Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial
BMJ 2021; 375 doi: https://doi.org/10.1136/bmj.n2635 (Published 02 November 2021) Cite this as: BMJ 2021;375:n2635Read our latest coverage of the coronavirus pandemic
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Dear Editor(s)
BMJ are to be congratulated on taking this important stand [1] on an issue I have been trying to highlight for several years. I note that as early as 2017 Seth Berkley of the global vaccine alliance GAVI was calling on “antivaxxers” to be removed from social media and this chant was unfortunately taken up by the Prime Minister [2]. I believe we are entering into dangerous territory if certain kinds of information can be excluded from the public domain on a generic basis or that citizens should be actively prevented from being able to talk about their experiences with a certain class of product [3,4]. The possibility that “antivaxxer” could become a legal status is also truly troubling. Just how much protection should an industry or a government policy have?
[1] Fiona Godlee and Kamran Abbasi, ‘Open letter from The BMJ to Mark Zuckerberg’, 17 December 2021, https://www.bmj.com/content/375/bmj.n2635/rr-80
[2] John Stone, ‘ Regarding the Use of the Term "Anti-Vaxxer", 27 August 2020, https://www.bmj.com/content/370/bmj.m3099/rr-5
[3] Cumberlege J. First do no harm: the report of the Independent Medicines and Medical Devices Safety Review. 2020 Jul 8. https://www.immdsreview.org.uk/Report.html.
[4] John Stone, ‘Informed Consent and the Government’s Legal Position’, 16 November 2020, https://www.bmj.com/content/371/bmj.m3933/rr-14
Competing interests: AgeofAutism.com, an on-line daily journal, concerns itself with the potential environmental sources for the proliferation of autism, neurological impairment, immune dysfunction and chronic disease. I receive no payment as UK Editor. I also moderate comments for the on-line journal ‘The Defender’ for which I am paid. I am also a member of the UK Medical Freedom Alliance
Dear Mark Zuckerberg,
We are Fiona Godlee and Kamran Abbasi, editors of The BMJ, one of the world’s oldest and most influential general medical journals. We are writing to raise serious concerns about the “fact checking” being undertaken by third party providers on behalf of Facebook/Meta.
In September, a former employee of Ventavia, a contract research company helping carry out the main Pfizer covid-19 vaccine trial, began providing The BMJ with dozens of internal company documents, photos, audio recordings, and emails. These materials revealed a host of poor clinical trial research practices occurring at Ventavia that could impact data integrity and patient safety. We also discovered that, despite receiving a direct complaint about these problems over a year ago, the FDA did not inspect Ventavia’s trial sites.
The BMJ commissioned an investigative reporter to write up the story for our journal. The article was published on 2 November, following legal review, external peer review and subject to The BMJ’s usual high level editorial oversight and review.[1]
But from 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.”
Readers were directed to a “fact check” performed by a Facebook contractor named Lead Stories.[2]
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
-- It has a nonsensical title: “Fact Check: The British Medical Journal Did NOT Reveal Disqualifying And Ignored Reports Of Flaws In Pfizer COVID-19 Vaccine Trials”
-- The first paragraph inaccurately labels The BMJ a “news blog”
-- It contains a screenshot of our article with a stamp over it stating “Flaws Reviewed,” despite the Lead Stories article not identifying anything false or untrue in The BMJ article
-- It published the story on its website under a URL that contains the phrase “hoax-alert”
We have contacted Lead Stories, but they refuse to change anything about their article or actions that have led to Facebook flagging our article.
We have also contacted Facebook directly, requesting immediate removal of the “fact checking” label and any link to the Lead Stories article, thereby allowing our readers to freely share the article on your platform.
There is also a wider concern that we wish to raise. We are aware that The BMJ is not the only high quality information provider to have been affected by the incompetence of Meta’s fact checking regime. To give one other example, we would highlight the treatment by Instagram (also owned by Meta) of Cochrane, the international provider of high quality systematic reviews of the medical evidence.[3] Rather than investing a proportion of Meta’s substantial profits to help ensure the accuracy of medical information shared through social media, you have apparently delegated responsibility to people incompetent in carrying out this crucial task. Fact checking has been a staple of good journalism for decades. What has happened in this instance should be of concern to anyone who values and relies on sources such as The BMJ.
We hope you will act swiftly: specifically to correct the error relating to The BMJ’s article and to review the processes that led to the error; and generally to reconsider your investment in and approach to fact checking overall.
Best wishes,
Fiona Godlee, editor in chief
Kamran Abbasi, incoming editor in chief
The BMJ
Competing interests:
As current and incoming editors in chief, we are responsible for everything The BMJ contains.
