9 ms·

FDA asks federal judge to wait until 2076 to fully release Covid vaccine data

79 points by emilfihlman 5y ago

imnotreallynew 5y ago
I’d recommend reading the original documents associated with the lawsuit (No. 4:21-cv-01058-P) instead of the article linked in this post. Some notable excerpts: > Plaintiff seeks the records submitted to the FDA by Pfizer to license its COVID-19 vaccine (the “FOIA request”) and requests an order requiring the FDA to produce all documents responsive to its FOIA request no later than March 3, 2022. This 108-day period is the same amount of time it took the FDA to review the responsive documents for the far more intricate task of licensing Pfizer’s Covid-19 vaccine. > Plaintiff is an organization comprised of over 30 accomplished academics, professors, and scientists from the medical schools and related departments of our most prestigious universities, including Yale, Harvard, UCLA, and Brown. > The ability of a majority of Americans to participate in civil society, and even exercise basic liberty rights, are now contingent on receiving this product. For example, the White House’s recent Covid-19 Action Plan and executive orders have made receipt of this product a condition of employment for more than 6 million federal workers and contractors, 22 million healthcare professionals, 84 million private sector employees, and the enlisted and reserve members of our armed forces. There are few whose livelihood, education, service, and participation in civil society are not contingent on a government requirement to receive this product. On this basis alone, basic liberty and government transparency demand that the documents and data submitted by Pfizer to license this product be made available to Plaintiff and the public forthwith, precisely as contemplated by federal regulations. > The acute need for transparency regarding this product is heightened by the fact that the secretary of Health and Human Services (“HHS”), the FDA’s parent department, has granted Pfizer complete immunity from financial liability for any injury caused by its product. > It took the FDA precisely 108 days from when Pfizer started producing the records for licensure on May 7, 2021,14 to when the product was licensed on August 23, 2021.15 We assume, as the FDA has stated, that it conducted an intense, robust, thorough and complete review and analysis of those documents in order to assure that the Pfizer vaccine was safe and effective for licensure. The FDA now has an equally important task of making those documents available to the Plaintiff in this case and the public at large in at least the same timeframe. The FDA’s own regulations envision and reflect upon the importance of making this information public as soon as a vaccine is licensed. Its regulations provide that it is to make “immediately available” all documents underlying licensure of a vaccine. 21 C.F.R. § 601.51(e). The FDA knew the intense public interest in that data and information. It should have been preparing to release it simultaneously with the licensure. Instead, it has done the opposite. Despite the passage of 84 days since licensure and 192 days since Pfizer started producing the records for licensure, the FDA has not released a single document submitted by Pfizer for the licensure of its Covid-19 vaccine. Not one page. I’m not a lawyer but the complaint seems perfectly reasonable.
- emilfihlman 5y ago
  Thank you for the summary! This submission was flagged once already but then cleared. The feedback was that linking to the actual document might in some instances be ok but then a good comment on why the document is interesting would be needed. I believe that with your comment linking to the actual document would be ok.
- TifMorgan 5y ago
  Pfizer will not release what is in the vaccines, according to scientist and CDC doctors, that exposed the vaccines, they are full of sh*t. Created in a bio lab in North Carolina, the date is 2012, the SARs virus was to the USA and messed with by a military complex as a bio Tec to stop Terrorist. A 3.7 trillion dollar grant by the US Government 2012 to Dr. Facui Three Stooges Act. The T-Cell of SARS Virus, after mutation is in the Vaccines. The T-Cell of HIV is found in the Vaccines. The T-Cells of aborted children is also found. Nano bots have been found in the Vaccines. I could give you a full list, most of the ingredient is used to bake a cake with...:) Oh yes, a undercover video, by a lady at a Health Care. Gov facility, she exposed Mercury is in the darn vaccines. LOL Tif
emilfihlman 5y ago
