A Pfizer sub-contractor “falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events” while managing three sites of Pfizer’s pivotal Covid vaccine trial, the BMJ reported on Tuesday in a bombshell expose.
The English and German language media have ignored the story – despite it concerning one of the most-discussed and controversial products of the year, a multi-billion-dollar pharma company, legal violations, failure of regulatory safeguards, and apparent corporate retaliation against a whistleblower.
In contrast, the same story was widely reported in the Russian and French media, and on Wednesday was trending on Twitter under #PfizerGate.
Editors’ widespread failure to pick up on the story is deeply problematic.
First and foremost, it lets the US Food and Drug Administration off the hook for what appear to be severe lapses in regulatory oversight over this trial, and weak oversight of the conduct of clinical trials in general. The BMJ notes that a 2007 report of the Office of the Inspector General found that that the FDA inspected only 1% of clinical trial sites. Where are the media outlets questioning the FDA about its oversight processes? Where are the politicians calling for an enquiry?
As Paul Thacker, the freelancer who broke the story, told a blogger:
“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.”
Second, its lets Pfizer off the hook for apparently failing to adequately oversee the operations of its subcontractor, the contract research organisation Ventavia Research Group. According to The BMJ, Pfizer hired Ventavia as a research subcontractor on four other vaccine clinical trials after the FDA had been informed of the violations. Where are the media outlets questioning Pfizer about its oversight and quality assurance processes? (TranspariMED asked both Pfizer and Ventavia for a statement. Neither responded.)
Third, it undermines confidence in democratic institutions and public health bodies because it gives citizens – including this writer – the impression that mainstream media are deliberately ignoring a big story in order to avoid fueling vaccine hesitancy. (For example, the Guardian on the same day did find space to run a non-story on the startup of a tiny new Covid trial.) As a result, English and German language discussion of the implications of the BMJ revelations for personal and public health choices is now led by Russian state-sponsored media, extremist websites, and whoever posts the most shocking content on social media. Ironically, these sources seem the least likely to highlight that the documented problems involved only three trial sites accounting for around 1,000 of the Pfizer trial’s 44,000 participants.
UPDATE 08 November 2021
A spokesperson for Ventavia provided the following comment to The Conversation:
"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."
According to Medpage Today, Pfizer said in a statement that 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."
UPDATE 10 November 2021
The website Lead Stories has published a "fact check" ostensibly debunking the BMJ story:
"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."
(Note: This framing is arguably misleading. While the BMJ story was widely shared by the tin foil hat brigade on social media, the BMJ article itself never claimed that issues with data quality for 1,000 of 44,000 trial participants discredit the data from the entire trial, and the BMJ article explicitly states that the FDA was made aware of these issues by the whistleblower.)
BMJ editor Kamran Abbasi commented on Twitter that:
"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"
Lead Stories' reporting contains the following new statement from Pfizer:
"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."
The Lead Stories "fact check" may have implications for whether and how the BMJ story can be shared on Facebook.
"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."
UPDATE 17 November
On 16 November, three Members of the European Parliament (all from the Green party) sent an open letter to the EMA. Referring to the BMJ story, the letter asks, among other questions: "Has the EMA been informed of any irregularities reported during the Phase 3 clinical trial coordinated by Ventavia?"
TranspariMED will provide further updates on this blog as the story evolves. At the same time, TranspariMED will not repost any documents whose authenticity it cannot verify.
UPDATE 18 November
A lawyer acting for the whileblower at the heart of the BMJ story sent a letter to Ventavia on 11 November "to demand an immediate retraction and public correction" of Ventavia's claim that “no part of her job responsibilities concerned the clinical trials at issue," and threatens legal action if the company does not comply. To date Ventavia does not appear to have issued the requested press release.
UPDATE 30 November
It is unclear how many of the trial's 44,000 participants were recruited by Ventavia up until the end of the trial. According to the BMJ, "neither Pfizer nor Ventavia will respond to questions from The BMJ to help clarify this matter." See also the discussion in this blog by Maryanne Demasi, published today.
Ventavia has still not made public an apology, as had been demanded by the whistleblower's lawyer.
UPDATE 21 December 2021
The editor in chief of The BMJ wrote an open letter to Mark Zuckerberg on 17 December
"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."
According to the letter:
[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.”
UPDATE 06 January 2022
Lead Stories, the Facebook contractor who lebeled The BMJ's article as "Missing Context", defended its decision in a blog published on 18 December 2021. According to Lead Stories, "Facebook users seeing BMJ.com's article are merely warned of "Missing Context", the lightest measure Facebook applies, with no restrictions in traffic, visibility or advertising revenue."
UPDATE 30 January 2022
Two senior BMJ journalists double down on BMJ's pushback against Facebook's 'fact checking' subcontractor Lead Stories. Writing in the Spectator, they noted that "Lead Stories identified no factual inaccuracies in the BMJ’s article." Reportedly, Facebook's parent company Meta itself had told the BMJ that the fact-checking process was "independent" from the company.
Jillian York, director for international freedom of expression at the Electronic Frontier Foundation, was quoted as saying that:
“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 BMJ is now making a final appeal to Meta’s Oversight Board.
Meanwhile, the European Commission has formally stated that:
"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."