Pesquisadores condenam produção e venda de inibidores de apetite
A Lei 13.454, de 23 de junho de 2017, que autoriza a produção, a comercialização e o consumo, sob prescrição médica, dos anorexígenos sibutramina, anfepramona, femproporex e mazindol, derrubou uma medida da Agência Nacional de Vigilância Sanitária de 2011, que havia proibido a comercialização de medicamentos desse tipo, e transformou em “decisão política” uma resolução que deveria ser estritamente técnica e baseada em evidências científicas. Em termos gerais, essa é a visão dos pesquisadores da Escola Nacional de Saúde Pública Sergio Arouca da Fundação Oswaldo Cruz (ENSP/Fiocruz). Os especialistas vão além, afirmam que o Estado tem o dever de proteger a saúde, e que cabe à Anvisa determinar, ou não, o uso de qualquer medicamento.
O Informe ENSP ouviu especialistas da área de toxicologia, epidemiologia, vigilância sanitária, assistência farmacêutica e segurança do paciente sobre a questionável decisão do Congresso Nacional. Todos os pesquisadores refutaram a sanção da lei, lembraram que esse tipo de aprovação pelo congresso brasileiro é única no mundo e questionaram os possíveis interessados na liberação dos inibidores de apetite.
UMA DECISÃO POLÍTICA E ÚNICA
Chefe do Laboratório de Toxicologia da ENSP, o pesquisador Francisco Paumgartten questiona a dimensão política do assunto em detrimento às evidências científicas do uso dos anorexígenos. Para ele, além da gravidade de contrariar uma decisão do órgão regulador, o Congresso Nacional não está preparado e não tem a competência necessária para realizar análise técnica das evidências de segurança eficácia dos inibidores de apetite. “A Lei de iniciativa parlamentar, do deputado Felipe Bornier, sancionada sem vetos pelo Executivo, transformou em decisão política a autorização para produção e comercialização de determinado medicamento no país”. (ouça no Podcast da ENSP o depoimento na íntegra)
Pamgartten afirma que trata-se um caso único – sem precedentes no cenário internacional – um Parlamento assumir a função de órgão nacional de regulação de medicamentos. “Não se tem notícia de que o Congresso Americano tenha deliberado sobre o registro de determinado medicamento e tenha revogado decisão da agência de drogas e alimentos (FDA). Não há registro de que o Parlamento Europeu tenha decidido sobre medicamentos específicos e desautorizado a Agência Europeia de Medicamentos. O mesmo pode ser dito dos parlamentos da Alemanha, França, Reino Unido, Japão, Austrália, e respectivas agências nacionais de regulação. Infelizmente, o Congresso Brasileiro não só foi único no mundo a assumir o papel da agência reguladora e ceder ao lobby de grupos de pressão política, como foi reincidente. No ano passado, contra a recomendação da Anvisa, o Congresso aprovou lei (também sancionada pela então Presidente da República sem vetos) autorizando o uso e dispensação da fosfoetanolamina, cujas alegadas propriedades anticâncer não haviam sido estudadas e demonstradas por ensaios clínicos”.
Segundo Paumgartten , o Congresso Nacional não está preparado e não tem a competência necessária para realizar a análise técnica das evidências de segurança e eficácia dos inibidores de apetite. “O mais grave no caso foi contrariar uma decisão do órgão (Anvisa) que tem as competências técnica e legal (Lei 9782/99 que cria a ANVISA) para decidir se este ou aquele medicamento é eficaz e seguro (Lei 6360/1976, Art 16, inciso II). Somente a Anvisa pode autorizar o acesso ao mercado consumidor e determinar em que condições o medicamento pode ser dispensado e utilizado com segurança”.
