"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.
I agree it is disturbing because our society has demanded that we have all the medical mumbo jumbo in our lives.
ReplyDeleteIf the father did not want the son to have the ICD, he may have gone to jail for child neglect. Our society demands that we use and abuse our medical policies to the fullest and the laws help them to do so.
However, if the people were paying out of their minimum wage jobs instead of the lousy healthcare they do receive - if any - they are mandated and bullied into receiving tremendous and excessive medical treatments.
It is tragic that the boy died, but he obviously already had heart problems. We cannot live forever. Why doesn't our society accept that. Yes, I agree - if you have the insurance and you are willing to risk your life for a medical procedure. Awesome, please feel free to do so. But also, on the same time, if we do not want medical procedures done - it is our own free choice.
Then when a life-saving device fails - everyone is in shock and dismay. Really? I find it not amazing at all. Why do rely so heavily on devices.
Why can't we focus more on healthy living and prevention of diseases. Prevention from pesticides, fungicides, environmental toxins in the air, and fluorides and other ingredients in our water.
Get this - it is now mandatory to have health insurance. I find to be amazing that America has agreed to this. Meanwhile, all the young working class barely (mostly minimum wagers) ever need insurance. It is when they become sick and/or old that they can no longer work. At that point, they no longer have a job - they are either retired or on disability. At that time, they are on the governments medical plan. It is very profitable to be a health care insurance company when most of your customers are healthy and they have opportunity to also dismiss your claims at their whim and to state that it was based on "previous ailment" (although now they cannot). They still would like to use more adverse selections as they can..
I agree it is disturbing because our society has demanded that we have all the medical mumbo jumbo in our lives.
ReplyDeleteIf the father did not want the son to have the ICD, he may have gone to jail for child neglect. Our society demands that we use and abuse our medical policies to the fullest and the laws help them to do so.
However, if the people were paying out of their minimum wage jobs instead of the lousy healthcare they do receive - if any - they are mandated and bullied into receiving tremendous and excessive medical treatments.
It is tragic that the boy died, but he obviously already had heart problems. We cannot live forever. Why doesn't our society accept that. Yes, I agree - if you have the insurance and you are willing to risk your life for a medical procedure. Awesome, please feel free to do so. But also, on the same time, if we do not want medical procedures done - it is our own free choice.
Then when a life-saving device fails - everyone is in shock and dismay. Really? I find it not amazing at all. Why do rely so heavily on devices.
Why can't we focus more on healthy living and prevention of diseases. Prevention from pesticides, fungicides, environmental toxins in the air, and fluorides and other ingredients in our water.
Get this - it is now mandatory to have health insurance. I find to be amazing that America has agreed to this. Meanwhile, all the young working class barely (mostly minimum wagers) ever need insurance. It is when they become sick and/or old that they can no longer work. At that point, they no longer have a job - they are either retired or on disability. At that time, they are on the governments medical plan. It is very profitable to be a health care insurance company when most of your customers are healthy and they have opportunity to also dismiss your claims at their whim and to state that it was based on "previous ailment" (although now they cannot). They still would like to use more adverse selections as they can..