UPDATE: Broad 329,000-Page Document Request Led to FDA's 2076 'Scheduling Dispute' (snopes.com) 443
UPDATE: While one group of physicians has complained that the FDA is slow-walking the release of vaccine-approval documents, Snopes.com points out you can also see this story from a different perspective:
A scheduling dispute related to a Freedom of Information Act (FOIA) request for more than than 329,000 pages of COVID-19 vaccine data led to misleading social media posts in November 2021. The U.S. Food and Drug Administration (FDA) proposed a schedule to process and release 500 pages every month, arguing that this is the standard rate to process FOIA requests as "reviewing and redacting records for exempt information is a time-consuming process." The FDA would start releasing this data immediately, but the full set of pages would not be processed until 2076. The FDA argued that the amount of time required to fulfill this request is due to the broad FOIA request that involves hundreds of thousands of pages.
Snopes emphasizes that the FDA "did not request a delay in the release of its COVID-19 data until 2076," and notes they were responding to a request for the 329,000 pages in just 108 days with a very small number of qualified respondents. "Courts do not waiver from the standard 500 page per month processing rate even when a FOIA request would take years to process..." [reads the FDA's response]. "FDA has invited Plaintiff to narrow its request by specifying records it no longer wants FDA to process and release, and Plaintiff has declined to do so. If Plaintiff decides to request fewer records, then FDA will be able to complete its processing at an earlier date."
Snopes adds that the scheduling issue will be settled by a U.S. district judge next month.
Slashdot reader schwit1 had shared this report from Substack, written by Aaron Siri. He is the Managing Partner of Siri & Glimstad, a law firm representing the plaintiffs in the case. From the report: The FDA has asked (PDF) a federal judge to make the public wait until the year 2076 to disclose all of the data and information it relied upon to license Pfizer's COVID-19 vaccine. That is not a typo. It wants 55 years to produce this information to the public. As explained in a prior article, the FDA repeatedly promised "full transparency" with regard to Covid-19 vaccines, including reaffirming "the FDA's commitment to transparency" when licensing Pfizer's COVID-19 vaccine.
With that promise in mind, in August and immediately following approval of the vaccine, more than 30 academics, professors, and scientists from this country's most prestigious universities requested the data and information submitted to the FDA by Pfizer to license its COVID-19 vaccine. The FDA's response? It produced nothing. So, in September, my firm filed a lawsuit against the FDA on behalf of this group to demand this information. To date, almost three months after it licensed Pfizer's vaccine, the FDA still has not released a single page. Not one. Instead, two days ago, the FDA asked a federal judge to give it until 2076 to fully produce this information. The FDA asked the judge to let it produce the 329,000+ pages of documents Pfizer provided to the FDA to license its vaccine at the rate of 500 pages per month, which means its production would not be completed earlier than 2076. Further reading: FDA Wants 55 Years To Process FOIA Request Over Vaccine Data (Paywalled Reuters story)
Snopes emphasizes that the FDA "did not request a delay in the release of its COVID-19 data until 2076," and notes they were responding to a request for the 329,000 pages in just 108 days with a very small number of qualified respondents. "Courts do not waiver from the standard 500 page per month processing rate even when a FOIA request would take years to process..." [reads the FDA's response]. "FDA has invited Plaintiff to narrow its request by specifying records it no longer wants FDA to process and release, and Plaintiff has declined to do so. If Plaintiff decides to request fewer records, then FDA will be able to complete its processing at an earlier date."
Snopes adds that the scheduling issue will be settled by a U.S. district judge next month.
Slashdot reader schwit1 had shared this report from Substack, written by Aaron Siri. He is the Managing Partner of Siri & Glimstad, a law firm representing the plaintiffs in the case. From the report: The FDA has asked (PDF) a federal judge to make the public wait until the year 2076 to disclose all of the data and information it relied upon to license Pfizer's COVID-19 vaccine. That is not a typo. It wants 55 years to produce this information to the public. As explained in a prior article, the FDA repeatedly promised "full transparency" with regard to Covid-19 vaccines, including reaffirming "the FDA's commitment to transparency" when licensing Pfizer's COVID-19 vaccine.
With that promise in mind, in August and immediately following approval of the vaccine, more than 30 academics, professors, and scientists from this country's most prestigious universities requested the data and information submitted to the FDA by Pfizer to license its COVID-19 vaccine. The FDA's response? It produced nothing. So, in September, my firm filed a lawsuit against the FDA on behalf of this group to demand this information. To date, almost three months after it licensed Pfizer's vaccine, the FDA still has not released a single page. Not one. Instead, two days ago, the FDA asked a federal judge to give it until 2076 to fully produce this information. The FDA asked the judge to let it produce the 329,000+ pages of documents Pfizer provided to the FDA to license its vaccine at the rate of 500 pages per month, which means its production would not be completed earlier than 2076. Further reading: FDA Wants 55 Years To Process FOIA Request Over Vaccine Data (Paywalled Reuters story)
That is pretty much insane (Score:3, Insightful)
Even if there is nothing suspicious in the data, speculation and conspiracy theories will not run rampart while the pandemic is still going strong. If they could have made a worse move, I do not know what it is. Well, they could have asked for 100 years or more.
