A rapid evidence assessment of recent therapeutic touch research.

AIM: To synthesize the most recent evidence investigating the effectiveness and safety of therapeutic touch as a complementary therapy in clinical health applications. DESIGN: A rapid evidence assessment (REA) approach was used to review recent TT research adopting PRISMA 2009 guidelines. METHODS: CINAHL, PubMed, MEDLINE, Cochrane databases, Web of Science, PsychINFO and Google Scholar were screened between January 2009-March 2020 for studies exploring TT therapies as an intervention. The main outcome measures were for pain, anxiety, sleep, nausea and functional improvement. RESULTS: Twenty-one studies covering a range of clinical issues were identified, including 15 randomized-controlled trials, four quasi-experimental studies, one chart review study and one mixed methods study including 1,302 patients. Eighteen of the studies reported positive outcomes. Only four exhibited a low risk of bias. All others had serious methodological flaws, bias issues, were statistically underpowered and scored as low-quality studies. No high-quality evidence was found for any of the benefits claimed.

Ethical issues on the "synthetic" phosphoethanolamine clinical trial.

Notwithstanding its approval by the National Committee for Ethics in Research (Conep) on April 19, 2016, a trial of the so-called "synthetic" phosphoethanolamine (syn-phospho) pill in cancer patients raises ethical concerns. An analysis by a laboratory contracted by the Ministry of Science, Technology and Innovation (MCTI) revealed that syn-phospho contained a great amount of impurities and did not meet standards of pharmaceutical quality required for an investigational drug. Cytotoxicity against human tumor cell lines and in vivo rodent xenograft tumor assays consistently failed to demonstrate a potential anticancer activity of syn-phospho. Preclinical safety studies of syn-phospho were also insufficient to support a trial of this investigational drug in cancer patients. Moreover, the ethical approval decision apparently overlooked two previous findings that suggested a possible enhancement of mammary carcinoma cell proliferation by phosphoethanolamine, and an apparent increase in lung metastases (rat implanted tumor assay) by syn-phospho. The syn-phospho risk-benefit ratio is clearly unfavorable and, thus, this trial in cancer patients does not fulfill a key requirement to make a clinical research ethical. There are also concerns regarding whether the study design is robust enough (scientific validity), and the social value of the trial of syn-phospho in cancer patients is questionable.

Ethical issues on the "synthetic" phosphoethanolamine clinical trial / Questões éticas sobre o ensaio clínico da fosfoetanolamina "sintética"

Summary Notwithstanding its approval by the National Committee for Ethics in Research (Conep) on April 19, 2016, a trial of the so-called "synthetic" phosphoethanolamine (syn-phospho) pill in cancer patients raises ethical concerns. An analysis by a laboratory contracted by the Ministry of Science, Technology and Innovation (MCTI) revealed that syn-phospho contained a great amount of impurities and did not meet standards of pharmaceutical quality required for an investigational drug. Cytotoxicity against human tumor cell lines and in vivo rodent xenograft tumor assays consistently failed to demonstrate a potential anticancer activity of syn-phospho. Preclinical safety studies of syn-phospho were also insufficient to support a trial of this investigational drug in cancer patients. Moreover, the ethical approval decision apparently overlooked two previous findings that suggested a possible enhancement of mammary carcinoma cell proliferation by phosphoethanolamine, and an apparent increase in lung metastases (rat implanted tumor assay) by syn-phospho. The syn-phospho risk-benefit ratio is clearly unfavorable and, thus, this trial in cancer patients does not fulfill a key requirement to make a clinical research ethical. There are also concerns regarding whether the study design is robust enough (scientific validity), and the social value of the trial of syn-phospho in cancer patients is questionable.

