Review In Brazil Research Articles

Tarlatamab: First Approval.

Tarlatamab (tarlatamab-dlle: IMDELLTRA™) is a first-in-class, half-life extended bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager being developed by Amgen for the treatment of small cell lung cancer (SCLC) and neuroendocrine prostate cancer. Tarlatamab binds to DLL3 on the surface of tumour cells and CD3 on the surface of cytotoxic T lymphocytes (CTLs), resulting in T-cell activation, release of inflammatory cytokines and CTL-mediated cell death of DLL3-expressing tumour cells. In May 2024, tarlatamab received its first approval in the USA for the treatment of adults with extensive stage SCLC (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Tarlatamab received accelerated approval for this indication based on overall response rate and duration of response in the pivotal phase 2 DeLLphi-301 study, and continued approval may be contingent on the demonstration of clinical benefit in a confirmatory trial(s). Tarlatamab is under regulatory review in Brazil, Canada, Israel and the UK, and clinical studies are underway in multiple countries. This article summarizes the milestones in the development of tarlatamab leading to this first approval for ES-SCLC with disease progression on or after platinum-based chemotherapy.

Decolonial scientific education to combat ‘science for domination’

In this article, we argue that mainstream science education is contaminated by neoliberal values and functions in the service of political domination and exploitation and that a neoliberal and exploitative science education does not contribute to the building of a sustainable and just world. The work from Paulo Freire and Enrique Dussel underpin the tenets of decolonial pedagogies. We draw on their work to analyze how decolonial pedagogies have been developed in Latin America. We carried out a literature review in Brazil and found two different ways of approaching decoloniality in science education: (a) studies that start from hybrid, interstitial spaces, as an enunciative locus that allows the construction of other logics of thought and (b) studies dedicated to denouncing the colonial power project from an anti-racist education that contests coloniality and oppression. We present examples of Freirean educational practices and proposals in science education that illustrate how decolonial pedagogies can reveal the coloniality of power/being/knowledge and potentialities of intercultural dialogues. We conclude with an explanation of how and why Freirean dialogicity and affection can counter science for domination.

Concentrated judicial review in Brazil and Colombia: which (or whose) rights are protected?

Over the last few decades, judicial power has expanded, especially in constitutional or supreme courts. Recently, scholars in comparative constitutional law have focused their attention on analyzing the causes and consequences of this expansion in different constitutional systems. There are still no studies that compare the role played by constitutional or supreme courts in the defense of individual and social rights, specifically with regard to the link between the protection of rights and the extent to which social actors are granted standing to assert constitutional claims. This paper intends to provide some thoughts on this issue. The text will analyze the relationship between the protection of rights and the extent to which plaintiffs are granted the right to file constitutional claims in Colombia and Brazil. We conclude that the comparison between Brazil and Colombia presents relevant insights into how the dimension of authority, specifically standing to access the main courts in each system, can make a large difference in the protection of social and individual rights.

Consumers’ knowledge and use of nutritional information on food labels

A rotulagem de alimentos é importante para a comunicação entre produtores e consumidores. No entanto, para ajudar os consumidores a ter maior autonomia em suas escolhas alimentares, é importante interpretar corretamente a rotulagem dos alimentos. Assim, esta pesquisa avaliou o conhecimento e o uso das informações nutricionais apresentadas nos rótulos dos alimentos. Pesquisa quantitativa, exploratória e transversal, realizada em 2018 em uma universidade pública no Brasil, com 415 consumidores com 18 anos ou mais. Para avaliar o conhecimento, aplicou-se questionário estruturado com pontuação de 0 a 24. Os dados foram analisados por meio de análise descritiva, correlação de Spearman e teste de Kruskal-Wallis e Mann Whitney. Participaram indivíduos com idade de 21,02 ± 2,89 anos, dos quais 58,31% eram do sexo feminino. Muitos consumidores liam frequentemente os rótulos dos alimentos (56,39%). A pontuação média de conhecimento foi de 14,99 ± 4,12. A média do escore de conhecimento foi afetada pela idade (p = 0,039) e renda (p = 0,020). Os participantes que utilizaram alegações nutricionais como critério de compra (p = 0,004) obtiveram maiores pontuações. Os maiores problemas na interpretação dos rótulos nutricionais estavam relacionados às reivindicações obrigatórias de nutrientes e aos termos "isento de gordura trans (0%)", "alimento funcional", "dieta" e "light". Considerando que a regulamentação dos rótulos de alimentos está em processo de revisão no Brasil, torna-se importante pesquisar seu uso e conhecimento por consumidores adultos jovens. Isso contribuirá para a discussão da revisão da legislação, além de ajudar os profissionais a orientarem os consumidores na interpretação dos rótulos.

