Accuracy of Disclosed Financial Relationships between Radiologists and Industry at the 2018 RSNA Annual Meeting.

Online supplemental material is available for this article. See also the editorial by Grant in this issue.

'Pro-tobacco propaganda': a case study of tobacco industry-sponsored elementary schools in China.

BACKGROUND: China is the largest producer and consumer of tobacco products worldwide. While direct marketing and advertisement of tobacco products is restricted, indirect marketing still exists under the guise of sponsorship and corporate social responsibility (CSR). This case study is focused on tobacco industry-sponsored elementary schools in Chinese rural areas. METHODS: Field visits were conducted in Yunnan province to interview students, teachers, school principals and parents to understand their perceptions of the tobacco industry and its sponsorship of schools. Interviews with tobacco control activists were conducted in Beijing to discuss national tobacco control efforts targeting tobacco industry sponsorship. Interview data were transcribed and coded, with key themes developed using thematic analysis. RESULTS: While health consequences of smoking are generally known, attitudes towards the tobacco industry and its CSR activities remain positive among the general public. Educators and parents do not perceive any impacts on schoolchildren from exposure to 'pro-tobacco propaganda' created by the industry's CSR activities. Attitudes among tobacco control activists were drastically different, with consensus that CSR activities constitute indirect marketing attempts that should be banned. CONCLUSION: National tobacco control legislation banning all forms of indirect marketing including CSR is needed in order to protect the health of future generations.

Practice in financial support of third party organised conferences and courses at a national level for health care professionals in Europe.

Background Ethical MedTech prescribes high standards for the participation of the in vitro diagnostics (IVD) industry in third-party organised educational events in terms of charitable donations, educational grants, scholarships and fellowships. We planned a survey to investigate the previous and current practice in terms of cooperation between professionals or professional societies and the IVD industry, as well as plans under the incorporation of the MedTech Europe Code. Methods Different questions, from general information to specific questions related to the practice and knowledge of the new Ethical MedTech Code, were included in two different surveys; for European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) National Societies' (NSs) representatives, and for their (NSs) individual members. Results Twenty-five out of 40 EFLM NS representatives replied; more than half declared that all different types of financial resources were available for supporting the continuing professional education of health care professionals (HCPs). In addition, 322 individual responses collected from 31 NSs, answered that the institutional director (50.3%) or laboratory chief (70.1%) made generally made a decision, without specific criteria. Conclusions The MedTech Europe Code is already adopted or is about to be adopted in numerous EFLM NSs, but most of them have not implemented it as yet. The use of the Code and better communication between IVD companies and HCPs are necessary to guarantee an improved and fair use of financial support, as well as better choices for the organisation and attendance at scientific events.

When patient advocacy organizations meet industry: a novel approach to dealing with financial conflicts of interest.

BACKGROUND: Much like academic-industry partnerships, industry financial support of patient advocacy organizations (PAOs) has become very common in recent years. While financial conflicts of interest (FCOI) between PAOs and industry have received more attention in recent years, robust efforts to mitigate these conflicts are still limited. MAIN BODY: The authors outline the possible benefits and ethical concerns that can result from financial interactions between biomedical companies and PAOs. They argue that the use of novel strategies, such as the creation of a standing ethics committee, could be helpful in managing FCOIs and ensuring the warranted trust of PAO's constituents. Although ethics committees to address FCOIs are common in the academic context, its use by PAOs is still limited. The authors conclude by describing the process of development and implementation of such an ethics committee at the Crohn's & Colitis Foundation. CONCLUSIONS: While collaborations with industry can result in conflicts of interest, PAOs can develop strategies to address those conflicts. One such strategy is the creation of a standing independent ethics committee to guide PAOs on new and/or existing programs and protocols as they pertain to their industry relationships.

If the Facts Were Not Untruths, Their Implications Were: Sponsorship Bias and Misleading Communication.

Sponsorship bias occurs when the financial interests of funders of scientific research influence claims made by scientists, especially in peer-reviewed publications. This article examines the relationship between sponsorship bias and misleading claims, understood as claims that are not necessarily false but which encourage those exposed to them to infer false conclusions. Misleading claims are relevant to how the term "bias" should be understood and thereby to evaluating a recent dispute about whether there is evidence of sponsorship bias in clinical research on statins. The concept of inferential asymmetry is introduced as an aid for understanding the relationship between misleading claims and sponsorship bias.

[Recomendaciones a los cuerpos directivos de las agrupaciones médicas en su relación con la industria].

Continuing medical education activities are often financially supported by pharmaceutical and device companies. With the purpose to ensure ethics and accountability in the management of this assistance, the Committee of Ethics and Transparency in the Physician-Industry Relationship of the National Academy of Medicine of Mexico formulates recommendations to medical associations' leaders in this text.

Las actividades de educación médica continua con frecuencia son apoyadas financieramente por la industria farmacéutica y de implementos médicos. Con el propósito de velar por la ética y rendición de cuentas en el manejo de estos apoyos, en el presente texto el Comité de Ética y Transparencia en la Relación Médico-Industria (Cetremi) de la Academia Nacional de Medicina de México formula recomendaciones a los directivos de agrupaciones médicas.

