An irregular experiment with human guinea pigs that would have left at least 200 deaths.
It is what the Brazilian authorities investigate, after the National Ethics Commission in Research (CONEP) denounced a few days ago an irregular study to test in patients with Covid-19 Proxalutamide, an experimental drug that is used to treat some types
Of cancer.
The CONEP, an organ ultimately linked to the Ministry of Health, formally requested the Prosecutor’s Office to investigate “the death of 200 people who participated in the study conducted with a proxalutamide in the State of Amazonas”, since according to the body, it was full
of irregularities.
The trial, led by the Endocrine Flávio Cadegiani and sponsored by the network of private hospitals SAMEL, was approved by the authorities at the end of January, but there was practically no one of the tax requirements.
Initially, the tests were going to be done with 294 volunteers in Brasilia, but the drug began to be applied without authorization in patients of Manaus and other cities in the State of Amazon.
In the end, there were 645 people.
In addition, the researcher stated that the proxalutamide would be administered to mild and moderate patients, but the results showed that the deaths were caused by renal or liver failure, characteristics of very serious patients.
In addition, at first the researcher pointed out that 170 people died, but then the figure rose to 178, and in a third version it was reached 200.
“There are two basic hypotheses: let’s say what they are saying is true and that the substance has a spectacular effect to fight the Covid-19, they committed a very serious mistake, because they would have to have interrupted the investigation after the death of the participants. The
Another hypothesis is that they have totally falsified the result. They broke out 200 people in an investigation that has no scientific value, is a complete absurd “, criticized the coordinator of the Conep, Jorge Venâncio.
The research was suspended by order of the CONEP at the end of May, but even so the researchers made a request to register other research centers, this time in the state of Santa Catarina.
They also conducted another clandestine clinical trial with proxalutamide in a military hospital in the city of Porto Alegre.
Last week, researchers from the Latin American and Caribbean Network of Education in Bioethics of UNESCO reported a note alert that this could be one of the “more serious and more serious episodes of ethical infringement and human rights violation of patients
In the history of Latin America. ”
“No health emergency or political or economic context justifies facts like these,” said the body, asking responsibilities to be investigated and depuff.
Last month, the National Health Surveillance Agency (ANVISA), the regulatory body in Brazil, vetoed the use of proxalutamide in clinical trials in the country.
In July, President Jair Bolsonaro defended the use of the substance in the fight against the disease, even though its effectiveness is not proven.
He also did it with other medications like, such as chloroquine, hydroxychloroquine and ivermectin.
To defend themselves from the accusations, Cadegiani, the doctor at the front of the study, stated that the CONEP used distorted information, denies that it will falsify certificates of ibito and affirm that the 200 notified deaths were not users of the substance, but of the group it took
A placebo, so they died from Covid-19.
In addition, he attacked the coordinator of the CONEP accusing him to defame the investigation only because Bolsonaro spoke in favor of the proxalutamide.
Venâncio rebuked that there is no problem with the substance (which was previously used in other studies carried out correctly), but with the lack of respect with the people involved.
He considers that if it is true that those who died were part of the placebo group and the others were healed, the study would have to be renewed.
“You can not passively observe so many people dying and not take action,” he said.
