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Original Article

Lack of involvement of medical writers and the pharmaceutical industry in publications retracted for misconduct: a systematic, controlled, retrospective study

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Pages 1175-1182 | Accepted 16 Mar 2011, Published online: 07 Apr 2011
 

Abstract

Objectives:

The primary objective of this study was to quantify how many publications retracted because of misconduct involved declared medical writers (i.e., not ghostwriters) or declared pharmaceutical industry support. The secondary objective was to investigate factors associated with misconduct retractions.

Design:

A systematic, controlled, retrospective, bibliometric study.

Data source:

Retracted publications dataset in the MEDLINE database.

Data selection:

PubMed was searched (Limits: English, human, January 1966 – February 2008) to identify publications retracted because of misconduct. Publications retracted because of mistake served as the control group. Standardized definitions and data collection tools were used, and data were analyzed by an independent academic statistician.

Results:

Of the 463 retracted publications retrieved, 213 (46%) were retracted because of misconduct. Publications retracted because of misconduct rarely involved declared medical writers (3/213; 1.4%) or declared pharmaceutical industry support (8/213; 3.8%); no misconduct retractions involved both declared medical writers and the industry. Retraction because of misconduct, rather than mistake, was significantly associated with: absence of declared medical writers (odds ratio: 0.16; 95% confidence interval: 0.05–0.57); absence of declared industry involvement (0.25; 0.11–0.58); single authorship (2.04; 1.01–4.12); first author having at least one other retraction (2.05; 1.35–3.11); and first author affiliated with a low/middle income country (2.34; 1.18–4.63). The main limitations of this study were restricting the search to English-language and human research articles.

Conclusions:

Publications retracted because of misconduct rarely involved declared medical writers or declared pharmaceutical industry support. Increased attention should focus on factors that are associated with misconduct retractions.

Transparency

Declaration of funding

No external sponsors were involved in this study and no external funding was used.

Declaration of financial/other relationships

All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare that: (1) all authors have support (e.g., reimbursement of expenses for conference travel; payment for independent academic statistical services for their research) from their employer, ProScribe Medical Communications, for the submitted work; (2) all authors provide ethical medical writing services to academic, biotechnology, and pharmaceutical clients; (3) all authors’ spouses, partners, or children have no financial relationships that may be relevant to the submitted work; (4) all authors are active in national and international not-for-profit associations that encourage ethical medical writing practices; and (5) all authors have delivered training courses on ethical publication practices or have provided ethical medical writing support to authors from low and middle income countries.

Acknowledgements

We are very grateful to Christine Wichems, PhD (CSL Ltd, Australia) and Jessica Armstrong, BPharm (University of Queensland, Australia) for assistance with data collection and thank Maria de Leon-Santiago, PhD, (ProScribe Medical Communications) for table preparation. We greatly appreciate the assistance provided by Varsha Parag, MS (New Zealand Clinical Trials Research Unit), an independent academic statistician who reviewed the design of our study and conducted all of the statistical analyses.

Previous presentations: a limited number of results from this study (no more than that included in the abstract of this manuscript) have been presented at the following conferences: 6th Annual Meeting of the International Society of Medical Publication Professionals, Arlington, USA, April 19–21 2010; 6th International Congress on Peer Review and Biomedical Publication, Vancouver, Canada, September 10–12 2009; 69th Annual Conference of the American Medical Writers Association, Dallas, USA, October 22–24 2009; 45th Annual Meeting of the Drug Information Association, San Diego, USA, June 21–25 2009; 18th ARCS Australia Annual Scientific Congress, Sydney, Australia, June 1–3 2009.

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