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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.

DOI:10.20529/IJME.2016.065
PMID:27608487
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。

相似文献

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Vioxx redux - or how I learned to worry about industry-sponsored clinical trials.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。
Indian J Med Ethics. 2016 Oct-Dec;1(4):224-226. doi: 10.20529/IJME.2016.065. Epub 2016 Aug 30.
2
The New England Journal of Medicine: commercial conflict of interest and revisiting the Vioxx scandal.《新英格兰医学杂志》:商业利益冲突与对万络丑闻的重新审视。
Indian J Med Ethics. 2016 Jul-Sep;1(3):167-71. doi: 10.20529/IJME.2016.046. Epub 2016 Jun 15.
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Commercial conflict of interest and medical publication: What should the practising physician do about it?商业利益冲突与医学出版:执业医师对此应如何应对?
Indian J Med Ethics. 2016 Oct-Dec;1(4):227-228. doi: 10.20529/IJME.2016.066. Epub 2016 Sep 14.
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How to avoid future Vioxx-type scandals.
Prescrire Int. 2005 Jun;14(77):115-7.
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How the New England Journal missed warning signs on Vioxx: medical weekly waited years to report flaws in article that praised pain drug; Merck seen as "punching bag".《新英格兰医学杂志》如何忽视万络的警示信号:医学周刊数年后才报道赞扬该止痛药文章中的缺陷;默克公司被视为“出气筒”
Wall St J (East Ed). 2006 May 15:A1, A10.
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Medical journal criticizes Merck over Vioxx data.医学期刊就万络数据批评默克公司。
N Y Times Web. 2005 Dec 9:A1, C13.
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Conflict of interest and bias in publication.出版中的利益冲突与偏见。
Indian J Med Ethics. 2016 Oct-Dec;1(4):219-222. doi: 10.20529/IJME.2016.063. Epub 2016 Aug 8.
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Merck disguised "marketing publication" as medical journal to help promote Vioxx, court hears.
BMJ. 2009 Apr 28;338:b1714. doi: 10.1136/bmj.b1714.
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Merck defends Vioxx in court, as publisher apologises for fake journal.默克公司在法庭上为万络辩护,同时出版商就假期刊致歉。
BMJ. 2009 May 11;338:b1914. doi: 10.1136/bmj.b1914.
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NEJM editor gives pretrial evidence in Vioxx case.《新英格兰医学杂志》编辑在万络案件中提供审前证据。
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