Discordance of conflict of interest self-disclosure and the Centers of Medicare and Medicaid Services.

BACKGROUND: The Open Payments Database (OPD) discloses financial transactions between manufacturers and physicians. The concordance of OPD versus self-reported conflicts of interest (COI) is unknown. MATERIALS AND METHODS: Our objectives were to compare (1) industry and self-disclosed COI in clinical literature, (2) payments within each disclosure level, and (3) industry- and self-disclosed COI and payments by specialty. This was an observational study. PubMed was searched for clinical studies accepted for publication from January 2014 to June 2016. Author and OPD-disclosed COIs were compared. Articles and authors were divided into full disclosure, incomplete industry disclosure, incomplete self-disclosure, and no COI. Primary outcome (differences in reported COI per article) was assessed using McNemar's test. Payment differences were compared using Kruskal-Wallis test. RESULTS: OPD- and self-disclosed COI differed (65.0% discordance rate by article, P < 0.001). Percentages of authors within each disclosure category differed between specialties (P < 0.001). Hematology articles exhibited the highest discordance rate (79.0%) and received the highest median payment for incomplete self-disclosure ($30,812). CONCLUSIONS: Significant discordance exists between self- and OPD-reported COI. Additional research is needed to determine reasons for these differences.

Corporate political activity of the dairy industry in France: an analysis of publicly available information.

OBJECTIVE: In the present study, we used a structured approach based on publicly available information to identify the corporate political activity (CPA) strategies of three major actors in the dairy industry in France. DESIGN: We collected publicly available information from the industry, government and other sources over a 6-month period, from March to August 2015. Data collection and analysis were informed by an existing framework for classifying the CPA of the food industry. Setting/Subjects Our study included three major actors in the dairy industry in France: Danone, Lactalis and the Centre National Interprofessionnel de l'Economie Laitière (CNIEL), a trade association. RESULTS: During the period of data collection, the dairy industry employed CPA practices on numerous occasions by using three strategies: the 'information and messaging', the 'constituency building' and the 'policy substitution' strategies. The most common practice was the shaping of evidence in ways that suited the industry. The industry also sought involvement in the community, establishing relationships with public health professionals, academics and the government. CONCLUSIONS: Our study shows that the dairy industry used several CPA practices, even during periods when there was no specific policy debate on the role of dairy products in dietary guidelines. The information provided here could inform public health advocates and policy makers and help them ensure that commercial interests of industry do not impede public health policies and programmes.

Contributors to primary care guidelines: What are their professions and how many of them have conflicts of interest?

OBJECTIVE: To determine the professions of those who contribute to guidelines, guideline variables associated with differing contributor participation, and whether conflict of interest statements are provided in primary care guidelines. DESIGN: Retrospective analysis of the primary care guidelines from the Canadian Medical Association website. Two independent data extractors reviewed the guidelines and extracted relevant data. SETTING: Canada. MAIN OUTCOME MEASURES: Sponsors of guidelines, jurisdiction (national or provincial) of guidelines, the professions of those who contribute to guidelines, and the reported conflict of interest statements within guidelines. RESULTS: Of the 296 guidelines in the family medicine section of the CMA Infobase, 65 were duplicates and 35 had limited relevance to family medicine. Twenty did not provide contributor information, leaving 176 guidelines for analysis. In total, there were 2495 contributors (authors and committee members): 1343 (53.8%) non-family physician specialists, 423 (17.0%) family physicians, 141 (5.7%) nurses, 75 (3.0%) pharmacists, 269 (10.8%) other clinicians, 203 (8.1%) nonclinician scientists, and 41 (1.6%) unknown professions. The proportion of contributors from the various professions differed significantly between provincial and national guidelines, as well as between industry-funded and non-industry-funded guidelines (both P < .001). For provincial guidelines, 30.8% of contributors were family physicians and 37.3% were other specialists compared with 13.9% and 57.4%, respectively, for national guidelines. Of industry-funded guidelines, 7.8% of contributors were family physicians and 68.6% were other specialists compared with 19.4% and 49.9%, respectively, for non-industry-funded guidelines. Conflicts of interest were not reported in 68.9% of guidelines. When reported, conflict of interest statements were present for 48.6% of non-family physician specialists, 30.0% of pharmacists, 27.7% of family physicians, and 10.0% or less of the remaining groups; differences were statistically significant (P < .001). CONCLUSION: Non-family physician specialists outnumber all other health care providers combined and are more than 3 times more likely to contribute to primary care guidelines than family physicians are. Conflict of interest statements were provided in the minority of guidelines, and for guidelines in which conflict of interest statements were included, non-family physician specialists were most likely to report them. Guidelines targeted to primary care should have much more primary care and family medicine representation and include fewer contributors who have conflicts of interest.

Five-step authorship framework to improve transparency in disclosing contributors to industry-sponsored clinical trial publications.