The different tests for the diagnosis of COVID-19 - A review in Brazil so far.

SARS-CoV-2 is a novel virus from the coronavirus family that emerged in the end of December 2019 in Wuhan, China. The virus is now widespread and causing the current pandemic of COVID-19, a highly pathogenic viral pneumonia, commonly presented with fever and cough, which frequently lead to lower respiratory tract disease with poor clinical outcomes associated with older age and underlying health conditions. Supportive care for patients is typically the standard protocol because no specific effective antiviral therapies have been identified so far. The current outbreak is challenging governments and health authorities all over the world. In here we present a comparison among the current diagnostic tools and kits being used to test Brazilian population.

What makes mucosal and anergic diffuse cutaneous leishmaniases so clinically and immunopathogically different? A review in Brazil.

American cutaneous leishmaniasis (ACL) is a parasitic protozoan disease caused by different Leishmania species widely distributed throughout Latin America. Fifteen Leishmania species belonging to the subgenera Viannia, Leishmania and Mundinia are known to cause ACL. Seven of these species are found in Brazil, of which Leishmania (Viannia) braziliensis and Leishmania (Leishmania) amazonensis have the highest potential to cause mucosal (ML) and anergic diffuse cutaneous leishmaniasis (DCL), respectively, the most severe forms of ACL. The clinical and immunopathological differences between these two clinical forms are reviewed here, taking into account their different physiopathogenic mechanisms of dissemination from cutaneous lesions to mucosal tissues in the case of ML and to almost all body surfaces in the case of anergic DCL. We also discuss some immunopathogenic mechanisms of species-specific Leishmania antigens (from the subgenera Viannia and Leishmania) that are most likely associated with the clinical and immunopathological differences between ML and anergic DCL. Those discussions emphasize the pivotal importance of some surface antigens of L. (V.) braziliensis and L. (L.) amazonensis, such as lipophosphoglycan, phosphatidylserine and CD200 (an immunoregulatory molecule that inhibits macrophage activation), that have been shown to exert strong influences on the clinical and immunopathological differences between ML and anergic DCL.

Review of Brazil and climate change beyond the Amazon

Brazil and climate change beyond the Amazon, by Eduardo Viola and Matias Franchini. Routledge, 2018.

Sistema brasileiro de revisão ética em pesquisa: percepção de pesquisadores


 
 
 
 O artigo apresenta a percepção de pesquisadores do Distrito Federal sobre o sistema de revisão ética em pesquisa no Brasil. A coleta de dados ocorreu mediante questionário respondido online, com questões sobre aspectos sociodemográficos, referentes à formação, atuação em pesquisa e percepção sobre o sistema de revisão ética brasileiro. Noventa e oito pesquisadores participaram, 56,1% com idades entre 41-60 anos, 67% do gênero feminino, 53,1% tinham doutorado, 78% realizavam pesquisa há mais de seis anos e 80,6% concordaram com a obrigatoriedade de submissão projetos de pesquisas a comitês de ética; 95% informaram conhecer a Resolução CNS 466/12 e 56,1% a Resolução CNS 510/16. Cerca de 93% consideraram a proteção do participante como o principal papel do sistema. Os pesquisadores demonstraram conhecer o funcionamento do sistema de revisão ética, todavia referiram dificuldades na submissão de projetos e obstáculos para a realização de pesquisas.
 
