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Scientists weigh arguments over home defibrillators

Tuesday, July 20, 2004

WASHINGTON -- Defibrillators that jump-start a stopped heart may save lives in airports and shopping malls, but few people keep them at home in case of collapse -- even though that's where most cardiac arrests occur.

Now a manufacturer hopes to spur sales by making the devices as easy to buy as a fire extinguisher, asking the government to lift its requirement that at-home defibrillators be sold only with a doctor's prescription.

It's a controversial issue. Would in-home use of the machines, which cost almost $2,000, save many lives, or instead waste precious minutes if distraught relatives hunted the device instead of dialing 911 first?

"People would be better off spending the money on a health club membership," said Dr. Thomas H. Lee, a Harvard Medical School cardiologist and editor of the Harvard Heart Letter.

Philips Medical Systems, maker of the HeartStart home defibrillator, argues that consumers deserve to decide but physicians often won't prescribe the easy-to-use devices.

Next week, the Food and Drug Administration's scientific advisers will debate Philips' request for over-the-counter sales. FDA's chief concern is whether ordinary people can figure out proper use on their own.

"I don't view this as a magical cure for the problem," said Dr. Jeremy Ruskin, Massachusetts General Hospital's cardiac arrhythmia chief, a defibrillator proponent helping Philips' push.

But, "even if five of every 100 cardiac arrest victims are ultimately saved, if there's ultimately widespread availability we will double the existing survival rate," he predicted. "The stakes are high."

Every year, about 220,000 Americans die of cardiac arrest, where the heart's electrical system goes haywire. CPR buys some time, but only a defibrillator can restart the heart, with a jolt of electricity. Every minute spent waiting for a paramedic to arrive with one lowers the chance of survival by 10 percent, and 95 percent of victims die.

The American Heart Association is cautiously backing over-the-counter sales. It won't say how many homes really need a defibrillator, but has decided a prescription isn't necessary to use it properly.

The machine measures heartbeat and won't deliver a shock unless someone truly is in cardiac arrest.

Step-by-step voice instructions guide users, and the machine chirps like a smoke alarm when the four-year battery runs low.

Insurance seldom pays for the $1,995 machine today. Philips, which has sold 5,000 prescription at-home defibrillators since 2002, says the price probably would drop if it could sell more over the counter.

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