FDA asks federal judge to wait until 2076 to fully release Covid vaccine data
aaronsiri.substack.com
aaronsiri.substack.com
Throw 6 people at it, throw in review processes, maybe you could get it done in a couple years. Say 5 to hedge.
That discrepency needs explaining, and the bar for acceptable excuses is high, and not met.
The FDA evaluated (very strongly) for a Very Specific criteria. Efficacy of the vaccine against a disease, versus possible complications. It is FREQUENT that medical trials collect enough personal information to ruin the lives of those involved, so that any commonalities or patterns of negative incidents among them can be connected to ancillary risks.
To release documents and make them public record should probably take a completely different process than traditional discovery. In that the relevant evidence should be extracted, and as much PII as possible removed entirely, and redacted on the pages that are released.
It might be more appropriate to disclose the equivalent of table headers and an evaluation of if data was missing, relevant but within tolerances or above/beneath typical measure. Just like with image censorship true redaction must destroy the accuracy of underlying data for security.
If there is really no answer between blind trust and dying of old age, .... there is no 'if' actually, it's simply unacceptible. Neither this data, nor any government policies based on it, are "acts of god" that humanity just has to live with like solar flares. They are both created by humans and there is simply no excuse for even attempting to float any such proposal as "we'll dribble this data out for 50 years" It doesn't matter what the logistical problems are.
Logistical problems are the most easily solvable problems. They require little to no artistic muse or genius. You just work on them, very plodding straightforward work.
For instance, you don't have the budget to do the work the old brute force way? Well considering the alternative is over 50 F-ing years and who knows how many man-years, that equates to a rather large budget to develop some better process, and then use it. Like a volunteer citizen science program complete with training certifications and cross-checking and oversight and accountability and everything necessary to maintain full integrity. Let's say that project is huge and takes TEN YEARS just to develop the procedures and stuff. Even something pie in the sky like that is still a fraction of 55 years! And really, even a single reasonably educated staffer couldn't develop at least the outline in say, one year? A whole year?
No matter what parts of this problem you want to look at, this "500 pages per month" BS still just does not add up, even if you pretend you're stupid and just accept the stated difficulties as actually being the problem.
Ok enough of that..,setting aside debunking the problem or coming up with new solutions to the problem, switching gears to "what would make it not a problem?" like in a perfect world, if you could have anything etc:
It sounds like what should happen is, the data should be supplied with the identifiers seperated by the original submitter. Like a standard that everyone follows where when you write the reports in the first place, everyone is subject A who works at employer X and lives in county Z, and the legend is in a seperate part of the document which is trivial to withhold.
Put both the job of segregating the data and the liability for doing it correctly on the submitter when they are creating the data in the first place.
Then the FDA or other similar body only has to do a reasonable minimal due dilligence to realease the anonymised data. If there are mistakes, make that the applicant's responsibility.
> No matter what parts of this problem you want to look at, this "500 pages per month" BS still just does not add up, even if you pretend you're stupid and just accept the stated difficulties as actually being the problem.
This is a processing quota per applicant. I agree it's a problem that the system isn't designed to require initial submitters to produce public-release-ready reports as well; though we would presumably need at least an N% (E.G. 20-25%) budget increase for the government across the board.
> It sounds like what should happen is, the data should be supplied with the identifiers separated by the original submitter. Like a standard that everyone follows where when you write the reports in the first place, everyone is subject A who works at employer X and lives in county Z, and the legend is in a separate part of the document which is trivial to withhold.
> Put both the job of segregating the data and the liability for doing it correctly on the submitter when they are creating the data in the first place.
Yes, this is also a logical solution, the inputs to the (government body) processes should have public-release-ready versions as well.
For both cases, please see my parent comment about the necessity of destructive fuzzing to sufficiently frost (ed window) the sensitive data.
The general public rightfully has a very low trust of the gov't and this certainly adds more validity to their distrust.
The issue stems from the number of total pages (329,000) and the proposed record release schedule of 500 pages per month
"FDA proposes to process and produce the non-exempt portions of responsive records at a rate of 500 pages per month. This rate is consistent with processing schedules entered by courts across the country in FOIA cases"
"FDA’s proposed schedule of 500 pages per month is consistent with schedules set by courts across the country, including in cases where the underlying records were of national significance"
"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. "
To me this seems like it is more about bureaucracy rather than maliciousness. And in my view a fair criticism of the slow pace that FOIA documents are released.
