Psychedelic drugs, once considered primarily recreational, are making their way into clinical settings—and increasingly, helping patients with a range of conditions.
Last fall, Harvard launched the Study of Psychedelics in Society and Culture: an interdisciplinary effort across the Faculty of Arts and Sciences, Harvard Law School, and Harvard Divinity School. At the end of this month, a three-day intensive training camp entitled “Psychedelics Bootcamp 2024” will take place on campus, as part of the work of the Petrie-Flom Center for Health Law and Policy, Biotechnology & Bioethics’s Project on Psychedelics Law and Regulation (POPLAR), which brings together leading scholars to explore and develop psychedelics law and policy.
In this interview, I. Glenn Gohen, Attwood and Williams professor of law and faculty director of the Petrie-Flom Center, discusses legal, ethical, and policy issues surrounding the use of psychedelics in medicine and society.
The therapeutic use of psychedelics for psychiatric treatment dates back to the early 20th century, despite their cultural rise in the 1960s, as Jerrold Rosenbaum, Stanley Cobb professor of psychiatry at Harvard Medical School discussed with Harvard Magazine in 2021. In recent years, clinical trials for psychedelics such as MDMA and psilocybin have intensified, with companies seeking FDA approval. The approval process is complex due to added ethical and patenting dilemmas.
Informed consent is particularly challenging due to the profound effects of psychedelics, which are influenced by the psychological state (“set”) and physical environment (“setting”). Concerns include patient vulnerability, potential misconduct, and equitable access, especially for disadvantaged groups. Trials face difficulties such as "functional unblinding," where participants recognize their treatment status, affecting trial integrity.
In a blinded study, information is withheld from participants, so they have less potential to influence study results. Randomized clinical trials (RCT) are the gold standard in evidence-based medicine—and usually operate as blind or double-blind studies. However, this is complicated in the case of psychedelics: most participants know they’re on a drug, even when they aren’t informed. “The reality [is] that the average participant probably knows which of the two states they are in,” says Cohen. Even a psychotherapist knows that they’re experiencing a psychedelic.
This becomes especially complicated in the context of vulnerable populations—patients who might benefit from psychedelic therapy but could also be easily coerced into taking part in a study or (or even using the treatments should they become available). Veterans with post-traumatic stress disorder (PTSD), for example, could be greatly benefited by drugs like psilocybin, which has been proven to alleviate some of the symptoms of the condition. Similarly, those in palliative care or hospice might find their transitions eased by certain psychedelic drugs, which promote feelings of wellbeing and connectedness surrounding extreme pain and death. Cohen emphasizes the need for tailored protocols to address unique needs and risks for these demographics.
Cohen outlines three models for integrating psychedelics into society: medical (FDA approval and licensed therapists), religious (legal exemptions for religious use), and personal (non-medical, non-religious use). Beyond clinical and legal frameworks, Cohen addresses the cultural dimensions of psychedelic use, stressing the need for inclusive governance and benefit-sharing to respect indigenous knowledge and practices. Indigenous communities, historically custodians of psychedelic traditions, face dilemmas of cultural appropriation and exploitation amid growing commercial interests.
“In the cosmology of some of these communities, [psychedelics] are not thought of as drugs. [They’re] thought about as something sacred,” says Cohen—as belonging to the community. “And there are also populations where… only this shamanic figure takes [psychedelics], rather than the people who are seeking to be helped.”
Ethical frameworks, regulatory foresight, and cultural sensitivity are essential for responsible and equitable integration of psychedelics into mental health treatment. These are among the issues that will be explored at Harvard Law School’s psychedelics bootcamp.
