Post-trial access to study medication: a Brazilian e-survey with major stakeholders in clinical research

Objectives To analyse the perspective of clinical research stakeholders concerning post-trial access to study medication. Methods Questionnaires and informed consents were sent through e-mail to 599 ethics committee (EC) members, 290 clinical investigators (HIV/AIDS and Diabetes) and 53 sponsors in Brazil. Investigators were also asked to submit the questionnaire to their research patients. Two reminders were sent to participants. Results The response rate was 21%, 20% and 45% in EC, investigators and sponsors' groups, respectively. 54 patients answered the questionnaire through their doctors. The least informative item in the consent form was how to obtain the study medication after trial. If a benefit were demonstrated in the study, 60% of research participants and 35% of EC answered that all patients should continue receiving study medication after trial; 43% of investigators believed the medication should be given to participants, and 40% to subjects who participated and benefited from treatment. For 50% of the sponsors, study medication should be assured to participants who had benefited from treatment. The majority of responders answered that medication should be provided free by sponsors; investigators and sponsors believed the medication should be kept until available in the public health sector; EC members said that the patient should keep the benefit; patients answered that benefits should be assured for life. Conclusions Due to the study limitations, the results cannot be generalised; however, the data can contribute to discussion of this complex topic through analysing the views of stakeholders in clinical research in Brazil.

Epidemiology of vampire bat-transmitted rabies virus in Goiás, central Brazil: re-evaluation based on G-L intergenic region

Abstract Background Vampire bat related rabies harms both livestock industry and public health sector in central Brazil. The geographical distributions of vampire bat-transmitted rabies virus variants are delimited by mountain chains. These findings were elucidated by analyzing a high conserved nucleoprotein gene. This study aims to elucidate the detailed epidemiological characters of vampire bat-transmitted rabies virus by phylogenetic methods based on 619-nt sequence including unconserved G-L intergenic region. Findings The vampire bat-transmitted rabies virus isolates divided into 8 phylogenetic lineages in the previous nucleoprotein gene analysis were divided into 10 phylogenetic lineages with significant bootstrap values. The distributions of most variants were reconfirmed to be delimited by mountain chains. Furthermore, variants in undulating areas have narrow distributions and are apparently separated by mountain ridges. Conclusions This study demonstrates that the 619-nt sequence including G-L intergenic region is more useful for a state-level phylogenetic analysis of rabies virus than the partial nucleoprotein gene, and simultaneously that the distribution of vampire bat-transmitted RABV variants tends to be separated not only by mountain chains but also by mountain ridges, thus suggesting that the diversity of vampire bat-transmitted RABV variants was delimited by geographical undulations.

Decentralization and regionalization: dynamics and conditioning factors for the implementation of the Health Pact in Brazil

Decentralization and regionalization represent constitutional guidelines for the organization of the Unified Health System, which in the last 20 years has required the adoption of mechanisms to coordinate and accommodate federative tensions in Brazil's healthcare sector. This paper analyzes the national implementation of the Health Pact between 2006 and 2010 involving a strategy that reconfigures intergovernmental relations in the sector. The study involved the analysis of documents, official data and interviews with federal, state and municipal managers in the Brazilian states. The content of the national proposal is initially discussed, including its implications for health policy. The different rhythms and degrees of implementation of the Health Pact are then reviewed, with respect to adherence by states and municipalities and the formation of Regional Management Boards. Lastly, the conditioning factors for the multiplicity of experiences observed in the country are identified and the challenges facing progress toward a decentralized and regionalized health system in Brazil are discussed.

Epidemiological intelligence as a model of organization in health

The concept of epidemiological intelligence, as a construction of information societies, goes beyond monitoring a list of diseases and the ability to elicit rapid responses. The concept should consider the complexity of the definition of epidemiology in the identification of this object of study without being limited to a set of actions in a single government sector. The activities of epidemiological intelligence include risk assessment, strategies for prevention and protection, subsystems of information, crisis management rooms, geographical analysis, etc. This concept contributes to the understanding of policies in health, in multisectorial and geopolitical dimensions, as regards the organization of services around public health emergencies, primary healthcare, as well as disasters. The activities of epidemiological intelligence should not be restricted to scientific research, but the researchers must beware of threats to public health. Lalonde's model enabled consideration of epidemiological intelligence as a way to restructure policies and share resources by creating communities of intelligence, whose purpose is primarily to deal with public health emergencies and disasters.

