Dear Reader,

Due to current events, the country is in a Mental Health Crisis. This memo is to both inform and guide decision-makers concerning the continuum of care in psilocybin assisted therapy. Federal legalization of synthetic psilocybin has been expedited. The FDA has awarded a breakthrough therapy designation for the use of psilocybin in Major Depressive Disorder and Treatment Resistant Depression. Unfortunately, striving to meet the needs of one group may completely ostracize the needs of many others. The challenges patients face include the potential lack of accessibility, lack of affordability, and unnecessary criminalization of those working with psilocybin mushrooms and other psilocybin-containing products. Therefore, PsiloHealth supports the decriminalization of all drugs and will contribute to the establishment of equitable regulatory structures for currently scheduled compounds, specifically psilocybin and psilocin.

Psilocybin is the inactivated precursor (prodrug) to psychoactive psilocin. These alkaloids (psilocybin and psilocin) are found in psilocybe mushrooms. In 1970, the Controlled Substances Act classified psilocybin and psilocin as Schedule I compounds. A Schedule I classification means that the drug has no accepted medical use, high abuse potential, and is unsafe to administer in a medically supervised setting. According to medical anthropologists, psychedelic fungi have been utilized for thousands of years in ancient and indigenous cultures, typically in community-based, ceremonial settings with a curendera, or shaman, present to facilitate the healing experience of the ingester(s). We now understand that these classifications were made with a political agenda and enacted against educated medical advice.

Fortunately, progress has continued despite the CSA. Many research institutions, primary investigators, and citizen scientists have been able to shed the stigma off of psilocybin mushrooms, psychedelics, and entheogens. We now recognize that these naturally-occurring alkaloids have a variety of indications for use, psilocybin is termed “anti-addictive” and used to treat substance use disorders, and the psychedelic community understands the importance of a psychedelic experience to be under direct supervision.

We understand that pharmacologically speaking, psilocybin is a prodrug to psilocin. Psilocin is a serotonin-2a receptor agonist. This means it stimulates a certain serotonin receptor subtype (specifically the 2a receptor) to produce its psychedelic effects. The typical psilocybin experience ranges from 2-5 hours. Common side effects are transient and subside after the experience is over. There is speculation that chronic use of psilocybin may cause valvular heart disease (VHD), but there have been zero reported cases of this. It should be understood that psilocybin has a commendable safety profile relative to current treatment strategy, and possesses medical utility warranting its rescheduling. 

There are problems that limit the sole use of Synthetic Psilocybin. Some of these include include:

• Limited access to the healing potential of medicinal plants and fungi containing psilocybin. As long as these medicinal molecules are illegal, people are prevented from healing their mental health.

• We are in a mental health crisis now. The pathway to synthetic psilocybin, despite being expedited, is years out. It is both impractical and unethical to wait for people to wait to heal.

• The expense to bring about a program using these medicinal plants/fungi is significantly less expensive than the drug trials required for FDA approval. These savings can be passed on to patients that may not have access to expensive drug therapies.

• Cultivation, testing, and dispensation creates local jobs and economic growth. Synthetic psilocybin manufacturing limits local economic growth.

• We have had an example set with cannabis. Medicine has tried to isolate specific medical molecules such as THC and CBD. Yet the overwhelming evidence is that these molecules work best in concert exerting a synergistic effect for the user. Leaders in the medicinal fungi field are convinced that there is also an entourage (concerto/synergistic) effect in psilocybin mushrooms.

  • Like cannabis, the evidence based medicine approach is impossible whilst the possession and use of these plants/fungi are a punishable offense. 

  • The cannabis model in states with medical programs has also exemplified that there is inherent mistrust of both medical models if done exclusively. Allowing both to exist exponentially increases the reach of the healing medical molecules.

At this critical point, policy makers, and medical professionals have the opportunity to:

• Completely reframe our mental healthcare system,

• Establish responsible drug reform policy,

• Promote cognitive liberty,

• Enact compassionate access through decriminalizing the possession, ingestion, and cultivation of psilocybe mushrooms and other psilocybin/psilocin-containing products, and

• Create an ideal regulatory framework to guide decision making and ensure all options are on the table for populations that can safely be administered psilocybin-containing products

Thank you for considering this memo. If this crisis strikes you the way it has struck our organization, please reach out so we can begin our collaboration immediately. If not, please consider our next communication that outlines our solution to many of these issues. The mental health crisis is now, exacerbating and complicating the ramifications of the SARS CoV2 global pandemic.