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FDA wants 55 years to process FOIA request over vaccine data
- userbinator 5y agoAt that rate, and given how often hacks occur, I think there's a much higher chance of some hackers leaking that data far sooner than 55 years.
- hermes8329 5y agoI wonder if someone at the FDA was like "hey, you know what would be funny....."
- tholman 5y agoOddly am hitting a paywall, is there a summary for this?
- deleted 5y ago[deleted]
- exikyut 5y agohttps://archive.md/jdb7t https://archive.md/jdb7t
- gigatexal 5y agoShenanigans like this are what fuel the anti vaccine conspiracy theorists
- Alex3917 5y agoUnfortunately 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.
- crymer11 5y agoSo they generally disregard federal law (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=601.51 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFR...)?
- DannyBee 5y agoThis is not correct, and i'm not sure why you think this. 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?
- Alex3917 5y agoYeah 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.
- DannyBee 5y agoSo, 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.
- nathanaldensr 5y agoMaybe they shouldn't be derogatorily called "anti vaccine conspiracy theorists," then, but merely "observant."
- tablespoon 5y ago> 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?
- trdlts 5y agoPer the OP >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.”
- tcmart14 5y agoAssuming 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.
- zzt123 5y agoAnd 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.
- Eelongate 5y agoI'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?
- noduerme 5y agoWas 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.
- Consultant32452 5y agoCan 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.
- Reuzel 5y agoHere 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. https://www.webmd.com/lung/news/20210720/ex-surgeon-general--says-cdc-mask-guidance-may-be-wrong 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.
- swayvil 5y agoShenanigans like this make the anti vaccine conspiracy theorists look pretty legit.
- lame-robot-hoax 5y agoHow so? What “shenanigans” are you talking about?
- encryptluks2 5y agoMany people being labeled anti-vaccine had no issues with previous vaccines, it was how the rollout was handled and the time frame that made many people suspicious. Calling people that are not interested in an experimental vaccines anti-vaxxers, is like calling someone not interested in hetrosexual intercourse anti-sexual.
- zokula 5y agoNah... Anti vaccine nutjobs still look like crazies.
- happytoexplain 5y agoMost conspiracy theories are unavoidably fueled by essentially everything, fact and fiction alike.
- dredmorbius 5y agoMore than anything else: motivation.
- pessimizer 5y agoWhereas 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?
- justsee 5y agoRevelations 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.
- throwntoday 5y agoCareful now, you're committing a thought crime.
- gigatexal 5y agoI 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. [1] https://www.bmj.com/content/375/bmj.n2635/rapid-responses https://www.bmj.com/content/375/bmj.n2635/rapid-responses
- deleted 5y ago[deleted]
- iratewizard 5y agoI think you mean anti-gene therapy conspiracy theorists
- solarkraft 5y agoNothing in this discussion has anything to do with that.
- gnabgib 5y agoDupe of [FDA asks federal judge to wait until 2076 to fully release Covid vaccine data](https://news.ycombinator.com/item?id=29261058 https://news.ycombinator.com/item?id=29261058) 1 day ago, 75 pts, 60 comments
- vnchr 5y agoDuplicate in subject but this is from a more qualified source which was a repeated point of discussion in the comments. I hope this thread stays.
- King-Aaron 5y ago> 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.
- Eelongate 5y agoThis 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.
- Someone1234 5y agoI'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.
- 1123581321 5y agoSeems 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.
- Spooky23 5y agoLol. 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.
- adolph 5y agoJustice 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."
- giantg2 5y agoCongress 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.
- xmprt 5y agoI'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?
- stjohnswarts 5y agoMy 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
- pas 5y agobecause 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.
- thrill 5y agoThat $30 trillion of debt sure has bought us some quality government.
- iscrewyou 5y agoAdd debt(increase spending) and take away the pay(tax cuts). 1-1=0.
- walterbell 5y ago> 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.
- smnrchrds 5y ago> 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.
- throwawayboise 5y agoWhy would the FDA need the PII from the patient data?
- loteck 5y agoI'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.
- post_from_work 5y agoImplement 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.
- giantg2 5y agoOr in this case, make companies submitting to the FDA file a sanitized version of the report along with the full one.
- stjohnswarts 5y agoThis would go a long way towards making the process feasible.
- propogandist 5y agothis 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: https://www.youtube.com/watch?v=OUUmK4u0kj8 https://www.youtube.com/watch?v=OUUmK4u0kj8 [1] https://www.euractiv.com/section/coronavirus/news/covid-vaccine-contract-nearly-a-quarter-obscured/ https://www.euractiv.com/section/coronavirus/news/covid-vacc...
- helsinkiandrew 5y agoIt’s a little different - the FDA are going to take 55 years to do the redacting - to remove ‘sensitive’ information.
- m0zg 5y agoAnd in related news, anyone vaccinated, but without a booster (AKA me) will soon become "unvaccinated". Good luck in the midterms, Brandon, you're gonna need it.
- ryan-allen 5y agoOf all the material that can play into those who suspect COVID-19 conspiracy, well, is this it?
- gvv 5y agoTrust don't verify I guess.