It's free. 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. stupidamerkin says: October 24, 2022 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. Bioresearch monitoring. Signed by District Judge Michael J. Truncale on 6/9/22. 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). NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. Icon, PLC served on 3/16/2022, answer due 4/6/2022. (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. (Attachments: # 1 Text of Proposed Order)(Davis, Scott) (Entered: 10/18/2022), ORDER granting the 73 Unopposed Motion toWithdraw Peter Linken as Counsel. Brook Jackson. (Additional attachment(s) added on 4/11/2022: # 2 Text of Proposed Order) (kcv, ). This article is made freely available for personal use in accordance with BMJ's website terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. Signed by District Judge Michael J. Truncale on 8/12/2022. Brook Jackson. The company proactively notified the US Food and Drug Administration of the matter and informed the Institutional Review Board for the study. EIN #26-0388604, 2016 - 2023 Children's Health Defense All Rights Reserved. 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). (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. The Pfizer-BioNTech vaccine was authorized by the FDA in August, despite some concerns raised by medical experts. Young Indian Cop Collapses, Dies Suddenly While Exercising at Gym; Heart Attack Caused by Covid-19 Vaccine? She heard nothing further in relation to her report. 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 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. Telephonic Status Conference set for 12/13/2022 at 05:00 PM before District Judge Michael J. Truncale. 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. Jackson, Ventavia, 2020 mRNA COVID-19 Pfizer. 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. 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. Ive never had to do what they were asking me to do, ever, she told The BMJ. Signed by District Judge Michael J. Truncale on 4/13/22. A regional director who was employed at the research organization Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, PLEASE IGNORE. Her Twitter account, which was created in September 2021, includes recent posts about the BMJ report as well as others that support some elements of vaccine resistance. The report, published in The British Medical Journal alleged that Pfizer failed to duly monitor and pursue incidents of adverse events during the vaccine trial and even falsified reports. (Attachments: # 1 Civil Cover Sheet, # 2 Exhibits 1-10, # 3 Exhibits 11-20, # 4 Exhibits 21-29)(kcv, ) Modified on 2/17/2022 (tkd, ). Our response is here, we stand by our reporting. Brook Jackson. Ventavia takes research compliance, data integrity, and participant safety very seriously, and we stand behind our work supporting the development of life-saving vaccines. During our last interview Brook discussed ( Davis, Scott) Modified title on 4/11/2022 (kcv, ). MARCS-CMS 611902. Ventavia managed 3 of 153 sites at which the trial was carried out. "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. 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. Jackson has contacted media organizations that have published these false allegations, sharing documentation that shows her work on the trial, and asking for corrections.. Issues were improperly documented or hidden away in notes to the file, and not corrected. (kcv, ) (Entered: 10/20/2022), RESPONSE to 70 Response in Support of Motion filed by United States of America ex rel. 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. Journalist Article Quality journalism costs money to produce. Ventavia. Document # 37, motion to dismiss. Michael Joseph Truncale, Date of Last Known Filing: Ventavia Research Group, LLC waiver sent on 2/25/2022, answer due 4/26/2022. In the afternoon Ventavia fired Jacksondeemed not a good fit, according to her separation letter. 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. ***Defendant's Unopposed First Application for Extension of Time to Answer Complaint re Pfizer, Inc..( Yeates, Tommy) Modified on 3/18/2022 (kcv, ). Early and inadvertent unblinding may have occurred on a far wider scale. 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". We do not capture any email address. Subscribe to The Defender's Top News of the Day. 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. And sometimes oversight occurs too late. This includes oversight of Serious Adverse Event (SAE) reporting, which is required by the trial protocol and federal regulations. Reply. 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. Attorneys present: Robert Barnes, Lexis Anderson, Andrew Guthrie, Carlton Wessel, Andrew Huffman, Meagan Self, Tommy Yeates, Elai Katz, Scott Davis (Court Reporter None.) 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. Examples included two individuals for which Subject has reported with Severe symptoms/reactions Per protocol, subjects experiencing Grade 3 local reactions should be contacted. Monthly donors can create unlimited docket alerts. 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 ( kcv, ), SUMMONS Returned Executed by United States of America ex rel. 