References:
[1] Thacker PD. Covid-19: Researcher blows the whistle on data integrity issues in Pfizer's vaccine trial. BMJ. 2021 Nov 2;375:n2635. doi: 10.1136/bmj.n2635. PMID: 34728500. https://www.bmj.com/content/375/bmj.n2635
[2] Miller D. Fact Check: The British Medical Journal Did NOT Reveal Disqualifying And Ignored Reports Of Flaws In Pfizer COVID-19 Vaccine Trials. Nov 10, 2021. https://leadstories.com/hoax-alert/2021/11/fact-check-british-medical-jo...
[3] https://twitter.com/cochranecollab/status/1458439812357185536
Competing interests: As current and incoming editors in chief, we are responsible for everything The BMJ contains.
Dear Editor
I am grateful to Thomas Finnegan [1] for pointing out my error and the Pfizer trial had in fact included British participants. I am also pleased to know of his FOI requests to the MHRA, but he will perhaps be concerned to learn that the MHRA has failed to publish a single FOI response since the end of June [2]. I have been in touch with them about this. Perhaps hundreds remain unpublished.
I am also concerned that that the MHRA licensed the trials for the Oxford/AZ product which included adenoviruses associated with blood clots and subsequently approved it as well as the similar Johnson & Johnson for roll-out [3,4]
[1] Thomas Finnegan, ‘ Re: Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial’, 24 November 2021, https://www.bmj.com/content/375/bmj.n2635/rr-60
[2] https://www.gov.uk/government/collections/freedom-of-information-respons...
[3] John Stone, ‘Re: Covid-19: Rare immune response may clause clots after AstraZeneca vaccine, say researchers’, 16 April 2021, https://www.bmj.com/content/373/bmj.n954/rr-2
[4] John Stone, ‘Had the MHRA done due diligence’, 21 April 2021, https://www.bmj.com/content/373/bmj.n961/rr-0
Competing interests: AgeofAutism.com, an on-line daily journal, concerns itself with the potential environmental sources for the proliferation of autism, neurological impairment, immune dysfunction and chronic disease. I receive no payment as UK Editor. I also moderate comments for the on-line journal ‘The Defender’ for which I am paid. I am also a member of the UK Medical Freedom Alliance
Dear Editor
David Healy [1] makes very important points, and too often in the present Covid debacle we have rushed forward with agendas which had insufficient evidence. I do not find myself among those who say we should have done even more perhaps without knowing really what we were doing. I feel concerned at an article such as the one by Andy Extance yesterday [2] which calls for the extension of mRNA technology as if its usefulness and safety have actually been established by the roll-out of current products, noting particularly the recent abstract by Steven Gundry [3] as well as the alarming issues raised by Paul Thacker [4].
[1] David Healy, ‘ Re: Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial’, 25 November 2021,
https://www.bmj.com/content/375/bmj.n2744
[2] Andy Extance, ‘mRNA vaccines: hope beneath the hype’, BMJ 2021; 375 doi: https://doi.org/10.1136/bmj.n2744 (Published 24 November 2021
[3] Steven R Gundry, ‘ Mrna COVID Vaccines Dramatically Increase Endothelial Inflammatory Markers and ACS Risk as Measured by the PULS Cardiac Test: a Warning’ , Circulation 8 November 2021, https://www.ahajournals.org/doi/abs/10.1161/circ.144.suppl_1.10712#
[4] Paul D Thacker. ‘ Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial’,
BMJ 2021; 375 doi: https://doi.org/10.1136/bmj.n2635 (Published 02 November 2021)
Competing interests: AgeofAutism.com, an on-line daily journal, concerns itself with the potential environmental sources for the proliferation of autism, neurological impairment, immune dysfunction and chronic disease. I receive no payment as UK Editor. I also moderate comments for the on-line journal ‘The Defender’ for which I am paid. I am also a member of the UK Medical Freedom Alliance
Dear Editor
The BMJ under the editorship of Dr Godlee are to be commended for publishing important and concerning articles. In 2015 they published Restoring Study 329, which was also about clinical trial practices. The original study led to a fraud charge and a US Department of Justice action. While it reported efficacy that it did not find and hid serious safety problems, some of which remain concealed, that study was run to higher standards than the current vaccine trials. There was no Contract Research Organization (CRO) involved in Study 329.
In health we now have a clinical trial problem and it is difficult to see how we can put this right without insisting on access to trial data. We now have disputes about mandates with Daniel Sokol in BMJ recently among many who cannot see a case against them - what about No Mandates Without Data? We have a Pandemic of Overtreatment because hiding harms and hyping efficacy transforms the poisons from which we hope to bring good into sacraments. If our treatments work so well and are so free of harms, do we need expensive treatment dispensers?
