Donations are tax deductible to the full extent of the law. 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. 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 Pfizer's pivotal phase III trial. However, at Ventavia, Jackson told The BMJ that drug assignment confirmation printouts were being left in participants charts, accessible to blinded personnel. Once installed, anything you buy on PACER gets automatically added to the RECAP Archive and anything another RECAP user has bought is automatically free to you. 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. ICON reminded Ventavia in a September 2020 email: The expectation for this study is that all queries are addressed within 24hrs. ICON then highlighted over 100 outstanding queries older than three days in yellow. Emails exposing Ventavias fear of an impending inspection by the U.S. Food and Drug Administration (FDA). document.getElementById( "ak_js_4" ).setAttribute( "value", ( new Date() ).getTime() ); Children's Health Defense is a 501(c)(3) non-profit organization. A regional director who was employed at the research organization Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, 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. (kcv, ) (Entered: 06/09/2022), PROTECTIVE ORDER. May 2021. 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. 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. 5. What I documented and reported to my former employer and to Pfizer during an internal audit was dangerous and violated Federal law. 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. 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. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. Editors note:Heres an excerpt from an article in The BMJ. Several documents show that Jackson worked on Pfizers clinical trial, Thacker wrote on Nov. 30. The employee, Brook Jackson, repeatedly notified Ventavia of her concerns according to the BMJ. Signed by District Judge Michael J. Truncale on 6/9/22. PLEASE IGNORE. You currently have alerts. ( 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. Spotted something? I dont know why theyre so afraid of them, she said. 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. (jmv, ), AMENDED SCHEDULING ORDER granting 78 Defendants' Motion to Continue Discovery Deadlines. Please, filed by whistleblower Brook Jackson alleging Pfizer and two of its contractors manipulated data and committed other. Signed by District Judge Michael J. Truncale on 4/22/2022. If you might need an exception, please let us know. Ventavia employed Relator Jackson as a Regional Director. If the FDA receives a complaint about a clinical trial, she says the agency rarely has the staff available to show up and inspect. Citizens for Responsible Care and Research Incorporated (CIRCARE). Brook Jackson knew things were wrong immediately after being hired in late 2020 by Ventavia Research Group. The company proactively notified the US Food and Drug Administration of the matter and informed the Institutional Review Board for the study. Please ignore. Letter to Scott Gottlieb and Jerry Menikoff. FDA takes key action in fight against covid-19 by issuing emergency use authorization for first covid-19 vaccine. Exasperated that Ventavia was not dealing with the problems, Jackson documented several matters late one night, taking photos on her mobile phone. I'm talking about data integrity," she said from a phone number listed to a Dallas suburb. A leading force in clinical research trials. Dec 2020. 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. Enough is enough! (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, ). The article said that ( kcv, ), SUMMONS Returned Executed by United States of America ex rel. This was to be done to preserve the blinding of trial participants and all other site staff, including the principal investigator. Let us know!. 107. Signed by District Judge Michael J. Truncale on 5/4/2022. Signed by District Judge Michael J. Truncale on 12/9/22. Ventavia Research Group, LLC waiver sent on 2/25/2022, answer due 4/26/2022. 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. Did the British Medical Association's news blog reveal flaws that disqualify the results of a contractor's field testing of Pfizer's COVID-19 vaccine, and were the problems ignored by the Food & Drug Administration and by Pfizer? 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. (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. (Anderson, Lexis) (Entered: 03/02/2022), ***FILED IN ERROR. Michigan Student Killed by 14-Year-Old and 13-Year-Old Boys in Attempted Carjacking After Offering Them Ride to Home. Skip to These protections become moot when fraud is proven, which is why whistleblower, Brooke Jacksons lawsuit against Pfizer is so important. Brook Jackson . Brook Jackson. We conducted a thorough investigation into the issues raised in accordance with Pfizer's quality management process related to clinical research. ), I dont think it was good clean data, the employee said of the data Ventavia generated for the Pfizer trial. 