Multiple recently conducted clinical trials show that therapy with psilocybin for relief of anxiety and depression in patients with advanced cancer is safe and remarkably effective. This is welcome news for patients with advanced illnesses and those who care for them. While much progress has been made in the past quarter century in addressing physical pain and suffering with new recognition of rights to choose end of life care options, little progress has been made in addressing non-physical suffering. My work of the past 30 years has focused on advocacy to promote improved end of life care, empowering terminally ill patients to determine how they journey through their illness and across the threshold of death consistent with their values, beliefs, and preferences. Sometimes this has involved advocacy to ensure that patients are informed about, and able to choose among, all end of life care options. Other times it has involved advocacy to ensure attentive and aggressive pain management. I have represented dozens of terminally ill patients in cases across the country in state and federal courts, and in legislative proceedings, seeking the right to choose a more peaceful death by ingesting medication intended for this purpose, a practice known as aid in dying. Law and medicine has evolved. The standard of care relating to pain and symptom management has also evolved and aggressive forms of pain management have become accepted in both law and medicine. This now includes palliative sedation, where consciousness is eradicated while food and fluid are withheld until death arrives. A broader range of options has also become more widely available, as a growing number of states permit aid in dying.
While all this progress is celebrated, a notable gap in the palliative care toolbox is evident. Modalities to address non-physical pain and suffering have not kept pace and the evidence shows that a significant percentage of terminally ill patients suffer unrelieved anxiety and depression. Hence the keen interest in the findings of clinical trials of psilocybin therapy showing remarkable efficacy in mitigation.
But the question remains: how can patients with life-threatening illness access psilocybin therapy? Psilocybin is listed on Schedule I of the Controlled Substances Act (CSA) meaning it is deemed to have no currently accepted medical use for treatment in the US. Therefore, clinicians cannot prescribe it and it is unlawful for them to manufacture, distribute, or possess it. Ongoing clinical trials are directed at the goal of rescheduling psilocybin under the CSA so that it can be prescribed and utilized for therapeutic purposes. However, those trials and the process of rescheduling can take many years. Dying patients do not have the luxury of time to wait.
In recent years, recognition of this reality led to the enactment of so-called Right to Try (RTT) statutes in more than 40 states, and, in 2018, by the US Congress. These laws are intended to allow patients with advanced life-threatening illness to access otherwise prohibited drugs if certain conditions are met, including that the drug has completed a Phase I clinical trial and remains under investigation.
All of the requirements of RTT are met with regard to psilocybin. Accordingly, it should be available to patients with advanced life-threatening illness, notwithstanding its designation on Schedule I. Interestingly, a few states do exclude Schedule I substances from their ambit; however, this is not the case with the majority of the state acts nor the federal statute. That said, it appears the DEA has not yet accommodated the Right to Try Act. This is clear for anyone who attempts to follow DEA rules and procedures for registering under the CSA. The registration options simply do not accommodate RTT and there is no provision for access to Schedule I drugs for therapeutic use (only research use is provided for).
Emerge Law Group is taking this issue forward on behalf of an integrative oncology clinic in Seattle, its palliative care director, and a number of their patients who want psilocybin therapy and for whom their palliative care clinician believes it would offer relief. We are seeking registration from the state and federal agencies vested with authority under the CSA, the Washington Department of Health’s Pharmacy Quality Assurance Commission, and the US Drug Enforcement Administration to enable the clinic to access this medicine. We are eager to see how the DEA comes to accommodate RTT. Once this accommodation is achieved, access nationwide for the population of terminally-ill patients and their providers will be possible, bringing relief to countless numbers of suffering patients.
