Newly released documents support whistleblower Brook Jacksons claims she was directly involved in Pfizers COVID vaccine phase 3 clinical trials, but Pfizer contractor, Ventavia Research Group, and media refuse to retract statements to the contrary. In addition to the emails to Alfaro and Livingston, Jackson released: Thacker said his Nov. 2 article was picked up by more than 91 media organizations, and Jackson asked for corrections from many of those media organizations that stated she wasnt involved in the trials. (Linken, Peter) (Entered: 04/12/2022), NOTICE of Attorney Appearance - Pro Hac Vice by Tammy Roy on behalf of Icon, PLC. On September 8, 2020, I accepted a new position as Regional Director with a company named Ventavia Research Group. Ventavia fired her later the same day. A former Ventavia employee told The BMJ that the company was nervous and expecting a federal audit of its Pfizer vaccine trial. (Mendenhall, Warner) (Entered: 08/22/2022), ***FILED IN ERROR. Learn more about Mailchimp's privacy practices here. 376 Qui Tam (31 U.S.C. Docket for United States of America ex rel. document.getElementById( "ak_js_4" ).setAttribute( "value", ( new Date() ).getTime() ); Children's Health Defense is a 501(c)(3) non-profit organization. . After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). 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. Pfizer delegated management of the clinical trial to subcontractor Defendant Icon PLC (Icon), an Irish clinical research organization. Brook Jackson. In early 2020, when the Government declared COVID-19 a pandemic, I was working as the Director of Operations for a multi-state Site Management Organization. Filing fee $ 100, receipt number 0540-8872723. Jackson has contacted media organizations that have published these false allegations, sharing documentation that shows her work on the trial, and asking for corrections.. In a November 10, 2021, email to Lead Stories, Pfizer senior manager for science media relations, Kit Longley, detailed Pfizer's response to the claims: Pfizer received communication from an anonymous complainant in September 2020 relating to a single clinical investigator site in Texas, USA. Such an analysis would give added confidence in the Phase III results. 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. Back in September 2020, Brook was hired to work as a Regional Director at two out of three clinical trial sites in Texas for Pfizers Phase III mRNA vaccine. RFK, Jr. & Robert DeNiro Press Conference, Subscribe to The Defender's Top News of the Day, DOE Finds COVID Likely Emerged From Wuhan Lab, Sparks Congressional Investigation, CDC Advisers Tout RSV Vaccines as FDA Admits Shots Linked to Rare Immune Disorder in Older Adults, EPA Still Hasnt Studied How Pesticides Disrupt Human Hormones 27 Years After Congress Demanded It. 7. (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 related document on 6/7/2022 (kcv, ). I dont know why theyre so afraid of them, she said. ( kcv, ), SUMMONS Returned Executed by United States of America ex rel. Signed by District Judge Michael J. Truncale on 8/23/22. EIN #26-0388604, 2016 - 2023 Children's Health Defense All Rights Reserved. Ventavia ultimately enrolled about 1,500 clinical trial patients. Signed by District Judge Michael J. Truncale on 6/9/22. To read the piece in its entirety,click here. In a text message sent in June the former official apologised, saying that everything that you complained about was spot on.. Actions were taken to correct and remediate where necessary. (Anderson, Lexis) (Entered: 03/01/2022), SUMMONS Returned Executed by United States of America ex rel. Here is the CBER report I filed on 25Sep2020. Final Pretrial Conference reset for 7/1/2024 at 09:00 AM in Ctrm 2 (Beaumont) before District Judge Michael J. Truncale. Journalist Article Quality journalism costs money to produce. More Than a Decade Later, Workers Battle Illness From Deepwater Horizon. Jackson spent two weeks in September 2020 as a regional manager overseeing vaccine trials Pfizer contracted Ventavia Research Group to perform. CourtListener is sponsored by the non-profit Free Law Project. According to Jackson's reports, Texas Contractor, Ventavia Research Group held unblinding phase III vaccine trial, leading to the vaccine's approval and deployment of insufficiently or not at all trained vaccinators. (Entered: 05/17/2022), NOTICE by Ventavia Research Group, LLC re 41 MOTION to Stay re 40 MOTION to Stay Motion to Stay Discovery and Memorandum in Support and Notice of Joinder in Pfizers Motion to Stay Discovery, 40 MOTION to Stay Motion to Stay Discovery and Memorandum in Support - Notice of Joinder in Pfizer and Icon's Motions to Stay Discovery (Brainin, Stacy) (Entered: 05/17/2022), STATUS REPORT Joint Report of Attorney Conference by