--:-- Sean Rameswaram: Welcome to Today Explained. I'm Sean Rameswaram here with our reporter Halima Shah, who last week brought us stories featuring people who had positive experiences with MDMA-assisted therapy.
--:-- Halima Shah: Yeah, this person was in a late-stage clinical trial, which reported that participants had a significant and robust improvement in PTSD symptoms over the course of the trial. But what this participant says is that she fell apart after the trial, and that's not reported.
--:-- Sean Rameswaram: That's right. And today, we're going to hear from someone who had a negative one. Yeah, this person was in a late-stage clinical trial, which reported that participants had a significant and robust improvement in PTSD symptoms over the course of the trial. But what this participant says is that she fell apart after the trial, and that's not reported.
--:-- Halima Shah: Yeah, this person was in a late-stage clinical trial, which reported that participants had a significant and robust improvement in PTSD symptoms over the course of the trial. But what this participant says is that she fell apart after the trial, and that's not reported.
--:-- Sean Rameswaram: The participant's name is Sarah McNamee, and I met her at her home in Montreal.
--:-- Halima Shah: I always enjoyed cooking as a kid. And then after I developed PTSD, I think cooking was like the only place where I fit.
--:-- Sean Rameswaram: What's she cooking?
--:-- Halima Shah: She's making tomato soup. And she spent years, actually, cooking professionally in restaurants.
--:-- Sean Rameswaram: And she found another world where she fit in. Trauma research.
--:-- Halima Shah: After six years in the restaurant industry, she decided to go back to school and got a master's degree in social work, focusing on trauma.
--:-- Sean Rameswaram: I did end up gravitating towards that, I think in large part to understand myself. I think I was diagnosed probably when I was about 22, but the PTSD developed like subsequent to like quite a violent attack.
--:-- Halima Shah: Like I was having panic attacks and I was, I was having a lot of nightmares. This is when I was early in the restaurant industry. So I was, I was using alcohol and drugs quite a bit to numb.
--:-- Sean Rameswaram: In the years that passed, Sarah found ways to cope. Therapy, self-care, good friends. But she had a relapse after another traumatic event, and she needed help.
--:-- Halima Shah: So she enrolled in a phase three clinical trial.
--:-- Sean Rameswaram: And I want to briefly remind our listeners how this works. It's an 18-week process. She's assigned to two therapists, and for her first experimental session, she gets MDMA or placebo.
--:-- Halima Shah: And then she processes that experience through a series of talk therapy sessions. And the whole sequence repeats itself two more times.
--:-- Sean Rameswaram: The company behind these trials is Lycos, which is the pharma spinoff of a group called the Multidisciplinary Association for Psychedelic Studies, or MAPS.
--:-- Halima Shah: Both are founded by a psychedelic evangelist named Rick Doblin, who's been at this for the last 40 years.
--:-- Sean Rameswaram: What we're talking about is a world of net zero trauma by 2070. So that is the new animating vision for me.
--:-- Halima Shah: Participants like Sarah say there was pressure in these trials to report positive outcomes so they could, quote, make history.
--:-- Sean Rameswaram: Hmm. There was such a strong feeling of it being part of something bigger than me and, like, helping to legalize psychedelics. It was, like, this movement.
--:-- Halima Shah: So when Sarah and I talk about this, she mentions several things that alarm her. And some of the big ones were that MDMA sometimes felt good and sometimes it felt agonizing.
--:-- Sean Rameswaram: The second is that, in hindsight, Sarah told me she couldn't always advocate for herself as a trial participant because she was on a lot of drugs and she was kind of advised to trust the process.
--:-- Halima Shah: And the third is that because of how the trial wrapped, Sarah said she fell apart afterwards.
--:-- Sean Rameswaram: So to walk you through her experience she shows up for her experimental session and takes her pill
--:-- Halima Shah: And I having like a lot of anxiety coming up and I just kind of like trying to breathe through it
--:-- Sean Rameswaram: It climbs and climbs and climbs to the point where, like, it really, there was no way I didn't have MDMA in my body.
--:-- Halima Shah: But the anxiety doesn't last the whole time. And then it shifted. I just felt really peaceful.
--:-- Sean Rameswaram: It still makes me really emotional to think about it. It was gorgeous, like I remember just feeling like I just slept for 100 years and I felt so rested after maybe 30 minutes of this.
