- Dr. Mithoefer’s Background with MDMA-Assisted Psychotherapy
- How PTSD Differs from Anxiety and Depression
- What MDMA Does for People with PTSD
- The Treatment Protocol for MDMA-Assisted Psychotherapy
- FDA Approval and Dr. Mithoefer’s Clinical Trials
- The Stigma around MDMA
- When This PTSD Treatment May Be Available to the Public
In this episode, we discuss:
- Mithoefer’s background with MDMA-assisted psychotherapy
- How PTSD differs from anxiety and depression
- What MDMA does for people with PTSD
- The treatment protocol for MDMA-assisted psychotherapy
- FDA approval and Dr. Mithoefer’s clinical trials
- The stigma around MDMA
- When this PTSD treatment may be available to the public
- RHR: How to “Hardwire Happiness,” with Dr. Rick Hanson, by Chris Kresser
- “MDMA-Assisted Psychotherapy for Treatment of PTSD: Study Design and Rationale for Phase 3 Trials Based on Pooled Analysis of Six Phase 2 Randomized Controlled Trials,” published in Psychopharmacology
- Participate in MDMA studies sponsored by MAPS
Hey, everybody, Chris Kresser here. Welcome to another episode of Revolution Health Radio. This week I’m really excited to welcome Dr. Michael Mithoefer as a guest on my podcast. We’re going to be talking about MDMA-assisted psychotherapy. You may know of MDMA as ecstasy. That’s its popular name. And you may have heard in the news recently that MDMA is being explored as a therapeutic tool for treating PTSD and other conditions.
I’ve been reading a lot about this myself and I’m really interested in it because there aren’t many good treatments for PTSD and many psychiatric conditions. And the treatments that do exist often have intolerable side effects or can even be worse than the disease or the condition itself.
So Dr. Mithoefer is a psychiatrist living in Asheville, North Carolina, and he was the co-investigator on two of the MAPS-sponsored phase 2 clinical trials for individuals with PTSD and a pilot study treating couples combining MDMA-assisted psychotherapy with cognitive behavioral therapy for PTSD.
He is the lead author of the MAPS manual for MDMA-assisted psychotherapy in the treatment of post-traumatic stress disorder. He’s a co-investigator in MT1, which is a protocol allowing MAPS-trained therapists to receive their own MDMA-assisted session, and he conducts MAPS therapist trainings with his wife Annie and is a supervisor for phase 3 therapists. He’s a clinical assistant professor in the Department of Psychiatry and Behavioral Sciences at the Medical University of South Carolina and has been board certified in internal medicine, emergency medicine, and psychiatry and is a fellow of the American Psychiatric Association. I’m really looking forward to this conversation. I hope you enjoy it, and let’s dive in.
Chris Kresser: Dr. Michael Mithoefer, welcome to the show. It’s a pleasure to have you on.
Dr. Michael Mithoefer: Thank you, Chris.
Dr. Mithoefer’s Background with MDMA-Assisted Psychotherapy
Chris Kresser: So I always like to start with background. Like how did you get interested in MDMA-assisted psychotherapy as a treatment for PTSD? Certainly we’ve been hearing a lot more about this in the news recently, but you’ve been involved with this for quite a while. So I’m curious to know how you came to it.
Dr. Michael Mithoefer: Well, it really came out of clinical need. I didn’t set out to be a researcher originally. I was in clinical practice and very interested in PTSD and treating a lot of people. And I was interested from the beginning of my psychiatry career. I actually practiced emergency medicine for 10 years and then in 1991, I went back and did psychiatry training. And I was very interested in the work of Stanislav Grof, who was one of the early LSD researchers and ended up studying with him in non-drug methods of shifting consciousness using breath work.
So I was very interested from the beginning of my psychiatry career and the potential of having ways to help people shift consciousness, kind of get out of their stuck mindset that tended to go along with lots of problems. But I assumed that that had to be done with non-drug methods. I was aware of earlier research with psychedelics and also some of the case reports about MDMA back when it was legal. And I’d had my own experiences with MDMA when it was legal in the therapeutic setting. So I had reason to think that these compounds could be useful, but I thought we wouldn’t, it was not possible to use them. So for 10 years or so, my wife and I had a practice and I practiced, I used some mainstream pharmaceutical psychiatric medicines. But I was much more interested in psychotherapy and the potential for having ways to enhance psychotherapy, basically.
