On this week’s episode of Cover Story: Power Trip, one of the participants of an MDMA-assisted-therapy clinical trial gets her hands on the data. Though her symptoms of PTSD lessened immensely with treatment and she was a success story on paper, she left the experiment more torn and depressed than before. Collaborator Lily Kay Ross and partner Dave Nickles turn to MAPS, the Multidisciplinary Association for Psychedelic Studies, for answers. Why did the data make it seem like every participant was a success story when that was not the case?
To hear more about the clinical trial and how MAPS defined the success of the participants, subscribe for free on Apple Podcasts or wherever you listen, and find the full transcript below.
Just a quick note: This series deals with sexual assault and suicide, so please keep that in mind when you decide when and where to listen. Also, to protect their identities, we’ve changed the names of some of the people we’ve interviewed.
Lily Kay Ross: I want to take you back one more time to the talk that Meaghan gave about her experiences in the MAPS clinical trial. There she was looking like another poster woman for MDMA healing and feeling torn up inside about what was happening back on Cortes. After she gave her talk, something really important happened. She got into a conversation with the man in charge of this whole research project.
Rick Doblin was also talking at the same conference. She’d been asking herself a lot of different questions about the study and her own place in it. And she realized in this conversation that this was it, this was her opening. So she asked Rick Doblin for the data from all the research sites in her clinical trial.
Meaghan: I said I was a clinical trial participant and I would love to see the clinical trial data. Do you think he’d send it to me? And he said, “sure.”
Lily: And this moment was the key to a doorway that we didn’t even know existed when we started our investigation. Meaghan has told Dave and me a lot about her escape from Cortes Island.
Meaghan: It was hard splitting from my ex-therapists.
Lily: It takes a few attempts before she finally gets out.
Meaghan: I was tied to them in this wretched way.
Dave Nickles: And as she takes account of those experiences, she realizes that there might be things she can do to hold her therapists accountable.
Lily: She tries to report Richard Yensen to multiple agencies that oversee psychologists.
Dave: But she discovers that he’s not actually licensed as a therapist.
Lily: She also starts questioning what is in that data that she’s gotten from Rick Doblin –
Meaghan: I just wanted to sit down and go through it, so I did.
Lily: This is a 90-ish page submission to the FDA that summarizes findings from across every MAPS study site for their PTSD research at the time.
Meaghan: And then I just went, “what the hell?” And so I read it again and I’m just like, “are you fucking kidding me?” And then I hauled out my pen. Why are they comparing apples to oranges? Because if there are seven different clinical trials and yet the patient screening is different and these patients were recruited.
Lily: If Meaghan thought that getting the data from Rick Doblin was going to answer her questions, it only raised more. She was reading about a bunch of tiny study sites that all had different rules and they all showed widely different outcomes.
Meaghan: It was just like screaming red flags to me.
Lily: The document includes unpublished data to support MAPS’ claim that MDMA was a promising treatment for PTSD – and that the research should move on to Phase 3.
Dave: We had heard rumors of therapists spooning with trial participants, rumors of trials that were stopped and restarted.
Lily: Now we had the document to look at, to pull apart, to ask questions about. So we started investigating. We started reaching out to experts to hopefully tell us that we were just wrong. We wanted to talk with research ethicists – people with a background in psychological and psychiatric research – And Dr. Erick Turner, who used to review psych drugs for the FDA.
Erick Turner: I haven’t seen an End of Phase Two briefing document since I was at the FDA.
Lily: The document that we are talking about is the end of Phase 2 submission to the FDA. It’s a companion document to a meeting where they’re deciding if the research can move from Phase 2 to phase 3.
Erick: The FDA is going to say, “yes, that’s fine.” Or they’ll say, “ah, well…” Phase three is the definitive look at whether the drug is effective and whether it’s safe.
Lily: The last phase before MDMA in combination with psychotherapy could be approved for PTSD.
Meaghan: For me, I was just like my head’s exploding.
Lily: Meaghan brought us this data and her questions about it. And we would be like, “Hey, have you seen this?” Sometimes it would jog her memory and she would be like, “well, let me tell you about that one.” Each of us talked to other participants in MAPS clinical trials…
Dave: And those participants talked to other participants.
Meaghan: I think it’s pretty rad that it’s people from the clinical trial who are doing this work.
Lily: It would take hours and hours to walk you through everything that we’ve learned in the depth and the detail that it deserves. But for now, we want to focus on three big ideas.
Dave: Three big ideas that make us worry that MDMA-assisted therapy isn’t as safe or effective as the MAPS researchers claim.
Lily: And the first of those ideas is this concept called equipoise. A couple of months back, one of the researchers was explaining this concept of clinical equipoise, which is the idea that the people involved in doing research should be equally prepared to figure out if this works? Does this not work? Dr. Emma Tumilty studies research ethics and misconduct.
