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Psychedelics are a group of psychoactive substances which produce complex and subjective changes to consciousness and carry unique safety considerations. There is a growing body of work investigating the use of psychedelics for mental health treatment alongside increasing socio-cultural and political acceptance. This rapid evolution has prompted corporations to fund psychedelic clinical trials, leading to a potential rise in conflicts of interest in relevant studies and publications. However, the body of evidence for the safety and efficacy of psychedelic-assisted psychotherapy for psychiatric illnesses is early. There is concern regarding the introduction of bias in psychedelic clinical trials and the selective reporting of results amidst and beyond corporate involvement. At a crucial time in psychedelic drug reform, this paper explores the safety concerns associated with psychedelics, the potential influences of financial stakeholders on safety outcome reporting and the importance of balanced science communication in maintaining public health and safety.
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INTRODUCTION: Chronic myeloid leukemia (CML) is a clonal myeloproliferative disorder characterized by the Philadelphia (Ph) chromosome. After the introduction of imatinib mesylate (IM) in 2000, the natural history of the disease changed. Data on the treatment of CML with IM are from randomized clinical trials. Establishing whether these results can be reproduced or if caution is needed when extrapolating data to the general population with CML is essential. OBJECTIVES: To evaluate the molecular response (MR) in patients with chronic-phase CML (CML-CP) not included in clinical studies and correlate them with the responses obtained in clinical trials. METHODS: Between January 2007 and January 2017, 227 patients newly diagnosed with CML-CP treated with IM as first-line treatment were included. This study is an observational, retrospective, and single-center study. RESULTS: At a median follow-up time of 7.3 years, 60.3% of the 227 patients who started IM were still on IM. Early molecular response (EMR) at 3 and 6 months was achieved by 74.2% and 65%, respectively. The median time to a MMR was nine months. The MR4.0 and MR4.5 were 67.2% and 51.1%, respectively. The overall survival (OS), progression-free survival (PFS), and event-free survival (EFS) of the patients who exclusively used IM were 91%, 91%, and 85.1%, respectively. CONCLUSION: The results presented are similar to those described in prospective and randomized trials, demonstrating that the outcomes are reproducible in the real world. EMR at 3 and 6 months reflects better long-term responses, including higher rates of deeper molecular responses. Considering treatment costs, the absence of literature evidence of an impact on overall survival demonstrated by first-line second-generation tyrosine kinase inhibitors (TKIs), and the global OS of 85.8%, imatinib mesylate (IM) is still an excellent therapeutic option.
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Antineoplásicos , Leucemia Mielogênica Crônica BCR-ABL Positiva , Humanos , Mesilato de Imatinib/uso terapêutico , Estudos Retrospectivos , Estudos Prospectivos , Resultado do Tratamento , Inibidores de Proteínas Quinases/uso terapêutico , Leucemia Mielogênica Crônica BCR-ABL Positiva/tratamento farmacológico , Cromossomo Filadélfia , Antineoplásicos/uso terapêutico , Proteínas de Fusão bcr-abl/genéticaRESUMO
Background: Confidence in the results reported by randomized clinical trials (RCTs) depends mainly on the internal validity of the trial and its conduct, but also on other aspects related to health research such as the complete reporting of conflicts of interest (COI), funding sources and approval by ethics committees. Bias in the study results may arise from any one of these elements. Prior studies have explored the reporting of these items in the medical literature, but there are no reports on RCTs published in Spanish and Latin American journals. This study aimed to evaluate the reporting of COIs, funding sources, and approval by ethics committees of RCTs published in Spanish and Latin American journals in dentistry, geriatrics and neurology. Methods: We did a systematic retrospective survey of all RCTs published from 1990 to 2018 in dentistry, neurology, and geriatrics journals published in Spain and Latin America and included in the BADERI database (Iberoamerican journals and trials database by its initials in Spanish). We completed with hand searching. We included RCTs with a recoverable full text published between 1990 and 2018. We extracted data on sources of funding, COI statements, and ethics reviews. The extraction of these items in the RCTs included was done independently by two pairs of reviewers and in parallel for each article, with a third independent reviewer resolving discrepancies. We analysed compliance for each item. Results: We identified RCTs in 69 journals from Spain and Latin American countries. Dentistry accounted for 75% (n = 52) of the journals, neurology 20.6% (n = 14), and geriatrics 4.4% (n = 3). Of the total number of RCTs included in this study (n = 392), only 102 (26%) reported the presence or absence of a COI, 103 (26%) studies reported funding, and 43 (36%) included the ethics committee approval. Conclusions: RCTs published in the Spanish language in dentistry, neurology, and geriatrics had poor compliance with the reporting of a COI, source of funding, and ethics committee approval. Future research should evaluate the accuracy and completeness of COI statements and their relationship to the funding source and direction of the results.
