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Medicine in small doses

When supervising a research project or agreeing to be the senior author, or even co-author, of a publication of the paper, be aware of your responsibilities, particularly when signing statements of involvement in the study and the approval of the final version of the manuscript. A paper that featured in Medicine in Small Doses in the ANZ Journal of Surgery (2008; 78: 93) by Strasser H et al. (Autologous myoblasts and fibroblasts versus collagen for treatment of stress urinary incontinence in women: a randomised controlled trial. Lancet 2007; 369: 2179–86), was retracted by the Editors of The Lancet in September 2008 (Lancet 2008; 372: 778; Lancet 2008; 371: 1490; Kleinert and Horton, Lancet 2008; 372: 789–90). This follows an investigation by AGES PharMED, for the Austrian Government Agency for Health and Food Safety on the instructions from the Austrian Ministry of Health after a question session in Parliament on 10 April 2008. The report raised serious doubts about numerous aspects of the trial and publication, including failure to obtain adequate consent from the patients, lack of Ethics Committee approval, inconsistent handling of patients, poor documentation of data entry, potential forging of patient’s documents, poor study design and failure to randomize patients properly. The report also raises doubts as to whether a trial ever existed. (Abbott A. Nature 2008: 454; 922–3; Br. Med. J. 2008; 337: a1711). Georg Bartsch, the senior author of this study, and Chairman of the Department of Urology at the Medical University of Innsbruck, where the study took place, claims that he had no knowledge of, nor played any part in the study but, paradoxically was exonerated by the AGES PharMED report. However, he and all the other coauthors signed the statement of participation in the investigations and approval for the final version of the manuscript submitted to The Lancet. What is even more concerning is that an almost identical study was published a few months later, namely that of Strasser H et al., World J. Urol. 2007; 25: 385–92, including all the co-authors of The Lancet paper. The Lancet warns that co-authors abrogating responsibility, and accepting the honorary or gift authorship, is becoming a recurrent theme in serious research misconduct cases, usually as a consequence of a lack of appropriate oversight. Gift or honorary authorship may be defined as naming, as an author, an individual, who does not meet authorship criteria and is often the head of a department. On one hand, an honorary or gift author may take the glory for a high profile publication, but as this experience in Innsbruck indicates, such a gift can be a poisoned chalice with the indignity of retraction of the publication, loss of credibility and even the potential loss of one’s own university tenure and its repercussions for the Dean of the Faculty (Smith R. Gift authorship; a poisoned chalice. Br. Med. J. 1994; 309; 1456–7). Moreover, the report in Nature indicates that several hundreds of patients, who have undergone the procedure by Dr Strasser’s team, whether it was inside or outside the trial, have complained of serious side-effects, such as bladder neck obstruction and even rupture of the bladder. Needless to say, the plaintiff lawyers in Innsbruck will have a field day. All this comes at a time when the Committee on Publication Ethics (COPE) is engaging in a major expansion programme as a consequence of strong support from important publishers in that their membership increased this year from 450 to 5000, and what was once a voluntary organization has appointed a full-time director. Committee on Publication Ethics is a forum of editors of peerreviewed journals to discuss issues related to the integrity of the scientific record; it supports and encourages editors to report, catalogue and instigate investigations into ethical problems in the publication process. Formed in 1997, the Committee has come a long way in the last 11 years, now recognized internationally as an ethical arbiter, with flow charts available for editors showing how to deal with misconducts, such as fraud, fabrication or plagiarism and has been established an editors’ code of conduct for biomedical journals. The main objective of COPE is to provide a sounding board for editors who are struggling with how best to deal with possible breaches in research and publication ethics (www.publicationethics. org.uk). The simple messages from this case in Innsbruck are be meticulous about who you supervise and be aware of what you sign, do not be tempted to expand your curriculum vitae by duplicate publication and gift authorship has its pitfalls.