Understanding the Impact of the FDA Vote on MDMA Therapy with Rachel Nuwer
10 Apr 2026 · 36 min
In this episode of The Psychedelic Report, host Dr. Dave Raven, a neuroscientist and psychiatrist trained in ketamine‑ and MDMA‑assisted psychotherapy, interviews journalist Rachel Nuwer, author of I Feel Love and New York Times reporter on MDMA‑assisted therapy. The conversation centers on the June 4th FDA Pharmacologic Advisory Committee vote that expressed concerns about the safety and efficacy of MDMA‑assisted therapy for PTSD. Nuwer explains that the advisory vote is non‑binding, expresses disappointment and emotional shock, and clarifies that headlines suggesting the therapy is “off the table” are misleading. Both guests critique the committee’s focus on trial design issues—especially blinding challenges—arguing that such concerns are common to all psychiatric trials and that the committee seemed unfamiliar with the unique constraints of psychedelic research. They review MAPS’s Phase 2 (MAP1) and Phase 3 (MAP2) data, noting high response rates (≈88% acute response, 67% remission) and durable benefits one year after treatment, contrasting this with the relapse rates of standard SSRIs. The discussion highlights the therapy’s safety profile, the relatively low adverse‑event rate, and the fact that the FDA does not require a mechanistic explanation for approval. Nuwer points out that therapist misconduct is a broader medical‑board issue, not a drug‑specific risk, and that the advisory panel’s focus on such peripheral concerns detracts from patient‑centered considerations. They also touch on diversity gaps in trial enrollment and the need for better public and professional education. Both agree that, despite the advisory setback, the FDA’s final decision in August is likely to favor approval, given the strong efficacy data and the urgent unmet need among veterans and other trauma‑affected populations. The episode concludes with resources for listeners (NYT article, Nuwer’s book, related podcasts) and a reminder that the host is not a personal medical advisor.
Chapters
It's Toyota Truck Month. Time for a truck that works as hard as you. Tacoma. Tundra. Built for the job and ready for the trail. Available with 4-wheel drive and connected tech. All backed by legendary Toyota reliability. Visit your local Toyota dealer for great financing and lease options available to qualified customers. Or visit buyatoyota.com to find your Truck Month deal today. That's buyatoyota.com. Toyota, let's go places. TaxAct understands you haven't memorized the tax code. That's why TaxAct has live experts to help. TaxAct can even do it for you if you prefer. It's the easiest way to know you're doing it right. Well, other than going back to college and obtaining a bachelor's degree in accounting with a minor in finance, then interning somewhere and becoming fluent in all tax forms. But that might be hard to accomplish before tax day. So maybe just stick with Tax Act. Tax Acts. Let's get them over with. The Psychedelic Report.
Psychedelic drugs have played their part in America's long, strange trip toward an understanding of mind-altering drugs.
The Psychedelic News. Leading physicians, scientists, and experts share their wisdom about psychedelic medicines and healing. 50 years ago, psychedelic drugs were at the center of America's counterculture. The brightest minds in psychedelic medicine. The Psychedelic Report. We use the ketamine-assisted psychotherapy model that happens to have psychedelic effects that were not predicted when the drug was first developed. From researchers to investors— I think the biggest mistake we've made as a culture is the war on drugs. —to physicians, to shamans, and nonprofit pioneers. Psychedelic drugs.
Recent research suggests some of them could have legitimate uses.
The Psychedelic News brings you diverse perspectives from the front lines of this exciting movement. The Psychedelic Report. The Psychedelic Report was brought to you by Apollo Neuroscience and produced by Future Medicine Media. Welcome to The Psychedelic Report, your single source of truth for the psychedelic news. I'm your host, Dr. Dave Raven. I'm a neuroscientist and psychiatrist trained in ketamine-assisted psychotherapy as well as MDMA-assisted therapy. Welcome back to The Psychedelic Report. I am here with Rachel the journalist who broke the stories from the first results of the MDMA-assisted therapy trials in the New York Times from the FDA Phase 3, and the author of I Feel Love, a new wonderful book about MDMA and the quest for connection in a fractured world. And Rachel, I really appreciate you taking time to join us in light of the recent votes from the US FDA Pharmacologic Advisory Committee that voted on June 4th about the safety ineffectiveness of MDMA with their opinions following the initial review of some of these trial results, which I think was surprising to many of us who have been following, you know, what you've been writing about and now many, many others. And so I was wondering, could you start out by just sharing initial thoughts on this vote and how you think that is being taken by the community?
