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The Fight for Women’s Health

When Medical Research Failed Women in the Wake of the Thalidomide Scandal, Dr. Nanette Wenger Fought Back.

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.

Dr. Nanette Wenger at the Grady EKG laboratory.

Source: Courtesy of the American Heart Association with permission from Nanette Wenger

At Grady Memorial Hospital, Wenger faced an unexpected challenge. She had female patients complaining of symptoms consistent with heart disease, but all that Wenger had learned of the disease referenced its presentation in men. 

Even so, these women were complaining of chest pain and angina, hallmarks of coronary artery disease, and important red flags for a heart attack. 

Wenger scoured the scientific literature for treatment guidelines and found very little information. There were several early long-term studies of heart disease underway at the time, but many didn’t include women, and others left data on women out of the results. Their justification for doing so was two-fold. Researchers were concerned about causing harm after thalidomide, and they feared that the hormonal changes women experience might influence the outcome of drug trials. The studies that did include women weren’t calibrated to their physiology, leading researchers to conclude that chest pain, while uncomfortable for women, wasn’t dangerous in the same way it was for men. 

Wenger begged to differ. And she spent decades trying to prove it. 

Fast forward to 1993. Wenger co-authored a seminal paper in the New England Journal of Medicine on cardiovascular health in women that established the first set of care recommendations for women with heart disease and detailed its impact.

Dr. Nanette Wenger at the American Heart Association's Scientific Sessions conference in New Orleans in 1992

Source: Courtesy of the American Heart Association with permission from Nanette Wenger

Illustrations by Lisk Feng

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The article stated that cardiovascular illness was not a male illness, but rather, a disease that in the United States killed 500,000 women and landed 2.5 million in the hospital every year. Doctors often missed the warning signs of heart disease in women because they didn’t know what to look for. 

One of the greatest risks for those suffering from coronary artery disease is a heart attack. The most common symptom of a heart attack in both men and women is chest pain, but women often experience other symptoms too. These “less common” symptoms aren’t well studied, leading women and their doctors to overlook them more often. 

Even recent studies suggest that women, and people of color, have to wait longer for medical care when they experience chest pain and are less likely to receive exhaustive testing than men.

The lines on this graph show the recorded heart disease deaths in men and women between 1950 and 2020. Documented cases were much higher in men before 1990, and began to decline as testing and treatment improved. Documented cases in women were relatively stable, and the decline has been far more subtle.

Source: World Health Organization mortality database

Eventually, the medical community began to acknowledge the differences between women’s and men’s hearts. But by excluding women from cardiac studies for so long, they’d put them at a greater risk of experiencing a cardiac event. 

The same year that Wenger’s paper was published, the U.S. passed a law reversing its previous recommendation to exclude women from clinical research and requiring that women and minorities be included in all federally funded research from that point forward. It would take time for science to do more than check a box with the data gathered. 

Many preliminary drug studies conducted before 1993 lacked important data on how the drugs impacted women. And even after the 1993 law, scientists weren’t required to break down their results by gender, race, or other categories until 2016. 

These errors of omission crop up everywhere, in all fields, but in medicine, they can be costly and deadly. 

Next time we explore the dosage problem. Evidence suggests that women’s bodies process drugs in different ways at different rates from men's, but dosage guidelines don’t often specify, and sometimes, it matters.

The lines on this graph show the recorded heart disease deaths in men and women between 1950 and 2020. Documented cases were much higher in men before 1990, and began to decline as testing and treatment improved. Documented cases in women were relatively stable, and the decline has been far more subtle.

Source: World Health Organization mortality database

The lines on this graph show the recorded heart disease deaths in men and women between 1950 and 2020. Documented cases were much higher in men before 1990, and began to decline as testing and treatment improved. Documented cases in women were relatively stable, and the decline has been far more subtle.

Source: World Health Organization mortality database