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Background: Omalizumab, an anti-immunoglobulin E antibody, reduces exacerbations and symptoms in uncontrolled allergic asthma. The study objective was to estimate the costs and consequences of omalizumab compared to usual care from a US payer perspective. Methods: We estimated payer costs, quality-adjusted survival (QALYs), and the incremental cost-effectiveness ratio (ICER) of omalizumab compared to usual care using a state-transition simulation model that included sensitivity analyses. Every 2 weeks, patients could transition between chronic asthma and exacerbation health states. The best available evidence (...) informed the clinical and cost input estimates. Five years of omalizumab treatment followed by usual care was assumed to estimate a lifetime horizon. Omalizumab responders (60.5% of treated) were modeled as a separate scenario where nonresponders reverted back to usual care after 16 weeks of active treatment. Results: The mean lifetime discounted costs and QALYs were $83 400 and 13.87 for usual care and $174 500 and 14.19 for omalizumab plus usual care resulting in $287 200/QALY (95% interval: $219 300, $557 900). The ICER was $172 300/QALY when comparing omalizumab to usual care in the responder scenario. One-way sensitivity analyses indicated that the results were sensitive to the difference in treatment-specific utilities for the chronic state, exacerbation-associated mortality, omalizumab price, exacerbation rates, and response definition. Conclusions: The results suggest that adding omalizumab to usual care improves QALYs at an increase in direct medical costs. The cost-effectiveness of omalizumab is similar to other chronic disease biologics. The value increases when omalizumab response is used to guide long-term treatment. (shrink)

The aim of this systematic review was to summarize and assess the quality of asthma intervention health economic studies from 2002 to 2007, compare the study findings with clinical management guidelines, and suggest avenues for future improvement of asthma health economic studies. Forty of the 177 studies met our inclusion criteria. We assessed the quality of studies using The Quality of Health Economic Studies validated instrument (total score range: 0-100). Six studies (15%) had quality category 2, 26 studies (65%) achieved (...) quality category 3, and the remaining eight (20%) studies were scored as the highest quality level, category 4. Overall, the findings from this review are in line with the Global Initiative for Asthma clinical guidelines. Many asthma health economic studies lacked appropriate long term time horizons to match the chronic nature of the disease and suffered from using effectiveness measures that did not capture all disease related risks and benefits. We recommend that new asthma simulation models: be flexible to allow for long term time horizons, focus on using levels of asthma control in their structure, and estimate both long term asthma specific outcomes like well-controlled time as well as generic outcomes such as quality adjusted survival. (shrink)

A good deal of attention has been recently focused on the presumed advertising excesses of the healthcare industry in its promotion techniques to healthcare professionals, whether through offering gratuities such as gifts, honoraria, or travel support2-6 or through deception. Two basic concerns have been expressed: Does the acceptance of gratuities bias the recipient, tainting his or her responsibilities as the patient's agent? Does acceptance of the gratuity by the healthcare professional contribute to the high cost of healthcare products? The California (...) Society of Hospital Pharmacists was recently asked by its members to formulate a policy for an appropriate relationship between the Society and the healthcare industry, addressing these concerns. In formulating its policy, it became clear that the Society depended on healthcare industry support, gathered through journal advertising, fees for booths at its various educational events, and grants for speakers. (shrink)

American orthodox medicine consolidated its professional authority in the early 20th Century on the basis of its unbiased scientific method. The centerpiece of such a method is a strategy for identifying truly effective new therapies, i.e., the randomized clinical trial (RCT). A crucial component of the RCT in illnesses without established treatment is the placebo control. Placebo effects must be identified and distinguished from pharmacological effects because placebos produce actual but unexplained therapeutic successes. The blinding necessary for a proper placebo-controlled (...) RCT therefore introduces an epistemic bias into orthodox medicine: therapeutic successes that rely upon a direct link between knowing and healing, such as placebo effects, are discarded in favor of therapeutic successes that rely upon an indirect link between knowing and healing, such as pharmacological interventions. Where the capacity to produce therapeutic results once validated the method of clinical medical science, now method validates results. The clinical consequences of this method of testing therapies include a diminished vision of the therapeutic potential of the doctor-patient relationship and of the potential human resources available for healing. Keywords: doctor-patient relationship, epistemology, placebo effect, professionalization, randomized clinical trials CiteULike Connotea Del.icio.us What's this? (shrink)

