7/3/17: THALIDOMIDE: Fifty-Five Years Later, An Inside Story in Installments

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[Most of the following is an excerpt from the introduction to my first book, “Starting With Serotonin.”]

On Sunday, July 15, 1962, my parents invited Dr. Frances (“Frankie”) Kelsey and her husband, Dr. Fremont (“Fred”) Ellis Kelsey, former colleagues of my father’s at the University of Chicago, to a backyard barbecue at our new two-story brick colonial in Bethesda, Md. Frankie was a review officer with the U.S. Food and Drug Administration, and Fred was an organic chemist employed by the National Institutes of Health, where I knew Dad also worked, but doing what, I couldn’t say. Judging by his stethoscope, briefcase, and air of authority, though, I figured it was important.

Bethesda, now a traffic-filled Washington, D.C., suburb known for its smart dining and inflated housing prices, was then a modest, and quiet, small town. The grownups drank Manhattans on the screened porch, while we kids played softball in the yard. Fred laughed a lot and loudly, and Frankie, whose pointed eyeglasses emphasized her round face, chatted in a friendly, unassuming way. It was a hot, slow summer day before the salvation of central air conditioning delivered us from the heat.

During the gathering, the phone rang, and my mother ushered Frankie Kelsey into her study. Soon, the older woman was speaking with an NBC radio interviewer about a recent decision of hers, reported that morning on the front page of The Washington Post.

“‘Heroine’ of FDA Keeps Bad Drug Off Market,” the headline read. Kelsey had thwarted U.S. approval of a popular European sedative called thalidomide.

[Contrary to media reports and what you may have read and learned to believe, thalidomide was not a morning-sickness drug. This is an unfortunate misconception perpetuated by people who don’t know its history.]

Although safe for its intended patients, thalidomide proved devastating to the fetuses of women who took it during their first trimester of pregnancy. The drug corrupted fetal limb development, causing the births of babies with shortened, flipper-like arms and legs. Toes grew directly from their hips, and hands sprouted at their shoulders.

Even as a child, I understood this tragedy and how Americans had been spared. As I listened on Dad’s transistor radio to the words that Kelsey spoke into Mom’s white rotary telephone, I became awestruck. Nearly forty years later, an 87-year-old Frances Kelsey, widowed since 1966 and still working part-time at the FDA, would tell me that she remembered a girl, about 7, solemnly saying, “History is being made in our house today.” It was a big pronouncement, she remarked, “for one so small.” Kelsey herself thought the news “would all blow over in a week.”

That day marked a turning point in my awareness of my father’s scientific stature and in my own developing sense of identity and purpose. It gave me a very big context and an ambitious model for life. Although it was a red-letter day for Kelsey, and a historic milestone in the development of U.S. drug law, it came to represent for me the beginning of my understanding of who my father was when he was being Albert Sjoerdsma, M.D., Ph.D., not just my Dad.

I wrote a biography about my father, titled “Starting With Serotonin: How a High-Rolling Father of Drug Discovery Repeatedly Beat the Odds,” which was published in 2008. Now 55 years after that significant July day, I would like to share with you in three installments a chapter from my book titled “The Thalidomide Shakeup.” Ironically, as you’ll learn, that same summer, U.S. Surgeon General Luther L. Terry, who was Dad’s first boss at the National Heart Institute–and the man who issued the ground-breaking report on the health risks of smoking–confided his concerns to him that Dr. Albert Sabin’s new oral polio vaccine—the sugar cube, which contained the live virus—was causing cases of polio among children and adults in the Northwest.

As chief of Experimental Therapeutics at the NIH’s National Heart Institute, a founding father of clinical pharmacology—which blends biochemistry, pharmacology, and clinical medicine; research into how chemically active compounds (drugs) work in people, not animals—and an early advocate of the rational design of drugs, my father was an inside player in the medical era known as the Golden Age of Research and Development (1950s-1960s). As you’ll see in the chapter about thalidomide, he never shied from expressing his opinion, and he never failed to have an opinion. He was not a fence sitter.

Please check back on Monday, July 10th, for the first installment of “The Thalidomide Shakeup.” Subsequent installments will be published on July 17th and July 24th.

Thank you.

Ann, 7/3/17

 

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