Jackson, Ventavia, 2020 mRNA COVID-19 Pfizer. (Mendenhall, Warner) (Additional attachment(s) added on 10/12/2022: # 1 Text of Proposed Order) (kcv, ). (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. 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. 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. Emails exposing Ventavias fear of an impending inspection by the U.S. Food and Drug Administration (FDA). I dedicated my near two decade career to helping get safe and effective therapeutics, vaccines, and devices to consumers. Both confirmed broad aspects of Jacksons complaint. Login for free View subscription options . 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. Bourla A. Public Citizen. 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. 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. Like many, I had confidence and trust in a regulatory process and in the federal agencies in place to protect public health. Document # 37, motion to dismiss. Under the False Claims Act, whistleblowers can be rewarded for confidentially disclosing fraud that results in a financial loss to the federal government. 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. Attorney Appearances: Plaintiff - Robert Barnes, Lexis Anderson, Warner Mendenhall and pltf Brook Jackson; Defense - Stacy Brainin, Andrew Guthrie, Taryn McDonald, Carlton Wessel, Andrew Hoffman II, Jack Carroll, Meagan Self, Elai Katz, Scott Davis. Internet Archive, Consent to Proceed Before Magistrate Judge. This claim is not true. Doesn't Recall Speaking With Mayor. (Anderson, Lexis) (Additional attachment(s) added on 8/23/2022: # 1 Text of Proposed Order) (kcv, ). We also published an article titled "Context Matters: Why Lead Stories Fact Checked The BMJ" to further clarify the reasons for the fact check after the BMJ published another article claiming this was an case where "fact checking goes wrong". Jackson told The BMJ it was the first time she had been fired in her 20 year career in research. (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. (bjc, ) (Entered: 04/25/2022), ***FILED IN ERROR per attorney. Our mission is to end corruption to save democracy. The BMJ investigation conducted by Paul Thacker reveals inside reports and evidence by Jackson about Pfizer allegedly 'manipulating clinical trials'. Its mission is to end childhood health epidemics by working aggressively to eliminate harmful exposures, hold those responsible accountable, and to establish safeguards to prevent future harm. (kcv, ), MOTION of Election to Decline Intervention by SEALED Movant. Become a Monthly Donor, Last Updated: Please ignore. Ventavia fired her later the same day. (Hoffman, Andrew) (Entered: 04/18/2022), MOTION to Dismiss 17 Relator's Amended Complaint and Memorandum of Law in Support by Pfizer, Inc.. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E, # 6 Exhibit F, # 7 Text of Proposed Order)(Wessel, Carlton) Modified on 4/25/2022 (bjc, ). The Pfizer-BioNTech vaccine was authorized by the FDA in August, despite some concerns raised by medical experts. Brook Jackson . ( kcv, ), Defendant's Unopposed Motion to Extend Time to Answer or Otherwise Respond to Complaint by Icon, PLC. (Attachments: # 1 Text of Proposed Order)(kcv, ) Modified on 2/11/2022 (kcv, ). (kcv, ) (Entered: 07/29/2022), Order on Motion for Extension of Time to File Response/Reply, ORDER denying as moot 50 Motion to Dismiss. Counsel has been notified. Pfizer had offloaded the clinical trial work onto what is known as a Contract Research Organisation (CRO). However, most have not run corrections, despite overwhelming evidence contradicting their statements. 13. Brook Jackson. (Entered: 06/06/2022), MOTION to Dismiss 17 Relator's Amended Complaint by Icon, PLC. Newly released documents support whistleblower Brook Jacksons claims she was directly involved in Pfizers COVID vaccine phase 3 clinical trials, but Pfizer 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. 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. "My story is not about whether the vaccine is efficacious. 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. In my mind, its something new every day, a Ventavia executive says. Based on what she saw, she brought suit against the Let us know!. Subscribe to The Defender's Top News of the Day. Monthly donors can create unlimited docket alerts. One of them was one of the officials who had taken part in the late September meeting. CourtListener is sponsored by the non-profit Free Law Project. 3 replies 13 retweets 107 likes. To read the piece in its entirety,click here. ***Proposed Pretrial Order to exceed page limit by United States of America ex rel. That moment led me to where I am today; A whistleblower who's fighting to hold those accountable for the. Relator shall have until October 27, 2022 to respond. It just seemed like something a little different from normalthe things that were allowed and expected.. They Want BP to Pay. BioNTech shares traded on the NASDAQ exchange briefly plummeted to around $60. That said, Pfizer might be wise to re-run their analysis excluding all Ventavia subjects and show if that does/does not change the results. