"At that rate, the 10 employees would have to work non-stop 24 hours a day, seven days a week to produce the 55,000 pages a month (and would still fall a bit short)."
The reporter suggests the FDA reassign other people to process the FOIA requests but I would prefer those people continue working on important things like reviewing the safety and efficacy of medical devices[1] and reviewing the safety of food and infant formula [2] rather than spending their time processing paperwork that will, at best, be used by anti-vaccine activists in social media disinformation.
I would be interested in seeing who this 'Public Health and Medical Professionals for Transparency' front group is. My guess is it's a group of charlatans looking to sell their own COVID cures similar to the doctor who produced the original study claiming vaccines cause autism (which was later retracted)
There's very little reason to believe that the reassignment will actually come from teams working on either of those two problems. This argument is a really long stretch - especially because there are other ways of meeting the deadline than reassignment to the FOIA office (hiring contractors, adding employees, using interns or HR folk) - picking out a highly specific and avoidable method of executing the FOIA to attack the idea of doing the FOIA at all is...questionable, to say the least.
Moreover, as a citizen of the US that has paid for the R&D of those vaccines through my tax dollars, I have a right to see the results of that research. This shouldn't be a controversial opinion. (it certainly wasn't when the House passed the Freedom Of Information Act 306 to 0 in 1966)
>Moreover, as a citizen of the US that has paid for the R&D of those vaccines through my tax dollars, I have a right to see the results of that research. This shouldn't be a controversial opinion.
Pfizer didn't take any US govt money for the R&D of the vaccine.
>Moreover, as a citizen of the US that has paid for the R&D of those vaccines through my tax dollars, I have a right to see the results of that research. This shouldn't be a controversial opinion. (it certainly wasn't when the House passed the Freedom Of Information Act 306 to 0 in 1966)
there's hundreds if not thousands of top secret military r&d projects funded by tax money that will never see the light of day regardless of foia, this isn't particularly special and could very well include classified info that needs to flow down very long approval and bureaucratic processes. Hiring more people and then training them on that process would just lengthen the time needed to release the info
> This argument is a really long stretch - especially because there are other ways of meeting the deadline than reassignment to the FOIA office (hiring contractors, adding employees, using interns or HR folk)
Reading a document and making an assessment of to the disclosure obligations under FOIA isn’t something you can just pluck an intern to do and hand them the box of documents.
So your for using power to totally destroy all the hard won battles for transparency, destroy trust in public institutions, and feed conspiracy theories?
I don't think you have thought this through. I don't think you read the part where the FDA has 18,000 employees.
The FDA should be above politics.
Isn't it suspicious that the FDA is doing this, and that the public have a right to know and see the underlying documents within 90 days of drug approval? Isn't is Phizers responsibility to submit the documents in a way that protects privacy?
All the norms are lost here. You couldn't find a better way to destroy the credibility of the FDA than to "never" have meaningful transparency on the fastest, most hastily produced, many corners cut drug.
Quite frankly, the FDA would rubber stamp a pile of cow poop if it were politically expedient.
The only way to win back trust is to hold them accountable, for better or for worse, even if it feeds vaccine conspiracies.
It can't be done in my generation, but maybe in the next when this COVID saga is largely memory holed
No, none of it is suspicious, unless you're a person who is trying to cast doubt on vaccines by claiming that vaccines on platforms that have been under development for two decades and went through enormous trials were 'hastily produced' with 'corners cut'
It's about being suspicious of the pharmaceutical industry and the FDA, which has a revolving door that has been abused.
The FDA has never been held to account for its improper handling of the opioid crisis. But the FDA’s conduct is all the more troubling in light of the close relationship between the agency officials responsible for opioid oversight and opioid manufacturers. For example, the 2 principal FDA reviewers who originally approved Purdue’s oxycodone application both took positions at Purdue after leaving the agency. Over the past 20 years, several other FDA staff involved in opioid approvals also left the FDA to work for opioid makers. Last January, the head of the FDA’s analgesic division retired from the FDA to start her own consulting business, which promises drug makers “help” to “successfully and efficiently bring your products to market” with “more than 30 years of experience at the FDA.”
To be clear, the revolving door between the FDA and the pharmaceutical industry is not limited to opioids. A 2018 study found that 11 of 16 FDA medical reviewers involved in approving 28 products now work for the companies whose products they regulated. Without appropriate limits on employment after leaving the FDA, staff might be tempted to put the interests of future employers, whose favor they wish to gain, ahead of public health.
you mean prove that conflict of interest is real? Isn’t that something that any experience with human behavior would confirm quite easily? Do we need to prove that judges should not receive money from one of the parties in a lawsuit they are presiding over?
Are you referring to the mRNA vaccine platform? Could you point me to the mRNA vaccine application that was approved before covid?
When I looked into it all, of them had been denied until covid and I did not hear of any breakthrough in mRNA technology that suddenly fixed the issues the previous ones (I found 8) had been denied for.
It's just a coincidence that these companies that have been working for years on this stuff failed every single time in the past, but then within a few weeks in early 2020 they suddenly figured everything out.
I am confused here. There were issues with the previously submitted mRNA vaccines created pre covid. Of the 8 I could find all were rejected. Doing a process that does not work in parallel will not suddenly fix it.
Moderna was founded precisely to find the Holy Grail. Making a breakthrough in a matter of weeks that couldn't be found for 8 years is incredibly hard to believe no matter how much additional money is thrown at the problem.
No, I can have both. For 8 years, they've tried a bunch of different things that they thought would work. Literally none of them did. And then in a matter of weeks, they figured the whole thing out.
Obviously they didn't start from zero. But it wasn't like they had something from, say, 2018 that was looking promising but just hadn't made it all the way through trials yet. They had nothing but failures.
They spent eight years iterating their technology. The idea that they had nothing but already-failed candidates at the start of the pandemic is simply false.
> We have a diverse pipeline of 24 development candidates, 12 of which are currently in clinical trials, and many of which have the potential to be first-in-class or best-in-class medicines.
All of this is a bit academic, anyways. We've plenty of evidence the Moderna vaccine works. You can quibble over the exact rate of rare side effects a little, but it's abundantly clear it's good at reducing deaths and severe disease in the vaccinated population.
So if they didn't make the breakthrough in weeks, what do you think happened? They already had a secret COVID vaccine for years? The trials were faked and all the post-trial evidence about vaccine efficacy is also faked?
> So if they didn't make the breakthrough in weeks, what do you think happened?
The expected vaccine sales were high enough to justify spending resources initiating developement on lots of candidate mRNA vaccines in parallel, and spending the money testing more of the potentially viable ones at a time than would otherwise have been the case. When you throw a lot more against the wall, you find something that sticks a lot faster.
Wait, what were the issues with the mRNA vaccines? If you are accusing the mRNA vaccines of having "issues" then it's important you provide details and a citation
> But the Crigler-Najjar treatment has been indefinitely delayed, an Alexion spokeswoman told STAT. It never proved safe enough to test in humans, according to several former Moderna employees and collaborators who worked closely on the project. Unable to press forward with that technology, Moderna has had to focus instead on developing a handful of vaccines, turning to a less lucrative field that might not justify the company’s nearly $5 billion valuation.
Of course, as the apocryphal Edison quote goes, "I haven't failed, I've found 10,000 ways that don't work."
If only Moderna had realized in that they could "do all the steps [they] can in parallel to speed things up" 8 years ago! They managed to accomplish what had eluded them for 8 years in a matter of weeks. Astounding stuff.
