NEJM Correction May Trigger Vioxx Retrials
The New England Journal of Medicine (NEJM), one of the most respected medical journals in the world, has reversed a previous statement - and that reversal may trigger at least two Vioxx retrials. On June 26, 2006 the NEJM released a new study into existing data from the controversial APPROVe clinical trial. Time-to-Event Analyses for Long-Term Treatments - The APPROVe Trial by Dr. Stephen W. Lagakos, a statistical consultant at the NEJM, dug back into the research to identify whether there was a “cut-off” point up to which patients could safely take Vioxx. The editors suggested in previous issues that the risk of heart attack became elevated after 18 months of Vioxx use.
However Dr. Lagakos’s review of the data suggested that although the risk of heart attack increases the longer the patient takes the drug, there is no “safe” amount of time that it can be used.
This information will have wide-reaching impact on upcoming cases, and will likely be the basis of two Vioxx retrials. Merck’s lawyers have used this 18-month threshold in several Vioxx cases already. At the time of the NEJM correction, the company had won three cases and lost three cases. In two cases that they won, patients had only been taking Vioxx for a few months.
In the past, the editors at the NEJM published “expressions of concern” about Merck’s manipulation of data and allegedly concentrated attempts to hide or skew results. These expressions of concern were basically reprimands for the inappropriate research methods that Merck used while testing Vioxx - though the journal stopped short of outright accusing the drug company of lying.
It was the results of the APPROVe trial that allegedly caused Merck to withdraw Vioxx from the market. Since then, new evidence - and further review of data from past research - suggest that Vioxx does carry an increased risk of cardiovascular events such as heart attack and stroke.
Despite the NEJM’s public retraction of its statement, Merck said that it will continue to use the 18-month benchmark noting that the NEJM has changed its position, not the company.
If you or a loved one has been injured while taking Vioxx for any amount of time, you could be facing increased medical costs and lost time from work. But worst of all is the impact that your prolonged illness will have on you and your family.