https://www.reddit.com/r/LockdownSkepticism/comments/1dxs5v9/the_fda_cut_corners_brownstone_institute/

The FDA Cut Corners
BY Maryanne DemasiMARYANNE DEMASI JULY 6, 2024 GOVERNMENT, PHARMA,
VACCINES 5 MINUTE READ

SHARE | PRINT | EMAIL
In 2020, governments around the world imposed brutal lockdowns across
the population, promising a safe and effective Covid-19 vaccine was just
around the corner.

The Trump administration made no secret of the fact that it wanted the
Food and Drug Administration (FDA) to hurry the process along.

Stephen Hahn, then FDA commissioner, was summoned to the White House and
asked to explain why he hadn’t moved faster to approve Pfizer’s Covid-19
vaccine.

It drew widespread criticism but Kayleigh McEnany, then White House
press secretary, defended Trump saying he would “never apologize” for
putting a fire under the FDA.

Hahn appeared to resist the pressure – publicly at least.

“We will make sure that our scientists take the time they need to make
an appropriate decision,” said Hahn “It is our job to get this right and
make the correct decision regarding vaccine safety and efficacy.”

Former FDA Commissioner Stephen Hahn with President Donald Trump. Saul
Loeb/AFP via Getty Images
Soon after the November 3, 2020 election, Pfizer’s vaccine authorisation
was imminent. But Trump would soon be replaced by President-elect Joe
Biden, and lamented that his successor would get all the credit.

“They will try and say that Biden came up with the vaccines,” said Trump
to Fox News a week after the election. “The vaccines were me, and I
pushed people harder than they’ve ever been pushed before.”

Warp Speed Authorisation
Pfizer (and its partner BioNTech) submitted its trove of clinical trial
data to the FDA on November 20, 2020.

The FDA completed its review and granted emergency authorisation for
Pfizer’s investigational mRNA vaccine on December 11, 2020.

The entire process took only 22 days.

The FDA assured the public that it conducted “a rigorous review of
laboratory and clinical data” but vaccine hesitancy was already sky-high.

Pew research found that 49% of Americans said they would ‘probably not’
or ‘definitely not’ get the vaccine in light of the fast-paced process.

Reviewing the Trial Data
Most regulators review data that have been curated by the trial sponsor.
Australia’s TGA for example, never received the source data from the
trial, only the aggregated data from the manufacturer in a dossier.

The FDA, however, is one of the few regulators that receives and reviews
the individual participant data (IPD) and other regulatory documents
that underpin approval decisions.

The data sets are enormous.

Pfizer’s mRNA trial, for example, would collect data on each of the
44,000 subjects – consent forms, case report forms, baseline values, and
tests from multiple follow-up visits.

Typically, a trial that size would gather hundreds of thousands, if not
millions, of pages.

So, did the FDA receive the IPD and review it all?

The FDA told me that it did, in fact, receive the IPD for Pfizer’s mRNA
trial, and in 22 days it “carried out a full analysis of those data
prior to authorizing the vaccine for emergency use.”

The FDA’s vaccine chief Peter Marks boasted that the effort was ‘heroic.’

“This was not business as usual,” Marks wrote in STAT. “FDA undertook an
all-hands-on-deck approach to this work.”

Peter Marks, director of FDA’s CEBR
Peter Gøtzsche is a Danish physician and has many years of experience
reviewing regulatory documents. He ridiculed the idea that a “thorough”
review could be completed in that timeframe.

“There’s no way the FDA carried out a ‘full analysis’ of the IPD in only
22 days,” remarked Gøtzsche. “It’s impossible. It would take a minimum
of 6 months to pull off such a complex analysis.”

“There can be millions of pages to a single trial. And if you are going
to do a thorough analysis, it requires very careful detective work to
review it all,” he said.

Danish physician and expert reviewer of regulatory data Peter Gøtzsche
Gøtzsche, who authored the book “Deadly Medicines and Organised Crime”
has been an expert witness in court cases for people who’ve been harmed
by psychiatric drugs.

He says after analysing trial data that have been subpoenaed in legal
cases, you really get a sense of just how much drug companies “lie and
cheat” in the volumes of data.

