Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails. 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. 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. Ive never had to do what they were asking me to do, ever, she told The BMJ. 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. Ventavias sites were not listed among the nine, and no inspections of sites where adults were recruited took place in the eight months after the December 2020 emergency authorisation. Jackson accuses Ventavia of 'poor practices', i.e. 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. 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. By clicking below to subscribe, you acknowledge that your information will be transferred to Mailchimp for processing. How to Cultivate a Marriage That Will Help Your Child Succeed. She heard nothing further in relation to her report. But 40 were from a site in Argentina thats currently undergoing an international investigation for fraud in the trials there, Brook said. . We interact with millions of Americans each week, publishing numerous articles each day and promoting them through vast social media and email networks. 1998 - 2023 Nexstar Media Inc. | All Rights Reserved. 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. Brook Jackson knew things were wrong immediately after being hired in late 2020 by Ventavia Research Group. An open letter from Pfizer chairman and CEO Albert Bourla. If Im your doctor and youre in a study and I know you got the v*ccine and you call me and say you have COVID symptoms, they use having had the vax as a default to rule out the possibility of you having COVID, she said. Though the regulator claims it doesnt have the manpower to actively monitor and investigate all clinical trials, one person told the BMJ she was surprised that the agency didnt inspect Ventavia even after an employee had filed a complaint. 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. 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. Jackson also raised suspicions on the 'selection of Ventavia' to quickly ramp up Pfizer's COVID vaccine trial. Cheryl Clark, Contributing Writer, MedPage Today Miss a day, miss a lot. Vaccines not being stored at proper temperatures, 6. One photo allegedly shows needles used in the vaccine trial discarded in a plastic biohazard bag instead of the approved sharps container box. The regional director for Ventavia, Jackson was fired immediately after she reported her concerns to the. She also brought to their attention the VRG's poor record-keeping, the unblinding of trial volunteers and staff, and the hiring of unqualified personnel. Part of the problem Brook faces in her lawsuit is not just the intransigence of government officials but also their stupidity. Brook Jackson knew things were wrong immediately after being hired in late 2020 by Ventavia Research Group. inaccurate stories, videos or images going viral on the internet. Protocol deviations not being reported, 4. 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. She repeatedly told company officials of the breaches in protocol and other actions that compromised the study, but her protests were ignored. These include trials on COVID-19 vaccines for children and young adults, pregnant women, and a booster dose. The report further stated that Jackson "provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails," some of which depict "poor laboratory management" by the firm. 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 . 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. The employee, Brook Jackson, who worked as a regional director for Ventavia, is said to have reported her concerns to the FDA. Hilton Hotels - Conrad Hilton. Jackson states she has audio recordings and copies of company documents backing up her claims about how the vaccine trial was conducted by VRG. You would think if theres a specific and credible complaint that they would have to investigate that, Fisher said. Countries that have suffered the most have the highest rates of vaccination & associated, draconian mandates. 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. In the 20 years that I have been involved in clinical research, I have never seen a study conducted by an investigative site, managed by a contractor, or overseen by a pharmaceutical sponsor that scared me, until then. You would think if theres a specific and credible complaint that they would have to investigate that, Jill Fisher, a former Ventavia employee, said. 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. "One photo showed needles discarded in a plastic biohazard bag instead of a sharps container box. Participants placed in a hallway after injection and not being monitored by clinical staff, 2. 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. 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. Most recently, he wrote the twice-weekly "Save the Free Press" column for The Seattle Times. 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. HKS - Hiroyuki Hasegawa and Goichi Kitagawa (plus Sigma Automotive) Hodder & Stoughton - Matthew Hodder and Thomas Wilberforce Stoughton. (Attempts to reach Thacker were unsuccessful. I think the only way forward is to be transparent in the failures, expose the corruption on all levels, and hold these criminals accountable. Targeting Ventavia staff for reporting these types of problems. 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. Its another thing entirely to see the v*ccine injured give their testimonies in person. In a further surprise, the FDA did not follow up on Jacksons complaint either. 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. Asked for a response, Ventavia spokeswoman Lauren Foreman objected to The BMJ article, written by investigative journalist Paul Thacker. Opens in a new tab or window, Visit us on Facebook. https://vivafrei.comRoyalty-free music at http://www.hooksounds.com/ref/vivafrei You also have the option to opt-out of these cookies. Liked by Brooke Jackson View Brooke's full profile See who you know in common Get introduced Contact Brooke directly Amy Jackson-Fisher Director at Pfizer San Diego, CA Teresa Ostapower. (AP Photo/Lynne Sladky, File) Department of Health and Human Services Office of Inspector General. The next morning, 25 September 2020, Jackson called the FDA to warn about unsound practices in Pfizers clinical trial at Ventavia. 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. It is mandatory to procure user consent prior to running these cookies on your website. And she explains that over her life she has not been opposed to v*ccines. Sign up for ourDaily Digestemail newsletter to receive intellectually engaging content and updates from our organization straight to your inbox. He has just 16k followers on Twitter. Was this good data?. 