Frances Kelsey: Science in the Public Interest

Sometimes it is nice to read a story about  how one person can make a difference, someone who can use the standards of science to stand up to the corporations who put profit over public safety, and who can win. It is especially heartening when that someone is a public administrator.  That person is Frances Kelsey, and Truthout published this story:

kelsey“You’ve probably never of her, but she may have saved your life. In the early 1960s, Kelsey – a doctor and research scientist with the FDA – saved thousands of babies from severe birth defects by stopping a big pharmaceutical company from marketing the drug thalidomide. Equally important, Kelsey’s courageous stance inspired Congress to revise the rules for approving new drugs protecting hundreds of millions of Americans, then and now, from unsafe medicines.

Kelsey’s battle with the makers of thalidomide is not only an inspiring tale of how one individual’s expertise and courage protected the public interest against the corporate push for profits, but also a warning to drug companies and their lobby groups fighting new drug safety rules that would put public health and safety over drug company profits.”

She demanded scientific evidence that the drug was effective but that it also did not produce harmful side-effects.

Frances Kelsey: 1962 stopped thalidomide in 1962

“Her concerns were vindicated when it came to light that at least 10,000 children in Europe were damaged by thalidomide. Thanks to Kelsey, the United States was spared this tragedy, with fewer than 50 cases of thalidomide-related birth defects, due to the samples the company provided doctors, who then gave the drug to their patients.”

“But Kelsey did more than stop one drug company from marketing a dangerous drug to the public. She was also the catalyst for a major change in federal drug safety laws.”

“Senator Estes Kefauver (D-Tenn.) had been trying for years to pass legislation to strengthen federal regulation of drug approvals, but industry lobbying had thwarted any progress. Then, on July 15, 1962, the Washington Post published a front-page article by reporter Morton Mintz, “Heroine of FDA Keeps Bad Drug Off Market,” exposing Kelsey’s role in preventing a thalidomide epidemic. The publicity strengthened Kefauver’s hand. The drug companies opposed Kefauver’s efforts to strengthen government rules and FDA authority. They claimed that new pretesting requirements would harm patients by keeping drugs off the market; that publicizing the side effects of drugs was unnecessary because it was really the physicians’ responsibility to warn their patients; and that increased regulation of drugs would give government control over our lives.”

“But as the horrible effects of thalidomide on newborns became public, the industry opposition was overwhelmed by public demands for more government regulation and safer drugs.”

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