“I know from experience that drug companies try to bury harms. For
example, they might use different words to describe the same harm so
that it doesn’t get picked up when you’re searching for those key terms
in the documents,” said Gøtzsche.

“The only way the FDA could have finished a full analysis of Pfizer’s
IPD in 22 days is if they cut corners or they only analysed the
aggregated information submitted in the dossier,” he added.

FDA Denies it Cut Corners
The FDA rejected the idea that 22 days was insufficient time to
thoroughly analyse the IPD.

“The FDA uses a team-based approach to evaluate and analyze data, and
staff with relevant knowledge, beyond the immediate review team, are
also involved,” stated the agency.

The FDA would not confirm exactly how many staff it assigned to the
task, but added, “Review of clinical trial participant data generally
involves staff from multiple offices in the center, who bring their
considerable medical and scientific expertise to the process.”

But Gøtzsche said this is not the way it works when analysing regulatory
filings.

“You can’t just divide up the pages among many staff members to get the
work done quicker,” explained Gøtzsche.

“You need consistency to do the job right. It requires the same person
reading the data and looking for patterns. The more pages that person
analyses, the more familiar he or she becomes with how the data have
been documented and what has been hidden,” added Gøtzsche.

More recently, regulatory documents have been digitised and are
available electronically, meaning they don’t come in hard copy, stacks
of paper.

In some instances, this enables researchers to perform ‘keyword
searches’ to look for information, but sometimes, the pages have been
scanned or photographed, which does not allow word searches.

My 2022 BMJ investigation found Japan’s drug regulator PMDA is the only
other major regulator that routinely receives IPD.

Currently, Tom Jefferson and colleagues at Trust the Evidence have spent
the last few months exploring the regulatory data sets for licensure of
Pfizer’s vaccine (Cominarty) thanks to a lawsuit filed against the FDA
by Aaron Siri, US attorney acting on behalf of the non-profit group,
Public Health and Medical Professionals for Transparency.

Republished from the author’s Substack

Published under a Creative Commons Attribution 4.0 International License
For reprints, please set the canonical link back to the original
Brownstone Institute Article and Author.

Author
Maryanne Demasi
Maryanne Demasi
Maryanne Demasi, 2023 Brownstone Fellow, is an investigative medical
reporter with a PhD in rheumatology, who writes for online media and top
tiered medical journals. For over a decade, she produced TV
documentaries for the Australian Broadcasting Corporation (ABC) and has
worked as a speechwriter and political advisor for the South Australian
Science Minister.

VIEW ALL POSTS

On Sun, 7 Jul 2024 19:22:44 -0700, Michael Ejercito
<MEjercit@HotMail.com> wrote:

