The Thalidomide Crusader

In today’s Washington Post, there’s a terrific tribute to Frances Oldham Kelsey, an FDA researcher who in 1960 refused to give the green light to thalidomide. She just didn’t buy the manufacturer’s “extravagant claims.” The article doesn’t say whether she had a hunch of the terrible birth defects caused by the drug, although in graduate school she had studied the effects of other drugs on fetuses. In any case, when it came out in 1962 that thousands of babies had been born with deformed arms and legs to mothers who had been prescribed thalidomide, Kelsey was hailed as a heroine.

The affair was a turning point in American medicine that shook people’s faith in the potential of science to cure all ills. Congress beefed up drug testing laws, requiring informed consent of patients to participate in clinical trials. Tomorrow, 50 years after her courageous stand, the FDA will present the physician-pharmacologist with the first Kelsey Award. I assume this won’t interfere with the nonagenarian’s daily rituals: “a glass of sherry at 11 a.m. and an old-fashioned cocktail at 5 p.m.”

I’ll add this footnote: Although thalidomide was demonized in the public’s mind, a few years later it was found to be a breakthrough drug for erythema nodosum leprosum (ENL), a painful complication of leprosy. Federal regulators granted an exemption for doctors to acquire small amounts for this purpose. However, thalidomide fell out favor as other more effective leprosy treatments were developed and it became apparent that prescribing thalidomide in poor countries where leprosy is still endemic and drug regulations are lax –Brazil, for example – was not a good idea. Per the World Health Organization:

Because of its known teratogenic effects, WHO does not recommend the use of thalidomide in leprosy. Experience has shown that it is virtually impossible to develop and implement a fool-proof surveillance mechanism to combat misuse of the drug. Today, a number of thalidomide babies continue to be born each year reflecting regulatory insufficiency and widespread use under inadequate supervision.

Even so, researchers continue to investigate the potent anti-inflammatory effects of thalidomide in a variety of cancers and other diseases.

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