[HN Gopher] Covid-19 vaccines and treatments: we must have raw d...
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       Covid-19 vaccines and treatments: we must have raw data, now
        
       Author : steelstraw
       Score  : 120 points
       Date   : 2022-01-20 21:11 UTC (1 hours ago)
        
 (HTM) web link (www.bmj.com)
 (TXT) w3m dump (www.bmj.com)
        
       | bryanlarsen wrote:
       | Who's responsible when it turns out that the anonymization of
       | highly confidential patient data in the raw data is flawed, as it
       | inevitably is?
        
         | someguydave wrote:
         | There is a tradeoff between an individual's absolute right to
         | "health secrecy" and advancing treatments. I think the pendulum
         | has swung too far towards privacy.
        
         | nradov wrote:
         | As long as they follow the official HHS guidance on de-
         | identification then it should be fine.
         | 
         | https://www.hhs.gov/hipaa/for-professionals/privacy/special-...
        
       | uvesten wrote:
       | It seems there has to be some amendments to rules about releasing
       | raw, anonymized trial data when the state is sponsoring
       | development of the drug. Also, how can Pfizer claim that their
       | "study" ends in 2023? Several hundred million people have already
       | received their vaccine, unaware that it's part of a study where
       | the clinical data is not even accessible to their doctors...
        
         | ceejayoz wrote:
         | > Also, how can Pfizer claim that their "study" ends in 2023?
         | 
         | Long-term studies are common. We still study Tylenol _to this
         | day_ , for example, to monitor for things like "does it
         | interact with newly approved drugs".
        
         | foolyvaxxed wrote:
        
         | dragonwriter wrote:
         | > Also, how can Pfizer claim that their "study" ends in 2023?
         | 
         | Because it does.
         | https://beta.clinicaltrials.gov/study/NCT04848584
         | 
         | > Several hundred million people have already received their
         | vaccine, unaware that it's part of a study
         | 
         | Because it's not. Use under the EUA and subsequent approval is
         | separate from and in parallel with continuing studies.
        
           | fsociety999 wrote:
           | > Because it's not
           | 
           | That is misleading at best. It absolutely is part of an
           | ongoing clinical trial regardless us if it is authorized for
           | emergency use.
           | 
           | How many people who were given the vaccine were told that it
           | is part of an ongoing clinical trial, authorized for
           | emergency use, and the data from the trial won't be available
           | for years? I suspect a very small percent.
        
             | mike_d wrote:
             | Trial participants sign agreements to be part of the trial
             | and usually receive compensation or free medical treatment
             | in exchange for being part of the trial and continued
             | health monitoring. This is a hard rule from the FDA, and
             | failure to do so is subject to criminal liability.
             | 
             | Individuals receiving drug under an EUA are not part of a
             | clinical trial, regardless of what you think of the drug.
        
             | ceejayoz wrote:
             | My kids were in a clinical trial on bilirubin lights, a
             | technology around since the 1950s. Would it be fair to
             | imply the lights are untested as a result?
        
       | aaron695 wrote:
        
       | hanselot wrote:
        
       | daenz wrote:
       | >The BMJ supports vaccination policies based on sound evidence.
       | As the global vaccine rollout continues, it cannot be justifiable
       | or in the best interests of patients and the public that we are
       | left to just trust "in the system," with the distant hope that
       | the underlying data may become available for independent scrutiny
       | at some point in the future. The same applies to treatments for
       | covid-19. Transparency is the key to building trust and an
       | important route to answering people's legitimate questions about
       | the efficacy and safety of vaccines and treatments and the
       | clinical and public health policies established for their use.
       | 
       | Serious question: if the raw data could potentially undermine
       | public trust in the US government, can it be classified as a
       | matter of national security?
        
         | YXNjaGVyZWdlbgo wrote:
         | Everythihng can be declared a matter of national security...
        
           | wyldfire wrote:
           | Yes, and there have been bad actors in the government who do
           | that to try and avoid accountability. Hopefully they usually
           | get overruled by someone with good sense in the executive
           | branch. But if not, the judicial branch could overrule an
           | invalid classification and order it be made public.
        
         | ceejayoz wrote:
         | > Serious question: if the raw data could potentially undermine
         | public trust in the US government, can it be classified as a
         | matter of national security?
         | 
         | No, probably not. The government doesn't really have the
         | authority to classify information generated by private entities
         | like Pfizer barring specific legislation.
         | 
         | The closest you'd likely come is
         | https://en.wikipedia.org/wiki/Invention_Secrecy_Act, but that
         | allows (temporary) suppression of patents, not clinical trial
         | data.
        
           | walterbell wrote:
           | _> The government doesn 't really have the authority to
           | classify information generated by private entities like
           | Pfizer barring specific legislation._
           | 
           | They can classify patents at will.
        
             | ceejayoz wrote:
             | Yes, and I cited the very specific legislation allowing
             | that.
        
               | [deleted]
        
               | walterbell wrote:
               | Thanks for the link. My comment was posted before you
               | added the citation.
        