That 0.25% is mostly known to subject matter experts. The rest is there to meet documentation requirements.
it is definitely NOT 329k pages of absolutely vital facts that can't be skipped.
besides, it can be split up among many people over the course of time.
experts know how to do this stuff.
Oh, yes.
>experts know how to do this stuff
https://www.americanbar.org/groups/judicial/publications/jud...
"One way to test the effectiveness of a redacted PDF document is by using a technique that nearly all word processing users know--copy and paste."
...nearly...all...
However with this they should be fully transparent with any and all vaccine related data as they are already suffering from credibility concerns when it comes to vaccine.
this group is an EXTREMELY vocal micro-minority.
Here's literally the law on what goes into a New Drug Application: https://www.law.cornell.edu/cfr/text/21/314.50
The idea is that it serves as the "whole story" of a drug, and includes everything from preclinical data demonstrating how the drug works on a molecular level, up through the plans for actually manufacturing and administering it. Thus, it includes a lot of things "for the record". For example....
If the application relies on material published in another language, then you are required to submit the original and a translated copy. It is very unlikely that the FDA is going to retranslate each article.
Similarly, you need to include individual case reports for any trial participants who die/drop out from adverse events even if in the placebo group and the cause is unrelated to the drug. If Mrs Jones from the control group got eaten by a shark after getting the placebo, a bunch of her medical info will be in there. This a) bulks up the application and b) slows down redaction but c) takes a reviewer about two seconds to realize they can ignore that entire section.
I'd expect that a lot of it is data that is gathered because it might be useful if certain things came to pass that did not come to pass.
For example, suppose in phase 3 they had found that the vaccine provides excellent COVID protection but it also has some terrible side effect in too many people to approve it for general use.
If they have extensive medical records on all the people in the trial they might be able to see some way to tell who is likely to have the bad reaction and who is not. Then they can try to find some way to mitigate that, or go for an approval for the vaccine for people other than those who are likely to react badly.
If things go smoothly on the other hand, there may be no need for anyone to look at much of that data.
Additionally I would say that foi requests are generally fulfilled more by document categorisation than by page, especially if the case is not about military secrets where much more careful screening might be required.
I doubt "copying" is the actual bottleneck. It's totally doable to photocopy 500 pages in an hour (if you have a document feeder). What they're talking about is probably more the manual work to search, evaluate material for appropriateness to release, etc.
It has nothing to do with medium, it has to do with review of mixed material for information that is not subject to FOIA (personal privacy, trade secret, confidential commercial data, and other legally protected information) and avoiding the requirement for that review being a mechanism for using FOIA as a denial-of-service attack on federal agencies.
> But these days, just one DVD or flash drive could hold all 329,000 pages.
Which doesn't materially impact the workload of reviewing it prior to release.
And looks like more narrow requests for documents would be completed faster: "If Plaintiff decides to request fewer records, then FDA will be able to complete its processing at an earlier date."
An alternative is of course that we would treat requests by multiple people as more important, for example, if we assume that 1000 people requested these documents it would only take less than a month, but imho that's a huge slippery slope where information can effectively be hidden by inflating the size of it.
Say: you have two weeks to submit any requests. After that, everything gets released. It's your trade secrets after all.
If someone actually wants to understand how/why the vaccine was approved, the most sensible option IMO would be to tailor the FOIA Request more narrowly. Request the summary section: it should lay out the rationale, without diving into specific details that might need redaction. The only other alternatives I see are lobbying congress to either a) allocate more money for FOIA or b) make some categories/documents releasable as-is.
OTOH, asking for a third of a million pages--many of which no one has real intention of reading--does seem like a good publicity stunt.
[0] If participating in a clinical trial gets (potentially embarrassing) personal details leaked, we won't have nearly as many volunteers next time.
In the Old Days, to file an NDA required special arrangements with printing companies who could handle such a job and a team who arranged for the fleet of trucks required to deliver the submissions.
Edit: NDA = New Drug Application which includes, among other things, basically all your raw data which includes hordes of PII.
TBF it also includes a lot of boring in vitro data and analysis, preclinical (animal and in vitro) data etc which will have minimal to no PII.
Every FOIA request is screened by humans, which can result in false positives and negatives. So could a machine-screened result. Would people be comfortable with an automated screener, which, while hard to do with classified info, would conceptually be possible with FDA records (from either food or drug side). The records are quite free form.
