FDA Team Advances Women's Health
As Assistant Commissioner for Women's Health at the Food and Drug Administration (FDA), Marsha B. Henderson directs the Office of Women's Health. She has led women's health research and educational programs at FDA for over 14 years.
Q: How does FDA work to protect and promote the health of women?
A: We provide women with the information they need to make decisions about the drugs and other medical products they use for themselves and their families. We support scientific and educational projects that promote a better understanding of health conditions that affect women. We also support research that looks for potential differences in how men and women respond to medicines.
Q: Can you provide an example of how men and women differ in response to medicines?
A: Medicines can sometimes cause people to have an irregular heart beat. This affects part of the heart's electrical cycle called the QT interval, and blood doesn't pump in and out of the heart at the right pace. This could lead to heart attacks or sudden death. We discovered that certain medicines cause this problem more often in women than in men.
My office provided the initial research grant that allowed scientists at FDA and Georgetown University to study this problem. Additional studies were conducted, and several drugs were removed from the market. FDA now requires that new products be studied to ensure that they do not affect the QT interval—a potentially life-saving requirement.
Q: Your office also works to ensure that women are included in clinical trials. Why is that important?
A: It's now very clear that medicines and diseases often affect our bodies differently. Women's body structure can also affect how well devices like hip implants and heart stents work for us. Having women included in clinical trials provides FDA with information that can be used to make better decisions about product safety for both men and women.
Q: Why have there been fewer women than men included in clinical trials?
A: In the 1960s, there were public health tragedies in other countries where babies were born with birth defects because their mothers took a medicine called thalidomide during pregnancy. Thanks to Dr. Frances Kelsey, a FDA scientist, we did not approve the drug for sale in the U.S. at that time. So, the problem did not affect as many women in this country. Nonetheless, the horror of thalidomide influenced FDA to set rules in 1977 that basically excluded women from participating in clinical trials. The ban was lifted in 1993. The Office of Women's Health led this effort and worked with FDA's review centers to change the regulations. The inclusion of women is much better today. Because some challenges remain, we continue to support projects on women in clinical research.
Q: What else are you working on?
A: The Office of Women's Health has an outreach program called "Take Time to Care" that connects women with easy-to-read materials and videos on everything from diabetes to hair dyes.
Q: How do you get the information to women?
A: Women can watch the videos and get free copies of our materials online at www.fda.gov/womens. We also work with a national network of partners who help disseminate our information. Our partners have ranged from health clinics and colleges to chain drug stores and the syndicated advice column "Dear Abby."
Q: Dear Abby?
A: Yes. For several years, the "Dear Abby" column has announced our information kits during National Women's Health Week in May to its 110 million readers. Partners like "Dear Abby" and Parade magazine have helped us reach out to women who wouldn't necessarily think to look to FDA for free health information.
Q. Earlier you also mentioned research and training.
A: We fund grants for scientists at FDA and our sister agencies, such as the National Institutes of Health (NIH), to conduct research in areas like breast cancer imaging, device safety and hormones. These projects have produced more than 200 published articles that help health professionals better understand and treat women's health problems. We also sponsor workshops for health professionals and we've partnered with NIH to develop free online courses which train researchers to look for sex differences.
Q: What is the greatest hope for improving women's health?
A: Most of the chronic conditions like heart disease can be avoided, or certainly delayed, by healthy behavior—eating right, getting screenings and using medicines wisely. My hope is that women can use FDA resources to help them make healthy life choices.
Q: You seem happy in your work. Why?
A: I work with dedicated, enthusiastic scientists and advocates for women's health. I enjoy mentoring the graduate students who come through our office. And I love the challenge of entrepreneurial government—building public-private partnerships.
March 11, 2013