Is the FDA really changing? Its hard to believe but the FDA finally acted in the best interests of consumers, shooting down a bio-tech drug that made Bayer millions and was at one time on the verge of becoming a blockbuster. I have openly criticized the FDA for some time on Trasylol, as it dragged its feet on this issue for almost two years.

It is better late than never. However, during the past two years that the FDA left Trasylol on the market it is likely that 20,000 or more Americans have suffered serious kidney damage requiring dialysis – costing the health care system several billion dollars a year. Additionally, many individuals have an increased risk of dying during the next five years following treatment with Trasylol. Trasylol-linked deaths are in the thousands and the full scope of the problem will not be known for several more years. As I have stated before, the Justice Department should be investigating Bayer, as the company intentionally mislead the FDA about the risks of this drug. When a foreign drug company markets a drug that kills Americans and hides the risk data, who is responsible and to what extent should criminal charges be pursued?