Prof. Dr. Ahmet Rasim Küçükusta

Introduction

The prevalence of financial conflicts of interest (COI) between clinicians and industry has been a topic of concern for the medical profession for more than two decades. The influence of COI on medical research and publishing has had recent attention,1 2 3 4 5 and the latest revelations about frequent and large “consultancy” payments to physicians, the practice of “ghost writing” by drug company employees, and the prevalence of industry funded “key opinion leaders” in medicine raise concern that physicians’ financial relations with industry may undermine the practice and promotion of high quality evidence based care.6 7 8 9 One area in which the presence of COI may be particularly concerning is the development of clinical practice guidelines.10 Guidelines serve to standardise care, to inform evidence based practice, and ultimately to protect patients, so their freedom from bias is particularly important.11 Over the past decade, most organisations that produce guidelines have adopted COI disclosure policies for members of guideline panels. Some organisations, such as the UK National Institute for Health and Clinical Excellence (NICE), have gone further, excluding authors with COI from relevant decision making.12 In contrast to guidelines from centralised organisations such as NICE, US and Canadian guidelines are issued by medical specialty societies, non-profit organisations, government agencies, and professional associations, each with their own guideline development processes and COI disclosure policies.

Although most organisations mandate some form of disclosure, complete transparency is often not achieved,13 14 and simple disclosure of COI may not be enough to prevent panel members’ bias from influencing recommendations.11 15 16 Emphasising the importance of having unbiased recommendations to guide clinical practice, the Institute of Medicine recently published recommendations on management of COI among authors of clinical practice guidelines.17 These recommendations call for the exclusion of panel members with financial COI, the appointment of a chair without COI, and an end to direct funding of guidelines by industry. They also recommend full disclosure of the COI policy of each guideline panel, along with the potential COI of all panel members. Lastly, they recommend that if appointing panellists with COI is unavoidable, their presence should be limited to a minority and they should be prohibited from voting.

Using the Institute of Medicine’s recommendations as a framework, we determined the prevalence of financial COI among guideline panellists from organisations considered likely to reflect best clinical practice and influence behaviour. We evaluated guidelines produced over the past decade by national organisations in the United States and Canada that covered screening for and treatment of diabetes and hyperlipidaemia. We hypothesised that a substantial proportion of members of guideline panels would have COI. We chose hyperlipidaemia and diabetes as representative disease categories because of the high prevalence of both diseases in the population. In addition, the drugs used to treat these diseases account for the largest share of prescription drug expenditures within the US Medicare population and some of the highest spending on prescription drugs worldwide.18