Release the data

[Rigid1]

Just now, akvanden said:

We're not talking about the manufacturers. 

Oh sorry man, I thought this was about phizers release of data......,...

[Rigid1]

Just now, akvanden said:

We're talking about the clinical trials here.

Who did the clinical trials??

[akvanden]

1 minute ago, Rigid1 said:

Oh sorry man, I thought this was about phizers release of data......,...

Nope.

 

"Federal Judge Squashes FDA's Plan to Keep COVID Vaccine Data Secret for Decades"

[Rigid1]

7 minutes ago, akvanden said:

Nope.

 

"Federal Judge Squashes FDA's Plan to Keep COVID Vaccine Data Secret for Decades"

Why would the FDA want to keep it hidden?? Kinda weird?? Right

[Highmark]

14 minutes ago, akvanden said:

I'll let the court documents explain (though we've already been down this road, a few months ago, but read it again.)

https://www.sirillp.com/wp-content/uploads/2021/11/020-Second-Joint-Status-Report-8989f1fed17e2d919391d8df1978006e.pdf

"A processing schedule is necessary because many different types of information are exempt from the FOIA, such that the government must redact that information before providing responsive records to the plaintiff. See 5 U.S.C. § 552(b)(1)–(b)(9). Reviewing and redacting records for exempt information is a time-consuming process that often requires government information specialists to review each page line-by-line. When a party requests a large amount of records, like Plaintiff did here, courts typically set a schedule whereby the processing and production of the non-exempt portions of records is made on a rolling basis."

And then if you go on to read 552(b)(1)–(b)(9) from the Freedom of Information Act

https://www.justice.gov/oip/freedom-information-act-5-usc-552

(b) This section does not apply to matters that are—

(1)(A) specifically authorized under criteria established by an Executive order to be kept secret in the interest of national defense or foreign policy and (B) are in fact properly classified pursuant to such Executive order;

(2) related solely to the internal personnel rules and practices of an agency;

(3) specifically exempted from disclosure by statute (other than section 552b of this title), if that statute--

(A)(i) requires that the matters be withheld from the public in such a manner as to leave no discretion on the issue; or

(ii) establishes particular criteria for withholding or refers to particular types of matters to be withheld; and

(B) if enacted after the date of enactment of the OPEN FOIA Act of 2009, specifically cites to this paragraph.

(4) trade secrets and commercial or financial information obtained from a person and privileged or confidential;

(5) inter-agency or intra-agency memorandums or letters which that would not be available by law to a party other than an agency in litigation with the agency, provided that the deliberative process privilege shall not apply to records created 25 years or more before the date on which the records were requested;

(6) personnel and medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy;

(7) records or information compiled for law enforcement purposes, but only to the extent that the production of such law enforcement records or information (A) could reasonably be expected to interfere with enforcement proceedings, (B) would deprive a person of a right to a fair trial or an impartial adjudication, (C) could reasonably be expected to constitute an unwarranted invasion of personal privacy, (D) could reasonably be expected to disclose the identity of a confidential source, including a State, local, or foreign agency or authority or any private institution which furnished information on a confidential basis, and, in the case of a record or information compiled by a criminal law enforcement authority in the course of a criminal investigation or by an agency conducting a lawful national security intelligence investigation, information furnished by a confidential source, (E) would disclose techniques and procedures for law enforcement investigations or prosecutions, or would disclose guidelines for law enforcement investigations or prosecutions if such disclosure could reasonably be expected to risk circumvention of the law, or (F) could reasonably be expected to endanger the life or physical safety of any individual;

(8) contained in or related to examination, operating, or condition reports prepared by, on behalf of, or for the use of an agency responsible for the regulation or supervision of financial institutions; or

(9) geological and geophysical information and data, including maps, concerning wells.

Any reasonably segregable portion of a record shall be provided to any person requesting such record after deletion of the portions which are exempt under this subsection. The amount of information deleted, and the exemption under which the deletion is made, shall be indicated on the released portion of the record, unless including that indication would harm an interest protected by the exemption in this subsection under which the deletion is made. If technically feasible, the amount of the information deleted, and the exemption under which the deletion is made, shall be indicated at the place in the record where such deletion is made.