Resumo Não obstante a sua aprovação pela Comissão Nacional de Ética em Pesquisa (Conep) em 19 de abril de 2016, um ensaio da pílula de fosfoetanolamina "sintética" (sin-fosfo) em pacientes com câncer levanta preocupações éticas. Uma análise feita por um laboratório contratado pelo Ministério da Ciência, Tecnologia e Inovação (MCTI) revelou que a sin-fosfo continha grande quantidade de impurezas e não satisfazia os padrões de qualidade farmacêutica exigidos para um medicamento experimental. Os ensaios de citotoxicidade com linhagens de células originárias de tumores humanos e testes in vivo em roedores com tumores xeno-enxertados falharam consistentemente em demonstrar uma potencial atividade anticâncer da sin-fosfo. Os estudos pré-clínicos de segurança da sin-fosfo também foram insuficientes para apoiar a realização de um ensaio desse medicamento experimental em pacientes com câncer. Além disso, a aprovação ética aparentemente desconsiderou dois achados anteriores, sugerindo uma possível exacerbação da proliferação de células de carcinoma de mama pela fosfoetanolamina, e um aparente aumento de metástases pulmonares (ensaio de tumores implantados em ratos) pela sin-fosfo. A relação risco-benefício é claramente desfavorável para a sin-fosfo e, portanto, esse ensaio em pacientes com câncer não atende um requisito essencial para que uma pesquisa clínica seja ética. Há também preocupações quanto ao delineamento do estudo ser suficientemente robusto (validade interna), e o valor social do ensaio da sin-fosfo em pacientes com câncer é questionável.

Evaluación clínica y funcional de pacientes con parálisis de Bell tratados con láser / Clinical and functional evaluation of patients with Bell´s palsy treated with laser

Se realizó una intervención terapéutica, multicéntrica, de 88 pacientes con parálisis de Bell tratados con láser en los servicios de rehabilitación de los policlínicos Julián Grimau, Ramón López Peña y 28 de Septiembre de Santiago de Cuba, desde enero de 2013 hasta diciembre 2014, para determinar la eficacia de este proceder según la evolución clínica y funcional de los afectados. La muestra aleatoria fue dividida en 2 grupos con 44 integrantes cada uno: los del grupo control recibieron magnetoterapia; los del grupo de estudio, láser en puntos locales y a distancia, para lo cual se empleó la estadística descriptiva, así como las pruebas T de Student, Mann Whitney, Ji al cuadrado de homogeneidad y de Pearson. Predominaron las féminas vinculadas laboralmente (76,1 por ciento) y las edades comprendidas entre 25 y 34 años (46,6 por ciento). En los tratados con láser prevalecieron los tiempos rápidos de respuesta con evolución satisfactoria y no hubo complicaciones. Se concluye que el láser de baja potencia es una modalidad no invasiva y eficaz, capaz de modificar parámetros clínicos y funcionales en corto tiempo, de modo que constituye una opción terapéutica válida(AU)

A multicenter therapeutical intervention of 88 patients with Bell´s palsy treated with laser in the rehabilitation services of Julián Grimau, Ramón López Peña and 28 de Septiembre polyclinics in Santiago de Cuba, was carried out from January, 2013 to December, 2014, to determine the effectiveness of this procedure according to the functional and clinical course from those affected. The random sample was divided in 2 groups with 44 members each: those from the control group received magnetotherapy; those from the study group, laser in local points and laser at distance, for which the descriptive statistic was used, as well as Student´s t, Mann Whitney, homogeneity chi-squared and Pearson tests. There was a prevalence of working women (76.1 percent) and the ages between 25 and 34 (46.6 percent). In those treated with laser the response quick times prevailed, with satisfactory clinical course and there were no complications. As a conclusion: low power laser is a non invasive and effective modality, able to modify clinical and functional parameters in short time, so it constitutes a valid therapeutic option(AU)

Examination regarding the tolerability of the homochord Acidum L(+)-lacticum at a dosage of sixty drops three times daily

