Thursday, October 19, 2006

When More Medicine Is Less

When More Medicine Is Less

A Dartmouth study finds a greater risk of death among patients treated in high-cost hospitals and clinics -- and highlights conflicts of interest

COVER STORY
By John Carey
BusinessWeek, MAY 29, 2006

Getting more medical care, and paying more for it, can actually make your health worse. That's the paradoxical conclusion of Dartmouth Medical School's Dr. Elliot S. Fisher. He found that the amount spent per person on health care varies dramatically in different parts of the country. Southern California is high cost, for instance, while Northern California is low cost. Spending is high in the Boston area, and low in Western Massachusetts and Minnesota.

Fisher originally expected to find that people in areas with more healthcare would be healthier and longer-lived. The opposite was true. "If anything, it looks like there is a substantially increased risk of death if cared for in high-cost systems," he says. The reason: The additional tests and procedures in the high-cost areas bring more risks than benefits. "A large portion of those extra costs are due just to proximity to health care," says George Bennett, CEO of Health Dialog Analytic Solutions, which tries to get unbiased information to patients. "Not all those expenditures are optimal or even appropriate."

Why does this happen? Clearly, one huge underlying cause is money. The way the U.S. health-care system is structured offers doctors, hospitals, and companies enormous financial incentives to provide more and more care. Surgeons will get paid if they do a bypass operations, insert ear tubes in children, or take out a prostate. If they recommend waiting or doing drug therapy instead, there's no payday.

"You get paid for operating and not paid for not operating," says Dr. Jack Paradise, a professor of pediatrics and otolaryngology at the Pittsburgh School of Medicine and Children's Hospital of Pittsburgh. "Conflict of interest is hard to rule out."

POTENTIAL CONFLICTS. Similarly, hospitals get higher revenues if they put more patients in their new catheter labs or operating rooms. This isn't to say financial considerations outweigh medical choices. But studies have shown wide variations in the amount of care among hospitals -- and again, more care doesn't bring better results.

Researchers at the Center for the Evaluative Clinical Sciences at Dartmouth Medical School have looked in detail at what happens in the last six months of life at 77 top hospitals in the U.S. The results were startling: The average number of days spent in the hospital during the last six months of life was 10.1 days at Stanford University hospital compared to 27.1 days at New York University Medical Center. The average number of doctors visits ranged from 17.6 to 76.2, with NYU at the top.

Yet there's no evidence that the more intensive care brings better outcomes or quality of life. In fact, the researchers suggest, the opposite is true. "The problem is not underuse in low-rate regions and hospitals, but overuse and inefficiency in high-rate regions," concludes Dr. John E. Wennberg, professor of medicine and director of Dartmouth's Center for the Evaluative Clinical Sciences.

The potential conflicts of interest are even starker with drug and medical device makers. The pharmaceutical and device industries are, after all, businesses. Like any businesses, they would be remiss in their duty to shareholders if they didn't try to sell as many of their products as possible.

GOVERNMENT CONCERN. Health care is different from, say, selling cars. No one is hurt if people buy one car over another, or more cars than they need. But for all their benefits, drugs have dangers. Taking the wrong one, or the wrong combination, or too high a dose, or one that's not needed, does hurt people -- and raises health care costs unnecessarily.

That's why the Food & Drug Administration puts curbs on the marketing practices of companies. But because of the huge amounts of money that come with increased sales, they have every incentive to push the envelope when it comes to marketing. As a result, they often work to turn ordinary conditions, like jittery legs, into "diseases" that need treatment (see BW Online, 05/08/06, "Hey, You Don't Look So Good").

They woo doctors with free samples, gifts, trips, and other enticements to prescribe more drugs and use additional devices. A recent lawsuit, for instance, accuses Medtronic (MDT ) of handing hundreds of thousands of dollars for minimal work to prominent back surgeons who are in a position to boost use of the company's spinal-implants. Medtronic spokesman Rob Clark notes that these are allegations. "We do not tolerate any kind of conduct that is unethical...or violate the law," he says.

BOTTOM-LINE BIAS. In another case, Warner-Lambert, a part of Pfizer, (PFE ) was ordered to pay $430 million after pleading guilty to charges of illegally marketing its epilepsy drug, Neurontin, for unapproved uses. The company aggressively pushed the drug for conditions like bipolar disorder, back pain, and headache -- for which there was little or no evidence of effectiveness.

The marketing campaigns, which included trips and big "speaker" fees to doctors, turned the drug into a blockbuster, with billions of dollars in sales per year. But while the practices fattened the company's bottom line, many patients may have been hurt by unnecessary use of the drug, which lawsuits allege can cause suicidal thoughts, tumors, and convulsions.

These powerful financial incentives make it that much harder to get the right treatments and the right amount of care to Americans.

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Medicine's Industrial Revolution

Medicine's Industrial Revolution

COVER STORY

By Howard Gleckman, with John Carey
BusinessWeek, MAY 29, 2006

Sometimes medicine performs just as it should. Vaccines have banished smallpox. Surgery can cure early-stage colon cancer. But the disturbing truth is treatments that are proven to work reach only about half of the Americans who need them, according to a series of studies by RAND Corp. And in hospitals, simple measures that protect patients' lives are often hard to implement.

