Financial Conflicts of Interest in Public Comments on Medicare National Coverage Determinations of Medical Devices.
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SUBMITTER: Lu A
PROVIDER: S-EPMC10436180 | biostudies-literature | 2023 Sep
REPOSITORIES: biostudies-literature
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Financial Conflicts of Interest in Public Comments on Medicare National Coverage Determinations of Medical Devices.
Lu Angela A Ji Robin Z RZ Ge Alex Y AY Ross Joseph S JS Ramachandran Reshma R Redberg Rita F RF Dhruva Sanket S SS
JAMA 20230901 11
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Project description:The Centers for Medicare & Medicaid Services (CMS) relies on public comments submitted in response to proposed national coverage determinations to assist the agency in determining the coverage of items and services for Medicare beneficiaries. In a cross-sectional study, we characterized the cited evidence and what funding supported the cited evidence submitted in public comments to CMS for all therapeutic medical device national coverage determinations finalized between June 2019 and June 2022. Of 681 public comments, 159 (23%) cited at least 1 identifiable published scientific journal article. Within these 159 public comments, 198 unique articles were cited, 170 (86%) of which included funding statements or author disclosures. Among these, 96 (56%) disclosed funding from manufacturers that would benefit from Medicare coverage and/or were written by author(s) who received funding from these manufacturers. In summary, most public commenters for national coverage determinations did not cite published scientific journal articles to support their positions. Among those who did, more than half of articles were directly funded by manufacturers that would benefit from coverage. Greater funding of independent, non-industry-supported research may help provide unbiased evaluations of benefits and harms to support Medicare coverage decisions.
| S-EPMC11196998 | biostudies-literature
Project description:AimsIndustry collaboration with arrhythmia and devices research is common. However, this results in conflicts of interest (CoI) for researchers that should be disclosed. This study aimed to examine the quality of CoI disclosures in arrhythmia and devices presentations.MethodsRecorded presentations from the Arrhythmia & Devices section of the ESC Annual Congress 2016-2020 were assessed. The number of words, conflicts, and time displayed was documented for CoI declarations. Meta-data including sponsorship by an industry partner, presenter sex, and institution were obtained.ResultsOf 1153 presentations assessed, 999 were suitable for inclusion. CoI statements were missing from 7.2% of presentations, and 58% reported ≥1 conflict. Those with conflicts spent less time-per-word on their disclosures (median 150 ms, interquartile range [IQR] 83-273 ms) compared with those without conflicts (median 250 ms, IQR 125-375 ms). One-in-eight presentations were sponsored (12.8%, n = 128). CoI statements were more likely to be missing in sponsored presentations (14.8%, n = 19) compared with non-sponsored presentations (6.1%, n = 53), P = 0.0003. Sponsored presentations contained a greater median number of CoIs (10, IQR 6-18) compared with non-sponsored sessions (1, IQR 0-5), P < 0.0001. Time-per-word spent on COI disclosures was 50% lower in sponsored sessions (125 ms, IQR 75-231 ms) compared with non-sponsored sessions (250 ms, IQR 125-375 ms), P < 0.0001.ConclusionThe majority of those presenting arrhythmia and devices research have CoIs to declare. Declarations were often missing or displayed for short periods of time. Presenters in sponsored sessions, while being more conflicted, had a lower standard of declaration suggesting a higher risk of potential bias which viewers had insufficient opportunity to assess.
| S-EPMC9935044 | biostudies-literature
Project description:Financial conflicts of interest (fCOI) can introduce actions that bias clinical trial results and reduce their objectivity. We obtained information from investigators about adherence to practices that minimize the introduction of such bias in their clinical trials experience.Email survey of clinical trial investigators from Canadian sites to learn about adherence to practices that help maintain research independence across all stages of trial preparation, conduct, and dissemination. The main outcome was the proportion of investigators that reported full adherence to preferred trial practices for all of their trials conducted from 2001-2006, stratified by funding source.844 investigators responded (76%) and 732 (66%) provided useful information. Full adherence to preferred clinical trial practices was highest for institutional review of signed contracts and budgets (82% and 75% of investigators respectively). Lower rates of full adherence were reported for the other two practices in the trial preparation stage (avoidance of confidentiality clauses, 12%; trial registration after 2005, 39%). Lower rates of full adherence were reported for 7 practices in the trial conduct (35% to 43%) and dissemination (53% to 64%) stages, particularly in industry funded trials. 269 investigators personally experienced (n = 85) or witnessed (n = 236) a fCOI; over 70% of these situations related to industry trials.Full adherence to practices designed to promote the objectivity of research varied across trial stages and was low overall, particularly for industry funded trials.
