Questions and Responses on NIH Funding for Harvard Humanized Mouse Programs

By Terence P. Jeffrey | June 21, 2019 | 6:20 PM EDT

(SAUL LOEB/AFP/Getty Images)

(CNSNews.com) - Below are the questions that CNSNews.com sent to the Department of Health and Human Services, the National Institutes of Health and Harvard and the responses CNSNews.com received from them about the programs at Harvard that get federal funding from NIH and make “humanized mice” with tissue taken from aborted babies.

CNSnews.com sent these question to HHS and NIH on May 15, 2019:

1--Does the NIH/HHS in any way contest the conclusion presented in the “background paper” that Harvard itself provided to the House Energy and Commerce Committee that creating mice with human immune systems—such as the BLT mice created at Harvard’s federally funded Human Immune System Mouse Core--requires human fetal tissue obtained from abortions?

2—The 2009 Journal of Virology article that the Human Immune System Mouse Core webpage links to in order to provide people with an illustration of the BLT humanized mice that the core creates—“Induction of robust cellular and humoral virus-specific adaptive immune responses in human immunodeficiency virus-infected humanized BLT mice”—says the mice used in the research described in that article were made with “human fetal thymus and liver (17 to 19 weeks of gestational age)” that was obtained from Advanced Bioscience Resources. 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 BLT humanized mice created by Harvard’s NIH-funded Human Immune System Mouse Core?

3--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 BLT humanized mice created by the Harvard’s NIH-funded Human Immune System Mouse Core?

4--What is the oldest gestational age of any unborn child whose tissue has been used to create BLT humanized mice at Harvard’s NIH-funded Human Immune System Mouse Core?

5--What is the youngest gestational age of any unborn child whose tissue has been used to create BLT humanized mice at this NIH-funded core?

6—Since at least 2009, according to the NIH RePORTER, Harvard has been receiving federal grants specifically to make “humanized BLT mice” made with “human fetal thymus, liver and hematopoietic stem cells.” In the years from 2009 forward, has Advanced Bioscience Resources been the only source for all of the human fetal tissue Harvard has obtained to use in making BLT mice at this NIH-funded core?

7—If Advanced Bioscience Resources has not been the sole source providing Harvard with the human fetal tissue needed to make BLT humanized mice at this NIH-funded core in the years from 2009 forward, what other sources have provided Harvard with this tissue?

8—From 2009 forward, how many aborted babies have provided Harvard’s NIH-funded Human Immune System Mouse Core with tissues to make BLT humanized mice?

9—Where have the abortions that produced the human fetal tissue used by Harvard to create BLT humanized mice in this NIH-funded program been carried out?

10—How much time can elapse between the abortion of a baby whose organs are going to be used to create BLT humanized mice in this NIH-funded program and the actual transplantation of that baby’s tissue into the mice?

11—Has Harvard made any types of payments to Advanced Bioscience Resources or any other human fetal tissue provider for the human fetal tissue it has obtained for creating BLT mice in the NIH-funded Human Immune System Mouse Core? If so, how much does this NIH-funded Harvard program pay at this time for the aborted-baby organs it needs to create BLT humanized mice?

12—In the period from 2009 forward, how much has this NIH-funded Harvard program paid in total to procure the aborted-baby organs it uses in making BLT humanized mice?

13—How many humanized mice does Harvard’s NIH-funded Human Immune System Mouse Core typically make with the liver and thymus from a single aborted baby?

14—Must the fetal livers and thymuses that Harvard’s NIH-funded Human Immune System Mouse Core uses to create BLT humanized mice be delivered to the core intact or can they be mutilated in any way?

15--Are there any methods of abortion that cannot be used to terminate an unborn baby whose tissue is going to be used to create BLT humanized mice at Harvard’s NIH-funded Human Immune System Mouse Core because that method of abortion would cause the tissue to be damaged or spoiled in a way that would make it unsuitable for creating those humanized mice?

16--Are the mothers who agree to donate tissue from their unborn babies to create the BLT mice made by Harvard’s NIH-funded Human Immune System Mouse Core informed that the tissue taken from their aborted baby will be transplanted into mice?

17—The fee schedule published by Harvard’s NIH-funded Human Immune System Mouse Core offers the “BLT (Bone-Marrow-Liver-Thymus) mouse” on an escalating payment scale. Researchers associated with PHS (Public Health Service) and HU CFAR (Harvard University Center for AIDS Research) pay the least ($800.00) for a BLT mouse. Academic researchers from non-PHS and non-HU CFAR pay the second least ($1,152.00) pay the second least. Researchers from “Industry” pay the most ($1,272.00). Does the NIH-funded Human Immune System Mouse Core sell humanized mice to private corporations?

