Judge Orders FDA To Hasten Release of Pfizer Vaccine Docs (reuters.com) 118
A federal judge in Texas on Thursday ordered the Food and Drug Administration to make public the data it relied on to license Pfizer's COVID-19 vaccine, imposing a dramatically accelerated schedule that should result in the release of all information within about eight months. Reuters reports: That's roughly 75 years and four months faster than the FDA said it could take to complete a Freedom of Information Act request by a group of doctors and scientists seeking an estimated 450,000 pages of material about the vaccine. The court "concludes that this FOIA request is of paramount public importance," wrote U.S. District Judge Mark Pittman in Fort Worth, who was appointed to the bench by former President Donald Trump in 2019.
The FDA didn't dispute it had an obligation to make the information public but argued that its short-staffed FOIA office only had the bandwidth to review and release 500 pages a month. While Pittman recognized "the 'unduly burdensome' challenges that this FOIA request may present to the FDA," in his four-page order, he resoundingly rejected the agency's suggested schedule. Rather than producing 500 pages a month -- the FDA's proposed timeline -- he ordered the agency to turn over 55,000 a month. That means all the Pfizer vaccine data should be public by the end of the summer rather than, say, the year 2097. "Even if the FDA may not see it this way, I think Pittman did the agency -- and the country -- a big favor by expediting the document production," writes Reuters' Jenna Greene. "Making the information public as soon as possible may help assuage the concerns of vaccine skeptics and convince them the product is safe."
"Still, the FDA is likely to be hard-pressed to process 55,000 pages a month," Greene adds. "The office that reviews FOIA requests has just 10 employees, according to a declaration filed with the court by Suzann Burk, who heads the FDA's Division of Disclosure and Oversight Management. Burk said it takes eight minutes a page for a worker 'to perform a careful line-by-line, word-by-word review of all responsive records before producing them in response to a FOIA request.' [...] But as lawyers for the plaintiffs Public Health and Medical Professionals for Transparency pointed out in court papers (PDF), the FDA as of 2020 had 18,062 employees. Surely some can be dispatched to pitch in at the FOIA office."
The FDA didn't dispute it had an obligation to make the information public but argued that its short-staffed FOIA office only had the bandwidth to review and release 500 pages a month. While Pittman recognized "the 'unduly burdensome' challenges that this FOIA request may present to the FDA," in his four-page order, he resoundingly rejected the agency's suggested schedule. Rather than producing 500 pages a month -- the FDA's proposed timeline -- he ordered the agency to turn over 55,000 a month. That means all the Pfizer vaccine data should be public by the end of the summer rather than, say, the year 2097. "Even if the FDA may not see it this way, I think Pittman did the agency -- and the country -- a big favor by expediting the document production," writes Reuters' Jenna Greene. "Making the information public as soon as possible may help assuage the concerns of vaccine skeptics and convince them the product is safe."
"Still, the FDA is likely to be hard-pressed to process 55,000 pages a month," Greene adds. "The office that reviews FOIA requests has just 10 employees, according to a declaration filed with the court by Suzann Burk, who heads the FDA's Division of Disclosure and Oversight Management. Burk said it takes eight minutes a page for a worker 'to perform a careful line-by-line, word-by-word review of all responsive records before producing them in response to a FOIA request.' [...] But as lawyers for the plaintiffs Public Health and Medical Professionals for Transparency pointed out in court papers (PDF), the FDA as of 2020 had 18,062 employees. Surely some can be dispatched to pitch in at the FOIA office."
hard-pressed to process 55,000 pages a month (Score:3, Funny)
Give it to the Fed. They can print 120 billion a month
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The fact is they've never once been caught doing anything shady or outright lying or that sort of thing They've never hidden bad outcomes in any of their clinical trials. They've never once sold a bad medicine and for that matter the FDA reviewed all this shit and those gu
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It's so good to see anonymous cowards standing behind their convictions.... ... oh wait.
