Shroom-Therapy Startup Edges Toward FDA Approval

“Just a few years ago, if you wanted to hear about the benefits of psychedelic drugs, your best bet was to head over to the parking lot outside the local jam band concert and flag down the guy in the tie-dye selling “magic mushrooms.” Today there are better options. You could, for instance, fly down to the Waldorf Astoria’s gated beachside resort in Boca Raton, Fla., and—between spa appointments and rounds of golf—take in the keynote address at the CNS Summit, an annual Big Pharma conference.

This plan might sound like swirling colors to anyone who lived through President Richard Nixon’s crusade against Harvard professor Timothy Leary, the high priest of acid trips. In the decades since Nixon branded Leary and hallucinogens, public enemies, as part of his “war on drugs,” all but a few psychiatrists have avoided publicly testing psychedelics’ medical benefits for fear of excommunication from their field. Now, though, attitudes are changing fast.

The advisers’ bona fides are at least as important as the eight-figure funding. For the FDA to say yes to shroom therapy, “you’re going to have to be more rigorous, and more risk-averse, and more Catholic than the pope,” says Insel, who’s also an investor. “You’re going to have to do this in a way that is very carefully scientific, with the best scientists, the best clinical trials, the most conservative and rigorous design, and the most careful data analysis.”

If psilocybin proves effective against treatment-resistant depression, patients may be content to leave some whys unanswered. Today’s go-to treatments, psycho­therapy, and selective serotonin reuptake inhibitors work for only about 70% of patients, leaving as many as 90 million still struggling around the globe, according to the World Health Organization.

Read the full article at Bloomberg Businessweek