Due to title length limit I had to shorten the title a little, original at the moment of submission was: "FDA Asks Federal Judge to Grant it Until the Year 2076 to Fully Release Pfizer’s COVID-19 Vaccine Data"
smoldesu 5y ago
I'm not here to burst any bubbles, but scrolling through this guy's substack history it would appear he's got a little more than just a passing interest in the topic of vaccine legitimacy. Of course, it's nice seeing people talk about legal discrepancies in the US, but at this point it's more of an inevitability than a surprise. Once you factor in personal beliefs, it can be a little hard to differentiate between the wheat and the chaff.
- dolni 5y ago
  I don't really care what his interests are or if he is head of the National Antivaxxer Association. If what he is saying is true, it's a massive problem.
  - setpatchaddress 5y ago
    It's not true. The headline is clickbait. Read the legal filing. He's bitching about slow FOIA document production. Not sure whether that's a reasonable complaint here or not, but he's asking for a fuckload of documents.
    - LargoLasskhyfv 5y ago
      There is a fuckload of government. What's wrong with the expectation to serve a fuckload of people fucking fast, for the fuckload of money those people pay it in a fuckload of ways?
    - perryizgr8 5y ago
      Is it reasonable to take 50 years to release the documents he's asking for? He and other taxpayers paid for the studies, they deserve a look in a reasonable time frame, no matter his personal beliefs. Freedom of information needs to be modernized. Document creation should be in the open from the start. There shouldn't be a reason to "release" them later. At least for civilian stuff like vaccine studies.
      - dragonwriter 5y ago
sebow 5y ago
If the vaccines or restrictions were not mandatory in many places, they could hold that data for themselves for 100 years for all I care.However that's obviously not the case, so unless this is a "typo" this is very worrisome.
skunkworker 5y ago
If I read the linked PDF correctly (https://www.sirillp.com/wp-content/uploads/2021/11/020-Second-Joint-Status-Report-8989f1fed17e2d919391d8df1978006e.pdf https://www.sirillp.com/wp-content/uploads/2021/11/020-Secon... PDF WARNING) The issue stems from the number of total pages (329,000) and the proposed record release schedule of 500 pages per month "FDA proposes to process and produce the non-exempt portions of responsive records at a rate of 500 pages per month. This rate is consistent with processing schedules entered by courts across the country in FOIA cases" "FDA’s proposed schedule of 500 pages per month is consistent with schedules set by courts across the country, including in cases where the underlying records were of national significance" "The FDA has proposed to produce 500 pages per month which, based on its calculated number of pages, would mean it would complete its production in nearly 55 years – the year 2076. " To me this seems like it is more about bureaucracy rather than maliciousness. And in my view a fair criticism of the slow pace that FOIA documents are released.
- emilfihlman 5y ago
  Imho the relevant thing here is that if this is allowed to stand, by inflating the size of data the goverment can effectively hide any data it wants and block the public from accessing it while retaining a veil of "nothing wrong done here". Additionally I would say that foi requests are generally fulfilled more by document categorisation than by page, especially if the case is not about military secrets where much more careful screening might be required.
- lborsato 5y ago
  My first thought is that there are 329,000 pages of data related to the Pfizer vaccine alone and we are supposed to believe that the FDA read and evaluated them before granting authorization.
  - naikrovek 5y ago
    it's not ALL first-order data, man. have you ever seen an official document of any size? 99% of it is description of the 0.25% which actually matters, and the remaining 0.75% (AT LEAST) is whitespace. That 0.25% is mostly known to subject matter experts. The rest is there to meet documentation requirements. it is definitely NOT 329k pages of absolutely vital facts that can't be skipped. besides, it can be split up among many people over the course of time. experts know how to do this stuff.
deleted 5y ago
[deleted]
rektide 5y ago
Out of curiosity, do we think there is there anything another branch of the government could do to alter such a decision, if made, & if higher courts don't take this up?
- landemva 5y ago
  Legislature could modify vaccine liability law to specifically require fast data release upon vaccine approval.
  - daddylongstroke 5y ago
