meeting, explaining that it doesn’t comment on drugs in development or
under regulatory review.)
Much the same thing happened in Europe, when, in 2016, researchers
approached the European Medicines Agency (EMA)—the European
Union’s drug-regulating body—seeking approval to use psilocybin in the
treatment of anxiety and depression in patients with life-changing
diagnoses. “Existential distress” is not an official DSM diagnosis, the
regulators pointed out, so the national health services won’t cover it. But
there’s a signal here that psilocybin could be useful in treating
depression, so why don’t you do a big, multisite trial for that?
The EMA was responding not only to the Hopkins and NYU data but
also to the small “feasibility study” of the potential of using psilocybin to
treat depression that Robin Carhart-Harris had directed in David Nutt’s
lab at Imperial College. In the study, the initial results of which appeared
in Lancet Psychiatry in 2016, researchers gave psilocybin to six men and
six women suffering from “treatment-resistant depression”—meaning
they had already tried at least two treatments without success. There was
no control group, so everyone knew he or she was getting psilocybin.
After a week, all of the volunteers showed improvement in their
symptoms, and two-thirds of them were depression-free, in some cases
for the first time in years. Seven of the twelve volunteers still showed
substantial benefit after three months. The study was expanded to
include a total of twenty volunteers; after six months, six remained in
remission, while the others had relapsed to one degree or another,
suggesting the treatment might need to be repeated. The study was
modest in scale and not randomized, but it demonstrated that psilocybin
was well tolerated in this population, with no adverse events, and most of
the subjects had seen benefits that were marked and rapid. The EMA
was sufficiently impressed with the data to suggest a much larger trial for
treatment-resistant depression, which afflicts more than 800,000 people
in Europe. (This is out of a total of some 40 million Europeans with
depressive disorders, according to the World Health Organization.)
Rosalind Watts was a young clinical psychologist working for the
National Health Service when she read an article about psychedelic
therapy in the New Yorker. The idea that you might actually be able to
cure mental illness rather than just manage its symptoms inspired her to
write to Robin Carhart-Harris, who hired her to help out with the
frankie
(Frankie)
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