13 ms·

Covid-19 vaccines and treatments: we must have raw data, now

220 points by steelstraw 5y ago

tomohawk 5y ago
> 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 5y ago
  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 5y ago
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 https://www.bmj.com/content/375/bmj.n2635 - "Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial"
- YXNjaGVyZWdlbgo 5y ago
  I can only recommend this article about bmj: https://respectfulinsolence.com/2021/11/15/wtf-happened-to-the-bmj/ https://respectfulinsolence.com/2021/11/15/wtf-happened-to-t...
  - shrubble 5y ago
    I find the author's take to be lacking in understanding of how contracting companies are hired and managed.
  - srcreigh 5y ago
    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 5y ago
      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 5y ago
        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 5y ago
        > 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 https://news.ycombinator.com/item?id=29206892 .
      - Fogest 5y ago
        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 5y ago
https://sciencebasedmedicine.org/what-the-heck-happened-to-the-bmj/ 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.
- drcross 5y ago
  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 5y ago
    - Shartacus 5y ago
    - blast 5y ago
      > 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 5y ago
readingnonsense 5y ago
- foolyvaxxed 5y ago
uvesten 5y ago
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 5y ago
  > 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 5y ago
- dragonwriter 5y ago
  > Also, how can Pfizer claim that their "study" ends in 2023? Because it does. https://beta.clinicaltrials.gov/study/NCT04848584 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 5y ago
    > 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.
    - ceejayoz 5y ago
      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?
daenz 5y ago
>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 5y ago
  Everythihng can be declared a matter of national security...
  - wyldfire 5y ago
    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 5y ago
  > 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 https://en.wikipedia.org/wiki/Invention_Secrecy_Act, but that allows (temporary) suppression of patents, not clinical trial data.
  - walterbell 5y ago
    > 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.
brianmcc 5y ago
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 5y ago
  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 5y ago
  - brianmcc 5y ago
    Yep I agree, that's my point!
fabian2k 5y ago
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.
- walterbell 5y ago
  > 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 5y ago
  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 5y ago
    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 5y ago
      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.
mberning 5y ago
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.
- jeromegv 5y ago
  You don't need to focus your conspiracy theory on clinical trials, there are billions of people who got the vaccine. Are you saying that every single of all those countries are part of a giant conspiracy that are hiding the impact of the vaccine under the rug?
  - mberning 5y ago
    It’s not a conspiracy theory. The number of reports to VAERS, which is the best data we have on population wide side effects, has been growing rapidly. To be fair it will be very hard to tease out strong evidence from that data set, but directionally it seems to indicate something is going on with these vaccines. Perhaps the clinical trial data will be released, VAERS will be combed through, new studies devised, and we will have some idea of the actual side effects and their relative frequency. It’s not going to be zero across the board. And that is just for the short term. We have zero idea what the long term side effects may be. I hope it is zero. But if it’s not there are going to be some very unfortunate people.
- trhway 5y ago
  The troubling result is that vaccines have been forced upon [majority] of the people to whom it has no public interest effect - the existing covid vaccines (except SinoVac for which there is no reliable data) don't reduce the spread nor affect hospitalization rate for most as the most have close to 0 chances of hospitalization to start with. When it comes to spread the vaccines may be even making the situation worse as the infected vaccinated people spread virus at the same level as infected unvaccinated while having less symptoms for the vaccinated means higher chances of them walking around spreading it. >there were very troubling results from the clinical trials that were swept under the rug this is why the clinical trials aren't going to conclude until few years down the road as operating under EUA is basically get-out-of-jail-free card for the BigPharma here.
bryanlarsen 5y ago
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?
- nradov 5y ago
  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-topics/de-identification/index.html https://www.hhs.gov/hipaa/for-professionals/privacy/special-...
- someguydave 5y ago
  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.
  - raxxorrax 5y ago
    I disagree, I think we see a lot of condemnation for having had a treatment or not. On the contrary, we should bring privacy back and make health a private issue completely. I also worked on medical devices and respective medical advisory boards. Getting people to share their data is just a question away. If you fail at that, I doubt any further inquiry would net any benefit.
- willcipriano 5y ago
  Same people who are responsible if you get a vaccine injury.
aaron695 5y ago
invokestatic 5y ago
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 5y ago
  And ? Where is the bad thing to open a dataset of comorbidities and related / suspected effect of vaccines / medications ?
  - jjulius 5y ago
    >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 5y ago
      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 5y ago
        > 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?
deleted 5y ago
[deleted]
hanselot 5y ago
bsder 5y ago
One thing I haven't seen is the "raw data" people being willing to pay for their own government certified consultants to anonymize the data. I presume this would actually be the solution if the "raw data" people were making good faith requests. Is there any reason why this wouldn't be viable?
- macilacilove 5y ago
  The public needs the data, so the public need to pay for it. We absolutely can. Yet the FDA says "sorry only 500 pages a month" which means 110 months.
  - bsder 5y ago
    "The Public" also need our institutions to be Denial of Service resistant. As a number of sanctioned and disbarred lawyers have demonstrated, several groups in the US are quite happy to launch Denial of Service attacks against our institutions. The easiest way to solve this is "You get <X> pages per month. If you want more than that, bring FDA certified folks to handle the job and pay them from your own coffers." I don't see the people requesting the data to also be ponying up the money to get the data faster.
pfisherman 5y ago
Ummm… no. In IRB applications and informed consent documents you have to be very clear and specific about who you might share their data with under what circumstances. And these documents tend to be legally binding. So this editorial is kind of nutty. To give you an idea, this is kind of like asking banks to release customer account data to the public.
- yread 5y ago
  IRBs implement the law. Here in the Netherlands the law specifically has exceptions for releasing data if it's in the interest of public health. It's weighed against other concerns of course but it's not impossible
  - pfisherman 5y ago
    I fail to see what benefits there are here. Are citizen biostatisticians going to verify the data and post about how everything checks out? That is quite naive seeing how the data from VAERS is being presented totally out of context in intellectually dishonest ways. Aside: the big problem with VAERS is that you do not have a denominator. Not to mention reporting biases, and the abysmal quality and assessment value of reports. Even if you did have some cadre if motivated, ethical citizen biostatisticians any type of post hoc analysis would be suspect and epistemologically weaker than the original statistical analysis because it would have been designed with prior knowledge of the data. Compare to the original study where the statistical analysis plan was prospectively designed and publicly disclosed BEFORE any patient enrollment or data collection.