    Apparently, the FDA itself already mandates this: FDA’s own regulations stipulates that the agency “is to make ‘immediately available’ all documents underlying licensure of a vaccine." But why would they want to (seemingly) hide something in this case, where they usually would publish to the public 'immediately'?
dklsf 5y ago
The issue is that the requester is asking for 329000 pages, and courts apparently previously ruled that a rate of 500 pages/month is reasonable for freedom of information requests. And looks like more narrow requests for documents would be completed faster: "If Plaintiff decides to request fewer records, then FDA will be able to complete its processing at an earlier date."
- emilfihlman 5y ago
  But shouldn't requests like this complete still in a timely matter? If the government uses data that is under freedom of information but effectively doesn't allow people to go over the data, isn't that perversion of the idea of freedom of information? An alternative is of course that we would treat requests by multiple people as more important, for example, if we assume that 1000 people requested these documents it would only take less than a month, but imho that's a huge slippery slope where information can effectively be hidden by inflating the size of it.
  - tssva 5y ago
    The issue is that not all of the data is subject to a freedom of information request because it may contain PII, trade secrets, etc. Therefore the data must be review to remove that information not releasable through a FOIA request.
    - vimax 5y ago
      If the government can't distinguish between sensitive and nonsensitive data then that sounds like something that should be fixed instead of being used as an excuse.
      - missblit 5y ago
        They can distinguish it... at a rate of around 500 pages per month.
    - native_samples 5y ago
josephcsible 5y ago
The 500 pages per month rule may have made sense back when everything was actually on paper. But these days, just one DVD or flash drive could hold all 329,000 pages. I'm guessing that it's actually more work for them to split the release into 500-page segments than it would be to release them all at once, so I'm inclined to assume they're intentionally going at the slowest allowed rate because there's information in there that they'd rather keep to themselves forever.
- tablespoon 5y ago
  > The 500 pages per month rule may have made sense back when everything was actually on paper. But these days, just one DVD or flash drive could hold all 329,000 pages. I doubt "copying" is the actual bottleneck. It's totally doable to photocopy 500 pages in an hour (if you have a document feeder). What they're talking about is probably more the manual work to search, evaluate material for appropriateness to release, etc.
  - pariahHN 5y ago
    If it's one person spending 4 hours a day, 500 pages/month is about 16 a day including weekends, 4 pages per hour, so 15 minutes to review each page for redactions. 500/month seems pretty fast given that there's probably only a few people that have had this dumped on their plate in addition to everything else they have to do.
- dragonwriter 5y ago
  > The 500 pages per month rule may have made sense back when everything was actually on paper It has nothing to do with medium, it has to do with review of mixed material for information that is not subject to FOIA (personal privacy, trade secret, confidential commercial data, and other legally protected information) and avoiding the requirement for that review being a mechanism for using FOIA as a denial-of-service attack on federal agencies. > But these days, just one DVD or flash drive could hold all 329,000 pages. Which doesn't materially impact the workload of reviewing it prior to release.
gallego2007 5y ago
Would love to see the US Digital Service step in to get this data released faster than 500 pages per month. Sheesh.
Fezzik 5y ago
This is exactly the type of behavior that gives people legitimate, reasonable arguments for not trusting the government. I’m pro-vaccine and I’m super-rankled by this nonsense. Also, I regularly review 500+ pages of discovery for redaction and disclosure, alone, over 3-4 days, while still working full-time… I’m pretty sure the federal government could figure out how to work a skosh faster.
- smaudet 5y ago
  This is a good data point, and it does point to wanting to limit liability, at your rate you could process 5000 pages a month, bringing the time down to 7 years instead of 72... Throw 6 people at it, throw in review processes, maybe you could get it done in a couple years. Say 5 to hedge.
  - Brian_K_White 5y ago
