Linked media – Connected media
The year was filled with anticipation for Lykos Therapeutics as they awaited a pivotal decision from the Food and Drug Administration (FDA). The drug company had submitted an application for the approval of MDMA as a treatment for post-traumatic stress disorder, expecting a positive outcome that would catapult them into new heights.
However, on August 9, the FDA’s response was a stark denial, a culmination of growing concerns about the quality of the clinical trials conducted by Lykos. Following this decision, the journal Psychopharmacology withdrew three studies related to MDMA research, citing unethical practices and referencing serious allegations, including sexual misconduct by an unlicensed therapist at one of the trial locations. Many of the authors implicated in these retractions had ties to Lykos.
This development represents a significant setback for what was once heralded as a leading innovation in the realm of psychedelic medicine. The FDA’s disapproval not only casts doubt on the immediate future of psychedelic therapies but also underscores the need for a profound transformation within the research culture itself. For the field to recover and advance, it will require a foundational shift that prioritizes ethical conduct and rigorous scientific standards above all.
Associated media – Connected media