 

 

 

"BUT, BUT..... - it's on a thumbdrive, just send it."

  Yes we did cover some of this and you're still a good little sheep.  

Dude the regulatory steps require them to do this.  Its hilarious that you think this data isn't easily available.  75 years.    

https://www.fda.gov/drugs/information-consumers-and-patients-drugs/fdas-drug-review-process-ensuring-drugs-are-safe-and-effective

New Drug Application (NDA)--This is the formal step a drug sponsor takes to ask that the FDA consider approving a new drug for marketing in the United States. An NDA includes all animal and human data and analyses of the data, as well as information about how the drug behaves in the body and how it is manufactured.

Edited January 11, 2022 by Highmark

[Rod]

75 years like wtf 

[Rigid1]

4 minutes ago, ACE said:

75 years like wtf 

I could see a few years, 2-3, but 75 years..wtf is right

[akvanden]

10 minutes ago, Rigid1 said:

Why would the FDA want to keep it hidden?? Kinda weird?? Right

They're not. Read the FOIA - you thought this was about the manufacturers. It's not. We don't need to surmise, just read it. 

 

11 minutes ago, Highmark said:

  Yes we did cover some of this and you're still a good little sheep.  

Dude the regulatory steps require them to do this.  Its hilarious that you think this data isn't easily available.  75 years.    

https://www.fda.gov/drugs/information-consumers-and-patients-drugs/fdas-drug-review-process-ensuring-drugs-are-safe-and-effective

New Drug Application (NDA)--This is the formal step a drug sponsor takes to ask that the FDA consider approving a new drug for marketing in the United States. An NDA includes all animal and human data and analyses of the data, as well as information about how the drug behaves in the body and how it is manufactured.

So now you're confusing a new drug application at the beginning of the process that pfizer/moderna/J&J send, with the end process of then redacting all the back and forth between the FDA and manufactures, all the internal FDA work, and releasing information? Ok. 

It's hilarious you think things are so simple. 

See, e.g., Documented NY v. U.S. Dep’t of State, No. 20 Civ. 1946 (AJN) (S.D.N.Y.) Dkt. 26 p.2 (denying plaintiff’s processing rate demand of 2,500 pages per month and adopting Department of State’s proposed 300 pages per month); NYCLU v. Admin. for Children & Families, No. 20 Civ. 183 (MKV), Dkt. No. 30 (S.D.N.Y. May 5, 2020) (400 pages per month); Color of Change v. U.S. Dep’t of Homeland Sec., 325 F. Supp. 3d 447, 451 (S.D.N.Y. 2018) (500 pages per month); Davis v. U.S. Dep’t of Homeland Sec., No. 11-cv-203 (ARR) (VMS), 2013 WL 3288418, at *1 (E.D.N.Y. June 27, 2013) (500 pages per month); Blakeney v. FBI, No. 17-cv-2288 (BAH), 2019 WL 450678, at *2 (D.D.C. Feb. 5, 2019) (500 pages per month); Colbert v. FBI, No. 16 Civ. 1790 (DLF), 2018 WL 6299966, at *3 (D.D.C. Sept. 3, 2018) (500 pages per month); Republican Nat’l Comm. v. U.S. Dep’t of State, No. 16 Civ. 486 (JEB), 2016 WL 9244625, at *1 (D.D.C. Sept. 16, 2016) (500 pages per month); Energy & Env’t Legal Inst. v. U.S. Dep’t of State, No. 17 Civ. 340 (D.D.C.), Minute Order of August 22, 2017 (300 pages per month); Judicial Watch, Inc. v. U.S. Dep’t of State, No. 17 Civ. 205 (D.D.C.), Minute Order of June 30, 2017 (300 pages every four weeks); Am. Ctr. for Law & Justice v. U.S. Dep’t of State, No. 16 Civ. 2516 (D.D.C.), Minute Order of June 27, 2017 (process 400 pages per month); Citizens United v. U.S. Dep’t of State, No. 16 Civ. 67 (D.D.C.), Dkt. 17 at 3 (declining “to adopt Plaintiff’s proposed production order of 2000 pages per month” and instead holding State “to its 300-page commitment”); Freedom Watch v. Bureau of Land Mgmt., No. 16 Civ. 2320 (D.D.C.), Minute Order of June 13, 2017 (500 pages every 30 days); Citizens United v. U.S. Dep’t of State, No. 15 Civ. 1720 (D.D.C.), Dkt. 11 ¶ 10 (500 pages every four weeks); Judicial Watch, Inc. v. U.S. Dep’t of State, No. 15 Civ. 687 (D.D.C.), Minute Order of April 4, 2017 (500 pages per month).

