Jackson was fired from her job the same day she filed a complaint with the FDA. Please ignore. Modified related document on 6/7/2022 (kcv, ). Brook Jackson. But she said she was surprised that the agency failed to inspect Ventavia after an employee had filed a complaint. Signed by District Judge Michael J. Truncale on 4/13/22. A clinical trial delegation log listing Jackson as a participant. EIN #26-0388604, 2016 - 2023 Children's Health Defense All Rights Reserved. Tommy Lee Yeates is withdrawn as co-counsel for Defendant Pfizer in this matter and Jack P. Carroll is to be substituted in as co-counsel. 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. This includes oversight of Serious Adverse Event (SAE) reporting, which is required by the trial protocol and federal regulations. 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. The report found that the FDA inspected only 1% of clinical trial sites.6 Inspections carried out by the FDAs vaccines and biologics branch have been decreasing in recent years, with just 50 conducted in the 2020 fiscal year.7. Michigan Student Killed by 14-Year-Old and 13-Year-Old Boys in Attempted Carjacking After Offering Them Ride to Home. from The Last American Vagabond:. Miss a day, miss a lot. (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. 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. ( kcv, ), SUMMONS Returned Executed by United States of America ex rel. (Mendenhall, Warner) (Entered: 08/22/2022), ***FILED IN ERROR. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails. I dont know why theyre so afraid of them, she said. 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. Spotted something? Brook Jackson. Learn more about Mailchimp's privacy practices here. (Anderson, Lexis) (Entered: 03/02/2022), ***FILED IN ERROR. By week 3 of her employment, Brook had Editors note:Heres an excerpt from an article in The BMJ. WebI Am Brook Jackson | Whistleblower for Pfizer's Clinical Trials DONATE WHO I AM I dedicated my near two decade career to helping get safe and effective therapeutics, Ventavia. (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. (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, ). (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. WebBrook Jackson - Former employee of the Ventavia Research Group/ Whistleblower: Brook Jackson - Former.. News video on One News Page on Monday, 21 March 2022. However, most have not run corrections, despite overwhelming evidence contradicting their statements. Plaintiff, Jurisdiction Type: A former Ventavia employee told The BMJ that the company was nervous and expecting a federal audit of its Pfizer vaccine trial. document.getElementById( "ak_js_4" ).setAttribute( "value", ( new Date() ).getTime() ); Children's Health Defense is a 501(c)(3) non-profit organization. Jury Selection and Trial set for 4/1/2024 09:00 AM in Ctrm 2 (Beaumont) before District Judge Michael J. Truncale. One photo, provided to The BMJ, showed needles discarded in a plastic biohazard bag instead of a sharps container box. In an article in MedPage, vaccine experts said the claims are not serious enough to jeopardize Pfizer's data. Ventavia executives later questioned Jackson for taking the photos. 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. Ventavia is not owned by Pfizer. Relator shall have until October 27, 2022 to respond. 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. An insightful, engaging interview with Brook Jackson recorded during the summer of 2022. (Entered: 03/18/2022), CORPORATE DISCLOSURE STATEMENT filed by Pfizer, Inc. (Yeates, Tommy) (Entered: 03/18/2022), Defendant's Unopposed First Application for Extension of Time to Answer Complaint is granted pursuant to Local Rule CV-12 for Pfizer, Inc. to 4/22/2022. 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). Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. (kcv, ) (Entered: 12/09/2022), Minute Entry for proceedings held before District Judge Michael J. Truncale: Telephone Status Conference held on 12/13/2022. Brook Jackson (Anderson, Lexis) (Entered: 12/01/2022), NOTICE by Icon, PLC re 78 Opposed MOTION to Continue Discovery Deadlines and Memorandum of Law in Support Notice of Joinder in Pfizer's Motion to Continue Discovery Deadlines (Davis, Scott) (Entered: 12/02/2022), ORDER SETTING TELEPHONIC STATUS CONFERENCE. 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. 107. 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. Court will enter scheduling order. 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. 107. 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. On September 7, 2020, Brook Jackson began her employment with Ventavia Research Group (Ventavia) as a Regional Director. 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. 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. Bourla A. 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. It just seemed like something a little different from normalthe things that were allowed and expected.. This is notable because Ventavia has said she was not part of that team. It is conducting an evidence review 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). A whistleblower by the name of Brook Jackson brought some damning facts about Pfizer's COVID vaccine trial in front of the world in her explosive report on Wednesday, November 3. Both confirmed broad aspects of Jacksons complaint. Ive never had to do what they were asking me to do, ever, she told The BMJ. A lawsuit filed by whistleblower Brook Jackson alleging Pfizer and two of its contractors manipulated data and committed other acts of fraud during Pfizers COVID-19 During 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. 