This 'n That 

Not All Warriors Carry Swords


A few years ago there was a certain book I couldn't wait to read. It was the story of a woman who stared down one of the most powerful political lobbies in America, and whose resolve and courage saved countless thousands of American families from heartbreak. I would have curled up in my favorite chair with a hot cup of joe, tossed the phone in a bucket of water, kicked off my shoes and spent a rainy evening with my face stuck in the pages.

But there was one little thing keeping me from reading that book: it didn't exist.

In 1960 Frances Oldham Kelsey was a young physician hired by the Federal Food and Drug Administration to review new drugs. One of her first assignments was to assess Thalidomide, a drug commonly being prescribed in Europe and Australia to treat pregnant women with morning sickness. Kelsey didn’t think the research results provided by the manufacturer were adequate, and refused to approve the drug for widespread distribution in the United States until more information was available.

In spite of intense lobbying from Richard Merrill, the manufacturer, Kelsey held firm. And she was vindicated when reports came in from Europe that Thalidomide had been linked to serious birth defects; some babies were born with stumps for arms and legs. Others blind or deaf. As the news spread, Kelsey was universally hailed as a hero; JFK awarded her the President’s Award for Distinguished Civil Service. She even had an asteroid named after her.

The Thalidomide incident moved Congress to pass The Kefauver-Harris Amendment in 1962, which required manufacturers to provide much more research and documentation for new drugs, and to report adverse reactions to the FDA. Kelsey was instrumental in helping to frame the language of the new law and played a key role in monitoring drug company compliance.

I learned some of the basic details about her life and career while doing research for another piece of writing and was blown away. I was even more amazed to discover that no one had written a book about her. About this wife, mother of two daughters, and physician whose courage prevented an untold number of serious birth defects? You can imagine the kind of pressure she was under, and all the horrible things said about her (and probably to her), with the huge profits at stake.

I suggested to a couple of writer colleagues that they tell her story, but no go. One said I should write it myself, but I’m not a biographer. I was giving the idea away for free; I just wanted a shout out in the foreword and a signed copy. And frankly, I wasn't sure how much longer I wanted to live  in a world where you could buy a biography of Snooki but not a book about one of the  greatest heroes in the history of medicine. Dr. Kelsey retired from the FDA in 2005 at ninety after forty-five years of service and enjoyed a quiet and much overdue retirement until she passed in 2015 at the age of one hundred and one.

It's sad that so much of her amazing story will remain forever untold...



Charles Coe1 Comment