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"At that rate, the 10 employees would have to work non-stop 24 hours a day, seven days a week to produce the 55,000 pages a month (and would still fall a bit sh

"At that rate, the 10 employees would have to work non-stop 24 hours a day, seven days a week to produce the 55,000 pages a month (and would still fall a bit short)." The reporter suggests the FDA reassign other people to process the FOIA requests but I would prefer those people continue working on important things like reviewing the safety and efficacy of medical devices[1] and reviewing the safety of food and infant formula [2] rather than spending their time processing paperwork that will, at best, be used by anti-vaccine activists in social media disinformation. I would be interested in seeing who this 'Public Health and Medical Professionals for Transparency' front group is. My guess is it's a group of charlatans looking to sell their own COVID cures similar to the doctor who produced the original study claiming vaccines cause autism (which was later retracted) 1. https://www.fda.gov/medical-devices https://www.fda.gov/medical-devices 2. https://www.fda.gov/food/recalls-outbreaks-emergencies/alerts-advisories-safety-information#infantformula https://www.fda.gov/food/recalls-outbreaks-emergencies/alert...

ipspam 5y ago
So your for using power to totally destroy all the hard won battles for transparency, destroy trust in public institutions, and feed conspiracy theories? I don't think you have thought this through. I don't think you read the part where the FDA has 18,000 employees. The FDA should be above politics. Isn't it suspicious that the FDA is doing this, and that the public have a right to know and see the underlying documents within 90 days of drug approval? Isn't is Phizers responsibility to submit the documents in a way that protects privacy? All the norms are lost here. You couldn't find a better way to destroy the credibility of the FDA than to "never" have meaningful transparency on the fastest, most hastily produced, many corners cut drug. Quite frankly, the FDA would rubber stamp a pile of cow poop if it were politically expedient. The only way to win back trust is to hold them accountable, for better or for worse, even if it feeds vaccine conspiracies. It can't be done in my generation, but maybe in the next when this COVID saga is largely memory holed
- dopylitty 5y ago
  No, none of it is suspicious, unless you're a person who is trying to cast doubt on vaccines by claiming that vaccines on platforms that have been under development for two decades and went through enormous trials were 'hastily produced' with 'corners cut'
  - keneda7 5y ago
    Are you referring to the mRNA vaccine platform? Could you point me to the mRNA vaccine application that was approved before covid? When I looked into it all, of them had been denied until covid and I did not hear of any breakthrough in mRNA technology that suddenly fixed the issues the previous ones (I found 8) had been denied for.
    - jaywalk 5y ago
      It's just a coincidence that these companies that have been working for years on this stuff failed every single time in the past, but then within a few weeks in early 2020 they suddenly figured everything out.
      - ceejayoz 5y ago
        Not a coincidence, no. Just a very different cost/benefit analysis on "do all the steps we can in parallel to speed things up" during a pandemic.
        jaywalk 5y ago
        If only Moderna had realized in that they could "do all the steps [they] can in parallel to speed things up" 8 years ago! They managed to accomplish what had eluded them for 8 years in a matter of weeks. Astounding stuff.
        ceejayoz 5y ago
