(bjc, ), ORDER denying as moot 26 Motion for Extension of Time to Answer. ( Davis, Scott) Modified title on 4/11/2022 (kcv, ). Ventavia executives later questioned Jackson for taking the photos. (kcv, ) (Entered: 12/09/2022), Minute Entry for proceedings held before District Judge Michael J. Truncale: Telephone Status Conference held on 12/13/2022. 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. Pfizer delegated management of the clinical trial to subcontractor Defendant Icon PLC (Icon), an Irish clinical research organization. (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. 30 Days Granted for Deadline Extension. Brooke Jackson. 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. 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. that expanded the scope of a legal principle known as . 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. 8. 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. 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. And sometimes oversight occurs too late. Document # 21, Defendant's Unopposed First Application for Extension of Time to Answer Complaint was filed incorrectly with an attachment. . 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. Ventavia fired her later the same day. WebBrook Jackson, known as the COVID-19 Whistleblower, is under scrutiny over her allegations against her former employer, Ventavia Research Group (VRG), and Pfizer, *** (kcv, ), ORDER granting the Relator's 63 Motion to Exceed Page Limit. To: Ventavia Research Group & Lauren Foreman Re: Libel of Brook Jackson Demand: Retraction Brook Jackson whistleblower lawsuit allegations against Ventavia Pfizer and Icon, Defendants admit fraud by filing that fraud is not material to the contract. MARCS-CMS 611902. Launched in 2010, the RECAP extension is a free tool for your browser that helps us collect the content you see on CourtListener. clinical trials is paused following a motion by the defendants to dismiss the case. (Davis, Scott) (Entered: 06/07/2022), NOTICE by Ventavia Research Group, LLC re 54 Reply to Response to Motion, 52 Reply to Response to Motion -- Notice of Joinder in Pfizer and Icon's Replies in Support of Motions to Stay Discovery (Brainin, Stacy) (Entered: 06/07/2022), Minute Entry for proceedings held before District Judge Michael J. Truncale: Telephonic Status Conference held on 6/9/2022. (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. Subscribe to The Defender's Top News of the Day. (Entered: 08/22/2022), ***FILED IN ERROR. Lead Stories is a U.S. based fact checking website that is always looking for the latest false, misleading, deceptive or 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. The FDA said, without explicitly saying it, that the allegations don't change the agency's assessment of the vaccine's safety. 3. Brook Jackson is a former clinical trial auditor who was let go for 'raising her voice'. , whistleblowers can be rewarded for confidentially disclosing fraud that results in a financial loss to the federal government. *** 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. CourtListener is sponsored by the non-profit Free Law Project. 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. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). The whistleblower is Brook Jackson, previously a regional director at a Texas-based contract research organisation called Ventavia, who supplied an account to Brook Jackson worked as an operator of three of Pfizers Covid-19 vaccine clinical trials sites for 18 days. Citizens for Responsible Care and Research Incorporated (CIRCARE). (kcv, ) (Entered: 12/15/2022), Scheduling Order AND ~Util - Terminate Motions. 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 early 2020, when the Government declared COVID-19 a pandemic, I was working as the Director of Operations for a multi-state Site Management Organization. Michael Joseph Truncale, Date of Last Known Filing: Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails. The Food and Drug Administrations oversight of clinical trials. 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. EIN #26-0388604, 2016 - 2023 Children's Health Defense All Rights Reserved. Brook Jackson has over 20 years of experience carrying out clinical trials. (jmv, ), RESPONSE in Opposition re 40 MOTION to Stay Motion to Stay Discovery and Memorandum in Support filed by United States of America ex rel. Please select all the ways you would like to hear from Lead Stories LLC: You can unsubscribe at any time by clicking the link in the footer of our emails. Both confirmed broad aspects of Jacksons complaint. Show more. 4. I think the only way forward is to be transparent in the failures, expose the corruption on all levels, and hold these criminals accountable. Ventavia fired her later the same day. Signed by District Judge Michael J. Truncale on 2/10/22. But she said she was surprised that the agency failed to inspect Ventavia after an employee had filed a complaint. 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. 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. Become a Monthly Donor, Last Updated: WebRetraction Letter - Brook Jackson Contributed by Paul Thacker . (bmf, ), REPLY to Response to Motion re 40 MOTION to Stay Motion to Stay Discovery and Memorandum in Support filed by Icon, PLC. 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. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. Pfizer is a federal contractor because it signed multiple contracts with the U.S. government to provide COVID-19 vaccines and Paxlovid, a pill used to treat the virus. 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. This site requires JavaScript to run correctly. 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. Like. 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. 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. Document # 37, motion to dismiss. The Pfizer-BioNTech vaccine was authorized by the FDA in August, despite some concerns raised by medical experts. pic.twitter.com/KmSpn2W5ui. Please ignore. Ventavia ultimately enrolled about 1,500 clinical trial patients. from The Last American Vagabond:. 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_3" ).setAttribute( "value", ( new Date() ).getTime() ); The Defender is the news and views website for Children's Health Defense. Ventavia failed to report the majority of its clinical trial protocol and regulatory violations to Pfizer or the external Institutional Review Board. 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. Bioresearch monitoring. Based on what she saw, she brought suit against the Learn more about Mailchimp's privacy practices here. WebBrooke Jackson Ventavia Click A message to Gawler police and all SAPOL officers, agents, contractors. (Additional attachment(s) added on 4/11/2022: # 2 Text of Proposed Order) (kcv, ). 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. Her job was to oversee its clinical trial of Pfizers not 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 Several documents show that Jackson worked on Pfizers clinical trial, Thacker wrote on Nov. 30. For example. 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. Jackson also raised suspicions on the 'selection of Ventavia' to quickly ramp up Pfizer's COVID vaccine trial. FDA spokesperson Alison Hunt wrote in a November 10, 2021, email to Lead Stories that the FDA still declares that the benefits outweigh risks that come with Pfizer's vaccine. A regional director who was employed at the research organization Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, Added link to BMJ's open letter and our response. Another showed vaccine packaging materials with trial participants' identification numbers written on them left out in the open, potentially unblinding participants," the BMJ article stated. She was tasked with overseeing site management, patient enrollment, quality assurance completion, event reporting, corrective action plan creation, communication with management, and staff training completion at the Keller and Fort Worth sites. Competing interests: PDT has been doubly vaccinated with Pfizers vaccine. Brook Jackson knew things were wrong immediately after being hired in late 2020 by Ventavia Research Group. 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. (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. Ventavia takes research Use tab to navigate through the menu items. From Icon, PLC served on 3/16/2022, answer due 4/6/2022. 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. 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. *** (bjc, ), PLEASE IGNORE Notice of Docket Correction regarding Doc# 37 motion to dismiss. 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