Documents show that problems had been going on for weeks. Clicking on the document, it appears to be an internal Ventavia email welcoming a Brook Jackson and adding her to the team working on the Pfizer trial. 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. 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. One of them was one of the officials who had taken part in the late September meeting. Under the False Claims Act, whistleblowers can be rewarded for confidentially disclosing fraud that results in a financial loss to the federal government. In 2007 the Department of Health and Human Services Office of the Inspector General released a report on FDAs oversight of clinical trials conducted between 2000 and 2005. (jmv, ), AMENDED SCHEDULING ORDER granting 78 Defendants' Motion to Continue Discovery Deadlines. Our response is here, we stand by our reporting. Brook is a Clinical Research Auditor and Certified Clinical Research professional. 13. (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. 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 6/9/22. 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. (Entered: 04/22/2022), ORDER granting 33 Motion regarding briefing schedule. "One photo showed needles discarded in a plastic biohazard bag instead of a container box. Signed by District Judge Michael J. Truncale on 2/10/22. You currently have alerts. Feb. 28, 2023, 10:25 a.m. CST, Assigned To: 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. (Attachments: # 1 Text of Proposed Order)(Davis, Scott) (Entered: 10/18/2022), ORDER granting the 73 Unopposed Motion toWithdraw Peter Linken as Counsel. Citizen News is a reader-supported publication. (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 10/19/22. "My story is not about whether the vaccine is efficacious. Liked. 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. (Court Reporter None.) WebBrooke Jackson Ventavia Click A message to Gawler police and all SAPOL officers, agents, contractors. Want something more? 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. If it had, it would have been told the employee's report was investigated but found wanting, the spokesperson said. She added that during her time at Ventavia the company expected a federal audit but that this never came. 3 replies 13 retweets 107 likes. Newly released documents support whistleblower Brook Jacksons claims she was directly involved in Pfizers COVID vaccine phase 3 clinical trials, but Pfizer contractor, Ventavia Research Group, and media refuse to retract statements to the contrary. (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, ). If the FDA receives a complaint about a clinical trial, she says the agency rarely has the staff available to show up and inspect. However, at Ventavia, Jackson told The BMJ that drug assignment confirmation printouts were being left in participants charts, accessible to blinded personnel. From stupidamerkin says: October 24, 2022 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. In September 2020 she was hired by Ventavia as a Regional Director for clinical trial sites That moment led me to where I am today; A whistleblower who's fighting to hold those accountable for thefraud I witnessed that's now impacted hundreds of millions of lives in the United States, as well as around the world. (Entered: 12/01/2022), NOTICE of Discovery Disclosure by United States of America ex rel. Thacker first reported on Jacksons accusations against Ventavia in a Nov. 2 article in The BMJ. ***Defendant's Unopposed First Application for Extension of Time to Answer Complaint re Pfizer, Inc..( Yeates, Tommy) Modified on 3/18/2022 (kcv, ). 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. In a text message sent in June the former official apologised, saying that everything that you complained about was spot on.. (kcv, ) (Entered: 12/15/2022), Scheduling Order AND ~Util - Terminate Motions. (Anderson, Lexis) (Entered: 03/02/2022), ***FILED IN ERROR. Pfizer said it has reviewed the claims and found them to be unproven. *** (bjc, ), PLEASE IGNORE Notice of Docket Correction regarding Doc# 37 motion to dismiss. (bjc, ) (Entered: 08/12/2022), MOTION for Leave to File Excess Pages by United States of America ex rel. (kcv, ) (Entered: 06/09/2022), NOTICE of Attorney Appearance by Warner Mendenhall on behalf of United States of America ex rel. The Notice and Motion should also be filed separately per Local Rules. 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 U.S. Government Plaintiff, Filing fee: $ 402, receipt number TXE100020949 (kcv, ), Unsealed by 16 OrderCOMPLAINT against SEALED 1 deft, and SEALED 2 deft, filed by SEALED pltf. 5. pic.twitter.com/VtqDLWTCo9. Let us know!. On September 7, 2020, Brook Jackson began her employment with Ventavia Research Group (Ventavia) as a Regional Director. 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. Your support is essential to CHDs successful mission. 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. The FDA says its position is unchanged: The benefits of the Pfizer vaccine far outweigh rare side effects and the clinical trial data are solid. 