You're a literal moron. The idea that frothing Trump-supporting conspiracy theorists are going to understand 450,000 pages of niche science enough to be able to draw any conclusions is ludicrous. I'll tell you what's going to happen: Trump-supporting conspiracy theorists are going to find keywords in a document they don't understand. Those keywords will be used to justify their next insane conspiracy theory.
You fuc
Re: hard-pressed to process 55,000 pages a month (Score:1)
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If there is nothing wrong, why does the FDA want to hide the data?
Because it's illegal to release it all.
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curious.
why would a group of liars and thieves and traitors want to hear the truth
Re: hard-pressed to process 55,000 pages a month (Score:1)
Because every employee is interchangeable (Score:5, Insightful)
the FDA as of 2020 had 18,062 employees. Surely some can be dispatched to pitch in at the FOIA office
Because every employee is completely interchangeable, does not require any training before reviewing the documents, does not have any other important work to do.
Also, as we all know 9 women can produce a baby in one month.
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Thank you. Came here to say something similar. People have no idea what it takes to do a FOIA request. You can't give Bob from accounting a stack of papers and say, "Start marking them."
Nor is this done in a vacuum. Most likely these same people are conferring with legal counsel to make sure they don't release something they shouldn't, or withhold something they should release.
Fortunately this will be appealed. There's no way the FDA, or any agency, can release 55,000 pages a month of fully vetted and red
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You can't give Bob from accounting a stack of papers and say, "Start marking them."
No, but you can get people from Department A to perform the administrative secretary duties normally performed by the people doing FOIA requests. And don't think for a second that it will take more than a few hours of training for random FDA employees to be trained to "black out all personal identifiers." Even the dumb ones can be trained to recognize personal identifiers and quickly rub a fat Sharpie over them.
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Nope, in this case it involves redacting patient data, so you need either trained medical record specialists, or lawyers.
This ruling will be appealed, as it is not possible for the FDA to do this without massive congressional funding approval. Judges cannot spend money via the FDA, that requires Congress. And the agency would still fail to hire enough lawyers that quickly for a temp job.
It isn't enough to hope somebody removed the personal information correctly. They have to be sure. The law requires it.
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Re:Because every employee is interchangeable (Score:4, Informative)
You're just pinning your politics to your sleeve and waving your hands in the air.
The judge can't appropriate money. Only Congress can do that. If they applied 100% of their congressional FOIA funding, they could not comply with this stupid order. And they won't. They'll appeal, and they'll win. It would be illegal for them to comply with this order. They don't have the funding to do it, they couldn't hire that many lawyers for a temp job anyway, and they're not allowed to release patient data so they can't release anything that hasn't been properly redacted according to existing standards.
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I'm confused here. Are all these records on hard print? None of them are electronic?
It seems to me that a list of participants could be generated and use a grep like command to substitute patient John doe with patient 0432a and similar. It should be electronic and easily manipulated. The bulk of the work would be in proof reading to ensure the documents were actually manipulated.
This isn't something where somebody has to ascertain context and national security implications. It just needs to obscu
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You can't use unique identifiers for the patients, you have to redact the information. Redact. Not modify and create a substitute document.
The whole pile of data is about patients. That's what you missed about this specious bullshit; this is all patient data. There is no utility in having it with the patient information redacted. This is a FOIA request to generate headlines, donations, and a big headache for the FDA because of political-conservative judges who see the propaganda value in these rulings.
You
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So your position is that electronic manipulation of text is impossible on the federal level?
And no, the standard or requirement by law is not redact. It is de-identify. This standard is spelled out in 45 CFR 164.514 . It even contains provisions for substitute identifiers and the ability deconstruct those to protected patient identifying information. This is something suited to digital processing quite well with some human proof reading added on.
Furthermore, compliance with a court order is actually an exe
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So your position is that electronic manipulation of text is impossible on the federal level?
It's not a "position," it's the way things work, and no, that is not what I said.
What I did say is right there, above. You don't actually have a question. And a judge cannot grant an "exemption" to a statute; if you obey the ruling, then when that ruling gets tossed out on appeal, oh look, you broke the law!
Judges can't write laws.
