The lead researcher on trials of Merck & Co’s now withdrawn painkiller Vioxx (rofecoxib) has testified in the first civil court case there was no evidence of a link to heart attack and stroke during clinical investigations, and denied that the US giant manipulated studies to boost the compound’s safety profile.
The trial was brought by the wife of Robert Ersnt, who died suddenly in his sleep after taking Vioxx for tendonitis. Merck has argued that he had a pre-existing heart condition, but lawyers for the plaintiff are arguing that he suffered a heart attack caused by Vioxx [[11/08/05c]]. Merck’s once multi billion dollar offering was pulled from the market last year after data showed it was linked to an increased risk of stroke and heart attack in patients who took the drug for more than 18 months.
Industry reports yesterday said Alise Reicin, Merck’s head of clinical trials, defended an email she is alleged to have written in 1997. According to a Business Week report, the email intimated that patients who had pre-existing cardiovascular conditions should be excluded from clinical trials to “decrease the [cardiovascular] event rate so that a difference between the two groups would not be evident.” Dr Reicin said the email in fact referred to a decision whether or not to include daily aspirin users, which Merck felt would skew results.