{"id":1767454,"date":"2022-12-08T07:48:21","date_gmt":"2022-12-08T12:48:21","guid":{"rendered":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/?p=1767454"},"modified":"2022-12-08T10:18:31","modified_gmt":"2022-12-08T15:18:31","slug":"fda-turned-a-blind-eye-to-submission-of-fraudulent-data-on-covid-vaccine-says-former-criminal-investigator","status":"publish","type":"post","link":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/fda-turned-a-blind-eye-to-submission-of-fraudulent-data-on-covid-vaccine-says-former-criminal-investigator\/","title":{"rendered":"FDA \u201cTurned a Blind Eye\u201d to \u201cSubmission of Fraudulent Data\u201d on COVID Vaccine, Says Former Criminal Investigator"},"content":{"rendered":"<aside class=\"mashsb-container mashsb-main mashsb-stretched\"><div class=\"mashsb-box\"><div class=\"mashsb-count mash-medium\" style=\"&quot;\"><div class=\"counts mashsbcount\">34<\/div><span class=\"mashsb-sharetext\">SHARES<\/span><\/div><div class=\"mashsb-buttons\"><a class=\"mashicon-facebook mash-medium mash-nomargin mashsb-noshadow\" href=\"https:\/\/www.facebook.com\/sharer.php?u=https%3A%2F%2Fwww.conservativenewsdaily.net%2Fbreaking-news%2Ffda-turned-a-blind-eye-to-submission-of-fraudulent-data-on-covid-vaccine-says-former-criminal-investigator%2F\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Facebook<\/span><\/a><a class=\"mashicon-twitter mash-medium mash-nomargin mashsb-noshadow\" href=\"https:\/\/twitter.com\/intent\/tweet?text=&amp;url=https:\/\/www.conservativenewsdaily.net\/breaking-news\/?p=1767454&amp;via=ConservNewsDly\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Twitter<\/span><\/a><a class=\"mashicon-subscribe mash-medium mash-nomargin mashsb-noshadow\" href=\"#\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Subscribe<\/span><\/a><div class=\"onoffswitch2 mash-medium mashsb-noshadow\" style=\"display:none\"><\/div><\/div>\n            <\/div>\n                <div style=\"clear:both\"><\/div><\/aside>\n            <!-- Share buttons by mashshare.net - Version: 4.0.47--><p><span>On Nov. 2, 2021,\u00a0<\/span><a href=\"https:\/\/www.bmj.com\/content\/375\/bmj.n2635\"><i><span>The BMJ<\/span><\/i><\/a><span>\u00a0broke the story of Brook Jackson, the regional director who blew the whistle on data integrity issues in Pfizer\u2019s pivotal COVID-19 vaccine trial. Weeks later, documents were\u00a0<\/span><a href=\"https:\/\/maryannedemasi.substack.com\/p\/fresh-doubts-over-data-integrity-in-pfizer-mrna-trial\"><span>leaked<\/span><\/a><span>\u00a0supporting Jackson\u2019s complaint about \u201cfalsified data.\u201d<\/span><\/p>\n<p><span>Among the leaked documents was an email, authored by a former federal agent in the <a href=\"https:\/\/www.theepochtimes.com\/t-fda\">FDA<\/a>\u2019s Office of Criminal Investigations (OCI), claiming Pfizer knowingly submitted fraudulent data to the FDA, and the agency responded by turning a blind eye.\u00a0\u00a0<\/span><\/p>\n<p><span>To grasp the gravity of what is written in the email, it\u2019s important to understand the role of OCI.<\/span><\/p>\n<h2><b>What Is OCI?<\/b><\/h2>\n<p><span>OCI is the FDA\u2019s criminal law enforcement arm.\u00a0Much like a police force, it\u00a0<\/span><a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/criminal-investigations\/about-oci#intro\"><span>conducts<\/span><\/a><span>\u00a0criminal investigations of illegal activities involving FDA-regulated products and brings them before the Department of Justice for prosecution.<\/span><\/p>\n<p><span>OCI consists of about 200 federal agents, hired from the US Secret Service, the FBI, or the Internal Revenue Service Criminal investigations unit. The agents are stationed throughout the US, as well as attach\u00e9s in overseas posts, and have the same type of arrest authority as other federal law enforcement agents.<\/span><\/p>\n<p><span>The unit was established by former\u00a0<\/span><a href=\"https:\/\/www.fda.gov\/about-fda\/fda-leadership-1907-today\/david-kessler\"><span>FDA Commissioner David Kessler<\/span><\/a><span>, off the back of the\u00a0<\/span><a href=\"https:\/\/pink.pharmaintelligence.informa.com\/PS015928\/GENERIC-DRUG-PROBE-INCLUDES-TWO-MORE-FDAers-BEING-INVESTIGATED-BY-US-ATTORNEY-AGENCY-CHEMIST-KLETCH-CHARGED-COM-YOUNG-CONDUCTING-INTERNAL-AUDIT\"><span>generic drug scandal<\/span><\/a><span>\u00a0in the late 80s. Kessler was determined to crack down on fraud after FDA employees were found guilty of accepting bribes from generic drug makers.