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. However, several vaccine experts familiar with COVID vaccine clinical trials questioned the article's accuracy, and advised people not to believe it outright. A second employee also described an environment at Ventavia unlike any she had experienced in her 20 years doing research. The second employee also described the environment at Ventavia as unlike anything she had experienced in her 20 years of research. Brook Jackson - Known as The COVID-19 Pfizer Whistleblower who reported her findings to the FDA on September 25, 2020. 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. 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. 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. Most seriously, she noted the improperly diluting of the vaccine and the failure to keep the vaccines at the recommended temperature. Essentially, it allows for the person responsible for informing the government of the wrongdoing (the whistleblower) to receive a portion of the money recovered from the guilty party. Right away, she found company officials were violating local, state, and federal laws and not putting patients interests ahead of making money. The FDA said, without explicitly saying it, that the allegations don't change the agency's assessment of the vaccine's safety. Opens in a new tab or window, Share on LinkedIn. 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. This is notable because Ventavia has said she was not part of that team. 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. Ive never been fired in my life, said Brook, whos been working in clinical research for 20 years. She added that after Jackson was fired, Pfizer had been notified of problems at Ventavia and that an audit took place. Pfizer's defense presented in court is that the FDA knew about the fraud and was And its about vaccines. But they didn't. Opens in a new tab or window, Visit us on Twitter. According to her, her superiors may have been aware of these problems even before she was hired. 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 allegations were investigated and determined to be unsubstantiated. I dont think it was good clean data, the employee said of the numbers Ventavia generated for the Pfizer trial. Want something more? Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails 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. Let us know!. Jackson received an email from the FDA acknowledging her complaint. "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 . It is powerful as it allows whistleblowers to the people involved in the fraud. 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. 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. You would think if theres a specific and credible complaint that they would have to investigate that, Fisher said. But should it make you any less confident in the vaccines themselves? But opting out of some of these cookies may affect your browsing experience. My main responsibility was to oversee the conduct of Pfizer's Phase 3 Covid-19 mRNA "vaccine" trial at several locations in Texas. The Pfizer Phase III trial involved 44,000 people and 153 locations. Part of my responsibility was to ensure the rights, safety, and welfare of the people volunteering . And then let's have the company respond.". "One photo showed needles discarded in a plastic biohazard bag instead of a sharps container box. Its another thing entirely to see the v*ccine injured give their testimonies in person. No, that's not true: Pfizer and the FDA were made aware of the allegations about the contractor in 2020. 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. 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. However, what is making waves is a whistleblower by the name of Brook Jackson. Lack of timely follow-up of patients who experienced adverse events, 3. Actions were taken to correct and remediate where necessary. 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. 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. Support us at www.VivaBarnesLaw.Locals.ComMerch store! In a text message sent in June the former official apologised, saying that everything that you complained about was spot on.. Department of Health and Human Services Office of Inspector General. The employee, Brook Jackson, who worked as a regional director for Ventavia, is said to have reported her concerns to the FDA. 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. Pfizer and the FDA ignored me in that they knew this fraudulent info was being used. : 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. 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. 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? by Nomi Prins Liquid Energy Stocks Are Cheap and Undervalued, HIPAA & HITRUST Compliance The Difference Explained. It is mandatory to procure user consent prior to running these cookies on your website. BMJ relied on copies of reports filed by a two-week employee of Ventavia. The email said the agency couldnt comment on any investigation that might result from her complaint. Every day the staff of Intellectual Takeout come to work eager to do their part to restore and improve our great nation. According to their website, they have eight locations in the state of Texas: Houston, Fort Worth, Plano, Arlington, Keller, Burleson, Weatherford, and Grapevine. Pfizer has since hired Ventavia as a research subcontractor for four other vaccine clinical trials. pic.twitter.com/VtqDLWTCo9. HKS - Hiroyuki Hasegawa and Goichi Kitagawa (plus Sigma Automotive) Hodder & Stoughton - Matthew Hodder and Thomas Wilberforce Stoughton. It is unclear if the needles were poking through the plastic bag creating a potential injury to anyone who was near the bag. 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. 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!". 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. What criminal fraud was committed? The full trial (registered under NCT04368728) enrolled around 44000 participants across 153 sites that included numerous commercial companies and academic centres. But Fisher who has authored books on the subject of clinical trials and was quoted in Thackers story says thats the wrong takeaway. Cheryl Clark, Contributing Writer, MedPage Today According to BMJ, she then listed a dozen concerns, including the following (quoted verbatim): 1. "As I've 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 But, for researchers who were testing Pfizer's vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety. 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. The next morning, 25 September 2020, Jackson called the FDA to warn about unsound practices in Pfizer's clinical trial at Ventavia. 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. This allows for a whistleblower to sue not just the company behind the fraud but individuals who were responsible for carrying out the fraud. My main responsibility was to oversee the conduct of Pfizer's Phase 3 Covid-19 mRNA "vaccine" trial at several locations in Texas. 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. And she asked me to never stop fighting for v*ccine-injured people., Image credit: RawPixel-Public Health Image Library, CC0 1.0. Subscribe to The Defender's Top News of the Day.It's free. 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