Hygiene is a good example. For 150 years we have known that doctors with unwashed hands pass infections from patient to patient. The Centers for Disease Control & Prevention figures that 80% of hospital-acquired infections are transmitted this way, costing billions of dollars annually to treat and killing thousands of people.

With this in mind, the University of Pittsburgh Medical Center's Presbyterian Hospital installed alcohol-wash dispensers in every room and allowed nurses to ban doctors who don't wash up from entering patients' rooms. Yet more than one-quarter of UPMC's doctors still haven't gotten the message, says Chief Medical Officer Loren H. Roth. Things have improved in recent years, "but a lot of physicians and residents are still not complying," he says.

One major cause for such huge gaps in care is that financial incentives can be skewed. Insurance companies, which have learned that high infection rates cost them money, are beginning to provide bonuses to encourage hospitals to make big improvements. Highmark Inc., which operates the Blue Cross/Blue Shield plans in Pittsburgh, will give UPMC $10 million this year for lowering infections.

But doctors don't have the same incentives. They are usually not hospital employees and are paid based on the number of patients they see and procedures they do. Repeatedly stopping to wash up may slow them down and cost them money. That has hospitals such as UPMC as well as private insurance companies and Medicare scrambling for new ideas. "How do we align incentives so we pay more for prevention than for solving the disaster after it happens?" asks Donald R. Fischer, chief medical officer at Highmark.

UPMC's Roth says that improving the quality of care may also mean challenging a bedrock belief: that each patient is unique and that doctors must bring individualized judgment to each case. This view "has a kind of appeal to it for both the profession and patients," says Roth, "but it is not so." Most illnesses and injuries can best be treated by standardizing care, he argues. The goal is to "industrialize every process we can."

This idea horrifies some doctors, but businesses and insurance companies, who pay many of the bills, are cheering Roth on. "We know if you take beta blockers, you are much less likely to have a heart attack," explains Helen Darling, president of the Washington-based National Business Group on Health, which represents major employers. "We can reward you for meeting those standards."

Independence Blue Cross has gone a step further. It gives physicians lists of members with chronic conditions such as diabetes and asthma. The list includes the recommended treatments and tells who has received them. "Then when a patient shows up, the missing services can be provided," explains Dr. I. Steven Udvarhelyi, senior vice-president at the insurer. Doctors, who were leery at first, have embraced the plan.

Of course, you have to get people into physicians' offices. To do this, several health plans and companies have teamed up with Health Dialog Analytic Solutions, which identifies employees or plan members with the greatest needs and reaches out through phone calls and mailings. "The touch is very soft," says Joe Checkley, director of global benefits at American Standard Cos (ASD ). "It's saying: 'Here are some tools for you, and what can I do to help?"'

The early results are good. At Independence Blue Cross, with about 2 million members, "we know that the program overall reduces medical costs by about 2%," says Udvarhelyi. "That's for the entire population, not just the people that we touch. For them the reduction is orders of magnitude larger." With efforts like these, treatments that do work are now getting to more of the people who need them.

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Medical Guesswork | A Lumpectomy May Do It

Medical Guesswork | A Lumpectomy May Do It

BusinessWeek, May 29, 2006

For Jeanine Whitney, the diagnosis of breast cancer last June was bad enough. But when her doctor told her that her best chance was an immediate mastectomy, "I cried for 24 hours. I felt that part of my womanhood would have been taken," says Whitney, who works at an air conditioner factory in Rushville, Ind. Her employer, American Standard Cos., had a program to provide workers with unbiased information about the risks and benefits of potential treatments. Thanks to the program, Whitney learned that there was no evidence that a mastectomy would have a better outcome than a lumpectomy, provided the tissue around the lump was clear of cancer. Twenty years after treatment, the outcomes were the same, according to studies. "It was a total surprise," she recalls. She requested a lumpectomy, which was carried out in July, followed by seven weeks of radiation and six of recovery. Now, Whitney is grateful that she was able to get the information she needed to buck her doctor's recommendation. If Whitney had had to make a decision without that, she says she would have "ended up in the psychiatric ward."

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Medical Guesswork | Bypass That Operation?

Medical Guesswork | Bypass That Operation?

BusinessWeek, May 29, 2006

Each year doctors perform 400,000 bypass surgeries and 1 million angioplasties, where mesh tubes are placed in diseased arteries to hold them open. While most people believe that such surgery is life-saving, the available data say otherwise. Except for about 3% of people with severe heart disease, treatment with drugs alone works just as well to extend life and prevent heart attacks as surgery does.

"Cardiologists like to open up arteries," says Dr. David D. Waters, chief of cardiology at San Francisco General Hospital. "But there is no evidence that opening up chronically narrowed arteries reduces the risk of heart attack." Harvard Medical School's Dr. Roger J. Laham figures that at least 400,000 angioplasties a year are unnecessary. "I'm sure we are way overtreating our patients," he says. Surgery carries big risks, such as mental declines after bypass operations. The overuse is exacting a big toll on individual patients and the health-care system, argue such experts as Dr. Nortin M. Hadler, professor of medicine at the University of North Carolina at Chapel Hill.

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Medical Guesswork | Leave Those Ears Alone

Leave Those Ears Alone

BusinessWeek, May 29, 2006

In the 1950s, kids routinely got their tonsils taken out. Then physicians such as Dr. Jack L. Paradise of the University of Pittsburgh School of Medicine showed that the procedure brought no benefits to most children.

