(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. 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. Miss a day, miss a lot. The BMJ investigative report has now alleged that the documentation of the clinical trials that Pfizer submitted to the FDA is brimming with data reporting errors and clinical trial misconduct. (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. Pfizer had offloaded the clinical trial work onto what is known as a Contract Research Organisation (CRO). You currently have alerts. Modified related document on 6/7/2022 (kcv, ). Icon was tasked with oversight of over 160 test sites worldwide, ensuring trial protocol compliance, and ensuring reporting of required information. Ventavia. fabrication and falsification of blood draw information, vital signs, signatures and other essential clinical trial data; enrollment and injection of ineligible clinical trial participants, including Ventavia employees family members; failure to timely remove ineligible patients data from the trial; failure to maintain temperature control for the vaccine at issue; failure to monitor patients after injection as required by the trial protocol; principal investigator oversight failures; use of unqualified and untrained personnel as vaccinators and laboratory personnel; failure to maintain the blind as required, which is essential to the credibility and validity of the observer-blinded clinical trial; ethical violations, such as failure to secure informed consent and giving patients unapproved compensation; improper injection of the vaccine (i.e., by over-diluting vaccine concentrate or using the wrong needle size); failure to ensure that trial site staff were properly trained as required by good clinical practices; safety and confidentiality issues, including HIPAA violations; and. Please ignore. The whistleblower is Brook Jackson, previously a regional director at a Texas-based contract research organisation called Ventavia, who supplied an account to Learn more about Mailchimp's privacy practices here. Michael Joseph Truncale, Date of Last Known Filing: Several documents show that Jackson worked on Pfizers clinical trial, Thacker wrote on Nov. 30. (bjc, ) (Entered: 04/25/2022), ***FILED IN ERROR per attorney. . Document # 37, motion to dismiss. Pfizer, Inc. served on 3/2/2022, answer due 3/23/2022. 7. EPA Green Lights Climate-Friendly Fuel From Discarded Plastics Despite High Cancer Risk, Fake Meat: Another Attempt for Global Control of the Food Supply, Mainstream Media Exposes The Real Anthony Fauci, Selfie Campaign I Know the Real Anthony Fauci. PLEASE IGNORE. Targeting of Ventavia staff for reporting these types of problems. 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. 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. The regional director for Ventavia, Jackson was fired immediately after she Brook Jackson has over 20 years of experience carrying out clinical trials. 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. No, that's not true: Pfizer and the FDA were made aware of the allegations about the contractor in 2020. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. Nine of the trials 153 sites were inspected. (Anderson, Lexis) (Entered: 03/01/2022), SUMMONS Returned Executed by United States of America ex rel. We know that its significant., Ventavia was not keeping up with data entry queries, shows an email sent by ICON, the contract research organisation with which Pfizer partnered on the trial. (Court Reporter Not Recorded.) Subscribe to The Defender's Top News of the Day. CROs work on a fee-for-service basis, and they have grown like However, in statements to other media outlets, Ventavia has claimed that its former employee Jackson did not work on Pfizers COVID-19 vaccine clinical trial. clinical trials is paused following a motion by the defendants to dismiss the case. We do not capture any email address. But she said she was surprised that the agency failed to inspect Ventavia after an employee had filed a complaint. Pfizer and Icon turned a blind eye to Ventavias misconduct, despite numerous warning signs. Brook Jackson. ( Davis, Scott) Modified title on 4/11/2022 (kcv, ). Such an analysis would give added confidence in the Phase III results. Filing fee $ 100, receipt number 0540-8872762. Subscribe to The Defender's Top News of the Day. (Mendenhall, Warner) (Additional attachment(s) added on 10/12/2022: # 1 Text of Proposed Order) (kcv, ). Jury Selection and Trial reset for 7/8/2024 at 09:00 AM in Ctrm 2 (Beaumont) before District Judge Michael J. Truncale. ( 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. She then reported her (kcv, ) (Entered: 12/15/2022), Scheduling Order AND ~Util - Terminate Motions. (Entered: 12/01/2022), NOTICE of Discovery Disclosure by United States of America ex rel. ( kcv, ), Defendant's Unopposed Motion to Extend Time to Answer or Otherwise Respond to Complaint by Icon, PLC. 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. 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. Brook Jackson, a trained clinical trial auditor with more than 15 years experience in clinical research coordination and management, worked for Ventavia Research Group of Texas for two weeks in September, 2020 and was fired the day she raised her concerns to the U.S. Food and Drug Administration (FDA). 