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. Signed by District Judge Michael J. Truncale on 12/15/22. Thacker first reported on Jacksons accusations against Ventavia in a Nov. 2 article in The BMJ. Signed by District Judge Michael J. Truncale on 5/4/2022. These same accusations were made a year ago, at which time Ventavia notified the appropriate parties. 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. 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 Ventavia Research Group, LLC waiver sent on 2/25/2022, answer due 4/26/2022. Modified related document on 6/7/2022 (kcv, ). What I documented and reported to my former employer and to Pfizer during an internal audit was dangerous and violated Federal law. (bjc, ) (Entered: 04/25/2022), ***FILED IN ERROR per attorney. We can sometimes provide need-based exceptions to these rules. Ventavia ultimately enrolled about 1,500 clinical trial patients. The claims were made in a November 2, 2021, article on the BMJ blog titled "Covid-19: Researcher blows the whistle on data integrity issues in Pfizer's vaccine trial" (archived here), which opened: Users on social media only saw this title, description and thumbnail: Revelations of poor practices at a contract research company helping to carry out Pfizer's pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight. In several cases Ventavia lacked enough employees to swab all trial participants who reported covid-like symptoms, to test for infection. Learn more about Mailchimp's privacy practices here. (kcv, ) (Entered: 06/09/2022), NOTICE of Attorney Appearance by Warner Mendenhall on behalf of 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. Miss a day, miss a lot. 6. 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. Pfizer and Icon turned a blind eye to Ventavias misconduct, despite numerous warning signs. other violations of the clinical trial protocol, FDA regulations, and Federal Acquisition Regulations and their DoD supplements. (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. Added link to BMJ's open letter and our response. I think the only way forward is to be transparent in the failures, expose the corruption on all levels, and hold these criminals accountable. This includes oversight of Serious Adverse Event (SAE) reporting, which is required by the trial protocol and federal regulations. (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, ). 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 Pfizer's pivotal phase III trial. In a recording of a meeting in late September2020 between Jackson and two directors a Ventavia executive can be heard explaining that the company wasnt able to quantify the types and number of errors they were finding when examining the trial paperwork for quality control. 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. And sometimes oversight occurs too late. (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. 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". Professor Douglas Drevets, M.D., of the University of Oklahoma College of Medicine, wrote in a November 10, 2021, email to Lead Stories that even if the claims are true, there is abundant proof the Pfizer vaccine works and is safe. 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. 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. Bourla A. (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, ). Signed by District Judge Michael J. Truncale on 4/13/22. Brook Jackson. One photo, provided to The BMJ, showed needles discarded in a plastic biohazard bag instead of a sharps container box. A second employee also described an environment at Ventavia unlike any she had experienced in her 20 years doing research. Michigan Student Killed by 14-Year-Old and 13-Year-Old Boys in Attempted Carjacking After Offering Them Ride to Home. Subscribe to The Defender's Top News of the Day. The Pfizer-BioNTech BNT162b vaccine was subsequently approved by the FDA, EMA and other regulatory authorities based on the robust data submitted from the clinical program. This question is for testing whether or not you are a human visitor and to prevent automated spam submissions. One is an email with Jackson thanking Pfizers Dr. Arturo Alfaro for giving her access to the COVID-19 clinical trial software.. Please ignore. Brook Jackson is a former clinical trial auditor who was let go for 'raising her voice'. 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. Phone texts and emails among Ventavia staff discussing a hectic environment and sloppy documentation.. Login for free View subscription options (kcv, ) (Entered: 12/15/2022), Scheduling Order AND ~Util - Terminate Motions. 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. My main responsibility was to oversee the conduct of Pfizer's Phase 3 Covid-19 mRNA "vaccine" trial at several locations in Texas. Brook Jackson @IamBrookJackson Hi Brook, you are popular in France too, can we plan an ITW together as you can explain all the GCP violations in the ventavia centers to my followers ? 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. 30 Days Granted for Deadline Extension. After a Harvard Nieman Fellowship, he served as Director of Stony Brook University's Center for News Literacy for six years, then as Senior Vice President/Content at Connecticut Public Broadcasting. (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. Pfizer said it has reviewed the claims and found them to be unproven. 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. Signed by District Judge Michael J. Truncale on 8/23/22. 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. If you are unable to import citations, please contact 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. 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. I dedicated my near two decade career to helping get safe and effective therapeutics, vaccines, and devices to consumers. Signed by District Judge Michael J. Truncale on 10/19/22. (Anderson, Lexis) (Entered: 03/01/2022), SUMMONS Returned Executed by United States of America ex rel. 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. Pfizer's investigation did not identify any issues or concerns that would invalidate the data or jeopardize the integrity of the study. In a second email, Ventavias Mercedes Livingston invites Jackson and other staff to a clean up call on Pfizers clinical trial. Signed by District Judge Michael J. Truncale on 6/9/22. On Twitter, Jackson does not express unreserved support for COVID vaccines. Relator shall have until October 27, 2022 to respond. 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. 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. *** (kcv, ), ORDER granting the Relator's 63 Motion to Exceed Page Limit. 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