Medical Ethics Unpacked: Unique Ethical Challenges of Psychedelic Therapies

As regulatory agencies weigh the approval of psychedelic therapies, the field of mental health care stands on the brink of a paradigm shift—one that offers patients a new treatment option that has a direct impact on brain activity.¹

The US Food and Drug Administration’s recent rejection of Lykos Therapeutics’ MDMA-assisted therapy for PTSD has reignited debates over the ethical concerns surrounding psychedelic treatments.²

In this episode of Medical Ethics Unpacked, psychiatrist Steve Levine, MD, and bioethicist Dominic Sisti, PhD, are joined by special guest Amy McGuire, JD, PhD, from Baylor College of Medicine, to discuss unique ethical challenges of psychedelic therapies—consent, access, setting intentions, and integration of traditional practices into mainstream medicine.

“It means there’s values and traditions that are embedded in these treatments that may not be compatible with mainstream medicine,” Sisti said.

Other ethical topics discussed included dosing sessions, therapeutic models, differences between psychedelics and empathogens like MDMA, and the focus on veterans in psychedelic clinical trials.

“To me, it's the combination of the altered state of consciousness that it brings you into and …they can be used in exceptional ways,” McGuire said. “Ceremonial use of these substances…is quite different. Now, whether we think they're different or not, I think it's a separate question of whether they should be treated [differently] as we go through the FDA pipeline, as we go through standard clinical practice. If they're adopted into Western medicine… I'm not so sure that there should be exceptional rules related to them, but I think that…to [not] acknowledge their distinctive features, and their potential to be used in really different types of ways…would be a mistake.”

About Hosts and Special Guest:

• Steve Levine, MD: Chief patient officer at Compass Pathways
• Dominic Sisti, PhD: Associate professor in the Department of Medical Ethics & Health Policy and the director of the Scattergood Program for the Applied Ethics of Behavioral Health Care at the University of Pennsylvania
• Amy McGuire, JD, PhD: Leon Jaworski professor of biomedical ethics and director at Baylor College of Medicine

Relevant disclosures included Lykos Therapeutics and Tactogen for Sisti and Compass Pathways for Levine. McGuire has no reported disclosures.

References

1. The Lancet Regional Health-Europe. Psychedelic-assisted psychotherapy: hope and dilemma. Lancet Reg Health Eur. 2023 Sep 4;32:100727. doi: 10.1016/j.lanepe.2023.100727. PMID: 38222970; PMCID: PMC10784116.

2. Derman, C. The Rise, Fall (and Future?) of MDMA-Assisted Therapy. HCPLive. December 23, 2024. https://www.hcplive.com/view/the-rise-fall-and-future-of-mdma-assisted-therapy. Accessed April 7, 2025.