Medical Research, Gender Issues in

History and Changes by Research Bodies

The U.S. Federal Food, Drug, and Cosmetic Act of 1938 required for the first time that drugs be proven safe through clinical trials before being made available [Page 918]to the public. The U.S. Food and Drug Administration (FDA) became the governing body for the oversight of clinical trials of new therapies. Trials are carried out in several phases, all of which include human subjects, to determine the toxic dose, efficacy of the medication, and effect on morbidity and mortality. During the 1940s and 1950s, most clinical trials used male volunteers, although women were sometimes subjects of research concerning the female reproductive system. Inclusion of both male and female subjects was not considered important in most research studies, since women were regarded essentially as smaller versions of men, biologically indistinguishable except for by their reproductive systems.

In the 1960s and 1970s, researchers recognized the connection between birth defects and two drugs: thalidomide, which had been widely prescribed for morning sickness in pregnant women, and diethylstilbestrol, a synthetic estrogen prescribed to prevent miscarriages. In an effort to protect women from such dangers, the FDA published a guideline in 1977 that excluded women of childbearing age from participating in most phases of clinical trials. Although the FDA's intention in issuing the exclusion guideline was the protection of women's and fetal health, it resulted in the systematic exclusion of women from clinical trials for a decade. However, by the mid-1980s, researchers began to see that the findings resulting from male-only trials could not be extrapolated to women as successfully as had once been thought.

Change was slow to come, since many researchers preferred the simplicity of male-only studies, which did not have to account for the extra variable of gender or the more cyclic nature of women's physiology. In 1986, the U.S. National Institutes of Health (NIH) began to deny funding for research that did not include both male and female subjects, but given the relatively minor percentage of research funded by NIH, their effort did not bring significant change. To further promote women's health, NIH created the Office of Research on Women's Health in 1990, which supports advocacy and education and works to ensure that women are adequately represented in medical research.

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