[HN Gopher] Judge orders FDA to hasten FOIA release of Pfizer va...
___________________________________________________________________
Judge orders FDA to hasten FOIA release of Pfizer vaccine docs
Author : Jimmc414
Score : 167 points
Date : 2022-01-07 17:17 UTC (5 hours ago)
(HTM) web link (www.reuters.com)
(TXT) w3m dump (www.reuters.com)
| fasteddie31003 wrote:
| 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 wrote:
| 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 wrote:
| >using released technical documents to support their ideas
|
| Yikes, not good!
| Bellamy wrote:
| Vaccines are brilliant but I don't like the idea that a company
| manipulates data and put people's lives at risk for profit.
| It's clearly criminal activity.
| dopylitty wrote:
| "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 2.
| https://www.fda.gov/food/recalls-outbreaks-emergencies/alert...
| avs733 wrote:
| If it's helpful, Alex Jones seems to love 'citing' (meaning
| lying about) the documents they have produced so far.
| throw10920 wrote:
| There's very little reason to believe that the reassignment
| will actually come from teams working on either of those two
| problems. This argument is a really long stretch - especially
| because there are other ways of meeting the deadline than
| reassignment to the FOIA office (hiring contractors, adding
| employees, using interns or HR folk) - picking out a highly
| specific and avoidable method of executing the FOIA to attack
| the idea of doing the FOIA at all is...questionable, to say the
| least.
|
| Moreover, as a citizen of the US that has paid for the R&D of
| those vaccines through my tax dollars, I have a right to see
| the results of that research. This shouldn't be a controversial
| opinion. (it certainly wasn't when the House passed the Freedom
| Of Information Act 306 to 0 in 1966)
| tut-le-tut wrote:
| "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.
| balefrost wrote:
| From earlier in the article, the total number of requested
| pages is 450,000. At 8 minutes per page, it's 60k man-hours,
| or 30 man-years, of work.
| lesuorac wrote:
| If they want their documents faster they should just pay for
| it. Requesting 300k+ pages is not a normal request, there is
| no way all of those pages will be of interest.
|
| Pay for it by paying a fee equal to the cost of hiring /
| training additional personal (https://www.foia.gov/faq.html).
| LegitShady wrote:
| Only the rich should get FOIA?
| Arainach wrote:
| The FOIA should not allow anyone to launch a denial of
| service attack on the government.
|
| The requester can specify the scope or the timeline. Not
| both. If my employer asked me to review this much content
| I would also give a timeline on the order of years.
| Saying "too bad, it has to be faster" doesn't change my
| estimate.
| tagoregrtst wrote:
| DOS attacks were pioneered by progressives in the 60s.
| We've had 60 years to make the system robust to DOD
| attacks
| LegitShady wrote:
| I have no problem with that, but if the paperwork isn't
| produced, the FDA can't enforce or use any of the process
| for any reason because its not transparent.
|
| Take as long as you want, just lose any legal power those
| documents give you so that you aren't unjustly using them
| if there is evidence of some kind of fraud or other
| issues.
|
| Take 100 years, but for those 100 years the paperwork
| can't be used with any legal authority because its not
| transparent.
|
| Problem solved.
| jcranmer wrote:
| Or maybe, if you think the FDA did something wrong, you
| should have enough of an idea of what it did wrong that
| you could confirm it by asking for something less than
| _literally everything Pfizer ever submitted to the FDA_?
| If you 're asking for that much information, that
| suggests that you're undertaking a fishing expedition
| rather than actually substantively accusing the FDA of
| something wrong.
| Arainach wrote:
| That is once again absurd and amounts to a denial of
| service attack. Reviewing documents for public
| disclosure, removing PII, etc. is a totally different
| process from reviewing their accuracy for medical
| purposes. It takes at least as long, probably longer.
| Mountain_Skies wrote:
| We're spending TRILLIONS of dollars on this pandemic.
| TRILLIONS! These FOIA requests are not DOS attacks. It's
| very clear that some are very scared of what these FOIA
| requests might reveal rather than a concern about the
| cost of spending 0.000001% of the response budget on it.
| Why are you personally so scared of what the documents
| might reveal? It's nothing to do with imaginary DOS
| attacks.
| Arainach wrote:
| I am all for the documents being released eventually, but
| it takes time to remove PII from 450,000 pages of medical
| records (themselves very dense with PII). I am not in
| favor of releasing them prematurely with identifying
| information, nor am I in favor of requiring an entire
| department to stop their (more important than this
| process) jobs at the whim of someone who doesn't even
| know what they're looking for.
| encryptluks2 wrote:
| So pay for transparency that is already expected? Should
| you have to pay to get your medical record?
| mike00632 wrote:
| It's asinine to think you have a right to see every
| document the government has including PII and trade
| secrets, even worse to base an anti-vaxx effort on such
| ideas.
| encryptluks2 wrote:
| It's crazy to me the amount of people that people would
| blindly trust the same government that did illegal
| experimentation in the past and gave unsuspecting
| populations syphilis.
| viro wrote:
| That's not how labor works. Adding more people often times
| increases the time a task takes.
| vorpalhex wrote:
| There are literally legal firms that employ hundreds of
| paralegals who do nothing but bulk redaction. They
| literally have systems to split up huge document bundles
| and do redaction in parallel.
| ethbr0 wrote:
| You're roughly talking about the trusts popularized as
| Amdahl's Law [0]. Which, to summarize the nuances in this
| context, says "It depends on the nature of the task."
|
| [0] https://en.m.wikipedia.org/wiki/Amdahl's_law
| jaywalk wrote:
| That adage is meant for tasks that require a large amount
| of coordination, e.g. large software projects. This is no
| such task.
|
| It's like saying you've got a large wall that needs to be
| scrubbed clean, and having 10 people do it at once would be
| slower than having one person do it. That is obviously not
| going to be the case.
| laluser wrote:
| Well, this task is highly parallelizable. Is it not? Why
| would there be a central bottleneck that you could not
| scale out?
| [deleted]
| [deleted]
| gruez wrote:
| >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)
|
| see page 3, paragraph 11:
| https://www.courtlistener.com/docket/60390195/1/public-healt...
