Participation of end users in decision-making on science is increasingly practiced, as witnessed by the growing body of scientific literature on case evaluations. In the biomedical field, however, end-user participation in decision-making is rare. Some scholars argue that because patients are stakeholders and relevant experts, they could also provide important contributions to decision-making within the field of biomedical research. But what strategies could be used to effectively implement patient participation in decision-making on biomedical research? In this article, we analyze strategies (...) for patient participation and conclude that these can hardly be regarded effective because they do not ensure patients' structural influence on decision-making. We identify obstacles for effective patient participation, which seem to reflect a resilience of the current biomedical decision-making network. We subsequently elaborate on the concept of transition management in the search for clues on how to breach this resilience and change the network toward the inclusion of patients. (shrink)

We have a thriving biotechnology industry in the United States. There are over 1,450 biotechnology companies developing diagnostic and treatment technologies in medicine, creating more nutritional foods, and innovating new industrial processes. Yet this $28.5 billion sector of the economy is not without controversy. The “bio” in biotechnology comes from living, biological entities - people, plants, animals, and even bacteria. In the realm of biobanking, people are the source of the raw material for the discovery of genes for research, diagnosis, (...) and therapy, raising a host of issues about rights and responsibilities, fiduciary duties and societal obligations. (shrink)

We have a thriving biotechnology industry in the United States. There are over 1,450 biotechnology companies developing diagnostic and treatment technologies in medicine, creating more nutritional foods, and innovating new industrial processes. Yet this $28.5 billion sector of the economy is not without controversy. The “bio” in biotechnology comes from living, biological entities - people, plants, animals, and even bacteria. In the realm of biobanking, people are the source of the raw material for the discovery of genes for research, diagnosis, (...) and therapy, raising a host of issues about rights and responsibilities, fiduciary duties and societal obligations. (shrink)

This article argues that we could improve the design of research protocols by developing an awareness of and a responsiveness to the social contexts of all the actors in the research enterprise, including subjects, investigators, sponsors, and members of the community in which the research will be conducted. ?Social context? refers to the settings in which the actors are situated, including, but not limited to, their social, economic, political, cultural, and technological features. The utility of thinking about social contexts is (...) introduced and exemplified by the presentation of a hypothetical case in which one central issue is limitation of the probability of injury to subjects by selection of individuals who are not expected to live long enough for the known risks of the study to become manifest as harms. Benefits of such considerations may include enhanced subject satisfaction and cooperation, community acceptance, and improved data quality, among other desirable consequences. (shrink)

The use of Ritalin and other stimulant drug treatments for attention-deficit hyperactivity disorder (ADHD) raises distinctive moral dilemmas for parents; these moral dilemmas have not been adequately addressed in the bioethics literature. This paper draws upon data from a qualitative empirical study to investigate parents' use of the moral ideal of authenticity as part of their narrative justifications for dosing decisions and actions. I show that therapeutic decisions and actions are embedded in valued cultural ideals about masculinity, self-actualization and success, (...) as well as in moral conceptions of authenticity and personal freedom. I argue that this investigation of parents' moral justifications and dosing dilemmas raises questions about the validity of authenticity as a transcendent moral principle. Moreover, this study demonstrates that in order to be relevant, bioethical analysis of neurocognitive enhancement must engage with ground-up studies of moral principles and decision-making in context. (shrink)

Citizens today are increasingly expected to be knowledgeable about and prepared to engage with biomedical knowledge. In this article, I wish to reframe this ‘public understanding of science’ project, and place fresh emphasis on public understandings of research: an engagement with the everyday laboratory practices of biomedicine and its associated ethics, rather than with specific scientific facts. This is not based on an assumption that non-scientists are ‘ignorant’ and are thus unable to ‘appropriately’ use or debate science; rather, it is (...) underpinned by an empirically-grounded observation that some individuals may be unfamiliar with certain specificities of particular modes of research and ethical frameworks, and, as a consequence, have their autonomy compromised when invited to participate in biomedical investigations. Drawing on the perspectives of participants in my own sociological research on the social and ethical dimensions of neuroscience, I argue that public understanding of biomedical research and its ethics should be developed both at the community level and within the research moment itself in order to enhance autonomy and promote more socially robust science. Public bioethics will have to play a key role in such an endeavour, and indeed will contribute in important ways to the opening up of new spaces of symmetrical engagement between bioethicists, scientists and wider publics—and hence to the democratisation of the bioethical enterprise. (shrink)

An ecological niche framework ( Hacking, 1998 ) is utilised to examine the growth of ADHD in North America. The analysis suggests ADHD flourishes, at least in part, due to a complex and historicall...

An ecological niche framework (Hacking, 1998) is utilised to examine the growth of ADHD in North America. The analysis suggests ADHD flourishes, at least in part, due to a complex and historically situated interaction of factors that created a niche within which a particular kind of explanation and treatment for the troubling behaviours of children can and does thrive.

The Diagnostic and Statistical Manual (DSM) of the American Psychiatric Association, currently in its fourth edition and considered the reference for the characterization and diagnosis of mental disorders, has undergone various developments since its inception in the mid-twentieth century. With the fifth edition of the DSM presently in field trials for release in 2013, there is renewed discussion and debate over the extent of its relative successes - and shortcomings - at iteratively incorporating scientific evidence on the often ambiguous nature (...) and etiology of mental illness. Given the power that the DSM has exerted both within psychiatry and society at large, this essay seeks to analyze variations in content and context of various editions of the DSM, address contributory influences and repercussion of such variations on the evolving landscape of psychiatry as discipline and practice over the past sixty years. Specifically, we document major modifications in the definition, characterization, and classification of mental disorders throughout successive editions of the DSM, in light of shifting trends in the conceptualization of psychopathology within evolving schools of thought in psychiatry, and in the context of progress in behavioral and psychopharmacological therapeutics over time. We touch upon the social, political, and financial environments in which these changes took places, address the significance of these changes with respect to the legitimacy (and legitimization) of what constitutes mental illness and health, and examine the impact and implications of these changes on psychiatric practice, research, and teaching. We argue that problematic issues in psychiatry, arguably reflecting the large-scale adoption of the DSM, may be linked to difficulties in formulating a standardized nosology of psychopathology. In this light, we highlight 1) issues relating to attempts to align the DSM with the medical model, with regard to increasing specificity in the characterization of discrete mental disease entities and the incorporation of neurogenetic, neurochemical and neuroimaging data in its nosological framework; 2) controversies surrounding the medicalization of cognition, emotion, and behavior, and the interpretation of subjective variables as 'normal' or 'abnormal' in the context of society and culture; and 3) what constitutes treatment, enablement, or enhancement - and what metrics, guidelines, and policies may need to be established to clarify such criteria. (shrink)

In this case study from litigation, we show how ghostwriting of clinical trial results can contribute to the manipulation of data to favor the study medication. Study 329 for paroxetine pediatric use was negative for efficacy and positive for harm. Yet the ghostwritten publication from this study concluded that paroxetine provided evidence of efficacy and safety and continues to be influential. Despite the role of named authors in revisions of the manuscript, the sponsor company remained in control of the message.

This article systematically reviews published studies of the association of pharmaceutical industry funding and clinical trial results, as well a few closely related studies. It reviews two earlier results, and surveys the recent literature. Results are clear: Pharmaceutical company sponsorship is strongly associated with results that favor the sponsors' interests.