Complacent and conflicting scientific expertise in British and American drug regulation: Clinical risk assessment of triazolam

This paper presents a case study in the production and interpretation of re gulatory science, focusing on the conflicting British and American clinical risk assessments of triazolam (Halcion) - the most controversial sleeping pill in the world. The regulation of triazolam is shown to be more permissi ve in the USA than in the UK. Six principal socio-political factors are put forward to explain this: differential regulatory trust; regulators' socio- technical data selections. medico-scientific disciplinary influences; organ izational and professional interests; conflicts of interest of expert advis ers; and the growth of the neo-liberal regulatory state. The risk assessmen ts of both the British and American regulatory agencies are shown to be com placent relative to technical standards which the agencies themselves later accepted. It is suggested that, when the interests of pharmaceutical manuf acturers and patients diverge, regulatory assessments are crucially affecte d by whether regulators are predisposed to award the benefit of the scienti fic doubts to the manufacturers or patients, and by the balance of such pre dispositions both within and between regulatory institutions of scientific expertise. The triazolam case indicates that the amount of trust placed in the pharmaceutical industry by the British and American regulatory systems may hamper detection of flaws in manufacturers' medical data in a timely ma nner and, as a consequence, compromise patients' interests. Some policy imp lications for drug regulation are sketched.