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Humanos , Publicações Seriadas , Conflito de Interesses , Comissão de Ética , Fontes de Financiamento de Pesquisa , Espanha , Odontologia , Geriatria , América Latina , NeurologiaRESUMO
En Medicina, intereses enfrentados a los valoressuperiores que sustentan su práctica con frecuencia nossumergen en desafíos éticos que debemos afrontar: Entretales intereses destacan los de carácter político, económico ymediático. En el presente ensayo se presentan y discuten trescasos de relevancia histórica y se analizan las cuestiones moralesconcernientes a cada uno(AU)
In medicine, interests opposed to the higher values that support its practice oîen immerse us in ethical challengesthat we must face: Among such interests, those of a political,economic and media nature stand out. In this essay three casesof historical relevance are presented and discussed and the moralquestions concerning each one are analyzed(AU)
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Conflito de Interesses , Ética Profissional , Política , Medicina Geral , Categorias de TrabalhadoresRESUMO
OBJECTIVES: The Chilean health system mandates providers to ensure assistance under a guaranteed system, the Explicit Guarantees in Healthcare (EGH) program. The Health Ministry has developed clinical practice guidelines (CPGs), but independent assessment of their quality is lacking. STUDY DESIGN AND SETTING: We assessed all CPGs of the EGH program using Appraisal of Guidelines for Research & Evaluation II (AGREE II) tool for appraising quality, validity period, and last update. RESULTS: Eighty-six CPGs were published between 2005 and 2016. Only 15 (17.4%) were updated. The overall mean raw score was 4.18 (±0.98). The scaled scores for each domain were: Scope and objectives 79.7%, Stakeholder involvement 46.2%, Rigor of development 36.3%, Clarity of presentation 82.8%, Applicability 23.5%, and Editorial independence 39.2%. The highest items were: overall objectives described, population described, options for management clearly presented, and key recommendations easily identifiable. The worst evaluated items were: views and preferences of the target population, strengths and limitations of the body of evidence, methods for formulating the recommendations, external review by experts, and description of facilitators and barriers to application. CONCLUSION: Most Chilean CPGs included in the EGH program are outdated and show items that should be improved, mainly through a more rigorous methodology, the inclusion of patients in its development, and appropriate consideration of its applicability.
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Países em Desenvolvimento , Programas Nacionais de Saúde , Guias de Prática Clínica como Assunto/normas , Chile , Estudos Transversais , Humanos , Melhoria de Qualidade , Reprodutibilidade dos Testes , Participação dos InteressadosRESUMO
PURPOSE: Because financial conflicts of interest (FCOIs) may potentially influence patient care, hospital drug formularies, and treatment guidelines, it is important that these are disclosed. The purpose of this observational study was to quantify the changes in FCOI among U.S.-based academic authors in industry-sponsored oncology trials after a high-impact publication. METHODS: A list of all U.S.-based academic authors (authors) of industry-sponsored solid tumor clinical trials published between August 1, 2014, and December 31, 2015, in 6 high-impact journals (New England Journal of Medicine, Nature, Science, Lancet Oncology, Journal of Clinical Oncology, and Cancer Discovery) was assembled. Studies were limited to solid tumor oncology trials. After all authors were identified, direct and research funding was tabulated from CMS Open Payments for the year prior (Ypre) and the first 3 years following publication (Y1, Y2, Y3) in the high-impact journal. Summary statistics were tabulated and repeated-measures linear mixed-effects regression models were fit to examine changes after publication. RESULTS: A total of 102 publications with a total of 620 authors were identified. No FCOI was declared by 11, 12, 21, and 24 authors in Ypre, Y1, Y2, and Y3, respectively. In Ypre, Y1, Y2, and Y3: median FCOI for direct payments was $16,702 (range: $0-$3,180,356), $20,830 (range: $0-$3,180,356), $22,031 (range: $0-$920,746), and $21,356 (range: $0-$920,707), respectively; while median research funding was $559,202 (range: $0-$19,973,818), $505,031 (range $0-$19,920,452), $502,726 (range: $0-$15,729,776), and $497,342 (range: $0-$43,036,716), respectively. There were nonsignificant increases in total direct payments and total direct payments received from the sponsor (P>0.0125 for both) and statistically significant decreases in total associated research funding and total research funding from the research sponsor in Y1, Y2, and Y3 as compared to Ypre (P<0.0001 for both). CONCLUSIONS: After publication of an industry-sponsored solid tumor clinical trial in a high-impact journal, authors had statistically significant decreases in research funding FCOI in the first 3 years postpublication compared to the year prior.