 

 

 

"BUT, BUT..... - it's on a thumbdrive, just send it."

[Highmark]

18 minutes ago, akvanden said:

They're not. Read the FOIA - you thought this was about the manufacturers. It's not. We don't need to surmise, just read it. 

 

So now you're confusing a new drug application at the beginning of the process that pfizer/moderna/J&J send, with the end process of then redacting all the back and forth between the FDA and manufactures, all the internal FDA work, and releasing information? Ok. 

It's hilarious you think things are so simple. 

See, e.g., Documented NY v. U.S. Dep’t of State, No. 20 Civ. 1946 (AJN) (S.D.N.Y.) Dkt. 26 p.2 (denying plaintiff’s processing rate demand of 2,500 pages per month and adopting Department of State’s proposed 300 pages per month); NYCLU v. Admin. for Children & Families, No. 20 Civ. 183 (MKV), Dkt. No. 30 (S.D.N.Y. May 5, 2020) (400 pages per month); Color of Change v. U.S. Dep’t of Homeland Sec., 325 F. Supp. 3d 447, 451 (S.D.N.Y. 2018) (500 pages per month); Davis v. U.S. Dep’t of Homeland Sec., No. 11-cv-203 (ARR) (VMS), 2013 WL 3288418, at *1 (E.D.N.Y. June 27, 2013) (500 pages per month); Blakeney v. FBI, No. 17-cv-2288 (BAH), 2019 WL 450678, at *2 (D.D.C. Feb. 5, 2019) (500 pages per month); Colbert v. FBI, No. 16 Civ. 1790 (DLF), 2018 WL 6299966, at *3 (D.D.C. Sept. 3, 2018) (500 pages per month); Republican Nat’l Comm. v. U.S. Dep’t of State, No. 16 Civ. 486 (JEB), 2016 WL 9244625, at *1 (D.D.C. Sept. 16, 2016) (500 pages per month); Energy & Env’t Legal Inst. v. U.S. Dep’t of State, No. 17 Civ. 340 (D.D.C.), Minute Order of August 22, 2017 (300 pages per month); Judicial Watch, Inc. v. U.S. Dep’t of State, No. 17 Civ. 205 (D.D.C.), Minute Order of June 30, 2017 (300 pages every four weeks); Am. Ctr. for Law & Justice v. U.S. Dep’t of State, No. 16 Civ. 2516 (D.D.C.), Minute Order of June 27, 2017 (process 400 pages per month); Citizens United v. U.S. Dep’t of State, No. 16 Civ. 67 (D.D.C.), Dkt. 17 at 3 (declining “to adopt Plaintiff’s proposed production order of 2000 pages per month” and instead holding State “to its 300-page commitment”); Freedom Watch v. Bureau of Land Mgmt., No. 16 Civ. 2320 (D.D.C.), Minute Order of June 13, 2017 (500 pages every 30 days); Citizens United v. U.S. Dep’t of State, No. 15 Civ. 1720 (D.D.C.), Dkt. 11 ¶ 10 (500 pages every four weeks); Judicial Watch, Inc. v. U.S. Dep’t of State, No. 15 Civ. 687 (D.D.C.), Minute Order of April 4, 2017 (500 pages per month).

 

 

 

"BUT, BUT..... - it's on a thumbdrive, just send it."

A federal judge ruled Thursday that Americans should get the data that the Food and Drug Administration relied upon when it approved Pfizer’s COVID-19 vaccine far sooner than the agency wanted.

Quoting a past court ruling that said “stale information is of little value,” the judge wrote that “the expeditious completion of Plaintiff’s request is not only practicable, but necessary.”

No I'm not confusing the beginning data.   Wrong again.  The data in the application is all trial testing data.   This was in the link I provided.

