3 ms·

Sure, and that should not take 50 years for a document that took a year to create and analyse well enough to authorise the vaccine based on the findings.

Uberphallus 5y ago
Reviewing/analysing data and filtering it are dramatically different tasks. With raw data, most of the heavy lifting is done by your data analysis stack, you don't crunch numbers yourself. Complying with FOIA requests though, is largely manual work. The FDA has 14,000 employees; its FOIA office has 10, and they go at roughly 80,000 pages per month, meaning each employee does 8,000 pages per month, or roughly 400 per working day per employee, less than a minute per page. That to my non expert opinion sounds pretty fast. That speed has been appropriate until now that the plaintiffs want 4 months' worth of FDA FOIA work for yesterday. I agree that there should be a solution for these cases, but it's this particular FOIA request that's the anomaly, not the FDA way of work.
- perryizgr8 5y ago
  If the FDA is not able to deliver our documents to us in time, maybe it is time to shut it down. Let public do the research and let consumers decide if they want to take the vaccine based on available results.
  - dragonwriter 5y ago
    > If the FDA is not able to deliver our documents to us in time, maybe it is time to shut it down. Let More sensibly, if we want the FDA to make delivering a particular set of documents a sizable piece of its job, we should (through Congress) direct that and allocate appropriate funding for that purpose.
    - daddylongstroke 5y ago
      I believe the FDA is already mandated by law to release this data, which is why the original lawsuit was filed. From a Reuters article on it: They also argue that Title 21, subchapter F of the FDA’s own regulations stipulates that the agency “is to make ‘immediately available’ all documents underlying licensure of a vaccine." So it really sounds like this is just part of the course of making sausage of approval. You have someone already embedded in the licensure project/process where this is all (very likely largely automagically) handled as it is always expected to be released to the public.
      - Uberphallus 5y ago
        Yeah, but this scale of documentation production is unprecedented. A lot of cash was dumped into fast and extensive R&D, trials and production scaling because of the urgency of the situation, and along comes an insane documentation backlog. To put in perspective, the original HPV vaccine R&D and trial spanned over 7 years with 25,000 patients (of which only 20,000 women), and assuming the documentation was provided to the FDA as it was produced, it could be FOIA'd relatively quickly. Pfizer/BioNTech did the same, with almost double the patients, in just over 6 months.
  - Uberphallus 5y ago
    Ironically, if the FDA could deliver those documents "in time" it would be a sign of a pretty limited trial, and people would be complaining about that instead. Damned if you do, damned if you don't.
dragonwriter 5y ago
> Sure, and that should not take 50 years for a document that took a year to create It's not a document, and many of the documents involved weren’t created by the government, and no government agency is funded for unlimited reserve capacity for doing public records releases just in case. In 2020, FDA spent a little under $5.5 million (a little over $5 million net after fees collected) handling over 10k FOIA requests. [0] There's not a lot of resources to dedicate to any one request. [0] https://www.hhs.gov/foia/reports/annual-reports/2020/index.html https://www.hhs.gov/foia/reports/annual-reports/2020/index.h...
- perryizgr8 5y ago
  IMO if the agency cannot disclose to the public the documents it prepared for the public, that's gross incompetence. It just adds to my argument that FDA should be shut down, since they are clearly incapable of doing their job.
  - dragonwriter 5y ago
    > IMO if the agency cannot disclose to the public the documents it prepared for the public It didn't prepare them for the public (and, in many cases, it didn't prepare them at all). It prepared or gathered them to support the function it performs for the public, much of which, by law, includes preparing, gathering, and reviewing legally non-disclosable information. That's the mandate it has in law—so it is not at all “incompetence” that that is how it operates. You may not like the law (given that elsewhere in the thread you have suggested it is literally equivalent to the institution of slavery, I assume that you do not), but it is not incompetent for government agencies to follow the law that actually exists rather than your individual preferences for what the law ought to be.

Uberphallus 5y ago

Reviewing/analysing data and filtering it are dramatically different tasks. With raw data, most of the heavy lifting is done by your data analysis stack, you don't crunch numbers yourself. Complying with FOIA requests though, is largely manual work. The FDA has 14,000 employees; its FOIA office has 10, and they go at roughly 80,000 pages per month, meaning each employee does 8,000 pages per month, or roughly 400 per working day per employee, less than a minute per page. That to my non expert opinion sounds pretty fast. That speed has been appropriate until now that the plaintiffs want 4 months' worth of FDA FOIA work for yesterday. I agree that there should be a solution for these cases, but it's this particular FOIA request that's the anomaly, not the FDA way of work.

perryizgr8 5y ago
If the FDA is not able to deliver our documents to us in time, maybe it is time to shut it down. Let public do the research and let consumers decide if they want to take the vaccine based on available results.
- dragonwriter 5y ago
  > If the FDA is not able to deliver our documents to us in time, maybe it is time to shut it down. Let More sensibly, if we want the FDA to make delivering a particular set of documents a sizable piece of its job, we should (through Congress) direct that and allocate appropriate funding for that purpose.
  - daddylongstroke 5y ago
    I believe the FDA is already mandated by law to release this data, which is why the original lawsuit was filed. From a Reuters article on it: They also argue that Title 21, subchapter F of the FDA’s own regulations stipulates that the agency “is to make ‘immediately available’ all documents underlying licensure of a vaccine." So it really sounds like this is just part of the course of making sausage of approval. You have someone already embedded in the licensure project/process where this is all (very likely largely automagically) handled as it is always expected to be released to the public.
    - Uberphallus 5y ago
      Yeah, but this scale of documentation production is unprecedented. A lot of cash was dumped into fast and extensive R&D, trials and production scaling because of the urgency of the situation, and along comes an insane documentation backlog. To put in perspective, the original HPV vaccine R&D and trial spanned over 7 years with 25,000 patients (of which only 20,000 women), and assuming the documentation was provided to the FDA as it was produced, it could be FOIA'd relatively quickly. Pfizer/BioNTech did the same, with almost double the patients, in just over 6 months.
- Uberphallus 5y ago
  Ironically, if the FDA could deliver those documents "in time" it would be a sign of a pretty limited trial, and people would be complaining about that instead. Damned if you do, damned if you don't.

dragonwriter 5y ago

> Sure, and that should not take 50 years for a document that took a year to create It's not a document, and many of the documents involved weren’t created by the government, and no government agency is funded for unlimited reserve capacity for doing public records releases just in case. In 2020, FDA spent a little under $5.5 million (a little over $5 million net after fees collected) handling over 10k FOIA requests. [0] There's not a lot of resources to dedicate to any one request. [0] https://www.hhs.gov/foia/reports/annual-reports/2020/index.html https://www.hhs.gov/foia/reports/annual-reports/2020/index.h...

perryizgr8 5y ago
IMO if the agency cannot disclose to the public the documents it prepared for the public, that's gross incompetence. It just adds to my argument that FDA should be shut down, since they are clearly incapable of doing their job.
- dragonwriter 5y ago
  > IMO if the agency cannot disclose to the public the documents it prepared for the public It didn't prepare them for the public (and, in many cases, it didn't prepare them at all). It prepared or gathered them to support the function it performs for the public, much of which, by law, includes preparing, gathering, and reviewing legally non-disclosable information. That's the mandate it has in law—so it is not at all “incompetence” that that is how it operates. You may not like the law (given that elsewhere in the thread you have suggested it is literally equivalent to the institution of slavery, I assume that you do not), but it is not incompetent for government agencies to follow the law that actually exists rather than your individual preferences for what the law ought to be.