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!

While wonderfully hungry in the Holy Spirit, Who causes (Deuteronomy
8:3) us to hunger, I note that you, Michael, are rapture ready (Luke
17:37 means no COVID just as eagles circling over their food have no
COVID) and pray (2 Chronicles 7:14) that our Everlasting (Isaiah 9:6)
Father in Heaven continues to give us "much more" (Luke 11:13) Holy
Spirit (Galatians 5:22-23) so that we'd have much more of His Help to
always say/write that we're "wonderfully hungry" in **all** ways
including especially caring to "convince it forward" (John 15:12) with
all glory (Psalm112:1) to GOD (aka HaShem, Elohim, Abba, DEO), in
the name (John 16:23) of LORD Jesus Christ of Nazareth. Amen.

Laus DEO !