The Food and Drug Administration is poised to approve nonprescription sales of a heart-shocking device called an automated external defibrillator, which could trigger a flood of direct-to-consumer marketing pitches asserting that no home is safe without the $1,000-to-$3,000 machines.
Automated defibrillators can reverse sudden cardiac arrest if applied quickly and have been shown to save lives in public settings such as airports, but experts say it is less clear how many Americans are at risk and that it would be worthwhile to have the devices in homes.
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"We're going to see, I will predict, ad campaigns that are likely to be more frightening than they are realistic," said Arthur L. Caplan, director of the Center for Bioethics at the University of Pennsylvania, "because you really can manipulate this into getting people to believe they need one."
Arthur Kellermann, chairman of emergency medicine at Emory School of Medicine in Atlanta, agreed that manufacturers are likely to overplay the value of the machines as a matter of life and death.
"This is a marketer's dream: It's dramatic, sensational -- it's very slick," Kellermann said. "What the FDA's been asked to do is authorize the sale of very expensive lottery tickets."
The defibrillators work only for a cardiac arrest, when the heart's regular beat dissolves into a random flutter that is too fast or too slow, causing it to stop pumping blood and leading to immediate loss of consciousness. The abnormal rhythm can be brought on by blocked arteries, a weakened heart or inherited conditions. It is not the same as a heart attack, though a heart attack triggers the chaotic rhythm in as many as half of arrests.
According to oft-quoted statistics, there are 350,000 to 400,000 sudden cardiac deaths a year -- 80 percent in the home -- but two recent studies have suggested that this estimate may be too high by one-third or more.
The devices tell users with step-by-step voice prompts where and how to apply two "paddles" to analyze the heart rhythm and shock it back to normal, if necessary. If the problem cannot be treated with a shock, the machine will not deliver one, and the user is prompted to start cardiopulmonary resuscitation and call 911.
Philips Medical Systems is seeking FDA clearance to sell its HeartStart machine over the counter. If the agency agrees, Philips said it is not planning a media blitz but will advertise through infomercials on cable TV and on health Web sites such as WebMD.
FDA officials do not comment on their deliberations, but Philips executives said, based on their meetings with the agency, that they believe approval is imminent.