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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.
- conflicts of interest
- pharmaceutical industry
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Footnotes
Patient consent for publication Not required.
Contributors RM, AL, HJ, GD, SG and LB conceived and designed the study. RM and LB supervised the study. RM, AL, EB and LB analysed the data. RM, AL, HJ, GD, SG, EB and LB interpreted the data. RM wrote the first draft of the manuscript, and RM, AL, HJ, GD, SG, EB and LB were involved in revisions of the manuscript. RM and LB are guarantors. All authors contributed to the planning, conduct and reporting of this study. All authors had full access to all data and can take responsibility for the integrity of the data analysis.
Funding RM is supported by a research fellowship funded by NHMRC, GNT1124207. EB is supported by grants from NHMRC to the Centre for Research in Evidence-Based Practice, Bond University.
Competing interests HJ was an employee of NHMRC. SG and GD are employees of NHMRC. LB is an employee of The University of Sydney and had no funding specifically for this work.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement We will share data where possible, within confines of guidance from Bond University Ethics Committee that the paper does not identify or describe any individuals.