Thirty years of inclusion: what it means for the future of women’s health

On June 10th, 1993, Congress passed a law requiring the National Institutes of Health to include women and minorities in clinical research. On the 30th anniversary of its passing, we’re looking at the progress and potential that lies ahead.

It was only thirty years ago this June 10th that Congress passed a law requiring the National Institutes of Health (NIH) to include women and minorities in all clinical research, as appropriate. The NIH had adopted a policy to include women several years earlier in 1986, however, an investigation concluded it failed to fully enact this policy.

It’s shocking that for only 30 years, women have regularly participated in clinical research. This is a solemn reminder of the wide gaps in understanding women’s bodies. The history of women’s health and progress in the study of women’s bodies is still in its early days. Previously, we covered the downstream effects that the exclusion of women has had on patients in traditional healthcare. In this post, however, we’ll share the progress and potential the future holds for women’s health.

New research challenges the male body as the “default”

Researchers in the past claimed that women’s bodies were too complex when it came to drug trials. They excluded women on the basis of hormonal fluctuations and “reproductive potential,” which made the research more expensive, with confounding factors from hormonal changes, and potentially dangerous to female participants. (Nevermind that when research excludes diverse participants, assuming that the results apply equally to everyone could be dangerous.)

The same assumption made its way to animal test subjects. Male mice, for example, are the default in most laboratories. In 2016, the NIH addressed this disparity with a new policy that required preclinical studies to use female cells and animals. New research is already illustrating how important this inclusion is: the New York Times called attention to a new study on mice that is “tipping all of these assumptions about sex differences and the influence of hormones on their head.” The study showed that male mice exhibited more unpredictable behavior, and that their hormones also fluctuated. The results reveal how gender bias allows unproven assumptions go unquestioned for decades. Fortunately, the policy changes and evidence continue to drive a shift in clinical research.

More medical specialties recognize women’s health needs

Due to the taboos around women’s bodies, the term “women’s health” often stands in for reproductive health. Yet women’s health encompasses more than the reproductive systems: it’s all the nuances of physical and mental health, too.

Heart disease, for example, is the leading cause of death in American women. Long stereotyped as a men’s disease, now that women are included in studies, several of them suggest that women face higher rates of misdiagnosis or delayed care due to this outdated notion and the lack of understanding of how heart disease presents in women. Medical institutions are evolving, however. More providers are factoring in a woman’s reproductive health history to help determine her risk of heart disease. New research is uncovering the links between the age someone starts menstruating, pregnancy outcomes, and menopause and increased risks of heart disease. Risk factors specific to women and their reproductive health history are now a part of understanding a woman’s heart health, too. Emerging fields like cardio-obstetrics bring together the sex-specific risk factors that women face with their heart health.

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In the words of Hello Alpha’s Chief Medical Officer, Dr. Jacobson, “There’s a broad range of women’s health issues and sex differences in medicine. It’s important that we recognize the impact of hormonal and neuroendocrine chemical changes on a woman’s health.”

All genders deserve high-quality, compassionate care steeped in the latest unbiased medical research. For most of its history, the traditional healthcare system defaulted to a male standard. It’s time that women receive healthcare that serves them: that puts more decisions in their hands, doesn’t paternalize or dismiss their concerns, and honors that they are patients and people. With more focus on women’s health now than ever before, we believe in a brighter future in health equity for women.

Sources

History of Women’s Participation in Clinical Research | Office of Research on Women’s Health. orwh.od.nih.gov/toolkit/recruitment/history.

— -. “NIH Revitalization Act of 1993 Public Law 103–43.” Women and Health Research — NCBI Bookshelf, 1994, www.ncbi.nlm.nih.gov/books/NBK236531/?report=reader.

Liu, Katherine A., and Natalie a. DiPietro Mager. “Women’s Involvement in Clinical Trials: Historical Perspective and Future Implications.” Pharmacy Practice (Internet), vol. 14, no. 1, Centro de Investigaciones y Publicaciones Farmaceuticas, Mar. 2016, p. 708. https://doi.org/10.18549/pharmpract.2016.01.708.

Clayton, Janine A., and Francis S. Collins. “Policy: NIH to Balance Sex in Cell and Animal Studies.” Nature, vol. 509, no. 7500, Nature Portfolio, May 2014, pp. 282–83. https://doi.org/10.1038/509282a.

Ghorayshi, Azeen. “Hormones Don’t Affect Behavior of Female Mice, Study Finds.” The New York Times, 7 Mar. 2023, www.nytimes.com/2023/03/07/science/female-mice-hormones.html.

Bugiardini, Raffaele, et al. “Delayed Care and Mortality Among Women and Men With Myocardial Infarction.” Journal of the American Heart Association, vol. 6, no. 8, Wiley, Aug. 2017, https://doi.org/10.1161/jaha.117.005968.

O’Connor, Anahad. “Why Heart Disease in Women Is So Often Missed or Dismissed.” The New York Times, 9 May 2022, www.nytimes.com/2022/05/09/well/live/heart-disease-symptoms-women.html.

“Heart Disease in Women: Understand Symptoms and Risk Factors.” Mayo Clinic, 20 Jan. 2022, www.mayoclinic.org/diseases-conditions/heart-disease/in-depth/heart-disease/art-20046167.

O’Kelly, Anna C., et al. “Pregnancy and Reproductive Risk Factors for Cardiovascular Disease in Women.” Circulation Research, vol. 130, no. 4, Lippincott Williams and Wilkins, Feb. 2022, pp. 652–72. https://doi.org/10.1161/circresaha.121.319895.

Stuenkel, Cynthia A., and JoAnn E. Manson. “Are Five Decades of Progress in Women’S Health in Peril?” STAT, 29 Aug. 2022, www.statnews.com/2021/06/14/are-five-decades-of-progress-in-womens-health-in-peril.