Posted by
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.
Kelsey, a middle-aged mother of two who previously had taught part-time at the University of South Dakota, moved to Washington when her husband got a job with the U.S. Health Service, and she had only been working for the FDA for less than a month. She was a low-level staffer who worked in a drab, windowless office in the agency’s basement. Nevertheless, Kelsey was not lulled by the hype about thalidomide.
“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.
Earlier in her career, Kelsey had worked as a researcher at the University of Chicago, where she had developed a concern about the effect of medications taken by pregnant women upon the fetuses in their wombs.
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.”
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.
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.
Towel-folding household robot debuts. It doesn’t leave wet towels on the bed, either, unlike your spouse.
Supernova shrapnel found in meteorite. The microscopic traces date back 4.5 billion years.
New study: mercury in vaccines not linked to autism. It may not convince Jenny McCarthy and other aggrieved parents, though.
The ultimate electric motorcycle? Except, perhaps, that the protagonists in Easy Rider wouldn’t be able to hide money in the gas tank any more.
