Health Equity in Pediatric Drug Development: Translating Aspiration into Operation.

The concept of health equity-the attainment of the highest possible level of health for all members of society-requires equitable access to all aspects of healthcare, including pediatric drug development. However, many communities are under-represented in pediatric drug development programs. Barriers to participation include geographic, economic, racial/ethnic bias, legal, cultural, linguistic, and other factors. While there is no "one size fits all" approach to addressing these barriers, community engagement and collaboration is recognized by the Centers for Disease Control, the World Health Organization, and other global health organizations as a cornerstone for building a more equitable healthcare system. In this article, we will present case studies of stakeholder and community engagement in clinical research for rare diseases and other areas of healthcare, as examples of strategies and practices for actively involving under-represented communities and fostering their participation in pediatric drug development programs. These studies may serve as templates for facilitating equity in pediatric drug development from aspiration into operation.

A eticidade de pesquisas bioantropológicas de delinquência no cenário científico contemporâneo / La eticidad de investigaciones bioantropológicas de delincuencia en escenario científico contemporáneo / The ethics of bioanthropological delinquency research in contemporary scientific scene

A criminalidade ou a delinquência foram objeto de diversas investigações na busca por bases científicas para sua solução. O presente trabalho objetiva analisar se seria razoável, do ponto de vista ético, o desenvolvimento de pesquisas que visam investigar elementos ou modelos bioantropológicos de delinquência no contexto contemporâneo. Foram aplicados os métodos dedutivo e comparativo para verificar se pesquisas do mesmo gênero, como o estudo proposto no Brasil em 2008, teriam respaldo moral no contexto atual, tendo em vista os fundamentos da bioética principialista e de reflexões da teoria política e jurídica que destacam a hipossuficiência do indivíduo perante a atuação punitiva do Estado.

La criminalidad o la delincuencia fueron objetos de un sin número de investigaciones en la búsqueda de bases científicas para su solución. El presente estudio tiene como objetivo examinar si sería razonable, desde el punto de vista ético, el desarrollo de investigaciones con el fin de examinar elementos o modelos bioantropológicos de delincuencia en el contexto contemporáneo. Se aplicaron los métodos deductivo y comparativo para comprobar si las investigaciones del mismo género, como el estudio propuesto en Brasil el 2008, tendrian apoyo moral en el contexto actual, en vista de los fundamentos de la bioética principialista y reflexiones de la teoría política y jurídica que destacan la fragilidad del individuo ante la acción punitiva del Estado.

Crime and delinquency were objects of several researches in the order to identify scientific bases for their solution. This paper aims to examine if it would be reasonable, from the ethical point of view, the development of research aimed at investigating elements or bioanthropological delinquency models in the contemporary context. Deductive and comparative methods were applied to verify if research of the same genre, as the study proposed in Brazil in 2008, would have moral support in the current context, in view of the foundations of Principialist Bioethics and reflections of political and legal theory that highlights the fragile state of the individual in the face of punitive state action.

Vivissecção no ensino: questães éticas e jurídicas / Vivisection in education: ethical and legal aspects

A vivissecção constitui prática usual e arraigada nas faculdades das áreas biológicas. Nas últimas décadas, tem-se questionado a legislação, senciência e legitimidade do modelo animal, aspectos investigados neste trabalho. A discussão acerca dos animais envolve sua condição de propriedade e atribuição de direitos morais, podendo a senciência ser base para a consideração de seu status moral. As leis 9.605/98 e 1.1974/08 regulamentam a utilização de animais no Brasil. Contudo, a extrapolação do modelo animal nem sempre é possível, podendo comprometer a pesquisa científica e o aprendizado, de modo que a vivissecção pode ser dispensada ou substituída em algumas aulas, com vistas à qualidade da educação e ao cumprimento das leis dos direitos animais. Sugere-se o incremento da oferta de métodos alternativos à vivissecção, considerando-se que sua proibição, sem métodos substitutivos, comprometeria o aprendizado e o avanço científico, não sendo moralmente aceitável.

Conflicts of interest in research involving human beings.