<\/span><\/p>\n<p><span>\u201cWhat I care about most is restoring the credibility and the integrity of the Food and Drug Administration,\u201d\u00a0<\/span><a href=\"https:\/\/www.nytimes.com\/1991\/06\/30\/magazine\/a-shot-in-the-arm-for-the-fda.html\"><span>said<\/span><\/a><span>\u00a0Kessler at the time,\u201d and the only way to do that is to focus on strong enforcement. We are going to enforce the law.\u201d\u00a0<\/span><\/p>\n<p><span>Since then, many OCI investigations have\u00a0<\/span><a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/criminal-investigations\"><span>led to<\/span><\/a><span>\u00a0arrests, hefty fines, and imprisonment such as the\u00a0<\/span><a href=\"https:\/\/www.justice.gov\/opa\/pr\/two-florida-medical-study-coordinators-sentenced-connection-scheme-falsify-clinical-trial\"><span>recent<\/span><\/a><span>\u00a0sentencing of two clinical trial researchers in Florida for conspiracy to falsify data by making it appear as though subjects were participating in the trials when, in truth, they were not.<\/span><\/p>\n<h2><b>The Leaked Email<\/b><\/h2>\n<p><span>The email, dated March 26, 2021, obtained by this reporter details the OCI officer\u2019s observations about the FDA\u2019s handling of Jackson\u2019s complaint.\u00a0<\/span><\/p>\n<p><span>\u201cHaving worked at FDA, I see it as surprising, for many reasons, that the agency turned a blind eye to a company\u2019s knowing submission of fraudulent data,\u201d wrote the OCI officer, whose identity is suppressed after signing a non-disclosure agreement.<\/span><\/p>\n<p><span>The FDA \u201clikely feared the criticism they undoubtedly would have received for holding up a vaccine (which they knew they would eventually approve anyway) at the expense of untold lives lost,\u201d added the OCI officer, acknowledging the FDA\u2019s dilemma in \u201cweighing the risk\/benefit ratio.\u201d\u00a0<\/span><\/p>\n<p><span>According to the email, the FDA had to decide if it served the public better to just approve a vaccine that had much greater efficacy than expected amid the emergency, or make a public issue of Pfizer\u2019s data integrity problems and damage public confidence in the vaccine.<\/span><\/p>\n<p><span>Notably, at the time, AstraZeneca had egg on its face after it released data from an \u201cinterim analysis\u201d of its rival adenovirus vector COVID-19 vaccine, claiming 79 percent efficacy.\u00a0<\/span><\/p>\n<p><span>The trial\u2019s own Data and Safety Monitoring Board\u00a0<\/span><a href=\"https:\/\/www.washingtonpost.com\/world\/astrazeneca-oxford-vaccine-concerns\/2021\/03\/23\/2f931d34-8bc3-11eb-a33e-da28941cb9ac_story.html\"><span>called out<\/span><\/a><span>\u00a0AstraZeneca for deliberately releasing \u201coutdated\u00a0and potentially misleading\u00a0data\u201d and overstating the effectiveness of its vaccine, forcing AstraZeneca to post updated (and less impressive) results.<\/span><\/p>\n<p><span>Reflecting on AstraZeneca\u2019s actions at the time, the OCI officer still thought it was \u201ca far cry\u201d from the company \u201cknowingly submitting false data\u201d but remained concerned that this type of deception would only sow public doubt.<\/span><\/p>\n<p><span>\u201cThe general public must be able to trust that the clinical results are valid to sell, approve or take medication,\u201d wrote the OCI officer, quoting a Wall Street Journal <\/span><a href=\"https:\/\/www.wsj.com\/articles\/fallout-from-astrazeneca-data-snafu-could-be-bigger-than-it-seems-11616511451?mod=Searchresults_pos3&#038;page=1\"><span>article<\/span><\/a><span> on the AstraZeneca event, adding that it was likely the vaccines were \u201cstill extremely likely to be safe and effective.\u201d<\/span><\/p>\n<p><span>\u201cMy point here is that instead of the regulators protecting the public, in our case, they were complicit in a fraud. At the time, they may have been doing what they believed to be the right thing under extraordinary circumstances. But now they may soon have some explaining to do,\u201d added the OCI officer, who did not respond to requests for an interview.<\/span><\/p>\n<h2><b>Response to Leaked Email?<\/b><\/h2>\n<p><span>This reporter reached out to the FDA for comment on claims that it turned a blind eye to fraudulent data, and what, if anything, had been investigated by OCI regarding Jackson\u2019s complaint. The agency said, \u201cThe FDA does not comment on possible criminal investigations as a general policy.