{"id":13791,"date":"2021-03-11T15:15:50","date_gmt":"2021-03-11T23:15:50","guid":{"rendered":"https:\/\/www.functionalps.com\/blog\/?p=13791"},"modified":"2021-03-11T15:34:15","modified_gmt":"2021-03-11T23:34:15","slug":"the-antibody-deception","status":"publish","type":"post","link":"https:\/\/www.functionalps.com\/blog\/2021\/03\/11\/the-antibody-deception\/","title":{"rendered":"The Antibody Deception"},"content":{"rendered":"\n<p><a href=\"https:\/\/www.rosemaryfrei.ca\/the-antibody-deception\/\">Source<\/a><\/p>\n\n\n\n<p>By Rosemary Frei, MSc<br>March 2, 2021<\/p>\n\n\n\n<figure><iframe loading=\"lazy\" src=\"https:\/\/player.vimeo.com\/video\/518739949\" width=\"420\" height=\"280\" allowfullscreen=\"\"><\/iframe><\/figure>\n\n\n\n<p>The world has been fixated for months on novel-coronavirus PCR testing, contact tracing and vaccination.<\/p>\n\n\n\n<p>Meanwhile, another major part of the Covid biomedical complex has received far less attention: the use of antibodies for detecting, diagnosing and treating infection with the novel coronavirus.<\/p>\n\n\n\n<p><a href=\"http:\/\/www.antibodysociety.org\/covid-19-biologics-tracker\">Hundreds<\/a>&nbsp;of antibodies have been approved for these purposes since January 2020. And&nbsp;<a href=\"https:\/\/chineseantibody.org\/covid-19-track\/\">hundreds more<\/a>&nbsp;are poised to start being marketed soon.<\/p>\n\n\n\n<p>This is part of the biomedical gold rush: by last summer already, antibodies were on track to become the&nbsp;<a href=\"https:\/\/www.biospace.com\/article\/biologics-market-monoclonal-antibodies-to-emerge-as-most-lucrative-product-segment\/\">most lucrative<\/a>&nbsp;medical product, with global revenue projected to reach nearly half a trillion dollars by 2024. Profit margins in the range of&nbsp;<a href=\"https:\/\/maynardpaton.com\/2015\/05\/06\/bioventix-67-margins-from-monoclonal-antibodies\/\">67%&nbsp;<\/a>aren\u2019t uncommon.<\/p>\n\n\n\n<p><a href=\"https:\/\/www.biospace.com\/article\/biologics-market-monoclonal-antibodies-to-emerge-as-most-lucrative-product-segment\/\">Pharma giants<\/a>&nbsp;such as AstraZeneca, Novartis, GlaxoSmithKline and Eli Lilly are among the companies grabbing the largest chunks of the novel-coronavirus-antibody market. And some of the most muscular government agencies, including Anthony Fauci\u2019s US National Institute of Allergy and Infectious Diseases and the US\u2019s Defense Advanced Research Projects Agency, are part of the action (see, for example, the second-last section of this article, on antibodies used to treat Covid).<\/p>\n\n\n\n<p>Virtually every study and piece of marketing material related to Covid is premised on scientists having positively and correctly identified the presence of the novel coronavirus (also known as SARS-CoV-2) in the material they\u2019re working with.<\/p>\n\n\n\n<p>The job of that identification is usually given to antibodies that are said to bind to the novel coronavirus. The assumption is these antibodies are able to pick out the virus and only the virus from among every other organism and substance surrounding it.<\/p>\n\n\n\n<p><strong>U<\/strong><strong>nfortunately<\/strong><strong>&nbsp;<\/strong><strong>it turns out&nbsp;<\/strong><strong>that&nbsp;<\/strong><strong>the antibodies&nbsp;<\/strong><strong>rarely&nbsp;<\/strong><strong>(if ever)<\/strong><strong>&nbsp;do that<\/strong><strong>.&nbsp;<\/strong><strong>This is because&nbsp;<\/strong><strong>of<\/strong><strong>, among other things, inadequate<\/strong><strong>&nbsp;<\/strong><strong>verification of the antibodies\u2019 accuracy in targeting the virus by the companies that manufacture and sell them. And there\u2019s&nbsp;<\/strong><strong>even<\/strong><strong>&nbsp;less&nbsp;<\/strong><strong>verification&nbsp;<\/strong><strong>by government&nbsp;<\/strong><strong>regulators<\/strong><strong>.<\/strong><\/p>\n\n\n\n<p>Let\u2019s take a 30,000-foot tour of a couple of the main features of the antibody-industry landscape, which is awash in complexity and cash.<\/p>\n\n\n\n<p><strong><em>Can Antibodies be Created That Only Bind to One Type of Virus or Another?<\/em><\/strong><\/p>\n\n\n\n<p>Antibodies are tiny, finely-tuned, parts of our immune system. One of their main functions is to seek out viruses and bacteria that may have the potential to cause disease. Antibodies bind to and neutralize these microbes so they can\u2019t multiply and spread.