Equity and women's health services for contraception, abortion and childbirth in Brazil

This paper addresses equity in health and health care in Brazil, examining unjust disparities between women and men, and between women from different social strata, with a focus on services for contraception, abortion and pregnancy. In 2010 women's life expectancy was 77.6 years, men's was 69.7 years. Women are two-thirds of public hospital services users and assess their health status less positively than men. The total fertility rate was 1.8 in 2011, and contraceptive prevalence has been high among women at all income levels. The proportion of sterilizations has decreased; lower-income women are more frequently sterilized. Abortions are mostly illegal; women with more money have better access to safe abortions in private clinics. Poorer women generally self-induce abortion with misoprostol, seeking treatment of complications from public clinics. Institutional violence on the part of health professionals is reported by half of women receiving abortion care and a quarter of women during childbirth. Maternity care is virtually universal. The public sector has fewer caesarean sections, fewer low birth weight babies, and more rooming-in, but excessive episiotomies and inductions. Privacy, continuity of care and companionship during birth are more common in the private sector. To achieve equity, the health system must go beyond universal, unregulated access to technology, and move towards safe, effective and transparent care. (C) 2012 Reproductive Health Matters

Work organization and the health of bank employees

The Brazilian banking sector has undergone an intense restructuring process and taken a leading position in the incorporation of new technologies and organizational innovations. Computerization in the industry, in association with forms of work organization, has resulted in changes that reflect on the workers' health. Based on the theoretical and methodological frameworks of historical and dialectical materialism, this qualitative study investigates the work conditions of bank employees in order to identify the extent to which changes in work organization interfere with these workers' health. Data were collected through interviews held with 11 bank employees. In addition to physical sickening due to occupational diseases directly related to work intensification, the results also show an increased incidence of mental suffering and a feeling of loss of professional identity. Work-related frustration, instability and concerns related to psychological pressure resulting from the need to achieve goals predominated in the reports.

Current issues regarding health surveillance of fluoride concentrations in foods

This study analyzed the position of the Federal (Brazil), State (Sao Paulo), and municipal (Bauru, Sao Paulo) governments, civil society representatives, the regulated sector, and research associations concerning issues with fluoride content in foods. Analysis of the interviews (N = 15) used a qualitative methodology (collective subject discourse theory). Various central ideas were identified, including the need for stronger health surveillance in monitoring and controlling fluoride levels, educational measures, and more research in the area. The study concludes that the health surveillance approach to fluoride levels in foods is necessary, but still incipient. There is a mismatch between research output and surveillance. Regulation alone does not suffice to solve all the issues. Health risk communication and health education measures need to be implemented. Issues with fluoride on food labels need further research for the intervention to be effective.

Antenatal depression strongly predicts postnatal depression in primary health care

Objective: To estimate the association between antenatal and postnatal depression and to examine the role of socioeconomic conditions in the risk of postnatal depression. Methods: A prospective cohort study, conducted between May 2005 and January 2006, with 831 pregnant women recruited from primary care clinics in the public sector in the city of Sao Paulo, Brazil. The presence of antenatal and postnatal depression was measured with the Self Report Questionnaire (SRQ-20). Sociodemographic and socioeconomic characteristics and obstetric information were obtained through a questionnaire. Crude and adjusted risk ratios (RR), with 95% CI, were calculated using a Poisson regression. Results: The prevalence of postnatal depressive symptoms was 31.2% (95% CI: 27.8-34.8%). Among the 219 mothers who had depressive symptoms, nearly 50% had already shown depressive symptoms during pregnancy. Women who had antenatal depression were 2.4 times more likely to present with postnatal depression than were women who did not have such symptoms during pregnancy. In the multivariate analysis, higher scores for assets (RR: 0.76, 95% CI 0.61-0.96), higher education (RR: 0.75 95% CI 0.59-0.96), daily contact with neighbors (RR: 0.68, 95% CI 0.51-0.90) and antenatal depression (RR: 2.44, 95% CI 1.93-3.08) remained independently associated with postnatal depression. Conclusions: Antenatal and postnatal depression are highly prevalent in the primary care setting.