's Vioxx, withdrawn from the market in September because the painkiller boosted heart attack risk.
Nissen has become one of the most prominent drug safety advocates in the U.S. since he warned in 2001 that Merck 's painkiller Vioxx caused heart problems.
Nissen has become one of the most prominent drug safety advocates in the U.S. since he warned in 2001 that Merck 's (nyse: MRK - news - people ) painkiller Vioxx caused heart problems.
But just two years later cardiologists warned of a potential problem: Merck's own 8, 000-person study, the same one that showed Vioxx reduced ulcer complications, also found that patients on the drug had more than double the risk of heart problems of those on another painkiller, naproxen (the ingredient in over-the-counter Aleve).
It faces the prospect of billions of dollars of claims after studies concluded that taking the painkiller increased the risk of heart problems in some patients.
The FDA was facing enormous pressure following controversies like the withdrawal of Merck's painkiller Vioxx, linked to heart attacks, and alleged overuse of anti-psychotic drugs like Zyprexa from Eli Lilly and Seroquel from AstraZeneca.
After Merck pulled painkiller Vioxx off the market in 2004 because it doubled heart attack and stroke risks, Frazier, then Merck's general counsel, decided to fight about 50, 000 patient lawsuits one by one, instead of negotiating a mammoth settlement covering most of them.
Cholesterol-drug Zocor loses patent protection next year, and the painkiller Vioxx was withdrawn in September because it increased the risk of heart attacks and strokes.
The published version of the study noted a higher heart attack rate in patients who took Vioxx compared with those who took naproxen, an older painkiller that is sold over the counter as Aleve.
To further cloud the matter, heart attacks and other cardiovascular problems will only be counted in the first 14 days after patients stop their painkiller.
Merck reached a settlement with the American government over Vioxx, its blockbuster painkiller that was pulled from the market in 2004 because it was found to increase the risk of heart attacks and strokes.
应用推荐