Literature DB >> 18792536

Industry-sponsored ghostwriting in clinical trial reporting: a case study.

Leemon B McHenry1, 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.

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Year:  2008        PMID: 18792536     DOI: 10.1080/08989620802194384

Source DB:  PubMed          Journal:  Account Res        ISSN: 0898-9621            Impact factor:   2.622


  10 in total

1.  Ghostwriting at elite academic medical centers in the United States.

Authors:  Jeffrey R Lacasse; Jonathan Leo
Journal:  PLoS Med       Date:  2010-02-02       Impact factor: 11.069

2.  The haunting of medical journals: how ghostwriting sold "HRT".

Authors:  Adriane J Fugh-Berman
Journal:  PLoS Med       Date:  2010-09-07       Impact factor: 11.069

3.  Legislation for trial registration and data transparency.

Authors:  Zhao-Xiang Bian; Tai-Xiang Wu
Journal:  Trials       Date:  2010-05-26       Impact factor: 2.279

4.  Focusing on Cause or Cure?: Priorities and Stakeholder Presence in Childhood Psychiatry Research.

Authors:  Lauren C Milner; Mildred K Cho
Journal:  AJOB Prim Res       Date:  2014-01-01

5.  Of sophists and spin-doctors: industry-sponsored ghostwriting and the crisis of academic medicine.

Authors:  Leemon McHenry
Journal:  Mens Sana Monogr       Date:  2010-01

6.  Legal remedies for medical ghostwriting: imposing fraud liability on guest authors of ghostwritten articles.

Authors:  Simon Stern; Trudo Lemmens
Journal:  PLoS Med       Date:  2011-08-02       Impact factor: 11.069

7.  Challenging medical ghostwriting in US courts.

Authors:  Xavier Bosch; Bijan Esfandiari; Leemon McHenry
Journal:  PLoS Med       Date:  2012-01-24       Impact factor: 11.069

8.  Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence.

Authors:  Joanna Le Noury; John M Nardo; David Healy; Jon Jureidini; Melissa Raven; Catalin Tufanaru; Elia Abi-Jaoude
Journal:  BMJ       Date:  2015-09-16

9.  Bias, spin, and misreporting: time for full access to trial protocols and results.

Authors:  An-Wen Chan
Journal:  PLoS Med       Date:  2008-11-25       Impact factor: 11.069

10.  Who has used internal company documents for biomedical and public health research and where did they find them?

Authors:  L Susan Wieland; Lainie Rutkow; S Swaroop Vedula; Christopher N Kaufmann; Lori M Rosman; Claire Twose; Nirosha Mahendraratnam; Kay Dickersin
Journal:  PLoS One       Date:  2014-05-06       Impact factor: 3.240

  10 in total

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