The whistleblower is Brook Jackson, previously a regional director at a Texas-based contract research organisation called Ventavia, who supplied an account to An Interview With Ventavia and Pfizer-BioNTech COVID Vaccine Trial Whistleblower Brook Jackson 71 10 comments Sonia Elijah Author at Trial Site News | Investigative journalist and broadcaster Mar. In one example CIRCARE and the US consumer advocacy organisation Public Citizen, along with dozens of public health experts, filed a detailed complaint in July 2018 with the FDA about a clinical trial that failed to comply with regulations for the protection of human participants.4 Nine months later, in April 2019, an FDA investigator inspected the clinical site. Spotted something? Signed by District Judge Michael J. Truncale on 7/29/22. In an interview with The Defender, Jacksons lawyer said Pfizer argued the lawsuit, which was filed under the False Claims Act, should be dismissed because the U.S. government knew of the wrongdoings in the clinical trials but continued to do business with the vaccine maker. *** (kcv, ), NOTICE by Icon, PLC re 40 MOTION to Stay Motion to Stay Discovery and Memorandum in Support ; Notice of Joinder in Pfizer's Motion to Stay Discovery (Davis, Scott) (Entered: 05/18/2022), NOTICE of Attorney Appearance by Stacy Lee Brainin on behalf of Ventavia Research Group, LLC (Brainin, Stacy) (Entered: 05/19/2022), NOTICE of Attorney Appearance by Andrew Wade Guthrie on behalf of Ventavia Research Group, LLC (Guthrie, Andrew) (Entered: 05/19/2022), NOTICE of Attorney Appearance by Taryn McKenzie McDonald on behalf of Ventavia Research Group, LLC (McDonald, Taryn) (Entered: 05/19/2022), Submission of Proposed Agreed Docket Control/Scheduling order by Pfizer, Inc. . She then reported her Pfizer and Icon turned a blind eye to Ventavias misconduct, despite numerous warning signs. tweet Brooke Jackson, Pfizer. The next morning, 25 September 2020, Jackson called the FDA to warn about unsound practices in Pfizers clinical trial at Ventavia. stupidamerkin says: October 24, 2022 "One photo showed needles discarded in a plastic biohazard bag instead of a container box. Ventavia managed 3 of 153 sites at which the trial was carried out. (kcv, ) (Entered: 12/15/2022), Scheduling Order AND ~Util - Terminate Motions. A regional director who was employed at the research organization Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators and was slow to follow up on adverse events reported in Pfizers pivotal phase 3 trial. China News Service, November 3, reported that the British Medical Journal (BMJ) quoted Brooke Jackson, the former regional director of Ventavia Research in the United States, as saying that in the fall of 2020, Ventavia will conduct a trial for Pfizer's new crown vaccine in Texas. Signed by District Judge Michael J. Truncale on 12/15/22. For example. Ventavia takes research compliance, data integrity, and participant safety very seriously, and we stand behind our work supporting the development of life-saving vaccines. inaccurate stories, videos or images going viral on the internet. This includes oversight of Serious Adverse Event (SAE) reporting, which is required by the trial protocol and federal regulations. WebBrook Jackson, known as the COVID-19 Whistleblower, is under scrutiny over her allegations against her former employer, Ventavia Research Group (VRG), and Pfizer, Ventavia. https://leadstories.com/hoax-alert/2021/11/fact-check-british-medical-journal-did-not-reveal-disqualifying-and-ignored-reports-of-flaws-in-pfizer-vaccine-trial.html, Fact Check: Three States Did NOT Pull CNN'S Broadcasting License -- As A Cable Network, CNN Is 'Non-Broadcasting', Fact Check: This Video Of Argument Over Vaccination Status On A Plane Is NOT Real -- It's An Ad-Eligible Skit Film With Actors, Context Matters: Why Lead Stories Fact Checked The BMJ, Covid-19: Researcher blows the whistle on data integrity issues in Pfizer's vaccine trial, wrote that vaccination makes sense if a person is in a high-risk category, Verified signatory of the IFCN Code of Principles, Facebook Third-Party Fact-Checking Partner. However, at Ventavia, Jackson told The BMJ that drug assignment confirmation printouts were being left in participants charts, accessible to blinded personnel. (Additional attachment(s) added on 4/11/2022: # 3 Revised Proposed Order) (kcv, ). 4. *** (kcv, ), ORDER granting the Relator's 63 Motion to Exceed Page Limit. These same accusations were made a year ago, at which time Ventavia notified the appropriate parties. (Entered: 06/06/2022), MOTION to Dismiss 17 Relator's Amended Complaint by Icon, PLC. The BMJ reported patient safety and data integrity were likely compromised by the practices of Ventavia Research Group, a contractor that oversaw three of the 153 sites where Pfizer trials on 46,000 patients were conducted. (kcv, ) (Entered: 04/14/2022), NOTICE of Attorney Appearance by Jennifer Neiman Hinds on behalf of Icon, PLC (Hinds, Jennifer) (Entered: 04/15/2022), Joint MOTION Regarding Briefing Schedule by Pfizer, Inc. (Attachments: # 1 Text of Proposed Order Order Regarding Briefing Schedule)(Yeates, Tommy) Modified title on 4/18/2022 (kcv, ). 