Consistency of Financial Interest Disclosures in the Biomedical Literature: The Case of Coronary Stents

Background Disclosure of authors' financial interests has been proposed as a strategy for protecting the integrity of the biomedical literature. We examined whether authors' financial interests were disclosed consistently in articles on coronary stents published in 2006. Methodology/Principal Findings We searched PubMed for English-language articles published in 2006 that provided evidence or guidance regarding the use of coronary artery stents. We recorded article characteristics, including information about authors' financial disclosures. The main outcome measures were the prevalence, nature, and consistency of financial disclosures. There were 746 articles, 2985 authors, and 135 journals in the database. Eighty-three percent of the articles did not contain disclosure statements for any author (including declarations of no interests). Only 6% of authors had an article with a disclosure statement. In comparisons between articles by the same author, the types of disagreement were as follows: no disclosure statements vs declarations of no interests (64%); specific disclosures vs no disclosure statements (34%); and specific disclosures vs declarations of no interests (2%). Among the 75 authors who disclosed at least 1 relationship with an organization, there were 2 cases (3%) in which the organization was disclosed in every article the author wrote. Conclusions/Significance In the rare instances when financial interests were disclosed, they were not disclosed consistently, suggesting that there are problems with transparency in an area of the literature that has important implications for patient care. Our findings suggest that the inconsistencies we observed are due to both the policies of journals and the behavior of some authors

Perception of the risks and benefits of bt eggplant by Indian farmers

Several researchers—most notably Lennart Sjoberg and his colleagues—have proposed that the moral aspects of risk provide a better explanation of risk perception than the psychometric paradigm or Cultural Theory, neither of which accounts for moral concerns. This study is possibly the first to assess empirically the perception of the risks and benefits of a transgenic food crop—transgenic Bt (Bacillus thuringiensis) eggplant—by farmers in a developing country such as India. It also aims to assess if the moral aspects of risk figure in Indian farmers ’ perception of Bt eggplant and if economic benefits outweigh perceived risks. To answer the research questions, a scenario was used to elicit perceptions of Bt eggplant among 100 eggplant farmers in the state of Maharashtra in India. The findings indicate that economic benefits, safety concerns, and accountability are most salient to Indian farmers’ perception of the risks and benefits of Bt eggplant. Significantly, none of the farmers mentioned moral concerns as an issue. The findings also make clear that economic benefits outweigh perceived risks. This study concludes that economic benefits are more salient than moral concerns to Indian farmers ’ perception Bt eggplant. It also proposes that an alternative theoretical model incorporating economic benefits, safety concerns, and accountability as key variables should be developed and tested for end users in the developing world. KEY WORDS: risk perception, biotechnology, developing countries, farmers 1

Representation and misrepresentation of scientific evidence in contemporary tobacco regulation:a review of tobacco industry submissions to the UK Government consultation on standardised packaging

BACKGROUND: Standardised packaging (SP) of tobacco products is an innovative tobacco control measure opposed by transnational tobacco companies (TTCs) whose responses to the UK government's public consultation on SP argued that evidence was inadequate to support implementing the measure. The government's initial decision, announced 11 months after the consultation closed, was to wait for 'more evidence', but four months later a second 'independent review' was launched. In view of the centrality of evidence to debates over SP and TTCs' history of denying harms and manufacturing uncertainty about scientific evidence, we analysed their submissions to examine how they used evidence to oppose SP. METHODS AND FINDINGS: We purposively selected and analysed two TTC submissions using a verification-oriented cross-documentary method to ascertain how published studies were used and interpretive analysis with a constructivist grounded theory approach to examine the conceptual significance of TTC critiques. The companies' overall argument was that the SP evidence base was seriously flawed and did not warrant the introduction of SP. However, this argument was underpinned by three complementary techniques that misrepresented the evidence base. First, published studies were repeatedly misquoted, distorting the main messages. Second, 'mimicked scientific critique' was used to undermine evidence; this form of critique insisted on methodological perfection, rejected methodological pluralism, adopted a litigation (not scientific) model, and was not rigorous. Third, TTCs engaged in 'evidential landscaping', promoting a parallel evidence base to deflect attention from SP and excluding company-held evidence relevant to SP. The study's sample was limited to sub-sections of two out of four submissions, but leaked industry documents suggest at least one other company used a similar approach. CONCLUSIONS: The TTCs' claim that SP will not lead to public health benefits is largely without foundation. The tools of Better Regulation, particularly stakeholder consultation, provide an opportunity for highly resourced corporations to slow, weaken, or prevent public health policies