> For instance, it took just under 16 weeks to recruit and enroll more than 43,000 volunteers for the final phases of testing Pfizer’s vaccine. When volunteer recruitment began for clinical trials of the rabies mRNA vaccine in 2013, it took 813 days to get 101 participants enrolled. Based on this comparison, that’s roughly 730 days — nearly two years — saved in recruiting alone.
The same article cites precisely one of those parallelization steps I'm talking about:
> In a final jolt of speed, some pharmaceutical companies, bolstered by big vaccine contracts and research cash from the U.S. government’s Operation Warp Speed, were also churning out doses during clinical trials in the hopes that the vaccines would work. Once the companies had emergency use authorization in hand, they were ready to ship doses immediately.
Sure, you're explaining why and how testing went faster. I totally understand that, but it's not at all what I'm talking about.
All of the previous mRNA drugs failed testing due to safety concerns. But we're expected to believe that those safety concerns were resolved in a matter of weeks.
> All of the previous mRNA drugs failed testing due to safety concerns.
Sure, and all the planes leading up to the Wright Flyer failed.
https://www.nature.com/articles/d41586-021-02483-w has a great timeline graphic of the various advances and breakthroughs required to get to this point, including the first drug using the lipid nanoparticles - key to fixing the safety concerns! - approved in 2018.
For sure. I know if I had an opportunity to create and sell a product that would be all but required for everyone across the world, I'd hurry my ass up to create it.
It boggles my mind that anyone can oppose transparency. Why do some people view these vaccines/pharma companies as something sacred, not to be questioned.
(disclaimer: my experience with FOIA is mostly at the state level and though I've read, used, and litigated federal FOIA issues, I'm no expert there)
Transparency doesn't work in isolation. If there's a problem where the release of 450,000 pages of patient information is so difficult that it can't be done, then there's a fundamental process fuckup that should be corrected. For example, if everything's on paper, then the process failure is in a lack of transcription. If it's because private information is typed in a form, that form should be broken up in a way so that the important private information is typed into another field. Generally there are ways to make sure these issues don't happen -- from the beginning. Keep in mind, these people are aware of the existence of FOIA and the possibility that these records would be subject to FOIA. These processes should be built with that in-mind, especially considering the importance of the information.
It's such a big deal that in states like Illinois, the law disallows the use of the unduly burdensome exemption if the gov agency doesn't respond within the time limits of the statute. Takes 10k hours? Big deal, shoulda responded in time.
A lot of these issues stem from the fact that in so many cases, the agency's estimates are either beyond any possible worst case scenario (ie, unrealistic), or an intentionally naive estimate in order to urge the requester to go away. If we take these public agencies at face value that something would take forever without litigation, then they can easily just make it a routine process to call something unduly burdensome, so it's important to call them out on their shit. See: https://mchap.io/that-time-the-city-of-seattle-accidentally-...
I would imagine it's like technical debt. There's benefits to paying that debt down, but there are always other issues that have higher priority. Sure, the software should have been architectured to be easily extensible / system should have been set up to make it easy to release half a million pages of documents, but this update has to be released in time to beat the competition / these drug approvals needs to be completed to save lives.
The argument on technical debt isn't wrong, but it doesn't fully take into account the importance of this information and the legal requirements these agencies are held to. Just because it's difficult doesn't mean the information shouldn't be released. If we accept that the request is difficult as a reason to not release the records, then they'll never get released. Once that seed's planted, it's so unbelievably hard to come out of. It's something you see with agencies that never get held accountable to their lack of transparency.
Absolutely. Even with highly profitable global megacorps, technical debt is an issue, but eventually they have to pay the piper. I'm not sure if it is true in this case, but my image of governmental agencies are that they are perpetually underfunded and short-staffed, so it must be an even greater difficulty to choose between what should be done and what must be done.
Remember pfizers own report and raw data are not the only options, it's a false dichotomy.
In order to make the report in the first place, Pfizer had to preprocess the data to intermediate, tabulated formats. However, this data is their secret IP, which in and of itself is absolutely insane, given that we're moving in the direction of mandates.
I don't get how one of the most foul industries – by public track record — suddenly get a carte blanche from otherwise sane and critical people. There are so many scandals in Pharma, and suddenly overnight you're a conspiracy theorist if you want independent scientists to double check the biggest public health mandate in history.
This is very useful information, though. People can analyze this to find out if there is any increased risk of adverse effects (or not) by all kinds of factors that hasn't been released. Things like underlying medical conditions.
Some people with certain medical conditions are vaccine-hesitant because of their health condition. If this data can prove that people with certain health conditions aren't at any increased risk from the vaccine, it could mean more people get vaccinated.
Sorry, no. These gov agencies don't tell us what information they have (often intentionally!) and so we can't always be explicit about what information we want. If they told us exactly the extent of information they have, then we wouldn't need to play these silly little games of requesting more than what necessarily exists.. but what choice do we have?
Who is against transparency? Has anyone argued that this information shouldn't be released? AFAICT the court battle is just about speed, and whether the FDA should go out of its way to satisfy this particular FOIA request more quickly.
Anyone taking the FDA's side is against transparency. In 75 years no one will care about this data except like a single historian working on their PhD in a bizarre medical history field.
> So your for using power to totally destroy all the hard won battles for transparency, destroy trust in public institutions, and feed conspiracy theories?
If the FDA screws up in their now legally compelled rush to produce these documents what happens?
Pfizer could have their trade secret info leaked (like it or not that shouldn't happen)
Participants in vaccine trials could have their private health information leaked (or have their identity stolen)
The FDA is responsible and liable
FOIA abuse is a thing, just like DMCA abuse is a thing. People abusing the FOIA process are the ones who are likely to lead to its power being destroyed, not the government here.
It isn't suspicious...this group is intentionally misinterpreting things in bad faith under the guise of accountability.
It's classic bad faith, and I'm deeply saddened at how easily this country falls for it.
>I would be interested in seeing who this 'Public Health and Medical Professionals for Transparency' front group is. My guess is it's a group of charlatans looking to sell their own COVID cures similar to the doctor who produced the original study claiming vaccines cause autism (which was later retracted)
- Aaron Kheriarty is no longer associated with UC Irvine after refusing their vaccine mandate (this changed between the filing and now) and tweets links to The American Conservative. https://twitter.com/akheriaty
- Harvey Risch published an opinion piece in favor of hydroxycholoroquine in the American Journal of Epidemiology which attracted opposition from many other scientists as inappropriate/unscientific (not simply wrong yet within the bounds of good-faith scientific inquiry) and a response from that journal. https://academic.oup.com/aje/article/190/4/491/5898696
Why do we care about this? Does he also have bad taste in summer outfits?
> which attracted opposition from many other scientists as inappropriate/unscientific (not simply wrong yet within the bounds of good-faith scientific inquiry)
That is incorrect. The counter arguments were narrow and about statistical methods, specifically risk ratio usage and confounders. Neither side appeared out of bounds in this debate.
> Peter McCullough appeared on an episode of Joe Rogan where even Joe Rogan correctly identified that his claims were implausible.
The NY Post article you link to is about getting both Covid and influenza at the same time. That may be rare.
Getting covid a second time after having previously had it (which is what McCullough erroneously claimed was near impossible) is in fact increasingly common.
Yes, but in the subsequent podcast with Joe Rogan and Robert Malone, Dr. Malone specifically says that Dr. McCullough asked that he let everyone know that he was basing his information on pre omicron variant and that reinfections are actually much more common with this variant.
Nah a lot of Delta cases where reinfections, I can't believe we are still arguing about wether COVID mutations can reinfect only because of McCullough.
