Attacks with vigor trial#

Even if they been included, assessment of the relative risks and widely overlapping 95% confidence intervals “does not suggest a difference in the conclusions,” they write. The authors say that they did not know about them during the review process. The three heart attacks were reported between 16 and 20 February 2000. The non-Merck authors say that they did not know of the cut-off date for reporting cardiovascular events. Merck decided to use the study termination date, 10 February 2000, as the cut-off date for reporting cardiovascular events, a month earlier than the cut-off date for reporting gastrointestinal events. Shortly before completion of the study, however, the independent data safety and monitoring board recommended to Merck that information on serious cardiovascular events be included. The 11 non-Merck authors say that they approved the study termination date of 10 February 2000 and the cut-off date of 9 March 2000 for reporting gastrointestinal events.Īnalysis of cardiovascular events, they write, was not part of the original study. Because these data were not included in the published article, conclusions regarding the safety of rofecoxib were misleading.”

was reported to the and posted on its website three months after publication of the VIGOR article, it was not made available to the journal editors during the manuscript review process. These data, which should have raised concern about potential cardiovascular toxicity of rofecoxib, are part of an internal Merck memorandum.

In the journal's reaffirmation of its original criticism, its editors say, “More than four months before the article was published, at least two of its authors were aware of critical data on an array of adverse cardiovascular events that were not included in the VIGOR article. The journal then published its expression of concern ( New England Journal of MedicineĢ005 353: 26, BMJ The editors said that they discovered that three patients had had heart attacks but had not been included in the published study.

Attacks with vigor trial#

Last year, the journal editors reviewed electronic documents relating to the study when the journal's executive editor, Gregory Curfman, was preparing to testify at a trial in which a man's wife charged that rofecoxib caused his fatal heart attack. The controversy concerns the VIGOR (Vioxx gastrointestinal outcomes research) study, which compared upper gastrointestinal toxicity of rofecoxib with naproxen and was published in the journal in 2000 ( New England Journal of MedicineĢ000 343: 1520-8 ). The journal also published responses from 11 authors of the study who are not employed by Merck, the drug's manufacturer, and from two authors who are (doi: 10.1056/NEJMc066096). The online editorial was published on 22 February 2006 (, doi: 10.1056/NEJMe068054). The New England Journal of Medicine last week reaffirmed the expression of concern that it made last December, about the omission of three heart attacks from a study of rofecoxib (Vioxx) published in 2000.