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?
Advice:
· We need a response from the authors as to when the work was done.
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The editor can point out to the authors that he is puzzled as the drug was withdrawn in 1993 and can question the legitimacy of the data.
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The editor said that the data were unbelievably clean and that a statistician should analyse them thoroughly. Conclusion
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The editor should ask the authors for copies of patients’ consent forms and the raw data.
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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.
Follow up:
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?