Scientists at the University of Wisconsin-Madison have spent years trying to unravel the details of Down syndrome: What happens inside the womb, how the genetic disorder alters the formation of neurons, and what specific processes affect brain development. The work can’t proceed without studying fetal tissue.
Anita Bhattacharyya, an associate professor of cell and regenerative biology, said her lab’s findings so far are significant, having identified a layer of late-developing neurons that are reduced in the brains of fetuses with Down syndrome. If she were to start her career again, however, she isn’t sure she would follow the same path. “It seems too risky,” she said. She warily monitors the state legislature, where there is ongoing debate, and therefore uncertainty, over changes to rules governing fetal tissue research. And much is riding on the outcome of the November presidential election.
Fetal tissue is used for a broad swath of biological and medical studies, including work with stem cells and research on cancer biology and brain development. The Trump administration created significant barriers to this research and, though they were lifted after President Biden’s election, federal funding of studies relying on fetal tissue has not fully rebounded.
Facing the possibility of Trump’s return to office, several U.S. scientists said uncertainty is making fetal tissue research increasingly untenable, and some warned, the country risks lagging in some areas of cutting-edge biology as a result. “The U.S. is falling behind,” said Dan Doherty, a pediatrics professor at the University of Washington.
A combination of factors have only heightened the importance of fetal tissue in recent years. Major advances in stem cell research have enabled scientists to create sophisticated human organoids — organ-like blobs of tissue grown in labs — to study the emergence of diseases and potential treatments; fetal tissue is needed to validate results. Stem cells resemble fetal cells before developing into the adult version, and human fetal tissue is crucial to ensure that organoids are progressing along the correct route.
The science has dramatically advanced in recent years, said Robin Lovell-Badge, head of the Stem Cell Biology and Developmental Genetics Laboratory at the Francis Crick Institute in London. “All sorts of things have come together now and it’s a pity if U.S. scientists don’t have access to material.”
Although there are alternative ways to check whether organoids grown from stem cells are on the right path, such as mouse tissue models, these often yield inaccurate results, which can lead research astray. And so fetal tissue is “absolutely essential,” said Lawrence Goldstein, professor of cellular and molecular medicine at the University of California, San Diego.
“If you haven’t seen a car before, someone’s got to show you a real one,” he said. Human fetal tissue provides the same role for demonstrating what normal human development looks like.
One scientist who relies on fetal tissue to develop human organ models, but declined to be quoted by name because of the political controversy around such research, said fetal tissue-based research has the potential to dramatically improve the number of drug studies that advance beyond the first stage. “The pharmaceutical model has not been a particularly successful one,” he said, not least because early research so often relies on animals.
Stem cell research isn’t the only field benefitting. Studies of brain development, cancer, immunology, and HIV depend on fetal tissue. Even some kinds of Alzheimer’s disease can be traced to developments in the womb, which can only be studied with fetal tissue. “We’re all products of what we were when we were a fetus,” said Lovell-Badge.
Altogether, said Justin Brumbaugh, assistant professor of molecular, cellular, and developmental biology at the University of Colorado, restricted access to fetal cells risks undermining biomedical research as a whole. “Based on the resources available, we [in the U.S.] were able to be trailblazers and I’d be concerned that position would be lost,” he said. “We will suffer in terms of our leading position in the world.”
The Supreme Court decision to overturn Roe v. Wade engendered a wave of abortion restrictions across the country, creating a patchwork of limitations in accessing both abortion and fetal tissue. The number of abortions nationally remained about the same in the year after the 2022 Dobbs ruling, largely because increasing numbers turned to abortion pills through telehealth services, offsetting the fewer women able to access clinics. Though many of the research institutions relying on fetal tissue tissue are in states that allow abortion, some scientists have started looking overseas for their tissue.
Lovell-Badge, who is on the ethics committee of the major U.K. fetal tissue bank, Human Developmental Biology Resource (HDBR), said there are growing requests for material from U.S. scientists, who then have to weather the costs and bureaucracy of shipping the fetal tissue overseas. “It shouldn’t have to happen like that,” he said. HDBR didn’t ask why the scientists were choosing to transport their tissue internationally, but Lovell-Badge said he suspected some U.S. abortion clinics were increasingly wary post-Dobbs of providing tissue for research.
