As the author of the article, journalist Paul Thacker, explains, the irregularities were detected by Brook Jackson, Ventavia's 'regional director', during a few weeks in September 2020, the period for which the researcher worked for the company. This means participants do not know certain information about the triallike whether theyre receiving the real treatment or placeboand this reduces bias and the placebo effect. Pfizer said it has reviewed the claims and found them to be unproven. Liked by Brooke Jackson View Brooke's full profile See who you know in common Get introduced Contact Brooke directly Amy Jackson-Fisher Director at Pfizer San Diego, CA Teresa Ostapower. I spent my entire career making sure that the data in clinical trials was backed by good data, Brook said. 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. The FDA published a summary of its inspection of the companys trial in August 2021, after it had given the Pfizer vaccine full (not emergency) authorisation. Jefferson County (FULL: Will utilize existing waitlist) 9:00 a.m. - 3:00 p.m., Ranson Civic Center, 432 West 2nd Avenue, Ranson, WV 25438. That is a great question, as we couldn't find anything mentioned in the lawsuit that could be deemed criminal fraud. I dont know why theyre so afraid of them, she said. These include trials on COVID-19 vaccines for children and young adults, pregnant women, and a booster dose. "As I've said before, we are operating at the speed of science," Bourla wrote, explaining to the public when they could expect a Pfizer vaccine to be authorised in the United States.1 But, for researchers who were testing Pfizer's vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety. Did the British Medical Association's news blog reveal flaws that disqualify the results of a contractor's field testing of Pfizer's COVID-19 vaccine, and were the problems ignored by the Food & Drug Administration and by Pfizer? However, you may visit "Cookie Settings" to provide a controlled consent. We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. But 40 were from a site in Argentina thats currently undergoing an international investigation for fraud in the trials there, Brook said. Most recently, he wrote the twice-weekly "Save the Free Press" column for The Seattle Times. The Department of Justice doesnt understand how clinical trials should be run, she noted. Opens in a new tab or window, Visit us on LinkedIn. However, what is making waves is a whistleblower by the name of Brook Jackson. 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. A former Ventavia employee told The BMJ that the company was nervous and expecting a federal audit of its Pfizer vaccine trial. ICON reportedly sent an email to Ventavia in September 2020 highlighting over 100 outstanding queries older than three days whereas [the] expectation is that all queries are addressed within 24 hrs. Medical experts disagree with claims that this contretemps calls into question the results of the Pfizer clinical trial. The named parties in the lawsuit, including ICON, Pfizer, and Ventavia, all made motions to dismiss. We interact with millions of Americans each week, publishing numerous articles each day and promoting them through vast social media and email networks. We do not capture any email address. View the profiles of professionals named "Brooke Jackson" on LinkedIn. I think thats definitely a narrative thats out there, she said. Pfizer Whistleblower Brook Jackson on alleged data 'clean up' and new documents, adverse effects. She reportedly also received a call from an FDA inspector a few days later to discuss her report, but hasnt heard anything more since. This is notable because Ventavia has said she was not part of that team. HKS - Hiroyuki Hasegawa and Goichi Kitagawa (plus Sigma Automotive) Hodder & Stoughton - Matthew Hodder and Thomas Wilberforce Stoughton. By appointment only. Brook Jackson, Plaintiff, v. VENTAVIA RESEARCH GROUP, LLC; PFIZER INC.; ICON PLC, Defendants. However, at Ventavia, Jackson told The BMJ that drug assignment confirmation printouts were being left in participants charts, accessible to blinded personnel. 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. After realising that Ventavia was unlikely to perform a course-correcting, Jackson said she was frustrated and documented several matters late one night, taking photos on her mobile phone. During the meeting that Jackson recorded in late September, one executive reportedly said, Were going to get some kind of letter of information at least, when the FDA gets here know it.. For 18 days I was telling them everything they were doing wrong. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. ICON, the contract research organisation with which Pfizer had partnered for the trial, may also have been aware of problems at Ventavia. Was there no media outlet willing to break the story because they felt it lacked real evidence? Most seriously, she noted the improperly diluting of the vaccine and the failure to keep the vaccines at the recommended temperature. After Jackson left the company problems persisted at Ventavia, this employee said. "Ventavia fired her later the same day." And she asked me to never stop fighting for v*ccine-injured people., Image credit: RawPixel-Public Health Image Library, CC0 1.0. Any cookies that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics, ads, other embedded contents are termed as non-necessary cookies. Muhammad Ali Record The GOAT The Greatest of All-Time. An open letter from Pfizer chairman and CEO Albert Bourla. 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? May 2021. Learn more about Mailchimp's privacy practices here. We conducted a thorough investigation into the issues raised in accordance with Pfizer's quality management process related to clinical research. In an article in MedPage, vaccine experts said the claims are not serious enough to jeopardize Pfizer's data. Use tab to navigate through the menu items. Its scary, she said. Its a crazy mess.. "That The BMJ published it doesn't make it any more true," Offit, who formerly sat on CDC's Advisory Committee on Immunization Practices, added. How to Cultivate a Marriage That Will Help Your Child Succeed. For information about our privacy practices, please visit our website. Brooke Jackson - Graduate Research Assistant - The University of Georgia | LinkedIn Brooke Jackson Doctoral Candidate at University of Georgia - Franklin College of Arts and Sciences Athens,. GTE Technology: How To Invest The RIGHT Way & Jeff Browns Claim of $2.1 Quadrillion World IPO Day Is It Legit or a Scam? We also use third-party cookies that help us analyze and understand how you use this website. If you are unable to import citations, please contact Jackson states she has audio recordings and copies of company documents backing up her claims about how the vaccine trial was conducted by VRG. This holds those accountable for serious wrongdoing. 