But after 10 years of that, with lots of encouraging results with breath work and other non-drug methods, there were still a lot of people who weren’t adequately treated with what we had. So I really, and around the late 90s, I just decided we really needed to do something to investigate the very encouraging reports from earlier of the potential, in particular, of MDMA, which had been used therapeutically for a number of years between the late 70s and 1985, when it became illegal. Some therapists were using it, and a number had published case reports, but no controlled research had been done. So that’s why I decided we needed to do some formal, very rigorous research with MDMA.
Chris Kresser: And did you find, when you were doing the pharmaceutical medications for PTSD, that they were effective? Or were they lacking?
Dr. Michael Mithoefer: They were definitely lacking. Sometimes they were helpful. Most of the of the existing psychiatric medicines are aimed at decreasing symptoms, rather than actually getting at the underlying cause of PTSD. And they sometimes were helpful, but they clearly were, for a lot of people, they weren’t helpful and they were not curative or a definitive treatment. And they have, of course, side effects and some downsides too. So I wasn’t against them in some global way, but I was very disappointed in how effective they were, and it was very clear we needed something better.
How PTSD Differs from Anxiety and Depression
Chris Kresser: So let’s talk a little bit more about PTSD. I mean, certainly the listeners are familiar with it, at least at a surface level. But how does it differ from other mental health disorders like anxiety and depression? And why is a new approach to treating it so important?
Dr. Michael Mithoefer: Well, that’s a big question about how is it different from other disorders. I think there are actually lots of problems with our diagnostic system. But the particular thing about MDMA is, I mean about PTSD, post-traumatic stress disorder, is it’s a cluster of symptoms that happens after traumatic events. And it is striking that, regardless of the kind of trauma—war trauma, physical assault, sexual abuse, childhood abuse—many of the kinds of symptoms people have are basically the same kinds of symptoms regardless of the cause. So it’s really about a response to trauma that starts as a response that pretty much anybody would have with symptoms right after trauma.
But then for a lot of people, those symptoms don’t resolve and they end up with this chronic condition in which they tend to have intrusive memories or nightmares or even flashbacks. And they tend to have trouble sleeping and a lot of anxiety and hyperarousal symptoms. They tend to avoid situations that remind them of the trauma and also avoid, kind of inner avoidance. They can be very cut off from their emotions, and they tend to have kind of a negatively skewed mindset and emotional difficulties as well.
So it’s a really debilitating and even life-threatening problem with a lot of associated medical problems, but also risk for suicide.
PTSD is notoriously difficult to treat, but one unconventional method is showing promising results. Check out this episode of RHR to learn how MDMA, used with psychotherapy, can treat the root cause of PTSD. #functionalmedicine #wellness #chriskresser
What MDMA Does for People with PTSD
Chris Kresser: So you mentioned that the pharmaceutical treatments can be helpful in addressing the symptoms. But they’re not really shifting the root cause of the problem and of course they have a lot of side effects, many of which can be quite severe. So how does MDMA differ as a modality, as a therapeutic modality? And maybe you can just start by explaining what MDMA is, for the listeners who are not aware, and how it affects the brain and what the potential is for this treatment, especially versus some of the pharmaceutical options that are out there now.
Dr. Michael Mithoefer: Sure. Well, MDMA is a molecule looks a little bit like methamphetamines. So it has some amphetamine qualities, and it looks a little bit like mescaline, from the psychedelic from the peyote cactus. So it has some features as a stimulant, but it also causes a very interesting psychological experience that can be extremely variable, and it depends a lot on the mindset of the person going into it and the setting in which they’re taking it. Whether it’s geared toward inner exploration and whether there’s support there to help somebody work with what comes up makes a big difference.
MDMA tends to, some of the time at least, give people pleasurable feelings and feel a sense of closeness to others and more compassion for others and for themselves and kind of, often a lot of insight about their inner experience. But it also can be very challenging. We’ve had a number of people in the study say, “I don’t know why they call this ecstasy,” referring to the fact that processing trauma is painful, with or without MDMA.
