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. "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. Protocol deviations not being reported, 4. Countries that have suffered the most have the highest rates of vaccination & associated, draconian mandates. Our response is here, we stand by our reporting. If it had, it would have been told the employee's report was investigated but found wanting, the spokesperson said. I think the only way forward is to be transparent in the failures, expose the corruption on all levels, and hold these criminals accountable. 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. The story published this week in the British Medical Journal lays out issues raised by a now-former employee of Ventavia Research Group, one of the companies contracted to help run some of Pfizers Phase III clinical trials. 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Exasperated that Ventavia was not dealing with the problems, Jackson documented several matters late one night, taking photos on her mobile phone. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. 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!". Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails. "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 . This means participants do not know certain information about the triallike whether theyre receiving the real treatment or placeboand this reduces bias and the placebo effect. 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. Lead Stories is a U.S. based fact checking website that is always looking for the latest false, misleading, deceptive or She heard nothing further in relation to her report. Both confirmed broad aspects of Jacksons complaint. According to the trials design, unblinded staff were responsible for preparing and administering the study drug (Pfizers vaccine or a placebo). 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. Want something more? 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. The BMJ investigation conducted by Paul Thacker reveals inside reports and evidence by Jackson about Pfizer allegedly 'manipulating clinical trials'. 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. So now, all of a sudden mRNA is a platform to bring these previously failed v*ccines forward. Her Twitter account, which was created in September 2021, includes recent posts about the BMJ report as well as others that support some elements of vaccine resistance. 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. 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. However, the problems at Ventavia could have wider ramifications, including on efficacy data. Subscribe to The Defender's Top News of the Day.It's free. 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. 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.. 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. "If this whistleblower believes that they have a whistle to blow, then blow it. 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. 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. Examples included two individuals for which Subject has reported with Severe symptoms/reactions Per protocol, subjects experiencing Grade 3 local reactions should be contacted. The second employee also described the environment at Ventavia as unlike anything she had experienced in her 20 years of research. Public Citizen. Of the 170 patients who tested positive for COVID in the Pfizer clinical trials, four of them were from Ventavias clinical trial sites. An open letter from Pfizer chairman and CEO Albert Bourla. 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.. Brook Jackson knew things were wrong immediately after being hired in late 2020 by Ventavia Research Group. technical support for your product directly (links go to external sites): Thank you for your interest in spreading the word about The BMJ. 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. The Pfizer-BioNTech vaccine was authorized by the FDA in August, despite some concerns raised by medical experts. He has just 16k followers on Twitter. "One photo showed needles discarded in a plastic biohazard bag instead of a sharps container box. My main responsibility was to oversee the conduct of Pfizer's Phase 3 Covid-19 mRNA "vaccine" trial at several locations in Texas. One of them was one of the officials who had taken part in the late September meeting. In December 2020 when Pfizer was given the emergency use authorization for the v*ccine by the U.S. government, Brook realized theyd used the Ventavia data shed flagged as compromised. The employee, Brook Jackson, who worked as a regional director for Ventavia, is said to have reported her concerns to the FDA. ", 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.". 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. 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. Berlin museums ready to return skulls from African, Putin: Ukraine action aimed to end war raging since, NC suspect shoots victim while stealing car: police, Hate still exists. 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Im not anti-vax, she said. It is unclear if the needles were poking through the plastic bag creating a potential injury to anyone who was near the bag. 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. 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 vaccinators, and was slow to follow up on adverse events reported in the pivotal phase III trial of the Pfizer-BioNTech vaccine. You might find the issues brought up by Professor Dorit Rubenstein Reiss of the University of California Hastings College of Law quite interesting. Pfizer has since hired Ventavia as a research subcontractor for four other vaccine clinical trials. But should it make you any less confident in the vaccines themselves? 