> 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”
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.
The FDA is required by the CFR to redact certain things from the publicly available file.
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.)
They should have redacted the info when they had advisory Committee's review it to recommend boosters and vaccines for kids. Usually when govt has personal identification, they use numeric identifiers in documents as HIPPA is very strict with personal identification. Proprietary data should be concentrated in specific documents and easily redacted. There is no excuse for what they are doing. I have worked with MEDI-CALand Sicial Security information on several occasions as an auditor and a fraud investigator. They have the resources and much of the proprietary and personal information is already coded in a manner that an outsider would not be able to decipher. 500 pages a month is ludicrous.
These companies were also granted liability waivers for these vaccines (and are making record profits from them). They should not get to preserve any "trade secrets."
Tell us about that time you and your neighbors called your representative and somehow "pressured" him to break against party, donors, and every other force acting in the opposite direction. Did you succeed because you and your neighbors made persuasive arguments, or were you important donors, or did you merely receive an equivocal response? Or was the matter a triviality with no important competing interests?
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.
There are literally tens of billions of dollars at work trying to block this release. The harder they try, the more that tells you something is up. Time and resources are not the reason they won't release the info. Unfortunately, the legislators are compromised because Pfizer is making huge contributions to each party's Political Action Committee's. There is an incestuous relationship between industy and politics. Trial Lawyers, Unions and Pharma are the biggest influence buyers.
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.
Moderna and BioNTech both made around $7 billion profit each, not revenue, just last year. Because of this, their share price is also up 11x since IPO 3 years ago, and 16x since IPO 2 years ago, respectively.
Damn, imagine making a world changing product used by close to half of the world's population to overcome a global crisis... and making less profit than a company that sells highly marked up leather bags.
Kind of a depressing thought the extent to which we prioritize things.
> These companies were also granted liability waivers for these vaccines (and are making record profits from them). They should not get to preserve any "trade secrets."
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.
Yet Pfizer et al got their fantasy and nobody blinks an eye?
Pfizer, Moderna, and Biontech were recently reported as making $1000 per second from the vaccines. Fuck their "trade secrets." Protect the privacy of individuals, but these companies were not given special exemptions so they could make bank, and should not expect business as usual.
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.
> Wouldn't this separation be designed into the process for data management during the clinical trial?
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.
Yeah, with 18,000 employees and a $6 Billion annual budget, the FDA clearly has sufficient resources to process the data. All personal information would be already be coded or assigned a numeric ID that would make it impossible to identify specific participants without the master key. To represent that this project would require additional resources via congressional action is complete nonsense. Redactions should have already been performed as most of this information has been reviewed during the FDA approval processes. I expect the judge will find that the March 2022 date requested by FOIA will be seriously considered by the Judge on December 14th, as people are being fired for not complying with vaccine mandates and this would merit an urgent matter. I can't believe they tried to release only 500 pages per month in thos polarized environment we live in.
> it did not take decades for computer-structured clinical trial data to move across the corporation->government boundary
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.
> FDA may inspect study records, for example, to assess investigator compliance with the study protocol and the validity of the data reported by the sponsor
PII is not just name and SSN. Using all the demographic information recorded for each participant and open-source intelligence, you should be able to uniquely identify them.
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.
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."
Congress passes all sorts of laws that need enforcement or implementation, yet the agencies are not staffed to enforce/implement them accordingly. Still, we clammer for more laws to "fix" things, even when the current ones are impossible to handle.
I'm always dumbfounded that the IRS isn't the most well funded branch with the best accountants in the country with the resources to actually go after some of the richest people in the country. Given how poorly funded they are right now, each employee should be able to net more than enough additional revenue to pay their salary.
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?
My guess is that mega-rich people (most of congress) prefer that the IRS not be more litigous and well-funded than it already is because a significant number of them have doubts about how legal their tax activities actually are. Also they certainly don't want to anger their donors and super PACs
because the Panama papers was mostly a non-event for US folks. FATCA was already in full force. that a few celebrities who have money had accounts there ... means nothing.
it was a big thing for countries where the leak uncovered (or "proved") corruption.
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".
I didn't dig into the FOIA submitters here, but I can say there are intentional, organized efforts by some people opposed to the vaccine to delay the rollout via paperwork requests.
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.
> The plaintiffs, a group of more than 30 professors and scientists from universities including Yale, Harvard, UCLA and Brown, filed suit in September in U.S. District Court for the Northern District of Texas, seeking expedited access to the records. They say that releasing the information could help reassure vaccine skeptics that the shot is indeed “safe and effective and, thus, increase confidence in the Pfizer vaccine.” -- TFA
“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.
Skepticism pursued in a manner that overly impacts others is morally wrong.
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.
