Health scare of the week: The danger of annual checkups - The Week

The danger of annual checkups

Visiting your doctor for an annual physical examination might actually have a negative impact on your health.

POSTED ON NOVEMBER 2, 2012, AT 11:49 AM

Visiting your doctor for an annual physical examination might actually have a negative impact on your health, WebMD.com reports. Danish researchers analyzed studies involving 183,000 patients and found that those who received regular checkups were no less likely to die of cancer or heart disease than those who only saw the doctor when they had symptoms. People who skipped their annual checkup were also no more likely than those who didn’t to end up in the hospital, become disabled, or miss work. Patients who saw the doctor regularly were more likely to be diagnosed with diseases and to take prescribed medication—but those added attentions didn’t seem to actually improve their health. That’s evidence that annual health check-ups actually increase the “risk of overdiagnosis,” which can lead to invasive and unnecessary biopsies, surgeries, and other treatments, says study author Lasse T. Krogsboll. Routine visits to the doctor can also cause undue stress, and sometimes even physical damage. “We are certainly not seeing the entire picture of the harms,” Krogsboll says.

More Treatment, More Mistakes - NYTimes.com

More Treatment, More Mistakes - NYTimes.com: 

July 31, 2012
Dr. Sanjay Gupta

"According to a 1999 report by the Institute of Medicine, as many as 98,000 Americans were dying every year because of medical mistakes... But a reasonable estimate is that medical mistakes now kill around 200,000 Americans every year. That would make them one of the leading causes of death in the United States. Why have these mistakes been so hard to prevent?

Here’s one theory. It is a given that American doctors perform a staggering number of tests and procedures, far more than in other industrialized nations, and far more than we used to. Since 1996, the percentage of doctor visits leading to at least five drugs’ being prescribed has nearly tripled, and the number of M.R.I. scans quadrupled.

Certainly many procedures, tests and prescriptions are based on legitimate need. But many are not. In a recent anonymous survey, orthopedic surgeons said 24 percent of the tests they ordered were medically unnecessary. This kind of treatment is a form of defensive medicine, meant less to protect the patient than to protect the doctor or hospital against potential lawsuits.

Herein lies a stunning irony. Defensive medicine is rooted in the goal of avoiding mistakes. But each additional procedure or test, no matter how cautiously performed, injects a fresh possibility of error. CT and M.R.I. scans can lead to false positives and unnecessary operations, which carry the risk of complications like infections and bleeding. The more medications patients are prescribed, the more likely they are to accidentally overdose or suffer an allergic reaction....

So what do we do to be safer? Many smart people have tackled this question. Peter Pronovost at Johns Hopkins developed a checklist shown to bring hospital-acquired infections down to close to zero. There are rules against disturbing nurses while they dispense medications and software that warns doctors when patients’ prescriptions will interact badly. There are policies designed to empower nurses to confront doctors if they see something wrong, even if a senior doctor is at fault.

What may be even more important is remembering the limits of our power. More — more procedures, more testing, more treatment — is not always better. In 1979, Stephen Bergman, under the pen name Dr. Samuel Shem, published rules for hospitals in his caustically humorous novel, “The House of God.” Rule No. 13 reads: “The delivery of medical care is to do as much nothing as possible.” First, do no harm.

 One place where I have seen these issues addressed is in Morbidity and Mortality, or M and M — a weekly gathering of doctors, off limits to the public, which serves in most hospitals as a forum for the discussion of mistakes, complications, deaths and unusual cases. It is a sort of quality-assurance conference where doctors hold one another accountable and learn from one another’s mistakes. They are some of the most candid and indelible meetings I have ever attended....

At my first M and M as a medical student, I heard the story of a patient who had received antibiotics for an upper respiratory tract infection. Two weeks later she developed joint pain and blisters on her chest and arms, a condition known as Stevens-Johnson syndrome, which can be caused by an allergic reaction to antibiotics. She ended up with sepsis, a bodywide infection, and spent two weeks in intensive care. She, too, survived, but most stunning was the doctor’s admission that her original ailment had been a mild viral illness — she hadn’t even needed the antibiotics that led to such a terrible reaction. Years later, that case still makes me think harder about every test I order and every medication I prescribe...."

Sanjay Gupta, the associate chief of neurosurgery at Grady Memorial Hospital and the chief medical correspondent for CNN, is the author of the novel “Monday Mornings.”

Steps to reduce leading causes of death

WHO outlines steps to reduce leading

causes of death

By Madison Park, CNN

updated 5:33 PM EST, Sun September 18, 2011

Deaths from noninfectious diseases are increasing, especially for low- and middle-income countries.

STORY HIGHLIGHTS

• WHO: Countries should tax tobacco and alcohol, discourage smoking, salt and trans fats
• They should also emphasize good diet, physical activity, health organization report says
• Recommendations were released to cut heart disease, cancer, lung disease, diabetes
• Not implementing interventions could cost countries $7 trillion in 15 years, study says

(CNN) -- To decrease deaths from noninfectious diseases, countries should pass excise taxes on tobacco and alcohol, encourage smoke-free public places, reduce salt and trans fat in foods, and increase awareness of diet and physical activity, according to a World Health Organization report.

