4 ms·

Meanwhile...the FDA says it needs 55 years to release Pfizer data. lol.

wsc981 5y ago
> Meanwhile...the FDA says it needs 55 years to release Pfizer data. This is crazy to be honest. If there was some malfeasance during the development of the vaccines, the people responsible will be long dead by then and cannot be punished. In that case Pfizer would just pay some fine and continue business as usual. The vaccine could be developed very quickly, I don't understand why there is the needs to wait so long to release the data - the data itself (emails, scientific documents and such) should be quite limited. I believe Pfizer claimed it's too much data to process and they need many years, but I find this quite unbelievable.
- detaro 5y ago
  With full details for all the participants etc and revisions the scientific data is probably quite a lot, so I can imagine that the blanked "we want all documents!" is actually the claimed 300k pages by some metric. But obviously "and it's ok if we only prepare 500 pages per month for release" is a very questionable position to take in such a situation, even if legal. Smells like usual bureaucracy crap, with no sense for the somewhat special situation here.
  - Fomite 5y ago
    Badly written or overly broad public records requests are often met with "Do you have any idea how long that will take?" "Just give me all of it" is easy to request, but hard to implement.
    - OrvalWintermute 5y ago
      They are a fortune 1000 in a heavily regulated industry. Their compliance and records systems probably have compliance and records systems Gathering this data would be a breeze.
      - detaro 5y ago
        The request is against the government, not the company. Now I wonder if they could release their copy of at least their data if they wanted, or if that is under some kind of restriction.
- tchalla 5y ago
  > But the FDA can’t simply turn the documents over wholesale. The records must be reviewed to redact “confidential business and trade secret information of Pfizer or BioNTech and personal privacy information of patients who participated in clinical trials,” wrote DOJ lawyers in a joint status report filed Monday. > The FDA proposes releasing 500 pages per month on a rolling basis, noting that the branch that would handle the review has only 10 employees and is currently processing about 400 other FOIA requests. https://www.reuters.com/legal/government/wait-what-fda-wants-55-years-process-foia-request-over-vaccine-data-2021-11-18/ https://www.reuters.com/legal/government/wait-what-fda-wants...

> Meanwhile...the FDA says it needs 55 years to release Pfizer data. This is crazy to be honest. If there was some malfeasance during the development of the vaccines, the people responsible will be long dead by then and cannot be punished. In that case Pfizer would just pay some fine and continue business as usual. The vaccine could be developed very quickly, I don't understand why there is the needs to wait so long to release the data - the data itself (emails, scientific documents and such) should be quite limited. I believe Pfizer claimed it's too much data to process and they need many years, but I find this quite unbelievable.

detaro 5y ago
With full details for all the participants etc and revisions the scientific data is probably quite a lot, so I can imagine that the blanked "we want all documents!" is actually the claimed 300k pages by some metric. But obviously "and it's ok if we only prepare 500 pages per month for release" is a very questionable position to take in such a situation, even if legal. Smells like usual bureaucracy crap, with no sense for the somewhat special situation here.
- Fomite 5y ago
  Badly written or overly broad public records requests are often met with "Do you have any idea how long that will take?" "Just give me all of it" is easy to request, but hard to implement.
  - OrvalWintermute 5y ago
    They are a fortune 1000 in a heavily regulated industry. Their compliance and records systems probably have compliance and records systems Gathering this data would be a breeze.
    - detaro 5y ago
      The request is against the government, not the company. Now I wonder if they could release their copy of at least their data if they wanted, or if that is under some kind of restriction.
tchalla 5y ago
> But the FDA can’t simply turn the documents over wholesale. The records must be reviewed to redact “confidential business and trade secret information of Pfizer or BioNTech and personal privacy information of patients who participated in clinical trials,” wrote DOJ lawyers in a joint status report filed Monday. > The FDA proposes releasing 500 pages per month on a rolling basis, noting that the branch that would handle the review has only 10 employees and is currently processing about 400 other FOIA requests. https://www.reuters.com/legal/government/wait-what-fda-wants-55-years-process-foia-request-over-vaccine-data-2021-11-18/ https://www.reuters.com/legal/government/wait-what-fda-wants...