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. 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. Your support is essential to CHDs successful mission. Brook Jackson . Webin the united states district court for the eastern district of texas beaumont division united states of america ex rel. However, most have not run corrections, despite overwhelming evidence contradicting their statements. (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. They Want BP to Pay. 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. Theres just a complete lack of oversight of contract research organisations and independent clinical research facilities, says Jill Fisher, professor of social medicine at the University of North Carolina School of Medicine and author of Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials. I'm talking about data integrity," she said from a phone number listed to a Dallas suburb. 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. stupidamerkin says: October 24, 2022 (Linken, Peter) (Entered: 04/12/2022), NOTICE of Attorney Appearance - Pro Hac Vice by Tammy Roy on behalf of Icon, PLC. Ventavia fired her later the same day. 376 Qui Tam (31 U.S.C. 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.. Examples included two individuals for which Subject has reported with Severe symptoms/reactions Per protocol, subjects experiencing Grade 3 local reactions should be contacted. The allegations were investigated and determined to be unsubstantiated. Pfizer's investigation did not identify any issues or concerns that would invalidate the data or jeopardize the integrity of the study. To: Ventavia Research Group & Lauren Foreman Re: Libel of Brook Jackson Demand: Retraction Who is Ethan Hooper? Brook Jackson . 13. CourtListener is sponsored by the non-profit Free Law Project. However, at Ventavia, Jackson told The BMJ that drug assignment confirmation printouts were being left in participants charts, accessible to blinded personnel. , whistleblowers can be rewarded for confidentially disclosing fraud that results in a financial loss to the federal government. ", Pfizer also released a statement and said it was "disappointed by the recent article published by the British Medical Journal that failed to contact us prior to publication and selectively reported certain claims with the goal of undermining confidence in a vaccine that has been given to hundreds of millions of people worldwide.". 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. BMJ relied on copies of reports filed by a two-week employee of Ventavia. (Anderson, Lexis) (Additional attachment(s) added on 8/23/2022: # 1 Text of Proposed Order) (kcv, ). Please ignore. (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, ). (bjc, ) (Entered: 08/12/2022), MOTION for Leave to File Excess Pages by United States of America ex rel. 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. Filing fee $ 100, receipt number 0540-8872721. Obviously we don't agree. WebBrook Jackson is a clinical trial researcher based out of Texas. 6. Citizens for Responsible Care and Research Incorporated (CIRCARE). 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. fraud I witnessed that's now impacted hundreds of millions of lives in the United States, as well as around the world. That moment led me to where I am today; A whistleblower who's fighting to hold those accountable for the. (Entered: 05/17/2022), ***FILED IN ERROR. Learn more about Mailchimp's privacy practices here. PFIZER REVEALS CONCERNS WITH DATA INTEGRITY VINDICATING PREVIOUS CLAIMS BROOK JACKSON INTERVIEW. (kcv, ) (Entered: 06/09/2022), PROTECTIVE ORDER. 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. 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. A former clinical trial auditor with 20 years experience, Brook lost her position as regional director for Ventavia, a clinical trial firm contracted by Pfizer to run clinical trials of its Covid-19 vaccine candidate, after she reported her concerns about Document # 41, Motion to Stay and Notice of Joinder do not contain the required Certificate of Conference. (jmv, ), AMENDED SCHEDULING ORDER granting 78 Defendants' Motion to Continue Discovery Deadlines. 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. Newly released documents back up claims by whistleblower Brook Jackson that she was directly involved in Pfizers COVID vaccine phase 3 clinical trials, which she previously alleged were seriously flawed. All attorneys are ordered to participate in the conference. Brook is a Clinical Research Auditor and Certified Clinical Research professional. (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, ). It just seemed like something a little different from normalthe things that were allowed and expected.. The Food and Drug Administrations oversight of clinical trials. Journalist Article Quality journalism costs money to produce. By clicking below to subscribe, you acknowledge that your information will be transferred to Mailchimp for processing. . (Court Reporter None.) (Lockhart, Michael) (Entered: 10/04/2022), MOTION for Leave to File Response to Statement of Interest by United States of America ex rel. As interpreted 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. I dedicated my near two decade career to helping get safe and effective therapeutics, vaccines, and devices to consumers. Want something more? What I documented and reported to my former employer and to Pfizer during an internal audit was dangerous and violated Federal law. 