Based on an article by Kate Rockwood from the AMT Pulse, Spring 2023.
Biologically, women are not just small men. Obvious, right? But that hasn’t been the case for much of modern medicine, with many studies and treatments focusing on men’s bodies, then applying the same insights to women.
Differences in body size, hormones and brain structures impact how men and women’s bodies react differently to disease, medication and even stress. For example, women’s bodies metabolize drugs differently than men’s, meaning they may need higher or lower doses of a medication for it to be effective. Heart disease, meanwhile, is the No. 1 killer for both men and women, but women develop heart disease later in life—about seven to 10 years later.
And while research has become much more equitable in recent years—women are now well represented in studies on hypertension and atrial fibrillation, for example—the scale is still tipped in favor of the study and treatment of men’s bodies, even though women make up 51% of the population.
“To this day, work based largely or exclusively on men is assumed, often with little question or evidence, to generalize to women,” says Chloe Bird, PhD, Director of the Center for Health Equity Research at Tufts Medical Center and a Senior Sociologist for the RAND Corporation.
Understanding crucial biological differences and how diseases manifest differently in women can help improve women’s health outcomes. Consider that women are 50% more likely to be misdiagnosed after a heart attack. That’s largely because the medical community and the general public often associate heart attacks with symptoms that men are more likely to experience, like crushing chest pain, versus symptoms more specific to women, such as nausea and indigestion.
“In the past, only men were studied, and everyone is really familiar with their symptoms. We’re all looking for those symptoms, and we miss women’s,” says Natasha Diaz, MD, Family Medicine Specialist and founder of Roots Health DPC.
Yet, only one-third of clinical trial participants for new heart disease treatments are women. “We have a growing body of work showing sex and gender differences down to the cellular level that are
How We Got Here
Part of the research dearth dates to decisions made decades ago. Between 1977 and 1993, the Food and Drug Administration (FDA) ruled that women of “childbearing potential”—a huge swath of the population—weren’t allowed to participate in clinical research trials in the U.S.
The FDA’s decree was meant to be protective after disastrous trials involving drugs such as thalidomide, which was later found to cause birth defects. But the decision hampered crucial medical research on women.
“Not only were pregnant women and those seeking to become pregnant excluded, but virtually all women seen as having the potential to become pregnant— except for some studies of nuns—were excluded,” Dr. Bird says. “As a result, we know relatively little about women’s health compared to men’s health.”
Women, and even female mice, were also often excluded from studies for fear that their monthly hormonal cycles would skew research, says Katie Schubert, President and CEO for the Society for Women’s Health Research in Washington, D.C.
“Researchers thought it was too challenging to get accurate results and that you could extrapolate out the [male-dominated] studies and apply them to women,” she adds.
In 1993, the FDA rescinded its policy. A year later, the National Institutes of Health (NIH) mandated the inclusion of women and ethnic minorities in studies. However, pregnant and lactating women are still often kept out of research trials today, even in cases where it may not be necessary.
“The reality is, we have not done enough trials on therapeutic interventions in pregnancy for COVID-19, which will certainly have an impact on people’s reproductive health,” says Tiffany Green, Assistant Professor, population health sciences and obstetrics and gynecology at the University of Wisconsin-Madison.
The solution isn’t to simply enroll more women in clinical research. On that front, things have actually gotten much better. Between 2011 and 2019 alone, the number of women in research studies increased by 49%, according to a study in Neuroscience and Biobehavioral Reviews. But what didn’t improve? The number of studies that break out results by sex.
Separating data by sex is often critical. A series of trials and driving simulations on sleeping pills 10 years ago shows why. The trials found that women taking sleeping pills containing zolpidem had high enough levels of the drug in their systems the next day to impair their alertness and driving. As a result, the FDA recommended cutting the dosage in half for women.
Research on health issues more common or solely found in women also tend to be underfunded. Outside of oncology, only about 1% of research and innovation is invested in female-specific health conditions. In fact, according to research in the Journal of Women’s Health, of the 25 most underfunded diseases in 2019, 14 of them were more female-dominant. Just one underfunded disease, liver cancer, was more male-dominant. (The female-dominant diseases included chronic fatigue syndrome, migraines and endometriosis.
Not only does women’s health research face an uphill battle, but women also often experience gender bias in their interactions with healthcare. That bias can show up in many ways, some of them dangerous. Women’s pain, for example, is often taken less seriously, research shows, and is much more likely to be attributed to psychological causes instead of physical ones. That can lead to women waiting longer to receive a diagnosis or receiving the wrong diagnosis altogether. This is an area where healthcare workers of all types can play a major role in improving the patient experience, especially for women of color or other marginalized groups such as transgender women.