I wasn't opining on the motive of the submitters of this FOIA request. I was saying "This is an unexpected thing I have seen first-hand from other parties. I think it's disingenuous. And it makes me suspicious of large document requests related to vaccine minutiae."
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.
this isn't isolated to the USA, it's happening in Europe too
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:
I'd welcome a sincere discussion regarding how to fix public records laws that are designed to be unrealistic and waste the maximum amount of time and effort for both the requester and the public agency.
We would all like the maximum safe transparency but I somehow doubt most of us would like to pay for it.
Implement records management/data management policies with metadata tagging for individual fields in a record.
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.
Revelations like this, the BMJ whistleblower claiming scientific fraud in the clinical trials, and other clear oddities are what fuels the interest of science-minded citizens.
Who cares about the fringe anti-vaxxers? Those who want to obscure legitimate concerns it would seem.
I support investigating these corner-cutting drug trial third-parties. [1]
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.
And dumb messaging such as telling people masks are ineffective and shouldn’t be worn by ordinary people.
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'm starting to get a sinking feeling in my gut that much of our modern society is a house of cards built out of people hoping nobody else notices they have no clue what they're doing.
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?
Was it ever not? Ineptitude and deferred consequences for laziness/stupidity have been baked into every society since anonymous caveman dropped a deuce in the water hole. On the upside, we've gotten a lot better at getting to the root causes of disasters more quickly - and at least outside of authoritarian states, people are allowed to inform one another of the causes and effects of mismanagement.
Can you find a public health official that has been willing to, on the record, give an approximate % of disease spread the typical cloth mask is preventing? I've seen individual studies with varying numbers, but have never seen an actual high level public official make a concrete statement.
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.
Here is a public health official (Surgeon General of the United States) saying quite as much as OP was saying:
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.
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.
Maybe I wasn't clear. I'm aware public health officials flipped the script on masks.
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.
I don't think a public health official averaged out all the research on masks and came up with a percentage. A lot of public policy was binary: masks prevent spread, but COVID can also spread through eyes and ears. We do not want general public to think they are fully protected with masks, and they will never understand nuance, only clear directions. So, do not wear masks, they are not effective for you. Ivermectin, Vitamin D, and HCQ are 100% ineffective, so get your shot.
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.
I agree there is a lot of research pre-pandemic on the effectiveness of various types of masks in preventing the spread of virus. The consensus before the pandemic was that the spread prevention was so low that it could not justifiably be recommended for the purpose of preventing spread of virus.
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.
> The consensus before the pandemic was that the spread prevention was so low that it could not justifiably be recommended for the purpose of preventing spread of virus.
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.
>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.
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.
The hypothesis in the article was that the cloth captures droplets/water vapor that is carrying virus. And then it's captured there for you to continually suck it out of the cloth when breathing. Without a mask it would've drifted away.
>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.
>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.
>The consensus before the pandemic was that the spread prevention was so low that it could not justifiably be recommended for the purpose of preventing spread of virus
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.
> Shenanigans like this are what fuel the anti vaccine conspiracy theorists
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?
They approved the vaccine. The general expectation is that they released the approval after reading relevant information. They have 329,000 pages of information, so it can only go 2 ways : They either had enough people to already go through those documents, analyse them and conclude the vaccine was safe in about a month. In which case, they could reallocate those people for a month to redact said documents. The alternative being that they reviewed a small portion of said documents, which would render their argument completely moot, since they would only need to release the documents they actually used during their decision
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.
> They either had enough people to already go through those documents, analyse them and conclude the vaccine was safe in about a month. In which case, they could reallocate those people for a month to redact said documents.
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.
"The alternative being that they reviewed a small portion of said documents, which would render their argument completely moot, since they would only need to release the documents they actually used during their decision"
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)
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.
> 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?
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.
Then no one will sign up for trials because that would mean all their personal information and medical history will become public which could result in them not getting hired.
Then filter out PHI/PII on ingress, not on egress. This isn't a problem that can't be solved.
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.
>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.”
> But the plaintiffs note that the FDA has 18,000 employees and a budget of $6 billion
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.
Assuming that all 18,000 employees can actually do the work. Im sure some FDA employees are spread through out various states and have various different responsibilities like focusing on the 'F' in FDA. And those people might not be qualified to work on the processing of papers on vaccines and drugs. That also assumes that they don't overload pfizer and other drug makers with questions that they can't answer in a reasonable time to meet the proposed deadline.
I'd bet that no one person has read all 329,000 pages, but I would bet that somebody looked at almost any given page.
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'm assuming whoever made the decision read the summary. The majority of those "pages" are probably just raw data. Most of it is probably each experimental patient's temperature and blood pressure, each time they got checked, one page at a time.
Should they have delayed the emergency authorization of the vaccines until these 330,000 pages had all been reviewed and redacted? It would have cost hundreds of thousands of lives, but I can't see any benefit from that course of action.
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.
