(CNSNews.com) – The National Institutes of Health will not decide whether to continue its long-term multimillion-dollar contract with the University of California, San Francisco to make “humanized mice” with organs taken from aborted babies until after it has completed its ongoing audit of all HHS-funded fetal tissue acquisitions and a comprehensive review of HHS-funded fetal tissue research.

In the meantime, NIH has given UCSF a 90-day extension on the contract.

The contract extension with UCSF was signed Dec. 4, 2018 and runs through March 5, 2019, according to the Federal Procurement Data System. It will pay the university $521,082.

“The contract remains on the 90-day extension to ensure continuity of service until the audit is completed and a final decision can be made about the contract,” the NIH said in a written statement provided in response to questions submitted by CNSNews.com.

“During the 90-day extension,” the NIH said, “the NIH Contracting Officer Representative can instruct UCSF to produce new mouse cohorts, obtain or engraft new fetal tissue, and/or start new in vitro or humanized mouse studies that are not already planned, if deemed scientifically necessary.”

CNSNews.com asked UCSF this week if it had produced any humanized mice since the extension was granted or whether it would be producing any humanized mice during the contract’s extension period. UCSF responded: “We are not going to have any further comment.”

 

Audit of All Acquisitions Involving Fetal Tissue

On Sept. 24, 2018, HHS announced it was cancelling a different contract that the Food and Drug Administration had with Advanced Bioscience Resources to acquire human fetal tissue. At the same time, HHS announced it was in the process of conducting an audit of all HHS-funded acquisitions of fetal tissue as well as a review of all HHS-funded research involving fetal tissue. This HHS announcement came after CNSNews.com reported on Aug. 7, 2018 that the FDA on July 25, 2018 had signed the contract with ABR to acquire human fetal tissue to transplant into mice.

“After a recent review of a contract between Advanced Bioscience Resources, Inc. and the Food and Drug Administration to provide human fetal tissue to develop testing protocols, HHS was not sufficiently assured that the contract included the appropriate protections applicable to fetal tissue research or met all other procurement requirements,” HHS said in the statement issued Sept. 24.

James H. Shannon Building at the NIH Campus in Bethesda, Md. (NIH Photo/Lydia Polimeni)

“As a result, that contract has been terminated, and HHS is now conducting an audit of all acquisitions involving human fetal tissue to ensure conformity with procurement and human fetal tissue research laws and regulations,” said the HHS statement.

“In addition, HHS has initiated a comprehensive review of all research involving fetal tissue to ensure consistency with statutes and regulations governing such research, and to ensure the adequacy of procedures and oversight of this research in light of the serious regulatory, moral, and ethical considerations involved,” said the Sept. 24 statement.

“Finally,” the statement said, “HHS is continuing to review whether adequate alternatives exist to the use of human fetal tissue in HHS funded research and will ensure that efforts to develop such alternatives are funded and accelerated.”

On Oct. 17, 2018, CNSNews.com reported that the NIH had also signed a contract—this one with the University of California, San Francisco–that involved the use of tissue from aborted babies to construct humanized mice. This contract was called “Humanized Mouse Models for HIV Therapeutics Development” and paid UCSF to make two different types of humanized mice using human fetal thymus and liver tissues.

The contract with UCSF was originally signed for a one-year period starting on Dec. 6, 2013 and gave the NIH the option to renew the contract for six additional one-year periods running through Dec. 5, 2020.

Before the latest one-year option period expired on Dec. 5, 2018, the NIH granted UCSF a 90-day extension rather than a full one-year renewal.

A record posted on the Federal Procurement Data System says that on Dec. 4, 2018 the NIH obligated $521,082 to UCSF for the contract for a period that runs through March 5, 2009.

In October, the NIH told CNSNews.com that if it exercised all of the contract’s options through Dec. 5, 2020, it would pay UCSF a total of $13,799,501. “We have obligated $9,554,796 to date,” NIH said then. The new record posted on the FPDS indicates that with the $521,082 payment for the current 90-day extension, the NIH has now paid UCSF a total of $10,075,878 on the contract.

The FPDS filing that records this $521,082 90-day contract extension that NIH granted to UCSF includes a section called “Description of Requirement.” It says: “This contract is for Humanized Mouse Models for HIV Therapeutics Development to conduct studies in vitro and in humanized mouse models, to improve the SCID-hu Thy/Liv and the second model, and to adapt other existing or newly discovered models, all for the purpose of developing novel therapies for HIV-1 disease.”

[Above is the “Description of Requirement” box in the FPDS record for the 90-Day $521,082 extension of UCSF’s humanized mouse contract with NIH.]

This ongoing NIH contract with UCSF follows up on an earlier contract NIH had with UCSF–“Tissue Based Small Animal Model for HIV Drug Discovery”–that also called for UCSF to make humanized mice using body parts from aborted babies.

 

‘Obtain Human Fetal Tissue’

The current “Humanized Mouse Models for HIV Therapeutics Development” contract requires UCSF to make at least two different types of humanized mice both of which must be constructed with liver and thymus tissues taken from aborted babies.

