Declaring interests and restoring trust in medicineBMJ 2019; 367 doi: https://doi.org/10.1136/bmj.l6236 (Published 06 November 2019) Cite this as: BMJ 2019;367:l6236
- Carl Heneghan, professor,
- Margaret McCartney, honorary fellow
- Correspondence to: C Heneghan
There is a long history of individuals and organisations attempting to fix the biases that arise from conflicts of interests. Such conflicts contribute to a breakdown in research integrity1 and lead to more favourable outcomes for sponsors,2 the withholding of results,3 and an overall lack of trust in research.4
Journals disclose authors’ potential conflicts of interest to improve the objective assessment of research, increase its credibility, and make peer reviewers, editors, and readers aware of—and account for—the biases that conflicts induce. The International Committee of Medical Journal Editors (ICMJE) considers the purposeful failure to disclose conflicts of interest a form of misconduct. Whether disclosure influences peer reviewers’ assessment of the quality of submitted research is, however, unclear.
In a linked paper, John and colleagues (doi:10.1136/bmj.l5896) tackled this issue by asking whether revealing authors’ conflicts at peer review affects the quality rating of submitted manuscripts.5 From a sample of 1480 research papers submitted to Annals of Emergency Medicine, peer reviewers were randomised to receive a full conflict of interest disclosure or no disclosure. Access to disclosures had no impact on reviewers’ quality rating of research.
To many, this result might not be surprising. Little agreement exists on what constitutes effective peer review or the skills required to provide it,6 and there is little evidence that peer review does what many think it should do—ensure the quality of research.7 Although peer review is highly regarded by researchers and considered essential for publication of research8 it has many flaws: In one study, 607 peer reviewers for The BMJ detected only one third of major errors inserted into test trial reports, despite training;9 In another, 260 readers missed 95% of the 39 discrepancies in a clinical trial report.10 Peer review itself is of questionable value and could offer false reassurance.
We don’t know what should happen when conflicts of interest are disclosed to peer reviewers. It is currently unclear if disclosure identifies, reduces, or avoids biases in research, or if it simply creates false reassurance among reviewers and readers,11 Estimating the impact of conflicts of interest is a difficult task.12
Goupil and colleagues (doi:10.1136/bmj.l6015) provide more tangible evidence that gifts from pharmaceutical companies to French general practitioners (GPs) might influence prescribing.13 Their retrospective study, using data from the French Transparency in Healthcare and National Health Insurance databases, reports that GPs who received no gifts prescribed cheaper generic drugs and had better drug prescription efficiency indicators than those in receipt of gifts.
While these results are consistent with previous evidence,14 they highlight the value of the Transparency in Healthcare database. Without it, gifts to French GPs from pharmaceutical companies would not be readily accessible for analysis.
The French “Sunshine Act” (The Loi Bertrand) established the Transparency in Healthcare database that became publicly accessible in 2018. The law requires health products companies to disclose agreements with healthcare providers publicly within 15 days. Any benefit to the healthcare provider exceeding a value of €10.00 (£8.60) in cash or in kind must be disclosed within six months.15 Although no direct causal link was found between the gifts received and GP prescribing, Goupil and colleagues’ study shows the importance of disclosure legislation: gifts to French GPs are common (36 232/41 257 GPs (87.8%) listed in the database had received gifts) and are associated with poorer prescribing practices and increased costs to the healthcare system.
The influence of organisational or individual conflicts on clinical practice demands a system-wide strategy to manage and mitigate such conflicts. Our current understanding of the effects of conflicts of interest is impeded by ineffective strategies to search for, report, and record them. Laws that mandate full transparency—with expectations on both individuals and industry to provide payment data—solve the problems associated with voluntary disclosure and might permit a more thorough understanding of the wide ranging impacts that conflicts of interest have across healthcare. Better data on conflicts would mean better research, a clearer understanding, and more coherent action to reduce harm—a process that might just restore some much needed trust in research.
Competing interests: CH receives funding support from the NIHR (National Institute for Health Research) School for Primary Care Research Evidence Synthesis Working group (NIHR SPCR ESWG project 390) and the NIHR Oxford Biomedical Research Centre. He is an NIHR senior investigator, editor in chief of BMJ Evidence-Based Medicine, and an NHS urgent care GP and has received payments for his media work (full declaration at www.phc.ox.ac.uk/team/carl-heneghan). MM is a regular columnist for The BMJ. She has received payment from royalties and freelance broadcasting and writing, some of which has been about conflicts of interest, she is a senior fellow for evidence and values at the Royal College of General Practitioners, a GP partner, and gives donations to Keep our NHS Public. Her full declaration is on whopaysthisdoctor.org
Provenance and peer review: Commissioned; not peer reviewed.