| geofft wrote:
| Yup, looks like it:
|
| - 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....
| colpabar wrote:
| Well I for one am glad that FOIA requests don't depend on
| whether you like the people filing them. I find it
| absolutely ridiculous that asking for this data is seen as
| a bad thing. Why are pharmaceutical companies suddenly
| beyond questioning?
| Robotbeat wrote:
| The ones doing the questioning absolutely make a
| difference. The world is a stochastic mess. Motivated
| cherrypicking allows a narrative to be spun (in any
| direction!) that is convincing to most people who don't
| have the time to deeply understand these issues.
|
| It's hard to overstate how easy it is to fool yourself
| through cherrypicking, let alone others receptive to your
| narrative.
|
| Maybe we legally and morally have to allow this, but I
| think you're absolutely foolish to suggest this can't
| have a strong negative effect "if they don't have
| anything to hide."
|
| EDIT: Quit downvoting me without reading and
| understanding my last sentence. The vaccine is being
| targeted like a politician for opposition research (where
| even totally honest and above-board info can be spun
| negatively). EVEN IF the right thing to do is open
| kimono, the end result could be a whole bunch of deaths
| and y'all better be honest with yourselves about it and
| make peace with that result instead of pretending nothing
| bad could happen from it.
| Karunamon wrote:
| Hiding information and general untrustworthiness harms
| credibility, which is a chicken that's going to come home
| to roost the next time there's a public health crisis.
|
| The CDC blew a lot of its credibility with the (arguably
| noble) early lie about masks not working.
|
| Pharma companies probably don't have that much to lose.
|
| Now it's the FDA's turn.
|
| "We must hide legally-required-to-be-available
| information because some people may misuse it" is a path
| with unlimited abuse potential, best avoided.
| Robotbeat wrote:
| Look, again, I'm not suggesting any legally required
| information should be hidden. But if you think the end
| result of releasing massive amount of even totally-above-
| board information is going to be increased public trust,
| then you must have sleepwalked the last 6 years.
|
| There's a good case to be made that releasing this is the
| best course. But let's not pretend that public trust
| won't be eroded because it takes an order of magnitude
| more work to disprove bulls### than to make it up (or
| twist it) in the first place. And it isn't any
| particularly information I'm talking about, simply the
| vast quantity involved.
|
| The vaccine becoming political is probably the worst
| thing to happen to humanity in the last 2-3 years. Worse
| probably than COVID itself.
|
| EDIT: just thought of one possible solution or at least
| mitigation to the "Bull### asymmetry principle" when
| combined with massive data dumps: Limit the amount of
| material that can be requested. Any specific dates or
| whatever could be requested within the stack. Or if a
| representative sample is desired, the entire dump is
| sectioned in pieces and each section is securely hashed.
| The one doing the request can then request, say, up to
| 100-1000 sections and each such section can then have its
| hash compared. That ensures the random selection is
| random to the satisfaction of the requesting party. And
| it limits the amount of bulls### that needs to be
| countered to some reasonable level. Otherwise, any
| attacker will be able to overwhelm the public with
| endless claims from a massive stash of requested
| documents.
|
| This doesn't limit the amount of work for scrubbing PII,
| though, since you'd have to scrub it before hashing or
| the hashing wouldn't be recreatable. But at least you'd
| limit the amount of unique bulls### that'd need to be
| countered.
| Mountain_Skies wrote:
| Humanity is who is asking for answers.
| Robotbeat wrote:
| Looking for answers or looking for ammunition in an
| ideological war against vaccination?
| colpabar wrote:
| Of course people are going to cherry-pick things that
| suit their narrative from this massive amount of
| information. But that's the game. If there are
| questionable things in this data, then it's up to our
| public health officials to explain them.
|
| This vaccine is a new type of medicine that was produced
| faster than vaccine before it. It also seems to work. But
| regardless, we all deserve to see every bit of
| information about its production, especially now that
| people's jobs depend on them getting it.
| geofft wrote:
| To be clear, I am not saying "This FOIA request is bad
| because I don't like the people filing them." I agree
| transparency is good, and I in fact think it should be
| the _default_ , no FOIA necessary, including and perhaps
| especially for things like medical approvals. That means
| the assumption of it being made public should be built in
| at every step of the process, including notes of patient
| trials.
|
| I am simply responding to the comment above that asks,
| who are the people who are requesting the information,
| and what is their agenda. That is also a very important
| thing to know for a vibrant public discourse.
| colpabar wrote:
| Fair enough; thanks for elaborating.
|
| 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.
| [deleted]
| vorpalhex wrote:
| > and tweets links to The American Conservative.
|
| 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.
| staticassertion wrote:
| > Why do we care about this? Does he also have bad taste
| in summer outfits?
|
| You can feign ignorance here but the answer is obvious.
| Anti-vax talking points are far more common in
| conservative media.
| Jimmc414 wrote:
| For the sake of argument even if they were conservatives
| or anti-vaxer or felons or insurrectionists the Freedom
| of Information Act still applies to them.
| samsa wrote:
| The NY Post article you link to is about getting both
| Covid and influenza at the same time. That may be rare.
|
| Getting covid a second time after having previously had
| it (which is what McCullough erroneously claimed was near
| impossible) is in fact increasingly common.
| vorpalhex wrote:
| Do you have a citation?
|
| > Cases of reinfection with COVID-19 have been reported,
| but remain rare .
|
| https://www.cdc.gov/coronavirus/2019-ncov/your-
| health/reinfe...
| geofft wrote:
| I agree that they are _rare_. Dr. McCullough 's claim was
| that they were _impossible_ , that Rogan's friend who got
| it twice actually had influenza or something one of the
| times - a diagnosis he made based on no information other
| than appearing to have gotten it twice.
|
| If he merely claimed they were rare, that would not
| discredit him.
| dublin wrote:
| And as mentioned above, he later clarified that he was
| talking about pre-Omicron variants, where that was true.