220 points by steelstraw 5y ago

> 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 5y ago
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 5y ago

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 https://www.bmj.com/content/375/bmj.n2635 - "Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial"

YXNjaGVyZWdlbgo 5y ago
I can only recommend this article about bmj: https://respectfulinsolence.com/2021/11/15/wtf-happened-to-the-bmj/ https://respectfulinsolence.com/2021/11/15/wtf-happened-to-t...
- shrubble 5y ago
  I find the author's take to be lacking in understanding of how contracting companies are hired and managed.
- srcreigh 5y ago
  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 5y ago
    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 5y ago
      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 5y ago
      > 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 https://news.ycombinator.com/item?id=29206892 .
    - Fogest 5y ago
      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 5y ago

https://sciencebasedmedicine.org/what-the-heck-happened-to-the-bmj/ 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.

drcross 5y ago
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 5y ago
  - Shartacus 5y ago
  - blast 5y ago
    > 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 5y ago

readingnonsense 5y ago

foolyvaxxed 5y ago

uvesten 5y ago

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 5y ago
> 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 5y ago
dragonwriter 5y ago
> Also, how can Pfizer claim that their "study" ends in 2023? Because it does. https://beta.clinicaltrials.gov/study/NCT04848584 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 5y ago
  > 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.
  - ceejayoz 5y ago
    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?

daenz 5y ago

>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 5y ago
Everythihng can be declared a matter of national security...
- wyldfire 5y ago
  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 5y ago
> 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 https://en.wikipedia.org/wiki/Invention_Secrecy_Act, but that allows (temporary) suppression of patents, not clinical trial data.
- walterbell 5y ago
  > 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.

brianmcc 5y ago

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 5y ago
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 5y ago
- brianmcc 5y ago
  Yep I agree, that's my point!

fabian2k 5y ago

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.

walterbell 5y ago
> 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 5y ago
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 5y ago
  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 5y ago
    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.

mberning 5y ago

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.