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. The expert acknowledged that in the earliest days, there was a rush to get trials up and running with different companies in various locations around the country. I recognized fraud right away, Brook said. In several cases Ventavia lacked enough employees to swab all trial participants who reported covid-like symptoms, to test for infection. Brook Jackson - Known as The COVID-19 Pfizer Whistleblower who reported her findings to the FDA on September 25, 2020. Among her other concerns: Participants were not properly monitored by clinical staff after their injections, vaccines not being stored at the right temperature and mislabeling of specimens. Medical experts disagree with claims that this contretemps calls into question the results of the Pfizer clinical trial. 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. 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. Most seriously, she noted the improperly diluting of the vaccine and the failure to keep the vaccines at the recommended temperature. Lack of training, yes. Learn more about Mailchimp's privacy practices here. Opens in a new tab or window, Visit us on TikTok. "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 second employee also described the environment at Ventavia as unlike anything she had experienced in her 20 years of research. 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. In the 20 years that I have been involved in clinical research, I have never seen a study conducted by an investigative site, managed by a contractor, or overseen by a pharmaceutical sponsor that scared me, until then. Hunt wrote: 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. BioNTech shares traded on the NASDAQ exchange briefly plummeted to around $60. The material on this site is for informational purposes only, and is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider. 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. 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. Shed lose connectivity on her computer, hear crackling sounds while talking on the phone, had a box of crickets set on her doorstep, and got an already-opened letter from the Department of Justice in her mailbox (the letter was a notice declining part of her lawsuit). The Pfizer Phase III trial involved 44,000 people and 153 locations. Also Read: How Covaxin Trial Participants in Bhopal Were Misled. Lead Stories is a U.S. based fact checking website that is always looking for the latest false, misleading, deceptive or She said she also provided dozens of internal company documents, photos, audio recordings and emails to BMJ. ", 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.". metatron.substack.com Of the 170 patients who tested positive for COVID in the Pfizer clinical trials, four of them were from Ventavias clinical trial sites. An article published Wednesday in The BMJ claimed that Texas contractor Ventavia Research Group unblinded patients in the phase III vaccine trial that led to the vaccine's approval and employed inadequately trained vaccinators. Brook Jackson, Plaintiff, v. VENTAVIA RESEARCH GROUP, LLC; PFIZER INC.; ICON PLC, Defendants. On September 25, 2020, I spoke to an agent at the FDA, and within hours, I was fired. 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. she wrote in a November 9, 2021 response to a Kennedy tweet blasting Sesame Street. Responding to comments and inquiries on Twitter, Jackson wrote in a November 9, 2021, tweet: "The organizational failures listed in the BMJ, although not exhaustive, led to violations that were repeated and deliberate, and the reliability and integrity of the data have been comprised.". Does that seem like a lot to you? 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. You might find the issues brought up by Professor Dorit Rubenstein Reiss of the University of California Hastings College of Law quite interesting. "One photo showed needles discarded in a plastic biohazard bag instead of a container box. These holes have not been addressed by Jackson or her legal team, as far as we can tell. So now, all of a sudden mRNA is a platform to bring these previously failed v*ccines forward. If you want to make sure you have the necessary supplies on hand to treat a future breakout, acne patches are the answer. The regional director for Ventavia, Jackson was fired immediately after she reported her concerns to the US Food and Drug Administration. The BMJ investigation conducted by Paul Thacker reveals inside reports and evidence by Jackson about Pfizer allegedly 'manipulating clinical trials'. 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? In the afternoon Ventavia fired Jacksondeemed not a good fit, according to her separation letter. According to the trials design, unblinded staff were responsible for preparing and administering the study drug (Pfizers vaccine or a placebo). This website uses cookies to improve your experience while you navigate through the website. But I think its really a much more important story about just how clinical research is done, what kinds of organizations and companies are part of it, Fisher said. Spotted something? 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. Muhammad Ali Record The GOAT The Greatest of All-Time. But should it make you any less confident in the vaccines themselves? These same accusations were made a year ago, at which time Ventavia notified the appropriate parties. Want something more? 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. Culture of Respect: Conservatives Need Not Apply? In a recording of a meeting in late September2020 between Jackson and two directors a Ventavia executive can be heard explaining that the company wasnt able to quantify the types and number of errors they were finding when examining the trial paperwork for quality control. In her 25 September email to the FDA Jackson wrote that Ventavia had enrolled more than 1000 participants at three sites. She then reported her concerns in an email to the agency. By appointment only. 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. 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. The Pfizer Phase III trial involved 44,000 people and 153 locations. Peter Doshi, the publications senior editor, said Thackers story was subject to the same rigorous peer review that scientific studies published by The BMJ are. Miss USA Becomes the First Filipino-American to Win Miss Universe Crown, Has Saudi Arabia Given Death Penalty to Awad Al-Qarni? And I dont think thats necessarily a fair narrative.. Unblinding trials effectively renders them useless, Brook noted. 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. May 2021. 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. 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. The FDA ruled there was no problem with the data submitted and no criminal fraud committed. She wheeled over in her wheelchair, and I reached down to give her a hug, and she wanted to stand up and hug me, Brook said. 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. Citizens for Responsible Care and Research Incorporated (CIRCARE). Jackson received an email from the FDA acknowledging her complaint. 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