18—To which private corporations has Harvard’s NIH-funded Human Immune System Mouse Core sold BLT humanized mice? How many BLT humanized mice has the core sold to private corporations?

19—Is Harvard’s NIH-Funded “Core B: Animal and Laboratory Core,” which also makes BLT humanized mice with human fetal livers and thymuses, and whose principal investigators are also associated with the Human Immune System Mouse Core, a part of CFAR? What is the U19 program it supports?

20—How many BLT humanized mice are currently being maintained in labs affiliated with this NIH-funded Harvard program?

21--If it were made illegal in the United States to abort an unborn child after that child has a detectable heartbeat would Harvard’s NIH-funded Human Immune System Mouse Core still be able to get the tissue it needs from aborted babies to construct the BLT humanized mice it constructs now? Or is this NIH-funded program’s ability to create BLT humanized mice dependent on it being legal in the United States to abort an unborn child who already has a beating heart?

 

NIH sent CNSNews.com this response on May 22:

"As we previously provided to you, NIH funds grants for research that involve human fetal tissue. The Estimates of Funding for Various Research, Condition, and Disease Categories (RCDC) provides official NIH figures on research spending by category. NIH grants and projects that include funding for research involving human fetal tissue in fiscal year 2018, the last complete fiscal year in which we have publicly available data, was $115 million*. Here is a link to the NIH RePORTER entry for the grant to Harvard University Center for AIDS Research (HU CFAR): https://projectreporter.nih.gov/project_info_description.cfm?aid=9527728&icde=0. A detailed description of what the grant funds is provided in the entry.

“*Note that the entire research budget of the project is counted in the category irrespective of how much of the budget is used to for research involving fetal tissue. This means that even if a small amount of a grant was devoted to research involving fetal tissue, the entire budget of the grant would be counted in this category.

“This is all the information we have to share.”

 

CNSNews.com sent these follow-up questions to NIH on May 23:

1-- The NIH RePORTER indicates that Harvard’s “Small Animal Containment” program received $1,723,026 in NIH grants in the period from 2009 through 2013. It also shows that Harvard’s “Humanized Mouse Core” program received $926,682 in NIH grants in the period from 2014 through 2018. Were these funds that NIH provided to the Small Animal Containment program and the Humanized Mouse Core program separate from—and, therefore, in addition to—the amounts listed for the overall grants to the Harvard Center for AIDS Research on its own NIH RePORTER pages for those years? I.e. Does the $3,540,479 the NIH RePORTER lists as the total funding for Harvard’s Center for AIDS Research in 2018 include the $168,320 the NIH RePORTER says was granted to the Harvard’s “Humanized Mouse Core” in 2018?

2—The NIH RePORTER description of the NIH’s “cooperative agreement” with Harvard for the “Core B: Animal and Laboratory Core” says: “The Animal and Laboratory Core (Core B) will provide this U19 Program with 'BLT' (bone marrow−liver−thymus) humanized mice, generated by surgically implanting human fetal thymic and liver tissue under the renal capsules of immunodeficient mice, concurrently with the intravenous transfer of autologous human hematopoietic stem cells (HSCs). ... Core B will generate BLT mice for all experiments using them that are proposed in Projects 1, 2 and 3 of this U19 Program application. As called for by different experiments, these BLT mice will be generated either with unmanipulated or with genetically manipulated HSCs. Core B will perform all treatments of BLT mice called for, including HIV infection, administration of anti-retroviral therapies (ART), and adoptive transfer of genetically manipulated HSCs or CD8+ T cells.” What functions do NIH employees, or any other government employees, perform in carrying out this cooperative agreement? Are NIH or other federal employees who participate in it involved in procuring tissue from aborted babies, recommending contractors or clinics that can provide the project with tissue from aborted babies, surgically creating the humanized mice, or experimenting on the humanized mice once they are created?

 

CNSNews.com sent these follow-up questions to HHS and NIH on June 7 after HHS had announced its new policy on June 5:

1—Has HHS informed Harvard that the new policy regarding fetal tissue research that HHS announced on June 5 will affect NIH funding of either the Harvard Human Immune System Mouse Core or the Core B: Animal and Laboratory Core? If so, how specifically will NIH funding of these Harvard programs be affected?

2—According to the NIH RePORTER, the current grant for the Human Immune System Mouse Core began on Aug 1, 2018 and ends on July 31, 2019. Will the NIH extend this grant beyond July 31, 2019? Or will NIH terminate this grant?