    The same data was delivered from Phizer to the FDA, and then supposedly analyzed by the FDA in only 108 days. That discrepency needs explaining, and the bar for acceptable excuses is high, and not met.
    - mjevans 5y ago
      As others have mentioned, it isn't a discrepancy. The FDA evaluated (very strongly) for a Very Specific criteria. Efficacy of the vaccine against a disease, versus possible complications. It is FREQUENT that medical trials collect enough personal information to ruin the lives of those involved, so that any commonalities or patterns of negative incidents among them can be connected to ancillary risks. To release documents and make them public record should probably take a completely different process than traditional discovery. In that the relevant evidence should be extracted, and as much PII as possible removed entirely, and redacted on the pages that are released. It might be more appropriate to disclose the equivalent of table headers and an evaluation of if data was missing, relevant but within tolerances or above/beneath typical measure. Just like with image censorship true redaction must destroy the accuracy of underlying data for security.
gumby 5y ago
Having done an FDA submission myself I am actually amazed at how short this time period would be. In the Old Days, to file an NDA required special arrangements with printing companies who could handle such a job and a team who arranged for the fleet of trucks required to deliver the submissions. Edit: NDA = New Drug Application which includes, among other things, basically all your raw data which includes hordes of PII. TBF it also includes a lot of boring in vitro data and analysis, preclinical (animal and in vitro) data etc which will have minimal to no PII.
- l8rpeace 5y ago
  Right but now those submissions are (mostly) electronic since the advent of eCTD (which has been in the works since 2002): https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/electronic-common-technical-document-ectd https://www.fda.gov/drugs/electronic-regulatory-submission-a...
  - gumby 5y ago
    My point was merely to give an idea of the sheer size of an application in a way that TB would not. Every FOIA request is screened by humans, which can result in false positives and negatives. So could a machine-screened result. Would people be comfortable with an automated screener, which, while hard to do with classified info, would conceptually be possible with FDA records (from either food or drug side). The records are quite free form. I’m in favor of these records being public except perhaps some proprietary process data. Of course it will be used by people who don’t understand it for wild attacks.
qwertyuiop_ 5y ago
Most adults who received the shot including the ones interested in the data would be dead by 2076.
brjsuitor 5y ago
https://www.ncbi.nlm.nih.gov/labs/pmc/articles/PMC7392193/bin/mmc2.pdf https://www.ncbi.nlm.nih.gov/labs/pmc/articles/PMC7392193/bi... No need. It’s all right here. Google everything so far simian virus mouse sarcoma mouse hepatitis cytomegalovirus retrovirus
- brjsuitor 5y ago
  @ofcomforts on Twitter
azsrz 5y ago
According to this guardian report aaron siri is connected to a the Texas anti-vaxxer group Ican (Informed Consent Action Network). They probably understands this is what they get from a government agency like FDA when asking for the data and it gives them ammunition. https://www.theguardian.com/us-news/2021/jun/22/anti-vax-group-legal-blitz-deter-vaccinations https://www.theguardian.com/us-news/2021/jun/22/anti-vax-gro...
- yehosef 5y ago
  Government agencies are allowed to prioritize FOIA requests based on if they agree with the motives of the applicant?
  - azsrz 5y ago
    What I wanted to say is of course the government is not expected to be a model of information sharing, especially when there are 300k pages. Anti-vaccine campaign knows this and takes advantage. They say anything about this anyway. They say 2076 when FDA gives them 500 pages per month. That’s a free win as they don’t even need to read the data. Give more they just read the data with bias and there are going to be more stories. You can not change people’s mind when they come with an agenda.
    - airmailspecial 5y ago
      >What I wanted to say is of course the government is not expected to be a model of information sharing The FDA has made a public commitment to transparency regarding Covid-19 vaccines.[1] Given that, I would absolutely expect them to be a model of information sharing. [1]https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-announces-advisory-committee-meeting-discuss-second-covid-19-vaccine https://www.fda.gov/news-events/press-announcements/coronavi...
neildavid 5y ago
The JFK FILES SPRINGS TO MIND.