Emma Tumilty: So if the Catholic Church was going to set up a bunch of trials to tell you how holy water was efficacious, we would all take those with a pinch of salt. We might think it was because the Vatican wanted more gold or we might think it’s because they believed in it, their motivations don’t matter. but you would generally think, “well, I’d like somebody else to do that study.
Lily: Obviously, this is an issue in all scientific research. Any pharmaceutical company that’s putting all the resources into investigating a new drug wants for that drug to work. But in the case of psychedelics, it’s the money, plus a whole movement cheerleading and even participating in the research. We have to start with Rick Doblin.
Rick Doblin: The first time I took MDMA, I was just stunned at how profound the experience was. I knew that it was great for PTSD.
Dave: Even as this research is going forward — while therapists and participants are still being recruited for studies – Doblin is often out in public saying things like:
Rick: It seems to work for a vast majority of the people in the hardest cases, and so don’t give up hope.
Lily: You have this really exciting media narrative of the latest intervention that is gonna help alleviate so much human suffering. And people within the movement of psychedelics feel like Doblin is this hero for getting the mainstream to accept these drugs.
Rick: To bring psychedelics back from the underground, it was necessary to have a patient population that the general public is sympathetic with. You know I’ve often felt that we don’t do science, we do political science.
Lily: In medical research, there are ways to combat the influence of hype and true belief: you have to design your research with checks and balances. And one of the most common is that you blind your study. This basically just means that neither the researchers nor the participants know if they’re getting the medicine – or a placebo. But the big problem with psychedelics is that almost everyone knows if they’re high. And The whole blinding thing mostly just goes out the window.
Dave: This combination of hype and the impossibility of blinding affects the researchers. And also the participants in their studies.
Mel: Everyone knows that if this is successful, it gets FDA approval and this miracle cure can go out to millions. That message right there gave this incredible sense of responsibility. If I’m not successful, I’m going to fuck it up for all the rest of America.
Lily: Mel remembers hearing about the clinical trials on TV.
Mel: I remember this guy, he was on the news. He had tried to kill himself. I think three times had the gun to his head. And every time the gun malfunctioned. His story was the one that I was like, “there we go. It worked for him. It can work for me.”
Lily: So, was that the moment that you decided that you wanted in?
Mel: Yeah. Three times he was ready to go.
Dave: From the outset, Mel put a lot of work into making sure she’d get accepted into the trial.
Mel: I got the MAPS protocol. I read all the exclusion criteria and tried to understand exactly where I needed to land to get in. I got all of the assessments that they use, the CAPS five. The one thing I remember is that question that followed like every question was “how much does that bother you?” What kind of a fucking question is that? “How much does that bother you?” Like a shit ton, it bothers me, what the fuck? Like I remember that used to aggravate me. But I took the CAPS several times to make sure that my answers wouldn’t come off too extreme.
Dave: Even once the trial started, Mel’s desire to succeed affected what she did and didn’t tell her therapists.
Lily: Can you tell us a bit about what the active sessions were like?
Mel: A lot of conversation about trusting my body’s ability to heal itself.
Lily: I think they call it inner healing intelligence?
Mel: Yes, the inner healer, that’s it! To listen to the inner healer. I don’t know where my inner healer is. I still don’t. That was so annoying because I didn’t understand it, but it was what I was supposed to do. I was supposed to trust my inner healer and ignore my inner critic. It was very vague. And not entirely helpful.
Dave: Did you say anything like that to your therapists?
Mel: No. I didn’t want to insult them. They believe it. And I’m sure they believe it because they’ve seen it work for some people. And that’s what I need to do and If I can’t figure that out, that’s on me.
LILY: Mel – and all the participants that we spoke to – remember the researchers telling them: you are so lucky to be in this trial. She told us she felt she had a responsibility to succeed.
Mel: I felt like I just needed to report how I was getting better, how things were improving. It didn’t feel like therapy. It felt like reporting. And I think part of the problem is, who’s reporting. I’m the one reporting all of this. I’m the one who wants nothing more than to be better. I’m the one who doesn’t want to disappoint my therapists. I’m the one who doesn’t want to screw everything up for every other person who wants to try this medicine.
Dave: How would you define disappointing them?
Mel: By not being better. That all their hard work was for nothing.
Lily: Is it fair to say that you wanted to believe that it was working?
Mel: Yeah. I wanted to believe that it was working.
Dave: At the end of the trial – when Mel had to answer the questions on that test called the CAPS, she says her answers were driven more by that belief than by what she was feeling.
Mel: I started high as having severe PTSD symptoms and I ended very low as having minimal to none.
Lily: And do you feel that that was reflective of what your lived experience was?
