55 years - Pfizer

[SencosRshit]

I’ve only just discovered this:

www.reuters.com/legal/government/wait-what-fda-wants-55-years-process-foia-request-over-vaccine-data-2021-11-18/

How many of you knew about this?

How many of you knew about this?

Most people who know how these things work.

If you read the actual article you’ve linked to, you’ll see that the info they are asking for is some 330,000 pages long, each of which must be checked for confidential information and redacted as necessary, and before you screech “what have they got to hide” such confidential information could be things like names of volunteers who are protected under GDPR.

“The FDA proposes releasing 500 pages per month on a rolling basis, noting that the branch that would handle the review has only 10 employees and is currently processing about 400 other FOIA requests”

For a bunch of people who are so fond of “doing the research” you sure are hesitant to read beyond the headlines.

I read about this earlier in the week.

Pfizer have applied to have their trial data (upon which their vaccine has been given emergency license) sealed and kept secret until 2076.

@Flyonawalk

I read about this earlier in the week.

Pfizer have applied to have their trial data (upon which their vaccine has been given emergency license) sealed and kept secret until 2076.

Why? Why are they so hesitant to share this?

@Flyonawalk

I read about this earlier in the week.

Pfizer have applied to have their trial data (upon which their vaccine has been given emergency license) sealed and kept secret until 2076.

That’s not what the article says, though.

Pfizer isn’t involved in this case. It’s the FDA defending the case based on their FOIA processing speed.

(As it’s the FDA, worth mentioning that Pfizer now has full regulatory approval for their vaccine.)

For a bunch of people who are so fond of “doing the research” you sure are hesitant to read beyond the headlines.

I think that’s being generous. The FDA is actually named in the headline here.

What’s people’s motivation to misrepresent here? I’m honestly curious.

I don't take anything at face value anymore. Unfortunately it's more than necessary to scrape a bit and look below the surface. Guided by our own government on this.

*Plaintiffs' lawyers argue that their request should be top priority, and that the FDA should release all the material no later than March 3, 2022.

“This 108-day period is the same amount of time it took the FDA to review the responsive documents for the far more intricate task of licensing Pfizer’s COVID-19 vaccine,” wrote Aaron Siri of Siri & Glimstad in New York and John Howie of Howie Law in Dallas in court papers.*

This worries me. Lawyers obviously think it should be possible to complete this by 2022. It says here that the far more intricate task of licensing Pfizer was completed in 108 days.

Pfizer are most probably paying the FDA to say it's impossible to do this quicker than 55 years. I mean - 55 years - that's ridiculous. Doesn't even compare to 108 days. It's a joke.

Pfizer are most probably paying the FDA to say it's impossible to do this quicker than 55 years

Ah so quick turnaround when you realise you didn't read the article properly and it isn't Pfizer causing the hold up @SencosRshit

‘If it doesn’t fit my preferred narrative, it must be a lie.’

Ok.

Tbh, I’ve had enough to do with bureaucracy in numerous countries that this looks like an entirely normal attempt by a government body to avoid having to hire any more people.

@YepNameChanged Presumably the data does not inspire confidence.

@JassyRadlett Yes it is the FDA who are asking for the documents to be sealed until 2076. I expect this is because they know gave emergency approval to the Pfizer vaccine on unsafe grounds, and don’t want this revealed to the public.

Yes it is the FDA who are asking for the documents to be sealed until 2076.

This is also incorrect, according to the article. They’re not asking for the documents to be sealed, are they?

I’m honestly curious why people feel the need to misrepresent things in this sort of case?

Sealed, withheld, not released. ‘Not fully released’ is the phrase in the first line of their submission.

I’m honestly curious why people feel the need to misrepresent things in this sort of case?

Firstly - lets look at our own government. Our own prime minister. It's been a shock to me how many lies can be told. How little respect he/they give us. It's been a wake up call. I've lots all trust in the government of my own country.