Chris Kresser: Right.
Dr. Michael Mithoefer: But with MDMA, for many people who hadn’t been able to successfully revisit and process a trauma in therapy, MDMA seems to make it possible for them to do it. People say, “This is still difficult, but now I have a real sense I can do it without being overwhelmed. I don’t have to run away from it.”
Chris Kresser: I imagine the caveat there is what you said, as long as they have adequate support. And that might be a lot more difficult to do if someone was doing it on their own.
Dr. Michael Mithoefer: Right. Absolutely. I mean we do hear from some people who have taken MDMA in less controlled settings, who have had benefit from it. But also, I’ve had patients outside the studies who, with PTSD, who took some ecstasy to party or something and then suddenly their traumatic symptoms started to come up, and it was a very, very problematic situation. Because they weren’t expecting it. They didn’t have support to work with what came up.
Chris Kresser: And what are some of the unique traits of PTSD that tend to respond well to MDMA? In other words, what’s the interaction that’s happening in the brain between MDMA and the effects that it causes and the characteristics of PTSD?
Dr. Michael Mithoefer: Yeah, that’s very interesting. Well, for one thing, what’s become clear in recent years is that the definitive treatment at this point for PTSD is psychotherapy, not psychopharmacology. And that wasn’t really acknowledged or realized for a while. But about several years ago, for instance, the VA put out a statement saying psychotherapy as the first-line treatment for PTSD. So one big difference with MDMA is we’re not using it as a daily pharmaceutical treatment. We’re using it only several times, usually three times in most of the studies at monthly intervals to help catalyze the psychotherapy.
So the whole model of the way we’re using MDMA is quite different from most psychopharmacology. We’re using MDMA as a catalyst for the therapy, and it’s a therapeutic experience that seems to get at the root cause of the trauma. Having said that, of course, MDMA has lots of pharmacological effects and we don’t fully know how much is kind of direct pharmacological effect and how much is catalyzing the therapy. But clearly a lot of it is the way it catalyzes people’s therapeutic experience and allows them to revisit the trauma with greater recall and a sense that they don’t have to avoid the trauma anymore. That they can really face it head on and talk about it and express feelings. So we know that people with PTSD kind of tend to have two extremes in terms of emotions. They can be sometimes overwhelmed by anxiety and intrusive memories come up or something triggers their memory of the experience. And that can be very overwhelming for them including trying to process the trauma in therapy.
Conversely, they can also have emotional numbing. So it’s difficult really connecting with and processing the feelings that go with the trauma. So there’s an idea that’s been described in other kinds of therapy called the optimal arousal zone, or the window of tolerance. Meaning that it seems that if people can talk about and process a trauma in therapy without either being overaroused or overwhelmed by the feelings or without being emotionally cut off, that’s when the therapy is effective. But often people can’t do that. So the MDMA seems to give people a period of time in that kind of optimal arousal zone where they’re not emotionally numb, they’re not sedated. Their memory is not interfered with by anti-anxiety drugs. But they’re also in that state where they feel they can kind of maintain their balance and really face the trauma without being overwhelmed.
And so we know that for instance, in terms of the biological effect, we know the people with PTSD have increased activity in the amygdala, the fear center of the brain, and they have decreased activity in the prefrontal cortex, the higher processing center. And those are people with PTSD. We know that MDMA causes decreased activity in the fear center, the amygdala, and increased activity in the prefrontal cortex and the higher processing centers. So it’s a lot more complicated than that. But that’s a part of it.
And that makes a lot of sense in terms of what we see in the studies clinically, that it makes sense that if the fear centers decrease and people are able to think about things more clearly, that could be a really helpful thing for processing trauma. And that’s what we’re seeing. And there are other interesting changes, too, about the way the neural networks interact with each other and give people a chance to kind of have a new experience rather than being stuck in the same old pattern of response. It’s so problematic.
Chris Kresser: Right. I’ve read a fair amount about neuroplasticity-based approaches to mental health disorders and integration of neuroplasticity-based methods into psychotherapy. I had Dr. Rick Hanson, a neuropsychologist, on the podcast recently, and we were talking about this. Do you think MDMA has ongoing or permanent or semipermanent neoplastic effects where as a result of doing this therapy, there are actually neuroplastic changes in the brain that are sustained even after the therapy has stopped?