Of course if you only look at the "variants of concern" that the media talks about you basically have to wait years until you have like 4 or 5 variants that went all around the world to see how common it is for it to mutate in a way that can reinfect, but considering Delta reinfections where common and now Omicron is also reinfecting everyone, I would just not loose any more time listening to McCullough. Note he says its _impossible_, not rare or weird or strange, _impossible_. He actually called bullshit on Rogan because Rogan said his friend got it twice because he got Delta and the first variant.
The first serious reinfection study I saw for Delta was the NHS study, with like 350+ reinfections over more than 35000 health workers. I think the chances for a case on that study to be a reinfection was something like 1.2% to 1.5%
I consider that "a lot" special when compared to McCulloughs prediction of 0.0% because reinfection was impossible.
I agree that they are rare. Dr. McCullough's claim was that they were impossible, that Rogan's friend who got it twice actually had influenza or something one of the times - a diagnosis he made based on no information other than appearing to have gotten it twice.
If he merely claimed they were rare, that would not discredit him.
And as mentioned above, he later clarified that he was talking about pre-Omicron variants, where that was true. It now seems possible to get Omicron more than once, but since it has virtually no impact (most people never even know they have it, especially here in Austin in Dec-Feb "Cedar Fever" season), it really makes no difference, other than that it's not yet known if it works the other way, so that an Omicron infection may provide protection against prior variants.
I'm hardly "upset" - I just think the doctor is not a reliable source of medical information and not operating in good faith.
Are you upset because I hold that view based on observable evidence? Like, genuinely, I'm confused why you're so invested in arguing against me. What's the thing I said that you disagree with? Are you saying that the doctor is a reliable source of medical information despite his entirely unsubstantiated pronouncement that there was no possible way Joe Rogan's friend could have gotten covid twice, and one of those cases must have been influenza or something?
Nothing suggests these folks are acting in good faith. They showed no willingness to bound an obviously over-scoped request. It is sad the judge didn't see this for what it is.
They are abusing the process to make the FDA and Pfizer look bad by requesting an absurd number of things and not scoping out things that they obviously are not entitle to. Pfizer, like it or not is entitled to have their trade secrets protected. Like it or not, Pfizer and teh FDA have a responsibility to protect the private healthcare information of patients who participated. That takes time. If I was a vaccine trial participant I would be suing the pants off these loons.
I feel like I'm living in crazy town...go read the emails that these loons attached of their own email conversation with the FDA. one person (the FDA rep) is trying to have a serious and productive conversation, the guy from PCP (or whatever) wants to stand on a street corner and shout. They attached this in support of their own lawsuit
Extraordinary claims require at least some effort. It isn't the job of everyone to engage and disprove everything stupid people say...at some point saying 'this dude is a loon' is a sufficient counter to 'why won't you debate me'. The preponderance of evidence, including engagement with things like the American Conservative and Joe Rogan as a source of healthcare information meaningfully suggest against taking these people seriously and that's all that is necessary.
I have this old quaint idea that government shouldn’t have too many secrets. That an informed public requires open records.
to flip what you are saying around, I believe that every government record should be born publicly available unless explicitly rendered secret (under review, of course). That is, I shouldnt have to file a FOIA, the agency should file a “Request for Secrecy”
In reality, the plaintiffs are the ones slowing the process of releasing this information down by being unreasonable. it means FDA is reviewing and denying OBVIOUSLY privileged or exempt documents that the group only asked for to then waive about the number of documents that the FDA 'wOuLdN't DiScLoSe'.
If you are playing quantitative games with FOIA request document numbers you are acting in bad faith. When you are trying to scope as many exempt documents as possible into your request so you can later use that number to push your narrative, you are acting in bad faith. Because when you aren't interested in the content of the documents, nothing you are doing has anything to do with serious efforts at transparency.
You gotta realize that these gov agencies give bad faith arguments to say that they can't release records routinely. These government agencies know full fucking well that these records will be responsive to FOIA and yet they still don't make efforts to make it accessible and releasable to the public. Same goes to Pfizer. It's our responsibility as a public to make sure important information like this isn't being hidden.
Their litigation is aggressive, there's no doubt there. But does that mean the information isn't any less important? Back when the pandemic started, a lot of FOIA nerds were hesitant to submit FOIAs because of the issues around quarantine, WFH etc. At the end though, transparency is such a fundamentally important part of our understanding of our own governance that it's important that we don't hold back on important issues like this.
It doesn't even really matter too much if the organization won't use the docs themselves. Their litigation is making it available to the public. If they're not going to look through them, someone will.
We are not talking about a request for POTUS tax returns.
The process is defined by the Freedom of Information Act itself and not the Department of Health and Human Services. Here is the act https://www.justice.gov/oip/freedom-information-act-5-usc-55...
and by law there only 9 exemption categories that allow a US agency to withhold information. They are:
1. classified information for national defense or foreign policy
2. internal personnel rules and practices
3. information that is exempt under other laws
4. trade secrets and confidential business information
5. inter-agency or intra-agency memoranda or letters that are protected by legal privileges
6. personnel and medical files
7. law enforcement records or information
8. information concerning bank supervision
9. geological and geophysical information
> We are not talking about a request for POTUS tax returns.
You're right, we're talking about random private citizens medical information, which falls under 6. That's what the majority of the pages requested are, and why it'll take so long to redact them: they're mostly clinical notes about people like you and me. The relevant information that won't be redacted is already publicly accessible.
People like you and me who willingly participated in a public funded study. If Pfizer did not anonymize the data from the beginning that is foolish at best.
…they wouldn’t be allowed to anonymize data they submit to the fda
Honestly this discussion is insane, this entire discussion presumes a bunch of people selling snake oil are more credible than the people trying to make sure drugs are safe. The “well the fda screws up sometimes” is only useful to that argument if you have already picked the narrative you want. Otherwise it’s like saying I’d rather go to see with a cannibal I have never met than my younger brother because he bit me once when we were kids.
For the sake of argument even if they were conservatives or anti-vaxer or felons or insurrectionists the Freedom of Information Act still applies to them.
Well I for one am glad that FOIA requests don't depend on whether you like the people filing them. I find it absolutely ridiculous that asking for this data is seen as a bad thing. Why are pharmaceutical companies suddenly beyond questioning?
To be clear, I am not saying "This FOIA request is bad because I don't like the people filing them." I agree transparency is good, and I in fact think it should be the default, no FOIA necessary, including and perhaps especially for things like medical approvals. That means the assumption of it being made public should be built in at every step of the process, including notes of patient trials.
I am simply responding to the comment above that asks, who are the people who are requesting the information, and what is their agenda. That is also a very important thing to know for a vibrant public discourse.
I just can't help but think that pfizer did this on purpose - not making redacted versions of their data, knowing it would take the FDA forever to do that if it ever got FOIA'd.
Of course people are going to cherry-pick things that suit their narrative from this massive amount of information. But that's the game. If there are questionable things in this data, then it's up to our public health officials to explain them.
This vaccine is a new type of medicine that was produced faster than vaccine before it. It also seems to work. But regardless, we all deserve to see every bit of information about its production, especially now that people's jobs depend on them getting it.
Hiding information and general untrustworthiness harms credibility, which is a chicken that's going to come home to roost the next time there's a public health crisis.
The CDC blew a lot of its credibility with the (arguably noble) early lie about masks not working.
Pharma companies probably don't have that much to lose.
Now it's the FDA's turn.
"We must hide legally-required-to-be-available information because some people may misuse it" is a path with unlimited abuse potential, best avoided.
Look, again, I’m not suggesting any legally required information should be hidden. But if you think the end result of releasing massive amount of even totally-above-board information is going to be increased public trust, then you must have sleepwalked the last 6 years.
There’s a good case to be made that releasing this is the best course. But let’s not pretend that public trust won’t be eroded because it takes an order of magnitude more work to disprove bulls### than to make it up (or twist it) in the first place. And it isn’t any particularly information I’m talking about, simply the vast quantity involved.