In Germany, the commission D recommends in its current dosage guidelines from March 17, 2004, that homeopathic dilutions higher than 24x will be prescribed in a daily application of five drops once. This recommendation is decisive for the German Regulatory Authority. Even though the homochord Acidum L(+)-lacticum 4x/6x/12x/30x/200x contains dilutions above 24x, it is commonly used in clinical practice for over 30 years in a dosage of 60 drops three times daily. In order to explore the clinical safety and tolerability of Acidum L(+)-lacticum 4x/6x/12x/30x/200x at a dosage of 60 drops three times daily, as well as lower dosages, a therapist survey was designed to address the questions. Highly experienced and licensed therapists, including general and alternative practitioners, reported their usual dosage of homochord, incidences of drug reactions, initial homeopathic aggravations as well as the diagnoses that led to the prescription of Acidum L(+)-lacticum 4x/6x/12x/30x/200x. 167 therapist responses were analyzed. Only four therapists reported occurrences that classify as initial aggravation, (2.40 %), compared to 159 with no incidences (95.21 %). Four therapists made no statement. Nevertheless, there were no adverse drug reactions documented in the survey. Consequently, Acidum L(+)-lacticum 4x/6x/12x/30x/200x at a dosage of 60 drops three times daily or lower dosages may be construed to be clinically tolerable and safe. This evidence might lead to further re-evaluations of other homochords, and rigorous clinical trials for its safety and tolerability...

Examination regarding the tolerability of the homochord Acidum L(+)-lacticum at a dosage of sixty drops three times daily

In Germany, the commission D recommends in its current dosage guidelines from March 17, 2004, that homeopathic dilutions higher than 24x will be prescribed in a daily application of five drops once. This recommendation is decisive for the German Regulatory Authority. Even though the homochord Acidum L(+)-lacticum 4x/6x/12x/30x/200x contains dilutions above 24x, it is commonly used in clinical practice for over 30 years in a dosage of 60 drops three times daily. In order to explore the clinical safety and tolerability of Acidum L(+)-lacticum 4x/6x/12x/30x/200x at a dosage of 60 drops three times daily, as well as lower dosages, a therapist survey was designed to address the questions. Highly experienced and licensed therapists, including general and alternative practitioners, reported their usual dosage of homochord, incidences of drug reactions, initial homeopathic aggravations as well as the diagnoses that led to the prescription of Acidum L(+)-lacticum 4x/6x/12x/30x/200x. 167 therapist responses were analyzed. Only four therapists reported occurrences that classify as initial aggravation, (2.40 %), compared to 159 with no incidences (95.21 %). Four therapists made no statement. Nevertheless, there were no adverse drug reactions documented in the survey. Consequently, Acidum L(+)-lacticum 4x/6x/12x/30x/200x at a dosage of 60 drops three times daily or lower dosages may be construed to be clinically tolerable and safe. This evidence might lead to further re-evaluations of other homochords, and rigorous clinical trials for its safety and tolerability. (AU)

Estimating the absorption of soil-derived uranium in humans.

The aim of the present study was to improve the estimation of soil-derived uranium absorption in humans. For this purpose, an in vitro solubility assay was combined with a human study by using a specific edible soil low in uranium. The mean bioaccessibility of the soil-derived uranium, determined by the solubility assay in artificial gastrointestinal fluid, was found to be 7.7% with a standard deviation of 0.2%. The corresponding bioavailability of the soil-derived uranium in humans was assumed to be log-normal distributed with a geometric mean of 0.04% and a 95% confidence interval ranging from 0.0049% to 0.34%. Both results were used to calculate a factor, denoted as fA(sol), which describes the relation between the bioaccessibility and the bioavailability of soil-derived uranium. The geometric mean of fA(sol) was determined to be 0.53% with a 95% confidence interval ranging from 0.06% to 4.43%. Based on fA(sol), it is possible to estimate more realistic values on the bioavailability of uranium for highly uranium-contaminated soils in humans by just performing the applied solubility assay. The results of this study can be further used to obtain more reliable results on the internal dose assessment of ingested highly uranium-contaminated soils.

Carbohydrate supplementation and prolonged intermittent high-intensity exercise in adolescents: research findings, ethical issues and suggestions for the future.

