(CNSNews.com) - A federally funded program at Harvard University is offering “humanized mice” made with organs taken from aborted babies for prices ranging from $800 to $1,272, according to the fee schedule Harvard has published online.
This program, which has received $926,682 in grants from the National Institutes of Health over the past 5 years, creates a demand for tissue—including livers and thymuses--taken from aborted babies.
Its current grant of $168,320 was awarded for a one-year period that started on Aug. 1, 2018 and will end on July 31, 2019.
On May 15, CNSNews.com asked NIH and the Department of Health and Services: “Will the NIH extend this grant beyond July 31, 2019? Or will NIH terminate this grant?”
On June 21, HHS indicated to CNSNews.com that this program and another federally funded Harvard program that uses tissue from aborted babies to make humanized mice will not be immediately subject to the new policy announced by the administration earlier this month that requires “extramural” HHS-funded programs that use fetal tissue to undergo a new layer of review by an ethics advisory board.
“The grants you reference went through the competitive renewal cycle prior to the announcement of the new policy,” an HHS spokesperson told CNSNews.com on Friday.
CNSNews.com followed up on that statement from HHS by asking: “Does the fact that they went through the competitive renewal cycle before HHS announced its new policy mean that 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?”
“We cannot generally terminate a grant if it’s up for a non-competitive renewal in 2020,” HHS responded.
(On May 15, CNSNews.com asked NIH, HHS and Harvard 21 questions about these NIH-funded programs at Harvard that make humanized mice using aborted baby parts. On May 23, CNSNews.com sent NIH two follow-up questions on these programs. On May 24, CNSNews.com sent Harvard 11 follow-up questions focusing on the second program at Harvard making the humanized mice. On June 7, CNSNews.com sent NIH and HHS and Harvard 5 additional follow-up questions in light of the new policy on fetal tissue research that HHS announced on June 5. On June 21, CNSNesws.com sent HHS another follow-up question. To see the questions that CNSNews.com asked and how the NIH, HHS and Harvard responded to them click here.)
Harvard’s Humanized Mice Fee Schedule
According to the “fee schedule” it published online, Harvard’s Human Immune System Mouse Core, as it is called, has an escalating price system for the “BLT (Bone Marrow-Liver-Thymus) Mouse.” The “fee” that researchers pay depends on their affiliation. Researchers associated with the Public Health Service (PHS) or Harvard’s Center for AIDS Research (CFAR) pay $800 per “BLT” humanized mouse. Academic researchers not associated with the PHS or Harvard’s CFAR pay $1,152 per mouse.
Entities that the fee schedule refers to only as “industry” pay $1,272 per BLT mouse.
The fee schedule also includes the pricing for other types of humanized mice that, unlike BLT mice, are not made with tissue taken from aborted babies. For example, it offers Hu-PBL mice, which it describes as being “generated by adoptive transfer of human peripheral blood leukocytes into immunodeficient mice.”
[This is a screen capture from the fee schedule for Harvard's Human Immune System Mouse Program.]
On Harvard’s fee schedule, these HU-PBL mice are not as expensive as BLT mice. For example, the program charges “industry” a fee of only $556.50 for an “Hu-PBL mouse,” which is less than half the $1,272 it charges for a “BLT (Bone Marrow-Liver-Thymus) mouse” made with tissue taken from an aborted baby.
The fee schedule also charges escalating fees for procedures it performs on the mice—such as vaccinations and drug administrations—with, for example, Harvard researchers paying $25.00 for the intraperitoneal vaccination of an HIV infected mouse and “industry” paying $39.75.
Given that Harvard’s fee schedule for these mice has a distinct price category for “industry,” CNSNews.com asked Harvard, the NIH and HHS these questions:
--Does the federally funded Human Immune System Mouse Core sell humanized mice to private corporations?
---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?
Harvard, the NIH and HHS did not respond to these questions.
