Association Between Conflict of Interest and Published Position on Hypoglossal Nerve Stimulation for Sleep Apnea.

OBJECTIVE: To determine if there is an association between authors' financial conflict of interest and published position on clinical use of hypoglossal nerve stimulation for obstructive sleep apnea. STUDY DESIGN: Retrospective cross-sectional analysis. SETTING: International roster of authors and articles analyzed. METHODS: A Google Scholar search was performed for editorials and reviews citing the 2014 New England Journal of Medicine article on hypoglossal nerve stimulation for obstructive sleep apnea. Included articles were coded as favorable or neutral. Conflict of interest was recorded as declared by the authors in these articles and as independently searched in the Open Payments registry. RESULTS: Sixteen articles from 45 independent authors were analyzed. Nine articles by authors were coded as favorable. Among authors of articles with favorable views, 16 (59%) had a financial conflict of interest with the manufacturer of the hypoglossal nerve stimulator device, as opposed to only 1 of 21 (5%) authors of neutral/unfavorable articles. When we included only authors to whom payments could be identified or excluded on Open Payments, 16 of 20 (80%; 95% CI, 62%-98%) authors of favorable articles had a financial conflict, while 1 of 10 (10%; 95% CI, 0%-29.6%) of neutral/unfavorable articles did (P = .004). CONCLUSION: Our study demonstrates an association between published position on hypoglossal nerve stimulator use and financial conflict with the device manufacturer. Several undeclared conflicts were also found, suggesting a role for independent search for conflicts during the review process.

'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.

Assessing the domino effect: Female physician industry payments fall short, parallel gender inequalities in medicine.

BACKGROUND: Physician-industry relationships have been complex in modern medicine. Since large proportions of research, education and consulting are industry-backed, this is an important area to consider when examining gender inequality in medicine. METHODS: The Open Payments Program (OPP) database from August 2013 to December 2016 was analyzed. In order to identify physicians' genders, the OPP was matched with the National Provider Index dataset. Descriptive statistics of payments to female compared to male surgeons were obtained and stratified by payment type, subspecialty, geographic location and year. RESULTS: 3,925,707 transactions to 136,845 physicians were analyzed. Of them, 31,297 physicians were surgeons with an average payment per provider of $131,252 to male surgeons compared to $62,101 to female surgeons. Significantly fewer women received consultant, royalty/licensure, ownership and speaker payments. However, women received a higher average amount per surgeon compared to their male counterparts within research payments. Overall payments to women trended upwards over time. CONCLUSION: Gender inequality still exists in medicine, and in industry-physician payments. Industry should increasingly consider engaging women in consultancies, speaking engagements, and research.

The Accuracy of Conflict-of-Interest Disclosures Reported by Plastic Surgeons and Industry.

BACKGROUND: The purpose of this study was to analyze the frequency and nature of self-reported conflict-of-interest disclosures in the plastic surgery literature and to compare these findings to the Physician Payments Sunshine Act database. METHODS: All articles published from August of 2013 through December of 2013 in four major plastic surgery journals were analyzed. For every publication, the conflict-of-interest disclosure statement for each investigator was reviewed. These statements were then compared to transactions of value for each investigator as reported by biomedical companies in the Sunshine Act database. An analysis was performed to identify and characterize specific factors associated with conflict-of-interest disclosures. RESULTS: A total of 1002 independent investigators/authors were identified. Of these, 90 investigators (9 percent) self-reported a conflict of interest. In contrast, a total of 428 authors (42.7 percent) were found to have received transactions of value from a biomedical company according to the Sunshine Act database. Conversely, a total of 22 authors (2.2 percent) self-reported a conflict of interest but were not found to have received transactions of value in the Sunshine Act database. Our analysis found that (1) academic investigators, (2) transactions of value in excess of $500, and (3) publishing articles related to the sponsoring biomedical company were all statistically associated with reporting conflicts of interest (p < 0.0001). CONCLUSIONS: Discordance exists between investigator/authors self-reporting in scientific journals and the government-mandated reporting of conflicts of interest by industry. Factors associated with conflict-of-interest disclosure include academic status, transaction amount, and article content related to the sponsoring biomedical company.

