, uh, very large job description, is that, you know, on one hand you can say, we’re only, you know, doing 12 people here in Canada and 12 in Switzerland and 24 here, but obviously that can generate a huge amount of media exposure, and so then when people, I mean, we had a PTSD sufferer in here.

1:27:27 His name was Jake Wood, and he had done some tours in Iraq and Afghanistan. He wrote a book called Among Us, and he had a very unique situation, because he was a Territorial Army officer, and he would go from Afghanistan and then he would come home and go right back into a banking job. So he had no kind of, he had no unit cohesion. He wasn’t on a base. It was just this, and it was, and it was like the juxtaposition of those two things gave him so much trauma, and the first thing I said to him was, you know, have you considered, you know, MDMA or psychedelic treatment, because of the message, like, you?

1:28:00 So immediately I’m saying something to him. He’s asking questions. His buddies are asking questions. They’re talking about it, which helps your agenda, ultimately, doesn’t it? Yeah, I think it does, because I think the military has this obligation to try to help people, and the fact that there are so many people that are not finding treatments at work for them, you know, we need to develop them.

1:28:22 So I think it is building support in a good way, and I think the problem is, the case that most of, um, people trying to find MDMA will not get pure MDMA. They will get some adulterated other substance or a little bit of MDMA mixed with caffeine, or who knows what the different things are, but um, you know, they’re not likely to find what they’re looking for, um, and so I’m hoping that that will, that the first, first off, the thought that here somebody with, you know, stuck from Vietnam can change, and that people are trying to seek their own treatments, you’ll expedite it, and that’s what I told Jim Fadiman. Okay, you know, I think that we don’t need to explain that.

1:29:08 I mean, it was clear that he heard about our research, and that’s what motivated Bob Walker, that’s what motivated him to seek the treatment. Right? What’s your biggest challenge in the next 12 months? Is it as simple as funding, or not? Well, I would say that, um, probably yes, because what we’ve done is with regulatory agencies around the world.

1:29:31 So let’s talk now about here in England, so that, we, cuz I thought Kickstarter when I thought about this latest thing in Cardiff. I got Kickstarter, and, but I don’t even know how that works or if it’s legal. Well, Kickstarter doesn’t do clinical research, but Indiegogo does, right? They don’t do medical trials, right? Kickstarter isn’t, right, does.

1:29:48 Right. Yeah, and we just did one that ended in December. Okay, um, and raised over $40,000 for MDMA PTSD research focused on the veterans. Okay, so, and we’re going to do another one, um, September or October or so. There’s going to be a book, um, coming out about our work with veterans, and it’s written by Tom Shroder, um, who was the editor of the Sunday magazine of the Washington Post.

1:30:13 Okay, and so this is going to be published by Penguin Press, which is a large, uh, media conglomerate, and they’re going to be putting major advertising into this book, and it tells the story of three different people. One of them is one of the vets in our study. The other is Michael Mithoefer, who’s our chief psychiatrist, and then the other is me, woven into the story of the psychedelic research from the early days to where we’re at now, and interviews with Roland Griffiths, who does some of the work at Johns Hopkins with S Simon.

1:30:43 So this is going to be a major book, and we are going to do another Indiegogo campaign. So I think that from a regulatory point of view, we can get permission for the research. I mean, that was blocked for decades and decades, but now we can do that. We have, um, a certain number of therapists that we feel are sufficiently trained. So for this study at Cardiff University that MAPS and Beckley Foundation would like to start, we have half the money.

1:31:15 So that the therapist, we can train them, the regulatory approvals we can obtain, but it is primarily a financial limitation. Okay, um, you know, we’ve specifically tried to do this where it’s only through donations, too, as opposed to, as opposed to like investments of some kind. It’s difficult to think of how to do investments, because the drugs are off patent. Right? But that there is a program where the European Medicines Agency, and this is where we get into the competition that we talked about, that it’s called data exclusivity, so that if you’re the first to make a medicine out of a drug that has no patent protection, in order to encourage the pharmaceutical industry to do this, you are the only one that can use your data, okay, for five years in the US or 10 years here through the European Medicines Agency.

1:32:10 Okay, somebody else can replicate the data, so it’s not the same as a patent. Okay, and that data could have value, that data could have value, because then you get the permission to market it. So what we’re thinking about more than investors is the idea of creating a sustainable nonprofit. Okay, so that if MAPS makes MDMA into a medicine, or he makes psilocybin into a medicine, then there is this period of data exclusivity where, unless somebody else wants to do the research, which we would welcome if they did, because it just helps in the integration in society, and we’re through nonprofits, our main goal is social transformation and healing, not amassing resources.