<\/p>\n\n\n\n<p>Humans and our ancestors have been making antibodies in our bodies to fend off infections for millions of years. Then a few decades ago companies got involved in the discovery and manipulation of antibodies, partnering with university labs.<\/p>\n\n\n\n<p>There are two main categories of antibodies. One is \u2018<a href=\"https:\/\/www.news-medical.net\/whitepaper\/20200128\/The-Differences-Between-Monoclonal-and-Polyclonal-Antibodies.aspx\">polyclonal<\/a>\u2019 antibodies. These are garden-variety antibodies that bind to a variety of different substances and\/or organisms.<\/p>\n\n\n\n<p>The other is monoclonal antibodies. As the name implies, cloning is involved in their creation. First an antibody that is specific to a particular amino-acid sequence (amino acids are the building blocks of proteins) of interest \u2013 for example, one from a protein on the surface of a virus or bacterium \u2014 is identified. Then the immune-system cell which produced that antibody is \u2018cloned\u2019 in the lab. As a result, each set of monoclonal antibodies binds to that particular amino-acid sequence.<\/p>\n\n\n\n<p>I emailed one of the English-speaking world\u2019s leading authorities on monoclonal antibodies, Harvard Medical School professor Clifford Saper, to get clarity on this. I asked him if it\u2019s true that, as most in the antibody-commercializing arena claim, a monoclonal antibody can be created that\u2019s specific for (that is, binds to) just one type of virus or just one other type of organism.<\/p>\n\n\n\n<p>Saper replied [bolding and italics added by me for emphasis]: \u201c<strong>No, t<\/strong><strong>here is no such thing as a monoclonal antibody that, because it is monoclonal, recognizes only one protein or only one virus<\/strong>.&nbsp;<strong>It will bind to any protein having the same&nbsp;<\/strong><strong>(<\/strong><strong>or a very similar<\/strong><strong>)<\/strong><strong>&nbsp;sequence.\u201d<\/strong><\/p>\n\n\n\n<p><strong>The implication of Saper\u2019s statement is that any attempt to use a monoclonal antibody to verify the presence of the novel coronavirus will yield a large rate of false-positive results. That is, they will indicate that the novel coronavirus is detected when in fact it hasn\u2019t been. That\u2019s because there\u2019s a high probability that the monoclonal antibody is binding to something else besides the virus (this is known as \u2018cross-reacting\u2019).<\/strong><\/p>\n\n\n\n<p>(I recommend&nbsp;<a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC2605712\/\">this review paper<\/a>&nbsp;by Saper, and&nbsp;<a href=\"https:\/\/www.future-science.com\/doi\/10.2144\/btn-2020-0095\">this one<\/a>&nbsp;and&nbsp;<a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC3891910\/#R26\">this one<\/a>&nbsp;co-authored by Yale pathology professor David Rimm, to anyone wishing to learn about antibody validation.)<\/p>\n\n\n\n<p><strong>And in fact<\/strong><strong>, t<\/strong><strong>he vast majority of&nbsp;<\/strong><strong>antibodies and monoclonal&nbsp;<\/strong><strong>antibodies marketed as being specific for the novel coronavirus&nbsp;<\/strong><strong>were developed&nbsp;<\/strong><strong>years ago for<\/strong><strong>&nbsp;<\/strong><strong>detecting&nbsp;<\/strong><strong>SARS-CoV-1.&nbsp;<\/strong><strong>They were&nbsp;<\/strong><strong>then&nbsp;<\/strong><strong>simply<\/strong><strong>repurposed&nbsp;<\/strong><strong>f<\/strong><strong>or&nbsp;<\/strong><strong>identifying&nbsp;<\/strong><strong>SARS-CoV-2 \u2014 with&nbsp;<\/strong><strong>very few if any<\/strong><strong>&nbsp;checks&nbsp;<\/strong><strong>for&nbsp;<\/strong><strong>whether they also&nbsp;<\/strong><strong>cross-react to<\/strong><strong>&nbsp;other organisms or substances<\/strong>.<\/p>\n\n\n\n<p>I sought confirmation of this repurposing from&nbsp;<a href=\"https:\/\/www.zoominfo.com\/p\/Zhen-Lu\/2942786785\">Zhen Lu<\/a>.&nbsp;She\u2019s the North American marketing manager for&nbsp;<a href=\"https:\/\/www.sinobiological.com\/\">Sino Biological<\/a>, a Beijing-headquartered company that develops and sells, among other things, hundreds of antibodies. Lu replied to me via email, \u201cYes, antibodies are repuposed [sic].\u201d<\/p>\n\n\n\n<p>I also checked and received confirmation from&nbsp;<a href=\"https:\/\/blog.benchsci.com\/author\/pratiek-matkar-phd\">Pratiek Matkar<\/a>, a senior staffer from BenchSci, an antibody-database company. And to see for myself, I logged into the BenchSci database (Matkar granted me a guest account), selected all antibodies for the novel coronavirus, and looked to see which organisms had been used in cross-reactivity tests for them. SARS-CoV-1 was the only one that came up in this check.