Unresolved issues in the evaluation of research projects involving induced pluripotent stem cells (iPS)

El presente trabajo identifica los problemas y analiza los conflictos que se plantean en la evaluación de los proyectos de investigación que involucran la obtención y el uso de células madre humanas de pluripotencia inducida (iPS) en España. La regulación actual conlleva problemas de interpretación, remisiones normativas innecesarias, inseguridad y dilaciones indebidas. Una situación que puede revertir en un inadecuado control y seguimiento e, incluso, cierta parálisis de la investigación en medicina regenerativa y terapia celular, por la que hoy, no obstante, se apuesta. El análisis de la normativa vigente y de la reflexión bioética que la acompaña, permite concluir que la evaluación de la investigación con iPS no puede ser asimilada a la investigación con células madre embrionarias humanas (hESC). En este contexto, se propone que los correspondientes Comités de Ética de la Investigación evalúen la investigación con células iPS y que sea la Comisión de Garantías para la Donación y Utilización de Células y Tejidos Humanos quien revise tal evaluación. Asimismo, se hace necesaria una efectiva articulación del Registro de Proyectos de Investigación para que sea accesible. Finalmente, se propone un modelo de Protocolo de verificación o checklist para la revisión de proyectos de investigación biomédica que involucren células madre iPS

Aspectos bioéticos de la evaluación de proyectos de investigación con células madre en España

La investigación con células madre humanas de pluripotencia inducida (iPS) plantea nuevos retos para los Estados y para los agentes implicados en investigación biomédica orientada a la terapia celular y la medicina regenerativa. Desde una concepción de la bioética práctica asociada a la función crítica que los comités de ética en investigación biomédica ejercen en los Estados, se analizan las cuestiones no resueltas en la evaluación de los proyectos de investigación que utilizan células iPS en España. El principal problema objeto de tratamiento es, a nuestro parecer, la equívoca equiparación que se efectúa entre células madre de origen embrionario y células iPS obtenidas de muestras biológicas de células adultas, tanto en la normativa vigente como por parte de los comités de ética encargados de la evaluación y control. De esta forma, el trabajo integra las bases científicas en investigación con células iPS y las implicaciones éticas, sociales y políticas aparejadas. En especial, se estudia la respuesta jurídica para entender cómo la bioética en acción que aquí se propugna permite una respuesta, si es preciso identificar debilidades e introducir mejoras y plantear propuestas para una correcta evaluación de este tipo de investigaciones. Consideramos que la visión crítica que ofrece este trabajo es fundamental para aportar elementos de debate a la reflexión bioética sobre las nuevas tendencias en investigación biomédica en la actualidad.Research on human induced pluripotent stem cells (iPS) raises new challenges for governments and for those biomedical researchers involved in cell therapy and regenerative medicine. Taking as a starting point a conception of bioethics as linked to the critical role of ethics committees in biomedical research, this article examines unresolved issues in the evaluation of research projects using iPS in Spain. We believe that the main problem is that both existing legislation and ethics review boards that evaluate and monitor this research misleadingly identify stem cells obtained from embryos and iPS derived from adult cells obtained from biological samples of human origin. This paper examines the scientific basis on iPS cell research and its ethical, social and political implications. We focus specifically on the legal response to some of these issues, in order to show that the kind of bioethics in action that we defend can provide answers, help us identify weaknesses in existing legislation and can promote a richer discussion and better approaches to achieve to assess this specific type of research. We consider that the critical insight provided by our work is crucial to encourage debate on bioethical reflection on emerging trends in biomedical research toda

Programa de autocuidados para mejorar la calidad de vida en las mujeres premenopáusicas