Have you seen this? But you know how many lies we've been told. You must know.

twitter.com/PeterStefanovi2/status/1459541907772780546

You'll say I'm derailing. But it stems from this. We can't trust our government - the prime minister of this country. Who can we trust?

Nothing. No one.

[quote Flyonawalk]@JassyRadlett Yes it is the FDA who are asking for the documents to be sealed until 2076. I expect this is because they know gave emergency approval to the Pfizer vaccine on unsafe grounds, and don’t want this revealed to the public.[/quote]
This makes complete sense. It's this.

It is very concerning. Hundreds of millions of people have taken these vaccines in good faith. How can it be right to hide the trial data?

They’re not asking for them to be sealed, held, or not released, though, are they? They’re asking for it to be released in 500-page monthly batches in line with existing departmental policies.

As I say, the rights and wrongs are for the judge, not me, and given their pressures they should probably hire more people

But sometimes when you hear hoofbeats, it’s not zebras.

I’ll be the first to agree that our government has told numerous shameless lies. No argument there.

But that’s not my question. Which is a really simple one of why do people - like those on this thread - feel the need to misrepresent information such as the reporting in the Reuters article to make it appear worse than the reporting would suggest? Why not be straightforward?

I honestly don’t understand it.

First it’s ‘Pfizer have…’ (no, it’s the FDA)
Then it’s ‘Pfizer must have asked them to seal the records’ (the defendants aren’t asking for the records to be sealed)

I really don’t get it.

I used to handle the French equivalent of FOIA requests once upon a time when I held a government job and while it is less intricate/complex than getting regulatory approval for anything, it can definitely be much more time consuming. 330,000 pages of material to get through is a Herculean task. It’s not like the FDA have unlimited personnel to do this. Usually handling FOIA is not a full time job of a person, but something to be done on top of their regular full time job in their spare work hours.

Any medical data about any person, even if you redact their name (which you have to by law), you also need their written permission to release it in anonymised form to the public (also by law). Tracking down and gettIng this permission would number into millions of letters I would think as trial data that goes to 330k pages would have the medical data of maybe a dozen people per page?

You also have to redact anything that might be proprietary to the company, Pfizer, in this case and the response has to go through their review process before released as well.

Usually once you have the FOIA response done per above, it then also has to go through review by government public affairs officers and government solicitors to ensure it has been done correctly.

There are also very limited budgets for FOIA requests, government agencies are only allowed to spend a small amount of resources on answering them. The FOIA handler has to record the cost of every hour worked, every phone call, every email, all postage, and a per page printing or copying cost. So you have to do accounting on top of answering the request and that takes time and god forbid you go over the money limit the agency has been authorised for FOIA requests because that is a sackable offence to spend more money than the agency has been given in public trust.

I don’t think anyone is hiding anything. The FDA’s response is reasonable to me because I’ve done FOIA requests before as a government employee.

@JassyRadlett

‘If it doesn’t fit my preferred narrative, it must be a lie.’

Ok.

Tbh, I’ve had enough to do with bureaucracy in numerous countries that this looks like an entirely normal attempt by a government body to avoid having to hire any more people.

This. I'm always slightly surprised that anyone thinks that any government bureaucracy anywhere is capable of some elaborate cover up because they're normally so poorly staffed and so disorganised that it would require a level of effort far beyond what is humanly possible.

@Flyonawalk

Sealed, withheld, not released. ‘Not fully released’ is the phrase in the first line of their submission.

Not fully released is perfectly normal though in FOIA requests. There are always some pieces of data that cannot be released by law, ie medical data of individuals, proprietary data of companies. So a FOIA never results in everything being fully released. That’s not the same as sealing, or calculated withholding of information. Read the USA FOIA regulations, there is list of types of data prohibited by law from being released to the public.

@PlanDeRaccordement

I used to handle the French equivalent of FOIA requests once upon a time when I held a government job and while it is less intricate/complex than getting regulatory approval for anything, it can definitely be much more time consuming. 330,000 pages of material to get through is a Herculean task. It’s not like the FDA have unlimited personnel to do this. Usually handling FOIA is not a full time job of a person, but something to be done on top of their regular full time job in their spare work hours.

