Both these things can be true:

That this BMJ article is correct and this particular part of the trial was botched by the contractor who covered it up, and the BMJ is unsatisfied with the level of follow-up by the FDA.

That the other trial sites were well managed and valid, that the results at this trial site do not overturn the overall results, and that the FDI found it unnecessary to investigate further.

There are multiple problems:

1. The Lead Stories article aims to debunks social media narratives linked to the BMJ article, but the result is the BMJ article itself being censored on social media (preventing it from being sent in DMs among other things)

2. The gist of the Lead Stories article is that Pfizer, the FDA, and Ventavia have found the whistleblower report "unsubstantiated". These organizations have not to my knowledge offered any facts that would lead us to doubt the whistleblower's report; and further, have made claims that were directly contradicted by the whistleblower (with proof), such as which team she worked on.

3. The last part of the LS article seems like it would be a violation of fact-checking ethics (if such a thing existed), since it brings the debate out of a dispassionate argument about facts, into an ugly ad-hominem attack (stating that she "does not express unreserved support for COVID vaccines" on her personal Twitter). Similar errors are made in another fact-check below the HN comment you link to (by Dr. David Gorsky, oncologist).

Given these points, I don't see how you can call the fact-check "correct".

Article makes claim X. Readers of article say it makes claims X, Y, and Z. Independent fact check puts a stamp on article saying "This doesn't say Y and Z", but to most people, who will for the same reason share an article after only reading a title or a little blurb their friend wrote, will write off the article as flawed or fake news because of the fact check stamp.

Not really sure what a good solution to this is, other than to "fact check" people's posts on facebook, as well as the links they share. So maybe this link can be shared without the fact checked stamp among epidemiologists on facebook, but Bob's anti-vaxx group may get fact check labels when they try to summarize what is in the article.

> "Readers of article say it makes claims X, Y, and Z."

says who?

"Intended for healthcare professionals" - it literally says so above the page header.

Edit: maybe fact checking systems need to label certain things as "This is a publication from a narrow domain venue intended for professionals. Specialized domain knowledge may be required to derive correct conclusions." instead of fact checking only the first few paragraphs using common journalistic standards because "users on social media only saw this title, description and thumbnail[...]".

I've read over both sides of this, and there is some editorializing going on in this medical journal that makes it less about facts. The title makes no mention of Ventavia, but instead mentions Pfizer. The headline doesn't specify that Ventavia managed 1/44th of the trial, nor anything factual (mostly speculation that the data integrity is questionable).

> 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.

The questions are all whether this one company had poor practices. It mixes comments regarding the larger trial of Pfizer with this isolated company trial. At times it's hard to tell if they're referencing Pfizer or Ventavia (as "company"). An investigation found nothing remarkable at other sites managed by other contractors, but then even that is questioned because this small company wasn't investigated.

I'm not actually sure what part of this medical journal _is_ factual.

It was ultimately Pfizer's trial and Pfizer bears all responsibility for their contractors.

What you’re saying is true, and completely tangential to the problem. When you are concerned that validation done by a subcontractor might be weak, it is entirely sensible that you subdivide the work. What we need is a statistical reanalysis that considers that, e.g., 10% of each step is done wrongly. And a regulatory regime that doesn’t hand wave away complaints, has rigorous protection for whistleblowers, and serious financial penalties for misconduct.

The BMJ might be right, but also have constructed an article that will be wildly misunderstood... and not sensible content for facebook.

It will not be misunderstood by intended readers of BMJ. As for facebook it has all kinds of readers and groups including those that are meant for professionals.

I think I completely understand the article but still think that it's editorializing facts. Why exactly would professionals feel differently? If they had done some investigations themselves and found a series of poor contractors that all reported similar issues, I think we could take this as much more concerning. This looks like a director from a single company and a few anonymous researchers at the same company came forward with bad practices for 1000 trials.

Also, as the article points out, investigations were performed at other contractors. Wild speculation, but that could be that Pfizer didn't even need a full 44k and they just ignored 1k? (For example, they concluded the trial with 41k getting a second dose.)

The issue is that proper investigation was not done. We need more transparency and this is not what is happening. What happened with the data from these researchers? There are no indications that they were removed from the study analysis. If the problems with this one researcher is swept under carpet, how do we know that there are not number of other researchers with different problems?

Without this vigilance how do you distinguish between ivermectin studies that showed a positive effect and vaccine studies? Some of ivermectin studies but not all were discovered to be total frauds. At some point when you see too many problems you just have to distrust them by default until proved otherwise.

In fact, I think that there is possibility that the Pfizer vaccine trial results turned out quite different from effectiveness in real life in part due to issues like this.

The BMJ article, near the end, reports that the FDA actually did investigate and did find issues with the trial.

