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)
Claude Bernard's concept of the internal environment ( milieu intérieur ) played a crucial role in the development of experimental physiology and the specific medical therapeutics derived from it. This concept allowed the experimentalist to approach the organism as fully determined yet relatively autonomous with respect to its external environment. However, Bernard's theory of knowledge required that he find organismic functioning as the result of an external necessity. He is therefore unable to explain adequately the origin or operation of organismic (...) autonomy. A more complete conception of biological autonomy must include a theory of knowledge that can accommodate the organism as a source of discrimination and determination. Only in this way will it be possible to see organisms as active as well as reactive, as ordering as well as ordered. This shift in perspective is crucial if medicine is to be able to characterize, for example, susceptibility to disease. A cognitive sense of the organic interior is proposed as an alternative to Bernard's internal environment. Keywords: biological autonomy, Claude Bernard, epistemology, internal environment ( milieu intérieur ) CiteULike Connotea Del.icio.us What's this? (shrink)
In this paper we evaluate two sets of theistic arguments against the traditional position that Cod created with absolute freedom. The first set features several variations of Leibniz’s basic proof that Cod must create the best possible world. The arguments in the second set base the claim that Cod must create on the Platonic or Dionysian principle that goodness is essentially self-diffusive. We argue that neither the Leibnizian nor the Dionysian arguments are successful.
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)
S. Adams, W. Ambrose, A. Andretta, H. Becker, R. Camerlo, C. Champetier, J.P.R. Christensen, D.E. Cohen, A. Connes. C. Dellacherie, R. Dougherty, R.H. Farrell, F. Feldman, A. Furman, D. Gaboriau, S. Gao, V. Ya. Golodets, P. Hahn, P. de la Harpe, G. Hjorth, S. Jackson, S. Kahane, A.S. Kechris, A. Louveau,, R. Lyons, P.-A. Meyer, C.C. Moore, M.G. Nadkarni, C. Nebbia, A.L.T. Patterson, U. Krengel, A.J. Kuntz, J.-P. Serre, S.D. Sinel'shchikov, T. Slaman, Solecki, R. Spatzier, J. Steel, D. Sullivan, (...) S. Thomas, A. Valette, V.S. Varadarajan, B. Velickovic, B. Weiss, J.D.M. Wright, R.J. Zimmer. (shrink)