--:-- Halima Shah: And then it was like I got strapped into the trauma roller coaster and the rest of the session was just intense reliving of trauma.
--:-- Sean Rameswaram: It felt very much out of my control. It didn't feel like I was making choices.
--:-- Halima Shah: She describes it as motor mouth, like her jaw was tense and chattering and she felt like she was almost compulsively telling her story.
--:-- Sean Rameswaram: What are you feeling right now talking about this?
--:-- Halima Shah: It's really complicated. There's a lot of mixed emotions.
--:-- Sean Rameswaram: It was difficult, but I think it ultimately did kind of help.
--:-- Halima Shah: Wow, I didn't see that coming, actually. I thought that sounded so negative for her that I thought it was going to be just a negative experience altogether.
--:-- Sean Rameswaram: But she's saying there still was some positive.
--:-- Halima Shah: Yeah, and Sarah said in that first session, she gets 120 milligrams of MDMA, which is a high dose.
--:-- Sean Rameswaram: Like, just for reference, a microdose would be around 40 milligrams or less.
--:-- Halima Shah: But in the second session, participants have the option of taking more MDMA for a potentially more intense, more healing experience.
--:-- Sean Rameswaram: But Sarah told me she felt like she couldn't handle more.
--:-- Halima Shah: And she said she told her therapists that too. But she still ends up taking the higher dose.
--:-- Sean Rameswaram: It was like brushed off. I don't know how exactly it got communicated, but I understood that they believed that a bigger dose would be better.
--:-- Halima Shah: And I would get more out of it.
--:-- Sean Rameswaram: And that I should just sort of like, you know, surrender was the keyword of the whole trial.
--:-- Halima Shah: I was supposed to just surrender to everything.
--:-- Sean Rameswaram: I've never been part of a psychedelic trial, but this sounds sketchy.
--:-- Halima Shah: Yeah, this is what Sarah told me.
--:-- Sean Rameswaram: And I also reached out to her trial therapists and they didn't respond to my request for comment.
--:-- Halima Shah: So there's only so much I can know about what happened inside these sessions.
--:-- Sean Rameswaram: They are all recorded, but for patient confidentiality reasons, I obviously can't see them.
--:-- Halima Shah: Sarah told me she got along with her therapists, and she believes they were trying to help her.
--:-- Sean Rameswaram: But in that second session, she said the trauma rollercoaster was so much worse.
--:-- Halima Shah: It's so hard to describe it. Like, I felt like I'd been beaten up.
--:-- Sean Rameswaram: I was having really intense physical experiences, a lot of pain.
--:-- Halima Shah: There were several points in time where I was just writhing on the floor in pain, crying.
--:-- Sean Rameswaram: I didn't feel healing.
--:-- Halima Shah: Sarah told me that when this happened, her trial therapists employed what the MAPS therapy manual refers to as focused body work.
--:-- Sean Rameswaram: The idea is that someone will apply physical pressure to the participant for them to resist against.
--:-- Halima Shah: And this is supposed to release like an energy blockage or some type of trauma that's manifested itself as physical pain in the body.
--:-- Sean Rameswaram: And according to the MAPS therapy manual, consent for any kind of touch needs to be obtained before the participant takes MDMA.
--:-- Halima Shah: And that touch can't be sexual and it has to be motivated by the participant's needs, not the therapist's.
--:-- Sean Rameswaram: I would hope so.
--:-- Halima Shah: You know, they were pushing on my stomach, but they put a pillow between their, you know, there were steps taken to mitigate the intimacy of the touch.
--:-- Sean Rameswaram: But looking back, she said the ethics of it all are tricky.
--:-- Halima Shah: It's tricky. I don't know the answer.
--:-- Sean Rameswaram: And especially, like, in retrospect, I do think that helped. But I don't feel good about it.
--:-- Halima Shah: And she's not alone in saying that.
--:-- Sean Rameswaram: The whole concept of touch in psychotherapy is controversial even without psychedelics.
--:-- Halima Shah: Given that MDMA famously makes people open to intimacy, how well-equipped is someone who's rolling to enforce boundaries around touch?
--:-- Sean Rameswaram: It's a question that MAPS has faced before.
--:-- Halima Shah: A couple years ago, a Phase II participant released a video of herself in distress in an MDMA session.
