In AIMS v. DEA, David N. Hoffman, J.D., assistant professor of bioethics at Columbia SPS—with Kathy Cerminara, professor of law at Nova Southeastern University, and Jill Simonian, adjunct faculty instructor at UC San Diego—submitted an Amicus Curiae, “friend-of-the-court,” brief in support of the reclassification of psilocybin, a natural substance found in certain mushrooms, from a Class I to Class II substance on the scheduling system under the Controlled Substances Act. This, the brief argues, would allow for greater ease of research on the use of hallucinogens in the treatment of a variety of conditions as well as unremitting suffering at the end-of-life. As it currently stands, the United States Drug Enforcement Administration (DEA) has declined to reclassify the drug or solicit scientific evaluation from the Food and Drug Administration (FDA), as the DEA is required to do.
As Hoffman asserted in the brief: "[We] learned during the early days of the HIV/AIDS [epidemic] when … legal protections only produce suffering and death they serve no legitimate legal and public health purpose. Sometimes, government can do best for its citizens by simply stepping out of the way.”
Hoffman is a health-care attorney, clinical ethicist and compliance officer for a group of rural New York hospitals, where he supports the clinical and administrative staff in the areas of ethical practice and legal compliance. He teaches several bioethics courses at Columbia SPS, including Clinical Ethics: End of Life Care, Organ Transplantation Ethics, and Organizational Ethics and Compliance.
Below is a summary of the brief.
The brief urges the court to vacate the DEA’s decision to deny rescheduling of psilocybin and remand it to comply with its obligation to consider the prevailing medical and scientific evidence on the efficacy of psychedelic drugs as a treatment option for depression and anxiety. The DEA’s refusal to reschedule psilocybin under the Controlled Substances Act prevents researchers from addressing a palliative care gap for terminally ill patients who have exhausted traditional treatment options, Hoffman, Cerminara, and Simonian argue.
The DEA’s decision also runs counter to current state and federal laws allowing research access to investigational drugs, the brief states. Under federal and state “Right to Try” laws, terminally ill patients have the option of accessing such drugs as long as they have completed Phase 1 safety trials. Psilocybin was also designated as a Breakthrough Therapy in 2018 and 2019 by the Food and Drug Administration based on a growing body of clinical evidence supporting its superiority to existing therapies for certain life-threatening conditions. The Controlled Substances Act of 1970, which calls for a periodic consideration of “changes in the accepted use of the covered controlled substances [in the act],” also seems to recognize the evolving nature of medical practice by linking drug control to the latest science.
The DEA’s interpretation of psilocybin as having “no current accepted medical use in treatment in the United States” seems unqualified. It is ignorant of clinical evidence and medical opinion and poses a roadblock for any future research around controlled substances with potentially transformative medical benefits. In denying rescheduling of psilocybin, the DEA has perhaps exceeded its authority and even undermined state authority over the practice of medicine. For these reasons, the court should grant the relief requested in the petitioner’s brief.
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Columbia University’s Master of Science in Bioethics grounds students in interdisciplinary approaches and models to address pressing bioethical challenges such as stem cell research and health-care reform. The program prepares students to act as responsible and responsive leaders in this new and ever-growing field. It also includes a concentration in global bioethics—the first of its kind in the U.S. Columbia's Bioethics program offers a range of degrees and courses. Applications are open for fall 2023 enrollment. Learn more here.