Mais de 100 especialistas alertam para falhas em estudo que condenou o uso da cloroquina no mundo
O responsável pelo programa de malária da OMS, Pedro Alonso, afirma que o trabalho, o maior sobre o medicamento já feito e publicado na The Lancet, tem “inconsistências alarmantes”
Mais de 100 médicos e estatísticos de vários países lançaram um alerta sobre graves irregularidades no maior estudo sobre a eficácia da cloroquiba e da hidroxicloroquina contra a covid-19 os responsáveis pela iniciativa exigiram que os dados do trabalho sejam revistos para que ele seja corrigido ou retirado. O estudo em questão provocou uma tempestade mundial em torno de dois possíveis tratamentos que há poucos meses eram considerados os mais promissores contra a doença, mas que agora parecem ter caído em desgraça. O trabalho foi uma análise de dados anônimos de mais de 96.000 pacientes em 600 hospitais do mundo todo. Concluiu que a cloroquina e a hidroxicloroquina não só não oferecem nenhum benefício para os pacientes, como também podem aumentar o risco de morte em 30%. O trabalho foi publicado na The Lancet, uma das revistas científicas de maior prestígio do mundo.
Mais de 100 especialistas alertam para falhas em estudo que condenou o uso da cloroquina no mundo
O responsável pelo programa de malária da OMS, Pedro Alonso, afirma que o trabalho, o maior sobre o medicamento já feito e publicado na The Lancet, tem “inconsistências alarmantes”

Mais de 100 médicos e estatísticos de vários países lançaram um alerta sobre graves irregularidades no maior estudo sobre a eficácia da cloroquina e da hidroxicloroquina contra a covid-19. Os responsáveis pela iniciativa exigiram que os dados do trabalho sejam revistos para que ele seja corrigido ou retirado.null
- O que fez a OMS suspender os ensaios com a hidroxicloroquina
- Um em cinco hospitalizados na Espanha por covid-19 morreu, e cloroquina foi usada em 85% dos casos
- Maior estudo sobre cloroquina e hidroxicloroquina demonstra que aumentam risco de arritmias e morte
null
O estudo em questão provocou uma tempestade mundial em torno de dois possíveis tratamentos que há poucos meses eram considerados os mais promissores contra a doença, mas que agora parecem ter caído em desgraça. O trabalho foi uma análise de dados anônimos de mais de 96.000 pacientes em 600 hospitais do mundo todo. Concluiu que a cloroquina e a hidroxicloroquina não só não oferecem nenhum benefício para os pacientes, como também podem aumentar o risco de morte em 30%. O trabalho foi publicado na The Lancet, uma das revistas científicas de maior prestígio do mundo.nullPUBLICIDADEnull
Como resultado desses dados, a Organização Mundial da Saúde (OMS) suspendeu o uso deste medicamentos no estudo clínico Solidarity, que tenta provar a eficácia de diversos tratamentos contra a Covid em hospitais do mundo inteiro. Foi uma suspensão temporária, até que um grupo independente analise os dados e responda se é seguro continuar. Mas depois do anúncio da OMS, a França proibiu o uso desses medicamentos como tratamento e parou os ensaios clínicos em andamento. A Itália também suspendeu seu uso como tratamento e a Bélgica alertou sobre sua utilização fora dos estudos clínicos, de acordo com a Reuters.
Na Espanha, a agência de medicamentos concluiu que o estudo não fornecia provas suficientemente sólidas sobre o risco associado aos dois medicamentos e recomendou que continuem em andamento os ensaios clínicos com esses fármacos no país. Um porta-voz da agência explicou ao EL PAÍS que até agora o órgão não havia recebido nenhum alerta de segurança por parte dos responsáveis por esses ensaios.
A origem inicial do boom que promoveu os dois medicamentos foi um estudo comandado pelo medico francês DIbier Raoult, que encontrou benefícios no uso contra a covid-19. A pesquisa, no entanto, foi considerada posteriormente como irregular, mal projetada e muito pouco confiável. Isso não evitou que esses tratamentos fossem apontados como “revolucionários”, nas palavras do presidente dos EUA, Donald Trump, que anunciou que toma hidroxicloroquina para se proteger do coronavírus, sendo seguido, posteriormente, pelo presidente brasileiro, Jair Bolsonaro. No momento, não existe nenhuma prova sólida de que esses medicamentos funcionem contra a doença. Existem apenas dados parciais apontando que eles podem aumentar o risco de arritmias em pacientes graves.
O último estudo, que condenou o uso da cloroquina e hidroxicloroquina, “tem um nível de inconsistências alarmante”, alerta Pedro Alonso, diretor do programa de malária da OMS, ao EL PAÍS. “Há enormes dúvidas sobre a qualidade desse trabalho e tanto seus autores como a revista que o publicou vão ter de prestar contas”, ressalta.
