When developing continuing medical education (CME) programs, there's probably no more important process than the selection of key opinion leaders (KOLs). Currently, KOLs are at the center of the controversy over industry's influence on clinical practice. It's important to identify KOLs who are known not only for their medical expertise, but also for their scientific integrity. Their foremost interest is patient care, not personal gain or career advancement.

By definition, KOLs are figuratively positioned between biopharma and clinical practitioners, and so they are always under scrutiny, if not suspicion.

The KOL Controversy

Generally speaking, there are two sides to the KOL controversy, and they're polar opposites.¹

One side says that KOLs are oblivious to pharma marketing: they're incorruptible and dedicated to improving patient outcomes. The opposite side is that biopharma, motivated solely by profit, is inherently corrupt, and corrupts by association. Thus, all data resulting from such associations, including associations with KOLs, are also corrupt.²

Both viewpoints are over-simplifications, and examples can be cited that support either position. But examples, taken individually or collectively, can't substantiate either position. Indeed, there may be partial truths in both positions. The reality is that pharma, clinicians, and KOLs don't (and probably can't) function independently of each other, and their interrelationships are commonplace.³

Based on study results from a late 2003/early 2004 survey, Campbell, et al. reported that 94% of physicians had some kind of relationship with pharma.³ Most of these relationships involved food in the workplace or drug samples. Over 33% of surveyed physicians said they were reimbursed for professional meetings or CME costs. More than 25% said they received payments for consulting, lecturing, or enrolling patients in clinical studies.

Because of these relationships, it's important to recognize KOLs who may be inappropriately influenced.

Image Is Everything

The appearance of being in cahoots can be as dangerous as being in cahoots.  When identifying a KOL, certain factors should raise a red flag simply because they don't look good, whether or not they have any basis in reality.  Much of this is common sense.

Potential Pitfalls in KOL Identification

Faculty-signed conflict-of-interest statements are standard forms of disclosure for potential faculty members. These statements reveal such connections as participation in biopharma-sponsored clinical trials, consultant agreements, and speaker's bureaus.

A KOL's biopharma connections should reflect in-depth interest in specific disease management.  In chronic disease management, for example, such as for multiple sclerosis or rheumatoid arthritis, the KOL's connections should indicate therapeutic interests beyond one pharmacologic category, such as the interferons or monoclonal antibodies; certainly, they should not reflect interest in just one therapeutic entity.