In the last decade, research has begun to investigate the efficacy of carbohydrate supplementation for improving aspects of physical capacity and skill performance during sport-specific exercise in adolescent team games players. This research remains in its infancy, and further study would be beneficial considering the large youth population actively involved in team games. Literature on the influence of carbohydrate supplementation on skill performance is scarce, limited to shooting accuracy in adolescent basketball players and conflicting in its findings. Between-study differences in the exercise protocol, volume of fluid and carbohydrate consumed, use of prior fatiguing exercise and timing of skill tests may contribute to the different findings. Conversely, initial data supports carbohydrate supplementation in solution and gel form for improving intermittent endurance running capacity following soccer-specific shuttle running. These studies produced reliable data, but were subject to limitations including lack of quantification of the metabolic response of participants, limited generalization of data due to narrow participant age and maturation ranges, use of males and females within the same sample and non-standardized pre-exercise nutritional status between participants. There is a lack of consensus regarding the influence of frequently consuming carbohydrate-containing products on tooth enamel erosion and the development of obesity or being overweight in adolescent athletes and non-athletes. These discrepancies mean that the initiation or exacerbation of health issues due to frequent consumption of carbohydrate-containing products by adolescents cannot be conclusively refuted. Coupled with the knowledge that consuming a natural, high-carbohydrate diet -3-8 hours before exercise can significantly alter substrate use and improve exercise performance in adults, a moral and ethical concern is raised regarding the direction of future research in order to further knowledge while safeguarding the health and well-being of young participants. It could be deemed unethical to continue study into carbohydrate supplementation while ignoring the potential health concerns and the possibility of generating similar performance enhancements using natural dietary interventions. Therefore, future work should investigate the influence of pre-exercise dietary intake on the prolonged intermittent, high-intensity exercise performance of adolescents. This would enable quantification of whether pre-exercise nutrition can modulate exercise performance and, if so, the optimum dietary composition to achieve this. Research could then combine this knowledge with ingestion of carbohydrate-containing products during exercise to facilitate ethical and healthy nutritional guidelines for enhancing the exercise performance of adolescents. This article addresses the available evidence regarding carbohydrate supplementation and prolonged intermittent, high-intensity exercise in adolescent team games players. It discusses the potential health concerns associated with the frequent use of carbohydrate-containing products by adolescents and how this affects the research ethics of the field, and considers directions for future work.

The first systematic experimentation in music therapy: the genius of James Leonard Corning.

BACKGROUND: The development of music therapy in the United States prior to 1950 has a fascinating but not well known history. The present study illuminates the music therapy research of James Leonard Corning (1855-1923), a prominent neurologist practicing during the late nineteenth-century in New York City. OBJECTIVE: The purpose of this study was to provide biographical information and description of a series of music therapy experiments conducted by Corning. His 1899 article appearing in the Medical Record: A Weekly Journal of Medicine and Surgery summarized a series of inventive experiments using music to affect emotional states in people with mild behavioral-emotional and sleep disorders. METHODS: Information was analyzed using a set of primary and secondary sources from contemporaneous books, newspapers and journals. These sources provided biographical information and insight into his experimental methods. Recent sources provided a framework to help understand his conclusions from the viewpoint of late nineteenth-century physicians and for current practitioners of music therapy. RESULTS: Findings indicate that Corning's rationale for using music, visual figures and, occasional medication in the treatment of behavioral-emotional disorders was successful in influencing feelings and emotions in a positive way. He believed that during pre-sleep and sleep, cognitive processes became dormant, allowing the penetration of "musical vibrations" into the subconscious eliminating morbid thoughts that plagued his patients. CONCLUSIONS: Understanding Corning's contributions to music therapy will assist contemporary educators and therapists to better understand the impact of early contributions to music therapy by late nineteenth-century practitioners such as Corning.

Pesquisa médica em seres humanos, não maleficência e autoexperimentação homeopática / Medical research in humans, non-maleficence and homeopathic self-experimentation

Este artigo, de natureza conceitual, objetiva estabelecer conexão entre a pesquisa médica em seres humanos, a não maleficência e a autoexperimentação homeopática. A pesquisa médica em seres humanos, geralmente realizada no outro, tem sido permeada de expressivos abusos em relação aos sujeitos participantes. É neste contexto que emerge a não maleficência, princípio ético básico limitante destas violaçães. A não maleficência é o pressuposto que deve nortear as decisães no campo da pesquisa médica, representando sua inocuidade ou moderação. No que tange ao sujeito que experimenta, a investigação no ser humano pode ser conduzida, também, como autoexperimentação, ou seja, como experimentação realizada em si mesmo. A autoexperimentação, de grande valor em diferentes áreas da medicina, é denominada, na homeopatia, de autoexperimentação homeopática. A autoexperimentação homeopática é dotada de importantes características não maleficentes, o que a torna prática ética segura, viável, reproduzível e consistente da pesquisa médica terapêutica em seres humanos.

