(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 Notice and Motion should also be filed separately per Local Rules. 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. document.getElementById( "ak_js_4" ).setAttribute( "value", ( new Date() ).getTime() ); Children's Health Defense is a 501(c)(3) non-profit organization. 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. According to the trials design, unblinded staff were responsible for preparing and administering the study drug (Pfizers vaccine or a placebo). WebBrooke Jackson Ventavia Click A message to Gawler police and all SAPOL officers, agents, contractors. document.getElementById( "ak_js_3" ).setAttribute( "value", ( new Date() ).getTime() ); The Defender is the news and views website for Children's Health Defense. 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. Bioresearch monitoring. 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. Your support is essential to CHDs successful mission. 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. They choose rather, to protect and serve the interests of powerful corporations and ignore the vaccine injuries and deaths. Ventavia executives later questioned Jackson for taking the photos. To: Ventavia Research Group & Lauren Foreman Re: Libel of Brook Jackson Demand: Retraction (kcv, ) (Entered: 12/09/2022), Minute Entry for proceedings held before District Judge Michael J. Truncale: Telephone Status Conference held on 12/13/2022. 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. Like. Please note: your email address is provided to the journal, which may use this information for marketing purposes. Letter to Scott Gottlieb and Jerry Menikoff. 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. 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. (Attachments: # 1 Declaration of Taryn M. McDonald, # 2 Exhibit 1, # 3 Exhibit 2, # 4 Exhibit 3, # 5 Exhibit 4, # 6 Exhibit 5, # 7 Exhibit 6, # 8 Exhibit 7, # 9 Exhibit 8, # 10 Text of Proposed Order)(Brainin, Stacy) Modified related document on 6/7/2022 (kcv, ). In an interview with The Defender, Jacksons lawyer said Pfizer argued the lawsuit, which was filed under the False Claims Act, should be dismissed because the U.S. government knew of the wrongdoings in the clinical trials but continued to do business with the vaccine maker. Signed by District Judge Michael J. Truncale on 12/15/22. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). Final Pretrial Conference set for 3/28/2024 09:00 AM in Ctrm 2 (Beaumont) before District Judge Michael J. Truncale. The employee, Brook Jackson, repeatedly notified Ventavia of her concerns according to the BMJ. Ventavia managed 3 of 153 sites at which the trial was carried out. (Court Reporter None.) Signed by District Judge Michael J. Truncale on 11/15/22. 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. PLEASE IGNORE. 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. (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. 6. know it, an executive stated. 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. Letter to John B Cole MD. During our last interview Brook discussed 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. Pfizer and Icon turned a blind eye to Ventavias misconduct, despite numerous warning signs. p. 1. 9, 2022, 7:32 a.m. 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 clinical trials is paused following a motion by the defendants to dismiss the case. (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. The allegations were investigated and determined to be unsubstantiated. This question is for testing whether or not you are a human visitor and to prevent automated spam submissions. (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. Pfizer said it has reviewed the claims and found them to be unproven. The vaccine has been given to hundreds of millions of people worldwide following approval. 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. 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, In May this year the FDA sent the triallist a warning letter that substantiated many of the claims in the complaints. 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. *** (bjc, ), PLEASE IGNORE Notice of Docket Correction regarding Doc# 37 motion to dismiss. (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. FDA takes key action in fight against covid-19 by issuing emergency use authorization for first covid-19 vaccine. Jackson was fired from her job the same day she filed a complaint with the FDA. Docket for United States of America ex rel. Pfizer had offloaded the clinical trial work onto what is known as a Contract Research Organisation (CRO). Emails exposing Ventavias fear of an impending inspection by the U.S. Food and Drug Administration (FDA). If you are not a monthly donor, we allow five alerts and give a bonus of 10 alerts to anybody with the RECAP Extension installed. (Entered: 01/18/2022), ORDER on the Government's 13 Notice of Election to Decline Intervention. According to Jackson's reports, Texas Contractor, Ventavia Research Group held unblinding phase III vaccine trial, leading to the vaccine's approval and deployment of insufficiently or not at all trained vaccinators. Documents show that problems had been going on for weeks. (Anderson, Lexis) (Additional attachment(s) added on 8/23/2022: # 1 Text of Proposed Order) (kcv, ). inaccurate stories, videos or images going viral on the internet. *** (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. . 