5 ms·

Not that I'm aware of. They were rushed to market and the clinical data was supposed to remain hidden for 75 years which certainly seems odd at the least.

teekert 4y ago
What?? I call bs unless you have some proof.
- gsibble 4y ago
  Which part? Here's a source on the 75 years: https://news.bloomberglaw.com/health-law-and-business/why-a-judge-ordered-fda-to-release-covid-19-vaccine-data-pronto https://news.bloomberglaw.com/health-law-and-business/why-a-...
  - mikeyouse 4y ago
    This is an not remotely true: > and the clinical data was supposed to remain hidden for 75 years which certainly seems odd at the least. They released all of the relevant clinical data right away - weird antivaxxers sued for the full patient records which the FDA will provide after redacting PII, which they estimated would take 75 years given the huge volume of pages they'd have to review and their current staff size / existing workload that they're legally obligated to address. The data "wasn't supposed to remain hidden" it's just never made public because the summary data already addressed everything in the individual patient files. The patient files can be made public after redaction but unless congress gives them a bunch more money to hire new staff, they're only capable of processing 500 pages/month.
    - teekert 4y ago
      Ah yes this sounds logical.
    - gsibble 4y ago
      I find it highly suspicious that removing PII would take 75 years. That's laughable. That's deleting some columns from a database.
      - mikeyouse 4y ago
        It's not a database - they're literal PDFs of patient charts with doctor notes. They would need to have a human review every page.
        gsibble 4y ago
        I could build software to automate that and it wouldn't take 75 years. 75 years is a joke.
        mikeyouse 4y ago
        Okay. Cool. Again, 75 years is just a dumb calculation of the number of pages responsive to the FOIA request divided by their 'free capacity' to review 500 pages per month. They weren't suggesting to actually spend the next 75 years doing it, they were hoping the requester would narrow their request to something relevant. You could just have congress authorize 10 more staff, increase their capacity to 50,000 pages/month and you'd have it in 9 months. There's no technical limitation, there's no conspiracy theory, it's just a question of staff time [they are legally obligated to process FOIAs, including all of the 'regular order' ones, so they can't just drop all of their other work to focus on this one request]
        gsibble 4y ago
        Why is the federal taxpayer paying for removing PII from a Pfizer study? Shouldn't Pfizer pay for it? I'm confused.
        mikeyouse 4y ago
        Pfizer isn't subject to FOIA - the government is. To get approval for the vaccine to be sold, Pfizer submits a massive amount of documentation to the FDA. They run studies with tens of thousands of patients and then do the typical statistics work to assess whether the vaccines were safe and effective (they were). They submit these studies along with all of the patient data collected during the trials and the FDA reviews the info to make their decision whether or not to approve the sale of the vaccine. These antivaxxers have decided that there must be something hidden in the patient files, so they filed a FOIA/lawsuit to have the FDA release all of these patient files. Those are the docs that would need to be scrubbed/anonymized. 450k pages of "Patient was administered vaccine, patient was fine".
  - teekert 4y ago
    What!?, why is that legal??
doesnotexist 4y ago
What are you talking about? You do know the vaccines were granted full FDA approval? How do you think that occured? "Full approval is granted when, over time, the FDA has amassed even more scientific evidence to support use of the COVID-19 vaccines, showing that the benefits of the vaccine are greater than its risks, and that the vaccines can be manufactured reliably, safely and with consistent quality." https://www.hopkinsmedicine.org/health/conditions-and-diseases/coronavirus/full-fda-approval-of-a-covid-19-vaccine-what-you-should-know https://www.hopkinsmedicine.org/health/conditions-and-diseas... Look at this ultra top secret data I found by typing "covid 19 vaccine clinical trials data" into google: https://www.pfizer.com/science/clinical-trials/data-and-results https://www.pfizer.com/science/clinical-trials/data-and-resu... wait till you type in "covid-19 vacccine risk benefit analysis" You'll be entered into a secret society with knowledge that has been kept from the sheeple.
- twofornone 4y ago
  Why are you so eager to take Pfizer's own statements at face value? Don't you think there's a bit of a conflict of interest here? And suddenly regulatory capture doesn't exist either? The clinical data is effectively a secret between the FDA and Pfizer, both orgs which have their own pressures to approve of the vaccine and possibly downplay adverse events. Not to mention Pfizer has been preemptively absolved of legal responsibility for any harm. People are right to be suspicious.
  - doesnotexist 4y ago
    First off, I'm not taking anything at face value. My point was that data isn't being kept hidden from the people for 75 years or whatever. And the commenters could have answered their own questions in about 10 seconds using google. As to your statements, I'm sorry but that just isn't how any of this works. Why do you think we have regulatory agencies, like the FDA I mentioned. Not to mention competition among companies and academic researchers. Unfortunately anti-vaccine inclined people aren't interested in facts. https://blogs.bmj.com/medical-ethics/2021/07/07/persuading-anti-vaxxers-stop-talking-about-facts/ https://blogs.bmj.com/medical-ethics/2021/07/07/persuading-a...
_Microft 4y ago
It wasn't "supposed to be hidden for 75 years". It would have taken 75 years to properly anonymize the 450,000 pages that some people thought they could just request.
- gsibble 4y ago
  How would it take 75 years to remove PII? That's deleting some columns from a database. Laughable explanation.
  - _Microft 4y ago
    Identifying what needs to be redacted is the difficult part. They requested full patient records which would have to be looked through in entirety by a human for identifying information.
    - gsibble 4y ago
      And it would take 75 years to build software to do that automatically? We went to the moon in 9 years. I don't think it would take 75 years to figure out how to clear up some PII in PDFs.

