The Disfranchisement of Fertile Women in Clinical Trials: The Legal Ramifications of and Solutions for Rectifying the Knowledge Gap
Twice as many women as men receive treatment for clinical depression, yet men benefit more than women from antidepressant drug treatment. Likewise, women use more prescription drugs than men, but suffer proportionally more side effects.' Such disparities stem from the traditional attitude of pharmaceutical companies and researchers to- ward the use of women in clinical trials. In general, researchers have tested drugs on young white males without regard for gender differences, often assuming that data extrapolated from studies on males are readily applicable to females. Even medical treatments designed exclusively for women are developed and tested based on a male model, regardless of the fact that women often react differently to many treatments than men do. Researchers generalize information received from male-oriented studies without sufficient information to show that such treatments will be effective or safe for use by women. The net result has been the marketing of drugs that are less effective for, and often dangerous to, women.
Researchers and pharmaceutical companies historically have given many reasons for their decision to use a male model in drug development and testing." Increasingly, however, the medical community, women's health organizations, Congress, and some administrative agencies believe that the exclusion of women from clinical trials is a grave oversight with potentially devastating consequences.' Recently, government agencies and private organizations have taken steps toward encouraging pharmaceutical companies and researchers to include women in clinical trials, but these efforts have had only moderate success."
L. Elizabeth Bowles,
The Disfranchisement of Fertile Women in Clinical Trials: The Legal Ramifications of and Solutions for Rectifying the Knowledge Gap,
45 Vanderbilt Law Review
Available at: https://scholarship.law.vanderbilt.edu/vlr/vol45/iss4/4