American Chemical Society - 240th national meeting - chemistry for preventing and combating disease: part 1.

The 240th National Meeting of the American Chemical Society, held in Boston, included topics covering new therapeutic research. This conference report highlights selected presentations on negative allosteric modulators of metabotropic glutamate receptor 5 (mGluR5) for the treatment of Parkinson's disease, BACE1 inhibitors and γ-secretase inhibitors for the prevention or treatment of Alzheimer's disease, opioid modulators for the treatment of reward disorders, SGLT2 inhibitors for the treatment of diabetes, backup compounds to the DPP-4 inhibitor sitagliptin (Januvia) for type 2 diabetes, and MCH R1 inhibitors for the treatment of obesity. Investigational drugs discussed include SCH-1359113 and SCH-1682496 (both Merck & Co), NGP-555 (NeuroGenetic Pharmaceuticals), ALKS-33 (Alkermes), dapagliflozin (Bristol-Myers Squibb/AstraZeneca) and GSK-882380 (GlaxoSmithKline).

Oficinas expressivas: uma inclusão de singularidades / Expressive ateliers: an inclusion of singularities / Ateliers expressifs: une inclusion des singularités / Oficinas expresivas: una inclusión de singularidades

Este artigo pretende fazer uma reflexão crítica sobre as atividades artísticas realizadas nos serviços de saúde mental e nos diversos espaços sociais. Inicialmente, contextualiza-se como a loucura tem sido percebida socialmente, como o trabalho tem sido visto na forma de tratamento moral e como a assistência psiquiátrica modificou-se no decorrer da história. A seguir, problematizam-se as formas ainda exclusoras de realizar oficinas terapêuticas apenas em serviços de saúde mental e unicamente com a participação de pessoas que possuem transtornos mentais. Questiona-se também a clínica tradicional e cronificante. Discute-se, ainda, a segregação daqueles que desviam da serialização de subjetividades impostas pela sociedade de controle. As atividades expressivas propõem a inclusão de múltiplas singularidades. Além disso, busca-se um acolhimento às diversas formas de linguagem, não apenas aquelas restritas ao verbal, e a circulação de afetos e de produções artísticas em diversos territórios comunitários

This article intends to make a critical reflection on the artistic activities accomplished in mental health services, and in many social spaces. Initially, it's contextualized how mental illness has been perceived in society, how the work seemed to be a moral treatment, and how the psychiatric assistance has been modified through history. Following, we consider the still excludent forms of accomplishing therapeutical workshops only in services of mental health, and with the exclusive participation of people with mental disturbances. The traditional and chronifying clinical practice is also questioned. Another discussion is about the segregation of people who deviate from the serialization of subjectivities imposed by a society of control. Expressive activities consider the inclusion of multiple singularities. Moreover, there is a search for a way of sheltering the multiple forms of language, not only those restricted to the verbal one, and the circulation of affection and artistic productions in different communitarian territories

Cet article vise à faire une réflexion critique sur les activités artistiques réalisées dans les services de santé mentale et dans divers espaces sociaux. Initialement, on contextualize comme la folie a été perçue socialement, comme le travail a été vu sous la forme de traitement moral et comme l'assistance psychiatrique s'est modifiée pendant l'histoire. À suivre, on pose quéstion sur les formes d'ateliers thérapeutiques qui encore excluent les personnes, dans la mesure où ils sont realisés seulement dans services de santé mentale et seulement avec la participation de personnes qui souffrent de bouleversements mentaux. On discute aussi la clinique traditionnelle et chronifiée et la ségrégation des personnes qui dévient de la serialization de la subjectivité imposée par la société de contrôle. Les activités expressives proposent l'inclusion de multiples singularités. En outre, on cherche accueillir les diverses formes de langage - non seulement celles-là restreintes au verbal - et permettre la circulation d'affections et de productions artistiques dans divers territoires communautaires

