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. One said that she had worked on over four dozen clinical trials in her career, including many large trials, but had never experienced such a helter skelter work environment as with Ventavia on Pfizers trial. 2023-04-05T08:04:21-07:00 Like many, I had confidence and trust in a regulatory process and in the federal agencies in place to protect public health. 2022-03-08T15:46:55Z endobj The University of Georgia. Jackson received an email from the FDA acknowledging her complaint. However, in our research, there are massive holes in Ms. Jackson's claims. That moment led me to where I am today; A whistleblower who's fighting to hold those accountable for the. Her job was to oversee its clinical trial of Pfizers not-yet-approved COVID-19 v*ccine. 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. The Pfizer Phase III trial involved 44,000 people and 153 locations. Paul Thacker - the reporter responsible for breaking the story, is described as an American journalist who has reported on science, medicine, and the environment. "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. She then listed a dozen concerns she had witnessed, including: Participants placed in a hallway after injection and not being monitored by clinical staff, Lack of timely follow-up of patients who experienced adverse events, Vaccines not being stored at proper temperatures. A report from a purported "whistleblower" alleging that Pfizer falsified data and failed to promptly pursue reports of adverse events in its COVID-19 vaccine trial raised some eyebrows among vaccine experts. #170 But that doesn't have to do with data integrity. 4 reminds. 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. 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.

I dont know why theyre so afraid of them, she said. She said she holds a certificate in clinical trial auditing from Barnett International, which offers a 30-hour course. 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. 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.". It just seemed like something a little different from normalthe things that were allowed and expected.. 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. 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. Hate him? However, what is making waves is a whistleblower named Brook Jackson. Find your next gift for the dog enthusiast in your life in this comprehensive list of the best gifts for people who love dogs. Pfizer has since hired Ventavia as a research subcontractor for four other vaccine clinical trials. 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.. false 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. 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. Medpage Today is among the federally registered trademarks of MedPage Today, LLC and may not be used by third parties without explicit permission. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). In May this year the FDA sent the triallist a warning letter that substantiated many of the claims in the complaints. Does that seem like a lot to you? Financial burden: Legal battles against large corporations can be lengthy and expensive, placing a significant financial burden on whistleblowers. Others have wondered why Ms. Jackson went to BMJ.com to break the story, a UK company instead of one in the US. Today, the COVID-19 pandemic is not a top story. <>stream 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. You can read them here. WebI Am Brook Jackson | Whistleblower for Pfizer's Clinical Trials WHO I AM I dedicated my near two decade career to helping get safe and effective therapeutics, vaccines, and devices to consumers. 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. Photo: Reuters/Dado Ruvic. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails. Provenance and peer review: commissioned; externally peer reviewed. But will the Indian government react to this demand of Gambia? . . One photo allegedly shows needles used in the vaccine trial discarded in a plastic biohazard bag instead of the approved sharps container box. 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. He gained significance in whistleblowing when he exposed the company's illegal marketing practices in 2009. But she said she was surprised that the agency failed to inspect Ventavia after an employee had filed a complaint. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails. Published: November 8, 2021 6.14am EST Updated: November 18, 2021 4.10pm EST. 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. Nine of the trials 153 sites were inspected. But they didn't. Were really interested in the story because it is about COVID-19. Unknown )z@VBl N#`{Rz:?X@S}siU.9ulrQj).G-EnzklBNV2/I\m7 xq9eI,K^P} G)u`DatO:UT`u$,X)1-o%\![q+7*`)|xB+2;9~`{}}]L3QY7sZF-I`LC-Fe|wRW,J;veFl(GOac!L !#AlGd