Re: That is pretty much insane (Score:5, Insightful)
One thing worse they could've done is said it's a "national security matter" and the congress will habe to vote on the release of information after those 100 years have lapsed.
Re:That is pretty much insane (Score:5, Informative)
It would be insane if the article wasn't so misleading.
First of all, let's be clear about what the data they are requesting here. It's likely mostly patient data from the clinical trials and must be redacted:
"such records can be expected to contain both confidential business and trade secret information of Pfizer or BioNTech and personal privacy information of patients who participated in clinical trials. FDA is required to protect certain information under the law and this type of information is exempt from production under the FOIA."
Public Health and Medical Professionals for Transparency requested "more than 329,000 pages" of information. It takes time to redact medical records properly and this is a lot of medical records for more than 44,000 people. The trial data likely has the complete medical history of all the participants. If you were in the trial, I don't think you would want your medical records redacted quickly.
Secondly, the FDA isn't waiting until 2076 to release the data. The FDA will release the data at the rate of 500 pages per month, but it won't be done until 2076.
That said, I think this is of sufficient public importance that spending a lot of public resources to get the data out there quickly would be worthwhile. To do this quickly would likely require congress allocating the FDA a lot of resources to redact the data.
The article and lawsuit are from anti-vaxxers who are looking for more ammunition. These are the people:
https://phmpt.org/ [phmpt.org]
Examples:
https://www.medpagetoday.com/s... [medpagetoday.com]
https://www.nydailynews.com/ne... [nydailynews.com]
Re:That is pretty much insane (Score:5, Interesting)
I filed a FOIA request in January for information related to a previous submission to the FDA's Center for Veterinary Medicine. The documents I was requesting were submitted to the agency back in the mid 2010's, and had already been released to someone else under a FOIA request previously. However, it still took until yesterday for them to release the documents to me. I didn't even get anything beyond an automated response until about 2 weeks ago, when someone asked me to clarify my request and possibly narrow he scope of my request. This is actually the 2nd time I've requested information via FOIA from FDA CVM, and it was actually faster than the previous request (over a year before anyone responded, and about 2 months after that before I had everything I'd requested).
FOIA document releases are slow because:
1) they are short staffed. When I made my first FOIA request there was not even a single employee assigned to do the job. It wasn't until someone sued the agency that they started filling positions in their FOIA office again. And even today, they don't have a large staff
2) There's a rather large back-log The FOIA requests kept coming in when the office was unstaffed, and they started with a huge back-log, which has never really come down. That is why it took almost a year to essentially send me something they had already prepared for someone else. If I'd needed them to review new documents for release, then it would have taken almost a year to start my request, and additional time to review all of those new pages for unreleasable information.
3) they have to very careful in what they release They are prohibited from releasing proprietary information or personal medical records. That requires every page be viewed individually and redacted to the extent necessary under the disclosure laws. As someone else pointed out, medical records are a large part of a vaccine trial disclosure to the agency, and as a result, that's a lot of pages where next to nothing will be released. However, they do not get to simply say "these 100 pages are redacted". They need to redact the specific information on each page individual, which takes a lot of man-hours. And since they are under-staffed, and over-worked already, it's not surprising that they'd request a page rate they believe they can manage.
Hopefully the courts will reject this document delivery pace. That will force the agency to allocate more resources (salaries and bodies) to the FOIA office, and speed up releases for everyone requesting information in the long-run.
Re:That is pretty much insane (Score:5, Funny)
1) they are short staffed.
Not sure taller employees would make any difference... :-)
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The Agency missed some statutory deadlines for different parts of the new rules to come out. They were sued, and new deadlines were issued b
Re:That is pretty much insane (Score:4, Insightful)
You're not very familiar with how the FOIA works. You used the process, but you didn't even read the FAQ.
The deadlines are for small requests.
If they had to hire people... the people requesting the data would have to pay those costs. In the case of medical records, we're talking about hiring full time lawyers.
The Judge is not part of the Executive Branch, and has very limited powers to require than they hire people. A ruling of that sort would be appealed, and tossed out.
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Mod Parent Up (Score:3)
And you can't even say the comments section took care of it. dszd0g's comment isn't even one of the top modded comments, so unless you click "show all comments" you don't see it, you mostly see anti-vax comments and then one guy pointing out that the anti-vax guys will have a field day with this.
The editors should be ashamed of themselves.
Re: That is pretty much insane (Score:3, Interesting)
Are you suggesting parent is serving as a PR person for the FDA, trying to do damage control? If so, I'm surprised to have someone from the FDA here in a /. comments section.
I agree with the parent's point about redacting. I was wondering why there are so many pages of data, but of course, medical records. However, There has to be a middle ground here. First, do plaintiffs really want the actual medical records, or more abridged results? It seems to me that the FDA could get the most important non-identif
Re: That is pretty much insane (Score:5, Informative)
A few years ago I was working with a clinical trial report for a new animal drug that ran to 23,000 pages - for five (5) subject animals. Drug development processes that reach clinical trials generate an amount of records that can be staggering. And often a lot of it is captured with paper-and-pen and scanned as images (e.g. field records from the trial ).