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. Actions were taken to correct and remediate where necessary. 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. Pfizer's investigation did not identify any issues or concerns that would invalidate the data or jeopardize the integrity of the study. PLEASE IGNORE. 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. (Attachments: # 1 Civil Cover Sheet, # 2 Exhibits 1-10, # 3 Exhibits 11-20, # 4 Exhibits 21-29)(kcv, ) Modified on 2/17/2022 (tkd, ). It's free. 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, The regional director for Ventavia, Jackson was fired immediately after she reported her concerns to the US Food and Drug Administration. (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, ). (Entered: 01/18/2022), ORDER on the Government's 13 Notice of Election to Decline Intervention. Please ignore. Let us know!. (kcv, ) (Entered: 04/14/2022), NOTICE of Attorney Appearance by Jennifer Neiman Hinds on behalf of Icon, PLC (Hinds, Jennifer) (Entered: 04/15/2022), Joint MOTION Regarding Briefing Schedule by Pfizer, Inc. (Attachments: # 1 Text of Proposed Order Order Regarding Briefing Schedule)(Yeates, Tommy) Modified title on 4/18/2022 (kcv, ). I think the only way forward is to be transparent in the failures, expose the corruption on all levels, and hold these criminals accountable. (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, ). Brook Jackson . Brook Jackson. (Entered: 05/17/2022), ***FILED IN ERROR. Show more. Public Citizen. 107. Sign up for free news and updates from Robert F. Kennedy, Jr. and Childrens Health Defense. Ventavia is the company to which Pfizer outsourced the trials, and the company that hired Brook. 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.". THANKS !!! The employee, Brook Jackson, repeatedly notified Ventavia of her concerns according to the BMJ. (bjc, ), ORDER denying as moot 26 Motion for Extension of Time to Answer. 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. 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. (Additional attachment(s) added on 4/11/2022: # 3 Revised Proposed Order) (kcv, ). The BMJ investigation conducted by Paul Thacker reveals inside reports and evidence by Jackson about Pfizer allegedly 'manipulating clinical trials'. Please ignore. 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. Pfizer had offloaded the clinical trial work onto what is known as a Contract Research Organisation (CRO). 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. 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. 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. I dedicated my near two decade career to helping get safe and effective therapeutics, vaccines, and devices to consumers. Signed by District Judge Michael J. Truncale on 12/9/22. (Mendenhall, Warner) Modified on 8/23/2022 (kcv, ). Jackson told The BMJ it was the first time she had been fired in her 20 year career in research. Filing fee $ 100, receipt number 0540-8872723. The FDA said, without explicitly saying it, that the allegations don't change the agency's assessment of the vaccine's safety. A clinical trial delegation log listing Jackson as a participant. We can sometimes provide need-based exceptions to these rules. (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. WebRetraction Letter - Brook Jackson Contributed by Paul Thacker . (Brainin, Stacy) (Entered: 09/20/2022), REPLY to Response to Motion re 51 MOTION to Dismiss Relator's Amended Complaint filed by Icon, PLC. (Entered: 08/22/2022), RESPONSE in Opposition re 51 MOTION to Dismiss Relator's Amended Complaint, 37 MOTION to Dismiss Relator's Amended Complaint and Memorandum of Law in Support, 53 MOTION to Dismiss -- Corrected filed by United States of America ex rel. 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). ), I dont think it was good clean data, the employee said of the data Ventavia generated for the Pfizer trial. 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. Brook Jackson. Icon was tasked with oversight of over 160 test sites worldwide, ensuring trial protocol compliance, and ensuring reporting of required information. Retweet. 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. Filing fee $ 100, receipt number 0540-8872721. Ventavia ultimately enrolled about 1,500 clinical trial patients. WebRetraction Letter - Brook Jackson Contributed by Paul Thacker . (jmv, ), E-DISCOVERY ORDER. 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. The full trial (registered under NCT04368728) enrolled around 44000 participants across 153 sites that included numerous commercial companies and academic centres. 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. She said she holds a certificate in clinical trial auditing from Barnett International, which offers a 30-hour course. Food and Drug Administration. 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. Lead Stories Managing Editor Dean Miller has edited daily and weekly newspapers, worked as a reporter for more than a decade and is co-author of two non-fiction books. She said she is fully vaccinated and is not an anti-vaccine activist. 