57 ms·

Judge orders FDA to hasten FOIA release of Pfizer vaccine docs

182 points by Jimmc414 5y ago

Jimmc414 5y ago
https://archive.fo/XWnSn https://archive.fo/XWnSn
Jimmc414 5y ago
Here is the court order https://fingfx.thomsonreuters.com/gfx/legaldocs/gdvzykdllpw/Pittman%20FOIA%20Order.pdf https://fingfx.thomsonreuters.com/gfx/legaldocs/gdvzykdllpw/...
- gruez 5y ago
  and docket: https://www.courtlistener.com/docket/60390195/public-health-and-medical-professionals-for-transparency-v-food-and-drug/ https://www.courtlistener.com/docket/60390195/public-health-...
lalaland1125 5y ago
The judge here is being incredibly silly. They are ordering the FDA to perform medical grade redaction on 55,000 pages a month. These clinical trial documents are chock full of patient data and clinical notes.
- bingohbangoh 5y ago
  The pharmaceutical companies have had a gangbusters year and we're implementing vaccine passports in places like NYC on the basis of this data. I think they can hurry.
  - Imnimo 5y ago
    These are FDA's documents, not Pfizer's. The pharma companies aren't the ones doing the redaction.
    - bingohbangoh 5y ago
      Ahhhh ok, was not aware, thanks! But my point on this being the subject of a vaccine mandate still holds.
- prepend 5y ago
  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.
  - lalaland1125 5y ago
    > 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.
    - prepend 5y ago
      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. [0] https://www.hhs.gov/hipaa/for-professionals/privacy/special-topics/de-identification/index.html https://www.hhs.gov/hipaa/for-professionals/privacy/special-...
  - lesuorac 5y ago
    Would you not use trial data to determine if Pfizer's vaccine should be approved? 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 ...
    - prepend 5y ago
- tut-le-tut 5y ago
  "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.
- sebow 5y ago
  Standard procedure is being silly?
- kansface 5y ago
  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?
  - lalaland1125 5y ago
    The FDA already released the evidence it considered for the approval. It's available right on the FDA website: https://www.fda.gov/media/151733/download https://www.fda.gov/media/151733/download 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.
    - encryptluks2 5y ago
      If the evidence references other evidence and you don't have access to that other evidence then you do not have evidence at all.
      - lalaland1125 5y ago
        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.
        rajin444 5y ago
        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.
      - mike00632 5y ago
        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?
- bluGill 5y ago
  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.
  - lalaland1125 5y ago
    > 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.
    - core-utility 5y ago
      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.
      - kube-system 5y ago
        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.
- tehwebguy 5y ago
  The FDA offered a timeline of 500 pages / month (75 years) which far sillier.
  - kbelder 5y ago
    My quick calc showed that's roughly one guy redacting 2.8 pages per hour. I know people who'd LOVE that job.
- tagoregrtst 5y ago
  The FDA played a stupid game by offering 500 pages a month. Thats a ream of paper. A person could redact that in a couple days. The Judge told the FDA to take the FOIA law seriously and, so they remember to next time, ordered them to do so quickly.
dopylitty 5y ago
"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) 1. https://www.fda.gov/medical-devices https://www.fda.gov/medical-devices 2. https://www.fda.gov/food/recalls-outbreaks-emergencies/alerts-advisories-safety-information#infantformula https://www.fda.gov/food/recalls-outbreaks-emergencies/alert...
- ipspam 5y ago
  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
  - dopylitty 5y ago
    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'
grumple 5y ago
What do they need to strip? 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.
- o10449366 5y ago
  Why do you think it would be easy to achieve 100% redaction accuracy with NLP?
  - grumple 5y ago
    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.
- bryanlarsen 5y ago
  Many of those documents contain personal medical information.
barbacoa 5y ago
- encryptluks2 5y ago
  Hm, but I thought that this corrupt medical company with a history of lying to increase profits had our best interests in mind.
- mijowi 5y ago
  Where is that in the document?
  - kansface 5y ago
    I am totally unfamiliar with this doc, but it does claim: > case outcome: .... fatal ... 1223
- jeromegv 5y ago
  False. Fact check: Clarifying claims around Pfizer vaccine deaths and side effects https://www.reuters.com/article/uk-factcheck-pfizer-health-concerns-idUSKBN28K2R6 https://www.reuters.com/article/uk-factcheck-pfizer-health-c...
  - encryptluks2 5y ago
    You are literally using a source where the CEO is on the board of Pfizer.
  - barbacoa 5y ago
    Please explain what part of that comment is false? I'll break down the claims and let you point out the false one. *This document was produced by Pfizer and submitted to the FDA. *This document was released by the FDA due to FOIA *This document shows that 1223 deaths are linked to the Pfizer vaccine in the first 90 days.
    - dragonwriter 5y ago
tintor 5y ago
How did the FDA even review 450,000 pages for EUA in the first place?
- defaultprimate 5y ago
  Pfizer financed an accelerated reading program for them
  - encryptluks2 5y ago
    Haha. Sure, I'll read for 160 hours in a day of you pay me enough. Just don't give me any quizzes.
    - defaultprimate 5y ago
      The program was named after Hooked on Phonics, but it was called Hooked on Pfizer, and they mostly looked over numbers and dollar signs.
- lalaland1125 5y ago
  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.
  - bryanlarsen 5y ago
    Hopefully they also statistically validly sampled the full patient information.
- albatross13 5y ago
  Pessimist opinion? They didn't. The FDA has people move to private enterprise (https://www.cnbc.com/2019/06/27/former-fda-commissioner-scott-gottlieb-joins-pfizers-board.html https://www.cnbc.com/2019/06/27/former-fda-commissioner-scot...) and vise versa (I don't have sources, but I would be shocked if it didn't happen). 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.
calebm 5y ago
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.
- nradov 5y ago
  Transparency is necessary but there's no evidence that Merck hid Vioxx clinical trials data from the FDA. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/vioxx-rofecoxib-questions-and-answers https://www.fda.gov/drugs/postmarket-drug-safety-information...