Dr. Michael Mithoefer: I think probably so. There’s evidence for that for MDMA and other psychedelics increasing neuroplasticity. And what we see is, one of the striking things about what we’re seeing so far in our clinical trials is the results are better at one year than they were two months after the last time people take MDMA. Most of them still have, that’s when we measure the improvement. But then we measure it again at one year or more. And on average, people have fewer PTSD symptoms a year later than, even than they did two months later. So the effect is not only sustained, but it has a tendency, at least again, based on our data so far, it has a tendency to increase. The improvement gets even greater over time.
So it’s very clear that there’s some kind of process going on that is sustained well after the MDMA’s out of people’s system. It’s out of the system within a couple days, and people are still improving a year or more later. We’ve measured actually results up to an average of three and a half years later.
Chris Kresser: Wow.
Dr. Michael Mithoefer: And the results are sustained at that point for most people. Not for everybody. Like anything else, this doesn’t always work. But in a high percentage of people, the results are sustained. So something’s going on where the process is catalyzed or the obstacles to continued growth and healing are somehow mitigated or removed, and the people continue to grow and heal quite often.
Chris Kresser: That’s remarkable, and that alone distinguishes it from many other of the therapies for these kinds of disorders, which as you mentioned, only really deal with the symptoms and don’t cause these permanent changes.
Dr. Michael Mithoefer: Yeah, and it’s nice in terms of side effects too. Like any other drug, MDMA has side effects. And in the wrong situation and the wrong person, it can be very problematic or even deadly, although overall it has a good safety profile under the right circumstances. But it does have side effects. But if you’re only taking a drug three times a month apart, it tends to be very helpful with mitigating the side effects compared to drugs that you have to take every day.
The Treatment Protocol for MDMA-Assisted Psychotherapy
Chris Kresser: Right, right. So you mentioned just now, they take it three times a month apart. Is that the full course, or does it depend on the patient and the extent of their condition, their symptoms? Can you tell us just a little more about what treatment actually looks like for patients?
Dr. Michael Mithoefer: Sure. Yeah, well one of the important features is it’s always in conjunction with psychotherapy. So we have careful preparation after we’ve done the informed consent for the studies, then people have medical and psychological screening. We do lab tests, EKG, and rule out serious underlying conditions that might make MDMA more dangerous. Because MDMA does increase blood pressure and pulse. So if somebody had significant heart disease or other vascular disease, that could be a problem. So people are screened and then we have three 90-minute preparatory sessions with two therapists. This model uses two co-therapists. So there’s a lot of attention to preparing people for the experience.
And then during the MDMA sessions, people are, they’re day-long sessions, at least eight hours with two therapists. And the people take the MDMA, they usually come in around 9:30 in the morning, take the MDMA at 10, and then the therapists are with them all day for eight hours. And during that period, there are alternating periods of sometimes people are focusing inward, encouraged to just pay attention to their inner experience without talking, often with eye shades and headphones listening to music some of the time, if they’re comfortable with that. And then those alternate with periods of talking to the therapists.
So it’s very much an MDMA-assisted psychotherapy session. And then there’s close follow-up. In many of the studies, people spend the night in the clinic with a night attendant, and some studies they’re able to go home if they have a supported situation. But in any case, they meet with the therapist again the next morning and then meet several more times over the next few weeks before the next MDMA session. So those are called integration sessions. So the idea is, people have a profound experience, but it may be challenging to kind of integrate it into their life or make sense of other … continue to work with the material that’s come up in the MDMA session. So we think all those elements are very important.
Chris Kresser: Yeah.
Dr. Michael Mithoefer: The preparation and the follow-up sessions.
Chris Kresser: I would imagine that’s true, just having all those different layers of support seems really critical. It’s fairly intensive. So have you done any preliminary studies or even just thought about the scalability of this and how this would compare to the cost, for example, of treating a patient with PTSD? And the example I use in Functional Medicine, I don’t know if it applies here, is it costs about $15,000 a year to treat a patient with type 2 diabetes. And that patient could have that condition for 40 years, so that’s $600,000. Even if we spent $10,000 upfront to prevent type 2 diabetes from happening at the prediabetes stage, we could save $590,000 over the course of that lifetime.