Mel: No. I think in the end I had more symptoms than when I started. And now it was coupled with the fact that I had been given a miracle cure and wasted it. That I had tasted what life is supposed to be like. And somehow I managed to blow it.
Dave: So, without revealing her identity, we brought Mel’s story to one of MAPS’ leading researchers.
Lily: There’s a person we spoke to who told us that they didn’t tell MAPS researchers that they were going through a really hard time, precisely because they didn’t want to be a black mark on the research.
Dr. Michael Mithoefer: Well that’s a challenge, too – I’ve heard people tell me the same kind of thing. That they didn’t want to hurt the research results.
Dave: Dr. Michael Mithoefer is MAPS’ Senior Medical Director. He wasn’t surprised by Mel’s story. He told us he’s also experienced this idea of ‘expectancy’ being a problem.
Michael: Our approach to that is to impress upon people, what helps us the most is for you to let us know what you’re experiencing. And we want to know if you’re having difficulty and we try hard to help people get over that worry about hurting the study, but it’s because it’s kind of, there’s a lot of media that makes that more challenging.
Dr. Mithoefer: MAPS has an aggressive media campaign.
Micheal: It would be a lot easier if we could just quietly do the research without any attention, but that’s not the situation.
Lily: Dr. Mithoefer explained to us that expectancy can kind of cut both ways - sometimes expectancy can cause people to report feeling better than they are and sometimes it can cause people to be extra disappointed if the treatment isn’t working for them.
Dr. Mithoefer: We’ve certainly had people that felt they weren’t helped nearly as much as other people. But in our questionnaires, they’ve never said they were worse off afterward.
LILY: Mel told us she was worse off after the trial — maybe you remember the analogy she used to describe what she felt like.
Mel: Like someone did open heart surgery, but then everyone just walked away from the table and my chest was still wide open.
LILY: At that point – she was done with the trial and she didn’t tell anyone from MAPS how much she was struggling.
Mel: Three months later, suicide was not just a daily option. It was a moment-to-moment option.
Lily: The research paper that included her trial data came out in Nature Medicine and, by the numbers, she was one of the people who got better.
Lily: Can you tell us about the sort of overall feeling you have towards your therapists from the trial?
Mel: It’s so mixed. I know that they cared about me. I know that they had really good intentions.
Lily: Mel doesn’t blame her therapists for any of what happened to her. She says that she thinks people like Dr. Mithoefer and the people over at MAPS are just doing what they believe in. She just worries about that.
Mel: They believe that they’ve found a miracle cure, but they’re so blinded by what they believe that they found, they can’t see the truth. I do not doubt in my mind that that soldier who put the gun to his head three times is doing wonderful. I’m not doubting his experience or his story in any way, or any of the people who have been in the media and shared their experience. But what I’m saying is I don’t think that we’re outliers. I think we’re more the norm. And they’re the exception and it’s a beautiful exception and I’m thrilled for them. And freely admit that I am jealous of them. But you can’t pick and choose what you show.
Lily: The trial participants who’ve found their way to us are saying that by the numbers, they got better. But they feel like some things got worse. If Mel’s story is about not telling researchers how hard things were…the next story is about someone who did try and tell - yelled and called and emailed and rattled the cage-
Leah: I was trying to communicate that I was not okay.
Dave But who also never saw her experience reflected in the published research.
Leah: You can only capture the things you measure. And the things they measured made me look pretty good on paper. So like on my final CAPS, I looked like the all-star participant.
Lily: So big, bold takeaway number two has to do with what you measure and what you don’t measure.
Dave: What makes it into the frame or doesn’t. Leah was one of the trial participants we talked to from the Phase 3 clinical trials – so that would be the last set of trials before the FDA potentially approves this drug/therapy combination for the public.
Lily: At the beginning of the study, she was asked to select one trauma that would be the focus of her assessment.
Leah: You have to pick the one biggest trauma. And I’ve had multiple traumatic experiences. So, I picked the one that led to the PTSD diagnosis. I think it might’ve been a bit hard for my therapist to keep up.
Dave: It was just a large volume of traumatic experiences. And, as the trial progressed, she was scared there wouldn’t be time to deal with it.
Leah: I was feeling this very subtle, but growing sense of danger in the relationship with the therapists, cause like feeling that depending on anybody is kind of terrifying.
Dave: She voiced this concern to her therapists and they told her to trust the process.
Leah: They did a lot of things like trying to reframe it as “this is a new beginning.” And I would get pissed off at them because I was like, “this is not, no, you’re not hearing me right now.”
Dave: And when she got to the end of the trial,
Leah: Something was not right? What did I say? Like “hell was inside of me and was only halfway out and it got stuck.” I felt like I got stuck. And I was supposed to leave. I couldn’t make my body go. And I could tell that they were getting frustrated with me. And they walked me out. I made it like half a block and ended up puking in the back alley.
