Concern about the ethics of clinical drug trials research on patients and healthy volunteers has been the subject of significant ethical analysis and policy development—protocols are reviewed by Research Ethics Committees and subjects are protected by informed consent procedures. More recently attention has begun to be focused on DNA banking for clinical and pharmacogenetics research. It is, however, surprising how little attention has been paid to the commercial nature of such research, or the unique issues that present when subjects (...) are asked to consent to the storage of biological samples. Our contention is that in the context of pharmacogenetic add-on studies to clinical drug trials, the doctrine of informed consent fails to cover the broader range of social and ethical issues. Applying a sociological perspective, we foreground issues of patient/subject participation or ‘work’, the ambiguity of research subject altruism, and the divided loyalties facing many physicians conducting clinical research. By demonstrating the complexity of patient and physician involvement in clinical drug trials, we argue for more comprehensive ethical review and oversight that moves beyond reliance on informed consent to incorporate understandings of the social, political and cultural elements that underpin the diversity of ethical issues arising in the research context. (shrink)

Even in the increasingly individualized American medical system, advocates of 'personalized medicine' claim that healthcare isn't individualized enough. With the additional glamour of new biotechnologies such as genetic testing and pharmacogenetics behind it, 'Me Medicine'-- personalized or stratified medicine-- appears to its advocates as the inevitable and desirable way of the future. Drawing on an extensive evidence base, this book examines whether these claims are justified. It goes on to examine an alternative tradition rooted in communitarian ideals, that of (...) the common good as a goal in medicine. (shrink)

The observation that a crisis of confidence regarding Psychiatry exists is a notion shared even among psychiatrists themselves. Psychiatry has a checkered history and its alliance with the pharmaceutical industry, aka Big-Pharma, continues to reinforce a need for healthy skepticism. Why? Mainly, an over-reliance on the questionable expertise and authority afforded psychiatry as the specialists of mental health. I contend that the authority of psychiatry is misplaced and too often harmful. Since the criteria required to justify and satisfy psychiatric expertise (...) is not fully established as can be substantiated by compelling reasons to rethink its authority as a reliable profession in its current form. Psychiatric expertise is not particularly scientific and this is especially dangerous in a sector that prescribes mind-altering drugs. There are a number of identified criteria that would otherwise substantiate psychiatric expertise and whilst partially existent, are nonetheless deficient. These major yet deficient aspects of psychiatric practice concern diagnostic problems – reliability and verification of diagnoses and accurate testable validity of diagnoses - mainly due to an absence of identifiable underlying biomarkers ordinarily related to disease or biological conditions. Psychiatrists often fail to distinguish between reactive-depression (reaction to external event or circumstance) and endogenous-depression (biological) resulting, in part, from incorrectly distinguishing between conditions constitutive of ‘trait’ (endogenous) and of those of ‘state’ (e.g. reactive depression; adverse effects from medication, etc.). (shrink)