Journals question integrity of almost 200 papers by Japanese anaesthetist

The editors in chief of the world’s leading anaesthetics journals have offered Tokyo’s Toho University an ultimatum: vouch for the integrity of all research conducted by the anaesthetist Yoshitaka Fujii or the journals will retract his research papers.

The letter asks the university to verify the authenticity of 193 papers. The university has until 30 June to respond with a timeline for assessing the papers. It has been asked to confirm that each study occurred as represented in the relevant paper and that appropriate ethical approval was obtained. It has also been asked to examine the original research data and verify that they are authentic.

Toho University has already undertaken an investigation to look at the credibility of nine papers published by Fujii. The investigation, which began in September 2011, found that although the research had purportedly been conducted at Ushiku Aiwa General Hospital, only one clinical study by Fujii was officially recorded at the hospital and the other eight had been conducted without any ethics committee approval (BMJ 2012;344:e2019, doi:10.1136/bmj.e2019).

The university said in a statement that Fujii admitted that the clinical studies had taken place without ethics committee approval. He subsequently sent letters of retraction to the four journals that published the eight affected articles and was dismissed from Toho University on 29 February after a disciplinary hearing.

Last month Steve Yentis, editor in chief of Anaesthesia, told the BMJ that he expected that further papers would have to be retracted. He added that the investigating committee had not implied that the studies were fabricated but had left it unclear “as to whether these studies took place at all or whether they took place but without approval.”

A paper in Anaesthesia on 8 March analysed 168 papers by Fujii and found “extremely aberrant data distribution,” raising questions over the data’s authenticity and validity (doi:10.1111/j.1365-2044.2012.07128.x). The author, John Carlisle, a consultant anaesthetist at Torbay Hospital, concluded, “The distributions of continuous and categorical variables reported in Fujii’s papers, both human and animal, are extremely unlikely to have arisen by chance and if [they have], in many cases [it is] with likelihoods that are infinitesimally small.”

Seventeen editors in chief of anaesthetics journals have written to Toho University thanking it for its initial investigation of nine papers and asking it for clarification on other research by Fujii. They pointed out that Anaesthesia published a paper that “appears to present overwhelming evidence that the distributions of many variables reported by Dr Fujii, in 168 published trials conducted under the auspices of your respective institutions, could not have occurred by chance,” and ask for the university to confirm the validity of the research in these 168 papers and another 25 identified through a comprehensive Medline search.

Last year the editors in chief of 18 anaesthetics journals were forced to retract 88 articles by the German anaesthetist Joachim Boldt after it became apparent that they had been conducted without ethics approval and had therefore been “misrepresented in the published article” (BMJ 2011;342:d833, doi:10.1136/bmj.d833).