The official NIH solicitation for this contract expressly stated that the contractor would be required to obtain fetal tissue. It said: “Specifically, the contractor shall: … Obtain the necessary human fetal tissues for use under the contract, consistently and reliably, and in accordance with all applicable Federal, State, and Local guidelines and regulations regarding the use of human fetal tissues.”

[This passage from the “Statement of Work” attached to the solicitation for the Humanized Mouse Models for HIV Therapeutics Development contract specifically informs the contractor that one function of this federal contract is to obtain human fetal tissue.]

On Nov. 9, 2018, CNSNews.com asked HHS if it intended to exercise its option to extend this humanized mouse contract with UCSF when the then-current contract year expired on Dec. 5, 2018. On Nov. 14, NIH responded: “There has been no final decision on the contract extension.”

On Nov. 29, 2018, CNSNews.com asked HHS again if it intended to exercise its option to extend the contract with UCSF past the Dec. 5, 2018 deadline. On Dec. 3, 2018, NIH responded: “As mentioned previously, no final decision has been made. Per HHS earlier statement the HHS audit process is still ongoing.”

The 90-day extension, according to the FPDS, was signed on Dec. 4. 2018.

On Dec. 5, 2018, the Washington Post published a story about the UCSF contract that carried this headline: “Trump administration threatens future of HIV research hub.”

The Post noted of the fetal parts used to create the humanized mice: “The tissue comes from elective abortions.”

But it also characterized both the now-cancelled FDA contract with ABR and the NIH contract with UCSF as targets of a “conservative crusade.”

“The UCSF research has been a particular target of opponents’ ire,” said the Post. “Several dozen lawmakers signed a letter asking the administration to cut its funding. And in recent weeks, a columnist for the conservative website CNSNews.com wrote repeatedly that the administration had not canceled the contract.”

In fact, the letter cited by the Post was signed by 74 members of Congress. These included Rep. Chris Smith (R.-N.J.), chairman of the House Pro-Life Caucus, Rep. Vicky Hartzler (R.-Mo.); House Republican Whip Steve Scalise (R.-La.); and Rep. Mark Meadows (R.-N.C.), the chairman of the House Freedom Caucus.

In their letter, which was addressed to HHS Secretary Alex Azar, the 74 House members commended HHS for cancelling the FDA’s fetal tissue contract with ABR, called for cancelling the UCSF contract, and urged HHS to “end all complicity in research that uses aborted fetal tissue.”

In its Dec. 5 story, the Post cited unnamed sources in claiming that the top researcher at UCSF responsible for the NIH humanized mouse contract had been told that it was going to be cancelled.

The Post said:

“The researcher who runs the UCSF laboratory was given a 90-day extension on the contract, rather than another year’s $2 million installment, as had been routine. A few days earlier, she had been told the money would be cut off immediately, according to a virologist familiar with the events.”

It also said:

“According to the virologist, the principal investigator was told in a telephone conversation with an NIH employee last Wednesday that the AIDS division was exercising its discretion to discontinue the contract. A university spokeswoman, speaking on the condition of anonymity because she had no authorization to discuss the matter, confirmed the university was informed last week the contract was not being extended.”

HHS immediately published a statement rebutting the Post’s Dec. 5 story and stated, again, that no decision had yet been made on the fate of the UCSF contract.

“Yesterday evening the 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 from senior officials at both the National Institutes of Health and in the Office of the Secretary, that the claims by the anonymous source were incorrect,” said the HHS statement.

“No decision has been made on the extension of a University of California San Francisco contract with the NIH regarding research involving fetal tissue,” it said.

“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,” said the HHS statement. “A decision will be made when the contract has been reviewed, pursuant to the ongoing audit/review process.

“Unfortunately,” HHS said, “the Washington Post chose to report assertions that are completely false. HHS strives to work transparently and productively with members of the media who accurately and responsibly cover issues related to the department.”

Along with this Dec. 5 statement responding to the Washington Post story, the HHS released a copy of the statement by HHS Spokesperson Caitlin Oakley that had been provided to the Washington Post. This statement reiterated that HHS was conducting on audit of “all acquisitions involving human fetal tissue” and “a comprehensive review of all research involving fetal tissue.”

“Regarding the extension on the UC San Francisco contract, no final decision has been made,” Oakley told the Post in that Dec. 5 statement. “A decision will be made when the contract has been reviewed, pursuant to the ongoing audit/review process. There is a provision for continuity of work while the contract is being reviewed.”

The NIH estimates that it spent $103 million on research using human fetal tissue in fiscal 2018 and that it will spend $95 million in fiscal 2019.

The Labor-HHS-Education bill that the House Appropriations Committee approved last July—when the Republicans still controlled the chamber—specifically prohibited federal funding of research using tissue from aborted babies.

However, the “minibus” appropriation that married the Defense and HHS funding bills that the full Congress enacted–and President Trump signed–in September did not include that prohibition.

Whether or not the federal government continues to fund human fetal tissue research that creates a demand for tissue taken from aborted babies is now an internal policy decision in the hands of the Trump Administration.