Patients' interests: paramount in randomised trials

The early stopping of the MA17 trial, with data released to the media before the trial participants or health professionals had been given time to assess the implications, led to speculation in the medical press about how far patients' interests were being considered. 1 Similarly, recent articles have alleged that several pharmaceutical companies may have withheld product safety data, ranging from harmful effects of paroxetine in adolescents, to cardiovascular events associated with rofecoxib, with consequent speculation about the possibility of similar adverse effects from other COX-2 inhibitors. 2 3 Sir Tom McKillop, the chief executive officer of AstraZeneca, said: "If we put consumer protection as the only thing the regulator needs to worry about, that will be a huge block to progress and innovation."