Turf war? Woolies' health checks fuss not just about patients

When supermarket chain Woolworths announced plans to offer in-store “health checks” earlier this week, health groups came out in force to criticise the move. But scratch the surface and it’s apparent that the criticisms aren’t just about protecting the public. The checks, which have been pitched by Woolworths as a service for their customers, will see final year pharmacy students, graduating pharmacists, and nurses measuring blood pressure and cholesterol, among other things. Professional health groups, the Pharmacy Guild and the Australian Medical Association (AMA) have reacted negatively. AMA president Brian Owler has described the proposal as: a dangerous idea that should be stopped before it gets off the ground. And the Pharmacy Guild has argued Woolworths is attempting to: hoodwink consumers into believing they can get professional pharmacist advice and products from a supermarket. Cause for concern?NHMR

Reconfiguring tissue banking consent through enrichment of a restricted debate

Tissue banks are thought to be an essential resource for medical research in the post-genomic age. Collections of tissue, usually removed in the course of diagnostic or therapeutic procedures, enable laboratory-based epidemiological studies to be carried out, linking abnormalities in the tissue to disease aetiology, prognosis and treatment responsiveness. There are, however, a number of technical, regulatory and ethical concerns that challenge those wishing to engage in tissue banking research. It is becoming increasingly apparent that tissue banking research is not without risk of harms, even though there is no direct physical risk to donors. This is because, in order to be most useful, banked specimens need to be linked to personal information about tissue donors and this poses the risk of inadvertent disclosure of personal─ particularly genetic─ information to those who might exploit such information (eg. insurance companies and employers). Furthermore, the long-term storage of specimens, and the impossibility of predicting all potential types of research programs for which they might be useful, raises the possibility that future projects will be carried out that are unacceptable to some (past) tissue donors. The ethical principles of autonomy and respect for persons demand that research subjects be informed of such risks and of the nature of the research, and that they participate willingly. On the other hand, there is a desire for science to progress unhindered by stringent consent requirements. For these reasons, a debate has emerged in the academic (bioethical and biomedical) literature and in the legal (law reform) sphere over what would constitute adequate consent. Despite an extensive discourse, it is still unclear whether it is permissible to carry out research on archival tissue that was originally taken for diagnostic purposes and whether project-specific (as opposed to open-ended) consent is required for research on tissue collected today. This lack of clarity is of concern to researchers, ethics committees and research subjects, all of whom recognise the importance of tissue banking research, yet fear that current consent procedures may be ethically or legally inadequate. Thus it is important that the consent dilemma be resolved as quickly and definitively as possible. Ongoing controversy and regulatory ambiguity are appropriate when morally contentious issues are at stake, and their existence does not, on its own, signal any flaws in the discourse process. There are, however, two reasons to suspect that the current 'consent to tissue banking' debate, as portrayed in the academic literature and law reform documentation, is problematic. Firstly, the debate appears to be mired in an intractable conflict between those who want to maximise personal autonomy through stringent consent requirements, and those who want the scientific endeavour to progress in a manner that is unconstrained by what are viewed as arduous consent procedures. Secondly, the possible practical options (consent models) being generated by the debate are all limited because they are underpinned by a restricted notion of consent as an individualistic, legalistic and static activity, without consideration of any alternative conceptualisations of consent. Through a thematic analysis of the current 'consent to tissue banking' debate in the academic and law reform literature (Section 3), this thesis shows that debate is essentially occurring between those who see individual autonomy (and stringent consent) as being of primary importance, and those who see unimpeded, market-driven scientific progress as the more important social good, which should not be impeded by unnecessarily stringent consent. Thematic analysis also confirms the existence of the two problems described above, and a failure of those engaged in the debate to reflect on, and challenge, the value-level assumptions underpinning their arguments and those of their opponents. It is argued that this lack of reflection accounts for the two problems: • Firstly, it precludes recognition of the cause of─ and, therefore, ways of resolving─ the intractable conflict at the centre of the debate. Value-level reflection shows that this is a result of the logical and moral conflict within western liberalism, between two modernist goods: individual freedom and scientific progress. • Secondly, it precludes the generation of varied conceptions of consent. Value-level reflection shows that the current range of consent models is restricted to procedures which are individualistic, abstract, static and legalistic, since they are underpinned by western liberal notions of autonomy and scientific progress. This recognition paves the way to consideration of alternative notions of autonomy, scientific progress and, therefore, consent, such as those derived from communitarian and feminist systems of values. A conceptually enriched model of tissue banking consent is then developed (Section 4). This model incorporates dominant (liberal) conceptions of autonomy and scientific progress as well as alternative notions of autonomy and scientific progress espoused by communitarian and feminist systems of values. It is argued that this conceptually-enriched model provides a practical solution to the two problems associated with the standard 'consent to tissue banking' debate. In relation to the philosophically intractable conflict─ or what is termed the 'modernist dilemma'─ between those privileging autonomy and those privileging scientific progress, it shows how the two apparently conflicting 'modernist' goods can both be accommodated at a practical level, thus making the 'consent to tissue banking' debate more tractable and fruitful. In relation to the restricted range of consent models being generated by the current debate, it provides new insights into the ways in which consent might be obtained such that a broader range of community values can be accommodated. More specifically, it stimulates the construction of a model that 1) involves communities, as opposed to merely individuals, in all stages of the scientific process; 2) is flexible and able to adapt consent procedures to specific contexts, rather than predefining procedures in abstract terms; and 3) is transactional and relational rather than static and legalistic. This outcome has interesting philosophical as well as practical implications. It shows that despite apparently unresolved, and possibly irresolvable, normative-level conflicts between the two modernist elements of western liberalism (autonomy and scientific progress), and between liberal, feminist and communitarian systems of values, a multi-perspectival, inclusive, model-building approach provides a practical solution that circumvents these normative-level conflicts

