title: Miracle drug: Brazil approves never-tested cancer medicine.
abstract: Background Brazil recently approved synthetic phosphoetanolamine, a popularly dubbed 'cancer pill', a substance that has been shown to kill cancer cells in lab animal models but was not yet formally accessed in humans, and thus despite the existence of any evidence of its efficacy and safety. Methods The authors describe the recent decision of Brazil to aprove phosphoetanolamine in the context of growing 'judicialization' to promote access to medicines and thus reinforcing a growing sense of legal uncertainty. Results The approval of phosphoetanolamine despite the existence of any evidence of its efficacy and safety represents to the authors one of the saddest and surrealistic episodes in Brazil's recent public health history. Brazil's current economic crisis is fueling the 'judicialization' to promote access to medicines and thus reinforcing a growing sense of legal uncertainty in the context of rising economic constrains and a progressive failing state. The authors state that the Phosphoetanolamine's approval bill violates current legal prohibition of commercialisation of drugs without the Brazilian national drug regulatory agency's approval and thus may represent a potential menace to Brazil's pharmacogovernance and the country's governance to health technology assessment at the Brazilian national health systems. Conclusion Phosphoetanolamine's approval illustrates that the combination of flawed decision making, economic crisis and political interference may threaten weak governance mechanisms for drug regulation and health technology assessment and thus representing an extra burden in the sustainability of universal access-based national health systems.
authors: Graduate Studies in Epidemiology, Instituto de Avaliação de Tecnologia em Saúde (IATS), Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
authors: Ricardo S
authors: RS
authors: Kuchenbecker
authors: Graduate Studies in Epidemiology, Instituto de Avaliação de Tecnologia em Saúde (IATS), Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
authors: Daniel M
authors: DM
authors: Mota
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001938:Brazil; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004341:Drug Evaluation / Q000331:legislation & jurisprudence; D004983:Ethanolamines / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D011057:Politics; D013673:Technology Assessment, Biomedical / Q000331:legislation & jurisprudence
chemical_list: D000970:Antineoplastic Agents; D004983:Ethanolamines; C005448:phosphorylethanolamine
keywords: Pharmacovigilance; drug safety; health technology assessment; pharmacogovernance; rational use of medicines