In the afternoon Ventavia fired Jacksondeemed not a good fit, according to her separation letter. 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. Jackson spent two weeks in September 2020 as a regional manager overseeing vaccine trials Pfizer contracted Ventavia Research Group to perform. 13. Citizen News is a reader-supported publication. 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. A regional director who was employed at the research organization Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, Miss a day, miss a lot. 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. Your support is essential to CHDs successful mission. Well done you ETHICAL LADY for hoping to protect general members of the public and VENTAVIA should be brought to book for lack of Duty of Care. According to the trials design, unblinded staff were responsible for preparing and administering the study drug (Pfizers vaccine or a placebo). 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. Ventavia is the company to which Pfizer outsourced the trials, and the company that hired Brook. Lead Stories Managing Editor Dean Miller has edited daily and weekly newspapers, worked as a reporter for more than a decade and is co-author of two non-fiction books. Please ignore. 107. Modified related document on 6/7/2022 (kcv, ). Filing fee $ 100, receipt number 0540-8872723. Editors note:Heres an excerpt from an article in The BMJ. Doesn't Recall Speaking With Mayor. She added that during her time at Ventavia the company expected a federal audit but that this never came. 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). Food and Drug Administration. Medical experts disagree with claims that this contretemps calls into question the results of the Pfizer clinical trial. Brook Jackson. 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. They Want BP to Pay. Brook Jackson. Spotted something? document.getElementById( "ak_js_3" ).setAttribute( "value", ( new Date() ).getTime() ); The Defender is the news and views website for Children's Health Defense. 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. PLEASE IGNORE. 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. (Brainin, Stacy) (Entered: 09/20/2022), REPLY to Response to Motion re 51 MOTION to Dismiss Relator's Amended Complaint filed by Icon, PLC. BUY NOW: Ed Dowds Must-Read Book Cause Unknown. Pfizer delegated management of the clinical trial to subcontractor Defendant Icon PLC (Icon), an Irish clinical research organization. Pfizer's investigation did not identify any issues or concerns that would invalidate the data or jeopardize the integrity of the study. CHD is planning many strategies, including legal, in an effort to defend the health of our children and obtain justice for those already injured. Reply. (kcv, ) (Entered: 06/09/2022), PROTECTIVE ORDER. Counsel has been notified to refile documents. If it had, it would have been told the employee's report was investigated but found wanting, the spokesperson said. 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. "My story is not about whether the vaccine is efficacious. They choose rather, to protect and serve the interests of powerful corporations and ignore the vaccine injuries and deaths. (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, ). *** (bjc, ), PLEASE IGNORE Notice of Docket Correction regarding Doc# 37 motion to dismiss. Laboratory confirmed symptomatic covid-19 was the trials primary endpoint, the employee noted. Icon, PLC served on 3/16/2022, answer due 4/6/2022. She then reported her For information about our privacy practices, please visit our website. Court will enter scheduling order. ", 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.". Signed by District Judge Michael J. Truncale on 5/4/2022. CourtListener is sponsored by the non-profit Free Law Project. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson (video 1), emailed a complaint to the US Food and Drug Administration (FDA). Newly released documents support whistleblower Brook Jacksons claims she was directly involved in Pfizers COVID vaccine phase 3 clinical trials, but Pfizer See who is sharing it (it might even be your friends) and leave the link in the comments. 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. Another showed vaccine packaging materials with trial participants identification numbers written on them left out in the open, potentially unblinding participants. In September 2020 she was hired by Ventavia as a Regional Director for clinical trial sites In several cases Ventavia lacked enough employees to swab all trial participants who reported covid-like symptoms, to test for infection. 