- colpabar 5y ago
  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. https://www.justice.gov/opa/pr/justice-department-announces-largest-health-care-fraud-settlement-its-history 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.
  - dntrkv 5y ago
    Lex asks the Pfizer CEO that question in his interview: https://youtu.be/Z_LhPMhkEdw?t=1369 https://youtu.be/Z_LhPMhkEdw?t=1369
- ludamad 5y ago
  "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
- ceejayoz 5y ago
  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. https://pharmaceutical-journal.com/article/feature/still-feeling-the-vioxx-pain 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.
jart 5y ago
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 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.
- lame-robot-hoax 5y ago
  Looks pretty good I’d say. 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.
  - deleted 5y ago
    [deleted]
  - bumby 5y ago
    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.
    - jart 5y ago
      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.
nikkinana 5y ago
fasteddie31003 5y ago
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.
- kube-system 5y ago
  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.
  - creaghpatr 5y ago
    >using released technical documents to support their ideas Yikes, not good!
    - MaxDPS 5y ago
      > Anti-vaxxers are already using released technical documents to support their ideas using out-of-context or misinterpreted snippets of information. Is this intentional irony? If not, way to prove their point lol.
  - MrZongle2 5y ago
    Wait, how is anybody using technical documentation to support their position a bad thing? As opposed, say, to simply faith? Doesn't this mean that such positions can be more readily confirmed or rejected, based upon the validity of the source material?
    - kube-system 5y ago
      As I said: > 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.
deleted 5y ago
[deleted]
BoysenberryPi 5y ago
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."
- mistermann 5y ago
  I think this is somewhat by design on culture war topics (which anything covid definitely is). https://news.ycombinator.com/newsguidelines.html https://news.ycombinator.com/newsguidelines.html > 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.]
- dang 5y ago
  That's unfortunately how polarized topics work. We can't do much about human nature.
  - zo1 5y ago
    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.
    - dmatech 5y ago
      Fear tends to polarize people. It drives them to seek drastic solutions to problems because the stakes are seen as too high to be calm and deliberate.
pmontra 5y ago
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.
- nostromo 5y ago
  Clinical trial data is full of personally identifiable information and health records. Redacting that much information takes a bit of work.
  - sixstringninja 5y ago
    You can hire contractors for that
  - Karunamon 5y ago
    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.
  - Rd6n6 5y ago
    After redaction, can the info be combined with other data to reidentify it? Eg, like ordinary “anonymized” data Could these papers be used one day to dox patients’ medical records?
- john_moscow 5y ago
  They have to check it for private information (e.g. names of specific people) and keep the factual part without any PII.
randombits0 5y ago
So the FDA has 16,000 employees, 10 of which work in the FOIA office. That is the level of commitment to openness by a vital government agency.
- bumby 5y ago
  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.
  - parkingrift 5y ago
    Speaking of bureaucratic bloat... the FDA has 4,659 people working in "regulatory affairs" and 956 working in "family smoking prevention." 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.
    - bumby 5y ago
      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. [1]https://www.fda.gov/about-fda/fda-organization/office-regulatory-affairs https://www.fda.gov/about-fda/fda-organization/office-regula...
    - kube-system 5y ago
      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.
    - 5y ago
dang 5y ago
I know there were threads about this previously but I can't find them. Anyone? Edit: thanks all!
- Jimmc414 5y ago
  I searched for several different variations of this story before I posted it. I was not able to find them.
- trembonator 5y ago
- finite_jest 5y ago
  This one? https://news.ycombinator.com/item?id=29273132 https://news.ycombinator.com/item?id=29273132 (FDA wants 55 years to process FOIA request over vaccine data)
- miles 5y ago
  FDA wants 55 years to process FOIA request over vaccine data https://news.ycombinator.com/item?id=29273132 https://news.ycombinator.com/item?id=29273132 FDA asks federal judge to wait until 2076 to fully release Covid vaccine data https://news.ycombinator.com/item?id=29261058 https://news.ycombinator.com/item?id=29261058 CDC Wants to Hide the Post-Licensure Covid-19 Vaccine Safety Data https://news.ycombinator.com/item?id=29744140 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)
guerby 5y ago
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.
- mike00632 5y ago
  Sounds like an extreme amount of red tape, the same type of red tape that cost us hundreds of thousands of lives early in the pandemic.
- avs733 5y ago
  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.
- elliekelly 5y ago
  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.
avs733 5y ago
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: https://phmpt.org/wp-content/uploads/2021/12/023-FDA-Appendix-in-Support-1.pdf https://phmpt.org/wp-content/uploads/2021/12/023-FDA-Appendi...
- firstlink 5y ago
  You mean, literally the very first (non-nav) link on their homepage (https://archive.is/dL91E https://archive.is/dL91E)? I.e. https://phmpt.org/wp-content/uploads/2021/10/IR0546-FDA-Pfizer-Approval-FINAL.pdf https://phmpt.org/wp-content/uploads/2021/10/IR0546-FDA-Pfiz... ? The one titled "FREEDOM OF INFORMATION ACT REQUEST"? That FOIA request? Or are you talking about some other FOIA request? What is the "bonkers conduct"? What was the point of this lie?
Bellamy 5y ago
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.
- 37 5y ago
  Pfizers R&D? Comes from the tax payers? How, through subsidies? (genuinely curious, never heard this before)
  - tagoregrtst 5y ago
    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
xyzzy21 5y ago
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!
- elliekelly 5y ago
  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?

