Tech tonics

A defibrillator in every pot?


Richard Downs

The T-Stat oximeter looks like a slightly oversized ear bud. A few inches long with a small round pad at one end and a cord leading out of the other, it hardly seems a life saver. But the T-Stat can see something no other oximeter can — the amount of oxygen reaching the body’s tissues.

“Patients die in the hospital for really only one reason: insufficient oxygen in critical tissues,” notes David Benaron, MD, former Stanford associate professor and now president of Spectros in Portola Valley, which developed the T-Stat. “Whether it be a heart attack, stroke, organ failure or trauma, it all comes down to this one factor.”

The T-Stat, in short, can save your life. As if this weren’t enough, the monitor, which uses light waves to measure oxygen concentration, can also assess tissues, pinpointing infection or even cancer. “It can and will go places that we haven’t even imagined yet,” predicts Benaron.

Benaron brought the $40,000 oximeter to market for $10 million — a bargain when many medical devices cost in the hundreds of millions to develop. The T-Stat was just one of about 3,000 new medical devices on the U.S. market last year. The last few decades have produced so many of these gizmos — which include small tools such as surgical clamps and needles, large machines such as X-ray equipment and wearable devices such as artificial limbs or pacemakers — that the U.S. industry now comprises 5,000 companies, which rang up a total of $72 billion in 2005. Moreover, it’s expected to nearly double five years from now, to $139 billion. By comparison, consumer electronics rack up $125 billion in sales annually.

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Everyone wants the most advanced medical care. But as costs continue to rise, more people are likely to lose their insurance, and the cost of care might cause a consolidation of the health-care industry resulting in many hospital shutdowns. Indeed, many experts wonder whether we can afford to give all patients the high-tech care they desire. “New medical technology and innovative devices can provide indispensable treatment options,” says Mark McClellan, MD, PhD, who resigned in September as head of the U.S. Centers for Medicare & Medicaid Services. “Yet the costs of development and inappropriate use clearly contribute to the rising cost of health care.”

Some of these innovative devices are truly mind-boggling: A laser optical stretcher, which uses two laser beams to squeeze a cell and measure its elasticity (an indicator of malignancy) might be able to test for cancer with as few as 50 cells, allowing dentists to spot oral cancer with a cheek swab. Under development in Italy is a battery-powered wand, waved over the body like the tricorder in Star Trek. The device has been found to detect 93 percent of prostate tumors using tissue resonance interferometry, a method of reading thermal energy.

In addition, researchers are developing nano-robots that can travel the bloodstream or explore internal organs. Already, radio-controlled miniature robots sporting cameras and biopsy needles have removed gallbladders and prostate glands in live pigs at the University of Nebraska. After the pigs swallowed the robots, surgeons directed them to cut through the stomach wall into the abdominal cavity.

The same advances in technology that allow us to listen to tunes from a music player that fits in a chest pocket, take photographs with a cell phone and get directions from a box in the car are propelling an astounding array of machines that are saving lives or simply making life more livable. But these incredible devices have other consequences: Not only are these a force behind rising health-care costs, they also pollute the environment and the human body, raise ethical concerns and further alienate patients who yearn for hands-on care.

Gizmos through the ages

The first medical device presumably was a knife, though the cranial drill might not have been far behind: Ten-thousand-year-old skeletons have been found throughout the world with holes bored in their skulls. At least as early as 2750 B.C., ancient Egyptians were wearing artificial limbs and using tools to drain abscessed teeth.

Roman emperor Nero, in A.D. 60, watched gladiator races through an emerald, likely an extravagant tool to correct his near-sightedness. Tenth-century Arabs vastly improved on the vision-correcting glass lens, and by the time Marco Polo visited China in 1266, he found people wearing spectacles similar to the modern-day variety.

Nineteenth-century America produced what may be the low point in the history of medical devices: bloodletting machines — small boxes with rotating blades to cut the skin. But the same century gave birth, in France, to the stethoscope, a still-indispensable tool so closely linked to medicine that comic-strip physicians are rarely seen without one.

In 1973 arrived the CAT scan, that massive and at the time awe-inspiring machine that sees inside the body in three dimensions; in 1979 came ultrasound. That technology, used to give a clear, real-time picture without harmful X-rays, has taken the medical device to a new level: It’s a toy for the very wealthy, like actor Tom Cruise who bought one to view his child in utero whenever the mood struck, or even for a middle-class family, which can visit an imaging center at the mall to get pictures of prenatal Junior.

Medical devices are now being marketed where everyone can see them: on television. Golf pro Jack Nicklaus appears in commercials talking about his artificial hip made by Stryker and blues great B.B. King waxes poetic over his Ascensia glucose monitor. In a spot for the Fonar upright MRI scanner, an actress plays a patient who credits the machine with giving her a more accurate diagnosis than a reclining scanner.

