In the 1950s, a German drug company developed a new sedative that was supposed to be 100% safe: thalidomide. So safe, in fact, doctors prescribed it to women as a treatment for morning sickness.  It quickly became a bestseller. But in the early 1960s, shocking news started coming out of Europe. Thousands of babies were being born with shortened arms and legs, heart defects, and other serious problems. Many died.

In the United States things were different, thanks to one principled, strong-minded skeptic who joined the Food and Drug Administration in 1960 as a medical reviewer. One of her first assignments was to review the approval application of that very wonder drug, thalidomide. But the application was, to her mind, flawed.

Dr. Frances Oldham Kelsey was a physician, a pharmacologist, and a nitpicker who refused to be intimidated by big pharma.