Wait for the Science Before Widespread Use of Psilocybin

The momentum behind psilocybin as the next big “breakthrough” in treating psychiatric disorders is strong, but Oregon psychiatrists and APA have had to push back psilocybin enthusiasts from making unsafe and premature laws for the use of psilocybin for vulnerable psychiatric patients looking for a cure. Over 112,000 Oregon residents signed a petition and made campaign donations topping $1.2 million to put the question of whether psilocybin—which is not approved by the Food and Drug Administration (FDA)—should be legalized on the November ballot in Oregon. Measure 109, The Psilocybin Program Initiative, is the first psilocybin treatment measure being proposed in the United States. It is gaining significant support from the psilocybin community. The Oregon Psilocybin Society is leading the Yes vote on the Measure 109 campaign. The society was formed by Portland-area psychotherapists Thomas and Sheri Eckert (both master’s-level psychotherapists). Missing from the planning or initiation of the initiative is any mention of or oversight by Oregon psychiatrists.

The Oregon Psychiatric Physicians Association (OPPA) and APA have both voiced their opposition for this measure for three main reasons: (1) safety and efficacy have not yet been established for psilocybin, (2) using majority public vote via ballot initiative to bypass FDA approval for a new medical treatment is dangerous, and (3) if passed, the use of psilocybin will not require oversight by medical professionals, particularly psychiatrists.

Measure 109 as written would allow the “manufacture, delivery, and administration” of the hallucinogenic drug psilocybin for the treatment of “including but not limited to addiction, depression, anxiety disorders, and end of-life psychological distress” by nonmedical providers.

Those following the scientific data know that neither safety nor efficacy has been established according to FDA guidelines or clinical trials. The psychiatric community generally agrees with the FDA—that early limited trials have shown that this new treatment has potential. The FDA has given psilocybin “breakthrough therapy” status for major depressive disorder to Usona pharmaceuticals whose phase 2 trials are still under way. Phase 3 trials have yet to even start for psilocybin.

Psilocybin is believed to act on serotonin receptors and induce hallucinations as its main proposed mechanism of action. Studies have not yet explored basic drug interactions with other serotonergic or dopaminergic agents, the impact on psychiatric conditions vulnerable to psychosis, dose, side-effect profile, and efficacy for the treatment of substance use disorders, anxiety disorders, and other comorbid psychiatric conditions. In essence, Measure 109 allows prescribing of a non-FDA approved Schedule 1 controlled substance by a nonmedical practitioner for an overly inclusive range of psychiatric conditions.

In a letter in August to Oregon Secretary of State Bev Clarno, APA CEO and Medical Director Saul Levin, M.D., M.P.A., stated, “Treating patients with mental health and substance use disorders is complex, due to the fact that more than half of these patients also have an underlying physical illness. Given our limited understanding of psilocybin’s effects on patients and how it may interact with other medications, it is dangerous to allow practitioners—especially those with no medical training—to dispense a controlled substance.”

Psychiatrists, as physicians and experts in the treatment of psychiatric conditions, urge psilocybin nonphysician enthusiasts to slow down and wait for the science. It is dangerous to promote widespread use of psilocybin to vulnerable Oregonians with psychiatric conditions. ■

The letter by Saul Levin, M.D., M.P.A., is posted here.