RIO DE JANEIRO, BRAZIL – After a meeting with President Jair Bolsonaro, an enthusiast of the treatment of Covid-19 with Chloroquine and Hydroxychloroquine, the Federal Council of Medicine (CFM) announced on Thursday, April 23rd, the authorization to administer drugs containing these substances in patients with mild cases. Mauro Ribeiro, president of CFM, met with Bolsonaro in the morning.
Despite acknowledging that there is still no evidence of safety and efficacy in the treatment, the body states that release occurs due to the exceptionality of the pandemic.
The CFM has cleared doctors prescribing the drug of ethical violations in three circumstances. The first is for patients with mild symptoms at the onset of a clinical condition, in which other viruses (such as influenza, H1N1, dengue fever) have been ruled out and there is a confirmed diagnosis of Covid-19.
The use is also authorized for people with “significant symptoms” but who are not yet under intensive care or hospitalized.
In the last possible scenario, patients may be given the drug if they are in a critical condition and receive intensive care, including mechanical ventilation.
However, the CFM opinion points out that it is “difficult to conceive that in patients with established severe lung damage and, in most cases, systemic inflammatory response and other organic impairments, hydroxychloroquine or chloroquine may have a clinically significant effect”.
No evidence
In all cases, doctors need to clarify patients that there is no evidence to date of the benefits of using the drug against the novel coronavirus. They should also advise of side effects. In order to issue a prescription, a free informed consent form will need to be signed by the patient or relatives, if applicable.
In practice, doctors were already prescribing these drugs for mild cases of the disease, if they deemed it necessary. However, now there is the CFM’s endorsement that under these circumstances, an ethical infraction will not be committed by the prescribing physician.
The medical body, however, does not authorize the administration of the drug as a preventive measure for asymptomatic people or those who have not been confirmed as having Covid-19.
“The approach is that no strong scientific evidence sustains the use of hydroxychloroquine for the treatment of Covid-19. It is a drug widely used for other diseases, for 70 years now, but regarding the treatment of Covid there is no study, no prospective randomized clinical trial conducted by groups of respected researchers with papers published in a leading journal,” said the president of CFM, Mauro Ribeiro, when leaving the meeting with Bolsonaro.
The Minister of Health, Nelson Teich, also attended the meeting alongside the President. Bolsonaro is an enthusiast of chloroquine treatment and has already complained about the Ministry of Health’s more cautious stance towards the drug. The portfolio recommends its administration only for hospitalized patients, but has always acknowledged that doctors, by taking responsibility, may prescribe it for other cases.
Ribeiro emphasized that the CFM does not recommend the use of the drug, but releases its prescription at the doctors’ discretion, “within their professional independence, in a decision shared with the patient”.