Este articulo pretende hacer una reflexión sobre las actividades artísticas realizadas en los servicios de salud mental y en los diversos espacios sociales. Inicialmente, se contextualiza como la locura ha sido percibida socialmente, como el trabajo en la forma de tratamiento moral y como la asistencia psiquiátrica se ha modificado en el recorrer de la historia. A seguir se problematizan las formas todavía exclusoras de realizar oficinas terapéuticas solo en servicios de salud mental y solamente con la participación de personas que tienen trastornos mentales. Se cuestiona, aún, la clínica tradicional y cronificante. Se discute, todavía, la segregación de los que desvían de la socialización de subjetividades impuestas por la sociedad de control. Las actividades expresivas proponen la inclusión de múltiples singularidades. Fuera de eso, se busca un acogimiento a las diversas formas de lenguaje, no solo aquellas restrictas al verbal, pero también a la circulación de afectos y producciones artísticas en diversos territorios comunitarios

Oficinas expressivas: uma inclusão de singularidades / Expressive ateliers: an inclusion of singularities / Ateliers expressifs: une inclusion des singularités / Oficinas expresivas: una inclusión de singularidades

Este artigo pretende fazer uma reflexão crítica sobre as atividades artísticas realizadas nos serviços de saúde mental e nos diversos espaços sociais. Inicialmente, contextualiza-se como a loucura tem sido percebida socialmente, como o trabalho tem sido visto na forma de tratamento moral e como a assistência psiquiátrica modificou-se no decorrer da história. A seguir, problematizam-se as formas ainda exclusoras de realizar oficinas terapêuticas apenas em serviços de saúde mental e unicamente com a participação de pessoas que possuem transtornos mentais. Questiona-se também a clínica tradicional e cronificante. Discute-se, ainda, a segregação daqueles que desviam da serialização de subjetividades impostas pela sociedade de controle. As atividades expressivas propõem a inclusão de múltiplas singularidades. Além disso, busca-se um acolhimento às diversas formas de linguagem, não apenas aquelas restritas ao verbal, e a circulação de afetos e de produções artísticas em diversos territórios comunitários(AU)

This article intends to make a critical reflection on the artistic activities accomplished in mental health services, and in many social spaces. Initially, it's contextualized how mental illness has been perceived in society, how the work seemed to be a moral treatment, and how the psychiatric assistance has been modified through history. Following, we consider the still excludent forms of accomplishing therapeutical workshops only in services of mental health, and with the exclusive participation of people with mental disturbances. The traditional and chronifying clinical practice is also questioned. Another discussion is about the segregation of people who deviate from the serialization of subjectivities imposed by a society of control. Expressive activities consider the inclusion of multiple singularities. Moreover, there is a search for a way of sheltering the multiple forms of language, not only those restricted to the verbal one, and the circulation of affection and artistic productions in different communitarian territories(AU)

Cet article vise à faire une réflexion critique sur les activités artistiques réalisées dans les services de santé mentale et dans divers espaces sociaux. Initialement, on contextualize comme la folie a été perçue socialement, comme le travail a été vu sous la forme de traitement moral et comme l'assistance psychiatrique s'est modifiée pendant l'histoire. À suivre, on pose quéstion sur les formes d'ateliers thérapeutiques qui encore excluent les personnes, dans la mesure où ils sont realisés seulement dans services de santé mentale et seulement avec la participation de personnes qui souffrent de bouleversements mentaux. On discute aussi la clinique traditionnelle et chronifiée et la ségrégation des personnes qui dévient de la serialization de la subjectivité imposée par la société de contrôle. Les activités expressives proposent l'inclusion de multiples singularités. En outre, on cherche accueillir les diverses formes de langage - non seulement celles-là restreintes au verbal - et permettre la circulation d'affections et de productions artistiques dans divers territoires communautaires(AU)