Why would anyone want to see a doctor in person - if not for the ever fainter possibility they might meet someone willing to use a certain amount of discretion and stand by them if need be. Qualities Fiona Godlee has demonstrated during her tenure with BMJ.
Le Noury J, Nardo J, Healy D, Jureidini J, Raven M, Aba-Jaoude E, Tufanaru C (2015). Restoring Study 329: BMJ 2015; 351: h4320 | doi: 10 .113 6/bmj.h4320
Competing interests: No competing interests
Dear Editor
I think John Stone is mistaken regarding the evaluation and testing of the Pfizer-BioNtech Covid-19 vaccine for approval in UK (EAU).
The Pfizer website indicates that in fact clinical trials of the Pfizer-Biotech vaccine were carried out last year at 69 trial sites across UK, this involved some 977 patient subjects. These are listed on the NHS trials website.
I have put in some FOI requests to clarify whether in fact only UK trials data was used for approving the Pfizer-BioNtech vaccine in UK or if data from EU and USA trial sites were used. I have also asked whether due diligence and inspection of all UK trial sites was carried out by MHRA or other body, in order to ensure regulatory and safety compliance and importantly identify any deviations from clinical trials protocols, unblinding subjects, data integrity issues etc as detailed in this report.
In relation to the Pfizer-BioNtech booster shot, I have asked MHRA to confirm whether this is a brand new vaccine formulation or if it is exactly the same as in the first two vaccine doses. If it is an entirely new vaccine formulation, I have asked MHRA in my FOI request to provide details whether it has undergone trials and separate approval.
https://www.pfizer.co.uk/clinical-trials
https://www.nihr.ac.uk/search-results.htm?search=pfizer+biontech+vaccine
Competing interests: No competing interests
Dear Editor
Transparency and easy access of clinical trial data is crucial for an independent evaluation of the data Pfizer have submitted for regulator approval.
According to the documents filed in a U.S. District Court for the Northern District of Texas, the FDA have asked a federal judge for 55 years to complete a freedom of information request (FOIA) for data and information on the approval of Pfizer-BioNTech's COVID-19 vaccine, Comirnaty.
If the judge grants the FDA's request, the plaintiffs, Public Health and Medical Professionals for Transparency, would have to wait until the U.S. celebrates its 300th year anniversary in 2076 to view the full report.
The FDA's request comes about a month after the plaintiffs, comprising more than 30 professors and scientists from some of the country's top schools, filed suit (PDF) to expedite their FOIA request. The group originally asked for documentation after the vaccine's approval in August, but the FDA has yet to turn anything over.
The plaintiffs' lawyers say the FDA needs to fork over the information to "settle the ongoing public debate" around the agency's review process as well as to confirm its conclusion that the Pfizer vaccine is safe, effective and worthy of the public's trust.
The plaintiffs' request covers some 329,000 pages, which must first be processed and redacted before the FDA can hand them over, Department of Justice (DOJ) lawyers representing the regulator stated in court documents.
The group asked the FDA to satisfy their request by no later than March 3, 2022, giving the agency the same 108 days "from when Pfizer started producing the records for licensure on May 07, 2021, to when the product was licensed on August 23, 2021.
To meet that deadline, the FDA would need to process some 80,000 pages a month. That simply isn't feasible, the DOJ lawyers argued.
Reviewing and redacting records for exempt information is a time-consuming process that often requires government information specialists to review each page line-by-line," the defence said in this week's court filing. When a party requests a large amount of records, courts typically set a schedule whereby the processing and production of the non-exempt portions of records is made on a rolling basis.
Meanwhile, the time it takes an agency to process a FOIA request varies depending on the complexity of the request and any backlog of requests pending at the agency,
The branch that would be in charge of processing the plaintiffs' FOIA request only has 10 employees and is already saddled with about 400 outstanding bids for information, lawyers for the defence said. Instead, the FDA has proposed to release 500 pages per month. "By processing and making interim responses based on 500-page increments, FDA will be able to provide more pages to more requesters, thus avoiding a system where a few large requests monopolize finite processing resources," according to the agency's defence. U.S. District Judge Mark Pittman has set a scheduling conference for Dec. 14, 2021, to weigh the timeline for the plaintiffs' request.
Competing interests: No competing interests
Dear Editor
In Austria as a consequence of the pandemic worsening situation, we are now in a lockdown for the next 20 days.