Yeah, well, thank you so much for having me and just giving me this opportunity to hopefully clear up some misconceptions among listeners, which, you know, I, I don't blame people out there for being very confused about what, what's happening, for misinterpreting what's happening. Some of the headlines we've been seeing have basically been implying that MDMA-assisted therapy for PTSD is completely off the table moving forward, which is not the case. Fortunately, the big vote that FDA will take to actually make that decision happens in August. Whether or not that's a positive or a negative decision, we'll see. I think this latest advisory vote is, well, first of all, it's just that. It's advice that the FDA can take or not take. But it makes things harder. It's a setback for moving forward with this therapy. But all is not lost at this point, let's say. So I wasn't planning on reporting on this advisory committee meeting. I didn't have a great feeling moving forward with it because a couple months ago, there was a nonprofit industry group report that came out that had some negative things to say say about MDMA-assisted therapy. And it just felt like things were pretty off moving into this advisory committee meeting. So while I wasn't really surprised in the outcome, I was extremely disappointed. You know, just the reality of actually hearing that news and knowing that that was the news. Like, Dave, I think you texted me right after it happened, and you were one of the first people who reached out. And honestly, I was just kind of in a state of shock. I had to, like, literally take a few laps around the block just to kind of calm down and center and gather my thoughts. But same. Yeah, thank you. I did appreciate you reaching out. I was like, I'm not alone in this. But yeah, I was actually surprised by how sort of emotional my reaction is because as a journalist, I try to be, you know, as objective as possible, you know, follow science as well as I can, you know, get at truth, whatever that means, or as best we can approximate it. But honestly, I felt like the vote, you know, rejecting MDMA-assisted therapy's efficacy and also saying that the risks outweigh the potential benefits were just so far off the mark from what we've seen in the scientific trials, from what we know of more than 40 years of using this, this treatment, this molecule combined with therapy to help people get through PTSD and also other things that we have evidence about, whether it's couples therapy or people with autism getting over social anxiety, you know, the list goes on. But, you know, it just kind of flew in the face of everything we knew. And I have a list of notes that I can go through that I've kind of sat down and put my thoughts together for because it was a long meeting. It was like 8 hours or something. So there's a lot to digest.
Yeah, you're absolutely right. And I think it would be great to go through that list and to hear your thoughts on that. Sure. This was a very surprising result from this first meeting, given what has been surfacing about the trial's results. And that this had breakthrough status with the FDA to be fast-tracked for— Exactly. —and that MAPS and now Lykos has been working with the FDA for many years to structure these protocols around the unique nature of studying psychedelic-assisted therapy for really the very first time in an FDA protocol, FDA-compatible protocol, which presents its own unique challenges. Right. Which I think it's very clear this pharmacologic advisory committee was not really familiar with. Because exactly, you know, one of the things that I, you know, when they talk about reviewing the trial results in the context of, you know, risk versus benefit and whether or not this is worth pursuing for patients, I think one of the things that they— or a couple of things they focus on that were really surprising to me and kind of highlighted their unfamiliarity with the subject matter of MDMA-assisted therapy and psychedelics is that Number 1, blinding is always a challenge in trials. But in any mental health trial, blinding and placebo studies are always a challenge because people can usually guess when they're taking the active drug versus placebo because they have a conscious benefit experience. And so this is not just unique to psychedelics, but it's something we see that's a challenge across all mental health double-blind randomized placebo-controlled trials in this area. And at the same time, it's almost like they're nitpicking the— and really zoning in on the clinical trial structure rather than the results themselves and the actual demonstrated safety profile in the context of what our current standard of care is, which is SSRIs like Prozac and Zoloft that have to be taken daily, that have less than less than 30 or 40% response rates in terms of long-term benefit and have tons of side effects that we know about well and people have a really hard time coming off of them. But that seems sort of off base to me. And so I'd love to hear some of the notes that you've been thinking on with respect to some of these topics and especially around the risk profile and the clinical trial structure that they seem to be focused on.