 
 

Professional Practice and Neurosurgery: What Every Neurosurgeon Should Know about Malpractice

Introduction The objective of the present study was to review the epidemiological aspects of malpractice in neurosurgery and to identify preventive measures regarding malpractice for neurosurgeons. Methods The following terms (alone or in combination) were searched in the PubMed and Biblioteca Virtual em Saúde databases: neurosurgery (neurocirurgia), lawsuits (ações judiciais), malpractice (erro médico), and litigation (litígio) and identifying studies on these topics published from 2000 to April 2018. Literature Review In Brazil, 6.9% of the physicians are sued per year. The most common type of malpractice alleged in litigation is negligence. According to the literature, the neurosurgical disease that has sparked the most litigation is spinal disease. The outcomes of these cases vary: sometimes the neurosurgeon prevails, and at other times the plaintiff prevails. To prevent or reduce malpractice claims, the neurosurgeon should take the following precautions: 1. follow medical protocols; 2. perform surgeries in an environment consistent with good medical practice; 3. evaluate and monitor antibiotic prophylaxis; 4. develop a good relationship with the patient based on ethics, good faith and transparency; 5. request the presence of the patient and of his or her family when there is a problem in order to didactically explain the case; 6. keep good medical records to document all of the actions performed (informed consent and description of the surgery and of the pre and postoperative); 7. always seek technical improvement (continuing education/professional development); 8. in the case of attending physicians, monitor patients, treating any postoperative complications; and 9. conduct multidisciplinary team meetings to optimize treatment decisions and to share responsibility for making difficult decisions.

Environmental License for Carbon Capture and Storage (CCS) Projects in Brazil

This article presents the environmental licensing system in Brazil and its instrument, the environmental impact assessment (EIA) and its discussion on CCS activities. Globally, extractive industry development projects are well known to have environmental impacts, and Brazil is no exception. Since the adoption of the main Brazilian environmental laws, there has been a general perception that environmental licensing system and EIAs protects its environment. Besides the legal requirement for those tools, this article describes the specific rules on oil and gas projects (onshore and offshore). This research contributes as a review of Brazil’s environmental legislation, including the specific oil and gas legislation, presented along with a comprehensive discussion of those tools. Finally, this paper essays a general contribution for an understanding environmental licensing for CCS activities. The research was done using the inductive method, based on the methodology of legal science and with bibliographic and normative research techniques, including institutional analysis.

Review of Brazil's Emerging role in Global Governance: Health, Food Security and Bioenergy, by Markus Fraundorfer

Brazil's Emerging role in Global Governance: Health, Food Security and Bioenergy, by Markus Fraundorfer. Palgrave & Macmillan, 2016.

Globalization and convergence in judicial review: what can we learn from the case of Brazil?

This paper offers one way to verify the existence of dominant convergence trends in the market of legal ideas. By looking through the history of judicial review in Brazil, it aims to sketch some intuitions on the changing influences that can be spotted in such market. Being a peripheral jurisdiction and a traditional importer of legal ideas and doctrines, Brazil is relatively open to foreign influences and international trends. It is, in this sense, a good proxy of any domination occasionally being exerted. Thus, paying attention to the evolution of judicial review in Brazil can be a way to identify global developments.

Affirmative Action in the Brazilian Higher Education System

The purpose of this article is to discuss the advantages and disadvantages of affirmative action in the Brazilian system of higher education, which is aimed at benefitting Afro- Brazilians suffering from the legacy of structural racism and economic inequality. The authors will highlight some of the problems linked to the racial quota system, and demonstrate that its implementation is deeply hindered by several factors, such as traditional denial of existing racial prejudice in Brazilian society, a lack of precise, normative definitions of eligibility for programs, failure of pre-university public education to properly prepare students for university-level academics, and – last but not least – a lack of sufficient support from academic institutions. The article will present both quantitative and qualitative data that show the expectations, doubts, and fears of the Brazilian academic environment with regard to the racial quota system. After a review of Brazil’s racial history and an analysis of students’ and professors’ opinions, the authors will argue that, in order for colored citizens to become fully integrated into Brazilian society, they must first be legally enabled to overcome social, educational, and economic obstacles and handicap.

