June 6, 2019

HHS imposes new restrictions on research involving fetal tissue

Daily Briefing

    HHS on Wednesday announced new restrictions on government-funded research involving human fetal tissue collected from elective abortions—a move scientists say could interfere with the development of treatments for HIV and other diseases.

    Background

    U.S. researchers have used fetal tissue to conduct research since the 1930s. The fetal tissue is collected during elective abortions and the process is governed by strict rules. NIH last year spent about $100 million on research projects involving human fetal tissue, the New York Times reports.

    However, HHS in September 2018 terminated a $15,900 contract FDA had with Advanced Bioscience Resources to obtain fetal tissue from the firm to implant in mice for research. HHS at the time said it canceled the contract because the department "was not sufficiently assured that the contract included the appropriate protections applicable to tissue research or met all procurement requirements."

    HHS at that time also launched an audit and comprehensive review of all department-funded research involving human fetal tissue, including a $2 million annual contract HHS has held for 30 years with the University of California-San Francisco (UCSF), under which UCSF uses human fetal tissue to develop new HIV treatments.

    HHS announces new policies for human fetal tissue research, cancels contract with UCSF

    HHS on Wednesday said, as a result of its audits and comprehensive reviews, the Trump administration would no longer renew its contract with UCSF. HHS had been extending the contract in 90-day increments while it was completing its reviews, but said it allowed the latest extensions to expire on June 5 because of unspecified ethical reasons. HHS said it would not grant any further extensions of the contract.

    HHS also said it will suspend internal research projects at NIH that involve human fetal tissue collected from elective abortions. An HHS spokesperson said the policy will effect three of NIH's 3,000 current internal research projects, Reuters reports. The spokesperson said HHS will allow those three projects to continue until they run out of their currently supply of fetal tissue, according to Reuters.

    The new policy will not immediately affect the 200 government-funded projects that are being conducted externally at universities or other institutions during their currently approved project periods, the spokesperson said. However, HHS said it plans to change regulations and NIH grant policies to strengthen the safeguards and integrity of requirements for external research involving human fetal tissue. For instance, HHS said for new government-funded external projects, as well as for current projects that come up for renewal, the department will convene an ethics advisory board "to review the research proposal and recommend whether, in light of the ethical considerations, NIH should fund the research project—pursuant to a law passed by Congress."

    HHS said it also plans to continue working to identify an adequate alternative to human fetal tissue for research.

    Industry observers, stakeholders offer mixed reactions

    Antiabortion groups applauded the new policy, but scientists raised concerns.

    Marjorie Dannenfelser, president of the anti-abortion group Susan B. Anthony List, in a statement said, "We thank President Trump for taking decisive action. It is outrageous and disgusting that we have been complicit, through our taxpayer dollars, in the experimentation using baby body parts."

    David Prentice—vice president and research director at the Charlotte Lozier Institute, which is the Susan B. Anthony List's research arm—said, "There are ample ethically derived sources and alternatives" to fetal tissue collected from elective abortions, such as thymus tissue from newborn infants who have undergone heart surgeries.

    However, scientists have said there are no other effective alternatives to human fetal tissue for research, and they expressed disappointment over HHS' decision. They noted the role human fetal tissue has had in helping researchers gain new insights into diseases and conditions such as AIDS, cancer, and the Zika virus, and in developing treatments and vaccines for illnesses such as polio.

    Larry Goldstein, a professor at the University of California-San Diego who has advised scientific groups on fetal tissue research, said, "I think it's ultimately a terrible, nonsensical policy. Valuable research that is directed at helping to develop therapies for terrible diseases will be stopped. And tissue that would be used will be thrown out instead."

    Mary Alice Carter, a senior adviser at the HHS watchdog group Equity Forward, accused the administration of "putting millions of dollars in lifesaving research at risk to please a small group of antiabortion extremists."

    UCSF Chancellor Sam Hawgood said the administration's decision to extend its contract with UCSF was "abrupt." Hawgood said UCSF "exercised appropriate oversight and complied with all state and federal laws." He added, "We believe this decision to be politically motivated, shortsighted, and not based on sound science" (Abutaleb, Reuters, 6/5; Goldstein, Washington Post, 6/5; Goodnough, New York Times, 6/5; Owens, "Vitals," Axios, 6/6; HHS release, 6/5; Susan B. Anthony List release, 6/5).

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