MDMA Assisted Therapy - with Michael Mithoefer

Full Transcription

Today on IFS Talks we have the privilege of meeting with Dr. Michael Mithoefer. Michael is a psychiatrist living in Asheville, North Carolina, with a research office in Charleston, South Carolina. In the year 2000, he began collaborating with MAPS on the first US phase-two clinical trial of MDMA assisted psychotherapy. He and his wife, Annie have since conducted two of the six MAPS sponsored phase-two clinical trials, testing MDMA assisted psychotherapy for PTSD as well as a study providing MDMA assisted sessions for therapists who have completed the MAPS sponsored MDMA therapy training program, and a pilot study treating couples with MDMA assisted psychotherapy combined with cognitive-behavioral conjoint therapy.

He is now senior medical director for medical affairs, training and supervision at MAPS Public Benefit Corporation. He is a certified holotropic breathwork facilitator. He’s trained in EMDR and Internal Family Systems therapy. He also has nearly 30 years of experience treating trauma patients. Michael, thank you so much for being here with us today on IFS Talks. We're very excited to have this conversation with you.

Michael Mithoefer: You're welcome. Thank you. I'm looking forward to it too.

Aníbal Henriques: So, Michael, thank you so much for having us. Michael, it's been a long journey on this quest or crusade of yours and in many more like Rick Doblin to the MDMA assisted psychotherapy, and I guess with many setbacks and obstacles in the path. So, it took you decades of your life and your wife, Annie's life, Michael, to stand where MDMA research stands now, right?

Michael: It has taken a long time, yeah. Luckily, we didn't know what we were getting into when we started, as you know is a good thing. We didn't know how long it was going to take, but it has taken about 20...We've been working on it for about 20 years. And of course, Rick Doblin has been working on it for more than 30 years and laying the groundwork for making the research possible and for developing the organization to sponsor it.

Aníbal:So, how is it for you to hear this bio? What parts come up?

Michael:I've got kind of an amazed part that it actually, you know, we've been doing it for 20 years and we've got a part that's a little horrified that I'm a researcher because I'm really, have always felt I'm a clinician at heart and I didn't set out to be a researcher, but we felt we had to do the research because we needed better treatment for the, for our clinical practice. So, we kind of were forced to, to do the research, to get the clinical tools we needed. So, it's been, and I feel tremendous gratitude for having been able to do this work, that we were able to do what we thought made sense.

And of course, it wasn't our idea that MDMA could be useful for therapy. There was a lots of anecdotal reports and past experience, just no formal research. So, the fact that we, you know, people were...Another remarkable thing about the research to me has been, you know, it's all, non-profit, we've had no money from government or industry sponsors, just nonprofit people that saw the value of supporting this research. So, it's been overall, I'd say, when I hear it, it's been kind of...Gratitude is the main thing that comes up, that we've been able to do this.

Tisha:Michael, was there something that compelled you to pick up the research where it had been left off with MDMA? What was it that interested you?

Michael:Well, I went into psychiatry with an interest in non-ordinary states of consciousness, which is Stan Grof's term. So actually, you know, I originally trained in internal medicine and then practiced emergency medicine for 10 years before I went into psychiatry. And then in 1991, when I was looking for a change in my career, I've kind of felt...Well, I was getting a bit burnt out by the ER, was part of it, but also just feeling that was very satisfying work for a long time, but then I got a sense I wanted to kind of collaborate with people in a different way about their health instead of just doing things to them all the time. So, I was kind of looking for something to do with my medical degree that would feel more compelling at that point. This was about 1990. So, I came across an article about Stan Grof and I thought it was fascinating about his work with LSD research in, in the past, when it was legal. And then I followed up on that and found one of his books at the medical school library and read about his work. And so I decided that I was going to go into psychiatry. So I applied for psychiatry residency and went back and did that training. But I also trained with Stan Grof and his holotropic breathwork training.