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. Counsel has been notified. Brooke Jackson. Issues were improperly documented or hidden away in notes to the file, and not corrected. Signed by District Judge Michael J. Truncale on 2/10/22. 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. Brooks Jackson v. Ventavia Research Group, LLC, 1:21-cv-00008 Brought to you by the RECAP Initiative and Free (bjc, ) (Entered: 05/05/2022), Order on Motion for Extension of Time to Answer, MOTION to Stay Motion to Stay Discovery and Memorandum in Support by Pfizer, Inc.. (Attachments: # 1 Exhibit, # 2 Text of Proposed Order)(Self, Meagan) (Entered: 05/17/2022), ***FILED IN ERROR. resulted in a series of federal court decisions in which fraud cases brought under the False Claims Act were dismissed. 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. You would think if theres a specific and credible complaint that they would have to investigate that, Fisher said. 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. (Mendenhall, Warner) (Entered: 08/22/2022), ***FILED IN ERROR. (Anderson, Lexis) (Entered: 03/01/2022), SUMMONS Returned Executed by United States of America ex rel. Webin the united states district court for the eastern district of texas beaumont division united states of america ex rel. Install RECAP 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. Added link to BMJ's open letter and our response. Jackson was fired from her job the same day she filed a complaint with the FDA. (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. During our last interview Brook discussed (jmv, ), E-DISCOVERY ORDER. 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. Please select all the ways you would like to hear from Lead Stories LLC: You can unsubscribe at any time by clicking the link in the footer of our emails. (Davis, Scott) (Entered: 09/20/2022), RESPONSE in Support re 51 MOTION to Dismiss Relator's Amended Complaint, 53 MOTION to Dismiss -- Corrected filed by United States of America. 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. 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. More Than a Decade Later, Workers Battle Illness From Deepwater Horizon. Signed by District Judge Michael J. Truncale on 6/9/22. A second employee also described an environment at Ventavia unlike any she had experienced in her 20 years doing research. The FDA said, without explicitly saying it, that the allegations don't change the agency's assessment of the vaccine's safety. Document # 21, Defendant's Unopposed First Application for Extension of Time to Answer Complaint was filed incorrectly with an attachment. Based on what she saw, she brought suit against the The employee, Brook Jackson, who worked as a regional director for Ventavia, is said to have reported her concerns to the FDA. Donations are tax deductible to the full extent of the law. 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. 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. By clicking below to subscribe, you acknowledge that your information will be transferred to Mailchimp for processing. Jul 2018. 9, 2022, 7:32 a.m. Signed by District Judge Michael J. Truncale on 4/13/22. If the FDA receives a complaint about a clinical trial, she says the agency rarely has the staff available to show up and inspect. One said that she had worked on over four dozen clinical trials in her career, including many large trials, but had never experienced such a helter skelter work environment as with Ventavia on Pfizers trial. *** (kcv, ), Defendant's Unopposed First Application for Extension of Time to Answer Complaint re Pfizer, Inc..( Yeates, Tommy) (Main Document 22 replaced with flattened image on 3/18/2022) (kcv, ). (kcv, ), MOTION of Election to Decline Intervention by SEALED Movant. Her job was to oversee its clinical trial of Pfizers not She said she holds a certificate in clinical trial auditing from Barnett International, which offers a 30-hour course. You currently have alerts. Paul D Thacker reports In autumn 2020 Pfizer's 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. Documents show that problems had been going on for weeks. 376 Qui Tam (31 U.S.C. (kcv, ) (Entered: 10/20/2022), RESPONSE to 70 Response in Support of Motion filed by United States of America ex rel. Signed by District Judge Michael J. Truncale on 10/14/22. (kcv, ) (Entered: 06/09/2022), SCHEDULING ORDER granting in part the 40 MOTION to Stay Discovery. Feb. 28, 2023, 10:25 a.m. CST, Assigned To: Signed by District Judge Michael J. Truncale on 10/19/22. This article is made freely available for personal use in accordance with BMJ's website terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. Our response is here, we stand by our reporting. Brook Jackson (Mendenhall, Warner) (Entered: 07/22/2022), Unopposed MOTION for Extension of Time to File Response/Reply by United States of