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BACKGROUND: Brazilian patients have legal right to access unlicensed medicines undergoing clinical research, if there is evidence of efficacy and safety. This study investigated the occurrence of serious adverse events related to very high-cost medicines from clinical studies, expanded access and compassionate use programs, obtained by patients though health litigation. METHODS: A descriptive study using secondary data investigated unlicensed medicines obtained through lawsuits from 2010 to 2017, costing more than 1 million Brazilian reais (BRL), adjusted by the Brazilian Consumer Index to July 2017. Data sources were the Brazilian Health Surveillance Agency Registry (DATAVISA) and Adverse Events in Clinical Studies (NotivisaEC) Databases. Medicines were categorized by the Anatomical Therapeutic Chemical classification to level 03 and events by the WHO Adverse Drug Reaction Terminology. The study received ethical approval by the University of Brasilia Institutional Research Board. RESULTS: In the period, 812 drugs were obtained through litigation, and of these, 78 exceeded cost of 1 million BRL; 44 of them presented reports of 1,248 serious adverse events. Total Brazilian Government expenditure with these drugs was 3.2 billion BRL. Class L04A (n=7) showed greater expenditures (over 1.8 billion BRL). One hundred ninety-six deaths occurred and L01X was the most involved category (49.5%). Most other serious events (n=419) and sequelae (n=10) were related to L01X. CONCLUSION: Very high-cost drugs paid for by the government and obtained through health litigation presented deaths and serious adverse events in expanded access and compassionate use programs in Brazil.

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Background: Although policies and guidelines make use of the concept of vulnerability, few define it. The European Union's directive for clinical trials does not include explanations for or the reasoning behind the designation of certain groups as vulnerable. Emerging economies from lower middle-income countries have, in recent years, had the largest average annual growth rate, as well as increase, in number of clinical trials registered in the US government's database. Nevertheless, careful supervision of research activities has to be ensured. Objective: To describe and analyze the features of the clinical trials involving vulnerable populations in various countries classified by development status and geographic region. Methods: Retrospective study that involved analysis of data obtained from the International Clinical Trials Registry Platform (ICTRP) database between 01/2014 and 12/2014 from countries with (i) highest trial densities during 2005 to 2012, (ii) highest average growth rate in clinical trials, and (iii) greatest trial capabilities. Results: Statistical analysis of this study showed that patients incapable of giving consent personally are 11.4 times more likely to be vulnerable patients than patients who are capable, and that patients in upper-middle-income countries are 1.7 times more likely to be vulnerable patients than patients from high-income countries when participating in global clinical trials. Malaysia (21%), Egypt (20%), Turkey (19%), Israel (18%), and Brazil (17%) had the highest percentages of vulnerable populations involving children. Conclusions: Although the inability to provide consent personally was a factor associated with vulnerability, arbitrary criteria may have been considered when classifying the populations of clinical trials as vulnerable. The EU Clinical Trials Register should provide guidance regarding exactly what aspects or factors should be taken into account to frame given populations as vulnerable, because vulnerability is not applicable to all risk situations.

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OBJECTIVE: The aim of this study was to evaluate the effects of dietary supplementation with Agaricus sylvaticus fungus on hematological, immunological, and glycemia levels of postsurgical patients with colorectal cancer. METHODS: A randomized, placebo-controlled, clinical trial was conducted at the General Hospital of Brazil for 6 months. Fifty-six patients with colorectal cancer (stages I, II, and III) were divided into 2 groups: A. sylvaticus (30 mg/kg/day) and placebo. Complete hemogram, serum iron, and fasting glycemia evaluations were carried out throughout the treatment course. Subjects were divided according to body mass index (BMI), sex, and stage of colorectal cancer. Data were analyzed using SPSS 14.0 programs, Student's t test, and F statistical test, with P < or = 0.05 considered significant. RESULTS: After 6 months of supplementation, the group that received A. sylvaticus showed significant increases in hemoglobin (P = 0.0001), hematocrit (P = 0.0001), erythrocytes (P = 0.01), mean cell volume (P = 0.01), mean cell hemoglobin (P = 0.0001), mean cell hemoglobin concentration (P = 0.0001), and neutrophil levels (P = 0.0001). The platelet count was significantly reduced (P = 0.03), but remained within normal levels. No significant alterations were observed in the placebo group. The study group was composed of 32 women (57.1%) and 24 men (42.9%). Mean BMI was 24.65 kg/m2. Glycemia levels in the placebo group (average age 59.14 +/- 12.95 years) were: initial, 94.36 +/- 15.34 mg/dl; 3 months, 98.12 +/- 15.54 mg/dl (P = 0.03); and 6 months, 98.52 +/- 9.03 mg/dl (P = 0.01). Glycemia levels in the supplemented group (average age 56.34 +/- 15.53 years) were: initial, 95.92 +/- 11.64 mg/dl, 3 months, 94.88 +/- 12.24 mg/dl (P = 0.65); and 6 months, 92.86 +/- 6.82 mg/dl (P = 0.01). CONCLUSIONS: The results of this study suggest that supplementation with A. sylvaticus produces benefits in hematological and immunological parameters and can reduce glycemia levels in patients with colorectal cancer.

