An American Sickness: How Healthcare Became Big Business and How You Can Take It Back

by Elisabeth Rosenthal

Vanda and the FDA originally agreed that nighttime total sleep would be the proper metric of success for the study, but Vanda had backed away from that. Instead of focusing on all nights, they included only the 25 percent of nights when subjects’ sleep times were lowest. On those nights, patients who took the drug slept fifty-three minutes more. Vanda also selected two other surrogate measurements to prove its drug’s efficacy: a urine test of melatonin and a “Non-24 quality of life scale,” designed by Vanda, which measured only days 112 to 183 of the study. “Changing the endpoints of an ongoing clinical trial—especially without the FDA’s blessing—is a sign of trouble,” Mr. Feuerstein wrote. “The story Vanda tells of its sleep-disorder drug doesn’t have a happy ending.” But it did.