Conflicts of interest are inherent to the majority of relationships among individuals and of these with companies and institutions and, certainly, research involving human beings is no exception. In relation to clinical research, the main focus of this manuscript, conflicts of interest occur at different levels and usually permeate among them: In the pharmaceutical industry in their decisions to invest to develop new products, especially vaccines and drugs, and also in relation to marketing of these products; Among the investigators the conflicts may be related to the financial gains to participate in pharma sponsored trials, or to the expected academic career boost attained with the publication of the results of the trials and also to personal interests such as the financial support for trips to international conferences. Often the participation of host country investigators is restricted to performing phase III or IV protocols developed abroad, many times with low scientific relevance, and even lower relevance to public health; Universities or research institutes themselves also have conflicts of interest, as the sponsored projects may help increase their budgets, both directly (taxes) and indirectly (e.g., improvement of physical infrastructure of laboratories or out patient clinics); For the trial volunteers in developing countries, and Brazil is no exception despite free and universal access to its health system, participation in clinical trials is many times seen as, and can really be, an unique opportunity of receiving better health care, better treatment by the health professionals, easier access to costly lab exams and also to receiving certain medications which would otherwise be difficult to have access to. In order to handle these conflicts of interest, Brazil has a well-established and respected legal support and ethical normatization. The latter is represented by Resolution 196/96 of the Brazilian National Research Ethics Committee (CONEP). This national system was established in 1996 providing guidance to all research involving human beings and currently there are approximately 500 local research ethical committees certified by CONEP in all States of Brazil. However, there is intense international pressure mainly from the pharmaceutical industry especially to the ethical requirements emanated from the Declaration of Helsinki (DH), aiming to lower the level of ethical requirements in research to be carried out with volunteers from developing countries. Fallacious reasoning includes that the equity stated at the DH, especially the access to the best proven medical care and to the developed products to all volunteers independently of where the trial is being held, would inflate the costs of research and drive the sponsors away from the developing countries. In this line of thought, if the volunteers have not the same rights that would constitute an unacceptable double standard, or in other words, the best for the volunteers from developed countries and whatever is possible for those in developing countries. This manuscript will focus on the various levels where conflict of interest issues are more prone to happen, such as in the actions of pharmaceutical industries, their relation to health professionals, the participation of universities and research institutes, the ethical research committees and their members, including the possible pressures exerted on them by researchers, sponsors and even their institutions. Emphasis will be given to the interrelation between conflicts of interest and vulnerability, and also the causes and possible solutions to lower the risks of exploitation of volunteers in research. It will also emphasize the need to guarantee access to products that are proven efficacious to all individuals who may need them. Possible ways of empowering these volunteers will be evaluated, so that they become aware of their rights and demand for them. It will discuss the need of separating economic interests from the real needs of public health and of demystifying economic arguments used in order to justify the lowering of ethical requirements. And finally it will address the search for or the establishment of real and effective involvement of all stakeholders in an international organism really representing everyone (e.g., WHO) in order to evaluate, debate, and decrease the risks of several conflicts of interest, aiming at the establishment of research projects that can truly contribute to lower the obscene disparities of health between developed and developing countries.

[Bioethical analysis of drugs advertisement and publicity]. / Análise bioética da propaganda e publicidade de medicamentos.

This study investigates how advertising campaigns for drugs influence drug prescription practices among physicians from a point of view of "protection ethics" and of "intervention bioethics". It also analyzes information quality in advertisements for prescription drugs before and after the ANVISA (National Agency for Sanitary Protection) RDC 102/200 Resolution wich regulates drugs advertising as well as discusses the regulating role of the state in this area. A first approach was to interview 50 physicians in Brasília/DF (25 general physicians and 25 surgeons) in order to examine how they perceive the effects of advertisement on their professional activities. A second approach was to study 10 publicity pieces, five from before and five from after the RDC Resolution. The results showed that: a) 98% of phsicians are visited by sales representatives on a regular basis; b) 86% of physicians receive gifts during these visits; c) 68% beleive that advertising strongly influences prescription practices; d) 14% related prescription practices to the receival of rewards; e) 68% beleive that information contained in advertisements is unreliable; f) before the RDC Resolution, 28% of advertisements had adequate information content (counter-indications, indications precautions, warnings, and adverse reactions); after the RDC Resolution, that number grew to 79%.

Análise bioética da propaganda e publicidade de medicamentos / Bioethical analysis of drugs advertisement and publicity