        Again, it's a cost/benefit analysis. The benefit went up. The acceptable costs of parallelization similarly went up. (Some steps got easier, too, for the same "everyone really wants a solution yesterday" reasons, like recruiting trial volunteers. For example: https://www.sciencenews.org/article/covid-coronavirus-vaccine-development-speed https://www.sciencenews.org/article/covid-coronavirus-vaccin...) > For instance, it took just under 16 weeks to recruit and enroll more than 43,000 volunteers for the final phases of testing Pfizer’s vaccine. When volunteer recruitment began for clinical trials of the rabies mRNA vaccine in 2013, it took 813 days to get 101 participants enrolled. Based on this comparison, that’s roughly 730 days — nearly two years — saved in recruiting alone. The same article cites precisely one of those parallelization steps I'm talking about: > In a final jolt of speed, some pharmaceutical companies, bolstered by big vaccine contracts and research cash from the U.S. government’s Operation Warp Speed, were also churning out doses during clinical trials in the hopes that the vaccines would work. Once the companies had emergency use authorization in hand, they were ready to ship doses immediately.
- avs733 5y ago
  > So your for using power to totally destroy all the hard won battles for transparency, destroy trust in public institutions, and feed conspiracy theories? If the FDA screws up in their now legally compelled rush to produce these documents what happens? Pfizer could have their trade secret info leaked (like it or not that shouldn't happen) Participants in vaccine trials could have their private health information leaked (or have their identity stolen) The FDA is responsible and liable FOIA abuse is a thing, just like DMCA abuse is a thing. People abusing the FOIA process are the ones who are likely to lead to its power being destroyed, not the government here. It isn't suspicious...this group is intentionally misinterpreting things in bad faith under the guise of accountability. It's classic bad faith, and I'm deeply saddened at how easily this country falls for it.
- daveevad 5y ago
  I'd like to add that the situation is so severe we should prioritize a solution to COVID at the expense of individual privacy. This is the biggest problem we've ever needed to solve as a society. Release the documents and we'll find the bugs.
tut-le-tut 5y ago
"At that rate, the 10 employees would have to work non-stop 24 hours a day, seven days a week to produce the 55,000 pages a month (and would still fall a bit short)." So 50 people on a normal (40 hour work week) could do this in a month. The FDA has 18 000 employees. I think the answer is clear.
- deleted 5y ago
  [deleted]
- lesuorac 5y ago
  If they want their documents faster they should just pay for it. Requesting 300k+ pages is not a normal request, there is no way all of those pages will be of interest. Pay for it by paying a fee equal to the cost of hiring / training additional personal (https://www.foia.gov/faq.html https://www.foia.gov/faq.html).
  - encryptluks2 5y ago
    So pay for transparency that is already expected? Should you have to pay to get your medical record?
    - mike00632 5y ago
      It's asinine to think you have a right to see every document the government has including PII and trade secrets, even worse to base an anti-vaxx effort on such ideas.
      - encryptluks2 5y ago
        It's crazy to me the amount of people that people would blindly trust the same government that did illegal experimentation in the past and gave unsuspecting populations syphilis. Or the same companies that paid billions for lying in the past.
  - LegitShady 5y ago
    Only the rich should get FOIA?
gruez 5y ago
>I would be interested in seeing who this 'Public Health and Medical Professionals for Transparency' front group is. My guess is it's a group of charlatans looking to sell their own COVID cures similar to the doctor who produced the original study claiming vaccines cause autism (which was later retracted) see page 3, paragraph 11: https://www.courtlistener.com/docket/60390195/1/public-health-and-medical-professionals-for-transparency-v-food-and-drug/ https://www.courtlistener.com/docket/60390195/1/public-healt...
- geofft 5y ago
  Yup, looks like it: - Aaron Kheriarty is no longer associated with UC Irvine after refusing their vaccine mandate (this changed between the filing and now) and tweets links to The American Conservative. https://twitter.com/akheriaty https://twitter.com/akheriaty - Harvey Risch published an opinion piece in favor of hydroxycholoroquine in the American Journal of Epidemiology which attracted opposition from many other scientists as inappropriate/unscientific (not simply wrong yet within the bounds of good-faith scientific inquiry) and a response from that journal. https://academic.oup.com/aje/article/190/4/491/5898696 https://academic.oup.com/aje/article/190/4/491/5898696 - Peter McCullough appeared on an episode of Joe Rogan where even Joe Rogan correctly identified that his claims were implausible. https://news.ycombinator.com/item?id=29655002 https://news.ycombinator.com/item?id=29655002 I got bored after the first page, I can look further....
