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?"'
Read article at the original source
Thursday, October 19, 2006
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.
Read article at original source
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.
Read article at original source
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
Read article at orignal source
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
Read article at orignal source
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.
See statistics at original source
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.
See statistics at original source
Friday, July 21, 2006
Medication errors injure more than 1.5 million yearly, study finds
Medication errors injure more than 1.5 million yearly, study finds
Hospital patients said at risk for at least one drug mistake daily
AP, July 20, 2006
Medication mistakes injure well over 1.5 million Americans every year, a toll too often unrecognized and unfought, says a sobering call to action.
At least a quarter of the errors are preventable, the Institute of Medicine said Thursday in urging major steps by the government, health providers and patients alike.
Topping the list: All prescriptions should be written electronically by 2010, a move one specialist called as crucial to safe care as X-ray machines.
Perhaps the report's most stunning finding was that, on average, a hospitalized patient is subject to at least one medication error per day.
A serious drug error can add more than $5,800 to the hospital bill of a single patient. Assuming that hospitals commit 400,000 preventable drug errors each year, that's $3.5 billion -- not counting lost productivity and other costs -- from hospitals alone, the report concluded.
"I'm a patient-safety researcher (yet) I was surprised and shocked at just how common and how serious a problem this is," said Dr. Albert Wu of Johns Hopkins University, co-author of Thursday's report.
Worse, there's too little incentive for health providers to invest in technology that could prevent some errors today, added Dr. J. Lyle Bootman, the University of Arizona's pharmacy dean, who co-chaired the IOM probe.
"We're paid whether these errors occur or not," lamented Bootman, who recently experienced the threat firsthand as his son-in-law dodged some drug near-misses while in intensive care in a reputable hospital.
The new probe couldn't say how many of the injuries are serious, or how many victims die. A 1999 estimate put deaths, conservatively, at 7,000 a year.
Even the total injury estimate is conservative, Bootman stressed. It includes drug errors in hospitals, nursing homes and among Medicare outpatients, but it doesn't attempt to count mix-ups in most doctors' offices or by patients themselves.
There have been efforts to improve patient safety in the six years since the IOM first spotlighted medical mistakes of all kinds, including recent bar-coding of drugs to minimize mix-ups in hospitals and pharmacies.
But clearly more are needed, and the new report highlights how the nation's fragmented health care system is conducive to drug errors, said Dr. Donald Berwick, a Harvard professor who heads the nonprofit Institute for Healthcare Improvement.
"This isn't a matter of doctors and nurses trying harder not to harm people," Berwick cautioned. "Safety isn't automatic. It has to be designed into the system."
Medications' sheer volume and complexity illustrate the difficulty. More than 10,000 prescription drugs are on the market, and 300,000 over-the-counter products. It's impossible to memorize their different usage and dosage instructions, which may vary according to the patient's age, weight and other risk factors, such as bad kidneys.
Plus, four of every five U.S. adults take at least one medication or dietary supplement every day; almost a third take at least five. The more you use, the greater your risk of bad interactions, especially if multiple doctors prescribe different drugs without knowing what you already take.
Add doctors' notoriously bad handwriting and sound-alike drug names: Was that order for 10 milligrams or 10 migrams? The hormone Premarin or the antibiotic Primaxin?
Moreover, consumer instructions are woefully inadequate, the report concludes. One study found parents gave their children the wrong dose of over-the-counter fever medicines 47 percent of the time.
Then there was man with newly diagnosed asthma wondering why his inhaler didn't work. Asked how he used it, the middle-age man squirted two puffs into the air and tried to breathe the mist. His original doctor had demonstrated the inhaler without telling him to spray it inside his mouth.
Among the report's recommendations:
•The government should speed electronic prescribing, including fostering technology improvements so that the myriad computer programs used by doctors, hospitals and drugstores are compatible.
Fewer than about 20 percent of prescriptions are electronic, said report co-author Michael Cohen, president of the Institute for Safe Medication Practices. E-prescribing does more than counter bad handwriting. The computer programs can be linked to databases that flash an alert if the prescribed dose seems high or if the patient's records show use of another drug that can dangerously interact.
•The government should speed electronic prescribing, including fostering technology improvements so that the myriad computer programs used by doctors, hospitals and drugstores are compatible.
Fewer than about 20 percent of prescriptions are electronic, said report co-author Michael Cohen, president of the Institute for Safe Medication Practices. E-prescribing does more than counter bad handwriting. The computer programs can be linked to databases that flash an alert if the prescribed dose seems high or if the patient's records show use of another drug that can dangerously interact.
•Patients and their families must be aggressive in questioning doctors, nurses and pharmacists about medications. Get a list of each drug you're prescribed, why and the dose from each doctor and pharmacy you use, and show it at every doctor visit.
"Take active steps to make sure you know what you're getting, and is it what you need," said report co-author Dr. Wilson Pace of the University of Colorado.
•The nation should invest about $100 million annually on research into drug errors and how to prevent them. Among the most-needed studies is the impact of free drug samples, which often lack proper labeling, on medication safety.
•The Food and Drug Administration should improve the quality of drug information leaflets that accompany prescription drugs, but often have incomplete information or are written in consumer-confusing jargon.
•The government should establish national telephone hotlines to help patients unable to understand printed drug information because of illiteracy, language barriers or other problems.
