PfizerGate: Media silence about vaccine trial scandal lets FDA and Pfizer off the hook (updated)

“Why is the FDA not inspecting clinical research sites when they are getting credible allegations about corruption? Where is the FDA office of criminal investigations? Where is the FBI healthcare fraud unit? They’re nowhere to be seen.”

"Ventavia is aware of recent accusations in an article written by Paul Thacker [investigative reporter and author of the BMJ article]. Mr. Thacker did not contact Ventavia prior to publication. The accuser was employed for approximately two weeks in September 2020, and no part of her job responsibilities concerned the clinical trials at issue. These same accusations were made a year ago, at which time Ventavia notified the appropriate parties. The allegations were investigated and determined to be unsubstantiated."

"Ventavia takes research compliance, data integrity, and participant safety very seriously, and we stand behind our work supporting the development of life-saving vaccines."

"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."

"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? No, that's not true: Pfizer and the FDA were made aware of the allegations about the contractor in 2020. Medical experts say the claims aren't serious enough to discredit data from the clinical trials, which is also what Pfizer and the FDA say they concluded. 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."

"This is nonsense. The investigation was fully fact checked and legally checked. It’s no surprise that Pfizer and FDA are saying there is nothing to see here. There is and trial participants and the public deserve better"

"Pfizer received communication from an anonymous complainant in September 2020 relating to a single clinical investigator site in Texas, USA. We conducted a thorough investigation into the issues raised in accordance with Pfizer's quality management process related to clinical research. Actions were taken to correct and remediate where necessary. Pfizer's investigation did not identify any issues or concerns that would invalidate the data or jeopardize the integrity of the study. The company proactively notified the US Food and Drug Administration of the matter and informed the Institutional Review Board for the study."

"Since February 2019 we are an active part of Facebook's partnership with third party fact checkers. Under the terms of this partnership we get access to listings of content that has been flagged as potentially false by Facebook's systems or its users and we can decide independently if we want to fact check it or not. In addition to this we can enter our fact checks into a tool provided by Facebook and Facebook then uses our data to help slow down the spread of false information on its platform. Facebook pays us to perform this service for them but they have no say or influence over what we fact check or what our conclusions are, nor do they want to."

"to raise serious concerns about the 'fact checking' being undertaken by third party providers on behalf of Facebook/Meta... We find the 'fact check' performed by Lead Stories to be inaccurate, incompetent and irresponsible. It fails to provide any assertions of fact that The BMJ article got wrong... What has happened in this instance should be of concern to anyone who values and relies on sources such as The BMJ."

[F]rom November 10, readers began reporting a variety of problems when trying to share our article. Some reported being unable to share it. Many others reported having their posts flagged with a warning about “Missing context ... Independent fact-checkers say this information could mislead people.” Those trying to post the article were informed by Facebook that people who repeatedly share “false information” might have their posts moved lower in Facebook’s News Feed. Group administrators where the article was shared received messages from Facebook informing them that such posts were “partly false.”

“Companies like Facebook and some of the traditional media establishments are reasonably concerned about vaccine misinformation. But they have swung so far in the opposite direction as to potentially shut down legitimate questions about major corporations like Pfizer".

"The European Medicines Agency (EMA), in close collaboration with the United States (US) Food and Drug Administration, has looked into the poor practices by the US research organisation Ventavia... "

"The issues reported concern one of the three sites. They were mainly due to lack of trained staff, which resulted in deficiencies such as delays in data entry and queries resolution. These issues were audited by the company holding the marketing authorisation at the end of 2020, and corrective actions were taken, including oversight visits and hiring of additional staff. These actions were deemed appropriate. None of the inspections carried out in other sites involved in the main study raised serious concerns."

"EMA concluded that the identified deficiencies do not jeopardise the quality and integrity of the data from the site concerned, and have no impact on the benefit-risk assessment nor on the conclusions on the safety, effectiveness and quality of the vaccine itself."