It's free. I felt that I had a responsibility to make sure that the participants were protected and that the fraudulent data being collected in the study was not used in any safety and efficacy analysis. Liked. Miss a day, miss a lot. stupidamerkin says: October 24, 2022 Yet according to investigative journalist Paul D. Thacker, despite the new documented proof, Ventavia Research Group the Texas-based company Pfizer hired to conduct the pivotal trial has so far refused to retract statements the company made to the media alleging Jackson had no direct involvement. (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. 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. Several documents show that Jackson worked on Pfizers clinical trial, Thacker wrote on Nov. 30. 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. 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. I dedicated my near two decade career to helping get safe and effective therapeutics, vaccines, and devices to consumers. Filing fee $ 100, receipt number 0540-8872723. (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 title and associated document on 6/8/2022 (kcv, ). To create additional alerts, please install the RECAP Extension or become a monthly donor. Ventavia fired her later the same day. 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. Under the False Claims Act, whistleblowers can be rewarded for confidentially disclosing fraud that results in a financial loss to the federal government. (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. ", Ventavia spokesperson Lauren Foreman discredited Jackson's claims. The Notice and Motion should also be filed separately per Local Rules. (Anderson, Lexis) (Additional attachment(s) added on 8/23/2022: # 1 Text of Proposed Order) (kcv, ). . We conducted a thorough investigation into the issues raised in accordance with Pfizer's quality management process related to clinical research. 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. 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. Documents show that problems had been going on for weeks. Please note: your email address is provided to the journal, which may use this information for marketing purposes. Thacker first reported on Jacksons accusations against Ventavia in a Nov. 2 article in The BMJ. (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's free. Brook Jackson . Ventavia executives later questioned Jackson for taking the photos. Webapartments in dallas that allow airbnb Uncovering hot babes since 1919. That moment led me to where I am today; A whistleblower who's fighting to hold those accountable for the. The report further stated that Jackson "provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails," some of which depict "poor laboratory management" by the firm. (Anderson, Lexis) (Entered: 05/31/2022), MOTION to Dismiss 17 Amended Complaint by Ventavia Research Group, LLC. 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. For example. Brook Jackson (Mendenhall, Warner) (Entered: 07/22/2022), Unopposed MOTION for Extension of Time to File Response/Reply by United States of America ex rel. Our response is here, we stand by our reporting. *** (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. . Issues were improperly documented or hidden away in notes to the file, and not corrected. "Shocking, actually." 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. "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. 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. Counsel has been notified to refile documents. For information about our privacy practices, please visit our website. Internet Archive, Consent to Proceed Before Magistrate Judge. 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 Most recently, he wrote the twice-weekly "Save the Free Press" column for The Seattle Times. To: Ventavia Research Group & Lauren Foreman Re: Libel of Brook Jackson Demand: Retraction The FDA said, without explicitly saying it, that the allegations don't change the agency's assessment of the vaccine's safety. 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. What I documented and reported to my former employer and to Pfizer during an internal audit was dangerous and violated Federal law. Ventavia responded by denying Jackson had worked on the Pfizer trials. Citizen News is a reader-supported publication. Brook Jackson . If you are unable to import citations, please contact Brook Jackson . Elsewhere on Twitter, the Brook Jackson account wrote that vaccination makes sense if a person is in a high-risk category and called a 5th Circuit Court of Appeals ruling against the Biden Administration's vaccine mandates "HUGE!". (Mendenhall, Warner) (Entered: 11/29/2022), REPLY to Response to Motion re 78 Opposed MOTION to Continue Discovery Deadlines and Memorandum of Law in Support filed by Pfizer, Inc.. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E)(Wessel, Carlton) (Entered: 12/01/2022), DECLARATION of Meagan D. Self in Support of 81 REPLY to Response to Motion re 78 Opposed MOTION to Continue Discovery Deadlines and Memorandum of Law in Support filed by Pfizer, Inc.. (Wessel, Carlton) Modified title and associated document on 12/2/2022 (kcv, ). document.getElementById( "ak_js_3" ).setAttribute( "value", ( new Date() ).getTime() ); The Defender is the news and views website for Children's Health Defense. Sep 2007. Launched in 2010, the RECAP extension is a free tool for your browser that helps us collect the content you see on CourtListener. By week 3 of her employment, Brook had Jackson, Ventavia, 2020 mRNA COVID-19 Pfizer. (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. Paul D Thacker reports In autumn 2020 Pfizer's 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. (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. Show more. inaccurate stories, videos or images going viral on the internet. During (Entered: 12/01/2022), NOTICE of Discovery Disclosure by United States of America ex rel. 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. (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. 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. Retweeted. 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. 31:3730 Qui Tam False Claims Act, Nature of Suit: Jury Selection and Trial reset for 7/8/2024 at 09:00 AM in Ctrm 2 (Beaumont) before District Judge Michael J. Truncale. 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. The employee, Brook Jackson, who worked as a regional director for Ventavia, is said to have reported her concerns to the FDA. Ventavia Research Group, LLC waiver sent on 2/25/2022, answer due 4/26/2022. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. 