I’m in favor of these records being public except perhaps some proprietary process data. Of course it will be used by people who don’t understand it for wild attacks.
Some notable excerpts:
> Plaintiff seeks the records submitted to the FDA by Pfizer to license its COVID-19 vaccine (the “FOIA request”) and requests an order requiring the FDA to produce all documents responsive to its FOIA request no later than March 3, 2022. This 108-day period is the same amount of time it took the FDA to review the responsive documents for the far more intricate task of licensing Pfizer’s Covid-19 vaccine.
> Plaintiff is an organization comprised of over 30 accomplished academics, professors, and scientists from the medical schools and related departments of our most prestigious universities, including Yale, Harvard, UCLA, and Brown.
> The ability of a majority of Americans to participate in civil society, and even exercise basic liberty rights, are now contingent on receiving this product. For example, the White House’s recent Covid-19 Action Plan and executive orders have made receipt of this product a condition of employment for more than 6 million federal workers and contractors, 22 million healthcare professionals, 84 million private sector employees, and the enlisted and reserve members of our armed forces. There are few whose livelihood, education, service, and participation in civil society are not contingent on a government requirement to receive this product. On this basis alone, basic liberty and government transparency demand that the documents and data submitted by Pfizer to license this product be made available to Plaintiff and the public forthwith, precisely as contemplated by federal regulations.
> The acute need for transparency regarding this product is heightened by the fact that the secretary of Health and Human Services (“HHS”), the FDA’s parent department, has granted Pfizer complete immunity from financial liability for any injury caused by its product.
> It took the FDA precisely 108 days from when Pfizer started producing the records for licensure on May 7, 2021,14 to when the product was licensed on August 23, 2021.15 We assume, as the FDA has stated, that it conducted an intense, robust, thorough and complete review and analysis of those documents in order to assure that the Pfizer vaccine was safe and effective for licensure. The FDA now has an equally important task of making those documents available to the Plaintiff in this case and the public at large in at least the same timeframe. The FDA’s own regulations envision and reflect upon the importance of making this information public as soon as a vaccine is licensed. Its regulations provide that it is to make “immediately available” all documents underlying licensure of a vaccine. 21 C.F.R. § 601.51(e). The FDA knew the intense public interest in that data and information. It should have been preparing to release it simultaneously with the licensure. Instead, it has done the opposite. Despite the passage of 84 days since licensure and 192 days since Pfizer started producing the records for licensure, the FDA has not released a single document submitted by Pfizer for the licensure of its Covid-19 vaccine. Not one page.
I’m not a lawyer but the complaint seems perfectly reasonable.
This submission was flagged once already but then cleared. The feedback was that linking to the actual document might in some instances be ok but then a good comment on why the document is interesting would be needed.
I believe that with your comment linking to the actual document would be ok.
The FDA has made a public commitment to transparency regarding Covid-19 vaccines.[1] Given that, I would absolutely expect them to be a model of information sharing.
[1]https://www.fda.gov/news-events/press-announcements/coronavi...
No need. It’s all right here. Google everything so far simian virus mouse sarcoma mouse hepatitis cytomegalovirus retrovirus
FDA’s own regulations stipulates that the agency “is to make ‘immediately available’ all documents underlying licensure of a vaccine."
But why would they want to (seemingly) hide something in this case, where they usually would publish to the public 'immediately'?
Freedom of information needs to be modernized. Document creation should be in the open from the start. There shouldn't be a reason to "release" them later. At least for civilian stuff like vaccine studies.
Absent Congress appropriating funds specifically for it, yes.
Should Congress do that? That's a separate issue, which is not the court’s job to address.
> He and other taxpayers paid for the studies,
Citizenship, not taxpaying, is relevant for public data, but citizens (through their representatives) didn't choose to pay for the segregation of public and nonpublic information for release on a schedule more expedited than general FOIA releases.
> Document creation should be in the open from the start.
Maybe, though for processes that can involve mixtures of personal private info, confidential commercial info, trade secrets, and public data that will significantly increase the upfront cost of operations.
But neither the executive branch alone nor the courts are the venue for that.
I disagree with that. FDA was able to produce and analyze the documents in roughly a years time. They scrutinized the data enough that they felt comfortable in approving a novel vaccine. Surely releasing a USB stick with the documents on it shouldn't take 50x the time to analyze and produce the documents in the first place.