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You should really read the law instead of just guessing. The law itself has an exemption to a judicial order. Compliance with a judicial order absolves the person the order was issued to and removes the de-identifing requirements. The order in this case doesn't appear to go that route though.
And yes, I was being hyperbolic suggesting your position. It doesn't seem to follow logic, law, or fact so I figured I would suggest how silly it was. Even your response is completely ignorant of the actual law involve
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Nope, in this case it involves redacting patient data, so you need either trained medical record specialists, or lawyers.
I had to redact medical record data all the time as a software engineer for a major healthcare information systems vendor. I was not a medical records specialist nor a lawyer. I had a few 1 hour training classes.
I also will bet that a lot of these records are reams of tabular data. So you just would need to determine what columns contain PHI, and black those out and be done with a 10,000 page report or whatever. There's obviously more to it than that, but you analyze things at the report level, not line by
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I had a few 1 hour training classes.
I signed on as a contractor for McKesson several years ago, and I had to take several tests to determine how to handle personal health information and even potential personal health information. The tests were uniformly, stupidly simple, and I had never worked in the health care field at all. I took the tests without bothering to watch the video lessons. They were something like this (not verbatim, just making a point):
Your friend Bob finds out you have access to patient information, and wants to discuss hi
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This isn't even remotely unreasonable.
Dammit, I missed an opportunity. That SHOULD have read:
"This isn't even remotely unreasonable. In fact, it's super easy; barely an inconvenience."
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No, but you can get people from Department A to perform the administrative secretary duties normally performed by the people doing FOIA requests
You realize the people "doing FOIA" only "do FOIA", right?
Here's how many FOIA requests the FDA receives per month: https://www.accessdata.fda.gov... [fda.gov]
The last reported month (Sept 2021) was 773 requests, and it was pretty normal.
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Thank you. Came here to say something similar. People have no idea what it takes to do a FOIA request. You can't give Bob from accounting a stack of papers and say, "Start marking them."
Of course you can, just like you can get nine women to produce a baby in one month. All you need is a judge to make a ruling that it has to be so and bingo!
Why doesn't the Requestor pay? (Score:2)
It does not seem unreasonable that requesting 450,000 pages of information is a cost that should be covered by the people asking for it. This way government can just hire and train the extra staff to handle these requests.
Re: Why doesn't the Requestor pay? (Score:2)
Then they can allocate some of the billions given to these companies to process a foia request. Or should we allow government to operate in a vacuum?
yo genius (Score:2, Informative)
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Re:yo genius (Score:4, Insightful)
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I remembered reading this comment when the story first broke, which points out just a couple edge cases that would need to be considered. There are many, many more, which is why it's such a difficult problem.
https://science.slashdot.org/c... [slashdot.org]
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the question is whether an automatic process can be created that is as good as or better than humans
No, the question is whether humans can cooperate with machines or are we cursed with falling between two stools.
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I think a lot of people have the impression this is more like clearing information for national security risks or something where it needs to have the context evaluated by thirty departments and lawyers and so on.
I think maybe the real reason might be to run interference over problematic discoveries or something. A simple "sed -i 's/John doe/patient/g' case.file" type of command could easily be constructed to redact identities. Of course it isn't that simple- it's just a simple example of how simple it c
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If the records were designed for anonymization, it would be as simple as "export this database without that table and this foreign key".
And if my Aunt had balls she'd be my Uncle.
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Apparently your brain is numbed by Fox news. It's the new opiate for the Trump-lovin' fuckwits in our society.
Yeah, this will help. (Score:2)
does not have any other important work to do
Well placed sarcasm.
The FDA is amazingly overwhelmed right now. They are reviewing data from other COVID vaccines, data from other COVID vaccine studies for other age groups, reviewing literally hundreds of COVID diagnostic tests including the OTCs. And that is on top of the typical workload of regulating a large fraction of the US economy https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance [fda.gov].
Additionally the FDA is having a hard time hiring and keeping qualified employees like all other employer
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Re: Because every employee is interchangeable (Score:3)
Call to exaggeration much?
500 pages a month is less than 25 pages a day. That's 3 pages per hour. One every 20 minutes. Up for review. That's not even a full-time position, at 20 minutes per page I'd probably be able to do my regular job on the side!
