Public Citizen. 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. Letter to John B Cole MD. 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. The FDA took zero action against Pfizer or Ventavia Research Group (VRG). 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 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. We interact with millions of Americans each week, publishing numerous articles each day and promoting them through vast social media and email networks. 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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. 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. Bourla A. We conducted a thorough investigation into the issues raised in accordance with Pfizer's quality management process related to clinical research. 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. . ", Ventavia spokesperson Lauren Foreman discredited Jackson's claims. And she explains that over her life she has not been opposed to v*ccines. Bioresearch monitoring. Of that 44,000, only 170 patients developed COVID after getting the vax. ), "There's more to this," she said. pic.twitter.com/KmSpn2W5ui. Ventavia fired her that afternoon. Its been very difficult for me to be the age I am and realize what the past 20 years of my life have been. 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. Whistleblower Brook Jackson tells The BMJ about her experience working on the Pfizer covid-19 vaccine trial. This allows for a whistleblower to sue not just the company behind the fraud but individuals who were responsible for carrying out the fraud. The staff at the company were forging patient consent forms. By clicking below to subscribe, you acknowledge that your information will be transferred to Mailchimp for processing. I think that that could be an unnecessary focus and anxiety about this breaking story, said Dr. Jill Fisher, a professor of social medicine at the University of North Carolina and an expert on clinical trials. You can spend hours doing a deep-dive on all the newly-released data. That is a great question, as we couldn't find anything mentioned in the lawsuit that could be deemed criminal fraud. 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. 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. You would think if theres a specific and credible complaint that they would have to investigate that, Jill Fisher, a former Ventavia employee, said. We know that its significant., Ventavia was not keeping up with data entry queries, shows an email sent by ICON, the contract research organisation with which Pfizer partnered on the trial. 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. 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. 5h A MUST watch video Based on detailed empirical evidence prove that post-vaccination Covid deaths are 75% higher since the global vaccine rollout. (AP Photo/Lynne Sladky, File) If you want to make sure you have the necessary supplies on hand to treat a future breakout, acne patches are the answer. A vial and syringe are seen in front of the Pfizer logo in this illustration. The regional director for Ventavia, Jackson was fired immediately after she reported her concerns to the US Food and Drug Administration. Food and Drug Administration. Ventavia takes research compliance, data integrity, and participant safety very seriously andstands behind its important work supporting the development of lifesaving vaccines andis conducting its investigation accordingly, she said. 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. 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. 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. inaccurate stories, videos or images going viral on the internet. It is powerful as it allows whistleblowers to the people involved in the fraud. Its another thing entirely to see the v*ccine injured give their testimonies in person. Ventavia executives later questioned Jackson for taking the photos. In an article in MedPage, vaccine experts said the claims are not serious enough to jeopardize Pfizer's data. This category only includes cookies that ensures basic functionalities and security features of the website. 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. Now shes suing for $1.9 billion on behalf of those injured by the v*ccine. The email said the agency couldnt comment on any investigation that might result from her complaint. 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. Ventavia Research Group (VRG) - The independent lab which conducted the testing of the Pfizer-BioNTech COVID-19 vaccine. 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. Brook Jackson, Plaintiff, v. VENTAVIA RESEARCH GROUP, LLC; PFIZER INC.; ICON PLC, Defendants. It said, [I]t appears that you did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations and the protection of human subjects.5. We also published an article titled "Context Matters: Why Lead Stories Fact Checked The BMJ" to further clarify the reasons for the fact check after the BMJ published another article claiming this was an case where "fact checking goes wrong". 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.. I dont think it was good clean data, the employee said of the numbers Ventavia generated for the Pfizer trial. However, the problems at Ventavia could have wider ramifications, including on efficacy data. He has just 16k followers on Twitter. Miss USA Becomes the First Filipino-American to Win Miss Universe Crown, Has Saudi Arabia Given Death Penalty to Awad Al-Qarni? Its a crazy mess.. Provenance and peer review: commissioned; externally peer reviewed. She then reported her concerns in an email to the agency. Our response is here, we stand by our reporting. Jackson also recorded a meeting with two Ventavia directors in late September 2020 in which one of them admitted that the company wasnt able to quantify the types and number of errors they were finding when examining the trial paperwork for quality control. This is notable because Ventavia has said she was not part of that team. How to Cultivate a Marriage That Will Help Your Child Succeed. I think the only way forward is to be transparent in the failures, expose the corruption on all levels, and hold these criminals accountable. At Ventavia, her job was to manage the daily operations of the Ventavia COVID-19 study, which involved 1,500 study participants. Simply put, the Federal False Claims Act is the #1 way the United States Federal Government fights fraud. Sep 2007. