Legion of Angels News Archive

The implanted defibrillator, a device that can automatically shock an erratically beating heart back to a normal rhythm, has been proved to save lives. Hence its nickname: an emergency room in the chest. Major medical groups have recommended that more patients receive the devices.

But in the last two years the number of patients receiving defibrillators has actually declined, as more doctors and patients decide the risks and uncertainties the devices pose may outweigh their potential benefits.

This trend — the first decline since implanted defibrillators were introduced in 1985 — has spotlighted a shortcoming that health experts have struggled with for years. Simply put, there is no adequate tool or test to predict which of the heart patients who might seem good candidates to get the expensive devices are the ones most likely to ever need their life-saving shock.

Defibrillators have undoubtedly saved the lives of tens of thousands of Americans. That is why insurers still typically pay for the devices and the surgical procedure to implant them, which can top $50,000 for each patient.

What makes many doctors and patients increasingly wary, though, is a string of highly publicized recalls in recent years, along with mounting evidence suggesting that a vast majority of people who get a defibrillator never need it.

Industry estimates and medical studies indicate that defibrillators have saved the lives of 10 percent of the more than 600,000 people in this country who have received them, at most. While survivors would no doubt take those odds, 9 of 10 people who get defibrillators receive no medical benefit. One big long-term medical study indicated the odds of a defibrillator saving a patient’s life might be even slimmer — about 1 in 14, over the five-year period studied.

The problem that defibrillators pose is in some ways singular among medical technologies. For devices like artificial knees, which improve lives but do not save them, few people would settle for only a 1 in 10 chance of success. For a potentially life-saving cancer drug, a patient might grasp at even much slimmer odds. Where defibrillators differ is that they are only a powerful standby — ready to intervene if necessary, but unlikely ever to be called into service.

If defibrillators were simply $50,000 life insurance policies, the relatively low rate of payoff might not matter much. But the long-shot statistics are significant to people who must weigh the risks of infection and malfunction after they have an electronic device anchored inside their hearts and its wires threaded through their arteries.

The slim odds also have large implications for the United States health care bill, adding billions of dollars annually to Medicare spending and to insurance payments. Dr. Larry A. Chinitz, director of the Heart Rhythm Center at New York University’s Langone Medical Center, said, “The answer isn’t just to keep implanting everybody” who fits the current guidelines.

More doctors are now thinking twice. From a peak of 160,000 new patients in 2005, the number has fallen to less than 140,000 last year, according to Lawrence H. Biegelsen, an analyst at Wachovia Capital Markets. He predicts this year’s total will end up even lower.

For the manufacturers, the numbers translate to a decline in defibrillator sales to $3.94 billion in this country last year, down from $4.29 billion in 2005, Mr. Biegelsen said.

Only overseas, where defibrillators have been slower to catch on, has the number of new implants continued to rise, hitting a new sales high of $1.93 billion last year.

Many patients, of course, are grateful for their defibrillators. “It’s saved me at least four times, including two when I passed out completely,” Matthew M. Murray, a 55-year-old former engineer in Riverbank, Calif., said of his implant.

And some experts worry that the pendulum may have swung too far away from defibrillators — putting countless lives at risk among people with the heart abnormalities and ailments most likely to cause cardiac arrest. At least several hundred thousand people in this country have such conditions, and some estimates place the figure at more than a million.

Medtronic, the leading maker of defibrillators, contends that each day 500 deaths are caused by sudden cardiac arrests among people who meet the current medical guidelines for the devices but do not have them.

(The NBC journalist Tim Russert, who died earlier this year, reportedly suffered a heart attack after an artery was blocked. While Mr. Russert had a history of heart disease, his condition was not one for which a defibrillator would have been prescribed.)

Dr. Eric N. Prystowsky, a nationally renowned heart rhythm specialist in Indianapolis, said every doctor in his field was haunted by individual cases, like that of a Purdue University graduate student who was referred to Dr. Prystowsky for a defibrillator. The student had an abnormally thick heart muscle, a known risk for sudden cardiac arrest.

“He kept putting it off,” Dr. Prystowsky said of the decision to get a defibrillator. “Six weeks later, his fiancée called to say he had been found dead in bed.”