Background: Demand for organisational ethics capacity is growing in health organisations, particularly among managers. The role of clinical ethicists in, and perspective on, organisational ethics has not been well described or documented in the literature. Objective: To describe clinical ethicists’ perspectives on organisational ethics issues in their hospitals, their institutional role in relation to organisational ethics, and their perceived effectiveness in helping to address organisational ethics issues. Design and Setting: Qualitative case study involving semi-structured interviews with 18 clinical ethicists across (...) 13 health organisations in Toronto, Canada. Results: From the clinical ethicists’ perspective, the most pressing organisational ethics issues in their organisations are: resource allocation, staff moral distress linked to the organisation’s moral climate, conflicts of interest, and clinical issues with a significant organisational dimension. Clinical ethicists were consulted in particular on issues related to staff moral distress and clinical issues with an organisational dimension. Some ethicists described being increasingly consulted on resource allocation, conflicts of interest, and other corporate decisions. Many clinical ethicists felt they lacked sufficient knowledge and understanding of organisational decision-making processes, training in organisational ethics, and access to organisational ethics tools to deal effectively with the increasing demand for organisational ethics support. Conclusion: Growing demand for organisational ethics expertise in healthcare institutions is reshaping the role of clinical ethicists. Effectiveness in organisational ethics entails a re-evaluation of clinical ethics training to include capacity building in organisational ethics and organisational decision-making processes as a complement to traditional clinical ethics education. (shrink)

Electrical resistivity and ac-calorimetric measurements reveal a complex magnetic phase diagram for single crystals of the ferromagnetic Kondo-lattice compound CeAgSb2 at high pressures up to 80 kbar. The ferromagnetic order at TC = 9.6 K at ambient pressure is completely suppressed at a critical pressure PC = 35 kbar. Another magnetic transition, possibly antiferromagnetic, found above 27 kbar, attains a maximum value TN 6 K at 44 kbar and then appears to be completely suppressed by 50 kbar. Thermodynamic and transport (...) measurements in the ferromagnetic state indicate an energy gap Δ 30 K in the spin-wave excitation spectrum at ambient pressure which decreases to Δ 10 K at P = 30 kbar. No superconductivity is observed at ambient pressure above T 0.1 K, under applied pressure in the ferromagnetic state (P = 28.5 kbar), nor in the antiferromagnetic state (P = 33 − 46 kbar) above 0.3 K. © 2003 The American Physical Society. (shrink)

Richard Rorty’s conception of literature has been criticised more than acclaimed. While Rorty certainly has impacted literary studies, a comprehensive account of his understanding of literature is still lacking. Moreover, while literature is seen as significant to his later work, the philosophical role this plays in Rortyan thought is underexamined and underappreciated. This paper aims to provide an account of the role of literature and the “literary” in Rorty’s philosophy and the functions he assigns to literature and poetry – in (...) a broad and narrow sense – in democratic cultures. Beginning with an account of Rorty’s conceptions of metaphor and “unfamiliar” language, it draws on this to explain Rorty’s parallel view of literature in the “narrower sense” as playing the same role in culture as metaphors do in language. “Stimulating” literature unsettles settled selves and beliefs and expands human imagination. Using Rorty’s readings of Lolita and 1984 as examples, it shows that to him, literature not only plays a part in increasing empathy and solidarity but has a distinct therapeutic epistemological task: it helps individuals and societies adopt a more pluralist, ironist, post-metaphysical outlook. Both are important democratic functions. For these reasons, Rorty recommends that we work to realise a “literary” culture that rejects any ontologically inflected distinctions between kinds of texts, where philosophy becomes comparative “literary” criticism, and we see literature in the “narrower sense” as equally necessary material for making selves, communities and just institutions as any philosophical or political treatise. (shrink)

