Historically, medical research has largely excluded women from clinical trials for drugs and medical devices. As a result, their participation remains disproportionately low in studies on critical health conditions such as cardiovascular diseases, psychiatric disorders, and cancer. The gap has led to a lack of gender-specific data, potentially impacting the effectiveness and safety of treatments for women.
“The gender gap in medical research, alongside overarching misogyny, results in real-life disadvantages for female patients,” says the study.
Further, in many cases research data have been collected from males and subsequently generalized to females. Several reasons, according to the study, are cited for preferring males over females in recruitment for clinical trials. Some of these include concerns for decreasing fertility or harming pregnancy, researcher bias from predominantly male researchers, and perception of the male as representative of the human species and, therefore, the norm.
The relatively low female participation in clinical trials may be attributed to an overarching misogyny. The lack of evidence-backed research from female patients may result in delay in treatment, incorrect, ineffective, or harmful treatment for women, putting women at a disadvantage in comparison to their male counterparts.
This gender disparity also reflects in the proportion of women investigators conducting the trial. According to a study published in Journal of the American College of Cardiology, “nowhere is the under-representation of women in cardiovascular medicine as conspicuous as in clinical trial leadership.”
“The disproportionate participation of women in clinical trials means that ultimately, we have this much bigger risk of not having good data about the safety of pharmaceuticals’ women patients and for consumers,” Jill Fisher, Professor of Social Medicine at the university of North Carolina, Chapel Hill is quoted to have said in an article published in Harvard Public Health.
Men being larger in size on average, with different fat and hormone content, trial phases with only male recruits may skew safe dosage results for women. Thus, underrepresentation of women in phase 1 clinical trials, where safe dosage is established, could translate to inaccurate dosage recommendation of women consumers of the drug. This may be the reason why, historically, the most adverse drug reactions have occurred among women consumers. History continues to repeat, with findings from a 2020 study validating that low female participation in clinical trials were still leading to overmedication of women.
“These drugs are optimized from the beginning to work on male bodies,” says Prof. Brian Prendergast, a UChicago psychologist and co-author of the study, quoted in an article published on the University of Chicago website. “We need to immediately reevaluate the widespread practice of prescribing the same doses to men and women.”
Also read: Women Twice as Likely to Die After a Heart Attack Than Men
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