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails. 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. Jackson was fired from her job the same day she filed a complaint with the FDA. 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. (kcv, ) (Entered: 11/16/2022), Opposed MOTION to Continue Discovery Deadlines and Memorandum of Law in Support by Pfizer, Inc.. (Attachments: # 1 Text of Proposed Order)(Wessel, Carlton) (Entered: 11/22/2022), NOTICE of Joinder by Ventavia Research Group, LLC in 78 Opposed MOTION to Continue Discovery Deadlines and Memorandum of Law in Support (Brainin, Stacy) Modified on 11/29/2022 (tkd, ). Please, filed by whistleblower Brook Jackson alleging Pfizer and two of its contractors manipulated data and committed other. https://leadstories.com/hoax-alert/2021/11/fact-check-british-medical-journal-did-not-reveal-disqualifying-and-ignored-reports-of-flaws-in-pfizer-vaccine-trial.html, Fact Check: Three States Did NOT Pull CNN'S Broadcasting License -- As A Cable Network, CNN Is 'Non-Broadcasting', Fact Check: This Video Of Argument Over Vaccination Status On A Plane Is NOT Real -- It's An Ad-Eligible Skit Film With Actors, Context Matters: Why Lead Stories Fact Checked The BMJ, Covid-19: Researcher blows the whistle on data integrity issues in Pfizer's vaccine trial, wrote that vaccination makes sense if a person is in a high-risk category, Verified signatory of the IFCN Code of Principles, Facebook Third-Party Fact-Checking Partner. 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. This was to be done to preserve the blinding of trial participants and all other site staff, including the principal investigator. (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, ). Since September 2020, I have worked around the clock, focused solely on compiling evidence for my legal team and to bring awareness to injuries and harms caused by the mRNA COVID-19 products. 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. Show more. Ventavia failed to report the majority of its clinical trial protocol and regulatory violations to Pfizer or the external Institutional Review Board. Jul 2018. (Lockhart, Michael) (Entered: 10/04/2022), MOTION for Leave to File Response to Statement of Interest by United States of America ex rel. (kcv, ) (Entered: 12/15/2022), Scheduling Order AND ~Util - Terminate Motions. 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. Brook Jackson is a former clinical trial auditor who was let go for 'raising her voice'. 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. In a second email, Ventavias Mercedes Livingston invites Jackson and other staff to a clean up call on Pfizers clinical trial. 9, 2022, 7:32 a.m. Reply. 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. Responding to comments and inquiries on Twitter, Jackson wrote in a November 9, 2021, tweet: "The organizational failures listed in the BMJ, although not exhaustive, led to violations that were repeated and deliberate, and the reliability and integrity of the data have been comprised.". "Shocking, actually." Filing fee $ 100, receipt number 0540-8872762. These protections become moot when fraud is proven, which is why whistleblower, Brooke Jacksons lawsuit against Pfizer is so important. In an article in MedPage, vaccine experts said the claims are not serious enough to jeopardize Pfizer's data. 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. Responses due by 6/20/2022 (Attachments: # 1 Text of Proposed Order)(Davis, Scott) Modified related document on 6/7/2022 (kcv, ). Please confirm if an UNPLANNED CONTACT was made and update the corresponding form as appropriate. According to the trial protocol a telephone contact should have occurred to ascertain further details and determine whether a site visit is clinically indicated.. inaccurate stories, videos or images going viral on the internet. 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. Your support is essential to CHDs successful mission. In a text message sent in June the former official apologised, saying that everything that you complained about was spot on.. (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. Sign up for free news and updates from Robert F. Kennedy, Jr. and Childrens Health Defense. clinical trials is paused following a motion by the defendants to dismiss the case. All signed consent forms, excluding pro se parties, should be filed electronically using the event Notice Regarding Consent to Proceed Before Magistrate Judge cc via email: pltf's atty. 107. brook jackson, plaintiff, v. ventavia research group, llc; pfizer (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), Unopposed Application for Extension of Time to Answer Complaint, Application Granted for Extension of Time to Answer Complaint, ***FILED IN ERROR. 