3—According to the NIH RePORTER, the current grant for the Core B: Animal and Laboratory Core began on April 1, 2019 and ends on March 31, 2020. Will the NIH extend this grant beyond March 31, 2020? Or will NIH terminate this grant?

4—Given that the Core B: Animal and Laboratory Core is a U19 program—a type of program in which, HHS says, federal staff “collaborate or participate in project or program activities”--what roles have NIH employees or any other federal employees performed in this project?

5—Does the new HHS policy announced on June 5 to discontinue “intramural research that involves the acquisition of fetal tissue from elective abortions” apply to the collaboration and participation of NIH employees in the activities of Harvard’s Core B: Animal and Laboratory Core? Or will NIH staff or any other federal employees continue to collaborate or participate in this program?

HHS responded to CNSNews.com on June 11 with this background information on their new policy of reviewing all grants using fetal tissue with an ethics advisory board operating under the terms of Section 492A of the Public Health Service Act:

· PHS Act § 492A contemplates that a separate ethics advisory board be empaneled for each proposed research project which an institutional review board (IRB) has approved or which has been recommended for approval.

· NIH employs 2 levels of scientific review for research grant applications to review and make recommendations with respect to funding of grant applications: peer review by a NIH-formed Scientific Review Group or study section and review by the Advisory Council or Board of the relevant Institute or Center.

· Research grant applications are recommended for approval if both the Scientific Review Group and the relevant Institute or Center Advisory Council or Board recommend the research for funding/deem the grant application fundable.

o The Scientific Review Group (SRG)/Study Section is composed primarily of non-federal scientists who have expertise in relevant scientific disciplines and current research areas.

o Institute/Center National Advisory Councils or Boards are composed of both scientific and public representatives chosen for their expertise, interest, or activity in matters related to health and disease.

· An ethics advisory board will, thus, be empaneled for research that has been recommended for funding by both Scientific Review Group (i.e., receives a fundable score) and the Advisory Council/Board. More applications are deemed fundable than there are funds for, so only fundable applications that, based on their score, fall within the Institute or Center’s payline (research projects that, based on funds available, could be funded by the Institute or Center) would be reviewed by ethics advisory boards.

· With respect to each project that proposes to use fetal tissue from elective abortion and that has been recommended for funding by the first two levels of external scientific reviews, under the Administration’s policy, the Department would, pursuant to PHS Act 492A, publish a Federal Register Notice with the determination that an ethics advisory board should be convened and requesting recommendations for the ethics advisory board for such project.

· The Secretary cannot make appointments to such advisory board until 30 days after the publication in the Federal Register.

· The statute, PHS Act § 492A, provides that an ethics advisory board be composed of 14-20 individuals who are not government employees and who have special qualifications and competence to provide advice and recommendations regarding ethical matters in biomedical and behavioral research.

o At least 1 must be an attorney.

o At least 1 must be an ethicist.

o At least 1 must be a practicing physician.

o At least 1 must be a theologian.

o Between 1/3 and ½ shall be scientists with substantial accomplishments in biomedical or behavioral research.

· Each advisory board is required to submit its report on its findings with respect to whether the Secretary should withhold funds for the project based on ethical considerations within 180 days of the publication of the Federal Register notice. The statute requires that the report be submitted to the Secretary, to the Committee on Energy and Commerce (House), and the Committee on Labor and Human Resources (Senate HELP Committee).

o PHS Act § 492A bars the Secretary from refusing to fund (or imposing a moratorium on) extramural fetal tissue research (or any other research) based on ethical concerns if the research has been approved by an Institutional Review Board (IRB) or recommended for funding after peer review.

§ The only exception under the statute is if a specially convened ethics advisory board determines the research would be unethical, or the Secretary finds that the board’s recommendation in favor of the research was arbitrary and capricious.

§ The statute contemplates that this review occur on a project-by-project basis.

§ The statute defines “ethical considerations” as “considerations as to whether the nature of the research involved is such that it is unethical to conduct or support the research.”

 

HHS provided this additional background to CNSNews.com on June 21:

“Cooperative agreements are treated as extramural grants.”

“The grants you reference went through the competitive renewal cycle prior to the announcement of the new policy.”

CNSNews.com asked this follow-up question on June 21:

“Does the fact that they went through the competitive renewal cycle before HHS announced its new policy mean that the Harvard's Humanized Mouse Core must have its grant renewed for another year when it expires at the end of July and that the Core B: Animal and Laboratory Core must have its funding renewed when its current funding period ends at the end of March 2020? Can they be cancelled at the end of their current funding periods?”

HHS responded on June 21:

“We cannot generally terminate a grant if it’s up for a non-competitive renewal in 2020.”

