A while back there was some concern about the reporting of adverse effects in the VIGOR trial (rofecoxib). The concern was that some cardiovascular events had been deleted. The NEJM have published an editorial called Expression of Concern Reaffirmed [PDF]
As part of our expression of concern, we also pointed out that three myocardial infarctions in the rofecoxib group were not included in the data submitted to the Journal. The authors state that these events did occur during the trial but did not qualify for inclusion in the article because they were reported after a “prespecified cutoff date†for the reporting of cardiovascular events. This date, which the sponsor selected shortly before the trial ended, was one month earlier than the cutoff date for the reporting of adverse gastrointestinal events. This untenable feature of trial design, which inevitably skewed the results, was not disclosed to the editors or the academic authors of the study.