The vaccine becoming political is probably the worst thing to happen to humanity in the last 2-3 years. Worse probably than COVID itself.
EDIT: just thought of one possible solution or at least mitigation to the “Bull### asymmetry principle” when combined with massive data dumps:
Limit the amount of material that can be requested. Any specific dates or whatever could be requested within the stack. Or if a representative sample is desired, the entire dump is sectioned in pieces and each section is securely hashed. The one doing the request can then request, say, up to 100-1000 sections and each such section can then have its hash compared. That ensures the random selection is random to the satisfaction of the requesting party. And it limits the amount of bulls### that needs to be countered to some reasonable level. Otherwise, any attacker will be able to overwhelm the public with endless claims from a massive stash of requested documents.
This doesn’t limit the amount of work for scrubbing PII, though, since you’d have to scrub it before hashing or the hashing wouldn’t be recreatable. But at least you’d limit the amount of unique bulls### that’d need to be countered.
The FDA could've had the policy that the data is scrubbed and made available as its ingested. And, quite honestly, I see this complaint of theirs as one made in bad faith. Once they have no other choice, they'll comply in a lot faster than 3/4 of a fucking century.
Really, I see FOIA requests as failures of government; as in they represent the government being poked to be transparent when transparency should be the default.
What I like most is that, whilr unapologetically conservative, they are fair and will acknowledge faults in the right and good in the left.
Take their editor Dreher. Dreher is a very social conservative, and economically populist. So is he a Trumpist? He despises Trump specifically for his character shortcomings and has no patience for someone who cant see Trump do any bad. Dreher also has complete intolerance for incivility towards his opponents.
Also, I havent found any other publication explain the damage that cars have caused America than their segment “The new Urbs”. Only Ivan Illich’s quip that cars average 5mph come close to the poignancy.
For TAC the car’s sins aren't CO2 emissions. The sin of the car is that it ripped our cities apart. For TAC, the electric car isn't the solution but a mere bandaid.
They are unabashedly anti-war and anti-interventionist in a manner that Mark Twain, or Smedley Butler would be were they alive (ie many of them, like Twain and Butler, made the mistake of believing the establishment narrative on foreign intervention and are furiously making amends).
Finally, TAC is a gateway to sober conservative intelligentsia, which exists, is very broad and very rich. How many have heard of Roger Scruton compare to Hannity?
EDIT:
Some criticism is in order.
They appear to be a talent incubator, a lot of their columnists are recent grads. They’re great, but they don't last long and I miss some of the old guys (especially their urbanism guy)
They are increasingly a christian focused magazine, which is fine by me, but does limit their palpability for HN readers. That being said, i suspect believers of any faith would be more comfortable reading TAC than NYT (in my experience religious people are more comfortable with people of other faith than with secularism - but its a long and off topic point)
Finally, about the ME coverage. Its simple, its not in the US interest or our problem. Agreed. However their stance on Israel is softer than it was but harsher than mainstream media. Everyone has a problem with men in the middle.
Thanks for taking the time to make such a thorough reply. I might give it a read.
As someone who leads liberal, but feels conservatives also have many good points, in addition to serving as the necessary counter-argument that strengthens everyone in a discourse, it's been hard to find sources in the Trump era that advance traditional conservative values in good faith.
The dog whistle stuff bothers me in the abstract (that it happens at all), but less so in the specific (where it feels like playing hidden words on a speech).
What irks me more is when people can't / won't enunciate their core beliefs as part of an argument.
If you think lower taxes create greater economic growth and freedom, then mention that! If you think higher taxes create greater economic growth and freedom, then mention that! But don't dance around the issue with five pages of rhetorical devices and examples, and never mention why you're advocating a position... as your core belief.
Read a couple articles last night, and enjoyed them. (Well balanced) food for thought.
To drive their honesty, anti-dog whistle nature and the inexperience of many of their colunist’s, you’ll often get a needlessly shocking but otherwise well argued column. Like a teen having fun shocking staid middle aged people; this is un-conservative, of course so I disagree.
(Declan, Im looking at you. You’re too intelligent to act like a shock jock)
> The reporter suggests the FDA reassign other people to process the FOIA requests but I would prefer those people continue working on important things like reviewing the safety and efficacy of medical devices[1] and reviewing the safety of food and infant formula [2] rather than spending their time processing paperwork
I'm puzzled why they didn't make the document FOIA friendly in the first place. It was pretty obvious that it was going to be requested as it is of extreme public interest.
I'm wondering if this "burden" wasn't intentionally planned. But there's no reason to do so: after all, the FDA should be working in the public's interests, and they have nothing to hide.
"At that rate, the 10 employees would have to work non-stop 24 hours a day, seven days a week to produce the 55,000 pages a month (and would still fall a bit short)."
So 50 people on a normal (40 hour work week) could do this in a month.
The FDA has 18 000 employees.
I think the answer is clear.
If they want their documents faster they should just pay for it. Requesting 300k+ pages is not a normal request, there is no way all of those pages will be of interest.
Pay for it by paying a fee equal to the cost of hiring / training additional personal (https://www.foia.gov/faq.html).
It's asinine to think you have a right to see every document the government has including PII and trade secrets, even worse to base an anti-vaxx effort on such ideas.
It's crazy to me the amount of people that people would blindly trust the same government that did illegal experimentation in the past and gave unsuspecting populations syphilis. Or the same companies that paid billions for lying in the past.
The FOIA should not allow anyone to launch a denial of service attack on the government.
The requester can specify the scope or the timeline. Not both. If my employer asked me to review this much content I would also give a timeline on the order of years. Saying "too bad, it has to be faster" doesn't change my estimate.
We're spending TRILLIONS of dollars on this pandemic. TRILLIONS! These FOIA requests are not DOS attacks. It's very clear that some are very scared of what these FOIA requests might reveal rather than a concern about the cost of spending 0.000001% of the response budget on it. Why are you personally so scared of what the documents might reveal? It's nothing to do with imaginary DOS attacks.
If by we you mean the FDA then no they are not.
Additionally said trillions aren't allocated to redacting documents so it really is like saying w're spending trillions on the military so deploy the national guard to redact the files. It's apples & oranges.
As outlined in the article, the FDA only has 10 people trained to do redactions and that's for all FOIA requests. Requesting 10 people to redact ~300k documents is going to delay (aka deny service) to anybody else requesting FOIA requests for the next year.
I am all for the documents being released eventually, but it takes time to remove PII from 450,000 pages of medical records (themselves very dense with PII). I am not in favor of releasing them prematurely with identifying information, nor am I in favor of requiring an entire department to stop their (more important than this process) jobs at the whim of someone who doesn't even know what they're looking for.
I have no problem with that, but if the paperwork isn’t produced, the FDA can’t enforce or use any of the process for any reason because its not transparent.
Take as long as you want, just lose any legal power those documents give you so that you aren’t unjustly using them if there is evidence of some kind of fraud or other issues.
Take 100 years, but for those 100 years the paperwork can’t be used with any legal authority because its not transparent.
That is once again absurd and amounts to a denial of service attack. Reviewing documents for public disclosure, removing PII, etc. is a totally different process from reviewing their accuracy for medical purposes. It takes at least as long, probably longer.
Or maybe, if you think the FDA did something wrong, you should have enough of an idea of what it did wrong that you could confirm it by asking for something less than literally everything Pfizer ever submitted to the FDA? If you're asking for that much information, that suggests that you're undertaking a fishing expedition rather than actually substantively accusing the FDA of something wrong.
