The BMJ is not the shining city on the hill here. You can have problems with Facebook policing information, but Thacker is unquestionably an anti-vax conspiracy theorist and the BMJ is allowing him to use their reputation to push that narrative.
I am firmly against this lowest common denominator approach of people not being able to publish any 'hard science' anywhere through fear of it being taken out of context on social media - particularly after the push of recent years to do the exact opposite and make such stuff open access for all.
The BMJ is not the problem in the world of fake/outrage/out of context news online.
- We think the BMJ is too complicated for you to properly understand.
as opposed to
- We had some group independently check and the BMJ is objectively wrong.
The first one seems a little un-pc, so I would say that people sharing stuff online and a loud minority going off on some mad conspiracy is the [acceptable] cost of being open with science and research.
In general, it's incredibly sad that Covid has lead to such politicisation around vaccines and trials. It seems (to me, at least) that most of what people (SBM, the FB fact-checkers) are concerned about is other people using the information "incorrectly".
Like, fundamentally, this is an impossible problem to solve (none of us can control others interpretations of things) and the attempts to solve this "problem" are likely to result in much worse outcomes.
If the headline was "Questions about data integrity in Ventavia-run vaccine trials" or "Allegations of misconduct at three vaccine trial sites" I might be more sympathetic; but as it stands I think classifying this as agenda-based spin is a fair assessment, as on the whole there are no concerns about about the Pfizer vaccine trial, only the three sites administered by Ventavia. The distinction being that the integrity of the Pfizer trial stands on solid ground even without the Ventavia data, which is a small fraction of the total data set.
That the agenda the BMJ is spinning for is anti-vax is deeply disturbing to me, but that's a separate discussion. I hope you can at least see the concern about such a headline, how it might be perceived as spin, even if you personally don't view it as such.
Like, the numbers for hospitalisation were very very small indeed, and while I (personally) don't believe that the entire trial was flawed (the extensive real world evidence would suggest otherwise), clinical trials are super important, and fixing flaws in them and reporting on them is exactly what I want the BMJ to do.
Additionally, the Lead Stories people are engaging in politics over this report, which kinda sickens me, to be honest. Both them and SBM are using ad-hominems to avoid engaging with the detail of this report, and that's concerning (particularly the fact checkers).
More generally, fact checking being done like this is very worrying (like the Cochrane collaboration got banned from IG for a while, which is nuts).
I guess my meta-point here is that standards of discourse are dropping everywhere, it's all explosions of rage in defence of a pre-determined outcome (which I mostly agree with, tbh) and this is very, very sad and bodes badly for humanity's ability to solve the problems in front of us over the next few decades.
Sad.
https://jessesingal.substack.com/p/science-based-medicines-c...
Now, someone post a takedown of Singal so we can keep the chain going ...
Publishing missteps are inevitable. The BMJ is claiming authorial supremacy above its critics, that's the root of the controversy.
It smacks of "Yes, some sloppy science was done here, but you can't prove it changed the results? Can you? Can you prove it? Huh? No? Well then shut your dirty mouth!"
Yes, this was supposed to be a blind study but participants had pages detailing whether they had the placebo or not in their notes. Did anyone actually read those pages? Nobody knows. Did you read those pages? Did you? I bet they didn't! I bet NOBODY reads the participants notes! Nobody ready them, it's all fine, and they yanked those pages out within a few somethings (We'll gloss over how someone might have found this out, and whether they were likely to be privy to the information already)
Yes, there were a bunch of used needles discarded in normal binbags rather than in a sharps box, but that doesn't PROVE that they were poorly trained! Oh no. It was probably just a bad day. Did it change the outcome? You can't prove it did! Don't tell me about it unless you're sure!
No, there's no evidence that THESE issues were reported, but look! Other issues were reported! The management had previously discussed how bad they were at the science! If they knew they were bad, they wouldn't continue to be bad would they! And if things were reported, and other things weren't, that's not likely is it... that's just confusing... CONFUUUUUUSSIIIIINNNGG
Yes, they had to take corrective action, but at least they took corrective action! There couldn't have been THAT many people affected, could there? Do you know? I don't know. I bet there weren't many. A handful maybe. Probably just an old couple who were discarded early on for licking the other participants faces. It's inconsequential. Definitely not a problem. No problems here! Move on!
It's almost comical.
It also really bugs me that rather than saying "The article says", throughout they say "Thacker says". They've made it a personal vendetta against an evil person making things up, like they're not even trying to be balanced about it.
That said, I love the summary: "In the end, we’re left with a lot of smoke, but no clear fire." Hmm.. if only there was a well known saying about this. No ... something ... without ... oh, I don't know. Seems legit.
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.
> 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.
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?
- https://leadstories.com/hoax-alert/2021/11/fact-check-britis...
- https://leadstories.com/analysis/2021/12/lead-stories-respon...
"[the company that did the fact checking] said Jackson was not a “lab-coated scientist” and that her qualifications amounted to a “30-hour certification in auditing techniques.” Jackson has more than 15 years’ experience in clinical research coordination and management and previously held a position as director of operations."
Talk about missing context and misleading statements...