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万络风波再现——以及我是如何学会对行业资助的临床试验忧心忡忡的。

Vioxx redux - or how I learned to worry about industry-sponsored clinical trials.

作者信息

Brophy James M

机构信息

Department of Medicine; Professor of Medicine and Epidemiology (McGill), McGill University Health Centre, Royal Victoria Hospital, 1001 Decarie Blvd, Montreal, QC, CANADA H4A 3J1,.

出版信息

Indian J Med Ethics. 2016 Oct-Dec;1(4):224-226. doi: 10.20529/IJME.2016.065. Epub 2016 Aug 30.

Abstract

I read with interest Mark Wilson's recent article, "The New England Journal of Medicine: commercial conflict of interest and revisiting the Vioxx scandal". I believe this is an important contribution that underlines the aphorism "Those who don't know history are doomed to repeat it." As Vioxx is a seminal example, it is important to place it in its proper context, examining if this malfeasance extends beyond the VIGOR study. While the epicentre of this conflict of interest surely begins with the sponsor, I believe the following essay demonstrates that this wave of egregiously unethical behaviour can exist and be propagated only with the complicity of academic investigators, medical journals, a flawed peer-review system and an uncritical medical readership. Perhaps the most troubling is that the factors that coalesced into the Vioxx scandal are, if anything, more ubiquitous today, mandating increased vigilance to decrease the probability of "getting fooled" again.

摘要

我饶有兴趣地阅读了马克·威尔逊最近的文章《〈新英格兰医学杂志〉:商业利益冲突与重审万络丑闻》。我认为这是一项重要的贡献,它强调了这句格言:“那些不了解历史的人注定会重蹈覆辙。”由于万络是一个具有开创性的例子,将其置于恰当的背景中很重要,要审视这种不当行为是否超出了VIGOR研究的范围。虽然这种利益冲突的核心肯定始于赞助商,但我认为以下文章表明,这股极其不道德的行为浪潮只有在学术研究者、医学期刊、有缺陷的同行评审系统和不加批判的医学读者的同谋下才可能存在并蔓延。也许最令人不安的是,促成万络丑闻的因素如今如果有什么不同的话,那就是更加普遍了,这就要求提高警惕,以降低再次“被愚弄”的可能性。

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