Cases like that may be inevitable as long as doctors cannot give patients more certainty about whether a defibrillator will actually help them.

Better clues could be submerged in the medical records of the people who have gotten defibrillators over the decades. Three years ago, Medicare ordered the creation of a nationwide registry, or database, for implanted defibrillators. Overseen by two leading professional groups, the American College of Cardiology and the Heart Rhythm Society, the registry has amassed about 270,000 records from 1,500 hospitals.

But the data mining has only recently begun, and results are not expected before 2010 at the earliest.

There is no guarantee that the information will lead to more effective use of defibrillators. Unlike drugs, many medical devices evolve so quickly that long-term data on their performance can be obsolete by the time it is available.

There are also efforts to find genetic markers and to develop new diagnostic tests that might more precisely identify patients who are predisposed to the type of sudden cardiac arrest a defibrillator could prevent. So far, though, the only federally approved screening test identifies some patients who are unlikely to need a defibrillator in the next year — not those most likely to require one.

The defibrillator decline began after highly publicized reports of a small number of deadly malfunctions. The biggest blow came in June 2005, when the Guidant Corporation — later acquired by Boston Scientific — recalled 29,000 implanted defibrillators because of flaws that might have caused them to short-circuit instead of delivering critical shocks. At the time, at least two deaths had been linked to the failure.

Medtronic, the market leader, and St. Jude Medical, the third major player, subsequently announced product recalls, although neither was prompted by known deaths.

Heading into 2007, as those headlines faded, many analysts predicted a rebound in defibrillator sales. But last fall Medtronic recalled its newest version of the main wire that connects a defibrillator to the heart. A small percentage of the more than 200,000 Fidelis-brand leads that had been implanted were developing fractures suspected of either preventing some defibrillators from delivering shocks when needed or causing them to deliver unnecessary shocks.

Even with properly functioning devices, patients risk unnecessary shocks — jolts recipients often describe as a painful and frightening kick in the chest. “Almost as many get shocked unnecessarily as benefit,” Dr. Paul J. Hauptman, a professor of medicine at St. Louis University, said.

And even problem-free patients need surgery to replace their unit’s batteries when they run low. Most of today’s batteries are expected to last five to seven years. Manufacturers say patients generally get better software and longer battery life with each replacement. But the repeat procedures also raise costs and risks.

Meanwhile, there are signs that improved treatment of cardiac disease with drugs, diet and behavioral changes could be reducing the need for defibrillators. At a meeting of heart rhythm specialists in May in San Francisco, Dr. Douglas P. Zipes, an Indiana University medical professor, cited data suggesting a decline in the percentage of heart patients who suffered the kinds of heart stoppages that defibrillators were intended to address.

Hoping to stay relevant, the makers of defibrillators have been developing higher-priced devices with new features, including software to limit unnecessary shocks. Most are built to communicate wirelessly, allowing doctors to remotely monitor their performance. Many can perform other rhythm-regulating functions, like synchronizing contractions in different chambers of the heart.

“Adding additional therapy will get at more of the market,” said Daniel J. Starks, chief executive of St. Jude Medical, citing plans to add sensors that could warn of impending heart failure. But adding complexity could also make it even more difficult to calculate the costs and benefits of implanting the devices in the first place.

That bothers patients like one 50-year-old business consultant in the San Francisco Bay Area. The man, who declined to be identified for fear of alarming his clients, ignored recommendations from three doctors to get a defibrillator. Online research suggested his risk of sudden cardiac arrest would be 3 percent a year without a defibrillator — and about 1 percent with one.

Doctors thinking about thousands of patients might see that as a significant difference, he said. But for him, he said, it did not seem a fair tradeoff for becoming “part of the medical-industrial complex for the rest of your life.”

Source — The New York Times

It’s becoming a rite of summer: as the mercury rises, Apple introduces a new version of its iPhone. And as the new-and-improved device went on sale last week, campers once again lined the sidewalk in midtown Manhattan. The new iPhone features faster Web browsing, clearer audio and basic GPS functions; so far, reviews have been mostly positive. But as early adopters clamor for this latest high-tech status symbol, let us consider the group at the other end of the wireless bell curve: the one in seven Americans who still don’t have a cell phone.

