A psychedelic train wreck

Last week's disastrous FDA hearing on MDMA therapy

I tend to refrain from reporting extensively on the happenings within the psychedelic ecosystem. Many do it well (such as Zach Haigney, Jules Evans, jane c. hu, and Josh Hardman). But in light of the magnitude of the events last week, it feels off to talk about anything other than the shitshow that just went down.

On Tuesday, June 4th, the FDA Advisory Committee held its day-long hearing to vote on whether the evidence on the efficacy of MDMA-Assisted Therapy (MDMA-AT) for PTSD was sufficient, and whether the benefits outweighed the risks.

As a colleague said, watching the hearing was like “watching a train slowly crash”.

The committee voted 9:2 against MDMA-AT’s clinical efficacy, and 10:1 against the statement that benefits outweighed risk. Note: This is not the vote on FDA approval itself, it is simply a vote by an independent advisory committee that will inform the FDA’s decision, which will happen by August 11.

After a presentation on the clinical results, abuse potential, and the FDA’s tentative plan to address safety concerns, several testimonies were given (20 in favor of MDMA-AT, 10 against). You can find a more detailed run-down of the events here.

There were many warning signs. Pivotal moments when the Lykos train (the drug sponsor, incubated within MAPS) began getting off track, starting with a podcast exposing misconduct in 2021, and peaking with a recent report from independent research think tank ICER arguing that clinical evidence for MDMA-AT was insufficient.

In addition to what’s been said about clinical limitations inherent in psychedelic research (functional unblinding), expectancy effects, selection bias, MAPS culture, the problems with therapy models centered around “inner healing intelligence”, and the risks of misconduct, I have only three observations to offer:

1. The public hearing was not a discussion about the science

2. The committee members were ill-equipped to assess the intervention

3. The discussion of clinical need was grossly lacking

The public hearing was not a discussion about the science

Rather, it turned into a character assassination. MAPS founder Rick Doblin was criticized for his mission of “global spiritualization”, his organization was depicted as a therapy cult, and Lykos CEO Amy Emerson was slandered. But this was not what the FDA was here to discuss: The hearing’s purpose was to assess whether clinical data was sufficient and whether the risks outweighed the benefits. Instead, the hearing turned into a public commentary on the character of individuals and psychedelic stereotypes more broadly.

It was obvious that several committee members arrived with pre-existing stigma against psychedelics, which opposing public comments only fueled. One comment from a committee member shows this perfectly: “I felt weird voting “no” on something with a p-value with three zeros in front of it.” And yet he did, because it was not a vote on science.

The committee members were ill-equipped to assess the intervention

Drug-enhanced therapy is a novel mental health intervention. The FDA does not regulate therapy — consequently, the advisory committee was not equipped to evaluate the therapeutic components.

This points to a more fundamental issue with psychedelic therapy: it is not simply a new treatment, it is a new model of care. As such, it will not fit into existing structures and processes for the approval and implementation of new treatments.

Mainstream psychiatry is not properly educated on the nature of the intervention. Perhaps Lykos asked for too much from the FDA when it made therapy an explicit, regulated component. But the alternative seems scarier than a well-intended model subject to the same risks that all therapy is subject to, albeit amplified.

It will be interesting to see whether more conventional for-profit psychedelic pharmaceuticals that have stripped away the therapy component completely will have it easier with the FDA…I suspect so.

The discussion of clinical need was grossly lacking

Most poignantly, an essential question to whether a treatment should be made available or not — the severity and volume of those in need suffering — was left largely untouched.

As Zach Haigney points out, one committee member — a VA psychologist nonetheless — stated that “we already have PTSD treatments that are evidence-based, work well, and require fewer resources”. Comments as such demonstrate the removal of the committee from the severity of the day-to-day realities of treating PTSD patients.

Up to 40 veterans commit suicide each day. This number has remained stagnant since the 2000s, there has been virtually no innovation in trauma treatments in decades. If existing treatments worked, we would not still have millions of veterans struggling with PTSD, and thousands of those killing themselves every year. The evidence-based PTSD treatments widely available across the VA do not work for everyone, and more importantly, have high dropout rates (35-62%). And that’s just veterans, who aren’t even the biggest PTSD population.

(In previous Lykos studies, only patients with severe PTSD were treated, who had tried all existing paths to recovery and suffered on average for 14 years. After a few months of treatment, two-thirds of them no longer qualified for a PTSD diagnosis.)

Lykos is imperfect. Psychedelic therapy is imperfect. Because humans are imperfect. Criticism was barely directed towards MDMA as a substance but towards the people who developed the therapy, the people who provided it, and the people running the organizations involved.

Misconduct occurs in all therapy, not just in psychedelic therapy. Because individuals are much more susceptible to lasting harm in altered states, we must come together to define guardrails that minimize risk and provide support structures for the harmed.

While concerns regarding scientific limitations and the nature of the therapeutic modality may be valid, they must be weighed against the detriments of non-action.

It is unacceptable to withhold this treatment from the millions suffering from the effects of trauma, first and foremost women with a history of sexual assault. As someone who may very well no longer be here if it weren’t for psychedelic therapy, I am frustrated by the lack of big-picture thinking and objective reasoning. My heart bleeds for all the trauma victims who do not have the awareness of psychedelic therapy that I had, or the money to attend a multi-thousand dollar retreat abroad.

This was a humbling moment for a movement known to lack ownership and receptivity. One individual noted that this hearing could have been much less dramatic if key stakeholders had listened earlier and acted more proactively and with intention.

What now?

There is still a 1 in 3 chance that the FDA will go against the AdComm’s recommendation. FDA uses these committees not to assess whether or not drugs should be approved, but rather to illuminate what prevents drugs from being approved. Ironically, the FDA held a public meeting yesterday to discuss its use of AdComms altogether, questioning whether they remain useful.

MDMA approval has officially returned to what psychedelics have been since the 70s — a political fight. The main opposition is not the lack of science, but the stigma.

There are a few possible outcomes: if the political environment allows for it (or demands it), MDMA-AT could still be approved. The FDA may ask for follow-up studies to answer open questions — worst case, Lykos would need to repeat its Phase 3 study. This would set the field back by years, and it is questionable whether funding would be available for such an endeavor.

The FDA’s answer would not be “no” but “not yet”. If the FDA fails to approve within the next year, my faith in the medical model of psychedelics will begin to dwindle, which has inherent problems to begin with. Thankfully, this is not the only path, as successful state-legalized programs and decriminalization efforts across the country have proven. (In other bad news, California’s bill to regulate psilocybin failed a few weeks ago, the team behind the bill is allegedly pivoting to a 2026 ballot measure now, following the footsteps of Oregon and Colorado.)

We shall wait until August.