It’s clear that Pfizer aren’t to be trusted (and that the Pope prayed today). I wonder what impact this will have. I also wonder if the BMJ, despite doing some public good here, will have pressed hard enough to uncover any ‘big one’, any smoking gun.
The article is faithful to the BMJ report here,
In the BMJ it’s always worth clicking on the Responses tab. Only one so far, but it draws attention to discrepancies between the data in Pfizer’s trials and the data from the vaccine rollout.
"It’s hard to understand how we can trust the safety data provided by Pfizer [1]; we can see that the official package insert approved by the FDA for Comirnaty [2] states that acute allergic reactions (including anaphylaxis) have been reported only in post-marketing surveillance (including EUA); while in the real world [3] the observed rate of acute allergic reactions is close to 2% (1.95% [95% CI, 1.79%-2.13%] ) and the observed rate of anaphylaxis is close to 1/3700 for mRNA Covid-19 vaccines (Pfizer 0.027% [95% CI, 0.011%-0.056%]). It’s impossible to miss that in a cohort of 21,700 vaccinated individuals in a clinical trial.
This observational study has been published online in March 2021, it was clear that we could question the authenticity of the safety data published by Pfizer early in the roll-out of this vaccine."
Surya ARBY
Consultant
Rueil-Malmaison, France
Justice Department Announces Largest Health Care Fraud Settlement in Its History
##Pfizer to Pay $2.3 Billion for Fraudulent Marketing
What a time for the FDA to NOT bother with inspections. The RT articles notes:
" The second former employee echoed the first’s comments, describing the environment at Ventavia as unlike any they’d experienced in their 20-year research career. They also alleged that, shortly after Jackson was fired, Pfizer was notified of problems with the vaccine trial at Ventavia and that an audit took place.
Yet, in the briefing document Pfizer submitted to the FDA advisory committee December 2020 in support of its application for emergency-use vaccine authorization, no mention was made of any problems at Ventavia. The next day, authorization was [duly granted](FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine | FDA).
In August this year, after full approval was granted for Pfizer’s jab, the FDA published a summary of its inspections of the company’s vaccine trial sites. Nine of the 153 had been inspected, but none of those had been operated by Ventavia, and no inspections had been conducted at all in the eight months after the December 2020 emergency authorization, on the basis that “the study was ongoing, and the data required for verification and comparison were not yet available.”"
That last excuse seems flimsy - just inspect after the mess has been cleaned up?
The BMJ notes that the concerns were raised by the employee with the FDA in September 2020, who was told “the FDA could not comment on any investigation that might result” - the investigation that did not result, that is.
With only 9 out of 153 sites inspected, and none in the 8 months since approval, and with the FDA turning a blind eye to obvious problems, it’s hard to see much difference between Pfizer and the FDA itself.
Also came across this Brussells Times article from March:
11/3/21 Revealed: early vaccines from Pfizer were below specifications (see below)
This was only revealed due to a deliberate external hack of EMA communications, after which anonymous files were sent to ‘journalists and academics’, including the BMJ.
As the piece reports, it is unclear how the EMA became satisfied the issue (which was about the degradation of the mRNA) was resolved. The BMJ suggested this may have been due to a simple email from the US. Although it was clearly marked by the EMA as a safety and efficay issues, it doesn’t seem to have been documented in any process at the EMA end.
(emphasis is mine)
ED
Revealed: early vaccines from Pfizer were below specifications
Some of the early batches of the Covid-19 vaccine produced by Pfizer/BioNTech – the first to be approved in Europe – contained lower levels of intact mRNA than expected, leaked documents have revealed.
A report on the problem has been published by the British Medical Journal (BMJ), which received some of the documents obtained illicitly from a hack of the computer system of the European Medicines Agency (EMA) that took place in December last year.
The hackers took possession of some 40Mb of data, which they then sent anonymously to journalists and academics.
“They came from anonymous email accounts and most efforts to interact with the senders were unsuccessful,” the BMJ reports. “None of the senders revealed their identity, and the EMA says it is pursuing a criminal investigation.”
In the meantime, the documents have been studied, and reveal some concerns around messenger RNA, the active ingredient of the new vaccines.
To quote the website of the Centers for Disease Control in the US: “mRNA vaccines are a new type of vaccine to protect against infectious diseases. To trigger an immune response, many vaccines put a weakened or inactivated germ into our bodies. Not mRNA vaccines,” the site explains.
“Instead, they teach our cells how to make a protein—or even just a piece of a protein—that triggers an immune response inside our bodies. That immune response, which produces antibodies, is what protects us from getting infected if the real virus enters our bodies.”
When EMA scientists studied the batches of vaccine Pfizer was proposing for commercial distribution, they found the mRNA present did not meet the manufacturer’s own specifications. And what is more, the implications of that discovery were not at all clear.
The differences ranged from 78% of healthy mRNA to only 55%, and the effect on the safety and efficacy of the vaccine as a result of the deterioration was, the EMA said, “yet to be defined”.
The EMA approved the Pfizer vaccine on 21 December, by which time its misgivings had been resolved enough for it to publish in its public assessment report that “the quality of this medicinal product, submitted in the emergency context of the current (covid-19) pandemic, is considered to be sufficiently consistent and acceptable.”
The BMJ speculates, based on another email from the US, that rising percentages of intact mRNA were behind the decision to approve.
This, the journal writes, raises a number of issues on a series of extremely technical matters surrounding the safety and effectiveness of the new generation of mRNA vaccines.
“Of particular concern is RNA instability, one of the most important variables relevant to all mRNA vaccines that has thus far received scant attention in the clinical community,” the journal states.
“It is an issue relevant not just to Pfizer-BioNTech vaccine but also to those produced by Moderna, CureVac, and others, as well as a ‘second generation’ mRNA vaccine being pursued by Imperial College London.”
Alan Hope
The Brussels Times
“Although the agency cannot comment further at this time in this ongoing matter, FDA has full confidence in the data that were used to support the Pfizer-BioNTech Covid-19 Vaccine authorization and the Comirnaty approval.”
Nicely worded!
H/t Itchy Bootmore at The Lifeboat News:
Fiona Godlee & Kamran Abbasi, Open letter from The BMJ to Mark Zuckerberg [Fri 17 Dec 2021]
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 BMJCompeting 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
Talking about incompetent fact checking:
It looks like your link to www.bmj.com was already posted in the topic by @evvy_dense in a reply on 3 Nov '21 – are you sure you want to post it again?
That’s false, isn’t it? If it’s true, then I’m sorry!
Hey @Twirlip, I’d call it a follow-up, and a good one, not a repost. The earlier link was the story that Zuck’s hit men supposedly debunked. I think the various Fact Check agencies are probably very busy, and not necessarily being very thorough (if ever they were), trying to rebut the stories getting most traction. Hence keywords like Malone, Desmet, Pfizer, BMJ, Nuremberg. As soon as they think they’ve cut off a tentacle another two replace it.