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Thread: How One FDA Scientist Saved American Children From a Birth Defect Catastrophe

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    Administrator Islander's Avatar
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    Default How One FDA Scientist Saved American Children From a Birth Defect Catastrophe

    "Katherine"
    July 24, 2019


    When pharmacologist Dr. Frances Oldham Kelsey started working at the U.S. Food and Drug Administration (FDA) in 1960, one of the first files to cross her desk was an approval request for thalidomide. The drug had already been prescribed widely in Europe and other countries as a treatment for morning sickness in pregnant women, but Kelsey wasn't convinced it was safe. Her refusal to approve the drug, despite intense pressure from its manufacturer, likely saved tens of thousands of babies in America from devastating birth defects. "Representatives for the company thought I was crazy because it was such a popular drug in Europe, and they were losing money by my pigheadedness," asserted Kelsey in a later interview. "I held my ground. I just wouldn't approve it."

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    Default Re: How One FDA Scientist Saved American Children From a Birth Defect Catastrophe

    What a wise, intelligent, courageous woman! It's too bad the FDA doesn't have more people like her today.

    I remember seeing photos in the newspaper of 'thalidomide babies' with malformed limbs when I was a child. It made quite an impression on me.
    Last edited by Pattypans; 08-10-19 at 04:56 AM. Reason: Fix spacing

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    Veteran Member grulla's Avatar
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    Default Re: How One FDA Scientist Saved American Children From a Birth Defect Catastrophe

    I recall growing up in my younger years in NJ, circa 1950-60s, I had a neighbor friend who was born without his lower left arm, the result of having been a thalidomide child, as they became to be known, as I was told.

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    Veteran Member Mr. Wizard's Avatar
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    Default Re: How One FDA Scientist Saved American Children From a Birth Defect Catastrophe

    Kudos for everything Pattypans said. Dr. Frances O. Kelsey was truly a rare breed. Having worked 45 yrs. for FDA, she could have commanded millions of dollars if she'd decided to jump ship and go work for the BigPharma, as an estimated 60% of FDA medical scientists do. Her refusal to approve thalidomide was all the more remarkable considering she had been employed for only "several months" when gave the manufacturer a "no go" decision, and the drug was being used by other countries around the entire world. What a spine of steel she must have had to stand firm in her assuredly unpopular decision within the agency. Thank goodness this took place at a time when FDA employees did not see themselves as an extension of BigPharma.

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