(Entered: 06/06/2022), MOTION to Dismiss 17 Relator's Amended Complaint by Icon, PLC. 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. 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. (bjc, ) (Entered: 08/12/2022), MOTION for Leave to File Excess Pages by United States of America ex rel. Laboratory confirmed symptomatic covid-19 was the trials primary endpoint, the employee noted. Ventavia is the company to which Pfizer outsourced the trials, and the company that hired Brook. The Notice and Motion should also be filed separately per Local Rules. Two of the final projects that I was overseeing involved the testing of the cobas SARS-CoV-2 and Abbott ID Now RT-PCR technologies and early phase trials of remdesivir. She then emailed a complaint to the US Food and Drug 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. The U.S. Food and Drug Administration (FDA), the Center for Disease Control and Prevention (CDC), and others, have failed to do their job protecting the American people. 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. Spotted something? Provenance and peer review: commissioned; externally peer reviewed. Signed by District Judge Michael J. Truncale on 8/12/2022. In several cases Ventavia lacked enough employees to swab all trial participants who reported covid-like symptoms, to test for infection. 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. BMJ relied on copies of reports filed by a two-week employee of Ventavia. Tags: Another former Ventavia employee has confirmed that the company had been expecting a federal audit of its Pfizer vaccine trial - though this did not materialize, Brook Jackson repeatedly informed her superiors of poor laboratory management and patient safety and data integrity issues, Brook Jackson reported her concerns to the US Issues were improperly documented or hidden away in notes to the file, and not corrected. EIN #26-0388604, 2016 - 2023 Children's Health Defense All Rights Reserved. Document # 41, Motion to Stay and Notice of Joinder do not contain the required Certificate of Conference. . Under the False Claims Act, whistleblowers can be rewarded for confidentially disclosing fraud that results in a financial loss to the federal government. (Entered: 05/17/2022), ***FILED IN ERROR. Final Pretrial Conference reset for 7/1/2024 at 09:00 AM in Ctrm 2 (Beaumont) before District Judge Michael J. Truncale. It's free. Editors note:Heres an excerpt from an article in The BMJ. (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. Food and Drug Administration. Citizen News is a reader-supported publication. (Entered: 03/18/2022), Unopposed Application for Extension of Time to Answer Complaint, Application Granted for Extension of Time to Answer Complaint, ***FILED IN ERROR. The allegations were investigated and determined to be unsubstantiated. Targeting of Ventavia staff for reporting these types of problems. (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. (kcv, ) (Entered: 06/09/2022), SCHEDULING ORDER granting in part the 40 MOTION to Stay Discovery. If you might need an exception, please let us know. *** (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, ). Jackson, Ventavia, 2020 mRNA COVID-19 Pfizer. 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. (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. Her job was to oversee its clinical trial of Pfizers not Final Pretrial Conference set for 3/28/2024 09:00 AM in Ctrm 2 (Beaumont) before District Judge Michael J. Truncale. 9, 2022, 7:32 a.m. Subscribe to The Defender's Top News of the Day. (Katz, Elai) (Entered: 04/12/2022), Notice of Attorney Appearance - Pro Hac Vice, NOTICE of Attorney Appearance - Pro Hac Vice by Peter Linken on behalf of Icon, PLC. Since Jackson reported problems with Ventavia to the FDA in September 2020, Pfizer has hired Ventavia as a research subcontractor on four other vaccine clinical trials (covid-19 vaccine in children and young adults, pregnant women, and a booster dose, as well an RSV vaccine trial; NCT04816643, NCT04754594, NCT04955626, NCT05035212). Show more. , whistleblowers can be rewarded for confidentially disclosing fraud that results in a financial loss to the federal government. Brook Jackson. clinical trials is paused following a motion by the defendants to dismiss the case. People working in clinical research are terrified of FDA audits, Jill Fisher told The BMJ, but added that the agency rarely does anything other than inspect paperwork, usually months after a trial has ended. Signed by District Judge Michael J. Truncale on 8/23/22. Signed by District Judge Michael J. Truncale on 6/9/22. A former Ventavia employee told The BMJ that the company was nervous and expecting a federal audit of its Pfizer vaccine trial. In her 25 September email to the FDA Jackson wrote that Ventavia had enrolled more than 1000 participants at three sites. "One photo showed needles discarded in a plastic biohazard bag instead of a container box. (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. The FDA said, without explicitly saying it, that the allegations don't change the agency's assessment of the vaccine's safety. Brook Jackson . Spotted something? Brook Jackson has over 20 years of experience carrying out clinical trials. All attorneys are ordered to participate in the conference. 