The report, released Sunday, warned that people in rich and poor countries continue getting noninfectious diseases related to lifestyle and the use of tobacco and alcohol.

These diseases -- heart disease, cancer, lung disease and diabetes -- are not only the leading killers in the world, with 36 million deaths a year, their economic toll can be devastating.

If these noncommunicable diseases flourish at their current rate, low- and middle-income nations could lose about $7 trillion from 2011 to 2025. These estimates are results from a World Economic Forum and Harvard School of Public Health study also released Sunday.

A 2009 survey of business leaders by the World Economic Forum called chronic disease one of the leading threats to global economic growth.

For only the second time in its history, the United Nations General Assembly, which is meeting this week, has put a health issue on its agenda. Nations will meet Monday and Tuesday to develop an international plan for preventing and controlling noncommunicable diseases.

The need for action is urgent, said Dr. Ala Alwan, assistant director-general for noncommunicable diseases and mental health at the WHO.

"The world is now recognizing the enormous health impact of noncommunicable diseases, particularly the four major groups: cardiovascular disease, cancer, chronic lung disease, diabetes. This is now emerging as a major social-economic problem as well," he said.

Deaths from noninfectious diseases are increasing, especially for low- and middle-income countries, some of which are grappling with other health issues such as malnourishment and infectious diseases.

"We know there are 100 million people who are pushed into poverty every year, because they have to pay directly for health care," Alwan said. "Most of the health care requirements are for noncommunicable diseases: cardiovascular disease, stroke, lung disease, diabetes or cancer."

These illnesses hurt household income for the affected individuals and their families, but also translate to loss of productivity and physical disability.

"When much of the work force is sick and dies in their productive years, national economies lose billions of dollars in output. And millions of families are pushed into poverty," Jean Pierre Rosso, managing director at the World Economic Forum, said in a news release.

The diseases also affect the United States, which spends $2 trillion a year on health expenses, according to the WHO report.

CNNMoney: Health care's big money wasters

WHO grouped heart disease, cancer, lung disease and diabetes because these account for 80% of the deaths from noncommunicable diseases, and they share common risk factors. These include tobacco use, harmful use of alcohol, physical inactivity and an unhealthy diet.

It recommended several public health steps to help countries take action such as discouraging smoking, reducing salt in foods and encouraging healthier habits.

The WHO studied 48 low- and middle-income countries all over the world over 10 years. The countries, such as Sri Lanka, Ukraine and Kenya, implemented measures such as salt reduction campaigns and tobacco control.

The measures resulted in a "considerable reduction" in the incidence of noncommunicable disease and death, Alwan said. He called these steps "best buys," because they cost little money and have the potential to "save literally millions of lives over the next 15 years."

These recommendations also include screening people who are at risk for heart disease, cervical cancer screenings and hepatitis B immunization to prevent liver cancer.

The cost of adopting these interventions in all low- and middle-income countries would be $12 billion per year. Inaction would result in about $7 trillion in losses over the next 15 years for these nations.

Unlike infectious diseases, these chronic diseases have been slow to get attention. The U.N'.s focus on the topic is much needed, said Yanzhong Huang, a senior fellow for global health at the Council on Foreign Relations think tank.

"It's a difficult thing to do, to frame it as something sexy that mobilized policy makers or society groups," he said. The pervasive thought is that, "this is a lifestyle disease. It's because of the lack of exercise, too much high-fat food, you deserve it. It's your problem."

New research shows how some common tests and procedures aren’t just expensive, but can do more harm than good

One Word Can Save Your Life: No!

New research shows how some common tests and procedures aren’t just expensive, but can do more harm than good.

A growing body of evidence shows that some common tests and procedures are overused and often don't help patients. Another resource is uspreventiveservicestaskforce.org, which offer recommendations based on reviews of research by an independent panel of medical experts and physicians.

by Sharon Begley | Newsweek | August 14, 2011 10:0 AM EDT

Dr. Stephen Smith, Professor emeritus of family medicine at Brown University School of Medicine, tells his physician not to order a PSA blood test for prostate cancer or an annual electrocardiogram to screen for heart irregularities, since neither test has been shown to save lives. Rather, both tests frequently find innocuous quirks that can lead to a dangerous odyssey of tests and procedures. Dr. Rita Redberg, professor of medicine at the University of California, San Francisco, and editor of the prestigious Archives of Internal Medicine, has no intention of having a screening mammogram even though her 50th birthday has come and gone. That’s the age at which women are advised to get one. But, says Redberg, they detect too many false positives (suspicious spots that turn out, upon biopsy, to be nothing) and tumors that might regress on their own, and there is little if any evidence that they save lives.