Read article at the original source
Hospital patients said at risk for at least one drug mistake daily
AP, July 20, 2006
Medication mistakes injure well over 1.5 million Americans every year, a toll too often unrecognized and unfought, says a sobering call to action.
At least a quarter of the errors are preventable, the Institute of Medicine said Thursday in urging major steps by the government, health providers and patients alike.
Topping the list: All prescriptions should be written electronically by 2010, a move one specialist called as crucial to safe care as X-ray machines.
Perhaps the report's most stunning finding was that, on average, a hospitalized patient is subject to at least one medication error per day.
A serious drug error can add more than $5,800 to the hospital bill of a single patient. Assuming that hospitals commit 400,000 preventable drug errors each year, that's $3.5 billion -- not counting lost productivity and other costs -- from hospitals alone, the report concluded.
"I'm a patient-safety researcher (yet) I was surprised and shocked at just how common and how serious a problem this is," said Dr. Albert Wu of Johns Hopkins University, co-author of Thursday's report.
Worse, there's too little incentive for health providers to invest in technology that could prevent some errors today, added Dr. J. Lyle Bootman, the University of Arizona's pharmacy dean, who co-chaired the IOM probe.
"We're paid whether these errors occur or not," lamented Bootman, who recently experienced the threat firsthand as his son-in-law dodged some drug near-misses while in intensive care in a reputable hospital.
The new probe couldn't say how many of the injuries are serious, or how many victims die. A 1999 estimate put deaths, conservatively, at 7,000 a year.
Even the total injury estimate is conservative, Bootman stressed. It includes drug errors in hospitals, nursing homes and among Medicare outpatients, but it doesn't attempt to count mix-ups in most doctors' offices or by patients themselves.
There have been efforts to improve patient safety in the six years since the IOM first spotlighted medical mistakes of all kinds, including recent bar-coding of drugs to minimize mix-ups in hospitals and pharmacies.
But clearly more are needed, and the new report highlights how the nation's fragmented health care system is conducive to drug errors, said Dr. Donald Berwick, a Harvard professor who heads the nonprofit Institute for Healthcare Improvement.
"This isn't a matter of doctors and nurses trying harder not to harm people," Berwick cautioned. "Safety isn't automatic. It has to be designed into the system."
Medications' sheer volume and complexity illustrate the difficulty. More than 10,000 prescription drugs are on the market, and 300,000 over-the-counter products. It's impossible to memorize their different usage and dosage instructions, which may vary according to the patient's age, weight and other risk factors, such as bad kidneys.
Plus, four of every five U.S. adults take at least one medication or dietary supplement every day; almost a third take at least five. The more you use, the greater your risk of bad interactions, especially if multiple doctors prescribe different drugs without knowing what you already take.
Add doctors' notoriously bad handwriting and sound-alike drug names: Was that order for 10 milligrams or 10 migrams? The hormone Premarin or the antibiotic Primaxin?
Moreover, consumer instructions are woefully inadequate, the report concludes. One study found parents gave their children the wrong dose of over-the-counter fever medicines 47 percent of the time.
Then there was man with newly diagnosed asthma wondering why his inhaler didn't work. Asked how he used it, the middle-age man squirted two puffs into the air and tried to breathe the mist. His original doctor had demonstrated the inhaler without telling him to spray it inside his mouth.
Among the report's recommendations:
•The government should speed electronic prescribing, including fostering technology improvements so that the myriad computer programs used by doctors, hospitals and drugstores are compatible.
Fewer than about 20 percent of prescriptions are electronic, said report co-author Michael Cohen, president of the Institute for Safe Medication Practices. E-prescribing does more than counter bad handwriting. The computer programs can be linked to databases that flash an alert if the prescribed dose seems high or if the patient's records show use of another drug that can dangerously interact.
•The government should speed electronic prescribing, including fostering technology improvements so that the myriad computer programs used by doctors, hospitals and drugstores are compatible.
Fewer than about 20 percent of prescriptions are electronic, said report co-author Michael Cohen, president of the Institute for Safe Medication Practices. E-prescribing does more than counter bad handwriting. The computer programs can be linked to databases that flash an alert if the prescribed dose seems high or if the patient's records show use of another drug that can dangerously interact.
•Patients and their families must be aggressive in questioning doctors, nurses and pharmacists about medications. Get a list of each drug you're prescribed, why and the dose from each doctor and pharmacy you use, and show it at every doctor visit.
"Take active steps to make sure you know what you're getting, and is it what you need," said report co-author Dr. Wilson Pace of the University of Colorado.
•The nation should invest about $100 million annually on research into drug errors and how to prevent them. Among the most-needed studies is the impact of free drug samples, which often lack proper labeling, on medication safety.
•The Food and Drug Administration should improve the quality of drug information leaflets that accompany prescription drugs, but often have incomplete information or are written in consumer-confusing jargon.
•The government should establish national telephone hotlines to help patients unable to understand printed drug information because of illiteracy, language barriers or other problems.
Read article at the original source
Monday, May 29, 2006
Medical Guesswork
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
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.
Can one computer program offset all the ill-advised treatment options for a whole range of different diseases?
Read the entire article at the original source
From heart surgery to prostate care, the health industry knows little about which common treatments really work
By John Carey, BusinessWeek, May 29, 2006
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.
Can one computer program offset all the ill-advised treatment options for a whole range of different diseases?
Read the entire article at the original source
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