           | mike_d wrote:
           | > The government doesn't really have the authority to
           | classify information generated by private entities
           | 
           | Pfizer is a defense contractor. It is pretty standard
           | boilerplate that when you receive DoD funds the government
           | can restrict access to information, even unrelated to the
           | products or research directly attributable to that funding.
           | 
           | Not to say that I think the government would actually do
           | that, just that they could.
        
         | kklisura wrote:
         | You know what else could undermine public trust in
         | institutions? Classifying this data as a matter of national
         | security.
        
       | brianmcc wrote:
       | I remember writing the following about the AstraZeneca vaccine in
       | Nov 2020 when concerns were raised with it.
       | 
       | Two things can be both be true:
       | 
       | - the vaccine is safe and effective
       | 
       | - parts of approach in running studies weren't as good as they
       | should have been
       | 
       | Seems to perhaps apply here too.
        
         | fabian2k wrote:
         | Why not? Any mistake or design flaw in the trials reduces their
         | value, it doesn't completely eliminate it.
         | 
         | The mistake in the AZ trial is something I consider extremely
         | embarassing and stupid (assuming the published information
         | about it is correct). It's the kind of mistake nobody that
         | actually works in a lab should make, and I really question the
         | competency of the people involved here. But in the end this
         | meant that a part of the study got a half-dose of the vaccine.
         | That makes the interpretation a bit more difficult, but it does
         | not invalidate the trial.
        
           | hanselot wrote:
        
       | fabian2k wrote:
       | At this point the original phase 3 trials are pretty much
       | irrelevant, we have so much more data now from the actual use of
       | the vaccines. They really play no role at all now. In terms of
       | effectivness we're three major SARS-CoV2 variants further, and
       | for looking at rare side effects we have billions of doses now
       | compared to tens of thousands in those trials.
       | 
       | I'm all for putting pressure on everyone in Science to publish
       | more raw data. This kind of data is likely more complicated
       | because it's really hard if not impossible to anonymize the
       | actual patient-level data. It still should be as accessible as
       | possible to other scientists.
        
         | diroussel wrote:
         | It's hard to analyse the data from treatments, as treatments
         | don't have a control group. Trials are designed with control
         | groups, placebos and double-blind process to gather data and
         | then analyse it.
         | 
         | We may have loads of data from real people being treated, but
         | good luck trying to analyse it in a scientific way.
         | 
         | We need effective vaccines, and we need to be able to trust
         | them. Just treating people with a vaccine doesn't always give
         | that trust and confidence.
         | 
         | (I hope I got my medical terminology right, I'm not a
         | clinician, but have been close to covid-19 related medical
         | research)
        
           | fabian2k wrote:
           | It's much, much harder to understand the data if you don't
           | have a control group. But once you have an effective
           | treatment, you no longer have a control group if you're at
           | all ethical. You cannot keep a working treatment from people
           | just to do more science, that is deeply and fundamentally
           | unethical.
           | 
           | So the moment we knew the vaccines worked, the science got
           | harder. Well, that point also save an enormous amount of
           | lives, so I don't think this is something to complain about.
           | It's still possible to do a lot of good science now, even
           | randomized controlled trials. They just can't compare to
           | unvaccinated groups, but you can still do stuff like compare
           | double-vaccinated with triple vaccinated.
        
             | lurquer wrote:
             | > But once you have an effective treatment, you no longer
             | have a control group if you're at all ethical. You cannot
             | keep a working treatment from people just to do more
             | science, that is deeply and fundamentally unethical.
             | 
             | You could easily find millions of potential study
             | participants who don't want the vaccine. The study wouldn't
             | be double-blind, but it would be single-blind and better
             | than what they chose to do.
        
             | incrudible wrote:
             | A lot of data now shows that double vaccinated are infected
             | with Omikron more often than unvaccinated. I do not know
             | what causes this or what it means, but imagine for a moment
             | there were no unvaccinated left: Your vaccine could be
             | arbitrarily harmful with a new variant and you would not be
             | able to tell.
        
               | fabian2k wrote:
               | That is simply wrong.
               | 
               | There is one study that listed negative effectiveness
               | against Omicron for the vaccines. That study did not
               | control for any confounding factors, it simply was not
               | designed to measure this particular thing, it was focused
               | on a different question.
               | 
               | There are some strong fundamental reasons why we would
               | not expect the vaccine to be harmful with future
               | variants. And even then we would still be able to detect
               | if it was.
        
               | incrudible wrote:
               | It is not one study, national data from Denmark, UK,
               | Germany and Canada shows that double vaccinated are
               | infected at a higher rate. I am not jumping to
               | conclusions that this means efficacy is negative, because
               | that would require a _controlled trial_ with an
               | unvaccinated group. Do you catch my drift?
        
               | bigfudge wrote:
               | There's no way of running a controlled trial of this sort
               | when 80% of the population have already been vaccinated.
               | You can design better or larger observational studies
               | though.
        
               | fabian2k wrote:
               | Please show the data that claims that double vaccinated
               | are more likely to be infected than unvaccinated people
               | by Omicron. And raw infection counts are not an answer
               | here as the vaccinated and unvaccinated people are
               | clearly not matched populations you can compare without
               | adjustments.
        