America ex rel. Researcher Blows Whistle on Data Integrity Issues in Pfizers Vaccine Trial. Signed by District Judge Michael J. Truncale on 8/12/2022. Pfizer is a federal contractor because it signed multiple contracts with the U.S. government to provide COVID-19 vaccines and Paxlovid, a pill used to treat the virus. (bjc, ) (Entered: 08/12/2022), MOTION for Leave to File Excess Pages by United States of America ex rel. pic.twitter.com/VtqDLWTCo9. (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. The BMJ investigation conducted by Paul Thacker reveals inside reports and evidence by Jackson about Pfizer allegedly 'manipulating clinical trials'. The article said that The employee, Brook Jackson, repeatedly notified Ventavia of her concerns according to the BMJ. 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. This was to be done to preserve the blinding of trial participants and all other site staff, including the principal investigator. (Mendenhall, Warner) Modified on 8/23/2022 (kcv, ). Bourla A. All attorneys are ordered to participate in the conference. 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. Enough is enough! After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). (kcv, ) (Entered: 02/11/2022), AMENDED COMPLAINT against All Defendants, filed by United States of America ex rel. other violations of the clinical trial protocol, FDA regulations, and Federal Acquisition Regulations and their DoD supplements. Ventavia Research Group, LLC waiver sent on 2/25/2022, answer due 4/26/2022. Brook Jackson knew things were wrong immediately after being hired in late 2020 by Ventavia Research Group. 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. 5. "One photo showed needles discarded in a plastic biohazard bag instead of a container box. ), I dont think it was good clean data, the employee said of the data Ventavia generated for the Pfizer trial. These same accusations were made a year ago, at which time Ventavia notified the appropriate parties. The regional director for Ventavia, Jackson was fired immediately after she reported her concerns to the US Food and Drug Administration. 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. Who is Ethan Hooper? Phone texts and emails among Ventavia staff discussing a hectic environment and sloppy documentation.. My main responsibility was to oversee the conduct of Pfizer's Phase 3 Covid-19 mRNA "vaccine" trial at several locations in Texas. 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. A regional director who was employed at the research organisation 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 III trial. Its a crazy mess.. The FDA says its position is unchanged: The benefits of the Pfizer vaccine far outweigh rare side effects and the clinical trial data are solid. After the explosive whistleblower report came out, shares of BioNTech, the German company that co-developed the vaccine with Pfizer, took a drastic 20% plunge on Friday, November 5. Early and inadvertent unblinding may have occurred on a far wider scale. On Twitter, Jackson does not express unreserved support for COVID vaccines. (Mendenhall, Warner) (Additional attachment(s) added on 10/12/2022: # 1 Text of Proposed Order) (kcv, ). 3729(a)), Jury Demand: 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. (Additional attachment(s) added on 4/11/2022: # 3 Revised Proposed Order) (kcv, ). We can sometimes provide need-based exceptions to these rules. You may download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained. The whistleblower is Brook Jackson, previously a regional director at a Texas-based contract research organisation called Ventavia, who supplied an account to Brook Jackson is a former clinical trial auditor who was let go for 'raising her voice'. Obviously we don't agree. Docket alerts are an advanced feature of CourtListener. CHD is planning many strategies, including legal, in an effort to defend the health of our children and obtain justice for those already injured. However, at Ventavia, Jackson told The BMJ that drug assignment confirmation printouts were being left in participants charts, accessible to blinded personnel. (Hoffman, Andrew) (Entered: 04/18/2022), MOTION to Dismiss 17 Relator's Amended Complaint and Memorandum of Law in Support by Pfizer, Inc.. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E, # 6 Exhibit F, # 7 Text of Proposed Order)(Wessel, Carlton) Modified on 4/25/2022 (bjc, ). The Notice and Motion should also be filed separately per Local Rules. Docket for United States of America ex rel. On 8/23/2022 ( kcv, ) ( Entered: 08/12/2022 ), SCHEDULING ORDER granting in part 40. In late 2020 by Ventavia Research Group to perform to these rules Group to perform study (! 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