The problem of female misrepresentation in medical studies is very real

Reference Man

The misrepresentation of women in medical studies is a problem that has misled medical officials for generations. In “On the Generation of Animals”, Aristotle characterized a female as a mutilated male. No one corrected him. Instead, we make medical decisions based on data derived from Reference Man. Reference Man is a Caucasian male, aged twenty-five to thirty, weighing about 155 lbs. Reference-Man fails to represent half of the world population’s anatomy. Women have worked tirelessly to right these wrongs — and receive accurate medical care.

Through a whirlwind of decisions made from 1977 and 1993, women lost their right to participation and they took it right back. In 1977, women “of childbearing potential” were removed from the possible subject pool of medical studies. This was due to the fact that 10,000 children had been born between 1960 and 1962 with thalidomide-related disabilities because doctors prescribed it to pregnant women for morning sickness. Drug developers and doctors everywhere had made the mistake, and women continued to pay the price. In 1985, Public Health Reports released “Report of the Public Health Service Task Force on Women’s Health Issues”, which called for data on women – not data on Reference Man. Because the data simply did not exist. In response, NIH and FDA worked to develop more inclusive guidelines regarding the inclusion of women in medical studies. In 1993, the 1977 ban was rescinded. 

Yet we fail to learn from our mistakes. In 2012 and 2013, as recounted by Vox producer Kim Mas, headline after headline read that women were crashing their cars the morning after taking a sleeping pill, Zolpidem, commonly known as Ambien. Why? Men and women received the same prescription of a ten-milligram dosage for eight hours of sleep. But developers had failed to test the drug’s effects on women. Women’s metabolism took twice as long as men to break down the drug and remove it from their system. So, when they got started with their day the following morning, they were still under the influence of Ambien, impairing their ability to operate a motor vehicle. But the doctor prescribed it, so how could it be their fault? 

Well, it was. Surprise! Reference Man had gone through the trials, and his results were not generalizable. Not to women, and not to anyone besides Reference Man. Rather than take the time and money to test more subjects, developers assumed the data they had covered it all. Plus, the Vox report illustrates how even if women are included in these studies, their results are usually lost amidst the overwhelming male data. Following this scandal, the FDA released a safety warning in 2013 cutting the Ambien dosage for women in half. If drug companies cannot take the time to test the effects of their drugs on women, how can we trust our medical care? And how can we expect anyone else to give a damn about our needs?

We can’t. In February 2018, the British Journal of Clinical Pharmacology published an all-male-authored medical paper entitled ‘Gender differences in clinical registration trials: is there a real problem?’. Their conclusion? No, the problem was not “real”. If you ask me, when women are crashing their cars because their doctors did not know the effects of the drug dosage they were prescribing, I’d say that’s a real problem.

(Photo Credit: Vox)