           | mike_d wrote:
           | Depending on the phase of clinical trials, they don't need to
           | be double blind or controlled.
           | 
           | You can absolutely analyze real world mass vaccination data
           | in a scientific way. Just treat pre-vaccination and post-
           | vaccination as two different patients. The numbers are so
           | large that other factors (environmental, genetics, etc)
           | cancel out. So if your post-vaccination population has a rate
           | of heart attacks 80% lower than the established norm, you
           | know that is worth further investigation.
           | 
           | (Full disclosure: my family used to own a company that ran
           | clinical trials for pharmaceutical companies)
        
             | timr wrote:
             | > You can absolutely analyze real world mass vaccination
             | data in a scientific way. Just treat pre-vaccination and
             | post-vaccination as two different patients.
             | 
             | Yes, you can do this. No, it's not the same.
             | 
             | With this kind of uncontrolled, longitudinal study, yes,
             | some things are quasi-controlled: genetics, possibly
             | lifestyle, other drugs, etc. Anything that plausibly
             | doesn't change (much) in a single person from time A to
             | time B.
             | 
             | Some things you can't control for, but still matter:
             | changes in behavior due to the event itself. Placebo
             | effect. Sample bias (e.g. the patients receiving treatment
             | X were selected to receive treatment X _because it was felt
             | that they would benefit from it_. This is subtle, but can
             | really mislead. In the example of vaccination, imagine that
             | the people most likely to vaccinate their young kids are
             | _also_ the ones most likely to keep their kids isolated at
             | home...)
             | 
             | > So if your post-vaccination population has a rate of
             | heart attacks 80% lower than the established norm, you know
             | that is worth further investigation.
             | 
             | The key part of that is the last three words: _worth
             | further investigation_. To get the final answer, you still
             | need a controlled experiment.
        
         | aeternum wrote:
         | > This kind of data is likely more complicated because it's
         | really hard if not impossible to anonymize the actual patient-
         | level data. It still should be as accessible to other
         | scientists as possible.
         | 
         | I disagree with both parts of this. Why not associate each
         | patient with a number then log all data against that? Patient
         | names and other identifying information should simply never be
         | attached to trial-related data (except for in a well-protected
         | lookup file with highly restricted access).
         | 
         | Making scientific data accessible only to other scientists is
         | highly anti-scientific. Feynman, one of the greatest scientists
         | of all time has many quotes around exactly this mindset:
         | 
         | "Have no respect whatsoever for authority; forget who said it
         | and instead look at what he starts with, where he ends up, and
         | ask yourself, 'Is it reasonable?' ... we will doom humanity for
         | a long time to the chains of authority, confined to the limits
         | of our present imagination. It has been done so many times
         | before."
         | 
         | "Science is the belief in the ignorance of experts"
         | 
         | "Our freedom to doubt was born out of a struggle against
         | authority in the early days of science. It was a very deep and
         | strong struggle: permit us to question - to doubt - to not be
         | sure. I think that it is important that we do not forget this
         | struggle and thus perhaps lose what we have gained."
        
           | throwawaygh wrote:
           | Anonymization is difficult and sometimes impossible because
           | reidentification attacks are _extremely_ difficult to
           | prevent. Anonymization is much more complex than people
           | typically assume; see [1,2] for surveys.
           | 
           | The more data you release, the more difficult it is to ensure
           | that subjects cannot be reidentified by combining the
           | "anonymized" dataset with other publicly available data.
           | 
           | Important note: It's not _just_ a case of putting in the work
           | and being willing to share. There are impossibility results
           | in this space. That is, there are reasonable formal threat
           | models for which it is mathematically impossible to release
           | any version of the dataset that is (a) useful (ie contains
           | enough data to replicate findings) and (b) not subject to
           | unacceptable levels of reidentification.
           | 
           | I am generally in favor of releasing data and
           | code/spreadsheets, but anything involving patients becomes
           | difficult quickly. There are also reasonable middle grounds
           | between "no access for anyone" and "throw it in a public s3
           | bucket". E.g., making data more available to researchers and
           | medical practitioners -- or even sufficiently interested &
           | motivated members of the public -- but under strict data
           | handling rules, enforceable audit trails, and legal
           | consequences for being reckless with sensitive patient data.
           | 
           | Hell, odds are better than even that your employer made you
           | sign a document that would allow them to sue you into
           | oblivion for forwarding some sure-to-be-doomed product launch
           | draft to the wrong person. Being at least that careful with
           | fine-grained medical data on hundreds/thousands of patients
           | isn't exactly unreasonable...
           | 
           | Drawing a hard line on 100% complete, anonymous, and
           | consequence-free access to troves of patient data isn't a
           | reasonable position.
           | 
           | [1] https://journals.plos.org/plosone/article/file?id=10.1371
           | /jo...
           | 
           | [2] https://www.ccs.neu.edu/home/jullman/cs7880s17/DSSV.pdf
        
           | msbarnett wrote:
           | Simply removing the name isn't enough to anonymize the data,
           | because as another commenter noted, the data submitted
           | includes detailed patient histories and information about all
           | of their other conditions, which is more than enough to
           | uniquely identify someone.
           | 
           | And you can't simply strip out that data, because a lot of
           | the subsequent analysis of effectiveness is _dependent_ on
           | it.
        