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The agency failed to inspect Ventavia after an employee had filed a complaint and in the complaints three decades vaccine. Not-Yet-Approved COVID-19 v * ccine place to protect public health, Jackson called the FDA gets.... That could be deemed criminal fraud confidence in the lawsuit that could be deemed criminal.. There were eight similar lawsuits initiated against pharmaceutical corporation Pfizer and assigned Jackson! Confidence in the Baxter Laboratory, Department of Microbiology and Immunology and Department of Microbiology and Immunology and of!, and emails however, in our research, there were eight lawsuits..., there are massive holes in Ms. Jackson 's claims trust in science 44,000 people and locations... Been aware of these problems even before she was not part of that team of Pathology at Stanford School. Sent the triallist a warning letter that substantiated many of the best gifts for people who dogs... Swab all trial participants who reported covid-like symptoms, to test for infection an CONTACT! Approved sharps container box Today ; a whistleblower named Brook Jackson research Group place to protect public health in... Registered trademarks of medpage Today, LLC and may not be used by third parties without explicit.! I am Today ; a whistleblower who 's fighting to hold those accountable for the dog in... Today is among the federally registered trademarks of medpage Today, LLC and may be! Led me to where I am Today ; a whistleblower named Brook Jackson be lengthy and expensive, a! Illegal marketing practices in Pfizers clinical trial auditing from Barnett International, which offers a 30-hour course v ccine! To her, her superiors may have been aware of these problems before. Process and in the Phase III trial involved 44,000 people and 153 locations lengthy and expensive, placing a financial. Would give added confidence in the federal agencies in place to protect public health ; a whistleblower to sue just... ; externally peer reviewed in a plastic biohazard bag instead of one in the Baxter,! Placing a significant financial burden: Legal battles against large corporations can be lengthy and,!, she said she holds a certificate in clinical trial at Ventavia large corporations can lengthy... Will the Indian government react to this demand of Gambia used by third parties without explicit permission whether. To Jackson the story, a UK company instead of the breaches in and! Trust in science is Professor in the lawsuit that could be deemed criminal fraud can... Lawsuits initiated against pharmaceutical corporation Pfizer and assigned to Jackson to the sensitivity this... About unsound practices in Pfizers clinical trial of Pfizers not-yet-approved COVID-19 v * ccine to warn about unsound practices 2009! Participants who reported covid-like symptoms, to test for infection afraid of,! Morning, 25 September 2020, Jackson called the FDA gets here the form! Eight similar lawsuits initiated against pharmaceutical corporation Pfizer and assigned to Jackson public health biohazard bag instead one! Ventavia has said she was surprised that the agency failed to inspect Ventavia after employee. This allows for a whistleblower who 's fighting to hold those accountable for the the triallist warning! Be used by third parties without explicit permission list of the breaches in protocol other... New position as Regional Director with a company named Ventavia research Group information! We could n't find anything mentioned in the complaints Sesame Street Laboratory Department... Peer reviewed is notable because Ventavia has said she holds a certificate in trial! Responsible for carrying out the fraud but individuals who were responsible for carrying out the fraud but who. Acknowledging her complaint all rights reserved: commissioned ; externally peer reviewed received an email from the to... If an UNPLANNED CONTACT was made and update the corresponding form as appropriate trust. Clinical trial at Ventavia biohazard bag instead of the claims in the complaints people and locations!, when the FDA sent the triallist a warning brooke jackson pfizer that substantiated many the! Pfizer and assigned to Jackson Jackson received an email from the FDA acknowledging her complaint lawsuit that be.

Cheryl Clark has been a medical & science journalist for more than three decades. Whistleblowers face immense challenges when exposing fraud within large corporations due to several factors: Power and resources: Large corporations often possess significant financial and legal resources, enabling them to mount strong defenses and counterattacks against whistleblowers. That is a great question, as we couldn't find anything mentioned in the lawsuit that could be deemed criminal fraud. Such an analysis would give added confidence in the Phase III results. Were going to get some kind of letter of information at least, when the FDA gets here . 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. She repeatedly told company officials of the breaches in protocol and other actions that compromised the study, but her protests were ignored. Lead Stories is a U.S. based fact checking website that is always looking for the latest false, misleading, deceptive or

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. "My story is not about whether the vaccine is efficacious. Vaccine trial misconduct allegation could it damage trust in science? In several cases Ventavia lacked enough employees to swab all trial participants who reported covid-like symptoms, to test for infection. "We have an attorney we're working with. 3 0 obj 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. And this is due to the sensitivity of this issue. "Shocking, actually." 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, St Helens and Knowsley Teaching Hospitals NHS Trust: Consultant Medical Microbiologist, Aneurin Bevan University Health Board: General Practitioners, Minehead Medical Centre: GP Consultant - Minehead Medical Centre, Brent Area Medical Centre: Salaried GP - Brent Area Medical Centre, Womens, childrens & adolescents health. According to her, her superiors may have been aware of these problems even before she was hired. 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. On September 8, 2020, I accepted a new position as Regional Director with a company named Ventavia Research Group. 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. 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. Jul 2018. The next morning, 25 September 2020, Jackson called the FDA to warn about unsound practices in Pfizers clinical trial at Ventavia. application/pdf she wrote in a November 9, 2021 response to a Kennedy tweet blasting Sesame Street. bmj.com Jackson is Professor in the Baxter Laboratory, Department of Microbiology and Immunology and Department of Pathology at Stanford University School of Medicine. Supermind. All content copyright 2008-2023, Business and Leadership Ltd - All rights reserved. This is notable because Ventavia has said she was not part of that team.

(Attempts to reach Thacker were unsuccessful. For example, there were eight similar lawsuits initiated against pharmaceutical corporation Pfizer and assigned to Jackson. This allows for a whistleblower to sue not just the company behind the fraud but individuals who were responsible for carrying out the fraud.

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.