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In Germany on Christmas Day 1956 a baby girl was born without ears. She was the first victim of the notorious thalidomide epidemic. There would be over 10,000 more across 46 countries. For years the world believed the United States had avoided the catastrophe. After Frances Kelsey at the FDA became suspicious of the dangers of thalidomide in 1960, she led a successful fight to block its commercial approval. But now, having probed government and corporate archives and interviewed hundreds of key players, Jennifer Vanderbes reveals a darker truth that lay buried for decades.

In 1959, a Cincinnati pharmaceutical firm, the William S. Merrell Company, quietly began distributing samples of an exciting new wonder drug already popular around the world. Touted as a sedative without risks, thalidomide was handed out freely, under the guise of clinical trials, by doctors who believed approval by the Food and Drug Administration was imminent. But in 1960, when the application for thalidomide landed on the desk of FDA medical reviewer Frances Kelsey, she quickly grew suspicious.