Managing scientific uncertainty in health legislation

Legislation and regulation are one means of controlling biomedical research and its clinical applications. This is seldom a one-off process since biomedical science evolves rapidly, dynamically and often unpredictably, and legislative and regulatory reviews are often required in response to the emergence of apparently new ethical and legal issues. In recent years, there have been several reviews of Australian biomedical legislation including the Australian Law Reform Commission’s “Inquiry into the Protection of Genetic Information in Australia” (“the ALRC Inquiry”) released in 2003 1, and the Legislative Review of the Prohibition of Human Cloning Act 2002 and the Research Involving Human Embryos Act 2002, (“the Lockhart Review”) which was released in December 2005 2. The ALRC Inquiry was a response to developments in genetic research, particularly genetic epidemiological research involving powerful new techniques such as microarrays (gene chips). The Lockhart Review was concerned with developments in stem cell research, including the use of embryos produced in the course of assisted reproductive technology (ART) and through cloning. These two reviews, when juxtaposed, highlight the key elements—both recurring and review-specific—of biomedical legislative review

Generating a taxonomy of regulatory responses to emerging issues in biomedicine

In the biomedical field, calls for the generation of new regulations or for the amendment of existing regulations often follow the emergence of apparently new research practices (such as embryonic stem cell research), clinical practices (such as facial transplantation) and entities (such as Avian Influenza/’Bird Flu’). Calls for regulatory responses also arise as a result of controversies which bring to light longstanding practices, such as the call for increased regulation of human tissue collections that followed the discovery of unauthorised post-mortem organ retention. Whilst it seems obvious that new regulations should only be generated if existing regulations are inadequate (a practice referred to in this paper as ‘regulatory syncretism’), this does not always occur in practice. This paper examines the conceptual steps involved in generating regulatory responses to emerging phenomena. Two decision points are identified. First, a stance is taken as to whether the emerging phenomenon raises unique ethical or legal issues (exceptionalism versus non-exceptionalism). Second, the decision is made as to whether new regulation should be generated only for truly unique phenomena (syncretism versus asyncretism). It is argued here that it is important to make a careful assessment of novelty, followed by a reflective and deliberate choice of regulatory syncretism or asyncretism, since each type of regulatory response has advantages which need to be harnessed and disadvantages which need to be managed—something that can only occur if regulators are attentive to the choices they are making. Keywords: Exceptionalism, regulation, tissue banking, health polic

Pharmaceuticals, money and the health care organisational field

Using an institutional theory framework, this article discusses the place of the pharmaceutical industry within the health care organizational field, and the wideranging effects the industry has on the other organizations in the field. It then provides a snapshot of the discourse that has emerged about the pharmaceutical industry, and about commercialization and marketization of the health care more generally. This paints a picture of deep ambivalence towards the pharmaceutical industry, both within and between stakeholder groups. The article ends with an effort to explain this ambivalence as the effect of competing institutional logics. This, in turn, points to some suggestions as to how the pharmaceutical industry might be better accommodated within the health care organizational field, without losing sight of the need for ongoing critique of industry behavior. KEYWORDS Pharmaceutical industry, institutional theory, organizational field, institutional logic, commercialization, marketizationNHMR