These physicians are not anti-medicine. They are not trying to save money on their copayments or deductibles. And they are not trying to rein in the nation’s soaring health-care costs, which at $2.7 trillion account for fully one sixth of every dollar spent in the U.S. They are applying to their personal lives a message they have become increasingly vocal about in their roles as biomedical researchers and doctors: more health care often means worse health. “There are many areas of medicine where not testing, not imaging, and not treating actually result in better health outcomes,” Redberg says. In other words, “less is more.” Archives, which is owned by the American Medical Association, has been publishing study after study about tests and treatments that do more harm than good.

That less health care can lead to better health and, conversely, that more health care can harm health, runs counter to most patients’ conviction that screenings and treatments are inherently beneficial. That belief is fueled by the flood of new technologies and drugs that have reached the market in the past two or three decades, promising to prevent disease and extend life. Most of us wouldn’t think twice if our doctor offered a test that has the power to expose a lurking tumor, or a clogged artery, or a heart arrhythmia. Better to know—and get treated—than to take any risks, the reasoning goes.

In fact, for many otherwise healthy people, tests often lead to more tests, which can lead to interventions based on a possible problem that may have gone away on its own or ultimately proved harmless. Patients can easily be fooled when a screening test detects, or an intervention treats, an abnormality, and their health improves, says cardiologist Michael Lauer of the National Heart, Lung, and Blood Institute. In fact, says Lauer, that abnormality may not have been the cause of the problem or a threat to future health: “All you’ve done is misclassify someone with no disease as having disease.”

From PSA tests for prostate cancer (which more than 20 million U.S. men undergo every year) to surgery for chronic back pain to simple antiobiotics for sinus infection, a remarkable number and variety of tests and treatments are now proving either harmful or only as helpful as a placebo.

This realization comes at a time when Medicare has emerged as a fat target in the debate over taming the deficit, with politicians proposing to slash costs by raising the age of eligibility or even eliminating the program. Experts estimate that the U.S. spends hundreds of billions of dollars every year on medical procedures that provide no benefit or a substantial risk of harm, suggesting that Medicare could save both money and lives if it stopped paying for some common treatments. “There’s a reason we spend almost twice as much per capita on health care [as other developed countries] with no gain in health or longevity,” argues Dr. Steven Nissen, the noted cardiologist at the Cleveland Clinic. “We spend money like a drunken sailor on shore leave.”

Many medical advances, of course, have saved lives and eased suffering for millions of people. Screening tests like mammograms can lead to early treatment of breast cancer, especially for women with hereditary risk or a strong family history of the disease. For cancer patients who report back pain, MRIs can prove invaluable for spotting tumors that have metastasized to the bones, allowing doctors to intervene before it’s too late. The years between 1980 and 2004 saw a 50 percent decline in the death rate from coronary heart disease thanks to better treatments and drugs that reduce cholesterol and blood pressure. At least 7,300 lives are saved every year thanks to colonoscopies.

The dilemma, say a growing number of physicians and expert medical panels, is that some of this same health care that helps certain patients can, when offered to everyone else, be useless or even detrimental. Some of the most disturbing examples involve cardiology. At least five large, randomized controlled studies have analyzed treatments for stable heart patients who have nothing worse than mild chest pain. The studies compared invasive procedures including angioplasty, in which a surgeon mechanically widens a blocked blood vessel by crushing the fatty deposits called plaques; stenting, or propping open a vessel with wire mesh; and bypass surgery, grafting a new blood vessel onto a blocked one. Every study found that the surgical procedures didn’t improve survival rates or quality of life more than noninvasive treatments including drugs (beta blockers, cholesterol-lowering statins, and aspirin), exercise, and a healthy diet. They were, however, far more expensive: stenting costs Medicare more than $1.6 billion a year.

If that finding makes you scratch your head—how can propping open a narrowed blood vessel not be wonderfully effective?—you’re not alone. Many cardiologists had the same reaction when these studies were published. It turns out that the big blockages that show up on CT scans and other imaging, and that were long assumed to cause heart attacks, usually don’t—but treating them can. That’s because when you disrupt these blockages through surgery, you “spray a whole lot of debris down into the tiny blood vessels, which can trigger a heart attack or stroke,” says Nortin Hadler, a professor of medicine at the University of North Carolina, whose book on overtreatment in the elderly, Rethinking Aging, will be published next month. Many of the 500,000 elective angioplasties (at least $50,000 each) performed every year are done on patients who could benefit more from drugs, exercise, and healthy eating.

New technology has sometimes made the problem more acute. Where once arterial blockages were detected by chest X-ray, now doctors can use cardiac CT angiography, which shows the heart and coronary arteries in dramatic 3-D. When it was introduced a decade ago to screen for cardiovascular disease, it seemed almost miraculous: a 2005 cover of Time trumpeted that it could “stop a heart attack before it happens.” Difficult as it is to believe, however, there can be such a thing as too much information, especially from new imaging technology. “Our imaging and diagnostic tests are so good, we can see things we couldn’t see before,” says Lauer of the National Heart, Lung, and Blood Institute. “But our ability to understand what we’re seeing and to know if we should intervene hasn’t kept up.”

