The XX Factor

Just Say No

Like Emily , I am enthralled by the story of Dr. Frances Oldham Kelsey, who is being honored today with the FDA’s first-ever Kelsey Award, which will be given each year to an outstanding employee. Kelsey’s name crops up regularly in histories of reproductive health and childbirth. Her commitment to rigorous pharmaceutical testing saved untold numbers of American babies from being born with deformities. In 1960, Kelsey was the newly hired FDA officer who thwarted an application from a drug company, William S. Merrell, that wanted to sell thalidomide in the U.S. At that time, the drug, a sedative, was being used in Europe, where it was peddled as a preventative for morning sickness and a way to help pregnant women sleep. It also-people would learn-caused severe birth defects, most notably missing or flipperlike limbs. To appreciate the extent to which Kelsey was bucking the culture of her time: The ‘50s and ‘60s, remember, was the era of “better living through chemistry,” an era of supreme confidence in the fruits of scientific endeavor, a time when drug companies tried to push a variety of insufficiently tested drugs on pregnant women, arguing that the drugs were safe, probably, and anyway that the placenta created a barrier that would protect the baby from any ill effects, an assertion we now know to be untrue. DES, another drug, incorrectly touted as preventing miscarriage, was distributed for years to pregnant women despite mounting evidence of its dangers; the fallout from DES (with which thalidomide is often confused) was girls born with a vulnerability to vaginal cancer and reproductive malformations causing infertility. So it was an unlikely time for a junior bureaucrat to defy the scientific industrial complex. 

Also like Emily, I devoured every scrap of her personal narrative , related in the New York Times : I love the fact that Kelsey was born in 1914 to parents who expected a daughter to be as well-educated as a son. And that she was hired at the University of Chicago because her boss-to-be mistook her name for that of a male. And that, when she worried about the ethics of “taking” a job that could have been held by a breadwinning man (a widespread concern at that time), her professor at McGill told her that was nonsense. I also loved the story of her courtship with her husband, a fellow scientist: She’d taken some experimental malaria drug and had to provide urine samples, and when one collection time occured during a theater date, he waited for her outside the ladies’ room and chivalrously held the bag containing the specimen afterward. (He apparently also was not put off by the fact that the drug had turned her yellow.)

One suspects she got where she did thanks not only to her own talent and mettle, but also to the support of independent-minded mentors and family members. 

Oh, and I love the fact that at 96, according to the Washington Post , she not only “spends her time playing bridge, watching birds at the feeders on her windowsills and completing crossword puzzles in ink” but also has a glass of sherry in mid-morning and a cocktail promptly at 5.

What her story also reminds us is that sometimes, one of the best and hardest things a civil servant can do is say “No.” Or at least, “Not until you give us more evidence of the safety of whatever it is that you want our approval to peddle.” The drug company cried bloody murder when she turned them down; they whined to her bosses and even to the FDA commissioner. She was steadfast, and also she was supported. When the company finally stood down, she later told the Times , “I was so relieved to get them off my back.” In the recent past, we’ve seen all too many cases of regulators who caved and said yes to risky financial products, or to coal mines that flout safety regulations, or to deep-sea drilling platforms with inadequate emergency backup plans. We’ve seen compliant bureaucrats ready to defy the recommendations of scientific panels and bow to political pressures surrounding a well-tested drug like Plan B. All civil servants should draw comfort from her courage and backbone, and be reminded of their own importance and power.

And, as one who was born and spent six months in utero in the very year when Kelsey had the temerity to say no, I’d like to say to her, personally: Thank you.