Thursday, June 23, 2011

A Rigged System

If you want to see a good example of how bias warps decision-making, check out this article in The Wall Street Journal, which has been reporting on developments regarding medical device giant Medtronic Inc. (Disclosure: I have friends and family who work for medical device makers.)

According to the Journal, the Senate Finance Committee is investigating whether surgeons who received lots of money from Medtronic for consulting and other work failed to note complications associated with a Medtronic product that has become widely used in spinal surgery.

Medtronic would have us believe the answer is no. It says it provides data about adverse events that occur in clinical trials of its products “irrespective of any financial relationship” between the company and those involved in the studies.

But academic research suggests otherwise. As Princeton professor and Nobel Laureate Daniel Kahneman and colleagues note in a recent article in the Harvard Business Review, “Research has shown that professionals who sincerely believe that their decisions are “not for sale” (such as physicians) are still biased in the direction of their own interests.”

And in the case of Medtronic, those are quite some interests. According to the Journal, Medtronic paid one Wisconsin surgeon involved in one of its trials $19 million from 2003 to 2007. Another doctor involved in a trial received more than $1.5 million between 2001 and 2006.

The Senate committee’s investigation was triggered in part by a forthcoming study in a medical journal. That study shows that numerous complications – including potentially fatal ones -- associated with Medtronic’s Infuse Bone Graft occurred in clinical trials.

But – and this is an important but – those complications went unreported in a dozen research papers about those trials that Medtronic sponsored between 2000 and 2009. (Italic mine.)

Here you have the nub of the problem: industry money typically funds these trials.

As the old adage says, he who pays the piper calls the tune. And if you have any doubts, we got a great lesson during the recent financial crisis. We know now that many of the allegedly objective ratings agencies gave high ratings to mortgage securities that later turned out to be junk. Those rosy ratings, of course, favored the ratings agencies’ clients.

And we have much the same situation with medical trials. They are paid for, in whole or in part, by the companies that make the products being tested. Imagine if we conducted, say, civil trials the same way: the evidence used in court would be paid for by one of the two parties. Which party do you think the evidence would favor?

The answer here is obvious: we need a system where companies do not directly pay for the evidence used to determine whether their products are safe. Anything else is a rigged system.

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