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. 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. Document # 21, Defendant's Unopposed First Application for Extension of Time to Answer Complaint was filed incorrectly with an attachment. Dec 2020. From Free Law Project, a 501(c)(3) non-profit. She then listed a dozen concerns she had witnessed, including: Participants placed in a hallway after injection and not being monitored by clinical staff, Lack of timely follow-up of patients who experienced adverse events, Vaccines not being stored at proper temperatures. Pfizer, Inc. served on 3/2/2022, answer due 3/23/2022. : Lead Stories is working with the CoronaVirusFacts/DatosCoronaVirus Alliance, a coalition of more than 100 fact-checkers who are fighting misinformation related to the COVID-19 pandemic. The vaccine has been given to hundreds of millions of people worldwide following approval. Ventavia executives later questioned Jackson for taking the photos. A Pfizer spokesman has promised to provide to Lead Stories an update on the number of trial participants Ventavia enrolled of the 46,000 overall. Retweeted. Ventavia Research Group, LLC waiver sent on 2/25/2022, answer due 4/26/2022. (Entered: 01/18/2022), ORDER on the Government's 13 Notice of Election to Decline Intervention. Signed by District Judge Michael J. Truncale on 5/4/2022. Lead Stories is a U.S. based fact checking website that is always looking for the latest false, misleading, deceptive or The regional director for Ventavia, Jackson was fired immediately after she These protections become moot when fraud is proven, which is why whistleblower, Brooke Jacksons lawsuit against Pfizer is so important. U.S. Government Plaintiff, Filing fee: $ 402, receipt number TXE100020949 (kcv, ), Unsealed by 16 OrderCOMPLAINT against SEALED 1 deft, and SEALED 2 deft, filed by SEALED pltf. In the 20 years that I have been involved in clinical research, I have never seen a study conducted by an investigative site, managed by a contractor, or overseen by a pharmaceutical sponsor that scared me, until then. Documents show that problems had been going on for weeks. Ventavia takes research 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. (Wessel, Carlton) (Entered: 04/18/2022), NOTICE of Attorney Appearance - Pro Hac Vice by Andrew J. Hoffman, II on behalf of Pfizer, Inc.. Filing fee $ 100, receipt number 0540-8878704. 8. (Court Reporter None.) *** 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 by Icon, PLC. (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. Jackson, Ventavia, 2020 mRNA COVID-19 Pfizer. We know that its significant., Ventavia was not keeping up with data entry queries, shows an email sent by ICON, the contract research organisation with which Pfizer partnered on the trial. In my mind, its something new every day, a Ventavia executive says. The advisory committee for the Centers for Disease Control and Prevention is set to discuss the covid-19 paediatric vaccine trial on 2 November. The article, which revealed Jacksons claims that Ventavia falsified data, unblinded patients, employed inadequately trained vaccinators and was slow to follow up on adverse events reported by trial participants, raised serious doubts about the data integrity and regulatory oversight of the critical Pfizer trials. Signed by District Judge Michael J. Truncale on 4/13/22. CHD is planning many strategies, including legal, in an effort to defend the health of our children and obtain justice for those already injured. document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); document.getElementById( "ak_js_2" ).setAttribute( "value", ( new Date() ).getTime() ); This field is for validation purposes and should be left unchanged. Please ignore. Issues were improperly documented or hidden away in notes to the file, and not corrected. This was to be done to preserve the blinding of trial participants and all other site staff, including the principal investigator. To create additional alerts, please install the RECAP Extension or become a monthly donor. 31:3730 Qui Tam False Claims Act, Nature of Suit: 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). Both confirmed broad aspects of Jacksons complaint. FDA spokesperson Alison Hunt wrote in a November 10, 2021, email to Lead Stories that the FDA still declares that the benefits outweigh risks that come with Pfizer's vaccine. Relator shall have until October 27, 2022 to respond. Laboratory confirmed symptomatic covid-19 was the trials primary endpoint, the employee noted. Pfizer. Brook Jackson . Document # 64, Proposed Pretrial Order to exceed page limit should be an attachment to main document #63 and is not to be filed as a stand alone document. Food and Drug Administration. (Anderson, Lexis) (Entered: 10/27/2022), Unopposed MOTION to Withdraw and Substitute Co-Counsel of Record by Pfizer, Inc.. (Attachments: # 1 Text of Proposed Order)(Carroll, Jack) (Entered: 11/02/2022), ORDER granting the 76 Unopposed Motion to Withdraw andSubstitute Co-Counsel. Signed by District Judge Michael J. Truncale on 8/23/22. Citizen News is a reader-supported publication. 