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J Med Ethics. 2011 Nov;37(11):688-92. doi: 10.1136/jme.2011.043133. Epub 2011 May 17.

Retractions in the medical literature: how many patients are put at risk by flawed research?

Author information

1
MediCC, Medical Communications Consultants, LLC, 103 Van Doren Place, Chapel Hill, NC 27517, USA. g_steen_medicc@yahoo.com

Abstract

BACKGROUND:

Clinical papers so flawed that they are eventually retracted may put patients at risk. Patient risk could arise in a retracted primary study or in any secondary study that draws ideas or inspiration from a primary study.

METHODS:

To determine how many patients were put at risk, we evaluated 788 retracted English-language papers published from 2000 to 2010, describing new research with humans or freshly derived human material. These primary papers-together with all secondary studies citing them-were evaluated using ISI Web of Knowledge. Excluded from study were 468 basic science papers not studying fresh human material; 88 reviews presenting older data; 22 case reports; 7 papers retracted for journal error and 23 papers unavailable on Web of Knowledge. Overall, 180 retracted primary papers (22.8%) met the inclusion criteria. Subjects enrolled and patients treated in 180 primary studies and 851 secondary studies were combined.

RESULTS:

Retracted papers were cited over 5000 times, with 93% of citations being research related, suggesting that ideas promulgated in retracted papers can influence subsequent research. Over 28 000 subjects were enrolled-and 9189 patients were treated-in 180 retracted primary studies. Over 400 000 subjects were enrolled-and 70 501 patients were treated-in 851 secondary studies which cited a retracted paper. Papers retracted for fraud (n=70) treated more patients per study (p<0.01) than papers retracted for error (n=110).

CONCLUSIONS:

Many patients are put at risk by retracted studies. These are conservative estimates, as only patients enrolled in published clinical studies were tallied.

PMID:
21586404
DOI:
10.1136/jme.2011.043133
[Indexed for MEDLINE]

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