Well the judge agreed it was more simple than you.   55,000 pages a month to be completed in 8 months vs 500 pages a month in 75 years.     My guess he knows more about it than either you or I.    I'll translate for you.  

 

 

Edited January 11, 2022 by Highmark

[akvanden]

6 minutes ago, Highmark said:

Well the judge agreed it was more simple than you.   55,000 pages a month to be completed in 8 months vs 500 pages a month in 75 years.     My guess he knows more about it than either you or I.    I'll translate for you.  

 

 

Simple? Well, here are his words: "Here, the Court recognizes the “unduly burdensome” challenges that this FOIA request may present to the FDA." Yeah, sounds like he recognizes this will be simple. 

Unduly burdensome - requiring such a high investment of money, time, or any other resource or asset to achieve compliance that a reasonably prudent businessperson would not operate.

"BUT, BUT..... - it's on a thumbdrive, just send it."

 

 

SO, like the exact same thing I said two months ago, it can be done, but they'll have to pile on a load more people into the project to be compliant.

 

And thanks for all the sheep commentary, your such a nice lion.

[Highmark]

1 hour ago, akvanden said:

Simple? Well, here are his words: "Here, the Court recognizes the “unduly burdensome” challenges that this FOIA request may present to the FDA." Yeah, sounds like he recognizes this will be simple. 

Unduly burdensome - requiring such a high investment of money, time, or any other resource or asset to achieve compliance that a reasonably prudent businessperson would not operate.

"BUT, BUT..... - it's on a thumbdrive, just send it."

 

 

SO, like the exact same thing I said two months ago, it can be done, but they'll have to pile on a load more people into the project to be compliant.

 

And thanks for all the sheep commentary, your such a nice lion.

So what's more unreasonable?   500 pages a month when the American people have a right to the information or 55,000 pages a month so some bureaucrat's have to put in a little overtime?

The FDA could and should have been working on the releasable data from the moment it starting receiving it.  With the controversies around the vaccines they absolutely knew significant parts of the American public would want and had the right to know in a reasonable timeframe. 

If the FDA and CDC are going to push to give something to virtually every man women and child in this country it shouldn't take 75 fucking years to release the safety data.   They released the efficacy data AS THE TRIALS WERE BEING CONDUCTED.  We were hearing this on the nightly news.   

Carry on Mr. Woolensworth.

 

 

Edited January 11, 2022 by Highmark

[ArcticCrusher]

22 minutes ago, akvanden said:

Simple? Well, here are his words: "Here, the Court recognizes the “unduly burdensome” challenges that this FOIA request may present to the FDA." Yeah, sounds like he recognizes this will be simple. 

Unduly burdensome - requiring such a high investment of money, time, or any other resource or asset to achieve compliance that a reasonably prudent businessperson would not operate.

"BUT, BUT..... - it's on a thumbdrive, just send it."

 

 

SO, like the exact same thing I said two months ago, it can be done, but they'll have to pile on a load more people into the project to be compliant.

 

And thanks for all the sheep commentary, your such a nice lion.

Just give it up sheep.

[Highmark]

1 hour ago, Rigid1 said:

Oh sorry man, I thought this was about phizers release of data......,...

FDA release but it was the drug company data.   The FDA doesn't complete the trials themselves.   The drug companies do.   It would be better to get the data directly from the drug companies as they could and have with held data from the FDA. 

[akvanden]

50 minutes ago, Highmark said:

So what's more unreasonable?   500 pages a month when the American people have a right to the information or 55,000 pages a month so some bureaucrat's have to put in a little overtime?

The FDA could and should have been working on the releasable data from the moment it starting receiving it.  With the controversies around the vaccines they absolutely knew significant parts of the American public would want and had the right to know in a reasonable timeframe. 

If the FDA and CDC are going to push to give something to virtually every man women and child in this country it shouldn't take 75 fucking years to release the safety data.   They released the efficacy data AS THE TRIALS WERE BEING CONDUCTED.   

Carry on Mr. Woolensworth.

 

 

Hey, we’re making progress. I think you’re understanding this is no easy feat. And I agree, throw more manpower at it and get it done.

 

 

mr Lion.

[Highmark]

1 hour ago, akvanden said:

Hey, we’re making progress. I think you’re understanding this is no easy feat. And I agree, throw more manpower at it and get it done.