182 points by Jimmc414 5y ago

https://archive.fo/XWnSn https://archive.fo/XWnSn

Here is the court order https://fingfx.thomsonreuters.com/gfx/legaldocs/gdvzykdllpw/Pittman%20FOIA%20Order.pdf https://fingfx.thomsonreuters.com/gfx/legaldocs/gdvzykdllpw/...

gruez 5y ago
and docket: https://www.courtlistener.com/docket/60390195/public-health-and-medical-professionals-for-transparency-v-food-and-drug/ https://www.courtlistener.com/docket/60390195/public-health-...

lalaland1125 5y ago

The judge here is being incredibly silly. They are ordering the FDA to perform medical grade redaction on 55,000 pages a month. These clinical trial documents are chock full of patient data and clinical notes.

bingohbangoh 5y ago
The pharmaceutical companies have had a gangbusters year and we're implementing vaccine passports in places like NYC on the basis of this data. I think they can hurry.
- Imnimo 5y ago
  These are FDA's documents, not Pfizer's. The pharma companies aren't the ones doing the redaction.
  - bingohbangoh 5y ago
    Ahhhh ok, was not aware, thanks! But my point on this being the subject of a vaccine mandate still holds.
prepend 5y ago
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.
- lalaland1125 5y ago
  > 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.
  - prepend 5y ago
    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. [0] https://www.hhs.gov/hipaa/for-professionals/privacy/special-topics/de-identification/index.html https://www.hhs.gov/hipaa/for-professionals/privacy/special-...
- lesuorac 5y ago
  Would you not use trial data to determine if Pfizer's vaccine should be approved? 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 ...
  - prepend 5y ago
tut-le-tut 5y ago
"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.
sebow 5y ago
Standard procedure is being silly?
kansface 5y ago
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?
- lalaland1125 5y ago
  The FDA already released the evidence it considered for the approval. It's available right on the FDA website: https://www.fda.gov/media/151733/download https://www.fda.gov/media/151733/download 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.
  - encryptluks2 5y ago
    If the evidence references other evidence and you don't have access to that other evidence then you do not have evidence at all.
    - lalaland1125 5y ago
      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.
      - rajin444 5y ago
        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.
    - mike00632 5y ago
      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?
bluGill 5y ago
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.
- lalaland1125 5y ago
  > 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.
  - core-utility 5y ago
    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.
    - kube-system 5y ago
      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.
tehwebguy 5y ago
The FDA offered a timeline of 500 pages / month (75 years) which far sillier.
- kbelder 5y ago
  My quick calc showed that's roughly one guy redacting 2.8 pages per hour. I know people who'd LOVE that job.
tagoregrtst 5y ago
The FDA played a stupid game by offering 500 pages a month. Thats a ream of paper. A person could redact that in a couple days. The Judge told the FDA to take the FOIA law seriously and, so they remember to next time, ordered them to do so quickly.