According to the latest data, the U.S. “adoption rate” for mobile phones stands at 85 percent. That’s higher than the percentage of Americans who have DVD players (84 percent), home PCs (80 percent), digital cameras (69 percent) or MP3 players (40 percent), according to the Nielsen Co. “The concept that within my lifetime we’d have the kind of penetration we have today is unimaginable,” says Martin Cooper, 79, the former Motorola researcher who invented the portable cell phone in 1973. But for wireless providers, it’s a mixed blessing. With fewer virgin customers to bring online, the industry’s subscriber base grew by just 8.8 percent in 2007. To keep revenues rising, the big carriers are focused mostly on stealing each others’ existing customers and getting mobile users to spend more on ringtones, streaming music and other add-ons. But a handful of start-ups are aggressively pursing wireless holdouts. The bulk of the un-mobile fall into three groups, says senior analyst Chris Collins of Yankee Group: children, the elderly and the credit-challenged. (There’s actually a fourth group, prison inmates, but companies haven’t yet found a way to target that elusive niche.)

Lots of parents have mixed feelings about kids’ having phones, but they’re showing up in school backpacks at earlier ages. By some estimates, half the country’s 28 million 8- to 14-year-olds already have handsets of their own. To attract these youngsters, big carriers all offer discounted “family plans,” but lately smaller companies have tried to sell phones and service plans designed specifically for kids. Among the latest entries is one from a company called kajeet. Its phones allow parents to set limits on calls or texts; remotely turn off the device during school hours, or block calls or texts from bullies. To prevent surprise $300 monthly bills, kajeet features a pay-in-advance system, with a basic charge of $10 a month and 10 cents per minute. CEO Daniel Neal says consumers are becoming more averse to the “hidden gotchas”—cancellation fees, service fees and random charges—found in typical wireless plans. Neal believes 80 percent of the 8-to-14 crowd will have a phone within three years.

Fear of runaway bills is a hurdle for elderly consumers, too. But more of them (and their adult children) are becoming convinced it’s good to have a phone handy for emergencies. To appeal to this crowd, last year Jitterbug began selling a $147 phone with an uncluttered keyboard, a huge display and other elder-friendly features (including a $15-per-month, 30-minute rate plan). It has no camera or text messaging, and if a user gets confused while making a call, he can hit zero and ask an operator to connect him to someone on his contact list. Jitterbug hopes the phones may have appeal beyond the elderly: in a May survey it commissioned, 32 percent of mobile subscribers said their current phone has more features than they know how to use. “Simplicity is really the cornerstone of our business,” says cofounder Arlene Harris.

For consumers without bank accounts or credit scores—the third big group of cell-phone holdouts—prepaid phones have long offered an alternative to traditional wireless contracts. Lately, per-minute charges have come down from 35 cents to 10 cents, and companies have offered a better variety of phones; as a result, prepaid phones have been the fastest-growing segment of the cell business. Even so, companies are trying new ways to make them appealing. Trumpet Mobile, which began selling prepaid phones in Radio Shack stores last year, gives customers a phone, a prepaid debit card and the ability to send money via mobile phone using Western Union. Trumpet hopes its service becomes popular among Latino immigrants, who are already using it to send money to relatives overseas.

While these start-ups are long on imagination, so far none will say exactly how many customers they’ve signed up. That leads observers to believe their numbers are low and their odds of survival are unclear. Indeed, one reason big wireless companies haven’t chased the holdouts more aggressively is that they aren’t likely to spend $49 per month—the amount of the average U.S. mobile customer’s bill—making them only marginally profitable (if not unprofitable). And while parts of Europe and Asia feature wireless penetration rates above 100 percent (thanks to people who carry multiple phones), no one is ready to bet when America may hit the magic number, partly because our country still has rural areas with poor coverage. “There is some argument that it will never get there—that it will never be cost-effective,” says Richard Siber, a veteran industry consultant. So even as the early adopters keep buying phones full of new tricks, there will remain at least a smattering of folks who can’t be blamed for the obnoxious ringtones that have become so much a part of life in our wireless age.

Source — Newsweek

NEW YORK (Fortune) – The new Apple iPhone went on sale Friday morning, but early reports of software problems overshadowed the debut of the faster, cheaper device.

