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3.
BMJ ; 368: l6925, 2020 01 22.
Artículo en Inglés | MEDLINE | ID: mdl-31969320

RESUMEN

OBJECTIVE: To investigate pharmaceutical or medical device industry funding of patient groups. DESIGN: Systematic review with meta-analysis. DATA SOURCES: Ovid Medline, Embase, Web of Science, Scopus, and Google Scholar from inception to January 2018; reference lists of eligible studies and experts in the field. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Observational studies including cross sectional, cohort, case-control, interrupted time series, and before-after studies of patient groups reporting at least one of the following outcomes: prevalence of industry funding; proportion of industry funded patient groups that disclosed information about this funding; and association between industry funding and organisational positions on health and policy issues. Studies were included irrespective of language or publication type. REVIEW METHODS: Reviewers carried out duplicate independent data extraction and assessment of study quality. An amended version of the checklist for prevalence studies developed by the Joanna Briggs Institute was used to assess study quality. A DerSimonian-Laird estimate of single proportions with Freeman-Tukey arcsine transformation was used for meta-analyses of prevalence. GRADE (Grading of Recommendations Assessment, Development, and Evaluation) was used to assess the quality of the evidence for each outcome. RESULTS: 26 cross sectional studies met the inclusion criteria. Of these, 15 studies estimated the prevalence of industry funding, which ranged from 20% (12/61) to 83% (86/104). Among patient organisations that received industry funding, 27% (175/642; 95% confidence interval 24% to 31%) disclosed this information on their websites. In submissions to consultations, two studies showed very different disclosure rates (0% and 91%), which appeared to reflect differences in the relevant government agency's disclosure requirements. Prevalence estimates of organisational policies that govern corporate sponsorship ranged from 2% (2/125) to 64% (175/274). Four studies analysed the relationship between industry funding and organisational positions on a range of highly controversial issues. Industry funded groups generally supported sponsors' interests. CONCLUSION: In general, industry funding of patient groups seems to be common, with prevalence estimates ranging from 20% to 83%. Few patient groups have policies that govern corporate sponsorship. Transparency about corporate funding is also inadequate. Among the few studies that examined associations between industry funding and organisational positions, industry funded groups tended to have positions favourable to the sponsor. Patient groups have an important role in advocacy, education, and research, therefore strategies are needed to prevent biases that could favour the interests of sponsors above those of the public. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42017079265.


Asunto(s)
Organizaciones del Consumidor/economía , Industria Farmacéutica/economía , Administración Financiera/legislación & jurisprudencia , Organizaciones del Consumidor/ética , Organizaciones del Consumidor/legislación & jurisprudencia , Revelación/ética , Revelación/legislación & jurisprudencia , Industria Farmacéutica/ética , Administración Financiera/ética , Estudios Observacionales como Asunto , Política Organizacional
6.
Gac Med Mex ; 155(5): 563-564, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31695240

RESUMEN

Conflicts of interest are situations in which judgment and integrity of medical decisions or actions are influenced by a secondary interest, often of an economic nature. The Committee of Ethics and Transparency in the Physician-Industry Relationship of the National Academy of Medicine of Mexico recognizes that these conflicts occur in health professionals' daily life, but also in public and private institutions that provide health services, as well as in the academy and in research activities. Therefore, it is necessary to identify conflicting situations and always act in accordance with the patient's interest.


Asunto(s)
Códigos de Ética , Conflicto de Intereses , Comités de Ética , Ética Médica , Industria Farmacéutica/ética , Humanos , Aseguradoras/ética , Relaciones Médico-Paciente/ética , Relaciones Profesional-Familia/ética
7.
J Nepal Health Res Counc ; 17(3): 345-350, 2019 Nov 13.
Artículo en Inglés | MEDLINE | ID: mdl-31735930

RESUMEN

BACKGROUND: Drug Promotional Literatures are usually relied upon for drug promotion, however studies have shown them to contain several pitfalls. World Health Organization has time and often revised the guideline to address the issue and World Health Organization Ethical Criteria for Medicinal Drug Promotion was established. Based on this guideline, several regional as well as national guidelines have been formulated. Though laws to regulate drug promotion is existent, studies have shown problems with drug promotional literatures in Nepal also. This study was carried out to analyse the drug promotional literatures distributed by pharmaceutical companies in Nepal as per World Health Organization Ethical Criteria for Medicinal Drug Promotion. METHODS: A cross-sectional study over a period of one year was conducted at our department. Pharmaceutical companies registered in Department of Drug Administration, Kathmandu and consenting for the study were requested to provide ten unique drug promotional literatures of their products. Collected drug promotional literatures were analysed for inclusion of essential information as per World Health Organization Ethical Criteria for Medicinal Drug Promotion, level of biasness. Different drug promotional literatures were also classified and compared for these aspects. RESULTS: A total of 48 pharmaceutical companies were included in the study. Drug promotional literatures (n = 372) were analysed during the study. Adherence to criteria concerned with positive attributes of the promoted medicine was found to be higher, most of the drug promotional literatures adhered to 5-8 criteria of World Health Organization Ethical Criteria for Medicinal Drug Promotion and were categorised into grade B. Difference in adherence as well as number of biased drug promotional literatures was also seen when drug promotional literatures were compared on different basis. CONCLUSIONS: Adherence to World Health Organization Ethical Criteria for Medicinal Drug Promotion was found to vary when drug promotional literatures were classified as per pharmaceutical company, type of formulation being promoted, type of drug promotional literatures.