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A partir de uma abordagem multimetódos baseada em pesquisa qualitativa de observação não-participante, análise de conteúdo e técnicas de snowballing de recomendação algorítmica, a proposta deste artigo é mapear a circulação de três disputas de informação científica ligadas à saúde em páginas e grupos brasileiros no Facebook movimento antivacina, fosfoetanolamina e Mineral Miracle Solution (MMS). Os resultados apontam para um campo de disputa no qual a autoridade científica é um valor relevante, sendo recorrentemente acionada como signo de convencimento junto ao público. Ainda, as fake sciences são um campo de disputa que envolvem 1) interesses comerciais em torno da crença em soluções rápidas e alternativas, 2) implicações jurídicas em torno do discurso pelo direito à informação e acesso a esses tratamentos alternativos, 3) sistema de reputação na busca por interseção na formulação de políticas e a alocação de recursos públicos e 4) uma descrença nas instituições epistêmicas, fazendo os sujeitos acreditarem apenas em experiências individuais baseadas no discurso de testemunho.
From a multi-method approach based on qualitative research of non-participant observation, content analysis and snowballing techniques with algorithmic recommendation, the purpose of this article is to map the circulation of three scientific information disputes related to health on pages and groups on Facebook anti-vaccine movement, phosphoethanolamine and Mineral Miracle Solution (MMS). The results point to a field of dispute in which scientific authority is a relevant value in these spaces, being repeatedly used as a sign of convincing the public. Still, fake sciences are a field of dispute that involve 1) commercial interests around the belief in quick and alternative solutions, 2) legal implications around the discourse for the right to information and access to the alternative treatments, 3) system of reputation in the search for intersection in the formulation of policies and the allocation of public resources and 4) a disbelief in epistemic institutions, making subjects believe only in individual experiences based on the testimony discourse.
Desde un enfoque de métodos múltiples basado en la investigación cualitativa de observación no participante, análisis de contenido y técnicas de snowballing con recomendación algorítmica, el propósito de este artículo es mapear la circulación de tres disputas de información científica relacionadas con la salud en páginas y grupos en Facebook: movimiento antivacunas, fosfoetanolamina y solución de milagro mineral (MMS). Los resultados apuntan a un campo de disputa en el que la autoridad científica es un valor relevante en estos espacios, y se usa repetidamente como un signo de convencer al público. Aún así, las fake sciences son un campo de disputa que involucra 1) intereses comerciales, en torno a la creencia en soluciones rápidas y alternativas, 2) implicaciones legales en torno al discurso sobre el derecho a la información y el acceso a estos tratamientos alternativos, 3) sistema de reputación en la búsqueda de intersección en la formulación de políticas y la asignación de recursos públicos y 4) una incredulidad en las instituciones epistémicas, haciendo que los sujetos crean solo en experiencias individuales basadas en el discurso del testimonio.
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Humanos , Conflito de Interesses , Pesquisa Qualitativa , Mídias Sociais , Movimento contra Vacinação , Fraude , Programas de Imunização , Falsidade Ideológica , Disseminação de Informação , Rede SocialRESUMO
ABSTRACT The doctor-patient relationship is often discussed from the perspective of patient vulnerability. Little attention is given to the vulnerability of nephrologists in their professional practice, a reality often affected by profound cultural transformation arising from technological development. Nephrology is based on research and procedure instrumentalization, both permeated with technology. In addition, the relationship between nephrologists and institutions is governed by market rules. Recent data showed a shortage of new nephrologists and the need to improve the technical training of new professionals, foster the establishment of interventional nephrology, and attract more graduating physicians to this medical specialty. Bioethics offers a different perspective on the issue, since it takes the subjective concerns of medical doctors and the social environments they participate in into consideration in order to enhance their ethical autonomy. These ideas may be discussed as part of undergraduate or specialization programs, thus reinforcing the acknowledgement of vulnerability as a condition and of the relevance of adopting a reflective attitude toward the events of everyday life that interact with the morality of nephrologists, so that risks are adequately faced having bioethical parameters as a reference.
