Tuesday, February 21, 2012

Is There Such a Thing as “Created” COI?

Our friend Dr. Roy Poses, over at Health Care Renewal blog, has coined a new term, “created” conflict of interest:

Here’s the basic idea: “We have repeatedly discussed the adverse effects of conflicts of interest on health care. Recently, I argued that the most pernicious are conflicts of interest created as an incentive for trusted health care leaders, usually respected health care professionals or academics, to promote the vested interests of those who pay them, in the guise of the leaders' professional roles. In this capacity, the leaders are often dubbed "key opinion leaders" by those who employ them, but may be regarded as mere "salesmen" by the corporate personnel who recruit them. (See posts here and here) These relationships may be hidden, often behind confidentiality agreements, unless revealed by litigation. Documents revealed by discovery in legal actions showed how companies planned other organized stealth marketing efforts for drugs that included activities by KOLs (e.g., see post here about marketing of Lexapro, and here about Neurontin).”

So let me see if I can dissect this a bit. Some COIs simply appear or emerge. An example: A case comes before a judge. At first glance there is nothing suggestive of a COI, the judge does not know of any special relationship he might have with any of the parties to the case. But as the facts unfold, the judge comes to realize that one of the parties to the case has a close relationship with Company X, and a close relative of the judge is an executive with company X. The judge now decides to recuse himself because of possible bias. If we call this COI and not simply “bias” then it would seems a good example of non-created COI. No one set out to create a situation in which this judge would be biased; it simply seemed to happen.
I take it that the contrast then is with a drug company bribing a KOL. The company deliberately set out to create the COI. Now, is that quite an accurate description? In one sense the company did not set out to create a conflict of interest; they merely wished to create a strong interest in the KOL shilling for them loyally and enthusiastically. But in another sense they did create the conflict quite deliberately. The KOL has to have interest #2 (supposedly being a neutral and unbiased scientific authority) in order for the company to regard him as a KOL and so worth tempting with interest #1.

One could further quibble: just who “created” the conflict? One could of course say the drug company did; they set out to corrupt this person to be used as a marketing tool. But one could also say that the would-be KOL could have said no to the company and so by agreeing it was the individual and not the company that “created” the COI.

So I end up with the skeptical stance that once we explain (ethically) just what is worrisome about COI, I am not sure that we say a heck of a lot more by adding the modifier “created.” Some COIs are in fact innocent and others are problematic but relatively easily managed. So COI lies along a spectrum of severity.

Of all COIs, I agree with Dr. Poses that instances where the industry deliberately corrupts KOLs so as to use their supposed scientific objectivity for marketing purposes are among the most severe. The reason for this (as I discussed in HOOKED, citing the work of my colleague Len Weber) is the way in which medical professionalism is deliberately dragged into the gutter for profit. This is a form of COI even more to be ethically deplored for that reason.

I cannot in the end dispute the use of the modifier “created” for come COIs. So why am I resisting? I guess my only reason is that I see COI, as noted, lying along a spectrum of severity. I think a spectrum metaphor is a more useful way to approach the COI question that a dichotomy, “created” vs. “not created.” But let’s let Dr. Poses run with his idea and I’ll see if he’ll convince me of its utility.


HGH said...

I take it that the contrast then is with a drug company bribing a KOL

green tea benefits said...

I acknowledge with Dr. Creates that circumstances where the market purposely corrupts KOLs so as to use their expected medical detachment for promotion requirements are among the most serious.

Aseptic filling said...

interesting perspective on the COI debate!