National and international research cultures for the innovation of new medicines involve various value claims about the ethics of the placebo entity as differentiating comparator. Yet, in turn, the instantiation of the placebo comparator as cultural artefact for the creation and identification of the ‘control group’ depends also upon prior social understandings of ‘comparability’. Reading back the ethics controversies surrounding the Risperidone psychiatry trials in India, the paper illustrates why drug efficacies need to be studied not only through comparative (...) techniques such as randomised controlled trials, but also through analytical modes of inquiry that can begin to place the problem of efficacy within particular social and cultural contexts, as well as across disciplines. It is suggested that future bioethics debates could benefit from a revised conception of the interdisciplinary placebo — one that is rooted in ‘placebo politics’ and that listens responsively to the voices of the global South. (shrink)

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. (shrink)