Conflict of Interest Policies at Canadian Universities: Clarity and Content

[À l'origine dans / Was originally part of : ESPUM - Dép. médecine sociale et préventive - Travaux et publications]Abstract Discussions of conflict of interest (COI) in the university have tended to focus on financial interests in the context of medical research; much less attention has been given to COI in general or to the policies that seek to manage COI. Are university COI policies accessible and understandable? To whom are these policies addressed (faculty, staff, students)? Is COI clearly defined in these policies and are procedures laid out for avoiding or remedying such situations? To begin tackling these important ethical and governance questions, our study examines the COI policies at the Group of Thirteen (G13) leading Canadian research universities. Using automated readability analysis tools and an ethical content analysis, we begin the task of comparing the strengths and weaknesses of these documents, paying particular attention to their clarity, readability, and utility in explaining and managing COI.This study was supported by a grant from the Institute of Genetics of the Canadian Institutes of Health Researc

Funding source, trial outcome and reporting quality: are they related? Results of a pilot study

BACKGROUND: There has been increasing concern regarding the potential effects of the commercialization of research. METHODS: In order to examine the relationships between funding source, trial outcome and reporting quality, recent issues of five peer-reviewed, high impact factor, general medical journals were hand-searched to identify a sample of 100 randomized controlled trials (20 trials/journal). Relevant data, including funding source (industry/not-for-profit/mixed/not reported) and statistical significance of primary outcome (favouring new treatment/favouring conventional treatment/neutral/unclear), were abstracted. Quality scores were assigned using the Jadad scale and the adequacy of allocation concealment. RESULTS: Sixty-six percent of trials received some industry funding. Trial outcome was not associated with funding source (p= .461). There was a preponderance of favourable statistical conclusions among published trials with 67% reporting results that favored a new treatment whereas 6% favoured the conventional treatment. Quality scores were not associated with funding source or trial outcome. CONCLUSIONS: It is not known whether the absence of significant associations between funding source, trial outcome and reporting quality reflects a true absence of an association or is an artefact of inadequate statistical power, reliance on voluntary disclosure of funding information, a focus on trials recently published in the top medical journals, or some combination thereof. Continued and expanded monitoring of potential conflicts is recommended, particularly in light of new guidelines for disclosure that have been endorsed by the ICMJE

A proposed framework for the systematic review and integrated assessment (SYRINA) of endocrine disrupting chemicals