1:32:49 But it is difficult to be constantly asking people for money. Everybody I meet, I’m constantly thinking, are they going to be a donor, or do they know a donor, or, you know, it changes your relationships with people in a very capitalistic way, constantly like on the prowl for money. But, you know, I, I at least I’ve realized that, um, that there’s a fair exchange in the sense that people have money, are looking for meaning and purpose, and and trying to help the world.

1:33:16 So it’s not just I’m asking for something, but I’m offering something, which is the opportunity to be part of this movement. Yeah. This is historic. I mean, 50 years from now we won’t be doing this anymore. There is a certain point in time where this is happening.

1:33:28 You could even argue it’s not going to happen even in 10 years from now. So this is, yeah, yeah. So people, you know, really find a lot of meaning in this. So I think the main limitations in this study in England right now are financial, and I think we’ve addressed a lot of the methodological issues now that we understand how to deal with the double blind, that was the biggest issue for me before these last five years. Okay, um, was trying to figure out, actually, the last 10 years we started our study in 2004 in the United States, and we started a previous one in Spain in 2000 with José Carlos Bouso, that was the world’s first MDMA PTSD study.

1:34:08 Okay, and then that was shut down for political reasons in 2002, and we didn’t have the power to reopen it. So we’ve basically resolved the scientific methodological questions that we need to resolve to do the phase three studies, and the main last thing we need to learn from our current studies, is what are the range of outcomes from different therapy teams with different groups of patients in different cultural contexts. So once you see the magnitude of the effect and the variance of the effect, then you can do your statistics to size the phase three studies, to know when you get a signal that’s reliable enough that you’re going to get statistically significant results.

1:34:51 Right? So we’re in the process of figuring that out over the next year or so as we finish these other studies. So our main challenge is funding, and, um, now that’s not the case with marijuana. So now we can pivot back. Mar, let’s finish up marijuana, because I know people are curious about this.

1:35:08 It’s something that we didn’t get a chance to talk about much last time, because there wasn’t as much to talk about. So what’s been going on? Yeah, well, let me first off by saying that, in my view, marijuana, and not just my view, marijuana has incredible therapeutic potential in all sorts of areas. Most of them are in treating the body, you know, in, and there’s people with cancer. Marijuana, cannabis, can help with the treatment of cancer in some circumstances.

1:35:39 It doesn’t always work just from smoking, because you have to get enough of the cannabis to the tumors. There’s, with epilepsy, CBD, cannabidiol, helps reduce epileptic seizures, and there’s incredible effects on nausea control for cancer, ethia on pain, on spasticity and there are some approaches, some therapeutic uses of marijuana, that are more for mental diseases, which is what we’re primarily interested in. Okay, including post-traumatic stress disorder.

1:36:11 Even the treatment of drug addiction. There’s more and more research that’s looking at how marijuana can be a substitute for alcohol or other drugs, and marijuana, less dangerous, like methadone is a substitute for heroin, but you can get it legally. So the area that we’ve chosen with marijuana, I’ve been trying to study the medical uses of marijuana for a very long time. I did my master’s thesis from 1988 to 1990 at the Kennedy School on the use of marijuana for nausea control for cancer chemotherapy.

1:36:48 Okay, and then through the ’90s, I worked on two different protocols. One was for marijuana for AIDS wasting, HIV-positive people would waste away because they weren’t eating enough. They weren’t eating, and they were nauseous, and we had FDA approval, we had Ethics Committee approval, but we could not get approval to purchase the marijuana from the monopoly held by the National Institute on Drug Abuse. Right? Then later in the ’90s, we had another study, marijuana for migraines, and that was done by Dr. Ethan Russo, who is now one of the chief scientists for GW Pharmaceuticals, which is the British company that’s trying to develop marijuana into a medicine in non-smoking delivery systems.

1:37:34 Okay, so they have a spray under the tongue that’s 50% CBD, 50% THC, called Sativex. Okay, and then they’ve developed a drug called Epidiolex, which is mostly CBD for epilepsy. Right? But they do the marijuana extracts. So what we were unable to get permission for this study with Ethan Russo.

1:37:54 So then it became clear to me that the research with marijuana was blocked for political reasons, and that the research with psychedelics was being permitted, and so it felt to me important to protect the research that we’re making with psychedelics, to look at, we’re politics is blocking science, and if we can switch that around, then that protects the freedom that we have to do the scientific research with psychedelics, which we didn’t have for several decades after the crackdown of the ’60s. Right? So it’s more of a strategic focus on medical marijuana.