Pfizer, Inc.. (Attachments: # 1 Exhibit A - Proposed Scheduling Order, # 2 Exhibit B, # 3 Exhibit C)(Wessel, Carlton) Modified Exhibit description on 5/18/2022 (kcv, ). Michigan Student Killed by 14-Year-Old and 13-Year-Old Boys in Attempted Carjacking After Offering Them Ride to Home. Counsel has been notified to refile documents. More Than a Decade Later, Workers Battle Illness From Deepwater Horizon. She added that during her time at Ventavia the company expected a federal audit but that this never came. We also published an article titled "Context Matters: Why Lead Stories Fact Checked The BMJ" to further clarify the reasons for the fact check after the BMJ published another article claiming this was an case where "fact checking goes wrong". 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. (Court Reporter None.) A few days later Jackson received a call from an FDA inspector to discuss her report but was told that no further information could be provided. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. 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. One of them was one of the officials who had taken part in the late September meeting. document.getElementById( "ak_js_3" ).setAttribute( "value", ( new Date() ).getTime() ); Sign up for free news and updates from Robert F. Kennedy, Jr. and Childrens Health Defense. Ventavia is not owned by Pfizer. Our content exposes the corporations, elected officials, government agencies and individuals who put profits before people and planet. These protections become moot when fraud is proven, which is why whistleblower, Brooke Jacksons lawsuit against Pfizer is so important. As interpreted by the Supreme Court, if the government continued paying a contractor despite the contractors fraudulent activity, the fraud was not considered material to the contract. In an article in MedPage, vaccine experts said the claims are not serious enough to jeopardize Pfizer's data. WebBrook Jackson, known as the COVID-19 Whistleblower, is under scrutiny over her allegations against her former employer, Ventavia Research Group (VRG), and Pfizer, By clicking below to subscribe, you acknowledge that your information will be transferred to Mailchimp for processing. A clinical trial delegation log listing Jackson as a participant. They choose rather, to protect and serve the interests of powerful corporations and ignore the vaccine injuries and deaths. (Entered: 08/22/2022), ***FILED IN ERROR. (Attachments: # 1 Proposed Order)(Davis, Scott) Modified on 5/18/2022 (kcv, ). 30 Days Granted for Deadline Extension. (Mendenhall, Warner) (Additional attachment(s) added on 10/12/2022: # 1 Text of Proposed Order) (kcv, ). Lauren Foreman, director of business development & communications, wrote: The accuser was employed for approximately two weeks in September 2020, and no part of her job responsibilities concerned the clinical trials at issue. Foreman noted that Jackson was employed "for approximately 2 weeks in September 2020, and no part of her job responsibilities concerned the clinical trials at issue. A regional director who was employed at the research organization Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, The company proactively notified the US Food and Drug Administration of the matter and informed the Institutional Review Board for the study. (Entered: 05/17/2022), ***FILED IN ERROR. According to the trials design, unblinded staff were responsible for preparing and administering the study drug (Pfizers vaccine or a placebo). Once installed, anything you buy on PACER gets automatically added to the RECAP Archive and anything another RECAP user has bought is automatically free to you. WebRetraction Letter - Brook Jackson Contributed by Paul Thacker . If you are not a monthly donor, we allow five alerts and give a bonus of 10 alerts to anybody with the RECAP Extension installed. Your support is essential to CHDs successful mission. know it, an executive stated. To: Ventavia Research Group & Lauren Foreman Re: Libel of Brook Jackson Demand: Retraction Date: November 11, 2021 Delivery: Personal Service I write on behalf of Brook Jackson, my client, to demand an immediate retraction and public correction of a false statement made by 3729(a)), Jury Demand: From Free Law Project, a 501(c)(3) non-profit. Brook Jackson knew things were wrong immediately after being hired in late 2020 by Ventavia Research Group. Learn more about the alliance here. (kcv, ), MOTION of Election to Decline Intervention by SEALED Movant. She then reported her concerns in an email to the agency. Ventavia spokeswoman Lauren Foreman said in a statement that the company is investigating the allegations made by Jackson. May 2021. A second employee also described an environment at Ventavia unlike any she had experienced in her 20 years doing research. According