CHEVY CHASE, Md. — She is unlikely to be mentioned at any 50th-birthday parties this year, but she is the reason many of those celebrations will take place.
Dr. Frances Oldham Kelsey is 96 now, nearly deaf and barely mobile, as modest as her faded house in this Washington suburb. And though her story is nearly forgotten, she was once America’s most admired civil servant — celebrated for her dual role in saving thousands of newborns from the perils of the drug thalidomide and in serving as midwife to modern pharmaceutical regulation.
On Wednesday, Dr. Margaret Hamburg, commissioner of the Food and Drug Administration, will honor Dr. Kelsey with the first Kelsey award. It will be given to a F.D.A. staff member annually. The award will come 50 years after Dr. Kelsey, then a new medical officer at the agency, first sat down to consider an application from the William S. Merrell Company of Cincinnati to sell a sedative named Kevadon, which was widely prescribed in Europe for morning sickness in pregnancy.
As it turned out, the drug (better known by its generic name, thalidomide) would cause thousands of children in Europe to be born limbless or with flipperlike arms and legs. With her probing analysis of Merrell’s application and her insistence on scientific rigor, Dr. Kelsey ensured that the effects in the United States were far more limited.
The thalidomide disaster led Congress to pass legislation giving the F.D.A. authority to demand that drug makers prove their products safe and effective. Moreover, Dr. Kelsey helped write the rules that now govern nearly every clinical trial in the industrialized world, and was the first official to oversee them.
Doctor Kelsey resisted pressure from the pharmaceutical corporations and lobbyists to be a good girl and just go along. She was a female in a male organization, and the one doctor who stood in the way of a drug that left such a path of destruction in Europe being pushed on pregnant women in the US.
Today thalidomide is marketed for some cancers and for some complications of AIDS, but I’m not happy to see it back, no matter how many safeguards they put in place. The acne drug, Accutane, can causes birth defects, and a program to prevent use by women who might become pregnant has not been as successful as it might be if people were rational and doctors never cut corners.
Thank you Doctor Kelsey, for all the lives you saved, for all the sorrow you prevented. The free market may be fine for deciding what color shirt to buy, but when you have to trust that a drug is safe, a car is road-worthy, food isn’t contaminated– then you need some gummint interference.