Yeah. So it really did feel to me that as I think Matthew Baggett tweeted this, the neuroscientists from the company Tactogen that's making MDMA-like molecules, he tweeted something like, okay, the FDA advisory committee panel seems to be letting perfect be the enemy of good enough. And I really felt like that was the case. And I felt like also they were trying to hold MDMA to a higher standard of perfection. Than, like you said, pretty much any other drug on the market or any other therapy, much less some novel drug therapy combination, which just doesn't seem realistic or fair. And you also touched on this issue of kind of losing the forest for the trees. Like, okay, that's great. A lot of participants guessed which arm of the trial they were in, but people came out with their lives changed for the better. So why are we not focusing on that? Yeah. So the first thing is just every drug treatment on the market has problems. And MAPS has been working with the FDA for literally 23 years now. And particularly in the years since MDMA-assisted therapy was given breakthrough designation, MAPS has had a lot of meetings with the FDA about what would constitute a well-designed study. What would they accept? What effect size do they need to see? What significance? What efficacy? MAPS did deliver, you know, studies that met those criteria that they agreed with in advance for the FDA, with the FDA, that would be acceptable. And now, you know, years after these efforts were started, you've got a group of what seemed to me like completely, you know, MDMA science naive establishment psychiatry people who were just sort of competing to see who could like find the most flaws in this study that, you know, MAPS really trailblazed for the entire field of psychedelic science. That has been working with the FDA closely along every step of the way.
I think you're absolutely spot on, right? That this is not MAPS just throwing a trial together and saying, hey, FDA, you have to accept whatever we decided to do. It's been constructed with and run with FDA guidance for a very long time. And the MAPS team has been really diligent about that. And I'm not sure— it doesn't seem like the committee was really aware of or caught up on the prior conversation around how to study a unique substance like this in the randomized double-blind clinical trials framework.
Yeah, exactly. And, you know, like, I get it. This— there's so much baggage with this field and like what has been done up to this point. It's not like someone just woke up a few years ago and decided to do this. You know, that's why I wrote a whole book about it, to provide that context that a lot of people are missing. So yeah, this whole issue of unblinding kind of plugs into that. I mean, unblinding or the blinding issue with psychedelic-assisted therapy trials was the subject or part of the subject of Rick Doblin's 2001 PhD dissertation. This is not a new issue in psychedelic science. You know, how do we give people a convincing placebo so they don't immediately know that they've taken a mind-altering medicine? I mean, that's not an easy question to answer. Nobody has the answer yet. If we did, then MAPS would have done it in this trial.
And that PhD thesis was out of the Kennedy School, right? The Harvard School of Public Health. Yes, exactly.
At Harvard. Yeah, it's legitimate. So, yeah. And there's been tons of talk about this in the scientific literature. Sheila Love wrote an excellent piece about it recently. And also, it's worth pointing out to listeners, and I only just learned this myself, the FDA actually does not require blinding for clinical trials for new drug applications. So I actually didn't know that myself at all. I thought it was a requirement. So that aside, saying that just because the participants and likely the therapists were effectively unblinded, and then there's just kind of throwing our hands up and saying, okay, well, all this data is invalidated. There's no way we can interpret it. Can't say it works. I mean, that just seems really not productive to me or not helpful. And it's not like the advisory committee was offering any solutions for this. Were just, you know, poking holes in it and basically saying, you know, there's nothing you could do to allow us to get past this blinding issue with this class of treatments. You know, they also were saying things like, you know, how come you didn't do a study with like a third arm? Well, you know, another thing that I think was lost in all these discussions was just how difficult it has been to get these studies done. You know, for the vast majority of the time, MAPS has done this purely on donations, which is like absolutely incredible. And I don't know any other example of that. Maybe they exist, but I don't know.
I don't think so.