> Citizenship, not taxpaying, is relevant for public dat
Distinction without a difference in this case.
> citizens (through their representatives) didn't choose to pay for the segregation of public and nonpublic information for release on a schedule more expedited than general FOIA releases.
This is circular reasoning. When owning slaves was legal I could have said "citizens did not pay for law enforcement to catch slave owners". But that wouldn't be the end of the discussion. If a rule or law is wrong, we must fix it, not accept it as the eternal truth.
> Maybe, though for processes that can involve
It is hardly relevant what is involved. People paid for the research, subjected themselves to a vaccine you said is ok. They deserve to know the reasoning behind the conclusions.
Absolutely disagree.
If I have the following: "Joe blogs who is 89 and lives at 1400 West Rd, Los Angeles, CA 10921, today went to go obtain a vaccine and got the sniffles. His wife had eaten pizza, says Pfizer, and so precipitated a reaction via airborne cheese reactivity', it probably took you all of two seconds to read that. If you have to redact any of that, you first must confirm what to redact, whether talking about Joe's wife somehow constitutes a breach of personal information, etc.
Maybe the address information is fine to leave in, maybe its not. But now instead of just regurgitating a couple sentences, you have to sit and deconstruct the sentence, match it to various classifications, etc., all by hand.
Does that make FOIA requests somewhat useless? Perhaps, but we never mandated that the information going in had to be foia compliant. If you want it faster, sue for the public disclosure of all vaccine materials regardless of classification, and contact your senator, not your foia office. IMO the various vaccines should be public property anyways, not the property of any one corp, especially given we all are paying the price...
Producing documents in response to a FOIA request isn't just a matter of simply copying them. If the documents contain anything that is not legal to release to the general public (such as personal information of patients) that has to be redacted first.
The FDA has 14,000 employees; its FOIA office has 10, and they go at roughly 80,000 pages per month, meaning each employee does 8,000 pages per month, or roughly 400 per working day per employee, less than a minute per page. That to my non expert opinion sounds pretty fast.
That speed has been appropriate until now that the plaintiffs want 4 months' worth of FDA FOIA work for yesterday.
I agree that there should be a solution for these cases, but it's this particular FOIA request that's the anomaly, not the FDA way of work.
More sensibly, if we want the FDA to make delivering a particular set of documents a sizable piece of its job, we should (through Congress) direct that and allocate appropriate funding for that purpose.
From a Reuters article on it: They also argue that Title 21, subchapter F of the FDA’s own regulations stipulates that the agency “is to make ‘immediately available’ all documents underlying licensure of a vaccine."
So it really sounds like this is just part of the course of making sausage of approval. You have someone already embedded in the licensure project/process where this is all (very likely largely automagically) handled as it is always expected to be released to the public.
A lot of cash was dumped into fast and extensive R&D, trials and production scaling because of the urgency of the situation, and along comes an insane documentation backlog.
To put in perspective, the original HPV vaccine R&D and trial spanned over 7 years with 25,000 patients (of which only 20,000 women), and assuming the documentation was provided to the FDA as it was produced, it could be FOIA'd relatively quickly.
Pfizer/BioNTech did the same, with almost double the patients, in just over 6 months.
Damned if you do, damned if you don't.
It's not a document, and many of the documents involved weren’t created by the government, and no government agency is funded for unlimited reserve capacity for doing public records releases just in case.
In 2020, FDA spent a little under $5.5 million (a little over $5 million net after fees collected) handling over 10k FOIA requests. [0] There's not a lot of resources to dedicate to any one request.
[0] https://www.hhs.gov/foia/reports/annual-reports/2020/index.h...
It didn't prepare them for the public (and, in many cases, it didn't prepare them at all). It prepared or gathered them to support the function it performs for the public, much of which, by law, includes preparing, gathering, and reviewing legally non-disclosable information. That's the mandate it has in law—so it is not at all “incompetence” that that is how it operates.
You may not like the law (given that elsewhere in the thread you have suggested it is literally equivalent to the institution of slavery, I assume that you do not), but it is not incompetent for government agencies to follow the law that actually exists rather than your individual preferences for what the law ought to be.
It is most definitely the court's job to determine if the time it takes to produce documents is reasonable or not. Courts order all branches government to produce documents on the court's schedule all the time and the government must do whatever is required to produce those documents on the prescribed schedule.
That's exactly not what I said wasn't the court’s job, so you are just inventing things to argue against.