This preprint includes data from human subjects that are under ethical scrutiny. The majority of patients enrolled were not informed nor agreed on participating in the study. The Brazilian National Comission for Research Ethics (CONEP) has been bypassed, documents have been tampered, and the situation is now under investigation.
References supporting this statement (both in English and in Portuguese):
https://brazilian.report/liveblog/2021/08/25/proxalutamide-military-trials/
Three of the references are not about this study, but from the South Arm instead. The other two references are from an Unesco statement that has been deleted a few days later. It means that none of the references has any validation. The Brazilian National Ethics Committee (CONEP) has never been bypassed, and there absolutely all the documents were shown. On the other hand, CONEP acted purely motivated by politics, by changing its behavior after a supposed support from the current government, did not respect the project protocol they approved, illegally disregarded a report from the responsible ethics committee approving all our data, illegally 'investigated' using unprecedented and highly questionable methods, and turned public confidential data. Not unexpectedly, so far we won in justice against CONEP president. This is a quite easy situation to understand, unless the analysis is media-based, politically motivated, and science and actual human ethics are forgotten.
Of note, BMJ defined it as "among worst medical ethics violations in Brazil’s history": https://www.bmj.com/content/375/bmj.n2819 .
The claim of that being the "worst medical ethics violations in Brazil’s history" came from a "regulator", according to the BMJ article.
The reference for that claim is an article in Portuguese that has never claimed that (although it has raised ethical concerns about the study being discussed here).
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