Women’s Health Research: 25 Years of Progress (and Counting)

By Dr. Janine A. Clayton

dr claytonThinking about women's health is a big part of my life. I often think about the projects I'm working on now and ones that I'll be working on in the future. But during National Women's Health Week, May 8–14, I want to take a step back to think about the "what ifs" of women's health. What if the champions of women's health had not been there and done what they did?

What if Dr. Ruth Kirschstein had continued her successful career as a bench scientist and was not in position to help establish ORWH, or to mentor so many scientists who made women's health their focus?

Where would we be without the support of a fiery group of Congresswomen who pushed women's health and the establishment of the ORWH to the front burner?

If Dr. Bernadine Healy had not been appointed NIH Director, would we have the Women's Health Initiative, a stunningly successful study that changed medical practice and saved us about $37 billion in health costs?

If Dr. Vivian Pinn hadn't been appointed the first director of ORWH, would women's health research be as vibrant? Would more than half of the participants of NIH clinical research be women?

The ORWH will host the inaugural Vivian W. Pinn Seminar at 2 p.m. on May 10 at Cloisters Hall (Building 60). Keynote speaker Dr. Lauren V. Wood of the National Cancer Institute will discuss a cancer vaccine trial she is running. Registration is not required. Please stop by!

Highlights in Women's Health

It's hard to answer the "what if" questions with any certainty. But we do know that we've made some good progress in women's health since they first championed the cause of women's health research.

One year after opening its doors in 1990, the ORWH helped launch the Women's Health Initiative (WHI). This study found that the routine prescription of menopausal hormone therapy (MHT) did not have the positive effects we thought it had, and even placed women at risk for cardiovascular disease and breast cancer. As a result, women are not routinely prescribed this therapy, and we know about the risks. Women can speak to their healthcare provider about understanding their individual risks.

A study released in 2014 estimated that the WHI led to 76,000 fewer cases of cardiovascular disease and 145,000 fewer cases of breast cancer. The trial's return on investment was $140 for every $1 spent! Unfortunately, this change in practice also led to 263,000 more fractures. ORWH and NIH continue to fund research on bone health, including osteoporosis, to try to address this serious health problem.i

NIH-funded research has led to many advances in women's health over the ensuing 26 years. To mention a few, there is the invention of the home pregnancy test, the near-elimination of mother-to-child HIV transmission, and the development of the human papillomavirus vaccine to protect women against most cervical cancers.

Women's health research has been gaining in strength. When ORWH was established in 1990, few women got to participate in research. In 1993, Congress passed the NIH Revitalization Act, which required that women be included in clinical research. Today, women represent about half of all participants in NIH-funded clinical research, and our knowledge of women's health is much richer for their participation.

However, there is more work to be done. There are still disparities in clinical trial participation by sex/gender, race, age and ethnicity. We are working hard to change this because, if we intend clinical research to address public health, we must include all the populations affected.

The ORWH has been working hard to get more people from underrepresented groups involved in research. If you're a clinical researcher, you will want to look at the NIH Outreach Toolkit that ORWH developed, which provides tools, stories, and strategies that clinical researchers can use to conduct high-quality research studies with varied populations.

Focus on the Future: Sex as a Biological Variable

I've written quite a bit recently about including sex as a biological variable  (PDF - 74.6KB) in NIH-funded preclinical research, so I won't go into detail here. Suffice it to say that we can't provide appropriate health care to male and female people without including male and female animals and cells (yes, even cells have a sex) in preclinical research. As of this year, sex as a biological variable must be included in NIH-funded preclinical research.

Many a good work of fiction has been built upon the "what if." If we could go back in time and change one small thing, that change could cause a ripple that changes thousands of events over time. I hope that the changes we've made to advance women's health will cause the ripple that gives us, our children, and grandchildren a healthier future.


i Roth, J. A., Etzioni, R., Waters, T. M., Pettinger, M., Rossouw, J. E., Anderson, G. L., … Ramsey, S. D. (2014). Economic Return From the Women's Health Initiative Estrogen Plus Progestin Clinical Trial: A Modeling Study. Annals of Internal Medicine, 160(9), 594–602. PMID: 24798522