Is 1 person, out of 18,000 plus change, really the only one who can review FOIA material? Part time?! GTFO.
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Yes, because as we all know, there is only one FOIA request at a time.
Re: Because every employee is interchangeable (Score:2)
Well, how many are there, how many pages to they have, and how long does it take, on average, to review a page?
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The last month the FDA has reported data (Sep 2021), there were 773 FOIA requests.
https://www.accessdata.fda.gov... [fda.gov]
500 pages a month is actually fast for FOIA requests. If you'd like to change that, call your Congresspeople.
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The last month the FDA has reported data (Sep 2021), there were 773 FOIA requests.
If that takes 773 people, that still leaves well over 17,000 to choose from for the vaccine FOIA request.
500 pages a month is actually fast for FOIA requests. If you'd like to change that, call your Congresspeople.
I don't need to. Apparently a judge already took care of that. What I'm trying to show is that it's not unreasonable to request that it be done faster, like you implied.
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If that takes 773 people, that still leaves well over 17,000 to choose from for the vaccine FOIA request.
The FDA does more than handle FOIA requests. The other employees are not available. They're busy doing things like reviewing other COIVD medications.
I don't need to. Apparently a judge already took care of that.
The judge can't appropriate money, only Congress can. His ruling appropriates money. His ruling is going to be thrown out because it's illegal for the FDA to comply with it.
What I'm trying to show is that it's not unreasonable to request that it be done faster
It is not unreasonable if you have Congress appropriate the funds to hire more FOIA examiners. Without that, no you can't just abandon everything else the FDA does to service one fishin
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No.
Fed agencies don't get a pass.
They know damn well what it costs to process a FOIA request.
They deliberately under-fund the process to evade responsibility and transparency.
I'm glad there are still some judges that will hold the Feds to their responsibilities to the People!
Public Health and Medical Professionals... (Score:3, Informative)
So here's a link to their site [phmpt.org], in case anyone was wondering.
Some of the doctors hail from the theory of non-specific effects of vaccines research. Such as Peter Aaby who has this wonderful piece [nih.gov] under their name. Which digging in on all of that wonderful stuff leads to this WHO study. [who.int]
The six studies with very high risks of bias produced highly variable results, and do not contribute to our conclusions or GRADE assessments.
Phew. Yeah the group states.
Making the information public as soon as possible may help assuage the concerns of vaccine skeptics and convince them the product is safe
Look up a lot of these doctors with the group, they want anything but that.
Now there's a couple of doctors in this group that are just the hyper-critical think kind. Whatever the group think is, they just exist to say the opposite. And whatever, such is their lot in life. And to round out the group, there's a few in there are just quacks with a PhD.
At any rate the whole.
the FDA as of 2020 had 18,062 employees. Surely some can be dispatched to pitch in at the FOIA office.
Tracks with this group because the lot of them think that someone with little to no medical training can just go be a doctor.
At any rate. Judge can't squeeze blood from a rock. If the FOIA office is under staffed then it's under staffed and this group that "just wants information to be free" should spend less time in a courtroom and more time lobbying Congress for more funds to hire employees.
Which that's another fun thing. The fact that the FOIA is understaffed there comes as a shock to zero people. The government (yes, it doesn't really matter which political party is in charge. It may only move the needle just a hair one way or the other) is notoriously bad at being transparent. The nice thing however, is that the vast majority of what these people are seeking is things that they themselves can go check out, it's just they won't. Because they just want to make noise that eventually will be ignored by 99% of the population. And the 1% that will listen to this group, well they weren't going to believe in anything "Big Brother" had to say anyway.
All in all. This is literally the same thing that's been going on for the last thirty plus years since the US passed the 1986 NCVIA. It's neat that Slashdot is highlighting it, but this kind of stuff has been playing out for decades and if history is any lesson. The FDA will publish that information somewhere between when they've been ordered and two Presidents from now, court be damned. This group will get that information, make a big stink about some really obscure point buried 160,000 pages deep, ultimately nobody will care, the group will see that nobody gives a fuck and move on to the next "on TV" medicine to kick dirt on, and the cycle repeats. Money will be wasted, time will have been wasted, nothing new ever came to light, and nobody will change their already established position. *slow claps all around*.
