FDA wants 55 years to process FOIA request over vaccine data
reuters.com
reuters.com
Wouldn't this separation be designed into the process for data management during the clinical trial?
Almost all content is managed by computer systems that are designed to protect PII and intellectual property, with managed restriction or redaction for external distribution. If it did not take decades for computer-structured clinical trial data to move across the corporation->government boundary, why would it take decades to move from government->citizens?
If necessary, the reports can be re-exported from the corporate systems used for clinical trial data management, with additional computer-enforced redaction of sensitive data. There is also AI-assisted software used in legal discovery, which can quickly parse a large document corpus, to flag material for human review.
Do companies redact patient data before submitting it to the FDA? Are they even allowed to? That sounds like the sort of information that the FDA should have access to.
https://www.fda.gov/regulatory-information/search-fda-guidan...
Man, if that were true it would be great. It would show that we could reward providing society with enormous benefts with enormous awards. If only that were true.
Kind of a depressing thought the extent to which we prioritize things.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFR...
Part e and friends.
These laws need tearing down in a big way.
> That's a nice theory,
"...but in practice you're naïve to think that citizens have any rights at all."
The real means of pressuring legislators (that is to say, how it is routinely done) is via regulatory capture. To have any influence you need to somehow bring more pressure to bear on your legislator than the current forces which determine your legislator's incentives. Let the legislator weigh in one hand angry constituent phone calls to his staff, and in the other, important donors, access to funding organizations, post-public sector job opportunities, etc. etc. Which hand is more weighed down?
When someone points out the depth of corruption and dysfunction and this elicits the response "just call your legislator", it strikes me as either patronizing or merely naive.
You are welcome to convince Congress to retroactively change the rules based on which the firms invested in the research (and then to have the government try to convince the Courts that that change is not a taking under the 5th Amendment), but FDA has to comply with the law as it exists, not your fantasy of what the law should be.
These vaccines are the product of tax dollars and abeyance of the laws, every cent of profit in excess of time and material should be going back to the US government. Pandemics shouldn't be winning lottery tickets - that's an obscene incentive for an industry already known for its blackhearted exploitation of human misery. "But muh rules" is already out the window. These companies already have the means to create pandemics, let's not set the precedent that worldwide plagues are great for the bottom line.
If you want solutions, and you have capitalism, there isn't much choice. I’m perfectly fine with dismantling capitalism, but that's not really the role of the court adjudicating an FOIA case.
> "But muh rules" is already out the window.
No, the rule of law and Constitutional guarantees against arbitrary deprivation of liberty and property are not out the window.
I get that some people in this thread desperately want them to be, though.
The privately available file (IE what they get) is not redacted.
You are correct that there are complex data management systems managing the trial, but i don't think they can quite meet all the CFR requirements in practice. At least, they couldn't when i used to know a lot more about this.
Neither side is right - the plaintiffs are playing language games in a lot of places to make it seem like this is easy. Even with the management systems, it's not.
Th FDA is playing games in saying thy need to review 330,000 pages (like, tons of them are just trial data and chart results. They are standardized page formats, etc. There will be no additional text or names.)
No.
> Almost all content is managed by computer systems that are designed to protect PII and intellectual property
Having worked in public sector entities dealing with masses of private data that deals with public records requests against that data for decades, no, its almost certainly mostly not,
> If it did not take decades for computer-structured clinical trial data to move across the corporation->government boundary, why would it take decades to move from government->citizens?
Because the first transition basically requires the confidential data, and even where it doesn't strictly require it, it is low legal risk in the event of error because the government is bound not to release it.
> If necessary, the reports can be re-exported from the corporate systems
No, even if that was useful, they legally can't, because only the records actually held by the government are subject to FOIA. The material held in corporate systems from which reports were made to the federal government is not subject to FOIA.
This sounds like an entire problem of its own. We're talking a medical treatment the government is doing its damnedest to mandate.
There needs to be an exceptional level of transparency here.
The FDA proposes releasing 500 pages per month on a rolling basis, noting that the branch that would handle the review has only 10 employees and is currently processing about 400 other FOIA requests.
[Plaintiffs] 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."
Genuine question: How did nothing happen after the Panama papers were leaked? What literally all of that legal or was it because the IRS didn't have time to investigate all the cases?
it was a big thing for countries where the leak uncovered (or "proved") corruption.
FATCA fixed nothing at all.
> it was a big thing for countries where the leak uncovered (or "proved") corruption.
How can you possibly say that the US is not in that category?!
