July 2025
TO: MEMBERS OF THE LONG ISLAND JEWISH
ORGANIZED MEDICAL STAFF
As reported in the NY Health Journal, mental health ailments are reaching epidemic levels. As of 2022, over 49,000 Americans died by suicide, making it a leading cause of death in the United States.
In recent years, nearly 67% of Americans have reported an inability to access mental health treatment, even if insured. Factors such as workforce shortage, low insurance reimbursement rates for providers, and failure of insurance companies to cover care have left many without access to treatment that could be, in some cases, lifesaving.
Alternative forms of treatment are being explored. One in particular is Psilocybin (more commonly referred to as magic mushrooms or shrooms). However, the Controlled Substances Act restricts access to this treatment.
Clinical results have been successful and documented of record, psilocybin remains a Schedule I controlled substance, which means it is inaccessible for both medicinal and recreational purposes.
The legality of drugs is largely determined by the scheduling of the drug within the Controlled Substances Act (CSA). The intent of the CSA is to regulate interstate and foreign commerce related to substances that have “useful and legitimate medical purpose” but that, when imported, manufactured, distributed, possessed, or used illegally, have a “substantial and detrimental effect on the health and general welfare of the American people.”
Psilocybin produces a hallucinogenic effect or altered state of consciousness by acting as a partial agonist of the serotonin 5HT2A receptor. Serotonin 5HT2A receptors are distributed throughout the central nervous system; as an agonist, psilocybin binds to these receptors and triggers the same response that serotonin would upon binding to the receptor. Thus, unlike traditional anti-depressants, such as SSRIs, psilocybin does not aim to increase the level of serotonin within the body; instead, it allows the serotonin receptors within the body to temporarily “fire” as if they were saturated with serotonin. This temporary state produces a psychedelic or hallucinogenic experience that lasts between three and four hours.
A Johns Hopkins study published in 2022, conducted a randomized and waitlist controlled clinical trial which demonstrated that two doses of psilocybin, – combined with supportive psychotherapy, – had an immediate and long-lasting antidepressant effect, lasting at least one year post-administration. The researchers noted that prior research suggested that the antidepressant effect observed in these participants would continue, possibly for up to 4.5 years; however, additional research and follow-up would be needed to confirm this.
Psilocybin is a Schedule I controlled substance, which means that the DEA and the FDA have determined that: (1) psilocybin has no legitimate medical purpose; and (2) psilocybin has an elevated risk of abuse and physical/psychological dependency.
Like marijuana, psilocybin legalization started with legalization and/or decriminalization at the state (or even city) level, while remaining completely illegal at the federal level. On January 1, 2023, Oregon became the first state to legalize adult-use psilocybin; as a result, within Oregon, individuals over the age of 21 can consume mushrooms under the supervision of a state-certified facilitator. Colorado has passed similar legislation, several cities have decriminalized psilocybin, and several states have legislation pending that would legalize psilocybin to some degree.
Early research and anecdotal evidence have shown that psilocybin may carry significant benefits without significant risks in the treatment of mental health conditions such as TRD and MDD, so much so that the FDA has granted breakthrough status to psilocybin.
Despite early promising research on psilocybin’s safety and efficacy, it remains classified as a Schedule I controlled substance, which means that it cannot be prescribed or used legally under federal law leading to significant barriers to performing clinical trials involving psilocybin.
Following the footprint of legalization of marijuana, some states and cities are working toward decriminalization and/or legalization of psilocybin within their own borders, despite its continued illegality under federal law. It is likely that we will continue to see this approach in other states, including New York, although the recent move to reschedule marijuana under the CSA, combined with promising early research for medicinal uses of psilocybin, may promote a speedier resolution of the conflict between federal and state laws than that seen with legalization of marijuana.[1]
Respectfully submitted.
Schaum Law
[1] Keri MahoneyRN, CPHRM