Drug company's defence in Vioxx case suffers setback

THE drug company Merck's defence against claims for damages by people who suffered heart attacks after taking its painkiller Vioxx has taken a blow from a pillar of the medical establishment. In an online "expression of concern", The New England Journal of Medicine claims that Merck knowingly omitted three instances of heart attacks from a clinical study published in the journal in 2000.
The journal learned of the omission from documents submitted in one of around 7000 lawsuits pending against Merck since it withdrew the drug in September 2004. So far, Merck has suffered a $253.4 million loss from a wrongful death lawsuit in August, but successfully defended a personal injury suit last month. A third case ended on Monday when it was declared a mistrial.
The editorial calls for a correction to be submitted to the journal (DOI: 10.1056/NEJMe 058314). Merck responded with a statement denying that it had deliberately deleted any significant information from the study.
George Moseley, an expert in health law at the Harvard School of Public Health, says that issuing a correction to the published results would be seen as an admission of wrongdoing. Courts will now have to judge whether the omission of the data put patients at risk. "What the courts really have to decide is whether or not that led to injury," he says.