--:-- Sean Rameswaram: Her therapists are recorded pinning her down and cuddling her.
--:-- Halima Shah: The participant later filed a civil claim, alleging that her male therapist sexually assaulted her in follow-up treatment after the trial.
--:-- Sean Rameswaram: And the parties agreed to dismiss the lawsuit, but the terms weren't disclosed.
--:-- Halima Shah: MAPS said the therapists violated protocol and barred them from the trials.
--:-- Sean Rameswaram: But the ethical questions around the use and risk of therapeutic touch and psychedelic-assisted therapy remain, especially because the treatment is still so novel.
--:-- Halima Shah: I mean, this is red flag on red flag.
--:-- Sean Rameswaram: And you're saying this trip was worse than her first one.
--:-- Halima Shah: Yeah. But what she tells me is that her therapist suggested that this really painful stuff that was coming up was stuff that needed to be faced.
--:-- Sean Rameswaram: They really believe that you just need to surrender.
--:-- Halima Shah: And this was always repeated. Like, just, you know, see if you can surrender. Like, what's coming up is coming up to be healed.
--:-- Sean Rameswaram: There were these, like, catchphrases almost that they used really regularly.
--:-- Halima Shah: There's a concept within the MAPS therapy manual about the inner healing intelligence.
--:-- Sean Rameswaram: It's an idea that each person has an innate capacity to heal their own trauma.
--:-- Halima Shah: The MDMA and the therapists are just facilitators.
--:-- Sean Rameswaram: You know what best for you. You are the key to your own healing.
--:-- Halima Shah: I think it's a gorgeous clinical concept, but I think it's getting twisted.
--:-- Sean Rameswaram: There was a point in the trial where it was like trust the process and trust yourself and trust your inner wisdom.
--:-- Halima Shah: Very much became trust us and trust the protocol and trust MAPS.
--:-- Sean Rameswaram: As a participant, Sarah said she did trust her trial therapists.
--:-- Halima Shah: She even became dependent on them.
--:-- Sean Rameswaram: But that degree of reliance in retrospect is troubling to her.
--:-- Halima Shah: You're already taking away a lot of people's agency by giving them drugs that make them super vulnerable.
--:-- Sean Rameswaram: And then you're, like, taking even more of their agency away by not listening to the boundaries.
--:-- Halima Shah: Or by framing boundaries as something that needs to be overcome.
--:-- Sean Rameswaram: I just, like, after that second session, like, I was so shattered.
--:-- Halima Shah: Does she continue with this trial or does she bow out?
--:-- Sean Rameswaram: She stays. She continues.
--:-- Halima Shah: Sarah said that she and her therapists were pretty convinced that this trial was going the way it was supposed to, even when it was uncomfortable.
--:-- Sean Rameswaram: Especially because Sarah told me she was reporting a decrease in flashbacks and nightmares on her PTSD assessments.
--:-- Halima Shah: Lycos uses the industry standard measures to assess PTSD symptoms and suicidality.
--:-- Sean Rameswaram: They had independent raters administer it, not therapists, to avoid the bias.
--:-- Halima Shah: But the problem is this instrument doesn't always capture the full picture.
--:-- Sean Rameswaram: And Sarah said it made her look like her PTSD was improving, even when she was telling her therapists that she was seriously struggling.
--:-- Halima Shah: I was feeling like really like they'd ripped me open and now they were just going to go away and I was going to be left to deal with this.
--:-- Sean Rameswaram: So it was like as I was contemplating losing their support that I got very scared.
--:-- Halima Shah: And my mental health took a nosedive after that.
--:-- Sean Rameswaram: And then after the trial, Sarah told me she was suicidal.
--:-- Halima Shah: She reported it to her trial therapists and Lycos in documents I've reviewed.
--:-- Sean Rameswaram: Wow. I'd say in the year and a half after the trial, it was not at all clear to me or my doctor that I was going to survive.
--:-- Halima Shah: What does Lycos or MAPS have to say about all this?
--:-- Sean Rameswaram: That was my question too. And we'll hear from the CEO of Lycos, Amy Emerson, next.
--:-- Amy Emerson: I spoke to Amy Emerson, whose clinical trial career spans two decades.
