Supremacía del derecho federal sobre el Common Law en materia de requisitos de seguridad y eficacia terapéutica de productos sanitarios. Comentario a Riegel v. Medtronic, Inc. [552 U.S.__ (2008); February 20, 2008]

En Riegel v. Medtronic Inc. (552 U.S.__2008; February 20, 2008), el Sr. Riegel tuvo que ser sometido a un by-pass como consecuencia de la rotura del catéter, fabricado por Medtronic, con el que su médico le practicaba una angioplastia. A pesar de que el catéter había obtenido la autorización de comercialización de la FDA y cumplía los requisitos de seguridad previstos por el sistema regulatorio federal, el Sr. Riegel y su mujer interpusieron una acción de daños contra Medtronic –y no contra el médico- conforme a las reglas de responsabilidad civil objetiva y por negligencia del Common Law neoyorquino. Sin embargo, el Tribunal Supremo federal de los EE.UU., en ponencia del Magistrado Antonin Gregory Scalia, votó, por mayoría de ocho magistrados, rechazar el recurso de la Sra. Riegel y confirmar la sentencia de segunda instancia, desestimatoria de la demanda, porque consideró que la regla de primacía del derecho regulatorio federal sobre seguridad de productos sanitarios [Medical Device Amendments de 1976, 21 U.S.C. Artículo 360k(a)] excluye la aplicabilidad no sólo del derecho regulatorio estatal sobre seguridad de productos sanitarios, sino también del Common Law sobre responsabilidad civil del fabricante.

Involvement of family physicians in structured programs for chronic diseases or multi-morbidity in Switzerland.

The increasing prevalence of chronic diseases and multi-morbidity represents challenges for health systems worldwide. In that perspective, the current organization of healthcare delivery, fragmentation of care, limited use of evidence-based guidelines and patients'insufficient empowerment are some reasons explaining the current limited effectiveness of the management of chronically ill patients. Based on theoretical models such as the Chronic Care Model (CCM), initiatives targeting improvements in the care of patients with chronic diseases have been implemented worldwide since more than a decade. Their development in Switzerland, a health system where more than half of practices are still single handed [6], is only recent and infrequent. Structured programs for patients with chronic diseases or multimorbidity usually propose patient-centered interventions and consider an integrative multidisciplinary approach. Currently, little is known on the existence of such programs and on the role of family physicians (FPs)within these programs, in Switzerland. The objective of this study was to identify and describe current structured programs targeting chronic diseases or multi-morbidity in Switzerland. This may help in examining innovative approaches that are only developed locally but would deserve wider interest for further implementation. We conducted a telephone-based survey between June and November 2013 and contacted systematically key institutions, informants and stakeholders nationwide and in the 26 cantons...

Steady-state global optimization of metabolic non-linear dynamic models through recasting into power-law canonical models

Background: Design of newly engineered microbial strains for biotechnological purposes would greatly benefit from the development of realistic mathematical models for the processes to be optimized. Such models can then be analyzed and, with the development and application of appropriate optimization techniques, one could identify the modifications that need to be made to the organism in order to achieve the desired biotechnological goal. As appropriate models to perform such an analysis are necessarily non-linear and typically non-convex, finding their global optimum is a challenging task. Canonical modeling techniques, such as Generalized Mass Action (GMA) models based on the power-law formalism, offer a possible solution to this problem because they have a mathematical structure that enables the development of specific algorithms for global optimization. Results: Based on the GMA canonical representation, we have developed in previous works a highly efficient optimization algorithm and a set of related strategies for understanding the evolution of adaptive responses in cellular metabolism. Here, we explore the possibility of recasting kinetic non-linear models into an equivalent GMA model, so that global optimization on the recast GMA model can be performed. With this technique, optimization is greatly facilitated and the results are transposable to the original non-linear problem. This procedure is straightforward for a particular class of non-linear models known as Saturable and Cooperative (SC) models that extend the power-law formalism to deal with saturation and cooperativity. Conclusions: Our results show that recasting non-linear kinetic models into GMA models is indeed an appropriate strategy that helps overcoming some of the numerical difficulties that arise during the global optimization task.