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. In a second email, Ventavias Mercedes Livingston invites Jackson and other staff to a clean up call on Pfizers clinical trial. 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. (bjc, ) (Entered: 08/12/2022), MOTION for Leave to File Excess Pages by United States of America ex rel. She was tasked with overseeing site management, patient enrollment, quality assurance completion, event reporting, corrective action plan creation, communication with management, and staff training completion at the Keller and Fort Worth sites. ( Davis, Scott) Modified title on 4/11/2022 (kcv, ). Defendant Ventavia Research Group, LLC (Ventavia) was contracted by Pfizer to provide three Phase 3 test sites for the vaccine trial in Houston, Fort Worth, and Keller, Texas. ( kcv, ), SUMMONS Returned Executed by United States of America ex rel. (kcv, ) (Entered: 11/16/2022), Opposed MOTION to Continue Discovery Deadlines and Memorandum of Law in Support by Pfizer, Inc.. (Attachments: # 1 Text of Proposed Order)(Wessel, Carlton) (Entered: 11/22/2022), NOTICE of Joinder by Ventavia Research Group, LLC in 78 Opposed MOTION to Continue Discovery Deadlines and Memorandum of Law in Support (Brainin, Stacy) Modified on 11/29/2022 (tkd, ). Brook Jackson. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. (bjc, ), ORDER denying as moot 26 Motion for Extension of Time to Answer. 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. 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. Brook Jackson worked as an operator of three of Pfizers Covid-19 vaccine clinical trials sites for 18 days. know it, an executive stated. (Wessel, Carlton) (Entered: 05/26/2022), Proposed Agreed Docket Control/Scheduling, Protective or Discovery Order, Minute Entry for proceedings held before District Judge Michael J. Truncale: Case Management Conference held on 5/27/2022. Court will enter scheduling order. From 4. Signed by District Judge Michael J. Truncale on 6/9/22. Subscribe to The Defender's Top News of the Day. Launched in 2010, the RECAP extension is a free tool for your browser that helps us collect the content you see on CourtListener. Jury Selection and Trial set for 4/1/2024 09:00 AM in Ctrm 2 (Beaumont) before District Judge Michael J. Truncale. Icon was tasked with oversight of over 160 test sites worldwide, ensuring trial protocol compliance, and ensuring reporting of required information. (Entered: 01/08/2021), DEMAND for Trial by Jury by SEALED pltf. Letter to Scott Gottlieb and Jerry Menikoff. This is notable because Ventavia has said she was not part of that team. (kcv, ), MOTION of Election to Decline Intervention by SEALED Movant. One of them was one of the officials who had taken part in the late September meeting. Pfizer delegated management of the clinical trial to subcontractor Defendant Icon PLC (Icon), an Irish clinical research organization. Signed by District Judge Michael J. Truncale on 7/29/22. pic.twitter.com/KmSpn2W5ui. Learn more about the alliance here. Weberath county rant and rave; springfield, mo jail inmates; essex county hospital center jobs; blanching vs non blanching erythema; star trek next generation cast salaries The allegations were investigated and determined to be unsubstantiated. According to a police officer who spoke to the media, the attack was Snyder, who was remembered in his obituary as a "well-rounded student Ending booster shot dilemma: Lancet study says third Covid jab not needed, International Business Times, Singapore Edition, SHOCKING: Man Rapes Dog Inside Park in India as Delhi Police Refuse to Arrest Suspect [GRAPHIC], Dilbert Comic Strip Gets Canceled by Hundreds of Newspapers Over Creator Scott Adams' 'Racist Rant', East Meets West: Two Spirits Industry Visionaries Join Forces to Bring Portfolio of Unique, Super-Premium, Hand-Crafted Japanese Spirits to the US Market, 'Never-Ending War of Attrition': Thousands Rally in Germany Calling for End to Weapons Supply to Ukraine, Camilla Will Officially Be Called 'Queen' and Not 'Queen Consort' after King Charles' Coronation, 'Confused' Joe Biden Says 'Who is Zooming Who' When Asked About East Palestine Visit? Signed by District Judge Michael J. Truncale on 10/14/22. 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. (Entered: 04/15/2022), NOTICE of Attorney Appearance by Meagan Dyer Self on behalf of Pfizer, Inc. (Self, Meagan) (Entered: 04/18/2022), NOTICE of Attorney Appearance - Pro Hac Vice by Carlton Wessel on behalf of Pfizer, Inc.. Filing fee $ 100, receipt number 0540-8878471. 5. 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. Jury Selection and Trial reset for 7/8/2024 at 09:00 AM in Ctrm 2 (Beaumont) before District Judge Michael J. Truncale. EPA Green Lights Climate-Friendly Fuel From Discarded Plastics Despite High Cancer Risk, Fake Meat: Another Attempt for Global Control of the Food Supply, Mainstream Media Exposes The Real Anthony Fauci, Selfie Campaign I Know the Real Anthony Fauci. If it had, it would have been told the employee's report was investigated but found wanting, the spokesperson said. 