Originally published September 23 2005
FDA may have known about short-circuiting heart devices months before issuing warning
by Mike Adams, the Health Ranger, NaturalNews Editor
The FDA, in June, issued a safety warning on heart defibrillators made by Guidant Corporation, but records show the agency may have received information from Guidant Corporation that some of their defibrillators were short-circuiting months before issuing the warning.
Months before the Food and Drug Administration issued a safety alert in June about problems with Guidant Corporation heart devices, the agency received a report from the company showing that some of those units were short-circuiting, agency records obtained by The New York Times show.
While the agency has a policy of reviewing the reports within 90 days, it is unclear when regulators did so within that time frame or how they first interpreted the information.
A report provided to doctors by the Guidant Corporation indicates the likelihood that a defibrillator will not have to be replaced.
Defibrillators use jolts of electricity to stop erratic heart rhythms, which can be fatal.
Guidant, which knew about the model's flaw for three years but did not tell physicians about it until May, has recently found itself in the spotlight.
But the disclosure that the F.D.A. also had data that might have alerted doctors is likely to increase scrutiny of the agency's policy of not releasing the information it requires heart device makers to submit, as well as how quickly it reviews such reports.
The issue of how much safety data is disclosed to doctors and patients is expected to be a major focus of a meeting on Friday of heart specialists in Washington that was called as a result of the Guidant controversy.
That meeting may pit physicians who want more information about device failures against manufacturers, as well as other doctors, who say the current system is adequate to ensure patient safety.
Last year, both the F.D.A. and the drug industry came under fire for failing to release data about clinical drug trials like those involving the use of antidepressants in children.
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