The authors argue against the idea that psychedelics raise uniquely exceptional ethical issues in clinical medicine, comparing this position to earlier debates about genetic exceptionalism in bioethics. They contend that psychedelics share more commonalities with existing medical interventions than is often assumed, and that adopting a stance of "psychedelic ethical exceptionalism" carries risks. Instead, they propose that consistent ethical rules and evidentiary standards should apply across all relevant areas of clinical medicine. While changes to existing standards may be warranted, such changes should not be justified by appealing to the alleged uniqueness of psychedelics.
Psychedelic medicines are undergoing a research revival, prompting debate over whether they require unique regulatory and ethical treatment or should be held to the same standards as other medical interventions. This article analyzes the arguments for and against special consideration, examining how psychedelics are researched, regulated, commercialized, and administered. It concludes that while psychedelics present distinct features, they do not inherently warrant a separate regulatory framework; instead, existing standards can be adapted to address their specific risks and benefits.
The FDA rejected Lykos Therapeutics' application for MDMA-assisted therapy for PTSD in August 2024, partly due to a highly publicized case of alleged sexual misconduct by an unlicensed therapist during a Phase 2 trial. Several other cases of misconduct by facilitators at psychedelic retreats have raised questions about whether physical contact is ever appropriate during psychedelic-assisted therapy. Drawing on research about supportive touch in other clinical settings and considering features of psychedelics that increase the potential for harm, the authors advocate for a precautionary approach to harm-reduction while arguing that supportive touch should not be entirely discarded.