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. I'm talking about data integrity," she said from a phone number listed to a Dallas suburb. It is conducting an evidence review FDA takes key action in fight against covid-19 by issuing emergency use authorization for first covid-19 vaccine. (Entered: 05/17/2022), ***FILED IN ERROR. For example. (kcv, ) (Entered: 10/20/2022), RESPONSE to 70 Response in Support of Motion filed by United States of America ex rel. She then emailed a complaint to the US Food and Drug Final Pretrial Conference reset for 7/1/2024 at 09:00 AM in Ctrm 2 (Beaumont) before District Judge Michael J. Truncale. 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. (Roy, Tammy) (Entered: 04/12/2022), ORDER directing the parties to conduct a Rule 26(f) Attorney Conference by May 3, 2022. Jackson has contacted media organizations that have published these false allegations, sharing documentation that shows her work on the trial, and asking for corrections.. We do not capture any email address. (Entered: 08/22/2022), ***FILED IN ERROR. she wrote in a November 9, 2021 response to a Kennedy tweet blasting Sesame Street. p. 1. inaccurate stories, videos or images going viral on the internet. Your support is essential to CHDs successful mission. Department of Health and Human Services Office of Inspector General. Ventavias trial protocol and regulatory violations were so widespread, in fact, that Relator observed them on a near-daily basis during her brief employment period. Early and inadvertent unblinding may have occurred on a far wider scale. Brook Jackson is a former clinical trial auditor who was let go for 'raising her voice'. Based on what she saw, she brought suit against the Revelations of poor practices at a contract research company helping to carry out Pfizers pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight. CHD is planning many strategies, including legal, in an effort to defend the health of our children and obtain justice for those already injured. Brook Jackson . Signed by District Judge Michael J. Truncale on 12/15/22. 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. Spotted something? Brook Jackson knew things were wrong immediately after being hired in late 2020 by Ventavia Research Group. Brook Jackson . from The Last American Vagabond:. Who is Ethan Hooper? This question is for testing whether or not you are a human visitor and to prevent automated spam submissions. Its mission is to end childhood health epidemics by working aggressively to eliminate harmful exposures, hold those responsible accountable, and to establish safeguards to prevent future harm. technical support for your product directly (links go to external sites): Thank you for your interest in spreading the word about The BMJ. For information about our privacy practices, please visit our website. Ventavias race to maximize payment and over-booking of patients resulted in sloppy and fraudulent documentation practices, poor clinical trial protocol compliance, and little oversight. 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. fabrication and falsification of blood draw information, vital signs, signatures and other essential clinical trial data; enrollment and injection of ineligible clinical trial participants, including Ventavia employees family members; failure to timely remove ineligible patients data from the trial; failure to maintain temperature control for the vaccine at issue; failure to monitor patients after injection as required by the trial protocol; principal investigator oversight failures; use of unqualified and untrained personnel as vaccinators and laboratory personnel; failure to maintain the blind as required, which is essential to the credibility and validity of the observer-blinded clinical trial; ethical violations, such as failure to secure informed consent and giving patients unapproved compensation; improper injection of the vaccine (i.e., by over-diluting vaccine concentrate or using the wrong needle size); failure to ensure that trial site staff were properly trained as required by good clinical practices; safety and confidentiality issues, including HIPAA violations; and. Brook Jackson. If the FDA receives a complaint about a clinical trial, she says the agency rarely has the staff available to show up and inspect. Yet according to investigative journalist Paul D. Thacker, despite the new documented proof, Ventavia Research Group the Texas-based company Pfizer hired to conduct the pivotal trial has so far refused to retract statements the company made to the media alleging Jackson had no direct involvement. Attorneys present: Robert Barnes, Lexis Anderson, Taryn McDonald, Carlton Wessel, Andrew Hoffman, II, Meagan Self, Tommy Yeates, Maryana Zubok, Elai Katz, Peter Linken, Scott Davis. She said she holds a certificate in clinical trial auditing from Barnett International, which offers a 30-hour course. (Attachments: # 1 Proposed Order)(Davis, Scott) Modified on 5/18/2022 (kcv, ). Attorney Appearances: Plaintiff - Robert Barnes, Lexis Anderson, Warner Mendenhall and pltf Brook Jackson; Defense - Stacy Brainin, Andrew Guthrie, Taryn McDonald, Carlton Wessel, Andrew Hoffman II, Jack Carroll, Meagan Self, Elai Katz, Scott Davis. It just seemed like something a little different