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. Exasperated that Ventavia was not dealing with the problems, Jackson documented several matters late one night, taking photos on her mobile phone. 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. Under the False Claims Act, whistleblowers can be rewarded for confidentially disclosing fraud that results in a financial loss to the federal government. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). May 2021. Our mission is to end corruption to save democracy. Ventavia fired her later the same day. other violations of the clinical trial protocol, FDA regulations, and Federal Acquisition Regulations and their DoD supplements. Donations are tax deductible to the full extent of the law. ( kcv, ), SUMMONS Returned Executed by United States of America ex rel. 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. (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 related document on 6/7/2022 (kcv, ). 31:3730 Qui Tam False Claims Act, Nature of Suit: The regional director for Ventavia, Jackson was fired immediately after she (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. The next morning, 25 September 2020, Jackson called the FDA to warn about unsound practices in Pfizers clinical trial at Ventavia. Revelations of poor practices at a contract research company helping to carry out Pfizers pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight. 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. (kcv, ) (Entered: 06/09/2022), PROTECTIVE ORDER. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. PLEASE IGNORE. 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. Learn more about Mailchimp's privacy practices here. Final Pretrial Conference reset for 7/1/2024 at 09:00 AM in Ctrm 2 (Beaumont) before District Judge Michael J. Truncale. Subscribe to The Defender's Top News of the Day. Brook Jackson. 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. It is conducting an evidence review *** (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. . 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 Like. 107. On September 7, 2020, Brook Jackson began her employment with Ventavia Research Group (Ventavia) as a Regional Director. (Additional attachment(s) added on 4/11/2022: # 3 Revised Proposed Order) (kcv, ). 8. Based on what she saw, she brought suit against the 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. WebRetraction Letter - Brook Jackson Contributed by Paul Thacker . 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). She was tasked with overseeing site management, patient enrollment, quality assurance completion, event reporting, corrective action plan creation, communication with management, and staff training completion at the Keller and Fort Worth sites. Document # 21, Defendant's Unopposed First Application for Extension of Time to Answer Complaint was filed incorrectly with an attachment. 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. 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: 10/11/2022), ORDER granting the 71 Motion for Leave to Respond to Statement of Interest. A former Ventavia employee told The BMJ that the company was nervous and expecting a federal audit of its Pfizer vaccine trial. 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. Your support is essential to CHDs successful mission. CourtListener is sponsored by the non-profit Free Law Project. Back in September 2020, Brook was hired to work as a Regional Director at two out of three clinical trial sites in Texas for Pfizers Phase III mRNA vaccine. . p. 1. An open letter from Pfizer chairman and CEO Albert Bourla. (Attachments: # 1 Text of Proposed Order)(Davis, Scott) (Entered: 10/18/2022), ORDER granting the 73 Unopposed Motion toWithdraw Peter Linken as Counsel. Both confirmed broad aspects of Jacksons complaint. Issues were improperly documented or hidden away in notes to the file, and not corrected. ), I dont think it was good clean data, the employee said of the data Ventavia generated for the Pfizer trial. Pfizer's investigation did not identify any issues or concerns that would invalidate the data or jeopardize the integrity of the study. (kcv, ) (Entered: 12/15/2022), Scheduling Order AND ~Util - Terminate Motions. 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.. (Davis, Scott) (Entered: 09/20/2022), RESPONSE in Support re 51 MOTION to Dismiss Relator's Amended Complaint, 53 MOTION to Dismiss -- Corrected filed by United States of America. Early and inadvertent unblinding may have occurred on a far wider scale. To receive new posts and support my work, consider becoming a free or paid subscriber. Competing interests: PDT has been doubly vaccinated with Pfizers vaccine. Phone texts and emails among Ventavia staff discussing a hectic environment and sloppy documentation.. Please ignore. 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. To read the piece in its entirety,click here. (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. Brook Jackson . 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. (Entered: 06/07/2022), NOTICE of Hearing: Status Conference set for 6/9/2022 at 11:30 AM via TELEPHONE CONFERENCE (Beaumont) before District Judge Michael J. Truncale. Brook Jackson. 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. 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. If the FDA receives a complaint about a clinical trial, she says the agency rarely has the staff available to show up and inspect. Brook Jackson whistleblower lawsuit allegations against Ventavia Pfizer and Icon, Defendants admit fraud by filing that fraud is not material to the contract. Signed by District Judge Michael J. Truncale on 5/4/2022. @Christi67158123. The allegations were investigated and determined to be unsubstantiated. Rule 16 Case Management/Scheduling Conference set for 5/27/2022 11:30 AM in Room 221 before District Judge Michael J. Truncale. 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. In an article in MedPage, vaccine experts said the claims are not serious enough to jeopardize Pfizer's data. 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. from The Last American Vagabond:. Most recently, he wrote the twice-weekly "Save the Free Press" column for The Seattle Times. 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. Signed by District Judge Michael J. Truncale on 10/14/22. (Entered: 12/01/2022), NOTICE of Discovery Disclosure by United States of America ex rel. Brook Jackson . "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. (kcv, ) (Entered: 06/09/2022), SCHEDULING ORDER granting in part the 40 MOTION to Stay Discovery. Your support is essential to CHDs successful mission. 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. Ventavia executives later questioned Jackson for taking the photos. Feb. 28, 2023, 10:25 a.m. CST, Assigned To: 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. (Entered: 05/17/2022), ***FILED IN ERROR. I'm talking about data integrity," she said from a phone number listed to a Dallas suburb. Sign up for free news and updates from Robert F. Kennedy, Jr. and Childrens Health Defense. Brook Jackson. Docket alerts are an advanced feature of CourtListener. In an interview with The Defender, the lawyer representing whistleblower Brook Jackson said Pfizer is arguing the court should dismiss Jacksons lawsuit alleging fraud in Pfizers COVID-19 clinical trials because the U.S. government knew about the wrongdoings but continued to do business with the vaccine maker. (kcv, ) (Entered: 07/29/2022), Order on Motion for Extension of Time to File Response/Reply, ORDER denying as moot 50 Motion to Dismiss. 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. "Ventavia fired her later the same day." For example. Bourla A. Ventavia takes research compliance, data integrity, and participant safety very seriously, and we stand behind our work supporting the development of life-saving vaccines. document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); document.getElementById( "ak_js_2" ).setAttribute( "value", ( new Date() ).getTime() ); This field is for validation purposes and should be left unchanged. 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. Liked. Another showed vaccine packaging materials with trial participants identification numbers written on them left out in the open, potentially unblinding participants. 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. (kcv, ) (Entered: 10/14/2022), Unopposed MOTION to Withdraw Peter Linken as Counsel by Icon, PLC. An insightful, engaging interview with Brook Jackson recorded during the summer of 2022. Let us know!. BMJ relied on copies of reports filed by a two-week employee of Ventavia. In a text message sent in June the former official apologised, saying that everything that you complained about was spot on.. (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. Corruption to save democracy the photos another showed vaccine packaging materials with trial participants identification numbers written on them out... Unblinding may have occurred on a far wider scale for Extension of Time to Answer Complaint was filed incorrectly an! 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