September 3, 2021

08:09

Bruno Pacheco – from Cenarium

MANAUS – The National Health Surveillance Agency (Anvisa) decided to suspend, this Thursday, 2, unanimously and cautiously, the importation and use of the substance proxalutamide in scientific research with humans in Brazil. The decision was announced in the late afternoon, on the website of the institution linked to the Ministry of Health (MS). The anti-androgenic drug, used to treat cancer, is studied in patients by the Samel Group, in Manaus, in the fight against Covid-19.

According to Anvisa’s decision, an administrative proceeding was also opened to investigate possible sanitary infractions with the presentation, by importers, of documents or information that aim to induce the agency to approve the irregular importation of drugs for use in humans. The institution also determined the establishment of an investigation dossier, aiming to obtain more information about the products based on proxalutamide imported and used in Brazil to take sanitary actions in order to mitigate the risk to users of these products.

“The decision was motivated by inquiries from the Attorney General’s Office in Rio Grande do Sul and by the news about research conducted with the use of proxalutamide in humans, which indicate that hospitals and clinics are using the product based on proxalutamide in spite of scientific studies approved by the Research Ethics Committee/National Commission on Ethics in Research (CEP/Conep)”, says the agency’s note.

The proxalutamide

The drug is a male hormone blocker (antiandrogen), still under development by the Chinese pharmaceutical company Kintor. The drug is being tested in patients with some types of cancer, such as prostate cancer, and, like chloroquine and ivermectin, drugs with no efficacy in fighting Covid-19, has been advocated by President Jair Bolsonaro against coronavirus.

According to the publication, Anvisa will request information from Conep about all approved researches using the substance proxalutamide in Brazil, including information about the status of the researches, respective amounts of the drug to be used in each one of them, and institutions authorized to conduct them.

Samel Group

In March of this year, the Samel hospital group presented a study, during a press conference in the capital of Amazonas, in which it points to proxalutamide as a drug that is also able to reduce the length of hospitalization and the number of patient deaths from Covid-19. The research, not yet published in a scientific journal, is done in partnership with the American biotechnology company specialized in developing drugs for hair diseases, Applied Biology.

The initiative tried to observe whether the drug prevented Covid-19 from entering the cells and decreased virus replication. The results, according to the researchers, were promising. In the event, the Samel Group highlighted that the use of the drug was responsible for a 92% reduction in deaths caused by the disease and a reduction in hospitalization time by about three times.

In all, 600 patients divided into two groups participated in the clinical trial. In the first group, proxalutamide was administered, and in the second, a placebo. In the proxalutamide group (296 patients) 12 deaths were recorded, only 3.7 percent of the total number of patients.

In the placebo group (294 patients), 141 deaths were recorded, equivalent to 47.6%. The conclusions of the study show that proxalutamide reduced the number of deaths, the length of hospital stay, inhibited the progression of Covid-19, and seems to act on the main mechanisms of death by coronavirus.

Deaths

Last week, columnist Malu Gaspar, of the newspaper O Globo, revealed that the National Research Ethics Commission (Conep) informed the Federal Public Ministry of Amazonas (MPF-AM) that researchers who tested proxalutamide in hospitals in the State, last February, did not comply with the rule that requires the reporting of deaths and adverse effects that occurred during the research spontaneously and within 24 hours.

The newspaper shows that the coordinator of the commission, Jorge Venâncio, states that the omission is a “serious failure”. “The non-notification of serious adverse events to the CEP/Conep system constitutes a serious failure in the conduct of the clinical trial,” says Venâncio, in a letter sent to the Federal Public Ministry, which is investigating irregularities in the study.

According to O Globo, the confidentiality of the civil investigation underway in the state of Amazonas was lifted on Wednesday, August 25, by the attorneys Michele Diz y Gil Corbi and Igor da Silva Spindola. According to the newspaper, the document, dated May 12, also states that it is impossible to assess the 92% effectiveness in reducing deaths that the researchers attributed to the experimental drug.

No return

CENARIUM contacted Samel Group, through the phone number 304 ending, from the communication department, requesting a position on the suspension of the use of the drug by Anvisa. As of the publication of this article, there has been no reply.