RESUMO A vulnerabilidade do paciente é sempre foco de maior atenção quando se analisa a relação médico-paciente. Pouca ênfase é dirigida à vulnerabilidade do nefrologista em relação à própria prática profissional, frequentemente afetada pelas profundas transformações culturais decorrentes do desenvolvimento tecnológico. A atividade da Nefrologia é embasada na pesquisa e na instrumentalização dos procedimentos, ambos permeados pela tecnologia. Além disso, os relacionamentos com instituições são regidos por regras mercadológicas. Dados recentes constatam a escassez de novos nefrologistas, fato que mobiliza a proposta de melhorar a capacitação técnica de novos nefrologistas, favorecendo o estabelecimento da Nefrologia Intervencionista e o implemento durante a graduação médica de ferramentas que aumentem a atratividade por tal especialidade. A Bioética lança um olhar diferente sobre essa questão, pois considera aspectos subjetivos relacionados ao profissional e ao seu entorno social com o intuito de potencializar sua autonomia ética. Essa proposição pode ser considerada durante a graduação e a especialização para o reconhecimento da sua condição de vulnerabilidade e da importância de uma atitude reflexiva que levaria a perceber as incidências cotidianas que agem sobre a moral do nefrologista, para ser possível enfrentar adequadamente os riscos baseado em parâmetros bioéticos.
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Tecnologia Biomédica , Nefrologia/estatística & dados numéricos , Poder Psicológico , Mão de Obra em SaúdeRESUMO
La declaración de las relaciones financieras y personales de los investigadores con las compañías farmacéuticas es percibida como un paso esencial en la gestión de los potenciales conflictos de interés. El objetivo del estudio fue evaluar las declaraciones de conflictos de interés en cuatro revistas biomédicas españolas publicadas en castellano: Atención Primaria, Medicina Clínica, Revista Clínica Española y Revista Española de Cardiología. Se analizaron las publicaciones de 2012 calificadas por las revistas como "Editorial", "Artículo original", "Documento de consenso", "Revisión" y "Artículo especial". De 412 artículos, 315 (76%) presentaron declaración de conflictos de interés. Por revista, el 73% de los artículos de Atención Primaria, el 68% de Medicina Clínica, el 60% de Revista Clínica Española y el 100% de Revista Española de Cardiología tenía declaración de conflictos de interés. Solo el 12% de las declaraciones describía alguna actividad susceptible de generar conflicto de interés, mientras que el resto afirmaba no tener. Además de una variabilidad considerable en la frecuencia de declaración de conflictos de interés, la presencia de actividades declaradas es baja. Parece necesario mejorar la uniformidad y transparencia de las políticas de declaración de conflictos de interés.
Disclosure of financial relationships between researchers and pharmaceutical companies is seen as an essential step in the management of potential conflicts of interest. The objective of the study was to evaluate the frequency of conflicts of interest disclosure in four Spanish biomedical journals: Atención Primaria, Medicina Clínica, Revista Clínica Española and Revista Española de Cardiología. Publications qualified as "Editorial", "Original Article", "Consensus Document", "Review" and "Special article" in 2012 were analyzed. Of 412 articles, 315 (76%) had a conflict of interest statement. By journal, 73% of the articles in Atención Primaria, 68% in Medicina Clínica, 60% in Revista Clínica Española and 100% in Revista Española de Cardiología had disclosure of conflicts of interest. Only 12% of disclosures reported activities, while the rest maintains "No conflict of interest". In addition to a considerable variability in the frequency of conflicts of interest disclosure, the presence of activities disclosed is low. It would be necessary to improve the consistency and transparency of the policy declaration of conflicts of interest.