> An FDA review memorandum released in August this year states that across the full trial swabs were not taken from 477 people with suspected cases of symptomatic covid-19.

Of course, this comes after insinuating earlier that there is a complete lack of oversight.

> “There’s just a complete lack of oversight of contract research organisations and independent clinical research facilities,” says Jill Fisher, professor of social medicine at the University of North Carolina School of Medicine and author of Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials.

I guess since you yourself were misled according to their own inconsistencies, maybe that is enough to convince you that the article is misleading.

I don't know what FDA review memorandum involves but it doesn't sound that the FDA did investigation. It could be simply that the FDA checked submitted documentation from that site and concluded this because the CRO hadn't provided any test results.

Sorry, I don't see any inconsistencies. The box clearly explains what they mean by complete lack of oversight – doing inspections many months after the trial and even then just checking the paperwork.

Not necessarily. If there's an instance of someone blowing the whistle, and there's no investigation it's completely reasonable to suspect that the whole integrity of the process might be iffy.

Blocking the article (instead of opening relevant books to show that in fact it was just exception to otherwise solid prices makes) makes even stronger case that the prices is not honest.

I guess it's not so hard to believe you're getting downvoted by shedding light on a situation about censorship.

The first question in everybody's head when reading this article is, "Were the vaccine trials legitimate or not?"

BMJ does not even come close to truthfully answering this question. With their authority as a medical journal and a very limited amount of evidence, they give a clear and incorrect impression that the vaccine trials were not legitimate.

Do they report on the limitations of their evidence? No. Do they report on the perspective of employees at other trial sites? No. Do they get quotes from Pfizer, other health orgs, Ventavia executives? No. Do they report about other speculative factors at play from Ventavia ex-employees? No.

Are they purposefully hiding new relevant information? Yes. They leaked in their own article that the FDA is aware and reviewed the Ventavia trial.

> An FDA review memorandum released in August this year states that across the full trial swabs were not taken from 477 people with suspected cases of symptomatic covid-19.

After insinuating earlier that there is a complete lack of oversight.

> “There’s just a complete lack of oversight of contract research organisations and independent clinical research facilities,” says Jill Fisher, professor of social medicine at the University of North Carolina School of Medicine and author of Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials.

Honestly, BMJ seems to be working very hard to lie using true facts. I have no objections to their articles being marked as false.

>> The first question in everybody's head when reading this article is, "Were the vaccine trials legitimate or not?"

You are writing complete rubbish. BMJ does not question the legitimacy of the vaccine trials. With this sentence you are making very serious accusations to healthcare professionals. Most likely you don't even understand how clinical trials work or terminology used in the original article. If BMJ were not a serious journal, nothing in medicine would be serious including those trials.

BMJ is questioning some irregularities brought to the light by a whistle-blower. It shows some evidence confirming issues about one particular clinical research organization and lack of reaction from the FDA. These issues should be addressed and resolved to remove doubts that the data from vaccine trials can be sufficiently trusted.

Also FDA memorandum does not confirm that the FDA has investigated the sites. You probably don't even understand what the quoted professor meant by “oversight”. It definitely is not just checking and fully trusting the submitted paperwork.

The title BMJ chose is "Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial"

And? It's very precise and describes exactly what happened.

Wouldn't it be a lot clearer if it were something like "issues at three sites doing Pfizer vaccine trials" instead of "issues in Pfizer’s vaccine trial"?

The singular "trial" in the headline implies that the flaws are in the trial as a whole rather than in a particular distinct subset of the trials.

You apparently use the word trial differently than it is used in pharma.

Pfizer had one large trial that involved many sites. Three of those sites run by Ventavia had problems. That's why the headline says “in trial”. But even if you didn't know that it is explained in BMJ article “... Ventavia had enrolled more than 1000 participants at three sites. The full trial (registered under NCT04368728) enrolled around 44 000 participants across 153 sites that included numerous commercial companies and academic centres.”

Well, there are: The provable lack of regulatory oversight and demonstration of the existence of poor practices at the company.

The argument that just because one of a company's trials are unsound doesn't mean that the rest aren't is not a good one, when the whole objective is to provide assurance in proving the safety of a product.

I get that it's hard to find the best balance in a headline let alone in a summary article. Yes, evidence of a problem in a portion of a trial is indeed evidence of problems in the trial.

I can see room for misunderstanding no matter what. Emphasize the portion of sites where the problem was observed and it wrongly can be inferred that the other sites are fine even if they have no evidence either way. Emphasize the problem as a generic feature of the trials overall and it can be wrongly inferred that the whistle is being blown on some aspect of the trial that doesn't have any site-specific aspect.

The story that I'm hearing in all this is that the whistleblower brought out issues that were specific to certain sites in a way that has no direct bearing on other sites besides being a reason to scrutinize the rest of the sites as well.