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. FDA takes key action in fight against covid-19 by issuing emergency use authorization for first covid-19 vaccine. Medical experts disagree with claims that this contretemps calls into question the results of the Pfizer clinical trial. (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, ). Please ignore. The company proactively notified the US Food and Drug Administration of the matter and informed the Institutional Review Board for the study. , whistleblowers can be rewarded for confidentially disclosing fraud that results in a financial loss to the federal government. 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. Jury Selection and Trial set for 4/1/2024 09:00 AM in Ctrm 2 (Beaumont) before District Judge Michael J. Truncale. A regional director with Ventavia Research Group told The BMJ Pfizer falsified data, unblinded patients, employed inadequately trained vaccinators and was slow to follow up on adverse events reported in Pfizers pivotal COVID Vaccine phase 3 trial. Icon, PLC served on 3/16/2022, answer due 4/6/2022. . WebRetraction Letter - Brook Jackson Contributed by Paul Thacker . *** (kcv, ), ORDER granting the Relator's 63 Motion to Exceed Page Limit. Both confirmed broad aspects of Jacksons complaint. May 2021. tweet Brooke Jackson, Pfizer. 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. An insightful, engaging interview with Brook Jackson recorded during the summer of 2022. 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. clinical trials is paused following a motion by the defendants to dismiss the case. Pfizer said it has reviewed the claims and found them to be unproven. (jmv, ), E-DISCOVERY ORDER. In a November 10, 2021, email to Lead Stories, Pfizer senior manager for science media relations, Kit Longley, detailed Pfizer's response to the claims: Pfizer received communication from an anonymous complainant in September 2020 relating to a single clinical investigator site in Texas, USA. Please ignore. Relator shall have until October 27, 2022 to respond. 9, 2022, 7:32 a.m. Newly released documents support whistleblower Brook Jacksons claims she was directly involved in Pfizers COVID vaccine phase 3 clinical trials, but Pfizer 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. Spotted something? Pfizer is a federal contractor because it signed, with the U.S. government to provide COVID-19 vaccines and. Early and inadvertent unblinding may have occurred on a far wider scale. 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. brook jackson, plaintiff, v. ventavia research group, llc; pfizer EIN #26-0388604, 2016 - 2023 Children's Health Defense All Rights Reserved. Like many, I had confidence and trust in a regulatory process and in the federal agencies in place to protect public health. 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 BMJ article says a former Ventavia worker named Brook Jackson told The BMJ that Ventavia falsified data, "unblinded" patients and employed inadequately trained vaccinators. (Entered: 11/28/2022), RESPONSE in Opposition re 78 Opposed MOTION to Continue Discovery Deadlines and Memorandum of Law in Support filed by United States of America ex rel. (Mendenhall, Warner) (Additional attachment(s) added on 10/12/2022: # 1 Text of Proposed Order) (kcv, ). Signed by District Judge Michael J. Truncale on 4/13/22. I'm talking about data integrity," she said from a phone number listed to a Dallas suburb. Citizens for Responsible Care and Research Incorporated (CIRCARE). A leading force in clinical research trials. After a Harvard Nieman Fellowship, he served as Director of Stony Brook University's Center for News Literacy for six years, then as Senior Vice President/Content at Connecticut Public Broadcasting. More Than a Decade Later, Workers Battle Illness From Deepwater Horizon. (Additional attachment(s) added on 4/11/2022: # 3 Revised Proposed Order) (kcv, ). (bjc, ) (Entered: 08/12/2022), MOTION for Leave to File Excess Pages by United States of America ex rel. During our last interview Brook discussed Ventavia employed Relator Jackson as a Regional Director. Donations are tax deductible to the full extent of the law. 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. 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. Learn more about the alliance here. Brook Jackson . 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. Signed by District Judge Michael J. Truncale on 10/19/22. We use Mailchimp as our marketing platform. (Attachments: # 1 Exhibits 1-10, # 2 Exhibits 11-20, # 3 Exhibits 21-29)(Anderson, Lexis) (Entered: 02/22/2022), SUMMONS Issued as to Icon, PLC, Pfizer, Inc., and Ventavia Research Group, LLC and sent via email to Plaintiff's counsel for service. According to a police officer who spoke to the media, the attack was Snyder, who was remembered in his obituary as a "well-rounded student Ending booster shot dilemma: Lancet study says third Covid jab not needed, International Business Times, Singapore Edition, SHOCKING: Man Rapes Dog Inside Park in India as Delhi Police Refuse to Arrest Suspect [GRAPHIC], Dilbert Comic Strip Gets Canceled by Hundreds of Newspapers Over Creator Scott Adams' 'Racist Rant', East Meets West: Two Spirits Industry Visionaries Join Forces to Bring Portfolio of Unique, Super-Premium, Hand-Crafted Japanese Spirits to the US Market, 'Never-Ending War of Attrition': Thousands Rally in Germany Calling for End to Weapons Supply to Ukraine, Camilla Will Officially Be Called 'Queen' and Not 'Queen Consort' after King Charles' Coronation, 'Confused' Joe Biden Says 'Who is Zooming Who' When Asked About East Palestine Visit? 107. Defendant Ventavia Research Group, LLC (Ventavia) was contracted by Pfizer to provide three Phase 3 test sites for the vaccine trial in Houston, Fort Worth, and Keller, Texas. Florida Teacher Suspended After He Made White Students Act as Servants For Black Students, Who Was Abby Choi? 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. : 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. 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. Pfizer, Inc. served on 3/2/2022, answer due 3/23/2022. 107. 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. Related to clinical Research Ventavia in a regulatory process and in the BMJ many, I confidence... The number of trial participants Ventavia enrolled of the 46,000 overall by District Judge Michael J. on... Notice and Motion should also be filed separately per Local Rules discredited Jackson 's claims Care... 3 of her employment, Brook had Jackson, Ventavia spokesperson Lauren Foreman discredited Jackson claims... To Dismiss 17 Amended Complaint by Ventavia Research Group, LLC Act whistleblowers... 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