How to Piss Off KOLs

Key Opinion Leaders -- or KOLs as they are known by pharmaceutical marketers -- are physicians who influence their peers' medical practice, including but not limited to prescribing behavior. Pharmaceutical companies generally engage key opinion leaders early in the drug development process to provide advocacy activity and key marketing feedback.

Pharma companies devote considerable time and money cultivating KOLs, often treating them to dinner meetings and hiring them as paid consultants (see "Gifts That Keep on Giving"). In fact, a whole cadre of pharma employees -- called Medical Science Liaisons or MSLs -- are in charge of the care and feeding of KOLs.

It is a rare thing, therefore, for a pharmaceutical company to piss off KOLs they have employed as advisors, yet this is exactly what J&J may have done.

The Wall Street Journal reports that J&J has dragged its feet launching a study to test the safety of its "controversial" heart-failure drug Natrecor (see "Critics Assail J&J For Delaying A Safety Study" -- subscription required). This may be one of those FDA required "post marketing" studies that are stuck in "pending" limbo (see "Spinning Bad News about FDA & Drug Safety"). [Actually, I see from the WSJ article that the FDA hasn't even asked J&J to do the study. So much for the FDA's willingness, not to mention capability, to ensure the safety of our drug supply!]

Bad enough that J&J has been dragging its feet for a whole year -- "There are just a couple of details that we're putting the finishing touches on," said Roger Mills, vice president of medical affairs at Scios, the J&J unit that makes Natrecor -- but J&J has pissed off a panel of influential cardiologists (ie, KOLs) it convened. The panel "urged the company to proceed with a follow-up study to resolve the matter."

I think no one on the panel imagined that the recommendation would be followed by silence for a year," said Milton Packer, a member of the advisory committee and professor at University of Texas Southwestern Medical School in Dallas. "It's an unacceptably long period of time."

Discussing J&J's handling of Natrecor in a recent talk to blood-pressure specialists in New York, Dr. Nissen [an influential cardiologist at the Cleveland Clinic who opposed the drug as a member of the expert panel that advised the Food and Drug Administration on the drug's approval five years ago.] said: "After the incredibly good fortune of gaining approval of nesiritide with marginal efficacy and safety data, what did its manufacturer do? Did they design and launch a large, well-powered morbidity and mortality trial? No." Instead, he said, the company aggressively marketed Natrecor without performing the research that would settle questions about the drug.

I imagine the poor MSLs at J&J charged with the handling of cardiologist KOLs are not having a good time over this.

These days, MSLs are asked to contribute more to the bottom line of companies (see, for example, "The Changing World of MSLs: Determining Value"). What's the value of a KOL that is turned from a friend into a foe? That's got to be some huge negative number! KOLs sit at the top of a pyramid of physician influence:

The classic Pyramid of Influence is a power-based model, in which most key opinion leaders sit atop the pyramid by dint of their organizational (sometimes academic) position and strength. They are usually perceived to be worldwide influencers who do the most research and writing, and in turn, influence national, regional, and local clinical leaders. In this model, their influence runs downhill and in many instances, it is still how MSLs perceive the KOLs with whom they need to cultivate relationships. [From The Changing World of MSLs: Determining Value]

Although a KOL may not write very many scripts, each KOL influences the script writing of hundreds of high prescribers. It doesn't pay, therefore, to piss them off.