Ethics, Policy Concerns in Clinical Psychedelic Therapies

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As government agencies around the globe contemplate approval of the first psychedelic medicines, many questions remain about their ethical integration into mainstream medical practice. In a new paper published in JAMA Network Open, a team of bioethicists, clinicians, researchers, Indigenous groups, industry, philanthropy, veterans, retreat facilitators and training program leaders identify key ethics and policy issues related to the integration of psychedelic therapies into clinical practice and areas for further research and deliberation.

The paper is the result of a workshop held at the Banbury Center of Cold Spring Harbor Laboratory and funded by the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, which is supported by the Saisei Foundation, Tim Ferriss and Matt Mullenweg, Baylor College of Medicine through the Ortus Foundation, and the Cold Spring Harbor Laboratory Corporate Sponsor Program. The meeting was organized by researchers from the Center for Medical Ethics and Health Policy at Baylor, Petrie-Flom Center, Harvard Law School and the University of Pennsylvania Perelman School of Medicine.

“There will be novel ethical challenges that accompany the approved medical use of psychedelics, and we must understand the issues at hand, anticipate obstacles and work to surmount them quickly and efficiently so clinicians can focus on utilizing approved psychedelics to provide evidence-based care to patients,” said Dr. Amy McGuire, corresponding author of the paper, Leon Jaworski Professor of Biomedical Ethics and director of the Center for Medical Ethics and Health Policy at Baylor. “We hope this paper will inspire greater collaboration and action now so that when psychedelics are soon approved there is ethical and safe uptake. “

In the paper, the team focuses on bioethics and regulatory issues in the U.S., which may be generalized globally and identifies 20 points of consensus across five topics (reparations and reciprocity, equity and respect; informed consent; professional boundaries and physical touch; personal experience; and gatekeeping). The authors note that many of the traditional frameworks of bioethics and drug policy are inadequate to meet the moment and that policy makers must take seriously the challenges ahead, while not losing sight of the rich cultural histories and traditions from which contemporary medical uses of psychedelics have emerged.

“There are so many stakeholders with interests in this area – patients, Indigenous populations, veterans and active service members, mental health professionals, pharmaceutical companies, religious leaders – it was a great opportunity to bring together so many different perspectives and try to determine where there was ethical consensus about how to move forward,” said I. Glenn Cohen, deputy dean and James A. Attwood and Leslie Williams Professor of Law, Harvard Law School, and faculty director of the Petrie-Flom Center.

“The paper represents a brief roadmap for future psychedelic bioethics scholarship and policy development,” said Dr. Dominic Sisti, director of the Scattergood Program for the Applied Ethics of Behavioral Health Care and associate professor in the Department of Medical Ethics & Health Policy at the University of Pennsylvania Perelman School of Medicine.

For a full list of paper authors and affiliations, see the publication.

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