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By Terence P. Jeffrey | CNS<\/p>\n
(CNSNews.com) – A federally funded\u00a0program at Harvard University<\/a>\u00a0is offering \u201chumanized mice\u201d made with organs taken from aborted babies for prices ranging from $800 to $1,272,\u00a0according to the fee schedule Harvard has published online<\/a>.<\/p>\n 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\u2014including livers and thymuses–taken from aborted babies.<\/p>\n Its\u00a0current grant of $168,320<\/a>\u00a0was awarded for a one-year period that started on Aug. 1, 2018 and will end on July 31, 2019.<\/p>\n On May 15, CNSNews.com asked NIH and the Department of Health and Services: \u201cWill the NIH extend this grant beyond July 31, 2019? Or will NIH terminate this grant?\u201d<\/p>\n 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 \u201cextramural\u201d HHS-funded programs that use fetal tissue to undergo a new layer of review by an ethics advisory board.<\/p>\n \u201cThe grants you reference went through the competitive renewal cycle prior to the announcement of the new policy,\u201d an HHS spokesperson told CNSNews.com on Friday.<\/p>\n CNSNews.com followed up on that statement from HHS by asking: \u201cDoes 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?\u201d<\/p>\n \u201cWe cannot generally terminate a grant if it\u2019s up for a non-competitive renewal in 2020,\u201d HHS responded.<\/p>\n (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\u00a0click here<\/a>.)<\/p>\n Harvard\u2019s Humanized Mice Fee Schedule<\/strong><\/p>\n According to the \u201cfee schedule<\/a>\u201d it published online, Harvard\u2019s Human Immune System Mouse Core, as it is called, has an escalating price system for the \u201cBLT (Bone Marrow-Liver-Thymus) Mouse.\u201d The \u201cfee\u201d that researchers pay depends on their affiliation. Researchers associated with the Public Health Service (PHS) or Harvard\u2019s Center for AIDS Research (CFAR) pay $800 per \u201cBLT\u201d humanized mouse. Academic researchers not associated with the PHS or Harvard\u2019s CFAR pay $1,152 per mouse.<\/p>\n Entities that the fee schedule refers to only as \u201cindustry\u201d pay $1,272 per BLT mouse.<\/p>\n 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 \u201cgenerated by adoptive transfer of human peripheral blood leukocytes into immunodeficient mice.\u201d<\/p>\n [This is a screen capture from the fee schedule for Harvard’s Human Immune System Mouse Program.]<\/strong><\/p>\n On Harvard\u2019s fee schedule, these HU-PBL mice are not as expensive as BLT mice. For example, the program charges \u201cindustry\u201d a fee of only $556.50 for an \u201cHu-PBL mouse,\u201d which is less than half the $1,272 it charges for a \u201cBLT (Bone Marrow-Liver-Thymus) mouse\u201d made with tissue taken from an aborted baby.<\/p>\n The fee schedule also charges escalating fees for procedures it performs on the mice\u2014such as vaccinations and drug administrations\u2014with, for example, Harvard researchers paying $25.00 for the intraperitoneal vaccination of an HIV infected mouse and \u201cindustry\u201d paying $39.75.<\/p>\n Given that Harvard\u2019s fee schedule for these mice has a distinct price category for \u201cindustry,\u201d CNSNews.com asked Harvard, the NIH and HHS these questions:<\/p>\n –Does the federally funded Human Immune System Mouse Core sell humanized mice to private corporations?<\/p>\n —To which private corporations has Harvard\u2019s federally funded Human Immune System Mouse Core sold BLT humanized mice?<\/p>\n –How many BLT humanized mice has the core sold to private corporations?<\/p>\n Harvard, the NIH and HHS did not respond to these questions.<\/p>\n 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\u2019s webpage included separate bullet points regarding \u201cPrices\u201d and \u201cPayments\u201d for the mice. The bullet point on \u201cPrices\u201d said: \u201cA 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.\u201d The words \u201cFee Schedule\u201d linked to a PDF of the program\u2019s four-page fee schedule.