An FDA application for a Boston Scientific (NYSE:[[ticker:BSX]]) coronary stent currently awaiting approval was supported by a flawed statistical equation, according to today’s Wall Street Journal. Citing its own review of a clinical study of the device, the paper said the Taxus Liberte stent, which is already approved for use abroad, would have been judged “a failure by the common standards of statistical significance in research,” even though the statistical method that Boston Scientific used is widely employed by other stent manufacturers as well. A Boston Scientific spokesman said the company used standard methodology. BSX stock was down more than 5 percent, to $12.69, in early trading today.
Author: Robert Buderi
Bob is Xconomy's founder and chairman. He is one of the country's foremost journalists covering business and technology. As a noted author and magazine editor, he is a sought-after commentator on innovation and global competitiveness. Before taking his most recent position as a research fellow in MIT's Center for International Studies, Bob served as Editor in Chief of MIT's Technology Review, then a 10-times-a-year publication with a circulation of 315,000. Bob led the magazine to numerous editorial and design awards and oversaw its expansion into three foreign editions, electronic newsletters, and highly successful conferences. As BusinessWeek's technology editor, he shared in the 1992 National Magazine Award for The Quality Imperative.
Bob is the author of four books about technology and innovation. Naval Innovation for the 21st Century (2013) is a post-Cold War account of the Office of Naval Research. Guanxi (2006) focuses on Microsoft's Beijing research lab as a metaphor for global competitiveness. Engines of Tomorrow (2000) describes the evolution of corporate research. The Invention That Changed the World (1996) covered a secret lab at MIT during WWII. Bob served on the Council on Competitiveness-sponsored National Innovation Initiative and is an advisor to the Draper Prize Nominating Committee. He has been a regular guest of CNBC's Strategy Session and has spoken about innovation at many venues, including the Business Council, Amazon, eBay, Google, IBM, and Microsoft.
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