Is Sex Discrimination in Medical Research Thwarting a Cure for COVID?

The fact that, in 2020, researchers would blindly assume women’s bodies behave like men’s is troubling.

The Pandemic Politics of Reproductive Health Care

This piece is part of “Women on the Frontlines: COVID and Beyond,” an online symposium examining the political, economic, social and legal status of women.

Sponsored by the Cornell Law Review with the Center for Biotechnology and Global Health Policy and co-hosted by Ms. and others, the symposium brings to light the ways women labor and lead at the forefront of society, constituting the foundation of essential workers, and performing critical services from child to medical care. But during the pandemic, women (especially women of color) suffer persistent economic constraints; health and death disparities; obstruction of rights; and the troubling perceptions of expendability. Watch “Women on the Frontlines: COVID and Beyond” for a discourse about the role of women and pathways toward a more just society.


Is Sex Discrimination in Medical Research Thwarting a Cure for COVID?

When I read that men are twice as likely to die from COVID-19 as women, I thought of science fiction books that posit pandemics that wipe out men.  Only men. 

Is Sex Discrimination in Medical Research Thwarting a Cure for COVID?
The Female Man, 1975. (Wikipedia)

Since the publication of Joanna Russ’s 1975 novel, The Female Man, novelists have imagined gender-specific pandemics.  In Russ’s novel, the female survivors live in a utopia once all those nasty men are out of the way. 

In Mario Bellatin’s Beauty Salon, the government, through inaction, fails to stem a pandemic affecting only men.  

Such scenarios could plausibly exist, given the biological differences between men and women.  Women have a more aggressive immune response than do men.  Women’s hormones, too, play a role in fighting infections by slowing the process that causes tissue damage, while testosterone can help an infection enter the cells. 

During previous pandemics, including the 1918 Spanish flu and the SARS outbreak, men died at higher rates than women did—even when, as was the case with SARS, women had higher rates of infection.

Despite the knowledge we might gain about COVID-19 and other infectious diseases from research on women, most medical research focuses on men.

  • A study of heart disease—the leading cause of death among women—was undertaken on 22,000 men and no women. 
  • A federal study on health and aging proceeded for twenty years with only male subjects. 
  • Absurdly, even though women account for 80 percent of autoimmune disorder patients, the main research subjects are—you guessed it—men. 
  • Even basic biological research is done mainly with male mice!  

Male-Centered Research Is Killing Us

The dangers from male-centered research are profound.  Even though women consume 80 percent of medications in the U.S., drug research is still predominantly conducted on men and fails to consider how drugs act over the course of a woman’s menstrual cycle.  Consequently, drugs can reach the market that are actually harmful to women.  In fact, eight of the ten dangerous drugs removed from the market between 1997 and 2000 caused greater harm and fatalities for women. 

A wide range of medications, including some antihistamines, gastrointestinal drugs, antibiotics and antipsychotics trigger potentially fatal heart arrhythmias more often in women than men.  

In 1993, Congress adopted a law designed to ensure that women were allowed to participate in medical research. 

When discrimination persisted, the National Institutes of Health in 2016 announced guidelines requiring federally-funded scientists to enroll women in studies, to disaggregate medical research data by sex, and to study female animals and female cells as well.


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Discrimination Against Women Persists in COVID-19 Research

Is Sex Discrimination in Medical Research Thwarting a Cure for COVID?
Spc. Kwabena Anim-Appiah and Sgt. Carlene McKenzie, combat medics with the Delaware Army National Guard, at a drive-thru testing site for COVID-19 at the University of Delaware in Newark, Delaware, on June 12. (The National Guard / Flickr)

Then along came COVID-19, with its tsunami of scientific articles.  By May 13, 2020, there were more than 23,000 papers published on COVID-19 with the number of articles doubling every twenty days. 

When I analyzed the burgeoning medical research literature about COVID-19 along with my team at the Institute for Science, Law and Technology at Chicago-Kent College of Law, we found that the historical discrimination against women in medical research still exists. 

Only a few scientific articles about COVID-19 analyze the difference in symptoms between men and women.  Most not only fail to break down the symptoms by sex, but also erroneously assume that the death rate of men and women is the same—ignoring the numerous studies that already demonstrated that men with COVID-19 die at a higher rate than women.

The fact that, in 2020, researchers would blindly assume women’s bodies behave like men’s is troubling.

Is Sex Discrimination in Medical Research Thwarting a Cure for COVID?
Akiko Iwasaki. (Kike Calvo)

Some researchers—mainly female researchers—are challenging the male-centric approach. 

Dr. Akiko Iwasaki and her team at the Yale School of Medicine analyzed the differences between men’s and women’s immune systems’ responses to COVID-19.  Women’s immune systems responded in a more favorable way, with an initial triggering of cytokines that then activated a more robust and helpful T-cell infection-fighting response.  Men with serious COVID-19 infections did not develop enough T-cell immunity, while women with serious infections exhibited a malfunction involving their cytokines.  

Ultimately, Iwasaki’s study suggests immunological answers to the question of why women fare better with a coronavirus infection than men.  But it also indicates that different treatments for men and women might be necessary.  Men may need a treatment to enhance T-cell response, while women may need one to ensure they produce the right amount of cytokines. 

Given the historic and seemingly abiding male-centric approach to clinical research, I’m concerned that the development of treatments for COVID-19 will again focus on men.  There is a danger that researchers will use the knowledge gained from women to help men—such as in current studies in New York and California that administer female hormones as a treatment for male COVID patients, rather than also exploring a different strategy of treatment to benefit women. 

Is Sex Discrimination in Medical Research Thwarting a Cure for COVID?
Spc. Kwabena Anim-Appiah and Sgt. Carlene McKenzie, combat medics with the Delaware Army National Guard. (Army National Guard / Capt. Brendan Mackie)

Policy Changes Can Help Reduce Sex Discrimination in Medical Research

Policy changes are needed to reduce sex discrimination in medical research in order to vanquish COVID-19. 

Any scientific reporting about COVID—whether to the World Health Organization, to the Centers for Disease Control, or in a medical journal—should disaggregate symptoms by sex. 

Any proposal for funding from the National Institutes of Health or for drug approval from the Food and Drug Administration should be required to indicate whether the research included female cells, female animals, and women and how their responses differed, if at all, from male responses. 

The penalties for not doing so should be severe—including, for example, a multi-year suspension of the researchers and their organizations from being able to get any federal funding from the NIH or get any treatment approved by the FDA.  

By failing to disaggregate symptoms by sex, researchers are failing to comply with existing legal requirements. More importantly, they are missing the opportunity to better understand—and to better treat and prevent—the further spread of the global pandemic.  Remedying sex discrimination in medical research is not only necessary to achieve justice, but may also point our way to a healthier future.

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About

Lori Andrews is a health law professor at Chicago-Kent College of Law and the author of IMMUNITY, a novel about a pandemic during a presidential election.