>https://www.reddit.com/r/LockdownSkepticism/comments/1dxs5v9/the_fda_cut_corners_brownstone_institute/
>
>
>The FDA Cut Corners
>BY Maryanne DemasiMARYANNE DEMASI JULY 6, 2024 GOVERNMENT, PHARMA,
>VACCINES 5 MINUTE READ
>
>SHARE | PRINT | EMAIL
>In 2020, governments around the world imposed brutal lockdowns across
>the population, promising a safe and effective Covid-19 vaccine was just
>around the corner.
>
>The Trump administration made no secret of the fact that it wanted the
>Food and Drug Administration (FDA) to hurry the process along.
>
>Stephen Hahn, then FDA commissioner, was summoned to the White House and
>asked to explain why he hadn’t moved faster to approve Pfizer’s Covid-19
>vaccine.
>
>It drew widespread criticism but Kayleigh McEnany, then White House
>press secretary, defended Trump saying he would “never apologize” for
>putting a fire under the FDA.
>
>Hahn appeared to resist the pressure – publicly at least.
>
>“We will make sure that our scientists take the time they need to make
>an appropriate decision,” said Hahn “It is our job to get this right and
>make the correct decision regarding vaccine safety and efficacy.”
>
>
>Former FDA Commissioner Stephen Hahn with President Donald Trump. Saul
>Loeb/AFP via Getty Images
>Soon after the November 3, 2020 election, Pfizer’s vaccine authorisation
>was imminent. But Trump would soon be replaced by President-elect Joe
>Biden, and lamented that his successor would get all the credit.
>
>“They will try and say that Biden came up with the vaccines,” said Trump
>to Fox News a week after the election. “The vaccines were me, and I
>pushed people harder than they’ve ever been pushed before.”
>
>
>Warp Speed Authorisation
>Pfizer (and its partner BioNTech) submitted its trove of clinical trial
>data to the FDA on November 20, 2020.
>
>The FDA completed its review and granted emergency authorisation for
>Pfizer’s investigational mRNA vaccine on December 11, 2020.
>
>The entire process took only 22 days.
>
>The FDA assured the public that it conducted “a rigorous review of
>laboratory and clinical data” but vaccine hesitancy was already sky-high.
>
>Pew research found that 49% of Americans said they would ‘probably not’
>or ‘definitely not’ get the vaccine in light of the fast-paced process.
>
>Reviewing the Trial Data
>Most regulators review data that have been curated by the trial sponsor.
>Australia’s TGA for example, never received the source data from the
>trial, only the aggregated data from the manufacturer in a dossier.
>
>The FDA, however, is one of the few regulators that receives and reviews
>the individual participant data (IPD) and other regulatory documents
>that underpin approval decisions.
>
>The data sets are enormous.
>
>Pfizer’s mRNA trial, for example, would collect data on each of the
>44,000 subjects – consent forms, case report forms, baseline values, and
>tests from multiple follow-up visits.
>
>Typically, a trial that size would gather hundreds of thousands, if not
>millions, of pages.
>
>So, did the FDA receive the IPD and review it all?
>
>The FDA told me that it did, in fact, receive the IPD for Pfizer’s mRNA
>trial, and in 22 days it “carried out a full analysis of those data
>prior to authorizing the vaccine for emergency use.”
>
>The FDA’s vaccine chief Peter Marks boasted that the effort was ‘heroic.’
>
>“This was not business as usual,” Marks wrote in STAT. “FDA undertook an
>all-hands-on-deck approach to this work.”
>
>
>Peter Marks, director of FDA’s CEBR
>Peter Gøtzsche is a Danish physician and has many years of experience
>reviewing regulatory documents. He ridiculed the idea that a “thorough”
>review could be completed in that timeframe.
>
>“There’s no way the FDA carried out a ‘full analysis’ of the IPD in only
>22 days,” remarked Gøtzsche. “It’s impossible. It would take a minimum
>of 6 months to pull off such a complex analysis.”
>
>“There can be millions of pages to a single trial. And if you are going
>to do a thorough analysis, it requires very careful detective work to
>review it all,” he said.
>
>
>Danish physician and expert reviewer of regulatory data Peter Gøtzsche
>Gøtzsche, who authored the book “Deadly Medicines and Organised Crime”
>has been an expert witness in court cases for people who’ve been harmed
>by psychiatric drugs.
>
>He says after analysing trial data that have been subpoenaed in legal
>cases, you really get a sense of just how much drug companies “lie and
>cheat” in the volumes of data.
>
>“I know from experience that drug companies try to bury harms. For
>example, they might use different words to describe the same harm so
>that it doesn’t get picked up when you’re searching for those key terms
>in the documents,” said Gøtzsche.
>
>“The only way the FDA could have finished a full analysis of Pfizer’s
>IPD in 22 days is if they cut corners or they only analysed the
>aggregated information submitted in the dossier,” he added.
>
>FDA Denies it Cut Corners
>The FDA rejected the idea that 22 days was insufficient time to
>thoroughly analyse the IPD.
>
>“The FDA uses a team-based approach to evaluate and analyze data, and
>staff with relevant knowledge, beyond the immediate review team, are
>also involved,” stated the agency.
>
>The FDA would not confirm exactly how many staff it assigned to the
>task, but added, “Review of clinical trial participant data generally
>involves staff from multiple offices in the center, who bring their
>considerable medical and scientific expertise to the process.”
>
>But Gøtzsche said this is not the way it works when analysing regulatory
>filings.
>
>“You can’t just divide up the pages among many staff members to get the
>work done quicker,” explained Gøtzsche.
>
>“You need consistency to do the job right. It requires the same person
>reading the data and looking for patterns. The more pages that person
>analyses, the more familiar he or she becomes with how the data have
>been documented and what has been hidden,” added Gøtzsche.
>
>More recently, regulatory documents have been digitised and are
>available electronically, meaning they don’t come in hard copy, stacks
>of paper.
>
>In some instances, this enables researchers to perform ‘keyword
>searches’ to look for information, but sometimes, the pages have been
>scanned or photographed, which does not allow word searches.
>
>My 2022 BMJ investigation found Japan’s drug regulator PMDA is the only
>other major regulator that routinely receives IPD.
>
>
>Currently, Tom Jefferson and colleagues at Trust the Evidence have spent
>the last few months exploring the regulatory data sets for licensure of
>Pfizer’s vaccine (Cominarty) thanks to a lawsuit filed against the FDA
>by Aaron Siri, US attorney acting on behalf of the non-profit group,
>Public Health and Medical Professionals for Transparency.

