For the second time, the FDA has avoided answering very simple questions about discrepancies concerning the numbers of deaths in Pfizer’s clinical trial, citing “resource constraints” 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 the reports of death in the Pfizer Covid-19 clinical trial data. Specifically, ICAN sought answers to two questions, both critically important because in Pfizer’s Covid-19 vaccine clinical trial the final death count in the vaccine group was higher than in the placebo group:
- Why do the death counts in the Statistical Review not add up to the numbers in the Clinical Review Memo from which they are said to be sourced and why do both of those differ from the death counts in the Summary Basis for Regulatory Action?
- 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 (a biostatistical 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 reiterating those same two questions.
Incredibly, when the FDA did respond, it did not provide an answer to either of the two questions posed. Instead, the individuals at FDA’s Center for Biologics Evaluation and Research took the time to 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 the reason it was unable to “respond substantively”:
We are unable to respond substantively at this time due to resource constraints and the ongoing pandemic response. It is thus necessary for the Agency to prioritize its responses to individual inquiries. We note that the Agency is providing to your law firm, in response to a FOIA request, an unprecedented volume of records that comprise the license application for this product. Additionally, there are more than 50 pending FOIA requests submitted by your firm for data and information about COVID‐19 vaccines.
Perhaps the FDA should have properly done its job when approving Pfizer’s vaccine. Then it would not need to devote an incredible amount of resources to trying to cover-up its abject failure in approving and promoting a product with serious safety and efficacy issues. That would free up a lot of FDA time – just being transparent and honest about its mistakes. Consider this: in the time it took to obtain the FOIA count, the FDA could have simply provided a substantive and adequate response to the questions asked. These are dead people – one would imagine you would have the numbers right. The FDA instead chooses to avoid answering by giving an excuse akin to “my dog ate my homework.”
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 an organization that actually serves the public interest and not that of pharma and its political handlers. ICAN intends to continue to shine a light on these issues until this comes to pass.
