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Nov 2, 2026 Regulatory

A Palliative Care Doctor Asks Why Psychedelic Research Never Reaches the Dying

A guest essay in today's New York Times, by Dr. Daniela J. Lamas — a pulmonary and critical care physician at Brigham and Women's Hospital — argues that psychedelic research almost never reaches the patients she treats: people dying in the hospital, often in the I.C.U. The trials that have found psilocybin eases existential distress in people with life-threatening cancer, dating back to landmark 2016 studies, enroll patients well enough to sit through hours of preparatory therapy, a supervised multi-hour session, and weeks of follow-up. Someone actively dying in a hospital bed usually can't clear that bar, and Lamas's case is that regulators building the delivery framework for these drugs should design for that patient too, not just the one stable enough to travel to a clinic.

The regulatory backdrop she's writing into is real and recent: the FDA finalized its guidance on psychedelic drug clinical trials in July 2026, and followed it in September with a public hearing — "Considerations for Potential Future Therapeutic Use of Psychedelic Drugs," held Sept. 14 — gathering input on exactly the delivery questions Lamas raises, from provider credentialing to patient monitoring. She notes the FDA could decide on psilocybin for treatment-resistant depression as soon as early 2027, which lines up with outside estimates we've seen elsewhere tying a possible first approval to roughly the same window.

Lamas is careful about the limits of the case she's making. She flags, unprompted, that psychedelic trials are nearly impossible to blind — patients who know they got something they've read could change their life may feel better partly because of that belief, or because of the hours of dedicated therapy that come with it, independent of the drug — and that there are documented accounts of harm, including persistent anxiety, especially outside research settings. What's actually available to her today is ketamine, already approved for sedation and pain control, which she's seen colleagues like Dr. Zachary Sager at Dana-Farber use off-label for existential distress with some patients, by his account to her — a single case of a 78-year-old cancer patient whose wish to hasten death resolved for nearly a week, that she's explicit is not proof of anything, since trials of ketamine for this use have had mixed results.

Worth being precise about what this is: a practicing physician's opinion essay, not a trial result, and nothing here is evidence that psilocybin or ketamine treats dying patients' distress outside a research setting. It's a useful read anyway for naming a real gap — between who psychedelic trials are designed to enroll and who's actually sitting in the hospital beds these drugs are increasingly being discussed for.

Read at The New York Times (Opinion)