Asunto(s)
Publicidad/ética , Industria Farmacéutica/ética , Pautas de la Práctica en Medicina/estadística & datos numéricos , Estudios Transversales , Industria Farmacéutica/métodos , Humanos , Nepal , Organización Mundial de la Salud
9.
BMC Med Ethics ; 20(1): 64, 2019 09 18.
Artículo en Inglés | MEDLINE | ID: mdl-31533704

RESUMEN

BACKGROUND: Most studies are inclined to report positive rather than negative or inconclusive results. It is currently unknown how clinicians appraise the results of a randomized clinical trial. For example, how does the study funding source influence the appraisal of an RCT, and do positive findings influence perceived credibility and clinical relevance? This study investigates whether psychiatrists' appraisal of a scientific abstract is influenced by industry funding disclosures and a positive outcome. METHODS: Dutch psychiatrists were randomized to evaluate a scientific abstract describing a fictitious RCT for a novel antipsychotic drug. Four different abstracts were created reporting either absence or presence of industry funding disclosure as well as a positive or a negative outcome. Primary outcomes were the perceived credibility and clinical relevance of the study results (10-point Likert scale). Secondary outcomes were the assessment of methodological quality and interest in reading the full article. RESULTS: Three hundred ninety-five psychiatrists completed the survey (completion rate 45%). Industry funding disclosure was found not to influence perceived credibility (Mean Difference MD 0.12; 95% CI - 0.28 to 0.47, p?) nor interpretation of its clinical relevance (MD 0.14; 95% CI - 0.54 to 0.27, p?). A negative outcome was perceived as more credible than a positive outcome (MD 0.81 points; 95% Confidence Interval (CI) 0.43 to 1.18, p?), but did not affect clinical relevance scores (MD -0.14; 95% CI - 0.54 to 0.27). CONCLUSIONS: In this study, industry funding disclosure was not associated with the perceived credibility nor judgement of clinical relevance of a fictional RCT by psychiatrists. Positive study outcomes were found to be less credible compared to negative outcomes, but industry funding had no significant effects. Psychiatrists may underestimate the influence of funding sources on research results. The fact that physicians indicated negative outcomes to be more credible may point to more awareness of existing publication bias in the scientific literature.


Asunto(s)
Ensayos Clínicos como Asunto/economía , Ensayos Clínicos como Asunto/ética , Conflicto de Intereses , Industria Farmacéutica/economía , Industria Farmacéutica/ética , Psiquiatría/economía , Psiquiatría/ética , Apoyo a la Investigación como Asunto/ética , Humanos , Países Bajos
10.
J Leg Med ; 39(2): 151-167, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31503532

RESUMEN

U.S. consumers pay high drug prices. Brand-name drug companies claim that these prices are justified by pathbreaking research and development. But, sometimes the prices result from anticompetitive conduct. This article offers three case studies of how such behavior can increase price based on wakefulness drug Provigil, the allergic-reaction-treating EpiPen, and infection-treating Daraprim. The article contends that behavior that makes no sense other than by harming a competitor, that undercuts a regulatory regime, or that involves collusive conduct should not be protected. In targeting this behavior, antitrust scrutiny promises to lower drug prices.


Asunto(s)
Costos de los Medicamentos/ética , Costos de los Medicamentos/legislación & jurisprudencia , Honorarios Farmacéuticos/ética , Honorarios Farmacéuticos/legislación & jurisprudencia , Modafinilo/economía , Pirimetamina/economía , Leyes Antitrust , Industria Farmacéutica/economía , Industria Farmacéutica/ética , Industria Farmacéutica/legislación & jurisprudencia , Competencia Económica , Humanos , Estados Unidos
12.
J Anesth Hist ; 5(2): 32-35, 2019 04.
Artículo en Inglés | MEDLINE | ID: mdl-31400833

RESUMEN

A comprehensive investigation was undertaken to find evidence of the frequently reported, but never authenticated, "purchase of 150 inmates" from Auschwitz concentration camp by Bayer to test a new narcotic, resulting in the death of all investigated inmates. The archives of Auschwitz camp, Bayer, and the so-called former Soviet Union, where evidence of this alleged misconduct could have been saved, were investigated, but no evidence was found. Many records concerning concentration camp experiments on humans had been destroyed, but given the Nazis' meticulous record-keeping, the death of 150 inmates should have been recorded somewhere. Unethical medical research was indeed undertaken by physicians in concentration camps in many medical specialties, but no records regarding anesthesia-related medical misconduct during the Nazi period were found despite the allegations to the contrary that have been investigated here.