3. A regional director with Ventavia Research Group told The BMJ Pfizer falsified data, unblinded patients, employed inadequately trained vaccinators and was slow to follow up on adverse events reported in Pfizers pivotal COVID Vaccine phase 3 trial. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. WebBrook Jackson - Former employee of the Ventavia Research Group/ Whistleblower: Brook Jackson - Former.. News video on One News Page on Monday, 21 March 2022. Elsewhere on Twitter, the Brook Jackson account wrote that vaccination makes sense if a person is in a high-risk category and called a 5th Circuit Court of Appeals ruling against the Biden Administration's vaccine mandates "HUGE!". Like many, I had confidence and trust in a regulatory process and in the federal agencies in place to protect public health. (Entered: 06/07/2022), NOTICE of Hearing: Status Conference set for 6/9/2022 at 11:30 AM via TELEPHONE CONFERENCE (Beaumont) before District Judge Michael J. Truncale. Please confirm if an UNPLANNED CONTACT was made and update the corresponding form as appropriate. According to the trial protocol a telephone contact should have occurred to ascertain further details and determine whether a site visit is clinically indicated.. The regional director for Ventavia, Jackson was fired immediately after she reported her concerns to the US Food and Drug Administration. More Than a Decade Later, Workers Battle Illness From Deepwater Horizon. Reply. The BMJ investigation conducted by Paul Thacker reveals inside reports and evidence by Jackson about Pfizer allegedly 'manipulating clinical trials'. Pfizer, aiming for the title of first successful COVID-19 vaccine, pushed Ventavia to enroll as many patients as possible in the vaccine trial as quickly as possible. She then emailed a complaint to the US Food and Drug Ventavia spokeswoman Lauren Foreman said in a statement that the company is investigating the allegations made by Jackson. Jackson was a trained clinical trial auditor who previously held a director of operations position and came to Ventavia with more than 15 years experience in clinical research coordination and management. (Attachments: # 1 Declaration of Taryn M. McDonald, # 2 Exhibit 1, # 3 Exhibit 2, # 4 Exhibit 3, # 5 Exhibit 4, # 6 Exhibit 5, # 7 Exhibit 6, # 8 Exhibit 7, # 9 Exhibit 8, # 10 Text of Proposed Order)(Brainin, Stacy) Modified title and associated document on 6/8/2022 (kcv, ). Under National Institutes of Health standards, a "double-blind" clinical trial is one in which neither the patient nor the person giving the medicine knows if the patient is getting a placebo or the actual drug. Signed by District Judge Michael J. Truncale on 4/22/2022. A whistleblower by the name of Brook Jackson brought some damning facts about Pfizer's COVID vaccine trial in front of the world in her explosive report on Wednesday, November 3. In May this year the FDA sent the triallist a warning letter that substantiated many of the claims in the complaints. p. 1. Brook Jackson. PLEASE IGNORE. On its website Ventavia calls itself the largest privately owned clinical research company in Texas and lists many awards it has won for its contract work.2 But Jackson has told The BMJ that, during the two weeks she was employed at Ventavia in September 2020, she repeatedly informed her superiors of poor laboratory management, patient safety concerns, and data integrity issues. Jackson, Ventavia, 2020 mRNA COVID-19 Pfizer. You currently have alerts. As Ive said before, we are operating at the speed of science, Bourla wrote, explaining to the public when they could expect a Pfizer vaccine to be authorized in the U.S. This site requires JavaScript to run correctly. (Attachments: # 1 Text of Proposed Order Proposed Order Granting Motion and Setting Dates)(Mendenhall, Warner) (Entered: 07/29/2022), Motion for Extension of Time to File Response/Reply, ORDER granting the 60 Unopposed Motion to Amend BriefingSchedule and Other Deadlines. WebRetraction Letter - Brook Jackson Contributed by Paul Thacker . What I documented and reported to my former employer and to Pfizer during an internal audit was, On September 25, 2020, I spoke to an agent at the FDA, and within hours, I was fired. Her Twitter account, which was created in September 2021, includes recent posts about the BMJ report as well as others that support some elements of vaccine resistance. What I documented and reported to my former employer and to Pfizer during an internal audit was dangerous and violated Federal law. (bjc, ) (Entered: 08/12/2022), MOTION for Leave to File Excess Pages by United States of America ex rel. We conducted a thorough investigation into the issues raised in accordance with Pfizer's quality management process related to clinical research. All signed consent forms, excluding pro se parties, should be filed electronically using the event Notice Regarding Consent to Proceed Before Magistrate Judge cc via email: pltf's