In the interim, we are 100% prepared/protected in the "full armor of
GOD" (Ephesians 6:11) which we put on as soon as we use Apostle Paul's
secret (Philippians 4:12). Though masking is less protective, it helps
us avoid the appearance of doing the evil of spreading airborne
pathogens while there are people getting sick because of not being
100% protected. It is written that we're to "abstain from **all**
appearance of doing evil" (1 Thessalonians 5:22 w/**emphasis**).

Meanwhile, the only *perfect* (Matt 5:47-8 ) way to eradicate the
COVID-19 virus, thereby saving lives, in the US & elsewhere is by
rapidly (i.e. use the "Rapid COVID-19 Test" ) finding out at any given
moment, including even while on-line, who among us are unwittingly
contagious (i.e pre-symptomatic or asymptomatic) in order to
"convince it forward" (John 15:12) for them to call their doctor and
self-quarantine per their doctor in hopes of stopping this pandemic.
Thus, we're hoping for the best while preparing for the worse-case
scenario of the Alpha lineage mutations and others like the Omicron,
Gamma, Beta, Epsilon, Iota, Lambda, Mu & Delta lineage mutations
combining via slip-RNA-replication to form hybrids like "Deltamicron"
that may render current COVID vaccines/monoclonals/medicines/pills no
longer effective.

Indeed, I am wonderfully hungry (
https://groups.google.com/g/sci.med.cardiology/c/6ZoE95d-VKc/m/14vVZoyOBgAJ
) and hope you, Michael, also have a healthy appetite too.

(FDA) 07/07/24 Again not a LoosePeeledDisgustingMemoryQuackBigot...

https://groups.google.com/g/sci.med.cardiology/c/Ai33hw5PINI/m/wytVpY68MwAJ

Instead be "woke" to the sin of racial prejudice:

https://tinyurl.com/JesusIsWoke (i.e. not a Nazi bigot) *and* risen!!!

