FDA Asks the Court to Delay First 55,000 Page Production Until May (1 Viewer)

[IvanKaramazov]

you realize this isn't Pfizer at all, right?  The FDA is being asked to produce, and is producing, 450,000 documents on an expedited basis.

this is one FOIA request out of 400 pending requests.

there is no story here.

My awareness of the details of this story is nearly zero.  I was mainly just responding to some of the folks up top in the thread who were dismissive of the idea that the public should have access to this stuff.  That's a no-brainer IMO.

 

[LawFitz]

But you believe and spread conspiracy theories without question.  

Nope. I question all of it. All the time. Feel free to believe otherwise. I absolutely zero ####s about what you, in particular, think.

 

[dawgtrails]

Nope. I question all of it. All the time. Feel free to believe otherwise. I absolutely zero ####s about what you, in particular, think.

Dude. This is a forum for discussing things. If you don't want to discuss, then why post?

 

[-fish-]

Dude. This is a forum for discussing things. If you don't want to discuss, then why post?

Because his purpose is to spread vaccine conspiracies.   

 

[LawFitz]

Dude. This is a forum for discussing things. If you don't want to discuss, then why post?

I'm all for discussion. That guy was leveling a personal attack against me, which is his SOP. I don't see how my response to his attack warrants your comment above. At all. Did he make any mention of the ridiculous and alarming FDA refusal to release the Pfizer data in a reasonably timely manner? 

 

[LawFitz]

Because his purpose is to spread vaccine conspiracies.   

Case in point.

 

[-fish-]

I'm all for discussion. That guy was leveling a personal attack against me, which is his SOP. I don't see how my response to his attack warrants your comment above. At all. Did he make any mention of the ridiculous and alarming FDA refusal to release the Pfizer data in a reasonably timely manner? 

FDA has not refused anything.   You don't understand FOIA requests or document review.   There is no conspiracy, as much as you want to continue to spread your fake vaccine garbage.   And every new thread you post spreading a false vaccine conspiracy I will point out the falsehood and your disingenuous goal.

 

[-fish-]

Case in point.

This is what, the fifth thread you've started pushing a vaccine conspiracy?   You should at least own it.   It's your thing.   Denying it seems pretty silly.

 

[LawFitz]

FDA has not refused anything.   You don't understand FOIA requests or document review.   There is no conspiracy, as much as you want to continue to spread your fake vaccine garbage.   And every new thread you post spreading a false vaccine conspiracy I will point out the falsehood and your disingenuous goal.

Read the OP. Or don't and just keep making foolish and/or trollish comments. Who am I kidding... Just keep making your foolish trollish comments. They're par at this point.

 

[LawFitz]

This is what, the fifth thread you've started pushing a vaccine conspiracy?   You should at least own it.   It's your thing.   Denying it seems pretty silly.

This is what the fiftieth time you've been a complete #####. You should at least own it. It's your thing.

 

[-fish-]

Sorry I spoiled your fishing expedition again. 

Actually, I'm not.  

Maybe you should learn that nobody is buying what you're selling.   

 

[LawFitz]

Sorry I spoiled your fishing expedition again. 

Actually, I'm not.  

Maybe you should learn that nobody is buying what you're selling.   

Haha, you've spoiled nothing but your own reputation and karma. Repeatedly.

 

[-fish-]

Haha, you've spoiled nothing but your own reputation and karma. Repeatedly.

If you're going to stick to trolling on vaccine conspiracies, at least be entertaining.   Your threads are as low effort as they are low value.   

 

[LawFitz]

Your threads are as low effort as they are low value.   

LOL. You might be the most low effort and low value poster on this board. You're clearly self-projecting. All good, man. Feel better. 

 

[LawFitz]

LOL. You might be the most low effort and low value poster on this board. You're clearly self-projecting. All good, man. Feel better. 