Lily: The participants we’ve spoken to have said ending this therapy after three MDMA sessions was really hard. And it’s something Dr. Mithoefer told us he knows can be difficult.
Dr. Mithoefer: We find that difficult also. People do deep work and it’s over a relatively short period of time when it’s in a clinical trial.
Lily: Ethics-wise, in a clinical trial, researchers have a responsibility to pay close attention to participants who are saying they’re not okay at the end of the trial. MAPS says that they do, that they provide “an exit plan.” And that plan can include referrals to doctors and therapists.
MAPS also told us something surprising to the other researchers we’ve talked to, their research therapists are allowed to keep working with trial participants, as long as the trial has ended. And as long as that specific study site allows it.
Dr. Mithoefer: It is inherently challenging in clinical trials that you do this deep work with a pair of therapists, and then after a few months that ends.
Lily: And the thing is, yes it’s a clinical trial, but it’s also the number of sessions that MAPS is asking the FDA to review. And yet, in the published research – and in the news – it’s really hard to find any discussion of people suffering because those sessions aren’t enough.
Dave: Leah has a whole list of really hard experiences, both during and after the trial which to other researchers we talked to, seems like a big deal. And worth bringing to the public’s attention.
Lily: But they also haven’t appeared in MAPS’s papers.
Dave: For example, in between the sessions, Leah says she was dipping really low.
Leah: I don’t think I’ve ever before or since, felt like that level of depression. I could barely move my body.
Lily: So MAPS offers trial participants access to this emergency phone line that goes to their research therapist’s phone – and Leah says her therapists told her to go ahead and call them if she needed to talk. She says they also let her know that if the calls went longer than 30 minutes, they were gonna have to record that in the study data.
Dave: At the time, just like Mel, she didn’t want her own experience to be a stumbling block to the broader public having access to this miracle cure. She wanted to help make the research look as promising as possible - so she kept the calls under the limit.
Lily: We’ve looked at Leah’s cell phone records and there are multiple calls a week with her therapists that last for just under 30 minutes.
Dave: Leah says the calls made her feel even more dependent on her therapists. But none of this, not the intense feelings of dependence or even the calls themselves, made it into the narrative.
Lily: Three weeks after the trial is over, Leah really goes downhill.
Leah: I emailed them that I was in crisis and I needed support.
Lily: She wrote: “I don’t know if I’m allowed to ask, but I need to talk to someone, please.”
Leah: Over the course of the next few months, I emailed them in crisis probably three or four times.
Lily: “I am really scared of what’s happening to me.”
Leah: I was extremely suicidal by then.
Lily: “I feel like I’m a ticking time bomb and I’m scared I’m going to explode my life even more than it already is.”
Leah: I just got these very curt responses, bouncing me back to my therapists. I needed someone who knew about MDMA therapy, because I felt like I was having things that were specific to their expertise. I couldn’t access it anywhere else. I kept having these visions that would pop up spontaneously.
Lily: “Delusions. Paranoia.” What she described as “leftover psychedelic effects.”
Leah: I’d go to the grocery store and I brushed shoulders with this man. Then, the next thing I knew, I was him at age four and my dad was coming at me with a belt and I was hiding behind a furnace. It felt like I was starting to have other people’s mostly traumatic memories.
Lily: There’s a pretty common understanding that certain people are predisposed to psychotic symptoms after taking psychedelics. For example, people with bipolar disorder or borderline personality disorder. I want to be clear: Leah has no personal or family history of psychosis, bipolar, or personality disorders. MAPS screened her for all of that, and they just wouldn’t have let her into the trial if she did.
Dave: Other psychedelic researchers have told us that the symptoms Leah was talking about were definitely red flags.
Leah: I didn’t really know what to make of these experiences.
Lily: It started just days after her last MDMA session and then escalated.
Leah: Like at last a few times a week. This was part of the reason why I was really focused on having somebody who knew about psychedelics.
Lily: So she emailed her MAPS therapists.
Leah: And even when I wrote about having leftover psychedelic effects they kind of just sort of just glossed that one over and were like, “this isn’t about psychedelics. This is about your attachment problems and your trauma.”
Lily: Their response to her really highlights this idea of what’s in the frame and what’s not in the frame. Because the way that they view it, what she’s going through now, isn’t related to the MDMA trial. They think that it’s just related to her trauma in general.
Lily: We asked Dr. Mithoefer about this, how can you sort through whether symptoms like that are or are not related to the clinical trial?
Dr. Mithoefer: Well, it’s very difficult for me to comment on some situation that I know very little about
Lily: Dr Mithoefer told us that he couldn’t comment on Leah’s specific case.
Dr. Mithoefer: I’m sure all therapists don’t do everything perfectly at all times.