So, I went into psychiatry with an orientation toward wanting to explore more about what Stan calls the healing potential of non-ordinary states of consciousness. The idea, if you can shift consciousness in the right setting with the right support, you can access this internal healing intelligence that Stan refers to. And that just made a lot of sense to me. And plus, reading his work explained some of my own experiences back in the, you know, I was in college in the sixties and I had experienced with psychedelics and we had experienced MDMA with the therapist back when it was legal. So I had some idea, but I sort of left that behind thinking that we had to do it with non-drug ways. So what Stan trained, you know, Stan has a training program and I'm using holotropic breathwork as another powerful way to shift consciousness. So I went into psychiatry with an orientation toward wanting to work that way, but assuming we'd have to do it without drugs because the drugs were now illegal, the psychedelic medicines. So, Andy and I did holotropic breathwork groups for 10 years. And it was kind of very much connected to our psychiatry practice. So, we were seeing people in the office, but then people were coming to our monthly breathwork groups and we were kind of already working with ways of shifting consciousness to help people access their own healing potential. The idea that they have the power of the information and the intelligence for healing within them.

Aníbal:It's amazing. That was back then in the 80's or the 90's?

Michael:That was...I went back and started my psychiatry training in 91, finished that in 94. So then it was between, you know, for the first part of my career we were just using the breathwork, we didn't use the MDMA. And then, over time we realized this is very powerful. The breathwork was really a powerful healing tool for people, but not everybody responded. So we realized, you know, there was every reason to think from prior reports that some of these medicines like MDMA could help to catalyze the therapeutic process. So we realized, okay, yes, holotropic breathwork is very helpful for a lot of people and there's some people that don't respond. And so that's why we decided it was important to study these other medicines and starting with MDMA.

Aníbal:Michael, help me walk us through these long and brave MDMA assisted therapy quest timeline. MDMA was criminalized in 1985. So, 35 years ago.

Michael:That's right. It was...MDMA was originally synthesized by Merck pharmaceutical in 1912 and patented in 1914. So, but they never did anything with it. So, it had been off patent for a long time, which is one reason it's non-profit research. So it had been...nothing was happening with it. There were a few things. The military did something, some experiments, but basically nothing happened until the 70's. And one of the main people that kind of brought it into awareness was Sasha Shulgin, Alexander Shulgin. And he synthesized it and took it himself and then gave it to his friend, Leo Zeff, who was a therapist who retired, and Leo Zeff came out of retirement to use. He saw the potential for MDMA as a therapeutic tool. And so he trained, he started working with his clients with it, and then trained a lot of other psychiatrists and psychologists and other therapists to use it. So there was a, you know, a small but significant group of professionals using MDMA in conjunction with psychotherapy between the late seventies and then 1985, when it became illegal.

You know, there were hearings at that time and that the administrative law judge for the DEA recommended that it be put in schedule three so that it can be used medically, but not sold in bars, but the DEA administrator overruled that and put it in schedule one anyway. So that's when it became illegal for therapeutic use and very much harder to do research in. So, no research happened for between 85 and then in 2000, fall of 2000, was when we got approval from FDA for our first study. But then we didn't get the DEA approvals in 2004, is when we finally started the research.

Aníbal:So immediately one year after MDMA became criminalized in 1996, MAPS was founded by Rick Doblin. Right?

Michael:First has something called Earth Metabolic Design, Earth Metabolic Design Laboratory, I think it was. And then it changed to MAPS around...I think it was 84, that MAPS was actually found it. I'm not, I've forgotten exactly, but he founded MAPS...Basically the first thing, well, the first thing they did was, you know, get the FDA to have hearings, the DEA, to have hearings about MDMA, which is what led to the hearings because the DEA was planning to just criminalize it and thought no one would care. They weren't even aware that it had been used therapeutically until MAPS brought the appeal for the hearings.

Tisha:Were you surprised to get the schedule 3 breakthrough?

Michael:Well, we didn't get schedule 3, that's something different.

