Celebrating women’s health and looking to the future
April 5, 2019
A guest blog by Dr. Amy M. Miller, President and CEO, Society for Women’s Health Research
The Society for Women’s Health Research (SWHR) has spent the past 30 years promoting and improving women’s health through science, policy, and education. As we prepare for National Women’s Health Week, which begins May 12, it’s a good opportunity to celebrate all that we’ve accomplished — and to acknowledge how much more needs to be done.
One of SWHR’s foundational goals is to advocate for more women to be involved in clinical research. It was just 26 years ago in 1993 that the NIH Revitalization Act mandated women and minorities be included in clinical trials funded by the federal government. Until that point, women were almost entirely absent from clinical trials — even though they would ultimately be using the medical therapies being tested — because researchers felt their frequent hormonal changes would complicate study design and potentially cloud results.
This led to a tremendous shortage of data on how diseases and drugs affect women, which continues to put women’s health at risk even today. According to the U.S. Government Accountability Office, 80 percent of drugs pulled off the market from 1997 to 2001 because of unacceptable health risks were found to be more harmful to women than to men.
The Revitalization Act aimed to change the harmful status quo on women in research, and it has had a remarkable impact. By including women in research and then looking at sex differences, studies have found examples of diseases that present differently in women and men, conditions for which women’s risk is higher than men’s, and treatments that have differing effects based on sex. For example, research shows that women are more likely than men to develop lung cancer, that women are more susceptible than men to many sexually transmitted diseases, and that women respond differently than men to immunotherapies used to treat certain advanced cancers.
We’ve seen increased investment in research focused on women’s health, resulting in new therapies for conditions that exclusively or disproportionately affect women. In 2018, the FDA approved a drug to treat endometriosis pain, making it the first approved oral treatment in more than a decade for this condition, which affects an estimated 10 percent of reproductive-age women. In the same year, the FDA also approved the first-ever drug designed specifically to prevent migraine, which is three times more common in women than men. With three new drugs for migraine, one for endometriosis, one for breast cancer, and one for pregnancy prevention all in 2018, it’s not surprising that the FDA reported the number of women in U.S. clinical trials jumped to 56 percent, compared to 49 percent in 2015-2016.
Of mice and women
While great strides have been made, there is still much more work to be done. The Revitalization Act increased the number of women in human research, but it wasn’t until 2016 that the NIH made the same requirements for vertebrate animal studies, for which scientists had been using almost all male animals in early phase research to avoid the effects of hormonal fluctuations. That means all clinical research in the decades prior to 2016 is based on a foundation of scientific knowledge that does not consider the unique biological makeup of the female cells.
The entire research community — academia, government, and industry — needs to invest more time, money, and resources into better understanding female-dominant conditions and creating noninvasive diagnostics and treatments for them. We also need to encourage more open dialogue about these conditions and women’s issues like menstruation, painful sex, and menopause. When these topics are perceived as awkward and even shameful, many women won’t discuss them with their doctors, which delays their access to treatment options and may also cloud industry perspective on how widespread these conditions are.
It is time for health care industry professionals to dismantle the stigma associated with women’s health and to address these needs head on. National Women’s Health Week encourages women to take steps to improve their health, and as industry professionals, it is our duty to help them take these steps to live healthier, more productive lives.