Lily: MAPS has generally said that these symptoms are not related to the clinical trial - they attribute them either to the original trauma, or to the process of psychotherapy - but not the MDMA session. But other researchers have told us that in an untested therapy like this one - you should exercise a lot of caution, and look really closely at any symptoms that come up.
Understandably, Leah gets more and more upset as they continue to deny there’s any connection between what’s happening to her and the clinical trial. So on one hand, she told us, she was feeling terrible about herself - like this was all her fault. And on the other hand–
Leah: I kind of snapped and I lashed out at them by email.
Lily: About six months after the last MDMA session, she writes to her therapists: “This situation is not okay. You gave me a drug that would make me trust you and bond with you. And then you severed that attachment.”
She starts dropping f-bombs.“Where the fuck is the concern for participants wellbeing after the study?” “Who the fuck designs, a researcher protocol that leaves people in this kind of shape and then cuts ties with them?” “Where the fuck is the aftercare?”
Lily: The therapists write back and say –
Leah: “I feel surprised by your email. I do not experience our connection as severed, nor have I cut ties with you. However, I’m sorry for not responding to some emails. I can see how that would make you feel abandoned.”
Lily: “It sounds like a young part that wants to sabotage all of the healing and growth that I witnessed in you.”
Leah: It was a power struggle for who got to tell this story of what was wrong with me.
Lily: There comes a point where Leah’s therapists do eventually offer her more sessions. By that time – it’s half a year later – their rapport is really strained and talking to her therapists is making Leah feel a whole lot worse. But something important starts to happen around the same time: Leah starts to meet other participants from other study sites. And she realizes that she’s not the only one. And as she hears their stories she gets more furious than ever — and she becomes really set on making sure that her own experience gets on the record, one way or another.
Leah: I started coming up with very elaborate plans. I wrote like probably dozens, if not more, suicide notes that I was planning on sending to the media, because I wanted to really make it clear that this was tied to the MDMA trial.
Lily: In June of 2020, she writes to the principal investigator for the site where she did her therapy.
Leah: I told her “I think that there are things that you don’t understand about the drugs that you’re using. And I think you need to know what’s happening to me”
Lily: The investigator asks her to consider sending along a write-up summary of her experience in the trial.
Leah: So I did. I wrote a pretty long document really detailing everything.
Lily: In that writeup, Leah outlines a couple of adverse events like suicidal thoughts “starting to turn into actions,” she says PTSD symptoms were returning, she had difficulty caring for herself.
Leah: And I also wrote that I was having leftover psychedelic effects.
Lily: The principal investigator thanks her and assures her that they’re exploring all of this and that it’s going to have an impact on their research.
Leah: Multiple people at multiple levels of the organization were looking into this and that they were taking it very seriously.
Lily: And they were going to share what they’ve learned with her. Over three months after Leah makes contact the principal investigator writes to say that it turns out she doesn’t have any more information to share, aside from that they updated the informed consent form a little bit. But she assures Leah that her experience will have an impact on the research that’s done.
Dave: At some later point, Leah asked MAPS to help pay for therapy she needed after the trial. MAPS declined, writing, “there is no evidence of a study related injury.” We actually spoke to one of her doctors and he confirmed Leah’s view - that she’d been a quote “high functioning person” before the trial, he also said it was “reasonable to make the association” between her decline and the trial.
Lily: So then fast forward to May 10th, 2021. Phase three results are published.
Dave: There was a huge celebration within the psychedelic research community.
Lily: It seemed like MDMA for severe PTSD was not only impressively effective, but that there seemed to be very little potential for harm. So the study comes out and Leah is reading it. And she’s thinking, “where is my experience of the study in this paper?”
Leah: There was a line in it that basically was saying like one participant from the MDMA group pulled out before the trial ended, because of a severe lowering of mood following one of the MDMA sessions, and otherwise, no adverse events of lowering of mood following MDMA sessions were reported.
I had very severe mood drops after all three of my MDMA sessions that my therapists were aware of. And like lowering of mood after an MDMA session is not quite as serious on the grand scheme of things as was acutely suicidal for a fucking year after the study ended.
Lily: There’s no mention of leftover psychedelic effects in the nature article. So these are three major events for Leah that seemed to have just disappeared from the scientific record.
Dave: So we’ve gone to MAPS and asked them where this person’s experience is? And why isn’t it reflected in the data or the discussion of these results?
Lily: MAPS told us that “reports of negative experiences following study termination are not considered SAE” or serious adverse events,” by the FDA.” Basically, they aren’t captured in the study data. MAPS added that that’s why the long term follow up studies are so important to fill in that gap.
Dave: In Leah’s case, her long term follow up was planned for a year after her trial. It was actually over 20 months before she was contacted about it.
