Prevent Senior Doctor Admits Mistake in Chloroquine Study Record

Prevent Senior physician Rodrigo Barbosa Esper, author of the study on the effectiveness of hydroxychloroquine in the treatment of patients with Covid, acknowledged that he made a mistake in the document’s record that analyzed the reaction of patients to the drug.

In testimony to the CPI of Prevent, conducted by the City Council of São Paulo, this Thursday (11), Esper said that he analyzed the data from the telemonitoring team of the operator’s patients with flu-like symptoms in early April 2020, days after the Covid’s first records.

Of the approximately 600 patients, in a total of 1,700 consultations, 1.9% of those who took the so-called “Covid kit”, consisting of drugs such as chloroquine and azithromycin —which have not been proven to be effective in treating the disease— needed hospitalization. Among those who did not take the hospital, the percentage was 5.4%.

“When I came across this, I understood that it was an ethical and moral duty to advise the medical community,” Esper said during his testimony to councilors.

Based on these data, the physician reported that he wrote an observational article and wrongly included it under the number of another type of investigation registered with Conep (National Commission for Research Ethics).

“I found out about the record at Conep of an outpatient study and, by mistake, I understood that there was a group writing the research protocols [sobre uso de hidroxicloroquina em pacientes com Covid]. I took that authorization, at dawn, and put it in the manuscript”, said the doctor about the procedure for registering scientific research.

To carry out research in Brazil, it is necessary to ask Conep for authorization. In Esper’s case, he used the record of a study by Prevent Senior’s colleague, physician Rafael de Souza da Silva, on a study to analyze the administration of hydroxychloroquine in about 200 of the operator’s patients for 28 days.

Souza da Silva’s study was authorized on April 14, but the data used by Esper went back to the end of March, so he could not have used the same record. Starting a study without authorization is an ethical violation, according to Conep.

Upon realizing the error, a few days later after repercussion of the information, Esper said that he automatically removed the study from the platform. “This was never published,” said the doctor, who was summoned by Conep at the time to give explanations. Then the study was suspended by the agency.

The director of Conep, Jorge Venâncio, said in testimony to the CPI of the Chamber that there was strong evidence of fraud in the study presented by the Prevent Senior physician.

In his testimony to councilors, Esper denied any type of experimentation with Prevent Senior patients, and acknowledged that there are off-label practices, the name given to the use of drugs for purposes not foreseen in the original package insert, as was the case with hydroxychloroquine during the pandemic.

Esper’s analysis of Prevent Senior’s telemonitoring numbers was published by President Jair Bolsonaro (non-party) on a social network.

Favorable to the use of chloroquine, Bolsonaro attributed the data to the president of the health operator, Fernando Parrillo, and used the numbers to defend the use of the “Covid kit”.

Esper complained about what he called the politicization of experimental treatment in the pandemic. “I want to make it clear that I’m not linked to any political party like Prevent Senior,” he said.

Prevent Senior’s CPI also heard this Thursday from three other members of the health operator: physician Rafael de Souza da Silva, director of the telemedicine department, clinical director Daniella Cabral de Freitas, and managing director Sérgio Antônio Dias Silveira

The doctors had been summoned to testify as witnesses to the CPI at last week’s session, but their participation was postponed until this Thursday. At the time, the doctors’ lawyer presented a preventive habeas corpus that guaranteed them the right to remain silent and not produce evidence against themselves.

At the time, in a statement, Prevent Senior said that it was expected that doctors would participate remotely, but as physical presence was required, the statements had to be postponed.

Upon being questioned by the president of the CPI, councilor Antonio Donato (PT), about sending messages to doctors about the duty to prescribe flutamide — yet another drug with no proven efficacy — to patients with Covid, Esper denied any interference in the autonomy of professionals.

Physicians heard acknowledged the existence of a clinical guide that guided care at the beginning of the pandemic.

First to be heard, physician Rafael de Souza da Silva, director of the operator’s telemedicine department, also denied any guidance that would interfere with the physician’s autonomy.

According to testimonies of doctors who denounced Prevent Senior to the Senate CPI, there was an express determination by the company’s management to prescribe the drugs in the “Covid kit”, despite the advance in research that led to the finding of the ineffectiveness of the drugs to treat the disease.

The doctor also denied that he signed all prescriptions for the “Covid kit” prescribed via telemedicine, information verified by the CPI, according to Donato.

The director of telemedicine acknowledged that, at the beginning of the pandemic, Covid kits were prescribed to patients with flu-like symptoms even without confirmation of coronavirus infection because “tests were scarce and took up to 14 days to obtain the result”.

Task force

Medical entities that are partners in the task force set up by the Public Ministry of São Paulo to investigate Prevent Senior will examine the operator’s patients who had health problems after taking the medication in the “Covid kit”.

At least four patients heard by prosecutors reported problems such as shortness of breath and arrhythmia during treatment.

The exams will be carried out by the APM (Paulista Association of Medicine) and by Cremesp (Regional Council of Medicine of São Paulo). The entities were also invited to analyze the medical records of Prevent Senior’s patients.

The task force is investigating whether the administration of the “Covid kit” has harmed or worsened the health of patients with heart disease.

This Wednesday (10), prosecutors received a terabyte of documents from members of the Senate CPI.