Introducción: el climaterio es la etapa en la vida de las mujeres en la que se pierde la capacidad reproductiva, y está caracterizada por una gran cantidad de cambios físicos, pero también psíquicos y sociales. En España hay un gran número de mujeres comprendidas en edades premenopáusicas, las cuales deben conocer tales cambios, así como las consecuencias derivadas y las posibles terapias u opciones que tienen a su disposición para tratarlas y así mantener una calidad de vida óptima. Objetivos: realizar un programa de educación para la salud dirigido a mujeres premenopáusicas para mejorar su calidad de vida mediante el aprendizaje de autocuidados durante el climaterio. Metodología: se ha realizado una búsqueda bibliográfica para informarse del contenido actualizado sobre el climaterio en bases de datos especializadas en las ciencias de la salud, así como en diversas páginas web. Conclusiones: desarrollando un programa de autocuidados se consigue explicar a las mujeres los datos necesarios sobre la etapa que están viviendo, intentando que comprendan su nueva situación de salud de manera objetiva y clara, además de estar aplicando una atención biopsicosocial sobre este grupo de población.<br /

Budgetary impact analysis of buprenorphinenaloxone combination (Suboxone®) in Spain

Background: Opioid addiction is a worldwide problem. Agonist opioid treatment (AOT) is the most widespread and frequent pharmacotherapeutic approach. Methadone has been the most widely used AOT, but buprenorphine, a partial kappa-opiod agonist and a my-opiod antagonist, is fast gaining acceptance. The objective was to assess the budgetary impact in Spain of the introduction of buprenorphine-naloxone (B/N) combination. Methods: A budgetary impact model was developed to estimate healthcare costs of the addition of B/N combination to the therapeutic arsenal for treating opioid dependent patients, during a 3-year period under the National Health System perspective. Inputs for the model were obtained from the specialized scientific literature. Detailed information concerning resource consumption (drug cost, logistics, dispensing, medical, psychiatry and pharmacy supervision, counselling and laboratory test) was obtained from a local expert panel. Costs are expressed in euros ( , 2010). Results: The number of patients estimated to be prescribed B/N combination was 2,334; 2,993 and 3,589 in the first, second and third year respectively. Total budget is 85,766,129; 79,855,471 and 79,137,502 in the first, second and third year for the scenario without B/N combination. With B/N combination the total budget would be 86,589,210; 80,398,259 and 79,708,964 in the first, second and third year of the analyses. Incremental cost/ patient comparing the addition of the B/N combination to the scenario only with methadone is 10.58; 6.98 and 7.34 in the first, second and third year respectively. Conclusion: Addition of B/N combination would imply a maximum incremental yearly cost of 10.58 per patient compared to scenario only with methadone and would provide additional benefits

Declaración Universal sobre Bioética y Derechos Humanos de la Unesco y la discapacidad

La Unesco propugna que la Declaración Universal sobre Bioética y Derechos Humanos puede y debe ser considerada como un marco de principios y pautas bioéticas que se deben aplicar, también, en el tratamiento de las cuestiones de la discapacidad. Este libro aporta claves que permiten a los estados y al resto de agentes implicados adoptar la perspectiva de la diversidad funcional y las capacidades diferenciadas que evite la exclusión, desde un enfo­que basado en los derechos humanos

Cost-effectiveness analysis of antipsychotics in reducing schizophrenia relapses

BACKGROUND: Schizophrenia is a severe form of mental illness which is associated with significant and long-lasting health, social and financial burdens. The aim of this project is to assess the efficiency of the antipsychotics used in Spain in reducing schizophrenia relapses under the Spanish Health System perspective. MATERIAL AND METHODS: A decision-analytic model was developed to explore the relative cost-effectiveness of five antipsychotic medications, amisulpride, aripiprazole, olanzapine, paliperidone Extended-Release (ER) and risperidone, compared to haloperidol, over a 1-year treatment period among people living in Spain with schizophrenia. The transition probabilities for assessed therapies were obtained from the systemic review and meta-analysis performed by National Institute for Health and Clinical Excellence (NICE). RESULTS: Paliperidone ER was the option that yielded more quality-adjusted life years (QALYs) gained per patient (0.7573). In addition, paliperidone ER was the least costly strategy (€3,062), followed by risperidone (€3,194), haloperidol (€3,322), olanzapine (€3,893), amisulpride (€4,247) and aripiprazole (€4,712). In the incremental cost-effectiveness (ICE) analysis of the assessed antipsychotics compared to haloperidol, paliperidone ER and risperidone were dominant options. ICE ratios for other medications were €23,621/QALY gained, €91,584/QALY gained and €94,558/QALY gained for olanzapine, amisulpride and aripiprazole, respectively. Deterministic sensitivity analysis showed that risperidone is always dominant when compared to haloperidol. Paliperidone ER is also dominant apart from the exception of the scenario with a 20% decrease in the probability of relapses. CONCLUSIONS: Our findings may be of interest to clinicians and others interested in outcomes and cost of mental health services among patients with schizophrenia. Paliperidone ER and risperidone were shown to be dominant therapies compared to haloperidol in Spain. It is worthwhile to highlight that schizophrenia is a highly incapacitating disease and choosing the most appropriate drug and formulation for a particular patient is crucial. The availability of more accurate local epidemiological data on schizophrenia would allow a better adaptation of the model avoiding some of the assumptions taken in our work. Future research could be focused on this

