A Comment in this week's edition of The Lancet explains why the journal has decided to retract a paper from the published record: autologous myoblasts and fibroblasts for treatment of stress urinary incontinence: a randomised controlled trial*, by Hannes Strasser and colleagues.
A report by AGES PharmMed, a department of the Austrian Government's Agency for Health and Food Safety, concluded that the study was conducted neither according to Austrian law nor according to the standards of the International Conference on Harmonisation of Good Clinical Practice. The report concluded that there had been critical deficiencies in how patients' consent was obtained and that many documents presented to inspectors were copies and existed in both undated and unsigned versions. According to the report, in one case — a patient's insurance confirmation — the document was alleged to have been forged. The Lancet had already published both a correction to the manuscript and a statement of concern regarding the study. The Comment says: "In our view, the conclusions of this official investigation pinpoint so many irregularities in the conduct of [the authors'] work that, taken together, the paper should be retracted from the published record."
The Comment also discusses that senior author Georg Bartsch, the Chairman of the Department of Urology at the University of Innsbruck (where the study was done), has stated as a reaction to the AGES PharmMed report that he had no part in the study. He contacted The Lancet by email on July 31 requesting that his name be withdrawn from the paper for 'several reasons'; and again on August 13 asking that the Department of Urology, including co-authors Germar Michael Pinggera and Michael Mitterberger, be withdrawn from the paper, again for 'several reasons.' As is standard practice at The Lancet, all above-mentioned authors had signed a statement confirming that they have performed all investigations and therapies and have read and approved the final version of the manuscript. An accompanying Editorial explains the roles and responsibilities of co-authors, and concludes: "With credit comes responsibility—always."
Note to editors: *for a copy of the original Article, published 30 June 2007, the correction (department of error) (9 February 2008), the statement of concern (3 May 2008) and the original press release issued with the Article on 27 June 2007, please see http://press.thelancet.com/retractionextras.pdf
Full Comment and Editorial: http://press.thelancet.com/retraction.pdf
Journal
The Lancet