<\/p>\n The bullet point on \u201cPayments\u201d said: \u201cPayments 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.\u201d<\/p>\n [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.]<\/strong><\/p>\n (After CNSNews.com sent its questions to Harvard about the program, the above-quoted language about \u201cPrices\u201d and \u201cPayments\u201d on the program\u2019s webpage was removed. However, the webpage still includes a link to the fee schedule and the last paragraph on the updated page says: \u201c[F]or more detailed information on the Human Immune System Mouse Core Program, please refer to our partner website:\u00a0http:\/\/ragoninstitute.org\/research\/services\/humanized-mouse<\/a>.\u201d This links to\u00a0a webpage maintained by the Ragon Institute of MGH (Massachusetts General Hospital), MIT and Harvard<\/a>\u00a0that includes a subsection headlined \u201crates.\u201d That subsection still features the language on \u201cPrices\u201d and \u201cPayments.\u201d)<\/p>\n As of June 21, a subsection headlined “Rates” on the webpage of the\u00a0Ragon Institute of MGH (Massachusetts General Hospital), MIT and Harvard<\/a>\u00a0discussed the “Prices” and “Payments” for humanized mice made by the Harvard’s Human Immune System Mouse Program.<\/strong><\/p>\n <\/p>\n \u201817 to 19 Weeks of Gestational Age\u2019<\/strong><\/p>\n What is the BLT humanized mouse that Harvard offers researchers for prices ranging from $800 to $1,272?<\/p>\n The\u00a0webpage of Harvard’s Human Immune System Mouse Core<\/a>\u00a0answers that question by linking to an article published in\u00a0the July 2009 issue of the Journal of Virology<\/a>. This article, authored by a group of researchers associated with Harvard Medical School, describes \u201chumanized BLT mice\u201d made with livers and thymuses taken from babies aborted at 17 to 19 weeks of gestational age. Under the heading, \u201cTransplantation of human tissue,\u201d it says:<\/p>\n \u201cBLT mice were generated as previously described (33<\/a>,\u00a034<\/a>,\u00a041<\/a>,\u00a060<\/a>). Briefly, NOD\/SCID mice or NOD\/SCID\/\u03b3c\u2212\/\u2212 mice at 6 to 8 weeks of age were conditioned with sublethal (2 Gy) whole-body irradiation. They were anesthetized the same day, and \u223c1-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 \u00d7 105 to 5.0 \u00d7 105 cells\/mouse) within 6 h.\u201d<\/p><\/blockquote>\n The first footnote (\u201c33\u201d) in the paragraph above links to an article that a group of researchers associated with Harvard Medical School\u00a0published on July 15, 2006 in Blood<\/a>. 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.<\/p>\n \u201cHuman fetal thymus and liver tissues of gestational age of 17 to 20 weeks were obtained from Advanced Bioscience Resource (Alameda, CA),\u201d this article said.<\/p>\n Since 2009, according to the federal government\u2019s online database for NIH grants (NIH RePORTER), the description of the annual grant made to \u201cCore H\u201d at Harvard\u2019s Center for AIDS Research has specifically stated that the first service or aim of this core is the \u201cgeneration of humanized BLT mice.\u201d<\/p>\n From 2009 through 2013, the description on the NIH RePORTER gave Harvard\u2019s \u201cCore H\u201d the title \u201cSmall Animal Containment.\u201d From 2014 through 2018, it gave \u201cCore H\u201d the title \u201cHumanized Mouse Core.\u201d<\/p>\n From 2009 through 2013, the\u00a0NIH\u2019s project description for Harvard\u2019s \u201cSmall Animal Containment\u201d<\/a>\u00a0grant said the following: \u201cSite 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.\u201d<\/p>\n [This is the description of Harvard’s “Small Animal Containment” grant on the\u00a0NIH RePORTER database<\/a>.]<\/strong><\/p>\n From 2014 through 2018, the\u00a0NIH\u2019s project description for Harvard\u2019s \u201cHumanized Mouse Core\u201d grant<\/a>\u00a0said: \u201cBuilding 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. \u2026 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.\u201d<\/p>\n [This is the description of Harvard’s “Humanized Mouse Core” grant on the\u00a0NIH RePORTER database<\/a>.]