Merck & Co stands by Vioxx article, after corrected analysis shows no delay in CV risk

US drug major Merck & Co says that it stands behind the original results of the APPROVe study, even though a corrected statistical analysis of the data published in the New England Journal of Medicine showed that Vioxx (rofecoxib) raised the risk of cardiovascular disease through the treatment period, and not only after 18 months of use as originally stated (Marketletter June 5).

Earlier this year, Merck notified the journal of an error in one of the statistical methods used in its off-drug follow-up of patients from the APPROVe study, which eventually prompted the NEJM to the rare move of issuing an on-line correction.

In 2004, it was the first results from the APPROVe study which led to the market withdrawal of Merck's $2.5 billion a year painkiller and caused the firm's share price to plummet 23% (Marketletters passim). Industry observers fear that the correction could damage Merck's effort to defend itself against 11,500 law suits from people alleging that Vioxx caused heart attacks and strokes.