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The objective of this article is to relate the experience of the Research Ethics Committee of the Secretary of Health, Federal District, Brazil (CEP/SES/DF) during 10 years (1997-2007) from its creation. It deals with a descriptive and documentary evaluation, in the form of case studies, utilizing all projects subject to protocol in CEP/SES/DF (Number 052/08) during that period.The most frequent conflicts were: terms of free and informed consent (30%), identification page (25%), methodology (20%), curriculum vitae (12%), budget (9%), others (4%).The activity report of CEP/SES/DF in 10 years revealed, as a result of its productivity, legitimacy in the process of ethical analysis of protocols which confirms the protection of research participants.

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O objetivo deste artigo é relatar a experiência do Comitê de Ética em Pesquisa da Secretaria de Estado de Saúde do Distrito Federal (CEP/SES/DF) Brasil, durante o período de 10 anos a partir de sua fundação. Trata-se de uma avaliação descritiva e documental, na modalidade estudo de caso, utilizando-se a totalidade de projetos protocolados no CEP/SES/DF (Nº 052/08) nesse período. As pendências mais freqüentes dos projetos foram: termo de consentimento livre e esclarecido (30 por cento), folha de rosto (25 por cento), metodologia (20 por cento), curriculum vitae (12 por cento), planilha de orçamento (9 por cento), outros (4 por cento). O relato das atividades do CEP/SES/DF no período de 10 anos revelou, através de sua produtividade, a legitimidade do processo de análise ética dos protocolos visando à proteção dos participantes da pesquisa.

El objetivo de este artículo es relatar la experiencia del Comité de Ética en Investigación de la Secretaría de Estado de Salud del Distrito Federal (CEP/SES/DF), Brasil, durante un período de 10 años (1997-2007) a partir de su fundación. Se trata de una evaluación descriptiva y documental, en la modalidad estudio de caso, utilizándose la totalidad de proyectos protocolizados en el CEP/SES/DF (Número 052/08) en ese período. Los conflictos más frecuentes fueron: término de consentimiento libre e informado (30 por ciento), protocolo de investigación (25 por ciento), metodología (20 por ciento), currículum vitae (12 por ciento), planilla de presupuesto (9 por ciento), otros (4 por ciento). El informe de las actividades del CEP/SES/DF en 10 años reveló, a través de su productividad, la legitimidad del proceso de análisis ético de los protocolos, confirmando la protección de los participantes en la investigación.

The objective of this article is to relate the experience of the Research Ethics Committee of the Secretary of Health, Federal District, Brazil (CEP/SES/DF) during 10 years (1997-2007) from its creation. It deals with a descriptive and documentary evaluation, in the form of case studies, utilizing all projects subject to protocol in CEP/SES/DF (Number 052/08) during that period. The most frequent conflicts were: terms of free and informed consent (30 percent), identification page (25 percent), methodology (20 percent), curriculum vitae (12 percent), budget (9 percent), others (4 percent). The activity report of CEP/SES/DF in 10 years revealed, as a result of its productivity, legitimacy in the process of ethical analysis of protocols which confirms the protection of research participants.

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It has been suggested that the administration of certain nutrients may improve the immune response of patients with cancer. Experimental studies have shown that deficiencies in specific amino acids have a worse effect on humoral immunity than they do on cell-mediated immunity because they impair antibody synthesis. Here, arginine plays a particularly important role, and research with several experimental and human tumor models to determine the therapeutic utility of this amino acid is under way. In this paper, we review current literature on the use of arginine as pharmacologic nutritional support for cancer patients. Dietary supplementation with arginine has been shown to benefit these patients by reducing the growth of transplantable tumors, the incidence of metastases, and the tumor-producing potential of carcinogens. However, results observed in humans have given rise to controversy regarding the optimal dosage of arginine supplementation and the types of cancer best treated with amino acids. Further prospective and randomized studies will be necessary in order to determine the proper utilization and the therapeutic benefits of such dietary supplementation.

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