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Scientists at the federal Rocky Mountain Laboratories in Hamilton, Montana, ​have restarted an HIV study that was interrupted by an order to stop acquiring human fetal tissue.

National Institute of Allergy and Infectious Diseases/National Institutes of Health (CC BY-NC)

United States extends fetal tissue contract and revives one experiment

The U.S. government’s leading medical research agency is quietly extending and reviving research that relies on human fetal tissue, even as President Donald Trump’s administration ponders the future of the controversial work in a far-reaching review.

Early this month, the National Institutes of Health (NIH) in Bethesda, Maryland, told researchers it intends to extend a key agency contract that funds work using human fetal tissue to develop mice used to test drugs against HIV. Without NIH action, the $2 million annual contract between its National Institute of Allergy and Infectious Diseases (NIAID) and scientists at the University of California, San Francisco (UCSF), will expire on 5 March.

Normally, the contract, which has been in place for years, is renewed each December. But in December 2018, NIH extended it for just 90 days. Officials said the shorter renewal was a response to an ongoing review of federally funded fetal tissue research by the U.S. Department of Health and Human Services (HHS), and that no final decision on the contract’s fate would be made until that review was complete. The newest extension would keep the contract alive for an additional 90 days, through 5 June, according to a 7 February letter from NIH to UCSF obtained under the Freedom of Information Act.

“We are working with NIH to extend the contract. We remain confident that the critically important work of the lab will be continued,” UCSF said in a statement.

NIH has also revived an HIV experiment that was derailed last fall, days after the Trump administration launched a review of all U.S. government–funded research that uses fetal tissue donated by women after elective abortions. The study was being conducted at NIAID’s Rocky Mountain Laboratories (RML) in Hamilton, Montana, where scientists receive fetal tissue that they use to create mice with humanlike immune systems. Lab dish studies had led them to believe that an antibody might prevent HIV from establishing reservoirs in the human body. They were preparing to use the humanized mice in a trial testing the antibody when they received an order from HHS directing them to stop acquiring fetal tissue from Advanced Bioscience Resources, a company in Alameda, California. (Days earlier, HHS had canceled a Food and Drug Administration contract with the company.)

The HHS order “effectively stops all of our research to discover a cure for HIV,” Kim Hasenkrug, lead scientist at RML, wrote at the time to a collaborator, Warner Greene of the Gladstone Center for HIV Cure Research in San Francisco.

Alerted to the experiment’s derailing, Lawrence Tabak, deputy director of NIH, said in December 2018 that the stoppage had resulted from a miscommunication. “We’re now figuring out ways to address that,” Tabak said at that time.

Since then, NIH has found another fetal tissue supplier for the scientists at RML. This allowed the antibody experiment to launch last month, Greene told ScienceInsider yesterday, with 18 mice receiving the antibody and 18 control mice not receiving it. Another cohort of 22 treated mice and 22 controls was launched in early February, and the RML investigators expect in March or April to receive additional mice that will allow more cohorts to be tested, Greene said.

“Our studies are back on track, thanks to the efforts of the NIH,” says Greene, whose lab did early experiments that revealed the antibody’s potential role, and then provided the antibody for the studies. “I just want to emphasize how gratifying it has been to work positively with the NIH on this to solve this problem.” Greene declined to say what supplier is providing fetal tissue for the experiments.

Renate Myles, an NIH spokesperson, wrote in an email today: “The HHS audit is in no way intended to impede research. The delay in Hasenkrug’s research was unintentional and the issue was remediated once we were made of aware of the need for new [fetal tissue] procurement.”

But research advocates praised the NIH for acting. “It’s very important that NIH is finding ways to continue this critical research. The development of these fetal tissue mice currently is the state of the art” in key areas of HIV research, says Sally Temple, scientific director of the Neural Stem Cell Institute in Rensselaer, New York, and a former president of the International Society for Stem Cell Research.

NIH estimates it will spend $95 million on projects involving human fetal tissue this year, down from an estimated $103 million in 2018.

The Susan B. Anthony List, an antiabortion organization, declined to comment. (In September 2018, the group spearheaded a letter from 45 groups to HHS Secretary Alex Azar that complained about U.S. funding for research that uses fetal tissue, helping catalyze the HHS review.) David Prentice, vice president and research director at the Charlotte Lozier Institute in Arlington, Virginia, the research branch of the Susan B. Anthony List, said he was unavailable for comment.

Brett Giroir, the physician-scientist who is assistant secretary for health, is leading the broad review of U.S.-funded fetal tissue research that was launched in September 2018. Spokespeople at HHS did not respond to questions about the UCSF contract renewal and the status of the 5-month-old review, including when it might wrap up.

Update, 25 February, 2:41 p.m.: After deadline, an HHS spokesperson responded by email to ScienceInsider’s questions about the review’s status, writing: “We will provide an update on the review once it has concluded and as appropriate.”  The email also stated that NIH responded for the department on questions about the UCSF contract renewal.