In the wake of the Dobbs v. Jackson Women’s Health decision, the future of the clinical research landscape for women’s health has largely been in question. Recent data suggests that the U.S. is moving backward when it comes to pregnancy-related complications and continues to have the highest rate of maternal mortality among high-income countries. Females make up over half of the U.S. population, but medical conditions that affect them continue to be underfunded at alarming rates. According to the National Institutes of Health, 80% of maternal deaths are preventable, but severe maternal morbidity has almost doubled in the last ten years. Despite 80% of those who are pregnant taking at least one medicine, pregnant women and women of childbearing potential have long been excluded from many medical trials. When women experience pregnancy, their pre-existing conditions do not go away, but the understanding of them largely does.
Even before the Supreme Court’s pivotal decision in Dobbs, the United States has experienced major challenges when it comes to inclusion and representation in clinical trials. Paternalistic views on protecting women and their future children allowed women to be excluded from trials based on their reproductive potential until 2000 when the Food and Drug Administration required their inclusion for trials involving life-threatening diseases. Restrictions on pregnant women were even more stringent due to “potential fetal risk.” Women of color, and black women specifically, have long been underrepresented in clinical trials, despite knowledge that many conditions such as gestational diabetes, affect women of color at a higher rate than white women.
The decision in Dobbs will only further the gender and diversity gap in clinical research. Researchers are likely to cease trials in states where access to abortion is restricted due to increased liability to themselves and their patients. Research into birth control and hormone therapies could now be viewed as illegal. Trials, especially involving reproductive treatments, often involve regular pregnancy tests. A positive test followed by a miscarriage could cast suspicion onto both providers and patients and in states such as Texas, both could be liable for criminal prosecution. In states where abortion access is available, patients might be more hesitant to enter trials due to an overall environment of increased scrutiny of their personal health decisions.
The potential harm to women’s health in America cannot be overstated. Due to increased concerns over legal risks, the costs to include female participants in clinical trials will increase and will likely have an adverse effect on the number of women included in trials broadly. Because medication affects men and women differently, decreasing the percentage of women in clinical studies will reduce the safety and efficacy of new treatments. Healthcare providers may face increasing situations where they must decide whether to prescribe medication to a pregnant woman without knowing the effects it may have on their patient’s health or their fetus. The majority of Black Americans now live in restricted states, largely in the Deep South, and are likely to be summarily excluded from participating in trials where a drug could pose a potential risk to a fetus. The process of clinical research as we know it is likely to be rewritten.