Abstract
The ethical controversies raised by an industry-sponsored placebo-controlled trial of Risperidone for mania, conducted across eight sites in India, provide opportunities for dialogue, reflection and interdisciplinary consensus building on the processes and validity of the methods of evaluating the efficacy of interventions in health care. This commentary contextualises the debate in considerations of the evolution of morality and double standards. It is suggested that a productive interpretation of this unfolding drama should appreciate the folly of dissociating ethical standards in routine health care from those used in health research, the culturally and economically grounded preferences in research priority setting, and the choice of ethical principles underlying participation in, and conduct of, clinical research. A broader discussion of ethical problems in clinical trials which includes questions about the evidence that informs ethical opinion is required to prevent harm to participants and subsequent recipients of health care and to restore confidence in the methods and the results of research in health care.