Merck Sharp and Dohme defends Vioxx study results

Merck Sharp and Dohme (MSD) has defended the original results of the APPROVe study, which was published in the New England Journal of Medicine and confirmed the increased relative risk of thrombotic cardiovascular events for Vioxx patients.

Vioxx, a non-steroidal anti-inflammatory drug, was withdrawn after concerns that the drug was responsible for an increased number of heart attacks and strokes. Last month, the authors of the APPROVe study were forced to issue a correction over a statistical method used during the study.

MSD has asserted that the correction did not materially alter the results of the study and said it should be taken in context.

Peter S Kim, president of MSD’s research laboratories, said: “It is important to understand that the correction centered on the description of a single statistical method. Merck used a number of analytical and graphical methods to evaluate whether the relative risk changed over time.”

MSD’s senior vice-president and general counsel, Kenneth C Frazier, stated that the debate about the APPROVe study’s adherence to sound scientific practice would not alter the way in which the company defends its Vioxx lawsuits, of which there are over 11,000 in the US.

He said: “The individual facts of each Vioxx case are very important. Unfortunately, thrombotic cardiovascular events are a major health problem and stem from many risk factors unrelated to Vioxx.”

Vioxx was prescribed in the UK for the treatment of arthritis in over 400,000 patients, according to the BBC. Last year, the Sunday Times reported that up to 2,000 British patients could have died after using the drug.

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