HeartDoc Andrew wrote:
> On Sun, 7 Jul 2024 19:22:44 -0700, Michael Ejercito
> <MEjercit@HotMail.com> wrote:
>
>> https://www.reddit.com/r/LockdownSkepticism/comments/1dxs5v9/the_fda_cut_corners_brownstone_institute/
>>
>>
>> The FDA Cut Corners
>> BY Maryanne DemasiMARYANNE DEMASI JULY 6, 2024 GOVERNMENT, PHARMA,
>> VACCINES 5 MINUTE READ
>>
>> SHARE | PRINT | EMAIL
>> In 2020, governments around the world imposed brutal lockdowns across
>> the population, promising a safe and effective Covid-19 vaccine was just
>> around the corner.
>>
>> The Trump administration made no secret of the fact that it wanted the
>> Food and Drug Administration (FDA) to hurry the process along.
>>
>> Stephen Hahn, then FDA commissioner, was summoned to the White House and
>> asked to explain why he hadn’t moved faster to approve Pfizer’s Covid-19
>> vaccine.
>>
>> It drew widespread criticism but Kayleigh McEnany, then White House
>> press secretary, defended Trump saying he would “never apologize” for
>> putting a fire under the FDA.
>>
>> Hahn appeared to resist the pressure – publicly at least.
>>
>> “We will make sure that our scientists take the time they need to make
>> an appropriate decision,” said Hahn “It is our job to get this right and
>> make the correct decision regarding vaccine safety and efficacy.”
>>
>>
>> Former FDA Commissioner Stephen Hahn with President Donald Trump. Saul
>> Loeb/AFP via Getty Images
>> Soon after the November 3, 2020 election, Pfizer’s vaccine authorisation
>> was imminent. But Trump would soon be replaced by President-elect Joe
>> Biden, and lamented that his successor would get all the credit.
>>
>> “They will try and say that Biden came up with the vaccines,” said Trump
>> to Fox News a week after the election. “The vaccines were me, and I
>> pushed people harder than they’ve ever been pushed before.”
>>
>>
>> Warp Speed Authorisation
>> Pfizer (and its partner BioNTech) submitted its trove of clinical trial
>> data to the FDA on November 20, 2020.
>>
>> The FDA completed its review and granted emergency authorisation for
>> Pfizer’s investigational mRNA vaccine on December 11, 2020.
>>
>> The entire process took only 22 days.
>>
>> The FDA assured the public that it conducted “a rigorous review of
>> laboratory and clinical data” but vaccine hesitancy was already sky-high.
>>
>> Pew research found that 49% of Americans said they would ‘probably not’
>> or ‘definitely not’ get the vaccine in light of the fast-paced process.
>>
>> Reviewing the Trial Data
>> Most regulators review data that have been curated by the trial sponsor.
>> Australia’s TGA for example, never received the source data from the
>> trial, only the aggregated data from the manufacturer in a dossier.
>>
>> The FDA, however, is one of the few regulators that receives and reviews
>> the individual participant data (IPD) and other regulatory documents
>> that underpin approval decisions.
>>
>> The data sets are enormous.
>>
>> Pfizer’s mRNA trial, for example, would collect data on each of the
>> 44,000 subjects – consent forms, case report forms, baseline values, and
>> tests from multiple follow-up visits.
>>
>> Typically, a trial that size would gather hundreds of thousands, if not
>> millions, of pages.
>>
>> So, did the FDA receive the IPD and review it all?
>>
>> The FDA told me that it did, in fact, receive the IPD for Pfizer’s mRNA
>> trial, and in 22 days it “carried out a full analysis of those data
>> prior to authorizing the vaccine for emergency use.”
>>
>> The FDA’s vaccine chief Peter Marks boasted that the effort was ‘heroic.’
>>
>> “This was not business as usual,” Marks wrote in STAT. “FDA undertook an
>> all-hands-on-deck approach to this work.”
>>
>>
>> Peter Marks, director of FDA’s CEBR
>> Peter Gøtzsche is a Danish physician and has many years of experience
>> reviewing regulatory documents. He ridiculed the idea that a “thorough”
>> review could be completed in that timeframe.
>>
>> “There’s no way the FDA carried out a ‘full analysis’ of the IPD in only
>> 22 days,” remarked Gøtzsche. “It’s impossible. It would take a minimum
>> of 6 months to pull off such a complex analysis.”
>>
>> “There can be millions of pages to a single trial. And if you are going
>> to do a thorough analysis, it requires very careful detective work to
>> review it all,” he said.
>>
>>