As of May 15, the day that CNSNews.com first sent Harvard (and the NIH and HHS) a set of questions about the NIH-funded Human Immune System Mouse Core, the program’s webpage included separate bullet points regarding “Prices” and “Payments” for the mice. The bullet point on “Prices” said: “A list of prices for the generation of the various types of humanized mice and for the procedures performed on them by the Humanized Mouse Core are contained in this Fee Schedule.” The words “Fee Schedule” linked to a PDF of the program’s four-page fee schedule.
The bullet point on “Payments” said: “Payments for mice purchased are due prior to the initiation of experiments with them. Payments for procedures performed on the mice in the course of experiments are due upon completion of the experiments. Collaborating investigators whose funds are at Partners Healthcare institutions can simply designate a fund number for costs to be applied to. Collaborating investigators at non-Partners Institutions can either send a check or a purchase order number.”
[These bullet points about the "Prices" and "Payments" for humanized mice at Harvard's Human Immune System Mouse Core appeared on the program's webstie as of May 15, 2019.]
(After CNSNews.com sent its questions to Harvard about the program, the above-quoted language about “Prices” and “Payments” on the program’s webpage was removed. However, the webpage still includes a link to the fee schedule and the last paragraph on the updated page says: “[F]or more detailed information on the Human Immune System Mouse Core Program, please refer to our partner website: http://ragoninstitute.org/research/services/humanized-mouse.” This links to a webpage maintained by the Ragon Institute of MGH (Massachusetts General Hospital), MIT and Harvard that includes a subsection headlined “rates.” That subsection still features the language on “Prices” and “Payments.”)
As of June 21, a subsection headlined "Rates" on the webpage of the Ragon Institute of MGH (Massachusetts General Hospital), MIT and Harvard discussed the "Prices" and "Payments" for humanized mice made by the Harvard's Human Immune System Mouse Program.
‘17 to 19 Weeks of Gestational Age’
What is the BLT humanized mouse that Harvard offers researchers for prices ranging from $800 to $1,272?
The webpage of Harvard's Human Immune System Mouse Core answers that question by linking to an article published in the July 2009 issue of the Journal of Virology. This article, authored by a group of researchers associated with Harvard Medical School, describes “humanized BLT mice” made with livers and thymuses taken from babies aborted at 17 to 19 weeks of gestational age. Under the heading, “Transplantation of human tissue,” it says:
“BLT mice were generated as previously described (33, 34, 41, 60). Briefly, NOD/SCID mice or NOD/SCID/γc−/− mice at 6 to 8 weeks of age were conditioned with sublethal (2 Gy) whole-body irradiation. They were anesthetized the same day, and ∼1-mm3 fragments of human fetal thymus and liver (17 to 19 weeks of gestational age) (Advanced Bioscience Resources) were implanted under the recipient kidney capsules bilaterally. Remaining fetal liver tissue was used to isolate CD34+ cells with anti-CD34 microbeads (Miltenyi Biotec), which then were injected intravenously (1.0 × 105 to 5.0 × 105 cells/mouse) within 6 h.”
The first footnote (“33”) in the paragraph above links to an article that a group of researchers associated with Harvard Medical School published on July 15, 2006 in Blood. In that article, the researchers said the liver and thymuses used to make the humanized mice came from babies at 17 to 20 weeks of gestational age.
“Human fetal thymus and liver tissues of gestational age of 17 to 20 weeks were obtained from Advanced Bioscience Resource (Alameda, CA),” this article said.
Since 2009, according to the federal government’s online database for NIH grants (NIH RePORTER), the description of the annual grant made to “Core H” at Harvard’s Center for AIDS Research has specifically stated that the first service or aim of this core is the “generation of humanized BLT mice.”
From 2009 through 2013, the description on the NIH RePORTER gave Harvard’s “Core H” the title “Small Animal Containment.” From 2014 through 2018, it gave “Core H” the title “Humanized Mouse Core.”