           | fabian2k wrote:
           | I'm not fully up to speed with all the research here, but as
           | far as I understand it's quite easy to de-anonymize many
           | datasets of exactly the kind you describe. If you're not
           | really, really careful there will be lots of information in
           | simple demographic data that could easily be matched to other
           | data sources.
        
           | gpm wrote:
           | > Why not associate each patient with a number then log all
           | data against that? Patient names and other identifying
           | information should simply never be attached to trial-related
           | data
           | 
           | Because "patient name" isn't the only way a patient can be
           | identified.
           | 
           | "Male, 27, admitted to Sunnybrook hospital for stitches to
           | his forehead due to knife wound on January 20th 2022" is
           | almost certainly uniquely identifying (actually it's made up
           | so it probably identifies no one), is in the person's medical
           | data for the trial, and clearly needs to either be redacted
           | or in some other way separated from the other line that says
           | "contracted HIV on January 19th 2022". Yet both are relevant
           | when investigating causes of side effects.
        
             | cogman10 wrote:
             | I think HIPAA is something we should be re-evaluating as a
             | nation. Back in '96 it was certainly a good idea given how
             | devastating things like an HIV diagnosis could be for a
             | family member in a fundamentalist family. Or the impact of
             | said diagnosis on insurance coverage.
             | 
             | With the ACA, the insurance coverage problem is gone. Pre-
             | existing conditions can't be used as a reason to deny or
             | change insurance rates.
             | 
             | The Fundamentalist problem exists, but seems like much less
             | of an issue with LGBT acceptance being so much better now
             | than it was in the 90s.
             | 
             | I just don't think that health information is so valuable
             | that guarding it like a state secret is warranted. I'm ok
             | with the notion of putting in basic safeguards like not
             | attaching a patient name with the information but I don't
             | see it has horrible if some system can infer absolute
             | identity from that stuff.
             | 
             | After all, seems far more scary that my web browsing
             | generates a far clearer picture of who I am than what you
             | could glean from my medical records.
             | 
             | Having health information public and easy to gather would
             | (potentially) be a significant boon to the study of health
             | information. It would also make it a lot easier for us to
             | make health information sharing systems so you don't have
             | to fill out the same 500 forms every time you go to a
             | different hospital or doctor.
        
               | YarickR2 wrote:
               | six week old pregnancy terminated while her official
               | partner is on tree month long business trip. instant
               | divorce.
        
         | nsainsbury wrote:
         | Actually, I would argue we don't have good data from the use of
         | the vaccines. Part of the reason is because all the mechanisms
         | used for reporting things like side-effects, effectiveness,
         | etc. have a litany of confounding variables which haven't been
         | controlled for which could be far better corrected for/isolated
         | with good studies.
         | 
         | For example, when it comes to vaccine side-effects, I don't
         | think there exists a true account for how common the side-
         | effects really are. The most common way to report side-effects
         | (VAERS, and similar national databases) are dismissed due to
         | the self-reporting nature, local GPs frequently dismiss side-
         | effects and tell people to just go home and take a Panadol with
         | zero reporting going on (I had this happen to me - started
         | experiencing severe chest pain 2 days post-Pfizer. Subsequently
         | saw a cardiologist after months of pain and his comment to me
         | was "I'm seeing young people like you daily and your cases are
         | going widely underreported"), etc.
         | 
         | Likewise, when it comes to vaccine effectiveness, there are a
         | million and one confounding variables from % of the population
         | that already had natural immunity, covid variants, health, age,
         | seasonality, societal lockdowns, isolation, etc.
         | 
         | Also, it's important I think for us to raise the bar to the
         | highest possible standard when you're talking about a medical
         | intervention that was forced under significant duress (loss of
         | job, social stigma, public/medical shaming) on a substantial
         | percentage of the world's population. We should not be content
         | as a society to come within inches of worldwide medical
         | authoritarianism without asking some seriously hard fucking
         | questions and imposing the absolute strictest and highest
         | possible scientific standards to justify why.
        
           | fabian2k wrote:
           | But we actually don't need the VAERS data to examine if the
           | vaccines are better than the alternative. We do need it to
           | provide accurate labels for side effects, but that is all.
           | 
           | We can simply look at infection, hospitalization and death in
           | vaccinated and unvaccinated populations. If we properly match
           | the populations, we can determine if the vaccine saves lives,
           | and it turns out that they do save a lot of lives.
        
