Dataset Information

Undisclosed financial ties between guideline writers and pharmaceutical companies: a cross-sectional study across 10 disease categories.

ABSTRACT: OBJECTIVES:To investigate the proportion of potentially relevant undisclosed financial ties between clinical practice guideline writers and pharmaceutical companies. DESIGN:Cross-sectional study of a stratified random sample of Australian guidelines and writers. SETTING:Guidelines available from Australia's National Health and Medical Research Council guideline database, 2012-2014, stratified across 10 health priority areas. POPULATION:402 authors of 33 guidelines, including up to four from each area, dependent on availability: arthritis/musculoskeletal (3); asthma (4); cancer (4); cardiovascular (4); diabetes (4); injury (3); kidney/urogenital (4); mental health (4); neurological (1); obesity (1). For guideline writers with no disclosures, or who disclosed no ties, a search of disclosures in the medical literature in the 5 years prior to guideline publication identified potentially relevant ties, undisclosed in guidelines. Guidelines were included if they contained recommendations of medicines, and writers included if developing or writing guidelines. MAIN OUTCOME MEASURES:Proportions of guideline writers with potentially relevant undisclosed financial ties to pharmaceutical companies active in the therapeutic area; proportion of guidelines including at least one writer with a potentially relevant undisclosed tie. RESULTS:344 of 402 writers (86%; 95%?CI 82% to 89%) either had no published disclosures (228) or disclosed they had no ties (116). Of the 344 with no disclosed ties, 83 (24%; 95%?CI 20% to 29%) had potentially relevant undisclosed ties. Of 33 guidelines, 23 (70%; 95%?CI 51% to 84%) included at least one writer with a potentially relevant undisclosed tie. Writers of guidelines developed and funded by governments were less likely to have undisclosed financial ties (8.1%vs30.6%; risk ratio 0.26; 95%?CI 0.13 to 0.53; p<0.001). CONCLUSIONS:Almost one in four guideline writers with no disclosed ties may have potentially relevant undisclosed ties to pharmaceutical companies. These data confirm the need for strategies to ensure greater transparency and more independence in relationships between guidelines and industry.

SUBMITTER: Moynihan R

PROVIDER: S-EPMC6377504 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Undisclosed financial ties between guideline writers and pharmaceutical companies: a cross-sectional study across 10 disease categories.

Moynihan Ray R Lai Alexandra A Jarvis Huw H Duggan Geraint G Goodrick Stephanie S Beller Elaine E Bero Lisa L

BMJ open 20190205 2

<h4>Objectives</h4>To investigate the proportion of potentially relevant undisclosed financial ties between clinical practice guideline writers and pharmaceutical companies.<h4>Design</h4>Cross-sectional study of a stratified random sample of Australian guidelines and writers.<h4>Setting</h4>Guidelines available from Australia's National Health and Medical Research Council guideline database, 2012-2014, stratified across 10 health priority areas.<h4>Population</h4>402 authors of 33 guidelines, i ...[more]

PMID: 30813119

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Project description:Objective To examine the association between the presence of individual principal investigators' financial ties to the manufacturer of the study drug and the trial's outcomes after accounting for source of research funding.Design Cross sectional study of randomized controlled trials (RCTs).Setting Studies published in "core clinical" journals, as identified by Medline, between 1 January 2013 and 31 December 2013.Participants Random sample of RCTs focused on drug efficacy.Main outcome measure Association between financial ties of principal investigators and study outcome.Results A total of 190 papers describing 195 studies met inclusion criteria. Financial ties between principal investigators and the pharmaceutical industry were present in 132 (67.7%) studies. Of 397 principal investigators, 231 (58%) had financial ties and 166 (42%) did not. Of all principal investigators, 156 (39%) reported advisor/consultancy payments, 81 (20%) reported speakers' fees, 81 (20%) reported unspecified financial ties, 52 (13%) reported honorariums, 52 (13%) reported employee relationships, 52 (13%) reported travel fees, 41 (10%) reported stock ownership, and 20 (5%) reported having a patent related to the study drug. The prevalence of financial ties of principal investigators was 76% (103/136) among positive studies and 49% (29/59) among negative studies. In unadjusted analyses, the presence of a financial tie was associated with a positive study outcome (odds ratio 3.23, 95% confidence interval 1.7 to 6.1). In the primary multivariate analysis, a financial tie was significantly associated with positive RCT outcome after adjustment for the study funding source (odds ratio 3.57 (1.7 to 7.7). The secondary analysis controlled for additional RCT characteristics such as study phase, sample size, country of first authors, specialty, trial registration, study design, type of analysis, comparator, and outcome measure. These characteristics did not appreciably affect the relation between financial ties and study outcomes (odds ratio 3.37, 1.4 to 7.9).Conclusions Financial ties of principal investigators were independently associated with positive clinical trial results. These findings may be suggestive of bias in the evidence base.

