Risking public safety: experts, the medical profession and 'acceptable' drug injury

By locating expertise within an institutional framework, this paper examines the roles of regulators, the pharmaceutical industry and the medical profession in drug risk assessment and in the construction of 'acceptable' drug injury in particular. It is suggested that, while public perceptions of risks are important, they may be extremely limited due to relative secrecy surrounding some risk-generating activities, such as pharmaceutical development and regulation. Under these circumstances, a necessary starting point is the investigation of the formation of expert risk assessments. Taking the case of the anaesthetic drug, Althesin, the article explains how drug risks, largely unknown to the public, came to be defined as acceptable by expert and regulatory interpretation for over a decade. The reasons for and drivers of the regulatory route taken, together with alternative regulatory approaches are identified in relation to the salient risk - benefit problems: extrapolation of animal toxicology to humans, construction of therapeutic benefit, comparative risk assessment, unpredictability of risk and risk - benefit evaluation. It is argued that professional closure between expert regulators, the manufacturer and sections of the anaesthesiology profession led to passive decision-making and a regulatory approach towards acceptable drug injury unlikely to have been sustainable if it had been subjected to public accountability. The Althesin experience also suggests that regulators, the medical profession and other stakeholders concerned about drug risks should focus their attention not only on improving the evidence-base of risk assessment, but also on more robust interpretation and informative communication of the evidence already available at any particular time. Finally, the Althesin case demonstrates that, contrary to popular claims, major drug risks have not necessarily only been discovered upon widespread use after marketing approval and that, even after discovery of life-threatening risks, drugs have not necessarily been withdrawn quickly by the UK regulatory authorities despite the availability of safer alternatives.