Questions Sent to HHS and UCSF on Humanized Mouse Contract; Response Statements from HHS and UCSF

By Terence P. Jeffrey | October 17, 2018 | 2:35 PM EDT

The National Institutes of Health (NIH Photo)

(CNSNews.com) - CNSNews.com sent sixteen questions to the Department of Health and Human Services and the University of California at San Francisco about the “Humanized Mouse Models for HIV Therapeutics Development” contract that the National Institutes of Health has with UCSF. NIH and the University of California responded to CNSNews.com’s inquiry with statements.

Below are the questions CNSNews.com asked and the statements NIH and the University of California provided in response.

 

CNSNews.com’s questions:

1—Does the NIH in any way contest the conclusion presented in the “background paper” that Harvard University provided to the House Energy and Commerce Committee that creating mice with human immune systems requires human fetal tissue obtained from abortions?

2--The Statement of Work for the “Humanized Mouse Models for HIV Therapeutics Development” contract says that the contractor will be required to produce at least two cohorts of humanized mice per month. These include “one cohort of up to 50 SCID-hu Thy/Liv mice per month, engrafted with tissue from a single donor” and “one cohort of up to 40 mice per month, engrafted with tissue from a single donor.” Given that the human “donors” whose tissue is used to create these mice are aborted babies, is it not correct that this federal contract requires the contractor to obtain tissue from at least two aborted babies per month?

3--Has UCSF fulfilled this term of the contract and created at least two cohorts of humanized mice--each made with tissue from a single aborted baby—in each month since the contract was signed on Dec. 6, 2013?

4—Under the terms of this federal contract, how many total aborted babies to date have donated their tissue to create the mice required by this contract?

5--What is the total number of donor babies who are expected to donate their tissue to create humanized mice in the current year for this contract (Dec. 5, 2017-Dec. 5, 2018)?

6--The instructions for the technical proposal for this contract required the contractor to “identify the source for the human fetal tissues to be used” in constructing the humanized mice mandated by this contract. What sources have provided UCSF with the human fetal tissue used to create the mice required by this government contract?

7—Has some, or all, of the human fetal tissue used to create the mice required by this contract come from abortions done at the University of California, San Francisco itself?

8—Do the contractors at UCSF need to know in advance that an abortion will be taking place that will produce fetal tissue suitable for use under this contract so they will be prepared to transplant that tissue into mice in a timely manner?

9--The UCSF professor who is the principal investigator for this contract said at the NIH’s “New Humanized Rodent Models 2007 Workshop” that the SCID-hu Thy/Liv model was constructed using human fetal liver and thymus from babies that were 20 to 24 gestational weeks in age. The same principal investigator co-authored a 2017 article in Pathogens that said the SCID-hu gut mice used in research funded by this contract were constructed using “fetal gut tissues” taken from babies in “normal pregnancies” who were subjected to “elective termination for nonmedical reasons” at 18 to 24 weeks gestational age. What is the youngest gestational age an unborn baby can be and still be able to donate the type of tissue needed to create the humanized mice required by this federal contract?

10--What is the oldest gestational age an unborn baby can be and still be able to donate the type of tissue needed to create the humanized mice required by this federal contract?

11--What is the oldest gestational age of any unborn child whose tissue has been used to create the humanized mice required by this contract?

12--What is the youngest gestational age of any unborn child whose tissue has been used to create the humanized mice required by this contract?

13--Are there any methods of abortion that cannot be used to terminate an unborn baby whose tissue is going to be used to create the humanized mice required by this contract because that method of abortion would cause the tissue to be damaged or spoiled in a way that would make it unsuitable for creating these humanized mice?

14--How much time can elapse between the abortion that yields the fetal tissue used to create the mice required by this contract and the transplantation of that tissue into the mice?

15--Are the mothers who agree to donate tissue from their unborn babies to create the mice required by this federal contract informed that the tissue taken from their aborted baby will be transplanted into mice?

16--If it were made illegal in the United States to abort an unborn child after that child has a detectable heartbeat would this federal contractor still be able to get the tissue it needs from aborted babies to construct the humanized mice required by this contract? Is this federal contract dependent on it being legal in the United States to abort an unborn child who already has a beating heart?

Statement from the NIH:

“NIH takes very seriously all ethical concerns surrounding fetal tissue research, and has a robust policy framework in place to ensure this research continues responsibly with the ultimate goal of improving health. As you may be aware, HHS is currently reviewing all acquisitions involving human fetal tissue to ensure conformity with procurement and human fetal tissue research laws and regulations. Regarding NIH-funded and conducted research, NIH is a biomedical research agency and conducts and funds research to enhance health, lengthen life, and reduce illness and disability. NIH does not regulate and is not involved with medical services for abortions. In connection with some research projects, NIH-funded researchers obtain human fetal tissue for biomedical research under conditions governed by law, specifically sections 498A and 498B of the PHS Act, 42 U.S.C. §§ 298g-1 and 298g-2, through intermediaries such as university tissue banks, and clinics associated with universities and companies. Additionally, NIH expects informed consent to have been obtained from the donor for any NIH-funded research using human fetal tissue as articulated in NOT-OD-16-033, which applies to all NIH-funded competing grant awards, non-competing grant awards, and R&D contracts. Legal requirements applicable to all NIH-conducted and funded research are outlined in the NIH Grants Policy Statement, which binds NIH grantees.

“Through research involving both humans and animals, scientists identify new ways to treat illnesses, extend life and improve health and well-being. When necessary, new hypotheses are tested in animals first in order to gather sufficient evidence of benefits and risks before considering possible use in humans. Importantly, mouse models with human immune cells derived from the transplantation of human fetal tissues have been used in various areas of research for some time, including to study HIV pathogenesis and test new drugs against HIV. Research to develop new mouse models with human immune cells is an active area of research. NIH is currently funding research creating mouse models with components of the human immune system which do not use human fetal tissue as the source for the human immune cells. For example, grant 5R01AI132963 was awarded to the University of Massachusetts Medical School, Worcester, to develop a humanized mouse model from human umbilical cord blood cells. Regarding the specific contract in question, this contract is for the production of specified numbers of humanized mice, which are necessary for certain biomedical research as noted in the Harvard background paper that you attached. This contract is not specific as to the source or quantity of donor tissue that is used in the production of these animal models.

 

Statement from the University of California:

"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 and is in keeping with the university’s education, research and public service missions. Since the 1930s, fetal tissue has been a critical component of biomedical science and breakthroughs that fundamentally changed the practice of medicine. Its importance to researchers today has not diminished, and it is still essential to ensuring that cells and tissues created from stem cells are correct. Fetal tissue is used for a broad range of research, from cell biology to the development of vaccines, including the polio vaccine that saved hundreds of thousands of lives and merited the 1954 Nobel Prize for Medicine."

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