The Fight for Women’s Health

Our latest five-part series, The Devil in the Details, tells the story of Dr. Francis Oldham Kelsey, a female scientist at the U.S. Food and Drug Administration who fought to keep a dangerous medicine called thalidomide off the market in the 1960s. 

In Europe and beyond, thalidomide caused serious birth defects in babies whose mothers took the drug while pregnant. Thousands of babies were born with shortened limbs, and countless others died in the womb. Kelsey’s vigilance prevented the same tragedy from unfolding in the U.S. and highlighted gaping holes in the regulatory system.  

This near-miss prompted a slew of new legislation to improve drug safety. The U.S. government began rolling out policies to bolster safety protocols, including one in 1977 that recommended excluding women from early-stage drug trials. 

Indeed, it was decades before the medical community began to grasp what was happening. Leaving women out of clinical drug studies didn’t protect them, it created new vulnerabilities. 

For years diseases that impacted both men and women were studied in just men, causing doctors to overlook symptoms that are specific to women and skew treatment regimes toward male biology. For conditions that impacted women alone, the situation was even worse. 

Take heart disease, for example. When researchers began studying the condition, they assumed it was a male affliction and overlooked women altogether. 

Nanette Wenger noticed problems right away and began challenging the status quo as soon as she joined the cardiology team at Atlanta’s Grady Memorial Hospital in 1958, just two years before Kelsey took a job at the FDA.