Re: That is pretty much insane (Score:5, Insightful)
I would deny the request and give them 6 months to fully redact the report and release it. If they need 10 guys to sit there to do it, I am sure they have the manpower.
The math: 329,000 pages /10 people / 6 months / 28 working days a month / 8 hours / 60 minutes = 0.4 pages per person per minute. And that is assuming this is the only request they work on for the next 6 months. I am pretty sure this is not the only FOIA request the FDA has.
We taxpayers give them 15,000 employees
Not everyone who works in the FDA works on FOIA requests just like any other organization different people do different jobs. That is like saying everyone at Intel works in the fab making chips.
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Have you ever actually seen a medical record? I'm guessing no. I have seen mine. Everything from before maybe 8 years ago is a SCANNED IMAGE of hand-written notes. And as an example, mine contains a line like this (hand-written in doctor scrawl) - (my name) states was admitted to (name of hospital) between (dates) for (reason). According to HIPAA rules, the 'my name', 'name of hospital' and 'dates' (except for the year portion) must be removed. The 'reason' can stay because it may be important. Now,
Re: That is pretty much insane (Score:4, Interesting)
They are scanned images because that is what the doctors provide when they transfer a medical record.
The point you (and lots of others) seem to be completely missing is that MOST of the time they don't need those records. They collect the records from everyone at the start of the trial, so they know they have them available. Then, if during the trial, say 50 people develop some weird reaction, they can look at THOSE records (just as they received them) to see if they have something in common (maybe a medicine or prior illness). All the rest of the records may never be looked at. Doing something to 'convert' all those records into some sort of database would be nothing but a huge waste of resources.
Then, when they go for approval they turn over ALL the stuff they have to the FDA, including things they never looked at because the FDA may still want to look at it. Again, the FDA is certainly not going to transcribe all that stuff, it would just be another waste of resources.
Re: That is pretty much insane (Score:5, Informative)
Re: That is pretty much insane (Score:5, Interesting)
Medical record deidentification is nowhere near as simple as you make it. There are countless edge cases that make automation seemingly impossible.
For example, your suggestion of automatically redacting name, address, and phone. Seems like a simple no brainer, right. Easy enough when it's in a field labelled "name". But names also get embedded in pages and pages of free text narrative. So you've got to read through all that and redact it to. Now a smart programmer would say "but this is so simple. I can just automate a search and replace". Genius. Except for the fact that the narratives often contain the names of diagnoses, procedures, tools, techniques, and other terms (collective, I'll call "things"). Many of these "things" are named after the person that invented them. The problem is, when a patient has one of these "things" documented in their narrative, and that "thing" happens to be the same name as their own name. When you redact it, you actually reveal exact what you've redacted.
To give a basic example, suppose a patient came in, unconscious and with no identification. In the narrative the nurse mentions "John Doe was admitted with cranial trauma". Later on the patient is conscious, identity is established, and the patient records updated. Except nobody goes back to change the "John Doe" reference (and in fact, you wouldn't want to, as noting the patient was unknown at the time is valuable documentation to establish timeline, like if the hospital were sued for not timely notifying family). Now you want to deidentify the record. Simple enough. Except the patient's first name in this case was actually John. You redact it, and now the narrative says "xxx Doe was admitted with cranial trauma". Anyone looking at that deidentified record can immediately know the patient's name is either John or Jane, and a quick check of the gender on the record will tell you which one of. So through the process of deidentifying, you actually just partially REidentified the patient.
Then there is the issue of famous/public people and events. If somewhere in the narrative the nurse refers to the patient as "the senator", you've just drastically narrowed down the list of potential patients, and it may be a simple matter of checking news reports and finding a story about a senator having the same procedure in the same time frame. Or even for a non-famous person, if the narrative noted that the patient was in a car accident and was found on the scene impaled by a ski pole, and there happens to be a news story about a car accident where the driver ended up impales by a ski pole...
Deidentifying medical record properly is an EXTREMELY difficult process. Near impossible to automate reliably, and you can't just throw money at the problem by hiring grunts, because the people deidentifying need to be carefully trained and experienced to look for these sorts of hidden potentially-reidentifying notes.
Re:That is pretty much insane (Score:4, Informative)
I tried to find out more about "Public Health and Medical Professionals for Transparency", but the only stuff that comes is up their own website (which is free of information) and the lawsuit.
The lawsuit says "numerous public health officials, media outlets, journalists, scientists, politicians, public figures, and others with large social or media platforms have publicly raised questions regarding the sufficiency of the data and information" which seems like a pretty big red flag. Of that long list, which includes people who have a lot of followers on social media(!), the only people really qualified to have an opinion here are the unspecified scientists.
They do go on to list some people who they seem to think are authoritative, but some of them clearly aren't. Like a professor of psychology. And as we have seen during the pandemic, just having a PhD in a medical science doesn't mean they aren't a crackpot.
Re:That is pretty much insane (Score:5, Insightful)
And here it is, Luckyo the anti-vaxxer getting to pretend he's the victim and that it's the evil government intentionally hiding stuff.
