The scientific journal British Medical Journal (BMJ) has released a statement this week in which it expresses its concern about the study it published on the use of an unpublished dose of the drug proxalutamide in a patient with covid-19 in Brasilia. The treatment was prescribed by the endocrinologist Flavio Adsuara Cadegiani without proper scientific and ethical support. The statement is published after EL PAÍS denounced it. The magazine reinforces the concerns raised by Brazil’s National Health Council (CNS) about the experiment Cadegiani led, which would have used the same drug with 645 human guinea pigs in three Brazilian states and may have killed 200 people. According to BMJ, would be “among the worst violations of medical ethics in Brazil.”
In the case described in the article, a “critically ill” coronavirus-infected patient received a 600-milligram dose of proxalutamide at the Instituto Corpometria, Cadegiani’s private clinic in Brasilia. The drug, which is studied to treat cancer, is not authorized in Brazil and the doctor used it without the consent of the National Health Surveillance Agency (Anvisa) and without meeting the basic requirements of the National Research Ethics Council (CONEP) . The dose was higher than that registered in any other relevant scientific study consultation website, such as Clinical Trials and Pub Med.
At the time, the magazine BMJ responded to EL PAÍS that it would investigate the case. “Following concerns raised with the BMJ, we are investigating the use of the drug reported in this case (proxalutamide) and the circumstances surrounding its availability and license for use. While the investigation is taking place, we would like to alert readers to this expression of concern, ”the magazine reported.
On November 17, the magazine published an article titled EExperimental trial of a ‘cure for covid-19’ is one of the worst violations of medical ethics in Brazil’s history, regulators say, which also draws attention to the irregular investigation with proxalutamide in Brazil. The text cites not only the case of Brasilia, presented by EL PAÍS, but also the experiment with 645 people in the states of Amazonas, Santa Catarina and Río Grande del Sur, which is the subject of complaints by the CNS and CONEP.
“The proxalutamide clinical trial ‘ignores almost the entire protocol’ and may have contributed to the death of 200 people, reveals the CNS, the body that regulates clinical research in Brazil,” says the article. “Doctors prescribed the treatment as if it were an established medical treatment, the CNS said, even though it was only approved for clinical trials. The number of people who took the drug was also greater than what was approved for research, ”he continues.
“The Spanish newspaper EL PAÍS denounced that patients trusted that doctors would give them the best possible treatment, but were not informed that they were taking an experimental drug in the framework of a clinical trial. Some say that the medical team did not supervise the treatment. The consent form that was given to the patients omitted important information about the right of the study participants and also details about the study itself, the CNS said. Magazine BMJ reinforces the conclusion reached by the Council: “In the entire history of the National Health Council of Brazil, there has never been such a great lack of respect towards the ethical guidelines and the rights of the participants in a study.”
As Cadegiani was also not authorized to use the drug to treat a patient in his private clinic, the case has also become an object of investigation by Anvisa. The agency has stated that “it has identified discrepancies in the process of importing proxalutamide to Brazil and has adopted some investigative measures, which are ongoing.” However, it also states that “considering that the administrative investigation process is still ongoing —and it is secret— it is not possible to anticipate details about the measures taken. Flavio Cadegiani is also among the 80 suggestions to denounce the report of the Parliamentary Investigation Commission of the Pandemic for a crime against humanity.
The following also sign the article on the case that EL PAÍS denounced: Carlos Gustavo Wambier, dermatologist and professor at Brown University; Erica Lin, a Brown University medical student; and Andy Goren, dermatologist and medical director of Applied Biology. Wambier and Cadegiani defended themselves saying that the use of proxalutamide did not require Anvisa’s approval; that the 600 mg dose was “probably ideal”, although unpublished; and that the study with the drug was done without violating any ethical or procedural norm in the country. However, the main regulatory bodies for clinical trials in Brazil, and now the journal itself that gave space to researchers, challenge their statements.
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