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The technological constitution of medicine's future: ontological and epistemological issues concerning "biomarkers"

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The technological constitution of medicine’s future: Ontological and epistemological issues concerning ‘biomarkers’

Marianne BOENINK

Department of Philosophy

University of Twente, The Netherlands

m.boenink@utwente.nl

Since the completion of the Human Genome Project, the hope that genetic markers would enable a predictive and preventive medicine, geared towards one’s genetic constitution, has gradually been proven vain. The actual results harvested from genetic and genomic research have been disappointing compared to the promises and expectations raised. This has not discouraged biomedical researchers and policy makers, however, to keep pursuing the ideal of predictive, preventive and, in particular, personalized (PPP--‐) medicine. Their focus of attention has shifted, and now ‘biomarkers’ seem to have replaced ‘genes’ as the hope for the future of PPP--‐medicine.

This rise of interest in ‘biomarkers’ indicates a conceptual shift in biomedicine that is philosophically interesting for more than one reason. The most commonly used definition of a biomarker is “a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention” (1). Thus, a biomarker is a technologically and scientifically constituted entity, that is interpreted as a sign of real time bodily processes. A biomarkers is, then, a translator, opening up the domain of the body for discussion (and intervention). This is not a new phenomenon in medicine: cholesterol, blood pressure or PSA--‐levels are just some of the biomarkers ‘avant la lettre’ that have been around for

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quite some time. What is new, however, is that biomarkers are now sought for mainly on the molecular level (RNA, proteins), as well as the sheer increase in number of proposed biomarkers (2).

In addition, even though the phenomenon in itself may not be new, both the status of biomarkers and their role as a translator are philosophically opaque. First: What exactly is a biomarker? How can it be recognized? How does technology constitute this phenomenon and how does that determine the way it opens up the body for investigation and intervention? And secondly: How do biomarkers distinguish between ‘normal’ and ‘abnormal’ biological processes? Which concept of normality/abnormality is presupposed? And which concept of disease does it reinforce? And, taking the answers to the afore mentioned questions into account, how plausible is it that biomarkers will help establish PPP--‐medicine and if so, what would it look like?

In this presentation, I will first offer a brief overview of the way the search for biomarkers now informs biomedical research and research policy. Subsequently, I will go into the ontological and epistemological issues raised by the concept ‘biomarker’, using (among others) the work of Canguilhem (3) to reflect on the concept of (ab--‐)normality implied in most biomarker research. In conclusion, I will indicate how the philosophical questions and doubts raised by biomarkers may impact the plausibility of the PPP--‐vision of the future of medicine.

References

(1) Biomarkers Definition Working Group (2001), Biomarkers as Surrogate Endpoints: referred defitnitions and conceptual framework. Clin. Pharamcol. Ther. 69 (3), 89--‐95.

(2) Metzler, I. (2010), Biomarkers and their consequences for the biomedical profession: a social science perspective. Personalized Medicine 7(4), 407--‐420. (3) Canguilhem, G. (1991), The normal and the pathological. New York: Zone Books

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