A declaração das relações financeiras e pessoais de pesquisadores com empresas farmacêuticas é vista como um passo essencial na gestão dos potenciais conflitos de interesse. O objetivo do estudo foi avaliar as declarações de conflitos de interesses em quatro revistas biomédicas espanholas publicadas em castelhano: Atención Primaria, Medicina Clínica, Revista Clínica Española e Revista Española de Cardiología. Foram analisadas as publicações de 2012 classidicadas pelas revistas enquanto: "Editor", "Artigo Original", "Documento de consenso", "Revisão" e "Artigo especial". De 412 artigos, 315 (76%) apresentaram declaração de conflitos de interesses. Por revista, 73% dos artigos de Atención Primaria, 68% de Medicina Clínica, 60% da Revista clínica Española e 100% da Revista Espanhola de Cardiologia tinham declaração de conflitos de interesses. Apenas 12% das declrações descrevia qualquer atividade suscetível a gerar conflito de interesses, enquanto o resto alegou não ter. Ademais de uma considerável variabilidade na frequência de declaração de conflitos de interesses, a presença de atividades declaradas é baixa. Parece necessário melhorar a uniformidade e a transparência das políticas de declaração de conflito de interesses.
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Publicações Periódicas como Assunto , Atenção Primária à Saúde , Bibliometria , Conflito de Interesses , Políticas Editoriais , EspanhaRESUMO
RESUMO Introdução As companhias farmacêuticas representam a principal fonte de inovações terapêuticas na medicina, daí têm participação importante em eventos de educação médica continuada (EMC). Objetivos Conhecer as concepções de médicos (palestrantes ou ouvintes) acerca do significado dos conflitos de interesses em eventos de EMC e que tipo de relação deveria ser declarado. Metodologia Médicos que atuam numa universidade brasileira responderam a um questionário com perguntas abertas e fechadas. Os dados qualitativos foram analisados de acordo com uma análise de conteúdos, e os quantitativos submetidos a análise estatística apropriada. Resultados Setenta e seis médicos responderam ao questionário; 55,3% consideram o conflito de interesses como uma situação, enquanto 44,7% o consideram um comportamento. Além do financiamento de pesquisa relacionada ao tema da palestra, mais da metade dos participantes apontou outros seis tipos de relacionamento indústria/palestrante cuja declaração é desejável. Cinquenta por cento dos palestrantes e 18% dos ouvintes acreditam estar bem preparados para lidar com as indústrias farmacêuticas. Considerações finais Escolas médicas, Conselho Federal de Medicina e Associação Médica Brasileira deveriam trabalhar para aprimorar a compreensão dos médicos acerca do tema e criar regras claras sobre o que deveria ser declarado.
ABSTRACT Introduction Pharmaceutical companies are the main source of therapeutic innovations in medicine, thus playing an important role in continuing medical education (CME). Objectives To study physicians’thoughts on conflicts of interests at CME events. Methodology Physiciansworkingat a Brazilian public university responded to a questionnaire featuring open and closed questions, with qualitative data studied according to a content analysis and quantitative data subjected to a proper statistical analysis. Results 76 physicians answered the questionnaire, with 55.3% considering conflicts of interests to constitute‘situations’ and 44.7% seeingthem as a form of‘behavior’. Besides financial support for research related to the presentations, the majority of participants pointed to six other kinds of industry/speaker relationship in which a declaration should be mandatory. Only 50% of speakers and 18% of listeners feel prepared to deal with pharmaceutical companies’ issues. Final considerations Medical schools and medical representative entities should work toward improving physicians’ understanding of this issue and creating objective rules on what must be declared.
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AIM: The purpose of this study was to evaluate the dentoskeletal and soft tissue effects resulting from treatment with Klammt's elastic open activator (EOA) functional orthopedic appliance in patients with Class II malocclusion characterized by mandibular deficiency. MATERIALS AND METHODS: Teleradiographs were evaluated in the lateral aspect of the initial (T1) and final (T2) orthopedic phases for 16 patients with Class II, Division 1 malocclusion. The age range was from 9 to 11.2 years, with a mean age of 9.9 years. The cephalometric points were demarcated, and cephalometric measurements were obtained by the same investigator to avoid interobserver variability. RESULTS: The EOA promoted increased lower anterior facial height (LAFH), increased effective mandibular length, clockwise rotation of the mandible, retrusion and verticalization of the upper incisors, proclination and protrusion of the lower incisors, extrusion of the upper molars, mesial movement of the lower molars and anterior projection of the lower lip. CONCLUSION: Skeletal changes characterized by an increase in mandibular length and dentoalveolar changes with an emphasis on the verticalization and retrusion of the upper incisors, proclination of the lower incisors and mesial positioning of the lower molars were key to improving the occlusal relationship and esthetic facial factors. CLINICAL SIGNIFICANCE: The EOA is well indicated in patients with Class II malocclusion due to mandibular deficiency with increased overbite, proclined upper incisors and verticalized lower incisors.
