
FDA reviewer Dr. Frances Oldham Kelsey fought to keep thalidomide, which caused serious birth defects, off the U.S. market
I began in journalism at The University of Michigan student newspaper and became a fan of investigative journalist I.F. Stone’s weekly newsletter and the way he mined government documents to break stories. After 12 years at two St. Louis newspapers, I moved on to The Washington Post, which, in the summer of 1962, published my story about how “the skepticism and stubbornness” of Dr. Frances Oldham Kelsey, a Food and Drug Administration medical officer, “prevented what could have been an appalling American tragedy.”
Eight months after the application for marketing thalidomide was filed with the Food and Drug Administration, the terrible effects of the drug abroad were widely reported in this country. Fortunately, Kelsey had blocked its introduction here.
My story led to greatly heightened recognition among the press and public of the need for sustained government regulation of the pharmaceutical and medical device industries, as well as the need for congressional oversight of that regulation. The story and the reaction it elicited led me to focus on the safety of not only pharmaceuticals but medical devices and tobacco.