dopylitty 5y ago

"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) 1. https://www.fda.gov/medical-devices https://www.fda.gov/medical-devices 2. https://www.fda.gov/food/recalls-outbreaks-emergencies/alerts-advisories-safety-information#infantformula https://www.fda.gov/food/recalls-outbreaks-emergencies/alert...

ipspam 5y ago
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
- dopylitty 5y ago
  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'

grumple 5y ago

What do they need to strip? 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.

o10449366 5y ago
Why do you think it would be easy to achieve 100% redaction accuracy with NLP?
- grumple 5y ago
  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.
bryanlarsen 5y ago
Many of those documents contain personal medical information.

barbacoa 5y ago

encryptluks2 5y ago
Hm, but I thought that this corrupt medical company with a history of lying to increase profits had our best interests in mind.
mijowi 5y ago
Where is that in the document?
- kansface 5y ago
  I am totally unfamiliar with this doc, but it does claim: > case outcome: .... fatal ... 1223
jeromegv 5y ago
False. Fact check: Clarifying claims around Pfizer vaccine deaths and side effects https://www.reuters.com/article/uk-factcheck-pfizer-health-concerns-idUSKBN28K2R6 https://www.reuters.com/article/uk-factcheck-pfizer-health-c...
- encryptluks2 5y ago
  You are literally using a source where the CEO is on the board of Pfizer.
- barbacoa 5y ago
  Please explain what part of that comment is false? I'll break down the claims and let you point out the false one. *This document was produced by Pfizer and submitted to the FDA. *This document was released by the FDA due to FOIA *This document shows that 1223 deaths are linked to the Pfizer vaccine in the first 90 days.
  - dragonwriter 5y ago

tintor 5y ago

How did the FDA even review 450,000 pages for EUA in the first place?

defaultprimate 5y ago
Pfizer financed an accelerated reading program for them
- encryptluks2 5y ago
  Haha. Sure, I'll read for 160 hours in a day of you pay me enough. Just don't give me any quizzes.
  - defaultprimate 5y ago
    The program was named after Hooked on Phonics, but it was called Hooked on Pfizer, and they mostly looked over numbers and dollar signs.
lalaland1125 5y ago
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.
- bryanlarsen 5y ago
  Hopefully they also statistically validly sampled the full patient information.
albatross13 5y ago
Pessimist opinion? They didn't. The FDA has people move to private enterprise (https://www.cnbc.com/2019/06/27/former-fda-commissioner-scott-gottlieb-joins-pfizers-board.html https://www.cnbc.com/2019/06/27/former-fda-commissioner-scot...) and vise versa (I don't have sources, but I would be shocked if it didn't happen). 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.

calebm 5y ago

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.

nradov 5y ago
Transparency is necessary but there's no evidence that Merck hid Vioxx clinical trials data from the FDA. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/vioxx-rofecoxib-questions-and-answers https://www.fda.gov/drugs/postmarket-drug-safety-information...
colpabar 5y ago
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. https://www.justice.gov/opa/pr/justice-department-announces-largest-health-care-fraud-settlement-its-history 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.
- dntrkv 5y ago
  Lex asks the Pfizer CEO that question in his interview: https://youtu.be/Z_LhPMhkEdw?t=1369 https://youtu.be/Z_LhPMhkEdw?t=1369
ludamad 5y ago
"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
ceejayoz 5y ago
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. https://pharmaceutical-journal.com/article/feature/still-feeling-the-vioxx-pain 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.

jart 5y ago

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 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.

lame-robot-hoax 5y ago
Looks pretty good I’d say. 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.
- deleted 5y ago
  [deleted]
- bumby 5y ago
  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.
  - jart 5y ago
    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.

nikkinana 5y ago

fasteddie31003 5y ago

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.