Asunto(s)
Anestesiología/historia , Campos de Concentración/historia , Industria Farmacéutica/historia , Ética Médica/historia , Ética Farmacéutica/historia , Experimentación Humana/historia , Nacionalsocialismo/historia , Anestesiología/ética , Industria Farmacéutica/ética , Femenino , Alemania , Historia del Siglo XX , Experimentación Humana/ética , Humanos
16.
Nutr Hosp ; 36(4): 974-980, 2019 Aug 26.
Artículo en Español | MEDLINE | ID: mdl-31321984

RESUMEN

Introduction: The need to promote the right to nutritional care, to fight against malnutrition and to advance in education and research in clinical nutrition has led all the FELANPE's societies to sign on May 3rd, during the 33rd Congress of the Colombian Clinical Nutrition Association (ACNC) in the city of Cartagena, the International Declaration on the Right to Nutritional Care and the Fight against Malnutrition, "Declaration of Cartagena". The Declaration provides a coherent framework of 13 principles which can serve as a guide for societies, schools and associations affiliated to FELANPE in the development of action plans. In addition, it will serve as an instrument to promote, through governments, the formulation of policies and legislation in the field of clinical nutrition. We believe that the general framework of principles proposed by the Declaration can contribute to raise awareness about the magnitude of this problem and to promote cooperation networks among Latin-American countries. Although this Declaration does not have a binding legal effect, it has an undeniable moral strength and it can provide practical guidance to States. An implementation program will allow developing a toolkit to transform principles into actions.


Asunto(s)
Derechos Humanos , Cooperación Internacional , Desnutrición/prevención & control , Política Nutricional , Discusiones Bioéticas , Colombia , Prestación Integrada de Atención de Salud , Industria Farmacéutica/ética , Industria de Alimentos/ética , Abastecimiento de Alimentos , Guías como Asunto , Humanos , Cooperación Internacional/legislación & jurisprudencia , América Latina , Desnutrición/diagnóstico , Política Nutricional/legislación & jurisprudencia , Política Nutricional/tendencias , Ciencias de la Nutrición/educación , Apoyo Nutricional , Cultura Organizacional , Grupo de Atención al Paciente/organización & administración , Participación del Paciente , Investigación
19.
J Bone Joint Surg Am ; 101(11): e50, 2019 Jun 05.
Artículo en Inglés | MEDLINE | ID: mdl-31169583

RESUMEN

BACKGROUND: The Centers for Medicare & Medicaid Services (CMS) Open Payments public database, resulting from the Physician Payments Sunshine Act of 2010, was designed to increase transparency of physicians' financial relationships with pharmaceutical manufacturers. We compared physician-reported conflict-of-interest (COI) disclosures in journal articles with this database to determine any discrepancies in physician-reported disclosures. METHODS: COIs reported by authors from 2014 through 2016 were analyzed in 3 journals: Foot & Ankle International (FAI), The Journal of Bone & Joint Surgery (JBJS), and The Journal of Arthroplasty (JOA). Payment information in the CMS Open Payments database was cross-referenced with each author's disclosure statement to determine if a disclosure discrepancy was present. RESULTS: We reviewed 3,465 authorship positions (1,932 unique authors) in 1,770 articles. Within this sample, 7.1% of authorships had a recorded undisclosed COI (disclosure discrepancy), and 13.2% of articles had first and/or last authors with a disclosure discrepancy. Additionally, we saw a great variation in the percentage of authorships with disclosure discrepancies among the journals (JBJS, 2.3%; JOA, 3.6%; and FAI, 23.7%). CONCLUSIONS: Discrepancies exist between payment disclosures made by authors and those published in the CMS Open Payments database. Although the percentage of articles with these discrepancies varies widely among the journals that were analyzed in this study, no trend was found when analyzing the number of discrepancies over the 3-year period. CLINICAL RELEVANCE: COI disclosures are important for the interpretation of study results and need to be accurately reported. However, COI disclosure criteria vary among orthopaedic journals, causing uncertainty regarding which conflicts should be disclosed.


Asunto(s)
Centers for Medicare and Medicaid Services, U.S. , Conflicto de Intereses , Revelación , Industria Farmacéutica/ética , Ortopedia/ética , Médicos/ética , Bases de Datos Factuales , Humanos , Ortopedia/economía , Médicos/economía , Estados Unidos
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