Thursday, June 23, 2022
Allison Whelan, Unequal Representation: Women in Clinical Research, Cornell Law Review Online 2021
This Article engages with legal and social history to analyze the present-day consequences of two distinct, yet related historical wrongs: the exclusion of pregnant women and women of child-bearing potential from medical research and the unknowing or unwilling medical experimentation on women of color. It provides a critical contribution to the ongoing discourse about clinical trial representation, arguing in favor of policy considerations rooted in law and society to address the harms caused by this deeply rooted and problematic history.
The underrepresentation of women in clinical research throughout history is a well-recognized problem. Progress has been made, but there is still room for improvement and it must be recognized that not all women have been or continue to be treated equally in the context of clinical research. On the one hand, there is a long history of paternalism and lack of respect for women’s autonomy that has resulted in the exclusion of women from research, particularly pregnant women and women of childbearing potential. The potential consequences of this are many, including harm to women’s health because diseases and treatments can affect men and women differently.
On the other hand, there is also a long history of women of color being unknowingly or unwillingly subjected to unethical medical experiments and procedures. This includes experimentation during human enslavement, carried out most famously by doctors like James Marion Sims, who abused and terrorized Black women who he rented as slaves. He performed myriad gynecological experiments on these women, often without providing them any anesthesia. It is a glaring reflection on the multiple cruelties of slavery as well as the American experience of medical experimentation.
However, the horrors experienced by women of color in the medical setting are far more extensive, spanning into the nineteenth, twentieth, and twenty-first centuries. Famously, throughout the Jim Crow period, Black women became the unwitting subjects of eugenics platforms, legally blessed by the 1927 Supreme Court decision Buck v. Bell. In Mississippi, the frequency and normalization of sterilizations are revealed by the term “Mississippi Appendectomy” becoming associated with the practice. The term reveals the mistruths told to Black women and girls, as well as the callousness and neglect used to obtain consent for the real surgeries taking place. Most recently, during the COVID-19 pandemic, allegations of sterilizations at immigrant detention centers only further the concerns related to these matters, particularly as they affect vulnerable, poor women. This history has contributed to women of color’s distrust in the government, research institutions, and the medical system in general.
These two historical wrongs are distinct, yet related in that they both harm women’s health, dignity, and autonomy. As this Article will discuss, much progress has been made to increase women’s overall representation in clinical trials, but there is far more work to be done with respect to the representation of women of color, and people of color in general. The primary focus of this Article, therefore, is the inadequate representation of women of color, and people of color more generally, in clinical trials.