79 points by emilfihlman 5y ago

I’d recommend reading the original documents associated with the lawsuit (No. 4:21-cv-01058-P) instead of the article linked in this post. Some notable excerpts: > Plaintiff seeks the records submitted to the FDA by Pfizer to license its COVID-19 vaccine (the “FOIA request”) and requests an order requiring the FDA to produce all documents responsive to its FOIA request no later than March 3, 2022. This 108-day period is the same amount of time it took the FDA to review the responsive documents for the far more intricate task of licensing Pfizer’s Covid-19 vaccine. > Plaintiff is an organization comprised of over 30 accomplished academics, professors, and scientists from the medical schools and related departments of our most prestigious universities, including Yale, Harvard, UCLA, and Brown. > The ability of a majority of Americans to participate in civil society, and even exercise basic liberty rights, are now contingent on receiving this product. For example, the White House’s recent Covid-19 Action Plan and executive orders have made receipt of this product a condition of employment for more than 6 million federal workers and contractors, 22 million healthcare professionals, 84 million private sector employees, and the enlisted and reserve members of our armed forces. There are few whose livelihood, education, service, and participation in civil society are not contingent on a government requirement to receive this product. On this basis alone, basic liberty and government transparency demand that the documents and data submitted by Pfizer to license this product be made available to Plaintiff and the public forthwith, precisely as contemplated by federal regulations. > The acute need for transparency regarding this product is heightened by the fact that the secretary of Health and Human Services (“HHS”), the FDA’s parent department, has granted Pfizer complete immunity from financial liability for any injury caused by its product. > It took the FDA precisely 108 days from when Pfizer started producing the records for licensure on May 7, 2021,14 to when the product was licensed on August 23, 2021.15 We assume, as the FDA has stated, that it conducted an intense, robust, thorough and complete review and analysis of those documents in order to assure that the Pfizer vaccine was safe and effective for licensure. The FDA now has an equally important task of making those documents available to the Plaintiff in this case and the public at large in at least the same timeframe. The FDA’s own regulations envision and reflect upon the importance of making this information public as soon as a vaccine is licensed. Its regulations provide that it is to make “immediately available” all documents underlying licensure of a vaccine. 21 C.F.R. § 601.51(e). The FDA knew the intense public interest in that data and information. It should have been preparing to release it simultaneously with the licensure. Instead, it has done the opposite. Despite the passage of 84 days since licensure and 192 days since Pfizer started producing the records for licensure, the FDA has not released a single document submitted by Pfizer for the licensure of its Covid-19 vaccine. Not one page. I’m not a lawyer but the complaint seems perfectly reasonable.

emilfihlman 5y ago
Thank you for the summary! This submission was flagged once already but then cleared. The feedback was that linking to the actual document might in some instances be ok but then a good comment on why the document is interesting would be needed. I believe that with your comment linking to the actual document would be ok.
TifMorgan 5y ago
Pfizer will not release what is in the vaccines, according to scientist and CDC doctors, that exposed the vaccines, they are full of sh*t. Created in a bio lab in North Carolina, the date is 2012, the SARs virus was to the USA and messed with by a military complex as a bio Tec to stop Terrorist. A 3.7 trillion dollar grant by the US Government 2012 to Dr. Facui Three Stooges Act. The T-Cell of SARS Virus, after mutation is in the Vaccines. The T-Cell of HIV is found in the Vaccines. The T-Cells of aborted children is also found. Nano bots have been found in the Vaccines. I could give you a full list, most of the ingredient is used to bake a cake with...:) Oh yes, a undercover video, by a lady at a Health Care. Gov facility, she exposed Mercury is in the darn vaccines. LOL Tif

emilfihlman 5y ago

Due to title length limit I had to shorten the title a little, original at the moment of submission was: "FDA Asks Federal Judge to Grant it Until the Year 2076 to Fully Release Pfizer’s COVID-19 Vaccine Data"

smoldesu 5y ago

I'm not here to burst any bubbles, but scrolling through this guy's substack history it would appear he's got a little more than just a passing interest in the topic of vaccine legitimacy. Of course, it's nice seeing people talk about legal discrepancies in the US, but at this point it's more of an inevitability than a surprise. Once you factor in personal beliefs, it can be a little hard to differentiate between the wheat and the chaff.

