Retractions in the medical literature: how can patients be protected from risk?

R. Grant Steen

35 citations0/0 files storedJournal of Medical Ethics

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Academic integrity and plagiarism Academic Publishing and Open Access Pharmaceutical industry and healthcare

Abstract

BACKGROUND: Medical research so flawed as to be retracted may put patients at risk by influencing treatments. OBJECTIVE: To explore hypotheses that more patients are put at risk if a retracted paper appears in a journal with a high impact factor (IF) so that the paper is widely read; is written by a 'repeat offender' author who has produced other retracted research; or is a clinical trial. METHODS: English language papers (n=788) retracted from the PubMed database between 2000 and 2010 were evaluated. Only those papers retracting research with humans or freshly derived human material were included; 180 retracted primary papers (22.8%) met inclusion criteria. Subjects enrolled and patients treated were tallied, both in the retracted primary studies and in 851 secondary studies that cited a retracted primary paper. RESULTS: Retracted papers published in high-IF journals were cited more often (p=0.0004) than those in low-IF journals, but there was no difference between high- and low-IF papers in subjects enrolled or patients treated. Retracted papers published by 'repeat offender' authors did not enrol more subjects or treat more patients than papers by one-time offenders, nor was there a difference in number of citations. However, retracted clinical trials treated more patients (p=0.0002) and inspired secondary studies that put more patients at risk (p=0.0019) than did other kinds of medical research. CONCLUSIONS: If the goal is to minimise risk to patients, the appropriate focus is on clinical trials. Clinical trials form the foundation of evidence-based medicine; hence, the integrity of clinical trials must be protected.

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References

2010Retractions in the scientific literature: is the incidence of research fraud increasing?2010Retractions in the scientific literature: do authors deliberately commit research fraud?2011Retractions in the medical literature: how many patients are put at risk by flawed research?2008Bias, Spin, and Misreporting: Time for Full Access to Trial Protocols and Results 2002Truth Survival in Clinical Research: An Evidence-Based Requiem?2008Falsified papers in high-impact journals were slow to retract and indistinguishable from nonfraudulent papers 2011Misinformation in the medical literature: What role do error and fraud play?: Table 1

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