| It now seems possible to get Omicron more than once, but
| since it has virtually no impact (most people never even
| know they have it, especially here in Austin in Dec-Feb
| "Cedar Fever" season), it really makes no difference,
| other than that it's not yet known if it works the other
| way, so that an Omicron infection may provide protection
| against prior variants.
| vorpalhex wrote:
| To recap, you are upset because a doctor on a podcast
| used the phrase "impossible" instead of "very rare"?
| akiselev wrote:
| What's the point of professionals and experts if they
| don't communicate clearly and precisely? Why even have
| him on a podcast?
| coderaptor wrote:
| Communicating technical concepts to lay audiences is
| difficult, and a universal problem these days.
|
| Very rare and impossible are nearly equivalent wrt
| policies that broadly and significantly impact personal
| health and liberty.
| akiselev wrote:
| I agree that communicating these concepts is hard, but
| that characterization of "very rare" and "impossible"
| only makes it harder.
|
| Pandemics are _very rare_. Flying unicorns shooting Ebola
| out of their horns are _impossible_.
| AlphaOne1 wrote:
| Yes, but in the subsequent podcast with Joe Rogan and
| Robert Malone, Dr. Malone specifically says that Dr.
| McCullough asked that he let everyone know that he was
| basing his information on pre omicron variant and that
| reinfections are actually much more common with this
| variant.
| pvarangot wrote:
| Nah a lot of Delta cases where reinfections, I can't
| believe we are still arguing about wether COVID mutations
| can reinfect only because of McCullough.
|
| Of course if you only look at the "variants of concern"
| that the media talks about you basically have to wait
| years until you have like 4 or 5 variants that went all
| around the world to see how common it is for it to mutate
| in a way that can reinfect, but considering Delta
| reinfections where common and now Omicron is also
| reinfecting everyone, I would just not loose any more
| time listening to McCullough. Note he says its
| _impossible_, not rare or weird or strange, _impossible_.
| He actually called bullshit on Rogan because Rogan said
| his friend got it twice because he got Delta and the
| first variant.
| vorpalhex wrote:
| > Nah a lot of Delta cases where reinfections,
|
| That is an amazing fact if true and you should alert the
| CDC immediately with your evidence.
| isItpossible8 wrote:
| avs733 wrote:
| Not facts and claims...common sense.
|
| 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...
| ds206 wrote:
| Trust the science. Btw, my name is Science ;)
| Jimmc414 wrote:
| US citizens are legally entitled to this information.
| avs733 wrote:
| >this information.
|
| 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.
| Jimmc414 wrote:
| We are not talking about a request for POTUS tax returns.
|
| The process is defined by the Freedom of Information Act
| itself and not the Department of Health and Human
| Services. Here is the act
| https://www.justice.gov/oip/freedom-information-
| act-5-usc-55... and by law there only 9 exemption
| categories that allow a US agency to withhold
| information. They are: 1. classified information for
| national defense or foreign policy 2. internal personnel
| rules and practices 3. information that is exempt under
| other laws 4. trade secrets and confidential business
| information 5. inter-agency or intra-agency memoranda or
| letters that are protected by legal privileges 6.
| personnel and medical files 7. law enforcement records or
| information 8. information concerning bank supervision 9.
| geological and geophysical information
| chaps wrote:
| You gotta realize that these gov agencies give _bad
| faith_ arguments to say that they can 't release records
| _routinely_. These government agencies know _full fucking
| well_ that these records will be responsive to FOIA and
| yet they still don 't make efforts to make it accessible
| and releasable to the public. Same goes to Pfizer. It's
| our responsibility as a public to make sure important
| information like this isn't being hidden.
|
| Their litigation is aggressive, there's no doubt there.
| But does that mean the information isn't any less
| important? Back when the pandemic started, a lot of FOIA
| nerds were hesitant to submit FOIAs because of the issues
| around quarantine, WFH etc. At the end though,
| transparency is such a fundamentally important part of
| our understanding of our own governance that it's
| important that we don't hold back on important issues
| like this.
|
| It doesn't even really matter too much if the
| organization won't use the docs themselves. Their
| litigation is making it available to the public. If
| they're not going to look through them, _someone_ will.
| tagoregrtst wrote:
| "[...] tweets links to The American Conservative"
|
| Cant blame him though. It _is_ a great magazine.
| ethbr0 wrote:
| What do you find great about it? (Honestly asked as a
| non-reader unfamiliar with its content, aside from the
| implication of the name)
| amanaplanacanal wrote:
| If you are a liberal interested in what conservatives
| think about things, without going full Q crazy, you could
| do worse.
|
| If you are interested in anti-trump conservative thought,
| The Bulwark is another good source.
| 908B64B197 wrote:
| > The reporter suggests the FDA reassign other people to
| process the FOIA requests but I would prefer those people
| continue working on important things like reviewing the safety
| and efficacy of medical devices[1] and reviewing the safety of
| food and infant formula [2] rather than spending their time
| processing paperwork
|
| I'm puzzled why they didn't make the document FOIA friendly in
| the first place. It was pretty obvious that it was going to be
| requested as it is of extreme public interest.
|
| I'm wondering if this "burden" wasn't intentionally planned.
| But there's no reason to do so: after all, the FDA should be
| working in the public's interests, and they have nothing to
| hide.
| Jimmc414 wrote:
| Do you think that sort of argument could delay an IRS audit for
| 55 years? Why should this be any different?
| tonfreed wrote:
| If you've ever dealt with public departments, you'd know that
| the vast majority of those they employ would be pencil pushers
| and meetware.
| ipspam wrote:
| 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 wrote:
| 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'
| steelstraw wrote:
| It's about being suspicious of the pharmaceutical industry
| and the FDA, which has a revolving door that has been
| abused.
|
| The FDA has never been held to account for its improper
| handling of the opioid crisis. But the FDA's conduct is all
| the more troubling in light of the close relationship
| between the agency officials responsible for opioid
| oversight and opioid manufacturers. For example, the 2
| principal FDA reviewers who originally approved Purdue's
| oxycodone application both took positions at Purdue after
| leaving the agency. Over the past 20 years, several other
| FDA staff involved in opioid approvals also left the FDA to
| work for opioid makers. Last January, the head of the FDA's
| analgesic division retired from the FDA to start her own
| consulting business, which promises drug makers "help" to
| "successfully and efficiently bring your products to
| market" with "more than 30 years of experience at the FDA."