 

 

mr Lion.

 Don't be putting words in peoples mouth Mr. Woolensworth.  As stated above they were releasing trial effectiveness data while the trials were going on.   Should not have been too hard to be compiling all the other data for quick release at the same time.   They no doubt were.   

You don't think for an instance this slow balling has been for a reason?   Come on dude.  

Edited January 11, 2022 by Highmark

[ArcticCrusher]

Mass Formation is good now.

Wake the fuck up sheep.

 

 

[Ez ryder]

6 hours ago, akvanden said:

Nope.

 

"Federal Judge Squashes FDA's Plan to Keep COVID Vaccine Data Secret for Decades"

Lmfao so are you saying you think the fda did there own testing.  Come on man you know better than that .

If not the drug manufactures do the testing and turn data over to the fda for approval.  And guess what it did not take more than a few mouse clicks to get it from phizer to the fda .far from 30 yrs 

[SkisNH]

21 hours ago, akvanden said:

I'm in agreement, but the page count was based on precedence and manpower. This will just force them to appropriate more people/budget to go through all these pages redacting, etc. A good thing.

F you...the FDA was given the same 400k pages and approved it in months. 

[Highmark]

55 minutes ago, SkisNH said:

F you...the FDA was given the same 400k pages and approved it in months. 

Oops.  

[akvanden]

2 hours ago, SkisNH said:

F you...the FDA was given the same 400k pages and approved it in months. 

F you… you you want the same hundreds of scientists now redacting papers? Guess they could…. We could call it operation warp redaction. 

And no they didn’t get 400k pages, they likely got a lot less, and then added to it with internal meetings, reviews, their own laboratory work, etc.

 

4 hours ago, Ez ryder said:

Lmfao so are you saying you think the fda did there own testing.  Come on man you know better than that .

No, they’re just the ones being sued under the FOIA, not the drug manufacturers. It’s the title/link that started this thread.

 

1 hour ago, Highmark said:

Oops.  

Or not.

[Rigid1]

Put the IRS on it for a few days, they can go thru it....  

[Ez ryder]

32 minutes ago, akvanden said:

F you… you you want the same hundreds of scientists now redacting papers? Guess they could…. We could call it operation warp redaction. 

And no they didn’t get 400k pages, they likely got a lot less, and then added to it with internal meetings, reviews, their own laboratory work, etc.

 

No, they’re just the ones being sued under the FOIA, not the drug manufacturers. It’s the title/link that started this thread.

 

Or not.

So no problem then right ? names have already been redacted under medical privacy laws . Hit send  Same way the fda got there copy . You know the copy they managed to go over in less than 30 days to give the emergency use stamp of approval for drug in question . 

[ArcticCrusher]

9 hours ago, Ez ryder said:

So no problem then right ? names have already been redacted under medical privacy laws . Hit send  Same way the fda got there copy . You know the copy they managed to go over in less than 30 days to give the emergency use stamp of approval for drug in question . 

Maybe they didn't read shit.

[ArcticCrusher]

Remember when it was said the shots will lower your immune system and that was called a conspiracy.

Well, another conspiracy debunked.

Wake up sheep.

 

European Union regulators warned that frequent Covid-19 booster shots could adversely affect the immune system and may not be feasible.  

https://www.bloomberg.com/news/articles/2022-01-11/repeat-booster-shots-risk-overloading-immune-system-ema-says

[irv]

35 minutes ago, ArcticCrusher said:

Remember when it was said the shots will lower your immune system and that was called a conspiracy.

Well, another conspiracy debunked.

Wake up sheep.

 

European Union regulators warned that frequent Covid-19 booster shots could adversely affect the immune system and may not be feasible.  

https://www.bloomberg.com/news/articles/2022-01-11/repeat-booster-shots-risk-overloading-immune-system-ema-says

I wonder what the magic number is? 4 or 5 that this starts to happen? 1 and 2 are super enhancers for sure and our current numbers prove that, but because Pfizer's CEO says we need more and more boosters, I'm wondering what number that will be that they become immune system depleter's? Just a guess here, but I am guessing when their sales numbers drop because people have woken up, that will be the magic number whatever that may be?