to Jackson, Ventavia "falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer's pivotal phase III trial. Signed by District Judge Michael J. Truncale on 12/15/22. Lead Stories is a U.S. based fact checking website that is always looking for the latest false, misleading, deceptive or (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. Brook Jackson whistleblower lawsuit allegations against Ventavia Pfizer and Icon, Defendants admit fraud by filing that fraud is not material to the contract. Signed by District Judge Michael J. Truncale on 6/9/22. We do not capture any email address. by the Supreme Court, if the government continued paying a contractor despite the contractors fraudulent activity, the fraud was not considered material to the contract. Brook Jackson. Competing interests: PDT has been doubly vaccinated with Pfizers vaccine. (kcv, ) (Entered: 08/23/2022), Order on Motion for Leave to File Excess Pages, REPLY to Response to Motion re 37 MOTION to Dismiss Relator's Amended Complaint and Memorandum of Law in Support filed by Pfizer, Inc.. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D)(Wessel, Carlton) (Entered: 09/20/2022), REPLY to Response to Motion re 53 MOTION to Dismiss -- Corrected filed by Ventavia Research Group, LLC. She said she is fully vaccinated and is not an anti-vaccine activist. Doesn't Recall Speaking With Mayor. (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. Researcher Blows Whistle on Data Integrity Issues in Pfizers Vaccine Trial. Signed by District Judge Michael J. Truncale on 4/22/2022. The cop, identified as Vishal, was seen coughing second before collapsing Hooper was a language teacher at Howard Middle School in Orlando. PLEASE IGNORE. Two former Ventavia employees spoke to The BMJ anonymously for fear of reprisal and loss of job prospects in the tightly knit research community. Several documents show that Jackson worked on Pfizers clinical trial, Thacker wrote on Nov. 30. In September 2020 she was hired by Ventavia as a Regional Director for clinical trial sites The next morning, 25 September 2020, Jackson called the FDA to warn about unsound practices in Pfizers clinical trial at Ventavia. Signed by District Judge Michael J. Truncale on 8/12/2022. Paul D Thacker reports, In autumn 2020 Pfizers chairman and chief executive, Albert Bourla, released an open letter to the billions of people around the world who were investing their hopes in a safe and effective covid-19 vaccine to end the pandemic. At several points during the late September meeting Jackson and the Ventavia executives discussed the possibility of the FDA showing up for an inspection (box 1). The whistleblower is Brook Jackson, previously a regional director at a Texas-based contract research organisation called Ventavia, who supplied an account to (Entered: 01/18/2022), ORDER on the Government's 13 Notice of Election to Decline Intervention. ICON reminded Ventavia in a September 2020 email: The expectation for this study is that all queries are addressed within 24hrs. ICON then highlighted over 100 outstanding queries older than three days in yellow. 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. Citizens for Responsible Care and Research Incorporated (CIRCARE). 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. In Pfizers briefing document submitted to an FDA advisory committee meeting held on 10 December 2020 to discuss Pfizers application for emergency use authorisation of its covid-19 vaccine, the company made no mention of problems at the Ventavia site. In a list of action items circulated among Ventavia leaders in early August 2020, shortly after the trial began and before Jacksons hiring, a Ventavia executive identified three site staff members with whom to Go over e-diary issue/falsifying data, etc. One of them was verbally counseled for changing data and not noting late entry, a note indicates. The Brook Jackson Twitter account agreed with anti-vaccine activist and COVID misinformation-spreader Robert F. Kennedy, Jr.'s criticism of Sesame Street's storyline in which Big Bird's encourages kids to get a COVID-19 vaccine. We can sometimes provide need-based exceptions to these rules. 107. 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. Signed by District Judge Michael J. Truncale on 7/29/22. However, in statements to other media outlets, Ventavia has claimed that its former employee Jackson did not work on Pfizers COVID-19 vaccine clinical trial. However, a 2016 U.S. Supreme Court decision that expanded the scope of a legal principle known as materiality resulted in a series of federal court decisions in which fraud cases brought under the False Claims Act were dismissed. (Additional attachment(s) added on 4/11/2022: # 2 Text of Proposed Order) (kcv, ). Liked. 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