Evidence Regarding the Impact of Conflicts of Interest on Environmental and Occupational Health Research.

PURPOSE OF REVIEW: This review describes published literature providing evidence for financial conflicts of interest in environmental and occupational health research. Secondary goals were to describe evidence that (a) utilized quantitative methods to evaluate the association of conflicts with study outcomes, and (b) assessed undisclosed as well as disclosed conflicts of interest. RECENT FINDINGS: Forty-three studies were identified which contained descriptions of the impact of financial conflicts of interest on research results; 11 of these conducted quantitative analyses to demonstrate these relationships. All 11 articles which quantified associations identified significant associations of the presence of financial conflicts of interest with study findings. In studies which measured undisclosed conflicts, these comprised a substantial proportion of all conflicts. Suggestions for improving understanding and interpretation of research results are presented.

[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.

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

Surgeon-industry conflict of interest: survey of opinions regarding industry-sponsored educational events and surgeon teaching: clinical article.

OBJECT: Conflict of interest (COI) as it applies to medical education and training has become a source of considerable interest, debate, and regulation in the last decade. Companies often pay surgeons as faculty for educational events and often sponsor and give financial support to major professional society meetings. Professional medical societies, industry, and legislators have attempted to regulate potential COI without consideration for public opinion. The practice of evidence-based medicine requires the inclusion of patient opinion along with best available evidence and expert opinion. The primary goal of this study was to assess the opinion of the general population regarding surgeon-industry COI for education-related events. METHODS: A Web-based survey was administered, with special emphasis on the surgeon's role in industry-sponsored education and support of professional societies. A survey was constructed to sample opinions on reimbursement, disclosure, and funding sources for educational events. RESULTS: There were 501 completed surveys available for analysis. More than 90% of respondents believed that industry funding for surgeons' tuition and travel for either industry-sponsored or professional society educational meetings would either not affect the quality of care delivered or would cause it to improve. Similar results were generated for opinions on surgeons being paid by industry to teach other surgeons. Moreover, the majority of respondents believed it was ethical or had no opinion if surgeons had such a relationship with industry. Respondents were also generally in favor of educational conferences for surgeons regardless of funding source. Disclosures of a surgeon-industry relationship, especially if it involves specific devices that may be used in their surgery, appears to be important to respondents. CONCLUSIONS: The vast majority of respondents in this study do not believe that the quality of their care will be diminished due to industry funding of educational events, for surgeon tuition, and/or travel expenses. The results of this study should help form the basis of policy and continued efforts at surgeon-industry COI management.

Editorial input for the right price: tobacco industry support for a sheet metal indoor air quality manual.

Following legal action in the 1990s, internal tobacco industry documents became public, allowing unprecedented insight into the industry's relationships with outside organizations. During the 1980s and 1990s, the National Energy Management Institute (NEMI), established by the Sheet Metal Workers International Association and the Sheet Metal and Air Conditioning Contractors' National Association, (SMACNA) received tobacco industry funding to establish an indoor air quality services program. But the arrangement also required NEMI to serve as an advocate for industry efforts to defeat indoor smoking bans by arguing that ventilation was a more appropriate solution to environmental tobacco smoke. Drawing on tobacco industry documents, this paper describes a striking example of the ethical compromises that accompanied NEMI's collaboration with the tobacco industry, highlighting the solicitation of tobacco industry financial support for a SMACNA indoor air quality manual in exchange for sanitizing references to the health impact of environmental tobacco smoke prior to publication.

Conflicts-of-interest disclosures at the 2010 AUGS Scientific Meeting.

