Our Bodies, Our Research

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It seems ironic to have celebrated National Women’s Health Week last month, as women across the country are preparing to lose access to reproductive healthcare services if Roe v. Wade is overturned. Women rightfully fear for the loss of their bodily autonomy and ability to make decisions about their health in a post-Roe America. However, the grim reality is that this is actually nothing new — women’s bodies have been understudied and their voices ignored when it comes to their health for decades.

Much of what we know about human health and disease was based on the assumption that, apart from their reproductive organs, women were simply “smaller men.” Biomedical research has overwhelmingly favored male patients and even male laboratory animals with claims that the main female reproductive hormones, estrogen and progesterone, cause too many variations in study results. In addition to these “pesky” hormones, women could also become pregnant — a major issue for clinical research.

In clinical research studies, the effects of a drug or treatment on a fetus are often unknown and could potentially cause harm. Events in the 1950s and 1960s demonstrated what could happen if unvetted drugs were given to pregnant women. The drugs thalidomide and diethylstilbestrol were prescribed to pregnant women to treat morning sickness and to prevent miscarriages, respectively. It was later discovered that these drugs caused birth defects and life-long health complications for children exposed to these drugs in utero. In response, in 1977, the FDA banned almost all women of reproductive age — not just pregnant women — from participating in early-stage clinical research. The mere possibility that a woman could become pregnant during a clinical trial was deemed too great a risk.

And so, biomedical research carried on. Advances in medicine were derived from mostly male studies despite the fact that men and women experience many diseases and disorders differently. Despite the growing knowledge about the influences of biological sex on health and disease, it wasn’t until Congress passed the 1993 NIH Revitalization Act that women were required to be included in clinical research. Yet, by that point the status quo was established and research studies continued to favor men.

This protectionist and male-centric attitude persists today. The most recent prominent example is the development of COVID-19 vaccines. Pregnant and lactating women were excluded from participating in the initial vaccine trials, and any initial evidence that the vaccine was safe and effective for pregnant patients was based on data from a handful of women who became pregnant during the course of the trial.

The American College of Obstetricians and Gynecologists called for the inclusion of pregnant and lactating patients in clinical research, especially as data emerged that pregnant women were at greater risk of severe health complications due to COVID-19. Pregnant healthcare workers were especially frustrated as they faced COVID-19 on a daily basis and were unable to make their own informed choice about whether to join a vaccine trial, bolstered by decades of data suggesting vaccines are generally safe during pregnancy and confer beneficial antibodies to infants. Yet, many pregnant women remained hesitant to receive the vaccine since their physicians could provide no meaningful data to assuage their concerns.

After the COVID-19 vaccines were authorized by the FDA, women took to social media with concerns about irregular menstrual cycles or breakthrough bleeding that occurred after vaccination. Because vaccine trials failed to ask about those “pesky” reproductive hormones, this side effect went unreported and scientists are now tasked with retroactively examining the impact of the vaccines on menstrual health.

These all-too-recent examples highlight how science and medicine still fail to take women’s health seriously. We also know now that excluding women from medical research is holding back our economy. A recent study by Women’s Health Access Matters, The WHAM Report, shows that even small investments in closing the gender research gap will add billions to our economy.

Should Roe fall, biomedical research focused on women may be the next battleground for women’s rights.

Will research into maternal and fetal health slow drastically? Will women once again be denied the agency and authority to fully participate in life-saving, biomedical research based on their ability to become pregnant? Will advances to promote the inclusion of women in research stagnate? The health of women in the U.S. is in grave peril should Roe v. Wade dissolve, and it will take much more than a National Women’s Health Week to acknowledge that we deserve better.

Nicole C. Woitowich, PhD, is a research assistant professor in the Department of Medical Social Sciences at Northwestern University’s Feinberg School of Medicine.

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