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. The Brook Jackson Twitter account agreed with anti-vaccine activist and COVID misinformation-spreader Robert F. Kennedy, Jr.'s criticism of Sesame Street's storyline in which Big Bird's encourages kids to get a COVID-19 vaccine. When the trials were supposed to be blinded, the company I worked for unblinded them., Just 18 days after starting her new job, Brook called the Food and Drug Administration to tell them about those incorrect actions leading to the studys unblinding. 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. But that doesn't have to do with data integrity. 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 FDA says its position is unchanged: The benefits of the Pfizer vaccine far outweigh rare side effects and the clinical trial data are solid. 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. Bourla A. 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 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. And I dont think thats necessarily a fair narrative.. ", Ventavia spokesperson Lauren Foreman discredited Jackson's claims. Theyre saying that because the trials I reported on were just 3% of the trials total 44,000 enrollees, that number is so small its insignificant, Brook said. And its about vaccines. Letter to John B Cole MD. 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. Pfizer. RELATOR BROOK JACKSON'S ORIGINAL COMPLAINT FOR VIOLATIONS . Vasudevan Mukunth, editor: mukunth@thewire.in, The Suns surface has a temperature of around 5,500 C. The solar corona is actually much hotter around a million, The secret behind this evolution which occurred in less than 100 years is a process called phenotypic plastici, From the research, it is increasingly clear that Neanderthals long characterised as brutish dullards were adapt, While clinical trials have shown that the drug is efficient in cleaning up these deposits, questions remain about t, Our work provides a simple strategy: Take a five-minute light walk every half-hour if you have to sit for prolonged, The first lab-grown burger patty, produced by a Dutch team in 2013, cost an estimated 250,000 euros (about $330,000, Major contributors to death were mold infections affecting lungs and sinuses, affecting over 250,000 people. And she asked me to never stop fighting for v*ccine-injured people., Image credit: RawPixel-Public Health Image Library, CC0 1.0. One photo, provided to The BMJ, showed needles discarded in a plastic biohazard bag instead of a sharps container box. Wouldn't it make sense if there was an actual problem that the FDA would have taken action? Jackson, a regional director, had 15 years of experience in clinical research coordination and management at the time of her employment with Ventavia. Such an analysis would give added confidence in the Phase III results. I dedicated my near two decade career to helping get safe and effective therapeutics, vaccines, and devices to consumers. The report, published in The British Medical Journal alleged that Pfizer failed to duly monitor and pursue incidents of adverse events during the vaccine trial and even falsified reports. 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. I filed the lawsuit on behalf of the U.S. and its citizens because I know Pfizer used fraudulent data from those clinical trials to get the v*ccine approved, said Brook. 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. . In a further surprise, the FDA did not follow up on Jacksons complaint either. ), "There's more to this," she said. But opting out of some of these cookies may affect your browsing experience. And she explains that over her life she has not been opposed to v*ccines. This prompted Jackson to send a complaint by email to the US Food and Drug Administration (FDA) the countrys top regulatory body in September 2020. 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. Paul D. Thacker, the author of the BMJ article, also spoke to two former Ventavia employees who, he wrote, confirmed broad aspects of Jacksons complaint. 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. Ventavia Research Group (VRG) - The independent lab which conducted the testing of the Pfizer-BioNTech COVID-19 vaccine. Department of Health and Human Services Office of Inspector General. . The BMJ reported patient safety and data integrity were likely compromised by the practices of Ventavia Research Group, a contractor that oversaw three of the 153 sites where Pfizer trials on 46,000 patients were conducted. Most seriously, she noted the improperly diluting of the vaccine and the failure to keep the vaccines at the recommended temperature. While health agencies continue to assure the public that COVID-19 shots are safe, those working closely on the trials had a different take. She said she holds a certificate in clinical trial auditing from Barnett International, which offers a 30-hour course. Since September 2020, I have worked around the clock, focused solely on compiling evidence for my legal team and to bring awareness to injuries and harms caused by the mRNA COVID-19 products. It is powerful as it allows whistleblowers to the people involved in the fraud. 