GP is bang on, the FDA is asking for the length of time it is because it doesn't have the resources to do it any faster. If it does that pulls resources from elsewhere. The anti-vaxxers know this, which is precisely why they file such lawsuits so that people like Luckyo can come here and say "See, the evil government", and play the victim by saying it's awful he's being called an anti-vaxxer, when, well, that's exactly what he is - a scientifically illiterate pleb causing drama and problems and controversy where there isn't any.
Fuck off Luckyo, your game is transparent, if you're too scared of needles to get vaccinated fine, but stop trying to justify the fact you're a pussy with some grand fucking conspiracy that doesn't exist. The only thing that's amazing here is that you duped enough mods into believing there's a genuine conspiracy here to mod you up, rather than recognising it for what it is - anti-vaxx drivel dressed up as legitimate controversy.
Re: (Score:2)
For those who haven't noticed yet, this is the standard of PR damage control of today.
1. Describe the task as supposedly daunting because you're trying the standard legal tactic of "drown the party seeking information in irrelevant information, so they end up looking for a needle in a haystack.
2. Argue that this is not your tactic of obfuscation, but something that other side specifically requested, i.e. it's not your malicious compliance, but other side's malicious request.
3. Accuse party of being "the side that is on the wrong side of history". In this case, "you're anti-vaccine".
It appears that the plaintiffs in this case are specifically seeking all this information, so it's hardly fair to accuse the FDA of trying to drown them in information via malicious compliance (let alone Slashdot poster 127522).
The rate of 500 pages per month is about half an hour per page if there's one full time employee working on it. For sensitive patient data, that's not that unreasonable an amount of time. Obviously the required could be cut in half with two full time employees, or cut into quarter wi
Re:That is pretty much insane (Score:4, Informative)
Let me guess - if they released less than the full amount of data you'd cry about a cover-up and things selectively missing? What other option do they have, other than to redact and release everything? And do you think they have an unlimited budget to hire a skyscraper full of people to redact this shit? It takes time.
So other than releasing less info, not releasing anything at all, or working through it as they can under the budget allocated to them by the United States Congress to comply with all relevant laws, what other options do you see? Or are you just bitching because you want to bitch and further a bunch of conspiracy nonsense?
Re:Did you read dszd0g's comment (Score:4, Informative)
I see what you're saying and mostly agree, but the problem with "they should spend the money" is that their budget, and line items in that budget, are laws.. They largely can't just reallocate funds from one place to another without Congress having a vote. So if you want them to "spend the money" then start writing your Congressperson.
Re:That is pretty much insane (Score:5, Insightful)
The poster above is very knowledgeable. You (Canberra1) are not.
Laws passed by Congress state that the FDA is not allowed to release much of the confidential and proprietary information that drug companies give to the FDA for review. Just because the FDA gets it, does not mean that you do.
Laws passed by Congress also state that the FDA is not allowed to release most patient data, just as hospitals and your doctor is not allowed to release that information.
And no, this is the 21st century, you can't just "run a black marker over names" and have everything be OK.
The people who have filed this FOIA request know full well that the FDA can't release all this data. But that is not what they really want anyway. What they really want is for the FDA to resist releasing this data (which they are legally required to do), so anti-science anti-vax nut bags can make a news story about it so that people like you become suspicious of the FDA, real science, and vaccines.
And you swallowed it hook, line, and sinker.
Re:That is pretty much insane (Score:4, Insightful)
A 'black marker' on 329,000 sheets of paper? Good one! You have heard of HIPAA, right? There are rules [hhs.gov] for de-identification of medical records, which have to be done for all the records of all 44,000 people involved in the study. I'm sure you could have it done in a weekend.
Re: (Score:3)
It's not difficult to redact patient data, assuming they have this data in a digital format (which they undoubtedly do, or they wouldn't have been able to review it in a reasonable manner). Assuming patient data is stored in a database, one merely has to create a bunch of unique IDs (one for each patient in the data), and replace the names with numeric IDs. If the data contains addresses, drop the house/street number and leave the city/state/zip code. "patient 20493 from zip code 75607" ought to be sufficiently generic to protect patient privacy while giving useful data.
No ZIP codes. There might be only a single patient from a given ZIP code, and now you have partially de-anonymized the data, and fully de-anonymized it if you happen to personally know that one person.
Re:That is pretty much insane (Score:4, Insightful)
This isn't 1947 when someone has to sit there with a felt pen and black out sensitive data one page at a time.
Actually, it is like that. I don't know where you (and other posters) get the idea that medical records are some sort of 'database' - they aren't. There may be PORTIONS of the record (like lab results) that are basically tabular, but the majority is just free-form text. And I can tell you from looking at my own records, everything from prior to 8-10 years ago is just scanned images of hand-written notes (in doctor scrawl). So yes, someone DOES have to read through every record and manually remove what needs to be removed - without missing anything.
Re: (Score:3)
Re:That is pretty much insane (Score:4, Informative)
Re: That is pretty much insane (Score:4, Informative)
Well, the first issue is that you aren't dealing with exhaustive medical history data for 45,000 people that were test subjects in a clinical trial for a drug. There's literally tens of thousands of pages of handwritten notes that were optically scanned. It's not as simple as dropping a column in a database and adding it back with bullshit data in it so you don't break the data model - each page of the hundreds of thousands of pages will have to be gone over, and then probably approved by another person.