Lily: When they did get in touch, Leah asked a bunch of questions about the informed consent document that she’d have to sign to participate. She’d been talking to a researcher friend who thought her concerns were big enough to ask about.
Dave: In an email the MAPS researcher wrote back: “My understanding is that you are declining study participation because the consent form raises concerns for you.”
Two hours later Leah wrote back. “No you’ve misunderstood” and said she just had some questions so she could feel “safe participating”.
Lily: Leah reminded them she had negative experiences and that she wanted those on the scientific record. But in the end they wrote it would be “inappropriate” for her to participate in the long term follow up.
Dave: All of this goes back to that question of framing. The way that you collect data affects the stories that you tell to the world.
Lily: When participants’ negative experiences are ignored, we can’t learn from it and we can’t evaluate safety or efficacy.
Lily: So here is a thing that’s unusual about these clinical trials. They’re combining a drug - MDMA - with psychotherapy. And this is a big deal because the FDA does not usually regulate psychotherapies.
Now for takeaway number three: What we like to talk about as the black box of therapy. MAPS presents these core ideas for how the therapy is supposed to be carried out. And it’s a, what they call a non-directive approach to therapy. The whole idea is that the therapists aren’t there to intervene or be heavy handed. It’s not for the therapists to lead. This is the participant’s trip.
Carlin: Lily, it’s good to see you. I haven’t seen you in a really long time.
Lily: The person in charge of training at MAPS now is someone I’ve known since my days as an aspiring psychedelic guide. And she told us that, for their most recent clinical trials, MAPS has been training all of its therapists to offer touch when it’s helpful
Carlin: Touch, like a hand to hold.
Lily: But to keep touch minimal.
Carlin: And practicing what that would look like. What parts of the body that would include or not include, times and situations that you would or wouldn’t offer it?
Lily: But in that manual, they give to all the therapists that they work with, they also list like a dozen different types of therapy that they say might occur spontaneously. And that list is broad. And colorful.
Erick: What’s this? Holotropic Breathwork?
Lily: Back when we met up with former FDA regulator Erick Turner, we walked him through the therapy manual.
Erick: Prolonged exposure, PE. Cognitive processing. Okay. So far so good.
Lily: It includes things people are more familiar with, but a lot of them are a bit more esoteric.
Erick: Internal family systems. IFS voice dialogue. Hakomi
Lily: Hakomi, which is very popular with Francoise Bourzat and her followers.
Lily: Psychosynthesis happens to be the name of the therapy that was designed by the infamous Salvador Roquet–
Erick: Blah, blah, blah. Okay.
Lily: Holotropic breathwork, which is like a hyperventilating to get high, healing modality popular among Boomer hippies.
Erick: Sounds like it’s kind of going to be real loosey goosey. I mean, usually in a clinical trial, you want one variable. You want to know: what is the drug doing? And if you add in a second variable, what one therapist compared to another could be doing, administering their therapy in very different ways…
Lily: They say the aim is to establish a “standardized approach to treatment.” And at the same time to provide “creative latitude”
Erick: To provide creative latitude. This is pretty frank, just say creative latitude, apply their own intuition and training. So it’s really enabling them to say, “do whatever you feel like in the moment. We trust you.”
Lily: Back in 2016, when Meaghan got that document – the one that summarized all the data from all the phase 2 trials – one of the things that really stood out to her was they were pooling all this data from these really small studies around the world – and she could see that different therapist teams had wildly different outcomes—but they were all mixed together as the evidence to show how well this was working. For example, the results from one therapist team were twice as good as another team. Or in another case, the placebo group actually did better than the drug group.
Meaghan knows now the extent to which at the end of the trial, she felt really dependent on her therapists — what she didn’t realize until we came along is what they did in that little incubator of a room where she got her therapy. The Black Box.
Meaghan: I don’t think there’s any way to process what I’ve heard about the clinical trials.
Lily: Her memory of what happened in those sessions was always a little bit blurry, but she did manage to get ahold of her videos from the trial.
Meaghan: All right. Take it away. Intrepid Video Watchers
Lily: As we were getting to know her, she asked Dave and me to watch the videos on her behalf.
Meaghan: What a horrible thing to have to do.
Lily: Could I walk you through some of what we saw, how it progressed? Just a reminder that you can say stop at any time.
Meaghan: Yeah, I’ll hold up my hand. I’m just going to listen for a while.
Lily: So within like an hour and a half of the tapes starting, there’s what I would describe as like an encroachment: knee against the bed, arms on the bed, hand holding, then he’s rubbing your back.