So that the treatment is more expensive upfront but could actually save the healthcare system money long term. Is there a similar phenomenon here, do you think?
Dr. Michael Mithoefer: Yes, yes, I think it’s a very similar phenomenon. And we’ve given a lot of thought to this, we continue to give a lot of thought to this. But it’s true that PTSD tends to go on for many years, and not only is the treatment for the PTSD itself very expensive, especially in terms of human suffering, but even if you’re just looking at the finances. And there’s a high degree of medical comorbidity with PTSD. There are lots of studies showing more medical utilization, higher degree of, higher levels of cardiovascular disease and metabolic syndrome and lots of problems that go with it.
So it is more expensive upfront with this intensive therapy. But we’re, in our phase 3 trials, we’ve added some measures to try to get some more direct evidence about how it might save money and medical utilization. But I think, I’m sure, but again, this needs to be improved, but just from clinical experience, I’m sure that for many people this could be a very cost-effective treatment. But we do need to have good evidence to make that argument because it costs more in the short run, then, I think, probably much less in the long run.
Chris Kresser: Right. This is a paradigm shift we need to make across the board with our medical model.
Dr. Michael Mithoefer: I think we do. I think so, yeah.
Chris Kresser: Emphasizing prevention and early intervention rather than waiting until we’ve passed the point of no return and then using heroic interventions at the later stage of these conditions which are extremely expensive and often not very effective.
Dr. Michael Mithoefer: Yeah, yeah. So in terms of human suffering and economics, it makes a lot of sense to investigate these other approaches.
FDA Approval and Dr. Mithoefer’s Clinical Trials
Chris Kresser: Absolutely. So regarding that investigation, I know you’re engaged in phase 2 clinical trials and upcoming phase 3 trials. So before we dive into that, I want to hear a little bit more about the trials. But I’m just curious what the response has been from the FDA and the powers that be. From what I understand, it’s been actually quite favorable, which may surprise some people.
Dr. Michael Mithoefer: Yeah. We submitted our first phase 2 protocol to the FDA in October 2001, and we got approval 30 days later.
Chris Kresser: Wow.
Dr. Michael Mithoefer: And it was a rigorous process, it was a 500-page application. We had some negotiation on a conference call about some of the details. But we spent a year developing a very rigorous protocol and had a lot of evidence to back up our thinking. All the review of the literature on MDMA. We then originally had about a two-and-a-half-year delay before we could get DEA approval. And we also had some delays with IRB approval, that’s the Institutional Review Board or Ethics Committee.
So it was a problem with the regulatory approvals, just with the DEA originally. But once we got past that original roadblock for the first phase 2 study that we did, my wife and I had been in Charleston, since then we haven’t had those kinds of delays with DEA. And we’ve had actually a meeting at the DEA headquarters about how to streamline the process a little better to make it a little more efficient with our phase 3 trials.
So it was a big challenge in the beginning with those delays. We had one delay with the IRB because of a paper from Johns Hopkins by George Ricaurte and colleagues that incorrectly claimed that MDMA caused toxicity to dopamine neurons. And that slowed us down by about a year. That was published in Science. We wrote a response saying that didn’t really make sense. And we thought there was something wrong. But it wasn’t until a year later when that paper was retracted because it turned out the bottles had been mislabeled. So they’d given methamphetamine to these primates instead of MDMA. And methamphetamine is a prescription medicine that is known to cause dopamine toxicity. So that error cost us some time too.
But since then, we got our first study, we got all the approvals in March of 2004, and since then it’s a time-consuming and somewhat slow process doing research with a Schedule 1 drug in any case. But it’s possible to do. And we have not had any undue delays in the other, we’ve now done six phase 2 trials, and we’re actually in phase 3 trials right now. The phase 2 trials are completed. But it’s, the regulations haven’t been a problem except for taking a lot of extra time and work.
Chris Kresser: Right.
Dr. Michael Mithoefer: But we haven’t had any undue delays since then.
