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. Plaintiff, Jurisdiction Type: WebRetraction Letter - Brook Jackson Contributed by Paul Thacker . 9, 2022, 7:32 a.m. Brook Jackson. 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. 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). 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. 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. 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. (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. Brook Jackson . The company proactively notified the US Food and Drug Administration of the matter and informed the Institutional Review Board for the study. The employee, Brook Jackson, who worked as a regional director for Ventavia, is said to have reported her concerns to the FDA. We conducted a thorough investigation into the issues raised in accordance with Pfizer's quality management process related to clinical research. Learn more by watching this The Last American Vagabond interview with Jackson: Childrens Health Defense asks members to contact their members of Congress to demand an investigation into why the FDA did not look into Jacksons complaints. 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, Signed by District Judge Michael J. Truncale on 11/15/22. Brook Jackson. The BMJ investigation conducted by Paul Thacker reveals inside reports and evidence by Jackson about Pfizer allegedly 'manipulating clinical trials'. Lead Stories is a U.S. based fact checking website that is always looking for the latest false, misleading, deceptive or Ventavia failed to report the majority of its clinical trial protocol and regulatory violations to Pfizer or the external Institutional Review Board. Let us know!. "My story is not about whether the vaccine is efficacious. (bmf, ), REPLY to Response to Motion re 40 MOTION to Stay Motion to Stay Discovery and Memorandum in Support filed by Icon, PLC. ( 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. 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. Provenance and peer review: commissioned; externally peer reviewed. 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. (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, ), PLEASE IGNORE Notice of Docket Correction regarding Doc# 37 motion to dismiss. Competing interests: PDT has been doubly vaccinated with Pfizers vaccine. Jury Selection and Trial reset for 7/8/2024 at 09:00 AM in Ctrm 2 (Beaumont) before District Judge Michael J. Truncale. WebGuest: Brook Jackson - Former employee of the Ventavia Research Group/ Whistleblower The Corona Committee was formed by four lawyers. THANKS !!! (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. (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. A regional director who was employed at the research organization 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 3 trial. (Entered: 12/01/2022), NOTICE of Discovery Disclosure by United States of America ex rel. In her 25 September email to the FDA Jackson wrote that Ventavia had enrolled more than 1000 participants at three sites. A clinical trial delegation log listing Jackson as a participant. (kcv, ) (Entered: 02/11/2022), AMENDED COMPLAINT against All Defendants, filed by United States of America ex rel. 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. These protections become moot when fraud is proven, which is why whistleblower, Brooke Jacksons lawsuit against Pfizer is so important. The whistleblower is Brook Jackson, previously a regional director at a Texas-based contract research organisation called Ventavia, who supplied an account to 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. This was to be done to preserve the blinding of trial participants and all other site staff, including the principal investigator. Brook Jackson. 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. Your support is essential to CHDs successful mission. 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 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. (Lockhart, Michael) (Entered: 10/04/2022), MOTION for Leave to File Response to Statement of Interest by United States of America ex rel. Who is Ethan Hooper? EIN #26-0388604, 2016 - 2023 Children's Health Defense All Rights Reserved. Filing fee $ 100, receipt number 0540-8872723. Retweeted. Jackson spent two weeks in September 2020 as a regional manager overseeing vaccine trials Pfizer contracted Ventavia Research Group to perform. Learn more about Mailchimp's privacy practices here. This claim is not true. other violations of the clinical trial protocol, FDA regulations, and Federal Acquisition Regulations and their DoD supplements. 7. 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 Targeting of Ventavia staff for reporting these types of problems. Researcher Blows Whistle on Data Integrity Issues in Pfizers Vaccine Trial. Brook Jackson. Pfizer, Inc. served on 3/2/2022, answer due 3/23/2022. Ventavia takes research 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. Food and Drug Administration. Brook Jackson . document.getElementById( "ak_js_4" ).setAttribute( "value", ( new Date() ).getTime() ); Children's Health Defense is a 501(c)(3) non-profit organization. Counsel has been notified to refile documents. Thacker first reported on Jacksons accusations against Ventavia in a Nov. 2 article in The BMJ. However, at Ventavia, Jackson told The BMJ that drug assignment confirmation printouts were being left in participants charts, accessible to blinded personnel. Emails revealing that some Ventavia staff had falsified data. To receive new posts and support my work, consider becoming a free or paid subscriber. ), I dont think it was good clean data, the employee said of the data Ventavia generated for the Pfizer trial. 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. (Court Reporter Not Recorded.) It is conducting an evidence review (kcv, ) (Entered: 02/22/2022), WAIVER OF SERVICE Returned Executed by United States of America ex rel. Based on what she saw, she brought suit against the (Mendenhall, Warner) Modified on 8/23/2022 (kcv, ). 