Women’s Health: Lost in Translation?
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There are many steps between an innovative idea and an FDA approved treatment. One of the first stages of preclinical experimentation is in the lab, using surrogate animal models. The research is done with only male animals because it vastly decreases cost and complexity.[2] The latter, however, dangerously simplifies the playing field. So much so, that the NIH changed their policy to require clinical testing to utilize both males and females. Yet still, incorporating the female anatomy is overlooked in this crucial initial stage of testing.
Why men? Historically speaking, our culture of chivalry emphasizes protecting women. Consider the next time a man waits in the back of the elevator until all women have exited, or how difficult it was for women to obtain the right to vie for combat roles in our military. Now combine this practice with the common notion that clinical trials are dangerous. Since clinical research practices were established, anything experimental is viewed as potentially harmful, and therefore not fit for female participation.
Researchers have made the argument that evidence from male study participants can translate to females because men and women are assumed alike. However, they fail to recruit women because their hormonal systems and subtle bodily differences create more complex data to analyze for publishing results. The logic here seems flawed. Men and women are physiologically and anatomically different. These differences are more significant than only the reproductive organs; they are systematic and influential, and they are affected by medical treatment.
Women are being fiscally, culturally, and conveniently excluded from clinical trials, and therefore the resulting medications are ill suited to treat us. We can have a role in instituting change. Simple gestures like participating in a research study, asking our doctors whether or not a suggested treatment has incorporated data for women, or furthering this conversation within our scientific and health communities can have real impact.