The restrictions on abortion, though, have had far less impact on fetal tissue research than the occupant of the White House. When President Trump was in office, he created an additional ethics review board that effectively blocked fetal tissue research. The U.S. has long mandated that any study funded by the National Institutes of Health must demonstrate the research uses the minimum possible amount of fetal tissue, and only when scientifically justifiable. There are also strict guidelines on how fetal tissue can be gathered for research: Those who have abortions can only be asked if they’re interested in donating after their decision to terminate their pregnancy, and they can receive no financial compensation if they choose to donate the tissue. Physicians who perform abortion care cannot also be involved in fetal tissue research.
After first freezing new fetal tissue purchases for NIH researchers, the Department of Health and Human Services under Trump declared in 2019 that any proposals involving fetal tissue research approved for NIH funding would go through an ethics review lasting up to six months, overseen by a panel consisting of at least one theologian and ethicist, and no more than 50% scientists.
Federally funded research plummeted. In 2018, NIH spent around $115 million on about 173 projects that use fetal tissue. Although projects that already had funding approved were able to continue, just 14 new projects were submitted for review to the new ethics board, and 13 of them were rejected. “You can always find a flaw if that’s what you’re looking for,” said Goldstein, who sat on the ethics board, and was the only one of the 15 members who publicly supported fetal tissue research, compared to 10 who publicly opposed it.
Although President Biden disbanded the additional ethics board after taking office, the impact of the Trump-era measures has continued. By 2022, the NIH was spending less than half 2018 levels for research involving fetal tissue, at $57 million. As research proposals take several years to conceive and undergo review, and those that were previously approved were allowed to continue under Trump, the full impact of the ethics review block didn’t become evident until around 2021, said Doherty, who works in the University of Washington’s birth defects research laboratory, which supplies fetal tissue to other researchers across the U.S.
While researchers have been able to apply for funding according to the usual protocol under Biden, they now face the risk that, should Trump win the 2024 election, their funding will again be jeopardized. “It’ll hold the field back. We’ll be like yo-yos again,” said Goldstein. Trump has not announced any new proposals to restrict fetal tissue research, and his campaign did not respond to requests for comment.
Some scientists are working to inform politicians of the risks of restricting funding and access. Lovell-Badge, a member of the International Society for Stem Cell Research (ISSCR), said he’s contributed to policy documents by the group outlining the importance of fetal tissue research, which has been distributed to “policymakers in Capitol Hill and elsewhere.”
Brumbaugh said he knew of fetal tissue researchers who are preparing to leave the country if restrictions are reinstated. “I understand where they’re coming from,” he said. “Historically, biomedical research in the U.S. leads the way. You’d hope one way or another we’d weather the storm.”
Others feel they have to plan their research around political whims. “We definitely look at election cycles to figure out strategies, which is not what a scientist wants to be doing,” said Doherty.
The instability is a big deterrent, said several scientists, for young researchers starting their careers. The skills required for fetal tissue research are complex, said Brumbaugh, and if a lab faces an unexpected budget shortfall, then postdocs getting training have to find another way to make a living. Bhattacharyya said she knows several young scientists who moved to other areas of research instead.
Others may move abroad. Although the U.S. has long had the resources to attract international researchers, several scientists said young post-docs are now looking to move to institutions in the U.K., Europe, or Australia, where the science doesn’t face such obstacles.
As research moves overseas, U.S. academics could face hurdles getting access to data. Huge amounts of fetal tissue research takes place in China, where the data are often inaccessible to international scientists. Even for research done in Europe, where the data are ultimately published in academic journals, U.S. scientists will be playing catch-up.
“The long term implications are we don’t have this information,” said Bhattacharyya. “We have to wait.” Although the effects might not be immediately obvious, said Goldstein, these delays will inevitably shape cutting-edge research for decades to come.
“In the U.K. we’re not struggling, the U.S. they are,” said Lovell-Badge. “Ultimately, the effects will become obvious.”
This story is part of ongoing coverage of reproductive health care supported by a grant from the Commonwealth Fund.