Coronavirus: Thread

[grarpamp]

Just like elections, if they're keeping SECRETS from you,
preventing you fro mseeing and auditing all the things,
they are hiding their own frauds, scams and crimes against you.
There is no other reason.


FDA Asks Court To Delay First 55K Batch Of COVID Docs; Pfizer Moves To
Join Case

https://aaronsiri.substack.com/p/fda-asks-the-court-to-delay-first
https://aaronsiri.substack.com/p/scientists-sue-the-fda-for-data-it
https://aaronsiri.substack.com/p/fda-asks-federal-judge-to-grant-it

https://aaronsiri.substack.com/p/fda-doubles-down-asks-federal-judge
https://phmpt.org/wp-content/uploads/2022/01/ORDER_2022_01_06.pdf
https://aaronsiri.substack.com/p/instead-of-fdas-requested-500-pages
https://phmpt.org/wp-content/uploads/2022/01/044-PL-PHPMTS-MOL-IN-OPPOSITION-TO-DEFENDANTS-MOTION-TO-MODIFY-THE-SCHEDULING-ORDER-OF-THE-COURT.pdf
https://phmpt.org/court-documents/
https://www.sirillp.com/wp-content/uploads/2022/01/044-PL-PHPMTS-MOL-IN-OPPOSITION-TO-DEFENDANTS-MOTION-TO-MODIFY-T-eb93e99875558a72d06df1f736cdb598.pdf

As explained in prior posts, in a lawsuit seeking all of the documents
the FDA relied upon to license Pfizer’s COVID-19 vaccine, a federal
judge shot down the FDA’s requested rate of 500 pages per month and
instead ordered the FDA to produce at the rate of 55,000 pages per
month starting on March 1.

Since the government has trillions of dollars of our money, it is
putting it to good use by fighting to assure that the public has the
least amount of transparency possible.  To that end, it has now asked
the Court to make the public wait until May for it to start producing
55,000 pages per month and, even then, claims it may not be able to
meet this rate.

The FDA’s excuse?  As explained in the brief opposing the FDA’s
request, the FDA’s defense effectively amounts to claiming that the 11
document reviewers it has already assigned and the 17 additional
reviewers being onboarded are only capable of reading at the speed of
preschoolers.

Meanwhile…

As the FDA tries to obtain months of delay, guess who just showed upon
in the lawsuit?  Yep, Pfizer.  And it is represented by a global chair
and team from a law firm with thousands of lawyers.  Pfizer’s legal
bill will likely be multiple times what it would cost the FDA to
simply hire a private document review company to review, redact, and
produce the documents at issue.  Within weeks, if not days.

Pfizer is coming in as a third party.  But Pfizer assures the Court it
is here to help expedite production of the documents.  Sure it is!
Where was Pfizer before the Court ordered the 55,000 pages per month?
Right, doing what it normally does: letting the government work on its
behalf – like the way the government mandates, promotes, and defends
Pfizer’s product.

But the government did not please Pfizer this time and so here it
comes, likely looking for a second bite at the apple.  Of course the
FDA consented to Pfizer appearing.  You can read the response my firm
filed to Pfizer’s motion , as well as all of the other relevant recent
filings in the link provided below.

Let me end by noting that all of this insanity is simply in response
to an attempt to obtain some basic transparency.  This should again
bring into sharp focus why the government should never coerce or
mandate anyone to get an unwanted medical product or procedure.  Just
look at this circus – the government mandates Pfizer’s product, gives
it immunity for any safety or efficacy issues, promotes its product
using taxpayer money, gives Pfizer over $17 billion and then uses
taxpayers’ money to fight to avoid providing even the most basic level
of transparency to the public.

The introduction from the brief opposing the FDA’s request is below
and you can find copies of all the relevant court filings (FDA Motion
to Modify Scheduling Order, January 18, 2022 / Plaintiff Opposition to
Motion to Modify, January 24, 2022 / Pfizer Motion to Intervene,
January 21, 2022 / FDA Response to Pfizer Motion, January 25, 2022 /
Plaintiff Response to Pfizer Motion, January 25, 2022) here:
INTRODUCTION TO OPPOSITION TO FDA’S MOTION

It is understandable that the FDA does not want independent scientists
to review the documents it relied upon to license Pfizer’s vaccine
given that it is not as effective as the FDA originally claimed, does
not prevent transmission, does not prevent against certain emerging
variants, can cause serious heart inflammation in younger individuals,
and has numerous other undisputed safety issues.[1]  However, the
FDA’s potential embarrassment over its decision to license this
product must take a back seat to the transparency demanded by FOIA and
the urgent need and interests of the American people to review that
licensure data.  The Court already recognized this unprecedented
urgent need in its January 6th order directing the FDA to produce
55,000 pages per month.

