I became involved in this issue after reports from doctors in a developing country that three papers in a systematic review published by my company may have been fabricated.
The papers in question had co-authors in two other countries and so I contacted them.
One co-author replied that he had concerns, but as none of the studies was conducted in his country, he had no data. He said he was unaware of the papers until Dr X told him they had been accepted in the journals.
Another co-author was unaware of when or where the studies took place. He said that Dr X had been suffering from depression for several years and had committed suicide. He had been included as a co-author on his last three articles more out of friendship than any active scientific cooperation.
A third co-author explained that his role was “philosophical” rather than clinical. To his knowledge the study was conducted personally by Dr X, probably in his own country, and he only helped him with discussions and text revisions.
Because several of Dr X’s papers were published by Journal A, I wrote to the editor of Journal A to see if he had any concerns. He replied that he had doubts about the validity of the data, which were raised in an editorial by Dr Z. I am waiting to hear if the editor of Journal A is willing to help investigate the papers. I also contacted Dr Z and raised the possibility of fraud with him. He said that he had “serious concerns about the work” but declined to help me investigate.
We have withdrawn the review until we can find out if the data are real. I have written to the National Committee on Ethics in Research in the author’s country but have had no reply. An international expert on the statistical detection of fraud is currently looking at the papers. He has some concerns but his investigation is ongoing.
Dr X was a prolific researcher with about 16 of his own first authored papers cited in his clinical trial reports. It appears that many doctors suspect misconduct but none has been prepared to voice their concerns or to take any action.
I would greatly appreciate COPE’s advice.
This complicated case provoked much discussion. The advice was to reinstate the review but without the three disputed papers, adding a note to say that there is a potential problem with these three papers. It was felt that if the data are fabricated, there was a responsibility on the part of the editor not to publish the data as there might be a significant risk to patients if the trial was repeated.
As there has been no useful response from the other journal editors who published other papers by this author, it seems there is no point in pursuing this line of enquiry. However, the editorial procedures in these journals must be criticised as the editors strongly suspected that the data were fabricated but still went ahead and published the papers. COPE could take some action if they were members, but they are not.
The committee agreed that the best approach for the editor would be to seek a retraction of the papers from the co-authors on the basis of gift authorship. The advice was to write to the co-authors, ask for the data, and if not provided, ask them to withdraw the papers. In this way, it is not necessary to say that the data are fraudulent, with all its legal implications. It was felt that the co-authors must take responsibility for the data as their names are on the paper. It is not acceptable to say that their contribution was merely “philosophical”. Gift authorship is not acceptable. Also, the co-authors’ institutions should be contacted and informed of the situation. In this instance, the editor should write to the co-authors informing them that he has contacted their institutions.
Following COPE’s advice, the living co-authors were contacted to see if they would retracted the reports in question on the basis that they were gift authors and could not take responsibility for the results. However, when this was raised with them they did not agree that they were gift authors and declined to seek retraction, arguing that the papers were published in an international peer reviewed journal, that the first author had taken responsibility for their content and that they knew the first author well and believed that “he would never have been able to do something false.” They persist in this view despite the fact that the stated deceased lead author’s affiliation has been contacted and they confirmed that the lead author was never employed by the university. It seems that the co-authors want it all ways—they claim that they are not gift authors but yet they refuse to take any responsibility for the content, even in the presence of evidence that the lead author gave incorrect information about his affiliation. The matter is ongoing.
Further update
This case has been the subject of an article and an editorial in the BMJ. The articles outline the details of the case and consider the wider implications of the case, a summary of which is given here:
We are left with serious doubt about important studies but with no way of determining with confidence whether the results are fabricated or real. The main author is dead. There is no institution to investigate. The implications for patients are serious. They are being treated on the basis of potentially unreliable evidence. It is plausible that this drug in high doses may worsen rather than alleviate the condition. Shortly after the withdrawal of the review, the journal was contacted by US researchers preparing guidelines for the management of this condition and by a UK group asking about the outcome of our investigation because the authors’ results were about to be incorporated into guidelines.
If it wants to retain the confidence of the public and politicians, the scientific community needs to do better. Only a minority of countries have an effective national system for responding to scientific misconduct. However, research is a global enterprise and a strong case exists for an international body to respond to the problem of research misconduct.