Hillman - William Hillman. My main responsibility was to oversee the conduct of Pfizer's Phase 3 Covid-19 mRNA "vaccine" trial at several locations in Texas. 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. 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. . Most seriously, she noted the improperly diluting of the vaccine and the failure to keep the vaccines at the recommended temperature. But Brooks findings regarding the trials so concerned her that in September 2020 she reported 14 findings she discovered in the Ventavia trials to the FDA. Added link to BMJ's open letter and our response. Ive never been fired in my life, said Brook, whos been working in clinical research for 20 years. "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. 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. She heard nothing further in relation to her report. The allegations were investigated and determined to be unsubstantiated. All rights reserved. What I documented and reported to my former employer and to Pfizer during an internal audit was dangerous and violated Federal law. . Brook Jackson - Known as The COVID-19 Pfizer Whistleblower who reported her findings to the FDA on September 25, 2020. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. In Pfizers briefing document submitted to an FDA advisory committee meeting held on 10 December 2020 to discuss Pfizers application for emergency use authorisation of its covid-19 vaccine, the company made no mention of problems at the Ventavia site. Such breaches of protocol also compromise patient treatments and patient safety. MARCS-CMS 611902. 1998 - 2023 Nexstar Media Inc. | All Rights Reserved. From August 2020 through Sept. 17, 2020 when she was fired Jackson told CBS 17 that Ventavia accounted for at least 1,200 of those people and accounted for three sites. She said she also provided dozens of internal company documents, photos, audio recordings and emails to BMJ. I feel lost, I feel betrayed, she said. Another showed vaccine packaging materials with trial participants' identification numbers written on them left out in the open, potentially unblinding participants," the article said. By appointment only. What I documented and reported to my former employer and to Pfizer during an internal audit was, On September 25, 2020, I spoke to an agent at the FDA, and within hours, I was fired. FDA spokesperson Alison Hunt wrote in a November 10, 2021, email to Lead Stories that the FDA still declares that the benefits outweigh risks that come with Pfizer's vaccine. . Vaccines not being stored at proper temperatures, 6. For information about our privacy practices, please visit our website. She believes integrity is important, and thats why she couldnt ignore the disregard for protocol, unblinding and dismissal of patients adverse COVID-19 vax reactions. In a recording of a meeting in late September2020 between Jackson and two directors a Ventavia executive can be heard explaining that the company wasnt able to quantify the types and number of errors they were finding when examining the trial paperwork for quality control. 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. Ive never had to do what they were asking me to do, ever, she told The BMJ. Here is the CBER report I filed on 25Sep2020. Director, Hematology Lifecycle and Portfolio Strategy at Pfizer Boulder, Colorado, United . The material on this site is for informational purposes only, and is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails. The company proactively notified the US Food and Drug Administration of the matter and informed the Institutional Review Board for the study. BROOK JACKSON INTERVIEW - PFIZER WHISTLEBLOWER EXPOSES COVER UP CALLING VACCINE DATA INTO QUESTION Browse more videos Playing next 0:40 COVID-19 vaccine ng Pfizer-BioNtech, mas epektibo raw sa Omicron variant kapag may booster shot na | UB GMA News 3:14 The BMJ investigative report has now alleged that the documentation of the clinical trials that Pfizer submitted to the FDA is brimming with data reporting errors and clinical trial misconduct. Even Thacker acknowledged that people are going to use this to push a political position because thats what theyre interested in.. Additionally we host events, provide commentary for traditional media shows, and give speeches to groups of all sizes. ", Ventavia spokesperson Lauren Foreman discredited Jackson's claims. 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. 