Chris Kresser: That’s fantastic. I mean, of course getting approval for any medication or treatment takes time, but it’s really great to hear that you haven’t been held up by any unnecessary or unjustified delays due to a stigma around MDMA.
Dr. Michael Mithoefer: Not lately.
Chris Kresser: Yeah, not lately.
Dr. Michael Mithoefer: Not in recent years.
The Stigma around MDMA
Chris Kresser: Right, yeah. So what about that? There is of course, a mainstream stigma, not just in the medical community, but also in the public around MDMA and ecstasy. Because it’s used as a recreational drug. And oftentimes when people are taking ecstasy recreationally it’s combined with other drugs that they may not know about, which may have affected their experience with it and influenced their perception of this as a valid psychotherapeutic therapy. So how do we overcome that?
Dr. Michael Mithoefer: Well, with data, I think, is the answer. Because in the beginning there was, we got a lot of criticism and a lot of resistance from, universities didn’t really want to be associated with this, and a lot of people didn’t want to be associated with this. A lot of people thought we’d never get anywhere with it. But that has really changed. Once we began, we’ve now published six results. But we’ve published six papers now about the phase 2 trials. There were six phase 2 studies, and we published papers based on four of those, and then an additional long-term follow-up paper. And also now just in May of this year, we published in Psychopharmacology, we published the pool data from the six phase 2 trials. So that’s, from the time we started to publish our first papers, the attitudes began to change. Because people could see that they’re very rigorously designed trials and we’re getting very promising results.
So now we have sites at three universities right now, we have phase 3 sites at the University of San Francisco, University of California, San Francisco (UCSF), University of Washington and NYU. And we’ve had recently inquiries from two other major universities that would like to get involved in the research. So the attitudes are changed dramatically in the academic and scientific community in recent years.
Chris Kresser: That’s encouraging. Are they still recruiting for these trials or are they full?
Dr. Michael Mithoefer: No, we’re still very much recruiting. We had, when we finished the six phase 2 trials, we had our end of phase 2 meeting with the FDA a couple summers ago, and we not only got permission to move into phase 3, we got what’s called breakthrough therapy designation from the FDA, meaning our phase 2 results are encouraging enough to warrant expediting the process through the FDA. We still have to do the phase 3 trials. We realize that we’re not over the finish line yet, and whether it can be approved as a drug is going to depend on the results of phase 3. But our phase 2 results were very promising.
So now we are actively recruiting in them 12 sites in the US, two in Canada and two in Israel. And so the phase 3 trials are well underway and there are going to be two phase 2 trials in sequence. So we’ll be recruiting at these sites for at least the next year.
Chris Kresser: And where can people learn more about that if they would like, if they happen to be near one of those sites and they would like to be involved?
Dr. Michael Mithoefer: There are two ways. They can go to MAPS.org, m-a-p-s dot o-r-g, and they can go to the research participation tabs and find the list with the contact. They also can go to clinicaltrials.gov, which is a government site where all human trials are registered, and they can find a list of the places there. Because we do have sites scattered around the country:
- New York
- New Orleans
- San Francisco
- Los Angeles, and then
- Vancouver, and
- Montréal, and also
- Madison, Wisconsin.
Chris Kresser: That’s great. I know a lot of listeners will be interested in this. So if you want to get involved, check out those websites and see if you meet the criteria and are able to participate. And I know this is always a hard question to answer. We’ve often had researchers and scientists involved with new therapies and the approval process, but do you have any sense of when this might become available given that it has been designated as a breakthrough therapy and your getting closer to the phase 3 trial?
When This PTSD Treatment May Be Available to the Public
Dr. Michael Mithoefer: Yeah, we have a sense, although the disclaimer is that we’re good at doing clinical trials, but we’re not very good at making predictions about how long things are going to take.
Chris Kresser: Yeah, I understand.
Dr. Michael Mithoefer: So our track record on the predictions is not good, but we think again, it all depends on phase 3, and we’re not making any assumptions. But we’re hopeful. And if the phase 3 trials go well, I think it’s possible that we could be applying for a new drug application from FDA based on the results in possibly late 2020 or early 2021. And then it takes a while for FDA to make a decision. But it’s possible that it could become a medicine in 2021. But there’s a lot to do between now and then.