From 2009 through 2013, the NIH’s project description for Harvard’s “Small Animal Containment” grant said the following: “Site A [of Core H] will provide the following services: 1. Generation of humanized BLT mice (NOD-SCID-Hu mice transplanted with human fetal thymus, liver and hematopoietic stems cells (HSC)) for CFAR investigators to use for experiments, to be performed at the MGH or DFCI Sites of this core, or at the site of the collaborating investigator, following transfer of the BLT mice to his/her animal facility.”
[This is the description of Harvard's "Small Animal Containment" grant on the NIH RePORTER database.]
From 2014 through 2018, the NIH’s project description for Harvard’s “Humanized Mouse Core” grant said: “Building on earlier models, HU CFAR Core H has been able to make an improved humanized BLT (bone marrow-liver-thymus) mouse model widely available that allows CFAR members to model the development of humoral and cellular human immune responses to HIV, and mucosal transmission of HIV. … Specific aims of this Core include: 1. Generation of humanized BLT mice. 2. Generation of Hu-HSC mice and Hu-PBL mice. 3. Performance of experimental procedures on humanized mice. 4. Further improvement of humanized mouse models of HIV.”
[This is the description of Harvard's "Humanized Mouse Core" grant on the NIH RePORTER database.]
(For a full listing of NIH grants made to the humanized-mouse-making Core H at Harvard’s CFAR from 2009 through 2018 click here.)
A ‘Cooperative Agreement’ With NIH
In addition to the Human Immune System Mouse Core, the NIH also funds a program at Harvard titled “Core B: Animal and Laboratory Core” that also makes humanized mice using tissue taken from aborted babies. The NIH has given this program $2,818,525 over the past five years. (For a full listing of the payments the NIH has made to this program click here.)
The NIH RePORTER database describes this core as follows: “The Animal and Laboratory Core (Core B) will provide the 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).”
[This is the description of Harvard's "Core B: Animal and Laboratory Core" on the NIH RePORTER database. This core is part of a "cooperative agreement that NIH has made with Harvard.]
This “laboratory core” is part of an NIH funded project at Harvard that is called “A Defend and Destroy Approach to Curing HIV.” This project is what HHS calls a “U19 Program”—or “cooperative agreement.”
A “cooperative agreement,” according to an HHS policy statement, is to be used instead of a grant “whenever substantial federal involvement with the recipient during the performance is anticipated.”
A “Grants Policy Statement” published by HHS defines a “cooperative agreement” as follows: “A financial assistance support mechanism used when there will be substantial federal programmatic involvement. Substantial involvement means that OPDIV [HHS operating division] program staff will collaborate or participate in project or program activities as specified in the NoA [Notice of Award].”
Given that the Core B: Animal and Laboratory Core is part of a “cooperative agreement” between the NIH and Harvard, CNSNews.com asked Harvard: “How do NIH staff collaborate and participate in the program activities of Harvard’s ‘Core B: Animal and Laboratory Core’?”
Harvard did not respond to this question.
CNSNews.com asked NIH about the Core B: Animal and Laboratory Core: “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?”
NIH did not respond to this question.
‘Important and Unique Resource’
On May 15, CNSNews.com sent public affairs officers at Harvard University and Harvard Medical School and researchers involved in Harvard’s Human Immune System Mouse Core a set of 21 questions. These questions included among others:
--“Where have the abortions that produced the human fetal tissue used by Harvard to create BLT humanized mice been carried out?”
--“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?”
--“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?”
--“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?”
At the same time, CNSNews.com sent essentially the same set of 21 questions to public affairs officials at HHS and NIH. (To see the full set of questions click here.)
Harvard did not answer the specific 21 questions CNSNews.com sent it on May 15. Instead, a spokesperson for Harvard Medical School sent CNSNews.com a one-sentence email on May 20. It said: “Here is information that will help address your question.”
The email contained two attached documents. One was a 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. The other was a letter to then-House Speaker Paul Ryan (R.-Wisc.), House Minority Leader Nancy Pelosi (D.-Calif.), Senate Majority Leader Mitch McConnell (R.-Ky.) and Senate Minority Leader Chuck Schumer (D.-N.Y.) that was signed by many professional medical societies (including the American Academy of Pediatrics) and universities, including Harvard.
