27 Feb New Report on Precision Medicine Illustrates How Sex and Gender Drive Innovation

White House and NIH Precision Medicine Initiatives Must Prioritize the Inclusion of Women and Focus on Sex and Gender

The Mary Horrigan Connors Center for Women’s Health & Gender Biology at Brigham and Women’s Hospital, a national leader in advancing gender-based research, released a report “Precision Medicine: How Sex and Gender Drive Innovation,” that calls for the inclusion of women in medical research and the analysis of sex differences as a priority in Precision Medicine and other biomedical research frontiers.  The report, published on June 30, 2016, asserts sex and gender specific medical research, particularly analysis of sex differences, can drive innovation in biomedical research.  Current biomedical research, however, overlooks the significant evidence that sex/gender impact disease

The White House and NIH recently announced a “Precision Medicine Initiative” (PMI), a new approach to studying the differences in people’s genes, environments, and lifestyle to develop targeted, more individualized treatments for a host of diseases. But the authors note that this landmark initiative can only be successful if it prioritizes the inclusion of women and focuses on sex- and gender-specific medical research.

The report calls for a multi-stakeholder approach to addressing the problem, recommending the following:

1. Hold all NIH investigators accountable for achieving health equity and driving innovation in their research. NIH should make reporting on the inclusion of women and racial/ethnic minorities in preclinical and clinical research a criteria of the NIH research review process and a stipulation of funding.  Data on the inclusion of women and minority must be made publicly available.  And investigators should be required, in all published work, to disclose how their study examines sex differences.
2. Reform the FDA preclinical and clinical research process. The FDA must ensure that products are developed through research that includes women and diverse populations in all phases of study.  Until this is achieved, medical device and pharmaceutical labels should include a warning label if testing did not include adequate numbers of female subjects.  Additionally, an online gateway should be developed to provide public access to subpopulation data.
3. Develop a national strategy for achieving health equity in biomedical research. NIH and the Department of Health and Human Services (HHS) must develop a strategic action plan to promote the inclusion of women and racial/ethnic minorities in all federally-funded preclinical and clinical research. The plan should ensure research adequately represents characteristics of the entire population and report out these disaggregated data by research area, condition, and disease.  Investments in all research must include all people with a standardized focus on the routine examination of sex and gender.

This report was written by authors from The Mary Horrigan Connors Center for Women’s Health and Gender Biology at Brigham and Women’s Hospital and from the Jacobs Institute of Women’s Health at the George Washington University Milken Institute School of Public Health, with support from The Boston Foundation