Dr. Frances Oldham Kelsey, who became famous for withholding Food and Drug Administration approval for Thalidomide in the early 1960s, died last week at 101. Notice of her death has been accompanied by retellings of the FDA’s early days, and of Kelsey’s heroic stand against the morning sickness drug later linked to terrible birth defects in other parts of the world. Rather than merely a story of one dogged researcher’s triumph, though, sociologist Monica Prasad sees the Thalidomide case as clear evidence against the notion of a laissez-faire United States government. Indeed, in The Land of Too Much: American Abundance and the Paradox of Poverty, excerpted below, Prasad offers the episode as an entry point for considering the weak U.S. welfare state as the product not of an unbridled free market but of a unique and remarkable system of American regulatory institutions.
Doctors began to notice the first cases of the strange disease in 1959. Thousands of babies with stunted limbs and other severe birth defects were being born all over Germany, Britain, Sweden, Australia, dozens of countries. Many died from their deformities at birth. Others would experience difficulties as they grew, including heart disease and spina bifida. Through 1960 and into 1961, all around the world, the number of cases mounted.
In 1961 two doctors traced the problems to a sedative called Contergan that had been developed in Germany and marketed worldwide under other names. Contergan was prescribed for insomnia and for nausea. It did not seem to have side effects and was not toxic in overdose, and it became so popular that it was called “West Germany’s baby sitter.” But as the incidents rose, pediatricians began to suspect and then to document an extremely strong association between the birth defects and Contergan taken in the first trimester of pregnancy. It was withdrawn from the market in 1961, and eventually conclusive evidence emerged of how the drug caused the malformations. By then it had already affected over 10,000 children in “one of the greatest medical disasters of modern times.”1
Amid the calamity, a stunning and justly celebrated act of resistance came to light: under the name Thalidomide, the drug had been kept off the American market by Frances Kelsey, a researcher at the Food and Drug Administration (FDA) with a hunch and a streak of self-confidence that led her to delay approval again and again, until the truth was finally known. Kelsey was well prepared for the task. She had done her graduate work in pharmacology at the University of Chicago (she was admitted on the assumption that “Frances” was a male name) in the lab that had identified the toxicity of an over-the-counter drug that had killed 107 people in 1937. The lab’s work led to the Food, Drug, and Cosmetic Act of 1938. During the war, Kelsey’s work on pregnant rabbits had shown her that drugs can cross the placental barrier and that pregnancy can change the body’s response to a drug.