Research ethics in times of pandemic: the case of proxalutamide to treat COVID-19 in Brazil
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Federal University of Santa Catarina, Brazil
Federal University of Santa Catarina/Université de Montreal, Canada
Salud y Farmacos, United States
Publication date: 2023-04-26
Popul. Med. 2023;5(Supplement):A1666
The Brazilian Federal Senate created a Parliamentary Commission of Inquiry (CPI) to investigate the Bolsonaro governments irregularities in managing the COVID-19 pandemic. One of the cases that drew attention was the Proxa-Rescue AndroCov Trial, which tested proxalutamide, a second-generation, non-steroidal antiandrogen, against COVID-19 in Brazil. This study analyzes the ethical and scientific integrity issues related to its implementation. We analyzed the Senate CPI report, the letters from the National Research Ethics Commission, the article published by the researchers, the clinical trial records in Brazilian and US platforms, and the information disseminated by the media. Our findings show numerous problems. Even with 200 deaths from a total of 645 participants in the study, there was no interruption to the research. Researchers changed the consent form approved by the ethics board, omitting critical information such as the risk of using proxalutamide in pregnant women. There is evidence of conflict of interest between researchers and sponsors and problems associated with scientific integrity. It is a case of scientific fraud that transgresses national and international ethical guidelines. The proxalutamide study served as government propaganda to promote ineffective drugs against COVID-19