<\/p>\n\n\n\n<p>This all explains something I observed last week: Sino Biological had just changed the content of its home page for the section of their website on&nbsp;<a href=\"https:\/\/www.sinobiological.com\/research\/virus\/sars-cov-2-antibody\">antibodies against SARS-CoV-2<\/a>. The page now announces that they\u2019ve introduced new<strong>&nbsp;\u201cmatched antibody pairs\u201d<\/strong>&nbsp;that work better at finding the virus. The pair consists of a \u201c<strong>capture antibody<\/strong>\u201d and a \u201c<strong>detection antibody<\/strong>.\u201d<\/p>\n\n\n\n<p>And they claim these pairs are more accurate at finding the novel coronavirus: that they \u201chave high specificity without cross-reactivity with MERS-CoV, [or with the common human coronaviruses] 229E, NL63, HKU1, [and] OC43.\u201d<\/p>\n\n\n\n<p><strong>The only way I can interpret that is&nbsp;<\/strong><strong>they know the antibodies they\u2019ve been&nbsp;<\/strong><strong>marketing for months as<\/strong><strong>&nbsp;being&nbsp;<\/strong><strong>specific for&nbsp;<\/strong><strong>the novel coronavirus&nbsp;<\/strong><strong>bind to<\/strong><strong>&nbsp;other things,&nbsp;<\/strong><strong>such as&nbsp;<\/strong><strong><a href=\"https:\/\/www.cdc.gov\/coronavirus\/general-information.html\">common human coronaviruses<\/a>.<\/strong><\/p>\n\n\n\n<p><em><strong>How Are Antibodies Harnessed in Tests for the Novel Coronavirus?<\/strong><\/em><\/p>\n\n\n\n<p>One of the main types of tests for the virus contains antibodies that are ostensibly specific for the novel coronavirus. The way they\u2019re designed to work is that if the virus is present in a blood sample the antibodies bind to it and, as a result, the test gives a positive signal.<\/p>\n\n\n\n<p>The other type of test contains sequences of protein from the novel coronavirus; if antibodies to the virus are present in a blood sample, they bind to the protein sequences and produce a positive result.<\/p>\n\n\n\n<p>The manufacturers are supposed to conduct accuracy checks of their test kits before they put them on the market. These checks largely consist of estimation of the rates of false positives and false negatives (the latter is a negative result when the antibody or protein of interest is contained in the sample being tested by the kit).<\/p>\n\n\n\n<p>However, companies do this cursory accuracy check with only very few samples of a small number of viruses \u2014 and rarely on bacteria or any other of the millions of biological substances that can be present in the blood.<\/p>\n\n\n\n<p>Despite this very inadequate validation and the strong incentive for the companies to make their products look good,&nbsp;<strong>as documented last May by David Crowe,&nbsp;<\/strong><strong>the manufacturers often record a&nbsp;<a href=\"http:\/\/theinfectiousmyth.com\/coronavirus\/AntibodyTestingForCOVID.pdf\">significant rate of false po<\/a><\/strong><a href=\"http:\/\/theinfectiousmyth.com\/coronavirus\/AntibodyTestingForCOVID.pdf\"><strong>sitive<\/strong><\/a>s.&nbsp;<strong>The false positives are<\/strong><strong>&nbsp;<\/strong><strong>to<\/strong><strong>&nbsp;everything from West Nile virus to&nbsp;<\/strong><strong>various<\/strong><strong>&nbsp;types of human coronavirus<\/strong><strong>es.<\/strong><\/p>\n\n\n\n<p><strong>U<\/strong><strong>sually the companies and government<\/strong><strong>s<\/strong><strong>&nbsp;wave that off as insignificant. Occasionally though, the test kits are so bad&nbsp;<\/strong><strong>that&nbsp;<\/strong><strong>they\u2019re taken off the market.<\/strong><\/p>\n\n\n\n<p>For example, an antibody-testing kit sold by a company called&nbsp;<a href=\"https:\/\/chembiodiagnosticsinc.gcs-web.com\/news-releases\/news-release-details\/chembio-announces-launch-dpp-covid-19-serological-point-care\">Chembio&nbsp;<\/a><a href=\"https:\/\/chembiodiagnosticsinc.gcs-web.com\/news-releases\/news-release-details\/chembio-announces-launch-dpp-covid-19-serological-point-care\">Diagnostics&nbsp;<\/a><a href=\"https:\/\/chembiodiagnosticsinc.gcs-web.com\/news-releases\/news-release-details\/chembio-announces-launch-dpp-covid-19-serological-point-care\">was&nbsp;<\/a><a href=\"https:\/\/chembiodiagnosticsinc.gcs-web.com\/news-releases\/news-release-details\/chembio-announces-launch-dpp-covid-19-serological-point-care\">launched on March 31, 2020<\/a>. It was almost immediately granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA). An EUA allows companies to rush products onto the market with very minimal oversight.