OBJECTIVES: To describe authors' trends in reporting conflicts of interest in their research at the 2010 Annual Scientific Meeting of the American Urogynecologic Society. METHODS: We extracted data regarding financial disclosures during oral presentations and compared the conflicts of interest disclosed during oral presentations with those enumerated in the published abstract. RESULTS: We collected data on 86 of 100 oral presentations given at the 2010 American Urogynecologic Society scientific meeting. Seventy-five (87%) of the 86 presentations included a disclosure slide. Twenty-six of the 86 presenters had no verbal mention of potential conflicts of interest. There was discordance between disclosures printed in the abstract and those listed in the oral presentation in 49% of the papers, with slides providing more comprehensive information in 64% of the entries. CONCLUSIONS: Despite instructions to the contrary, 13% of presentations in 2010 did not address potential influence by a financial subsidy. Explicit instructions, a streamlined reporting process, and prioritization by our scientific community may improve the consistency and uniformity of financial disclosure reporting.

Prevalence of financial conflicts of interest among panel members producing clinical practice guidelines in Canada and United States: cross sectional study.

OBJECTIVE: To determine the prevalence of financial conflicts of interest among members of panels producing clinical practice guidelines on screening, treatment, or both for hyperlipidaemia or diabetes. DESIGN: Cross sectional study. SETTING: Relevant guidelines published by national organisations in the United States and Canada between 2000 and 2010. PARTICIPANTS: Members of guideline panels. MAIN OUTCOME MEASURES: Prevalence of financial conflicts of interest among members of guideline panels and chairs of panels. RESULTS: Fourteen guidelines met our search criteria, of which five had no accompanying declaration of conflicts of interest by panel members. 288 panel members had participated in the guideline development process. Among the 288 panel members, 138 (48%) reported conflicts of interest at the time of the publication of the guideline and 150 (52%) either stated that they had no such conflicts or did not have an opportunity to declare any. Among 73 panellists who formally declared no conflicts, 8 (11%) were found to have one or more. Twelve of the 14 guideline panels evaluated identified chairs, among whom six had financial conflicts of interest. Overall, 150 (52%) panel members had conflicts, of which 138 were declared and 12 were undeclared. Panel members from government sponsored guidelines were less likely to have conflicts of interest compared with guidelines sponsored by non-government sources (15/92 (16%) v 135/196 (69%); P<0.001). CONCLUSIONS: The prevalence of financial conflicts of interest and their under-reporting by members of panels producing clinical practice guidelines on hyperlipidaemia or diabetes was high, and a relatively high proportion of guidelines did not have public disclosure of conflicts of interest. Organisations that produce guidelines should minimise conflicts of interest among panel members to ensure the credibility and evidence based nature of the guidelines' content.

Sponsorship of physical activity programs by the sweetened beverages industry: public health or public relations?

The growing evidence on the association between consumption of sugar-sweetened beverages, obesity and other chronic diseases has highlighted the need to implement policy actions that go beyond programs exclusively focused on individual responsibility. In order to protect their commercial goals in Latin America, the sugar-sweetened beverage industry practices intense lobbying at high government levels in several countries across the region. This strategy is accompanied by corporate social responsibility programs that fund initiatives promoting physical activity. These efforts, although appearing altruistic, are intended to improve the industry's public image and increase political influence in order to block regulations counter to their interests. If this industry wants to contribute to human well being, as it has publicly stated, it should avoid blocking legislative actions intended to regulate the marketing, advertising and sale of their products.

Relationships between authorship contributions and authors' industry financial ties among oncology clinical trials.