Better living through gadgetry

Richard Downs

It was just 12 years ago that Roland Popken, now 67, received one of the first coronary artery stents — now a commonplace treatment for atherosclerosis. He’d had angioplasty a few months earlier, but his artery quickly collapsed. Alan Yeung, MD, professor of medicine at Stanford, fitted Popken with the stent in his left anterior descending artery. Popken stayed in the hospital for 24 hours. “As soon as they let me out of bed, I was out of there and starting a normal life,” he says. “I was immediately better — I could exercise and not run out of air. There wasn’t any discomfort.” Before stents were available, a patient like Popken would have undergone cardiovascular surgery, which entails a week in the hospital and months of recovery.

Gallbladder removal also used to require a week in the hospital; today, with instruments and cameras mounted on scopes, physicians make only three small incisions, and the patient is usually home the next day. Medical devices have freed so many patients from radical, complication-prone surgery that only 37 percent of surgeries were performed on an inpatient basis in 2001, down from more than 80 percent in 1980.

Like Nicklaus, many osteoarthritis sufferers are playing golf again because of artificial hips and knees — manufactured joints that take the place of the damaged ones. “It’s a quality-of-life operation,” says William Maloney, MD, chair of orthopedic surgery at Stanford, about hip and knee replacement surgery. “You take patients with chronic pain — maybe they’re not sleeping well, they’re depressed — and you’re restoring them to normal or near-normal function.” And spinal cord injury patients whose breathing muscle no longer functions, like the late actor Christopher Reeve, can leave the ventilator behind thanks to a pacing system that tells the diaphragm when to contract.

More significantly, many people are alive simply because of a device. The mammogram machine, which flattens and holds breasts still to provide a better X-ray, is credited for about half of the drop in breast cancer deaths from 1990 to 2000. The implantable cardioverter defibrillator, placed under the skin of patients whose hearts have a tendency to beat too quickly or quiver ineffectively, keeps track of the heart’s beating and, if needed, sends an electrical shock to restore the rhythm.

Reality check

As great as these devices are, the growing reliance on them spells trouble. Most immediately painful is the expense. Says Laurence Baker, PhD, associate professor of health research and policy: “We all pay the price. As health-care costs rise, we collectively have to cover that bill.” Advances in medical technologies are thought to account for half or more of the growth in health-care costs, and a large portion of the costs are associated with new devices. We pay through taxes that cover Medicaid and Medicare and through higher health-insurance premiums.

As insurance becomes more expensive, a growing number of employers are dropping coverage, retirees are losing what they’ve come to expect and more private-pay individuals are relinquishing insurance all together. The result is more Americans who lack health-care coverage — now about 45 million. So while those with health insurance grumble about rising premiums, those without insurance pay for rising costs another way: They receive worse care. Uninsured patients wait longer for appointments and forgo preventive care and medications they can’t afford. Although a car accident victim without insurance will be treated in an emergency room — legally, the hospital can’t refuse such a patient treatment — the patient may not receive follow-up care such as physical therapy or surgery because the out-of-pocket cost is too high, notes Kate Bundorf, PhD, assistant professor of health research and policy.

A small number of devices do save money. For patients with rapid heartbeats, for example, a catheter with an electrode can destroy a tiny area of the heart, putting a stop to the extra impulses that cause the fast beating. The procedure costs $8,000, but it often eliminates the need for medication and reduces trips to the emergency room. Money-saving devices are rare, however: “It’s much more common to have something that’s effective but not cost-saving,” says Douglas Owens, MD, senior investigator at the VA Palo Alto Health Care System and professor of medicine. Rather than reduce the cost of care, most devices treat people who would either have died or simply lived with their symptoms. Implantable cardioverter defibrillators, for example, save lives, but at a price of at least $40,000 to $60,000 per implantation. And until laparoscopy was available for gallbladder removal, many people chose to live with gallstones rather than undergo traditional open-abdomen surgery. More than 500,000 now have the laparoscopic procedure each year in the United States.

These devices aren’t just expensive — they’re polluting. The manufacture of polyvinyl chloride, aka vinyl, used in tubing, blood pressure cuffs, breast pumps and many other devices, releases dioxins. And, once clinicians and patients are done with the devices, hospitals frequently burn them, which also releases dioxins. In 1994, medical waste incineration was the leading contributor to dioxin poisoning; today, because fewer hospitals are burning waste, it’s around third place.

Dioxins can cause cancer, harm to the reproductive system, developmental delays and increased susceptibility to infection. Once discharged, they ultimately settle down and enter the food chain, winding up in the milk, meat and fish that most of us eat. “The stuff doesn’t break down,” says Stacy Malkan of Health Care Without Harm, a public health advocacy group based in Arlington, Va. “It doesn’t go away. It’s in the air or in the landfill or in the water. It’s a huge problem.”

