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 ?