On September 8, 2020, I accepted a new position as Regional Director with a company named Ventavia Research Group. Responses due by 6/20/2022 (Attachments: # 1 Text of Proposed Order)(Davis, Scott) Modified related document on 6/7/2022 (kcv, ). The Pfizer-BioNTech BNT162b vaccine was subsequently approved by the FDA, EMA and other regulatory authorities based on the robust data submitted from the clinical program. Both confirmed broad aspects of Jacksons complaint. We do not capture any email address. Ventavias trial protocol and regulatory violations were so widespread, in fact, that Relator observed them on a near-daily basis during her brief employment period. Icon, PLC served on 3/16/2022, answer due 4/6/2022. 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. Install RECAP she wrote in a November 9, 2021 response to a Kennedy tweet blasting Sesame Street. Obviously we don't agree. In addition to the emails to Alfaro and Livingston, Jackson released: Thacker said his Nov. 2 article was picked up by more than 91 media organizations, and Jackson asked for corrections from many of those media organizations that stated she wasnt involved in the trials. The Brook Jackson Twitter account agreed with anti-vaccine activist and COVID misinformation-spreader Robert F. Kennedy, Jr.'s criticism of Sesame Street's storyline in which Big Bird's encourages kids to get a COVID-19 vaccine. In the afternoon Ventavia fired Jacksondeemed not a good fit, according to her separation letter. 107. 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. CHD is planning many strategies, including legal, in an effort to defend the health of our children and obtain justice for those already injured. 13. Jury Selection and Trial reset for 7/8/2024 at 09:00 AM in Ctrm 2 (Beaumont) before District Judge Michael J. Truncale. 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. 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. The Twitter user who purports to be the Ventavia whistleblower Brook Jackson said in a November 10, 2021, phone interview with Lead Stories that she is still employed in clinical trial auditing but is not using her real name and is not using her personal phone for fear of retribution. 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. 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. Pfizer, Inc. served on 3/2/2022, answer due 3/23/2022. In my mind, its something new every day, a Ventavia executive says. After a Harvard Nieman Fellowship, he served as Director of Stony Brook University's Center for News Literacy for six years, then as Senior Vice President/Content at Connecticut Public Broadcasting. Feb. 28, 2023, Cause: 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. (Anderson, Lexis) (Entered: 05/31/2022), MOTION to Dismiss 17 Amended Complaint by Ventavia Research Group, LLC. Signed by District Judge Michael J. Truncale on 7/29/22. document.getElementById( "ak_js_3" ).setAttribute( "value", ( new Date() ).getTime() ); The Defender is the news and views website for Children's Health Defense. Professor Douglas Drevets, M.D., of the University of Oklahoma College of Medicine, wrote in a November 10, 2021, email to Lead Stories that even if the claims are true, there is abundant proof the Pfizer vaccine works and is safe. (Attachments: # 1 Civil Cover Sheet, # 2 Exhibits 1-10, # 3 Exhibits 11-20, # 4 Exhibits 21-29)(kcv, ) Modified on 2/17/2022 (tkd, ). 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. (Entered: 06/06/2022), REPLY to Response to Motion re 40 MOTION to Stay Motion to Stay Discovery and Memorandum in Support filed by Pfizer, Inc.. (Attachments: # 1 Affidavit)(Wessel, Carlton) (Entered: 06/07/2022), MOTION to Dismiss 17 Amended Complaint Corrected by Ventavia Research Group, LLC. These same accusations were made a year ago, at which time Ventavia notified the appropriate parties. 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. A regional director with Ventavia Research Group told The BMJ Pfizer falsified data, unblinded patients, employed inadequately trained vaccinators and was slow to follow up on adverse events reported in Pfizers pivotal COVID Vaccine phase 3 trial. that expanded the scope of a legal principle known as . The BMJ reported patient safety and data integrity were likely compromised by the practices of Ventavia Research Group, a contractor that oversaw three of the 153 sites where Pfizer trials on 46,000 patients were conducted. Exasperated that Ventavia was not dealing with the problems, Jackson documented several matters late one night, taking photos on her mobile phone. Public Citizen. Miss a day, miss a lot. (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, ). 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. Retweeted. 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. The article said that Pfizer remained responsible for managing and quality checking all data for the entire clinical trial, per the trials protocol. Competing interests: PDT has been doubly vaccinated with Pfizers vaccine. Pfizer had offloaded the clinical trial work onto what is known as a Contract Research Organisation (CRO). (Anderson, Lexis) (Additional attachment(s) added on 8/23/2022: # 1 Text of Proposed Order) (kcv, ). 30 Days Granted for Deadline Extension. (Mendenhall, Warner) (Entered: 11/29/2022), REPLY to Response to Motion re 78 Opposed MOTION to Continue Discovery Deadlines and Memorandum of Law in Support filed by Pfizer, Inc.. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E)(Wessel, Carlton) (Entered: 12/01/2022), DECLARATION of Meagan D. Self in Support of 81 REPLY to Response to Motion re 78 Opposed MOTION to Continue Discovery Deadlines and Memorandum of Law in Support filed by Pfizer, Inc.. (Wessel, Carlton) Modified title and associated document on 12/2/2022 (kcv, ). Document # 21, Defendant's Unopposed First Application for Extension of Time to Answer Complaint was filed incorrectly with an attachment. Its a crazy mess.. We use Mailchimp as our marketing platform. Doesn't Recall Speaking With Mayor. (Wessel, Carlton) (Entered: 04/18/2022), NOTICE of Attorney Appearance - Pro Hac Vice by Andrew J. Hoffman, II on behalf of Pfizer, Inc.. Filing fee $ 100, receipt number 0540-8878704. If it had, it would have been told the employee's report was investigated but found wanting, the spokesperson said. They choose rather, to protect and serve the interests of powerful corporations and ignore the vaccine injuries and deaths. Ventavia executives later questioned Jackson for taking the photos. Added link to BMJ's open letter and our response. Ventavia fired her later the same day. The next morning, 25 September 2020, Jackson called the FDA to warn about unsound practices in Pfizers clinical trial at Ventavia. 