@-fish- Yo, dude. It's super lame that we are treating each other this way, and that is at least equally my bad. I apologize to you for my part in that dynamic. You do what you feel is right in terms of all of this toward me on these boards and I will try to be better toward you. I apologize for the post above. You are not a low value poster or person. It was not okay for me to say that and I regret it.

 

[Snotbubbles]

In our firm, the average reviewer can get through 200 documents a day.  That's documents, not pages.  FDA documents are large and technical, but there is no reason that a reviewer working 7.5 hours a day can only get through 50 pages.  If they took 5 minutes to read each page they could get through 90 pages in a 7.5 hour day.  With 28 reviewers that 50,000+ a month. 

Once you've read a few clinical study reports and some of the FDA submission docs, the formats of these docs are fairly similar in structure from study to study, submission to submission, so you can breeze through some sections that you know aren't confidential or privileged.  For example, in study reports and FDA submissions there will always be a section in reports for SAEs (serious adverse events), these are neither confidential or privileged and can be multiple pages long so you can just flip through these pages because they are usually in chart form and the information contained in the charts isn't something that you would need to flag for further review.    

 

[dawgtrails]

Just want to say that being a document reviewer sounds like an absolutely terrible job

 

[Snotbubbles]

I read it.  It's dumb.  Even with repetitive documents, an average person just can't do 7.5 hours (even if that was legal, which it's not) of review per day, every day.

Are the documents electronic?  Paper?  How are they organized?   Do you understand that when a document is redacted you need to separately log it, which also takes time?

The court was originally asking them to review 80,000 pages a month.   Now it's 55,000.   The request is for 450,000 pages of documents.  If I made a request like that, I'd expect the government to request a couple of years to respond.   They have 400 other requests that are also pending.

This is more of a non-story than the rest of your non-stories.

Swing and a miss again.

I worked on a couple drug cases for GSK.  Our reviewers worked 50 hours a week of straight document review for around 10 years (multiple different drugs).  Our first level reviewers had a 700 docs a week quota (we probably had around 50 reviewers).  Second level didn't have quotas, but they could get through more documents because it was easier because of notes from the first level reviewers.  The priv/redactions logs aren't really much extra work, first level flags a document as priv/redact, second level confirms redactions and a reviewer specifically doing privilege will confirm the priv call and write the log.  The priv logs can be produced at a later date and don't need to be sent with the original productions anyway.  

EDIT:  I'm working on a case now where we negotiated search terms with Defendants in October and November that resulted in over 1.5M documents to be produced by Defendants.  The Defendants started rolling productions in December.  They don't have years to make productions.  They have until June for the substantial completion of the productions.   In 6 weeks they've already produced over 5,000 documents totaling 80,000+ pages.  I really don't see this request as burdensome for the FDA to produce 55,000 pages a month.  I could get 10 people I know with experience doing this work and they could finish looking at the entire world of relevant documents in 12 weeks.  If there was time and a half overtime you could get it done in 10 weeks.     

 

[Witz]

My awareness of the details of this story is nearly zero.  I was mainly just responding to some of the folks up top in the thread who were dismissive of the idea that the public should have access to this stuff.  That's a no-brainer IMO.

sorry - who in this thread or anywhere else on this forum we’re dismissive or said they shouldn’t release or provide access to this stuff?

 

[rockaction]

I do. Just not all the time. And never without question.

It's so odd because I see you in the Shark Pool and you're one of the most thoughtful, well-articulated posters there. And I happen to think you're right about ~90% of the time, so maybe that's me. Like Aaron Donald and Henry Ruggs. I think you nailed both guys and your methodology, reasoning, and prescience was top-notch.

I'm just confused where this sort of questioning comes in when you can so obviously practice Occam's razor on a daily basis. I mean, what is throwing your personal calibration off with vaccines and their efficacy? It seems to me nearly every reputable study finds that they are preventing tons of deaths in people. All I'm seeing is that unvaccinated people are suffering deaths at such a high rate compared to vaccinated people that everyone who wants to get to the bottom of this issue can if they just follow the studies of vaccine efficacy. Forget what bold claims were made about them by Fauci or Biden or the FDA or CDC. Those are all politicians or political organs of the executive branch. Tread lightly. Read dispassionate studies and you'll find the efficacy there. 