>> Danish physician and expert reviewer of regulatory data Peter Gøtzsche
>> Gøtzsche, who authored the book “Deadly Medicines and Organised Crime”
>> has been an expert witness in court cases for people who’ve been harmed
>> by psychiatric drugs.
>>
>> He says after analysing trial data that have been subpoenaed in legal
>> cases, you really get a sense of just how much drug companies “lie and
>> cheat” in the volumes of data.
>>
>> “I know from experience that drug companies try to bury harms. For
>> example, they might use different words to describe the same harm so
>> that it doesn’t get picked up when you’re searching for those key terms
>> in the documents,” said Gøtzsche.
>>
>> “The only way the FDA could have finished a full analysis of Pfizer’s
>> IPD in 22 days is if they cut corners or they only analysed the
>> aggregated information submitted in the dossier,” he added.
>>
>> FDA Denies it Cut Corners
>> The FDA rejected the idea that 22 days was insufficient time to
>> thoroughly analyse the IPD.
>>
>> “The FDA uses a team-based approach to evaluate and analyze data, and
>> staff with relevant knowledge, beyond the immediate review team, are
>> also involved,” stated the agency.
>>
>> The FDA would not confirm exactly how many staff it assigned to the
>> task, but added, “Review of clinical trial participant data generally
>> involves staff from multiple offices in the center, who bring their
>> considerable medical and scientific expertise to the process.”
>>
>> But Gøtzsche said this is not the way it works when analysing regulatory
>> filings.
>>
>> “You can’t just divide up the pages among many staff members to get the
>> work done quicker,” explained Gøtzsche.
>>
>> “You need consistency to do the job right. It requires the same person
>> reading the data and looking for patterns. The more pages that person
>> analyses, the more familiar he or she becomes with how the data have
>> been documented and what has been hidden,” added Gøtzsche.
>>
>> More recently, regulatory documents have been digitised and are
>> available electronically, meaning they don’t come in hard copy, stacks
>> of paper.
>>
>> In some instances, this enables researchers to perform ‘keyword
>> searches’ to look for information, but sometimes, the pages have been
>> scanned or photographed, which does not allow word searches.
>>
>> My 2022 BMJ investigation found Japan’s drug regulator PMDA is the only
>> other major regulator that routinely receives IPD.
>>
>>
>> Currently, Tom Jefferson and colleagues at Trust the Evidence have spent
>> the last few months exploring the regulatory data sets for licensure of
>> Pfizer’s vaccine (Cominarty) thanks to a lawsuit filed against the FDA
>> by Aaron Siri, US attorney acting on behalf of the non-profit group,
>> Public Health and Medical Professionals for Transparency.
>
> In the interim, we are 100% prepared/protected in the "full armor of
> GOD" (Ephesians 6:11) which we put on as soon as we use Apostle Paul's
> secret (Philippians 4:12). Though masking is less protective, it helps
> us avoid the appearance of doing the evil of spreading airborne
> pathogens while there are people getting sick because of not being
> 100% protected. It is written that we're to "abstain from **all**
> appearance of doing evil" (1 Thessalonians 5:22 w/**emphasis**).
>
> Meanwhile, the only *perfect* (Matt 5:47-8 ) way to eradicate the
> COVID-19 virus, thereby saving lives, in the US & elsewhere is by
> rapidly (i.e. use the "Rapid COVID-19 Test" ) finding out at any given
> moment, including even while on-line, who among us are unwittingly
> contagious (i.e pre-symptomatic or asymptomatic) in order to
> "convince it forward" (John 15:12) for them to call their doctor and
> self-quarantine per their doctor in hopes of stopping this pandemic.
> Thus, we're hoping for the best while preparing for the worse-case
> scenario of the Alpha lineage mutations and others like the Omicron,
> Gamma, Beta, Epsilon, Iota, Lambda, Mu & Delta lineage mutations
> combining via slip-RNA-replication to form hybrids like "Deltamicron"
> that may render current COVID vaccines/monoclonals/medicines/pills no
> longer effective.
>
> Indeed, I am wonderfully hungry (
> https://groups.google.com/g/sci.med.cardiology/c/6ZoE95d-VKc/m/14vVZoyOBgAJ
> ) and hope you, Michael, also have a healthy appetite too.
>
> So how are you ?
>
I am wonderfully hungry!

