Meeting success and failure in Alzheimer's disease drug development.
Richard Milne (University of Cambridge)
Paper short abstract:
This paper examines the role of pharmaceutical 'failure' in shaping bioclinical and ethical thresholds between normal ageing and dementia. I draw on ethnographic work and analyses of scientific and company literature, informed by STS studies of expectations, hope and ambivalence.
Paper long abstract:
In this paper I examine the central role of pharmaceutical 'failure' in shaping emerging relationships and biological, clinical and bioethical thresholds between normal ageing and dementia. 'Success' has proved elusive in the development of drugs for Alzheimer's disease. Fewer than 1% of those candidates which have entered clinical trials have ultimately been marketed, at a cost of billions of dollars, and uncounted time on the part of clinical trial subjects and researchers. Even when compared with the unspectacular productivity of the wider biopharma industry, Alzheimer's research appears to be struggling. However, as 'success' has been elusive, failure has acquired its own value and promise. Work in STS has drawn attention to the role of pharmaceutical innovation and particularly marketing in shaping practices of regulation, diagnosis and prescription. In this paper, I follow the generative effects of repeated failure in the de- and re-stabilisation of what counts as Alzheimer's disease. I draw on ethnographic work at clinical trial conferences and analyses of scientific and company literature, informed by STS work on expectations, hope and more recently ambivalence. The paper focuses primarily on the story of Eli Lilly's candidate drug solanezumab, following it from discovery to its failure to show efficacy in large phase III trials. In doing so, I point to the co-production of therapeutic objects and subjects, and mediating techniques of assessment which constitute the emerging bioclinical infrastructure through which Alzheimer's disease is produced and reproduced.
Bio-objectification: meetings and new thresholds across the bio-social