Yeah, I mean, millions and millions of dollars just raised, um, you know, to fund these studies. So it's not like they— over $100 million, I think. Exactly, exactly. I think like maybe $150 or something. But, um, yeah, it's not like they could have just said, yeah, okay, sure, we're going to add like this arm with methamphetamine and we'll test placebo, meth, and MDMA and see what the differences are. You know, that would have been tremendously expensive. It would have held things up and The FDA did not require it. Again, this was all cleared in advance with the FDA. They didn't say you need that third arm.
Yeah, that's a really interesting point. And I think what is not taken into account also thinking about the effectiveness is really looking at the results of the Phase 2 and Phase 3 trials that were under review here. MAP1 and MAP2 are really paradigm shifting for the field of psychiatry. I think in MAP2, the most recent Phase 3 trial, which was run almost entirely by newly trained therapists. So it was really demonstrating a scalability of the treatment, which the FDA requested to see. It actually got better response rates than the first trial, the Phase 2 MAP big trial, MAP1, with I think it was an 88% response rate to treatment and then 67% or something like that of folks had entered symptom remission from PTSD after the treatment was done. But what's really fascinating about the Phase 2 trial results were that the, you know, when we look at what happens 1 year out, which was another criticism of the effectiveness, is how long do the effects last, right? And, you know, we know from every other mental health medication, whether you're talking about SSRI antidepressants or like Paxil and Zoloft, which are the only 2 antidepressants approved for PTSD, or you're talking about antipsychotic medication or amphetamines or other kinds of medications used for mental health indications, that almost every single study shows when people stop taking the medicine, they relapse the gross majority of the time, right? Most people wind up being heavily symptomatic again and have to restart the medication. So it's not actually solving the problem. One of the most paradigm-shifting things to me as a clinician and researcher studying this field in psychiatry is, you know, The MDMA is reversing that. At 1 year out, more people are better without additional treatment after just 3 doses of MDMA and 42 hours of psychotherapy over 12 weeks. And that increase after the treatment is stopped in improvement has really never been seen before in the history of psychiatry, which in and of itself is paradigm shifting. Right. And that's why we spent so much time talking about it on the first episode of Your Brain Explained, really breaking down how MDMA is actually working to achieve some of these benefits and why it's shifting the field of psychiatry towards, you know, in a lot of ways what the discovery of antibiotics did for infection. Yeah. Like back in the beginning of the 20th century, before the invention of penicillin by Alexander Fleming, you know, who ultimately won the Nobel Prize, infections were a terminal illness or an illness where you would lose a limb and a major cause of death in humanity. and we did not believe that you could cure them definitively. And then all of a sudden we invent antibiotics and infections become an extremely treatable thing that extends human life by 10 to 20 years across the board over the next century. And we're at that phase with mental health where we currently consider all mental health treatments or mental illnesses to be incurable and that people have them for life. And it often results in a lot of morbidity and mortality and suffering that may actually be able to diverted, and I don't get the sense that any of the folks who reviewed this work, except for maybe one who voted for it, yes, really didn't understand the benefits in the context of where we're at in the field of psychiatry today. You're listening to The Psychedelic Report.
