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The U.S. Department of Health and Human Services is disputing a news report that it has decided to end a multimillion-dollar contract that funds the use of human fetal tissue for HIV drug testing.

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Report that NIH will cancel fetal tissue research contract fuels controversy

*Update, 6 December, 11:45 a.m.: Responding to a Freedom of Information Act request from ScienceInsider, NIH has released its 3 December letter to UCSF indicating that a contract involving humanized mice might be terminated. Here is our original story from 5 December:

The U.S. Department of Health and Human Services (HHS) in Washington, D.C., is vigorously contesting a report, published by The Washington Post, that it has decided to cancel a $2-million-a-year contract that funds work using human fetal tissue to develop mice with humanlike immune systems for testing drugs against HIV.

HHS officials insist they have made no decision on the contract, and say they are still in the process of completing a previously announced review of all federally funded research that uses human fetal tissue derived from elective abortions. But the report comes as antiabortion groups have stepped up their long-standing efforts to end federal funding for research using human fetal tissue, which is legal under a 1993 law. And the battle over the contract is being followed closely by other researchers who rely on fetal tissue in their work.

In the online story posted yesterday, the Post reported that an official at the National Institutes of Health (NIH), part of HHS, had told researchers at the University of California, San Francisco (UCSF), that the agency would be canceling a 7-year contract awarded in 2013 that funds the humanized mouse work, and that “the decision was coming from the ‘highest levels,’ according to a virologist familiar with the events.” The Post story appeared 2 days after a columnist for CNS News, a politically conservative outlet, published a news story pointedly probing NIHs plans for the UCSF contract, and the same day, The Hill newspaper ran an opinion piece by Jeanne Mancini, president of March for Life in Washington, D.C., demanding that the contract be canceled.

Today, Caitlin Oakley, an HHS spokesperson, issued a statement challenging the Post’s reporting. It reads in part:

[T]he Washington Post chose to publish a story based on anonymous sources providing inaccurate information by telephone with no traceable records despite the fact that HHS provided multiple, on-the-record assurances … that the claims by the anonymous source were incorrect. … No contracting official would have had the authority to impart any communication to UCSF that the contract was being cancelled because no decision has been made.

The dueling versions of the contract’s status come amid HHS’s review of all U.S.-funded research using human fetal tissue from elective abortions—a review being led by Admiral Brett Giroir, HHS’s assistant secretary for health, who described the administration in a recent letter to Representative Mark Meadows (R–NC) as “pro-life, pro-science.” HHS launched the review in September, on the heels of pressure from antiabortion groups; 3 weeks ago, Giroir and other senior HHS officials met with research advocates in a “listening session” that is part of the review. 

NIH estimates it provided $103 million for research using human fetal tissue in 2018. HHS in September began to audit all department contracts that involve human fetal tissue. It has already canceled a $15,900 Food and Drug Administration contract that also used fetal tissue to develop humanized mice.

The contract between UCSF and NIH’s National Institute for Allergy and Infectious Diseases (NIAID) is extendable, year by year, through 2020. (The most recent year of the contract expired late in November, and the 1-year renewal was required by today, according to NIH’s RePORTER database.) Under it, researchers use immune tissues from electively aborted fetuses that would otherwise have been discarded to create mice with humanlike immune systems that are used to evaluate potential HIV drugs. (Such mice are also used to study other dangerous infectious diseases, like Ebola and Marburg.)

Admiral Brett Giroir, U.S. assistant secretary for health, is heading a government review of human fetal tissue research.

Texas A&M University System/Wikimedia Commons

If the contract is killed, “we are all going to lose the kind of research that is important to fight an epidemic that we still can’t cure and still can’t vaccinate against,” says Irving Weissman, an immunologist at Stanford University in Palo Alto, California, who has long used such mice for HIV studies.

But opponents of fetal tissue use say the scrutiny is welcome. “Irv Weissman says there is no alternative,” says David Prentice, research director at the Charlotte Lozier Institute in Arlington, Virginia, which opposes human fetal tissue research. “But there is at least one publication that shows neonatal thymus produces a better humanized mouse.” He pointed to this paper in Stem Cell Reports, in which humanized mice were developed using thymuses obtained from newborn babies who had undergone surgery to repair congenital heart defects.

(After reviewing the paper, Weissman argued the technique it describes would require additional invasive procedures to withdraw bone marrow from the infant donors, in order to replicate the method used now to create humanized mice using fetal tissue. He added that the method has not been reproduced in other labs, nor is it known whether the mice are susceptible to HIV infection. “It is unwise to ban a system that works in favor of an unproven system,” he wrote in an email.)

Yesterday, the Post reported that 5 days after UCSF had been told verbally that the contract would be canceled, the university received this letter from NIAID, notifying UCSF that the contract would be extended for 90 days, through 5 March, not the usual 1 year. The letter, dated Monday, 3 December, instructs the UCSF researchers to "finish ongoing studies.” But it adds: “Do not obtain or [implant] new fetal tissue” in mice; “do not produce” new mice; and “do not start new experiments in the mice,” unless otherwise instructed. It adds in black bolded letters that this “preliminary notice does not commit the Government to an extension” of the contract after 5 March.

The principal investigator on the contract did not respond to an email requesting comment. Instead, the office of Janet Napolitano, president of the University of California system, of which UCSF is a part, issued a statement that did not address the contract directly. It reads in part:

The University of California conducts research using fetal tissue that is vital to finding treatments and cures for a wide variety of adult and childhood diseases and medical conditions. This research is conducted in full compliance with federal and state law, as well as ethical standards, and is in keeping with the university’s education, research and public service missions.

The biomedical community is watching the fate of the UCSF process closely, and with some angst. One investigator at an institution with substantial NIH funding for fetal tissue research said his group has not had any communication from HHS or NIH indicating that the funding is in peril. But he is worried nonetheless. “Fetal tissue really is a powerful tool,” said the researcher, who asked to remain anonymous because he did not want to draw attention to the fact that his group uses fetal tissue. “A lot of basic research on diseases would be left reeling” if funding is cut off, he said, naming HIV/AIDS, Parkinson’s disease, and cancer research among those that would be affected.

Alta Charo, a bioethicist and lawyer at the University of Wisconsin in Madison, says the HHS review, including the imperiling of the UCSF contract, “continues to set a tone in which political symbolism trumps real public health needs. Because there is absolutely no evidence that any woman has ever decided to abort because of this research.”

Weissman adds that he is concerned by an invitation he recently received from NIAID to participate in an 18 December workshop exploring alternatives to the use of fetal tissue to generate humanized mice.

“Why are we having this discussion?” Weissman asked. “The force behind this discussion is coming not from scientists working in the field and trying to understand and treat these diseases. It’s a political force apparently coming from above the NIH level.”

With reporting by Jocelyn Kaiser.

*Update, 6 December, 4:35 p.m.: This article has been updated to include comments from Irving Weissman on the Stem Cell Reports paper and quotations from the 3 December letter.