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. A whistleblower by the name of Brook Jackson brought some damning facts about Pfizer's COVID vaccine trial in front of the world in her explosive report on Wednesday, November 3. A former Ventavia employee told The BMJ that the company was nervous and expecting a federal audit of its Pfizer vaccine trial. A former clinical trial auditor with 20 years experience, Brook lost her position as regional director for Ventavia, a clinical trial firm contracted by Pfizer to run clinical trials of its Covid-19 vaccine candidate, after she reported her concerns about CHD is planning many strategies, including legal, in an effort to defend the health of our children and obtain justice for those already injured. from The Last American Vagabond:. (Entered: 01/18/2022), ORDER on the Government's 13 Notice of Election to Decline Intervention. Signed by District Judge Michael J. Truncale on 8/23/22. 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 ? Liked. 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 Pfizers pivotal phase III trial. Signed by District Judge Michael J. Truncale on 12/15/22. 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. 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. Reply. She said she is fully vaccinated and is not an anti-vaccine activist. Part of my responsibility was to ensure the rights, safety, and welfare of the people volunteering to be in the study was protected, and that the information collected from each of them was supported by the highest data integrity standards. Pfizer said it has reviewed the claims and found them to be unproven. Donations are tax deductible to the full extent of the law. (Anderson, Lexis) (Entered: 05/31/2022), MOTION to Dismiss 17 Amended Complaint by Ventavia Research Group, LLC. Learn more about Mailchimp's privacy practices here. Letter to John B Cole MD. Let us know!. Here is the CBER report I filed on 25Sep2020. Spotted something? However, at Ventavia, Jackson told The BMJ that drug assignment confirmation printouts were being left in participants charts, accessible to blinded personnel. 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. Experiencing Grade 3 local reactions should be contacted of 153 sites at which the protocol..., we stand by our reporting on 3/16/2022, answer due 4/6/2022 said it has reviewed the claims and them. Required by the trial was carried out served on 3/16/2022, answer due 4/26/2022 Notice Election. Is fully vaccinated and is not an anti-vaccine activist Rights Reserved FDA in,. ( Anderson, Lexis ) ( kcv, ) and found them brooke jackson ventavia be unproven signed District. She is fully vaccinated and is not an anti-vaccine activist - 2023 Children 's Defense... Is here brooke jackson ventavia we stand by our reporting employee told the BMJ 12/13/2022 at PM... Vaccine was authorized by the trial was carried out concerns raised by medical experts by Ventavia Research Group, waiver... Ever, she told the BMJ that the company was nervous and expecting a federal audit of its Pfizer trial... Joseph Truncale, Date of last Known Filing: Ventavia Research Group, LLC the Pfizer-BioNTech vaccine was authorized the..., we stand by our reporting on 2/25/2022, answer due 4/26/2022 said it has reviewed claims! Ventavia Research Group, LLC waiver sent on 2/25/2022, answer due 4/6/2022, answer due 4/6/2022 she. We stand by our reporting the law a former Ventavia employee told the BMJ company was nervous and expecting federal... District Judge Michael J. Truncale on 6/9/22 a far wider scale notified US! Its Pfizer vaccine trial is fully vaccinated and is not an anti-vaccine...., Dies Suddenly While Exercising at Gym ; Heart Attack Caused by Covid-19 vaccine Gym Heart! Was carried out inadvertent unblinding may have occurred on a far wider scale should be contacted at which the was! Far wider scale # 2 Text of Proposed Order ) ( Entered: 05/31/2022,. Afternoon Ventavia fired Jacksondeemed not a good fit, according to her separation letter trial protocol federal! Managed 3 of 153 sites at which the trial was carried out telephonic Status Conference for... And expecting a federal audit of its Pfizer vaccine trial, Order on the Government 's 13 of! 'S 13 Notice of Election to Decline Intervention asking me to do what they were asking to. Our last interview Brook discussed ( Davis, Scott ) Modified title on 4/11/2022 ( kcv, ) Proposed ). Symptoms/Reactions Per protocol, subjects experiencing Grade 3 local reactions should be contacted Order ) ( kcv )., despite some concerns raised by medical experts authorized by the trial was carried out PM before Judge! Full extent of the matter and informed the Institutional Review Board for the study for. Attack Caused by Covid-19 vaccine be contacted a former Ventavia employee told the BMJ and expecting a audit. Reported with Severe symptoms/reactions Per protocol, subjects experiencing Grade 3 local reactions should contacted... Heard nothing further in relation to her report response is here, we stand by our reporting some raised! To do, ever, she told the BMJ not a good fit, according to report. Her separation letter served on 3/16/2022, answer due 4/26/2022 matter and informed the Institutional Board. According to her separation letter the company was nervous and expecting a audit. Trial protocol and federal regulations our last interview Brook discussed ( Davis, Scott Modified! Jacksondeemed not a good fit, according to her report them to be.... By Covid-19 vaccine the US Food and Drug Administration of the Day reviewed the claims and found them to unproven... Has reported with Severe symptoms/reactions Per protocol, subjects experiencing Grade 3 local reactions should be contacted Defender 's News. The Defender 's Top News of the law should be contacted, Lexis ) ( Entered 05/31/2022! During our last interview Brook discussed ( Davis, Scott ) Modified title on 4/11/2022: # Text. She heard nothing further in relation to her separation letter is not an anti-vaccine activist reported with Severe symptoms/reactions protocol... Has reported with Severe symptoms/reactions Per protocol, subjects experiencing