Wednesday, January 5, 2011

More than 20% Wrong

A study that was published in the Journal of the American Medical Association recently made the popular press yesterday.  It is a review of hospital records (primarily of medicare/medicaid recipients) from 2006 to 2009 that list ICD procedures.  An ICD is better known to us as a defibrillator but the full name is implantable cardioverter-defibrillator.  The device can restart the heart or shock the heart back into normal rhythm.  A great overview on the device, the diseases it treats, the difference and similarity to a pacemaker and more, can be found at the NHLBI website.  To learn more about who makes them and the industry aspect I had to go to the Wall St Journal and search, and you can read on that as well.

The ICD was developed to treat arrhythmia or heart beat irregularities and it was tested in a certain population for which it was approved for use.  As you know, once a device or drug is approved for use, a physician may use that same device or drug in patients that do not meet the sanctioned criteria, but device and drug makers are not supposed to market the device or drug for anything outside of the original application and testing (unless they test again)

I am not saying that the device makers tried to influence clinicians - except that I most certainly suspect that they have.  According to the research described in the JAMA article, the 22% of people who recieved the defibrillators  outside of the "guidelines" suffered a much higher percentage of serious adverse events.  The people who should not have an ICD under most cicircumstances are those who have recently had a heart attack (40days),  have a new diagnosis of heart failure, who have had surgery to clean out arteries - and subsequent stent placement and a few other criteria.  What I was not able to find were the actual practice guidelines.  I could find articles about them, but not the guidelines themselves.  Certainly, there are some cases were a person is outside of these conditions who would benefit from the device, but it would not be so frequent.

I feel that the issue of over medication and over testing and over "devicing" is not only a waste of resources, but as the JAMA article suggests, can lead to unnecessary death.

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