Can Life-Saving Decisions Really Be “Tough Calls”?

Big business means big decisions. Tough decisions.

In some industries, those decisions affect whether people live or die.

Here’s a story that gives insight into the thought process that goes into such a decision.

From BNET: How I Made the Toughest Call of My Career

Not many CEOs run companies whose products have saved the lives of family members; Bill Hawkins does, and his connection with Medtronic, the $14.6 billion Minneapolis-based medical device maker, runs deep. His father has had eight coronary stents implanted; his father-in-law has both a Medtronic heart valve and a pacemaker; and his uncle received Medtronic deep brain stimulation to control tremors caused by a World War II combat injury. “Medronic’s mission — to alleviate pain and to extend life — is something I take very seriously,” says Hawkins.

That sense of mission would be tested in October 2007, only two months into his tenure as CEO, when he learned that the company’s Sprint Fidelis lead might have been malfunctioning at an unacceptably high rate….

(FYI: The ‘Sprint Fidelis lead’ is a thin wire connecting an implanted defibrillator to the patient’s heart.)

Some of the people who left comments posted under BNET‘s story ridiculed Hawkins. How could it be counted as a difficult decision, they demanded, when lives are on the line? That should count as an easy one. Right?

No.

The criticism is badly off-target. What the people launching that criticism miss entirely is that the evidence in this case was ambiguous.

…data showed Fidelis’ rates of resistance to fractures had been comparable to that of other Medtronic leads (97.7 percent for the Fidelis vs. 99.1 percent for the previous model, the Sprint Quattro). This difference was not statistically significant. However, trends suggested that the Fidelis might not perform as well over time.

So, this wasn’t a clear case of ‘our product is killing people’. When Hawkins made his decision, all he had to go on was that there was a small statistical difference between the failure rate of the Sprint Fidelis and his company’s previous model of lead, the ‘Sprint Quattro.’ In fact, the lack of statistical significance means that it’s entirely possible that the Fidelis leads were every bit as good as the older leads. Pulling them off the market prematurely could have signalled to physicians — wrongly — that the leads were actually unsafe. This could have led to ‘explantations’ (removal of the defibrillator), which is a very risky procedure. In Medtronic’s case, it was very far from clear that taking the Fidelis lead off the market would save lives.

No health product is 100% safe-and-effective. Judging when evidence is sufficient to warrant taking a product off the market is a difficult thing, in part because risk assessment is not a cut-and-dried science. It seems to me that Medtronics’ Hawkins understands this better than his critics do.

2 comments so far

  1. DarryleHuffman on

    No medical advancement is 100% effective. Thier will always be some instances where malfanctions do occur. When people receive attention they do take chance that what is being done to them may malfunction. One must weigh all the evidence to make decision. In the decision they will notice thier is failure rate. If they still want to the product then they accept the reality that it may fail.

  2. LethaWilliams on

    This is indeed a sticky issue for the CEO. Let’s think about it from the patient’s point of view. Unless they are medical practitioners, patients typically do not have the knowledge or qualifications to effectively analyze risk; they must trust their physicians, who are risk-adverse when malpractice could be charged. It’s understandable (though perhaps not appropriate) that the medical community would react by not using the product. It’s even more understandable that lay-people reading the original article would react as they did. Most people don’t understand what “statistically insignificant” means. And is it insignificant if the statistic turns out to be you or someone you love? Yes, we all take risks when undergoing a medical procedure or even taking a medicine, but if our physician has recommended it, we assume it’s relatively safe. Should we assume this? Of course not, but we do. So the CEO of Medtronics is really between a rock and a hard place. You’re right Dr. MacDonald; it’s a tough call. But my guess is that he’s paid fairly well for making such decisions. If he can’t stand the heat, the kitchen isn’t a good place for him to hide.


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