“Omics” research, monetization of intellectual property and fragmentation of knowledge: can clinical epidemiology strengthen integrative research?

An analysis of the contributions of “omics technologies” to human health and clinical care needs to address the relationships between internal issues (e.g., methodological shortcomings in “omics” research and clinical biology) and external influences. Among the latter, monetization of intellectual property (IP) appears to be a powerful force favoring methodological limitations and an excessive reductionism and fragmentation of biological knowledge. Following economic successes in other industries (semiconductors, software, and “dot-coms”), monetization of IP tries to market small fragments of big research “puzzles”; the strategy seems partly responsible for the biotech industry having underperformed methodological, clinical, and economic expectations. Hence, internal, purely scientific reasons can hardly explain failures in the application of long-proven principles of clinical epidemiology to the discovery and validation of diagnostic and prognostic tests. Nevertheless, this paper also sketches methodological proposals that may help integrate microbiological, clinical, and environmental evidence. Clinical and epidemiological reasoning, knowledge, and methods need to be applied on a much wider scale than until now by “omics” studies that aim at making inferences relevant for human beings. Rather than adopting the values and norms of “science business,” “omics research” could apply a diversity of clinicoepidemiological models favoring integrative research.