atty. Copyright 2023 BMJ Publishing Group Ltd, Covid-19: Researcher blows the whistle on data integrity issues in Pfizers vaccine trial, https://www.pfizer.com/news/hot-topics/an_open_letter_from_pfizer_chairman_and_ceo_albert_bourla, https://www.citizen.org/wp-content/uploads/2442.pdf, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jon-b-cole-md-611902-05052021, https://www.oig.hhs.gov/oei/reports/oei-01-06-00160.pdf, https://www.fda.gov/media/145858/download, https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19, Birmingham and Solihull Mental Health NHS Foundation Trust: Consultant Psychiatrist General Adult - Northcroft CMHT, Brent Area Medical Centre: Salaried GP - Brent Area Medical Centre, Onebright Ltd: Consultant Psychiatrist (Neurodiversity) - Remote / London, The Royal Hospital for Neurodisability: Clinical Fellow, Womens, childrens & adolescents health. But she said she was surprised that the agency failed to inspect Ventavia after an employee had filed a complaint. See who is sharing it (it might even be your friends) and leave the link in the comments. Liked. (Entered: 06/06/2022), REPLY to Response to Motion re 40 MOTION to Stay Motion to Stay Discovery and Memorandum in Support filed by Pfizer, Inc.. (Attachments: # 1 Affidavit)(Wessel, Carlton) (Entered: 06/07/2022), MOTION to Dismiss 17 Amended Complaint Corrected by Ventavia Research Group, LLC. The BMJ investigative report has now alleged that the documentation of the clinical trials that Pfizer submitted to the FDA is brimming with data reporting errors and clinical trial misconduct. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails Jackson has told The BMJ that, during the two weeks she was employed at Ventavia in September 2020, she repeatedly informed her superiors of poor laboratory management, patient safety concerns, and data integrity issues. Signed by District Judge Michael J. Truncale on 2/10/22. Theres just a complete lack of oversight of contract research organisations and independent clinical research facilities, says Jill Fisher, professor of social medicine at the University of North Carolina School of Medicine and author of Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials. Icon, PLC served on 3/16/2022, answer due 4/6/2022. They Want BP to Pay. Brook began her employment with Ventavia on September 8, 2020 as a Regional Director on the Phase 3 trial of the Pfizer Covid-19 vaccine, supervising two of Ventavia's three clinical trial sites. ( kcv, ), SUMMONS Returned Executed by United States of America ex rel. (kcv, ) (Entered: 10/20/2022), RESPONSE to 70 Response in Support of Motion filed by United States of America ex rel. But, for researchers who were testing Pfizers vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety. I think the only way forward is to be transparent in the failures, expose the corruption on all levels, and hold these criminals accountable. Signed by District Judge Michael J. Truncale on 8/12/2022. Update: In response to this fact check the BMJ published an open letter to Mark Zuckerberg. Ventavia fired her later the same day. NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. I dont know why theyre so afraid of them, she said. Internet Archive, Consent to Proceed Before Magistrate Judge. Targeting of Ventavia staff for reporting these types of problems. (bjc, ) (Entered: 04/25/2022), ***FILED IN ERROR per attorney. ", Pfizer also released a statement and said it was "disappointed by the recent article published by the British Medical Journal that failed to contact us prior to publication and selectively reported certain claims with the goal of undermining confidence in a vaccine that has been given to hundreds of millions of people worldwide.". Jackson was fired from her job the same day she filed a complaint with the FDA. To: Ventavia Research Group & Lauren Foreman Re: Libel of Brook Jackson Demand: Retraction (kcv, ) (Entered: 07/29/2022), Order on Motion for Extension of Time to File Response/Reply, ORDER denying as moot 50 Motion to Dismiss. (Entered: 04/08/2022), Motion for Extension of Time to File Answer, CORPORATE DISCLOSURE STATEMENT filed by Icon, PLC (Davis, Scott) (Entered: 04/11/2022), NOTICE of Attorney Appearance - Pro Hac Vice by Elai Katz on behalf of Icon, PLC. In several cases Ventavia lacked enough employees to swab all trial participants who reported covid-like symptoms, to test for infection. Since September 2020, I have worked around the clock, focused solely on compiling evidence for my legal team and to bring awareness to injuries and harms caused by the mRNA COVID-19 products. The BMJ article says a former Ventavia worker named Brook Jackson told The BMJ that Ventavia falsified data, "unblinded" patients and employed inadequately trained vaccinators. Of the claims in the federal agencies in place to protect public health of Serious Adverse Event ( SAE reporting! By Jackson about Pfizer allegedly 'manipulating clinical trials ' 2022 `` One photo showed needles discarded in plastic. 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