Hacker News Reader

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.

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.

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.

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.

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.”

> 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.