 

CNSNews.com sent Harvard these questions on May 15:

1--Does Harvard in any way contest the conclusion presented in the “background paper” that Harvard itself provided to the House Energy and Commerce Committee that creating mice with human immune systems—such as the BLT mice created at Harvard’s federally funded Human Immune System Mouse Core--requires human fetal tissue obtained from abortions?

2—The 2009 Journal of Virology article that the Human Immune System Mouse Core webpage links to in order to provide people with an illustration of the BLT humanized mice that the core creates—“Induction of robust cellular and humoral virus-specific adaptive immune responses in human immunodeficiency virus-infected humanized BLT mice”—says the mice used in the research described in that article were made with “human fetal thymus and liver (17 to 19 weeks of gestational age)” that was obtained from Advanced Bioscience Resources. 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 BLT humanized mice created by Harvard’s Human Immune System Mouse Core?

3--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 BLT humanized mice created by the Human Immune System Mouse Core?

4--What is the oldest gestational age of any unborn child whose tissue has been used to create BLT humanized mice at Harvard’s Human Immune System Mouse Core?

5--What is the youngest gestational age of any unborn child whose tissue has been used to create BLT humanized mice at the core?

6—Since at least 2009, according to the NIH RePORTER, Harvard has been receiving federal grants specifically to make “humanized BLT mice” made with “human fetal thymus, liver and hematopoietic stem cells.” In the years from 2009 forward, has Advanced Bioscience Resources been the only source for all of the human fetal tissue Harvard has obtained to use in making these mice?

7—If Advanced Bioscience Resources has not been the sole source providing Harvard with the human fetal tissue needed to make BLT humanized mice in the years from 2009 forward, what other sources have provided Harvard with this tissue?

8—From 2009 forward, how many aborted babies have provided Harvard with tissues to make BLT humanized mice?

9—Where have the abortions that produced the human fetal tissue used by Harvard to create BLT humanized mice been carried out?

10—How much time can elapse between the abortion of a baby whose organs are going to be used to create BLT humanized mice and the actual transplantation of that baby’s tissue into the mice?

11—Has Harvard made any types of payments to Advanced Bioscience Resources or any other human fetal tissue provider for the human fetal tissue it has obtained for creating BLT mice in the Human Immune System Mouse Core? If so, how much does Harvard pay at this time for the aborted-baby organs it needs to create BLT humanized mice?

12—In the period from 2009 forward, how much has Harvard paid in total to procure the aborted-baby organs it uses in making BLT humanized mice?

13—How many humanized mice does Harvard’s Human Immune System Mouse Core typically make with the liver and thymus from a single aborted baby?

14—Must the fetal livers and thymuses that Harvard’s Human Immune System Mouse Core uses to create BLT humanized mice be delivered to the core intact or can they be mutilated in any way?

15--Are there any methods of abortion that cannot be used to terminate an unborn baby whose tissue is going to be used to create BLT humanized mice at Harvard’s Human Immune System Mouse Core because that method of abortion would cause the tissue to be damaged or spoiled in a way that would make it unsuitable for creating those humanized mice?

16--Are the mothers who agree to donate tissue from their unborn babies to create the BLT mice made by Harvard’s Human Immune System Mouse Core informed that the tissue taken from their aborted baby will be transplanted into mice?

17—The fee schedule published by Harvard’s Human Immune System Mouse Core offers the “BLT (Bone-Marrow-Liver-Thymus) mouse” on an escalating payment scale. Researchers associated with PHS (Public Health Service) and HU CFAR (Harvard University Center for AIDS Research) pay the least ($800.00) for a BLT mouse. Academic researchers from non-PHS and non-HU CFAR pay the second least ($1,152.00) pay the second least. Researchers from “Industry” pay the most ($1,272.00). Does the federally funded Human Immune System Mouse Core sell humanized mice to private corporations?

18—To which private corporations has Harvard’s federally funded Human Immune System Mouse Core sold BLT humanized mice? How many BLT humanized mice has the core sold to private corporations?

19—Is Harvard’s NIH-Funded “Core B: Animal and Laboratory Core,” which also makes BLT humanized mice with human fetal livers and thymuses, and whose principal investigators are also associated with the Human Immune System Mouse Core, a part of CFAR? What is the U19 program it supports?

20—How many BLT humanized mice are currently being maintained in labs affiliated with Harvard?

21--If it were made illegal in the United States to abort an unborn child after that child has a detectable heartbeat would Harvard’s Human Immune System Mouse Core still be able to get the tissue it needs from aborted babies to construct the BLT humanized mice it constructs now? Or is the core’s ability to create BLT humanized mice dependent on it being legal in the United States to abort an unborn child who already has a beating heart?