| S-EPMC3031202 | biostudies-literature
Project description:ImportanceApproximately one-third of U.S. life sciences faculty engage in industry consulting. Despite reports that consulting contracts often impinge on faculty and university interests, institutional approaches to regulating consulting agreements are largely unknown.ObjectiveTo investigate the nature of institutional oversight of faculty consulting contracts at U.S. schools of medicine and public health.DesignStructured telephone interviews with institutional administrators. Questions included the nature of oversight for faculty consulting agreements, if any, and views about consulting as a private versus institutional matter. Interviews were analyzed using a structured coding scheme.SettingAll accredited schools of medicine and public health in the U.S.ParticipantsAdministrators responsible for faculty affairs were identified via internet searches and telephone and email follow-up. The 118 administrators interviewed represented 73% of U.S. schools of medicine and public health, and 75% of those invited to participate.InterventionStructured, 15-30 minute telephone interviews.Main outcomes and measuresPrevalence and type of institutional oversight; responses to concerning provisions in consulting agreements; perceptions of institutional oversight.ResultsOne third of institutions (36%) required faculty to submit at least some agreements for institutional review and 36% reviewed contracts upon request, while 35% refused to review contracts. Among institutions with review, there was wide variation the issues covered. The most common topic was intellectual property rights (64%), while only 23% looked at publication rights and 19% for inappropriately broad confidentiality provisions. Six in ten administrators reported they had no power to prevent faculty from signing consulting agreements. Although most respondents identified institutional risks from consulting relationships, many maintained that consulting agreements are "private."Conclusions and relevanceOversight of faculty consulting agreements at U.S. schools of medicine and public health is inconsistent across institutions and usually not robust. The interests at stake suggest the need for stronger oversight.
| S-EPMC6205599 | biostudies-literature
Project description:ObjectiveTo systematically evaluate the prevalence of disclosed and undisclosed financial conflicts of interest (FCOI) among clinical practice guidelines (CPGs).MethodsIn this systematic review, we ascertained the prevalence and types of FCOI for CPGs from January 1, 1980, to March 3, 2019. The primary outcome was the prevalence of FCOI among authors of CPGs. FCOI disclosures were compared between medical subspecialties and societies producing CPGs.ResultsAmong the 37 studies including 14,764 total guideline authors, 45% had at least one FCOI. The prevalence of FCOI per study ranged from 6% to 100%. More authors had FCOI involving general payments (39%) compared with research payments (29%). Oncology, neurology, and gastroenterology had the highest prevalence of FCOI compared with other medical specialties. Among the 8 studies that included the monetary values in US dollars of FCOI, average payments per author ranged from $578 to $242,300. Among the 10 studies that included data on undisclosed FCOI, 32% of authors had undisclosed industry payments.ConclusionThere are numerous FCOI among authors of CPGs, many of which are undisclosed. Our study found a significant difference in FCOI prevalence based on types of FCOI and CPG sponsor society. Additional research is required to quantify the implications of FCOI on clinical judgment and patient care.
