Document Type

Working Paper

Publication Date

7-17-2009

Abstract

Progress toward personalized medicine remains stymied by several factors Most glaring is the questionable quality of the data expected to drive this new treatment paradigm Institutions and firms engaged in biomarkers research have systematically failed to validate newly discovered molecular variations be they genomic proteomic metabolomic or dynamic interactions amongst them all with clinical outcomes as they amass and unfold over time This is in part attributable to deficiencies in the present regulatory framework Ambiguous standards for evaluating study design and product risk as well as seemingly redundant requirements from different regulatory authorities have led some if not driven others to escape oversight However it also reflects a marked failure of coordination a failure not only to put into place largescale collections of biological specimens accompanied by longitudinal patient health information but a failure to ensure continuous data exchange amongst the researchers clinicians healthcare providers and private firms already attempting to commercialize biomarkerrelated technologies The argument advanced in this paper is that intellectual property rights especially patents and the set of practices that those rights tend to engender contribute significantly to the paucity of data sharing that currently pervades biomarkers research Further these patentrelated issues cannot be easily disentangled from other barriers facing personalized medicine particularly the deficiencies of the present regulatory framework And the way in which the discourse around the impact of patent rights upon early stage scientific research has been framed helps account for why this dimension of the problem has received minimal attention to date

Share

COinS