Background - The issue of endocrine disrupting chemicals (EDCs) is receiving wide attention from both the scientific and regulatory communities. Recent analyses of the EDC literature have been criticized for failing to use transparent and objective approaches to draw conclusions about the strength of evidence linking EDC exposures to adverse health or environmental outcomes. Systematic review methodologies are ideal for addressing this issue as they provide transparent and consistent approaches to study selection and evaluation. Objective methods are needed for integrating the multiple streams of evidence (epidemiology, wildlife, laboratory animal, in vitro, and in silico data) that are relevant in assessing EDCs. Methods - We have developed a framework for the systematic review and integrated assessment (SYRINA) of EDC studies. The framework was designed for use with the International Program on Chemical Safety (IPCS) and World Health Organization (WHO) definition of an EDC, which requires appraisal of evidence regarding 1) association between exposure and an adverse effect, 2) association between exposure and endocrine disrupting activity, and 3) a plausible link between the adverse effect and the endocrine disrupting activity. Results - Building from existing methodologies for evaluating and synthesizing evidence, the SYRINA framework includes seven steps: 1) Formulate the problem; 2) Develop the review protocol; 3) Identify relevant evidence; 4) Evaluate evidence from individual studies; 5) Summarize and evaluate each stream of evidence; 6) Integrate evidence across all streams; 7) Draw conclusions, make recommendations, and evaluate uncertainties. The proposed method is tailored to the IPCS/WHO definition of an EDC but offers flexibility for use in the context of other definitions of EDCs. Conclusions - When using the SYRINA framework, the overall objective is to provide the evidence base needed to support decision making, including any action to avoid/minimise potential adverse effects of exposures. This framework allows for the evaluation and synthesis of evidence from multiple evidence streams. Finally, a decision regarding regulatory action is not only dependent on the strength of evidence, but also the consequences of action/inaction, e.g. limited or weak evidence may be sufficient to justify action if consequences are serious or irreversible.The workshops that supported the writing of this manuscript were funded by the Swedish Foundation for Strategic Environmental Research “Mistra”. LNV was funded by Award Number K22ES025811 from the National Institute of Environmental Health Sciences of the National Institutes of Health. TJW was funded by The Clarence Heller Foundation (A123547), the Passport Foundation, the Forsythia Foundation, the National Institute of Environmental Health Sciences (grants ES018135 and ESO22841), and U.S. EPA STAR grants (RD83467801 and RD83543301). JT was funded by the Academy of Finland and Sigrid Juselius. UH was funded by the Danish EPA. KAK was funded by the Canada Research Chairs program grant number 950–230607

Características del liderazgo pedagógico del directivo docente de la I.E. de Jesús del municipio de Concordia

Esta investigación abordó el liderazgo pedagógico, específicamente el liderazgo directivo, su papel dentro del proceso pedagógico de la institución educativa está justificado por la relevancia que tiene en la gestión curricular, entre otras funciones, pues permite que las instituciones educativas - I.E marchen adecuadamente y alcancen mayores logros para todos los estudiantes. El objetivo consistió en identificar las características del liderazgo pedagógico del directivo docente de la I.E de Jesús del municipio de Concordia. Para esto se consideró una investigación enmarcada dentro del enfoque cualitativo de tipo descriptivo, el método fue estudio de caso. Los instrumentos que se utilizaron fueron, la entrevista, el diario de campo y el grupo focal. Con base en los resultados obtenidos en las entrevistas se destacan aspectos importantes de la comunicación y el liderazgo, vinculados a la gestión administrativa de la I.E. La investigación muestra la importancia que tiene el liderazgo pedagógico del directivo docente como elemento clave en el desarrollo y funcionamiento pedagógico-curricular de la I.E.This research addressed pedagogical leadership, such as one that focuses on the directive role, specifically on his role in the educational process on the educative institution; the relevance it's justified for this process for function properly on the institutions to and achieve greater achievements for all students. The objective was to identify the pedagogical leadership from the educative director of the Educative Institution of Jesus from the Concordia municipality. For this, was considered an investigation framed within the qualitative approach of descriptive type, the method was a study case. The instruments used were interview, field diaries and focus group. Based on the interview results obtained, important aspects of communication and leadership were highlighted, linked to the development processes on the educative institution. The research shows the importance on a pedagogical leadership of the teaching director as a key element within the institution.Magíster en EducaciónMaestrí

Using Automated Emergency Notification Systems to Inform the Public: A Field Experiment

Research and experience have shown that it can be difficult to get citizens to pay attention to risk messages and preparedness information in the absence of an actual emergency. As the use computerized systems that alert the public to hazards by automatically ringing their home phones increases, we thought it important to ask if tests of these “call down” systems can also be used to convey preemergency information. We worked with a local government to add instructions on how to shelter-in-place to the message on a routine test of a call down system. We then surveyed a test group and a control group before and after the test call and a second control group on after the call. The results indicate that the test call raised awareness of the emergency notification system without generating undue concern about the possibility of a chemical accident. Those who received the test call demonstrated significant improvements in their knowledge of how to shelter-in-place while no such improvement was observed in those who did not get the call. While the nature of the sample used in this study limits generalizability, we feel this outcome is positive enough to warrant further exploration of this method of disseminating risk information and preparedness instructions