|
| To be clear, the revolving door between the FDA and the
| pharmaceutical industry is not limited to opioids. _A 2018
| study found that 11 of 16 FDA medical reviewers involved in
| approving 28 products now work for the companies whose
| products they regulated._ Without appropriate limits on
| employment after leaving the FDA, staff might be tempted to
| put the interests of future employers, whose favor they
| wish to gain, ahead of public health.
|
| https://journalofethics.ama-assn.org/article/how-fda-
| failure...
| avs733 wrote:
| Do you have any evidence to support that accusation in
| the last paragraph or is it just a hypothesis that you
| linked to minimally related other facts?
| keneda7 wrote:
| Are you referring to the mRNA vaccine platform? Could you
| point me to the mRNA vaccine application that was approved
| before covid?
|
| When I looked into it all, of them had been denied until
| covid and I did not hear of any breakthrough in mRNA
| technology that suddenly fixed the issues the previous ones
| (I found 8) had been denied for.
| jaywalk wrote:
| It's just a coincidence that these companies that have
| been working for years on this stuff failed every single
| time in the past, but then within a few weeks in early
| 2020 they suddenly figured everything out.
| ceejayoz wrote:
| Not a coincidence, no.
|
| Just a very different cost/benefit analysis on "do all
| the steps we can in parallel to speed things up" during a
| pandemic.
| keneda7 wrote:
| I am confused here. There were issues with the previously
| submitted mRNA vaccines created pre covid. Of the 8 I
| could find all were rejected. Doing a process that does
| not work in parallel will not suddenly fix it.
| ceejayoz wrote:
| Well, let's say you're exploring a cave with six
| entrances.
|
| 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.
| jaywalk wrote:
| Moderna was founded precisely to find the Holy Grail.
| Making a breakthrough in a matter of weeks that couldn't
| be found for 8 years is incredibly hard to believe no
| matter how much additional money is thrown at the
| problem.
| ceejayoz wrote:
| "Matter of weeks" or "they've been working on the tech
| for eight years".
|
| Pick one. You can't have both.
| jaywalk wrote:
| No, I can have both. For 8 years, they've tried a bunch
| of different things that they thought would work.
| Literally none of them did. And then in a matter of
| weeks, they figured the whole thing out.
|
| Obviously they didn't start from zero. But it wasn't like
| they had something from, say, 2018 that was looking
| promising but just hadn't made it all the way through
| trials yet. They had nothing but failures.
| ceejayoz wrote:
| They spent eight years _iterating their technology_. The
| idea that they had nothing but already-failed candidates
| at the start of the pandemic is simply false.
|
| Their 10-K from the end of 2019: https://www.sec.gov/Arch
| ives/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.
| newrotik wrote:
| Moderna use has been suspended for individuals <30y in
| several Scandinavian countries due to its side effects.
|
| The point discussed is not whether it works or not, but
| what are the actual safety parameters.
| ceejayoz wrote:
| No, they're saying "Making a breakthrough in a matter of
| weeks that couldn't be found for 8 years is incredibly
| hard to believe".
|
| 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.
| allturtles wrote:
| So if they didn't make the breakthrough in weeks, what do
| you think happened? They already had a secret COVID
| vaccine for years? The trials were faked and all the
| post-trial evidence about vaccine efficacy is also faked?
| dragonwriter wrote:
| > So if they didn't make the breakthrough in weeks, what
| do you think happened?
|
| The expected vaccine sales were high enough to justify
| spending resources initiating developement on lots of
| candidate mRNA vaccines in parallel, and spending the
| money testing more of the potentially viable ones at a
| time than would otherwise have been the case. When you
| throw a lot more against the wall, you find something
| that sticks a lot faster.
| mike00632 wrote:
| Wait, what were the issues with the mRNA vaccines? If you
| are accusing the mRNA vaccines of having "issues" then
| it's important you provide details and a citation
| ceejayoz wrote:
| Moderna had some pre-COVID mRNA clinical trials that
| failed for various reasons. (As is, to say the least,
| common in the pharmaceutical industry.)
|
| 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."
| colpabar wrote:
| For sure. I know if I had an opportunity to create and
| sell a product that would be all but required for
| everyone across the world, I'd hurry my ass up to create
| it.
| jaywalk wrote:
| If only Moderna had realized in that they could "do all
| the steps [they] can in parallel to speed things up" 8
| years ago! They managed to accomplish what had eluded
| them for 8 years in a matter of weeks. Astounding stuff.
| ceejayoz wrote:
| Again, it's a cost/benefit analysis.
|
| 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.
| jaywalk wrote:
| Sure, you're explaining why and how _testing_ went
| faster. I totally understand that, but it 's not at all
| what I'm talking about.
|
| All of the previous mRNA drugs failed testing due to
| safety concerns. But we're expected to believe that those
| safety concerns were resolved in a matter of weeks.
| ceejayoz wrote:
| > All of the previous mRNA drugs failed testing due to
| safety concerns.
|
| Sure, and all the planes leading up to the Wright Flyer
| failed.
|
| https://www.nature.com/articles/d41586-021-02483-w has a
| great timeline graphic of the various advances and
| breakthroughs required to get to this point, including
| the first drug using the lipid nanoparticles - key to
| fixing the safety concerns! - approved in 2018.
| shard wrote:
| Nothing like a pandemic and millions of people dying to
| light a fire under some asses.
| hotz wrote:
| It boggles my mind that anyone can oppose transparency. Why
| do some people view these vaccines/pharma companies as
| something sacred, not to be questioned.
| allturtles wrote:
| Who is against transparency? Has anyone argued that this
| information shouldn't be released? AFAICT the court
| battle is just about speed, and whether the FDA should go
| out of its way to satisfy this particular FOIA request
| more quickly.
| merpnderp wrote:
| Anyone taking the FDA's side is against transparency. In
| 75 years no one will care about this data except like a
| single historian working on their PhD in a bizarre
| medical history field.