             | nsainsbury wrote:
             | That's true. And I agree that the vaccines have saved lives
             | - mostly, of the old and the very sick/unhealthy.
             | 
             | However, what is less clear today is whether there has been
             | a net positive or negative effect of the vaccine for young
             | healthy people. You can only come to that conclusion if you
             | actually had high quality data and studies on vaccine side-
             | effects, effectiveness in population groups stratified by
             | age, health, etc.
             | 
             | I suspect that the vaccines, mandates, lockdowns, etc. have
             | been a net negative for the overall health of young (<50),
             | and healthy people, and the body of scientific evidence
             | will support this position in the future. It's just cloudy
             | today because it's wrapped up in politics...but the science
             | will eventually win out.
        
             | ummonk wrote:
             | "If we properly match the populations," - that's a big if
             | though. Without any matching, vaccines appear to have
             | negative value because older people are more likely to get
             | vaccinated, but even controlling for age there are a
             | variety of potential confounding variables like general
             | health, risk-avoidance, etc.
        
         | walterbell wrote:
         | _> They really play no role at all now._
         | 
         | The (small) controlled trial data can be combined with the
         | (large) uncontrolled mass-population data, e.g. one can look at
         | the larger dataset for corroboration of weak signals in the
         | smaller dataset.
         | 
         | New controlled trials can be started, where further evidence is
         | needed.
        
         | cyanydeez wrote:
         | this stuff just smacks of iignorance and attempts to continue
         | tompoliticize clear public health concerns.
         | 
         | i am sure there will be a red herring in all the data that will
         | cash a small enough shadow.
         | 
         | but this jibbering is about dragging science down to the level
         | of far right ignorance, which is the onlymplace concervatives
         | can win.
        
           | planetsprite wrote:
           | Speculation is made either way without datapoints. What's the
           | harm in being transparent if at worst some spurious (but
           | provably spurious) correlations mislead a few people already
           | prone to mistrust? Higher transparency would also dissolve a
           | lot of the claims that the pharmaceutical companies are
           | "hiding" something regarding the actual effectiveness of
           | their vaccines and therapeutics.
        
             | bigfudge wrote:
             | I don't think people claiming pharma companies are going to
             | be satisfied by data dumps. They will simply claim the data
             | are fabricated.
             | 
             | There is so little correspondence between reality and
             | claims already- I think you're making the mistake that the
             | discourse is in good faith. It doesn't seem to be to me.
        
       | invokestatic wrote:
       | I'm a software consultant for Pharma companies and have worked on
       | projects that used the same kind of study design as the Pfizer
       | COVID vaccine (Kaplan-Meier).
       | 
       | "Raw data" is submitted to the FDA in the CDISC format. This
       | format contains a lot of pretty sensitive medical information,
       | including which diseases a patient has, their medical history,
       | what drugs they take, etc. This is supposed to be anonymized, but
       | if the public were to be able to get this info, I strongly
       | believe there is enough information to re-identify patients. And
       | it's not as simple as just removing the sensitive medical data
       | because the primary or secondary analyses may be dependent on
       | them.
        
         | rvnx wrote:
         | And ? Where is the bad thing to open a dataset of comorbidities
         | and related / suspected effect of vaccines / medications ?
        
           | jjulius wrote:
           | >And ?
           | 
           | What's not to get? OP said:
           | 
           | >... I strongly believe there is enough information to re-
           | identify patients.
           | 
           | Their concern is that just dumping raw data like this into
           | the public would be a massive violation of privacy for
           | countless individuals.
        
             | rvnx wrote:
             | Re-identify based on what ? There are no databases that you
             | can link against if you strip out the major identifiers
             | (like city and date of birth).
             | 
             | It's for the benefit of patients, and this raw data is
             | already available, but under a loose NDA for commercial
             | partners and researchers...
        
               | throwawaygh wrote:
               | _> Re-identify based on what ?_
               | 
               | The fact that you poo-poo this question is telling.
               | Preventing re-identification attacks is incredibly subtle
               | and sometimes impossible. Removing "city and date of
               | birth" is nowhere near sufficient.
               | 
               |  _> this raw data is already available, but under a loose
               | NDA for commercial partners and researchers... _
               | 
               | Yes. It's available to people who have their real
               | identities tied to their access and can be sued into
               | oblivion or possibly even prosecuted for wanton misuse of
               | the data. Surely you see how this is different from
               | throwing it on a public s3 bucket, right?
        
           | throwawaygh wrote:
           | What is your full name and address? Age? Weight? Height? Eye
           | color? Blood pressure? What STDs do you have, if any? How
           | often and how much do you drink? Smoke? Any history of drug
           | use? Mental disorders? What about your family?
           | 
           | Where is the bad thing in you posting this information here
           | right now?
           | 
           | Actually, that's not even analogous. A better analogy would
           | be you post all this info under a pseudonym -- e.g., "rvnx"
           | or something like that -- and then the mods doxing you
           | without your consent.
        
             | cogman10 wrote:
             | I'm 36, I weigh 190 lbs, I'm 6'1. My eyes are green. Blood
             | pressure 120/80 (last I checked). No STDs. I drink once a
             | week about 3 servings. I don't smoke. I don't use drugs or
             | have a history of metal disorders. Depression runs in my
             | family.
             | 
             | I only really hesitate to post full name and address but,
             | frankly, I'm sure given my user handle it wouldn't be
             | terribly hard for someone to find both of those.
             | 
             | So tell me, what harm have I done to myself by sharing this
             | information?
        