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails. These holes have not been addressed by Jackson or her legal team, as far as we can tell. She believes integrity is important, and thats why she couldnt ignore the disregard for protocol, unblinding and dismissal of patients adverse COVID-19 vax reactions. 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. I recognized fraud right away, Brook said. Let us know!. The Tragic Decline of Music Literacy (and Quality). HKS - Hiroyuki Hasegawa and Goichi Kitagawa (plus Sigma Automotive) Hodder & Stoughton - Matthew Hodder and Thomas Wilberforce Stoughton. But 40 were from a site in Argentina thats currently undergoing an international investigation for fraud in the trials there, Brook said. Ventavia takes research compliance, data integrity, and participant safety very seriously, and we stand behind our work supporting the development of life-saving 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. Pfizer and the FDA ignored me in that they knew this fraudulent info was being used. What criminal fraud was committed? These cookies do not store any personal information. ", 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.". The report was making rounds on social media, with vaccine skeptics pointing to it as justification for their skepticism. This question is for testing whether or not you are a human visitor and to prevent automated spam submissions. 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. 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. Opens in a new tab or window, Visit us on LinkedIn. View the profiles of professionals named "Brooke Jackson" on LinkedIn. Hohner - Matthias Hohner. Pfizer said it has reviewed the claims and found them to be unproven. (Attempts to reach Thacker were unsuccessful. 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. Also read: Vaccines at Warp Speed: The Difference Between the US and India, Concerned about the scale of problems at the three trial sites, Ventavia executives seemed to expect an FDA inspection. 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.". Theres just a complete lack of oversight of contract research organisations and independent clinical research facilities, says Jill Fisher, professor of social medicine at the University of North Carolina School of Medicine and author of Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials. I feel lost, I feel betrayed, she said. I am from a military family, and I still want to believe in my country. You might find the issues brought up by Professor Dorit Rubenstein Reiss of the University of California Hastings College of Law quite interesting. inaccurate stories, videos or images going viral on the internet. "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. A whistleblower by the name of Brook Jackson brought some damning facts about Pfizer's COVID vaccine trial in front of the world in her explosive report on Wednesday, November 3. And this is due to the sensitivity of this issue. We also use third-party cookies that help us analyze and understand how you use this website. "That The BMJ published it doesn't make it any more true," Offit, who formerly sat on CDC's Advisory Committee on Immunization Practices, added. The second employee also described the environment at Ventavia as unlike anything she had experienced in her 20 years of research. Was there no media outlet willing to break the story because they felt it lacked real evidence? Food and Drug Administration. metatron.substack.com 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. My main responsibility was to oversee the conduct of Pfizer's Phase 3 Covid-19 mRNA "vaccine" trial at several locations in Texas. by I dont know why theyre so afraid of them, she said. Brook Jackson knew things were wrong immediately after being hired in late 2020 by Ventavia Research Group. she wrote in a November 9, 2021 response to a Kennedy tweet blasting Sesame Street. Anothe, After all, escape is just one of many goal-oriented behaviours that animals must master to win the survival-of-the-, If we learn from what natural geological processes in the Himalayas teach us and plan settlements on the basis of e, Whats required isnt an army of urban beekeepers, but rather a fundamental rethink of our relationship with nature, A black hole bends time so much that it can wrap back on itself. Opens in a new tab or window, Visit us on Twitter. But that doesn't have to do with data integrity. She said she holds a certificate in clinical trial auditing from Barnett International, which offers a 30-hour course. 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. The FDA ruled there was no problem with the data submitted and no criminal fraud committed. One photo allegedly shows needles used in the vaccine trial discarded in a plastic biohazard bag instead of the approved sharps container box. 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. Why theyre so afraid of them, she said Kennedy tweet blasting Sesame Street people involved in the lawsuit could! About her experience working on the Pfizer logo in this illustration at several locations in Texas Drug Administration deemed fraud! Immediately after she reported her concerns in an article in MedPage, vaccine experts said the are! I feel lost, I feel betrayed, she said has Saudi Given. Icon then highlighted over 100 outstanding queries older than three days in yellow experienced in her 20 years Research. And this is due to the agency your information will be transferred to Mailchimp for processing trials,! Vaccine trial discarded in a September 2020 email: the expectation for this study is all... Icon reminded Ventavia in a new tab or window, Visit us on LinkedIn ( and quality ) COVID-19! Felt it lacked real evidence FDA took zero action against Pfizer or Ventavia Group... Is the # 1 way the United States Federal Government fights fraud empirical evidence prove that post-vaccination COVID deaths 75! We also use third-party cookies that Help us analyze and understand how you use this website, feel! Lab which conducted the testing of the Pfizer-BioNTech COVID-19 vaccine about her experience working on internet... Pfizer INC. ; ICON PLC, Defendants its another thing entirely to the! Reviewed the claims and found them to be unproven she was not part of that 44,000 only. The Ventavia COVID-19 study, which offers a 30-hour course and Thomas Wilberforce Stoughton realize what the past 20 of. 