 

Harvard sent this response on May 20:

“Here is information that will help address your questions.”

Attached to this email message were two documents: 1) the background paper on fetal tissue research that Harvard provided to the House Energy and Commerce Committee’s Select Investigative Committee on Infant Lives on July 7, 2016, and 2) a Sept. 10, 2018 letter on fetal tissue research addressed to then-House Speaker Paul Ryan, then-House Minority Leader Nancy Pelosi, Senate Majority Leader Mitch McConnell and Senate Minority Leader Chuck Schumer that Harvard signed along with multiple other universities and medical associations.

 

CNSNews.com sent Harvard these follow-up questions about its “Core B: Animal and Laboratory Core”:

1—What is the youngest gestational age an unborn baby can be and still have a liver and thymus that is usable in making the BLT humanized mice made by Harvard’s “Core B: Animal and Laboratory Core”? What is the oldest gestational age?

2—In the five years from 2015 to 2019, how many aborted babies have donated their livers and thymuses to Harvard’s “Core B: Animal and Laboratory Core” to make BLT humanized mice?

3--Where have the abortions that produced the human fetal tissue used by Harvard’s “Core B: Animal and Laboratory Core” to create these humanized mice been carried out?

4—How much time can elapse between the abortion of a baby whose organs are going to be used to create BLT humanized mice in the “Core B: Animal and Laboratory Core” and the actual transplantation of that baby’s tissue into the mice?

5—Has Harvard made any types of payments to human fetal tissue providers for the human fetal tissue it has obtained for creating BLT mice in the “Core B: Animal and Laboratory Core”? If so, who are the providers that Harvard has paid for the aborted-baby organs it needs to create BLT humanized mice in the “Core B: Animal and Laboratory Core” and how much has Harvard paid these providers?

6—How many humanized mice does Harvard’s NIH-funded “Core B: Animal and Laboratory Core” typically make with the liver and thymus from a single aborted baby?

7—Must the fetal livers and thymuses that Harvard’s “Core B: Animal and Laboratory Core” uses to make BLT humanized mice be delivered to the core intact or can they be mutilated in any way?

8--Are there any methods of abortion that cannot be used to terminate an unborn baby whose tissue is going to be used by this core 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?

9--Are the mothers who agree to donate tissue from their unborn babies to create the BLT mice made by this Harvard program informed that the tissue taken from their aborted baby will be transplanted into mice?

10—As noted in the HHS “Grants Policy Statement,” in a “cooperative agreement” such as this U19 cooperative agreement between Harvard and the NIH, NIH “program staff will collaborate or participate in project or program activities as specified in the NoA [Notice of Award].” How do NIH staff collaborate and participate in the program activities of Harvard’s “Core B: Animal and Laboratory Core”?

11—Do federal employees in any way help Harvard’s “Core B: Animal and Laboratory Core” find sources for human fetal tissue, obtain human fetal tissue, process human fetal tissue, help make BLT humanized mice using human fetal tissue, or handle and care for BLT humanized mice after they are made with human fetal tissue? If so, what exactly do these federal employees do?

 

CNSNews.com sent Harvard these follow-up questions on June 7 after HHS announced its new policy on June 5:

1--Has HHS informed Harvard that the new policy regarding fetal tissue research that it announced on June 5 will affect NIH funding of either the Harvard Human Immune System Mouse Core or the Core B: Animal and Laboratory Core? If so, how specifically will NIH funding of these Harvard programs be affected?

2—According to the NIH RePORTER, the current grant for the Human Immune System Mouse Core began on Aug 1, 2018 and ends on July 31, 2019. Has Harvard applied to the NIH—or does it intend to apply to the NIH—to have this grant extended beyond July 31, 2019?

3—According to the NIH RePORTER, the current grant for the Core B: Animal and Laboratory Core began on April 1, 2019 and ends on March 31, 2020. Has Harvard applied to the NIH—or does it intend to apply to the NIH--to have this grant extended beyond March 31, 2020?

4—Given that the Core B: Animal and Laboratory Core is a U19 program—a type of program in which, HHS says, federal staff “collaborate or participate in project or program activities”--what roles have NIH employees or any other federal employees performed in this project?

5—Has the new HHS policy announced on June 5 to discontinue “intramural research that involves the acquisition of fetal tissue from elective abortions” also terminated the collaboration and participation of NIH staff or other federal employees in the activities of Harvard’s Core B: Animal and Laboratory Core? Or will NIH staff or any other federal employees continue to collaborate or participate in this program?

 

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