Este articulo pretende hacer una reflexión sobre las actividades artísticas realizadas en los servicios de salud mental y en los diversos espacios sociales. Inicialmente, se contextualiza como la locura ha sido percibida socialmente, como el trabajo en la forma de tratamiento moral y como la asistencia psiquiátrica se ha modificado en el recorrer de la historia. A seguir se problematizan las formas todavía exclusoras de realizar oficinas terapéuticas solo en servicios de salud mental y solamente con la participación de personas que tienen trastornos mentales. Se cuestiona, aún, la clínica tradicional y cronificante. Se discute, todavía, la segregación de los que desvían de la socialización de subjetividades impuestas por la sociedad de control. Las actividades expresivas proponen la inclusión de múltiples singularidades. Fuera de eso, se busca un acogimiento a las diversas formas de lenguaje, no solo aquellas restrictas al verbal, pero también a la circulación de afectos y producciones artísticas en diversos territorios comunitarios(AU)

Current regulatory perspectives on genotoxicity testing for botanical drug product development in the U.S.A.

Genotoxicity testing is an important part of preclinical safety assessment of new drugs and is required prior to Phase I/II clinical trials. It is designed to detect genetic damage such as gene mutations and chromosomal aberration, which may be reflected in tumorigenic or heritable mutation potential of the drug. Botanical new drugs in the U.S. are entitled to a waiver for preclinical pharmacology/toxicology studies, including genotoxicity testing, in support of an initial clinical trial under IND, contingent on previous human experience. Recently, ethical concerns have been raised over conducting Phase I/II clinical trials of new drugs with positive genotoxicity findings in healthy volunteers. Although the relevance of this issue to patients, as opposed to healthy volunteers, depends on the drug's indication, duration of treatment, and specific findings related to the assays, the regulatory view is to avoid exposing patients to genotoxic compounds unnecessarily in clinical trials. This philosophy may impact on herbal supplement marketing and botanical drug development, in that genotoxicity data are often lacking while consumers are exposed to the herbal supplement, or healthy volunteers are tested in an initial Phase I/II clinical trial on the botanical drug. This paper presents results of a survey conducted on genotoxicity data in botanical INDs submitted to the Agency and discusses the significance of this information. The information presented indicates that the sponsors of botanical INDs have increasingly recognized the importance of genotoxicity information and may have prioritized its acquisition in their strategic drug development programs.

Sala de professores em instalação: considerações sobre a vivência estética na formação de educadores / Teachers' lounge in installation: considerations on the aesthetic grasp of living experience in the formation of teachers / Sala de profesores en instalación: consideraciones sobre la vivencia estética enla formación de educadores

A oficina com recursos expressivos e apresentada neste artigo como um método de formação contínua para profissionais da educação. Através da vivência estética foram problematizadas questões organizacionais, técnico-profissionais e pessoais pertinentes à organizaçãodo trabalho educativo, relacionando-as à estruturação de práticas pedagógicas inseridas no contexto específico de cada escola. Para a análise desta temática, foi realizada pesquisa participante em grupo com diferentes segmentos de trabalhadores de uma escola pública municipal de São Paulo. A ontologia de Martin Heidegger ofereceu suporte teórico e metodológico para a estruturação das oficinas e análise das produções estéticas. As considerações de Hannah Arendt sobre a crise da educação na América nortearam a compreensão a respeito da diluição da tradição e seus reflexos sobre a desvalorização da profissão docente. A leitura de Bachelard e Baudrillard, dentre outros, abriu possibilidades de superação dessa problemática, através do desvelamento da dimensão poética do espaço de trabalho. Para os participantes, as oficinas com recursos expressivos constituiram-se em um trabalho de alicerce, a partir da reflexão e construção de novos sentidos para o fazer educativo, evidenciando-se o caráter político e pedagógico da vivência estética

The workshop with expressive recourses is herein presented as a method of continous formation of professionals in the field of education. Through the aesthetic grasp of livind experience, organizational, techcnical-professional and personal matters were questioned, pertaining to the organization of the educational chores, relating them to the structuralization of pedagogical practices inserted in the specific context of each school. For analyzing such theme, participant research was carried out in group of workes of different segments of the public-school net of the state of São Paulo. Marting Heidegger's ontology offered the theoretical and methodological supports of the aesthetical production. Hannah Arendt's considerations on the educational crisis in the Americas set north to understanding the dilution of the tradition and its consequences on the devaluation of the teaching professionals. The reading of Bachelard and Baudrillard, among others, opened the possibilities for overcoming this problem through the revelation of the poetic dimension of the working space. For the participants, the workshops with expressive recourses were a foundation-laying activity from the reflection and construction of new feelings towards the educational deeds, evidencing the political and pedagogical character of the aesthetic grasp of living experience.