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. WebGuest: Brook Jackson - Former employee of the Ventavia Research Group/ Whistleblower The Corona Committee was formed by four lawyers. In an interview with The Defender, the lawyer representing whistleblower Brook Jackson said Pfizer is arguing the court should dismiss Jacksons lawsuit alleging fraud in Pfizers COVID-19 clinical trials because the U.S. government knew about the wrongdoings but continued to do business with the vaccine maker. The BMJ investigation conducted by Paul Thacker reveals inside reports and evidence by Jackson about Pfizer allegedly 'manipulating clinical trials'. 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. She then emailed a complaint to the US Food and Drug She then reported her (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. 13. Issues were improperly documented or hidden away in notes to the file, and not corrected. If you are unable to import citations, please contact 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 claims they can get away with fraud as long as the government would write them a check despite knowing about the fraud, attorney Robert Barnes said.. Brook Jackson has over 20 years of experience carrying out clinical trials. Ventavia was compensated by Pfizer mainly on a per-patient basisup to a weekly limitand rushed to enroll as many clinical trial participants as possible per week. Webapartments in dallas that allow airbnb Uncovering hot babes since 1919. THANKS !!! 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. (Mendenhall, Warner) (Entered: 08/22/2022), ***FILED IN ERROR. Brook Jackson. Document # 21, Defendant's Unopposed First Application for Extension of Time to Answer Complaint was filed incorrectly with an attachment. Jury Selection and Trial reset for 7/8/2024 at 09:00 AM in Ctrm 2 (Beaumont) before District Judge Michael J. Truncale. 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. fraud I witnessed that's now impacted hundreds of millions of lives in the United States, as well as around the world. (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. (kcv, ) (Entered: 06/09/2022), SCHEDULING ORDER granting in part the 40 MOTION to Stay Discovery. Signed by District Judge Michael J. Truncale on 5/4/2022. 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. Her job was to oversee its clinical trial of Pfizers not BUY NOW: Ed Dowds Must-Read Book Cause Unknown. Signed by District Judge Michael J. Truncale on 4/22/2022. Brooke Jackson. 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. (kcv, ), MOTION of Election to Decline Intervention by SEALED Movant. Competing interests: PDT has been doubly vaccinated with Pfizers vaccine. VIDEO: Joining me today is Brook Jackson, the whistleblower who sat down with The Last American Vagabond for her first video interview on December 2, 2021, to Within hours Jackson received an email from the FDA thanking her for her concerns and notifying her that the FDA could not comment on any investigation that might result. She said she is fully vaccinated and is not an anti-vaccine activist. *** (kcv, ), ORDER granting the Relator's 63 Motion to Exceed Page Limit. Pfizer, aiming for the title of first successful COVID-19 vaccine, pushed Ventavia to enroll as many patients as possible in the vaccine trial as quickly as possible. (Brainin, Stacy) (Entered: 09/20/2022), REPLY to Response to Motion re 51 MOTION to Dismiss Relator's Amended Complaint filed by Icon, PLC. WebBrook Jackson, known as the COVID-19 Whistleblower, is under scrutiny over her allegations against her former employer, Ventavia Research Group (VRG), and Pfizer, For example. (Additional attachment(s) added on 4/11/2022: # 3 Revised Proposed Order) (kcv, ). 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. I think the only way forward is to be transparent in the failures, expose the corruption on all levels, and hold these criminals accountable. U.S. Government Plaintiff, Filing fee: $ 402, receipt number TXE100020949 (kcv, ), Unsealed by 16 OrderCOMPLAINT against SEALED 1 deft, and SEALED 2 deft, filed by SEALED pltf. : 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. stupidamerkin says: October 24, 2022 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. We conducted a thorough investigation into the issues raised in accordance with Pfizer's quality management process related to clinical research. Joining me today is Brook Jackson, the whistleblower who sat down with The Last American Vagabond for her first video interview on December 2, 2021, to expose serious data integrity issues during the Pfizer trial for the COVID-19 injection, and providing all the source material to prove her claims. 