Rethinking Innovation Accounting in Pharmaceutical Regulation: A Case Study in the Deconstruction of Therapeutic Advance and Therapeutic Breakthrough

The controversy over the prescription drug, alosetron, is examined in order to investigate what is permitted to count as `therapeutic advance and `therapeutic breakthrough within pharmaceutical innovation and regulation. It is argued that those official accounting categories can mask very modest efficacy of some drugs by reference to the official techno-scientific evidence, thus leading to questionable acceptance of risks to public health. This is explained by: the drug availability options set by the commercial interests of manufacturers; the FDA managements need to demonstrate rapid approval of therapeutic advances to their budgetary masters, especially in the context of patient demands for access to new drugs; and the increasing capacity of patient groups, sometimes in collaboration with pharmaceutical manufacturers, to challenge techno-scientific expertise and evidence with experiential testimony. It is concluded that regulatory policy-makers need much more sophisticated accounting systems for differentiating between drugs defined as significant therapeutic advances, and between drugs (`therapeutic breakthroughs fast-tracked to treat serious or life-threatening conditions. Contrary to some STS analyses, the desirability of an ascendancy of patients anecdotal evidence in regulatory decisions for public health is questioned.