  - colpabar 5y ago
    Well I for one am glad that FOIA requests don't depend on whether you like the people filing them. I find it absolutely ridiculous that asking for this data is seen as a bad thing. Why are pharmaceutical companies suddenly beyond questioning?
    - Robotbeat 5y ago
      - 5y ago
avs733 5y ago
If it's helpful, Alex Jones seems to love 'citing' (meaning lying about) the documents they have produced so far.
- mansion7 5y ago
  No. It is not helpful, in the slightest.
throw10920 5y ago
There's very little reason to believe that the reassignment will actually come from teams working on either of those two problems. This argument is a really long stretch - especially because there are other ways of meeting the deadline than reassignment to the FOIA office (hiring contractors, adding employees, using interns or HR folk) - picking out a highly specific and avoidable method of executing the FOIA to attack the idea of doing the FOIA at all is...questionable, to say the least. Moreover, as a citizen of the US that has paid for the R&D of those vaccines through my tax dollars, I have a right to see the results of that research. This shouldn't be a controversial opinion. (it certainly wasn't when the House passed the Freedom Of Information Act 306 to 0 in 1966)
- kongolongo 5y ago
  >Moreover, as a citizen of the US that has paid for the R&D of those vaccines through my tax dollars, I have a right to see the results of that research. This shouldn't be a controversial opinion. (it certainly wasn't when the House passed the Freedom Of Information Act 306 to 0 in 1966) there's hundreds if not thousands of top secret military r&d projects funded by tax money that will never see the light of day regardless of foia, this isn't particularly special and could very well include classified info that needs to flow down very long approval and bureaucratic processes. Hiring more people and then training them on that process would just lengthen the time needed to release the info
- elliekelly 5y ago
  > This argument is a really long stretch - especially because there are other ways of meeting the deadline than reassignment to the FOIA office (hiring contractors, adding employees, using interns or HR folk) Reading a document and making an assessment of to the disclosure obligations under FOIA isn’t something you can just pluck an intern to do and hand them the box of documents.
- belltaco 5y ago
  >Moreover, as a citizen of the US that has paid for the R&D of those vaccines through my tax dollars, I have a right to see the results of that research. This shouldn't be a controversial opinion. Pfizer didn't take any US govt money for the R&D of the vaccine.
tonfreed 5y ago
If you've ever dealt with public departments, you'd know that the vast majority of those they employ would be pencil pushers and meetware.
908B64B197 5y ago
> The reporter suggests the FDA reassign other people to process the FOIA requests but I would prefer those people continue working on important things like reviewing the safety and efficacy of medical devices[1] and reviewing the safety of food and infant formula [2] rather than spending their time processing paperwork I'm puzzled why they didn't make the document FOIA friendly in the first place. It was pretty obvious that it was going to be requested as it is of extreme public interest. I'm wondering if this "burden" wasn't intentionally planned. But there's no reason to do so: after all, the FDA should be working in the public's interests, and they have nothing to hide.
Jimmc414 5y ago
Do you think that argument could delay an IRS audit for 55 years?
tmaly 5y ago
How many people produce this many pages? It seems if they kept data like this in digital format with meta data, production could be much easier. I do similar work, but for non-gov. It is a challenge.
sixstringninja 5y ago
I’m ok with this. More transparency

