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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)

In lieu of an abstract, here is a brief excerpt of the content:What Do You Mean, Rhetoric Is Epistemic?William D. HarpineIn 1967, Robert L. Scott (1967) advocated that "rhetoric is epistemic." This concept has enriched the work of rhetorical theorists and critics. Scott's essay is founded in a concept of argumentative justification in rhetoric, viewed as an alternative to analytic logic. Other writers, including Brummett (1976), Railsback (1983), and Cherwitz and Hikins (1986), have offered variations on Scott's theme. The thesis (...) that rhetoric is epistemic has been controversial, however, and from the tone of the debate one may draw two conclusions: many rhetorical theorists feel that Scott was on to something important, and the thesis as it has been developed is flawed. Much of the dispute centers on what the thesis means. These discussions have not yet adequately clarified that issue.The philosopher's most fundamental obligation is to define terms with care. It is in precisely this respect that the rhetoric-is-epistemic theorists have fallen short. Some of the key terms in this literature include rhetoric, knowledge, certainty, and truth. In too many cases, the writers on rhetorical epistemology have not defined their key terms at all. In other cases, their definitions are inadequate or inconsistent. This essay undertakes to sort out the most important definitional problems, which center on the rhetoric-is-epistemic theorists' habit of equivocating about the meanings of "rhetoric" and "certainty." The result makes it possible to endorse the validity of Scott's essentially ethical conclusions, while dismissing a number of unnecessary complexities in the arguments made by rhetoric-as-epistemic theorists. Finally, a few alternatives that might lead to more robust foundations for the rhetoric-as-epistemic thesis are suggested.In 1978, after reviewing four distinct interpretations of the claim that rhetoric is epistemic, Leff concluded that clarification of what that claim means "deserves more disciplined treatment than it has received in the recent literature" (1978, 77). The same could still be said. After some [End Page 335] thirty years of active research and speculation on the topic, one now sees fewer publications specifically advocating that rhetoric is epistemic. The distinguished rhetorical theorist Barry Brummett (1990) has declared the thesis deceased (69-72).All the same, textbook authors treat the thesis as a given, despite their tendency to interpret it in wildly different ways. Foss, for example, puts forward a view that "in the field of communication, the idea that rhetoric creates reality is known as the notion that rhetoric is epistemic, which simply means that rhetoric creates knowledge; epistemology is the study of the origin and nature of knowledge" (1989, 122; emphasis in the original). This version of the thesis, claiming that rhetoric actually "creates reality," might be more ontological than it is epistemic.1 Herrick takes a dialectical view that "through rhetorical interaction, people come to accept some ideas as true and to reject others as false. Thus, rhetoric's epistemic function in society can be seen in some ways to be a result of its benefit of testing ideas." Herrick continues that "once an idea has been tested thoroughly by a group, community, and society, it becomes part of what these groups take to be knowledge." Herrick contrasts this with the rejected view that "knowledge is all objective in nature and comes to us by way of direct experience or education" (1997, 22). Both Herrick and Foss offer interesting theses, and both attribute their views to Scott, but their views are obviously very different. There can be no surer evidence of the failure to use terms precisely.Brummett (1990) attributes the demise of rhetoric-is-epistemic research to the failure of critics to employ the idea in rhetorical criticism. Brummett might be right to the extent that much of the rhetoric-is-epistemic literature is indeed exceptionally abstract. Specific discussions might clarify some issues. Nonetheless, some notable rhetorical critics have indeed employed a concept that rhetoric is epistemic (e.g., Scott and Klumpp 1984; Sullivan 1992). The issues remain unclear. Furthermore, rhetorical criticism per se cannot clarify the meanings of theoretical terms. More likely, one sees less and less published research about the thesis that rhetoric is epistemic precisely because the thesis has not been laid out clearly... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:What Do You Mean, Rhetoric Is Epistemic?William D. HarpineIn 1967, Robert L. Scott (1967) advocated that "rhetoric is epistemic." This concept has enriched the work of rhetorical theorists and critics. Scott's essay is founded in a concept of argumentative justification in rhetoric, viewed as an alternative to analytic logic. Other writers, including Brummett (1976), Railsback (1983), and Cherwitz and Hikins (1986), have offered variations on Scott's theme. The thesis (...) that rhetoric is epistemic has been controversial, however, and from the tone of the debate one may draw two conclusions: many rhetorical theorists feel that Scott was on to something important, and the thesis as it has been developed is flawed. Much of the dispute centers on what the thesis means. These discussions have not yet adequately clarified that issue.The philosopher's most fundamental obligation is to define terms with care. It is in precisely this respect that the rhetoric-is-epistemic theorists have fallen short. Some of the key terms in this literature include rhetoric, knowledge, certainty, and truth. In too many cases, the writers on rhetorical epistemology have not defined their key terms at all. In other cases, their definitions are inadequate or inconsistent. This essay undertakes to sort out the most important definitional problems, which center on the rhetoric-is-epistemic theorists' habit of equivocating about the meanings of "rhetoric" and "certainty." The result makes it possible to endorse the validity of Scott's essentially ethical conclusions, while dismissing a number of unnecessary complexities in the arguments made by rhetoric-as-epistemic theorists. Finally, a few alternatives that might lead to more robust foundations for the rhetoric-as-epistemic thesis are suggested.In 1978, after reviewing four distinct interpretations of the claim that rhetoric is epistemic, Leff concluded that clarification of what that claim means "deserves more disciplined treatment than it has received in the recent literature" (1978, 77). The same could still be said. After some [End Page 335] thirty years of active research and speculation on the topic, one now sees fewer publications specifically advocating that rhetoric is epistemic. The distinguished rhetorical theorist Barry Brummett (1990) has declared the thesis deceased (69-72).All the same, textbook authors treat the thesis as a given, despite their tendency to interpret it in wildly different ways. Foss, for example, puts forward a view that "in the field of communication, the idea that rhetoric creates reality is known as the notion that rhetoric is epistemic, which simply means that rhetoric creates knowledge; epistemology is the study of the origin and nature of knowledge" (1989, 122; emphasis in the original). This version of the thesis, claiming that rhetoric actually "creates reality," might be more ontological than it is epistemic.1 Herrick takes a dialectical view that "through rhetorical interaction, people come to accept some ideas as true and to reject others as false. Thus, rhetoric's epistemic function in society can be seen in some ways to be a result of its benefit of testing ideas." Herrick continues that "once an idea has been tested thoroughly by a group, community, and society, it becomes part of what these groups take to be knowledge." Herrick contrasts this with the rejected view that "knowledge is all objective in nature and comes to us by way of direct experience or education" (1997, 22). Both Herrick and Foss offer interesting theses, and both attribute their views to Scott, but their views are obviously very different. There can be no surer evidence of the failure to use terms precisely.Brummett (1990) attributes the demise of rhetoric-is-epistemic research to the failure of critics to employ the idea in rhetorical criticism. Brummett might be right to the extent that much of the rhetoric-is-epistemic literature is indeed exceptionally abstract. Specific discussions might clarify some issues. Nonetheless, some notable rhetorical critics have indeed employed a concept that rhetoric is epistemic (e.g., Scott and Klumpp 1984; Sullivan 1992). The issues remain unclear. Furthermore, rhetorical criticism per se cannot clarify the meanings of theoretical terms. More likely, one sees less and less published research about the thesis that rhetoric is epistemic precisely because the thesis has not been laid out clearly... (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)