Since 1946, the number of women exceeds the number of men in the United States. Nonetheless, women remain underrepresented in medical research. A 2001 Institute of Medicine report concluded that “sex matters” in health and illness. It has been demonstrated that the symptoms of cardiac arrest differ between male and female, which can lead to delayed diagnosis and treatment of women. Likewise, differences in drug responses can have adverse effects on women when it is not studied specifically in females as well as males.
In 1977, the FDA issued a guideline which essentially banned women of child-bearing potential from participating in early phase clinical research, as a reaction to the thalidomide tragedy in Europe in the 1960s. It was not until the late 1980s that the NIH and FDA began calling for increased inclusion of women in medical and pharmaceutical studies. Since the creation of the Office of Research on Women’s Health at the NIH in 1990, significant progress has been made on some diseases such as breast cancer and cardiovascular disease. However, treatment of others, including maternal mortality and morbidity and autoimmune disease have made little progress.
At the present time (Late 2024), there are several initiatives within the federal government to support adequate representation of women in medical research.
White House Initiative on Women’s Health Research
Established in November 2023 by President Joe Biden and First Lady Jill Biden to fundamentally change how our country approaches and funds research on women’s health.
ARPA-H Sprint for Women’s Health
Part of the Advanced Research Projects Agency for Health, championing transformative innovations and answering critical unmet challenges in women’s health across all demographics, geographies, and socioeconomic statuses.
US NIH Office of Research on Women’s Health
Established in 1990 to promote consideration of sex and gender in research, support women in biomedical careers, ensure inclusion of women in research populations, and advance rigorous research relevant to the health of all women.
Despite the rising embrace of “anti-science,” effective health care depends on objective clinical research, which requires careful design and planning to include a broad spectrum of the population and sufficient time and resources to gather and analyze data. Of course, all of this is dependent on adequate funding and the willingness of women to participate in studies.
Call to Action
- With a new administration in Washington, DC, in 2025, it will be critical to monitor changes in funding for medical research and in requirements for participation. We must work to ensure that women continue to be included and that conditions which predominantly affect women are adequately studied. Watch for announcements and calls for advocacy to support continued funding and regulation.
- Women should consider participating in studies. Below are comments from an AAUW Naperville Branch member who participated in studies in the past. There are many factors to consider when agreeing to be a subject in a research study, but give any requests thoughtful consideration.
Personal Comments: I have participated in two clinical studies, although neither were geared specifically for women. The first one was for kidney cancer. Unfortunately this study resulted in a negative conclusion; and I had unpleasant side effects. More recently, I was part of a two-year structured study for the prevention of memory loss. Focused on lifestyle behavioral changes, my cohort all realized definite benefits from new education and guidance. Although the research is ongoing, preliminary findings are very encouraging on how we can make simple changes to have a healthier brain. After careful consideration of potential impacts to my own health and wellbeing, and despite one positive and one negative result, I am still glad I was part of the research and studies going forward. My personal philosophy both times was if I didn’t raise my hand and volunteer, how were they going to have the data to advance new science and discoveries?
- Carey IW, Hackett C. Global population skews male, but UN projects parity between sexes by 2050. Pew Research Center, Short Reads, August 31, 2022. https://www.pewresearch.org/short-reads/2022/08/31/global-population-skews-male-but-un-projects-parity-between-sexes-by-2050/#:~:text=The%20United%20States%20has%20had,is%20expected%20to%20be%2099. //www.merriam-webster.com/dictionary/anti-science
- Institute of Medicine (US) Committee on Understanding the Biology of Sex and Gender Differences; Wizemann TM, Pardue ML, editors. Exploring the Biological Contributions to Human Health: Does Sex Matter? Washington (DC): National Academies Press (US); 2001. Executive Summary. Available from: https://www.ncbi.nlm.nih.gov/books/NBK222287/
- Miguel-Aliaga, I. Let’s talk about (biological) sex. Nat Rev Mol Cell Biol 23, 227–228 (2022). https://doi.org/10.1038/s41580-022-00467-w
- Irving Zucker, Brian J. Prendergast. Sex differences in pharmacokinetics predict adverse drug reactions in women. Biology of Sex Differences, 2020; 11 (1) DOI: 10.1186/s13293-020-00308-5
- Liu KA, Mager NAD. Women’s involvement in clinical trials: Historical perspective and future implications. Pharm Pract (Granada). 2016 Mar 15;14(1):708. doi: 10.18549/PharmPract.2016.01.708
- Institute of Medicine (US) Committee on Women’s Health Research. Washington (DC): National Academies Press (US); 2010. https://www.ncbi.nlm.nih.gov/books/NBK210145/
- Anti-science is defined as a set or system of attitudes and beliefs that are opposed to or reject science and scientific methods and principles. https://www.merriam-webster.com/dictionary/anti-science