BioCentury published a Commentary in March criticizing FDA leadership for its long silence in the face of political bullying on Avandia rosiglitazone. We argued FDA had an obligation to respond to allegations from members of Congress that the agency's allegedly "cozy" relationship with Avandia's manufacturer, GlaxoSmithKline plc, had led it to look the other way while the drug "caused approximately 83,000 excess heart attacks between 1999 and 2007."

BioCentury added that FDA was at a critical inflection point: The way it handled Avandia would determine whether a culture of selective, misleading leaks to Congress, alarmist media coverage and grandstanding politicians would supersede scientific decision-making (see BioCentury, March 8).