Yeah, but you're allowed to fish, even if what you're fishing for is dumb. The obligation is for the government to provide transparency, not for it to proctor investigations.
Only the rich should be able to make unreasonable requests (its kind of how Capitalism works).
One trivial way for a normal person to do this FOIA would be to make a request for the document names that lead to the decision to approve Pfizer's vaccine. Redacting a ~10 word title is going to require way less time than redacting ~300k files. We also already know that the FDA knows what files lead to the decision (~300k) and which they are (cause they're redacting them atm). Once you have this list you can decide which files could help your case and request those.
As far as transparency, the FDA didn't just write down two words "Pfizer Approved" they've created document outlining why they approved the vaccine.
That adage is meant for tasks that require a large amount of coordination, e.g. large software projects. This is no such task.
It's like saying you've got a large wall that needs to be scrubbed clean, and having 10 people do it at once would be slower than having one person do it. That is obviously not going to be the case.
There are literally legal firms that employ hundreds of paralegals who do nothing but bulk redaction. They literally have systems to split up huge document bundles and do redaction in parallel.
You're roughly talking about the trusts popularized as Amdahl's Law [0]. Which, to summarize the nuances in this context, says "It depends on the nature of the task."
There have been successful FOI requests in other countries. Japan managed to get Pfizer to cough up some of their animal testing research https://files.catbox.moe/0vwcmj.pdf which has measurements of the lipid nanoparticle concentration in the brain, eyes, ovaries, etc. Does anyone know if there are similar measurements available for conventional vaccines? Since it'd be nice to be able to compare these numbers to something.
After giving a rat a 50ug dose (a single dose for a human is 30ug), the % of administered dose in the brain was .009, eyes .003, and heart .030. Comparatively, the injection site was 24.6 and liver 16.2.
Also, some of these rats were given some big ol’ doses. 1 mg RNA / kg.
What is the better measurement, % of total administered dose or the ug/g concentration? The latter shows a relatively high does for some organs, particularly liver, spleen, and ovaries. As a layman, it seems like the latter would be the better metric as it's a normalized value but I assume you chose the former for a valid reason.
I'd rather see number of nanoparticles per cell. There's about 300,000 eggs in an ovary and 300 are ovulated in a lifetime. Eggs are cells and cells weigh 1 nanogram each. Virus particles weigh less than a femtogram. I assume the same applies to these lipid nanoparticles. So by my calculation that would be 123 lipid nanoparticles for each cell in the ovaries. `1e-9 / (0.1e-3 * 1e-12) * (12.3e-6)`. Pfizer's drug works by programming cells to produce spike proteins on the membrane so that the immune system recognizes them as the enemy and destroys them. I wish I knew why Pfizer needed to choose a delivery method for their drug that crosses the blood brain barrier and accumulates a 10x concentration in the ovaries. Since modern delivery technologies are so advanced that they should have been able to do something less systemic.
What are you looking to compare? Conventional inactivated or attenuated pathogen vaccines don't use lipid nanoparticles at all, so the number will be 0 (barring some kind of contamination or measurement error).
Ever heard of Vioxx? It was a new drug to treat a condition which was already treatable with other drugs. Vioxx caused tens of thousands of deaths (~50,000?). Transparency is paramount with new medical interventions.
Also, are people unaware that pfizer had to pay a $2.3b settlement in 2009 for fraud? It was the largest health care fraud settlement ever at the time.
It's so odd to me that the whole "trust the science" mantra of this entire pandemic is thrown out the window when we ask to actually see the science for ourselves.
Vioxx gets complicated; other NSAIDs, including non-selective ones, turn out to have a pretty nasty cardiac risk profile too, and the withdrawal harmed a lot of patients who relied on it.
> After Vioxx was withdrawn, there were numerous papers and discussion on the increased risk of cardiovascular events with all NSAIDS and labelling changes were made. However, Silman argues that it has still not been proven in observational studies that Vioxx’s cardiovascular events were any higher than, for instance, diclofenac, a popular non-selective NSAID.
> It proved to be complex: not all COX-2 inhibitors have the same cardiovascular risks and not all non-selective NSAIDs have the same cardiovascular risks. “If the VIGOR study had been comparing Vioxx against diclofenac, it is entirely plausible that it would have shown no difference in cardiovascular events,” Silman points out.
> ...
> If MSD had not withdrawn the drug, perhaps regulators would have deemed that it not be used in patients with pre-existing heart conditions and the elderly, Silman ponders. “It was not necessarily a given that Vioxx should have been withdrawn completely. For instance, diclofenac has not been withdrawn and is still on the market but with advice to use with caution,” he says.
> Neither does Silman think Vioxx should have been withdrawn, since it proved to be a very effective anti-inflammatory drug. “The joke at the time of its withdrawal was that every rheumatologist was stockpiling Vioxx because of its efficacy.” The Vioxx story is not so simple and it was not about “Vioxx being the bad guy”, he says.
And accountability. I understand the need for urgency and the use of emergency orders, but once these are gone these companies will still be unaccountable and will still be getting paid even if their promise of efficacy are not held.
"increased risk of heart attack and stroke associated with long-term, high-dosage use" with benefit of the doubt, I'd imagine that people are quite interested in arthritis treatment alternatives, and it seems hard to determine the problems with trials? Apparently the drug did find a niche for "hemophilic arthropathy" per wikipedia post recall, so it seems far from an unmitigated disaster
Great. I am extremely pro vaccine. Not providing this data just gives anti-vaxxers more ammo. I just got Omicron and it was easiest cold I've ever had. I'd like to give the vaccines credit, but I'll have to wait on that research to come out.
Vaccines are brilliant but I don't like the idea that a company manipulates data and put people's lives at risk for profit. It's clearly criminal activity.
Anti-vaxxers are already using released technical documents to support their ideas using out-of-context or misinterpreted snippets of information. I don't think it's going to affect them much either way.
For instance, the most prevalent example of this is people taking reports from VAERS and presenting them in an article as if they’re assumed to be causal effects, rather than correlative.
It is quite easy to mislead people with highly technical information, because all you have to do is suggest an interpretation of the data that sounds plausible with an authoritative tone.
>the most prevalent example of this is people taking reports from VAERS and presenting them in an article as if they’re assumed to be causal effects, rather than correlative.
I think if the jump in VAERS reports since the vaccines were released wasn't ~2,700x, you wouldn't see as big of a deal about it. But you can cut that in half and still have an astronomically alarming number of vaccine adverse events reported.
The FDA generally would only review the summaries, not the full patient information.
A lot of those 450,000 pages are careful patient documentation that simply isn't necessary when you already have the total side effect counts.
At most the FDA might review the clinical history of the patients with severe side effects. They aren't going to be reading the notes about every Bob Smith reporting fatigue after getting a COVID-19 vaccine.
It was more or less common knowledge “big pharma” doesn’t have a strong record when it comes to trust before Covid. It’s pretty crazy how fast political tribalism can be used to change people’s minds. Just because your political enemy wants to do something does not mean it’s bad.
These vaccines were an amazing tool to help end the pandemic but the producers who are profiting heavily from these should be scrutinized as much as possible given there are hundreds of millions receiving this vaccine.
It has pretty much ended for the vaccinated. Vaccinated people have a very very low chance of death or hospitalization, an order of magnitude lower than the unvaccinated in many cases.
There are many countries where lockdown, daily restrictions, entry requirements and isolation are still normal. This pandemic is global - just because things have improved where you are doesn't mean that's the case for the other 95% of the world's population.
That's a non-sequitur. The pandemic, as in the actual killing / harming of people with the virus, is mostly over for vaccinated people.
True, some political response to the pandemic are still in place, but that would happen no matter what as politics tends to move slower than the reality on the ground.
