TAPED CALL: FDA Admits No "Stats Testing on Adverse Events" of Pfizer mRNA Vaccine Despite 7yo Death

Summary

In a critical meeting with FDA directors, researchers express deep concerns about the agency's approach to analyzing adverse events related to vaccines. The discussion highlights the FDA's reliance on participant counts over event counts in clinical trials, arguing this underrepresents the potential harms of vaccines. The researchers question the FDA's dismissal of statistical significance testing and the efficacy of current surveillance systems, citing real-world data discrepancies. They emphasize the need for more robust monitoring and a reevaluation of how vaccine safety is assessed, revealing systemic issues that could undermine public trust in health authorities.

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Q & A

What was the main critique raised by the directors regarding the study's analysis?

The directors critiqued that the study analyzed the total number of serious adverse events (SAEs) rather than the number of participants who experienced at least one event.

Why does the FDA not count the number of serious adverse events in clinical trials?

The FDA counts only the number of participants with events to ensure a clearer understanding of safety data, as multiple events in a single participant are counted as one.

What concern did the researchers express about the FDA's approach to analyzing adverse events?

Researchers were concerned that the FDA was evaluating randomized controlled trial data as if it were observational data, which undermines the reliability of findings.

How does the FDA justify not performing statistical significance testing on adverse events?

The FDA claims that they only look for large differences that are obvious without needing statistical tests, which the researchers found to be inadequate.

What is the significance of randomization in clinical trials according to the researchers?

Randomization is crucial as it helps identify causal relationships between the medical intervention and any observed adverse events.

What was the reaction of the researchers to the FDA's handling of adverse event reports?

The researchers were alarmed by the FDA's lack of follow-up on serious cases, such as a pediatric cardiac arrest following vaccination.

What is the concern regarding real-world data as mentioned in the transcript?

Real-world data, often considered observational, is viewed as unreliable compared to clinical trial data, raising questions about its validity in assessing vaccine safety.

What conflict of interest did the researchers highlight regarding the FDA?

The researchers pointed out that the same individuals approving vaccines are responsible for evaluating their safety, creating a potential conflict of interest.

How does the transcript suggest improving vaccine trial oversight?

It suggests that independent government oversight should be responsible for conducting trials and evaluating drug efficacy, rather than allowing pharmaceutical companies to manage their own trials.

What broader implication does the discussion have on drug approval processes?

The conversation underscores the need for transparency and accountability in drug approvals, highlighting systemic issues that could compromise public trust in medical interventions.