In a recent study, John McEvoy, a heart specialist at Johns Hopkins Medical Institutions, and colleagues found that 1,000 low-risk patients who had CT angiography had no fewer heart attacks or deaths over the next 18 months than 1,000 patients who did not undergo the screening. But they did have more drugs, tests, and invasive procedures such as stenting, all of which carry a risk of side effects, surgical complications, and even death. The CT itself has a potential side effect: by exposing patients to high levels of radiation, it raises the risk of cancer. “Low-risk patients without symptoms don’t benefit from CT angiography,” says McEvoy, though high-risk patients with heart disease might.

The Cleveland Clinic’s Nissen has seen firsthand what happens when doctors, armed with too much information, perform what turn out to be unnecessary procedures. In 2009 a 52-year-old woman with chest pain underwent a cardiac CT at a community hospital. Neither her LDL (bad) cholesterol nor her C-reactive protein (another risk factor for heart disease) were elevated. But since the CT showed several coronary plaques, her physicians performed coronary angiography. Complications ensued, and the woman wound up undergoing more procedures, one of which tore an artery. She eventually went to the Cleveland Clinic for a heart transplant—not because she had heart disease when it all started, says Nissen, but because of the cascading interventions triggered by the CT.

Nissen regularly counsels asymptomatic, low-risk patients against having cardiac CT, echocardiograms, and even treadmill stress tests; studies show they produce many false positives, leading to risky interventions. Even a clean scan can lead to worse health, if it makes people believe they can eat whatever they want and stop exercising. “I’ve had colleagues gain weight after a negative heart scan,” apparently figuring they were home free, says UCSF’s Redberg.

Radiologists and other physicians who diagnose or treat back pain have their own version of the CT: it’s called magnetic resonance imaging, or MRI. Just as cardiac CT makes sense in principle, so does getting a high-resolution image of the spine if someone is suffering lower back pain with no clear cause. An MRI typically costs about $3,000 and is designed to spot everything from bulging discs to hairline fractures. Find any of those things, the logic goes, and you can treat the problem surgically. But there’s a fundamental flaw: clinical trials have shown that back surgery, including vertebroplasty (putting special cement on a tiny spinal fracture) and spinal fusion, is no more effective at alleviating ordinary pain than plain-old rest and mild exercise. But like any surgery, it carries risks. Last year the American College of Physicians warned that “routine imaging [for low back pain] is not associated with clinically meaningful benefits but can lead to harms.” That’s because the “abnormalities” seen in an MRI often have nothing to do with the back pain (people without pain have them, too), but seeing something on a scan makes a physician feel compelled to get rid of it. “There is a longstanding fallacy among physicians that if you find something different from what you perceive to be ‘normal,’ then it must be the cause of the patient’s problem,” says UNC’s Hadler.

Dr. James Goodwin, a geriatrician at the University of Texas Medical Branch, cites an extreme example of this fallacy in the case of a frail 84-year-old woman who was told by her gastroenterologist that it was time for another colonoscopy, just a few years after her last one showed no problems. She died when the procedure perforated her colon. Though this outcome is rare, the recommendation that led to the woman’s death is all too common, says Goodwin, even though expert groups advise against screening colonscopies for anyone over 75 or who has had a normal result within the past 10 years. He says he was dumbfounded when his elderly patients kept receiving “reminders” from their gastroenterologists telling them it was time for another colonoscopy—seven or five or even two years after their last normal one.

Both curious and concerned, Goodwin launched a study of Medicare patients. Fully 46 percent had a screening colonoscopy fewer than seven years after a negative one. Making matters worse, many of them were over 80.

Medical practice also suffers from a kind of mission creep: if a treatment works in severe disease, some doctors assume it will work in milder disease. But that is not necessarily so. Antidepressants, for instance, have been shown in randomized trials to help with severe depression but not with moderate or mild depression, yet are widely prescribed for those conditions. Drugs called proton pump inhibitors (PPIs) are effective against gastric reflux and rare esophageal diseases as well as some ulcers, but at least half, and possibly 70 percent, of the 113 million U.S. prescriptions for PPIs each year are for conditions they don’t help, such as run-of-the-mill stomachaches. PPIs can cause bone fractures, severe and hard-to-treat bacterial infections, and pneumonia. Millions of people are being put at risk unnecessarily, which is one reason treating adverse drug reactions costs the U.S. $200 billion a year.

Statins, common cholesterol-reducing drugs, may also not benefit some people who are taking them. Statins are proved to help people with both heart disease and high cholesterol, but not those with just high cholesterol. The drugs are nevertheless widely prescribed to patients who fit the latter description, despite adverse effects, such as severe muscle disease in up to 20 percent of patients. Similarly, cardiac resynchronization therapy, a special pacemaker that causes the right and left ventricles to beat in sync, can save the life of a patient with congestive heart failure whose ventricles are at least 150 milliseconds out of sync. Yet patients with a mistiming of 120-150 milliseconds are receiving the devices.