In a study published last August, Paradise took on another common treatment: implanting tubes to drain the fluid in children's ears -- thought to hamper hearing and slow language development. Children with fluid do tend to have more speech problems. But Paradise believes the two conditions have a common cause: poor living conditions. "Medicine is fraught with error when people assume correlation is causality," he says. So Paradise did a study of 6,000 babies. By age three, 429 had persistent fluid in their ears. Half got ear tubes, the other half didn't -- and there was no difference in outcomes between the two groups.

Paradise's advice to parents of such kids: "Don't just do something. Sit there." Many doctors still perform the surgery, however. "People are reluctant to believe our results," Paradise says. Why? "You get paid for operating and not paid for not operating."

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Medical Guesswork | Curing Without Cutting

Medical Guesswork | Curing Without Cutting

BusinessWeek, May 29, 2006

Can you trust your doctor's recommendation to have surgery for an aching back? Make sure you have all the facts. Evidence says surgery does not fix the problem over the long term any better than time, physical therapy, and exercise. Indeed, says University of North Carolina's Dr. Nortin M. Hadler, pain clinics are full of people who have had back surgery and now are worse off. Geographic data suggest that such procedures may be a fad. In people with identical symptoms, operations like spinal fusion are performed 20 times as often in some parts of the U.S. as in others. 'Spinal fusion is the most variable condition in all of medicine,' says Dr. James N. Weinstein, editor of Spine magazine and chair of orthopedic surgery at Dartmouth.

Curing Without Cutting
Can you trust your doctor's recommendation to have surgery for an aching back? Make sure you have all the facts. Evidence says surgery does not fix the problem over the long term any better than time, physical therapy, and exercise. Indeed, says University of North Carolina's Dr. Nortin M. Hadler, pain clinics are full of people who have had back surgery and now are worse off. Geographic data suggest that such procedures may be a fad. In people with identical symptoms, operations like spinal fusion are performed 20 times as often in some parts of the U.S. as in others. 'Spinal fusion is the most variable condition in all of medicine,' says Dr. James N. Weinstein, editor of Spine magazine and chair of orthopedic surgery at Dartmouth."

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Medical Guesswork - the health industry knows little about which common treatments really work

Medical Guesswork

From heart surgery to prostate care, the health industry knows little about which common treatments really work

By John Carey
BusinessWeek, MAY 29, 2006

COVER STORY

The signs at the meeting were not propitious. Half the board members of Kaiser Permanente's Care Management Institute left before Dr. David Eddy finally got the 10 minutes he had pleaded for. But the message Eddy delivered was riveting. With a groundbreaking computer simulation, Eddy showed that the conventional approach to treating diabetes did little to prevent the heart attacks and strokes that are complications of the disease. In contrast, a simple regimen of aspirin and generic drugs to lower blood pressure and cholesterol sent the rate of such incidents plunging. The payoff: healthier lives and hundreds of millions in savings. "I told them: 'This is as good as it gets to improve care and lower costs, which doesn't happen often in medicine,"' Eddy recalls. "'If you don't implement this,' I said, 'you might as well close up shop."'

The message got through. Three years later, Kaiser is in the midst of a major initiative to change the treatment of the diabetics in its care. "We're trying to put nearly a million people on these drugs," says Dr. Paul Wallace, senior adviser to the Care Management Institute. The early results: The strategy is indeed improving care and cutting costs, just as Eddy's model predicted.

For Eddy, this is one small step toward solving the thorniest riddle in medicine -- a dark secret he has spent his career exposing. "The problem is that we don't know what we are doing," he says. Even today, with a high-tech health-care system that costs the nation $2 trillion a year, there is little or no evidence that many widely used treatments and procedures actually work better than various cheaper alternatives.

This judgment pertains to a shocking number of conditions or diseases, from cardiovascular woes to back pain to prostate cancer. During his long and controversial career proving that the practice of medicine is more guesswork than science, Eddy has repeatedly punctured cherished physician myths. He showed, for instance, that the annual chest X-ray was worthless, over the objections of doctors who made money off the regular visit. He proved that doctors had little clue about the success rate of procedures such as surgery for enlarged prostates. He traced one common practice -- preventing women from giving birth vaginally if they had previously had a cesarean -- to the recommendation of one lone doctor. Indeed, when he began taking on medicine's sacred cows, Eddy liked to cite a figure that only 15% of what doctors did was backed by hard evidence.


A great many doctors and health-care quality experts have come to endorse Eddy's critique. And while there has been progress in recent years, most of these physicians say the portion of medicine that has been proven effective is still outrageously low -- in the range of 20% to 25%. "We don't have the evidence [that treatments work], and we are not investing very much in getting the evidence," says Dr. Stephen C. Schoenbaum, executive vice-president of the Commonwealth Fund and former president of Harvard Pilgrim Health Care Inc. "Clearly, there is a lot in medicine we don't have definitive answers to," adds Dr. I. Steven Udvarhelyi, senior vice-president and chief medical officer at Pennsylvania's Independence Blue Cross.

