Duration: 20 minutes, 01 seconds

CHRIS AIKEN: Last week, an FDA panel rejected MDMA-assisted therapy for PTSD. The reasons why offer a cautionary tale.

Welcome to the Carlat Psychiatry Podcast, keeping psychiatry honest since 2003. I’m Chris Aiken, the editor in chief of the Carlat Report. And our co-host Kellie Newsome is on vacation today. 

Ten years ago, CBS aired an MDMA assisted therapy session for a woman with PTSD on its medical talk show The Doctors. We’re going to play that for you now, because based on last week’s vote at the FDA, this may be the only time we’ll get to hear this therapy, at least in the US. 

You can watch that on YouTube, and if you did you’d see wide eyed woman lying on a sofa, her therapist sitting close by. Her facial expressions are intense and her emotions rich and spontaneous. Radiant. With a sense of wonder as if she has just discovered a long lost treasure.

That’s one view of psychedelic assisted therapy, but it’s not the only one. We’re going to tell you about another video from 2014. This one is disturbing. It involves the MDMA dosing sessions in the MAPS clinical trials of a woman with PTSD from sexual assault. 

The woman is sitting on a bid, shaking, uncomfortable. She is surrounded by two therapists – a married couple, Drs. Donna Dryer and Richard Yensen. Dr. Dryer is a psychiatrist, and Dr. Yensen is a veteran psychedelic researcher and unlicensed therapist. 

As the patient starts to shake, the male therapist Dr. Yensen suggests she spread her legs while his wife takes her hand.

In the second session, the patient is much more distraught, crying in a panic. The male therapist is spooning her on the bed, and sometimes laying between her legs, while his wife offers blankets and support. In the last scene, both therapists are coddling and spooning her in the bed, telling her that it’s OK.

The videos were created as a kind of safety monitoring during the clinical trial, but things got much worse after the trial ended and the cameras were turned off. The patient moved to a remote Canadian island so she could continue the work of psychedelic healing with the two therapists she started the trial with. At that point, she alleges that Richard Yensen began making sexual advances, telling her that it was a form of exposure therapy that will help her heal from past sexual traumas. She was given other drugs like ketamine, and the therapist often demanded sex while she was in an intoxicated state. It was a slow process that tore away her defenses when she was already in a vulnerable state. In 2019, the patient filed a sexual assault complaint with the Canadian police. “I was seduced, drugged, raped, blamed and held as a sex slave for nearly two years," she says.

MAPS, the non-profit group that ran the trials, didn’t report this incident at first. They did so only after it came out in New York Magazine. The patient turned the video footage into the magazine, which featured it in season 1 of their Cover Story podcast: Power Trip. 

The media coverage has portrayed Richard Yensen – the male therapist – as an unlicensed therapist working at a low level in the MAPS trial. That is not the case. Richard is unlicensed, but he has practiced psychedelic therapy since the 1970’s as a licensed psychologist. He has directed institutes and taught at Harvard and Johns Hopkins. He helped develop MDA – a predecessor of MDMA – and lectured on how to avoid boundary violations during MDMA therapy. He is a giant in the field – someone who helped develop many of the therapeutic techniques in use today. Someone whom the US FDA has trusted with drug permits for investigational studies into LSD. 

 The incident caused Yensen’s wife to surrender her medical license. Both she and Yensen have acknowledged that the sexual relationship occurred, although Yensen argues that it was consensual. Lawsuits are underway, but I’ll point out that many believe that a consensual sexual relationship between a therapist and patient is not possible because of the power difference that exists. That is even more true when psychedelics are involved, which put people in a vulnerable state, wearing down their boundaries and will to say no. MDMA carries further risks, as the drug creates intimate feelings of love and trust.

The boundary violation loomed large in the FDA advisory panel’s decision to nix MDMA, but it wasn’t the only reason. We’ll get into that more in this two part series, but first an introduction to MDMA. We’re going to intersperse some clips from a recent interview with Owen Muir, a psychiatrist who coauthored a series of recent papers on psychedelics. Dr. Muir has no conflicts of interests with the psychedelic industry and declared that he has never tried the drugs himself. Kellie and I join him in that distinction. This interview was done in May 2024 before the FDA panel’s decision.