Then, there's a problem that you're probably looking at lawyers and paralegals to do this work, as it's a minefield of legal liability. They're going to have to reconcile multiple laws with the shedload of data in order to release what they are legally allowed to. Now add on that the office that does this probably only has a handful of people working there, and already has a huge backlog of requests from a fuckton of unrelated malpractice lawsuits and other trial lawyer bullshit combined with an inflexible budget that is set by the United States Congress, and now you see where the delay comes from.
As it turns out, not all data problems are the same.
Re: That is pretty much insane (Score:2)
Re: (Score:3)
Re: (Score:3)
This is the update which says that they did NOT ask for an additional 55 years. The law as it stands says 500 pages a year. This is not an FDA request, that's what they get by default. FDA is asking the plaintiff if they want a smaller subset of papers which will be faster, and the plaintiff declines to respond.
The plaintiff is wording things such that it seems like FDA is deliberately dragging their feet even though they are following normal FOIA rules.
Re: (Score:3)
Justice Department lawyers representing the FDA note in court papers that the plaintiffs are seeking a huge amount of vaccine-related material – about 329,000 pages.
Re: (Score:3)
What a great way (Score:3, Insightful)
Re: What a great way (Score:5, Insightful)
Why do you think the request was filed? And who did the filing and is behind it?
Anyone who has ever dealt with pharmaceutical licensing and with FOIA requests knows that this world be nearly impossible to produce on short notice. The requesting lawyers most certainly do.
This request was made for exactly one reason: political gains for the ones funding this.
Re: (Score:3, Informative)
What part of protecting patient records do you not understand? It takes time for FDA personnel to redact properly. It isn't as though they can just send the files to a printer. In addition, the FDA personnel used for redacting won't be doing their regular jobs.
Re: What a great way (Score:5, Informative)
Re: What a great way (Score:2, Troll)
Anything they received but didn't use, is not subject to the request
Wrong. If it was in any way related to the decision then it's targeted by the Request, which was submitted that way on purpose. Much of the data is supporting evidence which wouldn't have been looked at specifically but still has to be present. For example, you can't just say "these two thousand people had no serious underlying medical issues prior to joining the trial," you have to actually submit the full medical questionnaire they filled out. Most of that data has to be anonymized and redacted before bei
Re: (Score:3)
Re: (Score:3)
I also seriously doubt anyone at FDA read all of the 329,000 pages Pfilzer provided, and that they actually used more than 10% of what they read as relevant to their decision.
The problem in the medical field (like many other fields) is that you often don't know what you will need until later, so you collect everything. A simple patient procedure may result in many GB worth of waveform data collected, a lot of which will probably go unused. But years later, some researcher may have a theory about how certain indications during a procedure can be indicators of an impending outcome. They can then go through the data and look for correlations to prove or disprove their hypothesis an
Re: What a great way (Score:3, Interesting)
Truth be told, anti vaxxers and conspiracy theorists would also go crazy if the request would be for 24 months...
Told ya so...!
Re: (Score:3)
Next conspiracy theory: anyone taking the vaccine will die in 75 years!
At this age of my life, I'll take it!
Re: (Score:3)
And if you did the same search 24 months ago, you'd get the same fucking results. Just the same as if you search for purple cabbage [google.com] you get page after page of pictures and recipes utilizing cabbage.
Do you know what a search engine does? And you anti-vax guys wonder why everyone thinks you are fucking morons.
"Trust the science," they said (Score:2)
Lack of trust in the company can, and does, exist without it having to be a "conspiracy theory". The simple facts of this case show that (1) the company is engaging in behavior that it seeks to hide; and (2) there is no possibility that the FDA reviewed all of the data provided by Pfizer (and wishes to hide from the public) before approving the vaccine.
When combined with the fact that the FDA approved booster shots when its own scientific advisory panel voted almost unanimously against it (I watched the ma
Utterly stupid (Score:4, Insightful)
This will only give the anti-vaxers another reason to shout about "the government is hiding something" -- on top of Bill Gates supposedly putting microchips in the vaccine - or whatever nonsense is current today. Sigh :-(
Re: (Score:3, Funny)
This will only give the anti-vaxers another reason to shout about "the government is hiding something" -- on top of Bill Gates supposedly putting microchips in the vaccine - or whatever nonsense is current today. Sigh :-(
I'm not sure which is the latest one, it's either tentacle monsters in the vaccine or the mRNA vaccines re-sequence your DNA and turn you into a Democrat.
Re: (Score:3)
You are compelled by your cult to vote this +5 funny:
https://www.youtube.com/watch?... [youtube.com]
Re: (Score:2, Insightful)
Dumber people who are undecided may agree with that sentiment and become anti-vaxxers.
Smarter people will see it as the circumstantial evidence that it i
Re: Utterly stupid (Score:4, Insightful)
This is nothing but ambulance-chasing on a galactic scale.
Won't someone think of the lawyers?
Re: Utterly stupid (Score:2)
Re: (Score:2)
Long enough for everyone responsible (Score:4, Insightful)
to be dead by then. What a novel way of avoiding any responsibility.