Maybe an analogy would be helpful. If a whistleblower observed a disregard for safety protocols at a food processing facility, that's not a randomized sampling that indicates a high likelihood of the problem being throughout all similar facilities, but it doesn't indicate otherwise either. It opens the question whether this is a typical problem in such facilities or if that facility is an exception. If the facility was supplying brand X, there's at least some sense to criticizing a headline like "whisteblower reveals brand X unsafe food handling" instead of "whistleblower reveals unsafe food handling at facility run by brand X". The former implies wider issues, the latter errs toward not making that presumption.

Yes, the problems in one site, especially if not dealt with properly, might indicate larger problems.

We all know that the trials were rushed and for a very good reason, there was a pandemic. Still, if issues are discovered they should be resolved. Pfizer is a private company, they are not obliged to be very transparent with everything they do. FDA is the main organisation that oversees such trial in the US, so this is their responsibility to investigate.

Your argument is basically that this article may be largely speculation, assuming that no information was withheld (even though the article contradicts itself in its own communication about FDA review of the trial)... and that this speculation is the same as minimal conclusions based on available evidence.

I disagree. One bad study doesn't mean all scientific conclusions are bad. One bad study doesn't mean Pfizer's trials are bad. Ignorance doesn't prove anything...

I don't know if you imagine me to be partisan here. I was arguing simply that headlines are hard to balance, and that people can interpret articles with a slant.

I wasn't saying that one bad study means the overall trial was bad.

The issue is that SOME people might think that. (Also others might think that if it's ONE study that's bad, the overall trial WAS fine, when that's not clear either).

The risk is whether real people take away a too-strong message and run with it.

In other words, journalists have SOME responsibility to not mislead people even when the main way people get off-track is their own erroneous jumping-to-conclusions as readers. We KNOW that readers do such things, so we have to be careful to minimize it.

> The questions are all whether this one company had poor practices.

If the FDA did not follow up on the whistleblower report it raises far broader questions about oversight of the trials as a whole.

There are so many foaming at the mouth morons desperate to “prove” that the whole thing was a sham that it will take extraordinary evidence to convince me anything improper was done.

The solution is not to discredit BMJ but to explain how BMJ article doesn't mean what antivax is insinuating.

I totally understand that when BMJ writes that this clinical research organization did a mess is this trial, someone misreads it as all Pfizer vaccine results are false. But if you say that BMJ is hoax, then we have much stronger reason to distrust healthcare professionals. Do you see the paradox here?

BMJ is expressing concern about Pfizer and regulator's failures with the ultimate aim to fix them and increase the trust by showing that every fault is taken seriously. We cannot sweep unwanted things under the carpet and hope that nothing will happen. Bad actors should be appropriately punished.

I want to second this. Because of how badly the right wants the vaccine to be dangerous/fake/whatever I'm so sensitive to anything negative that I basically brush off articles like this. In my mind I just lump it in with people saying the vaccine will make you impotent.

Probably the wrong way to think about things but that's how my mind works.

It appears that the source of the confusion is the lack of articles. The 'true' headline is "revealed flaws in A Pfizer vaccine trial", the misleading interpretation is "revealed flaws in THE Pfizer vaccine trial". Lead Stories emphasizes the significance of the other trials, The BMJ emphasizes the significance of the findings, and neither is really lying.

Where Lead Stories goes overboard is in the way they present their title. It would be far more appropriate to title the story like this:

>Fact Check: The British Medical Journal Revealed Flaws In Only One Of Many Pfizer COVID-19 Vaccine Trials

In fact the use of the plural "Trials" in the fact-check title from Lead Stories is a malapropism, since the BMJ article clearly focuses on a single trial. The BMJ article also does not use the word "disqualifying" at all, nor does it supply such an implication.

The problem is not with fact-checking or even with attaching a fact-check to this particular story; the problem is that the content of the fact-check is structured like clickbait, with a classic motte-and-bailey title.

Except that's not the headline The BMJ ran, they ran: "Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial" This lacks significant context, which is exactly what FB said of it. Taken alone, I would call that headline false. There is no evidence of notable data integrity issues in Pfizer's vaccine trial beyond the typical levels of minor documentation issues expected in large human trials.

The entire article from the opening headline to the grey box take-aways to the closing paragraphs is framed to cast doubt on the entirety of Pfizer's vaccine operation. That they don't outright lie inside the article is beside the point, they don't need to. The goal is to sow fear, uncertainty, and doubt and give ammo to anti-vax advocates who know the general public only read the headlines.

The issues with Ventavia, if true, are not something typical or expected at all. And it is even less expected that any reported issues will not be followed up by the regulator. While it is true that many trials suffer from similar issues, it is not the standard that we should accept.