| Karunamon wrote:
| At least one person is arguing precisely that in this
| thread.
| Clubber wrote:
| lalaland1125 wrote:
| There is a difference between normal transparency and
| demanding the release of 450,000 pages of patient data.
| postalrat wrote:
| So in the future if they have something to hide just
| produce 450k pages of patient data to hide behind.
| lalaland1125 wrote:
| Or maybe the plaintiffs could be more explicit about what
| data in particular they are looking for.
|
| The reason why they are getting the endless pages of
| patient data is because the plaintiffs are asking for it.
| chaps wrote:
| Sorry, no. These gov agencies don't tell us what
| information they have (often intentionally!) and so we
| _can 't always_ be explicit about what information we
| want. If they told us exactly the extent of information
| they have, then we wouldn't need to play these silly
| little games of requesting more than what necessarily
| exists.. but what choice do we have?
| vorpalhex wrote:
| That is normal transparency.
| chaps wrote:
| (disclaimer: my experience with FOIA is mostly at the
| state level and though I've read, used, and litigated
| federal FOIA issues, I'm no expert there)
|
| Transparency doesn't work in isolation. If there's a
| problem where the release of 450,000 pages of patient
| information is so difficult that it can't be done, then
| there's a fundamental process fuckup that should be
| corrected. For example, if everything's on paper, then
| the process failure is in a lack of transcription. If
| it's because private information is typed in a form, that
| form should be broken up in a way so that the important
| private information is typed into another field.
| Generally there are ways to make sure these issues don't
| happen -- from the _beginning_. Keep in mind, these
| people are aware of the existence of FOIA and the
| possibility that these records would be subject to FOIA.
| These processes should be built with that in-mind,
| especially considering the importance of the information.
|
| It's such a big deal that in states like Illinois, the
| law disallows the use of the unduly burdensome exemption
| if the gov agency doesn't respond within the time limits
| of the statute. Takes 10k hours? Big deal, shoulda
| responded in time.
|
| A lot of these issues stem from the fact that in _so many
| cases_ , the agency's estimates are either beyond any
| possible worst case scenario (ie, unrealistic), or an
| intentionally naive estimate in order to urge the
| requester to go away. If we take these public agencies at
| face value that something would take forever without
| litigation, then they can easily just make it a routine
| process to call something unduly burdensome, so it's
| important to call them out on their shit. See:
| https://mchap.io/that-time-the-city-of-seattle-
| accidentally-...
| shard wrote:
| I would imagine it's like technical debt. There's
| benefits to paying that debt down, but there are always
| other issues that have higher priority. Sure, the
| software should have been architectured to be easily
| extensible / system should have been set up to make it
| easy to release half a million pages of documents, but
| this update has to be released in time to beat the
| competition / these drug approvals needs to be completed
| to save lives.
| chaps wrote:
| The argument on technical debt isn't wrong, but it
| doesn't fully take into account the importance of this
| information and the legal requirements these agencies are
| held to. Just because it's difficult doesn't mean the
| information shouldn't be released. If we accept that the
| request is difficult as a reason to not release the
| records, then they'll never get released. Once that
| seed's planted, it's so unbelievably hard to come out of.
| It's something you see with agencies that never get held
| accountable to their lack of transparency.
|
| It sucks, but the alternative is much worse.
| klabb3 wrote:
| Remember pfizers own report and raw data are not the only
| options, it's a false dichotomy.
|
| In order to make the report in the first place, Pfizer
| had to preprocess the data to intermediate, tabulated
| formats. However, this data is their secret IP, which in
| and of itself is absolutely insane, given that we're
| moving in the direction of mandates.
|
| I don't get how one of the most foul industries - by
| public track record -- suddenly get a carte blanche from
| otherwise sane and critical people. There are so many
| scandals in Pharma, and suddenly overnight you're a
| conspiracy theorist if you want independent scientists to
| double check the biggest public health mandate in
| history.
| Miner49er wrote:
| This is very useful information, though. People can
| analyze this to find out if there is any increased risk
| of adverse effects (or not) by all kinds of factors that
| hasn't been released. Things like underlying medical
| conditions.
|
| Some people with certain medical conditions are vaccine-
| hesitant because of their health condition. If this data
| can prove that people with certain health conditions
| aren't at any increased risk from the vaccine, it could
| mean more people get vaccinated.
| avs733 wrote:
| > So your for using power to totally destroy all the hard won
| battles for transparency, destroy trust in public
| institutions, and feed conspiracy theories?
|
| If the FDA screws up in their now legally compelled rush to
| produce these documents what happens?
|
| Pfizer could have their trade secret info leaked (like it or
| not that shouldn't happen)
|
| Participants in vaccine trials could have their private
| health information leaked (or have their identity stolen)
|
| The FDA is responsible and liable
|
| FOIA abuse is a thing, just like DMCA abuse is a thing.
| People abusing the FOIA process are the ones who are likely
| to lead to its power being destroyed, not the government
| here.
|
| It isn't suspicious...this group is intentionally
| misinterpreting things in bad faith under the guise of
| accountability.
|
| It's classic bad faith, and I'm deeply saddened at how easily
| this country falls for it.
| pmontra wrote:
| 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.
| john_moscow wrote:
| They have to check it for private information (e.g. names of
| specific people) and keep the factual part without any PII.
| nostromo wrote:
| Clinical trial data is full of personally identifiable
| information and health records. Redacting that much information
| takes a bit of work.
| Karunamon wrote:
| 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 wrote:
| 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?
| [deleted]
| dang wrote:
| I know there were threads about this previously but I can't find
| them. Anyone?
| Jimmc414 wrote:
| I searched for several different variations of this story
| before I posted it. I was not able to find them.
| trembonator wrote:
| finite_jest wrote:
| This one? https://news.ycombinator.com/item?id=29273132 (FDA
| wants 55 years to process FOIA request over vaccine data)
| xyzzy21 wrote:
| 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!
| randombits0 wrote:
| 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.
| jimbob45 wrote:
| It's a Titanic problem - too many people, not enough boats.
