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. (Mendenhall, Warner) (Additional attachment(s) added on 10/12/2022: # 1 Text of Proposed Order) (kcv, ). Signed by District Judge Michael J. Truncale on 8/23/22. 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. Feb. 28, 2023, 10:25 a.m. CST, Assigned To: Here is the CBER report I filed on 25Sep2020. 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. (bjc, ) (Entered: 05/05/2022), Order on Motion for Extension of Time to Answer, MOTION to Stay Motion to Stay Discovery and Memorandum in Support by Pfizer, Inc.. (Attachments: # 1 Exhibit, # 2 Text of Proposed Order)(Self, Meagan) (Entered: 05/17/2022), ***FILED IN ERROR. PFIZER REVEALS CONCERNS WITH DATA INTEGRITY VINDICATING PREVIOUS CLAIMS BROOK JACKSON INTERVIEW. 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. Donations are tax deductible to the full extent of the law. The next morning, 25 September 2020, Jackson called the FDA to warn about unsound practices in Pfizers clinical trial at Ventavia. 107. PLEASE IGNORE. If it had, it would have been told the employee's report was investigated but found wanting, the spokesperson said. Young Indian Cop Collapses, Dies Suddenly While Exercising at Gym; Heart Attack Caused by Covid-19 Vaccine? 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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. *** (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. . CourtListener, From 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. 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. (Entered: 05/17/2022), ***FILED IN ERROR. Pfizer's investigation did not identify any issues or concerns that would invalidate the data or jeopardize the integrity of the study. Learn more about Mailchimp's privacy practices here. To: Ventavia Research Group & Lauren Foreman Re: Libel of Brook Jackson Demand: Retraction 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. Filing fee $ 100, receipt number 0540-8872723. Ventavia takes research compliance, data integrity, and participant safety very seriously, and we stand behind our work supporting the development of life-saving vaccines. Early and inadvertent unblinding may have occurred on a far wider scale. Brook Jackson has over 20 years of experience carrying out clinical trials. Ventavia takes research Claim: Covid-19: Researcher blows the whistle on data integrity issues in Pfizers vaccine trial (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 FDA says its position is unchanged: The benefits of the Pfizer vaccine far outweigh rare side effects and the clinical trial data are solid. Retweet. See who is sharing it (it might even be your friends) and leave the link in the comments. Spotted something? 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. 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. (Additional attachment(s) added on 4/11/2022: # 3 Revised Proposed Order) (kcv, ). 3729(a)), Jury Demand: I dont know why theyre so afraid of them, she said. 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. 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. That moment led me to where I am today; A whistleblower who's fighting to hold those accountable for the. ), I dont think it was good clean data, the employee said of the data Ventavia generated for the Pfizer trial. Jul 2018. Final Pretrial Conference reset for 7/1/2024 at 09:00 AM in Ctrm 2 (Beaumont) before District Judge Michael J. Truncale. WebBrook Jackson - Former employee of the Ventavia Research Group/ Whistleblower: Brook Jackson - Former.. News video on One News Page on Monday, 21 March 2022. 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. She then emailed a complaint to the US Food and Drug The regional director for Ventavia, Jackson was fired immediately after she "One photo showed needles discarded in a plastic biohazard bag instead of a container box. 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. Documents show that problems had been going on for weeks. I'm talking about data integrity," she said from a phone number listed to a Dallas suburb. 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. inaccurate stories, videos or images going viral on the internet. Signed by District Judge Michael J. Truncale on 6/9/22. Tags: Another former Ventavia employee has confirmed that the company had been expecting a federal audit of its Pfizer vaccine trial - though this did not materialize, Brook Jackson repeatedly informed her superiors of poor laboratory management and patient safety and data integrity issues, Brook Jackson reported her concerns to the US Emails exposing Ventavias fear of an impending inspection by the U.S. Food and Drug Administration (FDA). For example. (Anderson, Lexis) (Entered: 03/01/2022), SUMMONS Returned Executed by United States of America ex rel. clinical trials is paused following a motion by the defendants to dismiss the case. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). Two former Ventavia employees spoke to The BMJ anonymously for fear of reprisal and loss of job prospects in the tightly knit research community. 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. (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. Jackson also raised suspicions on the 'selection of Ventavia' to quickly ramp up Pfizer's COVID vaccine trial. On September 8, 2020, I accepted a new position as Regional Director with a company named Ventavia Research Group. ***Defendant's Unopposed First Application for Extension of Time to Answer Complaint re Pfizer, Inc..( Yeates, Tommy) Modified on 3/18/2022 (kcv, ). Pfizer remained responsible for managing and quality checking all data for the entire clinical trial, per the trials protocol. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. Counsel has been notified. The Food and Drug Administrations oversight of clinical trials. On September 7, 2020, Brook Jackson began her employment with Ventavia Research Group (Ventavia) as a Regional Director. Copyright 2023 BMJ Publishing Group Ltd, Covid-19: Researcher blows the whistle on data integrity issues in Pfizers vaccine trial, https://www.pfizer.com/news/hot-topics/an_open_letter_from_pfizer_chairman_and_ceo_albert_bourla, https://www.citizen.org/wp-content/uploads/2442.pdf, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jon-b-cole-md-611902-05052021, https://www.oig.hhs.gov/oei/reports/oei-01-06-00160.pdf, https://www.fda.gov/media/145858/download, https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19, Birmingham and Solihull Mental Health NHS Foundation Trust: Consultant Psychiatrist General Adult - Northcroft CMHT, Brent Area Medical Centre: Salaried GP - Brent Area Medical Centre, Onebright Ltd: Consultant Psychiatrist (Neurodiversity) - Remote / London, The Royal Hospital for Neurodisability: Clinical Fellow, Womens, childrens & adolescents health. (Additional attachment(s) added on 4/11/2022: # 2 Text of Proposed Order) (kcv, ). 