jeromegv 5y ago
You don't need to focus your conspiracy theory on clinical trials, there are billions of people who got the vaccine. Are you saying that every single of all those countries are part of a giant conspiracy that are hiding the impact of the vaccine under the rug?
- mberning 5y ago
  It’s not a conspiracy theory. The number of reports to VAERS, which is the best data we have on population wide side effects, has been growing rapidly. To be fair it will be very hard to tease out strong evidence from that data set, but directionally it seems to indicate something is going on with these vaccines. Perhaps the clinical trial data will be released, VAERS will be combed through, new studies devised, and we will have some idea of the actual side effects and their relative frequency. It’s not going to be zero across the board. And that is just for the short term. We have zero idea what the long term side effects may be. I hope it is zero. But if it’s not there are going to be some very unfortunate people.
trhway 5y ago
The troubling result is that vaccines have been forced upon [majority] of the people to whom it has no public interest effect - the existing covid vaccines (except SinoVac for which there is no reliable data) don't reduce the spread nor affect hospitalization rate for most as the most have close to 0 chances of hospitalization to start with. When it comes to spread the vaccines may be even making the situation worse as the infected vaccinated people spread virus at the same level as infected unvaccinated while having less symptoms for the vaccinated means higher chances of them walking around spreading it. >there were very troubling results from the clinical trials that were swept under the rug this is why the clinical trials aren't going to conclude until few years down the road as operating under EUA is basically get-out-of-jail-free card for the BigPharma here.

bryanlarsen 5y ago

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?

nradov 5y ago
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-topics/de-identification/index.html https://www.hhs.gov/hipaa/for-professionals/privacy/special-...
someguydave 5y ago
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.
- raxxorrax 5y ago
  I disagree, I think we see a lot of condemnation for having had a treatment or not. On the contrary, we should bring privacy back and make health a private issue completely. I also worked on medical devices and respective medical advisory boards. Getting people to share their data is just a question away. If you fail at that, I doubt any further inquiry would net any benefit.
willcipriano 5y ago
Same people who are responsible if you get a vaccine injury.

aaron695 5y ago

invokestatic 5y ago

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 5y ago
And ? Where is the bad thing to open a dataset of comorbidities and related / suspected effect of vaccines / medications ?
- jjulius 5y ago
  >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 5y ago
    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 5y ago
      > 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?

deleted 5y ago

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hanselot 5y ago

bsder 5y ago

One thing I haven't seen is the "raw data" people being willing to pay for their own government certified consultants to anonymize the data. I presume this would actually be the solution if the "raw data" people were making good faith requests. Is there any reason why this wouldn't be viable?

macilacilove 5y ago
The public needs the data, so the public need to pay for it. We absolutely can. Yet the FDA says "sorry only 500 pages a month" which means 110 months.
- bsder 5y ago
  "The Public" also need our institutions to be Denial of Service resistant. As a number of sanctioned and disbarred lawyers have demonstrated, several groups in the US are quite happy to launch Denial of Service attacks against our institutions. The easiest way to solve this is "You get <X> pages per month. If you want more than that, bring FDA certified folks to handle the job and pay them from your own coffers." I don't see the people requesting the data to also be ponying up the money to get the data faster.

pfisherman 5y ago

Ummm… no. In IRB applications and informed consent documents you have to be very clear and specific about who you might share their data with under what circumstances. And these documents tend to be legally binding. So this editorial is kind of nutty. To give you an idea, this is kind of like asking banks to release customer account data to the public.

yread 5y ago
IRBs implement the law. Here in the Netherlands the law specifically has exceptions for releasing data if it's in the interest of public health. It's weighed against other concerns of course but it's not impossible
- pfisherman 5y ago
  I fail to see what benefits there are here. Are citizen biostatisticians going to verify the data and post about how everything checks out? That is quite naive seeing how the data from VAERS is being presented totally out of context in intellectually dishonest ways. Aside: the big problem with VAERS is that you do not have a denominator. Not to mention reporting biases, and the abysmal quality and assessment value of reports. Even if you did have some cadre if motivated, ethical citizen biostatisticians any type of post hoc analysis would be suspect and epistemologically weaker than the original statistical analysis because it would have been designed with prior knowledge of the data. Compare to the original study where the statistical analysis plan was prospectively designed and publicly disclosed BEFORE any patient enrollment or data collection.