Last year, the path to FDA authorization of the psychedelic drug MDMA for treatment of PTSD hit an unexpected snag. During a hearing before an advisory committee, which would have helped clear the way for a drug company called Lykos to use MDMA in concert with psychological treatments, a series of speakers stood up to give some unexpected testimony.
Their accounts raised concerns about the ethics of some of the therapists in Lykos’ MDMA clinical trials, and the committee ended up voting not to let Lykos proceed with FDA authorization.
It later emerged that all of these speakers were affiliated with a shadowy organization called Psymposia, and that their intentions were complicated.
Andrew Jacobs, a reporter for the New York Times, wrote about this bizarre plot twist and joined The Show to discuss.
SAM DINGMAN: One of the people that helped torpedo Lykos’ bid was named, and I apologize if I'm pronouncing this wrong. Is it Neşe Devenot?
ANDREW JACOBS: Neşe Devenot and the organization that they run, called Psymposia, it was widely believed to have played a role in the failure of this application. Hard to prove definitively, but my article tries to make the case that they did play some role.
DINGMAN: And Neşe Devenot, if I'm not mistaken, it's Dr. Neşe Devenot. But Dr. Devenot is not a medical doctor. I believe they're a senior lecturer in the Writing Program at Johns Hopkins. If I'm not mistaken.
JACOBS: Neşe Devenot is a writing teacher at Johns Hopkins, has done some work in bioethics, and self-describes as a psychedelics bioethics expert.
DINGMAN: Dr. Devenot comes to this public hearing, and makes this very inflammatory accusation that Lykos is a “therapy cult.” What proof, if any, did they offer for that accusation?
JACOBS: I would say zero. I think that's of their opinion about the therapy part of the application, and several members of this organization, Psymposia, testified at that hearing, none identified themselves as being affiliated with this organization, Psymposia, so it gave the appearance that you had seven or eight separate experts who were all singing the same tune. And I think that helped create this atmosphere of doubt that the ad com [advisory committee] members seems to have felt there was a lot of red flags here and they couldn't approve.
DINGMAN: Yeah, so tell us, this group, Psymposia. Who are they?
JACOBS: Psymposia is a nonprofit. They describe themselves as a media organization — whistleblowers, watchdogs that, broadly speaking, are for decriminalization of psychedelics that, also what's known as harm reduction, just making it safer for people who do use psychedelics, because you are in a vulnerable position when you are taking a drug like that. And there have been plenty of cases of of sexual abuse and unethical behavior during those journeys. On the other hand, they also have a very distinct leftist philosophy about the commercialization of psychedelics, and they do not support this regulatory process which will lead to commercializing these drugs, i.e. someone will make money off them.
DINGMAN: Yeah, well, you bring up a very puzzling irony in, in this story, which is that, if I'm not mistaken, Dr. Devenot themself is a survivor of sexual trauma who credits psychedelics with helping their recovery, right?
JACOBS: Correct, and I think you could say everyone who is allied, affiliated with Psymposia, has a similar story. They are all pro-psychedelic. Many of them have been aided by psychedelic healing.
DINGMAN: Yeah, this is one of the things that's really fascinating to me about your piece, is there's this sort of pretzel logic in effect. Because, as you point out, a lot of the folks who work with Psymposia have themselves been victimized by these really traumatic situations that psychedelics have been very helpful to them in overcoming. But they're also aware of the potential abuses of the relationship between a psychedelic counselor and a victim of trauma like what they've endured, and ostensibly, federal regulation would help make that less likely, but they're also against regulation and commercialization.
JACOBS: You hit the nail on the head. It's a very hard argument to wrap your head around. So a lot of people who supported this application were crestfallen by the rejection because they felt like with all the flaws in the application to the FDA, they believe that they could have been cleaned up and fixed post approval, especially given there's 13 million Americans with PTSD, and there's really not very good treatment. I'll say the Psymposia and this defense said that they believe we need to get this right the first time, it's so momentous that that's what they would say. They would say they're protecting the vulnerable.
DINGMAN: Did you get a sense from them in your interactions with representatives of Psymposia what that would look like?
JACOBS: Well, I will say that it's easier to figure out what Psymposia is against compared to what they're for. I didn't really get a good sense from them what their vision is, besides decriminalizing psychedelics. The one case of unethical behavior that was raised involved a patient in the clinical trials of MDMA, a woman who was taking the MDMA and she was in a session with two therapists, a husband and a wife. And while she's on her journey, as it were, she was very distressed, and these two therapists sort of cuddled and spooned her at one point, trying to calm her down. And that is generally not considered, obviously …
DINGMAN: Not ethical.
ANDREWS: But what happened after that is that patient ended up having a relationship with the male therapist, and later she sued him for sexual assault. Obviously, a very complicated story here, but the quick version is that MAPS did acknowledge this incident. It was reported and it was handled back in 2019, but that has not stopped Psymposia from alleging that there are other cases there, there's other things being hidden. But they have yet to produce anyone who can confirm those allegations. So they generally have traffic in innuendo and without providing much concrete detail.
DINGMAN: Right, so because there was this one situation that was disclosed where trust was abused, they're basically using that to suggest that there must be many more.
JACOBS: Correct. I will just note this was an unusual situation where you had the advisory committee, they did not, except for one of the 11 people, none of them had expertise in psychedelics. It's such a new therapy. And so I think those people didn't really fully understand what they were looking at. And that's generally a wide agreement in the field, that based on their questions and the remarks they were making, they didn't quite grasp what was before them. They had expertise in certain slices of what was before them — for example, addiction, PTSD — but none had that sort of special, you know, that, that precise expertise.
