What I documented and reported to my former employer and to Pfizer during an internal audit was dangerous and violated Federal law. An open letter from Pfizer chairman and CEO Albert Bourla. 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, (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". : 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. (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. (Attachments: # 1 Proposed Order)(Davis, Scott) Modified on 5/18/2022 (kcv, ). One is an email with Jackson thanking Pfizers Dr. Arturo Alfaro for giving her access to the COVID-19 clinical trial software.. (Court Reporter Not Recorded.) In one example CIRCARE and the US consumer advocacy organisation Public Citizen, along with dozens of public health experts, filed a detailed complaint in July 2018 with the FDA about a clinical trial that failed to comply with regulations for the protection of human participants.4 Nine months later, in April 2019, an FDA investigator inspected the clinical site. (kcv, ) (Entered: 02/22/2022), WAIVER OF SERVICE Returned Executed by United States of America ex rel. Your support is essential to CHDs successful mission. 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. Signed by District Judge Michael J. Truncale on 6/9/22. 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. 3 replies 13 retweets 107 likes. Paul D Thacker reports, 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. Skip to (kcv, ) (Entered: 06/09/2022), NOTICE of Attorney Appearance by Warner Mendenhall on behalf of United States of America ex rel. Jury Selection and Trial reset for 7/8/2024 at 09:00 AM in Ctrm 2 (Beaumont) before District Judge Michael J. Truncale. Brook Jackson. Our mission is to end corruption to save democracy. Feb. 28, 2023, Cause: PLEASE IGNORE. By week 3 of her employment, Brook had Sign up for free news and updates from Robert F. Kennedy, Jr. and Childrens Health Defense. This is notable because Ventavia has said she was not part of that team. (Mendenhall, Warner) Modified on 8/23/2022 (kcv, ). Jackson spent two weeks in September 2020 as a regional manager overseeing vaccine trials Pfizer contracted Ventavia Research Group to perform. Court will enter scheduling order. (Brainin, Stacy) (Entered: 09/20/2022), REPLY to Response to Motion re 51 MOTION to Dismiss Relator's Amended Complaint filed by Icon, PLC. Foreman noted that Jackson was employed "for approximately 2 weeks in September 2020, and no part of her job responsibilities concerned the clinical trials at issue. In her 25 September email to the FDA Jackson wrote that Ventavia had enrolled more than 1000 participants at three sites. Final Pretrial Conference set for 3/28/2024 09:00 AM in Ctrm 2 (Beaumont) before District Judge Michael J. Truncale. 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. The company proactively notified the US Food and Drug Administration of the matter and informed the Institutional Review Board for the study. The Notice and Motion should also be filed separately per Local Rules. And sometimes oversight occurs too late. The FDAs inspection officer noted: The data integrity and verification portion of the BIMO [bioresearch monitoring] inspections were limited because the study was ongoing, and the data required for verification and comparison were not yet available to the IND [investigational new drug]., In recent months Jackson has reconnected with several former Ventavia employees who all left or were fired from the company. CourtListener is sponsored by the non-profit Free Law Project. (kcv, ) (Entered: 07/29/2022), Order on Motion for Extension of Time to File Response/Reply, ORDER denying as moot 50 Motion to Dismiss. "As I've 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 authorised in the United States.1 But, for researchers who were testing Pfizer's vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety. These protections become moot when fraud is proven, which is why whistleblower, Brooke Jacksons lawsuit against Pfizer is so important. (Entered: 01/08/2021), DEMAND for Trial by Jury by SEALED pltf. Signed by District Judge Michael J. Truncale on 5/4/2022. A second employee also described an environment at Ventavia unlike any she had experienced in her 20 years doing research. Filing fee $ 100, receipt number 0540-8872723. It said, [I]t appears that you did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations and the protection of human subjects.5. Become a Monthly Donor, Last Updated: 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. She then emailed a complaint to the US Food and Drug 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. Brook Jackson. We can sometimes provide need-based exceptions to these rules. (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. Brook Jackson is a former clinical trial auditor who was let go for 'raising her voice'. . NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. Two former Ventavia employees spoke to The BMJ anonymously for fear of reprisal and loss of job prospects in the tightly knit research community. Signed by District Judge Michael J. Truncale on 2/10/22. We conducted a thorough investigation into the issues raised in accordance with Pfizer's quality management process related to clinical research. That moment led me to where I am today; A whistleblower who's fighting to hold those accountable for thefraud I witnessed that's now impacted hundreds of millions of lives in the United States, as well as around the world. A former Ventavia employee told The BMJ that the company was nervous and expecting a federal audit of its Pfizer vaccine trial. 