The FDA now insists it must delay its first 55,000-page production
until May 1, 2022 – four months after the Court entered its order.
However, the FDA’s own papers seeking this delay make plain it can
produce at a rate of 55,000 pages per month in February and March.
The FDA affirms it has already “allocated the equivalent of nearly 11
full-time staff to this project” and that “a review speed of 50
documents per hour was within the normal range for document review in
a complex matter” in private practice; and here the 50 document per
hour rate would be faster since there is only a need to review for
personally identifying information (“PII”) for most pages.  Hence, if
the FDA’s 11 full-time reviewers work only 7.5 hours per day and
review 50 pages (not documents) per hour, the FDA could review over
88,000 pages per month in February and March.  That is more than
sufficient to produce the 55,000 pages per month currently ordered for
these two months.

Instead of complying with this Court’s reasoned order, the FDA claims
these 11 reviewers can only review a total of 10,000 pages per month.
What the FDA does not say, and what basic math shows, is that a rate
of 10,000 pages a month for 11 full-time reviewers amounts to only 5
pages per hour!  This rate is made even more absurd because most of
the pages the FDA will be reviewing during this period are repetitive
data files that only require second level review to redact minimal
amounts of PII that Pfizer may have left in the documents.  FDA’s
reality defying claim and contemptuous approach to its production
obligations should not be countenanced.  (Infra § I.)

It is also apparent that the instant demand is just the start of a
campaign to delay the production ordered by the Court.  In this first
salvo, the FDA is not really asking the Court.  It is instead
expressly telling the Court it does not intend to produce more than
10,000 pages per month for February and March, and despite claiming it
is making “unprecedented” efforts, the FDA repeatedly tells the Court:
“It is not possible to guarantee that FDA will be able to fully
comply” with the 55,000-page production rate thereafter.  (Dkt. No. 38
at APPX004, APPX008.)  Americans must follow the law and the FDA, a
multi-billion-dollar agency, should similarly be given no safe harbor
from complying with the orders of this Court.  (Infra § II.)

The FDA should also be held to what it attests.  The FDA, with over
18,000 employees and an over $3 billion discretionary budget,
repeatedly assures the Court that it is taking steps to “marshal every
possible resource available to it,” “acting with maximal urgency to
assemble every possible resource available to it” and “putting every
available resource at its disposal into its efforts to achieve
compliance.”  (Dkt. No. 37 at 10, 3, 10.)  The FDA also attests that
over the coming weeks, it will have 28.5 full-time people reviewing
the documents.  Working 7.5 hours per day for 20 business days per
month, 28.5 people reviewing 50 pages per hour can review a total of
approximately 213,750 pages per month.  Putting aside that most of
this production can be reviewed far faster than the rate of 50 pages
per hour, Plaintiff asks that the FDA be held to its representations
and be directed to produce at the rate of 180,000 pages per month
starting in April.  (Infra § III.)

The Court is, other than Congress, the only check on the FDA.  In a
free country, transparency is paramount, and the FDA has chosen to
thwart transparency and the requirements of FOIA by anemically
understaffing the office it maintains to respond to FOIA requests.  It
is akin to the boy that kills his parents and asks for sympathy for
being an orphan.  Decrying that this Court is now making it comply
with the law – by actually producing documents in a timely manner – is
ridiculous.  It is also incredible for the FDA to claim that
compliance here would harm its health policy objectives.  Even if the
FDA really does need to spend $4 to $5 million which, as shown below,
is an absurd overestimate, that is an inconsequential amount of its
overall $3.41 billion discretionary budget.  Moreover, the issues with
the Pfizer vaccine – including waning immunity, variants evading
immunity, the failure to prevent transmission, myocarditis, and
pericarditis – show that the FDA’s priority should be to address this
product before rushing off to engage in other activities.  (Infra §
IV.)

For these reasons, as explained below, the Court should refuse to
reduce the rate of production in February and March and should
increase the rate of production for April and thereafter to 180,000
pages per month consistent with the FDA employing 28.5 full-time
reviewers in the coming weeks to conduct the review and the fact that
most of the pages need only be reviewed for PII.

…you can read the rest of the brief here

[1] Reflecting the issues with this product, the FDA failed to send a
representative to a federal court hearing in this matter on December
14th because of the “FDA’s protocols” regarding COVID-19. Meaning,
despite the FDA’s claim the vaccine is “effective,” the FDA is
apparently still scared to send a representative to the hearing.  Its
actions speak volumes and cast serious doubt on its words.