We examine the evolution of the concept of stability in community ecology, arguing that biologists have moved from an emphasis on biotic communities characterized by static balance, to one of dynamic balance (returning to equilibrium after perturbation), to the current concept of stability as persistence. Using Wimsatt's (1987) analysis of how false models can often lead to better ones, we argue that failed attempts to link complexity with stability have significant heuristic value for community ecologists. Nevertheless, we argue that, (A) (...) because there is no common characteristic that stability terms presuppose, community ecology might be better served by abandoning the concept of stability and by employing instead specific terms such as 'persistence', 'resistance', and 'variability'. (B) The current emphasis (of stability terms) on persistence of species provides little basis for explaining possible mechanisms that might account for persistence. (shrink)

No one doubts that Kierkegaard's Concluding Unscientific Postscript is one of the most important, one of the most artistically contrived, and certainly one of the wittiest works in the history of philosophy. Further, the Postscript has often been accorded a kind of centrality in the Kierkegaardian corpus. Kierkegaard himself seems to have assigned it some such role. He informs the reader in the ‘First and Last Declaration’ that he originally intended the Postscript to be his last word before retiring from (...) his authorship . In The Point of View for My Work as an Author he himself calls it both ‘the turning-point’ and ‘the middle point’ in the sense that ‘this work concerns itself with and sets “the Problem”, which is the problem of the whole authorship: how to become a Christian’. Aside from the way in which Kierkegaard may have conceived the Postscript as being central or pivotal to his whole enterprise, certainly scholars have sometimes treated the Postscript as, at least in some ways, his magnum opus and summum verbum – as I would also. But our concern here is not with the centrality of the Postscript but with the centrality within the Postscript. Most everyone would, I think, acknowledge that a central section of the Postscript may be identified, though I would go farther and claim that within this a central, pivotal, solitary statement may be identified. (shrink)

To examine the ethical issues involved in governmental decisions with potential health risks, we review the history of the decision to raise the interurban speed limit in Israel in light of its impact on road death and injury. In 1993, the Israeli Ministry of Transportation initiated an “experiment” to raise the interurban speed limit from 90 to 100 kph. The “experiment” did not include a protocol and did not specify cut-off points for early termination in the case of adverse results. (...) After the raise in the speed limit, the death toll on interurban roads rose as a result of a sudden increase in speeds and case fatality rates. The committee's decision is a case study in unfettered human experimentation and public health risks when the setting is non-medical and lacks a defined ethical framework. The case study states the case for extending Helsinki type safeguards to experimentation in non-medical settings. (shrink)

Background: Since the passage of the Patient Self-Determination Act, numerous policy mandates and institutional measures have been implemented. It is unknown to what extent those measures have affected end-of-life care, particularly with regard to the do-not-resuscitate order.Methods: Retrospective cohort study to assess associations of the frequency and timing of DNR orders with advance directive status, patient demographics, physician’s specialty and extent of documentation of discussion on end-of-life care.Results: DNR orders were more frequent for patients on a medical service than on (...) a surgical service and were made earlier in the hospital stay for medicine than for surgical patients . 22.18% of all patients had some form of an advance directive in their chart, yet this variable had no impact on the frequency or timing of DNR ordering. Documentation of DNR discussion was significantly associated with the frequency of DNR orders and the time from DNR to death .Conclusions: The physician’s specialty continues to have a significant impact on the frequency and timing of DNR orders, while advance directive status still has no measurable impact. Additionally, documentation of end-of-life discussions is significantly associated with varying DNR ordering rates and timing. (shrink)