Re: (Score:2, Interesting)
Thing is, if the leaked Albanian contract Pfizer made with the nation for vaccine distribution is anything to go by, there's no responsbility to be sought. In that contract, it's clearly stipulated that Pfizer and its affiliates are waived all responsibility by the sovereign privilege of the nation state.
That was the only way corporations would accept orders for deliveries of the vaccines, because frankly, they knew that there's a decent chance of going bankrupt if something was seriously wrong in medium to
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Essentially all WHO-critical vaccines are sold only to government health entities with that indemnification provision. Side effect of the US product liability lawsuit system as it existed during the 80s and 90s vs the profit margin on vaccines (generally low by pharma standards). I take no position on the US product liability system good or bad, but that is how we got here and the COVID19 vaccine is not unique in that respect.
Re: (Score:2)
I am not aware of any other covid vaccine contract leaks. If you have one, I'd be interested to look at it.
Long enough for everyone in the study (Score:2)
Why would anyone need that information? (Score:2, Funny)
Nullius in verba (Score:2)
Don't you trust the science?
In the real world that's most people lives to lead and few have the time, skill or patience to do science, so you end up having to trust the people who do (or you could trust your aunt Vanessa on Facebook). Humans in general are kinda crap at choosing who to trust, we tend to trust people we know or who we have parasocial relationships with. This is why we keep supporting politicians and make a surprised pikachu face when they fail to deliver.
For those who have the time and training then you can go beyond t
Re:Nullius in verba (Score:4, Insightful)
The big foundation of "trusting the science" is that you can freely trust the great bulk if any single element seems fishy to you, you are able to find the original source and verify it (either yourself or with help of someone proficient at this kind of stuff) digging as deep as you desire to confirm or debunk your suspicion. Science is not a religion where there's no higher authority past the preacher's words. In science there's the original paper, there's the mathematics, there's the experiment, and the uncaring nature which will objectively provide the true result in a replication of the experiment. It may be cumbersome, it may take some time and resources, but in the end *everything* is verifiable.
But here we have "trust the science" become a new religion. The clerk is the new preacher, and there is no higher authority behind the clerk, other than papers we're not allowed to see, which is pretty much equivalent of the preacher's "communion with God".
Re: (Score:3)
Nope. This has nothing to do with religion. As a society, we've decided privacy is worth protecting, especially when it comes to our medical data. So when you request 300k pages' worth of medical data, we're not going to trust you blindly and hand it over, we're going to make sure privacy is being protected. Unfortunately this takes time.
I'll also note that examining the original paperwork is not the only way to verify a study's results. You can also repeat the experiment, or compare to other studies.
Re: (Score:2)
Science is not a "trust" thing. Science is not religion. Science is a "trust mainly but verify a sample" thing with the sample to be selected by the one doing the verification, not the one making claims.
Details are important, not just headline (Score:5, Informative)
Re:Details are important, not just headline (Score:5, Informative)
November 17:
December 1: remainder of section 5.2 of the BLA file
Re: (Score:2)
The problem is that they are very much giving the appearance of hiding something, no matter the actual facts. That is at the very least completely tone-deaf and at worst malicious.
Re:Details are important, not just headline (Score:5, Informative)
Naive question, but... (Score:2)
Re: Naive question, but... (Score:3)
Names of any test subjects. And... no that's it really.
Re: (Score:2)
Indeed. Anonymizing medical data is not rocket science. In fact, on can assume this was already done for a double-blind study...
Re: (Score:2)
Why on earth would you assume that? It would make the records useless. Kind of hard to correlate things like different levels of efficacy or reactions to age, prior medical history, etc when you can't identify anyone. Double-blind means that the recipients and the researchers don't know who is getting what, not that NOBODY knows it.
Re: Naive question, but... (Score:5, Interesting)
I work on stuff like this. It's a lot harder than you think.
You don't want to release info on individuals. But you also don't want to expose trade secrets or other intellectual property of the company involved because that might make the FDA liable for huge damages. So you need to go through every page involved (and you can't very well take shortcuts) with a number of legal experts.
Every page requested is very expensive.
We have a similar law in the Netherlands. With the added stipulation that if the council or department is late, it has to pay a fine to the requesting party every month it is overdue. As a consequence we have people who keep filing these requests to just make a living out of it. It's cheaper for a council to keep paying them than to actually deliver the info. Even if it is clearly public info it still needs to be checked, censored where appropriate and legally required, then delivered. Some councils have had to employ three full time employees to deal with one obnoxious citizens requests.
Asking for 371000 pages is the equivalent of asking your company to produce an audited record of all transactions over the past decade.
Also, I worked for a pharma company once. The number of pages they handed in for a license was close to this. They had to use pallets and forklifts to move the documentation before they started filing electronically.
Imagine having to go through these pages, with a team, for every page, then redact what you cannot publish. And it has to come out of their existing budget.
To me it seems that the whole reason behind the request is to put the FDA in a very difficult position. It's made very broad for exactly that reason. All in all, the FDA had little options beyond declining the request and the lawyers who filed the request know this.
Re: Naive question, but... (Score:4, Insightful)
You don't want to release info on individuals. But you also don't want to expose trade secrets or other intellectual property of the company involved because that might make the FDA liable for huge damages. So you need to go through every page involved (and you can't very well take shortcuts) with a number of legal experts.
