Brook Jackson knew things were wrong immediately after being hired in late 2020 by Ventavia Research Group. Two of the final projects that I was overseeing involved the testing of the cobas SARS-CoV-2 and Abbott ID Now RT-PCR technologies and early phase trials of remdesivir. Ventavia spokeswoman Lauren Foreman said in a statement that the company is investigating the allegations made by Jackson. "There's a lot of stuff in there that really doesn't speak to whether the [Pfizer vaccine trial] data were recorded correctly.". Does this sound like criminal fraud to you? Additionally we host events, provide commentary for traditional media shows, and give speeches to groups of all sizes. 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). 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. fraud I witnessed that's now impacted hundreds of millions of lives in the United States, as well as around the world. We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. Most seriously, she noted the improperly diluting of the vaccine and the failure to keep the vaccines at the recommended temperature. 5h A MUST watch video Based on detailed empirical evidence prove that post-vaccination Covid deaths are 75% higher since the global vaccine rollout. 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. HKS - Hiroyuki Hasegawa and Goichi Kitagawa (plus Sigma Automotive) Hodder & Stoughton - Matthew Hodder and Thomas Wilberforce Stoughton. And sometimes oversight occurs too late. See who is sharing it (it might even be your friends) and leave the link in the comments. Let us know!. 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. not following the required protocols scrupulously. And this is due to the sensitivity of this issue. 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. Another prominent vaccine expert, who asked not to be quoted by name, said that many of the issues alleged by the article's main source "are things you wouldn't want to see happen, like needles and syringes and things discarded in bags. Ive never had to do what they were asking me to do, ever, she told The BMJ. GTE Technology: How To Invest The RIGHT Way & Jeff Browns Claim of $2.1 Quadrillion World IPO Day Is It Legit or a Scam? The staff at the company were forging patient consent forms. However, at Ventavia, Jackson told The BMJ that drug assignment confirmation printouts were being left in participants charts, accessible to blinded personnel. Simply put, the Federal False Claims Act is the #1 way the United States Federal Government fights fraud. Since September 2020, I have worked around the clock, focused solely on compiling evidence for my legal team and to bring awareness to injuries and harms caused by the mRNA COVID-19 products. I think thats definitely a narrative thats out there, she said. Of the 170 patients who tested positive for COVID in the Pfizer clinical trials, four of them were from Ventavias clinical trial sites. These same accusations were made a year ago, at which time Ventavia notified the appropriate parties. https://vivafrei.comRoyalty-free music at http://www.hooksounds.com/ref/vivafrei 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. 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. You might find the issues brought up by Professor Dorit Rubenstein Reiss of the University of California Hastings College of Law quite interesting. 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. 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? 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. 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. 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. Lack of training, yes. In a further surprise, the FDA did not follow up on Jacksons complaint either. The realization that her industry has been corrupted for a long time has been sobering for Brook. Jackson told The BMJ it was the first time she had been fired in her 20 year career in research. 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. She heard nothing further in relation to her report. 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. The FDA took zero action against Pfizer or Ventavia Research Group (VRG). Jackson states she has audio recordings and copies of company documents backing up her claims about how the vaccine trial was conducted by VRG. technical support for your product directly (links go to external sites): Thank you for your interest in spreading the word about The BMJ. Ventavia managed 3 of 153 sites at which the trial was carried out. Obviously we don't agree. 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. Paul Thacker - the reporter responsible for breaking the story, is described as an American journalist who has reported on science, medicine, and the environment. They were enrolling their own employees and family members in the study and allowing them to choose to get the actual v*ccine, not the placebo. 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. Added link to BMJ's open letter and our response. 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. 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 employee, Brook Jackson, who worked as a regional director for Ventavia, is said to have reported her concerns to the FDA. Food and Drug Administration. metatron.substack.com 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. This website uses cookies to improve your experience while you navigate through the website. They shouldnt have used the data from Ventavia to show the v*ccine was effective or safe. I feel lost, I feel betrayed, she said. Unblinding trials effectively renders them useless, Brook noted. She said she also provided dozens of internal company documents, photos, audio recordings and emails to BMJ. She added that after Jackson was fired, Pfizer had been notified of problems at Ventavia and that an audit took place. Letter to John B Cole MD. The FDA has not taken any action against Ventavia and fully accepted the data from the vaccine testing which was performed at Ventavia facilities. Miss USA Becomes the First Filipino-American to Win Miss Universe Crown, Has Saudi Arabia Given Death Penalty to Awad Al-Qarni? According to Jackson, Ventavia "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. 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. On September 25, 2020, I spoke to an agent at the FDA, and within hours, I was fired. Part of my responsibility was to ensure the rights, safety, and welfare of the people volunteering . And its about vaccines. The employee, former regional director Brook Jackson, told the publication that some paperwork may have been left out in the open, potentially unblinding some of the participants. "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. Was this good data?. Update: In response to this fact check the BMJ published an open letter to Mark Zuckerberg. These cookies do not store any personal information. Others have wondered why did Ms. Jackson go to BMJ.com to break the story, a UK company, instead of one in the US? 