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Rebuttal By Dr. Cadegiani To UNESCO's Accusation of Research Ethics Violations
An international organization posted a notice calling attention to Dr. Cadegiani's "possible ethical violations" after hit pieces were posted on random internet blogs. Here is his successful defense.
Google translated from Portugese:
CLARIFICATION OF THE UNESCO NOTE ON POSSIBLE ETHICS INFRINGEMENT
Endocrinologist Flávio Cadegiani comes to clarify the articles “For Unesco, the study of proxalutamide was one of the most serious violations of ethical rights in LA”, authored by Johanns Eller, published on October 8, 2021, on Malu Gaspar’s blog, on O Globo portal, and “Complaint about proxalutamide is one of the most serious in Latin American history, says Unesco”, published on October 11, 2021 on the Folha de São Paulo portal.
The texts already begin with untruth in the title, and the title of the Unesco note deals only with “possible ethical infraction”.
What is verified in the articles is that UNESCO was misled by biased statements, by untrue and distorted information provided by CONEP, resulting from illegal leaks, which are the subject of investigations by the control bodies and the Federal Court. Therefore, it is certain that UNESCO's manifestations are based on false premises, on narratives.
a) Initially, with regard to the statement of suspicions about 200 deaths in the study of proxalutamide, in Amazonas, it should be made clear that there were no suspected deaths by Conep, no suspicious circumstances. An opinion issued by the CEP/Conep System APPROVED all procedures and reports regarding the study in Amazonas (Opinion No. 4,690,573). This opinion was disregarded by Conep without any justification, and another was issued. But, in any case, it is certain that there were no suspicious deaths, since, after this study, OTHER 25 (TWENTY-FIVE) STUDIES were APPROVED with proxalutamide. After all, if there was even the slightest suspicion that proxalutamide caused someone's death, CONEP would never have approved any further study of the drug at all.”
b) The study approved by Conep did not include any hospital in Brasília. This is just another narrative by the Conep Coordinator, who did not even mention the name of the supposed hospital. The study was approved to be carried out in hospitals in Brazil, leaving the field open for the list of these hospitals (pages 8 of the approval opinion), which would be inserted in due course, with no deadline set for that;
c) As for the allegations that information on deaths was not provided within the deadline, these are also not true. According to the protocol approved by Conep, the ethical commitment would be to report serious adverse events within 24 hours, but only those resulting from the drug being tested. However, NO SERIOUS ADVERSE EVENTS resulted from the TEST MEDICATION. It is reiterated that CONEP subsequently approved 25 (twenty-five) other studies with THE SAME DRUG;
d) The researchers never refused to provide any clarification to Conep, they always promptly responded to all the commission's demands. At most, a request was made, in view of the leaks of strictly confidential information that occurred within the scope of that Commission, but which, in no way represented a refusal, it was just a request, to which Conep did not respond;
e) Regarding the claim that the tests should be interrupted, it is certain that, also according to the OPINION OF APPROVAL OF THE STUDY ISSUED BY CONEP, the interruption would only occur if the deaths were due to the use of the medication under study. An independent commission, indicated in the Research Protocol and duly approved by Conep, constantly monitored serious adverse events and deaths, and recommended the interruption at the appropriate time, and not due to deaths, since a total of ZERO deaths or events serious adverse events were associated with the drug;
f) The number of deaths reported was the SAME in ALL REPORTS. There were discrepancies due to untrue articles published by the media. Obviously, the number of deaths presented on March 11, 2021, when the survey was still taking place, is different from that verified at the end, in mid-April 2021.
As can be seen, there is not a single true information in which the UNESCO note, cited in the matters in question.
Contrary to what the text says, the scientific study obeyed all the strictest ethical principles, in addition to meeting all required formalities.
And who insists that everything is duly verified and clarified are the researchers.
Therefore, in the face of statements like these and of possible irregularities that come occurring in the conduct of procedures by CONEP member(s), as well as, in the face of statements that characterize leakage of information of a character strictly confidential, in violation of legal and regulatory norms, were made representations with the Ministry of Health - National Health Council, with the Office of the Comptroller General - CGU, and with the Attorney General's Office, for investigations, in order to protect the rights of the researcher, the rights of protection to the research, and, mainly, the protection of the research participants.
And more, in the face of untrue, distorted information and, with a clearly defamatory statement contained in the statements attributed to CONEP Coordinator, Jorge
Venâncio, is pending before the Federal Criminal Court, Criminal Interpellation, which already has with a favorable opinion from the Federal Public Ministry, and has already been granted by the MM. Federal judge competent.
In addition, the articles do not comply with the Journalists' Code of Ethics, Chapter III, Art.
12, item I - except for the specifics of the press office, OUVIR SEMPER,
BEFORE THE DISCLOSURE OF THE FACTS, the largest number of people and institutions involved in journalistic coverage, MAINLY THOSE WHO ARE
SUBJECT OF CHARGES NOT SUFFICIENTLY DEMONSTRATED OR
VERIFIED, as the reporter did not contact the doctor or his Press office.
Dr. Flávio Cadegani