September 23, 2021

08:09

Gabriel Abreu – from Cenarium

MANAUS – A scientific study with the drug proxalutamide – conducted and sponsored by the Samel network of hospitals – may have been responsible for the death of 200 patients with Covid-19, in Amazonas. The accusation of the study designed by physician Luís Alberto Nicolau was made last week by the National Ethics and Research Commission (Conep), of the National Health Council (CNS), to the Attorney General’s Office (PGR).

The PGR’s advisory office reported on Wednesday, 22, that there was a decline in jurisdiction for the Federal Public Ministry of the Federal District (MPF-DF), while the MPF-DF said the complaint is being investigated by the 2nd Office of citizenship, security and education of the entity. According to the report forwarded to the Public Ministry, in the clinical trial there was a high rate of Serious Adverse Events (SAE) in grade five, with deaths evidenced in the list.

Initially, Conep had granted a favorable opinion for the research to be conducted with 294 volunteers in Brasilia. However, Flávio Cadegiani would have started to apply the study without authorization in Amazonas, during the month of February, and only later requested an extension of the research in Manaus, Parintins, Itacoatiara, Coari, Manacapuru, Maués, and Manicoré.

Hypotheses

Conep coordinator Jorge Venâncio says there are two basic hypotheses about the substance used to combat Covid-19. “They made a very serious mistake because they would have had to stop the research after the deaths of the participants. The other hypothesis is that the result is entirely rigged. They subjected 200 people to die in research that has no scientific value whatsoever. It is completely absurd”, affirms Venâncio.

Conep also identified problems in the formation of the Independent Committee, a Conep requirement for clinical trials. “Every research has to have a committee formed by technicians that are not related to the institution or to the research supporter, people from outside, for the safety of the participants. In this case, besides not informing the complete composition of the committee, it is coordinated by a person from the company that funded the research”, adds Venâncio.

Suspension

On September 2, the National Health Surveillance Agency (Anvisa) decided to suspend the importation and use of the substance proxalutamide in scientific research with human beings in Brazil. 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 intended 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 for users of these products.

“The decision was motivated by inquiries from the Public Prosecutor’s Office in Rio Grande do Sul and by the news about the conduct of research using 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 a note from the agency.

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 the coronavirus.

According to the publication, Anvisa will request information from Conep about all approved researches with the use of 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 can also reduce the time of hospitalization and the number of deaths of patients 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.

In all, 600 patients divided into two groups participated in the clinical study. In the first group, proxalutamide was applied, and in the second, another 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 time of hospitalization, inhibited the progression of Covid-19, and seems to act on the main mechanisms of death by coronavirus.

Prevent Senior

Folha de São Paulo released information about a dossier signed by 15 doctors, where it pointed out that professionals from Prevent Senior were coerced to prescribe drugs such as hydroxychloroquine without consent of the patients’ relatives and were forced to work even when infected with the coronavirus.

In addition, the document states that Prevent allegedly omitted seven deaths during a clinical study on the efficacy of the drugs. Walter Correa de Souza Melo, one of the doctors who made the denunciations, recorded the telephone conversation of a call with Batista Júnior, after he reported irregularities to the press, under condition of confidentiality.

Analyses

The Federal Public Ministry of Amazonas (MPF-AM) reported that it opened, in April this year, a procedure to ” to investigate possible irregularity regarding possible serious failures and fraud in a study on the hormone blocker proxalutamide in the fight against Covid-19, in the network of Samel hospitals in Amazonas, in the period from February 2 to March 22, 2021.

After analyzing the information collected during the investigation and considering the closure of the studies, the MPF concluded that, “in the context of collective rights, there are no measures to be adopted in this specific area of action of the body, through the Regional Office of the Attorney General for the Rights of the Citizen, and determined the closure of the procedure”, says an extract from the note.

The MPF forwarded the records of the procedure to the Regional Medical Councils in the states of the doctors involved in the research, suggesting the opening of disciplinary administrative proceedings (PAD) against the professionals. The case was also forwarded to the criminal area of the MPF to investigate the occurrence of a possible crime. In this sphere of action, the MPF has already opened a procedure, which is being handled confidentially. The Center for Combating Corruption of the MPF in the Amazon will also evaluate the case to investigate possible omission of public officials.

Samel takes a position

Samel Group informed through a note that the death records pointed out refer to the research conducted throughout the state of Amazonas and that it can only respond for patients who used the drug in their hospital units.

“Further clarifications on the use of proxalutamide in other cities in the country and in other health centers that are not part of the Samel network should be requested directly from the researcher responsible for the study of proxalutamide in Brazil, who has already spoken on his social networks on the subject”, says another part of the note.