Brazilian Federal Prosecutors Seek Suspension of Use of Chloroquine for Covid-19

RIO DE JANEIRO, BRAZIL – Federal public prosecutors in four states – São Paulo, Rio de Janeiro, Pernambuco and Sergipe – have forwarded petitions to the Ministry of Health, the National Health Surveillance Agency (ANVISA ), the Federal Audit Court (TCU) and the Federal Medicine Council seeking suspension of the note from the Jair Bolsonaro government endorsing the use of chloroquine and hydroxychloroquine in the treatment of patients with Covid-19.

The Prosecutor’s Office also pointed out the lack of tests for the novel coronavirus in the country.

According to the Federal Prosecutor’s Office, the Ministry of Health has not complied with the legal procedure for registering drugs established by ANVISA and for incorporating technology into the Single Health System.

The federal government’s recommendation extended drug use to patients with mild and moderate Covid-19 cases – formerly, the two substances received the agency’s endorsement only for critically ill patients.

The prosecutors point out that the federal government’s new approach does not meet the minimum safety, efficacy and monitoring criteria for patients during use, contrary to the agency’s resolution.

The prosecutors further note that the incorporation of chloroquine and hydroxychloroquine can be swiftly carried out by the SUS’ National Commission for Technology Incorporation, but the efficacy, safety, and cost-effectiveness of the treatment must be demonstrated.

A study published by the Lancet conducted with more than 96,000 hospitalized patients showed that the use of chloroquine or hydroxychloroquine in patients with the novel coronavirus, even when associated with antibiotics, increased the risk of death and cardiac arrhythmia. The research is the largest ever conducted on the drugs’ effects.

“We were unable to confirm any benefit of chloroquine or hydroxychloroquine in Covid-19 hospitalized patients’ results. Both drugs have been associated with reduced survival of patients hospitalized and increased frequency of ventricular arrhythmia when used in the treatment of Covid-19,” concludes the study led by Professor Mandeep Mehra of Harvard Medical School.

The World Health Organization has also suspended clinical trials under its coordination worldwide until it was confirmed that chloroquine and hydroxychloroquine are safe for patients.

The Ministry of Health’s information note was published on May 20th and released the use of chloroquine to all Covid-19 patients in the country. The document authorizes the drug to be prescribed from the earliest symptoms of the disease, although there is no scientific evidence of its effectiveness.

President Jair Bolsonaro himself, who advocates the use of the drug, said there is no evidence the substance will help in treatment, but compared the drug’s prescription to fighting a war to support his claim to release it.

The Prosecutor’s Office also pointed out that, according to the government resolution, only patients who tested positive for the novel coronavirus should use chloroquine. However, the national testing plan is not able to meet the demand in early symptoms, with only the most critical cases being tested.

A further point that relates the lack of testing and the use of the drug is the SUS’ inability to adequately monitor people treated with chloroquine. The prosecutors note that in some cases at least three ECGs must be performed throughout the treatment, according to the Brazilian Society of Cardiology.

If a patient is not hospitalized, monitoring the condition becomes difficult and exposes the patient to the risk of adverse reactions.