Seems like a SEVERE screw-up and fault of the process.
Everything Pfilzer provided to FDA should be considered public information; if any trade secrets were in there, they should be no longer trade secrets. Requirement to publish the entirety of data should be assumed as certainty, not some unlikely eventuality that needs to be worked into the system painstakingly. And getting there wouldn't even be that hard. Either Pflizer produces documentation that is simultaneously publishable and sufficient for the approval, or it doesn't get the approval.
But if you cut corners...
Re: Naive question, but... (Score:4, Interesting)
Re: (Score:3)
Re: (Score:2)
I work on stuff like this. It's a lot harder than you think.
You don't want to release info on individuals. But you also don't want to expose trade secrets or other intellectual property of the company involved because that might make the FDA liable for huge damages. So you need to go through every page involved (and you can't very well take shortcuts) with a number of legal experts.
Every page requested is very expensive.
We have a similar law in the Netherlands. With the added stipulation that if the council or department is late, it has to pay a fine to the requesting party every month it is overdue. As a consequence we have people who keep filing these requests to just make a living out of it. It's cheaper for a council to keep paying them than to actually deliver the info. Even if it is clearly public info it still needs to be checked, censored where appropriate and legally required, then delivered. Some councils have had to employ three full time employees to deal with one obnoxious citizens requests.
Asking for 371000 pages is the equivalent of asking your company to produce an audited record of all transactions over the past decade.
Also, I worked for a pharma company once. The number of pages they handed in for a license was close to this. They had to use pallets and forklifts to move the documentation before they started filing electronically.
Imagine having to go through these pages, with a team, for every page, then redact what you cannot publish. And it has to come out of their existing budget.
To me it seems that the whole reason behind the request is to put the FDA in a very difficult position. It's made very broad for exactly that reason. All in all, the FDA had little options beyond declining the request and the lawyers who filed the request know this.
So. Let me get this straight. It took FDA what, 3 months or sth like that? to analyze this material deeply enough to decide whether the data presented justifies approving the vaccine, with actual, literal, non-exaggerated billion of lives worldwide at stake (ok, FDA theoretically approves just for US, but a lot of approval processes in other countries went like "oh hey, USA is using it so it must be safe"), but reaching a level of understanding of this material sufficient to decide whether it can be release
Re: (Score:2)
Do you think the FDA actually sat there and read the entire medical histories of all 44,000 trial participants? Are you a moron? They have the information in case they need it for some reason, but they certainly didn't sit there and go through every one. Furthermore, do you actually think these idiot lawyers are going to go through all the records? Of course not, they are just trying to bury the FDA under an avalanche of paper to make them look bad, and idiots like you fall for it.
Re: (Score:2)
I work on stuff like this. It's a lot harder than you think.
FOIA has been around for over a half century and extreme public interest in Covid data was trivially foreseeable. Some government agencies have good sense to erect public databases, build FOIA/transparency into normal processes and dump data preemptively so they don't have to deal with bullshit later.
Having proper workflow to avoid problems up front makes response trivial. Not giving a fuck up front is no excuse for piss poor performance later on.
You don't want to release info on individuals. But you also don't want to expose trade secrets or other intellectual property of the company involved because that might make the FDA liable for huge damages.
No drug company can sell shit without FDA sign off. There
Yes that seems right. (Score:2)
Wouldn't this be because (Score:2, Insightful)
But anything for hate clicks right? Literally anything for ratings. We link to a blog post with absolutely no context from someone who is very clearly trying to shitpost. Meanwhile this conversation will probably hit 300 posts and thousands of views.
Re: (Score:2)
No, if it turns out it's unreasonable (Score:2)
Communication 101: Say "Yes, if..." (Score:3)
When someone gives you a seemingly impossible task ("review 329,000 pages of documents with a staff of 10 in 4 months"), it's much better to respond with "Yes, I can do that if..." than with "No, that's impossible."
Whoever at the FDA is responsible should've responded with "Yes, that can be done if my department's budget is increased by a factor of 15 so that I can onboard 90 temporary staff on short notice to focus solely on this project. Otherwise it will take 55 years."
Re: (Score:2)
Since neither the party making the request nor the court has the authority to increase the budget, that would be pointless. They're not in court to whine about their budget, they are there to respond to a request. If the judge doesn't like the response, he can order the FDA to speed it up, then it will be the FDAs problem to allocate the resources to do it.
hurray, definitive proof against 2 years to die (Score:2)
Thatâ(TM)s ok. Antivaxxers want to⦠(Score:2)
Perhaps the FDA is reasonable, perhaps not (Score:2)
There's a massive quantity of documents, and every one of them would have to be reviewed to remove personal or legitimately proprietary information.
