US Federal PTSD Seminar: A Battleground for Psychedelic Advocacy

This article was first published on LinkedIn on Sep 6th, 2024. It has been slightly edited for our audience at The Psychedelic Pulse. 

Every so often, the US Federal Drug Administration (FDA) decides to engage with the public through seminars and public meetings. There are many reasons they might do this, ranging anywhere from public education, industry advocacy, or occasionally as a political response to public outcry.

On September 6th, FDA affiliate The Reagan-Udall Foundation hosted one such public meeting titled “Advancing Treatments for PTSD”, and it was unsurprisingly packed to the brim with references to psychedelics and MDMA. In these public meetings, members of the public are invited to share their often impassioned opinions and experiences.

How did the federal representatives frame the conversation, and what were the takeaways?

Read on to hear my take.

Context for the Meeting

As an initial context for those that haven’t been following psychiatry medical development news lately, this meeting is the FDA’s first major communication to the mental-health-concerned public after the recent rejection of Lykos Therapeutics’ New Drug Application for MDMA-Assisted Therapy for PTSD (You can read more about that in my recent publication here). Though neither MDMA nor psychedelics were referenced in the materials sent out before the meeting, savvy analysts could have reasonably predicted the purpose of this meeting to lie somewhere between a renewed call to action amidst an urgent mental health crisis and a PR play to quell public outrage. I suggest that most of all, this was a grounding exercise for the agencies themselves. More on that later.

Opening Remarks- Intro to Post-Traumatic Stress Disorder

The hybrid meeting was divided into two halves with rather distinct tones: first, a series of brief statements from representatives of various federal agencies on their research initiatives and priorities, followed by 1.5 hours of comments from members of the public, both virtually and in-person.

As part of the opening remarks, the meeting began with an accessible overview of PTSD as a disease state by Dr. Bernard Fischer, MD, Deputy Director of the Division of Psychiatry at FDA. With descriptions of symptoms, statistics, and even a reference to a case of PTSD from a Shakespearean play, this presentation centered the focus of the meeting squarely on serving the clinical benefit of patients.

Dr. Fischer ended with practical advice for designing clinical trials investigating new treatments for PTSD, which you can read in the slide excerpt below.

Practical trial design advice from FDA’s Deputy Director of Psychiatry:

• Make sure trials enroll representative sample

  • Good demographic mix (ethnicities, sexes)

  • Range of time since trauma

  • Experienced single events and repeated trauma

• Informed by knowledge of the brain/body

  • Brain circuitry in response to threat (can be studied in animals)

  • Biomarkers (risk, diagnosis, endpoints)

• Informed by studies of resilience

(As an aside, I provide consulting services for small-to-medium companies developing new treatments for psychiatric disorders, including PTSD. For help in implementing the above recommendations and more, reach out to by email at kevin@pharmakaclinical.com)

Federal Partner Discussion

Moving into the brief presentations by federal agency representatives, some common trends began to emerge. The panelists each highlighted their dedication to providing care for veterans, either through funding or conducting clinical research. Multiple panelists highlighted the somewhat-recent approval of Nightware, a device-app digital therapeutic meant to help PTSD patients with nightmare control, as important progress for patients.

The first mention of psychedelic medicine came from the Department of Defense and Veterans’ Affairs (VA) representatives. The VA representative described the availability of funding for VA researchers in studying psychedelic treatments, with particular nod to MDMA. Though she did not explicitly mention the FDA’s rejection of the MDMA application, the subtext read something like “we see the promise and will continue the research internally.”

It wasn’t until Dr. Leith J. States, MD, MPH, took up the mic that the panel addressed the “elephant in the room”. Dr. States, representing the Office of Assistant Secretary for Health within the Department of Health and Human Services (HHS), spoke openly in admitting that everyone in the room “feels some type of way” about the recent decision on MDMA – the ambiguity about which way appears intentional. He continued, stating his position that psychedelics have strong potential, and highlighting the need to move forward in a safe way, with innovative trial design for these new treatments.

Stakeholder Public Comments

A bit less than halfway through the meeting, the seminar opened the public comment period, allotting a tight 3-minute slot to each of the many public speakers lined up on zoom, waiting to share their statements over the following 90 minutes.