Low-tech tests should sometimes be avoided, too. In an Archives paper published this month, a panel of physicians, led by Brown’s Smith, announced its first list of tests and treatments that should be dropped altogether for certain patients and ailments: antibiotics for sinus infections, imaging for low back pain, osteoporosis screening for women under 65, and electrocardiograms and other cardiac screening in low-risk patients. Even blood panels for healthy adults made the list. Today’s comprehensive blood tests measure 15 or so enzymes, proteins, lipids, and the like. Yet by chance alone, if you test for 20 things, something will fall outside the bounds of “normal,” often due to simple lab error.

Many doctors don’t seem to be getting the message about useless and harmful health care. Medicare pays them more than $100 million a year for screening colonoscopies; some 40 percent are for people in whom they will almost certainly harm more than help. Arthroscopic knee surgery for osteoarthritis is performed about 650,000 times a year; studies show that it, too, is no more effective than placebo treatment, yet taxpayers and private insurers pay for it. And although several large studies, including the Occluded Artery Trial in 2006, have shown that inserting a stent to prop open a blocked artery more than 24 hours after a heart attack does not improve survival rates or reduce the risk of another coronary compared with drugs alone, the practice continues at a rate of 100,000 such procedures a year, estimate researchers led by Dr. Judith Hochman, a cardiologist at New York University. “We’re killing more people than we’re saving with these procedures,” says UT’s Goodwin. “It’s as simple as that.”

August 14, 2011 10:0am

Second opinion can give patient confidence about care

Consumer Reports Insights: Second opinion can give patient confidence about care

NYT, Tuesday, January 18, 2011; 12:00 AM

"About half of all Americans never seek a second opinion about a diagnosis, treatment, drug or operation, according to a 2005 Gallup poll. But if you want a second opinion, you needn't worry, says Orly Avitzur, medical adviser to Consumers Union.

Physicians are bound by a code of ethics to cooperate fully with patients seeking a second opinion, including sending records, prescriptions, test results, letters and photographs to other physicians. Any responsible doctor won't be insulted if you seek advice from another practitioner. In fact, if your doctor discourages you from seeking another opinion, you have even more reason to get one.

Here are six other reasons:

l You don't have confidence in your doctor. Avitzur found that patients are less likely to follow a course of treatment when it's prescribed by a doctor they don't trust anymore. She sends her own patients for second opinions when she knows she's not getting through to them. For example, a patient she strongly suspected had multiple sclerosis was clearly - and understandably - resisting the diagnosis. Because the disease might progress without treatment, Avitzur suggested the patient seek a second opinion from a specialist at a university medical center. It helped reassure her that medication was warranted, and she's now doing very well with treatment.

l You think there might be other treatments. If your doctor tells you there is only one course of action, it should raise a red flag. That's what happened to a physician who developed a painful kidney stone. His first doctor told him that if the stone didn't pass in a month, he could have a procedure in which it would be removed through an endoscopic tube. When he sought a second opinion at another medical center, he learned he was a good candidate for extracorporeal shock-wave lithotripsy, a less-invasive treatment that uses sound waves to pulverize the stone and allow it to pass. The first doctor hadn't even mentioned this idea, which may or may not have been related to the fact that his center didn't own a lithotripsy machine.

l Your doctor dismisses your concerns. One individual developed recurrent bouts of vertigo, but her family doctor said that nothing was wrong with her and that her symptoms were due to the stress of her mother's recent death. A second opinion uncovered an inner-ear disorder that promptly improved with vestibular rehabilitation therapy. You know your body best, and if your doctor doesn't take your symptoms seriously, see someone else.

l You're not getting better. This is the most common reason patients seek a second opinion. Medicine is as much an art as a science, so a fresh viewpoint might make all the difference if you're not recovering from an illness or surgery at the pace you expected. The amount of time a doctor spends with a new patient is two to four times as long as a follow-up visit, so not only will you get a new perspective but also more attention.

l Your doctor recommends surgery. An astute orthopedist recently asked Avitzur to see a woman with a foot drop (the inability to raise the front part of the foot) after another neurologist had referred her to him for surgery. She repeated the muscle and nerve tests and, as the orthopedist suspected, concluded that surgery was the wrong course of action. Anytime your doctor recommends elective surgery to correct such ills as back pain, cataracts, gallstones or a hernia, consider a second opinion.

l Your condition is uncommon. Some conditions are so rare that a primary-care physician encounters only one or two cases in a career. It's worthwhile to consult a doctor at a major medical center with expertise in cases like yours. You can find more information on rare diseases from the National Institutes of Health (https://rare diseases.info.nih.gov/gard) and from the National Organization for Rare Disorders (www.rarediseases.org)."

(c) Copyright 2010. Consumers Union of United States Inc.

As much as 90 percent of the published medical information that doctors rely on is flawed

Lies, Damned Lies, and Medical Science - Magazine - The Atlantic

"Much of what medical researchers conclude in their studies is misleading, exaggerated, or flat-out wrong. So why are doctors—to a striking extent—still drawing upon misinformation in their everyday practice? Dr. John Ioannidis has spent his career challenging his peers by exposing their bad science."

