WHITEHOUSE STATION, N.J., November 23, 2009 – Merck believes the article published in The Archives of Internal Medicine in today’s issue related to VIOXX used unreliable methods and reached incorrect conclusions.
The scientific exercise of examining what the data showed about VIOXX’s cardiovascular safety over time is an important one. Indeed, Merck scientists did exactly that, in real time and with pre-specified rules while VIOXX was on the market. These regularly updated analyses of a large body of data from randomized clinical trials, conducted in consultation with outside experts and with regulatory agencies, did not demonstrate an increased risk of thrombotic events when VIOXX was compared to placebo while VIOXX was on the market.
The first time Merck observed a difference in a placebo-controlled study was when it learned the results of the APPROVe study in September 2004. We voluntarily withdrew VIOXX from the market within a week of those results.
The methods used by the authors are not valid for a number of reasons, including:
- The authors relied exclusively on “investigator-reported” cardiovascular (CV) events. Merck took the same investigator-reported events and put them through a rigorous cardiovascular adjudication process put in place in 1999 in response to suggestions by its outside scientific consultants. The cardiovascular adjudication process was created to improve upon the accuracy of investigator-reported thrombotic CV events by sending patients' medical records to external blinded experts to determine if the events reported by investigators were in fact thrombotic. Merck’s real time analyses of VIOXX’s cardiovascular safety focused on the events that were confirmed by these blinded external adjudicators as thrombotic. This procedure was more rigorous than that used by the authors of the Archives paper.
- The authors then combined this less reliable endpoint with “all cause” deaths. We do not believe deaths from all causes -- including, in the case of VIOXX, electrocutions, infections and trauma -- are the most reliable way to examine a question about cardiovascular safety.
- The authors also included events that occurred after a patient had stopped taking any study drug. For example, many of the Alzheimer's disease patients were followed for up to a year or longer after they had stopped the study drug. Because the question being considered was the effect of VIOXX on thrombotic events while patients were taking the medicine, it does not make sense from a medical perspective to include events that occurred long after patients had stopped taking any medicine.
Merck acted responsibly – from researching VIOXX prior to approval in studies with approximately 10,000 patients – to monitoring the medicine while it was on the market -- to voluntarily withdrawing the medicine when it did. Our decisions were based on the data from well-controlled clinical trials.
Status of Litigation
Merck voluntarily withdrew VIOXX from the market on September 30, 2004. In November of 2007, Merck entered into an agreement to resolve state and federal myocardial infarction and ischemic stroke personal injury claims filed or tolled by Nov. 9, 2007. More than 99 percent of all eligible personal injury claimants enrolled in the program, and the program is proceeding as scheduled.
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