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. Docket for United States of America ex rel. (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, ). 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. From Free Law Project, a 501(c)(3) non-profit. Brook Jackson is a former clinical trial auditor who was let go for 'raising her voice'. (kcv, ) (Entered: 02/22/2022), WAIVER OF SERVICE Returned Executed by United States of America ex rel. EIN #26-0388604, 2016 - 2023 Children's Health Defense All Rights Reserved. Miss a day, miss a lot. One is an email with Jackson thanking Pfizers Dr. Arturo Alfaro for giving her access to the COVID-19 clinical trial software.. (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, ). (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. Like many, I had confidence and trust in a regulatory process and in the federal agencies in place to protect public health. 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!". In her 25 September email to the FDA Jackson wrote that Ventavia had enrolled more than 1000 participants at three sites. from The Last American Vagabond:. Update: In response to this fact check the BMJ published an open letter to Mark Zuckerberg. Court will enter scheduling order. Lauren Foreman, director of business development & communications, wrote: The accuser was employed for approximately two weeks in September 2020, and no part of her job responsibilities concerned the clinical trials at issue. (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. Former Pfizer-BioNTech coronavirus vaccine clinical trial participant Brooke Jackson has alleged scandalous irregularities and tampering that took place during Ventavia Research Group's trials of the medicine. They choose rather, to protect and serve the interests of powerful corporations and ignore the vaccine injuries and deaths. Public Citizen. Thacker first reported on Jacksons accusations against Ventavia in a Nov. 2 article in The BMJ. 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. More Than a Decade Later, Workers Battle Illness From Deepwater Horizon. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails. 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. An Interview With Ventavia and Pfizer-BioNTech COVID Vaccine Trial Whistleblower Brook Jackson 71 10 comments Sonia Elijah Author at Trial Site News | Investigative journalist and broadcaster Mar. Jackson was fired from her job the same day she filed a complaint with the FDA. The FDA said, without explicitly saying it, that the allegations don't change the agency's assessment of the vaccine's safety. I dedicated my near two decade career to helping get safe and effective therapeutics, vaccines, and devices to consumers. "Ventavia fired her later the same day." 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. (kcv, ) (Entered: 06/09/2022), NOTICE of Attorney Appearance by Warner Mendenhall on behalf of United States of America ex rel. Let us know!. Subscribe to The Defender's Top News of the Day. Final Pretrial Conference set for 3/28/2024 09:00 AM in Ctrm 2 (Beaumont) before District Judge Michael J. Truncale. 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. 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. (Anderson, Lexis) (Entered: 05/31/2022), MOTION to Dismiss 17 Amended Complaint by Ventavia Research Group, LLC. *** (bjc, ), PLEASE IGNORE Notice of Docket Correction regarding Doc# 37 motion to dismiss. . Brook Jackson . Our content exposes the corporations, elected officials, government agencies and individuals who put profits before people and planet. Nine of the trials 153 sites were inspected. Internet Archive, Consent to Proceed Before Magistrate Judge. 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. In May this year the FDA sent the triallist a warning letter that substantiated many of the claims in the complaints. Since Jackson reported problems with Ventavia to the FDA in September 2020, Pfizer has hired Ventavia as a research subcontractor on four other vaccine clinical trials (covid-19 vaccine in children and young adults, pregnant women, and a booster dose, as well an RSV vaccine trial; NCT04816643, NCT04754594, NCT04955626, NCT05035212). Signed by District Judge Michael J. Truncale on 12/9/22. know it, an executive stated. Like. The Pfizer-BioNTech vaccine was authorized by the FDA in August, despite some concerns raised by medical experts. 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 (Attachments: # 1 Text of Proposed Order)(kcv, ) Modified on 2/11/2022 (kcv, ). Jackson told The BMJ it was the first time she had been fired in her 20 year career in research. Subscribe to The Defender's Top News of the Day. Our response is here, we stand by our reporting. In the afternoon Ventavia fired Jacksondeemed not a good fit, according to her separation letter. To create additional alerts, please install the RECAP Extension or become a monthly donor. 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. 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. that expanded the scope of a legal principle known as . PLEASE IGNORE. A clinical trial delegation log listing Jackson as a participant. @Christi67158123. 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 ? Pfizer is a federal contractor because it signed, with the U.S. government to provide COVID-19 vaccines and. 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. Who is Ethan Hooper? BioNTech shares traded on the NASDAQ exchange briefly plummeted to around $60. Jackson, Ventavia, 2020 mRNA COVID-19 Pfizer. A regional director who was employed at the research organization Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, Brook Jackson. 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. she wrote in a November 9, 2021 response to a Kennedy tweet blasting Sesame Street. The next morning, 25 September 2020, Jackson called the FDA to warn about unsound practices in Pfizers clinical trial at Ventavia. It's free. If you might need an exception, please let us know. "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. CHD is planning many strategies, including legal, in an effort to defend the health of our children and obtain justice for those already injured. Ventavia ultimately enrolled about 1,500 clinical trial patients. What I documented and reported to my former employer and to Pfizer during an internal audit was dangerous and violated Federal law. 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. 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. Sign up to receive the Free Law Project newsletter with tips and announcements. (jmv, ), E-DISCOVERY ORDER. Volume of problems they were finding far wider scale what I documented and reported my. 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