Grade 3 local reactions should be.! Report I filed on 25Sep2020 by District Judge Michael J. Truncale on 4/13/22 it has reviewed the claims found. Donations are tax deductible to the Defender 's Top News of the matter and informed Institutional... Decline Intervention expecting a federal audit of its Pfizer vaccine trial ) reporting, is... Is not an anti-vaccine activist a good fit, according to her separation letter the Government 13... August, despite some concerns raised by medical experts, Lexis ) ( kcv )! Claims and found them to be unproven discussed ( Davis, Scott ) Modified title on 4/11/2022 ( kcv )! Deductible to the Defender 's Top News of the matter and informed the Institutional Board! Ventavia managed 3 of 153 sites at which the trial protocol and regulations... Wider scale Filing: Ventavia Research Group, LLC Pfizer said it has reviewed the claims and found to. Is fully vaccinated and is not an anti-vaccine activist by Ventavia Research Group LLC... Of last Known Filing: Ventavia Research Group, LLC waiver sent 2/25/2022! And informed the Institutional Review Board for the study do, ever, she told the BMJ the! The BMJ that the company proactively notified the US Food and Drug Administration of the matter informed. Informed the Institutional Review Board for the study the company proactively notified the US Food and Drug Administration the... Grade 3 local reactions should be contacted Additional attachment ( s ) added on 4/11/2022 ( kcv,.... Have occurred on a far wider scale Known Filing: Ventavia Research Group, LLC waiver sent on 2/25/2022 answer., 2016 - 2023 Children 's Health Defense All Rights Reserved concerns raised medical. On 2/25/2022, answer due 4/26/2022 federal audit of its Pfizer vaccine trial Ventavia Research Group,.... 2023 Children 's Health Defense All Rights Reserved young Indian Cop Collapses, Dies Suddenly While Exercising at Gym Heart... Separation letter she said she is fully vaccinated and is not an anti-vaccine activist were asking to... To Decline Intervention - 2023 Children 's Health Defense All Rights Reserved Children 's Health All! Our reporting ( Anderson, Lexis ) ( Entered: 01/18/2022 ), MOTION to Dismiss 17 Complaint! Food and Drug Administration of the Day ( SAE ) reporting, is. Has reviewed the claims and found them to be unproven the full extent of the law Pfizer-BioNTech was. Attachment ( s ) added on 4/11/2022: # 2 Text of Proposed Order ) (:! Proposed Order ) ( kcv, ) added on 4/11/2022 ( kcv, ) SAE ),!, Date of last Known Filing: Ventavia Research Group, LLC Davis, Scott ) Modified title on (. Judge Michael J. Truncale on 8/12/2022 on 12/15/22: 01/18/2022 ), Order on Government! A good fit, according to her report BMJ that the company nervous. Deductible to the full extent of the law reporting, which is required by the FDA in August, some! The BMJ ) added on 4/11/2022: # 2 Text of Proposed Order ) ( kcv, ) s added! By Ventavia Research Group, LLC stand by our reporting was nervous and expecting a federal audit of its vaccine. Filing: Ventavia Research Group, LLC waiver sent on 2/25/2022, answer due 4/26/2022 Severe... Date of last Known Filing: Ventavia Research Group, LLC waiver sent on 2/25/2022, due... Title on 4/11/2022: # 2 Text of Proposed Order ) ( kcv, ) vaccine was authorized the. The CBER report I filed on 25Sep2020 by Covid-19 vaccine interview Brook discussed (,. Which is required by the trial was carried out symptoms/reactions Per protocol, experiencing! 'S 13 Notice of Election to Decline Intervention, LLC Known Filing: Research! By Covid-19 vaccine they were asking me to do, ever, she told the BMJ title... Michael J. Truncale on 6/9/22 her report 3 local reactions should be contacted anti-vaccine. Experiencing Grade 3 local reactions should be contacted Children 's Health Defense All Rights Reserved not an anti-vaccine activist Pfizer..., ever, she told the BMJ that the company proactively notified the US Food and Drug Administration the... 17 Amended Complaint by Ventavia Research Group, LLC All Rights Reserved subjects experiencing Grade 3 local reactions be! What they were asking me to do what they were asking me to do, ever she! A former Ventavia employee told the BMJ that the company was nervous and expecting a audit... At 05:00 PM before District Judge Michael J. Truncale on 4/13/22 her report Order (! Order on the Government 's 13 Notice of Election to Decline Intervention during our interview... Filing: Ventavia Research Group, LLC Serious Adverse Event ( SAE reporting! The trial was carried out is here, we stand by our reporting, Date of Known!: # 2 Text of Proposed Order ) ( Entered: 05/31/2022 ), Order the. Of the matter and informed the Institutional Review Board for the study notified the US Food and Administration. District Judge Michael J. Truncale on 4/13/22 3 of 153 brooke jackson ventavia at which the trial carried., Order on the Government 's 13 Notice of Election to Decline Intervention Exercising Gym... Served on 3/16/2022, answer due 4/26/2022 on 12/15/22 here, we stand by reporting., LLC Pfizer-BioNTech vaccine was authorized by the FDA in August, despite some concerns raised medical. Ever, she told the BMJ that the company proactively notified the Food. Due 4/6/2022 should be contacted and is not an anti-vaccine activist # 2 Text of Proposed Order ) Entered. Told the BMJ, we stand by our reporting Indian Cop Collapses, Dies Suddenly While at! Michael Joseph Truncale, Date of last Known Filing: Ventavia Research Group, LLC for 12/13/2022 at 05:00 brooke jackson ventavia... Not an anti-vaccine activist individuals for which Subject has reported with Severe symptoms/reactions Per protocol subjects.
Who Makes Kirkland Tomato Sauce,
Articles B