\u201d<\/span><\/p>\n<p><span>The FDA has consistently underplayed Jackson\u2019s complaint. It has not made a public statement except to say that it had \u201cfull confidence in the data that were used to support the Pfizer-BioNTech COVID-19 Vaccine authorization and the Comirnaty approval.\u201d<\/span><\/p>\n<p><span>Those defending the FDA believe that even if there were data integrity issues at the three trial sites at the center of Jackson\u2019s complaint, it would be unlikely to impact Pfizer\u2019s\u00a0overall\u00a0trial results.\u00a0<\/span><\/p>\n<p><span>To be sure, I asked the FDA if it had performed a \u201csensitivity analysis\u201d to determine if excluding data from the three trial sites would impact the overall trial results, but the agency would not comment.<\/span><\/p>\n<p><span>In response to the leaked email, Pfizer made a statement which is published below in full.<\/span><\/p>\n<h3>Pfizer\u2019s Nov. 30 Statement<\/h3>\n<blockquote>\n<p>\u201cPfizer received communication from an anonymous complainant in September 2020 relating to a single clinical investigator site in Texas, USA. We conducted a thorough investigation into the issues raised in accordance with Pfizer\u2019s quality management process related to clinical research. Actions were taken to correct and remediate where necessary. Pfizer\u2019s investigation did not identify any issues or concerns that would invalidate the data or jeopardize the integrity of the study.<\/p>\n<p>The company proactively notified the US Food and Drug Administration of the matter and informed the Institutional Review Board for the study.<\/p>\n<p>The Pfizer-BioNTech BNT162b vaccine was subsequently approved by the FDA, EMA and other regulatory authorities based on the robust data submitted from the clinical program. The vaccine has been given to hundreds of millions of people worldwide following approval. Pfizer has a robust quality management system in place for all aspects of our clinical trials, as they are the foundation of our commitment to patient safety and the integrity of our trials. We take all concerns raised very seriously and thoroughly investigate them, and when necessary taking swift action to address challenges or issues.\u201d<\/p>\n<\/blockquote>\n<div class=\"author_wrapper\">\n<div class=\"one_author_block round\">\n<div class=\"top_row\">\n\t\t\t\t\t<a href=\"https:\/\/www.theepochtimes.com\/author-maryanne-demasi\"><img decoding=\"async\" src=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-content\/uploads\/2022\/12\/WEB_MaryanneDemasi.jpg\" alt=\"Maryanne Demasi\" \/><\/a><\/p>\n<p>Follow<\/p>\n<\/div>\n<p>Maryanne Demasi is an investigative medical reporter with a PhD in rheumatology, who writes for online media and top tiered medical journals. For over a decade, she produced TV documentaries for the Australian Broadcasting Corporation (ABC) and has worked as a speechwriter and political advisor for the South Australian Science Minister. Her work can be accessed on: https:\/\/maryannedemasi.substack.com<\/p>\n<\/p><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>On Nov. 2, 2021,\u00a0The BMJ\u00a0broke the story of Brook Jackson, the regional director who blew the whistle on data integrity issues in Pfizer\u2019s pivotal COVID-19 vaccine trial. Weeks later, documents<\/p>\n","protected":false},"author":1,"featured_media":1767457,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_mo_disable_npp":"","fifu_image_url":"https:\/\/cndimages.nyc3.digitaloceanspaces.com\/breaking-news\/wp-content\/uploads\/2021\/01\/IMG_2758-scaled-1.jpg","fifu_image_alt":"","footnotes":""},"categories":[547],"tags":[],"class_list":["post-1767454","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-the-bongino-report"],"fifu_image_url":"https:\/\/cndimages.nyc3.digitaloceanspaces.com\/breaking-news\/wp-content\/uploads\/2021\/01\/IMG_2758-scaled-1.jpg","_links":{"self":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/1767454","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/comments?post=1767454"}],"version-history":[{"count":0,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/1767454\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media\/1767457"}],"wp:attachment":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media?parent=1767454"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/categories?post=1767454"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/tags?post=1767454"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}