Sob a perspectiva da "ética da proteção" e da "bioética de intervenção", a pesquisa analisa a influência das peças publicitárias de medicamentos veiculadas à classe médica na prescrição de medicamentos. Estuda, ainda, a qualidade das informações nas propagandas de medicamentos de venda sob prescrição, antes e depois da Resolução da Diretoria Colegiada da Anvisa - RDC 102/2000, que regulamenta a propaganda de medicamentos no país, bem como discute o papel regulador do Estado na área. Primeiramente, foram entrevistados 50 médicos de Brasília, a fim de examinar como percebem os efeitos da propaganda sobre sua atividade profissional. Em seguida, foram avaliadas 10 peças publicitárias, 5 veiculadas antes e 5 depois da RDC 102/2000. Os resultados permitiram concluir que: a) 98 por cento dos médicos recebem visitas regulares de representantes comerciais; b) 86 por cento recebem brindes; c) 68 por cento crêem na influência direta da propaganda sobre a prescrição; d) 14 por cento disseram prescrever medicamentos em função do recebimento de prêmios; e) 68 por cento acreditam existir inverdades nas informações das peças publicitárias; f) antes da RDC, as informações (contra-indicações, indicações, precauções, cuidados e advertência) nas propagandas representava 28 por cento dos casos; após a RDC, foram encontradas informações em 79 por cento dos casos.

This study investigates how advertising campaigns for drugs influence drug prescription practices among physicians from a point of view of "protection ethics" and of "intervention bioethics". It also analyzes information quality in advertisements for prescription drugs before and after the ANVISA (National Agency for Sanitary Protection) RDC 102/200 Resolution wich regulates drugs advertising as well as discusses the regulating role of the state in this area. A first approach was to interview 50 physicians in Brasília/DF (25 general physicians and 25 surgeons) in order to examine how they perceive the effects of advertisement on their professional activities. A second approach was to study 10 publicity pieces, five from before and five from after the RDC Resolution. The results showed that: a) 98 percent of phsicians are visited by sales representatives on a regular basis; b) 86 percent of physicians receive gifts during these visits; c) 68 percent beleive that advertising strongly influences prescription practices; d) 14 percent related prescription practices to the receival of rewards; e) 68 percent beleive that information contained in advertisements is unreliable; f) before the RDC Resolution, 28 percent of advertisements had adequate information content (counter-indications, indications precautions, warnings, and adverse reactions); after the RDC Resolution, that number grew to 79 percent.

Ética em enfermagem: de um ensaio com enfoque deontológico para uma aprendizagem baseada na pedagogia da problematização / Ethics in Nursing - From a Deontological Focus to Learning Based on the Pedagogy of Problematization

O primeiro Código de Ética em Enfermagem foi elaborado pela Associação Brasileira de Enfermagem em 1958; posteriormente, em 1975, foi aprovado o Código de Deontologia em Enfermagem, que foi reformulado com a denominação de Código de Ética dos Profissionais de Enfermagem em 1993 e em 2000. O ensino de ética profissional sempre esteve presente nas escolas de enfermagem no Brasil. O Curso de Enfermagem da Universidade Estadual de Londrina (UEL), fundada em 1972 passou ao longo dos trinta e três anos de funcionamento por cinco reformas curriculares. Este trabalho tem como objetivo relatar a passagem do ensino da ética, com enfoque em legislação e deontologia, presente nas reformas iniciais para a inserção de discussões com abordagens mais reflexivas nas reformas realizadas no currículo de transição, implantado em 1996, e no currículo integrado em 2000. No currículo integrado em 2000, a bioética passou a integrar um dos temas transversais, as "seivas" que permeiam os conteúdos e práticas de enfermagem ao longo dos quatro anos de curso. Pretende-se com essa articulação formar enfermeiros com competência técnica, humana e comprometidos na solução das necessidades e problemas de saúde da população.

Genetic structure of honeybee populations from southern Brazil and Uruguay

Apis mellifera scutellata was introduced to Brazil in 1956 and Africanized honeybee populations have now spread from Argentina to the southwestern United States. Temperate climatic restrictions seem to be a natural limit to Africanized honeybee expansion around parallels 35º to 40º SL. We used allozyme loci (Mdh-1 and Hk-1) and mtDNA haplotypes to characterize honeybee populations in southern Brazil and Uruguay and define a possible transition area between Africanized and European bees. Samples of 194 bee colonies were collected from ten localities between 30º-35º SL and 52º-59º WL. The mtDNA restriction patterns of these colonies were obtained through digestion of the mitochondrial genome by Eco RI, or by digestion by Bgl II and Xba I of the cytochrome B locus and the COI-COII intergenic region, respectively. The distribution limit of African bee colonies, i.e., those populations with only the African mtDNA haplotype and with a high proportion of African genes as shown by allozyme analysis, is located in northern Uruguay, with a hybridization zone located farther south in Uruguay. A gradual cline from north to south was observed, confirmed by mtDNA, racial admixture, and genetic distance analyses. No evidence of either gametic disequilibrium between nuclear markers or cytonuclear disequilibrium among the nuclear and mtDNA genotypes was detected, suggesting that the hybridization process has been completed