Because US corruption is not hidden. There's nothing to uncover really. It's done in plain sight. There are two dedicated people for that for each state on the federal level. There are complete industries sustained by nothing but endless subsidies. Already super favorable tax regulations, already great ways to store wealth in ways that are conveniently inaccessible to public eyes.
Of course if by fix you mean putting an end to economic rent-seeking, then for that the way forward is healthier markets and/or "whatever the Nordic countries are doing".
We had some anti-vaccine literature emailed around at work that purported to be a legal form to submit to anyone pressuring you to take a vaccine.
Instead of, you know, politely opting out, it went straight down the rabbit hole of requesting every document that was legally required (e.g. full list of vaccine ingredients, verified chain of custody from point of manufacture, full study results including any reactions, etc).
I'm all for skepticism, but at some point, there's just being a dick and wasting the time of others trying to do their best in government bureaucracies.
“If you get to force me to put a possibly harmful thing in my body then I get to force you to do a ton of unreasonable paperwork about it”
I imagine if I had a problem with vaccines or with this particular vaccine (for which I was gladly first in line in my cohort), then I’d likely use every loophole at my disposal to delay or prevent being forced, pressured, cajoled, shamed, etc into getting one.
If someone doesn't want to be vaccinated -- refuse vaccination and deal with the consequences.
Don't request (to use my example, not the OP) 100s of pages that you have no intention of reading, the production of which consumes valuable resources during a public health crisis.
The reasonable outcome, if the purported goals are true, would probably be to scope the FOIA request down to a summary of materials available, and then work with the relevant departments to filter out extraneous records that the requestors don't see as valuable.
The sole contract the EU MPs got from a pharma company in January was heavily redacted
>A group of Green MEPs wrote to Commission President Ursula Von der Leyen ...demanding full access to all contracts signed between the EU Commission and pharmaceutical companies for COVID-19 vaccine contracts, arguing that MEPs have the right of access to documents when there is overriding public interest [1]
>Upon analysis of the contract, 4.22% of the liability section and 15.38% of the indemnification section was found to be redacted, while 0% of the section on the processing of personal data was redacted. [1]
> 23.79% of the agreement was found to be Redacted from the contract
The European MPs are still waiting for the details as of November 2021:
https://www.youtube.com/watch?v=OUUmK4u0kj8
[1] https://www.euractiv.com/section/coronavirus/news/covid-vacc...
We would all like the maximum safe transparency but I somehow doubt most of us would like to pay for it.
This could cover Unclassified/Secret/etc. as well as PII/PHI. Then when a FOIA requests comes in, the software handling the release automatically redacts the PII/PHI fields, does a timestamp check for the Secret+ fields and redacts if < (xx years).
This is why best practice is to put classification markings on every paragraph in a classified document (seems like a pain but clearly it's important and needed). It builds a mental "muscle memory" in the staff for granular metadata tagging that eases the production of derivative classified products, Foreign Disclosure, and FOIA.
The law on this is clear, and generally, FOIA requests for the data are met (AFAIK)
Can you point to an example where they have denied release?
"The fact that what gets published are the trials with positive results was most convincingly shown by a group of researchers at the Oregon Health and Science University, who followed up on our initial analysis of the FDA data by comparing the conclusions reached by the FDA with those reported by the drug companies in journal articles. Of 38 drug-company clinical trials that the FDA viewed as having positive results, all but one was published. In the same documents, the FDA described 36 trials as having negative or questionable results. Most of these negative trials were not published at all, and of the few that were published, most were described in the journal articles as showing positive results -- despite the fact that the FDA had concluded that they had not." Source: The Emperor's New Drugs, p. 67
Drug companies consider the raw data a trade secret, so they are never going to give it to you themselves.
It would take a very large permanent staff to do it. Or a new set of requirements placed on pharma for how data is submitted to reduce that burden. I'm not opposed, mind you, just saying what happens now would make it hard for the FDA to achieve "release by default" in practice[1]
Changing the rules here would also make things more adversarial in practice than they are now (for better or worse).
I think the value in the end is probably worth it, but i don't think it's as obvious a win as it is on paper. It's very easy to say how things should be abstractly. It's very hard to make systems that work in practice, and it's never as theoretically nice as we want them to be, nor can you really force them to be (which is often the proposed solution).
[1] you will also likely have to play whack-a-mole for a while (not saying it's not worth it mind you, just that it's not easy). IE you will now be given 5x the data just because they know it will take you a while to sort through it. It will take a few iterations and lawsuits to get regulation/etc right to cause this not to happen.