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. The regional director for Ventavia, Jackson was fired immediately after she 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. document.getElementById( "ak_js_3" ).setAttribute( "value", ( new Date() ).getTime() ); The Defender is the news and views website for Children's Health Defense. 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. Our content exposes the corporations, elected officials, government agencies and individuals who put profits before people and planet. They Want BP to Pay. PFIZER REVEALS CONCERNS WITH DATA INTEGRITY VINDICATING PREVIOUS CLAIMS BROOK JACKSON INTERVIEW. 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. (Anderson, Lexis) (Entered: 03/22/2022), Defendant's Unopposed First Application for Extension of Time to Answer Complaint re Icon, PLC. (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. Issues were improperly documented or hidden away in notes to the file, and not corrected. 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. (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. Provenance and peer review: commissioned; externally peer reviewed. Please ignore. she wrote in a November 9, 2021 response to a Kennedy tweet blasting Sesame Street. Monthly donors can create unlimited docket alerts. Bioresearch monitoring. Brook Jackson. "Ventavia fired her later the same day." In September 2020 she was hired by Ventavia as a Regional Director for clinical trial sites 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. 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. Sep 2007. CourtListener is sponsored by the non-profit Free Law Project. (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. More Than a Decade Later, Workers Battle Illness From Deepwater Horizon. Login for free View subscription options Our response is here, we stand by our reporting. The employee, Brook Jackson, who worked as a regional director for Ventavia, is said to have reported her concerns to the FDA. 8. 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. All attorneys are ordered to participate in the conference. 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. This claim is not true. Feb. 28, 2023, Cause: (Attachments: # 1 Text of Proposed Order)(Davis, Scott) (Entered: 10/18/2022), ORDER granting the 73 Unopposed Motion toWithdraw Peter Linken as Counsel. Hunt wrote: Although the agency cannot comment further at this time in this ongoing matter, FDA has full confidence in the data that were used to support the Pfizer-BioNTech COVID-19 Vaccine authorization and the Comirnaty approval. 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. Ventavia takes research 30 Days Granted for Deadline Extension. Food and Drug Administration. 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. I dedicated my near two decade career to helping get safe and effective therapeutics, vaccines, and devices to consumers. Jackson also raised suspicions on the 'selection of Ventavia' to quickly ramp up Pfizer's COVID vaccine trial. . Signed by District Judge Michael J. Truncale on 8/23/22. (Attachments: # 1 Proposed Order)(Davis, Scott) Modified on 5/18/2022 (kcv, ). WebGuest: Brook Jackson - Former employee of the Ventavia Research Group/ Whistleblower The Corona Committee was formed by four lawyers. (Court Reporter None.) The FDAs inspection officer noted: The data integrity and verification portion of the BIMO [bioresearch monitoring] inspections were limited because the study was ongoing, and the data required for verification and comparison were not yet available to the IND [investigational new drug]., In recent months Jackson has reconnected with several former Ventavia employees who all left or were fired from the company. One said that she had worked on over four dozen clinical trials in her career, including many large trials, but had never experienced such a helter skelter work environment as with Ventavia on Pfizers trial. On September 8, 2020, I accepted a new position as Regional Director with a company named Ventavia Research Group. Were going to get some kind of letter of information at least, when the FDA gets here . It's free. Jackson, Ventavia, 2020 mRNA COVID-19 Pfizer. 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. 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. 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. (kcv, ) (Entered: 06/09/2022), SCHEDULING ORDER granting in part the 40 MOTION to Stay Discovery. (Linken, Peter) (Entered: 04/12/2022), NOTICE of Attorney Appearance - Pro Hac Vice by Tammy Roy on behalf of Icon, PLC. My main responsibility was to oversee the conduct of Pfizer's Phase 3 Covid-19 mRNA "vaccine" trial at several locations in Texas. (Lockhart, Michael) (Entered: 10/04/2022), MOTION for Leave to File Response to Statement of Interest by United States of America ex rel. Pfizer's investigation did not identify any issues or concerns that would invalidate the data or jeopardize the integrity of the study. 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