PURPOSE To test the hypothesis that authors who play key scientific roles in oncology clinical trials, and who therefore have increased influence over the design, analysis, interpretation or reporting of trials, are more likely than those who do not play such roles to have financial ties to industry. METHODS Data were abstracted from all trials (n = 235) of drugs or biologic agents published in the Journal of Clinical Oncology between January 1, 2006 and June 30, 2007. Article-level data included sponsorship, age group (adult v pediatric), phase, single versus multicenter, country (United States v other), and number of authors. Author-level data (n = 2,927) included financial ties (eg, employment, consulting) and performance of key scientific roles (ie, conception/design, analysis/interpretation, or manuscript writing). Associations between performance of key roles and financial ties, adjusting for article-level covariates, were examined using generalized linear mixed models. Results One thousand eight hundred eighty-one authors (64%) reported performing at least one key role, and 842 authors (29%) reported at least one financial tie. Authors who reported performing a key role were more likely than other authors to report financial ties to industry (adjusted odds ratio [OR], 4.3; 99% CI, 3.0 to 6.0; P < .0001). The association was stronger among trials with, compared with those without, industry funding (OR, 5.0 [99% CI, 3.4 to 7.5] v OR, 2.5 [99% CI, 1.3 to 4.8]), but was present regardless of sponsorship. CONCLUSION Authors who perform key roles in the conception and design, analysis, and interpretation, or reporting of oncology clinical trials are more likely than authors who do not perform such roles to have financial ties to industry.

An analysis of studies on piezoelectric surgery in the oral and craniomaxillofacial region with regard to human subject protection and financial conflicts.

This retrospective, observational study investigated whether published studies on the use of piezoelectric surgery (PS) in the oral and craniomaxillofacial region fulfilled the requirements of the International Committee of Medical Journal Editors (ICMJE) and the Declaration of Helsinki (DoH) with respect to human subject protections (HSP) and disclosure of financial conflicts (FC). A Medline/PUBMED search was performed in April 2008 to identify all clinical studies on PS, published in English, French and German. Disclosure of HSP (obtaining ethical approval and subjects' informed consent) and FC mentioned in the retrieved articles were analysed. 29 clinical articles were identified in 18 journals, of which 14 journals (78%) required the disclosure of both HSP and FC. Ethical approval was documented in two studies (7%); patient consent was reported in four publications (14%). Four articles disclosed no FC. 21 reports (72%) mentioned neither HSP nor FC. The relationships between funding source and study outcomes could not be identified. Most studies on the use of PS hardly adhered to the regulations recommended by the ICMJE and DoH, and do not mention HSP and FC, indicating the study results with a high degree of suspicion. It is recommended that oral and craniomaxillofacial surgery journals adhere strictly to these regulations because they carry a heavy responsibility regarding the scientific integrity of publications in this specialty.

The impact of strategic funding by the tobacco industry of medical expert witnesses appearing for the defence in the Aho Finnish product liability case.

AIMS: To identify and evaluate tobacco industry strategies to recruit medical expert witnesses. METHODS: A systematic search was made of internal tobacco industry documents available on the Internet and at British American Tobacco Guildford Depository. Litigation by a plaintiff with laryngeal cancer against the tobacco industry in Finland was used as a case study of tobacco industry strategies to manipulate science and its use and deployment in defending a product liability claim. RESULTS: Thirty-three of 45 medical expert witnesses for the defence received research funding before or after testifying. One strategy was to employ those scientists as witnesses with whom the industry had worked since the 1960s. The older witnesses testified to the existence of a controversy which they had, in fact, helped to create. Those appearing in Helsinki District court apparently downplayed the importance of their involvement with the industry. Another strategy was the use of research funding to establish contacts with new potential witnesses, to strengthen existing contacts or to pay back helpful experts. CONCLUSIONS: The tobacco industry funded the majority of expert witnesses appearing for it, beyond simple recompense for the time involved. This may have unconsciously influenced the testimony given by the witnesses. This funding should be considered in court, but links between experts and the industry were often downplayed or, in some cases, the financial ties were being forged at the time and were not revealed. It would be helpful to establish norms to guide courts to understand the influences exerted by the tobacco industry in the preparation of cases requiring expert evidence.