Safety concerns about a Bayer AG heart surgery drug illustrate why the U.S. health-care system can't rely on pharmaceutical companies to provide research on risks.
Trasylol's links to heart attacks and strokes could have been evaluated through a large, randomized trial comparing the product with competing medicines without specifying how many patients would have to be involved. Such a study hasn't been conducted. It is naive to expect companies to voluntarily fund studies that could sink lucrative products. The FDA lacks the regulatory clout to require them and the U.S. should make a commitment to support studies of drug risks.
Bayer's Trasylol, used to prevent bleeding during heart surgery, has been linked to at least 51 deaths, according to the FDA. About 4.3 million patients received Trasylol from 1984 through last year. (Bloomberg)