A cloroquina e sua derivada são usadas para combater a malária há décadas e têm um perfil de segurança muito alto, lembra Alonso. Além disso, esses medicamentos são utilizados para combater doenças autoimunes como o lúpus. “Até agora não sabemos se funcionam ou não contra a covid-19, mas a solução não é interromper os ensaios com esses medicamentos e, sim, seguir adiante com eles, pois precisamos de bons ensaios clínicos controlados e randomizados para saber se oferecem algum benefício, principalmente para a segunda onda da doença”, considera Alonso.
O estudo em questão é assinado por Mandeep Mehra, do Hospital Brigham de Mulheres de Boston; Frank Ruschitzka, do Hospital Universitário de Zurique; Amit Patel, do departamento de bioengenharia da Universidade de Utah, e Sapan Desai, da empresa Surgisphere, que forneceu os dados anônimos dos 96.000 pacientes incluídos no estudo.
Mas o trabalho tem inconsistências, como o tratamento dos dados, que não foram publicados para que possam ser analisados pelo restante da comunidade científica, e a ausência de um comitê de ética para verificar se o tratamento dos dados dos pacientes está de acordo com a lei, segundo a carta aberta publicada quinta-feira, assinada por mais de 120 médicos, bioestatísticos e pesquisadores biomédicos e enviada à direção da revista The Lancet.
O estudo não dá informações detalhadas sobre os hospitais de cada país de onde vêm os dados, afirmam os signatários. Além disso, utiliza doses de cloroquina e hidroxicloroquina que são em média 100 miligramas mais altas do que as recomendadas pela agência de medicamentos dos EUA, acrescentam.
Na Austrália, o estudo considera um número de pacientes mortos (73 até 23 de abril) que é superior ao registrado em todo o país até essa data pela Universidade Johns Hopkins, segundo o jornal The Guardian. Na África, inclui 25% de todos os infectados que havia no continente e 40% de todos os falecidos, o que significaria, pela expressividade da amostra, que eles teriam acordos para poder acessar os dados computadorizados detalhados dos pacientes, algo que os signatários da carta consideram “pouco provável” —e Alonso considera “impossível”— dado o baixo grau de digitalização de muitos hospitais no continente. O estudo reúne informações de pacientes de seis continentes e, apesar das diferenças entre eles, a incidência de doenças prévias, como diabetes e os problemas cardiovasculares, é “extraordinariamente pequena”, assinala a carta.
Os signatários exigem que a empresa Surgisphere forneça todos os dados e que uma comissão independente da OMS ou outro organismo independente os analise. Também pedem à revista que cumpra os compromissos que assinou sobre dados públicos e publique também os detalhes da revisão desse estudo por especialistas independentes.
Na tarde de sexta-feira, a The Lancetpublicou uma correção, alterando o número de pacientes analisados na Ásia (8.101 em vez de 4.402) e na Austrália (63), mas sem mudar os resultados principais do estudo.
Mandeep Mehra, cardiologista do Brigham e primeiro autor do estudo, disse ao EL PAÍS que, além das correções, foi iniciada uma “revisão independente dos dados”, acrescentando: “Os resultados e conclusões do trabalho continuam sendo os mesmos”. A Surgisphere, empresa responsável pelo banco de dados, defendeu em um comunicado enviado ao EL PAÍS a validade de seu sistema, baseado no estabelecimento de acordos de colaboração com 1.200 hospitais de 45 países para que lhe deem acesso a dados anônimos de pacientes, e garantiu que cumpre as principais normas internacionais de proteção de dados.
Bloqueio de ensaios clínicos
O trabalho deu um golpe fatal em muitos dos ensaios clínicos que estavam em andamento. Isto, por sua vez, pode fazer com que nunca se saiba se, de fato, esses medicamentos podem ajudar contra a covid-19, possivelmente em doses que não sejam altas e com pacientes que não apresentam anomalias no batimento cardíaco. Para isso, são necessários ensaios controlados —nos quais um grupo não toma o medicamento ou toma um placebo— e randomizados, ou seja, cada paciente é colocado aleatoriamente em um dos grupos.
“Uma questão muito importante agora é que as pessoas com poder científico na organização de saúde apostaram em diferentes medicamentos que estão sendo testados em estudos randomizados”, afirma Julián Pérez Villacastín, presidente eleito da Sociedade Espanhola de Cardiologia. “[Os estudiosos da cloroquina e hidroxicloroquina] fizeram um investimento enorme e estão no meio do caminho, e em alguns casos, estão sendo forçados a parar. Além disso, têm o problema de que no início havia muitos pacientes e, com isso, poderiam ser obtidos resultados confiáveis em um prazo relativamente curto. Mas o que aconteceu é que o recrutamento ficou muito mais lento porque o número de pacientes diminuiu. Está sendo muito difícil concluir os estudos e muitos poderão não ser concluídos nunca”, assinala. Alonso ressalta também que, devido aos dados do estudo publicado na The Lancet, os pacientes não queiram participar de ensaios por “medo”.
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