       | [deleted]
        
       | mberning wrote:
       | It's incredible how quickly pharmaceutical companies rehabbed
       | their deservedly awful reputation by using the pandemic. Years
       | from now, maybe decades, I'm sure we will find out there were
       | very troubling results from the clinical trials that were swept
       | under the rug.
        
       | tomohawk wrote:
       | > After a freedom of information request to the agency for
       | Pfizer's vaccine data, the FDA offered to release 500 pages a
       | month, a process that would take decades to complete
       | 
       | 75 years, actually.
       | 
       | I don't mind trusting what someone says, but I need to be able to
       | verify it.
        
         | AnimalMuppet wrote:
         | Yeah, that was absolutely ridiculous. What are they doing,
         | evaluating it pixel by pixel? That's 25 pages a day (20 working
         | days a month), or 3 pages an hour (8 hour day). Does it really
         | take 20 minutes per page to prepare the data for release? Do
         | they really only have one person they can put on the task?
         | 
         | They deserved to have that both mocked and slapped down. It was
         | an insult to both our intelligence and our right to know the
         | truth about what they want us to take.
        
       | diroussel wrote:
       | The BMJ seems to be on good form. First publishing the whistle
       | blower account of pfizer [1], and now this call for raw vaccine
       | trial data.
       | 
       | I commend them on this approach, and can only hope that the
       | vaccines are as safe and effective as we have been told.
       | 
       | [1] https://www.bmj.com/content/375/bmj.n2635 - "Covid-19:
       | Researcher blows the whistle on data integrity issues in Pfizer's
       | vaccine trial"
        
         | YXNjaGVyZWdlbgo wrote:
         | I can only recommend this article about bmj:
         | https://respectfulinsolence.com/2021/11/15/wtf-happened-to-t...
        
           | hazza_n_dazza wrote:
           | I cannot recommend that article. Science exists in a realm of
           | science, just because a major medical organisation is
           | misunderstood dosen't make them 'antivaxxers'. BMJ is asking
           | for open data, something I think many people here could
           | utilise and find value in.
        
           | [deleted]
        
           | srcreigh wrote:
           | Yup. I'm not sure how many non anti vax people who comment in
           | support of BMJ actually read the original article.
           | 
           | If you are them please reveal yourself and explain how you
           | found nothing wrong with the original article. Most of these
           | comments in the threads just seem like tired knee jerk anti
           | big media / anti vax memes.
        
             | diroussel wrote:
             | I'm a pro vax person, and I've had three vaccine doses. But
             | I have a few anti-vaxers around in friends and family, and
             | it can be hard to argue with them that vaccines are totally
             | safe and effective for them (not talking about the
             | population as a whole).
             | 
             | I would like safe and effective vaccines, and I would like
             | to know that the vaccines I have been administered have
             | really got the backing of truly scientific trials.
             | 
             | Surely releasing the trial data is a net positive for all
             | the national populations that have paid for it.
        
               | drukenemo wrote:
               | In your definition, an anti-vaxxer is someone who refuses
               | the covid-19 jab or any jab? If it's the former, I find
               | that quite disingenuous.
        
               | miles wrote:
               | > it can be hard to argue with them that vaccines are
               | totally safe and effective for them
               | 
               | That is especially hard since there is simply no way to
               | know for sure whether the vaccine will be "totally safe
               | and effective for them":
               | https://news.ycombinator.com/item?id=29206892 .
        
               | Fogest wrote:
               | This is my thing as well. I work at vaccine clinics and
               | obviously am onboard with the vaccines, however I still
               | feel bad helping administer these vaccines to people who
               | are hesitant. Because of government vaccine mandates or
               | employer vaccine mandates it has made some people who
               | come in feeling "forced" to get a vaccine. And it
               | honestly does not feel like this is the proper scientific
               | or medical way. It sucks to give someone a vaccine when
               | you know they aren't fully trusting in the science behind
               | it. A lot of people are having to choose whether they put
               | uproot their whole families and lose their jobs, or
               | whether they just go and get the vaccine. They are not
               | technically forced, but it honestly seems like it pretty
               | much is. For me it does not feel morally right to have
               | people who feel forced to make medical decisions they
               | don't agree with without even having access to the raw
               | data that would help indicate it's safe.
               | 
               | And it doesn't help that there have been multiple leaks
               | now regarding companies like Pfizer that have made them
               | appear even more shady. Not to mention Pfizers multiple
               | billion dollar lawsuits/fines in the past. I don't blame
               | some people for being skeptical, nor do I blame them for
               | feeling like they are forced to get something they aren't
               | sure they can trust.
               | 
               | It's hard to just trust an organization that has already
               | done multiple things in the past to make you not want to
               | trust them.
               | 
               | The cases that feel even worse for me are the people who
               | have had previous doses and are coming in for 2nd doses
               | or boosters but have had previous unexplained side
               | effects shortly after the doses. Like side effects that
               | are beyond the "normal" ones. Many of these people have
               | visited hospitals or their family doctors, had multiple
               | tests, and get told that nothing is wrong, or that they
               | are not sure what is wrong. And these kind of cases are
               | often not counted an "adverse effect". I alone have had
               | many people tell me these things. They often again feel
               | forced to get the next dose because of pressure from
               | their employer or government. And it just feels bad
               | giving them the vaccine, because they don't sound anti-
               | vaxx, they sound like they legitimately had a severe
               | reaction to the vaccine. But often doctors and public
               | health agencies will brush these incidents off and
               | pretend like it's not because of the vaccine. They are
               | dismissed and considered an anti-vaxxer making things up.
               | And this really sucks. This is not the way medicine
               | should work.
        
