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. Even Thacker acknowledged that people are going to use this to push a political position because thats what theyre interested in.. 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. Every day the staff of Intellectual Takeout come to work eager to do their part to restore and improve our great nation. "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, said in the film.9 "What I saw was like nothing I've ever seen before." This article is made freely available for personal use in accordance with BMJ's website terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. Elsewhere on Twitter, the Brook Jackson account wrote that vaccination makes sense if a person is in a high-risk category and called a 5th Circuit Court of Appeals ruling against the Biden Administration's vaccine mandates "HUGE!". A former Ventavia employee told The BMJ that the company was nervous and expecting a federal audit of its Pfizer vaccine trial. One photo, provided to The BMJ, showed needles discarded in a plastic biohazard bag instead of a sharps container box. The FDA has not taken any action against Ventavia and fully accepted the data from the vaccine testing which was performed at Ventavia facilities. Jackson was a trained clinical trial auditor who previously held a director of operations position and came to Ventavia with more than 15 years experience in clinical research coordination and management. Medical experts disagree with claims that this contretemps calls into question the results of the Pfizer clinical trial. Also Read: How Covaxin Trial Participants in Bhopal Were Misled. But should it make you any less confident in the vaccines themselves? 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. One of them was one of the officials who had taken part in the late September meeting. Jackson states she has audio recordings and copies of company documents backing up her claims about how the vaccine trial was conducted by VRG. Its scary, she said. 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. Its a crazy mess.. The revelations reported in the BMJ article are limited to three of more than 150 trial sites, which enrolled only 1,000 of around the 44,000 overall participants. Brook believes the mRNA platform that was used to develop the COVID-19 v*ccines is being wrongly portrayed as an acceptable way to develop medicines to treat various illnesses. In a list of action items circulated among Ventavia leaders in early August 2020, shortly after the trial began and before Jacksons hiring, a Ventavia executive identified three site staff members with whom to Go over e-diary issue/falsifying data, etc. One of them was verbally counseled for changing data and not noting late entry, a note indicates. Countries that have suffered the most have the highest rates of vaccination & associated, draconian mandates. 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. Pfizer has since hired Ventavia as a research subcontractor for four other vaccine clinical trials. But Brooks findings regarding the trials so concerned her that in September 2020 she reported 14 findings she discovered in the Ventavia trials to the FDA. . 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. She added that after Jackson was fired, Pfizer had been notified of problems at Ventavia and that an audit took place. She then reported her concerns in an email to the agency. With millions of North Carolinians and billions of people around the globe fully vaccinated researchers have plenty of real-world data that show the safety and efficacy of the vaccines. BioNTech shares traded on the NASDAQ exchange briefly plummeted to around $60. View Brooke M. Baker, PhD, MBA'S profile on LinkedIn, the world's largest professional community. -- Brook Jackson (@IamBrookJackson) November 6, 2021 Clicking on the document, it appears to be an internal Ventavia email welcoming a Brook Jackson and adding her to the team working on the Pfizer trial. Culture of Respect: Conservatives Need Not Apply? They have just under 100 employees and have been performing clinical trial research since 2013. These include trials on COVID-19 vaccines for children and young adults, pregnant women, and a booster dose. 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. Was this good data?. By appointment only. (Attempts to reach Thacker were unsuccessful. by Miss a day, miss a lot. Another showed vaccine packaging materials with trial participants' identification numbers written on them left out in the open, potentially unblinding participants," the article said. Photo: Reuters/Dado Ruvic. He has just 16k followers on Twitter. Learn more about Mailchimp's privacy practices here. She repeatedly told company officials of the breaches in protocol and other actions that compromised the study, but her protests were ignored. This holds those accountable for serious wrongdoing. If you want to make sure you have the necessary supplies on hand to treat a future breakout, acne patches are the answer. 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. 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. 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. 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. RELATOR BROOK JACKSON'S ORIGINAL COMPLAINT FOR VIOLATIONS . 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. Here is the CBER report I filed on 25Sep2020. We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. You can read them here. Despite Jackson repeatedly notifying Ventavia of the problems, the company reportedly took no corrective action. However, you may visit "Cookie Settings" to provide a controlled consent. She repeatedly told company officials of the breaches in protocol and other actions that compromised the study, but her protests were ignored. In my mind, its something new every day, a Ventavia executive says. This website uses cookies to improve your experience while you navigate through the website. Please confirm if an UNPLANNED CONTACT was made and update the corresponding form as appropriate. According to the trial protocol a telephone contact should have occurred to ascertain further details and determine whether a site visit is clinically indicated.. This allows for a whistleblower to sue not just the company behind the fraud but individuals who were responsible for carrying out the fraud. As I listened to the v*ccine injured tell their stories, it changed me and my life forever in ways I cant explain, Brook said. BMJ relied on copies of reports filed by a two-week employee of Ventavia. In Pfizers briefing document submitted to an FDA advisory committee meeting held on 10 December 2020 to discuss Pfizers application for emergency use authorisation of its covid-19 vaccine, the company made no mention of problems at the Ventavia site. 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. Theres no accountabilitynone.. 