How many lives would that have cost, though, and for what benefit? The size of the sample that had already received the vaccine without issue made it basically impossible [0] for there to have been an unexpected danger. And without approval, the govt couldn't mandate federal employees take the vaccine, and that mandate has saved tens of thousands of lives.
Should they delay the FOIA release until these 330,000 pages had all been reviewed and redacted? I don’t think the answer to either of these questions are “no”, though ofc the standard could vary.
Unfortunately this is the status quo, not shenanigans. The data the FDA relies on to approve drugs and vaccines is considered a trade secret and is generally never made public.
Yeah fair you can FOIA it, if you have the money and are willing to wait multiple years. But the data is never released without doing that. The point is there is no way for the average person to know whether the drugs they are prescribed actually work or not, nor is there any way for doctors to know whether the drugs they're prescribing actually work or not, because whatever is published in the academic literature doesn't reflect the trial data. E.g.
"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.
So, releasing the data is hard by default because of what it would require - you are talking hundreds of thousands of pages for a single drug.
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.
Whereas most people most people who believe unfounded conspiracies suffer from a profound distrust in authorities and channels of information that are often deceitful and secretive, and turn to hucksters in a desperate search for an explanation for why the most powerful forces in the world are always lying to them.
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?
> 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.
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.
This country has more than 300 million people. Any federal agency having a bottleneck of merely ten clerks for processing FOIA requests is unreasonable to the absurd.
I see what you are saying, yet I wonder about the logistics of this. I doubt these a minimum wage jobs. Surely it takes a knowledgeable person who is willing to do this kind of tedious work. How many people fit the requirements? Do they have to live in a particular geographic location? Everyone is having trouble hiring people. Is the government any different? I assume they have to go through background checks and get trained. How long does that take? How many other FOIA requests do they have in the backlog? Is there a risk of the current 10 people quitting if the work load becomes to onerous? Can they really ramp up to get it all done by March? Maybe if the government threw insane amounts of money at problem. I don’t like tedious exacting work, but I’d happily do it for 1 million dollars a day.
Get 20x the staffing and see if these questions resolve themselves. It's not a challenge to hire more than 10 people, and training time is going to be significantly less than 55 years.
Why would they be paying you a million dollars a day again?
Consider it spending to prevent vaccine hesitancy. It would probably be more effective then a advertising campaign with the same money (provided the documents indicate everything is on the up and up) as it stands this looks bad and will push people further away.
What evidence is there that more lives would be saved by diverting FDA employees from other tasks (like evaluating the safety of drugs, vaccines, medical devices, food, etc) to redacting trade secrets from documents that on the order of 10^0 people will read? How does DDOSing the FOIA unit of the FDA undermine the wholely separate review process that conclusively found both mRNA vaccines to be completely safe and extremely effective at preventing serious harm? How could that be more persuasive than the fact that (per the NYTimes COVID tracker) unvaccinated people make up 6/7ths of new daily cases and 12/13ths of new daily deaths?
The people hesitating to get the vaccine aren't doing it for scientific reasons in the vast majority of cases and nothing will convince them short of losing their job or similar negative consequences.
That's a strawman considering the overwhelming majority of people taking vaccine aren't doing it for scientific reasons either. They're taking it because of social pressure, virtue signal, fear, etc. but certainly not knowledge about science since less than 1% of the population is PhD educated and know anything about how science is done in the first place.
I don’t think that’s true at all. I don’t worry about polio, smallpox, etc. because of vaccines. I got vaccinated as soon as possible because vaccines have been proven to work. Absolutely nobody pressured me and I certainly don’t care what other people think.
So only PhD's know how to science. Guess my master's in EE doesn't mean jack then. Why am I even trying to read academic papers or science journals related to my job? I mean I don't even have a PhD...
I'm certain the FDA would welcome more staffing across the board, including to handle FOIA requests. Might be worth people contact their representatives and raising the issue.
Seems more promising to pursue legislation that will circumvent the requirement to review documents so slowly. This staffing count decision was not made by people who love serving public interest transparently. Such people cannot be removed or ordered to change by the few representatives who would act on comments about FOIA.
Lol. I’ve run large government organizations. You don’t just make people appear out of thin air… the government tends to “grow” specialized people (mostly attorneys) like this into these roles; you can’t hire expertise because the pay sucks.
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.
Yes, if I understand your implied point, your experiences are congruent congruent with the view that there is little incentive to appropriately invest in this area, both into the ICs and higher up in the organization. A lighter standard for redaction would reduce the need for expensive external costs in the case that short response deadlines could successfully be imposed by a judge or Congress.
There are incentive problems but other governance issues are significant. Government entities are optimized for steady state and have controls to make individual failure less impacting and change hard. Think about how 50 state DMVs fundamentally work with a low error rate.
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.
"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!
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.