Tisha:Oh, got you. That’s something different. Yeah.

Michael:Yeah. We got, you know, that first study that we started in 2004, now there've been six MAPS, phase-two trials, which is one of the FDA phases of drug development. So the phases of drug research are different from the categories of drug classifications later. So it's confusing. Yeah. But it's an FDA term. The phase-two trials are the kinds we've been doing since then. That first one was a phase-two trial. And so we've done a series of phase-two trials, and that's what led to breakthrough therapy designation. At the end of the phase-three trials, phase-two trials, FDA not only gave us permission to go on to the larger phase-three trials - which we've now completed one of those, waiting for the results to be released. And so, they not only allowed us to go on to phase-three, but they gave what's called breakthrough therapy designation, meaning the results of the phase-two are so strong enough, so that they could represent a possibility for major advance and an important treatment. So they want to expedite it. So, it's like the FDA way of making the process a little more expedited. But we still have to complete the phase-three trials. And as I said, we, it's very exciting. The first one is finished, and the data is being analyzed and will be released after it's published, probably.

Aníbal:So, you submitted the protocol to the FDA on October 2001, I guess. And then the study starting in 2004.

Michael:That's right. Yeah. We got FDA approval in 30 days, but then it took until 2004, another two and a half years to get a DEA IRB, which is ethics committee and DEA approval.

Aníbal:Beautiful. And then in 2017, the FDA declared MDMA, a breakthrough therapy...

Michael:That's right. But that doesn't mean it's approved for clinical use. It just means it expedites the process through the clinical trials toward getting approval.

Aníbal:I just want to give an idea to our listeners of how long and how much work this implies, all this process, these studies. And finally, phase-two trial article paper published in May 2019. So, the most recent paper that you published with those results for the second trial, they're available since 2019 May, yeah.

Michael:Yeah, with the pooled results. Yeah. So we took the results of all the six studies, phase-two studies together, which were, you know, we did two of those in Charleston. And then there was one in Boulder and one in Canada, one in Switzerland, one in Israel. So, you know, different sites in different countries and they all had positive results. So, combining pooling the results showed a very large effect size, 0.8 is the effect size. So, it showed that across six different studies, we had a very strong effect size and a good safety profile. So that was very promising. But again, for approval, we have to see if we can show that in larger groups in phase-three trials, and you have to have two of those usually. So, we've finished one and the others, the second one is started, and we're also have, you know, trials about to start in Europe. We've met with the European medicines agency and we're developing, there's a phase-two protocol already soon to start. It's been delayed by Covid. Hopefully soon to start in Europe and then move on hopefully to a phase-three trials and probably seven different European countries. So, we're hoping that if it goes well again, we have to complete the phase-three and see how it comes out. But if everything goes well, we're hoping for approval in Europe, you know, maybe a year after approval in the us. That's our hope

Tisha:Are all these trials working with clients who experience PTSD?

Michael:Those six are all clients with PTSD. The way that drug approval process is you get a drug approved for a specific indication. So, with our limited resources, as a nonprofit, we're putting most of the effort into PTSD as the indication that we're going to apply for if, if our trials are successful, but MAPS is also interested in other possible indications. There have been small studies...well, you mentioned the one we did with couples that was also people with PTSD, but one person had PTSD and the other didn't and both people got MDMA at the same time. And we saw it really helpful for their relationship satisfaction, as well as the PTSD. Phil Wolfson and Julane Andries did a study and Moran with MDMA Assisted Therapy for anxiety, for people with life-threatening illness. Charlie Grob and Alicia Danforth did a study in Los Angeles with adults with social anxiety on the adults on the autism spectrum with social anxiety. That was promising result. And there's an eating disorder study soon to start. Ben Sessa did a study in England with, for alcoholism, with MDMA Assisted Psychotherapy. So, other indications are cropping up and we're actually getting a lot of people interested in doing investigator-initiated studies, studies about other things that other people want to do now with the MDMA that MAPS is happy to share with people for doing research.