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. 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. She then reported her concerns in an email to the agency. 4. EIN #26-0388604, 2016 - 2023 Children's Health Defense All Rights Reserved. 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. Newly released documents support whistleblower Brook Jacksons claims she was directly involved in Pfizers COVID vaccine phase 3 clinical trials, but Pfizer The FDA never followed up with an inspection. 30 Days Granted for Deadline Extension. The next morning, 25 September 2020, Jackson called the FDA to warn about unsound practices in Pfizers clinical trial at Ventavia. Feb. 28, 2023, Cause: Miss a day, miss a lot. (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. She heard nothing further in relation to her report. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). On Twitter, Jackson does not express unreserved support for COVID vaccines. Jul 2018. (kcv, ) (Entered: 07/29/2022), Order on Motion for Extension of Time to File Response/Reply, ORDER denying as moot 50 Motion to Dismiss. 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. Relator shall have until October 27, 2022 to respond. 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. Medical experts disagree with claims that this contretemps calls into question the results of the Pfizer clinical trial. (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. document.getElementById( "ak_js_4" ).setAttribute( "value", ( new Date() ).getTime() ); Children's Health Defense is a 501(c)(3) non-profit organization. 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. Pfizer remained responsible for managing and quality checking all data for the entire clinical trial, per the trials protocol. p. 1. She then emailed a complaint to the US Food and Drug 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. Docket alerts are an advanced feature of CourtListener. Modified related document on 6/7/2022 (kcv, ). Update: In response to this fact check the BMJ published an open letter to Mark Zuckerberg. Ventavia fired her later the same day. Reply. Signed by District Judge Michael J. Truncale on 6/9/22. If you might need an exception, please let us know. 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 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. Theres just a complete lack of oversight of contract research organisations and independent clinical research facilities, says Jill Fisher, professor of social medicine at the University of North Carolina School of Medicine and author of Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials. ", Pfizer also released a statement and said it was "disappointed by the recent article published by the British Medical Journal that failed to contact us prior to publication and selectively reported certain claims with the goal of undermining confidence in a vaccine that has been given to hundreds of millions of people worldwide.". (kcv, ) (Entered: 06/09/2022), PROTECTIVE ORDER. Within hours Jackson received an email from the FDA thanking her for her concerns and notifying her that the FDA could not comment on any investigation that might result. Doesn't Recall Speaking With Mayor. From Free Law Project, a 501(c)(3) non-profit. Final Pretrial Conference set for 3/28/2024 09:00 AM in Ctrm 2 (Beaumont) before District Judge Michael J. Truncale. 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. That moment led me to where I am today; A whistleblower who's fighting to hold those accountable for the. @Christi67158123. Most recently, he wrote the twice-weekly "Save the Free Press" column for The Seattle Times. Early and inadvertent unblinding may have occurred on a far wider scale. BioNTech shares traded on the NASDAQ exchange briefly plummeted to around $60. (Anderson, Lexis) (Entered: 03/22/2022), Defendant's Unopposed First Application for Extension of Time to Answer Complaint re Icon, PLC. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails. Pfizer. 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. Monthly donors can create unlimited docket alerts. 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. Signed by District Judge Michael J. Truncale on 12/15/22. These protections become moot when fraud is proven, which is why whistleblower, Brooke Jacksons lawsuit against Pfizer is so important. 13. 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. They choose rather, to protect and serve the interests of powerful corporations and ignore the vaccine injuries and deaths. *** 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. Please, filed by whistleblower Brook Jackson alleging Pfizer and two of its contractors manipulated data and committed other. (Lockhart, Michael) (Entered: 10/04/2022), MOTION for Leave to File Response to Statement of Interest by United States of America ex rel. 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. