On this day in 1960, a U.S. Food and Drug Administration regulator named Dr. Frances Kelsey, who had been assigned to review a seemingly routine application by William S. Merrell Co. to market the sedative Kevadon in the U.S., declined to approve it. The drug manufacturer was shocked. Kevadon–today better known by its generic name thalidomide–had been in use in West Germany and the United Kingdom since 1958. It supposedly was the best sleeping pill ever invented, one that worked quickly and left no grogginess when a user finally awakened.
“It just came with so many extravagant claims that I didn’t believe,” the retired physician and pharmacologist, who is now in her 90s, says today in a Washington Post interview.
But ultimately, Kelsey’s caution and her focus upon prenatal effects of thalidomide was soon vindicated. As 1962 New York Times article details, reports began to surface of pregnant women who had used Kevadon and then given birth to severely deformed babies who had flippers instead of arms and legs. In West Germany, for example, an estimated 3,500 to 5,000 such birth deformities occurred. Thanks to Dr. Kelsey, however, the only Americans exposed to the drug were participants in drug studies and a few travelers who took it while overseas.
The close call over thalidomide led Congress to pass the Kefauver act, requiring more extensive documentation and careful review of drug safety. As this 1963 article by investigative journalist Drew Pearson describes, drug companies tried to thwart the law by submitting so much documentation that government regulators would collapse under the strain. But Kelsey, who was now in charge of a new bureau to handle such reviews, was unrelenting in her scrutiny. The prospect that another thalidomide lurked under the mountain of paper on her desk, she told Pearson, was “too frightening to to think about.”
And with that, here are the science and technology stories of the day.
Humpbacked dinosaur has a unique story to tell. Researchers remain baffled by the function of the unusual protrusion on Concavenator corvocatus, discovered in Spain in 2003, which seems to be unique among dinosaurs.
Playing action video games improves decision making. New study finds that video game shooters are much better at figuratively shooting from the hip as well.