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【技术产业】支架背后的故事（2分鼓励）
新英格兰医学杂志社最近对哥伦比亚大学的Dr. Martin Leon做出严厉制裁决定：在未来五年内，禁止其在 NEJM上写作，评审和发表任何文章及内容。这对一名美国知名学校的著名教授学者是很罕见和严厉的惩罚。究竟是什么原因促使NEJM 对这位医学界的“摇滚明星”式的大牌下此狠招？因为Dr. Martin Leon博士违反了杂志社严格规定的禁令“不得在杂志社规定的期刊沉默期内对外公布或谈论未公开发表的论文及其数据结论等”。
Dr. Martin Leon博士何许人也？
他为什么要急于披露和谈论重要的临床试验结果？
学术会议和杂志为什么如此讲究论文沉默期？
在此事件背后的利益冲突和职业道德问题？
请大家编译以下文章：
COURAGE Embargo Break: Slip of the Tongue or Sabotage?
NEW YORK -- A leading light in interventional cardiology -- Martin B. Leon, M.D., of Columbia University -- may have leaked details of a major study weeks before it was scheduled to release.
A MedPage Today investigation uncovered a pattern of leaks by Dr. Leon beginning March 7, three weeks before results of the trial were to be presented at the American College of Cardiology meeting and simultaneously published in the New England Journal of Medicine.
This breach of confidentiality involved the results of the COURAGE trial, which found that stents were essentially co-equal with medical therapy for stable angina.
Dr. Leon obtained access to the data when the journal sent him a pre-publication manuscript of the COURAGE results for review.
MedPage Today found that once Dr. Leon reviewed the unpublished COURAGE study manuscript and realized it was unfavorable, he pursued a pattern of dropping hints of the results that he accompanied with criticism of the study design.
William Boden, M.D., lead author of the COURAGE trial said the leaks that occurred during the weeks leading up to the study's planned release amounted to a "premeditated campaign to discredit the COURAGE findings."
Dr. Boden characterized Dr. Leon's actions as "academic misconduct of the highest order. By his actions he deprived me and my co-investigators of the opportunity to be the first to present our data to our colleagues." Usurping that right, Dr. Boden said, was especially vexing because he and his co-investigators "worked for 11 years on the design and conduct of this trial."
The motivations for Dr. Leon's alleged actions remain unclear, except that he might have been trying to undercut the study's conclusions by pre-emptive criticism.
Pre-publication knowledge of the COURAGE results allowed the interventional cardiology community -- investigators and industry -- to try to spin the results in a way that minimized any negative impact on the stent industry.
The need for proactive damage control can be best understood in the context of the ongoing issue of late-stent thrombosis, which emerged in a study reported at the ACC in 2006 and has dogged drug-eluting stents in a series of studies reported over the past 12 months. During that time in the U.S. the use of drug-eluting stents has declined from about 90% to roughly 60% to 70% of all stent implants.
Ironically, Dr. Boden and his colleagues had hoped to present the COURAGE findings at the American Heart Association last November, but the analysis was not completed in time. "If we had reported the findings then before the worst of the drug-eluting stent publicity, I doubt this [embargo break] would have occurred," he said.
NEJM peer review is carried out in strictest confidentiality. Peer reviewers agree that nothing they learn about the results of a study they review will be disclosed publicly ahead of publication or online release. Even the very identity of the reviewer must never be divulged.
The journal alleged that Dr. Leon violated that covenant when he divulged study findings during remarks made at an industry symposium 36 hours before the results were to be released. At that time Dr. Leon made it clear that he possessed confidential information that the COURAGE study results were null, rather than positive in favor of stent intervention. He allegedly also divulged that as a reviewer he was in a position to know. Both were violations of his status as a confidential NEJM peer reviewer.
But a timetable constructed by MedPage Today suggests that the breach of confidentiality first occurred weeks earlier.
Dr. Boden submitted the COURAGE trial manuscript to NEJM on Feb. 6 and the journal editors immediately sent electronic copies of the COURAGE manuscript to five reviewers.
Each copy of the manuscript had a cover sheet stamped with these words in red: "CONFIDENTIAL Please destroy upon completion of review."
Additionally the instructions to reviewers warn that the manuscript should "be considered a privileged communication. You should not photocopy it, show it to another person without approval from the editorial office, or discuss your evaluation and recommendations with the author or any other person."
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作者:admin@医学,生命科学 2011-03-14 17:11
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