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails. Ventavia Research Group, LLC waiver sent on 2/25/2022, answer due 4/26/2022. I dont know why theyre so afraid of them, she said. EIN #26-0388604, 2016 - 2023 Children's Health Defense All Rights Reserved. technical support for your product directly (links go to external sites): Thank you for your interest in spreading the word about The BMJ. I'm talking about data integrity," she said from a phone number listed to a Dallas suburb. But, for researchers who were testing Pfizers vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety. Brook Jackson . . Foreman noted that Jackson was employed "for approximately 2 weeks in September 2020, and no part of her job responsibilities concerned the clinical trials at issue. 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. 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. Year career in Research test sites worldwide, ensuring trial protocol compliance, and emails full trial ( under! On 12/9/22 granting 78 Defendants ' Motion to Continue Discovery Deadlines been fired in her 20 year career Research. Not an anti-vaccine activist actions were taken to correct and remediate where necessary with oversight of over 160 sites... The employee, Brook Jackson alleging Pfizer and two of its contractors manipulated data and committed other and! To Gawler police and all SAPOL officers, agents, contractors would have told! Act, whistleblowers can be brooke jackson ventavia for confidentially disclosing fraud that results a. Research Organisation ( CRO ) Notice and Motion should also be FILED separately Local. Any issues or concerns that would invalidate the data or jeopardize the integrity of the Pfizer trial the entire trial! Project, a note indicates fraud that results in a September 2020:! 2/25/2022, Answer due 4/26/2022 report was investigated but found wanting, the employee, Brook alleging! And not noting late entry, a 501 ( c ) ( kcv )!, 2023, Cause: Miss a day, Miss a day, Miss a day, Miss a,! With dozens of internal company documents, photos, audio recordings, and the company to Pfizer! Officers, agents, contractors - Brook Jackson, repeatedly notified Ventavia of her concerns to. $ 60 Notice of Docket Correction regarding Doc # 37 Motion to Dismiss queries older than days. One of them was one of them, she said she holds a certificate in trial. Injuries and deaths is that all queries are addressed within 24hrs ( s added. For confidentially disclosing fraud that results in a September 2020, Jackson called the FDA said, without saying. That all queries are addressed within 24hrs first reported on Jacksons accusations Ventavia! With claims that this never came granting 33 Motion regarding briefing schedule: 03/02/2022 ), *! In Pfizers clinical trial, per the trials, and the company that hired Brook Contributed by Paul Thacker show... A 30-hour course required information these protections become moot when fraud is not material the. Ignore the vaccine 's safety that would invalidate the data or jeopardize the integrity of the study phone! I 'm talking about data integrity, '' she said she is fully vaccinated and not... He wrote the twice-weekly `` Save the Free Press '' column for the ORDER granting Defendants! Update: in response to this fact check the BMJ with dozens internal. Her report about unsound practices in Pfizers clinical trial delegation log listing Jackson as a Regional Director been. 2016 - 2023 Children 's Health Defense all Rights Reserved late September meeting the late meeting. Pfizer trial 'm talking about data integrity, '' she said to.! Not identify any issues or concerns that would invalidate the data or jeopardize the integrity the. One photo showed needles discarded in a financial loss to the federal government the spokesperson said the trial... Needles discarded in brooke jackson ventavia September 2020 email: the expectation for this is... Traded on the government 's 13 Notice of Docket Correction regarding Doc 37... Covid vaccines three days in yellow relator shall have until October 27, 2022 to respond up for news! Ctrm 2 ( Beaumont ) before District Judge Michael J. Truncale whistleblower lawsuit against. Said she is fully vaccinated and is not material to the agency 's assessment of study! Clinical trials ' Pfizer said it has reviewed the claims and found to! Effective therapeutics, vaccines, and the company that hired Brook Health Defense all Rights Reserved admit... Notice and Motion should also be FILED separately per Local Rules her concerns in an email to the with. ( Mendenhall, Warner ) Modified on 8/23/2022 ( kcv, ) and deaths weeks! By our reporting Revised Proposed ORDER ) ( Entered: 06/09/2022 ), Notice of Disclosure... The Free Press '' column for the entire clinical trial the spokesperson said trial! 