--:-- Halima Shah: She is actually someone who in the early aughts was so compelled by MDMA's potential to treat PTSD that she worked pro bono to set up clinical trials.
--:-- Sean Rameswaram: And today she's the CEO of Lycos.
--:-- Halima Shah: And I asked her about what we talked about, some of these participant concerns, especially the risk of increased suicidality.
--:-- Sean Rameswaram: suicidality. We enrolled a population of people with PTSD that had a high rate of suicidality.
--:-- Amy Emerson: Like over 90% of our patients in the study had this history.
--:-- Halima Shah: So it was really important to track that throughout our clinical trials.
--:-- Sean Rameswaram: And we used validated measures, one called the Columbia Suicide Severity Rating Scale, at every single visit.
--:-- Amy Emerson: So people were asked how they were doing, and they were asked to complete that at every visit.
--:-- Halima Shah: So these were then tracked and reported.
--:-- Sean Rameswaram: And if they went above that baseline, so remember 90% of the people in the study already had suicidality at baseline, then they were reported as adverse events.
--:-- Amy Emerson: So one way or another, it was collected in the study as long as they reported it.
--:-- Sean Rameswaram: I'm like, okay, but some said that they felt pressured to report positive outcomes to avoid jeopardizing legalization or blocking medical use for other PTSD patients.
--:-- Amy Emerson: So how could you know that participants weren't holding back in their self-reports?
--:-- Halima Shah: I can't know what somebody didn't report, right?
--:-- Amy Emerson: All we can do is look and ensure that what they did report was there and we can ensure that the therapists and the sites were trained appropriately for collecting adverse events.
--:-- Sean Rameswaram: But even with all the oversight, how did the study account for people like Sarah, who became suicidal after the trial?
--:-- Amy Emerson: Amy Emerson said there was a long-term follow-up study.
--:-- Halima Shah: We collected data in the long-term follow-up six months to a year later that we were doing the long-term follow-up.
--:-- Sean Rameswaram: In the second phase three study, it was closer to the six-month time point.
--:-- Amy Emerson: In those phase three follow-ups, did you find that anybody's suicidality exceeded their baseline?
--:-- Halima Shah: I don't have individual reports in my head, but for the people that did enroll in the long-term follow-up study, all of that data is published.
--:-- Sean Rameswaram: And there was not an increase in suicidality to the point that things were an adverse event or above the baseline
--:-- Halima Shah: Final data from the follow study has not been published yet and participation in that long follow study wasn a requirement
--:-- Sean Rameswaram: Almost a quarter of phase three participants weren't in it, including Sarah.
--:-- Halima Shah: In other words, the long-term follow-up study's data can't tell the full story.
--:-- Sean Rameswaram: And I should add that after my interview with Lycos, they announced that if the FDA approves their treatment, They'll add more oversight measures and collaborate with outside experts on therapy training.
--:-- Halima Shah: But this, like, you know, we spent two episodes talking about the potential here, this decades-long, you know, experimentation and belief that MDMA-assisted therapy can help people, can help our veterans who are experiencing PTSD.
--:-- Sean Rameswaram: But everything you've said so far in this episode makes me feel like there's a lot to still figure out here.
--:-- Halima Shah: Which way is the tide turning? Is it turning towards approving this or is it turning, you know, back to this is dangerous and should be a schedule one substance or whatever it is?
--:-- Sean Rameswaram: I do think that what's happening is that the hype bubble is starting to deflate a little.
--:-- Halima Shah: There is still a lot of public pressure from people who feel like this is their own or their loved one's last hope for treatment-resistant PTSD.
--:-- Sean Rameswaram: Last year, 50,000 Americans committed suicide. Another annual increase.
--:-- Halima Shah: Imagine how many lives your vote could save. Imagine how many will be lost if you vote against this vital therapy.
--:-- Sean Rameswaram: And the FDA can do a couple of things this month.
--:-- Halima Shah: It can wholesale greenlight this, which would be surprising.
--:-- Sean Rameswaram: It can wholesale reject this, or it can say, come back to us with more information.
--:-- Halima Shah: So where does that leave someone like Sarah, though, who sounds like, you know, she had this awful experience with MDMA-assisted therapy?
--:-- Sean Rameswaram: What's interesting is that Sarah did not come away from this experience thinking that MDMA is a bad drug.