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. To create additional alerts, please install the RECAP Extension or become a monthly donor. She said she holds a certificate in clinical trial auditing from Barnett International, which offers a 30-hour course. Our response is here, we stand by our reporting. Brook Jackson, a trained clinical trial auditor with more than 15 years experience in clinical research coordination and management, worked for Ventavia Research Group of Texas for two weeks in September, 2020 and was fired the day she raised her concerns to the U.S. Food and Drug Administration (FDA). Docket alerts are an advanced feature of CourtListener. A second employee also described an environment at Ventavia unlike any she had experienced in her 20 years doing research. (Mendenhall, Warner) (Entered: 08/22/2022), ***FILED IN ERROR. 376 Qui Tam (31 U.S.C. Ventavias race to maximize payment and over-booking of patients resulted in sloppy and fraudulent documentation practices, poor clinical trial protocol compliance, and little oversight. 30 Days Granted for Deadline Extension. 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. 3729(a)), Jury Demand: She told The BMJ that, shortly after Ventavia fired Jackson, Pfizer was notified of problems at Ventavia with the vaccine trial and that an audit took place. 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. This site requires JavaScript to run correctly. A clinical trial delegation log listing Jackson as a participant. Signed by District Judge Michael J. Truncale on 4/13/22. 3. Brook Jackson. 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. Spotted something? "Ventavia fired her later the same day." In several cases Ventavia lacked enough employees to swab all trial participants who reported covid-like symptoms, to test for infection. Donations are tax deductible to the full extent of the law. Miss a day, miss a lot. An insightful, engaging interview with Brook Jackson recorded during the summer of 2022. 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. Pfizer claims they can get away with fraud as long as the government would write them a check despite knowing about the fraud, attorney Robert Barnes said.. Her job was to oversee its clinical trial of Pfizers not FDA takes key action in fight against covid-19 by issuing emergency use authorization for first covid-19 vaccine. Ventavia is not owned by Pfizer. The next morning, 25 September 2020, Jackson called the FDA to warn about unsound practices in Pfizers clinical trial at Ventavia. (Attachments: # 1 Civil Cover Sheet, # 2 Exhibits 1-10, # 3 Exhibits 11-20, # 4 Exhibits 21-29)(kcv, ) Modified on 2/17/2022 (tkd, ). 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. Emails revealing that some Ventavia staff had falsified data. 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. Ventavia responded by denying Jackson had worked on the Pfizer trials. Ventavia fired her later the same day. The whistleblower is Brook Jackson, previously a regional director at a Texas-based contract research organisation called Ventavia, who supplied an account to Were going to get some kind of letter of information at least, when the FDA gets here . Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. , whistleblowers can be rewarded for confidentially disclosing fraud that results in a financial loss to the federal government. Please ignore. (jmv, ), AMENDED SCHEDULING ORDER granting 78 Defendants' Motion to Continue Discovery Deadlines. Pfizer and Icon turned a blind eye to Ventavias misconduct, despite numerous warning signs. Ventavia. Reply. No, that's not true: Pfizer and the FDA were made aware of the allegations about the contractor in 2020. Please ignore. (kcv, ) (Entered: 06/09/2022), NOTICE of Attorney Appearance by Warner Mendenhall on behalf of United States of America ex rel. Added link to BMJ's open letter and our response. (Entered: 01/18/2022), ORDER on the Government's 13 Notice of Election to Decline Intervention. Ventavia takes research compliance, data integrity, and participant safety very seriously, and we stand behind our work supporting the development of life-saving vaccines. Retweeted. 6. know it, an executive stated. 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. 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. She added that during her time at Ventavia the company expected a federal audit but that this never came. 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. Brook Jackson . In the afternoon Ventavia fired Jacksondeemed not a good fit, according to her separation letter. Feb. 28, 2023, Cause: (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. *** (bjc, ), PLEASE IGNORE Notice of Docket Correction regarding Doc# 37 motion to dismiss. 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. About whether the vaccine is efficacious despite some concerns raised by medical experts Doc # 37 MOTION dismiss... 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