....

Merk never used the drug, and it lingered on the shelf until it was rediscovered by the Alexander Shulgin. Shulgin was a pharmacologist and an active explorer of psychedelic drugs. His wife, Ann Shulgin, was a marital therapist, and she began using MDMA in her therapeutic work. She found it opened up couples to a more compassionate, connected state, though it could also bring out darker, “shadow” emotions and fantasies. 

This early MDMA assisted therapy was a small but legitimate movement for nearly a decade. They formed a professional body – the Association for the Responsible Use of Psychedelic Agents – which held annual meetings and developed guidelines for MDMA assisted therapy. The grappled with sexual abuse by therapists as two cases of such boundary violations came to light in the early 1980s. Richard Jensen – the therapist accused of sexual misconduct in the MAPs trials – was a pioneer in this early work and presented at those conferences. So was Rick Doblin, the founder of MAPs.

....

Meanwhile, MDMA was slipping out of the therapy room and into the streets, where it became a popular club drug known as Ecstasy or Molly. In 1985, the US government reclassified it as a schedule I substance – with a high potential for abuse and no medical benefits. That classification forced the therapeutic movement to go underground, which it did, and it’s estimated that about 60,000 people have been treated with underground MDMA. 

As soon as it went underground, researchers started submitting proposals to the FDA to study the drug. Year after year, each proposal was rejected, until 1992 the FDA allowed it to be studied for depression and anxiety in patients with terminal cancer. From there, PTSD was a natural next step. 

....

More than most other psychedelics, MDMA creates strong emotional responses, evoking intense feelings of empathy and connection. In that way alone it reverses one of the most impairing symptoms of PTSD, “Feelings of detachment or estrangement from others.” In MDMA assisted therapy, the drug is given in 3 dosing sessions which last 6-8 hours each. During that time, the patient lies on a sofa with headphones and eyemask on, and interacts as needed with two therapists who act as non-directive guides who support them in opening up to the new experiences the MDMA brings. Often patients are able to experience trust, connection, and meaning for the first time since the trauma. 

....

Each dosing session is followed by integration sessions, 9 in total, where the experience of the psychedelic therapy is channeled into real life changes. The integration sessions are also long – 90 minutes – and eclectic, drawing from draws from exposure-based, psychodynamic, Buddhist, existential, and somatic-experiencing approaches. It’s a standard model for psychedelic therapy, similar to psilocybin assisted therapy for depression and many others. The therapy manual is free online – just google A Manual for MDMA-Assisted Psychotherapy in the Treatment of Posttraumatic Stress Disorder at MAPS.org. 

On the surface, MDMA assisted therapy worked quite well. In two randomized two randomized phase III trials, MDMA-assisted therapy had a large effect size compared to placebo-assisted therapy, about double the effect we see with SSRIs. Two thirds of these patients no longer met criteria for PTSD at the end of the study. These benefits were durable – documented for several months after the brief 12 session therapy ended. And these were not easy to treat patients. Most had severe PTSD that had not responded to medications or therapy. No one flipped into psychosis; no one had developed cravings or addictive behaviors around MDMA – which is a street drug known as Molly or Ecstasy. There were transient increases in blood pressure - MDMA is an amphetamine derivative – but no cardiovascular events and no cases of overheating or seizures which are known risks with recreational MDMA use. The studies were small, totaling 194 patients, but the FDA had already allowed that to speed up approval through its “breakthrough therapy” status.

So why did they reject it? Boundary violations are part of the reason, but they are not the only one, and the reasons behind this rejection carry broader lessons for psychiatry. More on that in next week’s episode. Let’s end with a preview of the CME quiz for this episode, which you can take through the link in the show notes.

1. MDMA is a derivative of which psychoactive drug?

A. Phenelzine and other MAOIs

B. LSD

C. Amphetamine

D. Mescaline