dolni 5y ago
I don't really care what his interests are or if he is head of the National Antivaxxer Association. If what he is saying is true, it's a massive problem.
- setpatchaddress 5y ago
  It's not true. The headline is clickbait. Read the legal filing. He's bitching about slow FOIA document production. Not sure whether that's a reasonable complaint here or not, but he's asking for a fuckload of documents.
  - LargoLasskhyfv 5y ago
    There is a fuckload of government. What's wrong with the expectation to serve a fuckload of people fucking fast, for the fuckload of money those people pay it in a fuckload of ways?
  - perryizgr8 5y ago
    Is it reasonable to take 50 years to release the documents he's asking for? He and other taxpayers paid for the studies, they deserve a look in a reasonable time frame, no matter his personal beliefs. Freedom of information needs to be modernized. Document creation should be in the open from the start. There shouldn't be a reason to "release" them later. At least for civilian stuff like vaccine studies.
    - dragonwriter 5y ago

sebow 5y ago

If the vaccines or restrictions were not mandatory in many places, they could hold that data for themselves for 100 years for all I care.However that's obviously not the case, so unless this is a "typo" this is very worrisome.

skunkworker 5y ago

If I read the linked PDF correctly (https://www.sirillp.com/wp-content/uploads/2021/11/020-Second-Joint-Status-Report-8989f1fed17e2d919391d8df1978006e.pdf https://www.sirillp.com/wp-content/uploads/2021/11/020-Secon... PDF WARNING) The issue stems from the number of total pages (329,000) and the proposed record release schedule of 500 pages per month "FDA proposes to process and produce the non-exempt portions of responsive records at a rate of 500 pages per month. This rate is consistent with processing schedules entered by courts across the country in FOIA cases" "FDA’s proposed schedule of 500 pages per month is consistent with schedules set by courts across the country, including in cases where the underlying records were of national significance" "The FDA has proposed to produce 500 pages per month which, based on its calculated number of pages, would mean it would complete its production in nearly 55 years – the year 2076. " To me this seems like it is more about bureaucracy rather than maliciousness. And in my view a fair criticism of the slow pace that FOIA documents are released.

emilfihlman 5y ago
Imho the relevant thing here is that if this is allowed to stand, by inflating the size of data the goverment can effectively hide any data it wants and block the public from accessing it while retaining a veil of "nothing wrong done here". Additionally I would say that foi requests are generally fulfilled more by document categorisation than by page, especially if the case is not about military secrets where much more careful screening might be required.
lborsato 5y ago
My first thought is that there are 329,000 pages of data related to the Pfizer vaccine alone and we are supposed to believe that the FDA read and evaluated them before granting authorization.
- naikrovek 5y ago
  it's not ALL first-order data, man. have you ever seen an official document of any size? 99% of it is description of the 0.25% which actually matters, and the remaining 0.75% (AT LEAST) is whitespace. That 0.25% is mostly known to subject matter experts. The rest is there to meet documentation requirements. it is definitely NOT 329k pages of absolutely vital facts that can't be skipped. besides, it can be split up among many people over the course of time. experts know how to do this stuff.

deleted 5y ago

[deleted]

rektide 5y ago

Out of curiosity, do we think there is there anything another branch of the government could do to alter such a decision, if made, & if higher courts don't take this up?

