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Volume 356:325-328 January 25, 2007 Number 4 Next

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Last September, a firestorm was ignited over drug-eluting stents when data were released showing an increase in the risk of late stent thrombosis. In response, the Food and Drug Administration (FDA) held an open meeting of its Circulatory System Devices Panel on December 7 and 8, 2006.¹ The advisory group of about 20 academics and clinicians was sharply divided on the ramifications of the findings: a thoracic surgeon, on one side, argued that the new data necessitate a black-box warning; an interventional cardiologist, on the other side, said these data would barely change his practice. In part, the frequent disagreements . . . [Full Text of this Article]

Informing the Patients

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Dr. Shuchman is a national correspondent for the Journal.

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