Michael Ejercito wrote:
> HeartDoc Andrew, in the Holy Spirit, boldly wrote:
>> Michael Ejercito wrote:
>>
>>> https://www.reddit.com/r/LockdownSkepticism/comments/1dxs5v9/the_fda_cut_corners_brownstone_institute/
>>>
>>>
>>> The FDA Cut Corners
>>> BY Maryanne DemasiMARYANNE DEMASI JULY 6, 2024 GOVERNMENT, PHARMA,
>>> VACCINES 5 MINUTE READ
>>>
>>> SHARE | PRINT | EMAIL
>>> In 2020, governments around the world imposed brutal lockdowns across
>>> the population, promising a safe and effective Covid-19 vaccine was just
>>> around the corner.
>>>
>>> The Trump administration made no secret of the fact that it wanted the
>>> Food and Drug Administration (FDA) to hurry the process along.
>>>
>>> Stephen Hahn, then FDA commissioner, was summoned to the White House and
>>> asked to explain why he hadn’t moved faster to approve Pfizer’s Covid-19
>>> vaccine.
>>>
>>> It drew widespread criticism but Kayleigh McEnany, then White House
>>> press secretary, defended Trump saying he would “never apologize” for
>>> putting a fire under the FDA.
>>>
>>> Hahn appeared to resist the pressure – publicly at least.
>>>
>>> “We will make sure that our scientists take the time they need to make
>>> an appropriate decision,” said Hahn “It is our job to get this right and
>>> make the correct decision regarding vaccine safety and efficacy.”
>>>
>>>
>>> Former FDA Commissioner Stephen Hahn with President Donald Trump. Saul
>>> Loeb/AFP via Getty Images
>>> Soon after the November 3, 2020 election, Pfizer’s vaccine authorisation
>>> was imminent. But Trump would soon be replaced by President-elect Joe
>>> Biden, and lamented that his successor would get all the credit.
>>>
>>> “They will try and say that Biden came up with the vaccines,” said Trump
>>> to Fox News a week after the election. “The vaccines were me, and I
>>> pushed people harder than they’ve ever been pushed before.”
>>>
>>>
>>> Warp Speed Authorisation
>>> Pfizer (and its partner BioNTech) submitted its trove of clinical trial
>>> data to the FDA on November 20, 2020.
>>>
>>> The FDA completed its review and granted emergency authorisation for
>>> Pfizer’s investigational mRNA vaccine on December 11, 2020.
>>>
>>> The entire process took only 22 days.
>>>
>>> The FDA assured the public that it conducted “a rigorous review of
>>> laboratory and clinical data” but vaccine hesitancy was already sky-high.
>>>
>>> Pew research found that 49% of Americans said they would ‘probably not’
>>> or ‘definitely not’ get the vaccine in light of the fast-paced process.
>>>
>>> Reviewing the Trial Data
>>> Most regulators review data that have been curated by the trial sponsor.
>>> Australia’s TGA for example, never received the source data from the
>>> trial, only the aggregated data from the manufacturer in a dossier.
>>>
>>> The FDA, however, is one of the few regulators that receives and reviews
>>> the individual participant data (IPD) and other regulatory documents
>>> that underpin approval decisions.
>>>
>>> The data sets are enormous.
>>>
>>> Pfizer’s mRNA trial, for example, would collect data on each of the
>>> 44,000 subjects – consent forms, case report forms, baseline values, and
>>> tests from multiple follow-up visits.
>>>
>>> Typically, a trial that size would gather hundreds of thousands, if not
>>> millions, of pages.
>>>
>>> So, did the FDA receive the IPD and review it all?
>>>
>>> The FDA told me that it did, in fact, receive the IPD for Pfizer’s mRNA
>>> trial, and in 22 days it “carried out a full analysis of those data
>>> prior to authorizing the vaccine for emergency use.”
>>>
>>> The FDA’s vaccine chief Peter Marks boasted that the effort was ‘heroic.’
>>>
>>> “This was not business as usual,” Marks wrote in STAT. “FDA undertook an
>>> all-hands-on-deck approach to this work.”
>>>
>>>
>>> Peter Marks, director of FDA’s CEBR
>>> Peter Gøtzsche is a Danish physician and has many years of experience
>>> reviewing regulatory documents. He ridiculed the idea that a “thorough”
>>> review could be completed in that timeframe.
>>>
>>> “There’s no way the FDA carried out a ‘full analysis’ of the IPD in only
>>> 22 days,” remarked Gøtzsche. “It’s impossible. It would take a minimum
>>> of 6 months to pull off such a complex analysis.”
>>>
>>> “There can be millions of pages to a single trial. And if you are going
>>> to do a thorough analysis, it requires very careful detective work to
>>> review it all,” he said.
>>>
>>>