This section immediately opened up with 4 statements all concerning MDMA, as emblematic as they were polar opposites, bringing the audience straight back to the similarly divisive statements made during the FDA’s Advisory Committee meeting on MDMA-Assisted Therapy from back in June of this year (covered excellently by Josh Hardman ofPsychedelic Alpha here).

Statement 1

The first statement, spoken by Michael Abrams, a senior health researcher and member of watchdog organization Public Citizen, was staunchly negative on MDMA, giving a strong commendation to the FDA for rejecting the Lykos application. He proceeded to highlight the concerns often raised in opposition to psychedelic research at large, including challenges blinding trial participants, lack of standardization of psychotherapy support, and concerns about long-term abuse potential.

Statement 2

Abrams’ statement established a somber air as the stage opened to Mary Rachel Armstrong. Contrasting with Abrams’ public health stance, Armstrong’s story was compellingly personal, describing her struggles with sexual trauma in her youth, the suffering she endured in her adult life, and culminating with the tremendous healing and relief she experienced after participating as a patient in a clinical trial of MDMA. With passion echoing in her voice, she stated that she might not be alive today if it were not for that treatment, and urged regulators to make psychedelic therapy available as soon as possible, so that more lives like hers might be saved.

Statement 3

Following Armstrong, and in another 180 degree turn in stance, Neşe Devenot was next to speak. Devenot, a senior lecturer at Johns Hopkins University and board member of psychedelic watchdog organization Psymposia, further decried Lykos Therapeutics’ MDMA treatment paradigm and condemned the media campaign she described as pushing psychedelic therapy at any cost. Devenot mentioned the FDA’s Complete Response Letter sent to Lykos, which has not been released to the public, and provocatively asserted that she had learned of some or all of the contents of the letter after speaking with Lykos employees. She suggested that in the letter, the FDA required any future clinical trials of MDMA conducted by Lykos must use “evidence-based therapy”.

While Devenot’s claim is unverifiable while the FDA’s letter is held in confidentiality by Lykos, and exactly what “evidence-based therapy” entails in this context remains unclear, we could speculate about the ramifications. FDA may be suggesting something more along the lines of Cognitive Behavioral Therapy (CBT) as ripe for pairing with psychedelics, in which case Lykos may be pressed to toss out their protocolized Therapy Manual and rethink their whole “Assisted Therapy” approach. Much more can be written about this, but I digress.

Statement 4

The 4th public comment was given by Jesse Gould, who introduced himself as founder of the Heroic Hearts Project, an organization dedicated to providing veterans legal access to psychedelic medicines. He began by describing his reaction to the FDA’s recent decision as “disappointed, but not surprised”, and suggested many feel the same way about the regulators approach to psychedelic regulation. Gould asserted that Heroic Hearts and other similar organizations would continue to fight the battle to provide legal psychedelic access to veterans, and urged the federal agencies to prioritize the thousands of veteran lives lost to suicide every year due to inadequate treatment options.

From there, the 3-minute statements continued without any further comment from the agencies. Not every statement was about psychedelics – many were veterans speaking about their personal struggle and advocating for any new effective treatments. Still, the majority opinion was clear. More than 50% of the public speakers were fervently in favor of psychedelic medicine. This author did not hear any further statements against psychedelics beyond the two described above, but I may have missed a few, as I had to tune out 20 minutes before the end.

Conclusions

Reading into the subtext of the agencies presentations at this seminar, it is clear that the US federal agencies are navigating a complex and politically charged drug regulation landscape. Striking a balance between public safety and access to effective treatments is a dance that the FDA knows better than just about anyone.

This meeting shows with abundant clarity that the US government has heard and continues to make space for the public’s advocacy for new treatments for PTSD, including psychedelic medicines. I suggest that the preponderance of these many formally organized public statements is a major force that will allow these political agencies to act, serving as weighty evidence in the public health decision-makers’ toolbox. Time will tell how these sentiments will translate into policies, funding changes, and the building of public-private partnerships.

On the development side, technologies such as Nightware were highlighted and demonstrated the agencies’ willingness to adopt and pay for digital therapeutics for PTSD patients. The focus on innovative approaches to clinical trial design in psychedelic research signify positive news for the nascent psychedelic industry, particularly for sponsors willing to push the envelope. Close contact with FDA while planning clinical development programs will be essential in this rapidly changing environment.

You can view all of the meeting information for “Advancing Treatments for PTSD”, including the agenda, federal speakers, and introductory presentation slides here.