Dave: There’s like a thumb rubbing, that sort of like intimate partner contact. It’s not just a reassuring hand hold but it’s got that additional intimacy
Lily: There’s more than 75 hours of video recordings of what happened in that little basement room with the stained glass windows. And by halfway through the first session, there is a lot of touch. Richard Yensen is in almost constant physical contact with Meaghan. Like, she’ll go to brush her hair out of her face and he’ll grab her hand in the middle of it to hold her hand. And this escalates throughout the session. So eventually he’s like kneeling on the floor and kind of leaning over Meaghan, and then he’s in the bed with Meaghan and he’s holding Meaghan. And then Donna Dryer is in the bed with Meaghan as well. The music is driving and intense and percussive and overwhelming.
Meaghan: I remember it like the music wasn’t around me, but penetrating into me.
Lily: There are moments where you can see Meaghan is starting to show signs of distress and Richard reaches over to the computer and puts on more intense music.
Dave: You have to remember that Yensen was a devoted student and interpreter of Salvador Roquet.
Lily: It’s like it was designed to make you lose your shit.
Meaghan: Well, it probably was Lily.
Dave: There’s one point, in the second session, where Meaghan, at her therapists’ encouragement, is basically re-experiencing a sexual assault. Near the beginning of the session, Richard Yensen tells her to “lie back and spread your legs.” And Meaghan just snaps shut like a mousetrap. Then over time, they kind of console her and convince her she’s safe. And about two hours later, things start to escalate.
Lily: They engage Meaghan in this fighting where it starts off with holding her legs and feet and encouraging her to kind of kick, to putting more weight on her feet. She’s a really strong athlete. So it takes a lot to try to hold her down. There are moments where Richard Yensen has his whole body over the top of Meaghan and is pinning her down.
Dave: At one point, Meaghan is jerking her head around – she says she was basically looking to get away by just knocking herself out. There are points where she is screaming, crying, “get off me, get off me!”
Meaghan: How did they respond?
Dave: It’s hard to tell. Sorry.
Meaghan: No, keep going. I just, I can see it in my head. I got flashes of what it looked like and that was an extremely difficult session.
Lily: Shall I continue?
Lily: When they finally back off, they transitioned into a long period of cuddling her, stroking, her face and her hair nuzzling up to her Richard Yensen is eye gazing with her.
Dave: It’s like they’re offering themselves as comfort now, after this ordeal.
Lily: There’s a moment where he starts to fall asleep and Donna says she’s going to go make sandwiches. And as she gets up to leave the room, you can see Richard Yensen and hear Richard Yensen kiss Meaghan on the forehead. So, in that black box of therapy that we’ve been talking about, where the manual leaves so much room for the creativity and intuition of the therapists, this was what Meaghan got. It wasn’t until we watched and then described to Meaghan what her therapy looked like that we all wondered: were Richard and Donna following the protocol? Was this FDA-approved clinical trial therapy?
Dave: One person I thought might be able to answer that question was the lead investigator on Meaghan’s trial, Dr. Ingrid Pacey. Even though she hadn’t seen the videos, I described some of the practices that we had observed. Yensen and Dryer were putting a towel in the client’s mouth for her to bite on. In addition to lying on her and grappling or wrestling with her. Is that typical or an intervention strategy you’re familiar with?
Dr. Pacey: It’s used in holotropic breathwork. It is.
Lily: You may remember, holotropic breathwork is mentioned as a possibility in the manual. And lots of underground psychedelic people trained in it
Dr. Pacey: I can’t imagine the whole scene with him lying on top of her, but certainly in breathwork, what you’re trying to do is release the tension. Maybe the memory that’s held in the muscles. So you do that, you bite down and you pull the towel.
Dave: The MAPS manual suggests that using holotropic breathwork techniques is fine. Dr Pacey says it depends on the situation.
Dr. Pacey: All I can say is that I would not support a training that suggests that people do that to someone who’s taken MDMA.
Dave: Why not?
Dr. Pacey: Well, because I think with MDMA, you’re so opened up anyway, to have someone doing something as intrusive as that… no. With MDMA you don’t need to overwhelm anybody or push them into something.
Lily: The next question we had was even more basic than the last: had anyone at MAPS ever checked these videos to see if they thought the therapy was ok?
Hanna Rosin: Has anyone reviewed them?
Lily: That turned out to have a not so basic answer. Our Executive Producer asked Rick Doblin.
Rick: Yeah, of course. We reviewed them. Which videos?
Hanna: It’s the ones that Meaghan had, the ones of the clinical trial.
Lily: Later in the conversation Doblin sort of dismissed the videos as a non-issue.
Rick: Whatever made you uncomfortable watching those videotapes probably was not a sign that they were going to have a sexual relationship.
Hanna: I don’t know about that.
Rick: Maybe. I haven’t seen those particular ones.
Lily: So MAPS followed up to say that no one had seen the videos until we brought them up. But Meaghan says Dr. Mithoefer told her long ago that he did watch them - and wasn’t concerned.
When did you decide to review the videos of her MDMA sessions?
Dr. Mithoefer: I don’t know the answer to that, but it was after that.
