By Christoph Bublitz
The return of psychedelics such as psilocybin and LSD to medicine seems imminent. Once associated with the counterculture of the 1960s, these substances have been the subject of serious clinical research for over a decade. In April, the U.S. President signed an Executive Order in support of psychedelic medicine. Shortly thereafter, the FDA issued priority review vouchers for three psychedelics, among them Comp360, a psilocybin derivative developed by Compass Pathways, which intends to file a new drug application for its use for treatment-resistant depression before the year is out.
That the current U.S. administration would champion substances once associated with Woodstock and Timothy Leary may seem surprising. But psychedelics have accumulated bipartisan support over recent years, not least because of their potential to treat post-traumatic stress disorder in veterans, a cause that cuts across political lines.
Yet the return of psychedelics to the clinic is not simply a story about promising molecules. It raises complex ethical and legal questions. Psychedelic therapies typically work with altered states of consciousness, during which patients are acutely vulnerable and unusually suggestible. Some approaches also work with supportive touch. That calls for careful safeguards. More philosophically unsettling is the evidence that these substances can reshape patients’ beliefs, alter their outlook on life, and potentially shift their worldview. Should therapists actively steer such transformations to prevent harm, or should they rather refrain from doing so because this could be manipulative? Psychedelically-assisted therapies that combine drugs and psychotherapy also raise puzzles for regulators because the two are governed by separate legal regimes, and their combinations sit uneasily between them.
The new field of psychedelic ethics is addressing these questions. But many of them will only be resolved through practice, when real therapists treat real patients under real life conditions, and the consequences, good and bad, become visible. This situation calls for close oversight of psychedelic therapies in the early phases, until standards and safeguards have had time to solidify.
The stakes of getting the regulatory framework right became vivid in 2024, when a new drug application for MDMA, better known by its street name “ecstasy”, in combination with a specific psychotherapy (MDMA-AT) was rejected by the FDA. What makes the debate around MDMA-AT particularly interesting was that public commentators invoked numerous ethical concerns in argument for rejecting the application, from misconduct of therapists in previous clinical trials to above mentioned risks arising from altered states of consciousness. This is unusual. Drug approval is usually a technical endeavor that seeks to identify harms and benefits and determine whether the balance is favorable; ethical aspects are not part of the calculus, but may be recognized in product information as safety considerations. Whether ethical aspects affected the FDA decision in the case of MDMA-AT is uncertain; the FDA noted them in their rejection letter at the margins. More generally, however, it is important to recognize that ethical values operate in the background of the regulatory system for drugs because approving or denying a company to place them on the market directly affects the rights and interests of affected patients.
As ethical questions may resurface in coming applications for psychedelic drugs, it seems advisable to gain a better grip on their relevance for the drug approval process. This paper analyzes this through the lens of a key human right in this context, the right to health of patients. Centering that right suggests that drugs for unmet medical needs should be made available to patients who would benefit from them, even if the strict approval conditions are not fully met. It further suggests that ethical concerns about a future practice should not lead to the denial of an application, but should be accommodated in other ways, so as to restrict the right to health only to the least extent necessary. What remains open and will demand sustained ethical attention in the years to come is how to navigate the novel questions that various forms of psychedelic therapy bring with them, about autonomy, boundaries, consent, and the therapeutic relationship in altered states of consciousness.
Paper title: Market approval and the right to health: a human rights perspective on MDMA-Assisted Therapy
Author: Christoph Bublitz
Affiliation: University of Hamburg, Faculty of Law
The author declares no competing interests. His research is funded by the German Federal Ministry of Science, Technology and Space (PSYCHEDELSI).