Provenance of a correction: undisclosed court case involvement

Case number:
09-19

Case text (Anonymised)

The first author of a paper published in 2004 has submitted a “letter to the editor” (LTTE) offering some corrections, and reaffirming some conclusions. The letter has not been published. A pharma company (whose drug is linked by the paper to a negative side effect) has followed this up claiming that between authoring the original article and the letter, the author has become a paid expert witness in a trial relating to the drug in question (the LTTE was shown to the drug company’s counsel during the trial). The LTTE does not mention this. The drug company also claims that the letter’s corrections are based on its work and cross examination in court (again not stated in the LTTE). It also claims the author does not disclose or correct all the errors and downplays others. The company says its claims are backed up by the original study’s source data, currently embargoed by the author’s institution under a court confidentiality order.

Conflict of interest seems open-and-shut. However, a further question seems to be: can/should anything be done before the drug company is able to supply the original source data to the editors? And what if the source data remain embargoed?

Advice: 

The Forum thought that this was a major conflict of interest and found it difficult to believe that it was an oversight. All agreed that there is little that the editor can do while the court case is ongoing. It was suggested that the editor could consult the flowchart “What to do if a reviewer suspects undisclosed conflict of interest (CoI) in a submitted manuscript”. The editor should point out the seriousness of the CoI to the author. The editor cannot proceed with publication. It was suggested that the editor should make sure that he is not giving in to commercial pressure by not publishing the paper – there were concerns that the author was deliberately trying to influence the court case by publishing the additional data. The harm of not publishing was considered to be minimal. The consensus was that the editor should not publish the letter. It was suggested that the editor should inform the author that he will not publish the letter but if the author has new data, he should submit this in a new paper.

Follow up: 

The paper was returned to the authors and will not be published.

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