FDA Officer Who Kept Thalidomide Out Of US Dies At 101

Dr. Frances Oldham Kelsey, Canadian, died at the age of 101, less than 24 hours after receiving the Order of Canada in a quiet ceremony at her daughter's residence in London, Ontario, according to theguardian.

She was the woman who discovered the link between the drug thalidomide and severe birth defects in 1960. She was a medical officer at the Food and Drug Administration, when she ran into an application for FDA approval of the Kevadon, which was the brand name for thalidomide, according to npr.

It was manufactured by drug company William S. Merrell Company, Cincinnati.

The company had expected her to sign off the petition quickly, but was frustrated when she refused due to her concern about the side-effects. The company complained to her superiors and to her. "They were writing letters and telephoning," she said, according to latimes. "They were very anxious to get their product on the market. It had been very successful in other countries and they felt there would be a big market in this country."

Thalidomide had been sold to pregnant women in Europe and other places beginning 1950. Thousands of babies were reported in Europe, Australia, Canada and Japan to be born with abnormally short and sometimes without any arms, legs or hips.

It was invented to be an anti-nausea drug that could help to cure morning sickness. Merrell had applied for a license for the drug in the U.S.

But Kelsey wanted more information when she got the application. "Thus began a fateful test of wills. Merrell 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." 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," says nytimes.

A horrifying tragedy was aborted in the United States, with much credit due to Kelsey. ... For 19 months, she carefully stopped its approval, even as the drug company officials called her a "bureaucratic nitpicker."

In 1962, media reports described her as a "heroine" whose "skepticism and stubbornness ... prevented what could have been an appalling American tragedy."

The physician and pharmacologist died on August 7. Her daughter gave confirmation of her death but not the reason for it.

She still lives on, though, in the hearts and minds of the public, as an amazing heroine.