       | ceejayoz wrote:
       | https://sciencebasedmedicine.org/what-the-heck-happened-to-t...
       | has some stuff to say about the author (about 2/3 the way down),
       | including signing a petition doubting that HIV causes AIDS.
       | 
       | > Indeed, Doshi has history of playing footsie with the
       | antivaccine movement, amplifying antivaccine conspiracy theories,
       | downplaying the severity of influenza and thus feeding
       | antivaccine narratives, using sleight-of-hand to downplay the
       | effectiveness of flu vaccines, and generally playing the role of
       | a false skeptic with respect to vaccines. At this point, I can't
       | help but note that Doshi also once signed a petition
       | "questioning" whether HIV causes AIDS.
        
         | analyte123 wrote:
         | Many of the accusations in this allegedly science-based article
         | are purely guilt by association. In many cases there's no
         | _association_ at all, just fringe people referencing Doshi 's
         | peer-reviewed publications. If Hitler was against cigarettes,
         | does that mean I should smoke? I can literally not find two
         | consecutive sentences in this entire article without a snarky
         | ad hominem or tribal flag-wave.
        
         | drcross wrote:
         | I'm so sick of comments like this. I'll read the goddamn
         | information presented to me and use my own critical thinking
         | skills to determine what I see as useful. Whatever past the
         | person has, if there _is_ a potential issue with something, it
         | 's someone like this who has been paying attention with a focus
         | on the matter who will alert us first.
        
           | ceejayoz wrote:
           | > I'll read the goddamn information presented to me...
           | 
           | Cool. What if it's misleading?
           | 
           | > use my own critical thinking skills...
           | 
           | Neat. What if it requires some domain expertise to detect a
           | reasonable-sounding, but actually false claim?
           | 
           | As a programmer, I can probably convince a non-techie of
           | quite a few incorrect beliefs about computers if I put my
           | mind to it. If I have a _history_ of doing that sort of
           | thing, that 's a perfectly relevant issue to raise.
        
             | drcross wrote:
             | The chairman of Thompson Reuters, who professionally fact
             | check information for Facebook, is on the board of Pfizer
             | which is a grave conflict of interest and there's been
             | repeated examples of them lying outright so all bets are
             | off on who you may suggest is being misleading.
        
               | tazedsoul wrote:
               | Love how people won't even admit this fact into the
               | conversation. Thank you, sincerely, for bringing this up.
        
             | Shartacus wrote:
        
             | blast wrote:
             | > Cool. What if it's misleading?
             | 
             | That question applies in literally every case and therefore
             | doesn't change change the optimal strategy.
             | 
             | > What if it requires some domain expertise to detect a
             | reasonable-sounding, but actually false claim?
             | 
             | That question applies just as much to links from
             | "sciencebasedmedicine.org" as it does to the OP.
        
               | ceejayoz wrote:
               | > That question applies just as much to links from
               | "sciencebasedmedicine.org" as it does to the OP.
               | 
               | Sure, which is why being aware of _both_ is valuable.
        
             | choward wrote:
             | > Cool. What if it's misleading?
             | 
             | So? That's up to you to determine.
             | 
             | > Neat. What if it requires some domain expertise to detect
             | a reasonable-sounding, but actually false claim?
             | 
             | You don't need an expert to tell you transparency is good.
             | 
             | * Edited to be less snarky
        
               | ceejayoz wrote:
               | > So? That's up to you to determine.
               | 
               | Sure, which is why I find it useful to know about the
               | source, and criticism of their past work, when evaluating
               | an op-ed just published in a field that requires
               | substantial domain knowledge to fairly evaluate claims. I
               | linked an article not very charitable towards the author
               | because I consider it valuable in exactly this sort of
               | determination.
               | 
               | > You don't need an expert to tell you transparency is
               | good.
               | 
               | You don't need an expert to tell you complete
               | transparency can have downsides, especially where
               | patients' medical data is involved.
               | 
               | HN _usually_ takes a dim view of  "if you have nothing to
               | hide you have nothing to worry about", but the rapid
               | release of raw medical records is the sort of scenario
               | where people may have lots to hide.
        
               | dang wrote:
               | Please don't cross into snark and attack like that. It
               | adds poison to the ecosystem and weakens your argument.
               | More explanation here:
               | https://news.ycombinator.com/item?id=30016018.
               | 
               | If you wouldn't mind reviewing
               | https://news.ycombinator.com/newsguidelines.html and
               | taking the intended spirit of the site more to heart,
               | we'd be grateful.
        
