Fetal tissue has been used to develop vaccines as well as “humanized mice” used in pre-clinical trials.
The era of government-funded fetal tissue research to develop treatments for a host of diseases may be coming to an end — or at least put on pause for a while.
The Trump administration is ending all research conducted at the National Institutes of Health (NIH) using human fetal tissue from elective abortion as well as a new “competitive renewal process” for research using fetal tissue funded through the NIH, the Department of Health and Human Services (HHS) announced in a statement.
How long current medical research still under contract will continue isn’t certain and will most likely depend on who wins the 2020 presidential election.
Research conducted using fetal tissue has been going on for decades and has received bipartisan support since the Clinton administration lifted a Reagan-era ban on federal funding for the research in 1993.
Fetal tissue research has been involved in the development of vaccines against diseases such as rubella, hepatitis A, and chickenpox.
One of the most important uses of fetal tissue is in the creation of “humanized mice,” which uses the tissue to give mice human-like immune systems.
This allows for the possibility of testing non-human subjects to get a closer to human-like result in experiment before moving on to formal clinical trials.
These humanized mice were essential for testing and developing the HIV prevention drug Truvada.
While opponents of fetal tissue use say that there are other ways to effectively create these humanized mice, a 2018 NIH workshop concluded that there were no better alternatives to creating mice with human-like immune systems than fetal tissue, calling it the “gold standard” for research.
Fetal tissue is also used in research into Alzheimer’s treatment, Parkinson’s disease, and spinal cord injury.
More recently, the use of donated tissue has also been essential to understanding how the Zika virus crosses the placenta, researchers say.
“These new restrictions and requirements further erode the unique potential fetal tissue research holds for addressing such critical objectives as fighting blindness, ending Parkinson’s disease, and advancing maternal and child health,” Mary Woolley, chief executive officer of Research!America, said in response to the HHS letter.
In some ways, these moves represent the resurgence of a political tug-of-war that had lain dormant since the 1990s.
Before the Clinton administration lifted the ban, Congress and various administrations had been debating restrictions on fetal tissue research
That was evident again today as the House of Representatives voted to block the Trump administration’s ban on fetal tissue. The move is an amendment to a spending bill and must still be approved by the Senate.
Because fetal tissue for research purposes often comes from elective abortions, it’s become a hot-button issue for anti-abortion advocates who argue the research is simply unnecessary.
That’s the view of David Prentice, PhD, vice president of the anti-abortion nonprofit Charlotte Lozier Institute.
He told Healthline that fetal tissue science investigations are “relying on antiquated models.”
“The genetic and physiological variability of aborted fetal tissue makes experimental reproducibility questionable,” Prentice said. “Construction of humanized mice using postnatally-derived stem cells from cord blood and bone marrow as well as postnatal surgical tissue has been shown by published references to be as good or better in results, as well as more efficient and cost-effective, and perhaps most importantly, more clinically relevant in terms of immune system reconstruction.”
This view appears to be in the minority, however.
A 2018 letter signed by 70 prominent medical groups petitioned HHS Secretary Alex Azar to recognize the importance of fetal tissue in medical research.
“Fetal tissue research cannot be replaced with existing alternative research models,” the signatories wrote. “Cells from fetal tissue are more flexible and less specialized than cells from adult tissue and can be more readily grown in culture. The study of human fetal tissue provides researchers with incomparable insights into how birth defects arise and how they can be prevented as well as an unparalleled window into the complexity of human tissue development, including why serious congenital defects sometimes arise.”
“While there have been some advances in recent years that have reduced the need for fetal tissue in certain areas of research,” they acknowledge, “it remains critically important in many other areas.
The immediate implications of this new policy aren’t entirely clear.
The most significant was non-renewal of a contract with the University of California at San Francisco (UCSF) for fetal tissue research, which represented the end of a 30-year partnership with the NIH.
That research helped fund investigations into a cure for HIV.
“UCSF exercised appropriate oversight and complied with all state and federal laws,” Sam Hawgood, the university’s chancellor, said in a statement. “We believe this decision to be politically motivated, shortsighted, and not based on sound science.”
In the meantime, the HHS has said no other current NIH-funded research projects at external universities and institutions will be affected during their approved project period.
Instead, uncertainty is the mood of the moment.
“There is a lot of angst in the research community right now about the impact of this new policy on publicly funded research,” Barbara Binzak Blumenfeld, PhD, a shareholder at the law firm of Buchanan Ingersoll and Rooney, told Healthline. “At a minimum, the policy creates a hurdle for those people engaged in research using this type of tissue.”
One of the biggest questions, she said, is what the HHS’s newly announced ethics advisory board will look like and how it will function.
“It is possible that the new ethics advisory board process will be used to further narrow the availability of federal funding to human fetal tissue extramural research,” she said. “[But] we simply do not yet know all of the parameters about how this policy will be implemented.”
Perhaps the most significant implication of suspending federal funding for this tissue research is tied to an overall push to curtail abortion access at the state level, Dr. David Harari, an OB-GYN and president and chief medical officer at the Reproductive Science Medical Center in California, told Healthline.
“The regulations regarding the use of fetal embryonic tissues, including first-trimester pregnancy and early embryonic development tissues such as blastocysts, will only become more stringent due to recent trends of state legislatures to restrict elective abortions,” he said. “Sources of fetal tissues will become even rarer.”