>>> Danish physician and expert reviewer of regulatory data Peter Gøtzsche
>>> Gøtzsche, who authored the book “Deadly Medicines and Organised Crime”
>>> has been an expert witness in court cases for people who’ve been harmed
>>> by psychiatric drugs.
>>>
>>> He says after analysing trial data that have been subpoenaed in legal
>>> cases, you really get a sense of just how much drug companies “lie and
>>> cheat” in the volumes of data.
>>>
>>> “I know from experience that drug companies try to bury harms. For
>>> example, they might use different words to describe the same harm so
>>> that it doesn’t get picked up when you’re searching for those key terms
>>> in the documents,” said Gøtzsche.
>>>
>>> “The only way the FDA could have finished a full analysis of Pfizer’s
>>> IPD in 22 days is if they cut corners or they only analysed the
>>> aggregated information submitted in the dossier,” he added.
>>>
>>> FDA Denies it Cut Corners
>>> The FDA rejected the idea that 22 days was insufficient time to
>>> thoroughly analyse the IPD.
>>>
>>> “The FDA uses a team-based approach to evaluate and analyze data, and
>>> staff with relevant knowledge, beyond the immediate review team, are
>>> also involved,” stated the agency.
>>>
>>> The FDA would not confirm exactly how many staff it assigned to the
>>> task, but added, “Review of clinical trial participant data generally
>>> involves staff from multiple offices in the center, who bring their
>>> considerable medical and scientific expertise to the process.”
>>>
>>> But Gøtzsche said this is not the way it works when analysing regulatory
>>> filings.
>>>
>>> “You can’t just divide up the pages among many staff members to get the
>>> work done quicker,” explained Gøtzsche.
>>>
>>> “You need consistency to do the job right. It requires the same person
>>> reading the data and looking for patterns. The more pages that person
>>> analyses, the more familiar he or she becomes with how the data have
>>> been documented and what has been hidden,” added Gøtzsche.
>>>
>>> More recently, regulatory documents have been digitised and are
>>> available electronically, meaning they don’t come in hard copy, stacks
>>> of paper.
>>>
>>> In some instances, this enables researchers to perform ‘keyword
>>> searches’ to look for information, but sometimes, the pages have been
>>> scanned or photographed, which does not allow word searches.
>>>
>>> My 2022 BMJ investigation found Japan’s drug regulator PMDA is the only
>>> other major regulator that routinely receives IPD.
>>>
>>>
>>> Currently, Tom Jefferson and colleagues at Trust the Evidence have spent
>>> the last few months exploring the regulatory data sets for licensure of
>>> Pfizer’s vaccine (Cominarty) thanks to a lawsuit filed against the FDA
>>> by Aaron Siri, US attorney acting on behalf of the non-profit group,
>>> Public Health and Medical Professionals for Transparency.
>>
>> In the interim, we are 100% prepared/protected in the "full armor of
>> GOD" (Ephesians 6:11) which we put on as soon as we use Apostle Paul's
>> secret (Philippians 4:12). Though masking is less protective, it helps
>> us avoid the appearance of doing the evil of spreading airborne
>> pathogens while there are people getting sick because of not being
>> 100% protected. It is written that we're to "abstain from **all**
>> appearance of doing evil" (1 Thessalonians 5:22 w/**emphasis**).
>>
>> Meanwhile, the only *perfect* (Matt 5:47-8 ) way to eradicate the
>> COVID-19 virus, thereby saving lives, in the US & elsewhere is by
>> rapidly (i.e. use the "Rapid COVID-19 Test" ) finding out at any given
>> moment, including even while on-line, who among us are unwittingly
>> contagious (i.e pre-symptomatic or asymptomatic) in order to
>> "convince it forward" (John 15:12) for them to call their doctor and
>> self-quarantine per their doctor in hopes of stopping this pandemic.
>> Thus, we're hoping for the best while preparing for the worse-case
>> scenario of the Alpha lineage mutations and others like the Omicron,
>> Gamma, Beta, Epsilon, Iota, Lambda, Mu & Delta lineage mutations
>> combining via slip-RNA-replication to form hybrids like "Deltamicron"
>> that may render current COVID vaccines/monoclonals/medicines/pills no
>> longer effective.
>>
>> Indeed, I am wonderfully hungry (
>> https://groups.google.com/g/sci.med.cardiology/c/6ZoE95d-VKc/m/14vVZoyOBgAJ
>> ) and hope you, Michael, also have a healthy appetite too.
>>
>> So how are you ?
>
> I am wonderfully hungry!