Sala de professores em instalação: considerações sobre a vivência estética na formação de educadores / Teachers' lounge in installation: considerations on the aesthetic grasp of living experience in the formation of teachers / Sala de profesores en instalación: consideraciones sobre la vivencia estética enla formación de educadores

A oficina com recursos expressivos e apresentada neste artigo como um método de formação contínua para profissionais da educação. Através da vivência estética foram problematizadas questões organizacionais, técnico-profissionais e pessoais pertinentes à organizaçãodo trabalho educativo, relacionando-as à estruturação de práticas pedagógicas inseridas no contexto específico de cada escola. Para a análise desta temática, foi realizada pesquisa participante em grupo com diferentes segmentos de trabalhadores de uma escola pública municipal de São Paulo. A ontologia de Martin Heidegger ofereceu suporte teórico e metodológico para a estruturação das oficinas e análise das produções estéticas. As considerações de Hannah Arendt sobre a crise da educação na América nortearam a compreensão a respeito da diluição da tradição e seus reflexos sobre a desvalorização da profissão docente. A leitura de Bachelard e Baudrillard, dentre outros, abriu possibilidades de superação dessa problemática, através do desvelamento da dimensão poética do espaço de trabalho. Para os participantes, as oficinas com recursos expressivos constituiram-se em um trabalho de alicerce, a partir da reflexão e construção de novos sentidos para o fazer educativo, evidenciando-se o caráter político e pedagógico da vivência estética (AU)

The workshop with expressive recourses is herein presented as a method of continous formation of professionals in the field of education. Through the aesthetic grasp of livind experience, organizational, techcnical-professional and personal matters were questioned, pertaining to the organization of the educational chores, relating them to the structuralization of pedagogical practices inserted in the specific context of each school. For analyzing such theme, participant research was carried out in group of workes of different segments of the public-school net of the state of São Paulo. Marting Heidegger's ontology offered the theoretical and methodological supports of the aesthetical production. Hannah Arendt's considerations on the educational crisis in the Americas set north to understanding the dilution of the tradition and its consequences on the devaluation of the teaching professionals. The reading of Bachelard and Baudrillard, among others, opened the possibilities for overcoming this problem through the revelation of the poetic dimension of the working space. For the participants, the workshops with expressive recourses were a foundation-laying activity from the reflection and construction of new feelings towards the educational deeds, evidencing the political and pedagogical character of the aesthetic grasp of living experience. (AU)

Bioética: a ética da vida sob múltiplos olhares / Bioethics: the ethics of life in multiple views

Ao defender que o princípio de toda ética deve ser a reverência pela vida, o filósofo e humanista Albert Schweitzer descola o foco da ética tradicional, limitada ao aspecto das relações humanas, para uma posição de abrangência global que envolve todas as formas de vida, nelas incluída a própria natureza.Inspirado pelas ideias de Schweitzer e observando que o atual crescimento científico nem sempre é acompanhado em igual proporção pelo florescimento da ética na humanidade, Van Rensselaer Potter propõe, em 1971, o termo Bioética e enfatiza a necessidade premente de se procurar uma nova conduta, formada a partir de dois componentes que devem ficar inseparáveis: o conhecimento técnico-biológico e a promoção dos valores humanos.Hoje, quando é extrema a rapidez com que a ciência e a tecnologia se desenvolvem sem que haja a correspondente expansão dos processos éticos, torna-se indispensável que a Bioética passe a permear todos os outros saberes. Neste livro, olhares que se originam de múltiplas ciências confirmam a necessidade dessa presença em vários aspectos da vida cotidiana e trazem a experiência de pessoas que procuram aplicar em suas áreas de atuação a essência do pensamento bioético: a busca e o uso do conhecimento técnico-científico embasados numa conduta ética...