What's required is a revolution called "evidence-based medicine," says Eddy, a heart surgeon turned mathematician and health-care economist. Tall, lean, and fit at 64, Eddy has the athletic stride and catlike reflexes of the ace rock climber he still is. He also exhibits the competitive drive of someone who once obsessively recorded his time on every training run, and who still likes to be first on a brisk walk up a hill near his home in Aspen, Colo. In his career, he has never been afraid to take a difficult path or an unpopular stand. "Evidence-based" is a term he coined in the early 1980s, and it has since become a rallying cry among medical reformers. The goal of this movement is to pierce the fog that envelops the practice of medicine -- a state of ignorance for which doctors cannot really be blamed. "The limitation is the human mind," Eddy says. Without extensive information on the outcomes of treatments, it's fiendishly difficult to know the best approach for care.

The human brain, Eddy explains, needs help to make sense of patients who have combinations of diseases, and of the complex probabilities involved in each. To provide that assistance, Eddy has spent the past 10 years leading a team to develop the computer model that helped him crack the diabetes puzzle. Dubbed Archimedes, this program seeks to mimic in equations the actual biology of the body, and make treatment recommendations as well as figure out what each approach costs. It is at least 10 times "better than the model we use now, which is called thinking," says Dr. Richard Kahn, chief scientific officer at the American Diabetes Assn.

WASTED RESOURCES
Can one computer program offset all the ill-advised treatment options for a whole range of different diseases? The milestones in Eddy's long personal crusade highlight the looming challenges, and may offer a sliver of hope. Coming from a family of four generations of doctors, Eddy went to medical school "because I didn't know what else to do," he confesses. As a resident at Stanford Medical Center in the 1970s, he picked cardiac surgery because "it was the biggest hill -- the glamour field."

But he soon became troubled. He began to ask if there was actual evidence to support what doctors were doing. The answer, he was surprised to hear, was no. Doctors decided whether or not to put a patient in intensive care or use a combination of drugs based on their best judgment and on rules and traditions handed down over the years, as opposed to real scientific proof. These rules and judgments weren't necessarily right. "I concluded that medicine was making decisions with an entirely different method from what we would call rational," says Eddy.

About the same time, the young resident discovered the beauty of mathematics, and its promise of answering medical questions. In just a couple of days, he devoured a calculus textbook (now framed on a shelf in his beautifully appointed home and office), then blasted through the books for a two-year math course in a couple of months. Next, he persuaded Stanford to accept him in a mathematically intense PhD program in the Engineering-Economics Systems Dept. "Dave came in -- just this amazing guy," recalls Richard Smallwood, then a Stanford professor. "He had decided he wanted to spend the rest of his life bringing logic and rationality to the medical system, but said he didn't have the math. I said: 'Why not just take it?' So he went out and aced all those math courses."

To augment his wife's earnings while getting his PhD, Eddy landed a job at Xerox Corp.'s (XRX ) legendary Palo Alto Research Center. "They hired weird people," he says. "Here was a heart surgeon doing math. That was weird enough."

Eddy used his newfound math skills to model cancer screening. His Stanford PhD thesis made front-page news in 1980 by overturning the guidelines of the time. It showed that annual chest X-rays and yearly Pap smears for women at low risk of cervical cancer were a waste of resources, and it won the most prestigious award in the field of operations research, the Frederick W. Lanchester prize. Based on his results, the American Cancer Society changed its guidelines. "He's smart as hell, with a towering clarity of thought," says Stanford health economist Allan Enthoven.

Dr. William H. Herman, director of the Michigan Diabetes Research & Training Center, has a competing computer model that clashes with Eddy's. Nonetheless, he says, "Dr. Eddy is one of my heroes. He's sort of the father of health economics -- and he might be right."

Appointed a full professor at Stanford, then recruited as chairman of the Center for Health Policy Research & Education at Duke University, Eddy proved again and again that the emperor had no clothes. In one study, he ferreted out decades of research evaluating treatment of high pressure in the eyeball, a condition that can lead to glaucoma and blindness. He found about a dozen studies that looked at outcomes with pressure-lowering medications used on millions of people. The studies actually suggested that the 100-year-old treatment was harmful, causing more cases of blindness, not fewer.

Eddy submitted a paper to the Journal of the American Medical Assn. (JAMA), whose editors sent it out to specialists for review. "It was amazing," Eddy recalls. "The tom-toms sounded among all the ophthalmologists," who marshaled a counterattack. "I felt like Salman Rushdie." Stanford ophthalmologist Kuldev Singh says: "Dr. Eddy challenged the community to prove that we actually had evidence. He did a service by stimulating clinical trials," which showed that the treatment does slow the disease in a minority of patients.

By 1985, Eddy was "burned out" by the administrative side of academia, he says. Lured by a poster of the Tetons, he gave up his prestigious post. He moved to Jackson, Wyo., so he could climb in his spare time. He and a friend even made a first ascent of a new route on the Grand Teton, now named after them. Meanwhile, he carved out a niche showing doctors at specialty society meetings that their cherished beliefs were dubious. "At each meeting I would do the same exercise," he says. He would ask doctors to think of a typical patient and typical treatment, then write down the results of that treatment. For urologists, for instance, what were the chances that a man with an enlarged prostate could urinate normally after having corrective surgery? Eddy then asked the society's president to read the predictions.

The results were startling. The predictions of success invariably ranged from 0% to 100%, with no clear pattern. "All the doctors were trying to estimate the same thing -- and they all gave different numbers," he says. "I've spent 25 years proving that what we lovingly call clinical judgment is woefully outmatched by the complexities of medicine." Think about the implications for helping patients make decisions, Eddy adds. "Go to one doctor, and get one answer. Go to another, and get a different one." Or think about expert testimony. "You don't have to hire an expert to lie. You can just find one who truly believes the number you want."