Both documents indicated that fetal tissue research requires tissue from aborted babies—not babies who die because of miscarriages.
“Mice that have human immune systems are an invaluable scientific resource, but the mice are engineered to this condition only by means of the use of human fetal material,” said the Harvard backgrounder.
“If human fetal tissue is needed, why can it not be obtained from miscarriages instead of abortion?” the backgrounder rhetorically asked.
“Almost all miscarriages happen at home or in locations in which fetal material is not recovered and, importantly, preserved in a usable state,” said the backgrounder. “Just as obtaining tissue during a scheduled surgery or an in-hospital autopsy soon after death provides tissue that is untainted by decay relative to obtaining those same tissues from the morgue or a funeral home, obtaining fetal tissue from elective pregnancy termination is far superior to obtaining whatever material might be recoverable following spontaneous miscarriage, even assuming a mechanism existed for the collection of such material.”
“The use of human fetal tissue in research can be conducted in a fair and responsible manner,” said the Harvard backgrounder. “Abortions occur in this country because they are a legal medical procedure. Fetal remains from this procedure can simply be discarded as medical waste. Or, adult women can donate those remains to research, in much the way other human tissue and organs, following surgery or death, is donated to research.
“The process,” said the Harvard backgrounder, “requires attention to issues of informed consent and other ethical considerations (no financial or other inducements, a separation between the decision to undergo the procedure and a decision to donate, no change in treatment afforded whether a donation is made or not).”
“With these issues taken into consideration and properly conducted,” the Harvard backgrounder concluded, “the important and unique resource of human fetal tissue can be used responsibly in research.”
On July 11, 2018, the House Appropriations Committee approved a bill to fund the Departments of Labor, Health and Human Services and Education in fiscal 2019. That bill included language that expressly defunded research using fetal tissue taken from aborted babies. It said: “None of the funds made available by this Act may be used to conduct or support research using human fetal tissue if such tissue is obtained pursuant to an induced abortion.”
The letter to the congressional leaders that Harvard and other universities and medical societies signed was sent on Sept. 10, 2018 when the full House and Senate—then controlled by Republicans—were preparing to take up the final Labor, HHS, Education funding bill, which would be united with the Defense Department funding bill. The letter included a footnote pointing to the language in the House Appropriations Committee’s version of the bill that specifically prohibited funding of research using tissue from aborted babies.
“If enacted, the proposed prohibition would severely obstruct research that is necessary for the development of new treatments for a wide range of serious diseases,” said the letter.
“Tissue from spontaneous abortions is not a reliable substitute for tissue from ‘induced’ abortions,” the letter said. “Spontaneous abortions, commonly called miscarriages, often result from genetic defects, developmental abnormalities, or other conditions that undermine the usefulness of the tissue for research and generally do not occur in settings where the fetal tissue can be adequately preserved for research.”
The letter pointed out that research using this tissue taken from aborted babies has had “bipartisan support” in Congress and has been funded by the NIH.
“Rigorous legal and ethical oversight of fetal tissue research has been in place for decades,” the letter said. “This area of research has garnered bipartisan support in the U.S. Congress and has been funded by the National Institutes of Health (NIH). Numerous federal panels and reviews, conducted under both Republican and Democratic congressional majorities and presidential administrations, have evaluated human fetal tissue research and have concluded that it is critical for lifesaving biomedical research. This research has long been viewed as good public policy to improve human health and has proceeded with public support.”
The fiscal 2019 Defense, Labor, HHS, Education appropriation that was approved by the full Congress and signed by President Trump did not include the language prohibiting funding of fetal tissue research.
$115 Million on Human Fetal Tissue Research in FY18
After CNSNews.com on May 15 sent 21 questions to HHS and NIH about the NIH-funded research at Harvard using tissue from aborted babies to make humanized mice, the NIH responded on May 22 with a statement.
“As we previously provided to you, NIH funds grants for research that involve human fetal tissue,” said this statement from NIH. “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,” said the NIH statement. “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,” said the NIH statement.
