Making History Saving Babies

Posted by on Aug 20, 2015 in Uncategorized | 0 comments

Sometimes one really determined woman can change history. That’s what I learned when I wrote about the career of Francis Oldham Kelsey, MD, PhD, the US Food and Drug Administration official who helped block the sale of thalidomide in the United States. Kelsey, who died in early August at the age of 101, had a 45-year-long career at the FDA, but made her mark on history not long after walking in the door.

She joined the agency in 1960 and the application to market thalidomide was the first she reviewed. The drug was already being used in Europe and was likely to sail through the FDA review process. But Kelsey, who had a pharmacology degree and experience studying another drug that had caused many deaths, and her colleagues found the application lacking in key safety data and asked for more.

Soon after, a spike in cases of a severe and rare birth defect in Europe was traced to thalidomide. Kelsey is credited with saving many US infants from being exposed to the drug, which was used to treat nausea and sleep problems during pregnancy. I wrote about Kelsey and her career in JAMA in 2010.

In the process of reporting the story, I was really surprised to learn how limited the FDA’s powers were when Kelsey joined the agency. There is no doubt the thalidomide-linked birth defects helped win public support for more FDA oversight. In many ways, Kelsey was well-positioned to help bring the agency into a new era of oversight. Her background in pharmacology and her studies at the University of Chicago of another drug that had killed more than 100 patients likely gave her a perspective many other reviewers at the time would not have had. Additionally, Kelsey was a mother herself. Her story really reinforces the value of a diverse, and multidisciplinary work force.

I can only wonder how many other trailblazing women are currently out their making history in their respective fields. More about Kelsey’s trailblazing career can be found in the National Library of Medicine’s Changing the Face of Medicine profile of Kelsey.

 

 

 

 

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