How about "vaccine trust-reluctant?"
What shenanigans? Per the OP:
> That’s how long the Food & Drug Administration in court papers this week proposes it should be given to review and release the trove of vaccine-related documents responsive to the request....
> The 1967 FOIA law requires federal agencies to respond to information requests within 20 business days. However, the time it takes to actually get the documents “will vary depending on the complexity of the request and any backlog of requests already pending at the agency,” according to the government’s central FOIA website.
> 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...
> But the FDA can’t simply turn the documents over wholesale. The records must be reviewed to redact “confidential business and trade secret information of Pfizer or BioNTech and personal privacy information of patients who participated in clinical trials,” wrote DOJ lawyers in a joint status report filed Monday.
> The FDA proposes releasing 500 pages per month on a rolling basis, noting that the branch that would handle the review has only 10 employees and is currently processing about 400 other FOIA requests.
How long would it take a team of 10 people to even read 329,000 pages of documents in addition to their current workload, let alone review those documents, which likely would frequently require back and forth consultations with others to do properly (e.g. the legal department or Pfizer's people)? How likely is is that they'll get money appropriated to beef up staffing levels of their FOIA team to get this done much more quickly?
>To meet the plaintiffs’ proposed FOIA deadline, the FDA would have to process a daunting 80,000 pages a month. But the plaintiffs note that the FDA has 18,000 employees and a budget of $6 billion and “has itself said that there is nothing more important than the licensure of this vaccine and being transparent about this vaccine.”
So what? Are they supposed to do stuff like assign the software development team to do document review for the next couple years? Because I'm pretty sure almost all of those 18,000 employees have very different jobs than FOIA document review (and may not appreciate reassignment), and that budget is already allocated to other stuff that's probably higher priority.
Also, the bottleneck may not only be staffing. What if they staff this with 1,000 people, and those guys are all waiting on one dude at Pfizer?
> and “has itself said that there is nothing more important than the licensure of this vaccine and being transparent about this vaccine.”
A FIOA request has nothing to do with licensure, and transparency doesn't necessarily mean doing whatever someone demands (to give an exaggerated example: if you say it's important to be transparent, and someone asks for nudes "for transparency," they haven't proven you wrong if you don't provide them), or doing that thing on their schedule.
These shenanigans show that the approval can't have been based on all the information. They should have delayed the approval, at least until Phase III trial officially ended.
I'm hedging a bit on "any" because a New Drug Application is supposed to contain "the whole story of the drug." As a result, it includes the original and translated copies of any non-English publications related to the drug. It includes case reports for every participant who died during the trial, including in the placebo group. It includes information on related patents and licensing arrangements.
I would expect the redaction to be way less involved than their review and analysis.
Worst case, they could hire the same number of people for a month to do nothing but redact those documents. In the unlikely case their whole agency was busy reading and analyzing all 329k documents, and redactors would be paid on average the same amount as the average FDA employee, it would cost the FDA 10% of its annual 2020 HR budget, which would be $600M, or $2,000 per page, which sounds absolutely ludicrous.
on the other hand, it seems general population vaccination should be at the top of their priorities. Releasing those documents should only help them fulfilling that goal. So they should invest in said release.
No matter how you're looking at it, "shenanigans" seems to be the most appropriate term here.
This is incorrect - this is not actually what they requested. Look at the complaint (https://fingfx.thomsonreuters.com/gfx/legaldocs/klvykdlryvg/...), paragraph 5
CFR (code of federal regulations) says: "“After a license has been issued, the following data and information in the biological product file are immediately available for public disclosure unless extraordinary circumstances are shown: (1) All safety and effectiveness data and information. (2) A protocol for a test or study . . .” 21 C.F.R. § 601.51(e)."
They requested all data that 21 CFR 601.51 authorizes, except for the adverse reaction reports available in the VARS database.
So whether the FDA reviewed or relied on all 329,000 pages, they are requesting all 329,000 pages.
Worse, of course, is that they deliberately ...'d the part that makes it take so long (this will, btw, piss off the judge and clerk who read the brief, since they will go and read that and see immediately that it happened)
Go look at 21 CFR 601.51(e) and subsequent parts, and you can see the FDA is required to do exactly what they said: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFR...
In practice, this is just the posturing phase - 90% of what the plaintiffs requested is probably pointless.