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 WebRetraction Letter - Brook Jackson Contributed by Paul Thacker . Since September 2020, I have worked around the clock, focused solely on compiling evidence for my legal team and to bring awareness to injuries and harms caused by the mRNA COVID-19 products. According to the trials design, unblinded staff were responsible for preparing and administering the study drug (Pfizers vaccine or a placebo). Competing interests: PDT has been doubly vaccinated with Pfizers vaccine. Editors note:Heres an excerpt from an article in The BMJ. Please, filed by whistleblower Brook Jackson alleging Pfizer and two of its contractors manipulated data and committed other. The company proactively notified the US Food and Drug Administration of the matter and informed the Institutional Review Board for the study. 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. Food and Drug Administration. See who is sharing it (it might even be your friends) and leave the link in the comments. 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. If you are unable to import citations, please contact Donations are tax deductible to the full extent of the law. @Christi67158123. These same accusations were made a year ago, at which time Ventavia notified the appropriate parties. ***Defendant's Unopposed First Application for Extension of Time to Answer Complaint re Pfizer, Inc..( Yeates, Tommy) Modified on 3/18/2022 (kcv, ). Please confirm if an UNPLANNED CONTACT was made and update the corresponding form as appropriate. According to the trial protocol a telephone contact should have occurred to ascertain further details and determine whether a site visit is clinically indicated.. 3729(a)), Jury Demand: Telephonic Status Conference set for 12/13/2022 at 05:00 PM before District Judge Michael J. Truncale. On September 7, 2020, Brook Jackson began her employment with Ventavia Research Group (Ventavia) as a Regional Director. Internet Archive, Consent to Proceed Before Magistrate Judge. It is conducting an evidence review (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. Dec 2020. 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". During our last interview Brook discussed From For example. Ventavia executives later questioned Jackson for taking the photos. 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. (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. 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. 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. Responses due by 6/20/2022 (Attachments: # 1 Text of Proposed Order)(Davis, Scott) Modified related document on 6/7/2022 (kcv, ). We use Mailchimp as our marketing platform. Our response is here, we stand by our reporting. 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. Two former Ventavia employees spoke to The BMJ anonymously for fear of reprisal and loss of job prospects in the tightly knit research community. (Roy, Tammy) (Entered: 04/12/2022), ORDER directing the parties to conduct a Rule 26(f) Attorney Conference by May 3, 2022. Counsel has been notified. Sign up for free news and updates from Robert F. Kennedy, Jr. and Childrens Health Defense. The cop, identified as Vishal, was seen coughing second before collapsing Hooper was a language teacher at Howard Middle School in Orlando. Laboratory confirmed symptomatic covid-19 was the trials primary endpoint, the employee noted. Public Citizen. Jackson has contacted media organizations that have published these false allegations, sharing documentation that shows her work on the trial, and asking for corrections.. 30 Days Granted for Deadline Extension. Added link to BMJ's open letter and our response. Ventavia ultimately enrolled about 1,500 clinical trial patients. ", Ventavia spokesperson Lauren Foreman discredited Jackson's claims. This claim is not true. 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 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. 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. FDA takes key action in fight against covid-19 by issuing emergency use authorization for first covid-19 vaccine. "Ventavia fired her later the same day." Young Indian Cop Collapses, Dies Suddenly While Exercising at Gym; Heart Attack Caused by Covid-19 Vaccine? Install RECAP In addition to the emails to Alfaro and Livingston, Jackson released: Thacker said his Nov. 2 article was picked up by more than 91 media organizations, and Jackson asked for corrections from many of those media organizations that stated she wasnt involved in the trials. Whistleblower Brook Jackson tells The BMJ about her experience working on the Pfizer covid-19 vaccine trial. 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