Psychedelic Drugs as Therapeutics: No Illusions About the Challenges
Recent clinical trials with psilocybin for intractable anxiety and depression in patients with life‐threatening cancer, a Review article and Commentary in this journal, have renewed interest in the potential therapeutic usefulness of psychedelic agents.1 Medically, in addition to psilocybin, other substances with psychedelic properties, e.g., ketamine, 3,4methylenedioxymethamphetamine (MDMA), microdoses of lysergic acid diethylamide (LSD), and N, N‐dimethyltryptamine (DMT), have been proposed to treat psychiatric and other diseases. While most past hallucinogen research was entirely descriptive, attempts at improved exploratory studies (e.g., obsessive‐compulsive disorder, major depression, substance use disorders) have occurred in the past 20 years. While introducing elements of randomization, blinding, and a control arm, these are generally not placebo‐controlled studies. Research to understand the mechanism of action of psychedelic agents as neurochemical probes is of scientific interest. The possibility of resetting even part of the brain's default network would have wide scientific, medical, ethical, and social implications.4 The obstacles to drug approval remain daunting. This Commentary addresses some of the regulatory considerations and potential precedents.