The pluralization of the international: Resistance and alter-standardization in regenerative stem cell medicine

Rosemann, Achim; Chaisinthop, Nattaka

doi:10.1177/0306312715619783

Cited by 21 publications

(11 citation statements)

References 62 publications

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“…In fact, Rosemann and Chaisinthop argue that resistance to EBM is becoming more organized and global, especially in stem cell medicine [21]. RCTs have been criticized as too costly, lengthy and burdensome, hence increasingly less feasible to execute [22].…”

Section: Expertise Experience and Expediencymentioning

confidence: 99%

The Social Production of Evidence: Regenerative Medicine and the 21st Century Cures Act

Hogle

Das

2017

Regen. Med.

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Regenerative medicine (RM) has experienced uncertainty in regulatory review since the beginning. Political and social environments always affect policy: consistency and interoperability across societies has been hard to achieve, and over time, extreme precaution has largely been replaced with optimism and high expectations from patients, politicians and investors. Like all novel therapies, disputes about what sort of evidence matters and how it should best be produced dogged the field's early days. With little expertise from regulators or industry, and few standards to go on, safety and effectiveness requirements were negotiated. More recently, assumptions about what counts as acceptable evidence are being up-ended in light of new tools and techniques for the collection and analysis of data, but also decades of discontent with evidence-based medicine (EBM). Patients are also demanding to have a say in clinical research and may be willing to take greater risks. All this is happening in a political climate in which funding is being cut for scientific research and governmental oversight.Recent US laws portend further changes. While intended to provide a clear and lubricated pathway for product approval, new uncertainties may arise for RM. The US 21st Century Cures Act [1] (hereafter 'Cures Act') makes statutory changes to the US Department of Health and Human Services (DHHS) and the US FDA, directing the agencies to expedite product approvals by removing requirements viewed as burdensome while considering alternative forms of evidence. This entails fundamental changes to regulatory frameworks altering how evidence may be collected and evaluated. Simultaneously, Right-To-Try (RTT) laws aim to broaden access to experimental treatments with only preliminary evidence.Commentators portray the changes on the one hand as liberating patient access to treatments, encouraging innovation and lowering regulatory burdens, and on the other, encouraging false hope among vulnerable patients, attacks on science, lobbyist-driven maneuvering, and lowering rigorous standards. However, framing such controversies over regulatory review as polarities oversimplifies the situation. We argue that current changes need to be viewed within the broader contexts of social phenomena that shape what comes to count as valid evidence. We first briefly highlight features of the Cures Act, then situate it historically and politically within the longer history and broader contexts of evidence production. We close with implications for RM. New paradigms for producing evidence?The Cures Act was billed as a patient-centered effort to promote innovative therapies and reduce activities seen as barriers to research. One of the few successful bipartisan legislative efforts in a divisive Congress, it passed overwhelmingly at the end of 2016. This broad-sweeping law has many components, including increasing funding for specific medical research areas, authorizing broader data sharing, and reducing bureaucratic processes. Significantly, it directs the FDA to co...

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Section: Expertise Experience and Expediencymentioning

confidence: 99%

The Social Production of Evidence: Regenerative Medicine and the 21st Century Cures Act

Hogle

Das

2017

Regen. Med.

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“…It remains to be seen whether other countries will follow the Japanese regulatory model. However, the emergence of parallel (and potentially incommensurable) regulatory zones and networks [2,3,63], in which researchers and companies can choose between different regulatory options to bring stem cell-based treatments to the clinic and market is possible. Of interest is that regulatory heterogeneity in the stem cell field is not only emerging between countries (and in relation to global differentials of wealth, health care as well as scientific and regulatory resources [3]), but increasingly also within national jurisdictions in highincome countries [1,11,50,53].…”

Section: Future Perspectivesmentioning

confidence: 99%

“…With the increase of regulatory divergence at both national and international levels [2], various questions remain critical. What is the impact of the diversification of regulatory arrangements on the credibility of stem cell therapies, and how do actors determine which standards and products they can trust?…”

Section: Future Perspectivesmentioning

confidence: 99%

“…The regulatory conditions through which stem cell treatments are translated from the lab bench to the clinic and the market are currently in the midst of a renegotiation process [1], [2], [3]. A key problem for the stem cell field is that existing regulatory approaches for the clinical testing and market approval of new drugs do not neatly map onto stem cell interventions.…”

Section: Introductionmentioning

confidence: 99%

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Global Regulatory Developments for Clinical Stem Cell Research: Diversification and Challenges to Collaborations

et al. 2016

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In this article we explore regulatory developments in stem cell medicine in seven jurisdictions: Japan, China, India, Argentina, Brazil, the USA and the European Union. We will show that the research methods, ethical standards and approval procedures for the market use of clinical stem cell interventions are undergoing an important process of global diversification. We will discuss the implications of this process for international harmonization and the conduct of multicountry clinical research collaborations. It will become clear that the increasing heterogeneity of research standards and regulations in the stem cell field presents a significant challenge to international clinical trial partnerships, especially with countries that diverge from the regulatory models that have been developed in the USA and the European Union.

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“…High hopes and expectations on the side of all involved -patients, investors and policy makers, as well as biomedical communities and biotech firms betting on the speculative clinical and commercial value of RSCM -have created a veritable pressure to perform and bring stem cell-based therapies to clinic and market as rapidly as possible (Morrison, 2012). In a veritable "rush to the clinic" (Wilson, 2009) that has taken shape on a global scale, various clinical and corporate actors have sought to realize the promise of RSCM and deliver actual stem cell-based therapies to patients in need (Salter et al, 2015;Rosemann et al, 2016;Bharadwaj, 2018). Yet, not only have expectable challenges to the clinical translation process curbed hopes for rapid clinical uptake (REFs); strikingly divergent visions of what desirable and responsible innovation pathways for regenerative stem cell-based therapies are in the first place have also sparked substantive conflicts within and beyond biomedical communities (Haddad et al, 2013;Rosemann;Chaisinthrop, 2016).…”

mentioning

confidence: 99%

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

Haddad

2019

Sociologias

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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.

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The pluralization of the international: Resistance and alter-standardization in regenerative stem cell medicine

Cited by 21 publications

References 62 publications

The Social Production of Evidence: Regenerative Medicine and the 21st Century Cures Act

The Social Production of Evidence: Regenerative Medicine and the 21st Century Cures Act

Global Regulatory Developments for Clinical Stem Cell Research: Diversification and Challenges to Collaborations

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

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