... That's not the definition of pandemic. A pandemic is a very widespread infectious disease. Theoretically, the disease doesn't even have to be deadly.
It's true that the vaccines have substantially reduced risk for the vaccinated, but I don't think we can (yet) say the pandemic is over.
Omicron puts us in the endgame--Covid is an endemic disease now. It's not the endgame we wanted, but it's the endgame.
Omicron is apparently as contagious as chicken pox, and chicken pox effectively infected every person (generally in waves when enough new children hadn't had it). Due to Omicron, in 30-60 days, everyone will have been infected, vaccinated, or both.
Even if you could get all the human infections to zero, the animal reservoirs would simply start it up again.
Welcome to the new world. Perhaps people will take a pandemic slightly more seriously next time. But I doubt it.
They didn't, but that's not a bad thing. The way the process works is that companies give the FDA both summary statistics and underlying data. The FDA can recompute the stats from the data, confirm they match and approve. The reason for asking for the data isn't because they'll read it, it's so that the summary stats can't be faked without a massive amount of fraud that can be proven if the company lied.
Companies can't fake the data because if they got caught, there would be long jail terms and billions of dollars of fines (and they provide too much data for it to be easily forgable).
These dudes literally bake "billions in fines" into their operating model, and who cares when their latest and greatest customer puts a gun to everyone's head and says "take pfizer product or lose your livelihood". Billions in fines mean nothing when the federal government guarantees you 15x that in revenue a year.
And Oxycontin works, and was correctly approved by the FDA. The problem there wasn't approval, it was how it was used post-approval. That's not an argument that they shouldn't have authorized the drug.
What does Exxon have to do with the FDA or how medications are authorized?
Also, I don't think that the manufacturer of Oxycontin has tricked the authorization process (and then successfully covered up this fact for 20 years). As far as I know, the problem was their marketing strategy, how they convinced doctors (medical practitioners) and probably patients (I can remember the details). So while it's troubling, it's a completely unrelated process and thus unrelated issue.
Again, what does exactly the Exxon case 'prove' here? Also, how? Which act of theirs? (I'm pretty sure I miss a lot of details there and that might be the reason I have no idea what connection are you drawing here.)
Also, no one said "trust and don't verify". What was said is that they don't have to verify all the data and read through all the pages. Because the risk is just too high and they will obviously look into the details here and there.
I've always wondered why when government receive documents from private entities (because of law, contracts, whatever) and that those documents are likely covered by FOIA-like laws, they don't ask the private party to submit FOIA ready documents in addition to the full version. They could then automatically publish the FOIA ready part without having citizens ask a judge for it, the judges would just have to sample the non FOIA part.
There’s a conflict of interest. If I’m prepping a document to be filed with the government I can’t redact in accordance with the government’s interests under FOIA and redact it in the best interest of my client.
Or, to put it another way, would you want Monsanto or Philip Morris or Purdue Pharmaceuticals to “helpfully” redact documents on behalf of the government? It would largely defeat the purpose of FOIA.
Because then, when they got a FOIA request, the party submitting the request would inevitably challenge the redacted versions as over redacted. It isn't red light green light on words...your asking the judge to literally do the job that each department's FOIA folks are trained to do.
How many do you think are appropriate? Add too many and people will be complaining about bureaucratic bloat. Besides, the number of civil servants doesn't mean they can't hire contractors to help, but putting those contracts out for bid is not an instantaneous effort.
Those are parts of their core purpose, of course they spend a lot of resources on them. They're a regulatory organization that regulates tobacco products. Redacting documents, by contrast, is not a core mission of theirs.
This is to my point. There are a ton of single issues that some group is going to say needs to be a higher priority.
I was interested so I looked up the FDA's regulatory affairs [1], which "conducts sample analyses of regulated products and reviews imported products offered for entry into the United States" This seems pretty inline with their core mission so I'm not surprised they spend a lot of time on it.
There was another comment about the already released documents being taken wildly out of context and flat out lied about by anti-vaccine idiots.
This is the same type of thing honestly. The presumption that you have that you know what these numbers mean, entirely out of any meaningful context.
Let me sincerely ask, when you wrote this what did you assume someone in regulatory affairs at FDA did? What motivated you to think that number was too large?
simpler approach here is they are unwilling or unable to find a useful basis for the argument. They haven't considered what these people do, just assumed there are to many of them without considering it.
I agree with you in principle but may disagree in the mechanism.
Let's assume for a moment that the FDA's rate of review is accurate (for the record, I think they are severely low-balling it). They would need 100x the staff to review the records in time to meet the court order.
Keep in mind the number of documents may be unique because of the scale of the pandemic (maybe somebody can fact check that). Knowing how difficult it is get rid of government employees, does it make sense to hire that many people for a once-in-a-century one-off event and then...what? Have them sit around and do nothing afterwards? I think trying to fit someone into a later role they weren't hired for is a terrible choice in my experience.
But you say, "so what, it's the law"...so they're hired anyways. Maybe you get lucky and they're only hired as temp positions. Do you know how long the federal hiring practice takes? Because it's the government, most jobs have legalities around how they are posted, how long they need to be advertised, sometimes they require extending the ads internally first etc. due to union issues. If the job requires some sort of board approval, it may take months even after the selection is made, and they haven't even been trained yet.
If you say, "well, all that can be fixed by just hiring contractors." The bid process runs into the same time-lag due to it being a government contract and needing to be open-and-above board.
"Well, just use an emergency no-bid contract." Now you're running into all kinds of legalities to avoid political cronyism.
The point being, it isn't nearly as simple as many seem to think. IMO the solution isn't "just hire more people to be compliant with the law" it's figuring out why your review process is so inefficient to only produce 50 reviewed/approved pages per month per employee. Really!? You can only average a little over a page-and-a-half of review per day? I think they need to hire an industrial engineer to revise the process, not simply hire more people. 100x'ing the number of people into what appears to be a broken process will likely make things worse.
I work as a contractor to the government because Fed hiring is nearly impossible in my little corner. It took me months to get a $1000 piece of equipment I need to start my job. So, I know how long it takes and you’re right.
That being said, Ive taken all the FOIA trainings, and all the “blah blah” about the public’s right to know. 500 pages a month is not a serious answer, its dodging.
EDIT:
“ Let's assume for a moment that the FDA's rate of review is accurate (for the record, I think they are severely low-balling it)”
>500 pages a month is not a serious answer, its dodging.
I agree. That's why I think the focus should be on holding them accountable to a badly formed review process.
I think where we disagree is I also think the answer of "hire 100x the people" is an equally invalid answer. They know that's a non-starter as well. They know they won't be authorized to hire that many and they also know that even if they could, they wouldn't be spun up in time to meet the deadline.
I'd personally rather see an IG/GAO investigation into their process.
I think I'd disagree. That's 1% for one tangential aspect of operations. With nearly 3MM federal employees, that's 30k just for FOIA requests.
That's a single pet issue. For everyone who thinks transparency is important enough to have 1% of total employees allocated to it, there's going to be many more pet issues people would feel the same way about. I would prefer they look at improving their processes for complying in a more efficient manner rather than just layering more employees (and legacy costs that come with them) onto the solution.
It's worth noting (READ IT!) that the court order specifically calls out that given the urgency of the current disease situation and political and public health trust issues, it is the Court's opinion that there is almost nothing the FDA has to do that could be MORE important.
The FDA, at the behest of Pfizer, et al, have been deliberately obstructive in making publicly available drug trial information that is clearly required by both law and rule. All parties involved knew they needed to publish that info, and have steadfastly refused to do what the law requires them to do. If I were the judge, I'd have given them 90 days to turn over everything, and thrown the head of the FDA and the CEOs in jail for contempt until all those records are indeed published. IMO, they got off really easy.