1:38:35 I feel like the principle that illegal drugs should be evaluated for their medical purposes, they should not be suppressed, and since that suppression is still happening with marijuana in plant form, right, for political reasons, political reasons to try to block marijuana legalization in plant form, that that’s been an important area for MAPS to focus on. So we are looking at marijuana for post-traumatic stress disorder, because a lot of veterans are using marijuana for post-traumatic stress disorder, and our view is that patients deserve a wide range of treatment options, and they can choose what’s best for them, but in general, marijuana reduces symptoms of PTSD, but it doesn’t get to the cause, doesn’t cure it the way MDMA can, and marijuana is meant to be used as a daily chronic medication.

1:39:30 Right? And in general, we want people to be free of having to use drugs on a daily basis, unless they choose to. You know, so I don’t think it’s inappropriate. Some people may smoke pot every day. Um, I smoke pot almost every day, but not every day.

1:39:45 Okay, you know, but not for medical purposes, right? More for creativity and energy, and, um, you know, so I think as a treatment for post-traumatic stress disorder, marijuana is not ideal compared to MDMA. Okay, but I think it’s still very, very important, and for the same reasons that we’re making progress with the Department of Defense and the VA and with the culture with MDMA for veterans, as well as, you know, childhood sexual abuse and adult rape and assault and accidents, we’ve chosen the veterans as the vehicle to try to open, open the door to marijuana research.

1:40:22 Right now many people have heard that in the United States there’s now 21 states that have approved medical marijuana, and there’s two states that have legalized, but because those are all states, none of the marijuana that’s grown in those states is legal from a federal perspective, and we can’t use any of that marijuana in our FDA approval studies. So the way in which marijuana is being researched is being politically blocked, is the government monopoly, the existence of the government monopoly, and then they’ve required a special review conducted by the Public Health Service in addition to the FDA. The FDA is part of this group called Health and Human Services, and the public health service is also part of that group, but the Public Health Service reviewers, what they normally do is review grant applications where people want to get money from the government, and then it’s totally appropriate that they have all these scientists looking at how solid their protocols and their proposals are.

1:41:29 But the National Institutes of Health, when they have these grants for research, they’re the opposite of FDA drug development, where you don’t have to have the vaguest idea how the drug works. You just have to show that it’s safe and efficacious. Okay, and FDA will then let you market it without you knowing at all how it works, because people are suffering now. Now, but the National Institutes of Health approach, and the Public Health Service reviewers, are looking at trying to figure out how the brain works, how the body works, how these illnesses work, so they’re looking at mechanisms of action.

1:42:04 So, so how are you going to do this? Well, you get these. So the government of the United States has set up and sustained this monopoly, and at the same time they’ve made this Public Health Service review, and they’ve set up these guidelines that say that if you want to make the marijuana plant into a medicine, this marijuana is not for you. Okay, because we’ve already decided, even though the FDA hasn’t decided, the people that set this up in 1999 said, you know, marijuana and smoke form is no good, it’ll cause cancer, it should never be made into a medicine.

1:42:38 So the bias is built in, right? And the more important thing is the monopoly itself, because the National Institute on Drug Abuse can give marijuana to researchers, or, or sell marijuana to researchers, but they can’t provide it for prescription use. So nobody, no pharmaceutical company is going to spend 15-20 million on making marijuana into a medicine, with a drug that they can’t make into a medicine that they can’t sell. So is there no way around this, or how are you proceeding with your study?

1:43:10 Well, importation, okay, is going to be, there’s two ways, okay. So the breakthrough is that we recognized that, um, that the crisis of the veteran, the, the fact that many veterans use marijuana and that we have expertise in PTSD, we decided we would start a study with marijuana for PTSD, and we’ve also been engaged in a 12-year lawsuit that ended last year, trying to break the government monopoly. We wanted to get our own marijuana production facility at UMass Amherst with Professor Lyle Craker.

1:43:43 Okay, so I realized that the National Institute on Drug Abuse, their farm is way behind the times. So in 1998 or so is when GW Pharmaceuticals started in England, and they were aware that CBD has powerful therapeutic effects, not just THC. And so Sativex, CBD, is the synthetic version of, no, no, CBD is cannabidiol. It’s one of the main natural cannabis in marijuana. Okay, but it’s mostly been bred out because it doesn’t get you high.