A Streamlined Approach to Ethics Review in Brazil

A Streamlined Approach to Ethics Review in Brazil

Meningococcal B vaccination strategies and their practical application in Italy.

Immunisation against meningococcal meningitis has a long history, which has passed through several phases: the studies by Flexner, extraction of the polysaccharide capsule, the development of monovalent and multivalent conjugate vaccines, the outer membrane vesicle vaccines up to the development of effective and safe vaccines for meningococcal B invasive disease through the application of the techniques of molecular biology and reverse vaccinology. The new available vaccines are Bexsero® and Trumenba®. Bexsero ® has been approved and is available in Europe, the USA, Canada, Australia and Chile, and is currently under review in Brazil for the prevention of MenB invasive disease in subjects ≥ 2 months. Trumemba® is currently approved only in the USA, for use in adolescents and young adults. At present, the greatest obstacle to the extensive use of these vaccines in industrialised countries is the high cost and the need administer multiple doses in infants. However, in some European countries and in some Italian Regions, strategies (free and active call) to fight the disease through vaccination (Bexsero®) are already in place.

Boa administração pública e fundamentos constitucionais das políticas públicas na perspectiva do Supremo Tribunal Federal

This paper presents a brief reflection on the fundamental right to good administration, the constitutional foundations of public service and public policy and the possibilities and limits of judicial review in Brazil. The problem that drives this work is to understand whether there is plausibility in speaking of the right to good public administration in Brazil and to what extent it can be a basis for judicial review. The study is based on a survey of the literature, legislation and case law. It uses a deductive method and an analytical procedure, and aims to understand the limits and possibilities of the Judiciary’s action for the protection of fundamental rights, especially when they involve the discussion of good public administration (as a fundamental right) and the constitutional foundations of public service. Thus, the articles begins with a consideration of the conceptual aspects of the proposed topics and then analyzes the current perspectives on the topic based on the understanding of the Supreme Court in decisions involving the right to education.Keywords: good public administration, public service, jurisdictional control.

DIALOGICAL CONSTITUTIONALISM MANIFESTATIONS IN THE BRAZILIAN JUDICIAL REVIEW

The exponential growth in judicial review in Brazil, compared with the international scenery, is not out of tune – and it has a direct relation with many Brazilian constitutional features. An analytical text (with over 400 articles) and a large spectrum of fundamental rights, provide an ambience that favors highly intense controversy about State obligations in providing goods and public services, or even about the possible tensions that may arise between those same rights. The Brazilian Supreme Court faces that unmanageable number of lawsuits, notably related with claims regarding the non-granting of socioeconomic rights. That scenery is leading the Brazilian Supreme Court to some kind of experimentalism in the designing of its own rulings, applying techniques that can be easily associated with many manifestations of the so-called dialogical constitutionalism. All those experiences reveal that granting socioeconomic rights as a distributive justice goal requires a dialogic strategy in judicial review, in order to provide progressive implementation, preventing inequality. Still, those dialogic provisions face serious obstacles related with the menace of a merely symbolic use by the Judiciary and with a path of substitutive deliberation again by the Judiciary leading to reinforce Legislative inertia, social alienation from the debate and undermining democratic accountability. Adopting a dialogical constitutionalism model in Brazil might be a proper solution to allow its system to reach the functional development of the constitution’s goals – but it requires a deeper theoretical reflection.

Access, Fairness and Affordability: Procedural Justice in NICE, Anvisa and Conitec