teekert 4y ago

What?? I call bs unless you have some proof.

gsibble 4y ago
Which part? Here's a source on the 75 years: https://news.bloomberglaw.com/health-law-and-business/why-a-judge-ordered-fda-to-release-covid-19-vaccine-data-pronto https://news.bloomberglaw.com/health-law-and-business/why-a-...
- mikeyouse 4y ago
  This is an not remotely true: > and the clinical data was supposed to remain hidden for 75 years which certainly seems odd at the least. They released all of the relevant clinical data right away - weird antivaxxers sued for the full patient records which the FDA will provide after redacting PII, which they estimated would take 75 years given the huge volume of pages they'd have to review and their current staff size / existing workload that they're legally obligated to address. The data "wasn't supposed to remain hidden" it's just never made public because the summary data already addressed everything in the individual patient files. The patient files can be made public after redaction but unless congress gives them a bunch more money to hire new staff, they're only capable of processing 500 pages/month.
  - teekert 4y ago
    Ah yes this sounds logical.
  - gsibble 4y ago
    I find it highly suspicious that removing PII would take 75 years. That's laughable. That's deleting some columns from a database.
    - mikeyouse 4y ago
      It's not a database - they're literal PDFs of patient charts with doctor notes. They would need to have a human review every page.
      - gsibble 4y ago
        I could build software to automate that and it wouldn't take 75 years. 75 years is a joke.
        mikeyouse 4y ago
        Okay. Cool. Again, 75 years is just a dumb calculation of the number of pages responsive to the FOIA request divided by their 'free capacity' to review 500 pages per month. They weren't suggesting to actually spend the next 75 years doing it, they were hoping the requester would narrow their request to something relevant. You could just have congress authorize 10 more staff, increase their capacity to 50,000 pages/month and you'd have it in 9 months. There's no technical limitation, there's no conspiracy theory, it's just a question of staff time [they are legally obligated to process FOIAs, including all of the 'regular order' ones, so they can't just drop all of their other work to focus on this one request]
        gsibble 4y ago
        Why is the federal taxpayer paying for removing PII from a Pfizer study? Shouldn't Pfizer pay for it? I'm confused.
        mikeyouse 4y ago
        Pfizer isn't subject to FOIA - the government is. To get approval for the vaccine to be sold, Pfizer submits a massive amount of documentation to the FDA. They run studies with tens of thousands of patients and then do the typical statistics work to assess whether the vaccines were safe and effective (they were). They submit these studies along with all of the patient data collected during the trials and the FDA reviews the info to make their decision whether or not to approve the sale of the vaccine. These antivaxxers have decided that there must be something hidden in the patient files, so they filed a FOIA/lawsuit to have the FDA release all of these patient files. Those are the docs that would need to be scrubbed/anonymized. 450k pages of "Patient was administered vaccine, patient was fine".
- teekert 4y ago
  What!?, why is that legal??

doesnotexist 4y ago

What are you talking about? You do know the vaccines were granted full FDA approval? How do you think that occured? "Full approval is granted when, over time, the FDA has amassed even more scientific evidence to support use of the COVID-19 vaccines, showing that the benefits of the vaccine are greater than its risks, and that the vaccines can be manufactured reliably, safely and with consistent quality." https://www.hopkinsmedicine.org/health/conditions-and-diseases/coronavirus/full-fda-approval-of-a-covid-19-vaccine-what-you-should-know https://www.hopkinsmedicine.org/health/conditions-and-diseas... Look at this ultra top secret data I found by typing "covid 19 vaccine clinical trials data" into google: https://www.pfizer.com/science/clinical-trials/data-and-results https://www.pfizer.com/science/clinical-trials/data-and-resu... wait till you type in "covid-19 vacccine risk benefit analysis" You'll be entered into a secret society with knowledge that has been kept from the sheeple.

twofornone 4y ago
Why are you so eager to take Pfizer's own statements at face value? Don't you think there's a bit of a conflict of interest here? And suddenly regulatory capture doesn't exist either? The clinical data is effectively a secret between the FDA and Pfizer, both orgs which have their own pressures to approve of the vaccine and possibly downplay adverse events. Not to mention Pfizer has been preemptively absolved of legal responsibility for any harm. People are right to be suspicious.
- doesnotexist 4y ago
  First off, I'm not taking anything at face value. My point was that data isn't being kept hidden from the people for 75 years or whatever. And the commenters could have answered their own questions in about 10 seconds using google. As to your statements, I'm sorry but that just isn't how any of this works. Why do you think we have regulatory agencies, like the FDA I mentioned. Not to mention competition among companies and academic researchers. Unfortunately anti-vaccine inclined people aren't interested in facts. https://blogs.bmj.com/medical-ethics/2021/07/07/persuading-anti-vaxxers-stop-talking-about-facts/ https://blogs.bmj.com/medical-ethics/2021/07/07/persuading-a...

_Microft 4y ago

It wasn't "supposed to be hidden for 75 years". It would have taken 75 years to properly anonymize the 450,000 pages that some people thought they could just request.

gsibble 4y ago
How would it take 75 years to remove PII? That's deleting some columns from a database. Laughable explanation.
- _Microft 4y ago
  Identifying what needs to be redacted is the difficult part. They requested full patient records which would have to be looked through in entirety by a human for identifying information.
  - gsibble 4y ago
    And it would take 75 years to build software to do that automatically? We went to the moon in 9 years. I don't think it would take 75 years to figure out how to clear up some PII in PDFs.