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. metatron.substack.com An article published Wednesday in The BMJ claimed that Texas contractor Ventavia Research Group unblinded patients in the phase III vaccine trial that led to the vaccine's approval and employed inadequately trained vaccinators. But when people learned of her lawsuit, strange things started happening to her. A Pfizer spokesman has promised to provide to Lead Stories an update on the number of trial participants Ventavia enrolled of the 46,000 overall. Food and Drug Administration. inaccurate stories, videos or images going viral on the internet. Her job was to oversee its clinical trial of Pfizer's not-yet-approved COVID-19 v*ccine. In December 2020 when Pfizer was given the emergency use authorization for the v*ccine by the U.S. government, Brook realized theyd used the Ventavia data shed flagged as compromised. She then reported her concerns in an email to the agency. Targeting Ventavia staff for reporting these types of problems. Photo: Reuters/Dado Ruvic. She said Thacker's article did not include any of the evidence the accuser claims she had, and that he did not contact Ventavia for a response before publishing. When the trials were supposed to be blinded, the company I worked for unblinded them., Just 18 days after starting her new job, Brook called the Food and Drug Administration to tell them about those incorrect actions leading to the studys unblinding. That moment led me to where I am today; A whistleblower who's fighting to hold those accountable for the. 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. 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. Ventavia Research Group (VRG) - The independent lab which conducted the testing of the Pfizer-BioNTech COVID-19 vaccine. I knew this v*ccine would be used throughout the world, and I wanted it to be effective and work and help people. Pfizer and the FDA ignored me in that they knew this fraudulent info was being used. One woman approached Brook at an event, and the meeting left an impression on Brook. 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. Was this good data?. Essentially, it allows for the person responsible for informing the government of the wrongdoing (the whistleblower) to receive a portion of the money recovered from the guilty party. In early 2020, when the Government declared COVID-19 a pandemic, I was working as the Director of Operations for a multi-state Site Management Organization. She repeatedly told company officials of the breaches in protocol and other actions that compromised the study, but her protests were ignored. At Ventavia, her job was to manage the daily operations of the Ventavia COVID-19 study, which involved 1,500 study participants. I dont think it was good clean data, the employee said of the numbers Ventavia generated for the Pfizer trial. I recognized fraud right away, Brook said. Brook Jackson is a former clinical trial auditor who was let go for 'raising her voice'. Lead Stories is a U.S. based fact checking website that is always looking for the latest false, misleading, deceptive or Every day the staff of Intellectual Takeout come to work eager to do their part to restore and improve our great nation. Brook Jackson, a regional director who was employed by Ventavia Research Group, told British Medical Journal that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in the pivotal phase III trial of the Pfizer-BioNTech vaccine. . After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson (video 1), emailed a complaint to the US Food and Drug Administration (FDA). November 5, 2021. IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF TEXAS BEAUMONT DIVISION UNITED STATES OF AMERICA ex rel. "There's a lot of stuff in there that really doesn't speak to whether the [Pfizer vaccine trial] data were recorded correctly.". Its another thing entirely to see the v*ccine injured give their testimonies in person. It is unclear if the needles were poking through the plastic bag creating a potential injury to anyone who was near the bag. The Pfizer-BioNTech vaccine was authorized by the FDA in August, despite some concerns raised by medical experts. By appointment only. While health agencies continue to assure the public that COVID-19 shots are safe, those working closely on the trials had a different take. A few days later Jackson received a call from an FDA inspector to discuss her report but was told that no further information could be provided. 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. 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. Separately, Pfizer had submitted documents to the FDA that included details of a briefing on December 10, 2020, but didnt mention the problems at the Ventavia sites. She told The BMJ that, shortly after Ventavia fired Jackson, Pfizer was notified of problems at Ventavia with the vaccine trial and that an audit took place. According to her, her superiors may have been aware of these problems even before she was hired. My main responsibility was to oversee the conduct of Pfizer's Phase 3 Covid-19 mRNA "vaccine" trial at several locations in Texas. Shed lose connectivity on her computer, hear crackling sounds while talking on the phone, had a box of crickets set on her doorstep, and got an already-opened letter from the Department of Justice in her mailbox (the letter was a notice declining part of her lawsuit). She then reported her concerns in an email to the agency. She added that during her time at Ventavia the company expected a federal audit but that this never came. But should it make you any less confident in the vaccines themselves? RELATOR BROOK JACKSON'S ORIGINAL COMPLAINT FOR VIOLATIONS . 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. Added link to BMJ's open letter and our response. The Pfizer Phase III trial involved 44,000 people and 153 locations. Despite Jackson repeatedly notifying Ventavia of the problems, the company reportedly took no corrective action. We know that its significant., Ventavia was not keeping up with data entry queries, shows an email sent by ICON, the contract research organisation with which Pfizer partnered on the trial. 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