Another treacherous chemical in medical devices is di(2-ethylhexyl) phthalate, which is added to polyvinyl chloride to make it flexible — an obvious benefit for threading a catheter in a vein or other vessel. DEHP is less threatening to the environment than it is to patients: Animal studies have shown that DEHP harms the reproductive systems of young males. For this reason, the FDA has warned against using devices containing it on pregnant women and boys.

Testing medical devices presents another challenge, one that’s even thornier than for pharmaceuticals. Because frequently a physician will hatch an idea for a medical device, develop it, then start a company to produce and sell it, a conflict of interest can arise. The physician who develops a device is often ideally suited to test it out, as he or she best understands its use. But if that physician is part of the testing, “there’s a possibility of bias from the financial interest,” says Mildred Cho, PhD, associate director of Stanford’s Center for Biomedical Ethics and associate professor of pediatrics. Physicians might be so eager to prove a device’s value, Cho says, that they could overlook side effects or, if study subjects are hard to find, admit some despite disqualifying health conditions.

And of course, medical devices have an inherent downside: They can fail. Nearly 300,000 people with pacemakers or defibrillators have learned since 2005 that their life-saving machines made by Guidant (since purchased by Boston Scientific) might not give their hearts a zap when it’s needed. Faulty batteries and other parts were used in the devices’ manufacture. Unfortunately, patients can’t count on government oversight to prevent these defects, as the U.S. Food and Drug Administration, which oversees medical devices, has slacked off on inspections. From 2000 to 2005, the agency’s warning letters to medical device manufacturers dropped by two-thirds — and this in a rapidly growing field.

Perhaps the least understood side effect of medical devices is the damage they do to the relationship between a physician and patient. “Devices tend to redefine medicine by tool and procedure,” says psychiatrist David Spiegel, MD, medical director of the Center for Integrative Medicine at Stanford. “They give the sense of just fixing a machine.” But physicians who treat patients as people and not machines realize better outcomes. “It’s because of modern medical technology that people live,” says Dennis Goodman, MD, a cardiologist at the Scripps Center for Integrative Medicine in La Jolla. “But it has to go hand in hand with taking care of the whole patient.”

Your electronic future

A few decades from now, medical deviceware could well be the latest fashion statement — cunningly designed techno-trinkets clasping wrists or peeking out from behind an ear. Pacemakers will treat more neurological and neuromuscular diseases and possibly cancer as well as autoimmune diseases. Implantable devices will dispense medication in more accurate doses and at timely intervals. “It’s easy to foresee that a 55- or 65-year-old individual may well have two or three devices implanted or worn,” says Molly Joel Coye, MD, founder and CEO of the Health Technology Center, a nonprofit market research organization in San Francisco.

Other devices will become part of the furniture as more of them come home with us. As devices shrink and become increasingly user-friendly, instruments that check vital signs, reset heartbeats and clean blood will reside on a bed stand. Many of these will be available in a drugstore without a prescription.

As companies become more aggressive and sophisticated in their advertising — and as devices start crowding the shelves of drugstores — you might think that your life would be much better if you had a blood-oxygen monitor, or perhaps a bracelet that tests for malaria parasites. But advertising only highlights a cultural problem: Americans believe in receiving the best and most intensive medical care possible, even for 90-year-olds with multiple health issues and poor quality of life.

“Everyone wants the latest and greatest,” says David Magnus, director of the Center for Biomedical Ethics. “As long as we want everything, costs will continue to spiral.”

How can our society continue to pay for top-quality care — for everyone, not just those who can afford to pay for it themselves? Perhaps a greater number of medical devices will save money: As more self-diagnostic or self-treatment tools come on the market, for example, we could avoid large numbers of unnecessary visits to the clinic or hospital. There is also plenty of opportunity to cut waste from our inefficient health-care system. Physicians are reimbursed well when they perform procedures such as surgery on end-stage cancer patients; not so well when they screen patients for cancer. “We pay a lot for ineffective care, duplicative services, medical errors and preventable complications,” says Medicare’s McClellan, who’s an associate professor in economics and medicine on leave from Stanford. He adds that the agency is altering its reimbursement pattern to cover care that’s proven to be helpful.

Yet these developments likely won’t trim costs enough. Insurers already limit coverage, paying only a portion of fertility treatments and refusing to cover experimental procedures. Will the day come when the baby boomers, brought up in the world of access, will be forced to accept limits? Undoubtedly, insurance will cover only the most effective — and most cost-efficient — care. It’ll be easy enough to get a colonoscopy, but if you’re a 75-year-old hoping for a defibrillator, perhaps you’ll be out of luck.

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