landemva 5y ago
Legislature could modify vaccine liability law to specifically require fast data release upon vaccine approval.
- daddylongstroke 5y ago
  Apparently, the FDA itself already mandates this: FDA’s own regulations stipulates that the agency “is to make ‘immediately available’ all documents underlying licensure of a vaccine." But why would they want to (seemingly) hide something in this case, where they usually would publish to the public 'immediately'?

dklsf 5y ago

The issue is that the requester is asking for 329000 pages, and courts apparently previously ruled that a rate of 500 pages/month is reasonable for freedom of information requests. And looks like more narrow requests for documents would be completed faster: "If Plaintiff decides to request fewer records, then FDA will be able to complete its processing at an earlier date."

emilfihlman 5y ago
But shouldn't requests like this complete still in a timely matter? If the government uses data that is under freedom of information but effectively doesn't allow people to go over the data, isn't that perversion of the idea of freedom of information? An alternative is of course that we would treat requests by multiple people as more important, for example, if we assume that 1000 people requested these documents it would only take less than a month, but imho that's a huge slippery slope where information can effectively be hidden by inflating the size of it.
- tssva 5y ago
  The issue is that not all of the data is subject to a freedom of information request because it may contain PII, trade secrets, etc. Therefore the data must be review to remove that information not releasable through a FOIA request.
  - vimax 5y ago
    If the government can't distinguish between sensitive and nonsensitive data then that sounds like something that should be fixed instead of being used as an excuse.
    - missblit 5y ago
      They can distinguish it... at a rate of around 500 pages per month.
  - native_samples 5y ago

josephcsible 5y ago

The 500 pages per month rule may have made sense back when everything was actually on paper. But these days, just one DVD or flash drive could hold all 329,000 pages. I'm guessing that it's actually more work for them to split the release into 500-page segments than it would be to release them all at once, so I'm inclined to assume they're intentionally going at the slowest allowed rate because there's information in there that they'd rather keep to themselves forever.

tablespoon 5y ago
> The 500 pages per month rule may have made sense back when everything was actually on paper. But these days, just one DVD or flash drive could hold all 329,000 pages. I doubt "copying" is the actual bottleneck. It's totally doable to photocopy 500 pages in an hour (if you have a document feeder). What they're talking about is probably more the manual work to search, evaluate material for appropriateness to release, etc.
- pariahHN 5y ago
  If it's one person spending 4 hours a day, 500 pages/month is about 16 a day including weekends, 4 pages per hour, so 15 minutes to review each page for redactions. 500/month seems pretty fast given that there's probably only a few people that have had this dumped on their plate in addition to everything else they have to do.
dragonwriter 5y ago
> The 500 pages per month rule may have made sense back when everything was actually on paper It has nothing to do with medium, it has to do with review of mixed material for information that is not subject to FOIA (personal privacy, trade secret, confidential commercial data, and other legally protected information) and avoiding the requirement for that review being a mechanism for using FOIA as a denial-of-service attack on federal agencies. > But these days, just one DVD or flash drive could hold all 329,000 pages. Which doesn't materially impact the workload of reviewing it prior to release.

gallego2007 5y ago

Would love to see the US Digital Service step in to get this data released faster than 500 pages per month. Sheesh.

Fezzik 5y ago

This is exactly the type of behavior that gives people legitimate, reasonable arguments for not trusting the government. I’m pro-vaccine and I’m super-rankled by this nonsense. Also, I regularly review 500+ pages of discovery for redaction and disclosure, alone, over 3-4 days, while still working full-time… I’m pretty sure the federal government could figure out how to work a skosh faster.

