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Tuteur Law Networks | Knowledge is Power.
March 5, 2008
March 5th, 2008 11:23 am By Ed Silverman (Blog) — There’s nothing like irony, is there? Last September, Peter Smith stood before an FDA advisory committee and attested to the safety and effectiveness of Trasylol, the controversial med that was approved in the US in 1993 to reduce transfusions and bleeding during open-heart surgery, but was later linked to kidney failure and death. Smith, the chief of thoracic and cardiovascular surgery at Duke University Medical Center, was present on behalf of Bayer, which had already weathered a scandal over safety data that wasn’t provided to the FDA and was again defending the drug’s usefulness.
Here’s what Smith had to say: Trasylol “has a favorable risk-benefit profile when used in accordance with the label. It reduces blood loss, transfusion, re-exploration and it may reduce stroke. It is effective in patients with complex and evolving anti-platelet therapies that we have to deal with every day…It is an essential therapeutic option for CABG-surgery patients at increased risk for bleeding and transfusion,” according to the FDA transcript of the meeting (pages 153-154).
At the same time, however, 11 of Smith’s colleagues from Duke’s anesthesiology and surgery departments were wrapping up a review of 10,275 patients at Duke and found that Trasylol posed a 27 percent greater likelihood of death than a rival drug a decade after open-heart surgery. They presented their findings to the New England Journal of Medicine in November, when Bayer suspended sales after a pivotal Canadian trial linked the drug to higher death rates. Bayer promptly dismissed the Duke study.
Continue reading, ‘ A Lone Holdout? The Duke Doc & Bayer’s Trasylol.’