&nbsp;<a href=\"https:\/\/www.cnn.com\/business\/newsfeeds\/globenewswire\/7890831.html\">Brazil<\/a>&nbsp;and the&nbsp;<a href=\"https:\/\/www.globenewswire.com\/news-release\/2020\/05\/04\/2027033\/0\/en\/Chembio-Diagnostics-Attains-CE-Marking-for-DPP-COVID-19-System-for-IgG-and-IgM-Antibodies.html\">European Union<\/a>&nbsp;also gave the nod for the Chembio test to be sold in their jurisdictions in April and May 2020, respectively.<\/p>\n\n\n\n<p><strong>Then in June 2020 the FDA&nbsp;<\/strong><strong><a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-chembio-antibody-test\">pulled&nbsp;<\/a><a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-chembio-antibody-test\">it&nbsp;<\/a><a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-chembio-antibody-test\">off the market<\/a>.<\/strong><strong>&nbsp;<\/strong><strong>The<\/strong><strong>&nbsp;agency said \u201dthis test generates a higher than expected rate of false results.\u201d<\/strong>&nbsp;(Note that the top table on page 13 of the product insert for that \u201crevoked\u201d&nbsp;<a href=\"https:\/\/www.fda.gov\/media\/136963\/download\">Chembio test<\/a>&nbsp;indicates it cross-reacts to the human coronavirus 229E.)<\/p>\n\n\n\n<p><strong>But in<\/strong><strong><a href=\"https:\/\/chembio.com\/chembio-diagnostics-receives-anvisa-approval-for-dpp-sars-cov-2-antigen-test-system-in-brazil\/\">&nbsp;November&nbsp;<\/a><a href=\"https:\/\/chembio.com\/chembio-diagnostics-receives-anvisa-approval-for-dpp-sars-cov-2-antigen-test-system-in-brazil\/\">2020<\/a><\/strong><a href=\"https:\/\/chembio.com\/chembio-diagnostics-receives-anvisa-approval-for-dpp-sars-cov-2-antigen-test-system-in-brazil\/\"><strong>&nbsp;the Chembio antibody test again<\/strong><strong>&nbsp;was approved for use in<\/strong><\/a><strong><a href=\"https:\/\/chembio.com\/chembio-diagnostics-receives-anvisa-approval-for-dpp-sars-cov-2-antigen-test-system-in-brazil\/\">&nbsp;Brazil<\/a><\/strong><strong>. And on&nbsp;<\/strong><strong><a href=\"https:\/\/chembio.com\/chembio-diagnostics-announces-ce-mark-for-dpp-sars-cov-2-antigen-and-igm-igg-test-systems\/\">January&nbsp;<\/a><a href=\"https:\/\/chembio.com\/chembio-diagnostics-announces-ce-mark-for-dpp-sars-cov-2-antigen-and-igm-igg-test-systems\/\">14<\/a><a href=\"https:\/\/chembio.com\/chembio-diagnostics-announces-ce-mark-for-dpp-sars-cov-2-antigen-and-igm-igg-test-systems\/\">,&nbsp;<\/a><a href=\"https:\/\/chembio.com\/chembio-diagnostics-announces-ce-mark-for-dpp-sars-cov-2-antigen-and-igm-igg-test-systems\/\">2021, the test got the nod in the<\/a><a href=\"https:\/\/chembio.com\/chembio-diagnostics-announces-ce-mark-for-dpp-sars-cov-2-antigen-and-igm-igg-test-systems\/\">&nbsp;European Union, the UK and Ireland<\/a><\/strong><strong>.<\/strong><\/p>\n\n\n\n<p><strong>Is it&nbsp;<\/strong><strong>identical to&nbsp;<\/strong><strong>the rest that was&nbsp;<\/strong><strong>so inaccurate it was pulled off the market last June<\/strong><strong>? It\u2019s hard to tell.<\/strong>There is no product insert for it that I could find. In fact there\u2019s very little information about it on the&nbsp;<a href=\"https:\/\/chembio.com\/products\/dpp-sars-cov-2-igm-igg-system-europe\">webpage for the&nbsp;<\/a><a href=\"https:\/\/chembio.com\/products\/dpp-sars-cov-2-igm-igg-system-europe\">test<\/a>; you have to request the information. I submitted a request on Jan. 23 and haven\u2019t received it yet.<\/p>\n\n\n\n<p>Two of the heads of the FDA branch that approves testing devices penned a&nbsp;<a href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMp2033687\">February 1<\/a><a href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMp2033687\">8, 2021<\/a>,&nbsp;<em>New England Journal of Medicine<\/em>&nbsp;article. In it, the pair admitted that the FDA\u2019s EUAs allowed too-loose approvals for serology tests.<\/p>\n\n\n\n<p>They indicated the FDA has tightened its criteria for approval of these tests. They also point to efforts by other government agencies to evaluate serology tests.&nbsp;<strong>But&nbsp;<\/strong><strong>t<\/strong><strong>he&nbsp;<\/strong><strong>pair<\/strong><strong>&nbsp;don\u2019t say a word about&nbsp;<\/strong><strong>the need to move<\/strong><strong>&nbsp;toward objective, thorough test validation.&nbsp;<\/strong><strong>T<\/strong><strong>hey also are mute on the fact that&nbsp;<\/strong><strong>EUAs&nbsp;<\/strong><strong>are&nbsp;<\/strong><strong>s<\/strong><strong>till being issued<\/strong><strong>.