And I don't understand why so many think that BJM article tries to cast doubt on the entirety of Pfizer's vaccine operation? It is nothing like that at all. It clearly says the issue is with one research organization contracted by Pfizer. Maybe it is because you lack the context and jump to quick conclusions?

The issue is with how many will interpret that headline. People who already want to believe that 100% of the vaccine research is a sham will run with this. The burden is on BJM to be extremely clear if they don't want to add to the misinformation.

It is an issue but that issue has to be solved by different means than having fact-checkers saying that BMJ is wrong. BMJ clearly states at the top of every page that it is meant for healthcare professionals.

Pedantic, sorry, but I don't think "malapropism" means what you think it means:

Here are some examples of malapropisms: Mrs. Malaprop said, "Illiterate him quite from your memory" (obliterate) and "She's as headstrong as an allegory" (alligator). Officer Dogberry said, "Our watch, sir, have indeed comprehended two auspicious persons" (...suspicious persons). Rainy weather can be hard on the sciences. (sinuses)

https://examples.yourdictionary.com/examples-of-malapropism....

The BMJ article is light on conclusions and is mostly just a report of facts. In the way of true conclusions I can find these:

> 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.

> for researchers who were testing Pfizer’s vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety

Which of these conclusions do you think make zero sense? The entire rest of the article looks like a recitation of facts to me.

Facebook users aren't reading the article. They're reading the title, and saying "aha, I knew it. The vaccine was unsafe all along." That's literally all the fact checkers said, "potential to mislead".

> "potential to mislead"

I can't find that expression anywhere in the Lead Stories article. Facebook outright labelled the BMJ article "false" and containing "false information".

Beyond that, should fact-checkers really become an "optics police"? For every single news story, you will have (wild) misinterpretations on social media. It becomes too convenient if a fact-checker can point to those, and then have Facebook limit the spread of the original story. This is a question of poor FDA oversight. There have been several instances throughout this pandemic: see the recent FDA resignations, and the GAO report[0]. Oversight is not about pro vs anti vaccine, this is about people's health[1]. Oversight should always be robust, even in emergency situations.

[0]: https://www.raps.org/news-and-articles/news-articles/2021/11...

[1]: story from Japan https://www.theguardian.com/world/2021/sep/07/third-person-d...

My bad, the actual quote is "Missing context ... Independent fact-checkers say this information could mislead people"

As far as whether Facebook should become "optics police" I think it's obviously a difficult decision, but with life and death questions such as "is the vaccine safe" I have to go with yes, facebook shouldn't let itself propagandize people who decide to read headlines instead of articles.

>life and death questions such as "is the vaccine safe"

Is that not a misleading thing to say yourself? Plenty of vaccinated have died. And for those unjabbed but with permanent acquired immunity, the jab may be safe yet at the same time have no material effect to save their life.

As best we can tell, no one has "permanent acquired immunity". 36% of those infected never develop antibodies. Of the remaining 64% that do, most lose their antibodies in less than a year.

What's plenty? The number matters because it may be insignificant.

The CDC makes it hard to find the data but it's at least hundreds per day in the US.

For example in Texas, from Jan-Oct of this year 8 percent of covid deaths were fully vaccinated: https://www.washingtonpost.com/health/2021/11/09/texas-unvac...

Most of that time period was before Delta or Omicron were dominant, not to mention the effectiveness of the vaccine wanes greatly over a ~6 month period, so the situation today is likely higher than 8 percent.

I'm not sure I follow the thread on how plenty of folks that are vaccinated have died (from being exposed to COVID-19, likely from those unvaccinated) means that the vaccine is not safe. The article you linked says those unvaccinated are 40x more likely to die (although it might be more like 14x with more recent data). Similarly, unvaccinated are more likely to spread COVID-19.

Unvaccinated are more likely to contract the virus from a family member. [0]

> According to the analysis, 25 percent of vaccinated contacts exposed to a household member with an infection contracted one themselves.

> In contrast, 38 percent of unvaccinated contacts got an infection.

> The study results suggest that because the viral load of vaccinated people drops off more quickly, their infection may be infectious for a shorter time than for unvaccinated people.

https://www.healthline.com/health-news/vaccinated-people-can...

> Plenty of vaccinated have died.

From the vaccine?!?

> Facebook users aren't reading the article. They're reading the title, and saying "aha, I knew it. The vaccine was unsafe all along."

You literally just made this up.

It’s true. Spend a few minutes reading comments on major news sites’ articles and they’re always full of people making up theories that the article directly contradicts.

The first link is 404. Here's another link on the same topic: https://leadstories.com/hoax-alert/2021/11/fact-check-britis...

Fixed the first link, thanks.

The Lead Stories article sets up a straw man for claims not made in the BMJ article, then calls the story fake after debunking the straw man claims not made. The Lead Stories article is the "misinformation".