Why Dr. Frances Kelsey has The Right Stuff

“The Right Stuff ” is a term popularized by author Tom Wolfe in his rollicking, uproarious, roller-coaster-ride of a book by the same name:¬† a book about the¬†seven original astronauts¬†selected for Project Mercury.

They were men who had what it took to climb into a massive rocket loaded with explosive fuel and blast off into space. They had the Right Stuff.

In that spirit I’ll present awards from time to time to people with the Right Stuff. People who take on a challenge and triumph over obstacles. Or who suddenly, unexpectedly find themselves in a challenging situation and rise to the occasion quietly and competently. Those who demonstrate what a single person can accomplish if she or he has the Right Stuff.

And the fifth Right Stuff Award goes to Dr. Frances Kelsey

In 1960, a young pharmacologist and physician, Dr. Frances Oldham Kelsey, went to work at the Food and Drug Administration. One of the agency’s functions is to evaluate information about new drugs before they can be approved for sale in the United States. To gain approval, a pharmaceutical company tests the drug it has developed and submits its results to the agency. The FDA evaluates the data to determines whether the drug’s health benefits outweigh its risks.

Dr. Kelsey’s¬†first assignment

Working out of a prefabricated building from World War I, Dr. Kelsey was assigned to review an application to market a new drug called Kevadon, the brand name for thalidomide. At the time, the drug was being used widely in Britain, Germany, and other countries as a sedative prescribed to pregnant women for relief from morning sickness.

Dr. Kelsey questioned its safety and refused to approve it. The William S. Merrill Company, manufacturer of the lucrative drug, responded with what Dr. Kelsey later termed ‚Äúunrelenting pressure.‚ÄĚ

Dr. Kelsey under intense pressure

According to a recent article in the “Washington Post,”

The drug company pushed back and started an intense campaign, repeatedly calling and meeting with Kelsey and her superiors, including the FDA commissioner. Kelsey was steadfast, and her resistance became the stuff of legend when it turned out that thalidomide caused severe birth defects in thousands of babies born in Europe and elsewhere. The drug had been prescribed for women to help them sleep or manage morning sickness. The babies often had malformed arms or legs or extra appendages.

Dr. Kelsey honored for her work

As described in the same article, the FDA subsequently created a division of new drugs, and Dr. Kelsey directed drug evaluations for the rest of her long career at the agency.

In 1962 Frances Kelsey received the President’s Award for Distinguished Federal Civilian Service, presented by President John F. Kennedy

In 2005¬†she¬†retired from the FDA at the age of 90 and several months ago (on September 15, 2010)¬†became the first recipient of an award named in her honor‚ÄĒthe Dr. Frances O. Kelsey Award for Excellence and Courage in Protecting the Public Health.

Sometimes courage is not so much a matter of physical bravery, but of showing the courage of¬†your convictions in the face of unrelenting pressure. Do you think our culture recognizes and rewards such courage as often as it might? Can you think of others who¬†demonstrate such¬†Excellence and Courage in performing their work? I’d welcome¬†hearing your ideas.¬†

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  • Madeleine Kolb 12/28/2010, 8:06 pm

    Gip, It’s great to see you here again.

    I think it’s so important to recognize the courage that it took for Frances Kelsey to stand fast against intense pressure to approve thalidomide. People working in government are sometimes pressured to make decisions based on political rather than technical considerations. It would be interesting to know what the managers in the FDA were thinking during this time.

  • Gip 12/28/2010, 5:18 pm

    There are always more opportunities to recognize people for the valuable contributions they make.

    While it’s not a very good idea to take action hoping to be recognized or rewarded, we all like to be noticed.

    Thanks for a great post!
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