Industry-Sponsored Ghostwriting in Clinical Trial Reporting: A Case Study

TitleIndustry-Sponsored Ghostwriting in Clinical Trial Reporting: A Case Study
Publication TypeJournal Article
Year of Publication2008
AuthorsMcHenry, LB, Jureidini, JN
JournalAccountability in Research: Policies & Quality Assurance
Type of ArticleArticle
Publication Languageeng
ISSN Number08989621
Accession Number32964890
KeywordsACTIONS , Authorship , Central , Clinical , Conflict , final , GHOSTWRITING , GlaxoSmithKline , Human , industry-sponsored , key , MEDICINE , off-label , PAROXETINE , Paxil , primary , research , Scientific , secondary , serious , Seroxat) , SmithKline , University/Industry Collaboration
AbstractIn this case study from litigation, we show how ghostwriting of clinical trial results by industry can contribute to the manipulation of data to favor the study medication.
NotesMcHenry, Leemon B. 1; Email Address:; Jureidini, Jon N. 2; Affiliations: 1: Department of Philosophy, California State University, Northridge, Northridge, California, USA; 2: Discipline of Psychiatry, University of Adelaide, Adelaide, South Australia; Issue Info: Jul-Sep2008, Vol. 15 Issue 3, p152; Thesaurus Term: ACTIONS & defenses; Thesaurus Term: RESEARCH; Subject Term: GHOSTWRITING; Subject Term: CLINICAL trials; Subject Term: PAROXETINE; Subject Term: MEDICINE; Subject Term: HUMAN experimentation in medicine; Author-Supplied Keyword: Central Medical Affairs Team; Author-Supplied Keyword: clinical trials; Author-Supplied Keyword: conflict of interest; Author-Supplied Keyword: final clinical report; Author-Supplied Keyword: GlaxoSmithKline; Author-Supplied Keyword: industry-sponsored ghostwriting; Author-Supplied Keyword: key opinion leader; Author-Supplied Keyword: off-label prescriptions; Author-Supplied Keyword: paroxetine (Paxil; Author-Supplied Keyword: Paxil Team; Author-Supplied Keyword: primary efficacy variables; Author-Supplied Keyword: Scientific Therapeutics Information; Author-Supplied Keyword: secondary efficacy variables; Author-Supplied Keyword: serious adverse events; Author-Supplied Keyword: Seroxat); Author-Supplied Keyword: SmithKline Beecham; NAICS/Industry Codes: 541712 Reseach and Development in the Physical, Engineering, and Life Sciences (except Biotechnology); Number of Pages: 16p; Document Type: Article
Short TitleIndustry-Sponsored Ghostwriting in Clinical Trial Reporting: A Case Study
Full Text