kube-system 5y ago
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.
- creaghpatr 5y ago
  >using released technical documents to support their ideas Yikes, not good!
  - MaxDPS 5y ago
    > Anti-vaxxers are already using released technical documents to support their ideas using out-of-context or misinterpreted snippets of information. Is this intentional irony? If not, way to prove their point lol.
- MrZongle2 5y ago
  Wait, how is anybody using technical documentation to support their position a bad thing? As opposed, say, to simply faith? Doesn't this mean that such positions can be more readily confirmed or rejected, based upon the validity of the source material?
  - kube-system 5y ago
    As I said: > 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.

deleted 5y ago

[deleted]

BoysenberryPi 5y ago

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."

mistermann 5y ago
I think this is somewhat by design on culture war topics (which anything covid definitely is). https://news.ycombinator.com/newsguidelines.html https://news.ycombinator.com/newsguidelines.html > 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.]
dang 5y ago
That's unfortunately how polarized topics work. We can't do much about human nature.
- zo1 5y ago
  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.
  - dmatech 5y ago
    Fear tends to polarize people. It drives them to seek drastic solutions to problems because the stakes are seen as too high to be calm and deliberate.

pmontra 5y ago

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.

nostromo 5y ago
Clinical trial data is full of personally identifiable information and health records. Redacting that much information takes a bit of work.
- sixstringninja 5y ago
  You can hire contractors for that
- Karunamon 5y ago
  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.
- Rd6n6 5y ago
  After redaction, can the info be combined with other data to reidentify it? Eg, like ordinary “anonymized” data Could these papers be used one day to dox patients’ medical records?
john_moscow 5y ago
They have to check it for private information (e.g. names of specific people) and keep the factual part without any PII.

randombits0 5y ago

So the FDA has 16,000 employees, 10 of which work in the FOIA office. That is the level of commitment to openness by a vital government agency.

bumby 5y ago
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.
- parkingrift 5y ago
  Speaking of bureaucratic bloat... the FDA has 4,659 people working in "regulatory affairs" and 956 working in "family smoking prevention." 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.
  - bumby 5y ago
    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. [1]https://www.fda.gov/about-fda/fda-organization/office-regulatory-affairs https://www.fda.gov/about-fda/fda-organization/office-regula...
  - kube-system 5y ago
    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.
  - 5y ago

dang 5y ago

I know there were threads about this previously but I can't find them. Anyone? Edit: thanks all!

Jimmc414 5y ago
I searched for several different variations of this story before I posted it. I was not able to find them.
trembonator 5y ago
finite_jest 5y ago
This one? https://news.ycombinator.com/item?id=29273132 https://news.ycombinator.com/item?id=29273132 (FDA wants 55 years to process FOIA request over vaccine data)
miles 5y ago
FDA wants 55 years to process FOIA request over vaccine data https://news.ycombinator.com/item?id=29273132 https://news.ycombinator.com/item?id=29273132 FDA asks federal judge to wait until 2076 to fully release Covid vaccine data https://news.ycombinator.com/item?id=29261058 https://news.ycombinator.com/item?id=29261058 CDC Wants to Hide the Post-Licensure Covid-19 Vaccine Safety Data https://news.ycombinator.com/item?id=29744140 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)

guerby 5y ago

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.

mike00632 5y ago
Sounds like an extreme amount of red tape, the same type of red tape that cost us hundreds of thousands of lives early in the pandemic.
avs733 5y ago
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.
elliekelly 5y ago
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.

avs733 5y ago

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: https://phmpt.org/wp-content/uploads/2021/12/023-FDA-Appendix-in-Support-1.pdf https://phmpt.org/wp-content/uploads/2021/12/023-FDA-Appendi...

firstlink 5y ago
You mean, literally the very first (non-nav) link on their homepage (https://archive.is/dL91E https://archive.is/dL91E)? I.e. https://phmpt.org/wp-content/uploads/2021/10/IR0546-FDA-Pfizer-Approval-FINAL.pdf https://phmpt.org/wp-content/uploads/2021/10/IR0546-FDA-Pfiz... ? The one titled "FREEDOM OF INFORMATION ACT REQUEST"? That FOIA request? Or are you talking about some other FOIA request? What is the "bonkers conduct"? What was the point of this lie?

Bellamy 5y ago

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.

37 5y ago
Pfizers R&D? Comes from the tax payers? How, through subsidies? (genuinely curious, never heard this before)
- tagoregrtst 5y ago
  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

xyzzy21 5y ago

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!

elliekelly 5y ago
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?