ipspam 5y ago

So your for using power to totally destroy all the hard won battles for transparency, destroy trust in public institutions, and feed conspiracy theories? I don't think you have thought this through. I don't think you read the part where the FDA has 18,000 employees. The FDA should be above politics. Isn't it suspicious that the FDA is doing this, and that the public have a right to know and see the underlying documents within 90 days of drug approval? Isn't is Phizers responsibility to submit the documents in a way that protects privacy? All the norms are lost here. You couldn't find a better way to destroy the credibility of the FDA than to "never" have meaningful transparency on the fastest, most hastily produced, many corners cut drug. Quite frankly, the FDA would rubber stamp a pile of cow poop if it were politically expedient. The only way to win back trust is to hold them accountable, for better or for worse, even if it feeds vaccine conspiracies. It can't be done in my generation, but maybe in the next when this COVID saga is largely memory holed

dopylitty 5y ago
No, none of it is suspicious, unless you're a person who is trying to cast doubt on vaccines by claiming that vaccines on platforms that have been under development for two decades and went through enormous trials were 'hastily produced' with 'corners cut'
- keneda7 5y ago
  Are you referring to the mRNA vaccine platform? Could you point me to the mRNA vaccine application that was approved before covid? When I looked into it all, of them had been denied until covid and I did not hear of any breakthrough in mRNA technology that suddenly fixed the issues the previous ones (I found 8) had been denied for.
  - jaywalk 5y ago
    It's just a coincidence that these companies that have been working for years on this stuff failed every single time in the past, but then within a few weeks in early 2020 they suddenly figured everything out.
    - ceejayoz 5y ago
      Not a coincidence, no. Just a very different cost/benefit analysis on "do all the steps we can in parallel to speed things up" during a pandemic.
      - jaywalk 5y ago
        If only Moderna had realized in that they could "do all the steps [they] can in parallel to speed things up" 8 years ago! They managed to accomplish what had eluded them for 8 years in a matter of weeks. Astounding stuff.
        ceejayoz 5y ago
        Again, it's a cost/benefit analysis. The benefit went up. The acceptable costs of parallelization similarly went up. (Some steps got easier, too, for the same "everyone really wants a solution yesterday" reasons, like recruiting trial volunteers. For example: https://www.sciencenews.org/article/covid-coronavirus-vaccine-development-speed https://www.sciencenews.org/article/covid-coronavirus-vaccin...) > For instance, it took just under 16 weeks to recruit and enroll more than 43,000 volunteers for the final phases of testing Pfizer’s vaccine. When volunteer recruitment began for clinical trials of the rabies mRNA vaccine in 2013, it took 813 days to get 101 participants enrolled. Based on this comparison, that’s roughly 730 days — nearly two years — saved in recruiting alone. The same article cites precisely one of those parallelization steps I'm talking about: > In a final jolt of speed, some pharmaceutical companies, bolstered by big vaccine contracts and research cash from the U.S. government’s Operation Warp Speed, were also churning out doses during clinical trials in the hopes that the vaccines would work. Once the companies had emergency use authorization in hand, they were ready to ship doses immediately.
avs733 5y ago
> So your for using power to totally destroy all the hard won battles for transparency, destroy trust in public institutions, and feed conspiracy theories? If the FDA screws up in their now legally compelled rush to produce these documents what happens? Pfizer could have their trade secret info leaked (like it or not that shouldn't happen) Participants in vaccine trials could have their private health information leaked (or have their identity stolen) The FDA is responsible and liable FOIA abuse is a thing, just like DMCA abuse is a thing. People abusing the FOIA process are the ones who are likely to lead to its power being destroyed, not the government here. It isn't suspicious...this group is intentionally misinterpreting things in bad faith under the guise of accountability. It's classic bad faith, and I'm deeply saddened at how easily this country falls for it.
daveevad 5y ago
I'd like to add that the situation is so severe we should prioritize a solution to COVID at the expense of individual privacy. This is the biggest problem we've ever needed to solve as a society. Release the documents and we'll find the bugs.

tut-le-tut 5y ago

"At that rate, the 10 employees would have to work non-stop 24 hours a day, seven days a week to produce the 55,000 pages a month (and would still fall a bit short)." So 50 people on a normal (40 hour work week) could do this in a month. The FDA has 18 000 employees. I think the answer is clear.

deleted 5y ago
[deleted]
lesuorac 5y ago
If they want their documents faster they should just pay for it. Requesting 300k+ pages is not a normal request, there is no way all of those pages will be of interest. Pay for it by paying a fee equal to the cost of hiring / training additional personal (https://www.foia.gov/faq.html https://www.foia.gov/faq.html).
- encryptluks2 5y ago
  So pay for transparency that is already expected? Should you have to pay to get your medical record?
  - mike00632 5y ago
    It's asinine to think you have a right to see every document the government has including PII and trade secrets, even worse to base an anti-vaxx effort on such ideas.
    - encryptluks2 5y ago
      It's crazy to me the amount of people that people would blindly trust the same government that did illegal experimentation in the past and gave unsuspecting populations syphilis. Or the same companies that paid billions for lying in the past.
- LegitShady 5y ago
  Only the rich should get FOIA?

gruez 5y ago

>I would be interested in seeing who this 'Public Health and Medical Professionals for Transparency' front group is. My guess is it's a group of charlatans looking to sell their own COVID cures similar to the doctor who produced the original study claiming vaccines cause autism (which was later retracted) see page 3, paragraph 11: https://www.courtlistener.com/docket/60390195/1/public-health-and-medical-professionals-for-transparency-v-food-and-drug/ https://www.courtlistener.com/docket/60390195/1/public-healt...

