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