Adelaide Research & Scholarship
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https://hdl.handle.net/2440/54043
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| Type: | Journal article |
| Title: | Industry-sponsored ghostwriting in clinical trial reporting: A case study |
| Author: | McHenry, L. Jureidini, J. |
| Citation: | Accountability in research, 2008; 15(3):152-167 |
| Publisher: | Taylor & Francis Inc. |
| Issue Date: | 2008 |
| ISSN: | 0898-9621 1545-5815 |
| Statement of Responsibility: | Leemon B. McHenry and Jon N. Jureidini |
| Abstract: | 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. |
| Keywords: | Central Medical Affairs Team clinical trials conflict of interest final clinical report GlaxoSmithKline industry-sponsored ghostwriting key opinion leader off-label prescriptions paroxetine (Paxil Seroxat) Paxil Team primary efficacy variables secondary efficacy variables Scientific Therapeutics Information serious adverse events SmithKline Beecham |
| DOI: | 10.1080/08989620802194384 |
| Published version: | http://dx.doi.org/10.1080/08989620802194384 |
| Appears in Collections: | Aurora harvest Psychiatry publications |
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