Editorials
Declaring interests and restoring trust in medicine
BMJ 2019; 367 doi: https://doi.org/10.1136/bmj.l6236 (Published 06 November 2019) Cite this as: BMJ 2019;367:l6236Commercial influence in health: from transparency to independence
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Linked Research
Effect of revealing authors’ conflicts of interests in peer review
Linked Research
Association between gifts from pharmaceutical companies to GPs and their drug prescribing patterns
Transparency alone cannot counteract the harms of conflicts of interest
Heneghan and McCartney’s editorial related to an RCT showing the lack of influence of declaration of interests on peer reviewers – we agree that this is difficult to interpret; maybe the whole peer review system is poor, or possibly the good unpaid people who do it are largely fair and simply uninfluenced in their scientific judgments by such declarations? Like the authors, we want self-correcting science and to deal with biases in the medical sector as wasted research and wrong results harm and kill real people. We agree with the demand for declarations of financial conflicts of interest (CoI). However, we go further and question whether conflicts (the serving of two masters) can ever be managed, which would then make transparency a ‘necessary, but not sufficient’ condition to achieve our joint ends. Kassirer has long argued that transparency has hijacked the fundamental debate regarding CoI.(2)
Firstly, the pharmaceutical industry may be the greatest, serial, convicted corporate fraudster. (https://www.drugwatch.com/manufacturers/) . Recently, cartel behaviours have been demonstrated by the opioid epidemic and skyrocketing price of insulin. Accordingly, we must question why some professionals accept commercial links of interest and believe they can handle them. Evidence shows that mind lines work similarly whatever the kinds and sizes of payments, whether through large research grants or small industry provided lunches.(2) Whatever the roots (naivety, pride, self-deception), potential consequences cannot simply be dissolved via transparency.
Secondly, despite a decade’s experience, we have no evidence that current Sunshine Acts improve prescribing quality or trust, thus risking only acting as window-dressing for a rigged system. Experience of disclosure in Wall Street has not engendered public confidence in oversight.
Thirdly, there may be drawbacks and unintended harms from transparency: (a) It has been noted that "Physicians who openly acknowledge their ties tend to make even more extravagant claims about product safety and efficacy, and patients tend to view doctors who declare their ties as particularly ‘honest.’ “(3). This is not restricted to lay people: when in charge of the National Cancer Institute, the current French Secretary for Health claimed at Coffee Nile (a corporate Think Tank) that "the pharmaceutical industry plays its role, and I have never shouted with the wolves on this industry. It must be explained that wanting experts without any link with the pharmaceutical industry raises the question of the competence of experts." (https://loeildenile.eu/2013/02/21/quelques-questions-a-agnes-buzyn-lors-...) . (b) Transparency can lower levels of overall cooperation and inter-connectedness.(4) ( c) The publication of seeding studies, that promote the product marketed by the company without serving any scientific purpose, remains an issue.(5) Transparency cannot be the solution to the publication of grossly flawed-designed studies (that inevitably harm patients) and the tolerance of such behaviours in our communities.
Fourthly, non financial conflicts are also concerning.(6) They are more insidious, but illustrated by a patient’s prostate cancer treatment (e.g. active surveillance, radiotherapy or surgery) which depends heavily on the discipline of the doctor he meets: GP, oncologist or surgeon.(8) Obviously, the choice of treatment is mainly nurtured by cognitive biases and poor training (selection biases, rating evidence, benefit/harm ratio etc.). The consequences may be devastating and we ought to confess the worst distortions of informed consent do not originate from commercial endeavours. Historically, the recommendation for prone position to prevent cot death was based on a mistaken opinion about the potential role of reflux of gastric contents, not on robust evidence from well-designed clinical trials of relevant clinical outcomes.
Transparency should primarily focus on implementing shared decision making with patients. This needs commitment and robust data about harms and benefits, and explanations of the level of evidence. Similarly, we ought to inform patients when prescribing “off-label” about the risks.(8) Medicine must move beyond mere good intentions and belief onto the determined practice of the ethical responsibility of humility. We must be balanced. We should not nurture unrealistic hope about benefits, when only short-term surrogates have been evaluated in highly selected populations, while harms are ignored and underestimated. The worst conflicts arise from belief, certainty and pride. They come from within us, but the “risks” (a euphemism for harm) are offset to our patients. .(9)
1 Heneghan C, McCartney M. We need a system wide strategy to record and manage conflicts of interest across healthcare. BMJ 2019;367:l6236.
2 Kassirer JP. Medicine’s obsession with disclosure of financial conflicts: fixing the wrong problem. In: Snyder PJ, Mayes LC and Spencer DD (eds) Science and the Media: Delgado’s Brave Bulls and the Ethics of Scientific Disclosure. Amsterdam: Elsevier, 2009, pp.79–90.
3 Cain DL, Loewenstein G, Moore DA. The dirt on coming clean: perverse effects of disclosing conflicts of interest. J Legal Stud 2005;34:1-25. doi:10.1086/426699.
4 Nishi A, Shirado H, Rand DG, Christakis NA. Inequality and visibility of wealth in experimental social networks. Nature 2015;526:426-9.
5 Braillon A, Taiebi F, Bernoussi A. Nalmefene Phase IV Study: A Seeding Flying in the Face of Evidence? Clin Drug Investig 2018;38:385-386.
6 Anonymous. Nature journals tighten rules on non-financial conflicts. Nature. 2018;554:6.
7 Barry MJ. The prostate cancer treatment bazaar: comment on "Physician visits prior to treatment for clinically localized prostate cancer". Arch Intern Med 2010; 170:450-2.
8 Braillon A, Lexchin J. Off-Label Drug Use: Whose Interests Are Served?Am J Med Qual 2016;31:285.
9 Braillon A. Discrepant expectations about benefits and harms: innumeracy plus illiteracy? JAMA Intern Med 2017;177:1225-1226.
Response modified by Sharon Davies on 2 January 2020.
Competing interests: AB & SB are listed as industry independent experts.(https://jeannelenzer.com/list-independent-experts). SB chairs Healthwatch, a charity promoting science and integrity in healthcare (https://www.healthwatch-uk.org/) and her interests can be found at https://www.whopaysthisdoctor.org/doctor/58/active