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There is a clear potential for a conflict of interest in the interaction between the medical devices industry and interventional cardiologists. To be an interventional cardiologist and not acknowledge this is naïve and potentially damaging to the specialty. A conflict of interest may be defined as: a set of conditions where a primary interest (such as a patient’s welfare or the validity of a piece of research) tends to be unduly influenced by a secondary interest (such as financial gain). The conflict is not always, however, about financial gain. Influence over an individual can also be secondary to an enhancement of reputation; either of that individual or of his/her department. The combination of enhanced reputation and financial gain can, of course, be self-perpetuating.
An example of such a potential conflict can be highlighted by the following example. An interventional company may approach an individual or department asking them to take part in an important scientific study, using a device, which will be scientifically valid and will enhance the reputation of the institution. However, the company stresses that the department will only be given access to this study if the department is prepared to put patients into a “real world registry” for which the device will be paid for by the institution. The dilemma for the individual and the institution is clear, especially if the data for the device are less than robust. Although the interventional community would all like to claim this scenario never happens, it is clear that it does, with an unfortunately high frequency.
This topic has become particularly important recently because of two high-profile “events”. First, the very late stent thrombosis issue of drug-eluting stents (DES) has called into question the integrity of clinical investigators in this arena and the validity of clinical research sponsored by the …
Competing interests: MT has received funding and sponsorship for attending meetings, for research activity including the funding of research fellows and as an advisory board member from many medical device companies including Boston Scientific, Cordis, Medtronic, Abbott, Elli Lilly and Nycomed.
- drug-eluting stents