The Gender Gap in Medical Research: Why Women’s Health is Often Overlooked

For decades, the foundations of medical knowledge have been built on studies conducted primarily on men. This is because the concept of the “average” human in medical research has traditionally been modeled on the male body. From physiology to pharmacology, our fundamental understanding of human biology is biased toward the male model.

This historical bias has serious implications on women’s health, leading to misdiagnosis, ineffective treatments, and even harmful side effects. 

Why are women underrepresented in clinical trials and medical research?

The National Institutes of Health found that a major barrier to including women in clinical trials stems from a 1977 policy by the U.S. Food and Drug Administration (FDA) that excluded women of childbearing age from early stages of drug research unless the research was about a life-threatening disease. 

The FDA later reversed this policy with the passage of the NIH Restoration Act of 1993, which mandated the inclusion of women and minorities in government-funded health research, but many challenges remain. 

But the exclusion of women from medical research has deeper roots. Concerns about the complexity of women’s biology, their reproductive health, and the ethical considerations surrounding testing women contribute to this bias. Furthermore, the common perception that women are primarily caregivers, rather than independent patients, has marginalized women’s health needs.

Dosage and metabolism

Women metabolize drugs differently than men due to differences in body composition and hormonal influences, which can lead to under- or over-dosing with serious consequences.

According to an article in Nature magazine titled “Healthcare Inequalities,”

• Data from the United States Food and Drug Administration (US FDA) show that the incidence of drug-related adverse events is higher in women than in men: between 2004 and 2013, more than 2 million such cases were reported in women, exceeding the 1.3 million recorded in men.
• A report by the U.S. Government Accountability Office found that of the 10 drugs that were withdrawn from the U.S. market between 1997 and 2000, the majority were withdrawn because of side effects that primarily affected women.
• The first studies to look at the link between low-dose aspirin and reduced risk of heart attack were conducted only in male participants, and subsequent studies in women showed that while aspirin reduced the incidence of strokes, it was not equally effective in preventing heart attacks.
• Women metabolize the sleep aid Ambien (zolpidem) more slowly than men. Despite numerous reports of women falling asleep at the wheel and other accidents, the U.S. FDA has maintained its original dosing recommendations for more than 20 years. It wasn’t until 2013 that the agency adjusted its dosing guidelines to account for the differences in metabolism between the sexes.

Hormonal differences

Hormonal changes in women affected by the menstrual cycle, pregnancy and menopause create complex issues that are often overlooked in research. Drugs and treatments designed without considering these factors may be less effective or even harmful to women.

In the early 1960s, researchers realized that women had a lower incidence of heart disease than men until menopause, and began investigating hormone replacement therapy as a potential preventative measure. Of note, the initial trial of 8,341 participants included only male subjects.

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Additionally, an article titled “Women’s Inclusion and Justice in Clinical Research” reported that a pilot study funded by the Rockefeller University National Institutes of Health to examine the link between obesity and breast and uterine cancer excluded women entirely. 

Symptoms of the disease

Diseases often present differently in men and women: heart attacks, for example, often present with unique symptoms in women, leading to delayed diagnosis and increased mortality.

An article published in Nature, titled “Male dominance in animal research persists,” said the study shows significant gender disparities in animal research: for example, less than half of animal studies focusing on depression and anxiety involve female subjects.

Moreover, a review of leading nephrology journals revealed a staggering imbalance: for every study involving women, there were five studies involving only men. In some cases, this ratio was as high as 16:1. 

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Additionally, early research on coronary heart disease focused primarily on men, even though a significant percentage of women ages 40 to 60 have risk factors for coronary heart disease. This is of particular concern because CHD is the leading cause of death in women, and they often present with different symptoms than men.

Seeking change

The scientific community and regulatory authorities are recognising the limitations of male-dominated research and are increasingly emphasising the importance of considering sex and gender in research. 

• Inclusion of women in clinical trials: Efforts are underway to ensure adequate inclusion of women in clinical trials across a range of medical fields. 
• Gender analysis: Researchers are analysing data to identify differences in how the disease affects men and women, leading to more targeted treatment. 
• Funding research into women’s health: Increasing investment in research focused on women’s health is critical to closing current gaps. 

Challenges and opportunities

Despite progress, challenges remain. Overcoming deep-rooted biases, securing adequate funding, and designing complex studies that take sex and gender differences into account will require ongoing efforts. But the potential benefits of closing this gender gap are enormous. By prioritizing research into women’s health, we can develop more effective treatments, improve patient outcomes, and ultimately improve health for all.

The work towards gender equality in medical research continues. By acknowledging historical biases and taking proactive steps to include women in research, we can create a future where truly personalized and effective healthcare is available to all.