I've read the article, Facebook's "fact checker" page, the BMJ's response, and the fact checker's response, as well as the posted response from Science Based Medicine. None of it "smacks of" anything, the series of events is clearly laid out.
A former Ventavia regional director provided internal company documents to Thacker that laid out potential flaws in clinical trials run by the company for Pfizer's vaccine candidate. Thacker's reporting on these documents places noticeable spin towards anti-vax sympathies for example:
> Thacker writes in the introduction, in which he claims that Ventavia unblinded patients, not that “inadvertent unblinding may have occurred”. There’s a huge difference between the two.
Even without Thacker's spin, this is concerning and deserves investigation. However, for the overall safety of the Pfizer vaccine it's not a significant factor. Ventavia ran 3 out of 153 clinical sites, and signed up about 1000 of 44000 subjects who participated in the trial. Even completely disregarding any data that came from Ventavia, there would be overwhelming evidence of the vaccine's efficacy and safety.
The obvious framing here should be that Ventavia is potentially an irresponsible steward of pharmaceutical trials and Pfizer needs to have greater level of oversight over such contractors. The framing Thacker went with is that the Pfizer vaccine's safety and efficacy are in question due to falsified trials. The latter is simply untrue, and reveals an agenda that is concerning from an editor at the BMJ.
Inadvertent is no excuse and adding that "context" to the statement would tend to be misinformation as its not a valid excuse in the context of clinical trials governed by strict policy. Its "we followed policy" or "we failed to follow policy", FDA is not equipped to audit the entirety of all locations and there is a hell of a lot of trust involved. Pfizer getting their bell rung over these infractions should be expected and appreciated not refuted.
The complete story of what happened is never misinformation. Greater and more complete sets of facts, un-editorialized, is the basis from which we draw out conclusions.
That you view something through a certain binary lens does not make that the only valid lens through which the scientific community and the public will perceive something. An article that purports to be "just the facts" must report just that, the complete facts and context as best they are known. An article that is correctly represented as an editorialized opinion may do whatever it pleases. The BMJ in this instance is purporting to be the former, while carrying out the latter.
I don't have a problem with the opinion Pfizer should be pursued or have "their bell rung" or whatever. I have a problem with willfully ignoring what the BMJ has done here, which is to use their reputation as a factual medical authority to push spin and then have the audacity to express outrage at being called out for that.
"The British Medical Journal Did NOT Reveal Disqualifying and Ignored Reports of Flaws in Pfizer COVID-19 Vaccine Trials"
Did the original article claim trial disqualification? It's like pointing out a rotting foundation and someone says "Hey that's not fair! The house is still standing!" Who is doing the editorializing?
You're doing the same thing. You haven't mentioned Gorski here, you've mentioned "the article" vs "Thacker". You've ignored that one is actually a peer reviewed article, and that the other is clearly a very biased hit piece that aims to de-legitimise the peer reviewed article.
> Thacker writes in the introduction, in which he claims that Ventavia unblinded patients, not that “inadvertent unblinding may have occurred”. There’s a huge difference between the two.
The definition of unblinding does not require someone to actually see it.
If a doctor fixes your eyesight, and you refuse to open your eyes afterwards, have you been unblinded?
https://www.noclor.nhs.uk/active-research/unblinding : "Unblinding, sometimes referred to as code-break, is the process by which the treatment/allocation details are made available either purposefully (i.e according to the code-break procedures) or accidently."
If this information was made available - whether or not that information can be proven to be accessed - then an unblinding has occurred.
So to say that they "unblinded" some patients is not wrong. And if the person who found this out should have been blind to the data, then an unblinding access definitely did occur.
And if you're saying that they should have been more precise about this because people in the audience might not be in healthcare and might not know the technical definitions, I'll refer you to the header on the BMJ website: "Intended for healthcare professionals"
> The framing Thacker went with is that the Pfizer vaccine's safety and efficacy are in question due to falsified trials.
That isn't antivax spin. That's just using the correct terminology.
And also, that isn't the framing he went with:
"Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight."
In nice big letters.
Compare that to Gorski's framing:
"Last week, The BMJ published an “exposé” by Paul Thacker alleging patient unblinding, data falsification, and other wrongdoing by a company running three sites for the massive clinical trial of the Pfizer COVID-19 vaccine. It was a highly biased story embraced by antivaxxers, with a deceptively framed narrative and claims not placed into proper context, leading me to look into the broader question: What the heck happened to The BMJ?"
Exposé in quotation marks. "Embraced by antivaxxers" (not that he is claiming Thacker is one, of course, but blaming the article writer for the kind of people who reads it seems perverse at the least)
Then second paragraph of the introduction: "investigative journalist turned anti-GMO muckraking crank Paul Thacker"
Oof.
(Btw, I'm intentionally not looking Thacker up - don't care who he is or what ad-hominems actually contain truth. Seems like a fools game to me)
So given that, what was Gorski's problem with Thacker's framing?
"Notice the framing. Contrary to Bourla’s statement, the narrative goes, “several” (three, actually, as it turns out) sites in Texas run by Ventavia were supposedly flouting clinical trial safety"
Oh, and that he used the word "Whistleblower" to describe the whistleblower. And that can be misleading, because calling them that (aside from giving them all-important legal protection) might be considered positive in people's eyes.
Thacker using the word "several" which means "more than 3" is definitely wrong, unless he has evidence that the bad science is more widespread than just the three institutes he centers his report on.
And maybe there was a little sloppiness in the language, a little exaggeration in the effects or a little lack of detail in the way he amalgamated his data.
But it's still quite a long article that clearly shows "Ventavia is potentially an irresponsible steward of pharmaceutical trials and Pfizer needs to have greater level of oversight over such contractors".
Or, as Thacker _actually_ put it, poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight.
A former Ventavia regional director provided internal company documents to Thacker that laid out potential flaws in clinical trials run by the company for Pfizer's vaccine candidate. Thacker's reporting on these documents places noticeable spin towards anti-vax sympathies for example:
> Thacker writes in the introduction, in which he claims that Ventavia unblinded patients, not that “inadvertent unblinding may have occurred”. There’s a huge difference between the two.
Even without Thacker's spin, this is concerning and deserves investigation. However, for the overall safety of the Pfizer vaccine it's not a significant factor. Ventavia ran 3 out of 153 clinical sites, and signed up about 1000 of 44000 subjects who participated in the trial. Even completely disregarding any data that came from Ventavia, there would be overwhelming evidence of the vaccine's efficacy and safety.
The obvious framing here should be that Ventavia is potentially an irresponsible steward of pharmaceutical trials and Pfizer needs to have greater level of oversight over such contractors. The framing Thacker went with is that the Pfizer vaccine's safety and efficacy are in question due to falsified trials. The latter is simply untrue, and reveals an agenda that is concerning from an editor at the BMJ.