Friday, December 31, 2010

In Defense of Paranoia: Suspecting Deliberate Obfuscation in Medtronic's Payments to Spine Surgeons

For background you need to look at an earlier post:

--plus two more recent news items:

To develop further a brief comment made in my previous post, what we have here is roughly the following:
  • A number of spine surgeons, some academic types, some practitioners, are getting paid royalties and/or consulting fees by Medtronic to the tune of $500K-$1M or more per year.
  • The practicing surgeons are affiliated with hospitals where a very high volume of procedures are done using expensive devices manufactured by Medtronic. (A single surgery can result in using $20K worth of Medtronic stuff.)
  • The academic orthopedists have conducted research or published papers praising the Medtronic devices and the surgeries that use them--despite views among non-conflicted experts that many of these articles are simply infomercials and leave out all the minor things like complications, failures, etc.
  • Medtronic insists that it is getting very high value out of these guys, but is notably sketchy on providing any details as to just what is the intellectual property, consulting advice, etc. it has received in exchange for these vast sums
  • There is a strange disconnect between the Medtronic products that these surgeons routinely use and/or do research or write about, and the product for which they are paid the royalties or other fees
  • This disconnect allows both the surgeon and Medtronic to deny that there's any quid pro quo at work, since presumably, the surgeon is using vast quantities of, or shilling for, Device A, but is getting paid royalties or other fees related to Device B--hence, no conflict of interest exists
As I said in the previous post, this amounts to a mystery--why is Medtronic paying these guys huge sums in exchange for "intellectual property" related to devices that the surgeons do not routinely use or have not conducted research about? Just what sort of "intellectual property" fills the bill here? (Ouija board messages? Pieces of paper inside fortune cookies?)

There is a possible solution to this mystery, but offering it would open me up to charges of having gone off the deep end, becoming frankly paranoid, and no doubt being a candidate for at least one expensive brand-name antidepressant drug plus one expensive brand name atypical antipsychotic. The possible solution is: Medtronic anticipated the need to start posting all its payments to physicians on a publicly available website. Therefore it entered into tacit agreements with its most valuable KOLs, both the guys responsible for the highest volume of use of its devices, plus the academics who provided the best cover for their widespreead use. The agreement was--we'll label the payments we send you as being for some other device, not the one you use (or write about). We'll both know that if you want to keep getting such goodies in the future, you'll have to keep using the same device that you actually do use, at the same high volumes. But both of us now have deniability of any snoops ask why you're raking in so much dough. ("What? Reward docs with huge payments based simply on the volume of devices used? Perish the thought. They're getting paid for different devices entirely.")

If this suspicion holds any water, it shows that an important line has been crossed. As I was at pains to show in HOOKED, drug industry marketing to physicians has traditionally followed a certain pattern, especially well described by the former-drug-rep-turned-anthropologist, Michael Oldani. According to these practices, docs did what the company wanted them to, and in exchange, the company showered them with gifts--in the old days, sports event tickets, trips to resorts, etc.; in more recent times, fancy dinners, and consulting and speakers fees (after the most obvious luxury items were supposedly banned). But neither side admitted what was really happening. The company and the doc both pretended that the doc was a scientist of stalwart integrity who could never be bribed, and that these gifts were all legitimate forms of "education," not marketing.

If by chance I should be right about what Medtronic and these surgeons are up to, then an implicit arrangement papered over with rationalizations was probably not sufficient. It seems that an explicit arrangement of some sort would have had to be arrived at. If this is so, then these surgeons have shown us a new low within medicine. They have simply allowed unalloyed greed to take over, and don't care any more to try to disguise that fact either from themselves or from their Medtronic handlers. They can't any longer even blame self-deception for their blatant and unprofessional conflicts of interest.

OK, suppose that I'm way off base here and paranoia has truly set in. What would be required to show the world how silly are my fears and fantasies? The solution is simple. Medtronic and these surgeons simply have to demonstrate for us exactly what these surgeons did for Medtronic that was worth all that money for "intellectual property," other than old-fashioned payola. What has allowed all my suspicions to build up to this level is their failure to have provided us with any such information.

What if Medtronic cannot come up with such information (or won't)? Then, I am afraid, the implications for the "sunshine" approach to conflict of interest are serious. Up till now, we have imagined that if we could just shed a bright light on these activities, we would know what was going on and then be able to take appropriate corrective action. Medtronic seems intent upon showing us that we can demand all the daylight we want, and they can still create enough nooks and crannies to allow all the cockroaches to scurry about under the protection of darkness. In short, that we don't merely have lack of transparency; we have deliberate and sustained efforts to mislead and confuse us.


Arthur Schafer said...

I love this piece, Howard. But it confirms, what we already know: the drug and device industry are clever enough and unscrupulous enough to get round almost any "reform" measures that are imposed upon them. The only solution is outright prohibition: they must be forbidden by law from funding research or researchers, physicians or surgeons. COI can't be effectively "managed". It must be abolished.

Arthur Schafer

Willow said...

Hi Arthur Schafer

You're right, of course.

It needs to be defined as crime and the CEOs who instigate and practise it need to be tried in the criminal court and be sentenced with the utmost severity. Likewise the physicians and researchers who are their creatures and prostitute their knowledge and reputations should receive severe sentences.

Only when these heinous practices result in condign sanctions can actual or potential patient victims of pharmaceutical junk feel vindicated or safe.