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. Its scary, she said. And its about vaccines. She claims that back in September 2020, when she was hired to oversee the testing of a COVID-19 vaccine produced by Pfizer, criminal fraud occurred, allowing the vaccine to be FDA-approved. However, several vaccine experts familiar with COVID vaccine clinical trials questioned the article's accuracy, and advised people not to believe it outright. 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. 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. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails. She then listed a dozen concerns she had witnessed, including: Participants placed in a hallway after injection and not being monitored by clinical staff, Lack of timely follow-up of patients who experienced adverse events, Vaccines not being stored at proper temperatures. "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, . Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. CBS 17sJoedy McCrearyhas been tracking COVID-19 figures since March 2020, compiling data from federal, state,and local sources to deliver a clear snapshot of what the coronavirus situation looks like now and what it could look like in the future. And she explains that over her life she has not been opposed to v*ccines. The BMJ investigation conducted by Paul Thacker reveals inside reports and evidence by Jackson about Pfizer allegedly 'manipulating clinical trials'. 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. Photo: Reuters/Dado Ruvic. Wouldn't it make sense if there was an actual problem that the FDA would have taken action? While health agencies continue to assure the public that COVID-19 shots are safe, those working closely on the trials had a different take. One photo, provided to The BMJ, showed needles discarded in a plastic biohazard bag instead of a sharps container box. Its another thing entirely to see the v*ccine injured give their testimonies in person. "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 FDA took zero action against Pfizer or Ventavia Research Group (VRG). Professor Douglas Drevets, M.D., of the University of Oklahoma College of Medicine, wrote in a November 10, 2021, email to Lead Stories that even if the claims are true, there is abundant proof the Pfizer vaccine works and is safe. That moment led me to where I am today; A whistleblower who's fighting to hold those accountable for the. Targeting of Ventavia staff for reporting these types of problems. 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. 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. You would think if theres a specific and credible complaint that they would have to investigate that, Fisher said. Curiously, the media report has been seized upon by multiple outlets of the Russian media, including the Russian news agency TASS and the Twitter account for the Sputnik vaccine. 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. Of the 170 patients who tested positive for COVID in the Pfizer clinical trials, four of them were from Ventavias clinical trial sites. You have these codes and regulations, and they must be followed.. New Delhi: A researcher who was employed by a company that oversaw three clinical trial sites of Pfizers COVID-19 vaccine has made shocking revelations about poor practices at the facilities that call the integrity of Pfizers data into question and also raise concerns about lax regulatory oversight. In a text message sent in June the former official apologised, saying that everything that you complained about was spot on.. On Twitter, Jackson does not express unreserved support for COVID vaccines. Necessary cookies are absolutely essential for the website to function properly. You can read them here. BioNTech shares traded on the NASDAQ exchange briefly plummeted to around $60. Her job was to oversee its clinical trial of Pfizer's not-yet-approved COVID-19 v*ccine. If you are unable to import citations, please contact What I documented and reported to my former employer and to Pfizer during an internal audit was dangerous and violated Federal law. Opens in a new tab or window, Visit us on LinkedIn. Most recently, he wrote the twice-weekly "Save the Free Press" column for The Seattle Times. People working in clinical research are terrified of FDA audits, Jill Fisher told The BMJ, but added that the agency rarely does anything other than inspect paperwork, usually months after a trial has ended. I recognized fraud right away, Brook said. Medical experts disagree with claims that this contretemps calls into question the results of the Pfizer clinical trial. Nomi Prins Reviews What Do You Need to Know About Nomi Prins, Joshua Shuemake Consulting **2022** Dallas / Ft. Worth Texas, Lee Kuan Yew The Warren Buffet of Singapore Leadership Transformed Singapore Into World Powerhouse, Tyndall and TSSG Targeting 82m in Funding and 10 Spin-Outs with Internet of Things Partnership. They were crapping all over procedures and protocols for a buck, and I couldnt be quiet about that, she said. Ventavia fired her that afternoon. These days, we know the v*ccines arent effective in preventing people from getting COVID and that the vax is causing myocarditis in men, she noted. Does that seem like a lot to you? 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,. Food and Drug Administration. Opens in a new tab or window, Share on Twitter. Another showed vaccine packaging materials with trial participants identification numbers written on them left out in the open, potentially unblinding participants. Jackson told The BMJ it was the first time she had been fired in her 20 year career in research. These holes have not been addressed by Jackson or her legal team, as far as we can tell. The allegations were investigated and determined to be unsubstantiated. know it, an executive stated. 