         | fleetside72 wrote:
         | its really hard to ignore the persons character, but not
         | addressing the argument (and instead talking about the persons
         | character) is a logical fallacy.
        
         | Shartacus wrote:
         | How convenient it must be to discredit someone with a single
         | buzzword like antivaxxer or conspiracy theorist. It must save
         | you a lot of thinking.
        
           | dang wrote:
           | We've banned this account for repeatedly breaking the site
           | guidelines.
           | 
           | Crossing into personal attack and snark, besides being
           | against HN's rules, has the effect of discrediting your own
           | point of view. That is a poor trade to make in exchange for a
           | momentary bit of venting. Not only that, but if your view
           | happens to actually be correct, then it has the side effect
           | of discrediting the truth, which is not in any of our
           | interests. https://hn.algolia.com/?dateRange=all&page=0&prefi
           | x=true&sor...
           | 
           | Can you please not create accounts to break the HN guidelines
           | with?
           | 
           | https://news.ycombinator.com/newsguidelines.html
        
             | dgsilshdjglsd wrote:
        
             | ProvesMyPoint wrote:
             | This is the reason I made a new account, because of people
             | like you who find it too uncomfortable to even think you
             | could be wrong.
        
               | dang wrote:
               | How do you know I don't 100% agree with you? The comment
               | is just as much against the site guidelines either way.
        
           | YXNjaGVyZWdlbgo wrote:
           | Dude it's your fourth account in 5 minutes have some respect
           | for yourself.
        
             | Shartacus wrote:
        
         | choward wrote:
         | I love how people attack the character of anyone who says
         | anything even remotely against the pharmaceutical industry and
         | their narratives. They like to find some sort of evidence that
         | they are one of those "anti-vaxxers" and think that discredits
         | them. Now they don't have to debate anything.
         | 
         | How about you argue with the points made in the article? Do you
         | disagree with anything in the article? Is their dreaded
         | "misinformation" in it. If so point it out and ideally provide
         | some evidence.
         | 
         | I am pro transparency especially when it comes to a global
         | pandemic. I've always been that way. I'm not going to change my
         | opinion because some other person has the same opinion. I don't
         | give a rats ass who wrote the article. It could have been Santa
         | Claus. I like to read articles and do my own research and form
         | my own opinions. People like you who want to try to discredit
         | people so you can silence debate are the biggest problem in
         | this pandemic.
         | 
         | Oh, and you know who else got AIDS and HIV completely wrong?
         | Dr. Fauci.
        
           | readingnonsense wrote:
        
           | ceejayoz wrote:
           | > Do you disagree with anything in the article?
           | 
           | Absolutely, yes. I believe there to be an acute public health
           | interest in not letting antivax nuts run wild on raw data
           | like they do with VAERS, despite clear disclaimers not to do
           | so. Additionally, as a participant in a couple of trials, I
           | see a significant benefit to careful review before the
           | release of data that might inadvertently reveal my identity,
           | conditions, medical history, etc.
        
             | choward wrote:
             | So you are pro-censorship and anti-debate?
        
               | ceejayoz wrote:
               | I believe patients have a right to privacy that deserves
               | careful protection.
        
               | choward wrote:
               | Are you for vaccine mandates?
        
               | AnimalMuppet wrote:
               | We started down this thread with you asking people to
               | argue with the points of the article, not with who the
               | author was.
               | 
               | Now here you are, asking ceejayoz loaded question after
               | loaded question. You sure look like you're trying to find
               | some reason to dismiss what he says. That's not cool,
               | especially since you started us down the "discuss the
               | actual points" path.
        
               | choward wrote:
               | How are the questions loaded? They are relevant in making
               | my point. In order to have debate you need information.
               | If there's no transparency debate becomes pointless. The
               | debate just comes from to who you trust and not real
               | data.
               | 
               | ceejayoz said they're pro medical privacy but thinks that
               | people should have to let people know if they're
               | vaccinated. It makes no sense.
               | 
               | They also want people to be fired from their jobs for not
               | taking a vaccine whose data isn't being released.
               | 
               | In summary I find it hypocritical to be against vaccine
               | transparency but for mandates. It's also hypocritical to
               | be for medical privacy but be for vaccine mandates.
        
               | ceejayoz wrote:
               | That describes a wide variety of proposals.
               | 
               | I unequivocally support it for healthcare workers.
        
               | brandmeyer wrote:
               | There's no point in aiding someone whose interest lies in
               | flinging monkey poo instead of actually having a good-
               | faith debate.
        
             | ALittleLight wrote:
             | Ahh, trust in institutions through obscurity.
        
               | ceejayoz wrote:
               | Trust in institutions through difficulty of a global
               | cover-up requiring the cooperation of nearly two hundred
               | countries across nearly ten billion doses administered?
               | Sure.
        
       | readingnonsense wrote:
        
         | foolyvaxxed wrote:
        
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