This essay outlines the moral dilemma of funding orphan drug research and development. To date, ethical aspects of priority setting for research funding have not been an issue of discussion in the bioethics debate. Conflicting moral obligations of beneficence and distributive justice appear to demand very different levels of funding for orphan drug research. The two types of orphan disease, rare diseases and tropical diseases, however, present very different ethical challenges to questions about allocation of research funds. The dilemma is analysed considering utilitarian and rights based theories of justice and moral obligations of non-abandonment and a professional obligation to advance medical science. The limitations of standard economic evaluation tools and other priority setting tools used to inform health policy decision makers on research funding decisions are outlined.

This systematic review determines the benefit of treatment with Ginkgo biloba (Ginkgo) in Alzheimer's disease (AD) concerning patient-relevant outcomes. Bibliographic databases, clinical trial and study result registries were searched for randomized controlled trials (RCTs) in patients with AD (follow-up ≥16 weeks) comparing Ginkgo to placebo or a different treatment option. Manufacturers were asked to provide unpublished data. If feasible, data were pooled by meta-analysis. Six studies were eligible; overall, high heterogeneity was shown for most outcomes, except safety aspects. Among studies administering high-dose Ginkgo (240 mg), all studies favour treatment though effects remain heterogeneous. In this subgroup, a benefit of Ginkgo exists for activities of daily living. Cognition and accompanying psychopathological symptoms show an indication of a benefit. A harm of Ginkgo is not evident. An estimation of the effect size was not possible for any outcome. Further evidence is needed which focuses especially on subgroups of AD patients.

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Dieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFG geförderten) Allianz- bzw. Nationallizenz frei zugänglich.This publication is with permission of the rights owner freely accessible due to an Alliance licence and a national licence (funded by the DFG, German Research Foundation) respectively

ObjectivesTo apply the economic terminology of lean manufacturing and the Toyota Production System to the procurement of vascular stents in interventional radiology.MethodsThe economic- and process-driven terminology of lean manufacturing and the Toyota Production System is first presented, including information and product flow as well as value stream mapping (VSM), and then applied to an interdisciplinary setting of physicians, nurses and technicians from different medical departments to identify wastes in the process of endovascular stent procurement in interventional radiology.ResultsUsing the so-called seven wastes approach of the Toyota Production System (waste of overproducing, waiting, transport, processing, inventory, motion and waste of defects and spoilage) as well as further waste characteristics (gross waste, process and method waste, and micro waste), wastes in the process of endovascular stent procurement in interventional radiology were identified and eliminated to create an overall smoother process from the procurement as well as from the medical perspective.ConclusionEconomic terminology of lean manufacturing and the Toyota Production System, especially VSM, can be used to visualise and better understand processes in the procurement of vascular stents in interventional radiology from an economic point of view.

Purpose To identify evidence-based indications for PET/PET-CT scans in support of facilities planning and to describe a pilot project in which this information was applied for an investment decision in an Austrian region. The study updates a Health Technology Assessment (HTA) report (2015) on oncological indications, extending it to neurological indications and inflammatory disorders. Methods A systematic literature search to identify HTA reports, evidence-based guidelines, and systematic reviews/metaanalyses (SR/MA) was performed, supplemented by a manual search for professional society recommendations and explicit "not-to-do's". A needs-assessment was conducted in the context of the pilot study on investing in an additional PET-CT scanner in the Austrian region of Carinthia. Results Overall recommendations for indications as well as non-recommendations for the three areas (oncology, neurology, and inflammatory disorders) were compiled from the 2015 PET-HTA report and expanded for a final total of ten HTA, comprising 234 (positive and negative) recommendations from professional societies and databases, and supplemented by findings from 23 SR/MA. For the investment decision pilot study in Carinthia, 1762 PET scans were analyzed; 77.8% were assigned to the category "recommended evidence-based indications" (54.7%), "not recommended" (1.8%) or "contradictory recommendations" (21.3%). The remaining could not be assigned to any of the three categories. Conclusions The piloting of PET capacity planning using evidence-based information is a first of its kind in the published literature. On one hand, the high number of PET scans that could not be ascribed to any of the categories identified limits to the instructive power of the study to use evidence-based indication lists as the basis for a needs-assessment investment planning. On the other hand, this study reveals how there is a need to improve indication coding for enhanced capacity planning of medical services. Overall recommendations identified can serve as needs-based and evidence-based decision support for PET/PET-CT service provision.

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