Adelaide Research & Scholarship
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https://hdl.handle.net/2440/48037
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| Type: | Journal article |
| Title: | Clinical trials and drug promotion: Selective reporting of study 329 |
| Author: | Jureidini, J. McHenry, L. Mansfield, P. |
| Citation: | The International Journal of Risk and Safety in Medicine: side effects of drugs - devices - surgery - prevention - liability, 2008; 20(1-2):73-81 |
| Publisher: | IOS Press |
| Issue Date: | 2008 |
| ISSN: | 0924-6479 |
| Statement of Responsibility: | Jon N. Jureidini, Leemon B. McHenry, Peter R. Mansfield |
| Abstract: | Selective reporting is prevalent in the medical literature, particularly in industry-sponsored research. In this paper, we expose selective reporting that is not evident without access to internal company documents. The published report of study 329 of paroxetine in adolescents sponsored by GlaxoSmithKline claims that “paroxetine is generally well tolerated and effective for major depression in adolescents”. By contrast, documents obtained during litigation reveal that study 329 was negative for efficacy on all 8 protocol specified outcomes and positive for harm. |
| Keywords: | selective reporting SSRI litigation industry sponsorship |
| DOI: | 10.3233/JRS-2008-0426 |
| Published version: | http://dx.doi.org/10.3233/jrs-2008-0426 |
| Appears in Collections: | Aurora harvest 6 Paediatrics publications |
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