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. Ventavia spokeswoman Lauren Foreman said in a statement that the company is investigating the allegations made by Jackson. In my mind, its something new every day, a Ventavia executive says. 13. (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. Pfizer remained responsible for managing and quality checking all data for the entire clinical trial, per the trials protocol. ", Ventavia spokesperson Lauren Foreman discredited Jackson's claims. 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. 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. A former Ventavia employee told The BMJ that the company was nervous and expecting a federal audit of its Pfizer vaccine trial. When it comes to the FDA and clinical trials, Elizabeth Woeckner, president of Citizens for Responsible Care and Research Incorporated (CIRCARE),3 says the agencys oversight capacity is severely under-resourced. . (Attachments: # 1 Proposed Order)(Davis, Scott) Modified on 5/18/2022 (kcv, ). 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. Signed by District Judge Michael J. Truncale on 4/13/22. Court will enter scheduling order. By week 3 of her employment, Brook had Ventavia Research Group, LLC waiver sent on 2/25/2022, answer due 4/26/2022. Both confirmed broad aspects of Jacksons complaint. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails. 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 Her Twitter account, which was created in September 2021, includes recent posts about the BMJ report as well as others that support some elements of vaccine resistance. 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. 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. Early and inadvertent unblinding may have occurred on a far wider scale. Brook Jackson. (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, ). 30 Days Granted for Deadline Extension. 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. Relator shall have until October 27, 2022 to respond. Filing fee $ 100, receipt number 0540-8872762. Bourla A. Counsel has been notified to refile documents. inaccurate stories, videos or images going viral on the internet. Ventavia takes research 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). (Additional attachment(s) added on 4/11/2022: # 2 Text of Proposed Order) (kcv, ). Jackson has contacted media organizations that have published these false allegations, sharing documentation that shows her work on the trial, and asking for corrections.. 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. The cop, identified as Vishal, was seen coughing second before collapsing Hooper was a language teacher at Howard Middle School in Orlando. 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. Part of my responsibility was to ensure the rights, safety, and welfare of the people volunteering to be in the study was protected, and that the information collected from each of them was supported by the highest data integrity standards. Pfizer delegated management of the clinical trial to subcontractor Defendant Icon PLC (Icon), an Irish clinical research organization. Signed by District Judge Michael J. Truncale on 7/29/22. ***Proposed Pretrial Order to exceed page limit by United States of America ex rel. Newly released documents support whistleblower Brook Jacksons claims she was directly involved in Pfizers COVID vaccine phase 3 clinical trials, but Pfizer contractor, Ventavia Research Group, and media refuse to retract statements to the contrary. Phone texts and emails among Ventavia staff discussing a hectic environment and sloppy documentation.. 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. Reply. Newly released documents support whistleblower Brook Jacksons claims she was directly involved in Pfizers COVID vaccine phase 3 clinical trials, but Pfizer PLEASE IGNORE. (Mendenhall, Warner) (Additional attachment(s) added on 10/12/2022: # 1 Text of Proposed Order) (kcv, ). 30 Days Granted for Deadline Extension. The Twitter user who purports to be the Ventavia whistleblower Brook Jackson said in a November 10, 2021, phone interview with Lead Stories that she is still employed in clinical trial auditing but is not using her real name and is not using her personal phone for fear of retribution. Our response is here, we stand by our reporting. We do not capture any email address. *** (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, ). Drevets, who heads the infectious diseases department at University of Oklahoma Health Sciences Center, said the millions of doses administered more than prove this: there have been so many other studies of the Pfizer COVID-19 vaccine since the Phase III trial that people can be confident in its efficacy and safety profile. Employee told the BMJ investigation conducted by Paul Thacker reveals inside reports and evidence Jackson. Of Pfizers not BUY now: Ed Dowds Must-Read Book Cause Unknown new every day a... Was formed by four lawyers misconduct, despite numerous warning signs file, and not corrected Beaumont ) before Judge. The clinical trial to subcontractor Defendant Icon PLC ( Icon ), Order in. 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