Dr. Francis Kelsey - Savior of American Babies

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  • Dr. Frances Kelsey got a position at the University of Chicago because her boss didn't realize that she was a woman.

  • Early in her job at FDA, Kelsey was given the prenatal drug thalidomide to approve or disapprove. 

  • Thalidomide was supposed to help pregnant women stop throwing up and help them sleep.

  • Thalidomide had already been introduced in Europe and Africa. It had been considered a great success… so far.

  • The company would not provide Dr. Kelsey with real medical data about it - just the good comments from patients. “It’s wonderful! I’ve stopped throwing up!” That sort of thing.

  • But nothing about any side effects. Nada. Nope. Nothing….

  • Dr. Kelsey requested real numbers. Because the FDA could only withhold permission for 60 days at a time, she requested real scientific information every 60 days, over and over and over. That made everybody mad.

  • Why wouldn’t she shut up and leave everyone alone?

  • The company got angry and tried to pressure Dr. Kelsey and the FDA to approve the drug.

  • But the FDA stood behind Dr. Kelsey. Why WOULDN’T the company provide real numbers? HMMMMM?

  • One year later, extremely deformed babies were born, in Africa, Japan, Europe, Australia and New Zealand. 

  • Anywhere mothers took thalidomide, there were babies with many malformed body parts, including hearts and other organs. While many of these children did not survive, the survivors and their families faced monumental challenges.

  • But there were no such damaged babies born in the United States. Dr. Kelsey had withstood the pressure. She did not give in. 

  • Later, it turned out that the company had hidden data about birth defects in mice caused by thalidomide, data Dr. Kelsey had requested. 

Dr. Kelsey received the highest award possible from President John F. Kennedy: the President’s Award for Distinguished Federal Civilian Service in 1962, who praised her “exceptional judgment”.

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