More important, the lack of evidence creates a costly clash. Americans and their doctors want access to any new treatment, and many doctors fervently believe such care is warranted. On the other hand, those beliefs can be flat wrong. As a consultant on Blue Cross's insurance coverage decisions, Eddy testified on the insurer's behalf in high-profile court cases, such as bone marrow transplants for breast cancer. Women and doctors demanded the treatment, even though there was no evidence it saved lives. Insurers who refused coverage usually lost in court. "I was the bad guy," Eddy recalls. When clinical trials were actually done, they showed that the treatment, costing from $50,000 to $150,000, didn't work. The doctors who pushed the painful, risky procedure on women "owe this country an apology," Eddy says.

Is medicine doing any better today? In recognizing the problem, yes. But in solving it, unfortunately, no. Take prostate cancer. Doctors now routinely test for levels of prostate-specific antigen (PSA) to try to diagnose the disease. But there's no evidence that using the test improves survival. Some experts believe that as many cancers would be detected through random biopsies. Then, once cancer is spotted, there's no way to know who needs treatment and who doesn't. Plus, there is a plethora of treatment choices -- four kinds of surgery, various types of implantable radioactive seeds, and competing external radiation regimens, notes Dr. Eric Klein, head of urologic oncology at the Cleveland Clinic. "How is a poor patient supposed to decide among those?" he asks. Most of the time, patients don't even know the options.

VESTED INTERESTS
"Because there are no definitive answers, you are at the whim of where you are and who you talk to," says Dr. Gary M. Kirsh at the Urology Group in Cincinnati. Kirsh does many brachytherapies -- implanting radioactive seeds. But "if you drive one and a half hours down the road to Indianapolis, there is almost no brachytherapy," he says. Head to Loma Linda, Calif., where the first proton-beam therapy machine was installed, in 1990, and the rates of proton-beam treatment are far higher than in most other parts of the country. Go to a surgeon, and he'll probably recommend surgery. Go to a radiologist, and the chances are high of getting radiation instead. "Doctors often assume that they know what a patient wants, leading them to recommend the treatment they know best," says Dr. David E. Wennberg, president of Health Dialog Analytic Solutions.

More troubling, many doctors hold not just a professional interest in which treatment to offer, but a financial one as well. "There is no question that the economic interests of the physician enter into the decision," says Kirsh. The bottom line: The conventional wisdom in prostate cancer -- that surgery is the gold standard and the best chance for a cure -- is unsustainable. Strangely enough, however, the choice may not matter very much. "There really isn't good evidence to suggest that one treatment is better than another," says Klein.

Compared with the skepticism Eddy faced in the 1990s, many physicians now concur that traditional treatments for serious illnesses often aren't best. Yet this message can be hard for Americans to believe. "When there is more than one medical option, people mistakenly think that the more aggressive procedure is the best," says Annette M. Cormier O'Connor, senior scientist in clinical epidemiology at the Ottawa Health Research Institute. The message flies in the face of America's infatuation with the latest advances. "As a nation, we always want the best, the most recent technology," explains Dr. Joe Thompson, health adviser to Arkansas Governor Mike Huckabee. "We spend a huge amount developing it, and we get a big increase in supply." New radiation machines for cancer or operating rooms for heart surgery are profit centers for hospitals, for instance (see BW Online, 07/18/05, "Is Heart Surgery Worth It?"). Once a hospital installs a shiny new catheter lab, it has a powerful incentive to refer more patients for the procedure. It's a classic case of increased supply driving demand, instead of the other way around. "Combine that with Americans' demand to be treated immediately, and it is a cauldron for overuse and inappropriate use," says Thompson.

The consequences for the U.S. are disturbing. This nation spends 2 1/2 times as much as any other country per person on health care. Yet middle-aged Americans are in far worse health than their British counterparts, who spend less than half as much and practice less intensive medicine, according to a new study. "The investment in health care in the U.S. is just not paying off," argues Gerard Anderson, director of the Center for Hospital Finance & Management at Johns Hopkins' Bloomberg School of Public Health. Speaking not for attribution, the head of health care at one of America's largest corporations puts it more bluntly: "There is a massive amount of spending on things that really don't help patients, and even put them at greater risk. Everyone that's informed on the topic knows it, but it is such a scary thing to discuss that people are not willing to talk about it openly."

Of course, there are plenty of areas of medicine, from antibiotics and vaccines to early detection of certain tumors, where the benefits are huge and incontrovertible. But if these effective treatments are black and white, much of the rest of medicine is a dark shade of gray. "A lot of things we absolutely believe at the moment based on our intuition are ultimately absolutely wrong," says Dr. Paul Wallace, of the Care Management Institute.

The best way to go from intuition to evidence is the randomized clinical trial. Patients with a particular condition are randomly assigned to competing treatments or, if appropriate, to a placebo. By monitoring the patients for months or years, doctors learn the relative risks and benefits of the treatment being studied.

But such trials take years and cost many millions of dollars. By the time the results come in, science and medicine may have moved on, making the findings less relevant. Moreover, patients in a clinical trial usually aren't representative of real people, who tend to have complex combinations of diseases and medical problems. And patients often don't stick with the program.

