Merry Christmas and Happy Holidays! It’s time for some good news when it comes to researching ‘women’s diseases.’
Women’s health has long been an area that has been overlooked and understudied in medical research. Despite making up more than half of the population, women have historically been underrepresented in clinical trials and medical studies, leading to significant gaps in knowledge and understanding of women’s health issues. However, recent developments, such as the establishment of the White House Initiative on Women’s Health Research, are changing the landscape and paving the way for a new era of research and innovation in women’s health.
Table of contents
The Historical Underrepresentation of Women in Research
For decades, women’s health needs were considered a low priority in the scientific and medical fields. During the 1970s, when the women’s health movement emerged as part of the larger women’s movement, it became apparent that women were significantly underrepresented in medical and scientific research. At that time, there were few women working in medicine and science, and the lack of representation had serious implications for the understanding and treatment of women’s health conditions.
One significant example of the cautious approach towards including women in research was the Food and Drug Administration’s policy in 1977, which recommended excluding women of childbearing potential from early-stage drug trials. This policy was a response to the tragic consequences of the drug thalidomide, which caused severe birth defects in thousands of babies born to women who had taken the drug during pregnancy. While the intention was to protect women from potential harm, it resulted in a lack of data on how drugs specifically affected women.
The Shift Towards Inclusion and Advocacy
As awareness grew about the exclusion of women from research studies, advocacy groups and activists began to protest for change. They argued that individual women should be allowed to make informed decisions about participating in research and that excluding women limited their access to potentially life-saving treatments. The Public Health Service Task Force on Women’s Health Issues, in their 1985 report, called for long-term research on how behavior, biology, and social factors affect women’s health, further highlighting the need for inclusion.
In response to these concerns, the National Institutes of Health (NIH) established a policy in 1986 that encouraged the inclusion of women in studies. This policy, published in the NIH Guide for Grants and Contracts in 1987, urged researchers to include women and minorities in their studies and provided guidelines for doing so. The policy was further reinforced in 1989 when NIH announced that research solicitations should prioritize the inclusion of women and minorities.
The Founding of the White House Initiative on Women’s Health Research
In 1990, the Congressional Caucus for Women’s Issues requested an investigation into NIH’s implementation of guidelines for the inclusion of women in research studies. The subsequent report by the General Accounting Office (now known as the Government Accountability Office) highlighted inconsistencies in applying the inclusion policy and the need for improved communication. As a result, the Office of Research on Women’s Health (ORWH) was established in 1991 to monitor and promote the inclusion of women in research.
Under the leadership of Dr. Bernadine Healy, the first female NIH Director, the Women’s Health Initiative was launched in 1991. This initiative consisted of clinical trials and an observational study involving over 150,000 postmenopausal women. The trials aimed to investigate the effects of hormone therapy but was stopped due to incorrect interpretation of the data resulting in the majority of women stopping their hormone therapy overnight, literally. We are still dealing with the consequences of this today.
Legislation and Policies to Ensure Inclusion
While the inclusion of women in research was initially an NIH policy, it became federal law in 1993 through the NIH Revitalization Act. This act included provisions requiring the inclusion of women and minorities in clinical research funded by NIH. The law mandated that NIH ensure the inclusion of women and minorities and that trials be designed to analyze whether variables affect women and minorities differently. It also emphasized that cost should not be a reason for exclusion and called for outreach efforts to recruit diverse populations for clinical studies.
Since the establishment of the ORWH, the office has monitored adherence to inclusion policies and guidelines. Researchers receiving NIH funding are required to report on the sex, race, and ethnicity of participants enrolled in clinical trials. These reports contribute to the ongoing efforts to promote inclusivity and address health disparities among different populations.
Improving Women’s Health Through Research
The White House Initiative on Women’s Health Research, announced by President Biden and led by First Lady Jill Biden, signifies a renewed commitment to advancing women’s health research. The initiative aims to galvanize the federal government, private sector, and philanthropic communities to close research gaps, address health disparities, and pioneer the next generation of discoveries in women’s health.
Under this initiative, concrete recommendations will be delivered to the Biden-Harris Administration within 45 days, outlining actions to improve research on women’s health and maximize investments in this field. Priority areas of focus will be identified to ensure transformative outcomes, ranging from heart attacks in women to menopause and beyond. The initiative also seeks to engage stakeholders from the scientific, private sector, and philanthropic communities to drive innovation and foster collaborative partnerships.
By prioritizing research on women’s health, we can gain a deeper understanding of conditions and diseases that predominantly affect women, such as endometriosis, cardiovascular disease, and Alzheimer’s disease. This knowledge will enable healthcare providers to better prevent, diagnose, and treat these conditions, ultimately improving the lives of millions of women.
The establishment of the White House Initiative on Women’s Health Research and the ongoing efforts to promote inclusion in medical research mark significant milestones in addressing the historical underrepresentation of women in studies. Through policies and legislation, initiatives like the Women’s Health Initiative, and the monitoring of adherence to inclusion guidelines, progress is being made to close research gaps and improve women’s health outcomes.
Research plays a crucial role in understanding the unique aspects of women’s health and developing effective treatments and interventions. By prioritizing and investing in research on women’s health, we can empower women, healthcare providers, and researchers to make informed decisions and advancements that will positively impact the health and well-being of women across the nation. The White House Initiative on Women’s Health Research is a vital step towards achieving this goal and creating a future where women’s health is fully understood, supported, and prioritized.
What you can do!
The Initiative is accepting written comments and input, we urge everyone to get involved.
You can send in either a word document or PDF file to WomensHealthResearch@who.eop.gov
Related reading:
- Endometriosis Signs and Symptoms: Everything You Need to Know
- Endometriosis Facts & Myths: Dispelling the Misconceptions
- Why was iCareBetter built?
References:
- https://www.whitehouse.gov/briefing-room/statements-releases/2023/11/13/fact-sheet-president-joe-biden-to-announce-first-ever-white-house-initiative-on-womens-health-research-an-effort-led-by-first-lady-jill-biden-and-the-white-house-gender-policy-council/
- https://www.whitehouse.gov/gpc/briefing-room/2023/11/17/launch-of-white-house-initiative-on-womens-health-research/
- https://www.whitehouse.gov/briefing-room/speeches-remarks/2023/11/13/remarks-by-president-biden-and-first-lady-jill-biden-establishing-the-first-ever-white-house-initiative-on-womens-health-research/
- https://orwh.od.nih.gov/toolkit/recruitment/history#:~:text=Inclusion%20Becomes%20Law&text=In%201993%2C%20Congress%20wrote%20the,as%20Subjects%20in%20Clinical%20Research.
