Over 30 years ago, advocates and policymakers discovered that not only were women not being included in clinical research, they were actively excluded during their reproductive years.
It's 2021, and while we've made progress, focusing on and increasing research into women's health is just as important now as it was then.
The establishment of the several essential Offices of Women's Health (OWH) within our federal health agencies has been of critical importance to advancing women's health over the last several years. These offices, within HHS, the National Institutes of Health, Food and Drug Administration, Centers for Disease Control and Prevention, Substance Abuse and Mental Health Services Administration, and Health Resources and Services Administration, were made permanent in 2010 in the Affordable Care Act and provide tremendous service to women. We are grateful for the efforts and leadership of these organizations.
We've just celebrated National Women's Health Week (NWHW), started over two decades ago by HHS and OWH, because there was a need to establish an annual reminder to women to prioritize and take care of their health.
One of the significant highlights of this year's NWHW was the 5th Annual Vivian Pinn Symposium, hosted by the NIH Office of Research on Women's Health (ORWH). The event highlighted how different stakeholders have the power to work together to integrate sex and gender into biomedical research. When it was discovered that biomedical research was not studying women, NIH established ORWH. Although NIH thought creating this office would solve the problem, women continued to be ignored.
In 1993, a short time after the establishment of ORWH, the NIH Revitalization Act was passed by Congress requiring the agency to establish guidelines for including women and minorities in research, especially clinical trials. This meant that: 1) women and minorities had to be included in phase 3 of clinical trials; and 2) that the trial is designed and carried out in a manner sufficient to provide valid analysis of whether the variables studied in the trial affect women or minorities differently than other subjects in the study.
Regardless of the mandate, it still took years and enormous effort by advocacy groups, particularly the Society for Women's Health Research, to convince the scientific community that women are not the same as men and that basing treatment decisions on research done only on men does a disservice to the health and well-being of women.
Thirty years later, ORWH has made much progress, including implementing the policy for the inclusion of women and minorities and the requirement that all NIH-funded researchers consider sex as a biological variable in preclinical research. The 21st Century Cures Act directed NIH to ensure that basic research projects funded by NIH account for sex as a biological variable and examine and analyze differences between male and female cells and tissues. The act also requires examining and analyzing sex differences when using male and female research animal models.
The COVID-19 pandemic has exacerbated and exposed existing health disparities and inequities in health, especially when it comes to conversations around race and its inclusion in biomedical medical research. In 2016, FDA-OWH collaborated with NIH-ORWH to launch an initiative called the Diverse Women in Clinical Trials Initiative to raise awareness about participation of women of all ages, races and ethnicities in clinical trials including women with chronic health conditions and disabilities.
It is also important to leverage the power of working together to advance women's health. During NWHW, HealthyWomen helped launch the Friends of the Office of Research on Women's Health, which comprises groups committed to prioritizing the study of sex and gender in biomedical research and advancing women's health. The coalition's goal is to advocate for federal support for the important work of ORWH.
Every day, women across our nation rely on the important work and programs provided by all of these offices of women's health. HealthyWomen supports this important work and the organizations' continued efforts to drive women's health research and education to enhance our understanding of the diseases and illnesses that impact women. It is critical that Congress continue to provide them with the appropriate support and budgets essential to their success.