TEDxMidAtlantic: Why Ethics Matter in the Debate Around Psychedelics

A time capsule from the 2024 FDA Advisory Committee meeting on MDMA-assisted therapy.

Four days after the FDA advisory committee meeting on MDMA-assisted therapy last June, I spoke at a local TEDx in Washington, DC, accompanied by my family. I had anticipated talking about all of the things I wished the advisory committee had taken seriously. To my great surprise, it ended up being a victory speech.

Many people have taken issue with this word over the past year, but "victory" never meant "success at torpedoing MDMA therapy." That has been a convenient narrative for dehumanizing me and justifying hate, but it only seems plausible if you’re unaware of our years-long effort to provide critical safety information to those making decisions affecting society's most vulnerable people. We were finally heard and taken seriously, which — after everything we had seen and been through — seemed like a miracle.

In releasing the video of this talk, TEDx became the second independent organization that has vetted the accuracy and legitimacy of my claims, after the editorial board at The American Journal of Bioethics. Unrelated to accuracy, TEDx removed just over one minute where I discussed a beneficial experience with psychedelics, citing a policy of caution against unintentional promotion of experimental use. Needless to say, I am not an anti-psychedelic activist; I'm a psychedelic ethicist who understands the dangers of healing communities built on pseudoscientific beliefs.

Below, I include the full script of my presentation, which is also a poetic invocation of the work that I really want to be doing — the work that I put on hold, in order to speak up when it mattered. The framing and metaphors were drawn from the texts that I analyze in my book project on psychedelic poetics, which I’m writing my way back to.

Through it all, I find peace in remembering: what greater honor than to stand up for the truth when it matters?

Why Ethics Matter in the Debate Around Psychedelics | Neşe Devenot | TEDxMidAtlantic

My name is Neşe Devenot. After 3 postdocs and 10 years on the academic job market, I just finished my first year on the faculty at the Johns Hopkins University Writing Program.

Since 2010, I’ve been a psychedelic researcher, because psychedelics saved my life.

Back then, most people I met didn’t know what psychedelics were. Today — in 2024 — I bet some of you have heard of them.

Psychedelics are a diverse group of compounds that induce dramatic alterations of consciousness, including changes to perception, cognition, emotion — even sense of identity. Across many cultures and throughout time, psychedelics have been valued for their ability to occasion non-ordinary experiences that are often deeply meaningful and transformative.

When I was first offered acid — LSD — back in 2006, I didn’t know much about it. I didn’t realize that saying ‘yes’ meant that everything would change for me.

As some of my earliest memories, I’d been obsessed with a fear of death. The intrusive, repetitive, looping thoughts were often worst at night.

But then, on acid? I was with my best friend at dawn, in the forest at Bard College, when the sky crystalized into the first winter snow. I watched as the delicate snowflake structures seemed to vaporize as they collided with the ground — but then my vision went microscopic. Suddenly, in the spaces where the snowflakes had just been, dark-damp patches began burrowing deep into the soil. And for the first time, I saw death as a force of creation, transforming the conditions of possibility for new things to come into existence. 

And the intrusive thoughts about death stopped coming. 

Since psychedelics were illegal, the most profound experience of my life was an experience I wasn’t supposed to have, and I wanted to help change that.

I still think that psychedelics have extraordinary potential for healing and positive change, but during my many years in this field, I learned they also have a dark side, and the way we use them matters.

This week, working with a small team of collaborators at Psymposia, I organized the successful opposition to the first psychedelic therapy application before the FDA — Lykos Therapeutics’ new drug application of MDMA-assisted therapy for PTSD. Based on everything I just told you — that opposition might seem strange.

I didn’t challenge this because I don’t understand the value of psychedelics. I challenged it because they’re so important that we need to get this right.

In March 2024, a Lykos whistleblower entrusted me with disturbing allegations about the organization developing this therapy. These allegations included misreporting of serious adverse events in its clinical trials, such as one instance of suicidal behavior during an MDMA dosing session. Combining these accounts with my prior research and direct experiences, I realized the company’s culture was dangerous, and that this danger was linked to its rigid beliefs about healing.

Ultimately, I decided that the new allegations were too serious to keep quiet. If the industry moved forward under these conditions and people ended up getting hurt, I would feel complicit if I didn’t say anything.

Several of my contacts who’ve seen problems at Lykos have said they can’t speak up publicly due to various vulnerabilities. In my case — for the first time in my life — I have a secure job that is independent of the psychedelic medical industry.

And because I could speak up, I felt that I had to. Thinking forward to the future, I wanted to know that I did what I could.

In wrestling with what to do with that new information, I decided to organize a citizen petition to the FDA along with four co-authors, including Meaghan Buisson — my academic colleague and a former Lykos trial participant. We asked the FDA to convene an advisory committee meeting with an extended open public hearing so we could share concerns about the safety and efficacy of Lykos’ MDMA-assisted therapy. On May 30th, just over a week ago, the FDA granted our request to extend the open public hearing.

