It's been 5 years since the then CEO of giant drug-maker Merck, Raymond Gilmartin, testified to the US Senate Finance Committee regarding evidence showing that Vioxx increases the risk of death due to heart attacks, strokes and other cardiovascular events.
In a Summary of Prepared Testimony, Gilmartin stated that prior to the APPROVe trial (a study looking at the protective effects of Vioxx on the risk for colon cancer), the research done by his company 'showed no difference in confirmed cardiovascular event rates between Vioxx and placebo'.
But a new and comprehensive data analysis published in the November 23, 2009 issue of Archives of Internal Medicine, looked at all deaths that should have been reported by Merck from 1999 (when Vioxx entered the market) to September 2004 (when it was pulled from the market, after APPROVe was halted due to health risks to participants). The analysis pooled patient data from every available published and unpublished study and looked at the information in revised ways. Specifically, measurements for death from any cause and the risk for cardiovascular events were calculated. Over 20,000 patients were included. The researchers found that an association between taking Vioxx and increased risk for cardiovascular events was evident 3 ½ years before the drug was pulled from the market.
Some of the data used in this research became available only when litigation against Merck made it public. This means that it was highly likely Merck withheld some or all of its less favorable study results during the time the drug was on the market. (Yes, they could do that legally...) But the study's authors disclose their ties to industry, as well. In their report, they reveal that every member of the team has, either currently in the the past worked as a consultant for the people who took Merck to court (plantiffs) over the Vioxx issue.
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The Archives analysis evaluated the risk of death or the occurrence of a cardiovascular event in those who took Vioxx as it compared to those who took a placebo. Again, it used all studies, whether the results were good or bad for Merck. The analysis found that by the time the drug was off the market in September 2004, the risk was 43% greater for the Vioxx-takers. To be fair to Merck, the way this analysis was done was not standard industry practice.
One reason the study was done was to determine if Merck should have known (and made known the fact that) their drug posed serious risks to health when they first put it on the market. Another reason for the data analysis, according to its authors, was to help improve public health surveillance efforts for drug safety. The researchers believe the information from the analysis can be used to develop more targeted, comprehensive systems in the future.
I was interested in Merck's response to this new study, so I went to their website. Sure enough, a statement had been posted. Read more...