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. ", Pfizer also released a statement and 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.". On September 25, 2020, I spoke to an agent at the FDA, and within hours, I was fired. Two former Ventavia employees spoke to The BMJ anonymously for fear of reprisal and loss of job prospects in the tightly knit research community. The article said that Ventavia, who Jackson said was selected to. I am from a military family, and I still want to believe in my country. not following the required protocols scrupulously. Early and inadvertent unblinding may have occurred on a far wider scale. It just seemed like something a little different from normalthe things that were allowed and expected.. A leading force in clinical research trials. Targeting of Ventavia staff for reporting these types of problems. However, in the research we have conducted, there are massive holes in Ms. Jackson's claims, and while there are issues with mishandling the mishandling of biohazard materials during the testing process, that in no way constitutes a data integrity breach, as Ms. Jackson claims. Unblinding trials effectively renders them useless, Brook noted. 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. 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). In October 2022, the government supported Pfizer in the lawsuit, with a statement of interest saying the case should be dismissed due to the totality of the evidence. She said she holds a certificate in clinical trial auditing from Barnett International, which offers a 30-hour course. "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 . : 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. 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. Opens in a new tab or window, Visit us on Twitter. ICON reminded Ventavia in a September 2020 email: The expectation for this study is that all queries are addressed within 24hrs. ICON then highlighted over 100 outstanding queries older than three days in yellow. 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. The article said that Ventavia, who Jackson said was selected to quickly ramp up Pfizer's COVID vaccine trial, fired Jackson the same day she complained to the agency. Hilton Hotels - Conrad Hilton. The FDA ruled there was no problem with the data submitted and no criminal fraud committed. Both confirmed broad aspects of Jacksons complaint. 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. Want something more? "If this whistleblower believes that they have a whistle to blow, then blow it. However, several vaccine experts familiar with COVID vaccine clinical trials questioned the article's accuracy, and advised people not to believe it outright. Pfizer. At Ventavia, her job was to manage the daily operations of the Ventavia COVID-19 study, which involved 1,500 study participants. Pleasant Road, Millwood, WV 25262. According to BMJ, the FDA officials had inspected nine of the trials 153 sites none were Ventavias. technical support for your product directly (links go to external sites): Thank you for your interest in spreading the word about The BMJ. Its another thing entirely to see the v*ccine injured give their testimonies in person. Under National Institutes of Health standards, a "double-blind" clinical trial is one in which neither the patient nor the person giving the medicine knows if the patient is getting a placebo or the actual drug. She added that during her time at Ventavia the company expected a federal audit but that this never came. Cheryl Clark, Contributing Writer, MedPage Today Dont buy a teeth whitening gel before reading these reviews. The gold standard for clinical trials is for there to be blinding. 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. The allegations were investigated and determined to be unsubstantiated. The named parties in the lawsuit, including ICON, Pfizer, and Ventavia, all made motions to dismiss. 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. Like many, I had confidence and trust in a regulatory process and in the federal agencies in place to protect public health. Newly released documents back up claims by whistleblower Brook Jackson that she was directly involved in Pfizer's COVID vaccine phase 3 clinical trials, which she previously alleged were seriously flawed.. And she explains that over her life she has not been opposed to v*ccines. Examples included two individuals for which Subject has reported with Severe symptoms/reactions Per protocol, subjects experiencing Grade 3 local reactions should be contacted. But that doesn't have to do with data integrity. By appointment only. Director, Hematology Lifecycle and Portfolio Strategy at Pfizer Boulder, Colorado, United . It is mandatory to procure user consent prior to running these cookies on your website. Jackson told The BMJ it was the first time she had been fired in her 20 year career in research. Jackson states she has audio recordings and copies of company documents backing up her claims about how the vaccine trial was conducted by VRG. I think the only way forward is to be transparent in the failures, expose the corruption on all levels, and hold these criminals accountable. I dont know why theyre so afraid of them, she said. She said she also provided dozens of internal company documents, photos, audio recordings and emails to BMJ. 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. Why Are So Many Young People Dying Suddenly? 1998 - 2023 Nexstar Media Inc. | All Rights Reserved. Vaccines not being stored at proper temperatures, 6. Letter to Scott Gottlieb and Jerry Menikoff. 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). 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. 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. What I documented and reported to my former employer and to Pfizer during an internal audit was dangerous and violated Federal law. pic.twitter.com/VtqDLWTCo9. And then let's have the company respond.". The allegations were investigated and determined to be unsubstantiated. We use Mailchimp as our marketing platform. What I documented and reported to my former employer and to Pfizer during an internal audit was, On September 25, 2020, I spoke to an agent at the FDA, and within hours, I was fired. Ventavia executives later questioned Jackson for taking the photos. Wouldn't it make sense if there was an actual problem that the FDA would have taken action? Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails. Lead Stories is a U.S. based fact checking website that is always looking for the latest false, misleading, deceptive or (AP Photo/Lynne Sladky, File) The report was making rounds on social media, with vaccine skeptics pointing to it as justification for their skepticism. Let us know!. Of the 170 patients who tested positive for COVID in the Pfizer clinical trials, four of them were from Ventavias clinical trial sites. 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. If the FDA receives a complaint about a clinical trial, she says the agency rarely has the staff available to show up and inspect. 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