smaudet 5y ago
This is a good data point, and it does point to wanting to limit liability, at your rate you could process 5000 pages a month, bringing the time down to 7 years instead of 72... Throw 6 people at it, throw in review processes, maybe you could get it done in a couple years. Say 5 to hedge.
- Brian_K_White 5y ago
  The same data was delivered from Phizer to the FDA, and then supposedly analyzed by the FDA in only 108 days. That discrepency needs explaining, and the bar for acceptable excuses is high, and not met.
  - mjevans 5y ago
    As others have mentioned, it isn't a discrepancy. The FDA evaluated (very strongly) for a Very Specific criteria. Efficacy of the vaccine against a disease, versus possible complications. It is FREQUENT that medical trials collect enough personal information to ruin the lives of those involved, so that any commonalities or patterns of negative incidents among them can be connected to ancillary risks. To release documents and make them public record should probably take a completely different process than traditional discovery. In that the relevant evidence should be extracted, and as much PII as possible removed entirely, and redacted on the pages that are released. It might be more appropriate to disclose the equivalent of table headers and an evaluation of if data was missing, relevant but within tolerances or above/beneath typical measure. Just like with image censorship true redaction must destroy the accuracy of underlying data for security.

gumby 5y ago

Having done an FDA submission myself I am actually amazed at how short this time period would be. In the Old Days, to file an NDA required special arrangements with printing companies who could handle such a job and a team who arranged for the fleet of trucks required to deliver the submissions. Edit: NDA = New Drug Application which includes, among other things, basically all your raw data which includes hordes of PII. TBF it also includes a lot of boring in vitro data and analysis, preclinical (animal and in vitro) data etc which will have minimal to no PII.

l8rpeace 5y ago
Right but now those submissions are (mostly) electronic since the advent of eCTD (which has been in the works since 2002): https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/electronic-common-technical-document-ectd https://www.fda.gov/drugs/electronic-regulatory-submission-a...
- gumby 5y ago
  My point was merely to give an idea of the sheer size of an application in a way that TB would not. Every FOIA request is screened by humans, which can result in false positives and negatives. So could a machine-screened result. Would people be comfortable with an automated screener, which, while hard to do with classified info, would conceptually be possible with FDA records (from either food or drug side). The records are quite free form. I’m in favor of these records being public except perhaps some proprietary process data. Of course it will be used by people who don’t understand it for wild attacks.

qwertyuiop_ 5y ago

Most adults who received the shot including the ones interested in the data would be dead by 2076.

brjsuitor 5y ago

https://www.ncbi.nlm.nih.gov/labs/pmc/articles/PMC7392193/bin/mmc2.pdf https://www.ncbi.nlm.nih.gov/labs/pmc/articles/PMC7392193/bi... No need. It’s all right here. Google everything so far simian virus mouse sarcoma mouse hepatitis cytomegalovirus retrovirus

brjsuitor 5y ago
@ofcomforts on Twitter

azsrz 5y ago

According to this guardian report aaron siri is connected to a the Texas anti-vaxxer group Ican (Informed Consent Action Network). They probably understands this is what they get from a government agency like FDA when asking for the data and it gives them ammunition. https://www.theguardian.com/us-news/2021/jun/22/anti-vax-group-legal-blitz-deter-vaccinations https://www.theguardian.com/us-news/2021/jun/22/anti-vax-gro...

yehosef 5y ago
Government agencies are allowed to prioritize FOIA requests based on if they agree with the motives of the applicant?
- azsrz 5y ago
  What I wanted to say is of course the government is not expected to be a model of information sharing, especially when there are 300k pages. Anti-vaccine campaign knows this and takes advantage. They say anything about this anyway. They say 2076 when FDA gives them 500 pages per month. That’s a free win as they don’t even need to read the data. Give more they just read the data with bias and there are going to be more stories. You can not change people’s mind when they come with an agenda.
  - airmailspecial 5y ago
    >What I wanted to say is of course the government is not expected to be a model of information sharing The FDA has made a public commitment to transparency regarding Covid-19 vaccines.[1] Given that, I would absolutely expect them to be a model of information sharing. [1]https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-announces-advisory-committee-meeting-discuss-second-covid-19-vaccine https://www.fda.gov/news-events/press-announcements/coronavi...

neildavid 5y ago

The JFK FILES SPRINGS TO MIND.