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Did Medical Research Routinely Exclude Women? An Examination of the Evidence
Many persons have voiced the belief that medical research studies often excluded women. Wenger and colleagues argued, "The infrequent inclusion of women in clinical research until very recently warrants scrutiny to clarify whether women have been excluded from participation for medical reasons." LaRosa and Pinn lamented, "The exclusion of some women from clincal studies may sometimes be valid, but not all women all the time." A 1993 editorial in The New England Journal of Medicine made this categorical assertion: "There is little doubt that women have been systematically excluded as subjects for study...it is not surprising that most clinical trials have been heavily, if not exclusively, weighted toward men"
The purpose of this commentary is to examine the empirical basis for the proposition that medical research, especially research sponsored by the National Institutes of Health (NIH), commonly excluded women. I examine both epidemiologic studies and clinical trials, analyzing both the number of studies by the sex of their participants, and sex-specific enrollments in medical research studies. I draw upon previously-published articles, analyses of the Medline database (which first became operational in 1966), and internal NIH documents.
I pay particular attention to the period before 1990. I emphasize this time frame in order to minimize the effects of the establishment of the NIH Office of Research on Women's Health in 1990, the appointment of Dr. Bernadine Healey as NIH director in 1991, and the passage of federal legislation in 1993 intended to assure female participation in NIH research.
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