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. Ventavia fired her later the same day. (bjc, ) (Entered: 04/25/2022), ***FILED IN ERROR per attorney. Signed by District Judge Michael J. Truncale on 6/9/22. 5. (Attachments: # 1 Proposed Order)(Davis, Scott) Modified on 5/18/2022 (kcv, ). (Mendenhall, Warner) Modified on 8/23/2022 (kcv, ). The allegations were investigated and determined to be unsubstantiated. ( Davis, Scott) Modified title on 4/11/2022 (kcv, ). 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. 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. The BMJ investigation conducted by Paul Thacker reveals inside reports and evidence by Jackson about Pfizer allegedly 'manipulating clinical trials'. Document # 37, motion to dismiss. 3729(a)), Jury Demand: Early and inadvertent unblinding may have occurred on a far wider scale. 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). Nine of the trials 153 sites were inspected. *** (kcv, ), NOTICE by Icon, PLC re 40 MOTION to Stay Motion to Stay Discovery and Memorandum in Support ; Notice of Joinder in Pfizer's Motion to Stay Discovery (Davis, Scott) (Entered: 05/18/2022), NOTICE of Attorney Appearance by Stacy Lee Brainin on behalf of Ventavia Research Group, LLC (Brainin, Stacy) (Entered: 05/19/2022), NOTICE of Attorney Appearance by Andrew Wade Guthrie on behalf of Ventavia Research Group, LLC (Guthrie, Andrew) (Entered: 05/19/2022), NOTICE of Attorney Appearance by Taryn McKenzie McDonald on behalf of Ventavia Research Group, LLC (McDonald, Taryn) (Entered: 05/19/2022), Submission of Proposed Agreed Docket Control/Scheduling order by Pfizer, Inc. . resulted in a series of federal court decisions in which fraud cases brought under the False Claims Act were dismissed. The employee, Brook Jackson, who worked as a regional director for Ventavia, is said to have reported her concerns to the FDA. Login for free View subscription options Counsel has been notified to refile documents. 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. (bjc, ), ORDER denying as moot 26 Motion for Extension of Time to Answer. ( 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. Ventavia takes research compliance, data integrity, and participant safety very seriously, and we stand behind our work supporting the development of life-saving vaccines. 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. 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. pic.twitter.com/VtqDLWTCo9. Lead Stories is a U.S. based fact checking website that is always looking for the latest false, misleading, deceptive or fraud I witnessed that's now impacted hundreds of millions of lives in the United States, as well as around the world. Feb. 28, 2023, Cause: Letter to John B Cole MD. Several documents show that Jackson worked on Pfizers clinical trial, Thacker wrote on Nov. 30. Final Pretrial Conference set for 3/28/2024 09:00 AM in Ctrm 2 (Beaumont) before District Judge Michael J. Truncale. To receive new posts and support my work, consider becoming a free or paid subscriber. She added that during her time at Ventavia the company expected a federal audit but that this never came. MARCS-CMS 611902. For information about our privacy practices, please visit our website. *** (kcv, ), ORDER granting the Relator's 63 Motion to Exceed Page Limit. Researcher Blows Whistle on Data Integrity Issues in Pfizers Vaccine Trial. "After repeatedly notifying Ventavia of poor laboratory management, patient safety concerns, and data integrity issues, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA," the BMJ article said. Subscribe to The Defender's Top News of the Day. (kcv, ) (Entered: 06/09/2022), NOTICE of Attorney Appearance by Warner Mendenhall on behalf of United States of America ex rel. CHD is planning many strategies, including legal, in an effort to defend the health of our children and obtain justice for those already injured. Filing fee $ 100, receipt number 0540-8872721. Our response is here, we stand by our reporting. The regional director for Ventavia, Jackson was fired immediately after she reported her concerns to the US Food and Drug Administration. Brook is a Clinical Research Auditor and Certified Clinical Research professional. *** 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. Signed by District Judge Michael J. Truncale on 6/9/22. The FDA said, without explicitly saying it, that the allegations don't change the agency's assessment of the vaccine's safety. pic.twitter.com/KmSpn2W5ui. More Than a Decade Later, Workers Battle Illness From Deepwater Horizon. 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. BioNTech shares traded on the NASDAQ exchange briefly plummeted to around $60. THANKS !!! Learn more by watching this The Last American Vagabond interview with Jackson: Childrens Health Defense asks members to contact their members of Congress to demand an investigation into why the FDA did not look into Jacksons complaints. 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. The whistleblower is Brook Jackson, previously a regional director at a Texas-based contract research organisation called Ventavia, who supplied an account to , vaccine experts said the claims are not Serious enough to jeopardize Pfizer data! 09:00 AM in Ctrm 2 ( Beaumont ) before District Judge Michael J. 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