I'm not calling anyone the bad guy, but I find this Sisyphus style cat and mouse that gets played out to be an interesting way we waste taxpayer money. Government should absolutely be more transparent, don't get me wrong, this understaffed FOIA is absolutely not an "Oh no! If only we could hire more people!". But the people wanting this FOIA has zero people's best interest in their mind.
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FOIA requests are the only mechanism which American taxpayers have to get to (some of) the truth in government.
This kind of under-staffing cannot be accidental.
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> What percentage are tasked with producing the carefully edited, approved, and not necessarily truthful communications which the FDA provides to the public?
To calculate that, you divide the headcount of their communications department by their total headcount, then multiply by 100.
This lesson in elementary math, brought to you by grade school.
> FOIA requests are the only mechanism which American taxpayers have to get to (some of) the truth in government.
Right. Because our society doesn't have any ch
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Beautifully stated on all counts.
If anyone thinks that these folks are going to carefully read all the pages of data and then give an unbiased assessment and announce the vaccine is safe...well I hate to disappoint. I predict they get the entire document, throw up their hands and complain that something-something-something ISN'T THERE and they can't be bothered to read the rest. Flash forward about 2 hours and they declare that the difficulty in interpreting the data PROVES that the vaccine is unsafe and th
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A judge however can order the FDA to break the law, since by the nature of a court order, it isn't against the law.
Wrong.
A judge can't order random people in his court to violate laws the judge doesn't like. What a judge can do is find a law to be invalid if there is a case brought to the court that challenges the law.
If the plaintiffs would like to bring a case claiming that HIPAA does not apply to the patients in the study, the judge can rule on that. I guarantee any ruling that HIPAA does not apply will be tossed out on appeal because it is blatantly obvious that it does apply.
FDA bad at math (Score:5, Insightful)
Of course, a flat 8 minutes per page is absurd considering the vast majority of the data is in formats other than a flat image of a piece of paper. The vast majority of the data in question is in some structured format or other which can easily be redacted using automated means. Put a week of work into proper redaction software and you could dump 100k's of pages in a few hours. The concept of somebody sitting there with a black pen marking out people's names is just ludicrous, but that's literally what they're talking about doing until the next century.
Put your money where your mouth is (Score:5, Insightful)
Put a week of work into proper redaction software and you could dump 100k's of pages in a few hours.
Think so? You should slap that software together and sell it to the FDA then.
Don't forget to sign the indemnification agreeing to take personal responsibility for any errors -or are you suddenly not so sure it's that easy to get right?
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Put a week of work into proper redaction software and you could dump 100k's of pages in a few hours.
Think so? You should slap that software together and sell it to the FDA then.
Don't forget to sign the indemnification agreeing to take personal responsibility for any errors -or are you suddenly not so sure it's that easy to get right?
That would be assuming people get it right all the time and they don't. They often redact things that have no business being redacted and don't redact things that should be redacted. If you don't hold them personally responsible then why hold him personally responsible?
Better yet - just turn it all over. No redacted parts.
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The vast majority of the data in question is in some structured format or other which can easily be redacted using automated means. Put a week of work into proper redaction software and you could dump 100k's of pages in a few hours.
Dude Federal government already contracts out to a lot of different organizations for this. Good example is OneTrust [prnewswire.com]. That said, I bet you could name one agency within the US Federal Government that's been passed up on funding for procurement of automation redaction.
I get it seems like this should be a no brainer, but I know this might come as a shock so you may want to sit down for this. Some agencies are woefully underfunded in the US Government and just get told "No" when they ask for seemingly obviou
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If it takes 8 minutes to redact a page, a single employee can put out 60 pages per 8-hour shift. At approximately 21.5 work days per average calendar month, that's 1290 pages per month for a single person. If they only have the 10 workers claimed, that's 12,900 pages per month.