Such difficulties are highlighted by an eight-year study of low-fat diets that cost upward of $400 million. Most subjects failed to stick to the low-fat regimen, making it tough to draw conclusions. In addition, the study failed to take stock of different kinds of fats, some of which are now known to have beneficial effects. Many trials fall into similar traps. So it's no surprise that up to one-third of clinical studies lead to conclusions that are later overturned, according to a recent paper in JAMA.

Even when common treatments are proved to be dubious, physicians don't rush to change their practice. They may still firmly believe in the treatment -- or in the dollars it brings in. And doctors whose oxen get gored sometimes fight back. In 1993, the federal government's Agency for Health Care Policy & Research convened a panel to develop guidelines for back surgery. Fearing that the recommendations would cast doubt on what the doctors were doing, a prominent back surgeon protested to Congress, and lawmakers slashed funding for the agency. "Congress forced out the research," says Floyd J. Fowler Jr., president of the Foundation for Informed Medical Decision Making. "It was a national tragedy," he says -- and not an isolated incident. The agency's budget is often targeted "by special interest groups who had their specialty threatened," says Arkansas' Dr. Thompson.

With proof about medical outcomes lacking, one possible solution is educating patients about the uncertainties. "The popular version of evidence-based medicine is about proving things," says Kaiser's Wallace, "but it is really about transparency -- being clear about what we know and don't know." The Foundation for Informed Medical Decision Making produces booklets, videotapes, and other material to put the full picture in the hands of patients. Health Dialog markets the information to providers and companies, addressing back pain, breast cancer, uterine fibroids and bleeding, coronary heart disease, depression, osteoarthritis, and other conditions.

In studies where one group of patients hears the full story while other patients simply receive their doctors' instructions, a key difference emerges. The well-informed patients opt for more invasive, aggressive approaches 23% less often, on average, than the other group. In some cases, the drop is much bigger -- 50% to 60%. "Patients typically don't understand that they have options, and even if they do, they often wildly exaggerate the benefits of surgery and wildly minimize the chances of harm," says Ottawa's O'Connor, a leader in this field of so-called decision aids.

Eddy's computer simulation could help more patients attain appropriate care. His approach is to create a SimCity-like world in silicon, where virtual doctors conduct trials of virtual patients and figure out what treatments work. After getting funding from Kaiser Permanente in 1991, Eddy hired a particle physicist, Len Schlessinger, who knew how to write equations describing the complex interactions in biology. The pair selected diabetes as a test case. In their virtual world, each simulated person has a heart, liver, kidneys, blood, and other organs. As in real people, cells in the pancreas make insulin, which regulates the uptake of glucose in other cells. And as in the real disease, key cells can fail to respond to the insulin, causing high blood-sugar levels and a cascade of biological effects. The virtual patients come down with high blood pressure, heart disease, and poor circulation, which can lead to foot ulcers and amputations, blindness, and other ills. The model also assesses the costs of treating the complications.

Eddy dubbed the model Archimedes and tested it by comparing it with two dozen real trials. One clinical study compared cholesterol-lowering statin drugs to a placebo in diabetics. After 4 1/2 years, the drugs reduced heart attacks by 35%. The exact same thing happened in Eddy's simulated patients. "The Archimedes model is just fabulous in the validation studies," says the University of Michigan's Herman.

STANDARD OF CARE
The team then put Archimedes to work on a tough, real problem: how best to treat diabetes in people who have additional aliments. "One thing not yet adequately embraced by evidence-based medicine is what to do for someone with diabetes, hypertension, heart disease, and depression," explains Kaiser's Wallace. Doctors now typically try to treat the most pressing problems. "But we fail to pick the right ones consistently, so we have misdirected utilization and a great deal of waste," he says. Kaiser Permanente's Dr. Jim Dudl had a counterintuitive suggestion. With diabetics, doctors assume that keeping blood sugar levels low and consistent is the best way to ward off problems such as heart disease. But Dudl wondered what would happen if he flipped it around, aiming treatment at the downstream problems. The idea is to give patients a trio of generic medicines: aspirin, a cholesterol-lowering statin, and drugs called ACE inhibitors.

Using Archimedes and thousands of virtual patients, Eddy and Schlessinger compared the traditional approach with the drug combination. The model took about a half-hour to simulate a 30-year trial, and showed that the three-drug combination was "cost- and life-saving," says Kaiser's Wallace. The benefits far surpassed "what can be achieved with aggressive glucose control." Kaiser Permanente docs switched their standard of care for diabetes, adding these drugs to other interventions. It is too early to declare a victory, but the experience with patients seems to be mimicking Eddy's computer model. "It goes against our mental picture of the disease," says Wallace. But it also makes sense, he adds. "Cardiovascular disease is the worst complication of diabetes -- and what people die of."

Eddy readily concedes that this example is a small beginning. In its current state of development, Archimedes is like "the Wright brothers' plane. We're off the sand and flying to Raleigh." But it won't be long, he says, "before we're offering transcontinental flights, with movies."

The modeling approach allows each of us, in essence, to have an imaginary twin. We can use our twin to predict what our lives and state of health are likely to be with different lifestyles and approaches to care. Companies could create virtual clones of each employee, predicting what will occur with current care or with added prevention or treatment programs. "They can see what happens to such things as the complications suffered by diabetics, the lost time from work, the amount of angina or the rate of heart attacks, the number of deaths, and the cost of new employees if one dies," Eddy explains. "Our mission is that in 10 years, no one will make an important decision in health care without first asking: `What does Archimedes say?"'

