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Preventing another Vioxx

ANN ARBOR, Mich.-- The arthritis drug Vioxx eased the pain of millions of patients -- but it also greatly increased the risk of heart attack and stroke among some of them. And that extra risk only came to light through after-the-fact analysis of data from Vioxx research studies.

Failure to identify such medical safety problems may often go unnoticed but could frequently be prevented if medical researchers changed the way they evaluate new medicines, medical devices and other treatments, according to a new paper in the journal Health Affairs. Such changes may have to be mandated, say the authors from the Veterans Affairs Ann Arbor Healthcare System and the University of Michigan Health System.

The paper's authors say there are fundamental flaws in the way researchers usually analyze and report the results of medical studies, especially randomized clinical trials that are seen as the "gold standard" method for studying the effectiveness and safety of new treatments. Those flaws make it more likely that they'll miss signs of extra harm -- or extra benefit -- to subgroups of patients who have certain characteristics.

Only by analyzing results using a statistical method that considers several factors at once -- for instance, overall heart attack risk, rather than just individual risk factors such as age -- will researchers truly be able to see how the risks and benefits of a treatment vary from patient to patient, the study suggests.

This kind of analysis, called multivariable or risk-stratified analysis, would require more statistical know-how. But it could save lives and money, and allow patients to weigh a treatment's true risks and benefits to their health before starting treatment.

"Most studies currently emphasize the average risk and average benefit found in the study, but the average trial participant might get much less benefit than average, or even be harmed," says lead author Rodney Hayward, M.D. "If 9 people are in a r
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Contact: Kara Gavin
kegavin@umich.edu
734-764-2220
University of Michigan Health System
10-Nov-2005


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