MOVERS AND SHAKERS 2006
The industry's top-selling product, drug-eluting stents, saw sales fall as studies questioned whether they are too much of a risk because they could cause blood clots. FDA determined that they are safe and effective if used as approved, but 60% of the time they are not used as approved, and the negative publicity made skeptics out of some doctors and patients.
Government fared no better in the public eye. FDA commissioner Lester Crawford resigned under a cloud, undone by failing to sell off stocks in FDA-regulated companies.
Such events may seem better suited for gossip columns than MD&DI, but the situations produced valuable lessons for industry, clinicians, and regulators to learn. Many of them are explained in the stories below.