A Sept. 9 article about the sale of automated external defibrillators for home use incorrectly attributed a statement that Philips Medical Systems believes Food and Drug Administration approval of its HeartStart device is imminent. That statement should have been attributed to a public relations consultant to the company, not to company executives. (Published 9/11/04)
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.
"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.
The company, a subsidiary of the Dutch giant Philips Electronics NV, and several other manufacturers are clearly betting that over-the-counter approval will expand the market. Philips Vice President Deborah DiSanzo said sales could grow 50 percent a year over the next few years.
The company expects to sell 7,500 units this year, up from 2,500 in 2003.
Defibrillator sales to the public now account for 1 percent of the $275 million worldwide market, said Raymond W. Cohen, CEO of Cardiac Science, an Irvine, Calif.-based manufacturer that is also likely to seek FDA approval for over-the-counter sales.
Experts say cardiac arrest occurs often in people with no sign of heart trouble. In 40 percent of cases, there is no warning until the person collapses, said Graham Nichol of the University of Washington, who chairs an American Heart Association task force on automatic external defibrillators.
One just-published study suggests that the often-cited number of deaths may be overstated by as much as a third. The yearlong study, being published Wednesday in the journal of the American College of Cardiology, closely tracked the number of deaths from cardiac arrest in Multnomah County, Ore. It counted 353, compared with 1,007 deaths recorded a year earlier through less rigorous methods. Though the study was in only one community and for a limited time, it suggests that current statistics need to be reevaluated, said lead author Sumeet Chugh of the Oregon Health and Science University.
"If their results are accurate, past studies significantly overestimate the incidence of sudden cardiac death," Douglas Zipes of the Indiana School of Medicine, past president of the College of Cardiology, said in a statement.
In a paper in the New England Journal of Medicine in August, investigators said a three-year study of defibrillator use in public areas turned up only half the expected number of cardiac arrests.
"What has not been demonstrated is whether having [defibrillators] available without a prescription in the home will make a meaningful difference in the overall survival rate," said William Maisel of Boston's Brigham & Women's Hospital, a member of an FDA panel that evaluated HeartStart.
Though one is in the planning stages, there have been no studies of defibrillator use in homes, a factor that led the heart association two years ago to withhold judgment on direct-to-consumer sales. The group has since shifted its stance on the grounds that requiring prescriptions prevents wider use of the technology, Nichol said.
The change "means we think they are safe," he said. "We have not come out and said everyone should have these."
Safety is not an issue, Maisel said. But there are other concerns -- including whether panicked home users will remember to call 911.
Caplan worries that the device will be used on a victim whom no one saw collapse, and whose brain may have been deprived of oxygen for many minutes. Historically, about half of arrest victims live if shocked in the first two minutes. By 10 minutes, only 5 percent live.
The same could happen with delayed CPR, Caplan said, but "creating hundreds if not thousands more people in a persistent vegetative state or near-persistent vegetative states in nursing homes and hospitals will create an enormous emotional burden on families and much additional cost for a system already reeling from the results of the inappropriate use of life-saving technologies."
In the New England journal study, 26.7 percent of survivors given CPR and a shock had mild to moderate cognitive impairment.
Cardiac arrest survivors and friends and relatives of those who have died are among the most passionate backers of increased access to defibrillators, which they say should be viewed in the same light as fire extinguishers and smoke detectors: crucial home safety items.
But Kellermann and other physicians said the money would be better spent on a gym membership, cholesterol-cutting drugs or other ways to prevent heart disease.