As eager buyers flocked to Apple stores, news sites chronicled reports that Apple’s iTunes store was struggling with a massive outage that prevented buyers from activating their phones.

Apple’s new iPhone is built on third-generation, or 3G, technology that is speedier than the original iPhone’s network.

As Fortune.com first reported, AT&T, the iPhone’s exclusive carrier in the United States, cut the price of the iPhone in half: an 8-GB model sells for $199, or $200 less than the original iPhone. A 16-GB version costs $299.

The Apple Store on New York City’s tony Fifth Avenue, which drew a crowd of 150 people just after 5:00 a.m. ET, was moving customers through the line in about 10 minutes per customer when the doors opened at 8:00 a.m., according to Fortune’s Philip Elmer-DeWitt.

High expectations

But problems soon appeared. Elmer-DeWitt, who live-blogged from the store, was one of the first to report difficulty setting up his new phone. Eventually he was told, along with other customers, to go home and try to activate his device later.

Elmer-DeWitt was able to get his phone to work about three hours after his purchase. By early afternoon, there were more anecdotal reports online of users completing the activation process.

The system crash affected buyers throughout the 21countries where the new iPhone debuted Friday. Owners of the original iPhone and the iPod touch looking to upgrade their software were also hobbled by the breakdown.

The iTunes outage wasn’t the only glitch Apple customers encountered Friday. Users attempting to sign up for MobileMe, which synchs e-mail and other data across Mac devices, also experienced technical problems, according to the Associated Press. Apple began offering the $99-a-year service Friday.

The iPhone 3G rollout was in stark contrast to last year’s debut, when hordes of eager buyers camped out for days at Apple stores around the country and the purchasing process went off without a hitch - at least on Apple’s end. AT&T, meanwhile, was hounded with activation problems.

On Friday, AT&T was quick to pin the blame on Apple. “There’s a worldwide issue with iTunes that Apple is working to resolve,” an AT&T representative said in an e-mail. Apple did not respond to a request for comment.

Early hangups aside, one analyst predicted Friday that the second version of the iPhone will have a stronger debut than its predecessor.

One major reason: Apple is releasing the 3G model around the world on Friday. The original iPhone was rolled out from country to country over the course of the last year.

“Based on on pent up demand, expanded distribution, lower pricing,” RBC analyst Mike Abramsky wrote in a research note Friday, “Apple ships 1 million 3G iPhones in the first weekend.” Abramsky said that would be roughly four times the number of iPhones shipped during the same time frame last year.

Apple sold more than 6 million original iPhones.

Some analysts warn that expectations for the new iPhone are too high. For one thing, the economy is a lot weaker than it was a year ago. Consumers may not no so eager to shell out the $2,200 or more it would cost for the iPhone and the mandatory two-year subscription.

Early reviews were more subdued than the glowing critiques of the first iPhone.

David Pogue of the New York Times called the iPhone 3G “a nice upgrade,” but suggested it wasn’t something existing iPhone owners should rush out and buy. The real novelty, Pogue said, was the App Store, where owners of the old and new iPhone can purchase games and other software - most for $9.99 or less.

Source — CNN

Apple may be golden because of the iPhone, but the soon-to-be-updated device is also increasingly the source of forbidden fruit. Steve Jobs’ company is keeping a civil, if embarrassed, silence on one of the potentially most lucrative and controversial uses of its handheld jewel: porn.

The technological feats of the 3G iPhone are key to the coming pornucopia. To date, mobile porn has consisted largely of still images, racy text services and “moan tones,” which are sultry-sounding ringtones. In Europe there is an active market for video chatting; customers pay on average $50 a month to exchange dirty messages with actresses. But now, thanks in large part to the iPhone’s video dexterity, short clips are becoming a staple of the mobile porn business. The speed promised by the iPhone 2.0 is much anticipated. Google Trends, which measures Web buzz, shows a sharp increase over the past year in the popularity of the term “iPhone porn.”