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. 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. On September 25, 2020 which was the following morning Jackson said she called the FDA and warned the agency about unsound practices in Pfizers clinical trial at Ventavia, and also articulated her concerns in an emailed complaint. ", Asked whether the FDA is investigating the matter, a spokeswoman for the FDA said in an e-mail, "Although the agency cannot comment further at this time in this ongoing matter, FDA has full confidence in the data that were used to support the Pfizer-BioNTech COVID-19 Vaccine authorization and the Comirnaty approval.". It is mandatory to procure user consent prior to running these cookies on your website. These cookies will be stored in your browser only with your consent. Of that 44,000, only 170 patients developed COVID after getting the vax. A vial and syringe are seen in front of the Pfizer logo in this illustration. But should it make you any less confident in the vaccines themselves? Does that seem like a lot to you? . At a roundtable discussion for v*ccine-injured advocates in November 2021 organized by Senator Ron Johnson, the testimonies transformed Brook. 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. According to BMJ, in a list of action items circulated among Ventavia leaders in early August 2020, one executive reportedly identified three site staff members with whom the company needed to go over e-diary issue/falsifying data, etc. One of the staff members was also verbally counseled for changing data and not noting late entry, a note indicated, according to the report. The email said the agency couldnt comment on any investigation that might result from her complaint. One photo, provided to The BMJ, showed needles discarded in a plastic biohazard bag instead of a sharps container box. Subscribe to The Defender's Top News of the Day.It's free. Support us at www.VivaBarnesLaw.Locals.ComMerch store! 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. Also Read: How Covaxin Trial Participants in Bhopal Were Misled. It is powerful as it allows whistleblowers to the people involved in the fraud. The full trial (registered under NCT04368728) enrolled around 44000 participants across 153 sites that included numerous commercial companies and academic centres. 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. Targeting of Ventavia staff for reporting these types of problems. We use Mailchimp as our marketing platform. Necessary cookies are absolutely essential for the website to function properly. Letter to Scott Gottlieb and Jerry Menikoff. Let us know!. Documents show that problems had been going on for weeks. 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," the journal wrote. Jackson led the world's first COVID-19 clinical vaccine trial, overseeing the first shot of the Moderna vaccine in Seattle on March 16, 2020, and then later pivoting to help with the final stage . 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. As Ive 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. This holds those accountable for serious wrongdoing. Muhammad Ali Record The GOAT The Greatest of All-Time. The employee, Brook Jackson, who worked as a regional director for Ventavia, is said to have reported her concerns to the FDA. 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 Pfizer-BioNTech BNT162b vaccine was subsequently approved by the FDA, EMA and other regulatory authorities based on the robust data submitted from the clinical program. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. Cheryl Clark has been a medical & science journalist for more than three decades. Photo: Reuters/Dado Ruvic. . That moment led me to where I am today; A whistleblower who's fighting to hold those accountable for thefraud I witnessed that's now impacted hundreds of millions of lives in the United States, as well as around the world. Want something more? But less than 24 hours later, Ventavia fired her in an apparent reprisal. Was there no media outlet willing to break the story because they felt it lacked real evidence? Pfizer's investigation did not identify any issues or concerns that would invalidate the data or jeopardize the integrity of the study. Ventavia fired her later the same day. Another employee, on condition of anonymity, told BMJ that Ventavia didnt have enough people to collect swab samples from trial participants who had reported symptoms that were consistent with COVID-19. They were in a rush to get this v*ccine out and they wanted to be the first to market.. 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. she wrote in a November 9, 2021 response to a Kennedy tweet blasting Sesame Street. 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. "One photo showed needles discarded in a plastic biohazard bag instead of a container box. "It's all this sort of vague kind of hand waving; I have no idea whether any of this is true, nor do you," Paul Offit, MD, of Children's Hospital of Philadelphia, and a member of the FDA's Vaccines and Related Biological Products Advisory Committee, told MedPage Today. The Pfizer-BioNTech vaccine was authorized by the FDA in August, despite some concerns raised by medical experts. ", Foreman said the "accuser" Jackson was employed "for approximately 2 weeks in September 2020, and no part of her job responsibilities concerned the clinical trials at issue.". My main responsibility was to oversee the conduct of Pfizer's Phase 3 Covid-19 mRNA "vaccine" trial at several locations in Texas. She repeatedly told company officials of the breaches in protocol and other actions that compromised the study, but her protests were ignored. 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. Jackson states she has audio recordings and copies of company documents backing up her claims about how the vaccine trial was conducted by VRG. Targeting Ventavia staff for reporting these types of problems. 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 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. You have these codes and regulations, and they must be followed.. Bourla A. Spotted something? But Fisher who has authored books on the subject of clinical trials and was quoted in Thackers story says thats the wrong takeaway. 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. Jackson County (FULL: Will utilize existing waitlist) 9 a.m. - 4:00 p.m., Jackson County Armory, 8832 Pt. Brook Jackson is a former clinical trial auditor who was let go for 'raising her voice'. "One photo showed needles discarded in a plastic biohazard bag instead of a sharps container box. Theres no accountabilitynone.. 20052022 MedPage Today, LLC, a Ziff Davis company. know it, an executive stated. What I documented and reported to my former employer and to Pfizer during an internal audit was dangerous and violated Federal law.
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