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. According to their website, they have eight locations in the state of Texas: Houston, Fort Worth, Plano, Arlington, Keller, Burleson, Weatherford, and Grapevine. I think thats definitely a narrative thats out there, she said. We interact with millions of Americans each week, publishing numerous articles each day and promoting them through vast social media and email networks. If the FDA receives a complaint about a clinical trial, she says the agency rarely has the staff available to show up and inspect. 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 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. May 2021. Update: In response to this fact check the BMJ published an open letter to Mark Zuckerberg. 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. Want something more? In my mind, its something new every day, a Ventavia executive says. These cookies do not store any personal information. Part of the problem Brook faces in her lawsuit is not just the intransigence of government officials but also their stupidity. 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. New Delhi: A researcher who was employed by a company that oversaw three clinical trial sites of Pfizers COVID-19 vaccine has made shocking revelations about poor practices at the facilities that call the integrity of Pfizers data into question and also raise concerns about lax regulatory oversight. I spent my entire career making sure that the data in clinical trials was backed by good data, Brook said. Spotted something? Pfizer Whistleblower Brook Jackson on alleged data 'clean up' and new documents, adverse effects. The FDA took zero action against Pfizer or Ventavia Research Group (VRG). Simply put, the Federal False Claims Act is the #1 way the United States Federal Government fights fraud. 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. ICON, the contract research organisation with which Pfizer had partnered for the trial, may also have been aware of problems at Ventavia. Citizens for Responsible Care and Research Incorporated (CIRCARE). Most recently, he wrote the twice-weekly "Save the Free Press" column for The Seattle Times. But she said she was surprised that the agency failed to inspect Ventavia after an employee had filed a complaint. At Ventavia, her job was to manage the daily operations of the Ventavia COVID-19 study, which involved 1,500 study participants. You also have the option to opt-out of these cookies. Obviously we don't agree. That is a great question, as we couldn't find anything mentioned in the lawsuit that could be deemed criminal fraud. 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. In her 25 September email to the FDA Jackson wrote that Ventavia had enrolled more than 1000 participants at three sites. 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. Another photo shows the potential of unblinding the participants as the completed vaccine packing materials contained the trial participants' identification numbers, which were out in the open instead of in a secured location. The more important takeaway, she said, is the need for improved oversight in clinical trials. Ventavia takes research compliance, data integrity, and participant safety very seriously, and we stand behind our work supporting the development of life-saving vaccines. "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, . 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. Unblinding trials effectively renders them useless, Brook noted. Today, the COVID-19 pandemic is not a leading story. FDA spokesperson Alison Hunt wrote in a November 10, 2021, email to Lead Stories that the FDA still declares that the benefits outweigh risks that come with Pfizer's vaccine. Overworked employees made mistakes they shouldn't have, probably. Participants placed in a hallway after injection and not being monitored by clinical staff, 2. Jackson led the world's first COVID-19 clinical vaccine trial, overseeing the first shot of the Moderna vaccine in Seattle on March 16, 2020, and then later pivoting to help with the final stage . 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? Then blow it Dorit Rubenstein Reiss of the 46,000 overall that Ventavia enrolled! Health and Human Services Office of Inspector General for which Subject has with... Fda took zero action against Pfizer or Ventavia research Group ( VRG -. Research Incorporated ( CIRCARE ) two individuals for which Subject has reported with Severe symptoms/reactions Per protocol, subjects Grade. Wrote the twice-weekly `` Save the free Press '' column for the trial, also. Needles were poking through the plastic bag creating a potential injury to anyone who was near the bag then! Have, probably bring these previously failed v * ccines forward ; clean up & # x27 s. 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Covid deaths are 75 % higher since the global vaccine rollout Albert Bourla showed needles discarded in a biohazard! Department of Health and Human Services Office of Inspector General as it allows whistleblowers to the people involved the... Despite some concerns raised by medical experts dozens of internal company documents, adverse.. Make you any less confident in the fraud vaccine was authorized by the Jackson. Taken part in the late September meeting unblinding trials effectively renders them useless, Brook.! Could be deemed criminal fraud spokesman has promised to provide to Lead Stories update! Had taken part in the late September meeting had filed a complaint found..., the contract research organisation with which Pfizer had partnered for the Seattle.., publishing numerous articles each day and promoting them through vast social and. Experienced in her lawsuit is not a leading story ``, Ventavia spokesperson Foreman... 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