A conversation on women's health
Women’s Health Week just concluded. I’ve been thinking about this and how influenced we are by current events. This is particularly true with women’s health. Most people immediately think about birth control, pregnancy, and breast cancer as the big topics in women’s health. Historically and even today, the field of women’s health encompasses other issues just as urgent and often as controversial. Just to give you a sense of change over time, the primary causes of death for women in 1900 were tuberculosis and childbirth. Today it is heart disease. Another striking historical comparison: the average age at death for women in 1900 was 48 and today it is 80.
I asked Marsha Henderson, the Assistant Commissioner in charge of the U.S. Food and Drug Administration Office of Women’s Health about this. The FDA has been part of many of the significant events related to the health of women since it was created in 1906.
Q. How did you come to work on women’s health issues?
A: My mother was diagnosed with breast cancer when I was 11 years old and I spent a lot of time around doctors and hospitals. Things were very different in the early 1960s and the word “cancer” was often whispered. As a social worker, my mother tried to change that by running support groups and encouraging women struggling with cancer to talk openly about it.
I originally started out studying hospital administration, but realized my personality was better suited to working in health policy and consumer education. I worked on homelessness, infant mortality and workplace issues before finally being recruited to work on women’s health at the FDA.
Q. What do you think are the most striking changes in women’s health since the early 1900s?
A: In the early days, we often didn’t know what was in the medicines we took or the foods we ate. There were no national standards, and as a result many people were exposed to unsanitary food, dangerous devices and toxic chemicals. First Lady Eleanor Roosevelt brought a “Chamber of Horrors” exhibit to the White House to highlight the dangers of products like a “womb supporter” that could puncture the uterus and an eyelash dye that blinded women.
Womb supporters, also known as pessaries, could cause serious complications. These are just three of numerous designs marketed to women. From NMAH collections.
By collaborating with drug, device, cosmetic and other companies, we now have comprehensive food and drug labels that educate consumers about the products they use. We have vaccines to prevent many of the conditions that killed women just a century ago. History buffs can learn about more of our Milestones in Women’s Health on our website. The quality of the science has never been better and this work has never been more important, either.
Q. One of the big historical issues is how the male body was the standard for most of history, including for diagnostics, in drug clinical trials, and in therapeutics. Even pregnancy was sometimes considered a disease until relatively recently. This had grave consequences for diagnosis and treatment of diseases such as cancer and AIDS. What has been the FDA’s relationship to getting women into the picture?
A: In its early years, the Agency worked to ban harmful, addictive and poisonous tonics that were marketed as cure-alls for women. Later, FDA worked to help women avoid public health hazards like the serious birth defects seen in many countries where pregnant women used thalidomide – a drug that was not approved in the U.S. thanks to Dr. Frances Kelsey, an FDA medical officer.
Buyer Beware. This patent medicine for women’s menstrual discomfort was not only 17.5% alcohol, there was no guarantee that the combination of ingredients would not make you feel worse. From NMAH collections.
However, an unintended consequence of the thalidomide incident was an exclusion of all women of childbearing potential from clinical trials in 1977. In 1992, a GAO report emphasized the need to study sex and gender differences in FDA-regulated products, prompting FDA to lift the ban. The Office of Women’s health was also established to advocate for the participation of women in clinical trials. Through years of effort by FDA, the National Institutes of Health, and industry, 53% of participants in NIH funded studies were women in 2010.
Q. How has the Agency itself changed? What external factors have most effected the Food and Drug Administration?
The work of activists helped highlight the urgent need for improved treatments for life threatening conditions. We now have expedited review of products for serious conditions, like cancer and HIV/AIDS. With the passage of the Food and Drug Administration Modernization Act (FDAMA) in 1998, Congress enhanced the FDA’s mission to meet the challenges of the 21st century. It helped decrease the time FDA takes to review and approve applications. This Act also called for FDA to receive input from its stakeholders. As a result, the Agency doesn’t work in isolation. Contributions from patients and advocates help our scientists achieve the best possible outcomes.
Katherine Ott is Curator in the Division of Medicine and Science at the National Museum of American History.