Maybe I'm naive (and I couldn't read the article - "limit reached") but what all those people have to do? I expected they have a bunch of PDFs not sheets of paper to scan. If they don't, ask for PDFs next time.
450,000 pages at 1 to 10 MB per page would fit in a USB hard disk.
Isn't that information collected or stored in a standardized way? If we're talking about standardized/PDF forms or database fields, most of the people here could automate that task in short order.
It's worth noting that this group has posted all of the documents from the lawsuit on their webpage, but has not posted the original FOIA request.
What are they hiding?
It's also worth reading the brief from the (obviously exasperated) appendix to the FDA's response if you want to understand just how bonkers this conduct is:
The R&D is funded by the tax payers money so why the data is not public in the first place? Or at least mandatory to hand it over to the FDA / peer review process.
The US government finances a lot of private RnD projects and often the companies have sweet heart deals to use it. This appears to be particularly the case in biology (I'm in energy, so its different)
Also, the US government finances the vast majority of university biomedical grad students, each costing at least 100k/year. These grads then bring their knowhow to the companies. This is at least $0.5million/employee subsidy in free training.
In the end, it really depends who you ask. Left wingers will say that the government is getting a raw deal, right wingers will point out that the government gets its cut.
As to the Pfizer vaccine, Operation Warp Speed doled out billions for COVID vaccine R&D, but Pfizer claims to not have participated in the program.
…Except they did participated and they received >1billion from it.
… Except it was a purchase order, not R&D
… Except a guaranteed purchase order is effectively a subsidy (since your known risk is lowered)
… except
… except
CDC Wants to Hide the Post-Licensure Covid-19 Vaccine Safety Datahttps://news.ycombinator.com/item?id=29744140 (Full headline is The FDA Wants to Hide Pre-Licensure Data Until You’re Dead and Now the CDC Wants to Hide the Post-Licensure Safety Data)
The comments in HN threads regarding the vaccines are bizarre. The majority of stances here essentially boil down to "the vaccine is fine" vs "the vaccine is bad."
The majority of the comments that I see in this thread have to do with the FDA, FOIA, and transparency, with only a scarce few comments that are black-and-white like you described.
> Be kind. Don't be snarky. Have curious conversation; don't cross-examine.
> Eschew flamebait. [Which is essentially impossible on this topic if one is to disagree.]
> Please don't use Hacker News for political or ideological battle. It tramples curiosity.
This is offset by other guidelines, although it seems that erring on the side of harmony & homogeneity is preferred (which if the goal is entertainment, is probably right: HN is a site for intellectual curiosity, not epistemology):
> Comments should get more thoughtful and substantive, not less, as a topic gets more divisive.
> Please respond to the strongest plausible interpretation of what someone says, not a weaker one that's easier to criticize. Assume good faith.
> Avoid unrelated controversies and generic tangents.
> A good critical comment teaches us something.
> It tramples curiosity. [Implying curiosity is good/acceptable.]
It's more than just human nature this time around. Something about this whole polarization and specifically this stuff with Covid is just firing off alarm bells in my head.
From one page before the table (which itself is on page 7):
> An accumulation of adverse event reports (AERs) does not necessarily indicate that a particular AE was caused by the drug; rather, the event may be due to an underlying disease or some other factor(s) such as past medical history or concomitant medication.
If I gave 42,086 people a cup of water as my experiment, some non-zero number of people will die in the ensuing 90 days. Without analysis, your comment only serves to inflame.
EDIT: I think the 42,086 number I used was misleading because that appears to be the total number of reports and not the number of people that actually received the vaccine in that time period. Which means the rates are lower as the denominator is way larger than 42,086.
It should be worth remembering that we don't need trials anymore to predict what the results of vaccinating millions of people should be. We have already done that. Indeed, by looking at the results of actual vaccination, we can find things that have happened that won't be found in trials, because 1-in-a-million events aren't going to be found in trials. (Risk of myocarditis, for example, is something that's been found with actual vaccination.)
... so if you're claiming a risk is clearly visible in the trials, you should consider if the actual experience in mass vaccination actually bears that risk out. And if it doesn't, well, there's a good chance you simply misinterpreted the trial data.
It's extremely hard to extract meaningful insight from population data, because it's massively confounded.
Recently some locations locations have reported omnicron case _rates_ being higher in the vaccinated population than unvaccinated. Your logic would have us conclude that the vaccination increases the risk of becoming a covid case with this strain.
... in reality, the vaccinated population is likely more at risk and the vaccine protection isn't enough to offset the difference. But it's extremely hard to tell, which is why RCTs are so important.
Those one in a million events also don't get found outside of trials: They go unreported because outside of trials surveillance is very low, or if noticed they'll get attributed to something other than vaccination because without a control group you can't establish a baseline rate narrowly enough to attribute it to the treatment with any confidence.
Yes, and it's worth noting that the FDA, CDC, NIH, as well as their international counterparts, ALL missed the quite significant myocarditis side effects, especially in younger, fitter, men. It wasn't until the DoD had crippled thousands of its own warfighters (possibly for life) that that particular nasty side effect came to light.
It's looking increasingly likely that there are a great many other side effects that may only become obvious on a long term basis - by definition we still can have NO IDEA what the long term risks of these never-before-tried "vaccines" may be.
Bill Joy was absolutely right - biotech and genetic engineering is BY FAR the most dangerous technology on the planet, and we're seeing that play out to our horror right now - there is no way to stuff this gene-ie back in the bottle!
The vaccines caused myocarditis at roughly the rate of ~1 in 100,000 in young males. The DoD isn't large enough to have thousands of people with myocarditis at that occurrence rate, even assuming every single case results in "crippled ... (possibly for life)" (which it doesn't).
> Please explain what part of that comment is false?
This one:
> This document shows that 1223 deaths are linked to the Pfizer vaccine in the first 90 days.
“Occurred after” ≠ “linked to”, and the document does not show the latter.
EDIT: in fact, it provides detail (for at least those causes I reviewed, didn't do the whole thing) on reasons why the specific “occurred after” events should not be considered “linked to”.
As someone who works in medical publishing, you have no idea how infuriating posts like the one you were responding to make me.
This is HN, a group I would expect to have above average understanding of statistics and statistical analysis and yet the idea of causal relationships and that old adage of "correlation is not causation" STILL seems to slip past far too often.
To the larger world: There's a reason every single drug commercial/ad you've ever engaged with has a list of "possible side effect" and not "known things that will/did happen". The "possible" doesn't even always mean "this is a side effect we conclusively know this drug causes, and could possibly happen to you" but sometimes just "we couldn't prove this drug didn't cause someone to shit blood since we had one guy who did one time during our months of trials".
To be fair I never said causation nor meant to imply any. Perhaps correlation would have been a better word than linked.
My original point meaning being FDA probably does not want these records released because it could shine a unflattering light on how our pharmaceutical industry operates.
Just like states continually acknowledge widespread statistical errors after getting called out where they attribute deaths and hospitalizations to COVID and then someone points out that person was shot in the head or had a car accident or the kid went to ER with a broken bone?
This is called "whataboutery". It's also disingenuous.
In general, there's a fast statistic about COVID deaths, which is something like "deaths within N days of a positive PCR". This will catch some people who died for another reason, though if you think that's a serious problem, you'd need to argue that so many people could be expected to die for some other reason within N days that this would significantly bias the stat.
There's a slow stat, where COVID is a contributing or underlying cause on a death certificate. In the UK, these are in rough agreement. Notably, at the start of the pandemic, when testing wasn't available, the fast stat was an underestimate. https://www.nuffieldtrust.org.uk/news-item/measuring-mortali... has some links to the ONS and places like that.