<\/strong><\/p>\n\n\n\n<p>(Also note that the FDA and&nbsp;<a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/covid19-industry\/medical-devices\/testing\/serological\/notice-sensitivity-specificity-values.html\">Health Canada<\/a>&nbsp;listings of the 65 serology tests approved to date in the&nbsp;<a href=\"https:\/\/www.fda.gov\/medical-devices\/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices\/eua-authorized-serology-test-performance\">US<\/a>&nbsp;and 19 approved to date in&nbsp;<a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/covid19-industry\/medical-devices\/authorized\/list.html\">Canada<\/a>&nbsp;continue to give the sensitivity [correct identification of positive samples] of the tests by \u2018positive percent agreement\u2019 and specificity [correct identification of negative samples] by \u2018negative percent agreement.\u2019 These are relative measures of accuracy \u2013 that is, compared to other tests \u2013 rather than objective\/absolute accuracy, and therefore are poor facsimiles of accuracy.)<\/p>\n\n\n\n<p>One of the many major figures in the Covid-biomedical complex who are priming the pump of the antibody pipeline is&nbsp;<a href=\"https:\/\/www.pathology.columbia.edu\/profile\/w-i-lipkin-md\">Ian Lipkin<\/a>. He\u2019s director of the Center for Infection and Immunity at Columbia University in New York. Lipkin is involved at high levels in many global organizations including the World Health Organization and the Bill &amp; Melinda Gates Foundation, as well in pharmaceutical companies. (And he is quoted in a \u2018fact-check\u2019 of a July 2020 article I co-authored with Patrick Corbett titled, \u201c<a href=\"https:\/\/off-guardian.org\/2020\/07\/02\/no-one-has-died-from-the-coronavirus-president-of-the-bulgarian-pathology-association\/\">No one has died from the coronavirus<\/a>.\u201d Lipkin states, among other things, in the fact-check piece that \u201cConspiracy theorists are not persuaded by data.\u201d)<\/p>\n\n\n\n<p>Lipkin co-authored a&nbsp;<a href=\"https:\/\/www.nature.com\/articles\/s42003-021-01743-9.pdf\">Feb. 12, 2021<\/a>,&nbsp;paper in which he and his team claimed to have identified, using a new \u2018peptide-microarray\u2019 technology they invented, 29 amino-acid sequences unique to the novel coronavirus. They assert that antibodies specific to the sequences could be created \u2013 and that these in turn could be harnessed \u201cto facilitate diagnostics, epidemiology, and vaccinology\u201d for Covid. (The only conflict Lipkin and some of his co-authors disclose in the \u2018competing interests\u2019 paragraph at the end of article is that they invented the peptide-microarray technology described in the article.)<\/p>\n\n\n\n<p><em><strong>Do Antibodies Used to Treat Covid Fare Any Better?<\/strong><\/em><\/p>\n\n\n\n<p>Antibodies are also being marketed to treat Covid. Some are sold singly (known as \u2018monotherapy\u2019) and others in pairs. They are deemed to confer \u2018passive immunity.\u2019<\/p>\n\n\n\n<p>Among the most-reported-on set of antibodies for treating Covid is the Regeneron monoclonal antibodies casirivimab and imdevimab. This pair reportedly was used in&nbsp;<a href=\"https:\/\/www.washingtonpost.com\/health\/2020\/11\/21\/regeneron-fda-clearance\/\">October 2020<\/a>&nbsp;to treat then-U.S. President Donald Trump. The combo subsequently was granted an EUA by the FDA on&nbsp;<a href=\"https:\/\/www.fda.gov\/media\/143891\/download\">November 21, 2020<\/a>. It also is being considered for approval by&nbsp;<a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/covid19-industry\/drugs-vaccines-treatments\/authorization\/applications.html\">Health Canada<\/a>.<\/p>\n\n\n\n<p>I\u2019d like to focus on a somewhat lesser-known monoclonal antibody called&nbsp;<a href=\"https:\/\/www.covid19.lilly.com\/bamlanivimab\">bamlanivumab<\/a>. It\u2019s being used both singly and as one half of a pair for treatment of symptomatic Covid patients early in the course of their infection. The antibody was discovered, and&nbsp;<a href=\"https:\/\/www.niaid.nih.gov\/news-events\/nih-launches-clinical-trial-test-antibody-treatment-hospitalized-covid-19-patients\">clinical study<\/a>&nbsp;of it started, by the US National Institute of Allergy and Infectious Diseases (which is headed by&nbsp;<a href=\"https:\/\/www.niaid.nih.gov\/about\/director\">Anthony Fauci<\/a>) and a Vancouver, British Columbia-based company called&nbsp;<a href=\"https:\/\/www.abcellera.com\/\">AbCellera Diagnostics<\/a>. The antibody is being manufactured and sold by&nbsp;<a href=\"https:\/\/www.covid19.lilly.com\/bamlanivimab\">Eli Lilly<\/a>. It costs more than $1,200 a vial.