| Except here, it's too many projects, not enough funding.
|
| 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?
| dublin wrote:
| It's worth noting (READ IT!) that the court order
| specifically calls out that given the urgency of the current
| disease situation and political and public health trust
| issues, it is the Court's opinion that there is almost
| nothing the FDA has to do that could be MORE important.
|
| The FDA, at the behest of Pfizer, et al, have been
| deliberately obstructive in making publicly available drug
| trial information that is clearly required by both law and
| rule. All parties involved knew they needed to publish that
| info, and have steadfastly refused to do what the law
| requires them to do. If I were the judge, I'd have given them
| 90 days to turn over everything, and thrown the head of the
| FDA and the CEOs in jail for contempt until all those records
| are indeed published. IMO, they got off really easy.
| bumby wrote:
| 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.
| temac wrote:
| Not GP but 100. If people complain about "bloat" for less
| than 1% they can simply be ignored.
| bumby wrote:
| I think I'd disagree. That's 1% _for one tangential aspect
| of operations_. With nearly 3MM federal employees, that 's
| 30k just for FOIA requests.
|
| That's a single pet issue. For everyone who thinks
| transparency is important enough to have 1% of total
| employees allocated to it, there's going to be many more
| pet issues people would feel the same way about. I would
| prefer they look at improving their processes for complying
| in a more efficient manner rather than just layering more
| employees (and legacy costs that come with them) onto the
| solution.
| parkingrift wrote:
| 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.
| kube-system wrote:
| 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.
| avs733 wrote:
| There was another comment about the already released
| documents being taken wildly out of context and flat out
| lied about by anti-vaccine idiots.
|
| This is the same type of thing honestly. The presumption
| that you have that you know what these numbers mean,
| entirely out of any meaningful context.
|
| Let me sincerely ask, when you wrote this what did you
| assume someone in regulatory affairs at FDA did? What
| motivated you to think that number was too large?
|
| Here is their website. Is this what you thought they did?
| https://www.fda.gov/about-fda/fda-organization/office-
| regula...
| bumby wrote:
| 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-
| regula...
| avs733 wrote:
| 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-Appendi...
| Jimmc414 wrote:
| https://archive.fo/XWnSn
| barbacoa wrote:
| gareim wrote:
| From one page before the table (which itself is on page 7):
|
| > An accumulation of adverse event reports (AERs) does not
| necessarily indicate that a particular AE was caused by the
| drug; rather, the event may be due to an underlying disease or
| some other factor(s) such as past medical history or
| concomitant medication.
|
| If I gave 42,086 people a cup of water as my experiment, some
| non-zero number of people will die in the ensuing 90 days.
| Without analysis, your comment only serves to inflame.
|
| EDIT: I think the 42,086 number I used was misleading because
| that appears to be the total number of reports and not the
| number of people that actually received the vaccine in that
| time period. Which means the rates are lower as the denominator
| is way larger than 42,086.
| barbacoa wrote:
| The number of doses given is redacted which makes any kind of
| numerical analysis impossible.
| jcranmer wrote:
| It should be worth remembering that we don't need trials
| anymore to predict what the results of vaccinating millions of
| people should be. _We have already done that._ Indeed, by
| looking at the results of _actual_ vaccination, we can find
| things that have happened that _won 't_ be found in trials,
| because 1-in-a-million events aren't going to be found in
| trials. (Risk of myocarditis, for example, is something that's
| been found with actual vaccination.)
|
| ... so if you're claiming a risk is clearly visible in the
| trials, you should consider if the actual experience in mass
| vaccination actually bears that risk out. And if it doesn't,
| well, there's a good chance you simply misinterpreted the trial
| data.
| dublin wrote:
| Yes, and it's worth noting that the FDA, CDC, NIH, as well as
| their international counterparts, ALL missed the quite
| significant myocarditis side effects, especially in younger,
| fitter, men. It wasn't until the DoD had crippled thousands
| of its own warfighters (possibly for life) that that
| particular nasty side effect came to light.
|
| It's looking increasingly likely that there are a great many
| other side effects that may only become obvious on a long
| term basis - by definition we still can have NO IDEA what the
| long term risks of these never-before-tried "vaccines" may
| be.
|
| Bill Joy was absolutely right - biotech and genetic
| engineering is _BY FAR_ the most dangerous technology on the
| planet, and we 're seeing that play out to our horror right
| now - there is no way to stuff this gene-ie back in the
| bottle!
| mike00632 wrote:
| I'm going to call bullshit on your claim that the vaccine
| "crippled" thousands of service people.
| nullc wrote:
| It's extremely hard to extract meaningful insight from
| population data, because it's massively confounded.
|
| Recently some locations locations have reported omnicron case
| _rates_ being higher in the vaccinated population than
| unvaccinated. Your logic would have us conclude that the
| vaccination increases the risk of becoming a covid case with
| this strain.
|
| ... in reality, the vaccinated population is likely more at
| risk and the vaccine protection isn't enough to offset the
| difference. But it's extremely hard to tell, which is why
| RCTs are so important.
|
| Those one in a million events also don't get found outside of
| trials: They go unreported because outside of trials
| surveillance is very low, or if noticed they'll get
| attributed to something other than vaccination because
| without a control group you can't establish a baseline rate
| narrowly enough to attribute it to the treatment with any
| confidence.
| encryptluks2 wrote:
| Hm, but I thought that this corrupt medical company with a
| history of lying to increase profits had our best interests in
| mind.
| jeromegv wrote:
| False.
|
| Fact check: Clarifying claims around Pfizer vaccine deaths and
| side effects https://www.reuters.com/article/uk-factcheck-
| pfizer-health-c...
| barbacoa wrote:
| 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 wrote:
| > Please explain what part of that comment is false?
|
| This one:
|
| > This document shows that 1223 deaths are linked to the
| Pfizer vaccine in the first 90 days.
|
| "Occurred after" [?] "linked to", and the document does not
| show the latter.
|
| EDIT: in fact, it provides detail (for at least those
| causes I reviewed, didn't do the whole thing) on reasons
| why the specific "occurred after" events should not be
| considered "linked to".