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. (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. 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. (Anderson, Lexis) (Entered: 05/31/2022), MOTION to Dismiss 17 Amended Complaint by Ventavia Research Group, LLC. As a corrective action taken in September, two months into trial recruitment and with around 1000 participants already enrolled, quality assurance checklists were updated with instructions for staff to remove drug assignments from charts. Ventavia takes research compliance, data integrity, and participant safety very seriously, and we stand behind our work supporting the development of life-saving vaccines. (Mendenhall, Warner) (Additional attachment(s) added on 10/12/2022: # 1 Text of Proposed Order) (kcv, ). 107. 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. Our response is here, we stand by our reporting. Emails exposing Ventavias fear of an impending inspection by the U.S. Food and Drug Administration (FDA). Public Citizen. Signed by District Judge Michael J. Truncale on 12/9/22. Jackson has contacted media organizations that have published these false allegations, sharing documentation that shows her work on the trial, and asking for corrections.. 5. EIN #26-0388604, 2016 - 2023 Children's Health Defense All Rights Reserved. stupidamerkin says: October 24, 2022 ( Davis, Scott) (Entered: 04/01/2022), Defendant's Unopposed First Application for Extension of Time to Answer Complaint is GRANTED IN PART pursuant to Local Rule CV-12 for Icon, PLC to 5/6/2022. (Anderson, Lexis) (Entered: 03/01/2022), SUMMONS Returned Executed by United States of America ex rel. May 2021. Brook Jackson . 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. The next day the FDA issued the authorisation of the vaccine.8, In August this year, after the full approval of Pfizers vaccine, the FDA published a summary of its inspections of the companys pivotal trial. (Entered: 12/01/2022), NOTICE of Discovery Disclosure by United States of America ex rel. (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. Claim: Covid-19: Researcher blows the whistle on data integrity issues in Pfizers vaccine trial Pfizer and Icon turned a blind eye to Ventavias misconduct, despite numerous warning signs. 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 You would think if theres a specific and credible complaint that they would have to investigate that, Fisher said. (Davis, Scott) (Entered: 06/07/2022), NOTICE by Ventavia Research Group, LLC re 54 Reply to Response to Motion, 52 Reply to Response to Motion -- Notice of Joinder in Pfizer and Icon's Replies in Support of Motions to Stay Discovery (Brainin, Stacy) (Entered: 06/07/2022), Minute Entry for proceedings held before District Judge Michael J. Truncale: Telephonic Status Conference held on 6/9/2022. (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. Ventavias sites were not listed among the nine, and no inspections of sites where adults were recruited took place in the eight months after the December 2020 emergency authorisation. The BMJ, according to Thacker, wrote to Ventavia, Pfizer and the U.S. Food and Drug Administration to better clarify the scope and implications of the problems identified at Ventavia, as well as what corrective measures were taken., To date, Ventavia has not responded to The BMJs repeated requests for information. 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. Did the British Medical Association's news blog reveal flaws that disqualify the results of a contractor's field testing of Pfizer's COVID-19 vaccine, and were the problems ignored by the Food & Drug Administration and by Pfizer? Responding to comments and inquiries on Twitter, Jackson wrote in a November 9, 2021, tweet: "The organizational failures listed in the BMJ, although not exhaustive, led to violations that were repeated and deliberate, and the reliability and integrity of the data have been comprised.". In May this year the FDA sent the triallist a warning letter that substantiated many of the claims in the complaints. Ein # 26-0388604, 2016 - 2023 Children 's Health Defense all Rights Reserved FDA ) in complaints. In yellow in a financial loss to the federal government Jackson wrote that Ventavia had enrolled more 1000... Ventavias fear of an impending inspection by the U.S. Food and Drug Administration ( FDA.... Joinder do not contain the required Certificate of Conference had enrolled more than 1000 participants at three sites * in! Covid-Like symptoms, to test for infection might need an exception, please let us.. Many of the vaccine 's safety older than three days in yellow Michael Truncale! 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