for decades, medical research has largely overlooked the distinct biological and societal factors impacting women’s health, leading to potentially flawed diagnoses and treatments. This disparity stems, in part, from a historical exclusion of women from clinical trials following public health crises involving drugs like thalidomide and DES in the 1960s. Now, as highlighted in a new report, the medical community is revisiting these practices and working to address long-standing biases – a process that is proving complex, and critical for equitable healthcare outcomes. This week, we examine the ongoing efforts to re-integrate women into research and understand the importance of considering sex and gender in all aspects of medicine.
For decades, women have been underrepresented in medical research, leading to gaps in understanding how diseases and treatments affect them differently than men. This lack of inclusion can have serious consequences for women’s health, impacting diagnosis, treatment, and overall care. This week, we’ll be examining these biases and how the medical community is working to address them, starting with the slow re-integration of women into clinical trials.
Health Crises During Pregnancy Sparked Change
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Clinical trials are a critical phase in the development of any new medication, determining optimal dosage, potential toxicity, side effects, and overall effectiveness. To ensure reliable results, these studies need a diverse group of participants that accurately reflects the population who will ultimately use the drug. However, beginning in the 1960s, women were increasingly excluded from these trials. This shift followed two major public health scandals involving medications prescribed to pregnant women: thalidomide, used to combat morning sickness, and diethylstilbestrol (DES), prescribed to prevent miscarriages. Both drugs caused severe birth defects.
Women Aren’t Just Small Men
Following these tragedies, women were excluded from clinical trials for decades. This practice began to change with the publication of a U.S. report examining why drugs were being pulled from the market after their release. The report found that eight out of ten drugs withdrawn between 1997 and 2000 had adverse effects on women. Health authorities then encouraged the re-inclusion of women in studies, though parity remains a significant challenge. The findings highlighted the need for more inclusive research to better understand how medications affect all patients.
Beyond Biological Differences
The issue extends beyond clinical trials to the earlier stages of research. Until recently, animal studies were almost exclusively conducted on males, purportedly to avoid hormonal variations – despite the fact that hormones fluctuate in both sexes. As Anne-Sophie Grenouilleau, coordinator of the 2020 “Sex and Health” report, explains: “These two drugs caused very serious birth defects, and in addition, for DES, secondary effects on several generations of women and men.” This underscores a fundamental principle: women are not simply “small men.” “We are different not only in our reproductive system, but also because women’s kidneys and hearts don’t function exactly the same way as men’s, and that’s not just a question of size,” Grenouilleau emphasized.
Considering Sex and Gender is Crucial
This problem isn’t limited to women, but extends to all populations that don’t fit the standard used in many studies – a young, Western man weighing around 150 pounds. The dimension of gender also plays a role, referring to the social and cultural constructs associated with biological differences, going beyond just reproductive organs. For example, women are more likely to seek treatments like GLP-1 medications such as Ozempic, or previously, Mediator, not necessarily because they are more affected by obesity, but due to societal pressures to alter their bodies.
However, progress is being made. In France, the High Authority for Health is encouraging all stakeholders – from policymakers to scientists and healthcare professionals – to consider differences related to sex and gender. Sometimes these differences are central, and sometimes they are not. Ignoring sex-based differences introduces bias into medicine, but acknowledging them is a crucial step towards more equitable and effective healthcare. The full discussion with Anne-Sophie Grenouilleau provides further insight into why integrating sex and gender into medical research is a major scientific issue.