Remember lunch breaks, meetings, other projects, paperwork, and all the other annoying but necessary stuff that prevents 8 hours of on-task work.
Not to mention the fact that they have more than just that single FOIA request.
The assertion that they should only have to put out 500 per month is absurd, and the requirement of 55,000 per month is easily possible with the addition of 30ish more workers.
Assuming it scales linearly, which virtually nothing does.
Of course, a flat 8 minutes per page is absurd considering the vast majority of the data is in formats other than a flat image of a piece of paper. The vast majority of the data in question is in some structured format or other which can easily be redacted using automated means. Put a week of work into proper redaction software and you could dump 100k's of pages in a few hours.
Ummm, what do think redaction means? Are you under the assumption that they wrote all the secret stuff in Italics so you just need a little filter to detect and black out italicized text?
I don't know all the rules around redaction
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If it takes 8 minutes to redact a page, a single employee can put out 60 pages per 8-hour shift. At approximately 21.5 work days per average calendar month, that's 1290 pages per month for a single person. If they only have the 10 workers claimed, that's 12,900 pages per month
1) By your math, it will take 34 months with the 10 employees. 2) You are assuming that the FOIA employees has nothing else to do. I'm pretty sure this is not the only FOIA request the FDA has now or will every have.
The assertion that they should only have to put out 500 per month is absurd, and the requirement of 55,000 per month is easily possible with the addition of 30ish more workers.
1) I'm pretty sure the FDA like most government agencies has a budget and a hiring process. They cannot hire 30+ more people just because you think they can do something faster. At a minimum they will have to go to Congress to get a bigger budget. 2) What is the hiring process for a FOIA inspect
Re: FDA bad at math (Score:2)
This is so much fun watching the naÃve "big gov bad, privacy good" crowd on /. crashing so hard into reality.
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Trump, who appointed this judge, understands that public safety
Perhaps 10 isn't the right number (Score:3)
I suspect the FDA has a lot of documentation that probably should be in the public domain whether FOIA'd or not. Ten people can't monitor it all or perform the sorts of assessments needed.
In consequence, I suspect that department probably should be a lot larger anyway.
550x larger? Probably not, that's likely excessive, but they'd more likely get somewhere on appeal (IMHO) if they'd show willing to at least attempt to do as much as possible without diverting their entire budget to that one task.
assuage the concerns of vaccine skeptics (Score:2)
no it won't.
that's the whole problem with "vaccine skeptics"
They are not being skeptical is good faith, they're conspiracy theorists.
The evidence just doesn't matter. They'll move the goalposts or will take information out of context to support their claims.
Remember when the investigation of the climate change emails found that they had used a "trick" ?
Didn't Richilieu say something about "find me lines written my an honest man and i will find something with which to hang him" ?
Now they have 450,000 pages w
Re: assuage the concerns of vaccine skeptics (Score:2)
Which vaccine are you talking about. I donâ(TM)t hear anyone saying anything skeptical about sinovac, covaxin, novavax etc yet they still have not been authorized due to dubious data. Yet the Pfizer and Moderna vaccine data has not been released and we are left to look through VAERS. Sounds like the people have a right to be skeptical about specific mandated vaccines when other governments find value in all of the vaccines I mentioned.
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You use the word "mandate" but you appear not to know what it means.
Jenna Greene is dreaming. (Score:1, Troll)
"Even if the FDA may not see it this way, I think Pittman did the agency -- and the country -- a big favor by expediting the document production," writes Reuters' Jenna Greene. "Making the information public as soon as possible may help assuage the concerns of vaccine skeptics and convince them the product is safe."
No, no it won't. These "skeptics" are the same brand of idiots that deny climate change. You can give them all the information in the world and they won't even take a look at it. What we are dealing with isn't skepticism, it's anti-intellectualism. This means they put the same level of trust in a scientist as they put in a conspiracy theorist. Beyond that, most already believe bullshit about scientists having a vested interest.
There is absolutely nothing you can do to change their minds. We're better
at this point the judge should order them (Score:1)
to just dump the data raw, no reviewing or redacting.