<\/strong><\/p>\n (For a full listing of NIH grants made to the humanized-mouse-making Core H at Harvard\u2019s CFAR from 2009 through 2018\u00a0click here<\/a>.)<\/p>\n A \u2018Cooperative Agreement\u2019 With NIH<\/strong><\/p>\n In addition to the Human Immune System Mouse Core, the NIH also funds a program at Harvard titled \u201cCore B: Animal and Laboratory Core<\/a>\u201d 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.)<\/p>\n The\u00a0NIH RePORTER database<\/a>\u00a0describes this core as follows: \u201cThe Animal and Laboratory Core (Core B) will provide the U19 program with \u2018BLT\u2019 (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).\u201d<\/p>\n [This is the description of Harvard’s “Core B: Animal and Laboratory Core” on the\u00a0NIH RePORTER database<\/a>. This core is part of a “cooperative agreement that NIH has made with Harvard.]<\/strong><\/p>\n This \u201claboratory core\u201d is part of an NIH funded project at Harvard that is called \u201cA Defend and Destroy Approach to Curing HIV.\u201d This project is what HHS calls a \u201cU19 Program\u201d\u2014or \u201ccooperative agreement.\u201d<\/p>\n A \u201ccooperative agreement,\u201d according to an HHS policy statement, is to be used instead of a grant \u201cwhenever substantial federal involvement with the recipient during the performance is anticipated.\u201d<\/p>\n A \u201cGrants Policy Statement<\/a>\u201d published by HHS defines a \u201ccooperative agreement\u201d as follows: \u201cA 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].\u201d<\/p>\n Given that the Core B: Animal and Laboratory Core is part of a \u201ccooperative agreement\u201d between the NIH and Harvard, CNSNews.com asked Harvard: \u201cHow do NIH staff collaborate and participate in the program activities of Harvard\u2019s \u2018Core B: Animal and Laboratory Core\u2019?\u201d<\/p>\n Harvard did not respond to this question.<\/p>\n CNSNews.com asked NIH about the Core B: Animal and Laboratory Core: \u201cWhat 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?\u201d<\/p>\n NIH did not respond to this question.<\/p>\n \u2018Important and Unique Resource\u2019<\/strong><\/p>\n On May 15, CNSNews.com sent public affairs officers at Harvard University and Harvard Medical School and researchers involved in Harvard\u2019s Human Immune System Mouse Core a set of 21 questions. These questions included among others:<\/p>\n –\u201cWhere have the abortions that produced the human fetal tissue used by Harvard to create BLT humanized mice been carried out?\u201d<\/p>\n –\u201cHow 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\u2019s tissue into the mice?\u201d<\/p>\n –\u201cAre 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\u2019s 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?\u201d<\/p>\n –\u201cAre the mothers who agree to donate tissue from their unborn babies to create the BLT mice made by Harvard\u2019s Human Immune System Mouse Core informed that the tissue taken from their aborted baby will be transplanted into mice?\u201d<\/p>\n 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\u00a0click here<\/a>.)<\/p>\n 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: \u201cHere is information that will help address your question.\u201d<\/p>\n 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\u2019s 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.<\/p>\n Both documents indicated that fetal tissue research requires tissue from aborted babies\u2014not babies who die because of miscarriages.<\/p>\n \u201cMice 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,\u201d said the Harvard backgrounder.<\/p>\n \u201cIf human fetal tissue is needed, why can it not be obtained from miscarriages instead of abortion?\u201d the backgrounder rhetorically asked.<\/p>\n \u201cAlmost all miscarriages happen at home or in locations in which fetal material is not recovered and, importantly, preserved in a usable state,\u201d said the backgrounder. \u201cJust 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.\u201d<\/p>\n \u201cThe use of human fetal tissue in research can be conducted in a fair and responsible manner,\u201d said the Harvard backgrounder. \u201cAbortions 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.