"...Though the results of drug studies often make newspaper headlines, you have to wonder whether they prove anything at all. Indeed, given the breadth of the potential problems raised at the meeting, can any medical-research studies be trusted?

That question has been central to Ioannidis’s career. He’s what’s known as a meta-researcher, and he’s become one of the world’s foremost experts on the credibility of medical research. He and his team have shown, again and again, and in many different ways, that much of what biomedical researchers conclude in published studies—conclusions that doctors keep in mind when they prescribe antibiotics or blood-pressure medication, or when they advise us to consume more fiber or less meat, or when they recommend surgery for heart disease or back pain—is misleading, exaggerated, and often flat-out wrong. He charges that as much as 90 percent of the published medical information that doctors rely on is flawed. His work has been widely accepted by the medical community; it has been published in the field’s top journals, where it is heavily cited; and he is a big draw at conferences. Given this exposure, and the fact that his work broadly targets everyone else’s work in medicine, as well as everything that physicians do and all the health advice we get, Ioannidis may be one of the most influential scientists alive. Yet for all his influence, he worries that the field of medical research is so pervasively flawed, and so riddled with conflicts of interest, that it might be chronically resistant to change—or even to publicly admitting that there’s a problem....

[Ioannidis] goes on to suggest that an obsession with winning funding has gone a long way toward weakening the reliability of medical research....

In poring over medical journals, he was struck by how many findings of all types were refuted by later findings....

And before long he discovered that the range of errors being committed was astonishing: from what questions researchers posed, to how they set up the studies, to which patients they recruited for the studies, to which measurements they took, to how they analyzed the data, to how they presented their results, to how particular studies came to be published in medical journals.

This array suggested a bigger, underlying dysfunction, and Ioannidis thought he knew what it was. “The studies were biased,” he says. “Sometimes they were overtly biased. Sometimes it was difficult to see the bias, but it was there.” Researchers headed into their studies wanting certain results—and, lo and behold, they were getting them. We think of the scientific process as being objective, rigorous, and even ruthless in separating out what is true from what we merely wish to be true, but in fact it’s easy to manipulate results, even unintentionally or unconsciously. “At every step in the process, there is room to distort results, a way to make a stronger claim or to select what is going to be concluded,” says Ioannidis. “There is an intellectual conflict of interest that pressures researchers to find whatever it is that is most likely to get them funded.”....

How should we choose among these dueling, high-profile nutritional findings? Ioannidis suggests a simple approach: ignore them all.

For starters, he explains, the odds are that in any large database of many nutritional and health factors, there will be a few apparent connections that are in fact merely flukes, not real health effects—it’s a bit like combing through long, random strings of letters and claiming there’s an important message in any words that happen to turn up. But even if a study managed to highlight a genuine health connection to some nutrient, you’re unlikely to benefit much from taking more of it, because we consume thousands of nutrients that act together as a sort of network, and changing intake of just one of them is bound to cause ripples throughout the network that are far too complex for these studies to detect, and that may be as likely to harm you as help you. Even if changing that one factor does bring on the claimed improvement, there’s still a good chance that it won’t do you much good in the long run, because these studies rarely go on long enough to track the decades-long course of disease and ultimately death....

“The odds that anything useful will survive from any of these studies are poor,” says Ioannidis—dismissing in a breath a good chunk of the research into which we sink about $100 billion a year in the United States alone.

And so it goes for all medical studies, he says. Indeed, nutritional studies aren’t the worst. Drug studies have the added corruptive force of financial conflict of interest....

Nature, the grande dame of science journals, stated in a 2006 editorial, “Scientists understand that peer review per se provides only a minimal assurance of quality, and that the public conception of peer review as a stamp of authentication is far from the truth.”...

Doctors may notice that their patients don’t seem to fare as well with certain treatments as the literature would lead them to expect, but the field is appropriately conditioned to subjugate such anecdotal evidence to study findings. Yet much, perhaps even most, of what doctors do has never been formally put to the test in credible studies, given that the need to do so became obvious to the field only in the 1990s, leaving it playing catch-up with a century or more of non-evidence-based medicine, and contributing to Ioannidis’s shockingly high estimate of the degree to which medical knowledge is flawed. That we’re not routinely made seriously ill by this shortfall, he argues, is due largely to the fact that most medical interventions and advice don’t address life-and-death situations, but rather aim to leave us marginally healthier or less unhealthy, so we usually neither gain nor risk all that much.

Medical research is not especially plagued with wrongness. Other meta-research experts have confirmed that similar issues distort research in all fields of science, from physics to economics (where the highly regarded economists J. Bradford DeLong and Kevin Lang once showed how a remarkably consistent paucity of strong evidence in published economics studies made it unlikely that any of them were right). And needless to say, things only get worse when it comes to the pop expertise that endlessly spews at us from diet, relationship, investment, and parenting gurus and pundits. But we expect more of scientists, and especially of medical scientists, given that we believe we are staking our lives on their results. The public hardly recognizes how bad a bet this is. The medical community itself might still be largely oblivious to the scope of the problem, if Ioannidis hadn’t forced a confrontation when he published his studies in 2005....

