与罗菲可西布相关的出版物中的客人撰写和幽灵写作:从罗菲可西布诉讼中的行业文件的案例研究
Joseph S Ross1, Kevin P Hill, David S Egilman
1Department of Geriatrics and Adult Development, Mount Sinai School of Medicine, New York, New York 10029, USA. joseph.ross@mssm.edu
在rofecoxib出版物中,客人撰写和幽灵写作普遍存在. 赞助商的员工经常撰写手稿,外部学者被列为作者,有时未能披露财务关系.
科学领域:
- 生物医学出版伦理学
- 制药行业的影响力 制药行业的影响力
- 科学完整性 科学完整性
背景情况:
- 在生物医学出版物中的著作权赋予了认可和问责制.
- 关于rofecoxib的诉讼提供了一个调查疑似客人作者和幽灵写作的机会.
- 关于这些作者的做法,以前几乎没有任何文件.
研究的目的:
- 描述客人撰写和幽灵写作的类型和范围.
- 分析rofecoxib相关出版物中的著作权实践.
- 检查行业对科学报告的影响.
主要方法:
- 分析罗菲可西布诉讼中的法庭文件 (1996-2004).
- 在MEDLINE索引中的公开可用的rofecoxib文章的审查.
- 对文件进行反复审查和讨论,以确定著作权问题.
主要成果:
- 默克公司的员工与出版商合作准备手稿,招聘外部学者作为作者,经常处于领导职位.
- 营销员工制定了手稿的计划,签订了幽灵写作合同,并招募了学者作为唯一的作者,经常提供荣誉.
- 对临床试验 (92%) 的财务支持披露率很高,但对评论文章 (50%) 的披露率很低.
结论:
- 行业文件显示,赞助员工撰写了rofecoxib手稿,并将第一作者归因于外部学者,他们经常省略了财务披露.
- 评论手稿经常是幽灵写作,并归因于学者,他们经常未能披露行业的财政支持.
- 本案例研究突出了制药公司赞助的出版物中著作权和披露的重大问题.
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