Connors Center Report Spurs Federal Action

Two decades ago the National Institutes of Health (NIH) Revitalization Act of 1993, a landmark law mandating the inclusion of women and minorities in clinical research, was passed. Today, however, gender inequity remains omnipresent in biomedical research and medical science. A recent report by researchers at the Mary Horrigan Connors Center for Women’s Health and Gender Biology at BWH has revitalized the fight for health equity.

“The science that informs medicine routinely fails to consider the impact of sex and gender, and this occurs at some of the earliest stages of research—from animal to human studies” said report author Paula Johnson, MD,  professor of medicine at Harvard Medical School and executive director of the Connors Center. “This not only puts women’s health at risk, but also impedes our ability to identify important differences that would benefit the health of all.”

The report, entitled “Sex-Specific Medical Research: Why Women’s Health Can’t Wait,” has acted as a catalyst for historic progress, garnering federal response within two months of its March 3 release. The report shares staggering statistics revealing the lack of female models in preclinical trials and outlines recommendations to address inequity in medical research via a Women’s Health Equity Action Plan. The plan includes holding federal agencies accountable, promoting transparency and disclosure, expanding sex-based research, and calling for a gender-based lens in medical education.

Answering the Call

The NIH and the Government Accountability Office (GAO), as well as several members of Congress, have all responded to the call to action.

In a commentary published May 14 in Nature, the NIH outlined new guidelines mandating equal representation of both sexes in preclinical research in hope of reducing sex inequity in biomedical studies, exemplifying a recommitment to gender-based science.

“Over-reliance on male animals and cells in preclinical research obscures key sex differences that could guide clinical studies,” shares the NIH in their report. This practice may be harmful because “women experience higher rates of adverse drug reactions than men do.” In new policies rolling out in October 2014, the NIH will require researchers to include female cells and lab animals in NIH-funded medical research.

The GAO has agreed to conduct a study evaluating whether or not the level of participation of women in clinical trials is sufficient for researchers to provide meaningful results. A group of bipartisan senators and representatives have urged the United States Food and Drug Administration (FDA) to develop a strategy for including more women and minorities in clinical trials to ensure accurate information on the safety and effectiveness of new drugs and medical devices.

Moving Forward

The “Sex-Specific Medical Research” report finds that women receive recommendations on prevention strategies, diagnostic tests and medical treatments based on research that did not adequately include or report on the impact on women. Some of the statistics from the report include that in cardiovascular disease trials—the number one killer of women in the United States—only a third of participants are women and only one-quarter to one-third of trials report data outcomes by sex. In addition, lung cancer is the number one cancer killer of women in the United States, but researchers fail to analyze clinical research data by sex.

Currently, many preclinical studies and early stages of research fail to make distinctions based on sex or consider the critical impact of sex and gender. Lung cancer, heart disease, Alzheimer’s disease and depression disproportionately affect women but this knowledge is too often neglected in the design of trials and studies.

Leaders at BWH are working with others to bring about long-lasting changes in policy to incorporate the study of sex differences at every stage of research.

“The inequity that exists in biomedical research will only be addressed through the collective action of a range of stakeholders, including health care providers, patients, federal funding and regulatory agencies, pharmaceutical and device companies, medical journals, medical schools and teaching hospitals,” said  Johnson. “By changing the landscape of medical research, we can improve the overall health of men, women and future generations.”

Sex-Specific Medical Research: Why Women’s Health Can’t Wait,” is co-authored by Paula Johnson, MD, MPH, executive director, Mary Horrigan Connors Center for Women’s Health and Gender Biology; Therese Fitzgerald, PhD, MSW, director, Women’s Health Policy and Advocacy Program, Connors Center; Alina Salganicoff, PhD, Kaiser Family Foundation; Susan F. Wood, PhD, Jacob’s Institute for Women’s Health and George Washington University; and Jill M. Goldstein, PhD, MPH, director of Research, Connors Center.