Key opinion leaders: independent experts or drug representatives in disguise?

Key opinion leaders (KOLs) sought by industry are not only targeted for the promotion of new drugs but also technical devices developed for minimally invasive surgical approaches. Our commissioning experience suggests that clinicians are offered training and mentoring by an expert if they can guarantee purchasing in advance of a certain number of interventional devices by their trust or commissioning body. Approaches are then made to commissioners and specialty clinical networks. In national priority areas such as cancer and cardiology some commissioners do accede to persistent clinical demands even though the devices themselves may be at a developmental or evaluation stage. Often training,experience, education and service infrastructure requirements for the new devices are still unclear including the optimum numbers of procedures that should be carried out for the development and maintenance of individual operator and institutional skills. By their acquiescence a few commissioners inadvertently exert indirect pressure on their colleagues in other geographical areas. This is brought to bear by their clinicians and trusts anxious not to lag behind in the race for the latest technological advance. In the unstoppable momentum that develops an evidence based clinically and cost effective commissioning strategy based on an objective critique of the limited evidence and recommendations for further research becomes the casualty. Commissioners are inevitably left to pursue a rear guard damage limitation exercise by constructing retrospective clinical governance controls to supplement the short term outcomes from case series.

The losers are inevitably the patients at the receiving end of an intervention with short term outcome data, generally good technical placement results but no information on medium and long term clinical outcomes, quality of life, durability of device and reintervention rates. Another victim is medical science. The phase three trials that are needed will probably not be done or if done will report so late that their results will be meaningless as the technological goalpost will have shifted by that stage.

Commissioners must stand firm that only well researched interventions backed up by economic evaluation will be considered for new developments. Also conflicts of interest and financial links with the industry by proposers of new clinical developments must be clarified at the start.

Competing interests: None declared