Embodied values: post-pharmaceutical health and the accumulation of surplus vitality in regenerative stem cell medicine

Abstract

This paper analyzes an emerging form of post-pharmaceutical health and its underlying regime of value in the global bioeconomy of regenerative stem cell-based medicine (RSCM). Animated by a vision to overcome drug-based therapies and their underlying political economies, RSCM pursues a form of regenerative health that is strikingly at odds with pharmaceutical regimes of drug research, regulation and therapy. To offer a theoretical account of these competing forms of health, the paper provides an analysis of the regimes of values that underpin pharmaceutical and regenerative health respectively. This analysis is done alongside three dimensions: the interlinkage between knowledge, technology and economic value creation; its relation to normative values and ethics; and conceptions and valuations of the biomedical subject and his/her body in biomedical research, intervention and innovation. Contrasting these two diverging regimes of health and value suggests that in RSCM the pharmaceutical logic of accumulating “surplus health” is not entirely dismissed but re-articulated in a regime based on the (re-)generation of regenerative biovalue through the extraction and ex vivo accumulation of “surplus vitality”. Finally, the article discusses “post-pharmaceutical health” as a sensitizing concept that offers new research avenues into emergent forms of health, value, and subjectivity beyond RSCM.

Narratives, uncertainty and subjectivity in the context of regenerative medicine

“…The 2019 Biomass R&D Board document introduces the concept of the bioeconomy as a revolution that enables sustainable scientific and technological development [1]. From an American perspective, talking about the bioeconomy means treating agricultural biotechnologies as drivers of sustainable development.…”

“…In this sense, although we can talk about bioeconomies in the agricultural bioeconomy and the bioeconomy of assisted reproduction once they are on the market, in the pharmaceutical industry only 16% of new products have their origin in biotechnology. since 1987, and pharmacogenetics has not yet managed to establish itself in clinical practice [1].…”

2. Organoide in Forschung und Anwendung: eine Einführung

“…Auf Basis dessen lässt sich fragen, welche Formen und Kriterien für die Sicherheit und Wirksamkeit der klinischen Translation der Organoidforschung angemessen und welche Hürden absehbar sind. Im Zusammenhang damit sind einerseits die regulatorischen Herausforderungen des anvisierten Überganges organoid-basierter biomedizinischer Innovation in die Klinik vor dem Hintergrund vielfältiger Formen epistemischer Unsicherheit von Interesse, die bereits die klinische Translation der Stammzellforschung erschweren (Hauskeller 2018), andererseits sind die von Haddad (2019) in Bezug auf Stammzellen thematisierten Formen, Probleme und Herausforderungen post-pharmazeutischer Modelle der Gesundheitsforschung und -versorgung auch für Organoide relevant.…”

Alter-Standardizing Clinical Trials: The Gold Standard in the Crossfire

“…The paper of Rosemann, Vasen and Bortz, finally, suggests that the increasing diversification of regulatory standards indicates a broader shift towards deregulation and increased medical self-governance. Regulatory developments such as the 21st Century Cures Act in the USA, the early-stage conditional approval system in Japan and the creation of a legal market of stem cell therapies under the EU hospital exemption scheme (see also: Salter et al, 2014), suggest thatoutside of the regulation for pharmaceutical drugsstate intervention is downsized and partly replaced by self-regulation by medical institutions and associations (see also Cooper and Waldby, 2014;Rosemann and Chaisinthop, 2016;Kassirer, 2018;Haddad, 2019). A consequence of this is, however, that the oversight of experimental medical interventions is increasingly shaped and enacted by institutions and professional networks with vested interests.…”