Aníbal:These results, Michael, led the FDA in 2017 to declare MDMA Assisted therapy, a breakthrough therapy, and to bring light to phase-three trials. So, do you think is MDMA a breakthrough for treating PTSD and even other difficulties, as you just mentioned?

Michael:I'm very hopeful that it will be, you know, we have to be careful not to get ahead of ourselves and claiming things that we haven't definitively prove until we finished with phase-three. So, but I am very encouraged by what we're seeing so far, not only the strong results, but the, you know, which is what counts for FDA approval, you know, the numbers on the, on the PTSD scales and that's appropriate. But the other thing that we're seeing that I think is a really interesting part of it is just the, the depth and the richness of the kinds of experience people are having and the way they're describing their healing process. It is, not only fascinating, but clearly suggesting that the benefits are going well beyond just decreasing flashbacks or nightmares or PTSD symptoms, which, you know, very important that it does that too. But I think, you know, one of the things that makes it so compelling is just the nature of the process and the way people describe, you know, what they, the way they're able to revisit painful experience without being overwhelmed and face it with real honesty and without self-judgment or judgment of others or defensiveness, it tends to help people face problems with more of those, in IFS terms with more Self-energy, you know, I think I've talked to Dick Schwartz quite a bit about what we're seeing and I think one of the best ways to describe the effects of MDMA is it brings forth a great deal of Self-energy and makes people, helps people be more aware of their parts and have the Self-energy to work with them.

So, I think it's kind of beyond being very promising for the effect on PTSD symptoms, I think, in a way, these medicines, not only MDMA, but there's exciting with psilocybin, as you know, I'm sure. And hopefully with others, there is research with other psychedelics also. I think it's, in a way, again, reconnect psychotherapy and Psychiatry. So, I think, yes, the answer is, I don't know, because we won't know until we finish the phase-three trials, but I'm very hopeful that it will be a very powerful tool.

Tisha:You just made it clear why IFS works so well with MDMA. It sounds like it brings a lot of Self-energy and then allows people to see their parts more clearly in the process. How did you designate IFS as a primary treatment?

Michael:Well, we didn't actually.

Tisha:You didn't. Oh, ok.

Michael:That gets confusing because, you know, our...We have a manual that describes our research method and we have raters that are trained to see if we're following it. So, the idea is not that we set out to do IFS. The idea is we set out to have beginner's mind to encourage people to open and not having an agenda and be open to whatever comes. And then the therapist role is to then support them in working with whatever comes. So we don't, some people don't do any parts work, but what we find is, so often, because of that phenomenon that we're seeing of people start talking about their parts more and have more, where with all to be curious and compassionate and courageous and creative and all those Self-energy, where is, it's fun to talk to [crosstalk] IFS podcasts because people know what I'm talking about [inaudible] IFS terms.

So, you know, what we've found, well, when we started the first study, I didn't, I'd never heard of IFS. We had been working with people with dissociation a lot and, you know, the phenomenon of multiplicity. And I was very interested in things like, well, I'd read about psychosynthesis originally. And I knew some people that did voice dialogue. I thought that was interesting. And I was, I wouldn't say, I didn't know about IFS. I was aware of it, but I didn't know much at all about it. So, but I, I was interested in these ways, different ways of working with multiplicity, had been years, but then...Annie was taking, it was in the Hakomi training early on during that first study. And she, you know, one of their readings was the Mosaic Mind, Dick Schwartz's book with the woman's name that he wrote it with. But anyway, she said, there's this meeting down in Hilton head, and there's a four-day workshop on IFS. Do you want to go? And, you know, normally I've been my whole life, I'm like a junkie for learning something new. But at that point I was so maxed out on getting the research done and having my clinical practice and everything. I said, well, you know, my plate is full. I'm not really ready to learn anything new, but it's, you know, it's only a couple hour drive it's down by the beach. It's nice. It'd be fun to go together. So sure. Let's go. And I'll go to this workshop with this guy, Dick Schwartz. And I was so blown away by that. It was a four-day workshop that Dick showed video and did demos. And I, I lost my resolve to not add anything more to my plate very quickly. And by the end of that, I went up to Dick and I asked for a recommendation for my own IFS Therapist and how do I get in, where is the training. So, the next thing I knew, I had my own IFS therapist and I was in the Level 1 training pretty soon.