Turf war? Woolies' health checks fuss not just about patients

When supermarket chain Woolworths announced plans to offer in-store “health checks” earlier this week, health groups came out in force to criticise the move. But scratch the surface and it’s apparent that the criticisms aren’t just about protecting the public. The checks, which have been pitched by Woolworths as a service for their customers, will see final year pharmacy students, graduating pharmacists, and nurses measuring blood pressure and cholesterol, among other things. Professional health groups, the Pharmacy Guild and the Australian Medical Association (AMA) have reacted negatively. AMA president Brian Owler has described the proposal as: a dangerous idea that should be stopped before it gets off the ground. And the Pharmacy Guild has argued Woolworths is attempting to: hoodwink consumers into believing they can get professional pharmacist advice and products from a supermarket. Cause for concern?NHMR

Navigating tissue banking regulation: conceptual frameworks for researchers, administrators, regulators and policy-makers.

In the “post-genomic” age of biomedical research, researchers often wish to utilise collections of human tissue. This type of research raises many ethical and legal issues and anyone wishing to use such collections is faced with an enormously complex set of regulatory requirements, many of which are still ambiguous, reflecting ongoing ethical and legal debate. Whilst there is no way of entirely avoiding such regulatory complexity and ambiguity, conceptual frameworks can assist those who wish to use, administer, authorise and generate policy on tissue banking research. Two conceptual frameworks are described here: a taxonomy of tissue banking practices, aimed at assisting those who need to ensure that tissue banks meet ethical and legal requirements; and a “syncretic” approach to policy-making, for those who wish to generate new policy,or streamline existing policy relating to tissue banking researc

Review of Snyder L “Ethical choices. Case studies for medical practice 2nd edition”

Ethics teaching is often theoretical, emphasising broad ethical principles, such as autonomy, or normative theories, such as consequentialism. Case studies are used primarily to illustrate these principles and theories. As a case-based text, Ethical choices: case studies for medical practice eschews the theoretical approach to medical ethics, arguing that ethics is not just about philosophical and other principles, ideals and rigorous arguments, but about the very real aspects of what people do and why. Through commentaries on 28 cases, divided into four sections (The clinical encounter, Non-clinical dimensions, Medicines collective obligations and The business of medicine), Ethical choices illustrates the resolution of a wide variety of dilemmas. Commentators do not argue by analogy with other cases a finding consistent with the (potentially contestable) assertion that ethical concerns are raised only when suggested courses of conduct deviate from the norm. Instead, the emphasis is on the power of stories in ethics education, and on the importance of using individual cases in all their complexity

Regulations have improved since thalidomide but drug scares are still possible

The thalidomide tragedy, which resulted in thousands of deaths and disabilities in the late 1950s and early 1960s, changed medicine forever. One of its outcomes was the establishment of more robust mechanisms for the regulation of medicines and medical devices. Regulatory bodies – including the Therapeutic Goods Administration (TGA) in Australia, the Food and Drug Administration (FDA) in the United States and the Medicines and Health care products Regulatory Agency (MHRA) in the United Kingdom – now decide which products pharmaceutical and medical device companies can market. They also monitor the safety of medicines and devices once they are on the market. There is no doubt that the tightening of regulation has prevented countless deaths and disabilities, and saved many lives. But regulation cannot always protect us from harm and events disturbingly similar to the thalidomide tragedy continue to occur. Let’s look at two recent examples.NHMRC Career Development Fellowship APP106356

Beyond the consulting room: intuition and intersubjectivity in journal peer review

Imagine for a moment that you have been asked to review a manuscript for a peer reviewed psychiatric journal. The manuscript reports the results of a randomised trial of a new anti-depressant. What approach would you take? What principles would you apply? Perhaps, in thinking through your approach, you considered the importance of disinterestedness, and of the need to apply the principles of critical appraisal as set out in the many guidelines available on evaluating clinical research. Perhaps, in other words, you considered the need to be as “scientific” as possible in your approach to the review. This attitude would be pleasing to most journal editors, who would likely subscribe to the guidelines of the International Committee of Medical Journal Editors (ICMJE) which state that [1]: Unbiased, independent, critical assessment is an intrinsic part of all scholarly work, including the scientific process. Peer review is the critical assessment of manuscripts submitted to journals by experts who are not part of the editorial staff. Peer review can therefore be viewed as an important extension of the scientific process. At first glance this might appear to be a perfectly appropriate and realistic approach. After all, you are a scientist and you are reviewing a scientific manuscript, so it seems only reasonable that your approach to the review should be scientific too. But is it really so straightforward? Is a “scientific” approach to peer review really achievable? And even if it is achievable, is it necessarily desirable