<\/p>\n\n\n\n<p>AbCellera is developing a significant pipeline of other antibodies. Its capabilities for this were&nbsp;<a href=\"https:\/\/s26.q4cdn.com\/359178033\/files\/doc_news\/AbCellera-Discovered-Antibody-Bamlanivimab-Administered-with-Etesevimab-Receives-FDA-Emergency-Use-Authorization-for-COVID-19-2021.pdf\">developed over the past two-plus years as part of the Defense Advanced Research Projects Agency (DARPA) Pandemic Prevention Platform program.<\/a><\/p>\n\n\n\n<p>(AbCellera also has received hundreds of millions of dollars from the Canadian government, including for building an antibody-manufacturing plant. And&nbsp;<a href=\"https:\/\/www.businesswire.com\/news\/home\/20201119005352\/en\/Peter-Thiel-Joins-AbCellera%E2%80%99s-Board-of-Directors\">Peter Thiel<\/a>, who co-founded both PayPal and Palantir, is a board member. So is&nbsp;<a href=\"https:\/\/www.businesswire.com\/news\/home\/20201118006039\/en\/John-Montalbano-Joins-AbCellera%E2%80%99s-Board-of-Directors\">John Montalbano<\/a>, who\u2019s also on the board of the Canada Pension Plan Investment Board and until 2015 was CEO of RBC [Royal Bank of Canada] Global Asset Management. This and significant positive media coverage helped propel the company to the&nbsp;<a href=\"https:\/\/thelogic.co\/briefing\/abcellera-shares-soar-in-record-breaking-ipo\/\">biggest Canadian-biotech-company Initial Public Offering to date<\/a>, on Dec. 11, 2020.)<\/p>\n\n\n\n<p>Bamlanivumab was given an EUA by the FDA on&nbsp;<a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/coronavirus-covid-19-update-november-9-2020\">November 9, 2020<\/a>, for treatment of mild to moderate Covid. And Health Canada gave the monotherapy an interim authorization on&nbsp;<a href=\"https:\/\/www.reuters.com\/article\/us-health-coronavirus-canada-lilly\/eli-lilly-to-supply-26000-doses-of-covid-19-antibody-drug-to-canada-idINKBN2842XS\">November 17<\/a>. It\u2019s<strong>&nbsp;<\/strong><a href=\"https:\/\/www.theglobeandmail.com\/canada\/article-why-a-homegrown-coronavirus-wonder-drug-fell-flat\/\"><strong>not getting much traction<\/strong><\/a><strong>&nbsp;<\/strong><strong>in clinical practice so far i<\/strong><strong>n Canada<\/strong><strong>,&nbsp;<\/strong><strong>though,&nbsp;<\/strong><strong>perhaps because of the less-than-stellar results from clinical trials (see below).<\/strong><\/p>\n\n\n\n<p><strong>But this hasn\u2019t deterred<\/strong><strong>&nbsp;<\/strong><strong>the Canadian and US federal governments<\/strong>, which combined have purchased close to half a million of these tests. For example, most recently, on&nbsp;<a href=\"https:\/\/investor.lilly.com\/news-releases\/news-release-details\/lilly-announces-additional-doses-neutralizing-antibody-therapy\">February 26<\/a>, the US government bought 100,000 vials.<\/p>\n\n\n\n<p>The only study on bamlanivimab made public prior to the November 9 FDA approval was one posted<a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/33024963\/\">October 1, 2020<\/a>, on the website of the online-only journal&nbsp;<em>bioR<\/em><em>\u03c7<\/em><em>iv.&nbsp;<\/em>[My&nbsp;<a href=\"https:\/\/www.rosemaryfrei.ca\/laying-out-the-evidence\/\">Feb. 3, 2021<\/a>, and&nbsp;<a href=\"https:\/\/www.rosemaryfrei.ca\/the-modelling-paper-mafiosi\/\">Feb. 11, 2021<\/a>, articles \u2014 on the new variants and the associated modelling papers, respectively \u2013 noted that the journal and its sister publication&nbsp;<em>medR<\/em><em>\u03c7<\/em><em>iv<\/em>&nbsp;contain only non-peer-reviewed articles and were created by an organization headed by Mark Zuckerberg and his wife.]<\/p>\n\n\n\n<p>The study used rhesus monkeys and provided very extensive details about how the antibody was discovered and checked for specificity to the novel coronavirus. The researchers concluded that the antibody \u2013 at that time known as LY-CovV555 \u2014 has \u201cpotent neutralizing activity\u201d against SARS-CoV-2.<\/p>\n\n\n\n<p>On January 14 I emailed the lead author of that paper, Bryan Jones. He\u2019s a researcher in Lilly\u2019s Biotechnology Research Program. I asked Jones where in their paper is the proof the antibody is specific to SARS-CoV-2 (and therefore isn\u2019t binding to something else instead of, or in addition to, the novel coronavirus).