by Since the US Supreme Court toppled the monument Roe v. Wade ruling in 2022, which abolished abortion as a constitutional right, Fourteen states have banned abortion. Then, in February, the Alabama Supreme Court ruled that frozen embryos are considered “children” and that a person can be held liable for their destruction. Following the court order, some health care providers in the state suspended in vitro fertilization (IVF) services. Experts warn that these changes in legislation regarding abortion and IVF could create distrust and fear of sharing medical records among women, creating ripple effects in clinical research into women’s reproductive health.
Christopher Hart, a partner at law firm Foley Hoag, noted that reproductive rights are currently fragmented in the US. While some states have voted to protect women’s rights to abortion, others have chosen to ban them. These restrictive laws have created a hostile environment, he added.
Massachusetts was one of the first states to pass a shield law “to protect, to the greatest extent possible, reproductive health information from falling into the hands of hostile prosecutors in other states or hostile private parties seeking such information,” Hart said. Biospace‘S Denatured podcast. This is in contrast to “hostile states” like Tennessee, “where the opposite is happening,” with efforts to support criminal charges, he said.
“There is so much uncertainty about how such information will ultimately be protected in the long term,” Hart said Biospace. “I imagine some women will think twice before sharing the data for clinical research.”
Gaurav Josan, senior vice president of research and development at Clario, a clinical trial data management company, echoed this sentiment. “[Women] may want to withhold some information that they believe could be used against them.
Derailing progress
Historically, these have been women underrepresented in clinical trials. In 1977, an FDA policy was introduced recommended excluding women of childbearing age from phase I and early phase II drug trials after the use of a sedative called thalidomide by pregnant women led to the birth of babies with severe deformities.
“If a woman were to become pregnant during a clinical trial, we don’t know what the risk to the fetus is, and companies consider it riskier to include this woman,” said Kathryn Schubert, CEO of the Society for Women’s Health Research. “We saw this in the 1960s with thalidomide studies, and I think it remains a top priority for researchers and industry to this day.”
However, noticing the continued lack of data on women in clinical trials, the National Institutes of Health introduced the Revitalization Act in 1993, which required that all NIH-funded research include minorities and women, including those of childbearing age.
Some studies suggest that women’s participation in clinical trials has improved over the past decade; however, it is still far from equal to that of men.
Josan said the new laws could hinder efforts to increase women’s representation in clinical trials. “We were moving the needle in the right direction, and now there is a hesitation among women to share their medical background due to privacy concerns,” she said. Biospace.
But Karen Correa, former vice president and head of global clinical operations at Takeda Pharmaceuticals, pointed out that clinical trials typically do not require details about women’s abortion history. “In most clinical trials, female participants are asked whether they can have children and what form of contraception they use. I have rarely seen abortion history as an inclusion or exclusion criterion,” Correa said Biospace.
However, she added that abortion history may be part of the inclusion criteria for studies related to women’s reproductive health problems, such as polycystic ovary syndrome. “In such cases, I understand why women might choose to hide the data for fear of prosecution,” Correa said.
As for IVF, Elisa Cascade, chief product officer at clinical research firm Advarra, said it is unclear how the restrictions could affect clinical trial enrollment. In many cases, it can make women hesitant to share their IVF history. “Depending on the scope of the data and research, some women may choose not to participate at all.”
However, Cascade also pointed out another possibility: the restrictions could also spark interest in studies related to non-IVF-assisted reproductive technologies. “If IVF is denied due to state restrictions, this may spark interest in participating in studies of a new drug being tested for infertility.”
Broader consequences
According to Schubert, the new abortion laws could slow down research into women’s health in general. If women withhold information, she said, “it could result in an unintended consequence of a lack of inclusion and representation, a lack of desire to participate in these studies and broader research, and a wider gender health gap .”
Some expressed concern that if women’s participation in clinical trials declines, it could accentuate the gender gap in the data used to train AI models for clinical trials. According to Rohit Nambisan, CEO of Lokavant, which provides AI-driven data insights to clinical researchers, clinical trials have historically enrolled about 80% white participants, with most of that indexing focused on men versus women. The new laws could perpetuate this, he said. “The changes in the legal landscape for reproductive rights could have a substantial impact on the availability of women’s health data. If women have less access to certain health care services due to legal restrictions, the data collected will not adequately reflect the spectrum of women’s health needs and outcomes.”
Cascade said There is an urgent need to give women a sense of inclusion in clinical trials and to ensure fair representation of different ethnic groups so that new medicines on the market are safe and effective for everyone. “But the new laws could leave women feeling disenfranchised by the medical system and less willing to participate in clinical trials and provide medical information. I don’t think anyone has thought about the long-term consequences of this.”
