On Jan 20, 2022, in an unprecedented move, the Brazilian Secretary for Science, Technology, and Innovation overrode the Brazilian guideline for COVID-19 outpatient treatment. The guideline was originally demanded by the Ministry of Health, developed by a team of academics, specialists, and health technology analysts, according to GRADE-ADOLOPMENT methodology.1 The guideline, which recommended against the use of drugs without scientific proof of efficacy, such as hydroxychloroquine and ivermectin,2 was finally approved by the National Committee for Health Technology Incorporation (CONITEC) in December, 2021. In the Brazilian public health system, CONITEC has a central role in evaluating and recommending technology implementation on the basis of the scientific paradigms of efficacy, effectiveness, and cost-effectiveness.
Since the beginning of the COVID-19 pandemic, there has been endless and polarised debate regarding the use of unproven therapies for COVID-19 in Brazil, which, combined, are known as COVID Kit. COVID Kit was popularised by a populist federal government and, unfortunately, was adopted by some members of the medical community who failed to recognise the principles of scientific reasoning in medical decision making.3
Paradoxically, the anti-scientific decision against the guideline was taken by a secretary of science. The decision was accompanied by a long note of justification, which made use of epidemiological jargon to define a logic that clearly violated basic scientific principles. First, it suggested that statistical significance should not be a necessary condition for establishing drug efficacy; second, it proposed Bradford Hill criteria as a means to claim drug efficacy in the absence of controlled empirical observations, such as large and low risk of bias clinical trials; and finally, it concluded in favour of the effectiveness of hydroxychloroquine, while claiming that vaccination has no demonstrated effectiveness.4
It is natural for humans to suffer from intrinsic bias in the process of judgement. However, the present situation seems to be the result of a strongly polarised environment that led to this unfortunate conspiracy to replace scientific criteria with political interests.
Brazil has been an example of two opposite phenomena: the tendency of a populist government to undermine science, and the resistance of scientists under a strong democratic regimen that supports freedom of speech. We believe that with the support of the international scientific community, the latter will prevail.
© 2022 Francesca Gennari/Bloomberg/Getty Images
We declare no competing interests
References
- 1.Schünemann HJ, Wiercioch W, Brozek J, et al. GRADE Evidence to Decision (EtD) frameworks for adoption, adaptation, and de novo development of trustworthy recommendations: GRADE-ADOLOPMENT. J Clin Epidemiol. 2017;81:101–110. doi: 10.1016/j.jclinepi.2016.09.009. [DOI] [PubMed] [Google Scholar]
- 2.Ministry of Health Diretrizes Brasileiras para tratamento medicamentoso ambulatorial do paciente com COVID-19. November, 2021. http://conitec.gov.br/images/Consultas/Relatorios/2021/20211112_Diretrizes_Brasileiras_para_Tratamento_Medicamentoso_Ambulatorial_do_Paciente_com_Covid-19.pdf
- 3.Correia LC, Lopes JRP, Garcez FB, Campion EL, Barcellos G, Barreto-Filho JA. Physicians' preference towards the non-evidence based hydroxychloroquine treatment for COVID-19: the pandemic effect. Evidence. 2020;2:10–15. [Google Scholar]
- 4.National Commission for Health Technology Incorporation Fundamentação e decisão acerca das diretrizes terapêuticas para o tratamento farmacológica do COVID-19. 2021. http://conitec.gov.br/images/Audiencias_Publicas/Nota_tecnica_n2_2022_SCTIE-MS.pdf