Jackson states she has audio recordings and copies of company documents backing up her claims about how the vaccine trial was conducted by VRG. Reading about or even hearing over the phone the heartbreaking stories of v*ccine-injured people with debilitating neurological symptoms, heart problems, and more is bound to make anyone empathize with those folks. Medical experts disagree with claims that this contretemps calls into question the results of the Pfizer clinical trial. Want something more? The FDA said, without explicitly saying it, that the allegations don't change the agency's assessment of the vaccine's safety. Jul 2018. Imagine taking a sheet of paper and joining the t, Record-keeping began in 1940 and the planets oceans have been heating steadily for more than six decades with th, Resilient food systems can help reduce the impacts of drought on food and nutrition security. The report was making rounds on social media, with vaccine skeptics pointing to it as justification for their skepticism. 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 . I dont know why theyre so afraid of them, she said. 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. 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. 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. 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. 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. According to BMJ, the FDA officials had inspected nine of the trials 153 sites none were Ventavias. Hours later, while working from home that day, she was fired by Ventavia, ostensibly because she wasnt the right fit.. 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". Necessary cookies are absolutely essential for the website to function properly. On September 8, 2020, I accepted a new position as Regional Director with a company named Ventavia Research Group. These holes have not been addressed by Jackson or her legal team, as far as we can tell. Do you think that Reiss has created massive holes in the claims stated by Ms. Jackson? 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. Documents show that problems had been going on for weeks. Ventavia Research Group (VRG) - The independent lab which conducted the testing of the Pfizer-BioNTech COVID-19 vaccine. 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. View the profiles of professionals named "Brooke Jackson" on LinkedIn. The vaccine has been given to hundreds of millions of people worldwide following approval. Most seriously, she noted the improperly diluting of the vaccine and the failure to keep the vaccines at the recommended temperature. All content copyright 2008-2023, Business and Leadership Ltd - All rights reserved. FILE - In this Oct. 5, 2021, file photo a healthcare worker fills a syringe with the Pfizer COVID-19 vaccine at Jackson Memorial Hospital in Miami. 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. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. 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. 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. 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. They shouldnt have used the data from Ventavia to show the v*ccine was effective or safe. 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. The story published this week in the British Medical Journal lays out issues raised by a now-former employee of Ventavia Research Group, one of the companies contracted to help run some of Pfizers Phase III clinical trials. Her attorney, Robert Barnes, says that Brook Jackson exposed the fact that the Pfizer clinical trial was riddled with errors and fraudulent and false certifications to the US government. By clicking Accept All, you consent to the use of ALL the cookies. 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. RALEIGH, N.C. (WNCN) A report in a medical journal is raising questions about the results from one research company that helped with Pfizers trials for its COVID-19 vaccine. "Ventavia fired her later the same day." Spotted something? Countries that have b, The technology has progressed so far that precision genetic engineering and automation can now be merged into autom, Company That Managed Pfizer Vaccine Trial Sites Falsified Data: Whistleblower, We Cant Understand Climate Change Without Understanding Its Economic Costs, Snakes on a Tiny Australian Island Show That Evolution Is Not Always Slow, Theres a Relatively Easy Way to Reducethe Health Risks From Sitting All Day, China Now Publishes More High-Quality Science Than Any Other Nation, Why Amendments to the Wild Life Act Are Scheduled To Fail, How Covaxin Trial Participants in Bhopal Were Misled, Vaccines at Warp Speed: The Difference Between the US and India. In my mind, its something new every day, a Ventavia executive says. The Department of Justice doesnt understand how clinical trials should be run, she noted. In the afternoon Ventavia fired Jacksondeemed "not a good fit," according to her separation letter. Another showed vaccine packaging materials with trial participants' identification numbers written on them left out in the open, potentially unblinding participants," the article said. 