Industry-sponsored ghostwriting in clinical trial reporting: a case study.
نویسندگان
چکیده
In this case study from litigation, we show how ghostwriting of clinical trial results can contribute to the manipulation of data to favor the study medication. Study 329 for paroxetine pediatric use was negative for efficacy and positive for harm. Yet the ghostwritten publication from this study concluded that paroxetine provided evidence of efficacy and safety and continues to be influential. Despite the role of named authors in revisions of the manuscript, the sponsor company remained in control of the message.
منابع مشابه
The paroxetine 352 bipolar trial: A study in medical ghostwriting.
BACKGROUND The problem of ghostwriting in corporate-sponsored clinical trials is of concern to medicine, bioethics, and government agencies. We present a study of the ghostwritten archival report of an industry-sponsored trial comparing antidepressant treatments for bipolar depression: GlaxoSmithKline (GSK) paroxetine study 352. This analysis is based upon publicly available evidence presented ...
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عنوان ژورنال:
- Accountability in research
دوره 15 3 شماره
صفحات -
تاریخ انتشار 2008