Monday, October 4, 2010
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).