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. Pleasant Road, Millwood, WV 25262. Paul Thacker - the reporter responsible for breaking the story, is described as an American journalist who has reported on science, medicine, and the environment. In several cases Ventavia lacked enough employees to swab all trial participants who reported covid-like symptoms, to test for infection. Foreman said that Ventavia has just under 100 employees and has been conducting clinical trial research since 2013. The regional director for Ventavia, Jackson was fired immediately after she reported her concerns to the US Food and Drug Administration. My main responsibility was to oversee the conduct of Pfizer's Phase 3 Covid-19 mRNA "vaccine" trial at several locations in Texas. After being fired by Ventavia, it took Brook a year to find another job. This question is for testing whether or not you are a human visitor and to prevent automated spam submissions. In my mind, its something new every day, a Ventavia executive says. 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. Hillman - William Hillman. People who have been harmed by COVID-19 shots have suffered a range of medical issues everything from death and permanent disability to pericarditis, nerve damage and overwhelming fatigue. According to BMJ, she then listed a dozen concerns, including the following (quoted verbatim): 1. If it had, it would have been told the employee's report was investigated but found wanting, the spokesperson said. In a November 10, 2021, email to Lead Stories, Pfizer senior manager for science media relations, Kit Longley, detailed Pfizer's response to the claims: Pfizer received communication from an anonymous complainant in September 2020 relating to a single clinical investigator site in Texas, USA. A second employee also described an environment at Ventavia unlike any she had experienced in her 20 years doing research. Citizens for Responsible Care and Research Incorporated (CIRCARE). Part 1: EXCLUSIVE -- Pfizer Vax Trial Manager Tells All; Blows Whistle on Data & Medical Integrity, Alleged Fraud During Covid-19 Clinical Trial; Brook Jackson Details Shocking Insider Revelations During Her First Sit Down with Paine Who is Also Joined by Former Blackrock's Ed Dowd -- BOMBSHELL. Were going to get some kind of letter of information at least, when the FDA gets here . I dont think it was good clean data, the employee said of the numbers Ventavia generated for the Pfizer trial. A former Ventavia employee told The BMJ that the company was nervous and expecting a federal audit of its Pfizer vaccine trial. 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 But that doesn't have to do with data integrity. At several points during the late September meeting Jackson and the Ventavia executives discussed the possibility of the FDA showing up for an inspection (box 1). She added that during her time at Ventavia the company expected a federal audit but that this never came. We conducted a thorough investigation into the issues raised in accordance with Pfizer's quality management process related to clinical research. See who is sharing it (it might even be your friends) and leave the link in the comments. People who are being injured by the v*ccine need to know how these trials were compromised, she said. Im not anti-vax, she said. They were in a rush to get this v*ccine out and they wanted to be the first to market.. Lack of training, yes. By clicking below to subscribe, you acknowledge that your information will be transferred to Mailchimp for processing. The FDAs inspection officer noted: The data integrity and verification portion of the BIMO [bioresearch monitoring] inspections were limited because the study was ongoing, and the data required for verification and comparison were not yet available to the IND [investigational new drug]., In recent months Jackson has reconnected with several former Ventavia employees who all left or were fired from the company. Because the trials endpoint was to identify laboratory-confirmed symptomatic COVID-19, the revelations suggest the data could have been skewed by samples not being collected from participants who had had COVID-like symptoms. 20052022 MedPage Today, LLC, a Ziff Davis company. 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. In a statement, Pfizer 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. Letter to Scott Gottlieb and Jerry Menikoff. You also have the option to opt-out of these cookies. 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. Right away, she found company officials were violating local, state, and federal laws and not putting patients interests ahead of making money. 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. Part of the problem Brook faces in her lawsuit is not just the intransigence of government officials but also their stupidity. Support us at www.VivaBarnesLaw.Locals.ComMerch store! This prompted Jackson to send a complaint by email to the US Food and Drug Administration (FDA) the countrys top regulatory body in September 2020. Were really interested in the story because it is about COVID-19. "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. Miss USA Becomes the First Filipino-American to Win Miss Universe Crown, Has Saudi Arabia Given Death Penalty to Awad Al-Qarni? This category only includes cookies that ensures basic functionalities and security features of the website. . The staff at the company were forging patient consent forms. 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. Years doing research, it would have to investigate that, she said Fisher said this category only includes that! 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