This report regarding malpractice and data integrity issues during Pfizer vaccine trials in the US is very serious. It raises grave concerns on how clinical trials are audited and managed as both Dr O'Reilly in Belfast and Dr Peterson in Oxford explain clearly.
Austria has a low uptake for vaccination, this whistleblower report will make it even worse as the news has spread rapidly via social media. My colleagues inform me that patients are not attending vaccination appointments because they have concerns about the safety of the vaccine. Many ask for other types such as Astra Zeneca.
As Dr Peterson says, the conspiracy of silence in the media must end. We must have a public discussion about this grave matter to inform the public, to protect our patients from harm.
Competing interests: No competing interests
Dear Editor
There is still no information being given out by the UK media. Very many of us are relying on The BMJ for ongoing trustworthy information about Covid.
Jim Shannon MP N I is the only MP who has not only listened to the wise elderly people who expressed concerns but taken action as described in his r.r. I would like to ask you, Jim Shannon, if you might kindly keep us updated with the results of the actions you have taken. The media read The BMJ and would hopefully take more responsibility to inform the wider public. Thank you.
Competing interests: No competing interests
The fact checker's response to The BMJ open letter to Facebook
Dear Editor
Fact checker for Facebook, Dean Miller from Lead Stories, opines that the title of Paul Thacker’s BMJ article: "Covid-19: Researcher blows the whistle on data integrity issues in Pfizer's vaccine trial" [1] is misleading [2]. He also says that many anti-vaccine activists have used it as "proof" that the entire clinical trial was fraudulent and the vaccine unsafe [2].
However, the headline is factual and abuse by others cannot justify Facebook’s censorship. Moreover, it is not the task of fact checkers to police informative titles. Thacker’s article clearly explains that the data integrity issues concern only three of the 153 test sites. More importantly, Miller does not consider what this might mean for the other 150 trial sites. It takes a lot of courage to step forward publicly, and it carries a huge cost, as the whistleblower will never get a job in the drug industry again. People are therefore not likely to blow the whistle.
Facebook’s "Missing Context" label was also unjustified. Nothing in Thacker’s article can mislead “without additional context.”
Miller attempts character assassination by saying that the whistleblower, Brook Jackson, “is not a lab-coated scientist” and “holds a 30-hour certification in auditing techniques.” What matters is that she provided clear evidence of wrong-doing committed by the company. Moreover, she had more than 15 years’ experience in clinical research coordination and management.
Miller also uses the trick guilt by association when noting that Jackson tweeted something that agreed with what a “leading COVID misinformation-spreader” had written. He believes she is hugely biased because she wrote that vaccination makes sense if a person is in a high-risk category. But it is perfectly reasonable to suggest that people in a low-risk category, e.g. children, do not need to get vaccinated, which I have done based on the evidence [3]. Furthermore, whatever Jackson’s views of the COVID vaccines are, they are irrelevant.
Miller talked to people with vested interests and then concluded that “It's not at all clear yet whether there are data integrity issues if you ask the other stakeholders, and that's the crucial missing context.” This is utter nonsense, as it cannot annul the clear evidence produced by Jackson, which she shared with the BMJ.
Miller opines that the problems were not ignored, which is not true either. The company ignored them; the FDA ignored them; and the FDA did not even inspect the three trial sites after Jackson had informed the agency about the problems.
The only honourable thing to do would have been for Miller to admit he was wrong and to remove the flagging of Thacker’s article. Instead, he demonstrated to the whole world that he and Lead Stories cannot be trusted.
There are numerous other stories about busybody fact checkers, and they raise a pertinent question. Facebook and other social media get a large part of their income from advertisements. Could this be the reason why Lead Stories seems so unreasonable when it comes to vaccines?
The social media and their fact checkers appear to be a threat for our democracies, open societies, and free scientific debate. There was a Ministry for Truth in Orwell’s novel, 1984. But today, it is not only Big Brother is watching you, it has come close to everyone is watching everyone, and Big Brother is not the State but Big Tech, which cannot be overthrown by a revolution.
The social media have become monsters and we do not yet know how best to fight them. They remind me of the Inquisition. Only one opinion is allowed at a time when it comes to vaccines, which is the official one.
[1] Thacker PD. Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial. BMJ 2021;375:n2635.
[2] Miller D. Lead Stories' response to BMJ open letter objecting to a Lead Stories fact check. 2021; Dec 18. https://leadstories.com/analysis/2021/12/lead-stories-response-to-a-bmjc....
[3] Gøtzsche PC. Vaccines: truth, lies, and controversy. New York: Skyhorse; 2021.
Competing interests: No competing interests