Voltando ao caso Avandia. Na próxima, semana o FDA irá avaliar se o medicamento aumenta ou não o risco cardiovascular. Porém, será desconsiderado o artigo publicado no The New England Journal of Medicine porque:
We should note that while Dr. Nissen’s meta-analysis … engendered considerable public notice and concern … this metaanalysis, performed out of necessity on study level data, will not be a focus of this Advisory Committee meeting. … This is because we believe the results of the analysis performed by GSK and subsequently by the FDA on the more granular individual datasets do not greatly differ from that of Dr. Nissen … Importantly, though, we believe that the FDA analysis of the data, including patient level data, is more robust than would be possible for an analysis utilizing study-level data alone.
We should note that while Dr. Nissen’s meta-analysis … engendered considerable public notice and concern … this metaanalysis, performed out of necessity on study level data, will not be a focus of this Advisory Committee meeting. … This is because we believe the results of the analysis performed by GSK and subsequently by the FDA on the more granular individual datasets do not greatly differ from that of Dr. Nissen … Importantly, though, we believe that the FDA analysis of the data, including patient level data, is more robust than would be possible for an analysis utilizing study-level data alone.
O texto imenso com quase 500 páginas está disponível clicando aqui. Se for por motivo processual, com implicação jurídica, talvez tenha o mínimo de nexo. Porém, como não considerar estudo que até agora, apesar do imenso esforço não houve invalidação científica do método e resultado.
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