They choose rather, to protect and serve the interests of powerful corporations and ignore the vaccine injuries and deaths. from The Last American Vagabond:. ( 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. Brook Jackson. On September 8, 2020, I accepted a new position as Regional Director with a company named Ventavia Research Group. Headless Body of Missing Model Found in Refrigerator of Hong Kong Slaughter House as Police Arrest Ex-Husband and Father-In-Law, Who Was Jack Snyder? Retweet. document.getElementById( "ak_js_3" ).setAttribute( "value", ( new Date() ).getTime() ); The Defender is the news and views website for Children's Health Defense. 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. 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. If the FDA receives a complaint about a clinical trial, she says the agency rarely has the staff available to show up and inspect. Please ignore. Targeting of Ventavia staff for reporting these types of problems. An open letter from Pfizer chairman and CEO Albert Bourla. Ventavia is not owned by Pfizer. 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. 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. Ventavia takes research (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. Signed by District Judge Michael J. Truncale on 10/14/22. (Mendenhall, Warner) (Entered: 08/22/2022), ***FILED IN ERROR. WebRetraction Letter - Brook Jackson Contributed by Paul Thacker . (bjc, ) (Entered: 08/12/2022), MOTION for Leave to File Excess Pages by United States of America ex rel. 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 ? 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). 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. 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. Brook Jackson . This claim is not true. "One photo showed needles discarded in a plastic biohazard bag instead of a container box. 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. document.getElementById( "ak_js_4" ).setAttribute( "value", ( new Date() ).getTime() ); Children's Health Defense is a 501(c)(3) non-profit organization. EIN #26-0388604, 2016 - 2023 Children's Health Defense All Rights Reserved. Internet Archive, Consent to Proceed Before Magistrate Judge. 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. 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. 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. Skip to (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. Our content exposes the corporations, elected officials, government agencies and individuals who put profits before people and planet. Feb. 28, 2023, 10:25 a.m. CST, Assigned To: Signed by District Judge Michael J. Truncale on 11/15/22. (Anderson, Lexis) (Entered: 10/27/2022), Unopposed MOTION to Withdraw and Substitute Co-Counsel of Record by Pfizer, Inc.. (Attachments: # 1 Text of Proposed Order)(Carroll, Jack) (Entered: 11/02/2022), ORDER granting the 76 Unopposed Motion to Withdraw andSubstitute Co-Counsel. ), I dont think it was good clean data, the employee said of the data Ventavia generated for the Pfizer trial. FDA takes key action in fight against covid-19 by issuing emergency use authorization for first covid-19 vaccine. Our mission is to end corruption to save democracy. 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. EIN #26-0388604, 2016 - 2023 Children's Health Defense All Rights Reserved. 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. 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. 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.. she wrote in a November 9, 2021 response to a Kennedy tweet blasting Sesame Street. PLEASE IGNORE. 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. But she said she was surprised that the agency failed to inspect Ventavia after an employee had filed a complaint. Please, filed by whistleblower Brook Jackson alleging Pfizer and two of its contractors manipulated data and committed other. 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. CourtListener is sponsored by the non-profit Free Law Project. Public Citizen. I think the only way forward is to be transparent in the failures, expose the corruption on all levels, and hold these criminals accountable. The employee, Brook Jackson, repeatedly notified Ventavia of her concerns according to the BMJ. (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. (kcv, ) (Entered: 10/14/2022), Unopposed MOTION to Withdraw Peter Linken as Counsel by Icon, PLC. Your support is essential to CHDs successful mission. 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. 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. She added that during her time at Ventavia the company expected a federal audit but that this never came. Brook Jackson is a former clinical trial auditor who was let go for 'raising her voice'. That moment led me to where I am today; A whistleblower who's fighting to hold those accountable for the. 13. 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. 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. The FDA said, without explicitly saying it, that the allegations don't change the agency's assessment of the vaccine's safety. Docket for United States of America ex rel. Pfizer delegated management of the clinical trial to subcontractor Defendant Icon PLC (Icon), an Irish clinical research organization. Pfizer remained responsible for managing and quality checking all data for the entire clinical trial, per the trials protocol. Brook Jackson is a former clinical trial auditor who was let go for 'raising her voice'. Counsel has been notified to refile documents. Ventavia fired her later the same day. 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. tweet Brooke Jackson, Pfizer. 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? ***Defendant's Unopposed First Application for Extension of Time to Answer Complaint re Pfizer, Inc..( Yeates, Tommy) Modified on 3/18/2022 (kcv, ). Jackson also raised suspicions on the 'selection of Ventavia' to quickly ramp up Pfizer's COVID vaccine trial. Donations are tax deductible to the full extent of the law. (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. (Lockhart, Michael) (Entered: 10/04/2022), MOTION for Leave to File Response to Statement of Interest by United States of America ex rel. I'm talking about data integrity," she said from a phone number listed to a Dallas suburb. . 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. (Mendenhall, Warner) (Additional attachment(s) added on 10/12/2022: # 1 Text of Proposed Order) (kcv, ). This site requires JavaScript to run correctly. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails. 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. One is an email with Jackson thanking Pfizers Dr. Arturo Alfaro for giving her access to the COVID-19 clinical trial software.. ( kcv, ), SUMMONS Returned Executed by United States of America ex rel. If it had, it would have been told the employee's report was investigated but found wanting, the spokesperson said. 4. Letter to Scott Gottlieb and Jerry Menikoff. 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. (Additional attachment(s) added on 4/11/2022: # 3 Revised Proposed Order) (kcv, ). know it, an executive stated. Whistleblower Brook Jackson tells The BMJ about her experience working on the Pfizer covid-19 vaccine trial. When it comes to the FDA and clinical trials, Elizabeth Woeckner, president of Citizens for Responsible Care and Research Incorporated (CIRCARE),3 says the agencys oversight capacity is severely under-resourced. 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. 3729(a)), Jury Demand: Document # 41, Motion to Stay and Notice of Joinder do not contain the required Certificate of Conference. 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, 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. 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. 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