In fact, the link to the NIH RePORTER page that the NIH included in its statement went to the description of the NIH funding for the overall Harvard Center for Aids Research—not the specific NIH RePORTER page for Harvard’s “Humanized Mouse Core.” In its May 15 inquiry to NIH, CNSNews.com had specifically cited and quoted from the NIH RePORTER page for the “Humanized Mouse Core,” and cited the specific funding for this core as recorded on the NIH RePORTER. CNSNews.com had also followed up this May 15 inquiry by emailing the NIH (on that same day) screen captures of the actual NIH RePORTER pages describing the activities and stating the annual funding of Harvard’s “Humanized Mouse Core.”
The New Ethical Review
On June 5, HHS announced it was ending a contract it had with the University of California at San Francisco to make humanized mice using tissue from aborted babies. (CNSNews.com had first reported on this contract on Oct. 17, 2018.) At the same time it announced it was ending this contract, HHS also announced it was ending its intramural research using tissue from aborted babies.
However, the new policy did not end funding of “extramural” research programs using tissue from aborted babies such as Harvard’s NIH-funded humanized mouse programs.
“No current extramural research projects (research conducted outside NIH, e.g., at universities, that are funded by NIH grants) will be affected during their currently approved project period,” HHS said in its statement announcing the end of the UCSF contract and intramural HHS research using tissue from aborted babes.
“For new extramural research grant applications or current research projects in the competitive renewal process (generally every five years) that propose to use fetal tissue from elective abortions and that are recommended for potential funding through NIH’s two-level external scientific review process, an ethics advisory board will be convened to review the research proposal and recommend whether, in light of the ethical considerations, NIH should fund the research project—pursuant to a law passed by Congress,” said the statement.
In light of this announcement, CNSNews.com sent HHS and NIH questions about how this new policy would impact NIH funding of Harvard’s humanized mouse program and the “cooperative agreement” the NIH has with Harvard that involves the creation of humanized mice.
HHS responded on June 11 by providing background on how the ethics advisory boards that will review programs that use fetal tissue and seek federal funding will work. (To see HHS full background statement about the ethics advisory boards click here.)
But, on June 21, HHS followed up with CNSNew.com stating that: “Cooperative agreements [such as Harvard’s Core B: Animal and Laboratory Core] are treated as extramural grants.”
And: “The grants you reference [Harvard’s Humanized Mouse Core and Core B: Animal and Laboratory Core] went through the competitive renewal cycle prior to the announcement of the new policy.”
As noted, CNSNews.com followed up on that statement by asking HHS: “Does the fact that they went through the competitive renewal cycle before HHS announced its new policy mean that 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: “We cannot generally terminate a grant if it’s up for a non-competitive renewal in 2020."
Until now, HHS said in explaining its new policy, the NIH has used two levels of review for all grant applications.
“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," says HHS.
Under the new policy, a third level will be added: the secretary of HHS will appoint a special ethics advisory board to review each extramural project that uses human fetal tissue and seeks federal funding.
These ethics advisory boards, according to HHS, will be set up under Section 492A for the Public Health Service Act.
“The statute contemplates that this review occur on a project-by-project basis,” says HHS.
“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,” says HHS, “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.”
Under the terms of Section 492A, these ethics advisory boards will consist of between 14 and 20 people who are not federal employees. They will include at least one attorney, one practicing physician, one ethicist, and one theologian. At least a third of them—but no more than half—“shall be scientists with substantial accomplishments in biomedical or behavioral research.”
The law says this board “shall conduct inquiries and hold public hearings.”
Within 180 days of the notice published in the Federal Register indicating this board is being created, the board will provide the secretary of HHS, the House Committee on Energy and Commerce and the Senate Committee on Labor and Human Resources with a report containing its findings and its recommending whether or not the project in question should be funded.
Section 492A, HHS says, “bars the secretary from refusing to fund (or imposing a moratorium on) extramural fetal tissue research (or 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,” says HHS.