Halcion Takes Another Hit
But, for all the grief it’s causing, Protocol 321 may be the least of Upjohn’s problems. Far more critical to the U.S. Food and Drug Administration’s 1982 approval of Halcion was a clinical trial called Protocol 6045. Unlike Protocol 321, a six-week tolerance study conducted on 58 healthy prison inmates, Protocol 6045 included four 28-day studies involving 129 true insomniacs. It was the largest of three trials the FDA deemed “pivotal” to Halcion’s approval....