Fernando Hellmann argues that the Brazilian Ministry of Health Guidelines for early drug treatment of patients diagnosed with COVID-19 is not based on scientific criteria and puts the health of Brazilians at risk.
During the pandemic, Brazilian President Bolsonaro dismissed two physicians who held the position of Minister of Health within the space of less than a month. The last, Nelson Teich, was replaced by an Army General with no training in the area whatsoever. One of the main reasons for the replacement was that the two preceding Ministers did not agree with approving treatment with chloroquine or hydroxychloroquine for mild cases of COVID-19 outside the hospital context.
Fast becoming the epicenter of the pandemic worldwide, on May 20 the Brazilian government launched new “Ministry of Health Guidelines for early drug treatment of patients diagnosed with COVID-19” that remain in force at the present day. These guidelines are not based on scientific evidence and their maintenance is a populist act that puts the health of Brazilians at risk.
The guidelines recommend the off-label use of chloroquine or hydroxychloroquine in association with azithromycin, even for mild and unconfirmed cases of the disease, in all care settings, including those that are not equipped to assess the cardiovascular conditions of the patient prior to the start of the treatment or at follow-up. While the US FDA on June 15, 2020 revoked the emergency use of chloroquine to treat COVID-19, the US government still delivered 2 million doses of hydroxychloroquine to Brazil “as a demonstration of solidarity”. Then on June 17, the Brazilian Ministry of Health expanded the early use of these drugs for children and pregnant women. It is important to note that these drugs have a multiplicity of adverse effects. There is a “Consent Form” attached to the new guidelines written by the Ministry of Health as a condition to access off-label treatments. The consent form mentions only one Chinese study (in vitro) and an anecdotal French study for the use of hydroxychloroquine or chloroquine to treat COVID-19. Even though a study on these drugs was retracted from The Lancet, other recently published studies have demonstrated scientific evidence of the ineffectiveness of the drugs mentioned and point to greater risks than possible benefits, such as a decrease in the number of survivors and increased frequency of ventricular arrhythmias.
A number of factors make matters worse. There is a lack of information on the risks of taking such associated drugs (hydroxychloroquine or chloroquine and azithromycin). The COVID-19 Treatment Guidelines Panel in the US recommends against the use of chloroquine or hydroxychloroquine with or without azithromycin for the treatment of COVID-19. In May, France, Italy and Belgium stopped treating COVID-19 patients with hydroxychloroquine, and the World Health Organization suspended studies on this drug for COVID-19.
Brazilians, like many nations, are living through a scenario of collective despair precipitated by the current experience of a pandemic caused by a potentially lethal virus. There is a lack of proven curative therapies, and vaccines are not yet available. A large part of the Brazilian population lives in conditions of social vulnerability with low levels of education. Therefore, it is possible that the vast majority of Brazilians will not be properly informed and empowered to exercise their decision-making autonomously. And it is this vulnerable population that Bolsonaro addressed when, on May 21, he said “Let the poor and the elderly use chloroquine for free,” disregarding the potential iatrogenic consequences of the massive use of these drugs. The “standard” consent form will serve to exempt physicians from their prescriptive responsibility rather than adequately informing patients.
Unfortunately, the Brazilian Medical Association and the Federal Council of Medicine have supported this regrettable “public health” measure. The National Academy of Medicine, the Brazilian Society of Bioethics, the National Health Council, and several scientific entities of research and teaching have been rightly opposed to the protocol. The exceptional nature of the moment cannot mean that rationality should be abandoned and the population be exposed to conditions of greater vulnerability.
In a population of 209 million, the use of chloroquine or hydroxychloroquine, which have potentially adverse side-effects, alone or in combination with azithromycin, for COVID-19 will not facilitate determination of the impact of such a measure on the health of Brazilian patients. Additionally, hepatitis and neutropenia are clinical manifestations of COVID-19, and hepatic and bone marrow dysfunction could be worsened by the off-label use of these drugs. Thus, it would be impossible to differentiate drug-related adverse effects from disease manifestations in the absence of a control group.
It is ethically inadmissible that the scope of the Brazilian government’s guidance puts the lives of thousands of Brazilians at risk as a consequence of a populist and ideological measure, implemented without scientific support. To not jeopardize the Brazilian population, the “Ministry of Health Guidelines for early drug treatment of patients diagnosed with COVID-19” should be abolished immediately in the name of the principle of non-maleficence: first, do no harm.
Fernando Hellmann is a Professor at Federal University of Santa Catarina, Brazil.