Public scrutiny regarding the relationship between pharma companies and key opinion-leaders (KOLs) has reached a boiling point
due to recent changes in various policies and regulations regarding the relationship between physcians and the industry.
In short: it's becoming harder for pharma companies to work with physicians, and physicians are finding it harder (in some
cases impossible) to work with pharmaceutical companies.
IMAGEZOO, GETTY IMAGES
Pharma's negative public perception has caused KOLs to question whether relationships with drug makers will negatively affect
their reputations. The result is that KOLs now impose their own roadblocks to building relationships.
From the industry's perspective, the roadblocks imposed by governments, trade groups, industry associations, academic institutions,
and, now, physicians themselves will ultimately lead to less access to product education and, inevitably, poorer patient care.
The Shrinking KOL Pool
The number of entities, especially academic institutions, that have increased regulations on industry–physician relationships
has made forming relationships with thought leaders, and especially key opinion leaders, more difficult.
The Shrinking KOL Pool
In a recent survey by Cutting Edge Information, the head of one thought leader development team at a pharmaceutical company
reported having to send out three times as many advisory board invitations than usual. KOLs were declining because their academic
institution no longer allowed them to participate, or they felt the need to limit their relationships with the pharmaceutical
Prominent academic research institutions, such as Yale University and Stanford University, have begun to set standards (some
more stringent than others) for relationships between faculty and drug companies.
State Disclosure Laws (SOURCE (ALL CHARTS): CUTTING EDGE INFORMATION)
Many of the standards encompass changes the industry has already embraced, such as limiting meals and gifts for physicians.
But a common concern expressed by industry executives is that the changes in guidelines signal an even more serious trend—institutions
wanting a say in their faculty's involvement in private research. This would effectively ban the relationships and effectively
cut the industry off from experts in the field.
Pharmaceutical companies bear the consequences of a smaller opinion leader-pool. Companies struggling to launch novel medicines
now face the prospect of filing for approval without advice from the most expert medical professionals. And as more key opinion
leaders decline to work with pharmaceutical companies, clinical and marketing teams will lack knowledge of specific patient
needs and other information that helps develop better products.
Impact of State Disclosure Laws on Thought Leader Compensation
Furthermore, a smaller pool creates logistical problems for thought leader management executives whose goals are based on
the successful relationships that they develop. With fewer KOLs to draw from, they are forced to turn to established relationships,
hiring the same thought leaders over and over again, which gives the apperance of favoritism and large compensations and only
contributes to the very situation causing the current problem.
But academic institutions are not the only group targeting relationships between physicians and pharma companies. Some states
have imposed laws that require companies to report any payments above $25 made by drug companies to physicians. And many other
states are following suit. The sheer amount of work it entails to track all the different laws and guideline changes is putting
a tremendous burden on companies.
One pharmaceutical meeting planner reported that 75 percent of her staff's time is dedicated to tracking regulations for
Although medical affairs teams typically have more flexibility with their physician interactions compared to commercial teams
(which have restrictions on paying for meals or payment thresholds for certain activities), some companies have opted to simply
avoid building KOL relationships in states with restrictive spend-tracking regulations. The downside, of course, is that physicians
in these states—and their patients—will start to see limited access to innovative research opportunities.