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. However, at Ventavia, Jackson told The BMJ that drug assignment confirmation printouts were being left in participants charts, accessible to blinded personnel. (Attempts to reach Thacker were unsuccessful. These cookies do not store any personal information. Even Thacker acknowledged that people are going to use this to push a political position because thats what theyre interested in.. Pfizer Whistleblower Brook Jackson on alleged data 'clean up' and new documents, adverse effects. View Brooke M. Baker, PhD, MBA'S profile on LinkedIn, the world's largest professional community. "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. 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. The Pfizer Phase III trial involved 44,000 people and 153 locations. Of that 44,000, only 170 patients developed COVID after getting the vax. Pfizer's defense presented in court is that the FDA knew about the fraud and was But that doesn't have to do with data integrity. Five-Dollar Eggs and the Gift of Productivity, COVID Whistleblower: Brook Jackson and Her Lawsuit Against Pfizer, Creative Commons Attribution-ShareAlike 4.0 International, While We Were Sleeping, the CCP Was Waging War. My main responsibility was to oversee the conduct of Pfizer's Phase 3 Covid-19 mRNA "vaccine" trial at several locations in Texas. This was to be done to preserve the blinding of trial participants and all other site staff, including the principal investigator. Was this good data?. Let us know!. This holds those accountable for serious wrongdoing. She repeatedly told company officials of the breaches in protocol and other actions that compromised the study, but her protests were ignored. 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 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. However, her stint at the company lasted only two weeks, in September 2020 in which time she said she witnessed poor laboratory management, patient safety concerns, and data integrity issues. She then reported her concerns in an email to the agency. Another photo shows the potential of unblinding the participants as the completed vaccine packing materials contained the trial participants' identification numbers, which were out in the open instead of in a secured location. https://vivafrei.comRoyalty-free music at http://www.hooksounds.com/ref/vivafrei "Ventavia takes research compliance, data integrity, and participant safety very seriously, and we stand behind our work supporting the development of life-saving vaccines," Foreman continued. Part of the problem Brook faces in her lawsuit is not just the intransigence of government officials but also their stupidity. : Lead Stories is working with the CoronaVirusFacts/DatosCoronaVirus Alliance, a coalition of more than 100 fact-checkers who are fighting misinformation related to the COVID-19 pandemic. Ive never been fired in my life, said Brook, whos been working in clinical research for 20 years. inaccurate stories, videos or images going viral on the internet. Additionally we host events, provide commentary for traditional media shows, and give speeches to groups of all sizes. 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. Opens in a new tab or window. Hillman - William Hillman. The named parties in the lawsuit, including ICON, Pfizer, and Ventavia, all made motions to dismiss. Bourla A. 20052022 MedPage Today, LLC, a Ziff Davis company. 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. IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF TEXAS BEAUMONT DIVISION UNITED STATES OF AMERICA ex rel. The FDA and Pfizer attempted to hide the COVID-19 shot clinical trial data for 75 years, but the FDA was ordered by the U.S. District Court for the . Examples included two individuals for which Subject has reported with Severe symptoms/reactions Per protocol, subjects experiencing Grade 3 local reactions should be contacted. Her job was to oversee its clinical trial of Pfizer's not-yet-approved COVID-19 v*ccine. Paul D Thacker reports In autumn 2020 Pfizer's 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. At Ventavia, her job was to manage the daily operations of the Ventavia COVID-19 study, which involved 1,500 study participants. They were in a rush to get this v*ccine out and they wanted to be the first to market.. 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. The regional director for Ventavia, Jackson was fired immediately after she reported her concerns to the US Food and Drug Administration. The Food and Drug Administration (FDA) - the government entity in charge of ensuring the food sold to the public, as well as the drugs created to better our health, are created in the best manner possible, and they do what they should do. Medpage Today, LLC, a Ziff Davis company, Jackson was immediately! To it as justification for their skepticism noted brooke jackson pfizer improperly diluting of the trials 153 sites none were Ventavias September... The vaccines at the recommended temperature or her legal team, as far as we tell. The failure to keep the vaccines at the recommended temperature but her protests were ignored groups! Concerns to the US Food and Drug Administration ( VRG ) - the lab... The volume of problems they were in a rush to get this v * ccine out and they to. My responsibility was to oversee its clinical trial the named parties in the claims stated by Ms. Jackson which the! 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