Chris Kresser: And again, how would that work? Would a drug company develop a patented version of it? It’s a well-known molecule that is not patented, I imagine, now. So how would that work?
Dr. Michael Mithoefer: Well that’s another interesting thing that I really like about this research is it’s nonprofit. So MDMA was originally patented by Merck Pharmaceutical in 1914.
Chris Kresser: Oh, wow, I didn’t know that.
Dr. Michael Mithoefer: It’s been off patent for along time. So it can’t be patented. And beyond that, there is such a thing called use patents. So theoretically, somebody, we could’ve applied for a use patent to use it for MDMA or some other conditions. But because it’s a nonprofit effort, Rick Doblin, who is the president and founder of MAPS, actually hired a patent attorney some years ago to develop an anti-patent strategy to prevent MAPS or us or anybody else from getting use patents on it. So MAPS is really committed to keeping it in a nonprofit realm. So, and of course, the other problem for pharmaceutical companies is if you only need a medicine three times, it’s hard to make a lot of money on it.
So what is going to happen if it’s approved, MAPS will be the only person making it for a while, or having it made. MAPS has already contracted with a pharmaceutical manufacturing company in England, then an encapsulation company in the US. So the MDMA is being made by those companies and used in phase 3. Now, if it’s approved, it will be the same MDMA that can be then sold. So anyone else could go do their own research and get approval for making MDMA. But since it’s, but they’re not allowed, for five years no one else can use the MAPS data to market a generic.
So MAPS will be the only, well MAPS Public Benefit Corporation, which is a subsidiary of MAPS. It only has one shareholder and that’s the nonprofit. And because they’re a public benefit corporation, they will be allowed to sell MDMA and charge money for it, which MAPS as a nonprofit couldn’t do. But their goal is public benefit, not maximizing profit. So that’s how it’s going to work. And then after five years, anyone else could use the MAPS data to make another generic. But the medicine is not going to be that expensive. We’re not sure how much it’s going to cost. MAPS will make some profit on it, which it will roll back into research. I mean, MAPS Benefit Corporation will make some profit. It will be used for research, but the main cost is the therapy itself.
Chris Kresser: Right, right.
Dr. Michael Mithoefer: And we are looking at ways to, ideas about how to make it more cost-effective going forward as well with therapy itself.
Chris Kresser: Well, this is really exciting, Dr. Mithoefer. As someone who feels passionate about getting to the root cause of problems, rather than just suppressing symptoms with drugs and surgery, especially for these conditions which don’t have really great treatments available for them now, like PTSD, and which can cause so much suffering and can be so debilitating. It’s really exciting to see that this is happening and I just want to thank you for your pioneering work, you and Annie, and yeah, let us know how people can learn more and get involved and support this effort if they would like to.
Dr. Michael Mithoefer: Well, great, thanks. Yeah. If they go to MAPS.org, people can sign up for a free newsletter or email alerts and keep informed about what’s going on. And of course if they’d like to donate, that would be great too. One thing about this that’s so, I think so gratifying is it’s such a, this whole effort, we’ve had no government money, no industry money. It’s all supported by individual donations and some foundations. And so many people have worked hard to make this possible.
Chris Kresser: Yeah, that’s amazing and so refreshing in today’s environment.
Dr. Michael Mithoefer: I think so, yeah.
Chris Kresser: Yeah, we’ll just leave it at that.
Dr. Michael Mithoefer: Fair enough.
Chris Kresser: Yeah, well, thanks again, Dr. Mithoefer, for coming on the show.
Dr. Michael Mithoefer: Sure.
Chris Kresser: I know there’s been a lot of interest in our community on this topic and I’m really glad that you agreed to come talk to us about it. So good luck with the next phases of your trials, and perhaps we’ll have you back on when it’s approved to talk about some more case studies and effects that it’s having amongst the people who are using it.
Dr. Michael Mithoefer: Great, well, thanks very much. I enjoyed talking to you and appreciate your interest.
Chris Kresser: Great, take care.
Dr. Michael Mithoefer: Take care, bye.
Chris Kresser: Bye.