| S-EPMC8105509 | biostudies-literature
Project description:ObjectiveTo assess the extent and types of financial ties to industry of panel and task force members of the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, fifth edition, text revision (DSM-5-TR), published in 2022.DesignCross sectional analysis.SettingOpen Payments database, USA.Participants92 physicians based in the US who served as members of either a panel (n=86) or task force (n=6) on the DSM-5-TR with information recorded in the Centers for Medicare and Medicaid Services Open Payments database during 2016-19. This period was chosen to include the year that development of the DSM-5-TR began and the three years preceding, a time consistent with previous research on conflicts of interest and consistent with the American Psychiatric Association's disclosure requirements for the fifth revision (DSM-5) of the manual.Main outcome measuresType and amount of compensation the panel and task force members of DSM-5-TR received during 2016-19.ResultsAfter duplicate names had been removed, 168 individuals were identified who served as either panel or task force members of the DSM-5-TR. 92 met the inclusion criteria of being a physician who was based in the US and therefore could be included in Open Payments. Of these 92 individuals, 55 (60%) received payments from industry. Collectively, these panel members received a total of $14.2m (£11.2m; €13m). One third (33.3%) of the task force members had payments reported in Open Payments.ConclusionsConflicts of interest among panel members of DSM-5-TR were prevalent. Because of the enormous influence of diagnostic and treatment guidelines, the standards for participation on a guideline development panel should be high. A rebuttable presumption should exist for the Diagnostic and Statistical Manual of Mental Disorders to prohibit conflicts of interest among its panel and task force members. When no independent individuals with the requisite expertise are available, individuals with associations to industry could consult to the panels, but they should not have decision making authority on revisions or the inclusion of new disorders.
| S-EPMC10777894 | biostudies-literature
Project description:Background. Tobacco companies have actively promoted the substitution of cigarettes with purportedly safer tobacco products (e.g., smokeless tobacco, e-cigarettes) as tobacco harm reduction (THR). Given the tobacco, e-cigarette, and pharmaceutical industries' substantial financial interests, we quantified industry influence on support for THR. Objectives. To analyze a comprehensive set of articles published in peer-reviewed journals assessing funding sources and support for or opposition to substitution of tobacco or nicotine products as harm reduction. Search Methods. We searched PubMed, Embase, Web of Science, and PsycINFO with a comprehensive search string including all articles, comments, and editorials published between January 1, 1992, and July 26, 2016. Selection Criteria. We included English-language publications published in peer-reviewed journals addressing THR in humans and excluded studies on modified cigarettes, on South Asian smokeless tobacco variants, on pregnant women, on animals, not mentioning a tobacco or nicotine product, on US Food and Drug Administration-approved nicotine replacement therapies, and on nicotine vaccines. Data Collection and Analysis. We double-coded all articles for article type; primary product type (e.g., snus, e-cigarettes); themes for and against THR; stance on THR; THR concepts; funding or affiliation with tobacco, e-cigarette, pharmaceutical industry, or multiple industries; and each author's country. We fit exact logistic regression models with stance on THR as the outcome (pro- vs anti-THR) and source of funding or industry affiliation as the predictor taking into account sparse data. Additional models included article type as the outcome (nonempirical or empirical) and industry funding or affiliation as predictor, and stratified analyses for empirical and nonempirical studies with stance on THR as outcome and funding source as predictor. Main Results. Searches retrieved 826 articles, including nonempirical articles (21%), letters or commentaries (34%), editorials (5%), cross-sectional studies (15%), systematic reviews and meta-analyses (3%), and randomized controlled trials (2%). Overall, 23.9% disclosed support by industry; 49% of articles endorsed THR, 42% opposed it, and 9% took neutral or mixed positions. Support from the e-cigarette industry (odds ratio [OR] = 20.9; 95% confidence interval [CI] = 5.3, 180.7), tobacco industry (OR = 59.4; 95% CI = 10.1, +infinity), or pharmaceutical industry (OR = 2.18; 95% CI = 1.3, 3.7) was significantly associated with supportive stance on THR in analyses accounting for sparse data. Authors' Conclusions. Non-industry-funded articles were evenly divided in stance, while industry-funded articles favored THR. Because of their quantity, letters and comments may influence perceptions of THR when empirical studies lack consensus. Public Health Implications. Public health practitioners and researchers need to account for industry funding when interpreting the evidence in THR debates.