1:44:17 Okay, it has anti-pain properties, anti-anxiety properties, anti-epilepsy properties, but it doesn’t get you high, and so that’s why most growers have bred out the CBD and just produced higher and higher THC. Okay. GW Pharmaceuticals recognized that CBD has medical value, and that’s what they focused their product on over 15 years ago. Okay, right? So the National Institute on Drug Abuse, though, they’re not really trying to develop marijuana into a medicine.

1:44:46 They’re trying to develop, um, grow marijuana to give to researchers who will show what’s bad with marijuana, to sustain prohibition. Okay, so you’re going to import some of this for your study? Well, eventually, okay, we can’t quite yet import it. So I just want to explain to people that are listening, like, what’s the bottom line? How are you going to proceed with this study?

1:45:03 Well, we’ve been able to overcome the resistance. Over, um, three and a half years ago, the FDA approved our protocol, and then the Public Health Service rejected it, and they looked at it from a basic science review perspective. They rejected the protocol. Okay, then we went to the University of Arizona at Phoenix, their Ethics Committee, where we’re going to do the study, and we said, here’s all the reasons the Public Health Service rejected our protocol, and here’s our responses, why we think they’re wrong, and every single thing that they said, and why the FDA said yes, we can do the study, and then the Public Health, the Institutional Review Board approved the protocol as we designed it, and rejected what the Public Health Service said.

1:45:46 Okay, so then we resubmitted it to the Public Health Service. Now, meanwhile, three years ago NIDA claimed that they could provide the marijuana we need for the study, because we’re going to look at what does CBD do to help with PTSD, as well as what marijuana with THC does. So we were told in writing by NIDA that they had the marijuana that they could provide for the study, and a year ago, that’s why we lost the lawsuit after 12 years to set up our own farm, because NIDA and the DEA told the judge we’ve got all the marijuana these people need, we don’t need another supplier.

1:46:24 Okay, and the judge rejected our appeal. Okay, all right, so what the big, big breakthrough that happened in March was that we finally obtained permission from the Public Health Service to do this study in veterans, because again, we had FDA approval, we had the Institutional Review Board had rejected the Public Health Service critiques and approved it, we had the veterans on our side, and we had 21 medical marijuana states and two states for legalization. So how could they, how could they justify blocking research?

1:47:01 It just became so intable. So what happened was, March 16th we got the word, yes, the study is approved. Okay, and that was New York Times, that was broadcast everywhere, that was our major breakthrough. Congratulations. But there’s always a, what we just found out last Friday, NIDA has admitted that they don’t, don’t have the marijuana we need.

1:47:22 Okay, so they said we had the marijuana we need when the lawsuit was going on, right, to help us lose the lawsuit. Okay, now they claim that they don’t have the marijuana with CBD. Okay, but that they can grow it, and then two Fridays ago the DEA filed notice with the International Narcotics Control Board, which monitors international drug control treaties, that the quota for how much marijuana was going to be grown in the United States states in 2014 would be increased over 30 times.

1:47:55 Okay, now NIDA is committed to growing massive amounts of marijuana for researchers with all different amounts of CBD and whatever we need. They say they can provide it, but they still want to keep the monopoly, because that will still block us from doing these phase three studies. Okay, so they’re not going to let you use your marijuana source at Amherst, but they are going to grow you the marijuana with the CBD, and you have to wait for them to do that, another six months or so.

1:48:23 Okay, so they, and the law that was passed in 1970, the Controlled Substances Act, that provided for the licensing of producers for schedule one drugs, says that there has to be a continuous and uninterrupted supply. Okay, so now we have an interrupted supply of over six months. All right, so we’re willing to do this. So in six months we have to raise 950,000 to do this study. It’s a 2-to-3 study.

1:48:53 It will show, I believe, that it works, that marijuana helps reduce the symptoms. It helps people, um, who have PTSD not have nightmares. It helps them focus more on the here and now than on the past, and it gives a little anti-depressant mood for most people. Some people, as we all know, get nervous from marijuana, right, and they get panic. So there will be some people that marijuana will not work for, right?

1:49:17 Okay, and they will drop out of the study. So what we’re willing to do, because we’re in the phase 2 study, is start with the NIDA marijuana, but in two, three years, or now, when that study is done, we don’t want to use NIDA marijuana for the phase three study. So that’s where importation comes in. Okay, so that there’s the government of Canada has now licensed numerous large-scale for-profit medical marijuana producers. I just toured a facility that cost $10 million, just for the production facility, um, north of Vancouver that can produce marijuana for 5,000 patients, and the company that’s doing that is going to start another $10 million facility, and there’s all of these now spreading through Canada.

