The EUA-Psychedelics Backdoor Cracks Open Further
More evidence supporting a COVID-19 EUA for psychedelics
As I put the finishing touches on a post about the AIDS pandemic—and how it led to the precipitous rise of the FDA-pharma-industrial complex—a new research study interrupted my flow. It relates to my last post on the more recent COVID-19 pandemic, Emergency Use Authorizations (EUA), and psychedelics.
(To recap, my last essay proposed an unconventional legal strategy for how HHS could rather quickly introduce psychedelics and assisted-therapy into the medical system through the backdoor: Emergency Use Authorizations. Read it.)
Allora. Yesterday, Marijuana Moment published an article about this new study. Rather than reinvent the wheel, I’ll reproduce its first two paragraphs:
A newly published report in the Journal of the American Medical Association (JAMA) finds that psilocybin-assisted therapy in a group of frontline clinicians during the COVID-19 pandemic “resulted in a significant, sustained reduction of symptoms of depression.”
“In this randomized clinical trial, we aimed to investigate whether psilocybin therapy could improve symptoms of depression, burnout, and PTSD in clinicians who developed these symptoms from frontline clinical work during the pandemic,” authors wrote in the new report, adding that their findings “establish psilocybin therapy as a new paradigm of treatment for this postpandemic condition.”
The study concluded that psilocybin therapy resulted in a “significant, sustained reduction in symptoms of depression experienced by clinicians after frontline work during the COVID-19 pandemic.” That’s interesting.
So, I took a look at the underlying study. No slouch of a study. Small sample size, sure. But backed by the Cohen Foundation, the Riverstyx Foundation, and the Rita and Alex Hillman Foundation, it directly investigated the key question for an EUA:
Does psilocybin therapy improve symptoms of depression, burnout, and posttraumatic stress disorder in clinicians who developed these symptoms from frontline clinical work during the COVID-19 pandemic?
Consider the importance of the findings, if further validated. During preparation sessions, the health care workers made comments like “I feel more disposable than a used COVID-19 swab” and “It got to the point where I felt like I was participating in the torture of people.” Setting aside COVID-19 itself, having these sentiments among the public health workforce itself is a public health emergency.
And remember, the key to this backdoor isn’t establishing that COVID-19 is a public health emergency—that’s established. Rather, it requires showing:
COVID-19 can cause a serious or life-threatening disease or condition;
Based on the totality of scientific evidence available to the Secretary, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that the product may be effective in diagnosing, treating, or preventing
that disease or condition; and
No adequate, approved, and available alternative to the product for diagnosing, preventing, or treating that disease or condition.
This study, while small, did it the mighty way: randomized clinical trial, the gold standard of evidence-based medicine. True, there was “functional unblinding”—all participants knew about 2-hours in which therapy they received. But this is inherent to many psychedelics when used as therapeutics. And, here’s the other thing: the EUA statute is flexible enough to allow HHS to rely on the “totality of scientific evidence available to the Secretary.” That includes a whole lot: not just this study, but a bevy of other clinical and non-clinical research related to psilocybin’s medical uses.
See where I’m going with this?
Importantly, as my last post emphasized, while an HHS-led psychedelics EUA might push the boundaries of the statute, it might be exceedingly difficult to flip over in court due to standing doctrines. So, as a practical matter, an EUA with a colorable basis in science and logic may be un-voidable in court.
But here’s the really important last item: an EUA could force rescheduling.
As I’ve noted many times in many places, FDA-approval and scheduling/rescheduling under the Controlled Substances Act are two distinct enterprises. But, the CSA does incorporate an element of “accepted medical use.” And, once HHS blesses a controlled substance for a medical use—and it is exceedingly hard to argue that an EUA, even if unapproved by FDA, isn’t a medical use—that substance can’t remain in Schedule I.
TL;DR: Increasingly likely pandemic related mental illness could be legally used to reschedule controlled substances before FDA approval.
Hey Matt, I’m the first author on the frontline clinician study. Would you be open to a chat about your idea? Email me at tonyback@uw.edu—I’ll be back in the office Monday.
Brother, I share your goal of legal, science-based access to psychedelics, but the EUA path you propose still doesn’t fit the statute’s intent or precedent. Small trials and pandemic-related mental health data don’t clear the legal or evidentiary hurdles — and stretching emergency law risks backlash that could slow the movement. The sustainable path is the one we fought for in the AIDS crisis: activism powered by unshakable science.
A little about myself: I’ve spent many years in biotech, primarily in oncology, and my own life was profoundly changed by psilocybin‑assisted therapy for complex PTSD. I’m a committed advocate for legal, science‑based access to psychedelic therapies. I also noticed you’re working on a piece about the AIDS epidemic and the rise of the modern FDA — I look forward to reading it. I was there, in ACT UP, fighting for what became the Orphan Drug Act so we could bring treatments to the rare diseases killing my lovers, friends, brothers and sisters.
With that, here’s my take on your latest piece:
1. What This Trial Really Shows The JAMA trial you highlight is indeed promising, well‑designed, and on‑point — but as you acknowledge, it’s small and features functional unblinding, a known limitation in psychedelic research. One solid trial (even this one, which has been well recognized for a while by practitioners and advocates) especially of this size, is not enough for large‑scale deployment under EUA. Regulators want replication across multiple large, well‑controlled trials before even considering emergency use for a new therapy.
2. Statutory Boundaries of EUA Even with the statute’s allowance for “totality of evidence,” the prerequisites are strict:
* An active emergency tied to a biological, chemical, radiological, or nuclear (BCRN) threat.
* Reasonable belief the product may be effective for that specific threat.
* No adequate, approved, and available alternatives.
COVID‑19 qualified as a BCRN emergency — but that official emergency declaration has ended. Using EUA now for secondary conditions like depression and PTSD, even if pandemic-associated, would be unprecedented and outside historical use of the law.
3. The “No Alternatives” Barrier Standard treatments for depression and PTSD do exist, however imperfect: SSRIs, psychotherapies, and others. I know their limits personally, but the law measures this criterion on a population level. Their very existence — and broad availability — makes the EUA path an uphill battle here.
4. Rescheduling Isn’t Automatic An EUA wouldn’t automatically force DEA to reschedule under the Controlled Substances Act. “Accepted medical use” is determined through a multi‑factor review of safety, efficacy, and abuse potential — something DEA historically hasn’t granted on the basis of emergency or expanded‑access programs alone.
5. Risks of Overreach Even if legal challenges are procedurally hard due to standing rules, pushing EUA beyond its established scope risks political, judicial, and regulatory backlash. That could slow — not speed — the acceptance of psychedelic therapies.
6. The Sustainable Path Brother, I learned in the AIDS fight that our lasting wins came when loud, relentless advocacy met an unassailable scientific and legal case. We didn’t win orphan drug protections by skirting the law; we forced the law to bend by bringing overwhelming evidence to the table. For psychedelics, that means investing in large‑scale trials, leveraging existing mechanisms like Breakthrough Therapy and Expanded Access, and pushing for statutory reform.
Bottom line is that I’m with you on the end goal. I want MDMA‑ and psilocybin‑assisted therapy available to those who need them as much as anyone. But we only get there for the long haul by letting science lead, building the evidence until it’s undeniable, and reforming the law head‑on — just like we did when our friends’ lives depended on it in the 80s.