Opinion

Biomedical Research Must Consider How Sex and Gender Influence Health

Although more women than men have been diagnosed with COVID-19 in the United States, the majority of people dying from the disease are men. In the United States, for every 10 deaths among women, there are 13 deaths among men. To understand this disparity, researchers must determine the influence of sex and gender on COVID-19 infection, diagnosis and treatment.

Understanding the impact of sex and gender must become a higher priority — not just in COVID-19 research, but across all biomedical research. Failure to do so will lead to real-world consequences, including unforeseen drug side effects, promising medications that never make it to market and public health policies that fail to meet the needs of all people.

Both sex and gender influence our health across the lifespan. The terms “sex” and “gender” are not interchangeable as they encompass different aspects of health. “Sex” refers to biological classification of living things according to reproductive organs and chromosomes, while gender refers to the self-perception of one’s identity and the social, cultural and environmental influences that affect an individual’s health.

The vast majority of biomedical research was conducted exclusively on white men until Congress passed a law in 1993 requiring the inclusion of women and minorities in clinical studies funded by the National Institutes of Health. Only five years ago, NIH implemented a policy requiring grant applicants to consider sex as a biological variable for research in vertebrate animals and humans. If grant applicants seek to study only one sex, they must offer strong scientific justification for doing so.

The 21st Century Cures Act, signed into law in 2016, served to bolster NIH’s efforts regarding consideration of sex and gender by directing the agency to ensure that researchers comply with the 2016 policy and conduct valid analyses by sex and gender for applicable clinical trial results.

In addition, the Cures Act tasked NIH with forming a working group to develop recommendations for increasing rigor and transparency in research, including consideration of sex in preclinical experimental design. NIH is now implementing these changes to its grant application process and increasing training for researchers on SABV.

These policies served as a positive catalyst for advancing the study of sex as a biological variable in research. A recent analysis found significantly more preclinical articles published in 2019 included both sexes as subjects compared to articles published a decade earlier. However, the analysis also demonstrated that fewer of the recent studies analyzed and reported results by sex.

Efforts to bolster the study of sex and gender must extend beyond NIH to encompass the entire biomedical research ecosystem. While NIH is the largest public funder of biomedical research in the world, in reality, the agency funds a relatively small portion — about 18 percent — of all U.S. medical and health research and development.

Most of this research is conducted by industry, including pharmaceutical, medical technology, health care service and other companies. Many of these companies’ products — medications, vaccines, medical devices — are reviewed and approved by the Food and Drug Administration.

As Congress considers crafting a second iteration of the Cures Act, there is ample opportunity to build on efforts to promote the consideration of sex and gender in research. First, the Department of Health and Human Services needs a uniform, harmonized approach across all agencies — including NIH and FDA — that prioritizes consideration of sex and gender influences on health across all federally funded research and federal regulations around research and health care.

Policymakers should create incentives that encourage financial investment by the public and private sectors in research that better considers sex and gender. For example, this could be done through initiatives like NIH’s Sex & Gender Administrative Supplement Program, which grants supplemental funding as an incentive to add an SABV component to an existing research program, which usually means incorporating female subjects in a previously male-only study. Legislation could also set priorities to identify research and disease categories where sex and gender influences warrant more attention.

Whether through a follow-up to the Cures Act or alternative strategies, policymakers should work with the scientific community to advance the study of sex and gender influences. Until the inclusion, analysis and reporting of sex and gender is made a priority, we will struggle to understand why conditions like COVID-19 affect women and men differently, hampering our ability to respond efficiently and effectively to health crises like the pandemic. Understanding the influence of sex and gender on health and disease will foster development of better diagnostics, vaccines, treatments, and public health policies.

Kathryn G. Schubert is the president and CEO of the Society for Women’s Health Research. Dr. Margaret M. McCarthy is professor and chair of the Department of Pharmacology at the University of Maryland School of Medicine.

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