Dave: But you have reviewed the videos?
Dr. Mithoefer: They’re under review right now.
Dave: Yes, but…
Betty: Currently, sorry, I need to jump in here.
Lily: MAPS has a PR person named Betty Aldworth and she jumped in whenever the videos came up.
Dave: So Betty, I would like to ask you why you told us that no one at MAPS had seen the videos?
Betty: Sure. So your supposition is incorrect.
Lily: MAPS gave us more than five different answers about who had watched the videos and when. They also said “we can’t talk about it now” because now, more than half a decade after the recordings were made, and more than 3 years after Meaghan reported what happened on Cortes, MAPS is doing a compliance review.
And they’ve drafted a statement that says: “Though the review is ongoing, MAPS has determined that Yensen and Dryer did not follow MAPS therapeutic protocol on several occasions during the sessions.”
In medical research, there is supposed to be a whole system in place to track whether protocols are being properly followed. MAPS has people called “adherence raters” – they’re supposed to watch the therapy sessions and rate how well the therapists are doing certain things and note anything that is clinically questionable.
Dave: In one of the phase 2 MAPS trials in Switzerland, adherence raters caught therapists cuddling on the floor with participants.
Lily: That doesn’t show up in any documents that we have seen. And MAPS was able to move right along to Phase 3 clinical trials, which is the last set of studies before this is potentially approved for the general public. Dr. Mithoefer told us the training and supervision is a lot more robust this time around.
Dr. Mithoefer: What I’m telling you is that was before the system of adherence rating and robust supervision that we have now.
Dave: So phase two wasn’t doing adherence rating and robust supervision?
Dr. Mithoefer: Not in the same way and not at that point. We were doing a best practices type of supervision but it wasn’t as robust as we have now. And obviously it was not as robust as we needed it to be.
Rick: My simple answer is we’re dealing with humans. We can have everything in place, but some humans are going to cross lines they shouldn’t cross. I think this is an aberration.
Lily: What happens in the therapy matters. And, at the end of the study, MAPS needs to be able to say with confidence MDMA plus the specific psychotherapy works.
The thing that keeps me awake at night is that this is the safest and most closely monitored these sessions will ever be. And if this gets approved, who knows what will happen in that black box?
As I’ve seen for so long in the underground world of psychedelic therapy, hype is getting in the way of rational thought; bad experiences – especially those of women – are being explained away; and what I see is willful ignorance about what’s going on in the black box of the therapy. That’s not at all the way Dr. Mithoefer told us he sees it. And MAPS has already completed the first round of Phase 3 clinical trials, where 46 more people were given MDMA with their therapy.
Dr. Mithoefer:You know, we’ve had extensive meetings with the FDA and been through a special protocol assessment. A lot of very experienced scientists have agreed that this is adequate for approving this drug. I think we need to be careful, but also, people need better treatments.
Lily: I hear what you’re saying and in light of having spoken to participants who say, “hey my CAPS score shows dramatic improvement, my self reported symptoms are life threatening and severe.” And that we have not been able to find that in the data and so I’m wondering if you think that…
Dr. Mithoefer: How many people have you spoken to? More than 20, less than 10?
Dave: Less than 10. And we’re aware of double digit numbers of participants beyond those who have expressed some degree of distress. That seems to be at odds with the public narratives.
Dr. Mithoefer: Without wanting to dismiss your concern about these people I appreciate that you’re concerned about them, but the idea that after all this research, that we would decide to change our design based on you having talked to five people, five or less people, we can’t do science that way. There are reports of over 20 veterans a day committing suicide. We have people dying in large numbers every day with PTSD and people suffering. So I think we should stick to the science and see what we need to discover what treatments may be the most helpful for them.
Lily: Most people we’ve talked to in this show, including victims of harm, have told us that they’ve gotten relief and insight from psychedelics. But we don’t actually know how safe and effective this kind of MDMA treatment for PTSD is because the science, so far, is so flawed. Dr. Mithoefer says that our talking to 5 people isn’t enough for them to make changes. Other experts have told us 5 people would be a major issue. More importantly, the types of things the participants are reporting to us are a big deal even if they only happen to one person. So what’s it going to take?
Dave: We don’t have all the information. We’re not the FDA. But there is an FDA and they already know what happens when treatments that aren’t proven safe get rolled out to the public. Especially if they are targeting a vulnerable population.
Lily: We asked Doblin what it would take for the FDA not to approve MDMA-assisted therapy.
Hanna: In your mind, is there anything that could derail it?
Rick: In this second phase three study, if we had several people in the MDMA group kill themselves, that would call into question the safety of what we’re doing. Are we properly monitoring people as we bring these difficult emotions to the surface? So that’s one thing that I worry about.
Lily: Is that really what it’s gonna take?