Any medical data about any person, even if you redact their name (which you have to by law), you also need their written permission to release it in anonymised form to the public (also by law). Tracking down and gettIng this permission would number into millions of letters I would think as trial data that goes to 330k pages would have the medical data of maybe a dozen people per page?

You also have to redact anything that might be proprietary to the company, Pfizer, in this case and the response has to go through their review process before released as well.

Usually once you have the FOIA response done per above, it then also has to go through review by government public affairs officers and government solicitors to ensure it has been done correctly.

There are also very limited budgets for FOIA requests, government agencies are only allowed to spend a small amount of resources on answering them. The FOIA handler has to record the cost of every hour worked, every phone call, every email, all postage, and a per page printing or copying cost. So you have to do accounting on top of answering the request and that takes time and god forbid you go over the money limit the agency has been authorised for FOIA requests because that is a sackable offence to spend more money than the agency has been given in public trust.

I don’t think anyone is hiding anything. The FDA’s response is reasonable to me because I’ve done FOIA requests before as a government employee.

Surely when people take part in medical trials they agree to have the results of that trial published? So only their identifying information such as name address etc needs to be redacted.

Here is a quick fact sheet on the FDA FOIA exemptions, so a list of types of data that cannot be released to the public,
fdaatty.com/redacting-a-foia-request/

@JassyRadlett

They’re not asking for them to be sealed, held, or not released, though, are they? They’re asking for it to be released in 500-page monthly batches in line with existing departmental policies.

As I say, the rights and wrongs are for the judge, not me, and given their pressures they should probably hire more people

But sometimes when you hear hoofbeats, it’s not zebras.

I find it concerning that you are so desperate to defend them Jassy.

I find it odd and it makes me question who you are affiliated with. Or maybe you're just desperate not to believe that you could ever have been so easily conned.

Whatever the reason - now you will say that I've got a tin foil hat on or something trite like that.

We all need to start questioning things very seriously. All of us. The news today about Austria is one huge great fat sign post. Many of us have seen this coming. But if you're going to ignore this one - you're in trouble.

@theworldsgonefeckingmad
Surely when people take part in medical trials they agree to have the results of that trial published? So only their identifying information such as name address etc needs to be redacted.

Not really, they give permission for their medical data gathered during the trial to be used to then calculate and publish the summary results of the trial. As in “the vaccine was found to be 74% effective in trial A with 789 subjects aged 18-78, side effects were reported in 10% of headaches, 30% sore arms...” and so on (totally made up, but that’s how results of trials are published). The results of trials are never published on an individual subject basis. Ever.

Trial raw data which the FOIA is asking for will list:
Subject so and so, aged x, sex b, ethnicity purple, with comorbid health conditions x y z, given first dose date xx. Side effects noted were blah de blah de blah. Second dose given date xx. Side effects noted were blah blah de blah. Subject tested for Covid....date, date, date, date. At end of trial subject negative, vaccine effective. Side effects blah squared.

I find it concerning that you are so desperate to defend them Jassy.

I’m not. Like I said, one for the judge.

I find it curious that your automatic action based on this story was to misrepresent it to fit your preferred narrative, and then when challenge come up with new ways to make it fit your narrative, and then when asked why, make it all about me.

I’m all for letting the facts stand on their merits. Sometimes that means looking at the primary sources - like in this case, where it turns out the 500/pages a month is an existing FDA policy.

I’ll admit I find it less than plausible that they put this policy in place some time ago ready for the pandemic and the Pfizer vaccine. But that’s me.

As I say, not opining on the rights and wrongs (I reckon they might want to hire more people, it sounds like they’re drowning in FOIs). Just always curious why people feel the need to lie rather than arguing based on the evidence. Particularly when the lies are so easily found out.

But sure. That makes me an agent of the illuminati busy sharing papers from the Lancet on Mumsnet. Why not.