| moate wrote:
| As someone who works in medical publishing, you have no
| idea how infuriating posts like the one you were
| responding to make me.
|
| This is HN, a group I would expect to have above average
| understanding of statistics and statistical analysis and
| yet the idea of causal relationships and that old adage
| of "correlation is not causation" STILL seems to slip
| past far too often.
|
| To the larger world: There's a reason every single drug
| commercial/ad you've ever engaged with has a list of
| "possible side effect" and not "known things that
| will/did happen". The "possible" doesn't even always mean
| "this is a side effect we conclusively know this drug
| causes, and could possibly happen to you" but sometimes
| just "we couldn't prove this drug _didn 't_ cause someone
| to shit blood since we had one guy who did one time
| during our months of trials".
| barbacoa wrote:
| To be fair I never said causation nor meant to imply any.
| Perhaps correlation would have been a better word than
| linked.
|
| My original point meaning being FDA probably does not
| want these records released because it could shine a
| unflattering light on how our pharmaceutical industry
| operates.
| null4bl3 wrote:
| You more than implied.
|
| You straight up said deaths linked to the vaccine
| dublin wrote:
| As someone who understands basic logic and ethics, you
| have no idea how infuriating your defending the
| indefensible makes me!
|
| We're talking about a completely new type of "vaccine"
| that works in completely new and different ways than ANY
| previously, AND which has never been used in humans
| before (after all previous animal trials failed, AND is
| intended to be given under high urgency (even duress), to
| a large fraction of the population of the planet.
|
| DAMN STRAIGHT that under those unprecedented high-risk
| conditions the default assumption MUST BE that
| correlation IS causation - UNTIL PROVEN OTHERWISE.
|
| Anything else is gross and callous negligence and lack of
| consideration for your fellow man, not to mention the
| active shredding of medical ethics, including the
| Hippocratic oath and the Nuremberg code.
|
| This is all the more true now that, a year on, data is
| clearly showing that the danger of the virus itself was
| grossly exaggerated, and that we are now facing vaccine
| injuries and deaths that are at least of the same order
| of magnitude as the virus itself, and may yet prove to be
| considerably higher.
| neuronic wrote:
| We vaccinated millions of people with billions of doses
| with these vaccines. I have yet to see or hear of anyone
| who died of the vaccine and nearly everyone I know was
| vaccinated with Pfizer at some point.
|
| Safe to say you are purposely spreading misinformation, for
| example by misrepresenting real data to gullible people and
| I wonder what your agenda is.
| jeromegv wrote:
| I didn't imply that the document is false. It's your
| interpretation of it that is false. You imply that the
| deaths are caused by the vaccine, which is not what this
| document is showing in any way shape or form. So you lied
| to everyone reading this HN thread.
| [deleted]
| encryptluks2 wrote:
| You are literally using a source where the CEO is on the
| board of Pfizer.
| mwilliaams wrote:
| Where is that in the document?
| kansface wrote:
| I am totally unfamiliar with this doc, but it does claim:
|
| > case outcome: .... fatal ... 1223
| Jimmc414 wrote:
| Here is the court order
| https://fingfx.thomsonreuters.com/gfx/legaldocs/gdvzykdllpw/...
| gruez wrote:
| and docket:
| https://www.courtlistener.com/docket/60390195/public-health-...
| guerby wrote:
| 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.
| avs733 wrote:
| 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.
| mike00632 wrote:
| 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.
| tintor wrote:
| How did the FDA even review 450,000 pages for EUA in the first
| place?
| defaultprimate wrote:
| Pfizer financed an accelerated reading program for them
| encryptluks2 wrote:
| Haha. Sure, I'll read for 160 hours in a day of you pay me
| enough. Just don't give me any quizzes.
| defaultprimate wrote:
| 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 wrote:
| 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 wrote:
| Hopefully they also statistically validly sampled the full
| patient information.
| albatross13 wrote:
| Pessimist opinion? They didn't. The FDA has people move to
| private enterprise (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.
| rajin444 wrote:
| It was more or less common knowledge "big pharma" doesn't
| have a strong record when it comes to trust before Covid.
| It's pretty crazy how fast political tribalism can be used to
| change people's minds. Just because your political enemy
| wants to do something does not mean it's bad.
|
| These vaccines were an amazing tool to help end the pandemic
| but the producers who are profiting heavily from these should
| be scrutinized as much as possible given there are hundreds
| of millions receiving this vaccine.
| albatross13 wrote:
| > These vaccines were an amazing tool to help end the
| pandemic
|
| Oh, it has ended? lol.
| lalaland1125 wrote:
| It has pretty much ended for the vaccinated. Vaccinated
| people have a very very low chance of death or
| hospitalization, an order of magnitude lower than the
| unvaccinated in many cases.
| Handytinge wrote:
| There are many countries where lockdown, daily
| restrictions, entry requirements and isolation are still
| normal. This pandemic is global - just because things
| have improved where you are doesn't mean that's the case
| for the other 95% of the world's population.
| lalaland1125 wrote:
| That's a non-sequitur. The pandemic, as in the actual
| killing / harming of people with the virus, is mostly
| over for vaccinated people.
|
| True, some political response to the pandemic are still
| in place, but that would happen no matter what as
| politics tends to move slower than the reality on the
| ground.
| orra wrote:
| > The pandemic, as in the actual killing
|
| ... 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.
| adgjlsfhk1 wrote:
| They didn't, but that's not a bad thing. The way the process
| works is that companies give the FDA both summary statistics
| and underlying data. The FDA can recompute the stats from the
| data, confirm they match and approve. The reason for asking
| for the data isn't because they'll read it, it's so that the
| summary stats can't be faked without a massive amount of
| fraud that can be proven if the company lied.
|
| Companies can't fake the data because if they got caught,
| there would be long jail terms and billions of dollars of
| fines (and they provide too much data for it to be easily
| forgable).
| albatross13 wrote:
| It is a bad thing. Why would anyone trust Pfizer at this
| point?
|
| 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.
| pfortuny wrote:
| Yeah... good luck with that hope.
|
| Have you haerd of Exxon?
