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The Literature of Medicine |15 February 1995

Reviews and Notes: Ethics: Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies

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Anna C. Mastroianni, Ruth Faden, and Daniel Federman; eds. 247 pages. Washington, D. C.: National Academy Press; 1994.
Historically, health care research has been largely directed by and done on men, and the knowledge gained has been extrapolated to and applied to women. Numerous examples of differences between men and women in the incidence of disease, biodisposition of drugs, and response to therapy show the shortcomings and contradictions of this well-intentioned but flawed practice. Women of childbearing age, in particular, have generally been excluded as research subjects by the government and the pharmaceutical industry, although for different reasons. Before 1993, guidelines from the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) sought to protect women from exposure to potentially fetotoxic agents; the pharmaceutical industry shared this concern but was also motivated to avoid expensive reproductive toxicology studies—a usual prerequisite for including women of childbearing age in clinical trials. Thus, forces of exclusion were formidable, and ways to include women in health research safely and equitably has been the subject of recent public debate.
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Reviews and Notes: Ethics: Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies. Ann Intern Med. 1995;122:319–320. doi: 10.7326/0003-4819-122-4-199502150-00031

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Published: Ann Intern Med. 1995;122(4):319-320.

DOI: 10.7326/0003-4819-122-4-199502150-00031

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