The overturning of Roe v. Wade by the U.S. Supreme Court in 2022 has led to significant changes in reproductive health laws across the country. Since then, 14 states have enacted strict abortion bans. In February, the Alabama Supreme Court ruled that frozen embryos are to be considered “children,” which has prompted some healthcare providers in Alabama to suspend in vitro fertilization (IVF) services. Experts warn that these legal changes could lead to mistrust among women regarding their medical records, potentially impacting clinical research in female reproductive health.
Christopher Hart, a partner at the law firm Foley Hoag, highlighted the fragmented nature of reproductive rights in the U.S. While some states have enacted protective laws for abortion rights, others have imposed restrictions. Hart described this environment as hostile, particularly in states like Tennessee, where there are efforts to prosecute reproductive health providers.
To counter this hostility, Massachusetts has implemented a shield law to protect reproductive health data from being accessed by hostile parties. Hart noted the uncertainty surrounding the protection of this information, stating, “I can imagine it will make some women think twice before sharing the data for clinical trial research.”
Gaurav Josan, senior vice president of research and development at Clario, echoed Hart’s concerns, explaining that women might withhold information they fear could be used against them.
Historical Context and Current Challenges
Women have long been underrepresented in clinical trials. In 1977, the FDA recommended excluding women of childbearing age from early drug trials following the tragic outcomes of thalidomide, which caused severe deformities in babies born to pregnant women who took the sedative. Kathryn Schubert, CEO of the Society for Women’s Health Research, emphasized that the memory of such events continues to influence researchers’ decisions today.
In response to this historical bias, the National Institutes of Health (NIH) enacted the Revitalization Act in 1993, requiring all NIH-funded research to include women and minorities. While there has been some improvement in women’s participation in clinical trials over the past decade, significant disparities still exist.
Josan warned that the recent laws could undermine progress in increasing female representation in trials, as privacy concerns may deter women from sharing their medical histories.
Impact on Clinical Trials
Karen Correa, former vice president at Takeda Pharmaceuticals, noted that clinical trials typically do not require detailed abortion histories. Instead, trials often focus on whether women can have children and their contraceptive methods. However, she acknowledged that for trials related to female reproductive health issues, such as polycystic ovarian syndrome, abortion history might be relevant. This could lead some women to conceal their information due to fears of legal repercussions.
Regarding IVF, Elisa Cascade, chief product officer at Advarra, expressed uncertainty about how legal restrictions could affect clinical trial enrollment. Some women may hesitate to disclose their IVF history, which could discourage participation in trials. Conversely, these restrictions might generate interest in trials for new infertility treatments as women seek alternatives to IVF.
Broader Implications for Women’s Health Research
Schubert warned that the new abortion laws could hinder overall research on women’s health. If women feel compelled to withhold information, this could lead to fewer participants in clinical trials and widen the existing gender health gap.
Concerns have also been raised about the potential impact on data used for training AI models in clinical trials. Rohit Nambisan, CEO of Lokavant, pointed out that clinical trials have historically enrolled around 80% white participants, with a significant gender imbalance. The new legal restrictions could exacerbate this issue, resulting in a lack of diverse health data.
Cascade emphasized the importance of making women feel included in clinical trials. She warned that new laws could alienate women from the medical system, leading to lower participation rates and reduced willingness to share crucial medical information. “I don’t think anyone has thought through the long-term implications of this,” she concluded.
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