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. Ventavia fired her that afternoon. Share on Facebook. Pfizer Whistleblower Brook Jackson on alleged data 'clean up' and new documents, adverse effects. But she said she was surprised that the agency failed to inspect Ventavia after an employee had filed a complaint. If all of the clinical trial data were dependent on one particular site, and that sites data were called intoquestion, I think it would be a much bigger concern, Fisher said. The article said that Ventavia, who Jackson said was selected to. A leading force in clinical research trials. HKS - Hiroyuki Hasegawa and Goichi Kitagawa (plus Sigma Automotive) Hodder & Stoughton - Matthew Hodder and Thomas Wilberforce Stoughton. Opens in a new tab or window, Visit us on TikTok. A spokesperson for Texas-based Ventavia Research Group wrote in a November 10, 2021, email to Lead Stories that BMJ did not seek comment in advance of the report. The regional director for Ventavia, Jackson was fired immediately after she reported her concerns to the. How to Cultivate a Marriage That Will Help Your Child Succeed. However, in the research we have conducted, there are massive holes in Ms. Jackson's claims, and while there are issues with mishandling the mishandling of biohazard materials during the testing process, that in no way constitutes a data integrity breach, as Ms. Jackson claims. Though the regulator claims it doesnt have the manpower to actively monitor and investigate all clinical trials, one person told the BMJ she was surprised that the agency didnt inspect Ventavia even after an employee had filed a complaint. And then let's have the company respond.". Paul Thacker, the investigative journalist who wrote the story, told CBS 17 that it raised questions about what was this process like? Nomi Prins Liquid Energy Stocks Are Cheap and Undervalued, HIPAA & HITRUST Compliance The Difference Explained. Jackson also recorded a meeting with two Ventavia directors in late September 2020 in which one of them admitted that the company wasnt able to quantify the types and number of errors they were finding when examining the trial paperwork for quality control. Jackson told The BMJ it was the first time she had been fired in her 20 year career in research. Foreman said that Ventavia has just under 100 employees and has been conducting clinical trial research since 2013. A report from a purported "whistleblower" alleging that Pfizer falsified data and failed to promptly pursue reports of adverse events in its COVID-19 vaccine trial raised some eyebrows among vaccine experts. Please note: your email address is provided to the journal, which may use this information for marketing purposes. Ventavia managed 3 of 153 sites at which the trial was carried out. "I was working on Pfizer's trial," Brooke Jackson, a regional director formerly employed by Pfizer subcontractor Ventavia Research Group, which was testing Pfizer's COVID-19 vaccine, said in the film.9 "What I saw was like nothing I've ever seen before." 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. Provenance and peer review: commissioned; externally peer reviewed. Jackson claims she had repeatedly informed her superiors at Ventavia Research Group of problems due to substandard laboratory management, ongoing patient safety concerns (the trial participants), and key data integrity issues in Pfizer's vaccine trial. 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, Government of Jersey: Consultant in Stroke Medicine, South Infirmary-Victoria Hospital: Consultant Otorhinolaryngologist, Norfolk and Norwich University Hospitals NHS Foundation Trust: Consultant Medical Microbiologist, Womens, childrens & adolescents health. She repeatedly told company officials of the breaches in protocol and other actions that compromised the study, but her protests were ignored. I think that that could be an unnecessary focus and anxiety about this breaking story, said Dr. Jill Fisher, a professor of social medicine at the University of North Carolina and an expert on clinical trials. Wouldn't it make sense if there was an actual problem that the FDA would have taken action? Medpage Today is among the federally registered trademarks of MedPage Today, LLC and may not be used by third parties without explicit permission. Of that 44,000, only 170 patients developed COVID after getting the vax. And its about vaccines. The Pfizer-BioNTech vaccine was authorized by the FDA in August, despite some concerns raised by medical experts. Lauren Foreman, director of business development & communications, wrote: The accuser was employed for approximately two weeks in September 2020, and no part of her job responsibilities concerned the clinical trials at issue. Devin Willock: Georgia Offensive Lineman Devin Willock and Bulldog Staffer Die in Horrific Car Crash Hours after Title Celebration, Mo Shaikh's Incomparable Love for Dogs Is a Gift for All, Who Is R'Bonney Gabriel? I felt that I had a responsibility to make sure that the participants were protected and that the fraudulent data being collected in the study was not used in any safety and efficacy analysis. She repeatedly told company officials of the breaches in protocol and other actions that compromised the study, but her protests were ignored. Documents show that problems had been going on for weeks. Spotted something? In my mind, its something new every day, a Ventavia executive says. 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