The editors of the New England Journal of Medicine have renewed their criticism of the organisers of the VIGOR trial of Merck & Co’s painkiller Vioxx (rofecoxib), taken off the market in 2004 after being linked to an increased risk of heart attack and stroke.
In an editorial published yesterday, Gregory Curfman, Stephen Morrissey and Jeffrey Drazan said they had ‘reaffirmed their expression of concern’ at the exclusion of data on three heart attacks patients from the published account of VIGOR, first voiced in December.
The prompt for the new statement was the publication of correspondence from the VIGOR study authors in the NEJM, in which they argue that three heart attack cases had been excluded from the dataset because they occurred after a pre-specified cut-off point for reporting cardiovascular side effects in the trial – namely the conclusion of the study on February 20, 2000.
The authors also maintain that including the three cases in the trial would not have changed the conclusions of VIGOR with regard to Vioxx’ cardiovascular safety – a point strongly contested by the NEJM editors.
In a statement, Merck said it “stands firmly behind the propriety of the scientific analysis and presentation of data in the VIGOR publication, as well as our prompt disclosure of the post-cut-off date events to the US Food and Drug Administration and the medical community.”