News announcer: Concern over the tragic effects of the new sedative thalidomide prompts President Kennedy at his press conference to call for stronger, better administered drug laws.
Katie Hafner: In the early 1960s, shocking news came out of Europe. Germany and England had been struck by an epidemic. Thousands of babies had been born with shortened arms and legs, blocked intestines, heart defects. Many died. All because of a drug their mothers had taken during pregnancy, thalidomide
Trent Stephens: It was marketed as being a very safe drug. You couldn’t overdose on it.
Katie Hafner: Starting in the late 1950s, thalidomide was sold all over the world. In Germany, it was a runaway hit for the company selling it. But in the U.S., the story was very different. The drug was never approved because of one medical reviewer at the FDA, Frances Oldham Kelsey. In September 1960 she had just started at the agency when a new drug application landed on her desk.
Cheryl Warsh: It was assumed it was a shoe in and it was a really mild sedative that, you know, just rubber stamp, let the new girl rubber stamp it.
Katie Hafner: This is the story of a woman who was a skeptic, a nitpicker. a total nightmare for big pharma, who also happened to be a scientist beyond reproach. And she wielded her bureaucrat's pen to stop one epically harmful drug from going on the market in the United States.
Join us this September on Lost Women of Science for The Devil in the Details, the story of Frances Oldham Kelsey.
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