Why Medical Research Is Not One-Size-Fits-All…Especially for Women!

Women have outnumbered men in the United States since 1946, yet between 2014-2020 only 6% of medical studies were conducted on women exclusively. Only recently have we started to see the results of women-only medical studies. Our pharmaceuticals, medical equipment, and the way medical schools teach were all based on the study of men—not women. 

Thankfully, we are now in a golden age of medical science catching up. We are learning more and more about women’s bodies, health, and most importantly, how we are different from men. After all, “we are not little men” as Dr. Stacy Sims so accurately points out.

So why did it take so long for science to catch up to the needs of women? And what do the recent advances mean for our health?

For centuries, medical research ignored women. In the 19th and 20th centuries, most studies were conducted on men and results were generalized to everyone. Researchers claimed that women’s hormonal fluctuations made them “too complex” to study reliably. As a result, women were "protected" — also known as excluded — from research. For centuries, our pharmaceuticals,  medical equipment, and entire medical system was built upon the research of men.

In 1977, the Food and Drug Administration (FDA) created a policy to exclude women of reproductive potential from Phase 1 and 2 clinical trials unless they had a life-threatening condition. This was in response to a tragic outcome of a drug that caused severe birth defects — and sometimes death — for their babies. The FDA’s policy was interpreted broadly to mean no women of reproductive age should be studied. 

Failure to fully represent women in pharmaceutical research may even be the culprit behind women experiencing adverse effects from pharmaceuticals at twice the rate of men. 

Another challenge is that the science of wellness, and particularly the study of women’s health, is very new. Women-only medical studies did not begin until the 1990s, and women were not required to be included in clinical trials until 1993! 

In 1990, the National Institutes of Health (NIH) established the Office of Research on Women’s Health, which led to a variety of programs aimed at advancing research into women's health and increasing representation of women as participants and investigators in clinical research. Shortly afterward, Bernadine Healy, MD, was appointed as the first female director of the NIH. Then in 1994, the Office of Women’s Health was created by the FDA and charged with promoting the inclusion of women in clinical trials and the advancement of women’s health care.

While these advances were great, only 6% of studies were conducted on women-only subjects from 2014 to 2020! And many did not consider how our bodies change at various points of our cycles (and how that impacts the results of the studies).

Here’s why this matters, and why I am so passionate about diving into new research on women specifically. Because the clinical tests and medical studies affect how we are treated by medical professionals.

In 2013, researchers found that women's recommended dosage of Ambien should be 50% lower than the standard recommended amount (to men and women alike) due to the way women metabolize the medication. This was the first time we saw the huge need for scientific data based on sex differences. From here forward, women were not only considered a “subgroup” in medical research. This research paved the way for the understanding that sex matters in medicine—not just in reproductive health, but across all areas of clinical research. These findings fueled more sex-specific research, not only in reproductive health but across the medical field.

Sadly, the medical field is still catching up despite all of these advances. The best thing you can do is to be your own advocate. It’s vital that you have an open dialogue with your medical professionals at every appointment. Ask questions about their recommendations, where their science is coming from and how it impacts women at your age. It is always good to ask why they know that to be the case (aka are there any women-only studies to support what they are saying). Get the answers you need to make informed decisions.

We only have this one body. Let’s care for it the best we can. 

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