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. THANKS !!! Final Pretrial Conference set for 3/28/2024 09:00 AM in Ctrm 2 (Beaumont) before District Judge Michael J. Truncale. Counsel has been notified to refile documents. Well done you ETHICAL LADY for hoping to protect general members of the public and VENTAVIA should be brought to book for lack of Duty of Care. FDA takes key action in fight against covid-19 by issuing emergency use authorization for first covid-19 vaccine. clinical trials is paused following a motion by the defendants to dismiss the case. (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, ). The vaccine has been given to hundreds of millions of people worldwide following approval. (Additional attachment(s) added on 4/11/2022: # 2 Text of Proposed Order) (kcv, ). CHD is planning many strategies, including legal, in an effort to defend the health of our children and obtain justice for those already injured. Document # 41, Motion to Stay and Notice of Joinder do not contain the required Certificate of Conference. 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. *** 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 by Icon, PLC. 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. At several points during the late September meeting Jackson and the Ventavia executives discussed the possibility of the FDA showing up for an inspection (box 1). It is conducting an evidence review 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.. Please note: your email address is provided to the journal, which may use this information for marketing purposes. 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. Ventavia. 4. Emails revealing that some Ventavia staff had falsified data. By clicking below to subscribe, you acknowledge that your information will be transferred to Mailchimp for processing. Examples included two individuals for which Subject has reported with Severe symptoms/reactions Per protocol, subjects experiencing Grade 3 local reactions should be contacted. Two former Ventavia employees spoke to The BMJ anonymously for fear of reprisal and loss of job prospects in the tightly knit research community. Bourla A. Brook Jackson is a former clinical trial auditor who was let go for 'raising her voice'. Most recently, he wrote the twice-weekly "Save the Free Press" column for The Seattle Times. 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? This site requires JavaScript to run correctly. Issues were improperly documented or hidden away in notes to the file, and not corrected. Docket for United States of America ex rel. PFIZER REVEALS CONCERNS WITH DATA INTEGRITY VINDICATING PREVIOUS CLAIMS BROOK JACKSON INTERVIEW. ***Defendant's Unopposed First Application for Extension of Time to Answer Complaint re Pfizer, Inc..( Yeates, Tommy) Modified on 3/18/2022 (kcv, ). Pfizer said it has reviewed the claims and found them to be unproven. It just seemed like something a little different from normalthe things that were allowed and expected.. The form Consent to Proceed Before Magistrate Judge is available on our website. (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, ). 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. Document # 37, motion to dismiss. other violations of the clinical trial protocol, FDA regulations, and Federal Acquisition Regulations and their DoD supplements. (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. 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. ( kcv, ), Defendant's Unopposed Motion to Extend Time to Answer or Otherwise Respond to Complaint by Icon, PLC. Copyright 2023 BMJ Publishing Group Ltd, Covid-19: Researcher blows the whistle on data integrity issues in Pfizers vaccine trial, https://www.pfizer.com/news/hot-topics/an_open_letter_from_pfizer_chairman_and_ceo_albert_bourla, https://www.citizen.org/wp-content/uploads/2442.pdf, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jon-b-cole-md-611902-05052021, https://www.oig.hhs.gov/oei/reports/oei-01-06-00160.pdf, https://www.fda.gov/media/145858/download, https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19, Birmingham and Solihull Mental Health NHS Foundation Trust: Consultant Psychiatrist General Adult - Northcroft CMHT, Brent Area Medical Centre: Salaried GP - Brent Area Medical Centre, Onebright Ltd: Consultant Psychiatrist (Neurodiversity) - Remote / London, The Royal Hospital for Neurodisability: Clinical Fellow, Womens, childrens & adolescents health. 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. "One photo showed needles discarded in a plastic biohazard bag instead of a container box. During (Mendenhall, Warner) (Additional attachment(s) added on 10/12/2022: # 1 Text of Proposed Order) (kcv, ). Jury Selection and Trial set for 4/1/2024 09:00 AM in Ctrm 2 (Beaumont) before District Judge Michael J. Truncale. ", Ventavia spokesperson Lauren Foreman discredited Jackson's claims. (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. 30 Days Granted for Deadline Extension. 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. Our response is here, we stand by our reporting. . 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. WebGuest: Brook Jackson - Former employee of the Ventavia Research Group/ Whistleblower The Corona Committee was formed by four lawyers. document.getElementById( "ak_js_4" ).setAttribute( "value", ( new Date() ).getTime() ); Children's Health Defense is a 501(c)(3) non-profit organization. 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 But found wanting, the spokesperson said the appropriate parties they choose rather, to protect serve! 4/1/2024 09:00 AM in Ctrm 2 ( Beaumont ) before District Judge Michael Truncale... And Notice of Joinder do not contain the required Certificate of Conference responsible for and... Scope of a container box 3 local reactions should be contacted interests: PDT been! For fear of reprisal and loss of job prospects in the afternoon fired... Clinical trial protocol, subjects experiencing Grade 3 local reactions should be contacted INTEGRITY! A Kennedy tweet blasting Sesame Street Body of Missing Model found in Refrigerator of Hong Kong Slaughter as. Complaint by icon, PLC were improperly documented or hidden away in to. 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