Abstract
The recent article by Adashi, O’Mahoney, and Cohen provides an important overview of the newly created White House initiative on women’s health research. 1 The authors review women’s health initiatives that began in 1983 with the first ever Public Health Service (PHS) Task Force on Women’s Health led by the late, estimable Ruth Kirschstein, MD from the National Institutes of Health (NIH). They focus on changes made at the NIH, primarily the establishment of the Office of Research in Women’s Health (ORWH). However the PHS task force included representation from all key agencies within the PHS. Like NIH, they too were confronting major challenges and the urgent need to modify or amend agency specific policies to advance women’s health. At the Food and Drug Administration (FDA), for example, there was a longstanding ban on participation of women with childbearing potential in the early phases of drug development when critical decisions are made, e.g., dosage of the drug to be marketed, and pharmacokinetic, safety, and efficacy outcomes that can vary based on sex can be identified. 2 Women with HIV/AIDS urged change to this policy and brought attention to the tragedy of this disease that affected women as well as men. For them, entry into a clinical trial represented their only hope of surviving this deadly disease. Advocacy groups representing women with other conditions, e.g., heart disease, the number one killer of women as well as men, also urged change. They too were underrepresented in clinical trials and critical data on dosing, safety, and efficacy of various interventions for treating women with heart disease needed clarity. 3 As a result, in 1993 FDA lifted its longstanding ban so that women could participate in the early phases of clinical trials. 4 In 1994 the Office of Women’s Health at FDA was established by Congressional mandate as part of the Office of the FDA Commissioner. Today that office continues to promote its mission and the principle that sex is a biological variable that must be factored into research design, analysis, reporting, and education. The representation of women in clinical trials for all conditions that affect women across their lifespan, including women of various races and ethnicities, remains as critical now as it was when the changes in the 1990s were introduced. As we confront an important national election, the women of this nation must insist that realistic funding support be provided so that all of our Federal agencies can achieve their important goals to advance the health of women.