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Doctors say drugmakers are "disease-mongering" to boost sales

Hey, You Don't Look So Good

As diagnoses of once-rare illnesses soar, doctors say drugmakers are "disease-mongering" to boost sales

By Catherine Arnst
BusinessWeek, MAY 8, 2006

If you have high blood pressure, you may be at risk for heart disease. And given that an estimated 65 million Americans have hypertension, it's not surprising that drugs to treat it are among the most prescribed medicines in the world. But why stop at prescribing drugs to people whose readings are 140/90 or higher, the standard definition of high blood pressure? In the Apr. 20 issue of The New England Journal of Medicine, a research team reported on "prehypertension," the condition of being in danger of developing hypertension.

Prehypertension was first identified in 2003, and some studies claim as many as 50 million U.S. adults have the condition, defined as blood pressure readings from 120/80 to 139/89. This risk of being at risk can be modified with diet and exercise, but the NEJM study reports that it can also be treated with Atacand, a drug from AstraZeneca Pharmaceuticals PLC (AZN ).

To a growing chorus of physicians and health-care specialists, the very idea of treating the risk of a risk is wrong. They have labeled the phenomenon "disease-mongering," defined as the corporate-sponsored creation or exaggeration of maladies for the purpose of selling more drugs. Prehypertension "is a classic case of a risk factor being turned into the disease," says Dr. Steven Woloshin of the Veterans Affairs Outcomes Group in White River Junction, Vt. "If you make a cut-off for blood pressure that's close to the normal range, then just about everyone can be diagnosed." An AstraZeneca spokesman responds that the trial was considered important enough to be published in the prestigious NEJM. "I think that speaks for itself."

DEMAND FOR A QUICK FIX
According to critics, disease-mongering is on the rise. It starts when a drug is developed for some once-rare condition. Then heavily promoted disease-awareness campaigns kick into gear, leading to increasing numbers of diagnoses and prescriptions. The list of suspects includes restless legs syndrome, social anxiety disorder, premenstrual dystrophic disorder, irritable bowel syndrome, female sexual dysfunction, and more. "Of course, some people have these diseases very seriously," says Dr. Robert L. Klitzman, a psychiatrist and bioethicist at Columbia University. "The problem is that mild cases are being made to seem more serious than they are."

The other problem, say the anti-disease-mongerers, is that the vagaries of everyday life, such as sadness, shyness, forgetfulness, and the occasional upset stomach, are being turned into medical conditions. Before Pfizer Inc.'s (PFE ) Viagra was introduced, erectile dysfunction was a medical problem only when associated with an underlying biological cause, such as diabetes or prostate cancer. Now, Pfizer's Web site claims that half of all men over 40 have problems getting or maintaining an erection. Social anxiety disorder, defined as severe shyness, was rarely seen until GlaxoSmithKline PLC's (GSK ) Paxil was approved to treat it. A disease-awareness campaign by Glaxo in the late 1990s, with the tag line "imagine being allergic to people," was quickly followed by rising prevalence estimates.

Disease promotion is not just the purview of drug companies. "Doctors should set more boundaries," asserts Dr. David Henry, a pharmacology professor at the University of Newcastle in Australia and a leading critic of disease-mongering. Then there are patients seeking a quick fix for conditions that might better be treated through lifestyle changes. "Drug companies are playing off the desire we all have to get rid of things that bother us," says Klitzman. But ridding oneself of bothersome symptoms without changing the behaviors that contribute to them can mean taking a pill every day for years, a proposition that is both risky and costly.

YOUNGER AND YOUNGER
Also of concern are efforts to expand the definition of serious diseases to cover more and more people. Loosened criteria for bipolar disorder, a dire psychological disease once thought to affect only 0.1% of the population, have led some experts to claim prevalence rates of anywhere from 5% to 10%. Dr. David Healy of Cardiff University in Wales says the higher estimates are based on ill-defined surveys that followed the introduction in the mid-1990s of mood stabilizer drugs, promising relief even for people with mild emotional swings. In the U.S., children as young as age 2 are being diagnosed as bipolar even though, in the classic definition of the illness, symptoms don't usually show up until the teens. "These young kids are started on two or three medicines when there isn't even any evidence that any of them work in children," says Dr. Jon McClellan at the University of Washington in Seattle.

Disease-mongering isn't new. The term was coined by Lynn Payer in her 1994 book Disease-Mongers: How Doctors, Drug Companies, and Insurers are Making You Feel Sick. But the advent of direct-to-consumer advertising in the U.S. in 1999 fanned the trend, say drug industry critics. Their complaints reached a critical mass this spring. The April issue of the journal PLoS Medicine ran 11 articles on disease-mongering to coincide with the first conference devoted to the topic, held Apr. 11-13 in Newcastle.

Drugmakers say they're only trying to educate patients who are struggling with serious illnesses. "We realize that not every medicine is for every person," says a spokeswoman for Glaxo, which makes drugs for restless legs syndrome, social anxiety disorder, and other diagnoses that are under fire. "The labels contain important information about whether it's appropriate, and we're confident that doctors consulting with patients will assess their health-care issues and the risks and rewards and make an appropriate decision."

