The Pharmaceutical Journal
Vol 273 No 7325 p704
13 November 2004

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Vioxx “should have been withdrawn four years ago”

Merck had sufficient data to justify withdrawing Vioxx (rofecoxib) four years ago, a study published online by The Lancet claims.

In a comment on the study, Richard Horton, editor of The Lancet, said that The Lancet’s initial view that the withdrawal of Vioxx was “commendable and should serve as an example of responsible pharmaceutical industry practice” was premature: “For with Vioxx, Merck and the [Food and Drug Administration] acted out of ruthless, short-sighted and irresponsible self-interest.”

Merck & Co Inc is the parent company of Merck, Sharp & Dohme, which manufactured Vioxx in the UK.

Vioxx was withdrawn worldwide on 30 September following evidence of increased risk of heart attack and stroke seen in the unpublished APPROVe (adenomatous polyp prevention on Vioxx) study (PJ, 9 October, p505).

In the new Lancet study, Peter Jüni at the University of Berne and colleagues looked at the results of 18 randomised controlled trials and 11 observational studies, incorporating a total of 20,000 patients. They found that, by the end of 2000, there were 52 myocardial infarctions in the rofecoxib groups and 12 in the control groups and came to the conclusion that “rofecoxib should have been withdrawn several years earlier. The reasons why manufacturer and drug licensing authorities did not continuously monitor and summarise the accumulating evidence need to be
clarified”.

Merck issued a statement in response to Jüni et al’s paper. In it the company says: “The data contained in this meta-analysis are not new… like Merck’s published combined analyses, this meta-analysis shows no significant difference with Vioxx versus placebo, no significant difference with Vioxx versus non-naproxen [non-steroidal anti-inflammatory drugs] and a significantly lower risk with naproxen versus Vioxx.”

Merck argued that the difference between the data before and after 2000 are explicable by the inclusion of results from the VIGOR (Vioxx gastrointestinal outcomes research) study results and the combination of data from studies comparing rofecoxib with a variety of controls: “The inappropriate combining of heterogenous data by Jüni et al invalidates the results and conclusions of their meta-analysis,” and runs “counter to basic principles of meta-analysis”, Merck said.