Yeah, you touched there on one of my other criticisms from the advisory committee meeting, which was this implication that we can't accept the durability of these results because these long-term results that we're seeing where people actually get better over time are somehow contaminated by the fact that people have continued to seek out mental health care and services following the study. You know, that, oh, it would have been good science to, you know, keep these people in a box and not let them get more help after the study, which, you know, I just feel like very— that's a very cynical and unrealistic take. And again, losing sight of the fact that these are human beings who were, you know, desperate for healing, and maybe the MDMA opened them up to get that therapy and that help that they needed. I mean, one of the people I feature in my book is a Vietnam vet who for literally decades lived with crippling PTSD but wouldn't actually admit to himself or anyone else that he had it. And then he finally confronted that PTSD in the clinical trial, and, you know, at the end of the third, uh, experimental session, so the last one, he was left left very vulnerable, very open, needed more guidance, and went and sought out a professional therapist. And that therapist helped him navigate what had just happened to him and finally find a resolution and a way to move forward productively. And, you know, his life is way better now. He's not cured, but he, you know, he has a great relationship with his wife. He's working in outreach with other veterans. And, you know, to imply that someone like that hasn't gotten better at all because of the MDMA, we can't say that, oh, you know, that all that healing isn't due to just the therapy sought afterwards. I just I don't think that holds water at all. The other thing is the committee seemed to be getting hung up on how this actually works and being confused about how integral the therapy part of this is and saying, okay, well, we didn't test just the drug. Well, okay, we have millions of people out there who are doing MDMA outside of a clinical setting every year, and people by and large aren't reporting coming back from a rave or wherever it is that where they took MDMA saying that their trauma has been miraculously healed. Like, we know that that therapy— yeah, we know that therapy branch is integral. You cannot just give people MDMA and send them home on their way. But they just didn't seem to grasp that. And it's also important to point out that for the FDA to grant approval of any product, you don't have to actually show the mechanism of action. It would be nice to know, but that's not a requirement for approval. That said, there is very strong evidence from Gould Dolan's neuroscience lab. She's now at UC Berkeley. She did the research while at Johns Hopkins that the therapy arm really is absolutely instrumental, because without that sort of set and setting of going into these experiences with the right intention and guidance, you're not going to reopen what neuroscientists call critical periods, these windows of finite malleability where the brain can learn new things in that lasting, durable way, which seems to explain what what we're seeing with MDMA-assisted therapy and other psychedelic therapy.
Yeah, I think that's, that's also a great point in that, you know, we didn't know how Tylenol worked up until like 3 or 4 years ago.
Exactly. Yeah. I mean, Alexander Fleming, it took decades for that. Yeah. His discoveries to be proven how it actually stops bacteria from replicating. Right.
And most inhaled anesthetics, you know, that we put people under with, we've been using, including ketamine, you know, we've been using for how long? Right. 70, 100 years. And we haven't known the mechanism and that they are FDA or completely understood the mechanism and they are yet FDA cleared and available in every single hospital in the country. So, you know, I think the mechanism piece is really something that's interesting from a science perspective. I'm certainly interested in and it's a passion of my research, but it has never been required for FDA clearance. And but I think the, you know, the thing that is interesting is how much we do know about how MDMA is working from animal studies and the clinical trials around humans with PTSD involving fear conditioning, which is that MDMA works so well with therapy in the way that we deliver this particular form of therapy because it seems to be amplifying safety pathways in the emotional brain in both animals and humans that facilitate what we call fear extinction. Trauma being a fear training, fear learning state, and fear extinction is really safety learning. So it's like the opposite of trauma and that MDMA therapy does this by itself just by having a really safe, trusting relationship with your therapist. And we see that because even the placebo group that just got therapy had improvement. That improvement didn't last in half the people over a year's time, but they still had improvement because it's the actual safety and connection, trusting connection with your therapists and practitioners that creates that healing experience. But the MDMA amplifies it to not just more than doubly effective than the therapy, but also long-lasting. And that piece is really missing from, I think, the understanding of how effective this really is. And also the fact that the side effect profile is relatively low compared to a lot of the other treatments we have available today. Oh yeah, that's great.
I mean, that brings us to these inherent risks that the panel was really getting hung up on. You would know more about this than I do, but the physical safety arguments just didn't seem realistic and again seem to be holding MDMA to a higher standard than, say, like Adderall or Ritalin that also have strong cardiovascular effects and that you can go and get a prescription from, from a doctor and take that right home with you without having somebody there to monitor you. And even online now without it. Oh, yeah. Wow. Okay. I didn't know that, but I'm not surprised. Yeah. And just this idea too that elevated risk of malpractice is somehow like an inherent part of what MDMA-assisted therapy like comes with that, you know, there's something about using this drug that's going to tempt people to cross boundaries with patients. You know, it's— this isn't a risk that emanates from the drug. We know that 7 to 12% of therapists admit to abusing patients. This is— a human problem in the same way that male gynecologists sometimes abuse patients. So this isn't something for FDA to regulate. This is out of the purview of FDA. This is something that needs to be regulated by the people who regulate practitioners and the medical boards. Exactly. The medical boards. Thank you. So, yeah, all of the stuff about abuse. And by the way, out of 400+ people, I'm not at all minimizing this, but Out of 400+ people, we've had one instance of true abuse from the clinical trials. And that instance is absolutely horrific, and we need to do everything we can to make sure or try to make sure it doesn't happen again. But that's never going to be perfectly possible given the way that humans operate. There's always going to be bad actors and abuses are going to happen. But, you know, acknowledging that fact doesn't mean that we should just not move forward with this therapy and, you know, put it away, because then we're just actually making it more dangerous by forcing people to seek out practitioners underground, and then there won't be those medical boards to hold them accountable. Exactly.