Project description:Importance:Understanding the profitability of pharmaceutical companies is essential to formulating evidence-based policies to reduce drug costs while maintaining the industry's ability to innovate and provide essential medicines. Objective:To compare the profitability of large pharmaceutical companies with other large companies. Design, Setting, and Participants:This cross-sectional study compared the annual profits of 35 large pharmaceutical companies with 357 companies in the S&P 500 Index from 2000 to 2018 using information from annual financial reports. A statistically significant differential profit margin favoring pharmaceutical companies was evidence of greater profitability. Exposures:Large pharmaceutical vs nonpharmaceutical companies. Main Outcomes and Measures:The main outcomes were revenue and 3 measures of annual profit: gross profit (revenue minus the cost of goods sold); earnings before interest, taxes, depreciation, and amortization (EBITDA; pretax profit from core business activities); and net income, also referred to as earnings (difference between all revenues and expenses). Profit measures are described as cumulative for all companies from 2000 to 2018 or annual profit as a fraction of revenue (margin). Results:From 2000 to 2018, 35 large pharmaceutical companies reported cumulative revenue of $11.5 trillion, gross profit of $8.6 trillion, EBITDA of $3.7 trillion, and net income of $1.9 trillion, while 357 S&P 500 companies reported cumulative revenue of $130.5 trillion, gross profit of $42.1 trillion, EBITDA of $22.8 trillion, and net income of $9.4 trillion. In bivariable regression models, the median annual profit margins of pharmaceutical companies were significantly greater than those of S&P 500 companies (gross profit margin: 76.5% vs 37.4%; difference, 39.1% [95% CI, 32.5%-45.7%]; P?<?.001; EBITDA margin: 29.4% vs 19%; difference, 10.4% [95% CI, 7.1%-13.7%]; P?<?.001; net income margin: 13.8% vs 7.7%; difference, 6.1% [95% CI, 2.5%-9.7%]; P?<?.001). The differences were smaller in regression models controlling for company size and year and when considering only companies reporting research and development expense (gross profit margin: difference, 30.5% [95% CI, 20.9%-40.1%]; P?<?.001; EBITDA margin: difference, 9.2% [95% CI, 5.2%-13.2%]; P?<?.001; net income margin: difference, 3.6% [95% CI, 0.011%-7.2%]; P?=?.05). Conclusions and Relevance:From 2000 to 2018, the profitability of large pharmaceutical companies was significantly greater than other large, public companies, but the difference was less pronounced when considering company size, year, or research and development expense. Data on the profitability of large pharmaceutical companies may be relevant to formulating evidence-based policies to make medicines more affordable.

Project description:OBJECTIVE:To investigate the nature and extent of financial relationships between leaders of influential professional medical associations in the United States and pharmaceutical and device companies. DESIGN:Cross sectional study. SETTING:Professional associations for the 10 costliest disease areas in the US according to the US Agency for Healthcare Research and Quality. Financial data for association leadership, 2017-19, were obtained from the Open Payments database. POPULATION:328 leaders, such as board members, of 10 professional medical associations: American College of Cardiology, Orthopaedic Trauma Association, American Psychiatric Association, Endocrine Society, American College of Rheumatology, American Society of Clinical Oncology, American Thoracic Society, North American Spine Society, Infectious Diseases Society of America, and American College of Physicians. MAIN OUTCOME MEASURES:Proportion of leaders with financial ties to industry in the year of leadership, the four years before and the year after board membership, and the nature and extent of these financial relationships. RESULTS:235 of 328 leaders (72%) had financial ties to industry. Among 293 leaders who were medical doctors or doctors of osteopathy, 235 (80%) had ties. Total payments for 2017-19 leadership were almost $130m (£103m; €119m), with a median amount for each leader of $31?805 (interquartile range $1157 to $254?272). General payments, including those for consultancy and hospitality, were $24.8m and research payments were $104.6m-predominantly payments to academic institutions with association leaders named as principle investigators. Variation was great among the associations: median amounts varied from $212 for the American Psychiatric Association leaders to $518?000 for the American Society of Clinical Oncology. CONCLUSIONS:Financial relationships between the leaders of influential US professional medical associations and industry are extensive, although with variation among the associations. The quantum of payments raises questions about independence and integrity, adding weight to calls for policy reform.