If someone already had the time to *write* 450,000 pages knowing it was eventually going to have to be published...
who cares if it's a first draft--just dump the file already and be done with it.
Re: at this point the judge should order them (Score:2)
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If someone already had the time to *write* 450,000 pages knowing it was eventually going to have to be published...
Except that is not remotely true. Some of pages are medical notes which no one writing it would think it would be published.
Re: at this point the judge should order them (Score:3)
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That is the problem then. This kind of study data should always be anonymous and never contain personal information in the first place. No redactions should be necessary because of privacy concerns
So how do they find the study participants later to check things?
Hey look like it turns out if someone has xyz then the vaccine might kill them. Lets see if anyone else who has xyz is dead. Oops we can't because we don't know who the people are anymore.
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You could pre anonomize the data so you would be able to find out all the patients with xyz but what you would get back is a something like PAT:9238457293 which you would then need to look up to get the actual person. Then when the FOIA request comes in you just don't give them the lookup table to de anonomize the data.
That said I am sure that given this FOIA request is disingenuous in the first place they would not be happy with that.
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divide the work (Score:3)
If they divide the work evenly among the 18000 employees and each employee works at the 8 min/page rate, this could be done in 3 and half hours.
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Sarcasm is incredibly difficult to detect these days. You're either joking or fishing, I assume?
If you're fishing, that's some high-quality bait.
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If they divide the work evenly among the 18000 employees and each employee works at the 8 min/page rate, this could be done in 3 and half hours.
Yes because all people for work for the FDA 1) have nothing else to do 2) are qualified to analyze a document for FOIA requests on vaccines. For example, all the food inspectors who work in different states, should stop all food inspections and do FOIA requests for vaccines (a field which has nothing to do with food safety). All the research scientists working on medical devices should also do FOIA requests on vaccines even though they have no idea what to do. All the accounting, HR, payroll, administrative
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Right, exactly, for half a day. Does it take special skills to black out personal information? Because personal information of trial participants is the main issue here.
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Is it any more idiotic than saying it will take 10 people 75 years?
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https://www.cadc.uscourts.gov/... [uscourts.gov]
We can expect it from non-expert people that work in the courts.
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Re:divide the work (Score:4, Insightful)
Human work is rarely perfect, especially at a scale of 450,000 reviewed pages. Publishing the data that the FDA relied on to make decisions that affect millions of people is beneficial to society, let the record speak for itself. If we want people to trust in science then I think being transparent is the only way to get there. Its not about 'catering to antivax lunatics', its about showing them the facts. I think there is a fair point made that the government spent billions in public funds and the public has a right to know what came of that spending.
My original statement is just as lame as saying it will take 75 years to release all of the documents. Did I really mean that the FDA should drop everything and do only this? No. Is it reasonable to give each employee 25 pages and 3 weeks to review them, where they spend less than 10 minutes a day on it for 3 weeks? Yes, and that would get the work done in a month without too much interruption.
There are perfectly reasonable ways to review and release the documents in question, and doing so is beneficial - no matter your political or religious take on the matter.
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Is it reasonable to give each employee 25 pages and 3 weeks to review them, where they spend less than 10 minutes a day on it for 3 weeks? Yes, and that would get the work done in a month without too much interruption.
No it is not reasonable to give a meat inspector 25 pages of vaccine data and him/her to do a job for which they have no training or idea anymore it is reasonable to give a web page programmer your company books and ask them to balance the books for this quarter. I am sure no mistakes will be made and the IRS will be forgiving.
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Publishing the data that the FDA relied on to make decisions that affect millions of people is beneficial to society, let the record speak for itself. If we want people to trust in science then I think being transparent is the only way to get there. Its not about 'catering to antivax lunatics', its about showing them the facts. I think there is a fair point made that the government spent billions in public funds and the public has a right to know what came of that spending.
The point you missed is that this request has nothing to do with that data. That data is available already and has been published. This request is for EVERYTHING ELSE, and the requesters are not going to limit what they want despite repeated inquiries by the FDA. Imagine if a government agency did that you? The IRS has an issue with your tax return. Rather than tell you that there is a question about travel expenses, they want every receipt, bank record, credit card statement, depositions from every employe
Transparancy! (Score:2)
No mandatory vaccines till FOIA completed? (Score:2)
What if judge ordered that FOIA must be completed before that vaccine could be mandated or required of anybody?