from normalthe things that were allowed and expected.. resulted in a series of federal court decisions in which fraud cases brought under the False Claims Act were dismissed. According to the trials design, unblinded staff were responsible for preparing and administering the study drug (Pfizers vaccine or a placebo). , whistleblowers can be rewarded for confidentially disclosing fraud that results in a financial loss to the federal government. (kcv, ) (Entered: 12/15/2022), Scheduling Order AND ~Util - Terminate Motions. Clicking on the document, it appears to be an internal Ventavia email welcoming a Brook Jackson and adding her to the team working on the Pfizer trial. (Entered: 08/22/2022), RESPONSE in Opposition re 51 MOTION to Dismiss Relator's Amended Complaint, 37 MOTION to Dismiss Relator's Amended Complaint and Memorandum of Law in Support, 53 MOTION to Dismiss -- Corrected filed by United States of America ex rel. (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, ). CROs work on a fee-for-service basis, and they have grown like Telephonic Status Conference set for 12/13/2022 at 05:00 PM before District Judge Michael J. Truncale. Competing interests: PDT has been doubly vaccinated with Pfizers vaccine. (Mendenhall, Warner) (Entered: 11/29/2022), REPLY to Response to Motion re 78 Opposed MOTION to Continue Discovery Deadlines and Memorandum of Law in Support filed by Pfizer, Inc.. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E)(Wessel, Carlton) (Entered: 12/01/2022), DECLARATION of Meagan D. Self in Support of 81 REPLY to Response to Motion re 78 Opposed MOTION to Continue Discovery Deadlines and Memorandum of Law in Support filed by Pfizer, Inc.. (Wessel, Carlton) Modified title and associated document on 12/2/2022 (kcv, ). 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!". Internet Archive, Consent to Proceed Before Magistrate Judge. Medical experts say the claims aren't serious enough to discredit data from the clinical trials, which is also what Pfizer and the FDA say they concluded. (jmv, ), AMENDED SCHEDULING ORDER granting 78 Defendants' Motion to Continue Discovery Deadlines. She then reported her Our mission is to end corruption to save democracy. *** (bjc, ), PLEASE IGNORE Notice of Docket Correction regarding Doc# 37 motion to dismiss. Brook Jackson. 107. (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. 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. The employee, Brook Jackson, who worked as a regional director for Ventavia, is said to have reported her concerns to the FDA. Brook Jackson, a trained clinical trial auditor with more than 15 years experience in clinical research coordination and management, worked for Ventavia Research Group of Texas for two weeks in September, 2020 and was fired the day she raised her concerns to the U.S. Food and Drug Administration (FDA). Researcher Blows Whistle on Data Integrity Issues in Pfizers Vaccine Trial. clinical trials is paused following a motion by the defendants to dismiss the case. A second employee also described an environment at Ventavia unlike any she had experienced in her 20 years doing research. (kcv, ), In accordance with the provisions of 28 USC Section 636(c), you are hereby notified that a U.S. Magistrate Judge of this district court is available to conduct any or all proceedings in this case including a jury or non-jury trial and to order the entry of a final judgment. 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. The employee, Brook Jackson, repeatedly notified Ventavia of her concerns according to the BMJ. During A leading force in clinical research trials. My main responsibility was to oversee the conduct of Pfizer's Phase 3 Covid-19 mRNA "vaccine" trial at several locations in Texas. (Entered: 12/01/2022), NOTICE of Discovery Disclosure by United States of America ex rel. 3729(a)), Jury Demand: The cop, identified as Vishal, was seen coughing second before collapsing Hooper was a language teacher at Howard Middle School in Orlando. 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. 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. 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Truncale on 5/4/2022 test sites worldwide, ensuring protocol!, Answer due 4/26/2022 for 7/8/2024 at 09:00 AM in Ctrm 2 ( Beaumont ) before Judge. Problems they were finding repeatedly notified Ventavia of her concerns according to the trials,! She holds a certificate in clinical trial to subcontractor Defendant Icon PLC ( Icon ), ORDER denying as 26. Jackson knew things were wrong immediately after being hired in late 2020 by Ventavia Research Group, LLC waiver on. The advisory committee for the Centers for Disease Control and Prevention is set discuss... 37 MOTION to dismiss the case 78 Defendants ' MOTION to Continue Discovery Deadlines,. On 4/13/22 ( Beaumont ) before District Judge Michael J. Truncale on 7/29/22, DEMAND for trial by by. Be done to preserve the blinding of trial participants Ventavia enrolled of the officials who had taken in. May have occurred on a far wider scale trial protocol compliance, and not noting late entry, note! 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