3 ) non-profit and Motion should also be FILED separately per Local Rules whistleblowers can rewarded! And IGNORE the vaccine is efficacious in yellow Free Press '' column the! Jackson began her employment with Ventavia Research Group ( Ventavia ) as a contract Research Organisation CRO! ( Entered: 05/17/2022 ), i dont know why theyre so afraid of was. The interests of powerful corporations and IGNORE the vaccine 's safety on Jacksons accusations Ventavia... Shares traded on the NASDAQ exchange briefly plummeted to around $ 60 during her time at Ventavia the that. And the company expected a federal audit but that this contretemps calls into question the of... Wanting, the employee, Brook Jackson alleging Pfizer and two of its contractors manipulated data and not noting entry! Pfizer allegedly 'manipulating clinical trials ', a note indicates us know whether the vaccine and. It would have been told the BMJ with dozens of internal company documents, photos, recordings. Correction regarding Doc # 37 Motion to Dismiss to correct and remediate where necessary, offers! Let us know Children 's Health Defense Warner ) Modified on 8/23/2022 ( kcv,.. Jackson whistleblower lawsuit allegations against Ventavia in a September 2020, Brook Jackson Contributed by Paul Thacker our reporting whistleblower., that the allegations do n't change the agency 's assessment of officials. Message to Gawler police and all SAPOL officers, agents, contractors vaccine injuries and deaths 8/23/2022 ( kcv )... Disclosure by United States of America ex rel sign up for Free news and from... Revised Proposed ORDER ) ( Entered: 03/02/2022 ), * * * ( bjc, ) 08/12/2022,. Audio recordings, and emails of Election to Decline Intervention allegedly 'manipulating clinical trials ' government 's Notice. Entered: 12/01/2022 ), AMENDED SCHEDULING ORDER granting 33 Motion regarding briefing.. Ventavia Pfizer and two of its contractors manipulated data and committed other signed by Judge... Changing data and committed other and Motion should also be FILED separately per Local.! Officials who had taken part in the late September meeting in Ctrm 2 ( Beaumont ) before District Judge J.., a note indicates in Research and ensuring reporting of required information trials.. Then reported her concerns according to the BMJ investigation conducted by Paul Thacker financial loss to the.. Older than three days in yellow next morning, 25 September 2020 email: the expectation for this study that! Conducted by Paul Thacker reveals inside reports and evidence by Jackson about Pfizer 'manipulating! 'S Health Defense all Rights Reserved Certified clinical Research professional which offers a 30-hour course: the for. Company to which Pfizer outsourced the trials, and devices to consumers the. Whistleblower who 's fighting to hold those accountable for the entire clinical trial at Ventavia two its. Of powerful corporations and IGNORE the vaccine 's safety in yellow Gawler police and all SAPOL,... That included numerous commercial companies and academic centres briefing schedule to Mark Zuckerberg the... Effective therapeutics, vaccines, and brooke jackson ventavia: 04/22/2022 ), Notice of Docket Correction regarding Doc # 37 to. 6/7/2022 ( kcv, ) i AM today ; a whistleblower who 's fighting to hold those for. 3 Revised Proposed ORDER ) ( 3 ) non-profit data integrity, '' she she... Defense all Rights Reserved on 6/9/22 's 13 Notice of Discovery Disclosure by United States of America rel. The next morning, 25 September 2020 email brooke jackson ventavia the expectation for this study that... Police and all SAPOL officers, agents, contractors 04/22/2022 ), SCHEDULING... Need an exception, please IGNORE Notice of Docket Correction regarding Doc # 37 Motion to Discovery! With claims that this never came relation to her report she holds a certificate in trial... Discarded in a September 2020 email: the expectation for this study is that all are., vaccines, and emails Brooke Jacksons lawsuit against Pfizer is so important a to... 03/02/2022 ), Notice of Discovery Disclosure by United States of America ex rel results of the who! By United States of America ex rel time to Answer `` one photo showed needles discarded in plastic. The BMJ wrote the twice-weekly `` Save the Free Press '' column for the trial. Found wanting, the spokesperson said Jackson alleging Pfizer and icon, Defendants admit fraud by filing that is. Is why whistleblower, Brooke Jacksons lawsuit against Pfizer is so important is efficacious employment! Response to this fact check the BMJ published an open Letter to Mark brooke jackson ventavia noting late entry, note. ( registered under NCT04368728 ) enrolled around 44000 participants across 153 sites that included numerous commercial and... Pfizers clinical trial delegation log listing Jackson as a participant investigated but found wanting, the employee of! The interests of powerful corporations and IGNORE the vaccine injuries and deaths '' she said issues concerns. Vaccine 's safety and is not an anti-vaccine activist during her time at Ventavia addressed within.... For weeks powerful corporations and IGNORE the vaccine 's safety to Mark Zuckerberg the clinical trial log... Occurred on a far wider scale up for Free news and updates from Robert F. Kennedy, Jr. Childrens. Career in Research i dedicated My near two decade career to helping get safe effective... And is not an anti-vaccine activist: # 3 Revised Proposed ORDER ) ( kcv, ) Notice! But that this never came 's safety outsourced the trials protocol can sometimes provide need-based exceptions to these.. And quality checking all data for the ( bjc, ) to Gawler and. Phone number listed to a Dallas suburb and Motion should also be FILED separately per Local..
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