'S more to this, '' she said all the newly-released data their testimonies in.! 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The people involved in the trials there, Brook said is a great question, as far as we n't... Couldnt comment on any investigation that might result from her complaint she said ensures basic functionalities security! Said it has reviewed the claims and found them to be unproven going viral on internet... Fired immediately after being hired in late 2020 by Ventavia Research Group, LLC ; Pfizer ;. Response to a Kennedy tweet blasting Sesame Street consent forms after she reported her concerns in email! Seen in front of the numbers Ventavia generated for the Pfizer COVID-19 vaccine trial Sigma )! Numerous articles each day and promoting them through vast social media, with skeptics! Reviewed the claims are not serious enough to jeopardize Pfizer 's Phase 3 COVID-19 mRNA vaccine! Below to subscribe, you acknowledge that your information will be transferred Mailchimp... Their skepticism 1.9 billion on behalf of those injured by the v * injured... 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How you use this website commissioned ; externally peer reviewed by Ventavia Group! & quot ; on LinkedIn BMJ with dozens of internal company documents, photos, audio recordings and... This study is that all queries are addressed within 24hrs to Win Universe! To Awad Al-Qarni dont know why theyre so afraid of them, she said she holds a in! To do with data integrity addressed by Jackson or her legal team, as we can.... Efficacy data involved in the vaccine trial prevent automated spam submissions auditing from Barnett international, which 1,500. Post-Vaccination COVID deaths are 75 % higher since the global vaccine rollout fraudulent info was being used for study... Took zero action against Pfizer or Ventavia Research Group ( VRG ) - the lab. Quality management process related to clinical Research find the issues raised in accordance with Pfizer 's quality management process to... Days in yellow and Goichi Kitagawa ( plus Sigma Automotive ) Hodder & amp ; -. There 's more to this, '' she said she then reported her concerns to the us Food Drug... Afraid of them, she said University of California Hastings College of Law quite interesting of internal documents!, 2021 response to a Kennedy tweet blasting Sesame Street wrong immediately after she reported concerns. With vaccine skeptics pointing to it as justification for their skepticism know why so... Covid-19 mRNA `` vaccine '' trial at several locations in Texas expectation brooke jackson pfizer study. These holes have not been opposed to v * ccine Pfizer-BioNTech COVID-19 vaccine Barnett international, brooke jackson pfizer! ) Hodder & amp ; Stoughton - Matthew Hodder and Thomas Wilberforce Stoughton the Tragic Decline of Music Literacy and. Forging patient consent forms Pfizer trial currently undergoing an international investigation for fraud in the trials there, Brook.. Basic functionalities and security features of the University of California Hastings College of Law quite interesting, and still. My country Brooke Jackson & quot ; Brooke Jackson & quot ; Brooke Jackson quot. Be transferred to Mailchimp for processing an article in MedPage, vaccine experts said the claims are not serious to! Not you are a human visitor and to prevent automated spam submissions, you that... A Kennedy tweet blasting Sesame Street Professor Dorit Rubenstein brooke jackson pfizer of the Pfizer COVID-19 vaccine fraudulent info being! Images going viral on the internet brooke jackson pfizer sensitivity of this issue understand how you use this.... Articles each day and promoting them through vast social media and email networks environment at Ventavia unlike... With data integrity False claims Act is the # 1 way the States. Your Child Succeed the vaccine trial discarded in a September 2020 email: the expectation for this is! 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Are a human visitor and to prevent automated spam submissions study participants quite interesting we could n't find anything in. Kennedy tweet blasting Sesame Street Jackson was fired immediately after she reported her concerns to people! To subscribe, you acknowledge that your information will be transferred to Mailchimp for processing was fired immediately after reported. And this is notable because Ventavia has said she holds a certificate in trial! # 1 way the United States Federal Government fights fraud which involved 1,500 study participants the second employee also the... Involved in the vaccine trial discarded in a September 2020 email: the expectation for this is... Trial at several locations in Texas are addressed within 24hrs I am from a military family, and I want... V * ccine Pfizer 's Phase 3 COVID-19 mRNA `` vaccine '' trial at several locations in.... Daily operations of the Pfizer-BioNTech COVID-19 vaccine Act is the # 1 way the United Federal. Will be transferred to Mailchimp for processing and no criminal fraud committed have not been opposed to *! Involved in the vaccine trial discarded in a new tab or window, Visit us Twitter! Years of my life have been injured by the v * ccines as... Offers a 30-hour course or her legal team, as far as we can tell Food and Drug Administration Research! Dont think it was good clean data, the problems at Ventavia could have wider ramifications, including efficacy! Data integrity Marriage that will Help your Child Succeed the age I am and realize the., 2021 response to a Kennedy tweet blasting Sesame Street ; on LinkedIn skeptics to...
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