The investors of the microfinance sector

El sector microfinanciero ha experimentado un importante desarrollo en los últimos años favorecido por el impulso de la inversión socialmente responsable y también, por el exceso de liquidez que ha habido en el sistema financiero global. Las denominadas Instituciones Microfinancieras son los agentes clave de este desarrollo y su doble objetivo de rentabilidad no sólo social, sino financiera; les ha configurado como la principal vía de inversión, si bien, se han desarrollado otros canales y productos financieros directos o indirectos. El espectro de inversores, tradicionalmente públicos, también se ha ampliado, incorporándose aquellos de carácter comercial e incluso especulativo en su búsqueda de nuevas alternativas de inversión atractiva. De este modo, se ha abierto un nuevo campo financiero, no exento del debate ético por el objetivo primordial que hay detrás del sector microfinanciero: la reducción de la pobreza en el mundo.The microfinance sector has had an important development in the last years ought to the growth of the socially responsible investment and also, by the excess of global financial liquidity. Although there are other channels and other financial products, direct and indirect, what we called MicroFinancial Institutions have been the key agents for this development and their double objectives on profitability, social and financial has enable them to become the principal way to invest. The investment range that traditionally has been public has expanded into commercial and speculative investors in search of new attractive investment alternatives. So, a new financial area has opened; including the ethical discussion on the main objective behind the microfinancial sector: Reduction of poverty in the world

Combined effectiveness of prior and current season influenza vaccination in northern Spain: 2016/17 mid-season analysis

The 2016/17 mid-season vaccine effectiveness estimate against influenza A(H3N2) was 15% (95% confidence interval: -11 to 35) in Navarre. Comparing to individuals unvaccinated in the current and four prior seasons, effectiveness was 24% for current and 3-4 prior doses, 61% for current and 1-2 prior doses, 42% for only current vaccination, and 58% for 3-4 prior doses. This suggests moderate effectiveness for different combinations of vaccination in the current and prior seasons.This study was supported by the Horizon 2020 program of the European Commission (agreement 634446); by the I-MOVE (Influenza Monitoring Vaccine Effectiveness in Europe) Network funded by the European Centre for Disease Prevention and Control; by La Caixa Foundation; and by the Carlos III Institute of Health with the European Regional Development Fund (ERDF) (CM15/00119, INT15/00182).S

Gene editing in humans: Towards a global and inclusive debate for responsible research

In December 2016, the Opinion Group of the Bioethics and Law Observatory (OBD) of the University of Barcelona launched a Declaration on Bioethics and Gene Editing in Humans analyzing the use of genome editing techniques and their social, ethical, and legal implications through a multidisciplinary approach. It focuses on CRISPR/Cas9, a genome modification technique that enables researchers to edit specific sections of the DNA sequence of humans and other living beings. This technique has generated expectations and worries that deserve an interdisciplinary analysis and an informed social debate. The research work developed by the OBD presents a set of recommendations addressed to different stakeholders and aims at being a tool to learn more about CRISPR/Cas9 while finding an appropriate ethical and legal framework for this new technology. This article gathers and compares reports that have been published in Europe and the USA since the OBD Declaration. It aims at being a tool to foster a global and interdisciplinary discussion of this new genome editing technology