|
| The Sacklers held on for 20 years on Oxycontin...
| adgjlsfhk1 wrote:
| And Oxycontin works, and was correctly approved by the
| FDA. The problem there wasn't approval, it was how it was
| used post-approval. That's not an argument that they
| shouldn't have authorized the drug.
| atleta wrote:
| What does Exxon have to do with the FDA or how
| medications are authorized?
|
| Also, I don't think that the manufacturer of Oxycontin
| has tricked the authorization process (and then
| successfully covered up this fact for 20 years). As far
| as I know, the problem was their marketing strategy, how
| they convinced doctors (medical practitioners) and
| probably patients (I can remember the details). So while
| it's troubling, it's a completely unrelated process and
| thus unrelated issue.
| octopoc wrote:
| > What does Exxon have to do with the FDA or how
| medications are authorized?
|
| It proves that the FDA shouldn't use a "trust, and don't
| verify" approach to medical trials performed by
| megacorporations.
| atleta wrote:
| Again, what does exactly the Exxon case 'prove' here?
| Also, how? Which act of theirs? (I'm pretty sure I miss a
| lot of details there and that might be the reason I have
| no idea what connection are you drawing here.)
|
| Also, no one said "trust and don't verify". What was said
| is that they don't have to verify _all_ the data and read
| through _all_ the pages. Because the risk is just too
| high and they will obviously look into the details here
| and there.
| Bellamy wrote:
| 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 wrote:
| Pfizers R&D? Comes from the tax payers? How, through subsidies?
| (genuinely curious, never heard this before)
| BoysenberryPi wrote:
| 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."
| dang wrote:
| That's unfortunately how polarized topics work. We can't do
| much about human nature.
| zo1 wrote:
| 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.
| moate wrote:
| I mean, the majority of stances on any message board/comments
| section boil down to that. Why would HN be magically different?
| throw10920 wrote:
| The majority of the comments that I see in this thread have to
| do with the FDA, FOIA, and transparency, with only a scarce few
| comments that are black-and-white like you described.
| mistermann wrote:
| I think this is somewhat by design on culture war topics (which
| anything covid definitely is).
|
| 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.]
| calebm wrote:
| 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 wrote:
| 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...
| colpabar wrote:
| 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-...
|
| 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 wrote:
| Lex asks the Pfizer CEO that question in his interview:
| https://youtu.be/Z_LhPMhkEdw?t=1369
| TeeMassive wrote:
| And accountability. I understand the need for urgency and the
| use of emergency orders, but once these are gone these
| companies will still be unaccountable and will still be getting
| paid even if their promise of efficacy are not held.
| ludamad wrote:
| "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 wrote:
| 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-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.
| grumple wrote:
| 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 wrote:
| Why do you think it would be easy to achieve 100% redaction
| accuracy with NLP?
| bryanlarsen wrote:
| Many of those documents contain personal medical information.
| jart wrote:
| There have been successful FOI requests in other countries. Japan
| managed to get Pfizer to cough up some of their animal testing
| research https://files.catbox.moe/0vwcmj.pdf which has
| measurements of the lipid nanoparticle concentration in the
| brain, eyes, ovaries, etc. Does anyone know if there are similar
| measurements available for conventional vaccines? Since it'd be
| nice to be able to compare these numbers to something.
| xyzzy21 wrote:
| The locations correspond to known organs having adverse effects
| so that's useful.
| lame-robot-hoax wrote:
| 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.
| bumby wrote:
| 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.
| [deleted]
| nradov wrote:
| What are you looking to compare? Conventional inactivated or
| attenuated pathogen vaccines don't use lipid nanoparticles at
| all, so the number will be 0 (barring some kind of
| contamination or measurement error).
| Robotbeat wrote:
| Inactivitated pathogens are themselves nanoparticles. Many
| pathogens even are made of lipids as well.
| nikkinana wrote:
| lalaland1125 wrote:
| 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.
| bluGill wrote:
| 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.
| tzs wrote:
| All the data relevant to the EUA or full authorization is
| available.
|
| The data not available is personal medical information of
| patients that has to be collected for and during trials
| because some of it might become important if something bad
| happens during the trial. E.g, if some trial patients suffer
| serious adverse reactions you want to have all their medical
| information on hand to better understand what went wrong.
|
| For a trial that goes well the vast majority of that
| information turns out to not have been looked at or used.
| lalaland1125 wrote:
| > 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 wrote:
| 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 wrote:
| 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.
| bingohbangoh wrote:
| 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 wrote:
| These are FDA's documents, not Pfizer's. The pharma companies
| aren't the ones doing the redaction.
| bingohbangoh wrote:
| Ahhhh ok, was not aware, thanks!
|
| But my point on this being the subject of a vaccine mandate
| still holds.
| tehwebguy wrote:
| The FDA offered a timeline of 500 pages / month (75 years)
| which far sillier.
| kbelder wrote:
| My quick calc showed that's roughly one guy redacting 2.8
| pages per hour. I know people who'd LOVE that job.
| tut-le-tut wrote:
| "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 wrote:
| prepend wrote:
| 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.
| lesuorac wrote:
| 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 ...
| anigbrowl wrote:
| To be fair they were in a bit of a rush, and opted to dump
| the problem on the bureaucrats rather than spend more time
| designing protocols. This isn't an example of wicked
| plotting, it's just an argument about who picks up the tab
| for a large redaction job.
| robbedpeter wrote:
| >>If they are literally manually redacting...
|
| That's a feature, not a bug. Bureacracy is a game, and they
| are grandmasters.
| lalaland1125 wrote:
| > 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.
| kansface wrote:
| 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 wrote:
| 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
|
| 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 wrote:
| If the evidence references other evidence and you don't
| have access to that other evidence then you do not have
| evidence at all.
| mike00632 wrote:
| 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?
| encryptluks2 wrote:
| This is about data used in the vaccine approval. If you
| think vaccines don't need data to approve them then that
| throws science out the window. Also, do you ever comment
| on anything technical or is it just pro vaccines and
| corporate interests.
| lalaland1125 wrote:
| 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.
| [deleted]
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