Once dismissed as the dangerous dalliances of the counterculture, [psychedelic drugs] are gaining mainstream acceptance. Several states and cities in the United States are in the process of legalizing or decriminalizing psilocybin for therapeutic or recreational purposes. And respected institutions such as Imperial; Johns Hopkins University in Baltimore, Maryland; the University of California, Berkeley; and the Icahn School of Medicine at Mount Sinai in New York City have opened centres devoted to studying psychedelics.
Several small studies suggest the drugs can be safely administered and might have benefits for people with intractable depression and other psychological problems, such as post-traumatic stress disorder (PTSD). One clinical trial involving MDMA has recently ended, with results expected to be published soon.
But the strategies represent a new frontier for regulators. “This is unexplored ground as far as a formally evaluated intervention for a psychiatric disorder,” says Walter Dunn, a psychiatrist at the University of California, Los Angeles, who sometimes advises the US Food and Drug Administration (FDA) on psychiatric drugs.
Most drugs that treat depression and anxiety can be picked up at a neighbourhood pharmacy. These new approaches, by contrast, use a powerful substance in a therapeutic setting under the close watch of a trained psychotherapist, and regulators and treatment providers will need to grapple with how to implement that safely.