[His] bigger worry, he says, is that while his fellow researchers seem to be getting the message, he hasn’t necessarily forced anyone to do a better job. He fears he won’t in the end have done much to improve anyone’s health. “There may not be fierce objections to what I’m saying,” he explains. “But it’s difficult to change the way that everyday doctors, patients, and healthy people think and behave.”...

What [doctors are] not trained to do is to go back and look at the research papers that helped make these drugs the standard of care. “When you look the papers up, you often find the drugs didn’t even work better than a placebo. And no one tested how they worked in combination with the other drugs,” she says. “Just taking the patient off everything can improve their health right away.” But not only is checking out the research another time-consuming task, patients often don’t even like it when they’re taken off their drugs, she explains; they find their prescriptions reassuring.

In fact, the question of whether the problems with medical research should be broadcast to the public is a sticky one in the meta-research community. Already feeling that they’re fighting to keep patients from turning to alternative medical treatments such as homeopathy, or misdiagnosing themselves on the Internet, or simply neglecting medical treatment altogether, many researchers and physicians aren’t eager to provide even more reason to be skeptical of what doctors do—not to mention how public disenchantment with medicine could affect research funding. Ioannidis dismisses these concerns. “If we don’t tell the public about these problems, then we’re no better than nonscientists who falsely claim they can heal,” he says. “If the drugs don’t work and we’re not sure how to treat something, why should we claim differently? Some fear that there may be less funding because we stop claiming we can prove we have miraculous treatments. But if we can’t really provide those miracles, how long will we be able to fool the public anyway? The scientific enterprise is probably the most fantastic achievement in human history, but that doesn’t mean we have a right to overstate what we’re accomplishing.”...

But as long as careers remain contingent on producing a stream of research that’s dressed up to seem more right than it is, scientists will keep delivering exactly that.

“Science is a noble endeavor, but it’s also a low-yield endeavor,” he says. “I’m not sure that more than a very small percentage of medical research is ever likely to lead to major improvements in clinical outcomes and quality of life. We should be very comfortable with that fact.” "

Doctors have long resisted having science guide their practice

Why Doctors Hate Science | Sharon Begley | Newsweek.com:

"Doctors have long resisted having science guide their practice. That's obvious from the disparity in clinical practices from one region of the U.S. to another, as The Dartmouth Atlas of Health Care has been finding since the early 1990s. Rates of coronary-bypass surgery among Medicare patients in McAllen, Texas, are five times those in Pueblo, Colo. Rates of back surgery in Casper, Wyo., are six times those in Honolulu and the Bronx. From one city to another, the frequency of visits to specialists varies more than fivefold. Yet elderly people in Casper don't have worse back pain than those in the Bronx, and those in Texas aren't suffering occluded arteries at higher rates than those in Colorado. Instead, the enormous disparity in how doctors in different regions treat the same condition reflects medical culture, not medical science."

The simple choices that we make in our lifestyle can be as powerful as drugs and surgery

Deepak Chopra et. al.: 'Alternative' Medicine Is Mainstream - WSJ.com:

By Deepak Chopra, Dean Ornish, Rustum Roy and Andrew Weil

"...if we want to make affordable health care available to the 45 million Americans who do not have health insurance, then we need to address the fundamental causes of health and illness, and provide incentives for healthy ways of living rather than reimbursing only drugs and surgery.

Heart disease, diabetes, prostate cancer, breast cancer and obesity account for 75% of health-care costs, and yet these are largely preventable and even reversible by changing diet and lifestyle....

The latest scientific studies show that our bodies have a remarkable capacity to begin healing, and much more quickly than we had once realized, if we address the lifestyle factors that often cause these chronic diseases. These studies show that integrative medicine can make a powerful difference in our health and well-being, how quickly these changes may occur, and how dynamic these mechanisms can be.

Many people tend to think of breakthroughs in medicine as a new drug, laser or high-tech surgical procedure. They often have a hard time believing that the simple choices that we make in our lifestyle -- what we eat, how we respond to stress, whether or not we smoke cigarettes, how much exercise we get, and the quality of our relationships and social support -- can be as powerful as drugs and surgery. But they often are. And in many instances, they're even more powerful....

Our "health-care system" is primarily a disease-care system. Last year, $2.1 trillion was spent in the U.S. on medical care, or 16.5% of the gross national product. Of these trillions, 95 cents of every dollar was spent to treat disease after it had already occurred. At least 75% of these costs were spent on treating chronic diseases, such as heart disease and diabetes, that are preventable or even reversible....

The disease that accounts for more premature deaths and costs Americans more than any other illness is almost completely preventable simply by changing diet and lifestyle. And the same lifestyle changes that can prevent or even reverse heart disease also help prevent or reverse many other chronic diseases as well....

It's time to move past the debate of alternative medicine versus traditional medicine, and to focus on what works, what doesn't, for whom, and under which circumstances...."