Authorship guidelines have established criteria to guide author selection based on significance of contribution and helped to define associated responsibilities and accountabilities for the published findings. However, low awareness, variable interpretation, and inconsistent application of these guidelines can lead to confusion and a lack of transparency when recognizing those who merit authorship. This article describes a research project led by the Medical Publishing Insights and Practices (MPIP) Initiative to identify current challenges when determining authorship for industry-sponsored clinical trials and develop an improved approach to facilitate decision-making when recognizing authors from related publications. A total of 498 clinical investigators, journal editors, publication professionals and medical writers were surveyed to understand better how they would adjudicate challenging, real-world authorship case scenarios, determine the perceived frequency of each scenario and rate their confidence in the responses provided. Multiple rounds of discussions about these results with journal editors, clinical investigators and industry representatives led to the development of key recommendations intended to enhance transparency when determining authorship. These included forming a representative group to establish authorship criteria early in a trial, having all trial contributors agree to these criteria and documenting trial contributions to objectively determine who warrants an invitation to participate in the manuscript development process. The resulting Five-step Authorship Framework is designed to create a more standardized approach when determining authorship for clinical trial publications. Overall, these recommendations aim to facilitate more transparent authorship decisions and help readers better assess the credibility of results and perspectives of the authors for medical research more broadly. Please see related article: http://www.biomedcentral.com/1741-7015/12/214.

Attitudes of medical students towards incentives offered by pharmaceutical companies -- perspective from a developing nation -- a cross-sectional study.

BACKGROUND: A training physician has his first interaction with a pharmaceutical representative during medical school. Medical students are often provided with small gifts such as pens, calendars and books, as well as free lunches as part of drug promotion offers. Ethical impact of these transactions as perceived by young medical students has not been investigated in Pakistan before. This study aimed to assess the association of socio-demographic variables with the attitudes of medical students towards pharmaceutical companies and their incentives. METHODS: As part of a cross-sectional survey, a validated questionnaire previously used for assessing attitude of medical students towards pharmaceutical industry, was modified, pre-tested and distributed among consenting clinical year students at DUHS and AKU. Questions included acceptability of pharmaceutically sponsored gifts, events and tuition fee, and their impact on future prescription. Responses were graded as agree, disagree or neutral which were then scored according to the AMSA guidelines of ethical conduct. RESULTS: Out of a total of 353 targeted students 303 responded, corresponding to a response rate of 85.8%. Responses indicated that 42.7% students believed in no interaction with drug companies during medical school. However, 81% of students favored pharmaceutical sponsorship of student-body events/seminars at medical colleges. More than one-third of the students were comfortable receiving gifts from drug companies. Overall, the results of this study offer an interesting comparison between the students of a private medical school (AKU) and a public medical school (DUHS); AKU students exhibited a greater degree of mistrust towards drug information provided by pharmaceutical companies compared to DUHS students (p = 0.040). Furthermore, when asked if there was a need to incorporate guidelines in the undergraduate curriculum with regard to interaction with drug companies, 84.2% students at AKU agreed, compared to 54.9% at DUHS. Medical student Attitude Scores are more or less similar to each other independent of their various demographical differences. CONCLUSION: This study highlights that medical students in our population have a high level of acceptability towards incentives offered by pharmaceutical industry and that formal guidance regarding the subject should be incorporated into medical curriculum.

Conflict(s) of interest in peer review: its origins and possible solutions.

Scientific communication takes place at two registers: first, interactions with colleagues in close proximity-members of a network, school of thought or circle; second, depersonalised transactions among a potentially unlimited number of scholars can be involved (e.g., author and readers). The interference between the two registers in the process of peer review produces a drift toward conflict of interest. Three particular cases of peer review are differentiated: journal submissions, grant applications and applications for tenure. The current conflict of interest policies do not cover all these areas. Furthermore, they have a number of flaws, which involves an excessive reliance on scholars' personal integrity. Conflicts of interest could be managed more efficiently if several elements and rules of the judicial process were accepted in science. The analysis relies on both primary and secondary data with a particular focus on Canada.

[Ticagrelor in acute coronary syndrome. Explaining the inexplicable]. / Ticagrelor en el síndrome coronario agudo. Explicando lo inexplicable.

The PLATO study evaluated the efficacy of adding ticagrelor, instead of clopidogrel, to aspirin in patients with acute coronary syndrome, which showed surprisingly positive results making the drug acceptable to regulatory agencies and specialty societies worldwide. Notwithstanding the aforementioned success, contradictory information supplied by critical analysis was submitted by the sponsor. The controversial findings revealed several aspects that are difficult to explain, threatening the veracity of the study's conclusions. Mortality rate pattern, excessive benefit not comparable to prior studies, unexplained loss of follow-up development and inconsistency in findings in accordance with the country, the type of events arbitrator and monitoring committee are some of the most questionable issues. Dubious reaction to this trial is based on the fact that the information could not be found in published articles. This complex situation poses a challenge to the critical analysis of the text and raises questions as to how far the conflicts of financial interest influenced the development of the study, the communication of its results and probably, acceptance of the drug for commercial use.