But you're choosing isolated doctors and latching on to gotcha stories that don't seem to bear much fruit or have much evidence that doesn't cause one to outside of Occam in order to draw the conclusions you are drawing. I'm confused by your stance. But, more than that, I'm concerned with a lack of faith by a lot of people -- not just you -- in our institutions and methods and procedures. To have lost faith in certain practices is a troubling thought for democracy and information. I don't think those institutions or those people (outside of politics) warrant our distrust at this point yet. 

 

[dkp993]

It's so odd because I see you in the Shark Pool and you're one of the most thoughtful, well-articulated posters there. And I happen to think you're right about ~90% of the time, so maybe that's me. Like Aaron Donald and Henry Ruggs. I think you nailed both guys and your methodology, reasoning, and prescience was top-notch.

I'm just confused where this sort of questioning comes in when you can so obviously practice Occam's razor on a daily basis. I mean, what is throwing your personal calibration off with vaccines and their efficacy? It seems to me nearly every reputable study finds that they are preventing tons of deaths in people. All I'm seeing is that unvaccinated people are suffering deaths at such a high rate compared to vaccinated people that everyone who wants to get to the bottom of this issue can if they just follow the studies of vaccine efficacy. Forget what bold claims were made about them by Fauci or Biden or the FDA or CDC. Those are all politicians or political organs of the executive branch. Tread lightly. Read dispassionate studies and you'll find the efficacy there. 

But you're choosing isolated doctors and latching on to gotcha stories that don't seem to bear much fruit or have much evidence that doesn't cause one to outside of Occam in order to draw the conclusions you are drawing. I'm confused by your stance. But, more than that, I'm concerned with a lack of faith by a lot of people -- not just you -- in our institutions and methods and procedures. To have lost faith in certain practices is a troubling thought for democracy and information. I don't think those institutions or those people (outside of politics) warrant our distrust at this point yet. 

Confirmation bias is a powerful drug man.  We are all comforted by our feeling being confirmed by others.   It’s also more powerful, imo, when one’s feelings go against the standard narrative.  

 

[pinkham13]

I worked on a couple drug cases for GSK.  Our reviewers worked 50 hours a week of straight document review for around 10 years (multiple different drugs).  Our first level reviewers had a 700 docs a week quota (we probably had around 50 reviewers).  Second level didn't have quotas, but they could get through more documents because it was easier because of notes from the first level reviewers.  The priv/redactions logs aren't really much extra work, first level flags a document as priv/redact, second level confirms redactions and a reviewer specifically doing privilege will confirm the priv call and write the log.  The priv logs can be produced at a later date and don't need to be sent with the original productions anyway.  

EDIT:  I'm working on a case now where we negotiated search terms with Defendants in October and November that resulted in over 1.5M documents to be produced by Defendants.  The Defendants started rolling productions in December.  They don't have years to make productions.  They have until June for the substantial completion of the productions.   In 6 weeks they've already produced over 5,000 documents totaling 80,000+ pages.  I really don't see this request as burdensome for the FDA to produce 55,000 pages a month.  I could get 10 people I know with experience doing this work and they could finish looking at the entire world of relevant documents in 12 weeks.  If there was time and a half overtime you could get it done in 10 weeks.     

It took what eight months since the pandemic fear porn started in March 2020 to making a vaccine miracle drug in November? If you can approve a mandatory injection in just eight months surely you can report the data used to make that safe and effective false advertising to the public in 8 months….. right? It’s been a couple of years now. Why the hold up?

 

[the rover]

still not seeing the conspiracy here, although the FOIA does seek information reported through VAERS, so I can guess what the endgame is