Word: vioxx
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...least eight people have died from eating tainted peanut products in recent months, and the Food and Drug Administration has absorbed much of the blame. It is the latest in a series of black eyes for the FDA over unsafe foods, dangerous medicines such as Vioxx and allegedly cozy ties with the pharmaceutical industry it regulates. President Obama has promised an overhaul of the $2 billion agency, and he believes he's found the woman...
...drugs from doctors. Their symptoms might not require such medications, and when they do, cheaper generic drugs may be available. Such marketing probably drives up overall health-care costs. More important, new drugs that are aggressively marketed can pose a safety risk. Merck's heavy promotion of pain reliever Vioxx - look at Dorothy Hamill skating without any strain! - is a prime example of advertising gone awry. The drug was later taken off the market after it was found to increase risk for heart attacks...
Meanwhile, not only are regulators scrutinizing steep pricing models, but in this post-Vioxx era, agencies like the U.S. Food and Drug Administration (FDA) are also requiring more and more testing. That has led many firms to consult regulators much earlier in the R&D process. "You must align expectations as early as you can with the FDA," Roche CEO Severin Schwan says. "It leads to a much more efficient, effective use of resources on both sides...
Three years ago, concerns about the heart risks associated with the painkiller Vioxx triggered an escalating crisis for the drugmaker Merck that culminated with the withdrawal of the drug in September 2004, the eventual resignation of the CEO and fierce criticism of the Food and Drug Administration for failing to identify the risks of the drug before it was approved. Now a study released by the New England Journal of Medicine has linked one of the most commonly prescribed diabetes drugs, Avandia, to a significant increase in the risk of heart attack. But both the FDA and Avandia's manufacturer...
...Vioxx Court Losses Ouch for the painkiller's maker Merck suffered two defeats in litigation over its drug Vioxx, which can cause heart attacks. It plans to appeal--and with some 14,000 other cases still pending, could probably use ... a painkiller...