REAÇÕES ADVERSAS E INSTABILIDADE POLÍTICA
Suely Rosenfeld, pesquisadora do Departamento de Epidemiologia e Métodos Quantitativos em Saúde da ENSP, chama atenção para três aspectos sobre a aprovação da Lei: as reações adversas dos inibidores de apetite, o modelo de sociedade presente no país e a quem interessa essa aprovação. “A decisão de autorizar a comercialização desses medicamentos pelo Congresso Nacional é muito preocupante para os profissionais de saúde”. Suely destaca que a Anvisa, depois de muito debate, cancelou três dos quatro produtos liberados agora pela ineficácia e periculosidade. São ineficazes porque provocam uma perda de peso miúda e reversível e perigosos porque podem provocar fibrilação atrial, resultar em hipertensão arterial, nefrite intersticial e alguns outros efeitos adversos graves e não graves. “A lei reverte uma decisão correta da Anvisa, de anos atrás, que obteve amplo apoio dos profissionais de saúde”.
Outra análise feita pela pesquisadora diz respeito ao modelo de sociedade almejado. “Essa atitude se insere em um modelo de sociedade que não queremos, ou seja, uma sociedade de Estado mínimo, na qual o mercado ‘resolve’ todos os problemas. Há pessoas que defendem abertamente essa linha, mas ela não é a da saúde pública. É preciso ter Estado, ter regulação e ter proteção por parte dos órgãos de governo para que a população possa se sentir segura em relação à tecnologia da qual é usuária”.
PAPEL DA ANVISA É CONSTITUCIONAL
Vera Pepe, pesquisadora do Departamento de Administração e Planejamento e Saúde e do Centro Colaborador em Vigilância Sanitária da ENSP, lembra que não é a primeira vez que o Congresso Nacional delibera sobre questões exclusivas da saúde. Para ela, a Anvisa cumpre um papel, previsto na Constituição, de proteger a saúde da população. E a Lei contraria essa medida. “Há um certo perigo quando o Legislativo delibera sobre questões de saúde. Ocorreu o mesmo com a fosfoetanolamina, quando o congresso aprovou uma Lei que o próprio Supremo Tribunal Federal, por uma Ação Direta de Inconstitucionalidade, suspendeu. O STF alegou, na ocasião, necessidade de comprovação cientifica e afirmou que existe uma atribuição legal da Anvisa para controle dos medicamentos no país”.
Alguns autores consideram a aprovação da Lei 13.454 uma grave contrariedade a uma legitima decisão da Anvisa, que possui relatório técnico sobre o tema, recebeu orientação da Câmara Técnica de Medicamentos, promoveu consultas e audiências públicas. Portanto, a proibição de 2011 passou por processo democrático de consulta à sociedade. Se o legislativo passar a fazer aquilo que não é de sua competência, e pior, contrariando o que é de competência do órgão que, por lei, deveria fazer isso, cria-se um problema para democracia direta. Por isso, Abrasco e Idec pensam em uma Adin.
O Sistema Nacional de Vigilância Sanitária tem o dever constitucional de proteger a saúde da população. No SUS, essa ação cabe à Anvisa e, frente às evidencias cientificas que não corroboram a existência de uma boa relação benefício x risco desses medicamentos e à retirada desses medicamentos no mercados de países Europeus e dos EUA, ela tem a obrigação de proteger a saúde da população. A Agência Nacional de Vigilância Sanitária cumpre o dever constitucional de proteção da saúde.”
A SEGURANÇA DO PACIENTE
Victor Grabois, do Centro Colaborador para a Qualidade do Cuidado e Segurança do Paciente (Proqualis), afirma que a liberação desses produtos afeta diretamente a segurança do paciente o Brasil. “Esse assunto diz respeito à segurança do paciente. Não somente pela ausência de efetividade desses produtos, mas também pelos danos que provocam à saúde. Se sabemos, de antemão, da ineficácia de um medicamento, é claro que isso afeta a segurança do paciente. Várias dessas medicações contidas na lei não foram aprovadas ou tiveram sua venda proibida nos EUA e Europa.
Outro aspecto é que não diz respeito ao Congresso Nacional, e sim à Anvisa, definir sobre aquilo que deve ser introduzido no mercado. São aspectos de natureza técnica. É absurdo que algo que não possa ser usado nos EUA e Europa sirva para a população brasileira. Somos cidadãos que merecem usar produtos danosos à saúde?
Fonte: Ensp
Gostei.
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