Project description:OBJECTIVES:To determine the relationship between manufacturer-related financial ties among investigators of published drug trials and rates of discrepant registered and published primary trial outcomes. DESIGN:Cross-sectional study. SETTING:Human subjects drug trials published in 'core clinical' MEDLINE journals in 2013. PRIMARY AND SECONDARY OUTCOME MEASURES:The primary study endpoint was the presence of a prospectively registered, clearly defined primary outcome that matched the published primary outcome for each included trial. Secondary outcomes included assessments of registration timing and quality, and the impact of outcome discrepancies between registration and publication on the statistical significance of the included trials. RESULTS:Of 192 included trials, 134 (70%) were positive and 58 (30%) were negative. Financial ties were present between first or last authors and drug manufacturers for 130 trials (68%), of which 78% were positive, versus 53% of trials with no financial ties that were positive. Clearly defined, prospectively registered outcomes that matched the published outcomes were present in just 76 of the 192 trials (40%). After adjusting for study start date and sample size, the observed relationship between investigator financial ties and the presence of a match between prospectively registered and published primary outcomes was of borderline statistical significance (OR 2.12, 95% CI 0.998 to 4.50). Studies with financial ties present were more likely than studies without ties to have been prospectively registered (78%vs48%, P<0.001) and were more likely to have prospectively registered a clearly defined primary outcome(62%vs35%, P<0.001). CONCLUSIONS:Less than half of the trials in this cohort were prospectively registered with a clear primary outcome that was consistent with the primary outcome reported in the published manuscript. The presence of investigator financial ties was associated with higher quality registration practices, though this association diminished after adjusting for factors that impact registration quality.

Project description:ObjectivesTo investigate German physicians' attitudes towards and experiences with voluntary disclosure of payments by pharmaceutical companies in a public database and their impact on future decisions for or against disclosure.DesignA national cross-sectional survey conducted in 2018 among physicians who voluntarily disclosed at least one payment in the German transparency regulation.SettingRetrospective paper-pencil questionnaire about attitudes towards and experiences with voluntary payment disclosures in the first (2015) and second (2016) years of the German transparency regulation.ParticipantsGerman physicians who disclosed either in the first year only, the second year only, or in both years of the transparency regulation.Primary outcomes(1) The probability to disclose in 2016, predicted by physicians' experience of reactions from others in 2015, descriptive norms and attitudes towards transparency; (2) Frequency and (3) Content of reactions from others in 2015 compared with 2016.ResultsData of 234 respondents were analysed (n=42, 45 and 147 physicians who disclosed in 2015, 2016 or both years, respectively). The probability to disclose in 2016 was not predicted by perceived reactions, norms or attitudes towards transparency (p>0.01). Most participants reported not to have received any reactions by patients (190/234, 81%), colleagues (128/234, 55%) or the private environment (153/234, 65%). Neither frequency nor content of reactions differed between the first and second years (scale 1-5; frequency: Mdn 2015,2016 = 1.33 vs 1.00, r b=-0.17, p>0.01; content: Mdn 2015,2016 = 3.00 vs 3.00, r b=0.19, p>0.01). However, media reporting, fear of reputational damage and a feeling of being defamed were mentioned as reasons for non-disclosure.ConclusionsWhile confirmatory analyses did not provide significant results, descriptive analyses showed that participants who voluntarily disclose payments mainly do not experience any reactions towards their disclosures but report fears about losing their reputation due to disclosures.

Dataset Information

Undisclosed financial ties between guideline writers and pharmaceutical companies: a cross-sectional study across 10 disease categories.

Publications

Undisclosed financial ties between guideline writers and pharmaceutical companies: a cross-sectional study across 10 disease categories.

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