And so I ended up doing all three levels of IFS training, and I just found it very exciting because although we didn't set out to use IFS and, and the other thing about MDMA often, you don't have to do much at all. People often do it themselves. And you might've seen some of the videos that have shown, IFS meetings with Dick. One of the veterans is allowed Dick to show video of the amazing parts work that people do spontaneously. So it's, you know, the way our method is defined in the manual is, we, when whatever's happening for the client, the participant, we support with whatever tools we have, if they're needed, we stay out of the way if not needed, but we bring tools when they're useful. And so if people are talking about parts, our approach is very much IFS informed. Occasionally it ends up, you know, especially maybe during an integration session afterwards, it can look like in a part of an IFS session, certainly, but so often it just unfolds spontaneously in the MDMA sessions. And it really helps to, for me, as my way of understanding, what's happening for one thing, but also sometimes there's a backlash and you get, you know, very challenging protectors. And then, in that point, where people need more help getting unstuck, that's when I find my, you know, training and experience with IFS so helpful.

So, we ended up doing a little sub study. I devised a scale with like eight questions about things, about IFS, and I sent it to Dick and he thought it made sense. It's not a validated scale. No one else has ever used it. But in our study with veterans and first responders, we tracked, whether parts came up, the questions were like, did parts come up? If so, who brought it up? And then, you know, what happened with it? Was there a shift? Did they work further with it? So, what we found was, and in that study, we had three groups that people were either randomized to 125 milligrams of MDMA, 75 milligrams or 30 milligrams. And what we found was 75 and one 25 were both very effective. 30 was not effective. You know, the therapy alone was a little more of, with inactive placebo is a little more effective than with 30 milligrams. So, in terms of responding on the PTSD symptoms, the 30-milligram group did not respond. The others did. What we found on our little sub study was that in the 30-milligram group, parts only came up less than 30% of the time. In the other groups with the effective doses, parts came up more than 75% of the time.

And they were almost always, if it came up as almost always brought up by the participant, if it was brought up by the therapist, it was only in response to what the participant was talking about. You know, we wouldn't just say let’s work with parts. If people were basically talking about parts, you might say, it sounds like there might be a polarity between two parts of you. Is that feel like that's what happening? And they'll say, yeah, that's what's happening. And then we would work with it. So really, our intention for the scale was about whether it came up spontaneously, either explicitly, which often was the case, you know, on 70% of the time, people just started talking about their parts. The rest of the time, it was a therapist that may use the word, but it was really in response to what was already happening. So there does appear to be something about MDMA in this set and setting with this preparation, you know, all of that set and setting is so important to the effect, but it does appear that MDMA seems to raise awareness as a normal phenomenon of multiplicity or some people talk about it beforehand, but then we're able to work with it in a much different way in the sessions. For instance, an example, if anybody's seen the video that the veteran has allowed us to show, one of the videos we show and that Dick Schwartz has shown is a veteran who described, you know...He had a lot of PTSD symptoms. He'd been a Marine in Iraq with two tours and he had this, the thing about it and most of the rage that would come up and he'd yell at his wife, he was never physically violent, but so, and he had a lot of shame about that and remorse, but he couldn't stop himself. So he told us about it. It was like a part of him, you know, he'd never heard of IFS, but he told us this in the preparation sessions that he had this image of a part of him erupting from his torso and he was trying to strangle it and it was stabbing him in the side. That was his experience at wrestling with the rage that he said, he felt like it felt like a monster inside that would just erupt. And then during his first MDMA session spontaneously, he told us about this experience that he had of realizing that actually that was a part of him that he locked in a cage. He said, I looked at it and it's written, had these evil red eyes and they just eyes faded, and it didn't look evil anymore and I realized it's not a monster, it's a warrior. And I think I was so afraid of what I saw that he was capable of and Iraq that I tried to keep him in a cage. So of course, when he got out, he was going to be angry and hurt people. So, it would be so much better if we can work together. And so he, in that first MDMA session, he, you know, spontaneously brought all this Self-energy to have compassion and understanding, clarity to his part. So, and that was all. You know, IFS training helped me understand what was happening, but it wasn't necessary at that moment, because he just did the whole thing and described it to him himself. Other times it's more challenging where people get stuck and it can be really helpful to help them sort out what's going on with their parts.

