The processing of affectively valenced stimuli: The role of surprise

Two experiments tested the hypothesis that the surprise mechanism activates a threat detection system that prioritises the processing of threat-related stimuli. In Experiment 1, participants responded to a dot that appeared during the presentation of two words. In the critical trial, one of the two words was either pleasant or unpleasant. In Experiment 2, depending on the condition, the participants had to decide whether at least one of two simultaneously presented pictures depicted either a pleasant or an unpleasant stimulus. In the critical trial, both a pleasant and an unpleasant picture appeared. In both experiments, the stimuli in the critical trial were presented either during routine behaviour or in the context of a surprising event. The results showed that during routine behaviour unpleasant stimuli received more attentive resources than pleasant stimuli only if the affective valence of the stimuli was action-relevant (Experiment 2). In contrast, in the context of surprise, unpleasant words engaged more attentive resources than pleasant words although they were action-irrelevant (Experiment 1). In addition, in the context of surprise, the decision time increase was more pronounced in the pleasant than in the unpleasant experimental group. This finding was interpreted as evidence that the threat detection system of the surprise mechanism initially searches for a threat-related stimulus.     

Global Diversification in Medicine Regulation: Insights from Regenerative Stem Cell Medicine

ABSTRACT

Medicine regulation worldwide has undergone a process of regulatory diversification. The evidence-based medicine (EBM) paradigm, centered on multi-phase randomized controlled trials, is increasingly contested and replaced by new models of clinical validation. To explain these changes, STS research has cited just a few factors, e.g. growing pressure form health consumers; the role of pharmaceutical companies to lobby for fast, affordable drug development; the influence of neoliberal ideas and libertarian advocacy of deregulation; and the agency of national governments to enable domestic innovation opportunities in the context of global competition and inequalities. Those factors individually cannot account for the increasing variation in medicine regulation at both national and global levels. Instead it is helpful to integrate elements of existing explanations into a framework with four pairs of conflicting regulatory choices, which play a central role in the formation of medicine regulation. We use this framework to compare regulatory changes in the USA, European Union, China, India, Argentina, and Japan. Across these jurisdictions, the case studies illustrate four dynamics of diversification. Key regulatory concepts such as evidence, risk, safety, efficacy, responsibility and accountability acquire different meanings, reshaping medicine innovation in far-reaching and often contradictory ways. The boundaries between medical research and healthcare provision, commerce and humanitarian service, as well as state control and medical self-regulation are re-defined.     

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

ABSTRACT

The international landscape of medical research is in the midst of a process of diversification and change. The randomized controlled trial (RCT), long considered the global gold standard for clinical research, has become increasingly contested and is partly replaced by alternative methodologies, standards and forms of evidence. The contours of mainstream medical research are changing as a result. Regulatory paradigms and standards are, literally, being rewritten, at a global level. The evidence-based medicine (EBM) hierarchy of evidence is redefined. This special issue explores these developments through the concept of ‘alter-standardization’. The term refers to the processes, controversies and negotiations through which multiphase RCTs and the EBM system are challenged and gradually superseded by alternative methodological and regulatory forms and standards. This special issue examines the conceptual, practical and theoretical implications of these changes, and the ways in which these transformations influence the situation and possibilities of patients, knowledge producers, physicians, large pharmaceutical corporations, smaller biotech companies, as well as regulatory bodies, civil societal organizations and national health care systems. The articles in this special issue make use of comparative and historical perspectives that focus on scientific, social, economic and regulatory developments in the European Union, China, India, Japan, Argentina, the UK and the USA. They show that the alter-standardizing of clinical trials arises in a pluralistic way, that is driven by a variety of often conflicting factors, developments and expectations. These changes reflect a broad transformation in the culture and politics of biomedicine today, with implications for the ways in which new medicinal products, devices, procedures and technologies are developed, approved for clinical use, sold to consumers, and licensed by health care systems.