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Aparelhos Ativadores , Má Oclusão Classe II de Angle/terapia , Cefalometria , Criança , Feminino , Humanos , Masculino , Má Oclusão , MandíbulaRESUMO
In the last decade, dialogue between science and society has found a forum in an increasing number of publications on topics such as public engagement with science and public trust in science. Concerning the latter, issues that include cases of research misconduct, accountability in research, and conflicts of interest (COIs) have shaped global discussions on the communication of science. In the publication setting, the perception that hiding COIs and/or not managing them well may affect public trust in the research record has grown among editors. We conducted a search for editorials addressing COIs between 1989 and 2011, using four major databases: Medline/PubMed, Embase, Scopus, and Web of Knowledge. We explored the content of these editorials and the relationship they established between COIs and the public trust in science. Our results demonstrate that the relationship between disclosure of COIs and public trust in science has become a major concern among editors. We, thus, argue that COIs should be discussed more openly and frequently in graduate courses in the sciences, around the globe, not only in biomedical but also in non-biomedical areas. This is a critical issue in contemporary science, as graduate students are the future voices and decision-makers of the research community. Therefore, COIs, especially in the broader context of science and society, merit closer attention from policymakers, researchers, and educators. At times of great expectations for public engagement with science, mishandling of COIs may have undesirable consequences for public engagement with science and confidence in the scientific endeavor.
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Analisa o debate sobre os conflitos éticos dos artifícios utilizados pela indústria farmacêutica na pesquisa, produção e divulgação dos medicamentos. Três aspectos são examinados: o envolvimento dos profissionais de medicina com os representantes das indústrias farmacêuticas; o conflito de interesses quanto a sua atuação como patrocinadora de pesquisas científicas; a avaliação de fármacos em seres humanos. Verifica-se que a mensagem para promoção da saúde advém da medicalização; as grandes indústrias farmacêuticas não produzem exclusivamente mercadorias, mas, sobretudo, subjetividades. Dessa forma, descortina-se o tipo de ordem por elas estabelecida.
This paper analyzes the debate about the ethical conflicts of the methods used by the pharmaceutical industry in the research, production and dissemination of medicines. Three aspects are examined: the involvement of medical professionals with representatives of the pharmaceutical industry; the conflicts of interest regarding their role as sponsors of scientific research; and the evaluation of drugs on human beings. It is seen that the message for health promotion comes from medicalization; the major pharmaceutical industries do not exclusively produce merchandise, but especially subjectivities. In this way, the type of order established by them is revealed.
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Humanos , Preparações Farmacêuticas , Indústria Farmacêutica , Produção de Produtos , Promoção da SaúdeRESUMO
El artículo revisa el concepto de conflicto de intereses con la industria y el modo como este conflicto afecta el trabajo de los profesionales de la salud. Se examinan los conflictos de intereses de carácter colectivo, los conflictos en la investigación, en las publicaciones, en la redacción de guías de buenas prácticas médicas y, de modo cada vez más evidente, en las relaciones de las asociaciones de pacientes con la industria...
This article reviews the concept of conflicts of interest with industry and the way these conflicts affect health care professionals work. Conflicts of interest of collective type in research, publications, writing good medical practice guidelines and with an increasing evidence, the relations of patients associations with industry are examined...
O artigo revisa o conceito de conflito de interesses com a indústria e o modo como este conflito afeta o trabalho dos profissionais da saúde. São examinados os conflitos de interesses de caráter coletivo, os conflitos na investigação científica, nas publicações, na redação de guias de boas práticas médicas e, de modo cada vez mais evidente, nas relações das associações de pacientes com a indústria...