The CFR says " (g) For purposes of this regulation, safety and effectiveness data include all studies and tests of a biological product on animals and humans and all studies and tests on the drug for identity, stability, purity, potency, and bioavailability."
So like, this is probably tens of thousands of pages of blood pressure and heart rate readings for 10,000 anonymous people kind of thing. Along with tens of thousands of pages of blood test results, etc.
And then tens of thousands of pages of purity testing of random vaccine lots ;)
Usually, the judge will tell both sides to try to figure it out, they will get together and the plaintiffs decide "yeah, maybe we only really need 10k pages" and the defendants decide "yeah, we can do 10k pages in 3-4 months" and the case settles.
It would be super unlikely for the judge to order the FDA to produce 329,000 redacted pages of documents in very short order.
These are different jobs with different qualifications. The people who decide whether your vaccines are safe are not experts in processing FOIA requests, nor is that a reasonable use of their time when the FDA has actual regulatory work to do. And if it doesn’t violate any federal hiring regulations, it’s certainly a good way to lose important employees.
Why on earth is there even a potentiality of anything __compromising__ in there to even have to fucking review it?
Everything FDA should be presumed public. Like. Everything.
Naively, it seems to me that a regulator requires trade secrets to be disclosed to it in order to do its job well.
Don't accept documents that don't have these properly separated out. Don't accept documents that put non PII data in the "PII Pile".
If a company keeps fucking it up, fine them for all the extra work they've made FDA do and eventually drop trust in them and don't accept anything from them. Essentially kill the company.
FDA's data should not be private/for fee. Nor should any of the articles that the FDA uses to make its decisions.
I hope the important stuff is handled with more consideration than the way the pandemic has been handled. Specifically, hopefully the Fed knows what they are doing with this grand experiment that has been ongoing.
I know competent people exist.. but how many are in the positions that really matter? How many of our intuitions are held aloft by loony-toons inertial, like a coyote who ran off a cliff and hasn't looked down yet?
The people running the Fed are some of the best educated and most experienced people on the planet in this area. There is little doubt they know what they're doing. The bigger question is whether it's in your best interest.
Seriously people- STOP BUYING MASKS!
They are NOT effective in preventing general public from catching #Coronavirus, but if healthcare providers can't get them to care for sick patients, it puts them and our community at risk!
> There is little doubt they know what they're doing. The bigger question is whether it's in your best interest.
They knew what they were doing. But they did not know what they were doing. By not being honest and showing leadership, by politicizing science into scientism, by covering their asses for not buying enough PPE for the medics and soldiers, they heavily reduced trust in public institutions, and had to deal with the PR backlash of reversing an official stance mid-Pandemic, while whining about lab-leak "disinformation". Definitely not in our best interest.
https://www.webmd.com/lung/news/20210720/ex-surgeon-general-...
Same general was made aware by email (FOIA released) two weeks before taking to Twitter to complain about people wearing masks in an airplane, and that the real risk is the flu. Probably did not read it. The ones who did, got sidetracked by Trump, and warned their friends to wear masks and avoid cities, days before even notifying the public of the "potential" for community spread... but let's not assume evil, where no-skin-in-the-game suffices (who ever got real consequences for wrong or dumb stuff on pandemics, before 2020? You could grow solely through Powerpoints and grants and Nature articles.
Can you find ANY example of a public health official publicly stating how effective cloth masks are? Not that they ARE effective, but HOW effective? As in how much disease spread is prevented from wearing cloth masks.
I believe you will not be able to find any record of a public health official making a claim like "Wearing cloth masks reduces COVID spread by approximately X%."
My hypothesis for why you won't find this is because the % is extremely low, in the < 5% range.
You should test your hypothesis. Masks clearly help spread. But these are better at preventing spread to others, than for preventing catching COVID. So a larger percentage of people has to wear masks for it to be effective. I protect you, you protect me. There is a ton of research from before the pandemic (if you allow me to extrapolate influenza to a novel coronavirus with common sense, not wait on the randomized trial to finish), and now also a lot of reviews and aggregations of mask effectiveness.
If you believe that wasn't/isn't the scientific consensus, then I welcome you again to find any public health official willing to state on the record how much viral transmission they believe masks are preventing. I'll expand the challenge to include heads of top tier medical universities. And I'll even accept a range, like "between x and y%." You will not find such a thing.
Source? Mask wearing was quite prevalent in Japan and some asian countries.
>Despite common use of cloth masks in many countries in Asia, existing infection control guidelines do not mention their use (13).
