New legislation would require researchers to incorporate male and female subjects when conducting medical research
Washington, DC—The Endocrine Society endorsed new legislation introduced today by U.S. Rep. Jim Cooper and U.S. Rep. Cynthia Lummis called the Research for All Act. The proposed bill would require the inclusion and separate analysis of both male and female animals, tissues, and cells in basic research conducted and funded by the National Institutes of Health (NIH).
Currently, most medical research focuses on men despite significant differences in male and female physiology. The Endocrine Society applauds the recognition that sex is a critical biological variable that should be appropriately included in the design and reporting of basic and clinical research results.
“Unless information on sex differences in animal research and cellular models is considered as part of the experimental design of basic research, and reported in resulting publications, clinical trials could be designed based on fundamentally flawed data,” said Teresa Woodruff, PhD, president of the Endocrine Society. “Careful consideration of sex differences in all phases of the research enterprise is necessary to improve the health of women and men, and also maximize the return on taxpayers’ investment in biomedical research.”
The Society acknowledges that more work needs to be done to include women in clinical trials and investigate sex specific effects in basic research. The consequences of inaction are striking; for example, of the 10 drugs that were withdrawn from January 1, 1997 through 2001, 8 posed greater health risks for women. This demonstrates a critical flaw in the drug pipeline that has disproportionate consequences for women.
The Research for All Act would also direct NIH to update its guidelines to better enforce the current laws requiring women’s participation in clinical research and codify NIH’s existing sex differences research network program.
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Founded in 1916, the Endocrine Society is the world’s oldest, largest and most active organization devoted to research on hormones and the clinical practice of endocrinology. Today, the Endocrine Society’s membership consists of over 17,000 scientists, physicians, educators, nurses and students in more than 100 countries. Society members represent all basic, applied and clinical interests in endocrinology. The Endocrine Society is based in Washington, DC. To learn more about the Society and the field of endocrinology, visit our site at www.endocrine.org. Follow us on Twitter at https://twitter.com/#!/EndoMedia.