And, and I think to your point, you know, there are— I mean, if you really look at how many and the percentage of abuses that occur to patients, whether you're talking about in therapy crossing boundaries or in surgical procedures or in other areas of medicine that are not mental health related at all without drugs present. You know, you're right, this is, this is a medical board and people problem where, you know, there are people, you know, I think a lot of people are not— there's not proper enforcement that's effective to support patients. And also, you know, I think a lot of clinicians are not trained as well as they should on on respecting boundaries with patients and how to make sure that that is really held sacred in the practice of medicine, which traditionally it always was. But I think some of that has been lost over the years in treatment. But this is an issue that has been going on for many, many decades in the field, particularly in mental health.
Yeah, for sure. Yeah. And it's not a problem that MDMA can solve or like should be asked to solve. Or yeah, exactly. And I mean, that kind of brings me to, I think, my last point, but that's about just the amount of time spent at that meeting on things that were outside of the purview of the FDA. So the FDA doesn't regulate therapy. So while it's important to acknowledge these issues and, you know, make sure other people are dealing with it, that's the, that's the responsibility of other people. People of these boards, not the FDA. Um, right. And, you know, other things like discussing what percentage of the participants were non-white, um, again, extremely important subject, uh, extremely important point, but something that is not under the purview of the FDA. Uh, you know, it's— at one point, the FDA, uh, psychiatry director actually interrupted the meeting and was like, okay guys, we have to get back on point here. This is great, but it's not what we're talking about. So, you know, I do think that the FDA itself is aware that a lot of what was going on in the meeting wasn't even relevant to their decision making. And we're actually getting a little bit frustrated that there was so much time spent on that. Yeah, absolutely.
And it does really take away from the main point, which is, you know, what's in the best interests of patients. And, you know, our patients are really suffering, especially veterans and I think one of the— and it's not to say that they're suffering with other alternatives, right? Like our best treatments today really only work in— and this is not just in veterans, but in our most vulnerable populations, abused and battered women and people who have had severe PTSD from civilian life who have never had treatment. We're talking about something like maybe 40 million or more Americans who are struggling with this that are either currently diagnosed or undiagnosed because, as you described earlier, many people are embarrassed or afraid or in denial about their diagnosis and having had trauma that's negatively impacting their lives. And so, you know, I'd love to, to wrap up by how do you think this decision will, you know, is being seen by the public? And what do you think the impact of this release of this preliminary decision will have in the space around, you know, opinions of the FDA, the, the trust in the medical system, and, you know, how— where we kind of go from here as a, as a community of people who are really suffering in the, in the PTSD world who don't have adequate alternative treatments when whatever everything they've tried isn't working.