geofft 5y ago
Yup, looks like it: - Aaron Kheriarty is no longer associated with UC Irvine after refusing their vaccine mandate (this changed between the filing and now) and tweets links to The American Conservative. https://twitter.com/akheriaty https://twitter.com/akheriaty - Harvey Risch published an opinion piece in favor of hydroxycholoroquine in the American Journal of Epidemiology which attracted opposition from many other scientists as inappropriate/unscientific (not simply wrong yet within the bounds of good-faith scientific inquiry) and a response from that journal. https://academic.oup.com/aje/article/190/4/491/5898696 https://academic.oup.com/aje/article/190/4/491/5898696 - Peter McCullough appeared on an episode of Joe Rogan where even Joe Rogan correctly identified that his claims were implausible. https://news.ycombinator.com/item?id=29655002 https://news.ycombinator.com/item?id=29655002 I got bored after the first page, I can look further....
- colpabar 5y ago
  Well I for one am glad that FOIA requests don't depend on whether you like the people filing them. I find it absolutely ridiculous that asking for this data is seen as a bad thing. Why are pharmaceutical companies suddenly beyond questioning?
  - Robotbeat 5y ago
    - 5y ago

avs733 5y ago

If it's helpful, Alex Jones seems to love 'citing' (meaning lying about) the documents they have produced so far.

mansion7 5y ago
No. It is not helpful, in the slightest.

throw10920 5y ago

There's very little reason to believe that the reassignment will actually come from teams working on either of those two problems. This argument is a really long stretch - especially because there are other ways of meeting the deadline than reassignment to the FOIA office (hiring contractors, adding employees, using interns or HR folk) - picking out a highly specific and avoidable method of executing the FOIA to attack the idea of doing the FOIA at all is...questionable, to say the least. Moreover, as a citizen of the US that has paid for the R&D of those vaccines through my tax dollars, I have a right to see the results of that research. This shouldn't be a controversial opinion. (it certainly wasn't when the House passed the Freedom Of Information Act 306 to 0 in 1966)

kongolongo 5y ago
>Moreover, as a citizen of the US that has paid for the R&D of those vaccines through my tax dollars, I have a right to see the results of that research. This shouldn't be a controversial opinion. (it certainly wasn't when the House passed the Freedom Of Information Act 306 to 0 in 1966) there's hundreds if not thousands of top secret military r&d projects funded by tax money that will never see the light of day regardless of foia, this isn't particularly special and could very well include classified info that needs to flow down very long approval and bureaucratic processes. Hiring more people and then training them on that process would just lengthen the time needed to release the info
elliekelly 5y ago
> This argument is a really long stretch - especially because there are other ways of meeting the deadline than reassignment to the FOIA office (hiring contractors, adding employees, using interns or HR folk) Reading a document and making an assessment of to the disclosure obligations under FOIA isn’t something you can just pluck an intern to do and hand them the box of documents.
belltaco 5y ago
>Moreover, as a citizen of the US that has paid for the R&D of those vaccines through my tax dollars, I have a right to see the results of that research. This shouldn't be a controversial opinion. Pfizer didn't take any US govt money for the R&D of the vaccine.

tonfreed 5y ago

If you've ever dealt with public departments, you'd know that the vast majority of those they employ would be pencil pushers and meetware.

908B64B197 5y ago

> The reporter suggests the FDA reassign other people to process the FOIA requests but I would prefer those people continue working on important things like reviewing the safety and efficacy of medical devices[1] and reviewing the safety of food and infant formula [2] rather than spending their time processing paperwork I'm puzzled why they didn't make the document FOIA friendly in the first place. It was pretty obvious that it was going to be requested as it is of extreme public interest. I'm wondering if this "burden" wasn't intentionally planned. But there's no reason to do so: after all, the FDA should be working in the public's interests, and they have nothing to hide.

Jimmc414 5y ago

Do you think that argument could delay an IRS audit for 55 years?

tmaly 5y ago

How many people produce this many pages? It seems if they kept data like this in digital format with meta data, production could be much easier. I do similar work, but for non-gov. It is a challenge.

sixstringninja 5y ago

I’m ok with this. More transparency