Dr. Chopra, the author of more than 50 books on the mind, body and spirit, is guest faculty at Beth Israel Hospital/Harvard Medical School. Dr. Ornish is clinical professor of medicine at the University of California, San Francisco. Mr. Roy is professor emeritus of materials science at Pennsylvania State University. Dr. Weil is director of the University of Arizona Center for Integrative Medicine.

Better Final Days

Better Final Days

By Shannon Brownlee, New America Foundation
Los Angeles Times | November 26, 2005

Whenever Americans stop to think about how they want to die, most conclude that they don't want to spend their last days in a hospital bed. They don't want to be stuck in an intensive care unit unnecessarily, or hooked up to machines if they can possibly avoid it. And they do not want a lot of tests and procedures, especially painful ones, if undergoing them won't improve their chances of surviving -- or at least make their passing a little easier.

But that's exactly the sort of high-tech death thousands of elderly patients with chronic illnesses are suffering, depending on which hospital they find themselves in during the last two years of life. A landmark study, published by a team of Dartmouth University researchers in the journal Health Affairs last week, looked at the care received by Medicare recipients who died in 226 California hospitals between 1999 and 2003.

The study found huge variations in the amount of care being delivered in different hospitals to similar, chronically ill patients. Let's look first at UCLA Medical Center, a hospital that is renowned for its geriatric services. The average Medicare recipient who died there spent 19 days in the hospital during the last two years of life, 11 of them in the ICU. He saw a doctor in the hospital 52 times, and Medicare paid $71,922 for his care.

At Garfield Medical Center in Monterey Park, the average patient fared worse: He spent 23 days in the hospital, saw a doctor a whopping 92 times and cost Medicare $106,254.

But if that same patient had lived instead near UC Davis, he would have been hospitalized for just over 11 days, been in the ICU for about seven days and seen one-quarter the number of doctors for a cost to Medicare of $55,323.

Did the extra care make these chronically ill patients live longer or better? Probably not, according to a previous study by the Dartmouth team. That study, published in 2003 in the Annals of Internal Medicine, concluded that Medicare patients in higher-spending regions "receive more care than those in lower-spending regions but do not have better health outcomes."

Hospitals will correctly argue that there's no way to know ahead of time which patients are likely to recover with aggressive treatment and which are in their last few months of life. And academic medical centers such as UCLA will say they provide more care because they attract sicker patients.

But are the hospitals that are spending the most any better at helping patients get well? Most patients would agree that all those days in the hospital, doctor visits and often unpleasant tests and treatments would be worth it if it actually made a difference in the quality and length of their lives. But a growing body of research suggests that it does not. And more spending does not mean that hospitals are better at delivering proven treatments, like pneumonia vaccines or beta blockers for patients admitted to the hospital with a heart attack. In fact, patients in hospitals delivering the most intensive care were often less likely to get tests and treatments that are known to work, according to the latest California study as well as previous research.

What's more, winding up in those intensive-care hospitals may actually increase a patient's chances of dying by as much as 2% to 6%. That's because hospitals, for all their power to deliver lifesaving treatments, can also be dangerous places where every drug, every treatment, every test carries the risk of error and harm.

Americans have come to believe that more healthcare equals better health. But what these studies show is that's not always true. And as anybody who has spent time in an ICU can tell you, a lot of treatment for terminal conditions can certainly make a misery of a patient's final few weeks of life.

Certainly hospitals such as Garfield and UCLA, and the doctors who work in them, generally don't think they are delivering excess care--or that they are failing to provide needed care. But doctors and hospitals are paid more for doing more, not for doing better. They often profit from giving excess care and lose money when they provide some kinds of care that really makes a difference, such as monitoring a heart failure patient once he goes home.

Those who study healthcare also note that the supply of medical resources -- not how sick the patients are -- often determines what care patients get. The more beds a hospital has, the more patients will be hospitalized, and the more MRI machines a hospital buys, the more scans will be ordered. And as much as Americans like being able to see their specialists, having more specialists involved can complicate care.

How can this problem be fixed? Patients and their distraught families cannot possibly be expected to decide what kind of care is appropriate. It's up to insurers, Medicare and Congress to restructure the financial incentives to make sure that good care pays.

Whenever payers begin talking about cutting costs, Americans begin worrying about rationing. It would be rationing if hospitals or insurers were to withhold effective care in order to save money. This isn't about denying elderly patients treatment that could help them; it's about not inflicting expensive treatments that aren't likely to improve or substantially prolong their lives.

Before Americans broach the topic of rationing, we ought first to make our hospitals deliver better care more efficiently. If every hospital in the country were to hit the benchmark of those that keep unneeded care down and quality up, it would reduce Medicare costs by 30%.

The Dartmouth group is working on a similar study of hospitals across the nation. Acting on its findings could go a long way toward averting the fiscal train wreck that is facing Medicare in the next 50 years, when costs are projected to rise to $2.67 trillion. It might also make the end of life a little easier for millions of Americans.

Read the entire article at the original source

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.

Read article at the original source

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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