Judge orders FDA to hasten FOIA release of Pfizer vaccine docs
reuters.com
reuters.com
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...
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
The reason why they are getting the endless pages of patient data is because the plaintiffs are asking for it.
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.
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.
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-...
It sucks, but the alternative is much worse.
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.
Just a very different cost/benefit analysis on "do all the steps we can in parallel to speed things up" during a pandemic.
The benefit went up. The acceptable costs of parallelization similarly went up.
(Some steps got easier, too, for the same "everyone really wants a solution yesterday" reasons, like recruiting trial volunteers. For example: https://www.sciencenews.org/article/covid-coronavirus-vaccin...)
> 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.
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.
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.
If it's any old cave, you might just explore one at a time.
If you're pretty sure the Holy Grail is somewhere in it, you might hire six explorers, at higher initial expense.
Pick one. You can't have both.
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.
Their 10-K from the end of 2019: https://www.sec.gov/Archives/edgar/data/1682852/000168285220...
> 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.
The point discussed is not whether it works or not, but what are the actual safety parameters.
That's not a "Pfizer's is slightly safer in 30+ males and should be used preferentially in that population if both are available" safety quibble.
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.
https://www.statnews.com/2017/01/10/moderna-trouble-mrna/
> 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."
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.
https://journalofethics.ama-assn.org/article/how-fda-failure...
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.
This is the biggest problem we've ever needed to solve as a society. Release the documents and we'll find the bugs.
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.
Pay for it by paying a fee equal to the cost of hiring / training additional personal (https://www.foia.gov/faq.html).
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.
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.
Problem solved.
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.
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.
https://www.fda.gov/emergency-preparedness-and-response/coro...
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.
see page 3, paragraph 11: https://www.courtlistener.com/docket/60390195/1/public-healt...
- 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
- Peter McCullough appeared on an episode of Joe Rogan where even Joe Rogan correctly identified that his claims were implausible. https://news.ycombinator.com/item?id=29655002
I got bored after the first page, I can look further....
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.
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.
Your evidence here is an HN thread which restates the issue. Double infections are exceedingly rare (currently): https://nypost.com/2022/01/03/israel-reports-rare-double-inf...
Attack facts and claims, not people.
Getting covid a second time after having previously had it (which is what McCullough erroneously claimed was near impossible) is in fact increasingly common.
> Cases of reinfection with COVID-19 have been reported, but remain rare .
https://www.cdc.gov/coronavirus/2019-ncov/your-health/reinfe...
If he merely claimed they were rare, that would not discredit him.
Very rare and impossible are nearly equivalent wrt policies that broadly and significantly impact personal health and liberty.
Pandemics are very rare. Flying unicorns shooting Ebola out of their horns are impossible.
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?
Attack facts and claims, not people.
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.
That is an amazing fact if true and you should alert the CDC immediately with your evidence.
I consider that "a lot" special when compared to McCulloughs prediction of 0.0% because reinfection was impossible.
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.
[0] https://phmpt.org/wp-content/uploads/2021/12/032-Appendix-in...
what information...exactly what information?
if I file a FOIA request for the presidents tax return and it gets denied for a legal exemption is that the government hiding something?
There is a FOIA process, there are things that are exempt from disclosure - that is part of the law as well.
FDA follows a process, outlined here: https://phmpt.org/wp-content/uploads/2021/12/023-FDA-Appendi... (page 5+)
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.
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
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.
Or perhaps they’ll be “anonymized” which is tech’s go to term for running roughshod over our secrecy.
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.
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.
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”
Otherwise everything is automatically an openly available record.
You can feign ignorance here but the answer is obvious. Anti-vax talking points are far more common in conservative media.
> My guess is it's a group of charlatans looking to sell their own COVID cures
Cant blame him though. It is a great magazine.
If you are interested in anti-trump conservative thought, The Bulwark is another good source.
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.
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.
That’s not to say you’ll like it. But they’re fair and honest about what they believe (no “dog whistles” or whatever)
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.
(Declan, Im looking at you. You’re too intelligent to act like a shock jock)
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
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.
Pfizer didn't take any US govt money for the R&D of the vaccine.
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.
It seems if they kept data like this in digital format with meta data, production could be much easier.
I do similar work, but for non-gov. It is a challenge.
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.
https://www.fda.gov/drugs/postmarket-drug-safety-information...
https://www.justice.gov/opa/pr/justice-department-announces-...
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.
https://pharmaceutical-journal.com/article/feature/still-fee...
> 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.
Yikes, not good!
Is this intentional irony? If not, way to prove their point lol.
Doesn't this mean that such positions can be more readily confirmed or rejected, based upon the validity of the source material?
> out-of-context or misinterpreted
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.
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.
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.
To that end, my (pessimist) opinion is that there were likely some financial incentives for the FDA to uh...gloss over 60% of that 450,000.
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.
Oh, it has ended? lol.
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.
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).
Have you haerd of Exxon?
The Sacklers held on for 20 years on Oxycontin…
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.
It proves that the FDA shouldn't use a "trust, and don't verify" approach to medical trials performed by megacorporations.
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.
https://violationtracker.goodjobsfirst.org/parent/pfizer
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.
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.
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.
That is in addition to the other 11,000 civilian employees and 1,100 military employees.
Apparently the FDA spends 8.5 million hours per year on "regulatory affairs." Boy I'd like to see that hourly breakdown.
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.
[1]https://www.fda.gov/about-fda/fda-organization/office-regula...
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?
Here is their website. Is this what you thought they did? https://www.fda.gov/about-fda/fda-organization/office-regula...
I assume it’s like most government jobs. 70% waste.
Having worked on both public and private sides, I anecdotally saw roughly equal amounts of waste.
Thats not a serious answer.
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.
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)”
significantly low balling it indeed
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.
Sure, this sucks right now but who's to say that we wouldn't be on board with the tradeoff if we knew what otherwise wouldn't have received funding?
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.
450,000 pages at 1 to 10 MB per page would fit in a USB hard disk.
Could these papers be used one day to dox patients’ medical records?
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:
https://phmpt.org/wp-content/uploads/2021/12/023-FDA-Appendi...
What is the "bonkers conduct"?
What was the point of this lie?
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
Edit: thanks all!
FDA asks federal judge to wait until 2076 to fully release Covid vaccine data https://news.ycombinator.com/item?id=29261058
CDC Wants to Hide the Post-Licensure Covid-19 Vaccine Safety Data https://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)
https://news.ycombinator.com/newsguidelines.html
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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):
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These clinical trial documents are chock full of patient data and clinical notes.
I think they can hurry.
But my point on this being the subject of a vaccine mandate still holds.
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.
You can't fully automate this because we require almost 100% accuracy. You need a manual review to ensure no data is leaked.
This is how medical providers share notes without manually reviewing them all.
[0] https://www.hhs.gov/hipaa/for-professionals/privacy/special-...
The FOIA request was for all of the documentation used to approve the vaccine.
> I’m sure there are techniques that can be purchased for entity resolution that can automate the scrubbing for PHI and PII.
Sounds like a good way to have "anonymized" data that isn't actually anonymized like most datasets ...
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.
That's a feature, not a bug. Bureacracy is a game, and they are grandmasters.
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.
The plaintiffs in this case are asking for the clinical medical history of everyone in the clinical trials, which is a bit trickier to provide.
That doing their job is hard isn't an excuse to not do it.
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.
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.
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.
The Judge told the FDA to take the FOIA law seriously and, so they remember to next time, ordered them to do so quickly.
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.