In my comments to FDA’s advisory committee, I argued that Lykos qualifies as a “therapy cult” that indoctrinates its therapists and participants into an ideological system of “true beliefs.”

Therapy cults transform therapeutic theories into rigid ideologies that promise reductive solutions for healing. Despite specific patterns of harm, therapy cults encourage their adherents to view themselves as heroes struggling against ignorant forces to bring enlightenment to humanity. 

The prospect of a therapy cult guiding a suggestibility-enhancing drug through clinical trials presents unique risks that have never been publicly discussed. The trials should be scrutinized as if Scientology or NXIVM had submitted a new drug application to the FDA.

This analysis has explanatory power for idiosyncrasies and allegations that are too consistent to be dismissed as hearsay or coincidence.

It connects everything from the rosy published outcomes, to the organization’s internal culture, to the specific nature of the abuses in its clinical trials, to the allegations of data misconduct, to claims that it's more like a religious movement than a scientific organization.

This is how Lykos represents its therapy. This image was published in a press release for its Phase 3 clinical trials.

Lykos describes its therapy as nondirective and empathetic, but that's actually misleading. It gives the impression of therapists standing by, and allowing the patient to lead their own experience.

The therapy component matters, because everyone agrees that MDMA increases the vulnerability of patients while they’re in altered states. Lykos claims its therapy training reduces the risk of assault and other violations by teaching therapists the “specific psychological intervention” used in its clinical trials. In reality though, this intervention directly contributed to sexual and physical assaults by therapists in those trials.

Their actual therapy model is acknowledged in this 2015 paper by Founder Rick Doblin.

In this paper, Doblin admits that Lykos’ “entire therapeutic approach” is based on Stanislav Grof’s spiritual teachings, and that the “essence” of that treatment approach is a “death-rebirth” process that often involves reenacting interpersonal trauma.

This specific therapy is foundational to Lykos’ methodology. While it’s not mentioned in any of the briefing documents submitted by Lykos to the FDA, it’s associated with patterns of harm across Lykos’ clinical trials.

Lykos’ therapy is described more fully in this book, Integral Psychedelic Therapy. Two of its three editors were Lykos trainers and Phase 3 therapists, and it was endorsed by prominent members of Lykos’ inner circle.

In this book, Veronika Gold — a Lykos supervisor, trainer, and Phase 3 therapist — describes pinning down a patient as their distress escalated to the point of shouting, [quote]: “‘Go away! Get your [effing] hands away from me!’” [end-quote]

But Gold did not stop pushing.

As demonstrated by the many Lykos therapists who endorsed this abusive practice, this is an accepted component of the therapy that Lykos claims is necessary for positive patient outcomes on MDMA.

As another therapist stated in the parent company's bulletin: "To process trauma, I think we need the…perpetrator…to make an appearance” during the dosing session.

Lykos also claims that the only “significant boundary violations” in its clinical trials involved a single Phase 2 participant, whose assaults were widely reported in the media.

Long after that Phase 2 participant enlisted the media to draw attention to the dangers of Lykos’ therapy, the “methods” involved in her on-camera physical assault are still explicitly promoted and taught as part of Lykos’ therapy.

Lykos argues that its training will ensure that "boundaries are maintained,” but its intervention actually heightens the risks for patients by promoting boundary violations by therapists.

Ultimately, the most significant harms in Lykos’ clinical trials were not caused by MDMA, but by the people who were entrusted to supervise its administration.

When I was preparing for this week’s FDA Advisory Committee meeting, I thought that we would just be putting a warning on the official record, so that people who got hurt later could access resources for validation and justice. I thought the momentum behind MDMA could not be overcome by a small group of independent scholars, activists, and former trial participants.

But on Tuesday, beyond my wildest expectations, we made international news in a "dark horse" victory that contributed to a sweeping vote of "no confidence" in Lykos' application. While the FDA still has to make its final decision, the Advisory Committee outcome sent a message of validation to all the people who’ve been hurt.

Let's be very clear: Lykos bears the responsibility for this decision. Their research should have been ethical and rigorous. The ends do not justify their means. Since these harms are predictable, they are preventable — and preventable harms are never acceptable.

Although dominant forces would like you to think their power is inevitable, they often don’t notice — in their hubris — how reality is always shifting.

Our power isn’t from the establishment; it comes through solidarity, and from speaking truth to power.

In a comment to the FDA, one Lykos supporter dismissed me as just a "professional writer.” But I made history this week because I’m a writer, an educator, an ethicist, a poet.

I noticed a chink in the armor of a giant machine, and I fired the petition as a poison dart — as poetic technology, and a force of creation.

Through language, we can take control of the construct, changing the conditions of possibility for new realities in the present.

This opposition to Lykos came from within the psychedelic field.

I work in psychedelic science, but this is psychedelic humanities.

Thank you.

TEDxMidAtlantic 2024