Aníbal:Michael, these studies are manualized since the beginning, right?

Michael:Yeah. The first study we had an appendix to the protocol that I had written. And then we developed the manual. We develop that into the full manual based on the first study and looking at recordings and figuring out what we thought we were doing and what we thought we wanted to be doing.

Aníbal:It looks such a great manual. So detailed and considerate of so many complexities. So, congratulations.

Michael:Thank you.

Aníbal:And it really walks us through a real MDMA process and sessions. And in this manual, you recommend for trainings to be familiar with the holotropic breathwork with Internal Family Systems therapy, with a sensory motor psychotherapy training or background in Hakomi, and other mindfulness-based approaches. And then you say that strictly behavioral contributor approaches while applicable to some extent are likely to be limiting in the context of MDMA Assisted Psychotherapy. Why is that? Why those options?

Michael:Well, you know, we think that there are kind of two aspects to the way we think about our training, which is not to train therapists, but to train existing, not to train people to be therapists, obviously we're just training therapists about the way we approach using the MDMA. So, and they're kind of two aspects to that. One is what we can basically teach in a reasonable amount of time about the way we approach it. The other part is the therapist's own inner work and the ability to be present to have Self-energy themselves to work with their triggered parts if they come up in these very intense, long sessions. So, all of that is something that we can't teach in a, you know, several month therapy training, but they're very important for people to develop it and people do it in different ways. So, I think all of those kinds of trainings that you mentioned, holotropic breath, work on IFS and Somatic experiencing, those things fit very well with this approach in that they also involve, you know, people learning to be present with themselves. So, each person is going to have a different combination of experiences and inclinations. And then, also people are going to go on to do other research, it's already happening.

People are testing it in combination with other therapeutic methods. And we'll see, you know, this is not the only approach obviously. And I think it would be great to do a study with, you know, more specifically with IFS and MDMA. Hopefully that will happen. I think it probably will. So, I think, for one thing, if we get approval, it's going to be much easier to research all these other questions and, you know, be creative about how we make this available to different people in different contexts and with different needs. And I think it's, there's a lot to be learned for sure.

Aníbal:Exciting, yes.

Tisha:Beyond getting approval, what challenges do you perceive in bringing this therapeutic catalyst and bringing in this type of work into mainstream culture?

Michael:Our main challenge is now that...Along with kind of shepherding the phase-three trials and getting that done, we've already, for the last few years, we've been focusing on a few important challenges. One is diversity, cultural and ethnic diversity has been a real, has been limited in the psychedelic world or research in general. So when, and we've had trouble recruiting a very diverse population, so we're doing a little better with that. And we're making a big push to train a more diverse group of therapists to help get this treatment to a more diverse group of patients. So that's a big, there's a lot going on with that. And along with that is who's going to pay for this. You know, the drug is not going to be a big part of the expense because it's a, it's a public benefit corporation is not going to be trying to charge the maximum anyway, but it's also, most of the expense is therapy. So, I think it's a very cost-effective treatment, but it's more expensive upfront because the therapy is kind of concentrated. So how do we get insurance companies to pay for that and make it available to people, there's a big effort going on along those lines. And then the third, maybe major challenge in addition to getting the drug approved is how do we train enough therapist to meet the demand? Because, you know, we think if we get approval, the demand is going to be great.

