Right to Try

On behalf of terminally ill patients suffering anxiety and depression, we announce an advocacy effort to open access to psilocybin for terminally ill patients under shelter of state and federal “Right to Try” (RTT) laws. Well known patient rights advocate Kathryn Tucker, and Co-Chair of the Psychedelic Industry practice group of Emerge Law Group, represents a Seattle oncology clinic, Advanced Integrative Medical Science (AIMS) Institute, that provides cutting edge integrative medical care, research, and education in oncology. AIMS Institute and its co-director Sunil K. Aggarwal, MD, PhD, a noted palliative care specialist, are seeking permission to access psilocybin for the purpose of treating terminally ill patients suffering anxiety and/or depression.

AIMS Institute is relying upon state and federal RTT laws, which protect access to investigational drugs not yet been approved for use, recognizing that terminally ill patients do not have the luxury of time to await the slow process of new drug approval. The clinic has approached the federal Drug Enforcement Administration (DEA) to make psilocybin available for use in treating terminally ill patients suffering anxiety and/or depression. See letter to the DEA dated January 15, 2021. DEA responded in a letter dated February 12, 2021, stating that DEA has no authority to waive any of the provisions of the federal Controlled Substances Act, thereby denying therapeutic use. Read more about this Right to Try Effort in a recent Seattle Times article. On March 8, 2021, a Petition for Review was filed in the United States Court of Appeals for the Ninth Circuit by AIMS, Dr. Aggarawal and others seeking review of DEA’s decision in its February 12, 2021 letter. On April 5, 2021, Petitioners filed a Motion for Expedited Review. On May 14, 2021, Petitioners filed an Opening Brief along with Petitioners’ Excerpts of Record. On May 21, 2021, many parties joined the effort by filing amicus briefs in support of the Petitioners.

Medical research is establishing the powerful therapeutic uses of psilocybin in the alleviation of anxiety and depression in terminally ill patients. Patients with advanced cancer suffering from treatment, resistant anxiety, and/or depression experienced significant relief following a single treatment with psilocybin, with no safety concerns or clinically significant adverse events.

This is critically important because people with terminal disease experience emotional suffering to a greater extent than those in the general population. Dying patients frequently suffer depression and anxiety. For these patients, psychotherapy facilitated with psychedelics may provide much needed relief.

Yet, despite the clear benefits of psilocybin to relieve anxiety and depression in dying patients, it is not legally available. However, some otherwise prohibited drugs are intended to be accessible in certain situations under RTT laws; these laws allow terminally ill patients access to drugs still in investigational stages because such patients do not have the luxury of time to await the slow process of new drug approval. Psilocybin meets the requirements set by RTT laws: it has completed an FDA-approved Phase I clinical trial, it is not yet approved or licensed for use, and it remains under investigation in clinical trials.

The Nowak Society, a Colorado 501(c)(3) nonprofit public benefit corporation, is managing the advocacy fund for this effort.

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