The death of 200 patients admitted to various hospitals in Brazil after participating in a study of an experimental drug against covid-19 has alarmed the country, where the National Research Ethics Commission (CONEP) has already opened an investigation. This body authorized a study with proxalutamide at the beginning of this year 2021, however it claims that the trial carried out in the State of Amazonas involved more people than had been approved at the beginning since 645 human guinea pigs participated in the study when in fact only 294 participants had been authorized.
The study was carried out with “critically ill intensive care patients”, but CONEP claims that it had not been approved. The newspaper El País explains the case of Zenite Gonzaga Mota, 71, who began to suffer the symptoms of covid-19. She soon became a human guinea pig in a hospital 270 kilometers from Manaus, capital of the Amazon region, to test on covid patients proxalutamide, an experimental drug that is applied for some types of cancer but that “is not registered in Brazil and is not used in any treatment in the country”. The newspaper reports that neither she nor her relatives knew that she was part of an experiment that has placed Brazil at the center of a scientific scandal. After taking three capsules a day of proxalutamide and inhaling daily doses of hydroxychloroquine, Zenite died and now her family is asking the authorities for explanations as to whether the death is related to the new treatment.
“There are indications of irregularities in the study, as well as transgressions of the current norms on ethics in research with human beings,” states a document signed by the coordinator of CONEP, Jorge Venâncio, on September 3. The organization received several reports of the same experiment in Manaus, Maués and Parintins, all in the State of Amazonas, in northern Brazil, although cases have also been detected in the south of the country.
On October 9, researchers from Unesco’s Latin American and Caribbean Network for Bioethics Education pointed out in a document that this could be one of the “most serious and grave episodes of ethical violation” and “violation of the human rights” of patients in the history of Latin America. “It is urgent that, if irregularities are proven, all those involved be investigated, the text says.