Researchers at the National Institutes of Health have been ordered not to acquire new fetal tissue for their research since September, according to Science — the same month the Trump administration began an audit of research using the tissue funded by the NIH and other agencies.
The NIH confirmed the suspension on Friday to Science, which reported it affected two NIH labs, including halting an HIV research project. Spokespeople for the Department of Health and Human Services and the NIH institutes with affected labs did not respond to STAT’s request for comment on Sunday.
Researchers use fetal tissue to create mice with human-like immune systems — which is useful for biologists like Dr. Warner Greene who do HIV research.
“Humanized mice have been available for a long time,” Dr. Warner Greene, the director and senior investigator at the Center for HIV Cure Research at the Gladstone Institute, told STAT. His NIH collaborator was told in September that fetal tissue could no longer be ordered. “To have them removed — to have experimental programs stopped — because of politics is really disturbing,” Greene said. “I believe it’s scientific censorship.”
One firm, Alameda, Calif.-based Advanced Bioscience Resources, had provided fetal tissue to federal agencies in the past. According to a database of federal expenditures, the Food and Drug Administration paid the nonprofit about $100,000 since 2012, mostly for “humanized mice” or “human tissue.” The organization’s federal tax filings indicate it brought in about $1.3 million in revenue in 2016, the most recent year for which information is available. ABR did not return a voicemail left on Sunday.
HHS cancelled ABR’s contract with the FDA in September due to what it said were concerns about adherence to procurement regulations. In November, HHS announced it would hold “listening sessions” with experts in the field to discuss the need for fetal tissue in research and whether alternatives were possible. Greene said his collaborator was invited to such a session scheduled for Dec. 18.
A statement from the NIH published in Science said that researchers who needed additional fetal tissue after September should notify “NIH leaders,” but that Greene’s collaborator hadn’t done that. (The collaborator, Kim Hasenkrug, of the National Institute of Allergy and Infectious Diseases’ Rocky Mountain Laboratories, could not be reached for comment on Sunday.)
“We were unaware that there was an option to request tissue. There was a clear directive that no longer could you source fetal material from ABR, which was the sole source for fetal tissue for my collaborator,” Greene said.
Greene and Hasenkrug’s research examines how HIV reservoirs get established. These reservoirs can linger for years and create a resurgence of the illness if someone stops taking medication. In theory, Greene thinks, there may be a particular signal protein coming from lymph nodes where cells are first infected that draw in other cells to be killed or to be turned into reservoirs. If the scientists can establish what role this signal protein plays, then an antibody may stop new reservoirs from being established.
Greene and Hasenkrug need more fetal tissue to create enough mice to confirm experiments that have already been done, Greene said. “We are proceeding ahead to publish our in vitro results, we’ll get those published. But the in vitro results only go so far. To prove the model, we have to be in a real, living biological system. The humanized mice provide that opportunity,” Greene said.
Only researchers in the NIH’s intramural program were covered by September’s directive; outside researchers whose funding comes from the federal government were not. But even if Greene could do the necessary experiments to confirm the results with another scientist, he said that wasn’t an option.
“I don’t currently have the grant money to order animals or support the generation of animals,” he said, adding that, “I feel a loyalty to my collaborator to perform these experiments with him.”