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 authorised in the United States.1. Launched in 2010, the RECAP extension is a free tool for your browser that helps us collect the content you see on CourtListener. The report, published in The British Medical Journal alleged that Pfizer failed to duly monitor and pursue incidents of adverse events during the vaccine trial and even falsified reports. She told The BMJ that, shortly after Ventavia fired Jackson, Pfizer was notified of problems at Ventavia with the vaccine trial and that an audit took place. (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, ). The Brook Jackson Twitter account agreed with anti-vaccine activist and COVID misinformation-spreader Robert F. Kennedy, Jr.'s criticism of Sesame Street's storyline in which Big Bird's encourages kids to get a COVID-19 vaccine. That moment led me to where I am today; A whistleblower who's fighting to hold those accountable for the. Brook Jackson knew things were wrong immediately after being hired in late 2020 by Ventavia Research Group. Were going to get some kind of letter of information at least, when the FDA gets here . *** 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. Both confirmed broad aspects of Jacksons complaint. 9, 2022, 7:32 a.m. Ventavia spokeswoman Lauren Foreman said in a statement that the company is investigating the allegations made by Jackson. BMJ relied on copies of reports filed by a two-week employee of Ventavia. Food and Drug Administration. (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, ). 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. "Shocking, actually." Such an analysis would give added confidence in the Phase III results. *** (kcv, ), ORDER granting the Relator's 63 Motion to Exceed Page Limit. 30 Days Granted for Deadline Extension. . Counsel has been notified. WebBrooke Jackson Ventavia Click A message to Gawler police and all SAPOL officers, agents, contractors. (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. Document # 37, motion to dismiss. A spokesperson for Texas-based Ventavia Research Group wrote in a November 10, 2021, email to Lead Stories that BMJ did not seek comment in advance of the report. 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. For example. Plaintiff, Jurisdiction Type: 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. (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. Install RECAP Signed by District Judge Michael J. Truncale on 12/15/22. document.getElementById( "ak_js_3" ).setAttribute( "value", ( new Date() ).getTime() ); The Defender is the news and views website for Children's Health Defense. CROs work on a fee-for-service basis, and they have grown like , whistleblowers can be rewarded for confidentially disclosing fraud that results in a financial loss to the federal government. (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, ). Ventavia employed Relator Jackson as a Regional Director. Laboratory confirmed symptomatic covid-19 was the trials primary endpoint, the employee noted. 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 (Lockhart, Michael) (Entered: 10/04/2022), MOTION for Leave to File Response to Statement of Interest by United States of America ex rel. Icon, PLC served on 3/16/2022, answer due 4/6/2022. WebBrook Jackson is a clinical trial researcher based out of Texas. 3729(a)), Jury Demand: "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. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails. Ventavia. Department of Health and Human Services Office of Inspector General. (bjc, ), ORDER denying as moot 26 Motion for Extension of Time to Answer. 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 ? Competing interests: PDT has been doubly vaccinated with Pfizers vaccine. (Mendenhall, Warner) (Entered: 08/22/2022), ***FILED IN ERROR. From Free Law Project, a 501(c)(3) non-profit. It is conducting an evidence review Pfizer remained responsible for managing and quality checking all data for the entire clinical trial, per the trials protocol. Michigan Student Killed by 14-Year-Old and 13-Year-Old Boys in Attempted Carjacking After Offering Them Ride to Home. More Than a Decade Later, Workers Battle Illness From Deepwater Horizon. Medical experts disagree with claims that this contretemps calls into question the results of the Pfizer clinical trial. Brook Jackson worked as an operator of three of Pfizers Covid-19 vaccine clinical trials sites for 18 days.
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