--:-- Halima Shah: She came away thinking that she was in a bad trial that left her pretty traumatized.
--:-- Sean Rameswaram: And to work through it all, she's going to therapy.
--:-- Halima Shah: She still cooks.
--:-- Sean Rameswaram: I love this.
--:-- Halima Shah: And she's kind of taken matters into her own hands.
--:-- Sean Rameswaram: Paradoxically, what helped me, I think, in really significant ways, was MDMA.
--:-- Halima Shah: Like taking MDMA after the trial.
--:-- Sean Rameswaram: Yeah, which feels awkward to talk about.
--:-- Halima Shah: Wait, hold on.
--:-- Sean Rameswaram: Halima, is she saying that she's like now buying MDMA the way like ravers are or like, you know, college kids at a party are?
--:-- Halima Shah: She did say that she got MDMA illegally and that for a year she just waited to take it.
--:-- Sean Rameswaram: And then when she was ready, she used it to process her experience in the trial.
--:-- Halima Shah: And I did a session. I asked a really close friend of mine to be there, just to, like, make sure I didn't have a heart attack.
--:-- Sean Rameswaram: I took a really low dose, and I had the most beautiful session.
--:-- Halima Shah: And, like, I processed so much of what happened in the MAPS trial during that session.
--:-- Sean Rameswaram: So like you couldn't possibly say that I'm anti-drug because I do think that the MDMA ultimately really helped me and it helped me recover from what MAPS did to me.
--:-- Halima Shah: What made that experience so different from being in the session?
--:-- Sean Rameswaram: A lot of things, I think. Like one, I was with someone I knew really well and I trusted and I already had an established relationship with.
--:-- Halima Shah: I felt in control.
--:-- Sean Rameswaram: It's a surprising end after her experience in the trial, isn't it?
--:-- Halima Shah: I'm very surprised.
--:-- Sean Rameswaram: Yeah, but it's also not surprising.
--:-- Halima Shah: MDMA might be showing up in a medical framework now with therapists and regulators, but it hasn't shown up that way for most of its existence.
--:-- Sean Rameswaram: MDMA got going with Sasha Shulgin, a chemist in his tool shed in the 1970s.
--:-- Halima Shah: I looked upon it as a possible low-calorie martini or no-calorie martini.
--:-- Sean Rameswaram: His wife, Anne, thought it was penicillin for the soul.
--:-- Halima Shah: I realized that I was a treasure.
--:-- Sean Rameswaram: I felt as if I were held in the hands of God.
--:-- Halima Shah: But they didn't take it in therapy themselves.
--:-- Sean Rameswaram: They were self-experimenting.
--:-- Halima Shah: And whether or not the FDA approves MDMA this month, I can't see it taking decades to move the scientific process forward again.
--:-- Sean Rameswaram: I can see some serious wrangling with the group bringing this therapy into the mainstream and how they do it.
--:-- Halima Shah: But overall, I think MDMA's reputation as medically useless or poisonous has kind of worn off.
--:-- Sean Rameswaram: It's got a new reputation now as a potential healer.
--:-- Halima Shah: And I don't think that scientists or patients are ready to give up on that just yet.
--:-- Sean Rameswaram: Halima Shah, she's a reporter and a producer here at Today Explained.
--:-- Halima Shah: And this episode was the third in a three-part series she made about MDMA-assisted therapy.
--:-- Sean Rameswaram: You can find the other ones in our feed under the title Ecstasy Therapy.
--:-- Halima Shah: Our series was edited by Lissa Sowep and Matthew Collette, who also fact-checked today with help from Laura Bullard.
--:-- Sean Rameswaram: It was brought to you with support by a grant from the Ferris UC Berkeley Psychedelic Journalism Fellowship.
--:-- Halima Shah: We thank them for their support.
--:-- Sean Rameswaram: We were mixed by Rob Byers and Andrea Kristen's daughter.
--:-- Halima Shah: And we want to thank our colleagues over at New York Magazine who did a lot of foundational reporting that helped Halima in a show of theirs called Cover Story Power Trip.
--:-- Sean Rameswaram: You can find that show on those devices where you listen to your audio programs.
--:-- Halima Shah: This show is called Today Explained.
--:-- Sean Rameswaram: Thanks for listening to us.
--:-- Halima Shah: Thank you.