The skeptics aren't convinced that doctors will be so discriminating, in part because many get their information about disease treatment from the drug industry. Pharmaceutical companies routinely subsidize continuing medical education courses for doctors. They fund research for diseases that then gets published in medical journals, and they underwrite patient advocate groups, which in turn promote the underwriter's drugs on their Web sites. Witness the Child & Adolescent Bipolar Foundation: It lists four pharmaceutical companies as major donors, including Eli Lilly & Co. and Janssen LP, makers of leading mood stabilizers.

All these factors come into play with restless legs syndrome, a case history detailed in PLoS Medicine. Defined as the urge to constantly move one's legs, the condition can be truly disruptive for people with severe symptoms, but such severity is considered rare. That didn't stop GlaxoSmithKline from launching a disease awareness campaign in 2003. The company kicked off the blitz with a press release stating that a "new survey reveals a common yet underrecognized disorder -- restless legs syndrome -- is keeping Americans awake at night." News articles proliferated, most stating that the condition affects up to 10% of adults in the U.S., based on the study Glaxo promoted.

In 2005, Glaxo's Requip, a treatment for Parkinson's disease, was approved for restless legs. At the same time the Restless Legs Syndrome Foundation, which receives funding from Glaxo, issued a press release about "a new national survey that shows [the] syndrome is largely underrecognized and poorly understood." A Glaxo spokeswoman says that most Requip prescriptions are written for Parkinson's.

The VA's Dr. Woloshin grants that some people are helped by Requip, Paxil, and Viagra. But he worries that overtreatment drains money from research into more serious illnesses. "None of these companies is coming up with a cure for TB," he notes. That's a disease no one is trying to monger.

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Wednesday, October 18, 2006

Invasive Procedures: Less is More ... And Better

Invasive Procedures: Less is More ... And Better

By Donald M. Berwick, M.D.
Newsweek, October 16, 2006

The modern hospital is the cathedral of our time—gleaming, mystical, intimidating, even majestic. It seems to contain miracles and, sometimes, it does; bioscientific breakthroughs have changed the course of illness, curing cases of leukemia, fixing hearts, transplanting organs. It is easy to be in awe. We want whatever the magic of health care can give us—the more, the better.

So it comes as a surprise to most people that the facts often suggest otherwise, as researchers at Dartmouth Medical School—led by Profs. John Wennberg and Elliott Fisher—have been showing for years in the so-called Dartmouth Atlas project. They sort the United States into 307 geographically defined "hospital service areas," and study how often Medicare patients in those areas get specific medical and surgical procedures.

For many procedures, the variation is stunning. Compared with the lowest-use areas, people in the highest-use areas get 10 times as many prostate operations, six times as many back surgeries, seven times as many coronary angioplasties and 10 times as many hospital days if they have heart failure. It all raises an obvious question: if medical technology is being used so differently, who's right?

A lot of the variation depends not on clear-cut scientific evidence that one treatment is better than another, but on the beliefs of specialists in the area and the supply of doctors and hospital beds. The use of specialist visits varies by 660 percent, and what best predicts the rate is the number of specialists per capita. The more doctors, the more doctor visits. The more hospital beds, the more days spent in the hospital.

Are you lucky if you live in a high-use region? Not necessarily. Landmark studies by Fisher showed that high use did not mean better quality of care and outcomes. In fact, for many measures, quality and outcomes were best in the low-use areas and worst in the high-use areas. The less, the better.

Fisher and Wennberg suggest that the rates of use of health-care procedures and treatments should, indeed, vary a lot, but not according to where you live. Rather, variation should reflect the preferences of patients ("Would you rather wait a bit to see if your back pain gets better, Mr. Smith, or try surgery now?") instead of the local habits of doctors or, worse, the local supply of specialists. When patients are actually invited to participate in decisions about their care—"shared decision-making"—both costs and rates of use of expensive, invasive procedures tend to fall, and outcomes and satisfaction improve. The Dartmouth team calls this "preference-sensitive care," and it thinks health care driven by necessity rather than supply could be both more responsive to our needs and, overall, far less costly.


A shortlist of "high variation" surgical procedures in the Dartmouth Atlas includes gallbladder removal; coronary-artery bypass and coronary angioplasty (in people with minimal symptoms); hip replacement; carotid-artery surgery; radical breast surgery (instead of lumpectomy) for localized breast cancer, and prostate removal for benign enlargement of the gland. If you or a loved one is scheduled for one of these, you might pause and ask some questions. Do you understand the alternatives to surgery? Would a period of "watchful waiting" help? Is the decision to operate based on your own assessment of your options? Or does it reflect mainly the local habits of the medical-care system? Surgery may be the right choice, but that ought to depend on the patient's preferences as well as the scientific facts.

Berwick is clinical professor of pediatrics at Children's Hospital and Harvard Medical School, and CEO of the Institute for HealthcareImprovement. For health information from Harvard, go to health.harvard.edu

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The Toll on Patients - Injuries and deaths resulting from preventable errors in medical care

An alarming number of injuries and deaths result from preventable errors in medical care

Newsweek, October 16, 2006

An alarming number of injuries and deaths result from preventable errors in medical care

1.5 million Americans are harmed or killed by medication-related mistakes each year

$3.5 billion in extra medical costs is spent annually to treat injuries caused by drug-related errors.

44,000 to 98,000 Americans die each year of medical errors, such as wrong-site surgery.

18,000 Americans die each year of heart attacks because they didn't receive preventative drugs.

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