COVID AND THE VACCINE - TRUTH, LIES, AND MISCONCEPTIONS REVEALED, page-55920

For the second time, the FDA hasavoided answering very simple questions about discrepancies concerning the numbers of deaths in Pfizer’s clinical trial, citing “resourceconstraints” and blaming its workload, in part, on ICAN’s FOIA requests.

Back in February, ICAN announced it sent a letter to the FDA regarding discrepancies in thereports of death in the Pfizer Covid-19 clinical trial data. Specifically, ICAN sought answers to two questions, both critically important because inPfizer’s Covid-19 vaccine clinical trial the final death count in the vaccine group was higher than in the placebo group:

(1) Why do the death counts in the Statistical Review not add up to the numbers in theClinical Review Memo from whichthey are said to be sourced and why do both of those differ from the death counts in the Summary Basis for Regulatory Action?

(2) Why are the death data from a randomized controlled trial (“RCT”)treated like a clinical case-series rather than an RCT when it comes to assessing causality? And can you confirm that causality (abiostatistical construct in this case) is being assessed by biostatisticians rather than by clinicians?

Despite the enormity of the issue that ICAN was raising– people who died during a clinical trial – the FDA failed to respond, prompting ICAN to send a follow up on April 2022 reiteratingthose same two questions.

Incredibly, when the FDA did respond, it did not provide ananswer to either of the two questions posed. Instead, the individuals at FDA’s Center for Biologics Evaluation and Research took the timeto contact the FDA’s FOIA office and obtain a count of the total number of ICAN’s outstanding FOIA requests and then cite them as thereason it was unable to “respond substantively”:

We are unable to respond substantively at this time due to resource constraints and the ongoing pandemicresponse. It is thus necessary for the Agency to prioritize its responses to individual inquiries. We note that the Agency is providing toyour law firm, in response to a FOIA request, an unprecedented volume of records that comprise the license application for thisproduct. Additionally, there are more than 50 pending FOIA requests submitted by your firm for data and information about COVID‐19vaccines.

Perhaps the FDA should have properly done its job when approving Pfizer’s vaccine. Then it would not need to devote an incredibleamount of resources to trying to cover-up its abject failure in approving and promoting a product with serious safety and efficacy issues. Thatwould free up a lot of FDA time – just being transparent and honest about its mistakes. Consider this: in the time it took to obtain theFOIA count, the FDA could have simply provided a substantive and adequate response to the questions asked. These are dead people – one wouldimagine you would have the numbers right. The FDA instead chooses to avoid answering by giving an excuse akin to “my dog ate myhomework.”

This is yet another exhibit in the mountain of evidence as to why the FDA needs to be dismantled and rebuilt form the ground-up as anorganization that actually serves the public interest and not that of pharma and its political handlers. ICAN intends to continue to shine alight on these issues until this comes to pass.

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