The COVID-19 kit, often referred to as early treatment, is a term used to describe the denialist approach promoted by the Brazilian government led by Jair Bolsonaro and his supporters regarding the use of medications with no proven efficacy in treating COVID-19. This approach includes advocating for the use of drugs such as chloroquine, hydroxychloroquine, ivermectin, azithromycin, bromhexine, nitazoxanide, anticoagulants, and zinc supplements.
At the start of the pandemic, specifically in March 2020, chloroquine emerged as a possible treatment for the disease based on two studies of questionable quality. Notably, Donald Trump, United States President at the time, endorsed one of these studies, challenging the recommendations of the Food and Drug Administration (FDA), which led to the politicization of the issue. In Brazil, President Jair Bolsonaro quickly adopted this stance. In the following months, the Brazilian government took steps to promote chloroquine and hydroxychloroquine as treatments for COVID-19. This included ordering production, coordinating distribution, and spending approximately 90 million reais on acquiring these drugs. Additionally, the Ministry of Health, under the leadership of Eduardo Pazuello, expanded the use of these substances to treat mild cases of the disease.
The COVID kit created a false sense of security among the population, suggesting that life could return to normal without the need for social distancing measures. However, this approach led to an increase in infections, hospitalizations, and deaths. Furthermore, the widespread use of these medications, along with their potential side effects, caused significant harm to the kidneys and livers of users. This approach was widely criticized by health organizations and experts due to the lack of scientific evidence and the potential dangers associated with its use. Nevertheless, it became the subject of lawsuits and investigations related to possible favoritism involving public and private agents seeking financial gains.
Context
Having taken over the presidency in January 2019, Jair Bolsonaro consistently expressed interest in strengthening ties with then-President of the United States, Donald Trump. In the first half of 2020, as the COVID-19 pandemic intensified, Bolsonaro adopted rhetoric similar to Trump's, downplaying the severity of the disease's spread and advocating for the end of social isolation measures. Notably, Trump also supported the use of chloroquine based on a study published by the IHU-Méditerranée Infection Institute, a study that faced significant scrutiny from numerous scientists. Later, the institute's director, Didier Raoult, was accused by the French-Speaking Infectious Pathology Society (SPILF) of improperly promoting the drug. Shortly after Trump's endorsement, Bolsonaro also emphasized the efficacy of hydroxychloroquine, stating that "that drug, hydroxychloroquine, is working everywhere, right? I just got a French study sent to me now".
At the onset of the pandemic in Brazil, then-Health Minister Luiz Henrique Mandetta adopted the sanitary guidelines recommended by the World Health Organization (WHO). However, over time, increasing disagreements between Bolsonaro and the minister became evident. The then-president publicly advocated for the use of chloroquine and hydroxychloroquine while opposing social distancing measures. As a result of these divergences, Mandetta was fired, and oncologist Nelson Teich assumed the role of Health Minister, remaining in the position until May 15, 2020. His resignation stemmed from the government's push to expand the use of chloroquine in the treatment of COVID-19 patients and his perception that he lacked the necessary autonomy to lead the Ministry. Subsequently, Major General Eduardo Pazuello took over as interim Health Minister, being officially appointed four months later. During his tenure, the Ministry of Health promptly authorized the use of hydroxychloroquine for the treatment of patients with mild cases of COVID-19.
Throughout 2020, both Bolsonaro and Pazuello defended the use of drugs whose efficacy was under question. The federal government, in collaboration with the Brazilian Army and the Ministry of Foreign Affairs (Itamaraty), also coordinated the acquisition, production, and distribution of hydroxychloroquine. According to the Agência Pública, in March 2020 alone, the Brazilian Army produced and distributed 25,000 units of hydroxychloroquine. In total, over the course of that year, 3.2 million tablets of this drug were manufactured.
Manaus healthcare collapse
In January 2021, amid the worsening in the state of Amazonas, the Ministry of Health pressured the Manaus city government to distribute the medications in the so-called COVID kit. A document signed by Mayra Pinheiro, Secretary of Labor Management and Health Education, was issued by the ministry, stating that the non-use of these medications would be considered "unacceptable". Additionally, the document requested authorization to visit to promote early treatment in the city. Initially, the existence of this document was denied by Pazuello, but it was later acknowledged by Mayra Pinheiro herself.
During the same period, the Ministry of Health launched a mobile application called TrateCov on a trial basis, with the stated goal of assisting healthcare professionals, although it was accessible to anyone. The application sparked significant controversy by suggesting the prescription of various medications with unproven efficacy against COVID-19, including for newborns and animals. In response to criticism and the lack of scientific basis for its recommendations, the app was taken down the day after its launch.
