“Study errors do not affect safety”

“Study errors do not affect safety”
“Study errors do not affect safety”

On the ‘Pfizer case’, “what was reported to the BMJ is not the scandal of the century, it is the testimony of superficiality and little care in small procedures. We do not create panic and insecurity”. So at Adnkronos Salute Aureliano Stingi, researcher in Molecular Biology and Genetic Oncology and ‘fact checker’ against fake news from the World Health Organization (WHO), comments on the allegations of ‘data falsification’ and ‘delays in monitoring side effects’ by the Ventavia research group, commissioned by the multinational Pfizer to evaluate, for a small part, the effectiveness of its anti-Covid vaccine. A story on which an article by investigative journalist Paul D Thacker, published in the ‘British Medical Journal’, pointed the finger.

If there are errors in a clinical trial they must be reported and prosecuted but be careful – he warns – also not to emphasize things that do not affect the safety of the vaccine. anti-Covid Pfizer. Safety and efficacy are testified by the FDA, by enormous studies and by real life, also considering that the vaccine has been administered to billions of people “.

Stingi then details the story. “Let’s clarify the context: Pfizer uses external companies to follow the amount of studies it carries out, this kind of ‘deep throat’ – says Stingi referring to the employee of Ventavia, subsequently fired for reporting irregularities –revealed some inaccuracies and errors made during the conduct of some trials, 3 to be exact, out of hundreds (153) made for Pfizer. Ventavia’s data correspond to 1000 participants out of 44 thousand. If one reads the news on the fly, he is struck but if he also analyzes the statements – he underlines – he sees that there are procedural errors, for example of syringes thrown in plastic bags and not in the suitable container; patient names visible, 2 days delay in reporting undesirable effects. Let’s say they are errors that do not affect the reliability of the vaccine “.

But should Pfizer have checked? “Pfizer relies on recognized professionals and FDA approved certified companies,” replies Stingi. “Obviously Pfizer, in its own interest, must check that whoever works for it does it well.”

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Study errors affect safety

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