Aníbal:Huge, yeah.

Michael:I mean, we know how many people have applied to our studies that we don't have room for. So part of our challenge is how do we efficiently train a lot more therapists to use this and do it in a way that doesn't compromise quality, but it also maximizes speed in getting access to the therapy. So, that's going to be a big challenge going forward.

Aníbal:For sure. Michael, how difficult is it for a therapist, the task of being seated and assist a MDMA session?

Michael:Well, I think it...That's a really good question. I think it takes a certain type of person, sitting in eight-hour sessions is not for everybody. And I think it takes a certain amount of Self-energy to, you know, stay as present as possible during that time. At the same time, so it can be, it can be challenging and it can be emotionally challenging and it can be tiring, but it's also can be very invigorating and emotionally, you know, nourishing because you find you're able to help people that hadn't been helped before. Kind of the way you find with IFS often, you know, when you're able to have some tools that, that make a difference, then it makes it a much easier experience for the therapist as well. And also, you know, the two, two therapist model, which probably won't always be the case in every setting going forward, but it's still a really good model in terms of safety, but also, you know, in an eight hour session, it's really nice if you have a co-therapist that you trust and help hold the energy. So I think it's a wonderful process that in some ways it's more challenging than other kinds of therapies, but in other ways, this is a lot more fun and easier because it works.

Aníbal:And also, you use music as an agent to therapy. So, another tough and challenging task to use music in an effectively and fitting way. Right? So, it's another challenge.

Michael:Yeah. And, you know, in our case of art co-therapy team, Annie is really good at the music and she's very immersed in the music. So, and that makes it nice for therapists too in a long day, if there's music, we play the music in the room, we'll add them headphones. So, it's a very meditative experience in a lot of ways, sort of like meditation, you know, I noticed my mind wondering and then try to gently bring it back and just be present. We don't check email. We don't read, we take some notes for a research, but we try to manually be kind of just being present just there with people. So, it's a challenging, but that can be a really rich experience. Meditative kind of experience for the therapist, noticing my parts that want to take me away to this place.

Aníbal:Michael, coming back to the studies, I was impressed with the long list of publications and research papers, MAPS display in its web page since maybe 2010, I guess. So, for the last decade, when and where you play such an important role, what's coming up now? What's the most important step now?

Michael:One thing I want to mention is all the people that are working more behind the scenes to make this possible. You know, you're mentioning all the papers and stuff. We've got an amazing group of what I call young people now, because I'm in my seventies, the amazing group of just very bright, talented, highly trained and educated people working at MAPS and that, so a benefit corporation and it's growing, one of the challenges as it growths, MAPS, you know, in the beginning, there were just a few of us, now they're between MAPS and not public benefit corporation I think it's more than a hundred and they're hiring people fast because it's a huge thing to run these different trials in different countries.

Tisha:Where would you like to see this work go? Or where would you like to see it evolve over time?

Michael:I'd like to see the series of Psychedelic treatment training and research in every village and town in the world. [laughs] Again, we don't want to get ahead of ourselves, It's not a proven therapy yet. You got to make that clear until we finish phase-three, we don't know. And I think, you know, it'll remain to be seen if it's approved, how well it's accepted. We think the demand will be great. And I expect, obviously, we think we're correct in that, but not, it's not for everyone. Some people would rather just take a daily medicine to decrease their symptoms. This is a different model. You know, people have to be one thing that we prepare people for is, you know, this is about working with the underlying cause of the symptoms, which can involve sometimes having more symptoms, more prominent symptoms first. It can be an intense and challenging process. It's not about suppressing your symptoms, so, and people have to be prepared and choose that that's something they want. So not everybody's going to want it, but I think a lot of people are, and I think it's going to call for kind of a different model.