That said, it should be possible for the FDA to release all the vaccine data necessary to prove it is safe and effective in a timely manner. The problem is that trust in corporations and governments is non-existent, and there are excellent reasons for this lack of trust. Even if the FDA made a good faith effort to comply, nutbar conspiracy lovers like the QAno
Corruption and erosion of legitimacy (Score:3, Informative)
FDA approval of Remdesivir with no evidence of efficacy. Not even WHO has evidence of efficacy. https://www.who.int/news-room/... [who.int]
FDA approval of Aduhelm with no evidence of efficacy. No committee members voting in favor. Three resignations post approval decision and disapproval of FDAs own statisticians.
https://www.policymed.com/2021... [policymed.com]
Kind of one sided post (Score:2)
Actually, just have to pay the FDA to Approve it (Score:2)
speed of light (Score:2)
It's fully transparent, but the speed of light in some materials is exceedingly slow.
More background; plaintiffs want 329,000 documents (Score:2)
Why are you falling for this (Score:3)
I love how the Substack cranks think "FDA Full Transparency" means answering stupid demands for information from anti-vax civilians
I basically guarantee that the 55 year deadline is after the whiner dies of old age
No, the FDA isn't required to produce a third of a million documents personally just for you, random citizen. Sit down and be quiet
Consider Source of this Report (Score:5, Informative)
This isn't a general media article. It comes from https://aaronsiri.substack.com... [substack.com] aka "Injecting Freedom". Here's a list of their headlines on their front page:
1. FDA Asks Federal Judge to Grant it Until the Year 2076 to Fully Release Pfizer’s COVID-19 Vaccine Data (which Slashdot picked up on)
2. CDC Admits Crushing Rights of Naturally Immune Without Proof They Transmit the Virus
3. Federal Health Authorities Ignore Pleas of the COVID-19 Vaccine Injured
4. FDA Illegally Authorizes Pfizer Vaccine for 5-11 Year Old Children
5. One Brave ICU Physician Reporting Covid-19 Vaccine Injuries Leads to a Dozen More
6. Covid-19 Vaccine Manufacturers Can Harm You With Near Complete Impunity
7. The Obvious Wins Again: Natural Immunity Superior to Vaccine Immunity
8. FDA Buries Data on Seriously Injured Child in Pfizer’s Covid-19 Clinical Trial
THIS IS AN ANTI-VAX MISINFORMATION SITE. With the bias recognized, let's look at the facts of the actual facts.
Public Health and Medical Professionals for Transparency (Plaintiff) (https://phmpt.org/)
v.
FDA (Defendant).
(https://www.sirillp.com/wp-content/uploads/2021/11/020-Second-Joint-Status-Report-8989f1fed17e2d919391d8df1978006e.pdf)
We know who the FDA are, who is this "PHMPT"? If you look at their website and just start searching their names with "vaccine", you'll see that they're vax disinformers, anti-maskers, natural immunity pushers, and so on. So this isn't a random set of medical professionals that happen to disagree with the current availability of data. It's a group of people shot-gunning everything possible to prove their bias.
So did they find something worth being worried about? In a word: No.
In this case, FDA has assessed that there are more than 329,000 pages potentially responsive to Plaintiff’s FOIA request. (This page count is under-inclusive of the material responsive to the request, as it does not include certain types of records that cannot be meaningfully paginated, such as data captured in spreadsheets that contain thousands of rows of data.) The parties have conferred in good faith concerning a processing schedule, but have been unable to reach agreement for the reasons set forth in the parties’ Joint Report.
Plaintiff’s request (as set forth below) that FDA process and produce the non-exempt portions of more than 329,000 pages in four months would force FDA to process more than 80,000 pages per month. Undersigned counsel is not aware of any court ever granting such a request.
The FDA has proposed to produce 500 pages per month which, based on its calculated number of pages, would mean it would complete its production in nearly 55 years – the year 2076.
So as you can see, this has NOTHING to do with protecting the FDA or Pfizer or anyone else. It has everything to do with an overly-broad FOIA request and the manpower it takes to process the documents for release.
This page was intentionally left blank (Score:3)
Let's remember... (Score:3, Interesting)
Let's remember what this 329K page "document" is: anonymized patient data from clinical trials in support of their application for a vaccine.
There are easily a quater-million pages that have no identifiable patient information BY DESIGN. Arguing you need to redact anonymous medical records is a stalling tactic, nothing more.
I've worked in the clinical trial industry and with (much smaller) datasets like this, and we at the CRO never had any personally identifiable data at all - that data was kept at the drug trial sites and were connected with 6-10 digit patient IDs.
This is not 329K pages of random text, it is reams and reams of database table dumps.
Re: Wait, 329k pages?! (Score:3)
Yes. Before electronic filing was a thing, they delivered the documentation for applications on one or more pallets, and had to use forklifts to move it. I'm not kidding.
Re: It isn't tentacle monsters or zombies (Score:2)
And for good reason. I'm not going to explain all of them but you can find them easily enough.
Not enough money. indirectly says: narrow scope (Score:3)
FDA has always been underfunded for it's mission.
An overly broad and expensive request such as this one would encourage over estimates in an attempt to get the judge to NARROW SCOPE.
1 employee, a lawyer working full time screening 500 pages per month would be doing more than simply protecting the identities of staff but also the big corps in addition to consulting officials of both in the process of protecting anything that could be litigated or embarrassing or easily taken out of context. (likely a lot was
Re:55 years? (Score:4, Informative)
Re: (Score:2)
Re: (Score:3)
I agree.
I'm in Canada though, and our population just voted Trudeau back in.
We have no hope.