Everywhere, health care systems are making hard choices about medicines. These choices are sensitive, controversial and often result in litigation. For example, the recent report in the UK about the drug Tamiflu casts doubt on the efficacy of the treatment and its value for money to the public health system. In Brazil too, the uncontrollable judicialization of public health decision-making illustrates the gravity of these issues and the challenges they present. They demonstrate that health systems have to operate within finite budgets and that, because we cannot afford everything, we must ensure that treatments are effective and good value for money. We suggest that the hard choices required should not be made by judges deciding individual cases. National public authorities should perform these functions where possible, taking full account of public interests.All public authorities are subject to judicial supervision. Public health care resource allocators should work within a clear and transparent procedural framework which assures everyone the system is operating fairly and consistently. We should be clear about the role of public authorities and judicial review in decision-making, and the principles governing the incorporation of new treatments.A comparative study of Brazil - UK is helpful for two reasons. First, the rules governing judicial review in Brazil and the UK are different. In Brazil, the courts are more willing to take substantive responsibility for administrative decision-making by ordering that specific treatments are provided to individual patients. In the UK, by contrast, the principle of procedural review is normally limited to the reasonableness of the decision only, so that when a decision is wrong, it is referred back to the public authority to be reconsidered. Second, it is useful to compare the structural and procedural similarities of NICE, Anvisa and Conitec to assess the extent to which they are capable of promoting equality of access to a proper range of affordable medicines. In particular, we recommend a need for strong and transparent administrative procedures to relieve the courts of the duty to intervene in these cases.We also consider the many medicines which cannot be considered by national public authorities. Which local authorities decide about these medicines and what procedures should they follow? We recommend a framework of procedural values which reassures the courts that the system (whether national or local) is working fairly and consistently and does not require extensive interference from judges.Thus, we will consider: (A) The process for evaluating new technologies in NICE, Anvisa and Conitec, (B) The role of the courts in supervising these administrative procedures and (C) the residual role of judicial review of payment decisions in the NHS and SUS. The study concludes that the proper balance between increasing demand for health care, finite public health budgets and the promotion of public interests is best achieved through public authorities structured in ways which are open and accountable. We recommend that such bodies be subject to proper procedural judicial review and that “public” access to medicines is most likely to be served by courts which respect the public dimension of decision-making.

Avaliação Legislativa no Brasil: apontamentos para uma nova agenda de pesquisa sobre o modo de produção das leis

This article aims to analyze the strengths and limitations of the legislative review process to instruct the development and review of legislative acts in Brazil . Legislative assessment is a methodology designed to analyze normative acts from the standpoint of the effects they produce in society. From this perspective, it pertains to the the evaluator to measure, with the use of interdisciplinary research tools, the efficiency, the effectiveness and the impact of laws. Accordingly, this paper is divided into four parts. At first, we analyze the social, economic and intellectual conditions which favor the development of legislative review as a fundamental methodology in the process of law production. The article then examines the legislative review with the perspective of studying “Legistics Material”. This discipline, also known as “methodical legislation” aims to provide techniques for shaping the content of the law itself; in this process the analytical tools used are of paramount relevance. The third part will present some experiences of institutionalization of legislative review where it has been officially adopted in some jurisdictions as an essential mechanism of the lawmaking process. The article concludes by highlighting an analysis of how assumptions of “Legistics Material” have been inserted in the Brazilian legal system, and how these assumptions have been applied in practice. It will be seen that the modest use of legislative review in Brazil stems from the lack of knowledge of this important tool for improving the legislative technique .

Avaliação Legislativa no Brasil: apontamentos para uma nova agenda de pesquisa sobre o modo de produção das leis

This article aims to analyze the strengths and limitations of the legislative review process to instruct the development and review of legislative acts in Brazil . Legislative assessment is a methodology designed to analyze normative acts from the standpoint of the effects they produce in society. From this perspective, it pertains to the the evaluator to measure, with the use of interdisciplinary research tools, the efficiency, the effectiveness and the impact of laws. Accordingly, this paper is divided into four parts. At first, we analyze the social, economic and intellectual conditions which favor the development of legislative review as a fundamental methodology in the process of law production. The article then examines the legislative review with the perspective of studying “Legistics Material”. This discipline, also known as “methodical legislation” aims to provide techniques for shaping the content of the law itself; in this process the analytical tools used are of paramount relevance. The third part will present some experiences of institutionalization of legislative review where it has been officially adopted in some jurisdictions as an essential mechanism of the lawmaking process. The article concludes by highlighting an analysis of how assumptions of “Legistics Material” have been inserted in the Brazilian legal system, and how these assumptions have been applied in practice. It will be seen that the modest use of legislative review in Brazil stems from the lack of knowledge of this important tool for improving the legislative technique .