Remembering Thalidomide: In Praise of Regulations and Bureaucrats

Frances_O._Kelsey_(FDA_171)_(8211251003)

The front page of this morning’s New York Times carried an obituary for Dr. Frances Oldham Kelsey.  The name wasn’t familiar to me, but I knew the story for which she was famous: blocking the approval of thalidomide for use in the United States.  As the Times points out, by September 1960, “The drug had already been sold to pregnant women in Europe for morning sickness, and the application seemed routine, ready for the rubber stamp.”

Dr. Kelsey didn’t reach for the rubber stamp. From the Times:

“Thus began a fateful test of wills. Merrell [the company that wanted to sell the drug] responded. Dr. Kelsey wanted more. Merrell complained to Dr. Kelsey’s bosses, calling her a petty bureaucrat. She persisted. On it went. But by late 1961, the terrible evidence was pouring in. The drug — better known by its generic name, thalidomide — was causing thousands of babies in Europe, Britain, Canada and the Middle East to be born with flipperlike arms and legs and other defects.”

I was born on September 11, 1960, so this story hits home with me.  Merrell had already distributed 1000 samples to American doctors in 1960 for “investigational” research.  In plain English, pregnant women took thalidomide in the US.  The samples were traced, “but not all were retrieved. Seventeen births of babies with deformities were reported in the United States, according to the F.D.A.”  There but for the grace of God go I.

Merrell and its successor companies should thank Dr. Kelsey every day, for she not only saved directly the lives of thousands.  Dr. Kelsey saved an entire industry by sparking the creation of serious drug-safety testing in the US.

As much as American industry complains about government regulation and bureaucracy, we as a society benefit greatly from the accidents, side-effects, and pollution prevented through regulation.

The next time I hear someone grouse about a silly government regulation, I’m going to remind them about Dr. Frances Oldham Kelsey.


Picture source: “Frances O. Kelsey (FDA 171) (8211251003)” by The U.S. Food and Drug Administration – Frances O. Kelsey (FDA 171). Licensed under Public Domain via Wikimedia Commons – https://commons.wikimedia.org/wiki/File:Frances_O._Kelsey_(FDA_171)_(8211251003).jpg#/media/File:Frances_O._Kelsey_(FDA_171)_(8211251003).jpg