Fourteen states have banned abortion since the U.S. Supreme Court overturned the landmark Roe v. Wade decision in 2022, stripping abortion as a constitutional right. And in February, the Alabama Supreme Court ruled that frozen embryos are considered “children” and that those who destroy them can be held liable. Following a judicial order, some health care providers in the state have suspended in vitro fertilization (IVF) services. Experts say these changes to abortion and IVF laws could create mistrust among women, instill fear in sharing medical records, and have ramifications for clinical research on women’s reproductive health. It warns that there is.
Christopher Hart, a partner at law firm Foley Hogue, said reproductive rights are currently divided across the United States. Some states have voted to protect women’s right to abortion, while others have chosen to ban abortion. These restrictive laws are creating a hostile environment, he added.
Massachusetts passed a shield law “to protect, to the extent possible, reproductive health data from falling into the hands of hostile prosecutors in other states or hostile private parties seeking such information.” It was one of the first states to pass a law, Hart said on Biospace’s “Denatured” podcast. This is in contrast to “hostile states” like Tennessee, he said, where “the opposite is happening” in trying to support criminal prosecutions.
“There is a great deal of uncertainty about how such information will ultimately be protected over the long term,” Hart told BioSpace. “I can imagine some women will think twice before sharing their data for clinical trial research.”
Gaurav Josan, senior vice president of research and development at clinical trial data management company Clario, echoed this sentiment. “[Women] They may want to withhold information they believe could be used against them. ”
derailed progress
Historically, women have been underrepresented in clinical trials. In 1977, FDA policy shifted away 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. Recommended to exclude women.
Kathryn Schubert, CEO of the Women’s Health Research Association, said: “If a woman becomes pregnant during a clinical trial, we don’t know the risks to the fetus, but companies are willing to accept the higher risk of allowing women to participate.” I feel it,” he said. “We saw this in the 1960s with thalidomide trials, and I think it’s still a top priority for researchers and industry to this day.”
However, noting the consistent lack of data on women in clinical trials, the National Institutes of Health enacted the Activation Act in 1993, requiring all NIH-funded research to include minority and child-bearing age groups. mandated the inclusion of women, including women from all over the world.
Some studies suggest that women’s participation in clinical trials has improved over the past decade. However, it is still not comparable to that of men.
Josan said the new law could undermine efforts to increase the representation of women in clinical trials. “While we were moving the needle in the right direction, there is now a reluctance among women to share their medical background due to privacy concerns,” she told BioSpace.
However, Karen Correa, former vice president and head of global clinical operations at Takeda Pharmaceutical Co., noted that clinical trials typically do not require details about a woman’s abortion history. “Most clinical trials ask female participants whether they are capable of bearing children and what contraceptive methods they use. A history of abortion is rarely raised as a criterion for inclusion or exclusion. I’ve never seen it before,” Correa told BioSpace.
However, she added that abortion history could be part of the inclusion criteria in trials related to women’s reproductive health conditions, such as polycystic ovary syndrome. “In such cases, we can see why women would choose to hide their data for fear of prosecution,” Correa said.
When it comes to IVF, Elisa Cascade, chief product officer at clinical research services company Advara, said it’s unclear how the restrictions will affect clinical trial enrollment. Women can often be wary of sharing their IVF history. “Depending on the data and the scope of the trial, some women may choose not to participate at all.”
However, Professor Cascade also pointed to another possibility. This restriction may also increase interest in clinical trials of reproductive techniques that do not involve in vitro fertilization. “When IVF is denied due to state restrictions, there may be increased interest in participating in studies of new drugs to test for infertility.”
broader impact
Schubert said the new abortion law could slow down research into women’s health in general. Withholding information from women “can have unintended consequences such as a lack of inclusion and representation, a lack of willingness to participate in these trials and broader research, and widening health disparities between men and women,” she said. said.
Some have expressed concern that reduced female participation in clinical trials could highlight gender disparities in the data used to train AI models for clinical trials. Rohit Nambisan, CEO of Lokavant, a company that provides AI-powered data insights to clinical researchers, said clinical trials have historically enrolled about 80% white participants, the majority of whom are male. It is said to be a comparison between women. The new law could make this permanent, he said. “Changes in the legal landscape regarding reproductive rights can have a substantial impact on the availability of women’s health data. If legal restrictions prevent women from accessing certain health services, they may Data will no longer fully reflect women’s health needs and outcomes.”
Cascade said it is urgent to ensure that women feel included in clinical trials and that there is fair representation from different ethnic groups so that new drugs on the market are safe and effective for everyone. said that it was necessary. “However, the new law may make women feel disenfranchised by the health care system and may be less willing to participate in clinical trials or provide medical information. I don’t think anyone has thought it through.”