You know, the sessions are longer, but they're also possibilities for group therapy. And some people might be able to have somewhat shorter sessions if they have a good situation to go home to. So, I think, and the opportunity for young therapists to get experience if these are training centers as well, and also to do research about these new indications. So part of, you know, one of the exciting things, I think that MAPS and MAPS public benefit corporation are doing is not only this treatment model, but the drug development model. They're a drug development company. They're a pharma company, but they're doing it in a nonprofit, you know, in a public benefit way. And I don't think there's a precedent for that in the actual public benefit pharma company and, you know, public benefit corporations there have scorecards for different kinds of public benefit corporations, but there isn't a scorecard for pharma public benefit corporation. These are my understanding is there hasn't ever been one. So, they're all not only developing MDMA, but showing a model for drug development it's different.

Aníbal:It's amazing.

Michael:That I think it doesn't mean for-profit drug development will go away or should go away necessarily, but there's a place for that. But also, if there are companies working on a public benefit model, it puts downward pressure on prices for one thing, but also, you know, no one else would have studied MDMA, wasn't a good idea for profit because you can't patent it. And MAPS actually had an anti-patent strategy to prevent us, them, anyone from getting any use patents. So, you know, MAPS, could've theoretically tried to get a use patent for different indications, but then wanted it to stay in the non-profit world.

And so, they hired a patent attorney to help them prevent themselves from or anybody else from getting any use patents by putting everything out in the public domain. So, it's a very exciting model for developing drugs that otherwise wouldn't be developed and for doing it in a way that maximizes public benefit instead of profit. So, I think that's a whole exciting aspect of this that I really enjoy that part of it too. It feels...

Tisha:It's groundbreaking. You can really get behind, it feels good.

Michael:Yeah. People know when we're talking about our study results, no one's going to make any money selling MDMA except for MAPS. It's the only, the only shareholder in the public benefit corporation is the non-profit. So, it feels very clean to be able to, we report our results based on what it's doing for patients.

Aníbal:Michael, can we say we do have now a psychedelic science and a psychedelic medicine?

Michael:Yeah, I think we do, you know, there's not only all this research going on, especially with psilocybin and MDMA, but also with other psychedelics. And now, you know, universities are...Psychedelic centers are cropping up at major universities all over the country now. And when I speak at, you know, mainstream conferences, like the American Psychiatric Association or the American Psychological Association, there are always lots of residents and, you know, psychiatry residents and psychology graduate students and medical students coming up saying, you know, this is what I want to do with my career. There are going to be tracks and graduate programs that people can choose. Psychedelic medicine is already beginning to happen. So, I think, yeah, and you know, another challenge will be to, you know, work for an organization to support, you know, training and certification of psychedelic therapist. You know, MAPS doesn't want to be the gatekeeper. Yeah. MAPS wants to use its own MDMA responsibly and make sure people are trained. But ultimately, I think there need, hopefully there'll be, you know, a subspecialty in psychedelic medicine.

And I also, the other thing I hope for is ultimately that this will pave the way for other kinds of views that it's not just medicalized or that, you know, I think, hopefully we'll get to a model where people can responsibly access these medicines for personal growth and development and spiritual practice or whatever their responsible way of wanting to use these kinds of medicines would be. I hope eventually it'll that'll happen too. I think it's really important that we have him in for treating people that are suffering and dying so much. But ultimately, I think it, hopefully, attitudes will open up about the value of these medicines if they're used wisely. And that's a big IF, you know, it depends so much on the way they're used with the intention and what the certain setting is.

Aníbal:Michael such a well succeeded journey, yours, congratulations.

Michael:Thank you.

Aníbal:A long one and well succeeded. And so, thank you so much for having us. It was a joy to be here with you and Tisha, and we hope we can keep meeting and sharing this model, our work and our lives.

Michael:Thank you, really enjoyed talking to you.

Tisha:Yeah. Thank you for the time. We really appreciate your wisdom and all of the work that you're doing.

Michael:Thanks for your interest in them.

Recorded 3rd December 2020
Transcript Edition: Carolina Abreu