Tuesday, May 24, 2005

Guideant's Short Circuit

The New York Times reports yet another story of flawed implantable cardiac defibrillators (ICDs). This time, Guidant Corporation revealed that its ICDs manufactured from 2000 to 2002, can short circuit, fail, and thus become unable to prevent cardiac arrhythmias. Guidant corrected the design flaw that allowed these failures to occur in ICDs manufactured after mid-2002.
However, it only got around to notifying physicians and the public about the problem recently, after the company was informed that the Times was working on an article about the problem. The company's argument was that short-circuits are rare: only 25 cases of short-circuts are known. Furthermore, replacing the ICD requires an invasive procedure, and hence is not risk-free.
However, doctors and patients ought be able to decide about whether to take this risk, based on full disclosure of the relevant data.
This is the third problem with ICDs that has appeared in this blog. The others involved problems in devices manufactured by Access Cardiosystems, and by Medtronic.
The NY Times article notes that ICDs cost about $25,000 a piece, and that Guidant sold about $1.9 billion worth last year. Given the low cost of very sophisticated modern electronics, this unit price seems very high. IT should at least buy unimpeachable reliability. Why managed care has not been able to bargain down the prices of such devices remains an open question. But meanwhile they surely account for some of the seemingly inexorable rise of health care costs.
But regardless of what $25,000 ought to buy, there seems to be no good excuse to hide data about this device's flaws from the public and from doctors.

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