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Last month, the first psychedelic therapy treatment came before the Food and Drug Administration for a vote. But the FDA scientific advisory panel that evaluated this treatment voted overwhelmingly against approving it. The FDA panel was presented with allegations of misconduct and incongruous data, including a letter by trial participant Sarah McNamee. She joins guest host Rachel Feltman alongside Dr. Eiko Fried, a methodologist and psychologist at Leiden University in the Netherlands, to discuss the decision. If you or someone you know is struggling with PTSD or other mental health conditions, call for the suicide and crisis lifeline. MDMA therapy has looked promising as a treatment for PTSD and other mental-health conditions in some studies, but the FDA scientific advisory panel that saw the case voted overwhelmingly against approving it. Joining me today to talk about this are my guests. We have Sara McNamee, a trial participant, researcher at McGill University, and a licensed psychotherapist based in Montreal, Quebec; and Eiko Fried, a methodologist, psychologist, and associate professor at Leiden University in the Netherlands. Welcome, both of you, to Science Friday. This conversation is about post-traumatic stress disorder. If you or someone needs to talk, you can call from any phone for the Suicide and Crisis Lifeline. You were also one of the trial participants in this case. Was there past evidence on the therapy that interested you? I was on medical leave because I was experiencing a relapse of PTSD, and one of my friends had heard about it and jumped on the phone and called me and told me about it. And I immediately jumped on it and emailed the study site. Is that right? I was in a MAPS-sponsored study. Sort of the recipe is they give you three preparation sessions, which are just normal talk therapy where they kind of talk you through what the experience might look like and what your expectations are and what to expect. So in total, I got 12 talk-therapy sessions and three full-day sessions. And so much of what the so-called therapy part of MDMA therapy actually is really draws a lot on a whole bunch of pretty controversial stuff that I think myself, sort of retroactively, having spoken to a lot of therapists, raises a lot of red flags from a therapy perspective. If I think back to between the point where I heard about the trial and got enrolled in the trial, I researched it intensively, and everything just sounded so rigorous and so research based and so positive. Except for I was in the trial that was supposed to determine efficacy, so how did they know it was efficacious before the trial was even done? So that was my experience coming in. And I would love to see so much more discussion of that, the complexity of what the experience is. You have an idea. You think that MDMA combined with psychotherapy helps people more than nothing combined with psychotherapy, which is state of the art, right, at least for many mood and anxiety disorders. And so what you do is you do therapy plus MDMA and you do therapy plus placebo. The dropout rate is higher in the control group and so forth. First of all, we have the sort of expectation bias, that we have the hype and so on in the experimental group, and we have the disappointment in the placebo group. But what actually happens is that your experimental group, MDMA and psychotherapy, performs as well as you would expect from placebo, and your placebo group performs worse than your normal placebo group because folks are disappointed and so on. I just checked the MAPS website today before the interview, and they still maintain that both trials are double blind. The first is that the psychotherapy component and the MDMA component are sort of mixed together in a complex way. Sarah described that there was these three sessions, and you had psychotherapy in between. And so this is really entangled, and MAPS has actually never been really clear what the mechanisms are, what the proposed mechanisms are. Is MDMA supporting psychotherapy? Is psychotherapy supporting MDMA? And maybe Sarah received CBT, or maybe she received holotropic breathwork. It depends on her particular clinician, but there is no standardization. And you also want to specify what your MDMA component is supposed to do. What is the working mechanism? How is the client supposed to interact with the clinician and vice versa during these sessions? You need much more standardization. Maybe you get some anxiolytics adjacent to help with some of the anxiety. So you want to make sure that both treatment arms have the same amount of psychotherapy or have the same amount of contact with the clinician. You can have a better control group. And the second is you do a dose-response relationship studies. And that means you have, for example, four or five arms. There was a ketamine study on this pretty recently. All of these folks will probably know they get MDMA, right? Even minor doses will trigger experiences that are unblinding. But now you can see if the highest group with the highest dose works the best, and that would support a sort of MDMA mechanism underlying this whole thing. Did this trial change how you feel about MDMA therapy more broadly or the validity of continuing to study it? And then for the period that I was getting screened and then enrolled in the trial and maybe for a year afterwards, I was absolutely convinced beyond reason that MDMA was it. It was the cure. Everybody needed to have this. And this despite the fact that every single day I was trying not to kill myself. What has been really shaken for me is my trust in the research on psychedelic and in the researchers. I think I know of many participants who have really, really tried to make researchers aware of the problems, their experiences, and really been butting up against walls. So what do you think are the next steps for these populations? What should the research community be doing for them. This is something we all can come together on. And so my hope for, for example, MDMA-assisted psychotherapy would be that if we study this properly,. We can identify the folks for whom this is more promising than for other people and then sort of deliver the appropriate treatments for the people in need. They have positive experiences. And so I think we need to understand we need to recruit broader sets of participants. We need to record who they are. How many previous PTSD episodes have you had? Sort of this whole precision-medicine, precision-psychiatry angle that we have all been talking about for the last decade. Thank you both so much for joining us. All rights reserved. Science Friday transcripts are produced on a tight deadline by 3Play Media. Kathleen Davis is a producer at Science Friday, which means she spends the week brainstorming, researching, and writing, typically in that order. Science Friday. Latest Episode. Further Reading Watch a lecture from Dr. Fried about methodological problems found in psychedelic research. Segment Guests Sarah McNamee. More From Guest. Eiko Fried. Segment Transcript. Thank you. Meet the Producers and Host Kathleen Davis. Rachel Feltman. Explore More. X This website uses cookies to improve your experience. We'll assume you're okay with this, but you can opt-out if you wish. Read more. Manage consent. Close Privacy Overview This website uses cookies to improve your experience while you navigate through the website. 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After the Lykos debacle, what’s next for psychedelic therapies?