Leading porn purveyors see the iPhone as a dream come true. Its relatively ample screen size, speedy Web access and ease of use are just part of it. The device’s miniaturized version of Apple’s Safari software simplifies mobile access and streamlines the process of tailoring dirty sites for optimal viewing on the go. “It’s by far the porn-friendliest phone,” says Devan Cypher, representative for San Francisco–based Sin City Entertainment. As evidence of the gadget’s rocketing popularity in California’s porn capital, the San Fernando Valley, numerous iPhone-specific porn sites have been launched in recent months. “There are a few hundred iPhone porn sites now in use,” says Farley Cahen, vice president of business development for AVN Media Network, the adult industry’s trade body. Many others are currently in the works targeting the iPhone 2.0, which goes on sale July 11.

Apple spokeswoman Jennifer Bowcock says the company doesn’t condone iPhone porn distribution and will ban adult content from official applications, just as it has restricted adult content in the podcast section of the Apple store. But it can’t prevent customers from accessing porn through the device’s browser. Indeed, the new iPhone may eventually propel mobile porn deeper into the sphere of interactivity. Blogger Jason Swifter has already imagined one such scenario. “I wish there was an application that allowed you to undress people by dragging your fingers across the screen and literally dragging it off,” he wrote on iPhonematters.com. Apple says that more than 250,000 programming kits have been downloaded, enabling programmers to create their own iPhone applications, like games or chat services. Just as users have unlocked iPhones for use around the world, some may eventually figure out how to surreptitiously create and distribute iPhone porn applications.

Sensing the start of a profitable new era for pocket porn, the adult entertainment industry is investing heavily and feverishly broadening its marketplace of iPhone porn. The industry sees the iPhone 2.0 as having multiple advantages over the first model. For one thing, Apple’s new gadget is nearly twice as fast as its predecessor at loading Web pages, and even faster at running video, which is crucial for the porn industry. About a third of iPhone users watch video on their phone, according to Nielsen Mobile, which is nearly 10 times the number that watch video on other cell phones. Three out of four iPhone users are men with above-average incomes, and iPhone users spend heavily on entertainment. More than a third of iPhone users shell out more than $100 on phone and data charges every month, as compared with just one-fifth of other cell-phone users.

Furthermore, the new model will be available in at least 75 countries, enabling content providers to reach new mobile porn viewers all around the world. Mark Kirstein, president of Multimedia Intelligence, a mobile-research firm, says the iPhone is like a Trojan horse that lets smut providers cut out the carrier as middleman. “The iPhone becomes a portal where people can get to content directly without worrying about the social mores of the network operator,” he says, referring to carriers like Canada’s Telus, which canceled an experimental adult-content offer after receiving hundreds of customer complaints. That means better margins for direct porn providers amid this potential wave of new profits.

In 2007, the international market for mobile adult content reached $1.7 billion, according to Juniper; 45% of that revenue came from Western Europe, where mobile porn is more widely offered by carriers. “There’s less of a drive to regulate the industry in Europe,” says mobile-industry consultant Chetan Sharma, who adds that U.S. and Canadian carriers have largely avoided carrying porn applications for fear of a public backlash. Before the new iPhone was announced, Juniper projected that revenue from mobile adult content would rise to $4.6 billion by 2012. With millions of 3G iPhones in the market, Juniper’s principal analyst Windsor Holden says, the number could grow far larger. “A huge portion of the $13 billion adult market has been reliant on physical distribution,” says AVN Media Network’s Cahen. “That business model is shifting to downloadable and streaming content.”

Opposition to iPhone porn, however, may grow as well. The genre’s availability could spark new demand for mobile-phone porn blockers, as parents realize that children could access adult content on Apple’s device. “Our iPhone 2.0 software will give customers the opportunity to turn on parental controls,” says Apple spokeswoman Bowcock. Some parents may not be tech-savvy enough to figure that out, though, and some kids may be clever enough to find a work-around. “If a minor with one of these phones pokes around, he could easily access adult sites without his parents’ knowledge,” says Holden, who authored “Adult Content in the Palm of Your Hand,” Juniper’s latest research report.

Cahen says an industry group called the Association of Sites Advocating Child Protection has worked to promote industry-wide adherence to standards preventing youth access to porn. Problems may still arise, says Holden. “If the Janet Jackson episode led to a fine for a quick breast flash,” he says, “can you imagine what could happen to an American carrier if a child gets hold of some of the hard-core materials that are easily available? The FCC will have a field day.”

Source — TIME