A more important distinction, especially for a large company where the departments are siloed, divides experts into global,
national, regional, and local KOLs. Each is important to the company for different reasons, and must be managed by a different
sector of the company. Global KOLs, who publish in the New England Journal of Medicine or JAMA and speak at international conferences, are easily identified and well-known throughout the company. Contact should be maintained
at the highest level of management. Local leaders, who may not be known beyond neighboring county hospitals, help colleagues
with tricky diagnoses and influence many treatment decisions. These physicians, who may not publish or participate in clinical
trials, need to be identified and courted by local sales representatives with support from medical-science liaisons (MSLs).
Singling out the national and regional KOLs, especially the emerging stars, can be more difficult. Many, but not all, have
a significant presence in the public domain. They have published; they serve as principal investigators on studies; or they
are affiliated with hospitals or other large institutions that post a bio on their Web sites. In short, they leave an electronic
Who´s responsible for KOLs?
But showing up in Google is not enough. Companies must marshal other resources to reliably identify national, and especially
regional, KOLs. First, they need to poll experts within their own organization, especially if it is very large. If a company
is close to launching a product, it has already been working in the therapeutic area for at least ten years. People in early
clinical development or discovery have probably identified people who were doing cutting-edge science in that area. Also,
brand teams for other products in the same therapeutic area will know doctors. Other people in the company have been meeting
doctors at conferences and congresses.
Other physicians who have done consulting work with the company may know some KOLs. Companies should ask the opinion leaders
they already know. Most will be glad to offer objective feedback. Finally, there are third-party consultants that specialize
in tools such as influence mapping. They survey doctors in a discipline, such as oncology, about whom they turn to for diagnostic
help when a tough case comes along. Typically, such studies lead companies not just to the leading experts, but also to influential
people known primarily to their peers. Contact with regional and local KOLs can be maintained by medical-science liaisons
or other field-based roles.
If, as the Clarescent survey of global KOLs suggests, many physicians and scientists are working on a half-dozen projects
within a single pharmaceutical company, it is not easy to know how high their total fees are. Paying an individual consultant
too much over the course of a year can cause a public-relations nightmare or trigger an OIG investigation. How should a company
create a transparent structure to track payments?
First, the company needs to create a centralized position or department that is responsible for owning and managing opinion-leader
relationships—especially with a national or global KOL. Second, a central database should track every KOL who works for a
company, and note who within the company has had contact with him or her. (Business rules should govern who has to log contacts
with the KOL.) Each payment to the KOL should be entered in the centralized database, and a transparent rule should govern
the annual payment caps for consultants.
Of course, centralizing payments is not as easy as it sounds. Many KOLs appear under different descriptions. Sometimes a company
may pay the physician directly, which can be logged to a social security number. But other payments may go to an employee
ID number, to a hospital clinic, to an academic department at a university, to a private company developing CME materials,
or through another third party, such as a KOL agency supporting an advisory board. Each of these payments could benefit the
same doctor. In the end, companies will have to change their cultures to follow the money. Even when the transactions are
recorded between institutions, the deals are made by individuals. Team members will have to communicate—and document why they
deal with particular consultants or institutions.
OIG Is Watching