Friday, Sept. 16, 2005 | 8:54 a.m.
People whose lives depend upon a pacemaker would want to know immediately if any problems were being detected with the brand implanted within them. They would trust that their doctor, or the device's manufacturer, or the Food and Drug Administration -- somebody -- would make it a priority to inform them. But a report in the New York Times this week revealed that the current procedure for reporting heart-device failures tends to stay between the manufacturer and the FDA, while generally excluding doctors and patients.
The Times' interest in the issue began in March when a college student in Minnesota died. His pacemaker was flawed, the paper reported, and the manufacturer afterward issued a recall. The Times reported that the manufacturer, Guidant Corp., had known about the flaw in its Ventak Prizm 2 DR defibrillator for three years, but kept selling it anyway despite the introduction of an improved one. The corporation's excuse, that it had made all necessary disclosures in annual reports required by the FDA, is now under review. According to the Times, heart specialists are asking whether such routine and often vague disclosure is adequate protection for patients.
In our view, it is not. This became obvious when the Times reported that Guidant had provided exact statistics about the short-circuiting as part of its lengthy annual report submitted to the FDA in February. It took the FDA until June to alert the public, following reporting in the Times that had begun in May. That same month, Guidant finally got around to alerting doctors.
A spokesman for the FDA told the Times that it ties up too many resources to review the hundreds of filings the agency receives each year and determine what information should be released. That's because the FDA initially regards the annual reports as proprietary, meaning that its first instinct is to protect the manufacturers' competitive interests. In our view, the FDA's first instinct should be to protect the public. Manufacturers should be required to inform the FDA about possible risks to the public as soon as they become known. Separate risk reports are needed, as is an FDA that puts the public's interest ahead of the manufacturer's interest.
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