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.
In November, that’s where you’d have found George Goldsmith and Ekaterina “Katya” Malievskaia, the conservatively dressed, middle-aged married couple running a mental-health-care company in London called Compass Pathways Ltd. Among other things, they were stumping for their answer to treatment-resistant clinical depression: synthetic doses of the hallucinogen psilocybin, the active ingredient in shrooms. “Our goal is to develop psilocybin therapy—the preparation, the support for the actual dosing, the medicine, and the follow-up,” said Goldsmith, a lanky, bespectacled sixtysomething former executive coach. “And then other clinics and so forth will buy and deliver that.”
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 U.S. Food and Drug Administration has named Compass’s experimental treatment a “breakthrough therapy,” a designation that comes with extra guidance through a faster review process.
Compass is running a 216-patient Phase 2B clinical trial—typically the second-to-last stage before a drug gets the FDA’s nod—and has made enough synthetic doses of the psychoactive ingredient in magic mushrooms to supply more than 30,000 patients. It’s raised $58 million in venture funding from powerful tech figures including Trump ally Peter Thiel, investor Christian Angermayer, and Bitcoin booster Michael Novogratz. Thomas Insel, former director of the U.S. National Institute of Mental Health, and Paul Summergrad, former head of the American Psychiatric Association, are on its board of advisers.
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.”
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