>Rates of infection were consistently higher among those in the cloth mask group than in the medical mask and control groups. This finding suggests that risk for infection was higher for those wearing cloth masks.
From https://www.ucdavis.edu/coronavirus/news/your-mask-cuts-own-...
>A range of new research on face coverings shows that the risk of infection to the wearer is decreased by 65 percent, said Dean Blumberg, chief of pediatric infectious diseases at UC Davis Children’s Hospital.
Heh. This was the CYA they put out. Maybe it pays to publish only in the authoritative media channels if that's only what a large percentage of people read.
This was the public health consensus they themselves agreed on. Anyone who was in that room justifying not having people wear masks, has not rode in public transit in the last 20 years. Wear a mask and try spitting on the floor or picking your nose.
Scientific consensus was that masks clearly work to combat pathogen spread, and that's why they are in use in hospitals for at least 100 years. There even was scientific research on SARS-COV-1, comparing how many nurses got sick under different PPE policies, and how mask usage affected their recovery / long-SARS decline.
For a while, it was possible to define the (government) status of a person by the level of their PPE recommended to them. I think they ran their global pandemic surveillance systems searching for their own names and "N95 mask" and did not like the communities they were being discussed at. But not 100% certain of course.
I bet you won't find more than a few, if any, public health officials left willing to draw attention to their failures, or have been fired/retired in 2020 after spending their lives in pandemic control. Though it must hurt to leave with such a legacy, I can live with that. If you still need them to decide whether your kid should wear a mask at school or not, I sincerely feel for you. Information gathering and judging what is true absolutely sucked the past years, and it would have been nice if at least authority could have been trusted, more than, say, 4chan.
https://wwwnc.cdc.gov/eid/article/26/10/20-0948_article
>Despite common use of cloth masks in many countries in Asia, existing infection control guidelines do not mention their use (13).
>Rates of infection were consistently higher among those in the cloth mask group than in the medical mask and control groups. This finding suggests that risk for infection was higher for those wearing cloth masks.
Self-infection when taking it off, right?
The contempt for the general public from these people bordered on the perverse. How can they sleep at night? "We acted with the best information available at the time, and followed the scientific consensus to make our policy". Not even close to the truth, but maybe it helps a bit.
"If only you knew how bad things really are."
You really don't think distrust in government is fueled by an untrustworthy government - that everyone who distrusts now would distrust no matter what the government does or does not do?
You make an excellent case for ending all transparency or ethics monitoring. Haters gonna hate, right?
Who cares about the fringe anti-vaxxers? Those who want to obscure legitimate concerns it would seem.
That being said it would seem that the majority of evidence shows the Covid vaccinations are much more helpful than otherwise reducing symptoms of the infected (after having had the vaccine) by 90% and greatly increasing the chance of not dying from the disease.
But more to the point -- yeah I can see now how reasonable people can be dubious about the vaccine and the speed with which it was developed especially after these such bombshells albeit they are alleged the allegations are serious enough to warrant an investigation.
[1] https://www.bmj.com/content/375/bmj.n2635/rapid-responses
330,000 pages - I guess this seems reasonable. I mean, I don't think that there's any reason that the business/trade secrets really need protecting for something like this, but at least the FDA aren't just holding on to it all for that period of time.
I stepped into a role once where I led a team of 4 that replaced the last of a group of what had been 40 people that performed a function. Everyone had retired, predictably over 5 years. It was a mess, but the nuances of appropriations and government frugality created a situation where everything blew up. We fixed it, at great expense buying contractor services and ultimately automating most of the work.
In Federal government, you have the added impact of congressional meddling. So as a director managing potentially thousands of employees and a billion dollar budget, you don’t have the legal authority to reallocate people — you may in fact have people doing nothing on one side of the room while the people in the other side are working 12 hour days.
Also keep in mind that unlike corporate entities that can just settle awkward matters in court with NDAs, IC employees are held personally liable for their actions, will not stray off the path and have unions to protect them from management coercion. I consulted for some state/local entities that prosecuted 2-5 employees annually for significant breaches (both malicious and negligent) and would sanction folks with docked pay or progressive discipline for minor violations.
Why would they be paying you a million dollars a day again?
"The FDA - the actual FDA - tasked with protecting your food and drugs, employs more than a hundred people who do nothing - NOTHING - N O T H I N G - but process FOIA requests. What world is it where an agency supposed to protect us from bad food and drug products employs this many people to service paperwork requests from journalists and other random weirdos? It's a disgrace and it must stop, and it must stop NOW!