Monday, April 2, 2012
CBS Commits a Decision Cost Error
"Sunday Morning" on CBS aired a disturbing piece yesterday. In "When Medical Devices Fail," Jim Axelrod relates a gut-wrenching story of a 21 year old man with a known heart condition who died of a heart attack when his implanted cardiac defibrillator (ICD) failed to revive him. It turns out that these ICDs have a less than perfect track record. The story highlights an apparent lapse of judgement at the Food and Drug Administration (FDA) in approving the product and allowing design changes without enough oversight.
But what are the real decision costs here? That the device failed and this led to the death of a young man is tragic. This occurs "less than one percent of the time, much less," (this quote is a refrain from the story). What would have happened if the ICD was not available? People with this condition would still have had the heart attacks and, in more than 99% of cases, would not have enjoyed the benefits from the ICD. They might be revived by CPR or a "regular old defibrillator" not implanted, but I suspect not nearly as often. It seems like a no-brainer to me that 99% plus is better than nothing.
We can hope that these devices will become 99.999% effective. Even then, eventually there will be a father mourning his young son's death from a product failure when the device is designed imperfectly, or produced imperfectly by imperfect workers, or implanted imperfectly by imperfect surgeons, or implanted into patients who fit the candidate profile imperfectly. And his grief makes for good TV. There were no interviews of the 99 fathers who got to see their children grow into the fullness of adulthood because these devices did their jobs. Highlighting the one tragic case while ignoring the many who benefit is so damaging specifically because it skews the decision maker to be even more cautious. And, there is ample evidence that the FDA is already over-cautious.
Moreover, there is no conspiracy here. Holding them to a 99.999% standard instead of a "99% plus" suggests that the device maker just did not try hard enough. If Guidant, the maker of the ICD, could make the device 99.999% effective, I suspect that they work overtime to get it to the market as soon as possible. They make money by saving more lives. Incentives are aligned.
Yes, the piece was disturbing - but for all the wrong reasons.