IVF Restrictions, Demise of Roe v. Wade Could Endanger Women’s Health Research

Since the U.S. Supreme Court overturned the landmark Roe v. Wade ruling in 2022, taking away abortion as a constitutional right, 14 states have banned abortion. Then, in February, the Alabama Supreme Court ruled that frozen embryos are considered “children” and that a person could be held liable for destroying them. Following the judicial order, some healthcare providers in the state suspended in vitro fertilization (IVF) services. Experts warn that these changes in laws relating to abortion and IVF could create mistrust and instill a fear of sharing medical records among women, creating ripple effects in clinical research into female reproductive health.

Christopher Hart, a partner at the law firm Foley Hoag, noted that reproductive rights are currently fragmented across the U.S. While some states have voted to protect women’s rights to abortion, others have opted to ban them. These restrictive laws have created a hostile environment, he added.

Massachusetts was among the first states to pass a shield law “to, as much as possible, protect reproductive health data from falling into the hands of hostile prosecutors in other states or hostile private parties seeking such information,” Hart said on BioSpace’s Denatured podcast. This is as opposed to “hostile states” like Tennessee, “where the opposite is happening,” with attempts to support criminal prosecutions, he said.

“There is just so much uncertainty about how protected such information will ultimately be over the long run,” Hart told BioSpace. “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, a clinical trial data management company, echoed this sentiment. “[Women] might want to hold back some information which they feel can be used against them.”

Women have historically been underrepresented in clinical trials. In 1977, an FDA policy 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 the risk to the fetus, and companies feel it’s riskier to include them,” said Kathryn Schubert, CEO of the Society for Women’s Health Research. “We saw this in the 1960s with the thalidomide trials, and I think that still, to this day, is top of mind for researchers and industry.”

However, noting the consistent lack of data on women in clinical trials, the National Institutes of Health instituted the Revitalization Act in 1993, requiring all NIH-funded research to incorporate minorities and women, including those of childbearing age.

Some studies suggest that women’s participation in clinical trials has improved over the last decade; however, it is still nowhere near equal to that of men.

Josan said the new laws could mar the effort to increase representation of women in clinical trials. “We were moving the needle in the right direction, and now there is this hesitance among women to share their medical background due to privacy concerns,” she told BioSpace.

But Karen Correa, former vice president and head of global clinical operations at Takeda Pharmaceuticals, pointed out that clinical trials usually do not require details about women’s abortion history. “Most clinical trials would ask female participants if they can have children and what mode of contraception they use. I have rarely seen abortion history as an inclusion or exclusion criterion,” Correa told BioSpace.

She added, however, that abortion history may be a part of the inclusion criteria for trials related to female reproductive health conditions such as polycystic ovarian syndrome. “In such cases, I can see why women may choose to hide the data due to fear of prosecution,” Correa said.

As for IVF, Elisa Cascade, chief product officer at the clinical research services firm Advarra, said it is unclear how the restrictions may impact clinical trial enrollment. In many cases, it may make women wary of sharing their IVF history. “Depending on the scope of the data and the trial, some women may choose not to participate at all.”

Cascade also pointed out another possibility, however: the restrictions could also spark an interest in trials related to non-IVF-assisted reproductive technologies. “Being denied IVF due to state restrictions could generate interest in participating in studies for a new drug being tested for infertility.”

According to Schubert, the new abortion laws could slow down research on women’s health in general. If women hold back information, she said, “this could result in an unintended consequence of lack of inclusion and representation, lack of desire to participate in these trials and broader research, and a wider gender health gap.”

Some expressed concern that if women’s participation in clinical trials drops, it may 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 around 80% white participants, with a majority of that indexing toward males vs. females. The new laws may perpetuate this, he said. “The changes in the legal landscape for reproductive rights can substantively impact the availability of women’s health data. If women are less able to access certain health services due to legal restrictions, data collected will not well represent the spectrum of women’s health needs and outcomes.”

Cascade said there is a dire need to make women feel included in clinical trials and ensure equitable representation from different ethnic groups so that new medicines in the market are safe and effective for everyone. “But the new laws could make women feel disenfranchised by the medical system and less willing to participate in clinical trials and contribute medical information. I don’t think anyone has thought through the long-term implications of this.”