Yeah, I mean, that— I just don't know how it was possible for people to listen to the public testimonies from this advisory committee meeting when we're seeing, you know, veterans, we're seeing women who were sexually abused as children, um, you know, we're seeing all these people come forward with these heart-wrenching stories of the trauma they suffered, uh, the years of just, you know, excruciating symptoms they endured, and how all the standard accepted approved treatments we have today failed them. And then at one point, one of the panel advisory board members said something like, oh, well, we have exposure therapy and it works really well. So why are we looking at this weird new therapy? Paraphrasing there, obviously. But does it? Yeah, exactly. That's the thing. It's like, have you been listening? So I think what this advisory panel really shows us is You know, for people like you and me who are deep in this world, who are versed in the science, who have been following it for years, we just take this stuff for granted. But it shows how far we have to go in terms of educating the public and educating even the medical and scientific community to kind of come along. And, you know, MDMA has— it's, it's been like a nearly 40-year journey now trying to bring this medicine back into the light of scientific and medical respectability. And I think we're closer than ever, but this is just indicative of the battle that the people who have been trying to do this have faced all along. Yeah, and I think public misunderstanding remains a huge problem. The media isn't making it better with these very simplistic headlines and stories that oftentimes contain errors or gloss over the subtleties. I understand, I'm a reporter myself, people are on the clock. You've gotta get that story out and move on to the next thing. Budgets are tighter. Than ever. Newsrooms are smaller than ever, but it's really a shame that we have to kind of skimp on accuracy and nuance just in order to kind of get that headline going and move on to the next thing. So yeah, I honestly don't know what to think for August. I could see it going either way. Like I said, that the FDA director on the meeting, you know, if you kind of look between the lines, she does seem to be a little frustrated with what's going on. So I'm hoping the FDA sort of stays true to what they've been doing with MAPS all along, which is moving this therapy forward for hopefully approval in August.
I agree with you on that. I think there is hope for that still, right?
Absolutely. Absolutely. And even if it doesn't happen, I can promise you Rick Doblin is not going to give up on this. And I'm sure the folks at Lykos aren't either. So hopefully it'll just be a delay of a year or so rather than another 10-year ordeal trying to do clinical trials?
Yeah, I mean, I think it's not an if question as much as it's a when question. I agree. Yeah. Yeah. The results from the trials today are so good that on any thorough review, you can't deny the potential of this tool. And I think some of this has to be really thought of in terms of the public and anybody who's listening to this is the FDA is not really going to be able to say no because that would be a slap in the face of, you know, every American veteran without providing an alternative solution that says something to the effect of, you know, if we don't approve this right now and give it clearance, then this is what needs to be done for clearance and approval to be achieved. Yeah. And there needs to be a path set forward. And I think, you know, one way or the other, we're going to see that, you know, on August 11th, whether it gets approved or not. But I think to your point, based on the real impact discovery of this new therapy has demonstrated already, the FDA really needs to think carefully when they're evaluating the trial results and think about risk versus benefit compared to what we currently have available and how this impacts trust in the medical system because I think I think people are really at their wit's end in these communities, especially in the VA veterans community where they come back and they don't feel like the VA is adequately supporting their mental healthcare. And it's a real problem. And we really can't sustain another fracture of trust in the medical and mental health communities when trust is singly the most important required factor for healing to even occur. Occur. I really appreciate your time. And, you know, for anybody who's listening to this and wants to learn more about, um, the, uh, results of these trials and the impact of the discovery of MDMA-assisted therapy, um, you know, please check out our conversation, uh, Rachel and I with Rick Doblin and others on Your Brain Explained on, uh, Spotify and Apple Podcasts. And also check out Rachel's articles in the New York Times, uh, the article from from September 14th, 2023, is entitled MDMA Therapy Inches Closer to Approval. And for the deep dive, check out Rachel's new book, I Feel Love. And just want to say thank you again for taking the time out today from your busy schedule.
Oh yeah, thank you so much. I'm really happy for the opportunity to help readers out, or excuse me, help listeners out.
Well, thank you again and hope you have a great weekend.
You too. Thank you. Bye. Bye, Rachel.
Thanks for listening to The Psychedelic Report. Visit us at thepsychedelicreport.com. This show is recorded weekly on Clubhouse with a live audience. The Psychedelic Report was brought to you by Apollo Neuroscience and produced by Future Medicine Media. While I am a doctor, I'm not your doctor, so please don't take anything you hear on The Psychedelic Report as personal medical advice because we don't know you. If you have questions about anything you hear on this show, please consult with your doctor.
More from Michael
66: How Stored Trauma Rewires Your Biology, The Three-Level Healing Framework + The Inflammation-Trauma Feedback Loop | Dr. Aimie Apigian
#120 Mike Zeller - MDMA as a Therapeutic, Rewiring your Nervous System, Unblocking Love