Almost five years ago two outsiders approached an editor suggesting that a large series of papers from a particular researcher, including some published in high profile journals, might be fraudulent. Those contacting the editor thought it possible that the patients described in the studies had never existed at all. Round about the same time a few papers from this author were circulating in the journal’s peer review system. The editor asked an outside consultant epidemiologist and a statistical adviser to review both published papers and the papers in our system. The epidemiologist rapidly produced a report suggesting that many of the studies may have been fraudulent. The statistician began his work and, and after a while the author was asked to produce his original data. These data took a very long time to arrive, and they eventually arrived in a large box and written in pencil. These data were entered in the computer, but this proved a very time consuming and expensive process. The statistician, who had many other things to consider, got bogged down. Eventually a few months later the statistician produced a report on a particular paper, arguing very strongly that the data were probably fraudulent. The author resides abroad and seems to be the head of the institution in which he works. Because there was no formally appointed head of institution the editor wrote to him asking for a response and said that if none was provided, he would write to the national body. If this body cannot produce a response, then the editor will consider publishing a piece explaining the doubts about the 30 or so studies, most of which have appeared in prestigious journals on both sides of the Atlantic. The editor feels that he has been desperately slow, but is this what he should now be doing?
There has to be an investigation and it needs to be by a national body as the author is head of the institution.
The author replied that it’s “ex-colonials complaining about the downtrodden.” A national body has been asked to investigate. Three national bodies have now declined to investigate. The journal is currently considering publishing extensive details of the case.
A paper was submitted that described the use of a non-licensed investigational drug. One of the paper’s reviewers drew attention to the fact that none of the investigators in the study had been supplied with the drug since 1992/3. The drug is produced exclusively by one manufacturer who has operated an extremely restrictive policy regarding availability of the compound. I contacted the clinical director who confirmed that the group had not received supplies of the drug since 1992 and that the material supplied at that time had an expiry date of 1993. What should I do?
· We need a response from the authors as to when the work was done.
The editor can point out to the authors that he is puzzled as the drug was withdrawn in 1993 and can question the legitimacy of the data.
The editor said that the data were unbelievably clean and that a statistician should analyse them thoroughly. Conclusion
The editor should ask the authors for copies of patients’ consent forms and the raw data.
The dean should be informed about the expiry date of the drug if the work was done after that date and should also query if this research had ethics committee approval.
The paper was sent to a statistician who could not confirm or refute the “biological” or “non-biological” origins of the data. The authors responded that the study had been performed with the original drug supplied within the expiry date. The paper originated from outside the UK and there was insufficient evidence to inform the head of the institution. The paper was rejected on the grounds of low priority. Ideally this case should have been referred to an external agency and arrangements made to inspect patient report books and check dates of the study.
A reviewer expressed suspicion that data were manufactured. We wrote to the authors saying that our reviewer would like to see the original data. The author replied that this research was carried out in the USA. We then wrote back suggesting that his co-workers in the US would probably be delighted that this work was being submitted for publication and would happily send over the data but that without this we could no longer consider the paper. The line went dead. What should we do next?