FDA's Frances Kelsey Not Such a Hero?

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Following our article in Dispatch yesterday on an award to be named in honor of Dr. Frances Kelsey, the FDA official who kept thalidomide off the market in the U.S., we heard from two of our advisors questioning just how heroic her actions were.

Brad Rodu writes:

Kelsey’s action in keeping thalidomide off the American market benefited many pregnant women and their babies. However, thalidomide is a life-saving drug, with applications to a large number of diseases including multiple myeloma, other bone marrow disorders and immune-mediated diseases. I have heard that Kelsey kept thalidomide from being investigated in the U.S. for decades, even after other countries had permitted its use. So you are absolutely correct: it is ludicrous to portray regulatory actions like this only in a favorable light; they always have negative effects, sometimes considerable.

And Stan Young tell us:

By all accounts Kelsey was just plain lucky. She held up approval because she had an odd chicken egg test she wanted done. As luck would have it, then news broke in Europe so she became a hero. Massive testing of thalidomide in multiple species of animals only turned up birth defects in one strain of rabbits. To honor her is to honor plain dumb luck. People need to know/remember the rest of the story.

But Dr. Ross says while Dr. Kelsey’s delay of thalidomide to the market may have been serendipitous, it seems unfair to chalk it up to mere “dumb luck.” “The end result of her delaying thalidomide’s approval here — saving perhaps thousands of women from bearing limbless children — warrants paying her due respect, although we appreciate the added perspective supplied by our readers.”