Would that light a fire under the powers that make decisions?
Or that this kind of data has to be published to the public before full approval is granted -- that kind of makes sense to me.
I would have thought data like this that is destined to become public would have public/private identification as part of its creation and approval at least at the paragraph-levels for quick release to the public.
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You're drawing the wrong conclusion. There's no constitutional authority to mandate any vaccine.
Major trade secrets or major lies? (Score:1)
If the medical community is after its data, why it has to be reviewed and cannot be shared as is, since it came from health industry to health advisors about health data? If the provided documentation, made by a third party company to the US government, as a way to find a solution for a global problem, needs that much work to be released, does it means it is that full of trade secrets, or they will have to redact an insanely amount of lies used to get the emergency approval?
Even worse, perhaps nobody from F
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The "medical community" is not after this data. Conspiracy theorists, some of whom have some kind of medical background, are after this data and have no intention of actually reading it. Or at least not reading it in good faith. If the documents don't mention that Trump is fabulous, they're going to toss the entire pile in the trash and claim that the entire study was written to make Trump look bad and therefore cannot be trusted. Or something equally ridiculous.
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Yeah, so I just went ahead and did a quick Google search on that Yale doc (since you mentioned Yale by name it seemed a convenient place to start) and his activities don't seem to live up to that lofty impartial seeming header on their non-profit website:
"This nonprofit, made up of public health professionals, medical professionals, scientists, and journalists exists solely to obtain and disseminate the data relied upon by the FDA to license COVID-19 vaccines. The organization takes no position on the data
They can't be convinced (Score:1)
"assuage the concerns of vaccine skeptics and convince them the product is safe"
If that's the reason, don't fucking bother; NONE will change their minds.
Obvious problem witth FDA's position... (Score:2)
The same agency that told a judge there was so much documentation to read and absorb/process that it would require 75 YEARS before they could release it to the public, claims to have reviewed all the documents and approved the experimental new drugs in less than twelve months...
People really need to pay a LOT more attention to all the crap that people in positions of political power, in ANY political party, shovel, and notice all the insane and illogical nonsense they expect us to absorb. The non-elected ca
Speeding it up is pointless (Score:2)
"Making the information public as soon as possible may help assuage the concerns of vaccine skeptics and convince them the product is safe."
The resulting docs could demonstrate that Pfizer had discovered that the vaccine prevents cancer and makes blowjobs 75% more enjoyable for both parties involved. Skeptics would immediately bash Pfizer for concealing potential serious side effects from the public.
Holding administrators in custody (Score:2)
Until their department produces what is thought to be producible. IIRC that was done in the past when it was thought that lawful orders to produce documents weren't taken seriously.
Might have been done by a Congressional Committee though.
Follow the money (Score:2)
Secret docs (Score:2)
I learned the hard way long ago that FDA requires submission of documentation from drug companies which the companies consider to be "trade secrets." Consequently, FDA will not release that info to the public without a FOIA request.
For example, if you want to know how drug A performed in a trial against drug B, and this study was funded by a drug company looking to get either drug approved, you will need to submit a FOIA request to FDA. In accordance with law, they will act on it within a decade or two.
All Snark Aside... (Score:3)
The judge can order the agency to do something. The agency then has to choose how to do it, or with DOJ to appeal. Other agencies have gotten similar orders in the past, resulting in major disruption to normal operations - environmental agencies were prime recipients in the past, resulting in redeployment of internal staff and near-shutdown of permits and other normal operations. Yes, FDA could do the same thing, but would technically be violating the law in other ways and would delay, perhaps for a long time, review and approval of other drugs and vaccines (including updates of the Covid vaccines to cover new variants). Of course, this could be one of the goals of the litigants here.
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Trump lost the last election, got the jab himself, and encourages others to get the jab as well. It's silly to think he has anything to do with any of this.