| S-EPMC6603486 | biostudies-literature
Project description:BackgroundIndustry and orthopaedic surgeons often partner to develop new technology, which can lead to orthopaedic surgeons having financial conflicts of interest (FCOI). It is essential these FCOI be conveyed clearly to patients. It is unclear, however, whether and to what degree patients understand the ramifications of physician FCOI.Questions/purposesWe evaluated (1) patients' concerns regarding their surgeon having FCOI or the presence of institutional FCOI, (2) the effect of surgeon FCOI on patients' willingness to have surgery, and (3) patients' understanding of FCOI.MethodsWe asked 101 patients (66% female) receiving total joint arthroplasty from the orthopaedic practices of two surgeons at an academic health center to complete a descriptive, correlational designed survey at their 6-week followup appointment. The data collected included patient demographics, knowledge of FCOI, and the influence of FCOI on patient attitudes toward surgery and their surgeon.ResultsA minority of patients (13%) reported discussing FCOI with prior physicians and only 55% agreed or strongly agreed a surgeon should disclose FCOI. Only 15% of patients believed such conflicts would make them less likely to have their surgeon operate on them. Level of education was weakly correlated (Spearman's rho = 0.29) with patient understanding of FCOI.ConclusionsOverall, patients had a poor understanding of FCOI. Both level of education and previous discussions of FCOI predicted better understanding. This study emphasizes communication of FCOI with patients needs to be enhanced.
| S-EPMC3549175 | biostudies-literature
Project description:Background There is a high prevalence of financial conflicts of interest (COI) between physicians and industry. Objectives To conduct a systematic review with meta-analysis examining the completeness of self-reported financial COI disclosures by physicians, and identify factors associated with non-disclosure. Data sources MEDLINE, Embase and PsycINFO were searched for eligible studies up to April 2020 and supplemented with material identified in the references and citing articles. Data extraction and synthesis Data were independently abstracted by two authors. Data synthesis was performed via systematic review of eligible studies and random-effects meta-analysis. Main outcomes and measures The proportion of discrepancies between physician self-reported disclosures and objective payment data was the main outcome. The proportion of discrepant funds and factors associated with non-disclosure were also examined. Results 40 studies were included. The pooled proportion of COI discrepancies at the article level was 81% (range: 54%–98%; 95% CI 72% to 89%), 79% at the payment level (range: 71%–89%; 95% CI 67% to 89%), 93% at the authorship level (range: 71%–100%; 95% CI 79% to 100%) and 66% at the author level (range: 8%–99%; 95% CI 48% to 78%). The proportion of funds discrepant was 33% (range: 2%–77%; 95% CI 12% to 58%). There was high heterogeneity between studies across all five analyses (I2=94%–99%). Most undisclosed COI were related to food and beverage, or travel and lodging. While the most common explanation for failure to disclose was perceived irrelevance, a median of 45% of non-disclosed payments were directly or indirectly related to the work. A smaller monetary amount was the most common factor associated with nondisclosure. Conclusions Physician self-reports of financial COI are highly discrepant with objective data sources reporting payments from industry. Stronger policies are required to reduce reliance on physician self-reporting of financial COI and address non-compliance.
| S-EPMC8039229 | biostudies-literature
Project description:BackgroundFinancial conflicts of interest (FCOI) are known to be prevalent in medicine. Authorship of pivotal trials reap non-financial benefits including publication productivity that can be used for assessment of tenure positions and promotion. The purpose of this investigation was to quantify the prevalence and discordance of academic trial author (authors) FCOI in industry-sponsored drug trials that were initially presented as oral abstracts and subsequently resulted in a peer-reviewed publication.MethodsOral abstracts from the American Society of Clinical Oncology (ASCO) 2017 Annual Meeting that were subsequently published were identified. Studies that were non-industry sponsored, non-adult, or non-therapeutic trials were excluded. Studies that did not have a subsequent peer-reviewed publication or had a publication preceding the ASCO 2017 Annual Meeting were also excluded. FCOI was categorized and impact factor (IF) for the journal at the time of publication was retrieved. FCOI discordance between the oral abstract and publication was calculated based on geographic location and IF.ResultsA total of 22 paired abstract and publications met inclusion criteria for further analysis. A total of 384 authors were identified, of these 280 authors (74.1%) were included in both the oral abstract and subsequent publication. A total of 76% of these 280 authors had FCOI and 66.4% had FCOI discordance. There were statistically significant differences for the sum of FCOI discordance for U.S.-based authors (p = 0.0004) but not for journal IF. When analyzing the sum of absolute differences of FCOI discordance, statistical significance was reached for authors from any of the three geographic regions, as well as, low and high IF journals (all p-values < 0.0001).ConclusionsThis study draws attention to the lack of uniformity and vetting of FCOI reporting in abstracts and journals publishing solid tumor oncology trial results. This is particularly concerning, since FCOI is prevalent globally.
| S-EPMC6375255 | biostudies-literature