In 1956, a German company synthesized thalidomide (its brand name was “Contergan”) and launched it the next year in Europe as a sedative. Unlike sedatives available at the time, such as the barbiturates, thalidomide was apparently completely non-addictive and had few if any side effects. In fact, it was deemed so safe that it was approved for over-the-counter in some countries, became the third-largest selling drug in Europe, and was thought to be one of the few sedatives safe enough for use in pregnancy. In 1961, reports in the medical literature began to emerge connecting thalidomide to a severe birth defect called phocomelia, in which babies are born with stump-like legs. It was quickly taken off the market, and luckily had never been approved for use in the U.S. because of the heroic foresight of Dr. Frances Kelsey, the woman in charge of the F.D.A. application. Overall, 6,000 children were born with birth defects linked to thalidomide, and this debacle led to the 1962 passage of the Kefauver-Harris bill, which required much more stringent safety and efficacy testing for any new drug in the United States. Incidentally, thalidomide is now back on the market for the treatment of a complication of leprosy.