(CNSNews.com) - A multimillion-dollar contract that the National Institutes of Health has with the University of California, San Francisco, which pays UCSF to make “humanized mice” with tissue taken from aborted babies, will expire on Wednesday, Dec. 5, unless the NIH exercises an option to extend it.
As of Monday, Dec. 3, however, the NIH had not decided whether to do so.
The contract—"Humanized Mouse Models for HIV Therapeutics Development"--paid UCSF $2,018,293 in the current option year alone. Overall, in fiscal 2018, the NIH estimates it spent $103 million on research using human fetal tissue.
In a Nov. 14 story, CNSNews.com reported that the NIH said it had made “no final decision on the contract extension.” Following up on that story, CNSNews.com asked NIH again last week: “Does HHS intend to exercise its option to extend the Humanized Mouse Models for HIV Therapeutics Development contract for another year? Yes or no?”
“As mentioned previously, no final decision has been made,” NIH responded in an email sent at noon on Monday. “Per HHS’ earlier statement the HHS audit process is still ongoing.”
The “earlier statement” referenced here was published by the Department of Health and Human Services on Sept. 24. That statement said HHS had terminated a contract the Food and Drug Administration had signed with California-based Advanced Bioscience Resources, Inc., to acquire human fetal tissue.
CNSNews.com first reported on that contract on August 7. The FDA had signed it on July 25. The government’s official “presolicitation notice” for that FDA contract said: “The objective is to acquire Tissue for Humanized Mice.”
“ABR is the only company that can provide the human fetal tissue needed to continue the ongoing research being led by FDA,” the notice said. “Fresh human tissues are required for implantation into severely immune-compromised mice to create chimeric animals that have a human immune system.”
When it terminated this FDA contract in September, HHS said it had begun “an audit of all acquisitions involving human fetal tissue.”
“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,” said the September HHS statement.
“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,” the statement said.
“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,” it said.
“Finally, 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,” said the HHS statement.
As CNSNews.com reported on Oct. 17, the NIH originally signed its current humanized mouse contract with UCSF for a one-year period that started on Dec. 6, 2013. Under its terms, as explained in a solicitation notice, the government retained the option to renew this contract for up to six additional one-year periods running through Dec. 5, 2020.
The current one-year option period, according to the Federal Procurement Data System, was signed Nov. 30, 2017. It expires Dec. 5, 2018.
In October, the NIH told CNSNews.com that through this year it has spent $9,554,796 on this contract. NIH said that if the contract were to be extended through its final two option years it would pay a total of $13,799,501.
Like the now-terminated FDA contract with ABR, the NIH contract with UCSF involves transplanting human fetal tissue into mice.
The solicitation for the contract indicated that the contractor would be required to “[o]btain the necessary human fetal tissues for use under the contract,” and would be required make two types of humanized mice using human fetal thymus and liver tissue.
This contract with UCSF follows up and expands on an earlier contract the NIH had with UCSF to create humanized mice ("Tissue Based Small Animal Model for HIV Drug Discovery").
“The current contract was awarded in 2006 to the University of California, San Francisco (contract number HHSN266200700002C) and will expire in December, 2013,” said a solicitation for the follow-up contract that the government published on Dec. 31, 2012
“The animal model being used is an immunodeficient mouse engrafted with human fetal thymus and liver (severe combined immunodeficiency (SCID)-hu Thy/Liv) and infected with well-characterized isolates of HIV-1,” the solicitation said.
“This solicitation is seeking proposals for the SCID-hu Thy/Liv model and for a second humanized mouse model,” it said. “The second mouse model will consist of immunodeficient mice engrafted with human fetal thymus and liver tissue and other cells and/or tissues, such that the model (or mice) has the following characteristics: can be infected by the systemic or mucosal routs, reconstitutes gut-associated and other lymphoid tissues, and develops viremia and disseminated infection in engrafted human tissue.”
“The contractor shall provide both kinds of humanized mice,” the solicitation said.
On Feb. 27, 2017, the journal Pathogens published an article by a group of UCSF researchers in which they describe research funded by this NIH contract that involved taking intestines from babies aborted at 18 to 24 weeks gestational age.
“Fetal gut tissues (18-24 g.w.) were obtained from women with normal pregnancies before elective termination for nonmedical reasons with informed consent according to local, state and federal regulations,” wrote the UCSF researchers funded by this federal contract.
“Single intact segments of the human fetal intestine (2-3 cm in length) were transplanted subcutaneously on the back of 6-8 week old male C.B17 scid mice,” they wrote.
The front page of the Pathogens article noted that this “work was supported in part” by “National Institutes of Health Contract no. HHSN272201400002C.”