FDA Keeps Quiet About Faulty Defibrillators

If you want more proof the FDA is far more interested in protecting the fiscal health of big business at the expense of your own physical health, the feds kept quiet about a safety alert sent to them by Guidant Corp. about one of their more popular lines of defibrillators for at least 90 days!

Seems Guidant sent a report in February notifying the FDA that some of their Ventak Prism 2 DR line of defibrillators were short-circuiting at a rate of one a month. However, the agency didn't get around to issuing an alert until June, then updated it later to warn patients about the rare but significant risk of failure.

Interestingly, Dr. Daniel Schultz, a FDA director, noted putting these kinds of warnings on the fast track would tie up too many resources as it receives hundreds each year and would be hard pressed to determine what data could treated as public knowledge or not.

Thank goodness, Congress isn't letting the FDA get away with this nonsense, as Sen. Charles Grassley (R-Iowa) and Rep. Edward Markey (D-Mass.) issued separate statements criticizing the agency's silence.

Stories like this one explain why my Web site has grown in popularity especially over the past year, with an effective array of free tools at your disposal so you can begin to take responsibility for optimizing your own health, inexpensively and safely.

New York Times September 15, 2005

MSNBC September 12, 2005

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