Clinical Trials for Breast Cancer and Informed Consent

During the 1970s many women with breast cancer began to insist that clinicians deal less paternalistically with them, inform them of treatment options, and let them use their own values to determine which approaches were best. Their demands for better communication and choice had a well-documented impact on the women’s movement, the rejection of patriarchal institutions, the patients’ rights movement, and the denunciation of the authoritarian medical culture. In this paper I want to examine how these activists also helped to revolutionize the research culture by insisting that it be a cooperative venture. Their leverage was the power to defeat randomized clinical trials (RCTs) that did not include genuine options or consent. This struck at the heart of research practices since the RCT is generally regarded as the gold standard for evaluating alternative interventions. Many investigators during this period regarded gaining consent to be a misguided requirement. They argued that the women could not understand what was at stake and claimed that incorporating consent and choice would only ruin the structural integrity of the trials (Zelen 1979, 1241). In the 1970s and 1980s, many clinicians also resisted enrolling their patients in trials. These clinicians did not want to communicate the uncertainties about which therapies were best. They feared that informed consent would destroy trust in the doctor-patient relationship, and maintained they should simply pick the therapy that they believed was best for their patients (Taylor 1984, 1361). For some investigators and clinicians who were saturated in a positivistic philosophy of science, it was hard to admit that values were integral to science and needed to be justified. Consequently, the women’s demands for respect of their perspective seemed unreasonable. This is a philosophical paper about why it is rational to insist that research be a cooperative venture and uses this example about women’s demand for better How Women Helped Make Research a Cooperative V enture