A leading force in clinical research trials. 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. Of the 170 patients who tested positive for COVID in the Pfizer clinical trials, four of them were from Ventavias clinical trial sites. Such breaches of protocol also compromise patient treatments and patient safety. Guest Post by Steve Kirsch Brook Jackson is the Pfizer whistleblower. On September 8, 2020, I accepted a new position as Regional Director with a company named Ventavia Research Group. 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. Miss USA Becomes the First Filipino-American to Win Miss Universe Crown, Has Saudi Arabia Given Death Penalty to Awad Al-Qarni? At Ventavia, her job was to manage the daily operations of the Ventavia COVID-19 study, which involved 1,500 study participants. She said she holds a certificate in clinical trial auditing from Barnett International, which offers a 30-hour course. Miss a day, miss a lot. Obviously we don't agree. 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. 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'm talking about data integrity," she said from a phone number listed to a Dallas suburb. They shouldnt have used the data from Ventavia to show the v*ccine was effective or safe. Vaccines not being stored at proper temperatures, 6. 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. Most seriously, she noted the improperly diluting of the vaccine and the failure to keep the vaccines at the recommended temperature. Ventavia takes research compliance, data integrity, and participant safety very seriously, and we stand behind our work supporting the development of life-saving vaccines. All rights reserved. Such an analysis would give added confidence in the Phase III results. And of that 170, theyre saying that 162 were in the placebo group, [so] eight were in the vaccinated groupthats how they got 95% safe and effective.. He has just 16k followers on Twitter. Hewlett-Packard - William Hewlett and David Packard. If the FDA receives a complaint about a clinical trial, she says the agency rarely has the staff available to show up and inspect. The FDA says its position is unchanged: The benefits of the Pfizer vaccine far outweigh rare side effects and the clinical trial data are solid. The BMJ article says a former Ventavia worker named Brook Jackson told The BMJ that Ventavia falsified data, "unblinded" patients and employed inadequately trained vaccinators. Brook Jackson Lawsuit Contributed by Zack Stieber (Epoch Times) p. 1. Both confirmed broad aspects of Jacksons complaint. You may download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained. View Brooke M. Baker, PhD, MBA'S profile on LinkedIn, the world's largest professional community. Hewitt Associates - Ted Hewitt. Instead of reporting the potential unblinding, [Ventavia officials] sent a text message to the directors in the company to have them locate the info and destroy evidence of unblinding. Her job was to oversee its clinical trial of Pfizers not-yet-approved COVID-19 v*ccine. 5h A MUST watch video Based on detailed empirical evidence prove that post-vaccination Covid deaths are 75% higher since the global vaccine rollout. She then reported her concerns in an email to the agency. ", 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.". 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.. 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. Like many, I had confidence and trust in a regulatory process and in the federal agencies in place to protect public health. RELATOR BROOK JACKSON'S ORIGINAL COMPLAINT FOR VIOLATIONS . Letter to Scott Gottlieb and Jerry Menikoff. She repeatedly told company officials of the breaches in protocol and other actions that compromised the study, but her protests were ignored. The U.S. Food and Drug Administration (FDA), the Center for Disease Control and Prevention (CDC), and others, have failed to do their job protecting the American people. 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. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. 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. "Shocking, actually." While health agencies continue to assure the public that COVID-19 shots are safe, those working closely on the trials had a different take. Also Read: How Covaxin Trial Participants in Bhopal Were Misled. Pfizer. For 18 days I was telling them everything they were doing wrong. 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. 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. Department of Health and Human Services Office of Inspector General. 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. The FDA took zero action against Pfizer or Ventavia Research Group (VRG). Cheryl Clark, Contributing Writer, MedPage Today Hilton Hotels - Conrad Hilton. 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. See who is sharing it (it might even be your friends) and leave the link in the comments. 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. Its been very difficult for me to be the age I am and realize what the past 20 years of my life have been. pic.twitter.com/VtqDLWTCo9. A lawsuit filed by whistleblower Brook Jackson alleging Pfizer and two of its contractors manipulated data and committed other acts of fraud during Pfizer's COVID-19 clinical trials is paused following a motion by the defendants to dismiss the case. 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 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. The named parties in the lawsuit, including ICON, Pfizer, and Ventavia, all made motions to dismiss. 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. Early and inadvertent unblinding may have occurred on a far wider scale. It is mandatory to procure user consent prior to running these cookies on your website. 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. According to Jackson's reports, Texas Contractor, Ventavia Research Group held unblinding phase III vaccine trial, leading to the vaccine's approval and deployment of insufficiently or not at all trained vaccinators. We also use third-party cookies that help us analyze and understand how you use this website. Please select all the ways you would like to hear from Lead Stories LLC: You can unsubscribe at any time by clicking the link in the footer of our emails. inaccurate stories, videos or images going viral on the internet. Sign up for ourDaily Digestemail newsletter to receive intellectually engaging content and updates from our organization straight to your inbox. 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