1:50:04 Okay, they’re in the Ministry of Health in Israel. Israel has licensed multiple for-profit producers. The Czech Republic is moving towards medical marijuana. This is what you’re going to use for phase three. Phase three, I think we’re going to import.

1:50:15 Yes, but what has to happen is that these producers have to grow medical-grade marijuana, that’s called GMP, good manufacturing practices, that has to be accepted by FDA as medical grade for use in clinical trials. And so far nobody has done that. Okay, and the GW Pharmaceuticals have refused to sell us their marijuana because they don’t want their marijuana product, which is the extract under the tongue, to have to compete with smoked marijuana. So GW Pharmaceuticals has taken the view that smoked marijuana is bad and marijuana legalization is bad.

1:50:55 Right? Okay, because it’s not so good for their products. Now, the producers in Israel and Canada, soon to be the Czech Republic, Uruguay has just legalized marijuana. They’re talking about getting into production as well. Okay, they see their big market as not just patients but for legalization.

1:51:14 Right? Okay, all right, so they want to open up a door with the US market, and so this one of these Canadian companies has offered to pay for a research facility at UMass Amherst, okay, if we can get a license. So this is massively complicated. It’s still not over yet. Um, I think we just got a little bit of a peek into what it’s like to be Rick Doblin.

1:51:37 Uh, Jesus Christ, it’s not simple, is it? There are very, very complicated things going on here as far as policy, science, statistics, everything, fundraising. Yeah, if it was simple, I would be doing something else. I like complicated. You know, I, I titled our previous episode “Fighting the Good Fight.”

1:51:53 You know, and Rick, that’s what I really think you’re doing, it’s, you know, it’s probably a thankless job at times, but like, you really are an inspiration to me, and I think to a lot of people around the world, because what you guys are doing at MAPS, it’s, I don’t know, it seems really selfless. What you’re doing, well, in some ways it is, but it’s, you know, we all live in this world and we all want to make a better world, and also I’d say that the one thing that has really made it easier for me to do is being a parent. Okay, because I’ve just had my first.

1:52:22 I’ve got three kids. My wife and I have three kids. Our first one, uh, 19, almost 18, and 15, and so the first one has just gone off to college, and the second one is just graduating high school, and so it’s happened in the blink of an eye. And so for me, it used to be when you’re young and impatient you think a five-year plan is way too long for anything, right? But now seeing that these kids are 19 years old, my oldest, and where did the time go?

1:52:52 So a 20-year plan is not so intimidating anymore. Okay, okay. So if it’s going to take us till 2021 to make MDMA into a medicine, and then probably another 10 or 15 years before there’s psychedelic clinics set up all over the world where people can access these drugs, and then the consciousness change happens, and then we have religious freedom, and then we have end of prohibition, and then we have billions of people that have access to, you know, psychedelic inspiration if they want, then we have a more peaceful world.

1:53:24 A 100-year plan right? Yeah. But it’s, but you’re okay with that? I’m okay with that. I’ve become okay with that through seeing how fast time goes as a parent.

1:53:32 If your gravestone, God forbid, says here lies Rick Doblin, the man who legalized MDMA, or you know, that is quite a life’s accomplishment. Oh yeah, yeah, yeah, that would be fantastic. Every time I hear, like, a news piece about you guys, I just, I just feel like celebrating. I just feel like, yay, you know, just, I just feel like I’m just a constant cheerleader for everything you guys are doing. Just cuz.

1:53:53 Yeah, Brian, it’s, we appreciate it too and it just doesn’t seem like there’s a lot of other people that are sticking their necks out, doing the hard work. You know, I know there’s help everywhere, but you guys are really at the forefront of doing this stuff, so we’re big fans of what you guys do, and I think everyone is, around the world. Yeah, and we’re hoping to bring it to England. I mean, that’s really the purpose of my visit, is here for these couple days okay.

1:54:16 If someone listening with a checkbook wants to contact you, what’s the best way for them to get in touch? Well, right now what we’re saying is that the Beckley Foundation is a British nonprofit, and people can get tax deductions to donate to Beckley. Okay, and because MAPS is a US nonprofit, people in England who want to get a tax deduction, if they give it to MAPS, we can’t give them a tax deduction. Okay, and because MAPS is partnering with Beckley to fund the study at Cardiff University with 24 veterans with PTSD getting fMRI scans.

