Comment by perryizgr8 | Hacker News Reader

Comment by perryizgr8 | Hacker News Reader

Parent Full thread

> Absent Congress appropriating funds specifically for it, yes.

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.

> 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.

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.

Sure, and that should not take 50 years for a document that took a year to create and analyse well enough to authorise the vaccine based on the findings.

Reviewing/analysing data and filtering it are dramatically different tasks. With raw data, most of the heavy lifting is done by your data analysis stack, you don't crunch numbers yourself. Complying with FOIA requests though, is largely manual work.

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.

If the FDA is not able to deliver our documents to us in time, maybe it is time to shut it down. Let public do the research and let consumers decide if they want to take the vaccine based on available results.

> If the FDA is not able to deliver our documents to us in time, maybe it is time to shut it down. Let

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.

I believe the FDA is already mandated by law to release this data, which is why the original lawsuit was filed.

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.

Yeah, but this scale of documentation production is unprecedented.

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.

Ironically, if the FDA could deliver those documents "in time" it would be a sign of a pretty limited trial, and people would be complaining about that instead.

Damned if you do, damned if you don't.

> Sure, and that should not take 50 years for a document that took a year to create

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...

IMO if the agency cannot disclose to the public the documents it prepared for the public, that's gross incompetence. It just adds to my argument that FDA should be shut down, since they are clearly incapable of doing their job.

> IMO if the agency cannot disclose to the public the documents it prepared for the public

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.

> 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.

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...

Reply on news.ycombinator.com