Leiden buy MDMA pills

Find out more. Although the momentum for MDMA therapies hit resistance, experts maintain not all is lost, and there still could be a path for MDMA and psychedelics to get to patients. But the committee raised several issues with the data package. Firstly, members felt the risk of using an MDMA formulation as a therapeutic was not fully characterised. Rectifying measures were suggested by the committee; for example, increasing the supportive trial staff, gathering more comprehensive data, and instituting an updated risk evaluation and mitigation strategy REMS. Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge. We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form. Additionally, the committee noted problems with the study blinding. They worried patients would likely know which formulation they had received, given how apparent the effects of psychedelics are to those under their influence. Potential expectations of benefit among these patients led regulators to question the benefits of MDMA supposedly demonstrated. In such a backdrop, the FDA rejection may not have been fully unexpected, since some challenges, like with data blinding, are well understood in the field. But this may not be a critical factor blocking the approval of psychedelics, since creative approaches like replacing inert placebos with amphetamines to elicit similar experiential changes to MDMA can be employed, according to Pilecki. An important difference between MDMA and other psychedelics is that the former is administered within a broader course of psychiatric therapy, says Dr. According to him, MDMA acts as a catalyst, inducing a mental state more receptive to traditional therapy. This was the role the drug served in the Lykos trials, which incorporated MDMA into a recognisable, therapist-led course. However, this was a key issue raised by the FDA committee. The involvement of therapists throughout treatment in conjunction with MDMA dosing left concerns that functional unblinding of patients might also affect therapists who knew which of their patients received treatment. Despite these challenges, there is stout confidence in psychedelics among researchers. When asked about the prospects of these drugs, given the news from Lykos, Vermetten was resolutely optimistic. Lykos is not alone in MDMA research, as several other companies continue to push their candidates towards approval. Though Lykos had to demonstrate a drug effect while part of a multi part treatment, others may not use the same approach. Additionally, incorporating dose response analysis, expectancy assessment, blinded central raters, and excluding participants with prior psychedelic use are among measures that can shield MindMed from the failings of Lykos, says Karlin. Nonetheless, Karlin remains confident in getting psychedelics approved and, cited growing interest in psychedelics among groups supporting veterans with PTSD as a route to bipartisan political acceptance of these therapies. It is not just pharmaceutical companies looking closely at this space. He does not view psychedelic therapies as competitors, but as potential collaborators. The need for new treatments is another critical factor. Give your business an edge with our leading industry insights. Thematic Take monthly. I consent to Verdict Media Limited collecting my details provided via this form in accordance with Privacy Policy. View all newsletters from across the GlobalData Media network. The latest attempt at FDA approval for MDMA has failed, but those working with psychedelics maintain confidence that the therapy will ultimately see success. Go deeper with GlobalData. Data Insights The gold standard of business intelligence. How well do you really know your competitors? View profiles in store. Company Profile — free sample Thank you! Your download email will arrive shortly. Not ready to buy yet? Download a free sample We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form By GlobalData Submit. Tick here to opt out of curated industry news, reports, and event updates from Pharmaceutical Technology. Submit and download. Sign up for our daily news round-up! Sign up. Analyst Comment. Sign up to the newsletter: In Brief. I would also like to subscribe to:. Thank you for subscribing View all newsletters from across the GlobalData Media network.

Leiden buy MDMA pills