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Conflito de Interesses , Indústria Farmacêutica , Relações Interprofissionais , Pesquisa Biomédica/ética , PublicaçõesRESUMO
The question of how and when to communicate potential risks associated with new drugs has remained an important focus of tension between the pharmaceutical industry and regulatory entities, such as the American Food and Drug Administration. Recently there has been widespread concern related to the cardiovascular risks associated with the use of Avandia, a rosiglitazone produced by Glaxo Smith Kline. In fact, several metaanalyses involving rosiglitazone provided a relatively consistent message that rosiglitazone increases the risk of myocardial ischemic events. In the present article, we review the controversy regarding the way the pharmaceutical company handled this issue, and we describe examples of inappropriate conduct regarding an industry-sponsored clinical trial with this drug. We raise several important ethical questions related to the way researchers handle conflicts of interest when they are employees of the pharmaceutical industry. Finally, we discuss the requirements to conduct biomedical research funded by the pharmaceutical industry in Chile.
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Humanos , Pesquisa Biomédica , Doenças Cardiovasculares/induzido quimicamente , Indústria Farmacêutica , Hipoglicemiantes/efeitos adversos , Tiazolidinedionas/efeitos adversos , Chile , Conflito de Interesses , Pesquisadores , Fatores de RiscoRESUMO
El ejercicio de la medicina se ha regido tradicionalmente por los principios de la ética médica y los aspectos científicos que la definen. Sin embargo, la medicina actual se ve fuertemente influida por aspectos de otra índole como el interés económico, el encarnizamiento terapéutico, la medicina defensiva, la cirugía innecesaria, los conflictos de interés, las alteraciones en la aplicación del consentimiento informado, la relación con la industria farmacéutica, el respeto a la confidencialidad, la ética organizacional, y el ejercicio ético que escapa a la voluntad del profesional médico.
Medical practice has been traditionally ruled by the principles of medical ethics and the scientific aspects that define it. However, today's medical practice is largely influenced by other aspects such as: economic interests, abuse of therapeutics, defensive medicine, unnecessary surgeries and conflicts of interests without excluding alterations in the application of the informed consent, the relation with the pharmaceutical industry, respect of confidentiality, organizational ethics, and the ethical practice that escapes the will of the medical professional.
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Humanos , Ética MédicaRESUMO
There is concern regarding the possible health effects of cellular telephone use. We conducted a systematic review of studies of controlled exposure to radiofrequency radiation with health-related outcomes (electroencephalogram, cognitive or cardiovascular function, hormone levels, symptoms, and subjective well-being). We searched Embase, Medline, and a specialist database in February 2005 and scrutinized reference lists from relevant publications. Data on the source of funding, study design, methodologic quality, and other study characteristics were extracted. The primary outcome was the reporting of at least one statistically significant association between the exposure and a health-related outcome. Data were analyzed using logistic regression models. Of 59 studies, 12 (20 percent) were funded exclusively by the telecommunications industry, 11 (19 percent) were funded by public agencies or charities, 14 (24 percent) had mixed funding (including industry), and in 22 (37 percent) the source of funding was not reported. Studies funded exclusively by industry reported the largest number of outcomes, but were least likely to report a statistically significant result. The interpretation of results from studies of health effects of radiofrequency radiation should take sponsorship into account.
Foi realizada uma revisão sistemática de estudos de exposição controlada à radiação de radiofreqüência com resultados relacionados à saúde (eletroencefalograma, função cognitiva ou cardiovascular, níveis hormonais, sintomas e bem-estar subjetivo). Foram pesquisados o Embase, Medline e um banco de dados especializado e analisadas listas de referências de publicações relevantes. Foram extraídos dados sobre a fonte de financiamento, desenho do estudo, qualidade metodológica e outras características do estudo. A principal descoberta foi o relato de pelo menos uma associação estatisticamente significativa entre a exposição e um resultado relacionado à saúde. Os dados foram analisados usando-se modelos de regressão logística. De 59 estudos, 12 (20 por cento) foram financiados exclusivamente pela indústria de telecomunicação, 11 (19 por cento), por órgãos públicos ou de caridade, 14 (24 por cento) tiveram financiamentos combinados (inclusive da indústria) e em 22 (37 por cento) a fonte de financiamento não foi notificada. Os estudos financiados exclusivamente pela indústria tiveram o maior número de resultados, mas menos propensão a relatar um resultado significativo. A interpretação dos resultados dos estudos sobre os efeitos da radiação de radiofreqüência à saúde deve levar em conta o patrocínio.