Tuesday, September 14, 2010

An American Hero | 50 Years On -- The First "Modern" Drug Regulator

Gardiner Harris, for The New York Times, has a sublime piece in the Science section today. He details the story of one quiet, persistent doctor's role -- a half-century ago -- in largely preventing a widespread drug disaster here in the U.S., even as it was unfolding in Europe. Today the FDA will honor her as the first winner of an award bearing her name.

This is a compelling -- and inspiring -- story. This is what the agenecy should strive for. This was the FDA's "Mercury 7" moment. Do go read it all:

. . . .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. . . .

[T]halidomide 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.

“She had a huge effect on the science that we all take for granted today,” said Daniel Carpenter, a professor of government at Harvard and the author of “Reputation and Power” (Princeton, 2010), a definitive history of the F.D.A. . . . .

Terrific. Truly -- do go read it.

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