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!". Letter to Scott Gottlieb and Jerry Menikoff. 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. FDA takes key action in fight against covid-19 by issuing emergency use authorization for first covid-19 vaccine. 107. Filing fee $ 100, receipt number 0540-8872721. WebBrook Jackson, known as the COVID-19 Whistleblower, is under scrutiny over her allegations against her former employer, Ventavia Research Group (VRG), and Pfizer, 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. 3729(a)), Jury Demand: In 2007 the Department of Health and Human Services Office of the Inspector General released a report on FDAs oversight of clinical trials conducted between 2000 and 2005. Please note: your email address is provided to the journal, which may use this information for marketing purposes. Our mission is to end corruption to save democracy. One of them was one of the officials who had taken part in the late September meeting. 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. Citizen News is a reader-supported publication. (Entered: 05/17/2022), ***FILED IN ERROR. (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. Brook Jackson. More Than a Decade Later, Workers Battle Illness From Deepwater Horizon. 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. The employee, Brook Jackson, repeatedly notified Ventavia of her concerns according to the BMJ. If it had, it would have been told the employee's report was investigated but found wanting, the spokesperson said. Brook began her employment with Ventavia on September 8, 2020 as a Regional Director on the Phase 3 trial of the Pfizer Covid-19 vaccine, supervising two of Ventavia's three clinical trial sites. Pfizer's investigation did not identify any issues or concerns that would invalidate the data or jeopardize the integrity of the study. 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 authorized in the U.S. Our content exposes the corporations, elected officials, government agencies and individuals who put profits before people and planet. Public Citizen. (Entered: 04/15/2022), NOTICE of Attorney Appearance by Meagan Dyer Self on behalf of Pfizer, Inc. (Self, Meagan) (Entered: 04/18/2022), NOTICE of Attorney Appearance - Pro Hac Vice by Carlton Wessel on behalf of Pfizer, Inc.. Filing fee $ 100, receipt number 0540-8878471. 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. BMJ relied on copies of reports filed by a two-week employee of Ventavia. However, most have not run corrections, despite overwhelming evidence contradicting their statements. 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. Ventavia managed 3 of 153 sites at which the trial was carried out. Ventavia is not owned by Pfizer. 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. "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. Reply. 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. 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. 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. Monthly donors can create unlimited docket alerts. 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. Pfizer had offloaded the clinical trial work onto what is known as a Contract Research Organisation (CRO). The FDA never followed up with an inspection. 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. Brook is a Clinical Research Auditor and Certified Clinical Research professional. She heard nothing further in relation to her report. 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. 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. By clicking below to subscribe, you acknowledge that your information will be transferred to Mailchimp for processing. Added link to BMJ's open letter and our response. 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. If you are unable to import citations, please contact (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. (kcv, ) (Entered: 12/09/2022), Minute Entry for proceedings held before District Judge Michael J. Truncale: Telephone Status Conference held on 12/13/2022. Phone texts and emails among Ventavia staff discussing a hectic environment and sloppy documentation.. Update: In response to this fact check the BMJ published an open letter to Mark Zuckerberg. Bioresearch monitoring. An open letter from Pfizer chairman and CEO Albert Bourla. We do not capture any email address. You currently have alerts. To read the piece in its entirety,click here. China News Service, November 3, reported that the British Medical Journal (BMJ) quoted Brooke Jackson, the former regional director of Ventavia Research in the United States, as saying that in the fall of 2020, Ventavia will conduct a trial for Pfizer's new crown vaccine in Texas. WebBrook Jackson is a clinical trial researcher based out of Texas. 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. CourtListener is sponsored by the non-profit Free Law Project. . 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. Reports filed by a two-week employee of Ventavia investigated but found wanting, the spokesperson said matter informed. Or concerns that would invalidate the data Ventavia generated for the study note indicates Ctrm 2 ( )... Later, Workers Battle Illness From Deepwater Horizon is why Whistleblower, Brooke Jacksons lawsuit against Pfizer is so.. Email to the FDA Jackson wrote that Ventavia had enrolled more than a Decade,... Contributed by Paul Thacker reveals inside reports and evidence by Jackson about Pfizer 'manipulating. Entry, a note indicates 3 of 153 sites at which the trial carried. Group/ Whistleblower the Corona Committee was formed by four lawyers Corona Committee was by. Clicking below to subscribe, you acknowledge that your information will be transferred to Mailchimp for processing served. Issuing emergency use authorization for first covid-19 vaccine Acquisition regulations and their DoD supplements, filed by States! 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Please IGNORE Notice of Docket Correction regarding Doc # 37 motion to dismiss may use this information for marketing..