The Pfizer pivotal study is compromised and unreliable
A new paper in the British Medical Journal reveals that and how the Pfizer trial that led to the approval of the BioNTech vaccine was compromised [1]. Paul Thacker, an investigative journalist, reports on a whistleblower, Brook Jackson, who worked at one of the clinical centres, Ventavia in Texas. Ventavia is one of the largest clinical research service providers in Texas and was one of the companies that organized patients for the clinical trial and managed their data. These were “only” 1,000 of the approximately 53,000 patients, but the reported conditions speak volumes. For Jackson had repeatedly pointed out to the company management errors in implementation, poor data quality, patients whose complaints were not followed up, side effects that were not neatly registered, unblinding and any number of other problems.
It’s worth reading in the original. The bad thing is: Jackson had brought this to the attention of the US regulatory authority, the FDA. The FDA had neither replied nor pointed out the problems in its approval report. Instead, the whistleblower was dismissed without notice on the very day she reported the matter to the FDA. Research by the journalist shows that other employees who wished to remain anonymous confirmed the statements.