As someone who understands basic logic and ethics, you have no idea how infuriating your defending the indefensible makes me!
We're talking about a completely new type of "vaccine" that works in completely new and different ways than ANY previously, AND which has never been used in humans before (after all previous animal trials failed, AND is intended to be given under high urgency (even duress), to a large fraction of the population of the planet.
DAMN STRAIGHT that under those unprecedented high-risk conditions the default assumption MUST BE that correlation IS causation - UNTIL PROVEN OTHERWISE.
Anything else is gross and callous negligence and lack of consideration for your fellow man, not to mention the active shredding of medical ethics, including the Hippocratic oath and the Nuremberg code.
This is all the more true now that, a year on, data is clearly showing that the danger of the virus itself was grossly exaggerated, and that we are now facing vaccine injuries and deaths that are at least of the same order of magnitude as the virus itself, and may yet prove to be considerably higher.
>>DAMN STRAIGHT that under those unprecedented high-risk conditions the default assumption MUST BE that correlation IS causation - UNTIL PROVEN OTHERWISE.
I'm glad you're not in charge of Science, since this is literally the opposite of science. No matter how many caps you use. The default assumption is there is no default assumption, even if there's a gun to your head.
I'm not defending "the indefensible" I'm explaining common terms that are seemingly misunderstood by large groups of people.
We vaccinated millions of people with billions of doses with these vaccines. I have yet to see or hear of anyone who died of the vaccine and nearly everyone I know was vaccinated with Pfizer at some point.
Safe to say you are purposely spreading misinformation, for example by misrepresenting real data to gullible people and I wonder what your agenda is.
I didn't imply that the document is false. It's your interpretation of it that is false. You imply that the deaths are caused by the vaccine, which is not what this document is showing in any way shape or form. So you lied to everyone reading this HN thread.
This is the right decision. Honestly does NOT need editing by the FDA or Pfizer. They should publish it all as-is right now! What do they have to hide? Criminality? Malfeasance? Not a problem if everything was done above-board!
This would be a great way to make sure no one ever signs up to be part of another medical trial again. Would you want your medical history posted on the internet for the world to see just because the government couldn’t be assed to appropriately redact documents?
They should have been designed and planned with deidentification with the expectation that data would be released.
If they are literally manually redacting patient data from pages and notes then that is a flaw in the study, I think.
I would expect patient data to be pretty limited in the trial data since they are purposefully double blind. Notes are a different story, but I’m sure there are techniques that can be purchased for entity resolution that can automate the scrubbing for PHI and PII.
Seems more like the FDA and Pfizer being silly than the judge.
> Notes are a different story, but I’m sure there are techniques that can be purchased for entity resolution that can automate the scrubbing for PHI and PII.
You can't fully automate this because we require almost 100% accuracy. You need a manual review to ensure no data is leaked.
I’m not sure why you think we require 100% accuracy. The actual level depends on many factors. For example, the expert determination method of deidentification in hipaa safe harbor [0] can allow up to 1% reidentification and still be considered anonymized.
This is how medical providers share notes without manually reviewing them all.
That’s part of the downside of “anonymized” data as there’s not any clear legal definitions so it’s quite possible to identify some persons within anonymized data.
I think this is a big problem when it comes to stuff like data brokering and selling. Less so with issues like this because vaccine data researchers are less likely to cause harm to someone than others who buy anonymized data.
To be fair they were in a bit of a rush, and opted to dump the problem on the bureaucrats rather than spend more time designing protocols. This isn't an example of wicked plotting, it's just an argument about who picks up the tab for a large redaction job.
There is currently a government mandate requiring most adults be vaccinated while at the same time, the government (another agency) is unwilling to publish the evidence it considered in favor of the emergency authorization and the concomitant decision making process until after everyone mandated to take it has died... because that's the way they have always done things?
That's going to be the case for any paper evidence like this, included the 450,000 pages of personal medical information that the plaintiffs want. Unless you inspect the patient yourself, you are always going to be relying on someone else's word.
Do you ever check the underlying data when you write a database query? Same logic applies here. There’s limits to what you can do but don’t let perfect be the enemy of good.
So say you get doctor's notes saying that vaccinated patient didn't get COVID-19. What then? Do you need to interview the doctors? Where does the conspiracy theory end for you?
This is about data used in the vaccine approval. If you think vaccines don't need data to approve them then that throws science out the window and if that is the case then turns whatever theory into an actual conspiracy. Also, do you ever comment on anything technical or is it just pro vaccines and corporate interests?
This is something the FDA should have done automatically at the time the issued the EUA or full authorization. That is preparing and releasing all the data for independent review should be part of their review. there is no reason the FDA should try to keep this secret in the first place, and a number of reasons they should make it available.
That doing their job is hard isn't an excuse to not do it.
> no reason the FDA should try to keep this secret in the first place
Personal medical information, especially as part of clinical trials, is some of the most legally protected data in the world. You can't just hand it out to people. And even with medical grade redaction (which is very expensive) there is always a risk of leaked information getting past the filters.
I just find it funny that HN, usually a place very concerned with privacy, is now suddenly demanding the release of some of the most private and personal information of tens if not hundreds of thousands of individuals.
I don't believe he's arguing for the release of personal medical information, he's arguing for the automatic release of the documents redacted of personal medical information. In other words, the FDA should have been prepared for this all along.
Additionally, if Pfizer were to have been told to be prepared to redact PII, I'm sure authors could have easily marked PII during authoring for quick identification and removal. Someone had to write this stuff, it didn't just appear in the ether.
It's not that easy. The amount of information that the someone at the FDA might need to do their job is definitely not bounded by the limitations in FOIA, they need the details. The FOIA process has to happen afterwards by the FDA anyway by law, regardless of what Pfizer provided. Additionally, the healthcare professionals who collected the data are also not qualified to do FOIA compliance, nor is it always possible to tell if a single data element will be PII after it is compiled with other information at a later date, because PII can be indirectly inferred from other elements of information.
All the data relevant to the EUA or full authorization is available.
The data not available is personal medical information of patients that has to be collected for and during trials because some of it might become important if something bad happens during the trial. E.g, if some trial patients suffer serious adverse reactions you want to have all their medical information on hand to better understand what went wrong.
For a trial that goes well the vast majority of that information turns out to not have been looked at or used.
"At that rate, the 10 employees would have to work non-stop 24 hours a day, seven days a week to produce the 55,000 pages a month (and would still fall a bit short)."
So 50 people on a normal (40 hour work week) could do this in a month.
The FDA has 18 000 employees.
I think the answer is clear.
Seems like it would be pretty easy to have an NLP expert automatically redact secret data from the document set.using humans for this seems like malicious compliance in the first place.
I've done the job of redaction both manually and automatically. I don't think either will hit 100% accuracy, but the difference will be pretty negligible, but the automated method frees up 50 people for a year and gets the data out in a fraction of the time.
The reporter suggests the FDA reassign other people to process the FOIA requests but I would prefer those people continue working on important things like reviewing the safety and efficacy of medical devices[1] and reviewing the safety of food and infant formula [2] rather than spending their time processing paperwork that will, at best, be used by anti-vaccine activists in social media disinformation.
I would be interested in seeing who this 'Public Health and Medical Professionals for Transparency' front group is. My guess is it's a group of charlatans looking to sell their own COVID cures similar to the doctor who produced the original study claiming vaccines cause autism (which was later retracted)
1. https://www.fda.gov/medical-devices 2. https://www.fda.gov/food/recalls-outbreaks-emergencies/alert...