1:54:48 We encourage people to donate to Beckley and just say this is for the MDMA fMRI study. Okay, is that Americans, or that anyone even? Okay, yeah, if it’s, yeah, that’s in England. So if it’s, if it’s people outside, if it’s people in the United States, they should donate to MAPS. Okay, and if they’re people in England, they should donate to the Beckley Foundation, and if somebody wants to make up this 50% gap, is that going to be a very wealthy individual that should come straight to you?

1:55:15 Um, yeah, that would be the best, or to Amanda, depending on where they live. That, the study is about 188,000 as we said, and we’ve already, MAPS and Beckley are each contributing half of that, one quarter of that, so we need another 95 grand or 94 grand, or, well, another 90. Yeah, well, something like 90,000, 88,000 is what we’re still looking for. Okay, and if they want to make that donation, I think that would be massive, because this would be our first toehold inside the European Union.

1:55:49 Ah, yes, you know, and it would open up the door for further phase three studies here in England. Right, and that’s what we really need is to get some of the studies going in the European Union, right? And we know that the FDA will notice things like that. Well, well, it’s not that they notice it. We submit the protocols to the FDA, so we can take all of our US data and submit to the European Medicines Agency and vice versa.

1:56:15 Right, right. Very helpful, so it will be that way. Yeah. All right, fantastic. If you’re contacting Rick, what’s the best way for them to get a hold of you?

1:56:24 Uh, well, um, just send me an email, Rick, maps.org. I have a staff member that helps me deal with my email okay. So it might be slow, but if people send me emails, they’ll get a response. Okay, fantastic. And, uh, on Twitter you’re Rick Doblin.

1:56:38 MAPS is MAPS news, right? If people want to follow you, I think so. Yeah, I am going to try to whisk you off to the Neurons to Nirvana premiere happening now. Uh, can I put a link to that so people can find out more information about that? Yeah, I’ll put that on the YouTube comments here.

1:56:54 Okay. yeah, I mean, that’s happening tonight, and it’s sold out. Okay, right? I mean, uh, if people want to watch the trailer or something later, so yeah, I’ll give them, yeah, yeah. And you could put a link to the Beckley Foundation too for how they, people from England might want to do it.

1:57:09 And we also have, um, groups, you know, for our MDMA studies in Israel. If there were Israelis listening, they could donate directly to the hospital there, Beyaka of Mental Health Center and get a tax, an Israeli tax deduction. Okay, we, there’s a group, the Swiss Association for psychotic psychiatrists that takes money from people in Switzerland when we had our LSD and MDMA study in Switzerland. Okay, so there’s places everywhere to donate if you’re an international citizen, pretty, and in Canada, where for a Canadian study, yeah, Tides Canada will take money for MDMA research.

1:57:42 Okay. Uh, Rick, all the best of luck. It seems like you’re juggling so many balls. I don’t know how you keep everything. I don’t know how you keep track of everything.

1:57:51 Great staff. That’s a great staff, but you’ve got so many different, you know, I don’t know how you can, you know, juggle marijuana and then, you know, this MDMA and and the LSD studies, not to mention these bigger picture things like the film that you’re going to play tonight, but um it’s huge work you’re doing. Um, it’s always an honor to have you on the show. Uh, you’re just such a good person as well. So thanks so much, Rick, and um, all the best to you and MAPS.

1:58:14 Great, thank you, Brian, for this opportunity, because public education is really the key, that’s what’s, um, where the fear is anchored, that’s where the hope is anchored. And if we can switch from fear to hope and have more people thinking, uh, optimistically and participate, that there is hope. We’ll, we’ll get there. It’s strange, because it’s, it’s become, you know, just a such a a part of our identity here at London Real. It’s probably, you know, 20% of our episodes have some type of, you know, you know, psychedelic discussion, and it was never by design.

1:58:42 It was just by the fact that you know I’ve gone out there on the world and experienced the world and experienced these things, and I can’t not talk about it, and uh, for me I agree with what you said earlier. It’s not about dropping out or let’s dissolve the government. You know, I do another show called Silicon Reel about the tech industry. Um, I, I’m, I’m an open capitalist, you know. I have all sorts of other things that I love doing, and one of the, and I believe that psychedelics is just a, a part of the human experience, and a very critical part, and I, I think it’s going to make us all understand who we are, so that’s why I continually talk about it.

1:59:16 So anyways, thanks so much, Rick, and all the best