<\/p>\n \u201cThe process,\u201d said the Harvard backgrounder, \u201crequires 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).\u201d<\/p>\n \u201cWith these issues taken into consideration and properly conducted,\u201d the Harvard backgrounder concluded, \u201cthe important and unique resource of human fetal tissue can be used responsibly in research.\u201d<\/p>\n 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: \u201cNone 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.\u201d<\/p>\n 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\u2014then controlled by Republicans\u2014were 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\u2019s version of the bill that specifically prohibited funding of research using tissue from aborted babies.<\/p>\n \u201cIf enacted, the proposed prohibition would severely obstruct research that is necessary for the development of new treatments for a wide range of serious diseases,\u201d said the letter.<\/p>\n \u201cTissue from spontaneous abortions is not a reliable substitute for tissue from \u2018induced\u2019 abortions,\u201d the letter said. \u201cSpontaneous 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.\u201d<\/p>\n The letter pointed out that research using this tissue taken from aborted babies has had \u201cbipartisan support\u201d in Congress and has been funded by the NIH.<\/p>\n \u201cRigorous legal and ethical oversight of fetal tissue research has been in place for decades,\u201d the letter said. \u201cThis 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.\u201d<\/p>\n 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.<\/p>\n $115 Million on Human Fetal Tissue Research in FY18<\/strong><\/p>\n 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.<\/p>\n \u201cAs we previously provided to you, NIH funds grants for research that involve human fetal tissue,\u201d said this statement from NIH. \u201cThe\u00a0Estimates of Funding for Various Research, Condition, and Disease Categories (RCDC)<\/a>\u00a0provides 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):\u00a0https:\/\/projectreporter.nih.gov\/project_info_description.cfm?aid=9527728&icde=0<\/a>. A detailed description of what the grant funds is provided in the entry.\u201d<\/p>\n \u201cNote 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,\u201d said the NIH statement. \u201cThis 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.\u201d<\/p>\n \u201cThis is all the information we have to share,\u201d said the NIH statement.<\/p>\n 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\u2014not the specific NIH RePORTER page for Harvard\u2019s \u201cHumanized Mouse Core<\/a>.\u201d In its May 15 inquiry to NIH, CNSNews.com had specifically cited and quoted from the NIH RePORTER page for the \u201cHumanized Mouse Core<\/a>,\u201d 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\u2019s \u201cHumanized Mouse Core.\u201d<\/p>\n The New Ethical Review<\/strong><\/p>\n 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<\/a>.) 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.<\/p>\n However, the new policy did not end funding of \u201cextramural\u201d research programs using tissue from aborted babies such as Harvard\u2019s NIH-funded humanized mouse programs.<\/p>\n \u201cNo 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,\u201d HHS said in its statement announcing the end of the UCSF contract and intramural HHS research using tissue from aborted babes.<\/p>\n \u201cFor 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\u2019s 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\u2014pursuant to a law passed by Congress,\u201d said the statement.<\/p>\n In light of this announcement, CNSNews.com sent HHS and NIH questions about how this new policy would impact NIH funding of Harvard\u2019s humanized mouse program and the \u201ccooperative agreement\u201d the NIH has with Harvard that involves the creation of humanized mice.<\/p>\n![\"\"](\"https:\/\/www.cnsnews.com\/s3\/files\/styles\/content_100p\/s3\/feesc1.jpg?itok=9Vv66YqR\")
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