<\/p>\n\n\n\n<p>He responded promptly, as follows [bolding added by me for emphasis]: \u201cWhile we did determine that LY-CoV555 is specific to SARS-CoV-2 (and doesn\u2019t bind to the spike protein of SARS-CoV),&nbsp;<strong>that is not specified or detailed in any of the figures or tables [in the paper]<\/strong>.\u201d<\/p>\n\n\n\n<p>Jones pointed me to several parts of the paper and supplemental material published with it that he said show,&nbsp;<strong>via<\/strong><strong>&nbsp;<\/strong><strong>indirect&nbsp;<\/strong><strong>extrapolation<\/strong>, that the antibody is specific for the novel coronavirus.<\/p>\n\n\n\n<p>That\u2019s not exactly convincing.<\/p>\n\n\n\n<p><strong>Then on&nbsp;<\/strong><strong><a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/33356051\/\">December&nbsp;<\/a><a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/33356051\/\">22<\/a><\/strong><strong>&nbsp;a study in the&nbsp;<\/strong><em><strong>New England Journal of Medicine<\/strong><\/em><strong>&nbsp;gave a thumbs-down to the usefulness of bamlanivimab in people hospitalized after receiving a&nbsp;<\/strong><strong>Covid&nbsp;<\/strong><strong>diagnosis.<\/strong>&nbsp;The paper noted that in late October the study was stopped because the antibody&nbsp;<a href=\"https:\/\/www.physiciansweekly.com\/covid-19-trial-of-ly-cov555-stopped-for-futility\/\">didn\u2019t help the patients<\/a>&nbsp;any more than did placebo.<\/p>\n\n\n\n<p><strong>But this didn\u2019t deter Lilly.<\/strong>&nbsp;On&nbsp;<a href=\"https:\/\/investor.lilly.com\/news-releases\/news-release-details\/lillys-neutralizing-antibody-bamlanivimab-ly-cov555-prevented\">January 21, 2021<\/a>, the company issued a news release about a study of bamlanivumab in residents and staff of nursing homes. They claimed their research showed that the antibody \u201csignificantly reduced the risk of contracting symptomatic COVID-19.\u201d<\/p>\n\n\n\n<p>However, they didn\u2019t back this up with much information. The study hasn\u2019t been published in a journal or presented at a scientific\/medical meeting. And there\u2019s no word on when it will be.<\/p>\n\n\n\n<p>Despite that, on the same morning the release was sent out by Lilly, glowing articles appeared in major media outlets stating that the study showed bamlanivumab appears to significantly reduce Covid symptoms in the frail elderly.<\/p>\n\n\n\n<p>For example a&nbsp;<a href=\"https:\/\/www.bloomberg.com\/news\/articles\/2021-01-21\/lilly-s-antibody-helps-prevent-covid-19-in-nursing-home-study?srnd=premium\">Bloomberg&nbsp;<\/a>article was posted at 8 a.m. on Jan. 21 with the headline, \u201cEli Lilly Antibody Cuts Covid-19 Risk Up to 80% in Nursing Home Study.\u201d The article was carried in many other media outlets such as the&nbsp;<em>Globe &amp; Mail<\/em>.<\/p>\n\n\n\n<p>The article quoted Lilly\u2019s Chief Scientific Officer Daniel Skovronsky as saying, \u201cThis is an urgent situation. Where there\u2019s an outbreak in nursing homes and people haven\u2019t yet received the vaccine, this could be a potential way to protect them before they get it.\u201d<\/p>\n\n\n\n<p>And January 21&nbsp;<a href=\"https:\/\/www.nytimes.com\/2021\/01\/21\/health\/coronavirus-eli-lilly.html\"><em>New York Times<\/em><\/a><a href=\"https:\/\/www.nytimes.com\/2021\/01\/21\/health\/coronavirus-eli-lilly.html\">&nbsp;piece b<\/a><a href=\"https:\/\/www.nytimes.com\/2021\/01\/21\/health\/coronavirus-eli-lilly.html\">y<\/a>&nbsp;<a href=\"https:\/\/www.nytimes.com\/2021\/01\/21\/health\/coronavirus-eli-lilly.html\">senior science journalist Gina Kolata<\/a>&nbsp;quotes a vaccine expert at Boston Children\u2019s Hospital, Ofer Levy, who wasn\u2019t one of the scientists involved in the study, as saying, \u201cI see only positives here. This is a win.\u201d<\/p>\n\n\n\n<p>Kolata also reported that&nbsp;<strong>Lilly plans to ask the FDA for an EUA for bamlanivimab for prevention of Covid in the frail elderly, focusing on those in nursing homes and long-term-care homes.<\/strong><\/p>\n\n\n\n<p><strong>In parallel,&nbsp;<\/strong><strong>Lilly is<\/strong><strong>&nbsp;<\/strong><strong>pivoting to using&nbsp;<\/strong><strong>bamlanivumab&nbsp;<\/strong><strong>in combination<\/strong><strong>&nbsp;<\/strong><strong>with&nbsp;<\/strong><strong>another&nbsp;<\/strong><strong>monoclonal&nbsp;<\/strong><strong>antibody called etesevimab<\/strong>. A study on this combination in people with mild or moderate Covid was published on&nbsp;<a href=\"https:\/\/jamanetwork.com\/journals\/jama\/fullarticle\/2775647?utm_campaign=articlePDF&amp;utm_medium=articlePDFlink&amp;utm_source=articlePDF&amp;utm_content=jama.2021.0585\">January 21, 2021<\/a>. The results indicate it doesn\u2019t reduce symptoms, but only lowers the viral load of people.