On July 21, 2021, Jornal Nacional revealed the existence of documents obtained by the COVID-19 Parliamentary Inquiry Committee (COVID-19 CPI), which indicated the government's intent to persuade doctors and patients to use the medications in the COVID kit. According to the report, the Ministry of Health had funded a trip for 11 doctors to Manaus in January to train local healthcare professionals to prescribe medications with unproven efficacy against COVID-19. These doctors produced reports suggesting the establishment of "early treatment tents" to increase the availability of these medications and encourage self-medication with the COVID kit.
Parallel cabinet Following the establishment of the COVID-19 Parliamentary Inquiry Committee (COVID-19 CPI) in April 2021, information about the federal government's handling of the pandemic began to emerge. In the first testimony, former Health Minister Luiz Henrique Mandetta revealed the existence of a "parallel advisory group", later known as the parallel cabinet. The purpose of this group was to advise the federal government to adopt a stance against vaccination, instead promoting early treatment and the pursuit of herd immunity. Mandetta also reported facing internal competition within the government, with advisors, the president's sons, and doctors proposing a decree to include COVID-19 treatment in the chloroquine leaflet, a claim later confirmed by the then-director-president of the Brazilian Health Regulatory Agency (Anvisa), Antonio Barra Torres. As the investigations progressed, names such as Federal Deputy Osmar Terra, former government advisor Arthur Weintraub, doctor Nise Yamaguchi, and businessman Carlos Wizard were mentioned by the committee as possible members of the parallel cabinet. Documents from the Chief of Staff's Office also revealed that individuals identified as potential members of this group participated in at least 24 meetings to discuss the government's pandemic response strategies.
On June 4, 2021, the news outlet Metrópoles released a video of a meeting in which Bolsonaro met with several healthcare professionals, including Osmar Terra, Nise Yamaguchi, and virologist Paolo Zanotto. During this meeting, Zanotto suggested the creation of a "shadow cabinet" to advise the government on the pandemic. In this meeting, the participants also presented the then-president with opinions opposing vaccines and supporting the use of hydroxychloroquine.
Political interference in Conitec In July 2021, during Marcelo Queiroga's tenure, the Ministry of Health acknowledged the ineffectiveness of the COVID kit. This decision was based on an analysis conducted by the National Commission for the Incorporation of Technologies (Conitec), an advisory body of the Sistema Único de Saúde (SUS). However, despite this official stance, Bolsonaro and other government officials continued to advocate for early treatment.
On September 21, 2021, during the 76th United Nations General Assembly held in New York, Bolsonaro took the opportunity to defend early treatment. The following month, Conitec removed from its agenda the review of a study opposing the use of chloroquine in the treatment of COVID-19 patients. The Ministry of Health justified this decision, stating that the group of experts at Conitec chose to withdraw the document to refine the report. However, this sudden change surprised members of the body and raised suspicions of possible political interference.
Ministry of Health statement On December 7, 2021, Conitec approved a report that did not recommend the use of chloroquine, azithromycin, ivermectin, and other medications with unproven efficacy for the treatment of COVID-19. After the approval of this report, it was forwarded to the Secretariat of Science, Technology, Innovation, and Strategic Health Inputs of the Ministry of Health. However, it was subsequently blocked by Secretary Hélio Angotti Neto. At the same time, the Ministry of Health issued a statement that erroneously classified hydroxychloroquine as effective and vaccination as ineffective in combating COVID-19. This statement triggered widespread backlash and was condemned by experts and scientific organizations. Five days after the statement's release, the Ministry removed the table containing false information but upheld its decision to reject Conitec's guidelines.
The drugs Chloroquine and Hydroxychloroquine
Chloroquine and hydroxychloroquine are medications used to treat and prevent malaria, as well as to manage conditions such as rheumatoid arthritis and lupus erythematosus. Both drugs are administered orally. Chloroquine commonly causes side effects such as muscle problems, loss of appetite, diarrhea, and skin rashes. More severe side effects include vision problems, muscle damage, seizures, and a reduction in blood cell counts. Hydroxychloroquine may cause common side effects such as vomiting, headaches, vision changes, and muscle weakness, as well as severe side effects including allergic reactions, vision problems, and cardiac arrhythmias.
Both drugs can increase the pH in cellular compartments called endosomes and inhibit the fusion of the SARS-CoV-2 virus with host cell membranes. Additionally, chloroquine inhibits the glycosylation of angiotensin-converting enzyme 2, which may interfere with the binding of the coronavirus to the cellular receptor. In vitro studies suggest that these drugs may block the transport of SARS-CoV-2 from early endosomes to endolysosomes, potentially preventing the release of the viral genome.
However, despite demonstrating antiviral activity in some in vitro systems, hydroxychloroquine did not reduce viral loads in the upper or lower respiratory tract and showed no clinical efficacy. Two randomized clinical trials conducted in Brazil and the United Kingdom showed that these drugs did not improve clinical outcomes in patients with mild to moderate cases compared to standard treatment. Furthermore, the use of hydroxychloroquine did not reduce the risk of death or the need for mechanical ventilation.
Ivermectin