<\/p>\n\n\n\n<p><strong>This didn\u2019t deter Lilly either; it\u2019s spinning this in the media as a very positive result. And so is the FDA:<\/strong><strong>&nbsp;<\/strong><strong>o<\/strong><strong>n&nbsp;<a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibody-treatment-covid-19\">February 9<\/a><\/strong><strong>&nbsp;the agency<\/strong><strong>&nbsp;issued an&nbsp;<\/strong><strong>EUA<\/strong><strong>&nbsp;for the combination of the two antibodies for treating mild or moderate COVID.<\/strong><\/p>\n\n\n\n<p>Then the next twist in the plot happened, on&nbsp;<a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/33619479\/\">February 16<\/a>: a paper published that day in&nbsp;<em>bioR<\/em><em>\u03c7<\/em><em>iv<\/em>&nbsp;indicated that bamlanivumab doesn\u2019t neutralize the South African and Brazilian variants of the novel coronavirus.<\/p>\n\n\n\n<p><em><strong>I\u2019ll Leave the Last Words to Scott Adams<\/strong><\/em><\/p>\n\n\n\n<p>Dilbert-cartoon creator Scott Adams makes this observation on page 13 of his book&nbsp;<a href=\"https:\/\/www.penguinrandomhouse.com\/books\/607083\/loserthink-by-scott-adams\/\"><em>Loserthink<\/em><\/a>: \u201cOne thing I can say with complete certainty is that it is a bad idea to trust the majority of experts in any domain in which both complexity and large amounts of money are involved.\u201d<\/p>\n\n\n\n<p>This perfectly describes the situation with antibodies for the novel coronavirus.<\/p>\n\n\n\n<p>Buyer beware, follow the money and stay tuned.<\/p>\n\n\n\n<p><em>After obtaining an MSc in molecular biology from the Faculty of Medicine at the University of Calgary, Rosemary Frei became a freelance writer. For the next 22 years she was a medical writer and journalist. She pivoted again in early 2016 to full-time, independent activism and investigative journalism. Her website is&nbsp;<\/em><strong><a href=\"https:\/\/www.rosemaryfrei.ca\/\">RosemaryFrei.ca<\/a><\/strong><em>.<\/em><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Source By Rosemary Frei, MScMarch 2, 2021 The world has been fixated for months on novel-coronavirus PCR testing, contact tracing and vaccination. Meanwhile, another major part of the Covid biomedical complex has received far less attention: the use of antibodies for detecting, diagnosing and treating infection with the novel coronavirus. Hundreds&nbsp;of antibodies have been approved [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[1109,1701,2350,2365,2363,2332,2353,2360,2366,2361,2338,350,2352,2168,2364,986,678,79,2356,2358,2351,2354,1403,2357,2362,2355,2367,2359],"class_list":["post-13791","post","type-post","status-publish","format-standard","hentry","category-general","tag-advertising","tag-antibodies","tag-astrazeneca","tag-bamlanivumab","tag-casirivimab","tag-coronaviruses","tag-eli-lilly","tag-emergency-use-authorization","tag-etesevimab","tag-eua","tag-false-positives","tag-fda","tag-glaxosmithkline","tag-government","tag-imdevimab","tag-immune-system","tag-immunity","tag-media","tag-money-trail","tag-monoclonal","tag-novartis","tag-novel","tag-pharma","tag-pharmaceutical","tag-regeneron","tag-regulation","tag-spin","tag-validation"],"_links":{"self":[{"href":"https:\/\/www.functionalps.com\/blog\/wp-json\/wp\/v2\/posts\/13791","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.functionalps.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.functionalps.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.functionalps.com\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.functionalps.com\/blog\/wp-json\/wp\/v2\/comments?post=13791"}],"version-history":[{"count":2,"href":"https:\/\/www.functionalps.com\/blog\/wp-json\/wp\/v2\/posts\/13791\/revisions"}],"predecessor-version":[{"id":13793,"href":"https:\/\/www.functionalps.com\/blog\/wp-json\/wp\/v2\/posts\/13791\/revisions\/13793"}],"wp:attachment":[{"href":"https:\/\/www.functionalps.com\/blog\/wp-json\/wp\/v2\/media?parent=13791"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.functionalps.com\/blog\/wp-json\/wp\/v2\/categories?post=13791"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.functionalps.com\/blog\/wp-json\/wp\/v2\/tags?post=13791"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}